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Moradi I, Mustafa MS, Sardar Sheikh J, Shojai Rahnama B, Fredericks M, Kumar Yennam A, Arain M, Saha U, Richard Ma A, Nagendran A, Bin Omer M, Armaghan M, Jaimes DCC, Avinash Bojanki NLSV, Shafique MA. Comparative effectiveness of transcatheter vs surgical aortic valve replacement: A systematic review and meta-analysis. World J Cardiol 2025; 17:104168. [PMID: 40308627 PMCID: PMC12038701 DOI: 10.4330/wjc.v17.i4.104168] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2024] [Revised: 03/14/2025] [Accepted: 03/28/2025] [Indexed: 04/21/2025] Open
Abstract
BACKGROUND The management of severe symptomatic aortic stenosis has been revolutionized by transcatheter aortic valve replacement (TAVR), offering a minimally invasive alternative to surgical aortic valve replacement (SAVR). However, the comparative safety and efficacy of these interventions remain subjects of ongoing investigation. AIM To compare the clinical outcomes and safety of TAVR vs SAVR in patients with severe symptomatic aortic stenosis. METHODS A systematic review and meta-analysis were conducted according to PRISMA guidelines. Randomized controlled trials (RCTs) comparing TAVR and SAVR were identified from databases including PubMed, Scopus, and Web of Science up to May 31, 2024. Data were extracted on clinical outcomes, including mortality, procedural complications, and post-procedure adverse events. Risk ratios (RRs) with 95%CIs were calculated using a random-effects model. RESULTS A total of 10 RCTs were included. TAVR demonstrated a significantly lower risk of acute kidney injury (RR: 0.33; 95%CI: 0.25-0.44), major bleeding (RR: 0.37; 95%CI: 0.30-0.46), and new-onset atrial fibrillation (RR: 0.44; 95%CI: 0.34-0.57) compared to SAVR. However, TAVR was associated with higher risks of new permanent pacemaker implantation (RR: 3.49; 95%CI: 2.77-4.39), major vascular complications (RR: 2.47; 95%CI: 1.91-3.21), and paravalvular leaks (RR: 4.15; 95%CI: 3.14-5.48). Mortality at 30 days was comparable (RR: 0.95; 95%CI: 0.78-1.15), but long-term mortality was slightly higher with TAVR in some analyses (RR: 1.23; 95%CI: 1.01-1.49). Rates of stroke (RR: 0.97; 95%CI: 0.81-1.17) and myocardial infarction (RR: 0.91; 95%CI: 0.67-1.24) were similar between the groups. CONCLUSION TAVR offers a less invasive option with significant benefits in reducing acute kidney injury, major bleeding, and new-onset atrial fibrillation, making it particularly advantageous for high-risk surgical candidates. However, higher risks of permanent pacemaker implantation, vascular complications, and paravalvular leaks highlight the need for individualized patient selection and shared decision-making to optimize outcomes.
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Affiliation(s)
- Iman Moradi
- Department of Medicine, Saint George's University, Grenada 0000, Grenada
| | | | - Jannat Sardar Sheikh
- Department of Medicine, CMH Lahore Medical College and Institute of Dentistry, Lahore 54810, Punjab, Pakistan
| | | | - Matthew Fredericks
- Department of Medicine, Saint George's University, Grenada 0000, Grenada
| | - Anil Kumar Yennam
- Department of Medicine, Emilio Aguinaldo College, Manila 4100, Philippines
| | - Mustafa Arain
- Department of Medicine, Dow University of Health Sciences, Karachi 75500, Pakistan
| | - Utsow Saha
- Department of Medicine, Icahn School of Medicine at Mount Sinai Queens, New York, NY 11432, United States
| | - Andrew Richard Ma
- Department of Medicine, Saint George's University, Grenada 0000, Grenada
| | - Adithya Nagendran
- Department of Medicine, Rochester Regional Health-Unity Hospital, Rochester, NY 14617, United States
| | - Moosa Bin Omer
- Department of Medicine, CMH Lahore Medical College and Institute of Dentistry, Lahore 54810, Punjab, Pakistan
| | - Muhammad Armaghan
- Department of Medicine, CMH Lahore Medical College and Institute of Dentistry, Lahore 54810, Punjab, Pakistan
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Schonberg MA, Stout NK, Stein S, Corey M, Jushchyshyn J, Shah R, Wolfson E, Mandelblatt JS, Montori VM, Richman I, Matlock D, Schechter CB, Harris R, LeStage B, Jayasekera J, Schoenborn NL. Creating a Mammography Conversation Aid for Shared Decision-Making Between Clinicians and Women Aged 75 and Older. J Am Geriatr Soc 2025. [PMID: 40231782 DOI: 10.1111/jgs.19466] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2025] [Revised: 03/11/2025] [Accepted: 03/16/2025] [Indexed: 04/16/2025]
Abstract
BACKGROUND Guidelines recommend primary care practitioners ("PCPs") engage women ≥ 75 years in shared decision-making (SDM) around mammography screening. Therefore, we aimed to develop a web-based conversation aid about mammography screening for women ≥ 75 using output from established simulation models to provide screening outcomes based on > 23,000 combinations of individual women's health and breast cancer risk factors. METHODS We used an end-user centered design approach to develop a prototype web-based conversation aid incorporating feedback. From July 2023 to April 2024, 10 PCPs from a Boston-area health system and a safety-net hospital used the prototype aid during encounters with women ≥ 75 without breast cancer or dementia (n = 30; 1-5 patients per PCP). We observed aid use and assessed clinician effort to involve patients in SDM using OPTION5 (assesses five components of SDM, scores range 0-100). We surveyed PCPs and patients about the aid's acceptability. Patients completed the SDM-process scale (scores range 0-4) to rate the SDM quality experienced. Participants' comments were subject to thematic analysis. RESULTS Of 10 PCP-participants, seven were female and four were community-based. Of 30 patient-participants, 22 (73%) were non-Hispanic White, 9 (30%) had ≥ 2 Charlson comorbidities and mean age was 78.5 years (SD 2.8). Nine PCPs agreed that the aid helped them with SDM and was easy-to-use; six felt it had too much information; and seven planned to continue using the aid. Patients rated the SDM-process highly (scores = 3.0 [SD 0.9]) and we observed high SDM (mean OPTION5 = 77.9 [SD 20.6]). Participants felt the aid was "empowering" and "helpful for decision-making." After SDM discussions, seven patients intended to stop screening, nine to screen less frequently, and 14 to continue screening regularly. CONCLUSIONS We developed a novel conversation aid that supports SDM about mammography screening with women ≥ 75 years. Lessons learned will guide revisions of a final tool for testing in a clinical trial.
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Affiliation(s)
- Mara A Schonberg
- Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Natasha K Stout
- Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA
| | - Sarah Stein
- Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Healthcare Institute, Boston, Massachusetts, USA
| | - Matthew Corey
- Division of General Medicine and Geriatrics, Department of Medicine, Cambridge Health Alliance, Cambridge, Massachusetts, USA
| | - Jessica Jushchyshyn
- Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Ria Shah
- Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Emily Wolfson
- Division of General Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Jeanne S Mandelblatt
- Department of Oncology, Georgetown University Medical Center and Institute for Cancer and Aging Research (I-CARE) and Cancer Prevention and Control Program at Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA
| | - Victor M Montori
- Knowledge and Evaluation Research Unit and Division of Endocrinology, Diabetes, Metabolism, Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA
| | - Ilana Richman
- Division of General Internal Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut, USA
| | - Daniel Matlock
- Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA
- VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, Colorado, USA
| | - Clyde B Schechter
- Department of Family and Social Medicine and Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, USA
| | - Russell Harris
- Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
| | - Barbara LeStage
- Patient Advocate Committee, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
| | - Jinani Jayasekera
- Health Equity and Decision Sciences Research Lab, Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, Maryland, USA
| | - Nancy L Schoenborn
- Division of Geriatric Medicine and Gerontology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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3
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Brand A, Hornig C, Crayen C, Hamann A, Martineck S, Leistner DM, Dreger H, Sündermann S, Unbehaun A, Sherif M, Haghikia A, Bischoff S, Lueg J, Kühnle Y, Paul O, Squier S, Stangl K, Falk V, Landmesser U, Stangl V. Medical graphics to improve patient understanding and anxiety in elderly and cognitively impaired patients scheduled for transcatheter aortic valve implantation (TAVI). Clin Res Cardiol 2025; 114:302-312. [PMID: 38117299 PMCID: PMC11914359 DOI: 10.1007/s00392-023-02352-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2023] [Accepted: 11/29/2023] [Indexed: 12/21/2023]
Abstract
BACKGROUND Anxiety and limited patient comprehension may pose significant barriers when informing elderly patients about complex procedures such as transcatheter aortic valve implantation (TAVI). OBJECTIVES We aimed to evaluate the utility of medical graphics to improve the patient informed consent (IC) before TAVI. METHODS In this prospective, randomized dual center study, 301 patients were assigned to a patient brochure containing medical graphics (Comic group, n = 153) or sham information (Control group, n = 148) on top of usual IC. Primary outcomes were patient understanding of central IC-related aspects and periprocedural anxiety assessed by the validated Spielberger State Trait Anxiety Inventory (STAI), both analyzed by cognitive status according to the Montreal Cognitive Assessment (MoCA). RESULTS Patient understanding was significantly higher in the Comic group [mean number of correct answers 12.8 (SD 1.2) vs. 11.3 (1.8); mean difference 1.5 (95% CI 1.2-1.8); p < 0.001]. This effect was more pronounced in the presence of cognitive dysfunction (MoCA < 26) [12.6 (1.2) in the Comic vs. 10.9 (1.6) in the Control group; mean difference 1.8 (1.4-2.2), p < 0.001]. Mean STAI score declined by 5.7 (95% CI 5.1-6.3; p < 0.001) in the Comic and 0.8 points (0.2-1.4; p = 0.015) in the Control group. Finally, mean STAI score decreased in the Comic group by 4.7 (3.8-5.6) in cognitively impaired patients and by 6.6 (95% CI 5.8 to 7.5) in patients with normal cognitive function (p < 0.001 each). CONCLUSIONS Our results prove beneficial effects for using medical graphics to inform elderly patients about TAVI by improving patient understanding and reducing periprocedural anxiety (DRKS00021661; 23/Oct/2020).
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Affiliation(s)
- A Brand
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany.
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany.
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany.
| | - C Hornig
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany
| | - C Crayen
- Department of Education and Psychology, Freie Universität Berlin, Habelschwerdter Allee 45, 14195, Berlin, Germany
| | - A Hamann
- Mintwissen-Science Communication Agency and Publishing House, Paulusstr. 11, 40237, Düsseldorf, Germany
| | | | - D M Leistner
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
- Department of Cardiology, Angiology and Intensive Care Medicine, Goethe University Hospital, Universitäres Herz- und Gefässzentrum Frankfurt, Frankfurt am Main, 60590, Frankfurt, Germany
- DZHK (German Centre for Cardiovascular Research), partner site Rhein-Main, Munich, Germany
| | - H Dreger
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
| | - S Sündermann
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
- Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité, Berlin, Germany
| | - A Unbehaun
- Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité, Berlin, Germany
| | - M Sherif
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany
| | - A Haghikia
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
| | - S Bischoff
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany
| | - J Lueg
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany
| | - Y Kühnle
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany
| | - O Paul
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany
| | - S Squier
- Brill Professor Emeritus of English and Women's, Gender and Sexuality Studies, The Pennsylvania State University, University Park, PA, 16802, USA
| | - K Stangl
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany
| | - V Falk
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
- Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum der Charité, Berlin, Germany
| | - U Landmesser
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Benjamin Franklin, Berlin, Germany
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
| | - V Stangl
- Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Charité Mitte, Berlin, Germany
- DZHK (German Centre for Cardiovascular Research), partner Site Berlin, Berlin, Germany
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Gaur A, Al-Mohammad A, Warriner D. Current and future landscape of cardiogeriatrics. Future Cardiol 2024; 20:729-731. [PMID: 39508384 PMCID: PMC11622764 DOI: 10.1080/14796678.2024.2418761] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2024] [Accepted: 10/16/2024] [Indexed: 11/15/2024] Open
Affiliation(s)
- Akshay Gaur
- Department of Cardiology, Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Thorne Rd, Doncaster, UK, DN2 5LT
| | - Abdallah Al-Mohammad
- Department of Cardiology, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Herries Road, Sheffield, UK, S5 7AU
- Department of Infection, Immunity & Cardiovascular Disease, The University of Sheffield, Western Bank, Sheffield, UK, S10 2TN
| | - David Warriner
- Department of Cardiology, Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Thorne Rd, Doncaster, UK, DN2 5LT
- Department of Infection, Immunity & Cardiovascular Disease, The University of Sheffield, Western Bank, Sheffield, UK, S10 2TN
- Department of Adult Congenital Cardiology, Leeds General Infirmary,Leeds Teaching Hospitals NHS Trust, Great George St, Leeds, UK, LS1 3EX
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5
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Harris E, Benham A, Stephenson J, Conway D, Chong AY, Curtis H, Astin F. Patient decision aids for aortic stenosis and chronic coronary artery disease: a systematic review and meta-analysis. Eur J Cardiovasc Nurs 2024; 23:561-581. [PMID: 38147507 DOI: 10.1093/eurjcn/zvad138] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/24/2023] [Revised: 12/12/2023] [Accepted: 12/19/2023] [Indexed: 12/28/2023]
Abstract
AIMS Shared decision-making is recommended for patients considering treatment options for severe aortic stenosis (AS) and chronic coronary artery disease (CAD). This review aims to systematically identify and assess patient decision aids (PtDAs) for chronic CAD and AS and evaluate the international evidence on their effectiveness for improving the quality of decision-making. METHODS AND RESULTS Five databases (Cochrane, CINAHL, Embase, MEDLINE, and PsycInfo), clinical trial registers, and 30 PtDA repositories/websites were searched from 2006 to March 2023. Screening, data extraction, and quality assessments were completed independently by multiple reviewers. Meta-analyses were conducted using Stata statistical software. Eleven AS and 10 CAD PtDAs were identified; seven were less than 5 years old. Over half of the PtDAs were web based and the remainder paper based. One AS and two CAD PtDAs fully/partially achieved international PtDA quality criteria. Ten studies were included in the review; four reported on the development/evaluation of AS PtDAs and six on CAD PtDAs. Most studies were conducted in the USA with White, well-educated, English-speaking participants. No studies fulfilled all quality criteria for reporting PtDA development and evaluation. Meta-analyses found that PtDAs significantly increased patient knowledge compared with 'usual care' (mean difference: 0.620; 95% confidence interval 0.396-0.845, P < 0.001) but did not change decisional conflict. CONCLUSION Patients who use PtDAs when considering treatments for AS or chronic CAD are likely to be better informed than those who do not. Existing PtDAs may not meet the needs of people with low health literacy levels as they are rarely involved in their development. REGISTRATION PROSPERO: CRD42021264700.
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Affiliation(s)
- Emma Harris
- School of Health, Wellbeing and Social Care, Faculty of Wellbeing, Education and Language Studies, The Open University, Walton Hall, Kents Hill, Milton Keynes MK7 6AA, UK
| | - Alex Benham
- School of Human and Health Sciences, University of Huddersfield, Queensgate, Huddersfield HD1 3DH, UK
| | - John Stephenson
- School of Human and Health Sciences, University of Huddersfield, Queensgate, Huddersfield HD1 3DH, UK
| | - Dwayne Conway
- Department of Cardiology, Chesterman Wing, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield S5 7AU, UK
| | - Aun-Yeong Chong
- Department of Cardiology, University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario K1Y 4W7, Canada
| | - Helen Curtis
- The Library and Knowledge Service, Calderdale Royal Hospital, Calderdale and Huddersfield NHS Foundation Trust, Halifax HX3 0PW, UK
| | - Felicity Astin
- School of Health, Wellbeing and Social Care, Faculty of Wellbeing, Education and Language Studies, The Open University, Walton Hall, Kents Hill, Milton Keynes MK7 6AA, UK
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Godfrey S, Barnes A, Gao J, Sulistio MS, Katz JN, Chuzi S. Shared Decision-making in Palliative and End-of-life Care in the Cardiac Intensive Care Unit. US CARDIOLOGY REVIEW 2024; 18:e13. [PMID: 39494405 PMCID: PMC11526488 DOI: 10.15420/usc.2024.03] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2024] [Accepted: 04/29/2024] [Indexed: 11/05/2024] Open
Abstract
Patients and clinicians in the cardiac intensive care unit (CICU) are often tasked with making high-stakes decisions about aggressive or life- sustaining therapies. Shared decision-making (SDM), a collaborative process where patients and clinicians work together to make medical decisions that are aligned with a patient's goals and values, is therefore highly relevant in the CICU, especially in the context of palliative or end-of-life decisions. Despite its importance, there are barriers to optimal integration and implementation of SDM. This review describes the fundamentals and models of SDM, the role of SDM in the CICU, and evidence-based strategies to promote SDM in the CICU.
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Affiliation(s)
- Sarah Godfrey
- Division of Cardiology, University of Texas Southwestern Medical CenterDallas, TX
| | - Alexis Barnes
- Division of Cardiology, University of Pittsburgh Medical CenterPittsburgh, PA
| | - Jing Gao
- Department of Internal Medicine, Northwestern University Feinberg School of MedicineChicago, IL
| | - Melanie S Sulistio
- Division of Cardiology, University of Texas Southwestern Medical CenterDallas, TX
| | - Jason N Katz
- Division of Cardiology, NYU Grossman School of MedicineNew York, NY
| | - Sarah Chuzi
- Division of Cardiology, Northwestern University Feinberg School of MedicineChicago, IL
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Etiwy M, Flannery LD, Li SX, Morrison FJ, Kim J, Tanguturi VK, Fraccaro C, Coylewright M, Turchin A, Elmariah S, Wasfy JH. Examining lack of referrals to heart valve specialists as mechanisms of potential underutilization of aortic valve replacement. Am Heart J 2024; 274:54-64. [PMID: 38621577 DOI: 10.1016/j.ahj.2024.04.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/07/2024] [Revised: 03/29/2024] [Accepted: 04/11/2024] [Indexed: 04/17/2024]
Abstract
BACKGROUND Recent studies suggest that aortic valve replacement (AVR) remains underutilized. AIMS Investigate the potential role of non-referral to heart valve specialists (HVS) on AVR utilization. METHODS Patients with severe aortic stenosis (AS) between 2015 and 2018, who met class I indication for intervention, were identified. Baseline data and process-related parameters were collected to analyze referral predictors and evaluate outcomes. RESULTS Among 981 patients meeting criteria AVR, 790 patients (80.5%) were assessed by HVS within six months of index TTE. Factors linked to reduced referral included increasing age (OR: 0.95; 95% CI: 0.94-0.97; P < .001), unmarried status (OR: 0.59; 95% CI: 0.43-0.83; P = .002) and inpatient TTE (OR: 0.27; 95% CI: 0.19-0.38; P < .001). Conversely, higher hematocrit (OR: 1.13; 95% CI: 1.09-1.16; P < .001) and eGFR (OR: 1.01; 95% CI: 1.00-1.02; P = .003), mean aortic valve gradient (OR: 1.03; 95% CI: 1.01-1.04; P < .001) and preserved LVEF (OR: 1.59; 95% CI: 1.02-2.48; P = .04), were associated with increased referral likelihood. Moreover, patients assessed by HVS referral as a time-dependent covariate had a significantly lower two-year mortality risk than those who were not (aHR: 0.30; 95% CI: 0.23-0.39; P < .001). CONCLUSION A substantial proportion of severe AS patients meeting indications for AVR are not evaluated by HVS and experience markedly increased mortality. Further research is warranted to assess the efficacy of care delivery mechanisms, such as e-consults, and telemedicine, to improve access to HVS expertise.
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Affiliation(s)
- Muhammad Etiwy
- Department of Medicine, Division of Hospital Medicine, Dartmouth Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH; Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
| | - Laura D Flannery
- Department of Medicine, Division of Cardiology, OhioHealth Doctors Hospital, Columbus, OH
| | - Shawn X Li
- Department of Medicine, Division of Cardiology, The University of California San Francisco, CA
| | - Fritha J Morrison
- Department of Medicine, Division of Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
| | - Joonghee Kim
- Department of Medicine, Division of Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
| | - Varsha K Tanguturi
- Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
| | - Chiara Fraccaro
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy
| | - Megan Coylewright
- Erlanger Health System, University of Tennessee-Chattanooga, Chattanooga, TN
| | - Alexander Turchin
- Department of Medicine, Division of Endocrinology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
| | - Sammy Elmariah
- Department of Medicine, Division of Cardiology, The University of California San Francisco, CA,.
| | - Jason H Wasfy
- Department of Medicine, Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
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8
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Perpetua EM, Palmer R, Le VT, Al-Khatib SM, Beavers CJ, Beckman JA, Bozkurt B, Coylewright M, Lloyd Doherty C, Guibone KA, Hawkey M, Keegan PA, Kirkpatrick JN, Laperle J, Lauck SB, Levine G, Lindman BR, Mack MJ, Price AL, Strong S, Wyman JF, Youmans QR, Gulati M. JACC: Advances Expert Panel Perspective: Shared Decision-Making in Multidisciplinary Team-Based Cardiovascular Care. JACC. ADVANCES 2024; 3:100981. [PMID: 39130036 PMCID: PMC11312306 DOI: 10.1016/j.jacadv.2024.100981] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 09/07/2023] [Revised: 01/25/2024] [Accepted: 02/28/2024] [Indexed: 08/13/2024]
Abstract
Shared decision-making (SDM) and multidisciplinary team-based care delivery are recommended across several cardiology clinical practice guidelines. However, evidence for benefit and guidance on implementation are limited. Informed consent, the use of patient decision aids, or the documentation of these elements for governmental or societal agencies may be conflated as SDM. SDM is a bidirectional exchange between experts: patients are the experts on their goals, values, and preferences, and clinicians provide their expertise on clinical factors. In this Expert Panel perspective, we review the current state of SDM in team-based cardiovascular care and propose best practice recommendations for multidisciplinary team implementation of SDM.
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Affiliation(s)
- Elizabeth M. Perpetua
- Empath Health Services, Seattle, Washington, USA
- School of Nursing, Department of Biobehavioral Nursing and Informatics, University of Washington, Seattle, Washington, USA
| | - Roseanne Palmer
- Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA
| | - Viet T. Le
- Intermountain Health, Salt Lake City, Utah, USA
| | - Sana M. Al-Khatib
- Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA
| | - Craig J. Beavers
- University of Kentucky College of Pharmacy, Lexington, Kentucky, USA
| | - Joshua A. Beckman
- Southwestern Medical Center, University of Texas, Dallas, Texas, USA
| | | | | | | | | | - Marian Hawkey
- Hackensack University Medical Center, Heart and Vascular Hospital, Hackensack, New Jersey, USA
| | - Patricia A. Keegan
- Columbia University Irving Medical Center, Center of Interventional Therapy, New York, New York, USA
| | - James N. Kirkpatrick
- Emory Healthcare, Heart and Vascular, Atlanta, Georgia, USA
- Departments of Medicine and Bioethics and Humanities, Division of Cardiology, University of Washington, Seattle, Washington, USA
| | - Jessica Laperle
- Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, USA
| | - Sandra B. Lauck
- University of British Columbia, Vancouver, British Columbia, Canada
| | | | - Brian R. Lindman
- Vanderbilt University Medical Center, Division of Cardiovascular Medicine, Nashville, Tennessee, USA
| | | | | | | | - Janet F. Wyman
- Department of Structural Heart, Division of Cardiovascular Medicine, Henry Ford health System, Detroit, Michigan, USA
| | - Quentin R. Youmans
- Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
| | - Martha Gulati
- Preventive Cardiology, Barbra Streisand Women's Heart Center, Preventive and Cardiac Rehabilitation Center, Women's Cardiovascular Medicine & Research, Smidt Heart Institute, Cedars Sinai Medical Center, Los Angeles, California, USA
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9
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Coylewright M, Otero D, Lindman BR, Levack MM, Horne A, Ngo LH, Beaudry M, Col HV, Col NF. An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study. PLoS One 2024; 19:e0302378. [PMID: 38771808 PMCID: PMC11108138 DOI: 10.1371/journal.pone.0302378] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2023] [Accepted: 04/02/2024] [Indexed: 05/23/2024] Open
Abstract
BACKGROUND Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. METHODS This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. RESULTS 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. CONCLUSIONS AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. TRIAL REGISTRATION Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.
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Affiliation(s)
- Megan Coylewright
- Department of Cardiovascular Medicine, University of Tennessee Health Science Center College of Medicine-Chattanooga, Chattanooga, Tennessee, United States of America
| | - Diana Otero
- Department of Cardiovascular Medicine, Columbia University Medical Center, New York, NY, United States of America
| | - Brian R. Lindman
- Structural Heart and Valve Center, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America
| | - Melissa M. Levack
- Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America
| | - Aaron Horne
- Department of Medicine, Summit Health, Berkeley Heights, NJ, United States of America
| | - Long H. Ngo
- Harvard Medical School, Boston, Massachusetts, United States of America
| | - Melissa Beaudry
- Central Vermont Medical Center, Berlin, Vermont, United States of America
| | - Hannah V. Col
- Shared Decision Making Resources, Georgetown, ME and Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America
| | - Nananda F. Col
- Shared Decision Making Resources, Georgetown, ME and University of New England, Biddeford, Maine, United States of America
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10
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Pasceri V, Pelliccia F, Mehran R, Dangas G, Porto I, Radico F, Biancari F, D'Ascenzo F, Saia F, Luzi G, Bedogni F, Amat Santos IJ, De Marzo V, Dimagli A, Mäkikallio T, Stabile E, Blasco‐Turrión S, Testa L, Barbanti M, Tamburino C, Fabiocchi F, Chilmeran A, Conrotto F, Costa G, Stefanini G, Spaccarotella C, Macchione A, La Torre M, Bendandi F, Juvonen T, Wańha W, Wojakowski W, Benedetto U, Indolfi C, Hildick‐Smith D, Zimarino M. Risk Score for Prediction of Dialysis After Transcatheter Aortic Valve Replacement. J Am Heart Assoc 2024; 13:e032955. [PMID: 38533944 PMCID: PMC11179782 DOI: 10.1161/jaha.123.032955] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2023] [Accepted: 02/08/2024] [Indexed: 03/28/2024]
Abstract
BACKGROUND Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.
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Affiliation(s)
| | | | | | | | - Italo Porto
- Chair of Cardiovascular Disease, Department of Internal Medicine and SpecialtiesUniversity of GenoaItaly
- Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCSOspedale Policlinico San MartinoGenoaItaly
| | | | - Fausto Biancari
- Department of MedicineSouth Karelia Central Hospital, University of HelsinkiLappeenrantaFinland
| | - Fabrizio D'Ascenzo
- Department of Internal MedicineCittà della Salute e della ScienzaTurinItaly
| | - Francesco Saia
- Department of Cardiothoracic Vascular SurgeryUniversity HospitalBolognaItaly
| | - Giampaolo Luzi
- Cardiovascular DepartmentAzienda Ospedaliera Regionale “San Carlo”PotenzaItaly
| | - Francesco Bedogni
- Department of CardiologyIRCCS Policlinico San Donato, San Donato MilaneseMilanItaly
| | - Ignacio J. Amat Santos
- CIBERCV, Interventional CardiologyHospital Clínico Universitario de ValladolidValladolidSpain
| | - Vincenzo De Marzo
- Chair of Cardiovascular Disease, Department of Internal Medicine and SpecialtiesUniversity of GenoaItaly
- Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCSOspedale Policlinico San MartinoGenoaItaly
- Department of CardiologyASL2 AbruzzoChietiItaly
| | - Arnaldo Dimagli
- Department of Cardiothoracic SurgeryWeill Cornell MedicineNew YorkNY
| | - Timo Mäkikallio
- Department of MedicineSouth Karelia Central Hospital, University of HelsinkiLappeenrantaFinland
| | - Eugenio Stabile
- Cardiovascular DepartmentAzienda Ospedaliera Regionale “San Carlo”PotenzaItaly
| | - Sara Blasco‐Turrión
- CIBERCV, Interventional CardiologyHospital Clínico Universitario de ValladolidValladolidSpain
| | - Luca Testa
- Department of CardiologyIRCCS Policlinico San Donato, San Donato MilaneseMilanItaly
| | | | - Corrado Tamburino
- Division of CardiologyA.O.U. Policlinico “G. Rodolico—San Marco”CataniaItaly
| | - Franco Fabiocchi
- Centro Cardiologico Monzino, IRCCSMilanItaly
- Galeazzi‐Sant’Ambrogio Hospital, I.R.C.C.SMilanItaly
| | - Ahmed Chilmeran
- Department of CardiologyRoyal Sussex County HospitalBrightonUK
| | - Federico Conrotto
- Department of Internal MedicineCittà della Salute e della ScienzaTurinItaly
| | - Giuliano Costa
- Division of CardiologyA.O.U. Policlinico “G. Rodolico—San Marco”CataniaItaly
| | | | | | - Andrea Macchione
- Chair of Cardiovascular Disease, Department of Internal Medicine and SpecialtiesUniversity of GenoaItaly
- Cardiology Unit, Cardiothoracic and Vascular Department (DICATOV) IRCCSOspedale Policlinico San MartinoGenoaItaly
| | - Michele La Torre
- Department of Internal MedicineCittà della Salute e della ScienzaTurinItaly
| | - Francesco Bendandi
- Department of Cardiothoracic Vascular SurgeryUniversity HospitalBolognaItaly
| | - Tatu Juvonen
- Heart and Lung Center, Helsinki University Central HospitalUniversity of HelsinkiFinland
| | - Wojciech Wańha
- Division of Cardiology and Structural Heart DiseasesMedical University of SilesiaKatowicePoland
| | - Wojtek Wojakowski
- Division of Cardiology and Structural Heart DiseasesMedical University of SilesiaKatowicePoland
| | | | - Ciro Indolfi
- Division of CardiologyUniversity Magna GraeciaCatanzaroItaly
| | | | - Marco Zimarino
- Department of CardiologyASL2 AbruzzoChietiItaly
- Department of Neuroscience, Imaging and Clinical Sciences‘G. D’Annunzio’ University of Chieti‐PescaraItaly
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11
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Shi WY, Malarczyk A, Watson RA, Patel P, Newell P, Awtry J, McGurk S, Kaneko T. Impact of reintervention after index aortic valve replacement on the risk of subsequent mortality. JTCVS OPEN 2023; 16:93-102. [PMID: 38204628 PMCID: PMC10775045 DOI: 10.1016/j.xjon.2023.07.026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/12/2023] [Revised: 06/29/2023] [Accepted: 07/25/2023] [Indexed: 01/12/2024]
Abstract
Objectives The use of bioprosthetic aortic valve replacement (AVR) is inherently associated with a risk of structural valve degeneration (SVD) and the need for aortic valve (AV) reintervention. We sought to evaluate whether AV reintervention, in the form of repeat surgical AVR (SAVR) or valve-in-valve transcatheter aortic valve replacement (ViV-TAVR), negatively affects patients' subsequent long-term survival after index SAVR. Methods We identified patients who had undergone bioprosthetic SAVR from 2002 to 2017 at our institution. Median longitudinal follow-up after index SAVR was 7.3 years (10.9 years for those with and 7.2 years for those without AV reintervention), and median follow-up after AV reintervention was 1.9 years. Cox regression analyses using AV reintervention (re-SAVR and ViV-TAVR) as a time-varying covariate were used to determine the impact of reintervention on subsequent survival. Results Of 4167 patients who underwent index SAVR, 139 (3.3%) required AV reintervention for SVD, with re-SAVR being performed in 65 and ViV-TAVR in 74. Median age at the index SAVR was 73 years (interquartile range, 64-79 years), and 2541 (61%) were male. Overall, there were total of 1171 mortalities observed, of which 13 occurred after re-SAVR and 9 after ViV-TAVR. AV reintervention was associated with a greater risk of subsequent mortality compared with those patients who did not require AV reintervention (hazard ratio, 2.53; 95% confidence interval, 1.64-3.88, P < .001). This increased risk of subsequent mortality was more pronounced for those who received their index AVR when <65 years of age (hazard ratio, 5.60; 95% confidence interval, 2.57-12.22, P < .001) versus those ≥65 years (2.06, 1.21-3.52, P = .008). Direct comparison of survival between those who underwent re-SAVR versus ViV-TAVR showed 5-year survival to be comparable (re-SAVR: 74% vs ViV-TAVR: 80%, P = .67). Conclusions Among patients receiving bioprosthetic AVR, an AV reintervention for SVD is associated with an increased risk of subsequent mortality, regardless of re-SAVR or ViV-TAVR, and this risk is greater among younger patients. These findings should be balanced with individual preferences at index AVR in the context of patients' lifetime management of aortic stenosis.
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Affiliation(s)
- William Y. Shi
- Department of Cardiovascular Surgery, Northwell Health, New York, NY
| | | | - Ryan A. Watson
- Division of Cardiology, Allegheny Health Network, Pittsburgh, Pa
| | - Prem Patel
- Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, Mass
| | - Paige Newell
- Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, Mass
| | - Jake Awtry
- Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, Mass
| | - Siobhan McGurk
- Division of Cardiac Surgery, Brigham and Women’s Hospital, Boston, Mass
| | - Tsuyoshi Kaneko
- Division of Cardiothoracic Surgery, Barnes-Jewish Hospital, Washington University in St Louis, St Louis, Mo
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12
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Rosca A, Karzig-Roduner I, Kasper J, Rogger N, Drewniak D, Krones T. Shared decision making and advance care planning: a systematic literature review and novel decision-making model. BMC Med Ethics 2023; 24:64. [PMID: 37580704 PMCID: PMC10426137 DOI: 10.1186/s12910-023-00944-7] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2022] [Accepted: 08/02/2023] [Indexed: 08/16/2023] Open
Abstract
BACKGROUND AND AIMS Shared decision making (SDM) and advance care planning (ACP) are important evidence and ethics based concepts that can be translated in communication tools to aid the treatment decision-making process. Although both have been recommended in the care of patients with risks of complications, they have not yet been described as two components of one single process. In this paper we aim to (1) assess how SDM and ACP is being applied, choosing patients with aortic stenosis with high and moderate treatment complication risks such as bleeding or stroke as an example, and (2) propose a model to best combine the two concepts and integrate them in the care process. METHODS In order to assess how SDM and ACP is applied in usual care, we have performed a systematic literature review. The included studies have been analysed by means of thematic analysis as well as abductive reasoning to determine which SDM and ACP steps are applied as well as to propose a model of combining the two concepts into one process. RESULTS The search in Medline, Cinahl, Embase, Scopus, Web of science, Psychinfo and Cochrane revealed 15 studies. Eleven describe various steps of SDM while four studies discuss the documentation of goals of care. Based on the review results and existing evidence we propose a model that combines SDM and ACP in one process for a complete patient informed choice. CONCLUSION To be able to make informed choices about immediate and future care, patients should be engaged in both SDM and ACP decision-making processes. This allows for an iterative process in which each important decision-maker can share their expertise and concerns regarding the care planning and advance care planning. This would help to better structure and prioritize information while creating a trustful and respectful relationship between the participants. PROSPERO 2019. CRD42019124575.
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Affiliation(s)
- Ana Rosca
- Clinical ethics, Stadtspital Zürich, Birmensdorferstrasse 497, Zürich, 8063, Switzerland.
| | - Isabelle Karzig-Roduner
- Institute of Biomedical Ethics and History of Medicine, Clinical Ethics, University of Zürich, University Hospital Zürich, Zürich, Switzerland
| | - Jürgen Kasper
- Department of Nursing and Health Promotion, Oslo metropolitan Universita, Oslo, Norway
| | - Niek Rogger
- University of Applied Sciences Leiden, Leiden, Netherlands
| | - Daniel Drewniak
- Institute of Biomedical Ethics and History of Medicine, University of Zürich, Zürich, Switzerland
| | - Tanja Krones
- Institute of Biomedical Ethics and History of Medicine, Clinical Ethics, University of Zürich, University Hospital Zürich, Zürich, Switzerland
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13
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Zheng H, Zhang D, Xiang W, Wu Y, Peng Z, Gan Y, Chen S. Interventions to Facilitate Shared Decision-Making Using Decision Aids with Coronary Heart Disease Patients: Systematic Review and Meta-Analysis. Rev Cardiovasc Med 2023; 24:246. [PMID: 39076712 PMCID: PMC11266786 DOI: 10.31083/j.rcm2408246] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2023] [Revised: 05/13/2023] [Accepted: 05/24/2023] [Indexed: 07/31/2024] Open
Abstract
Background Coronary heart disease (CHD) is the leading cause of death in the world. There are some decision-making conflicts in the management of chest pain, treatment methods, stent selection, and other aspects due to the unstable condition of CHD in the treatment stage. Although using decision aids to facilitate shared decision-making (SDM) contributes to high-quality decision-making, it has not been evaluated in the field of CHD. This review systematically assessed the effects of SDM in patients with CHD. Methods We conducted a systematic review and meta-analysis of randomized controlled trials of SDM interventions in patients with CHD from database inception to 1 June 2022 (PROSPERO [Unique identifier: CRD42022338938]). We searched for relevant studies in the PubMed, Embase, Cochrane Library, Web of Science, CNKI, and Wan Fang databases. The primary outcomes were knowledge and decision conflict. The secondary outcomes were satisfaction, patient participation, trust, acceptance, quality of life, and psychological condition. Results A total of 8244 studies were retrieved. After screening, ten studies were included in the analysis. Compared with the control group, SDM intervention with patient decision aids obviously improved patients' knowledge, decision satisfaction, participation, and medical outcomes and reduced decision-making conflict. There was no significant effect of SDM on trust. Conclusions This study showed that SDM intervention in the form of decision aids was beneficial to decision-making quality and treatment outcomes among patients with CHD. The results of SDM interventions need to be evaluated in different environments.
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Affiliation(s)
- Haoyang Zheng
- Department of Neurosurgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, Hubei, China
| | - Duo Zhang
- Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, Hubei, China
| | - Wei Xiang
- Department of Neurosurgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, Hubei, China
| | - Yuxi Wu
- Department of Neurosurgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, Hubei, China
| | - Zesheng Peng
- Department of Neurosurgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, Hubei, China
| | - Yong Gan
- Department of Social Medicine and Health Management, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, 430030 Wuhan, Hubei, China
| | - Shengcai Chen
- Department of Neurology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 Wuhan, Hubei, China
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14
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Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant 2023; 42:e1-e64. [PMID: 36805198 DOI: 10.1016/j.healun.2022.10.028] [Citation(s) in RCA: 39] [Impact Index Per Article: 19.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2022] [Accepted: 10/28/2022] [Indexed: 02/08/2023] Open
Affiliation(s)
- Alexander M Bernhardt
- Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.
| | - Hannah Copeland
- Department of Cardiac Surgery, Lutheran Health Physicians, Fort Wayne, Indiana
| | - Anita Deswal
- Department of Cardiology, University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Jason Gluck
- Heart and Vascular Institute, Hartford Hospital, Hartford, Connecticut
| | - Michael M Givertz
- Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
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15
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Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Card Fail 2023; 29:304-374. [PMID: 36754750 DOI: 10.1016/j.cardfail.2022.11.003] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Affiliation(s)
- Alexander M Bernhardt
- Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.
| | - Hannah Copeland
- Department of Cardiac Surgery, Lutheran Health Physicians, Fort Wayne, Indiana
| | - Anita Deswal
- Department of Cardiology, University of Texas MD Anderson Cancer Center, Houston, Texas
| | - Jason Gluck
- Heart and Vascular Institute, Hartford Hospital, Hartford, Connecticut
| | - Michael M Givertz
- Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
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16
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Batchelor WB, Anwaruddin S, Wang DD, Perpetua EM, Krishnaswami A, Velagapudi P, Wyman JF, Fullerton D, Keegan P, Phillips A, Ross L, Maini B, Bernacki G, Panjrath GS, Lee J, Geske JB, Welt F, Thakker PD, Deswal A, Park K, Mack MJ, Leon M, Lewis S, Holmes D. The Multidisciplinary Heart Team in Cardiovascular Medicine: Current Role and Future Challenges. JACC. ADVANCES 2023; 2:100160. [PMID: 38939019 PMCID: PMC11198656 DOI: 10.1016/j.jacadv.2022.100160] [Citation(s) in RCA: 18] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 08/23/2022] [Accepted: 10/17/2022] [Indexed: 06/29/2024]
Abstract
Cardiovascular multidisciplinary heart teams (MDHTs) have evolved significantly over the past decade. These teams play a central role in the treatment of a wide array of cardiovascular diseases affecting interventional cardiology, cardiac surgery, interventional imaging, advanced heart failure, adult congenital heart disease, cardio-oncology, and cardio-obstetrics. To meet the specific needs of both patients and heart programs, the composition and function of cardiovascular MDHTs have had to adapt and evolve. Although lessons have been learned from multidisciplinary cancer care, best practices for the operation of cardiovascular MDHTs have yet to be defined, and the evidence base supporting their effectiveness is limited. This expert panel review discusses the history and evolution of cardiovascular MDHTs, their composition and role in treating patients across a broad spectrum of disciplines, basic tenets for successful operation, and the future challenges facing them.
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Affiliation(s)
- Wayne B. Batchelor
- ACC Interventional Cardiology Section Leadership Council, Inova Heart and Vascular Institute, Falls Church, Virginia, USA
| | - Saif Anwaruddin
- Division of Cardiology, ACC Interventional Section Leadership Council, St. Vincent Hospital, Worcester, Massachusetts, USA
| | - Dee Dee Wang
- ACC Cardiovascular Imaging Section Leadership Council, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan, USA
| | - Elizabeth M. Perpetua
- ACC Cardiovascular Team Section Leadership Council, Empath Health Services, Seattle, Washington, USA
- Seattle Pacific University, School of Health Sciences and School of Nursing, Seattle, Washington, USA
| | - Ashok Krishnaswami
- Division of Cardiology, ACC Geriatric Cardiology Section Leadership Council, Kaiser Permanente San Jose Medical Center, San Jose, California, USA
- Division of Geriatrics, Stanford University School of Medicine, Stanford, California, USA
| | - Poonam Velagapudi
- Division of Cardiology, ACC Early Career Professionals Section Leadership Council, University of Nebraska Medical Center, Omaha, Nebraska, USA
| | - Janet F. Wyman
- ACC Cardiovascular Team Section Leadership Council, Center for Structural Heart Disease, Henry Ford Health System, Detroit, Michigan, USA
| | - David Fullerton
- Division of Cardiothoracic Surgery, Department of Surgery, ACC Cardiac Surgery Team Section Leadership Council, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Patricia Keegan
- Division of Cardiology, ACC Cardiovascular Team Section Leadership Council, Emory Structural Heart and Valve Center, Emory University Hospital Midtown, Atlanta, Georgia, USA
| | - Alistair Phillips
- ACC Cardiac Surgery Team Section Leadership Council, The Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Laura Ross
- ACC Interventional Cardiology Section Leadership Council, Park Nicollet Heart and Vascular Center, St. Louis Park, Massachusetts, USA
| | - Brij Maini
- Charles E. Schmidt College of Medicine, Florida Atlantic University, Delray Medical Center, Delray Beach, Florida, USA
| | - Gwen Bernacki
- Cardiovascular Division, Department of Medicine, ACC Geriatric Section Leadership Council, Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA
- Veterans Administration of Puget Sound, University of Washington School of Medicine, Seattle, Washington, USA
| | - Gurusher S. Panjrath
- ACC Heart Failure and Transplant Section Leadership Council, George Washington University School of Medicine and Health Sciences, Washington, DC, USA
| | - James Lee
- ACC Cardiovascular Imaging Section Leadership Council, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan, USA
| | - Jeffrey B. Geske
- Department of Cardiovascular Medicine, ACC Cardiovascular Imaging Section Leadership Council, Mayo Clinic, Rochester, Minnesota, USA
| | - Fred Welt
- Division of Cardiovascular Medicine, ACC Interventional Cardiology Leadership Council, University of Utah Health Sciences Center, Salt Lake City, Utah, USA
| | - Prashanth D. Thakker
- Cardiovascular Division, Department of Medicine, ACC Fellows in Training Section Leadership Council, Washington University, Saint Louis, Missouri, USA
| | - Anita Deswal
- Division of Internal Medicine, Department of Cardiology, ACC Cardio-Oncology Leadership Council, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
| | - Ki Park
- Division of Cardiovascular Medicine, ACC Interventional Cardiology Section Leadership Council, University of Florida College of Medicine, Malcom Randall VA Medical Center, Gainesville, Florida, USA
| | - Michael J. Mack
- Division of Cardiothoracic Surgery, Department of Surgery, ACC Cardiac Surgery Team Section Leadership Council, Baylor Scott and White Health, Dallas, Texas, USA
| | - Martin Leon
- Division of Cardiology, Department of Medicine, ACC Leon Center Leadership Council, Columbia University Irving Medical Center, New York, New York, USA
| | - Sandra Lewis
- ACC Section Steering Committee, Legacy Medical Group Cardiology, Portland, Oregon, USA
| | - David Holmes
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA
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Lachonius M, Wallström S, Odell A, Pétursson P, Jeppsson A, Skoglund K, Nielsen SJ. Patients' motivation to undergo transcatheter aortic valve replacement. A phenomenological hermeneutic study. Int J Older People Nurs 2023; 18:e12521. [PMID: 36464490 PMCID: PMC10078399 DOI: 10.1111/opn.12521] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/26/2022] [Revised: 08/08/2022] [Accepted: 11/17/2022] [Indexed: 12/08/2022]
Abstract
BACKGROUND Aortic stenosis is the most common valvular disease, and its prevalence is increasing due to the ageing population. Transcatheter aortic valve replacement (TAVR) is the recommended method when treating frail, older patients. Knowledge of what motivates older patients to undergo TAVR is important, in order to meet patients' expectations. OBJECTIVE The study aimed to explore the meaning of older patients' motivation to undergo TAVR. DESIGN AND METHODS The design was a qualitative study, analysed using a phenomenological hermeneutic approach. In-depth, semi-structured interviews with open-ended questions were conducted. Participants were selected from a specialist cardiology clinic in Sweden. Eighteen patients, six women and twelve men, aged 66-92, were recruited. RESULTS The analysis showed that patients who had agreed to undergo TAVR were deeply affected by their body's failure. Before the TAVR procedure, the participants were limited in their daily activities and experienced that their life was on hold. They experienced that they were barely existing. They were aware of their life-threatening condition and were forced to confront death. Yet despite an advanced age, they still had considerable zest for life. It was very important to them to remain independent in everyday life, and fear of becoming dependent had a strong impact on their motivations for undergoing TAVR. CONCLUSION Older patients' motivations to undergo TAVR are strongly influenced by their fear of being dependent on others and their zest for life. Health care professionals need to support these patients in setting realistic and personalised goals. IMPLICATION FOR PRACTICE Person-centered care actions could facilitate patients' involvement in the decision about TAVR and strenghten patients' beliefs in their own capabilities, before and after TAVR.
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Affiliation(s)
- Maria Lachonius
- Department of Molecular and Clinical Medicine, Sahlgrenska AcademyGothenburg UniversityGothenburgSweden
- Department of CardiologySahlgrenska University HospitalGothenburgSweden
| | - Sara Wallström
- Institute of Health and Care SciencesUniversity of GothenburgGothenburgSweden
- Center for Person‐Centered Care (GPCC)University of GothenburgGothenburgSweden
- Department of Forensic PsychiatrySahlgrenska University HospitalGothenburgSweden
| | - Annika Odell
- Department of CardiologySahlgrenska University HospitalGothenburgSweden
- Institute of Health and Care SciencesUniversity of GothenburgGothenburgSweden
| | - Pétur Pétursson
- Department of Molecular and Clinical Medicine, Sahlgrenska AcademyGothenburg UniversityGothenburgSweden
- Department of CardiologySahlgrenska University HospitalGothenburgSweden
| | - Anders Jeppsson
- Department of Molecular and Clinical Medicine, Sahlgrenska AcademyGothenburg UniversityGothenburgSweden
- Department of Cardiothoracic SurgerySahlgrenska University HospitalGothenburgSweden
| | - Kristofer Skoglund
- Department of Molecular and Clinical Medicine, Sahlgrenska AcademyGothenburg UniversityGothenburgSweden
- Department of CardiologySahlgrenska University HospitalGothenburgSweden
| | - Susanne J. Nielsen
- Department of Molecular and Clinical Medicine, Sahlgrenska AcademyGothenburg UniversityGothenburgSweden
- Department of Cardiothoracic SurgerySahlgrenska University HospitalGothenburgSweden
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18
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Zhang D, Zhou Y, Liu J, Zhu L, Wu Q, Pan Y, Zheng Z, Zha Z, Zhang J, Chen Z. Application of patient decision aids in treatment selection of cardiac surgery patients: a scoping review. Heart Lung 2022; 56:76-85. [PMID: 35810676 DOI: 10.1016/j.hrtlng.2022.06.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2022] [Revised: 06/17/2022] [Accepted: 06/23/2022] [Indexed: 11/26/2022]
Abstract
BACKGROUND The choice of treatment is an unavoidable challenge faced in the day to day medical decision making pertaining to patients with organic heart disease. As a professional discipline, cardiac surgery focuses on creating and using the most advanced evidence-based patient decision aids (PtDAs) to achieve high-quality decision-making. OBJECTIVES To describe the basic situation, influencing factors, and the outcome of indicators of PtDAs among cardiac surgery patients. METHODS Seven electronic databases were systematically searched for relevant reviews on the application of PtDAs among cardiac surgery patients. The methodological framework proposed by Arskey and O'Malley was used to guide the scoping review. The extracted data was analyzed qualitatively and quantitatively. RESULTS After dual, blinded screening of titles and abstracts, 12 articles were included in the review. 10 were quantitative studies, 1 was a mixed study, 1 was a qualitative study. CONCLUSIONS Compared with the burden of heart disease and the huge evidence base, the application of PtDAs in cardiac surgery is obviously insufficient. The published literature mainly provide information about the factors to be solved from the perspective of researchers, and also summarize obstacle factors. This is the basis for the application and construction of PtDAs in cardiac surgery patients.
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Affiliation(s)
- Duo Zhang
- Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; School of Nursing, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yanrong Zhou
- Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
| | - Juan Liu
- Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Lisi Zhu
- Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Qiansheng Wu
- Department of Nursing, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Youmin Pan
- Division of Cardiothoracic and Vascular Surgery, Sino-Swiss Heart-Lung Transplantation Institute, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Zhi Zheng
- Division of Cardiothoracic and Vascular Surgery, Sino-Swiss Heart-Lung Transplantation Institute, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Zhengbiao Zha
- Division of Cardiothoracic and Vascular Surgery, Sino-Swiss Heart-Lung Transplantation Institute, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Jie Zhang
- Division of Cardiothoracic and Vascular Surgery, Sino-Swiss Heart-Lung Transplantation Institute, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
| | - Zelin Chen
- School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
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19
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Col NF, Otero D, Lindman BR, Horne A, Levack MM, Ngo L, Goodloe K, Strong S, Kaplan E, Beaudry M, Coylewright M. What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making. PLoS One 2022; 17:e0270209. [PMID: 35951553 PMCID: PMC9371337 DOI: 10.1371/journal.pone.0270209] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2021] [Accepted: 06/06/2022] [Indexed: 11/18/2022] Open
Abstract
Background
Guidelines recommend including the patient’s values and preferences when choosing treatment for severe aortic stenosis (sAS). However, little is known about what matters most to patients as they develop treatment preferences. Our objective was to identify, prioritize, and organize patient-reported goals and features of treatment for sAS.
Methods
This multi-center mixed-methods study conducted structured focus groups using the nominal group technique to identify patients’ most important treatment goals and features. Patients separately rated and grouped those items using card sorting techniques. Multidimensional scaling and hierarchical cluster analyses generated a cognitive map and clusters.
Results
51 adults with sAS and 3 caregivers with experience choosing treatment (age 36–92 years) were included. Participants were referred from multiple health centers across the U.S. and online. Eight nominal group meetings generated 32 unique treatment goals and 46 treatment features, which were grouped into 10 clusters of goals and 11 clusters of features. The most important clusters were: 1) trust in the healthcare team, 2) having good information about options, and 3) long-term outlook. Other clusters addressed the need for and urgency of treatment, being independent and active, overall health, quality of life, family and friends, recovery, homecare, and the process of decision-making.
Conclusions
These patient-reported items addressed the impact of the treatment decision on the lives of patients and their families from the time of decision-making through recovery, homecare, and beyond. Many attributes had not been previously reported for sAS. The goals and features that patients’ value, and the relative importance that they attach to them, differ from those reported in clinical trials and vary substantially from one individual to another. These findings are being used to design a shared decision-making tool to help patients and their clinicians choose a treatment that aligns with the patients’ priorities.
Trial registration
ClinicalTrials.gov, Trial ID: NCT04755426, Trial URL https://clinicaltrials.gov/ct2/show/NCT04755426.
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Affiliation(s)
- Nananda F. Col
- Shared Decision Making Resources, Georgetown, ME and University of New England, Biddeford, Maine, United States of America
- * E-mail:
| | - Diana Otero
- Department of Cardiovascular Medicine, University of Louisville School of Medicine, Louisville, Kentucky, United States of America
| | - Brian R. Lindman
- Structural Heart and Valve Center, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America
| | - Aaron Horne
- HeartCare Specialists, Medical City North Hills, North Richland Hills, Texas, United States of America
| | - Melissa M. Levack
- Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America
| | - Long Ngo
- Harvard Medical School, Boston, Massachusetts, United States of America
| | - Kimberly Goodloe
- American Heart Association Ambassador, Atlanta, Georgia, United States of America
| | - Susan Strong
- Heart Valve Voice US, Washington DC, United States of America
| | - Elvin Kaplan
- Patient Collaborator, Brownsville, Vermont, United States of America
| | - Melissa Beaudry
- Central Vermont Medical Center, Berlin, Vermont, United States of America
| | - Megan Coylewright
- Department of Cardiovascular Medicine, The Erlanger Heart and Lung Institute, Chattanooga, Tennessee, United States of America
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20
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Cocchieri R, van de Wetering B, van Tuijl S, Mousavi I, Riezebos R, de Mol B. At the Crossroads of Minimally Invasive Mitral Valve Surgery—Benching Single Hospital Experience to a National Registry: A Plea for Risk Management Technology. J Cardiovasc Dev Dis 2022; 9:jcdd9080261. [PMID: 36005425 PMCID: PMC9410306 DOI: 10.3390/jcdd9080261] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/27/2022] [Revised: 07/15/2022] [Accepted: 08/09/2022] [Indexed: 11/26/2022] Open
Abstract
Almost 30 years after the first endoscopic mitral valve repair, Minimally Invasive Mitral Valve Surgery (MIMVS) has become the standard at many institutions due to optimal clinical results and fast recovery. The question that arises is can already good results be further improved by an Institutional Risk Management Performance (IRMP) system in decreasing risks in minimally invasive mitral valve surgery (MIMVS)? As of yet, there are no reports on IRMP and learning systems in the literature. (2) Methods: We described and appraised our five-year single institutional experience with MIMVS in isolated valve surgery included in the Netherlands Heart Registry (NHR) and investigated root causes of high-impact complications. (3) Results: The 120-day and 12-month mortality were 1.1% and 1.9%, respectively, compared to the average of 4.3% and 5.3% reported in the NHR. The regurgitation rate was 1.4% compared to 5.2% nationwide. The few high-impact complications appeared not to be preventable. (4) Discussion: In MIMVS, freedom from major and minor complications is a strong indicator of an effective IRMP but remains concealed from physicians and patients, despite its relevance to shared decision making. Innovation adds to the complexity of MIMVS and challenges surgical competence. An IRMP system may detect and control new risks earlier. (5) Conclusion: An IRMP system contributes to an effective reduction of risks, pain and discomfort; provides relevant input for shared decision making; and warrants the safe introduction of new technology. Crossroads conclusions: investment in machine learning and AI for an effective IRMP system is recommended and the roles for commanding and operating surgeons should be considered.
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Affiliation(s)
- Riccardo Cocchieri
- Cardiothoracic Surgeon, OLVG Hospital, 1091 AC Amsterdam, The Netherlands
| | - Bertus van de Wetering
- Biomedical Engineer, LifeTec Group BV, 5611 ZS Eindhoven, The Netherlands
- Correspondence: (B.v.d.W.); (B.d.M.)
| | - Sjoerd van Tuijl
- Biomedical Engineer, LifeTec Group BV, 5611 ZS Eindhoven, The Netherlands
| | - Iman Mousavi
- Cardiothoracic Surgery Resident, OLVG Hospital, 1091 AC Amsterdam, The Netherlands
| | - Robert Riezebos
- Cardiologist, OLVG Hospital, 1091 AC Amsterdam, The Netherlands
| | - Bastian de Mol
- Department of Cardiothoracic Surgery, Amsterdam University Medical Center, 1105 AZ Amsterdam, The Netherlands
- Department of Biomedical Engineering, Eindhoven University of Technology, 5600 MB Eindhoven, The Netherlands
- Correspondence: (B.v.d.W.); (B.d.M.)
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21
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Khan S, Shi W, Kaneko T, Baron SJ. The Evolving Role of the Multidisciplinary Heart Team in Aortic Stenosis. US CARDIOLOGY REVIEW 2022; 16:e19. [PMID: 39600833 PMCID: PMC11588171 DOI: 10.15420/usc.2022.04] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2022] [Accepted: 05/15/2022] [Indexed: 11/04/2022] Open
Abstract
Transcatheter aortic valve replacement has transformed the paradigm of care for patients with severe aortic stenosis (AS). With transcatheter aortic valve replacement now commercially approved for AS patients of all surgical risk, clinical decision-making regarding the initial mode of valve replacement (e.g. surgical versus transcatheter) and prosthesis type has become even more complex. The updated American College of Cardiology/American Heart Association and European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on valvular heart disease offer a strong foundation from which to address the nuances of the treatment of AS; however, there remain several clinical scenarios for which evidence and thus definitive societal recommendations are lacking. As such, the heart team continues to play an invaluable role in the management of the AS patient by combining available scientific evidence, expertise across disciplines, and the patient's preferences to optimize individualized patient care and healthcare resource usage.
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Affiliation(s)
- Sahoor Khan
- Department of Cardiology, Lahey Hospital and Medical CenterBurlington, MA
| | - William Shi
- Department of Cardiac Surgery, Brigham and Women’s HospitalBoston, MA
| | - Tsuyoshi Kaneko
- Department of Cardiac Surgery, Brigham and Women’s HospitalBoston, MA
| | - Suzanne J Baron
- Department of Cardiology, Lahey Hospital and Medical CenterBurlington, MA
- Baim Institute for Clinical ResearchBoston, MA
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22
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Bittner M, Lyle-Edrosolo G. Aortic Stenosis in Elderly Populations: Measuring Value of Patient Shared Decision-Making for Transcatheter Aortic Valve Replacement (TAVR). Nurs Adm Q 2022; 46:266-269. [PMID: 35639533 DOI: 10.1097/naq.0000000000000532] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/15/2023]
Abstract
Previous Finance Matters columns in Nursing Administrative Quarterly have emphasized the importance of utilizing financial statements to build and promote a successful evidence-based business case. The latest column addressed return on investment substantiation to solidify the business case being presented. Given the current and future state of federal value-based payment models (where health care delivery providers will accept more downside risk for reimbursement), the cost-benefit and cost-effectiveness analyses can be useful measurements. This column defines utilization of cost-benefit analysis and cost-effectiveness analysis when framing the cost, value, and benefit of an innovative health care intervention.
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Affiliation(s)
- Mary Bittner
- Doctor Nursing Practice Programs, University of San Francisco, San Francisco, California (Dr Bittner); and Providence Saint John's Health Center, Santa Monica, California (Dr Lyle-Edrosolo)
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23
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Harris E, Conway D, Jimenez-Aranda A, Butts J, Hedley-Takhar P, Thomson R, Astin F. Development and user-testing of a digital patient decision aid to facilitate shared decision-making for people with stable angina. BMC Med Inform Decis Mak 2022; 22:143. [PMID: 35624456 PMCID: PMC9137092 DOI: 10.1186/s12911-022-01882-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/16/2022] [Accepted: 04/22/2022] [Indexed: 11/10/2022] Open
Abstract
Background Research shows that people with stable angina need decision support when considering elective treatments. Initial treatment is with medicines but patients may gain further benefit with invasive percutaneous coronary intervention (PCI). Choosing between these treatments can be challenging for patients because both confer similar benefits but have different risks. Patient decision aids (PtDAs) are evidence-based interventions that support shared decision-making (SDM) when making healthcare decisions. This study aimed to develop and user-test a digital patient decision aid (CONNECT) to facilitate SDM for people with stable angina considering invasive treatment with elective PCI. Methods A multi-phase study was conducted to develop and test CONNECT (COroNary aNgioplasty dECision Tool) using approaches recommended by the International Patient Decision Aid Standards Collaboration: (i) Steering Group assembled, (ii) review of clinical guidance, (iii) co-design workshops with patients and cardiology health professionals, (iv) first prototype developed and ‘alpha’ tested (semi-structured cognitive interviews and 12-item acceptability questionnaire) with patients, cardiologists and cardiac nurses, recruited from two hospitals in Northern England, and (v) final PtDA refined following iterative user-feedback. Quantitative data were analysed descriptively and qualitative data from the interviews analysed using deductive content analysis. Results CONNECT was developed and user-tested with 34 patients and 29 cardiology health professionals. Findings showed that CONNECT was generally acceptable, usable, comprehensible, and desirable. Participants suggested that CONNECT had the potential to improve care quality by personalising consultations and facilitating SDM and informed consent. Patient safety may be improved as CONNECT includes questions about symptom burden which can identify asymptomatic patients unlikely to benefit from PCI, as well as those who may need to be fast tracked because of worsening symptoms. Conclusions CONNECT is the first digital PtDA for people with stable angina considering elective PCI, developed in the UK using recommended processes and fulfilling international quality criteria. CONNECT shows promise as an approach to facilitate SDM and should be evaluated in a clinical trial. Further work is required to standardise the provision of probabilistic risk information for people considering elective PCI and to understand how CONNECT can be accessible to underserved communities. Supplementary Information The online version contains supplementary material available at 10.1186/s12911-022-01882-x.
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Affiliation(s)
- Emma Harris
- Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK
| | - Dwayne Conway
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
| | - Angel Jimenez-Aranda
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.,NIHR Devices for Dignity MedTech Co-Operative, Sheffield, UK
| | - Jeremy Butts
- Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, UK
| | - Philippa Hedley-Takhar
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.,NIHR Devices for Dignity MedTech Co-Operative, Sheffield, UK
| | - Richard Thomson
- Population Health Sciences Institute, Newcastle University, Newcastle, UK
| | - Felicity Astin
- Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK. .,Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, UK.
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24
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Picou K, Heard DG, Shah PB, Arnold SV. Exploring experiences associated with aortic stenosis diagnosis, treatment and life impact among middle-aged and older adults. J Am Assoc Nurse Pract 2022; 34:748-754. [PMID: 35394457 PMCID: PMC9048624 DOI: 10.1097/jxx.0000000000000714] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/14/2021] [Revised: 02/08/2022] [Accepted: 02/24/2022] [Indexed: 11/26/2022]
Abstract
BACKGROUND AND PURPOSE Although multiple studies have examined the clinical aspects of diagnosis, treatment, and management of patients with aortic stenosis (AS), limited data exist regarding patient experiences related to symptoms, diagnosis, treatment, and personal impacts of living with AS. METHODOLOGY Adults aged ≥40 years diagnosed with AS were recruited and separated into three cohorts: medically managed, surgical aortic valve replacement (SAVR), and transcatheter aortic valve implantation (TAVI). Forty-five semi-structured interviews were conducted (15 per treatment group) via teleconference using open-ended questions and probes. Interview recordings were transcribed, and inductive thematic analyses were conducted. RESULTS The majority of participants were male (55.6%), White (95.6%), and non-Hispanic (93.3%). Participants noting longer times to diagnosis also reported mild symptom onset and experiences of misdiagnoses. Participants described a strong reliance on their health care professionals (HCPs) to guide them through their treatment decisions, which were influenced by the effects of anticoagulation, future valve interventions, and recovery. Medically managed participants reported having to make lifestyle modifications to manage symptoms, while participants who underwent TAVI or SAVR reported positive sentiments in their ability to return to normal life following their treatment. CONCLUSIONS AND IMPLICATIONS Due to the varied experiences of AS patients, there is a need to improve patient resources to advance patient understanding and facilitate informed treatment decisions. Reported experiences also indicate a need for additional HCP education on early referral to a multidisciplinary heart valve team.
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Affiliation(s)
- Kylie Picou
- Data Science and Evaluation, American Heart Association, Dallas, Texas
| | - Debra G. Heard
- Data Science and Evaluation, American Heart Association, Dallas, Texas
| | - Pinak B. Shah
- Brigham and Women's Hospital, Heart and Vascular Center, Boston, Massachusetts
| | - Suzanne V. Arnold
- Saint Luke's Mid America Heart Institute and University of Missouri, Kansas City, Missouri
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25
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Valentine K, Marques F, Selberg A, Flannery L, Langer N, Inglessis I, Passeri J, Sundt T, Sepucha K, Elmariah S. Impact of Decision Aid on Decision-making of Patients With Severe Aortic Stenosis: Randomized Pilot Study. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2022; 1:100025. [PMID: 39132569 PMCID: PMC11308039 DOI: 10.1016/j.jscai.2022.100025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/20/2021] [Revised: 01/27/2022] [Accepted: 01/28/2022] [Indexed: 08/13/2024]
Abstract
Background Clinical guidelines recommend patients with aortic stenosis (AS) being considered for transcatheter aortic valve implantation or surgical aortic valve replacement to participate in shared decision-making (SDM) with a heart valve team (HVT). Data supporting these recommendations are limited. This project gathered data on feasibility and preliminary efficacy of a decision aid (DA) in decision-making for patients with severe AS deciding between transcatheter aortic valve implantation and surgical aortic valve replacement. Methods This institutional review board-approved randomized pilot trial assigned eligible patients to receive either the American College of Cardiology's DA for patients with AS or usual care. Patients were surveyed after their visit regarding knowledge, treatment-preference concordance, SDM (SDM process and CollaboRATE Scales), and decisional conflict. Patients were followed for 3 months to collect data on treatment received. Results Of 62 patients approached, 59 (95%) consented and participated. The average age of participants was 72 years, they were 100% white, and 32% of them were female. Intervention patients had higher knowledge scores (75.6 vs 65.5) and more frequently reported CollaboRATE top scores (67% vs 33%) than usual care patients. No other group comparisons reached significance. Patients who saw both members of the HVT before survey completion reported higher SDM process scores than those who saw only 1 specialist (3.1 vs 2.4). Conclusions The study exceeded enrollment targets, indicating feasibility. Results suggest the American College of Cardiology's DA improved patient knowledge and communication scores. Patients who met with both members of the HVT reported higher SDM. These observations highlight the importance of SDM and multidisciplinary HVT assessment in the management of severe AS.
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Affiliation(s)
- K.D. Valentine
- Department of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts
| | - Felisha Marques
- Department of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts
| | - Alexandra Selberg
- Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
| | - Laura Flannery
- Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
| | - Nathaniel Langer
- Division of Cardiac Surgery, Massachusetts General Hospital, Boston, Massachusetts
| | - Ignacio Inglessis
- Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
| | - Jonathan Passeri
- Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
| | - Thoralf Sundt
- Division of Cardiac Surgery, Massachusetts General Hospital, Boston, Massachusetts
| | - Karen Sepucha
- Department of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts
| | - Sammy Elmariah
- Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts
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26
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van Beek-Peeters JJAM, van der Meer JBL, Faes MC, de Vos AJBM, van Geldorp MWA, Van den Branden BJL, Pel-Littel RE, van der Meer NJM, Minkman MMN. Professionals' views on shared decision-making in severe aortic stenosis. Heart 2021; 108:558-564. [PMID: 34952859 DOI: 10.1136/heartjnl-2021-320194] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2021] [Accepted: 12/01/2021] [Indexed: 12/12/2022] Open
Abstract
OBJECTIVE To provide insight into professionals' perceptions of and experiences with shared decision-making (SDM) in the treatment of symptomatic patients with severe aortic stenosis (AS). METHODS A semistructured interview study was performed in the heart centres of academic and large teaching hospitals in the Netherlands between June and December 2020. Cardiothoracic surgeons, interventional cardiologists, nurse practitioners and physician assistants (n=21) involved in the decision-making process for treatment of severe AS were interviewed. An inductive thematic analysis was used to identify, analyse and report patterns in the data. RESULTS Four primary themes were generated: (1) the concept of SDM, (2) knowledge, (3) communication and interaction, and (4) implementation of SDM. Not all respondents considered patient participation as an element of SDM. They experienced a discrepancy between patients' wishes and treatment options. Respondents explained that not knowing patient preferences for health improvement hinders SDM and complicating patient characteristics for patient participation were perceived. A shared responsibility for improving SDM was suggested for patients and all professionals involved in the decision-making process for severe AS. CONCLUSIONS Professionals struggle to make highly complex treatment decisions part of SDM and to embed patients' expectations of treatment and patients' preferences. Additionally, organisational constraints complicate the SDM process. To ensure sustainable high-quality care, professionals should increase their awareness of patient participation in SDM, and collaboration in the pathway for decision-making in severe AS is required to support the documentation and availability of information according to the principles of SDM.
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Affiliation(s)
| | - Jop B L van der Meer
- Cardiothoracic Surgery, Amphia Hospital, Breda, The Netherlands.,Erasmus Medical Center, Rotterdam, The Netherlands
| | | | - Annemarie J B M de Vos
- Amphia Academy, Amphia Hospital, Breda, The Netherlands.,Academy of Nursing Science and Education, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands
| | | | | | - Ruth E Pel-Littel
- Vilans, Centre of Expertise for Long-term Care, Utrecht, The Netherlands
| | - Nardo J M van der Meer
- TIAS School for Business and Society, Tilburg University, Tilburg, The Netherlands.,Catharina Hospital, Eindhoven, The Netherlands
| | - Mirella M N Minkman
- Vilans, Centre of Expertise for Long-term Care, Utrecht, The Netherlands.,TIAS School for Business and Society, Tilburg University, Tilburg, The Netherlands
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Swift SL, Puehler T, Misso K, Lang SH, Forbes C, Kleijnen J, Danner M, Kuhn C, Haneya A, Seoudy H, Cremer J, Frey N, Lutter G, Wolff R, Scheibler F, Wehkamp K, Frank D. Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis: a systematic review and meta-analysis. BMJ Open 2021; 11:e054222. [PMID: 34873012 PMCID: PMC8650468 DOI: 10.1136/bmjopen-2021-054222] [Citation(s) in RCA: 31] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/21/2021] [Accepted: 10/26/2021] [Indexed: 12/14/2022] Open
Abstract
OBJECTIVES Patients undergoing surgery for severe aortic stenosis (SAS) can be treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). The choice of procedure depends on several factors, including the clinical judgement of the heart team and patient preferences, which are captured by actively informing and involving patients in a process of shared decision making (SDM). We synthesised the most up-to-date and accessible evidence on the benefits and risks that may be associated with TAVI versus SAVR to support SDM in this highly personalised decision-making process. DESIGN Systematic review and meta-analysis. DATA SOURCES MEDLINE (Ovid), Embase (Ovid) and the Cochrane Central Register of Controlled Trials (CENTRAL; Wiley) were searched from January 2000 to August 2020 with no language restrictions. Reference lists of included studies were searched to identify additional studies. ELIGIBILITY CRITERIA Randomised controlled trials (RCTs) that compared TAVI versus SAVR in patients with SAS and reported on all-cause or cardiovascular mortality, length of stay in intensive care unit or hospital, valve durability, rehospitalisation/reintervention, stroke (any stroke or major/disabling stroke), myocardial infarction, major vascular complications, major bleeding, permanent pacemaker (PPM) implantation, new-onset or worsening atrial fibrillation (NOW-AF), endocarditis, acute kidney injury (AKI), recovery time or pain were included. DATA EXTRACTION AND SYNTHESIS Two independent reviewers were involved in data extraction and risk of bias (ROB) assessment using the Cochrane tool (one reviewer extracted/assessed the data, and the second reviewer checked it). Dichotomous data were pooled using the Mantel-Haenszel method with random-effects to generate a risk ratio (RR) with 95% CI. Continuous data were pooled using the inverse-variance method with random-effects and expressed as a mean difference (MD) with 95% CI. Heterogeneity was assessed using the I2 statistic. RESULTS 8969 records were retrieved and nine RCTs (61 records) were ultimately included (n=8818 participants). Two RCTs recruited high-risk patients, two RCTs recruited intermediate-risk patients, two RCTs recruited low-risk patients, one RCT recruited high-risk (≥70 years) or any-risk (≥80 years) patients; and two RCTs recruited all-risk or 'operable' patients. While there was no overall change in the risk of dying from any cause (30 day: RR 0.89, 95% CI 0.65 to 1.22; ≤1 year: RR 0.90, 95% CI 0.79 to 1.03; 5 years: RR 1.09, 95% CI 0.98 to 1.22), cardiovascular mortality (30 day: RR 1.03, 95% CI 0.77 to 1.39; ≤1 year: RR 0.90, 95% CI 0.76 to 1.06; 2 years: RR 0.96, 95% CI 0.83 to 1.12), or any type of stroke (30 day: RR 0.83, 95% CI 0.61 to 1.14;≤1 year: RR 0.94, 95% CI 0.72 to 1.23; 5 years: RR 1.07, 95% CI 0.88 to 1.30), the risk of several clinical outcomes was significantly decreased (major bleeding, AKI, NOW-AF) or significantly increased (major vascular complications, PPM implantation) for TAVI vs SAVR. TAVI was associated with a significantly shorter hospital stay vs SAVR (MD -3.08 days, 95% CI -4.86 to -1.29; 4 RCTs, n=2758 participants). Subgroup analysis generally favoured TAVI patients receiving implantation via the transfemoral (TF) route (vs non-TF); receiving a balloon-expandable (vs self-expanding) valve; and those at low-intermediate risk (vs high risk). All RCTs were rated at high ROB, predominantly due to lack of blinding and selective reporting. CONCLUSIONS No overall change in the risk of death from any cause or cardiovascular mortality was identified but 95% CIs were often wide, indicating uncertainty. TAVI may reduce the risk of certain side effects while SAVR may reduce the risk of others. Most long-term (5-year) results are limited to older patients at high surgical risk (ie, early trials), therefore more data are required for low risk populations. Ultimately, neither surgical technique was considered dominant, and these results suggest that every patient with SAS should be individually engaged in SDM to make evidence-based, personalised decisions around their care based on the various benefits and risks associated with each treatment. PROSPERO REGISTRATION NUMBER CRD42019138171.
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Affiliation(s)
| | - Thomas Puehler
- Department of Cardiac and Vascular Surgery, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
- German Centre for Cardiovascular Research, Kiel, Germany
| | - Kate Misso
- Kleijnen Systematic Reviews Ltd, York, UK
| | | | | | | | - Marion Danner
- National Competency Center for Shared Decision Making, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Christian Kuhn
- German Centre for Cardiovascular Research, Kiel, Germany
- Department of Cardiology and Angiology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Assad Haneya
- Department of Cardiac and Vascular Surgery, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Hatim Seoudy
- German Centre for Cardiovascular Research, Kiel, Germany
- Department of Cardiology and Angiology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Jochen Cremer
- Department of Cardiac and Vascular Surgery, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Norbert Frey
- Department of Cardiology, Angiology, and Pneumology, University Hospital Heidelberg, Heidelberg, Germany
| | - Georg Lutter
- Department of Cardiac and Vascular Surgery, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
- German Centre for Cardiovascular Research, Kiel, Germany
| | | | - Fueloep Scheibler
- National Competency Center for Shared Decision Making, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Kai Wehkamp
- Department of Internal Medicine I, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
| | - Derk Frank
- German Centre for Cardiovascular Research, Kiel, Germany
- Department of Cardiology and Angiology, Universitätsklinikum Schleswig-Holstein, Kiel, Germany
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Jonik S, Marchel M, Pędzich-Placha E, Huczek Z, Kochman J, Ścisło P, Czub P, Wilimski R, Hendzel P, Opolski G, Grabowski M, Mazurek T. Heart Team for Optimal Management of Patients with Severe Aortic Stenosis-Long-Term Outcomes and Quality of Life from Tertiary Cardiovascular Care Center. J Clin Med 2021; 10:5408. [PMID: 34830690 PMCID: PMC8623928 DOI: 10.3390/jcm10225408] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2021] [Revised: 11/16/2021] [Accepted: 11/18/2021] [Indexed: 11/16/2022] Open
Abstract
BACKGROUND This retrospective study was proposed to investigate outcomes of patients with severe aortic stenosis (AS) after implementation of various treatment strategies following dedicated Heart Team (HT) decisions. METHODS Primary and secondary endpoints and quality of life during a median follow-up of 866 days of patients with severe AS qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and transcather aortic valve replacement (TAVR) or OMT and surgical aortic valve replacement (SAVR) were evaluated. As the primary endpoint composite of all-cause mortality, non-fatal disabling strokes and non-fatal rehospitalizations for AS were considered, while other clinical outcomes were determined as secondary endpoints. RESULTS From 2016 to 2019, 176 HT meetings were held, and a total of 482 participants with severe AS and completely implemented HT decisions (OMT, TAVR and SAVR for 79, 318 and 85, respectively) were included in the final analysis. SAVR and TAVR were found to be superior to OMT for primary and all secondary endpoints (p < 0.05). Comparing interventional strategies only, TAVR was associated with reduced risk of acute kidney injury, new onset of atrial fibrillation and major bleeding, while the superiority of SAVR for major vascular complications and need for permanent pacemaker implantation was observed (p < 0.05). The quality of life assessed at the end of follow-up was significantly better for patients who underwent TAVR or SAVR than in OMT-group (p < 0.05). CONCLUSIONS We demonstrated that after careful implementation of HT decisions interventional strategies compared to OMT only provide superior outcomes and quality of life for patients with AS.
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Affiliation(s)
- Szymon Jonik
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Michał Marchel
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Ewa Pędzich-Placha
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Zenon Huczek
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Janusz Kochman
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Piotr Ścisło
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Paweł Czub
- Department of Cardiac Surgery, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (P.C.); (R.W.); (P.H.)
| | - Radosław Wilimski
- Department of Cardiac Surgery, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (P.C.); (R.W.); (P.H.)
| | - Piotr Hendzel
- Department of Cardiac Surgery, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (P.C.); (R.W.); (P.H.)
| | - Grzegorz Opolski
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Marcin Grabowski
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
| | - Tomasz Mazurek
- 1st Department of Cardiology, Medical University of Warsaw, Banacha 1a Str., 01-267 Warsaw, Poland; (S.J.); (E.P.-P.); (Z.H.); (J.K.); (P.Ś.); (G.O.); (M.G.); (T.M.)
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29
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Ankolekar A, Dahl Steffensen K, Olling K, Dekker A, Wee L, Roumen C, Hasannejadasl H, Fijten R. Practitioners' views on shared decision-making implementation: A qualitative study. PLoS One 2021; 16:e0259844. [PMID: 34762683 PMCID: PMC8584754 DOI: 10.1371/journal.pone.0259844] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/13/2021] [Accepted: 10/28/2021] [Indexed: 12/15/2022] Open
Abstract
INTRODUCTION Shared decision-making (SDM) refers to the collaboration between patients and their healthcare providers to make clinical decisions based on evidence and patient preferences, often supported by patient decision aids (PDAs). This study explored practitioner experiences of SDM in a context where SDM has been successfully implemented. Specifically, we focused on practitioners' perceptions of SDM as a paradigm, factors influencing implementation success, and outcomes. METHODS We used a qualitative approach to examine the experiences and perceptions of 10 Danish practitioners at a cancer hospital experienced in SDM implementation. A semi-structured interview format was used and interviews were audio-recorded and transcribed. Data was analyzed through thematic analysis. RESULTS Prior to SDM implementation, participants had a range of attitudes from skeptical to receptive. Those with more direct long-term contact with patients (such as nurses) were more positive about the need for SDM. We identified four main factors that influenced SDM implementation success: raising awareness of SDM behaviors among clinicians through concrete measurements, supporting the formation of new habits through reinforcement mechanisms, increasing the flexibility of PDA delivery, and strong leadership. According to our participants, these factors were instrumental in overcoming initial skepticism and solidifying new SDM behaviors. Improvements to the clinical process were reported. Sustaining and transferring the knowledge gained to other contexts will require adapting measurement tools. CONCLUSIONS Applying SDM in clinical practice represents a major shift in mindset for clinicians. Designing SDM initiatives with an understanding of the underlying behavioral mechanisms may increase the probability of successful and sustained implementation.
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Affiliation(s)
- Anshu Ankolekar
- Department of Radiation Oncology (MAASTRO), GROW School for Oncology, Maastricht University Medical Centre+, Maastricht, The Netherlands
| | - Karina Dahl Steffensen
- Center for Shared Decision Making, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle, Denmark
- Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
- Department of Oncology, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle, Denmark
| | - Karina Olling
- Center for Shared Decision Making, Lillebaelt Hospital–University Hospital of Southern Denmark, Vejle, Denmark
| | - Andre Dekker
- Department of Radiation Oncology (MAASTRO), GROW School for Oncology, Maastricht University Medical Centre+, Maastricht, The Netherlands
| | - Leonard Wee
- Department of Radiation Oncology (MAASTRO), GROW School for Oncology, Maastricht University Medical Centre+, Maastricht, The Netherlands
| | - Cheryl Roumen
- Department of Radiation Oncology (MAASTRO), GROW School for Oncology, Maastricht University Medical Centre+, Maastricht, The Netherlands
| | - Hajar Hasannejadasl
- Department of Radiation Oncology (MAASTRO), GROW School for Oncology, Maastricht University Medical Centre+, Maastricht, The Netherlands
| | - Rianne Fijten
- Department of Radiation Oncology (MAASTRO), GROW School for Oncology, Maastricht University Medical Centre+, Maastricht, The Netherlands
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30
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Turkson-Ocran RAN, Ogunwole SM, Hines AL, Peterson PN. Shared Decision Making in Cardiovascular Patient Care to Address Cardiovascular Disease Disparities. J Am Heart Assoc 2021; 10:e018183. [PMID: 34612050 PMCID: PMC8751878 DOI: 10.1161/jaha.120.018183] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Affiliation(s)
| | - S Michelle Ogunwole
- Department of Medicine The Johns Hopkins University School of Medicine Baltimore MD.,The Johns Hopkins Center for Health Equity Baltimore MD
| | - Anika L Hines
- Department of Medicine The Johns Hopkins University School of Medicine Baltimore MD.,The Johns Hopkins Center for Health Equity Baltimore MD.,Department of Health Behavior and Policy Virginia Commonwealth University School of Medicine Richmond VA
| | - Pamela N Peterson
- Division of Cardiology University of Colorado, Anschutz Medical Campus Aurora CO.,Division of Cardiology Denver Health Medical Center Denver CO
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31
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Lauck SB, Baron SJ, Irish W, Borregaard B, Moore KA, Gunnarsson CL, Clancy S, Wood DA, Thourani VH, Webb JG, Wijeysundera HC. Temporal Changes in Mortality After Transcatheter and Surgical Aortic Valve Replacement: Retrospective Analysis of US Medicare Patients (2012-2019). J Am Heart Assoc 2021; 10:e021748. [PMID: 34581191 PMCID: PMC8751862 DOI: 10.1161/jaha.120.021748] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background The treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30‐day mortality, 30‐day readmission, and length of stay after TAVR and SAVR. Methods and Results We conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30‐day mortality; secondary end points were 30‐day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2‐way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7‐year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67–0.86]; 2016: HR, 0.39 [95% CI, 0.36–0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63–0.73]; 2016: HR, 0.43 [95% CI, 0.41–0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84–1.98]; 2019: HR, 5.34 [95% CI, 5.22–5.45]). These results were consistent in full aortic valve replacement hospitals. Conclusions The rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U‐shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long‐term implications of lowering risk profiles across treatment options to guide case selection and clinical care.
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Affiliation(s)
- Sandra B Lauck
- Centre for Heart Valve Innovation University of British Columbia Vancouver Canada
| | - Suzanne J Baron
- Department of Cardiology Lahey Hospital & Medical Center Burlington MA
| | - William Irish
- Department of Public Health Brody School of Medicine East Carolina University Greenville NC
| | - Britt Borregaard
- Department of Cardiology Odense University Hospital Odense Denmark
| | | | | | | | - David A Wood
- Centre for Heart Valve Innovation University of British Columbia Vancouver Canada
| | | | - John G Webb
- Centre for Heart Valve Innovation University of British Columbia Vancouver Canada
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32
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Tam DY, Miranda RN, Elbatarny M, Wijeysundera HC. Real-World Health-Economic Considerations Around Aortic-Valve Replacement in a Publicly Funded Health System. Can J Cardiol 2021; 37:992-1003. [PMID: 33940193 DOI: 10.1016/j.cjca.2020.11.015] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2020] [Revised: 11/25/2020] [Accepted: 11/27/2020] [Indexed: 11/24/2022] Open
Abstract
Herein, we describe the unique interplay among biomedical ethics, principles of distributive justice, and economic theory to highlight the role of health technology assessments to compare therapeutic options for aortic valve replacement. From the perspective of the Canadian health care system, transcatheter aortic-valve implantation is associated with higher costs but also higher incremental health benefits compared with surgical aortic-valve replacement. At current willingness to pay thresholds, transcatheter aortic-valve replacement is likely cost effective across the spectrum of risk, from inoperable patients to those at low surgical risk. However, we highlight the nuances within each subgroup of surgical risk that merit careful consideration by the heart team. Moreover, incorporation of patients and their preferences in decision-making is key. In particular, in young, low-risk patients, there remains uncertainty regarding the optimal treatment, with unique concerns around valve durability, selection of valve prosthesis, and consideration for special procedures such as the Ross procedure. Nonetheless, current research suggests that, universally, patients prefer a less invasive approach compared with a more invasive approach. Finally, we highlight that there remain critical issues around timeliness of access to care and unacceptable geographic inequities across Canada. Further research into alternative funding mechanisms and integrated cross-sector care pathways is necessary to address these issues.
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Affiliation(s)
- Derrick Y Tam
- Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
| | - Rafael Neves Miranda
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; ICES, Toronto, Ontario, Canada
| | - Malak Elbatarny
- Division of Cardiac Surgery, Department of Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
| | - Harindra C Wijeysundera
- Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Cardiology, Department of Medicine, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; ICES, Toronto, Ontario, Canada.
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33
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Lauck SB, Lewis KB, Borregaard B, de Sousa I. "What Is the Right Decision for Me?" Integrating Patient Perspectives Through Shared Decision-Making for Valvular Heart Disease Therapy. Can J Cardiol 2021; 37:1054-1063. [PMID: 33711478 DOI: 10.1016/j.cjca.2021.02.022] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2020] [Revised: 01/30/2021] [Accepted: 02/02/2021] [Indexed: 01/08/2023] Open
Abstract
Innovations in the treatment of valvular heart disease have transformed treatment options for people with valvular heart disease. In this rapidly evolving environment, the integration of patients' perspectives is essential to close the potential gap between what can be done and what patients want. Shared decision-making (SDM) and the measurement of patient-reported outcomes (PROs) are two strategies that are in keeping with this aim and gaining significant momentum in clinical practice, research, and health policy. SDM is a process that involves an individualised, intentional, and bidirectional exchange among patients, family, and health care providers that integrates patients' preferences, values, and priorities to reach a high-quality consensus treatment decision. SDM is widely endorsed by international valvular heart disease guidelines and increasingly integrated in health policy. Patient decision aids are evidence-based tools that facilitate SDM. The measurement of PROs-an umbrella term that refers to the standardised reporting of symptoms, health status, and other domains of health-related quality of life-provides unique data that come directly from patients to inform clinical practice and augment the reporting of quality of care. Sensitive and validated instruments are available to capture generic, dimensional, and disease-specific PROs in patients with valvular heart disease. The integration of PROs in clinical care presents significant opportunities to help guide treatment decision and monitor health status. The integration of patients' perspectives promotes the shift to patient-centred care and optimal outcomes, and contributes to transforming the way we care for patients with valvular heart disease.
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Affiliation(s)
- Sandra B Lauck
- St Paul's Hospital, Vancouver, British Columbia, Canada; School of Nursing, University of British Columbia, Vancouver, British Columbia, Canada.
| | - Krystina B Lewis
- Faculty of Health Sciences, University of Ottawa, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
| | - Britt Borregaard
- Department of Cardiology, Odense University Hospital, Odense, Denmark
| | - Ismalia de Sousa
- School of Nursing, University of British Columbia, Vancouver, British Columbia, Canada
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34
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Affiliation(s)
- Julian Yeoh
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
| | - Philip MacCarthy
- Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK
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35
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Wessler BS, Weintraub AR, Udelson JE, Kent DM. Can Clinical Predictive Models Identify Patients Who Should Not Receive TAVR? A Systematic Review. STRUCTURAL HEART-THE JOURNAL OF THE HEART TEAM 2020; 4:295-299. [PMID: 32905421 DOI: 10.1080/24748706.2020.1782549] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
Background One third of high- and prohibitive-risk TAVR patients remain severely symptomatic or die 1 year after treatment. There is interest in identifying individuals for whom this procedure is futile and should not be offered. Methods We performed a systematic review of the highest reported stratum of risk in TAVR clinical predictive models (CPMs). We explore whether currently available predictive models can identify patients for whom TAVR is futile, based on a quantitative futility definition and the observed and predicted outcomes for patients in the highest stratum of risk. Results 17 TAVR CPMs representing 69,191 treated patients were published from 2013 to 2018. When reported, the median number of patients in the highest stratum of risk was 569 (range 1 to 1759). Observed mortality for this risk stratum ranged from 9% at 30 days to 59% at 1 year after TAVR. Statistical confidence in these observed event rates was low. The highest predicted event rates ranged from 11.0% for in-hospital mortality to 75.1% for the composite of mortality or high symptom burden 1 year after TAVR. Conclusion No high-risk TAVR group in currently available TAVR CPMs had an appropriate event rate and adequate statistical power to meet a quantitative definition of futility.
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Affiliation(s)
- Benjamin S Wessler
- Division of Cardiology and the CardioVascular Center, Tufts Medical Center.,Predictive Analytics and Comparative Effectiveness (PACE) Center, Tufts Medical Center
| | - Andrew R Weintraub
- Division of Cardiology and the CardioVascular Center, Tufts Medical Center
| | - James E Udelson
- Division of Cardiology and the CardioVascular Center, Tufts Medical Center
| | - David M Kent
- Predictive Analytics and Comparative Effectiveness (PACE) Center, Tufts Medical Center
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36
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Lindman BR, Arnold SV, Bagur R, Clarke L, Coylewright M, Evans F, Hung J, Lauck SB, Peschin S, Sachdev V, Tate LM, Wasfy JH, Otto CM. Priorities for Patient-Centered Research in Valvular Heart Disease: A Report From the National Heart, Lung, and Blood Institute Working Group. J Am Heart Assoc 2020; 9:e015975. [PMID: 32326818 PMCID: PMC7428554 DOI: 10.1161/jaha.119.015975] [Citation(s) in RCA: 30] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
Over the past decade, the field of valvular heart disease (VHD) has rapidly transformed, largely as a result of the development and improvement of less invasive transcatheter approaches to valve repair or replacement. This transformation has been supported by numerous well-designed randomized trials, but they have centered almost entirely on devices and procedures. Outside this scope of focus, however, myriad aspects of therapy and management for patients with VHD have either no guidelines or recommendations based only on expert opinion and observational studies. Further, research in VHD has often failed to engage patients to inform study design and identify research questions of greatest importance and relevance from a patient perspective. Accordingly, the National Heart, Lung, and Blood Institute convened a Working Group on Patient-Centered Research in Valvular Heart Disease, composed of clinician and research experts and patient advocacy experts to identify gaps and barriers to research in VHD and identify research priorities. While recognizing that important research remains to be done to test the safety and efficacy of devices and procedures to treat VHD, we intentionally focused less attention on these areas of research as they are more commonly pursued and supported by industry. Herein, we present the patient-centered research gaps, barriers, and priorities in VHD and organized our report according to the "patient journey," including access to care, screening and diagnosis, preprocedure therapy and management, decision making when a procedure is contemplated (clinician and patient perspectives), and postprocedure therapy and management. It is hoped that this report will foster collaboration among diverse stakeholders and highlight for funding bodies the pressing patient-centered research gaps, opportunities, and priorities in VHD in order to produce impactful patient-centered research that will inform and improve patient-centered policy and care.
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Affiliation(s)
- Brian R Lindman
- Cardiovascular Medicine Division Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN
| | | | - Rodrigo Bagur
- Division of Cardiology University Hospital London Health Sciences Centre London Ontario Canada
| | | | - Megan Coylewright
- Heart and Vascular Center Dartmouth-Hitchcock Medical Center Lebanon NH
| | - Frank Evans
- National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda MD
| | - Judy Hung
- Cardiology Division Massachusetts General Hospital Harvard Medical School Boston MA
| | - Sandra B Lauck
- Centre for Heart Valve Innovation St. Paul's Hospital University of British Columbia Vancouver British Columbia Canada
| | | | - Vandana Sachdev
- National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda MD
| | | | - Jason H Wasfy
- Cardiology Division Massachusetts General Hospital Harvard Medical School Boston MA
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