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Robert P, Akodad M, Lattuca B, Gandet T, Meunier PA, Macia JC, Schmutz L, Steinecker M, Roubille F, Cayla G, Leclercq F. Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study. Catheter Cardiovasc Interv 2024; 104:97-104. [PMID: 38764290 DOI: 10.1002/ccd.31086] [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: 12/07/2023] [Revised: 04/05/2024] [Accepted: 05/08/2024] [Indexed: 05/21/2024]
Abstract
BACKGROUND The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.
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Affiliation(s)
- Pierre Robert
- Department of cardiology, Nimes University Hospital, Nimes, France
| | - Mariama Akodad
- Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France
| | - Benoit Lattuca
- Department of cardiology, Nimes University Hospital, Nimes, France
| | - Thomas Gandet
- Department of Cardiovascular Surgery, Montpellier University Hospital, Montpellier, France
| | | | | | - Laurent Schmutz
- Department of cardiology, Nimes University Hospital, Nimes, France
| | - Matthieu Steinecker
- Department of Cardiology, Montpellier University Hospital, Montpellier, France
| | - Francois Roubille
- Department of Cardiology, Montpellier University Hospital, Montpellier, France
| | - Guillaume Cayla
- Department of cardiology, Nimes University Hospital, Nimes, France
| | - Florence Leclercq
- Department of Cardiology, Montpellier University Hospital, Montpellier, France
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Jammoul N, Dupasquier V, Akodad M, Meunier PA, Moulis L, Soltani S, Macia JC, Robert P, Schmutz L, Steinecker M, Piot C, Targosz F, Benkemoun H, Lattuca B, Roubille F, Cayla G, Leclercq F. Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial. Am Heart J 2024; 270:13-22. [PMID: 38253304 DOI: 10.1016/j.ahj.2024.01.005] [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: 09/06/2023] [Revised: 01/14/2024] [Accepted: 01/15/2024] [Indexed: 01/24/2024]
Abstract
BACKGROUND Safety and feasibility of transcatheter aortic valve replacement (TAVR) without balloon aortic valvuloplasty (BAV) using the SAPIEN 3 balloon-expandable device has been previously demonstrated. The impact on long-term valve hemodynamic performances and outcomes remains however unknown. We evaluate long-term clinical and hemodynamic results according to the implant strategy (direct TAVR vs BAV pre-TAVR) in patients included in the DIRECTAVI randomized trial (NCT02729519). METHODS Clinical and echocardiographic follow-up until January 2023 was performed for all patients included in the DIRECTAVI trial since 2016 (n = 228). The primary endpoint was incidence of moderate/severe hemodynamic valve deterioration (HVD), according to the Valve Academic Research defined Consortium-3 criteria (increase in mean gradient ≥10 mmHg resulting in a final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade resulting in ≥ moderate aortic regurgitation). RESULTS Median follow-up was 3.8 (2.2-4.7) years. Mean age at follow-up was 87 ± 6.7 years. No difference in incidence of HVD in the direct implantation group compared to the BAV group was found (incidence of 1.97 per 100 person-years and 1.45 per 100 person-years, respectively, P = 0.6). Prevalence of predicted prothesis-patient mismatch was low (n = 13 [11.4%] in the direct TAVR group vs n = 15 [13.2%] in BAV group) and similar between both groups (P = .7). Major outcomes including death, stroke, hospitalization for heart failure and pacemaker implantation were similar between both groups, (P = .4, P = .7, P = .3, and P = .3 respectively). CONCLUSION Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up. These results guarantee wide use of direct balloon-expandable valve implantation, when feasible. CLINICAL TRIALS REGISTRATION NUMBER NCT05140317.
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Affiliation(s)
- Nidal Jammoul
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
| | - Valentin Dupasquier
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
| | - Mariama Akodad
- Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques-Cartier, Massy, France
| | - Pierre-Alain Meunier
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
| | - Lionel Moulis
- Epidemiological and Clinical Research Unit, CHU Montpellier, Montpellier, France.
| | - Sonia Soltani
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
| | - Jean-Christophe Macia
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
| | - Pierre Robert
- Department of cardiology, CHU Nimes, Montpellier University, Nimes, France
| | - Laurent Schmutz
- Department of cardiology, CHU Nimes, Montpellier University, Nimes, France
| | - Matthieu Steinecker
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
| | | | | | | | - Benoît Lattuca
- Department of cardiology, CHU Nimes, Montpellier University, Nimes, France
| | - François Roubille
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France
| | - Guillaume Cayla
- Department of cardiology, CHU Nimes, Montpellier University, Nimes, France
| | - Florence Leclercq
- Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.
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Beska B, Manoharan D, Mohammed A, Das R, Edwards R, Zaman A, Alkhalil M. Role of coronary angiogram before transcatheter aortic valve implantation. World J Cardiol 2021; 13:361-371. [PMID: 34589171 PMCID: PMC8436680 DOI: 10.4330/wjc.v13.i8.361] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/21/2021] [Revised: 05/26/2021] [Accepted: 07/16/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Coexistent coronary artery disease is commonly seen in patients undergoing transcatheter aortic valve implantation (TAVI). Previous studies showed that pre-TAVI coronary revascularisation was not associated with improved outcomes, challenging the clinical value of routine coronary angiogram (CA).
AIM To assess whether a selective approach to perform pre-TAVI CA is safe and feasible.
METHODS This was a retrospective non-randomised single-centre analysis of consecutive patients undergoing TAVI. A selective approach for performing CA tailored to patient clinical need was developed. Clinical outcomes were compared based on whether patients underwent CA. The primary endpoint was a composite of all-cause mortality, myocardial infraction, repeat CA, and re-admission with heart failure.
RESULTS Of 348 patients (average age 81 ± 7 and 57% male) were included with a median follow up of 19 (9-31) mo. One hundred and fifty-four (44%) patients, underwent CA before TAVI procedure. Patients who underwent CA were more likely to have previous myocardial infarction (MI) and previous percutaneous revascularisation. The primary endpoint was comparable between the two group (22.6% vs 22.2%; hazard ratio 1.05, 95%CI: 0.67-1.64, P = 0.82). Patients who had CA were less likely to be readmitted with heart failure (P = 0.022), but more likely to have repeat CA (P = 0.002) and MI (P = 0.007). In those who underwent CA, the presence of flow limiting lesions did not affect the incidence of primary endpoint, or its components, except for increased rate of repeat CA.
CONCLUSION Selective CA is a feasible and safe approach. The clinical value of routine CA should be challenged in future randomised trials
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Affiliation(s)
- Benjamin Beska
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
| | - Divya Manoharan
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
| | - Ashfaq Mohammed
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
| | - Rajiv Das
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
| | - Richard Edwards
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
| | - Azfar Zaman
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
| | - Mohammad Alkhalil
- Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, United Kingdom
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Role of coronary angiogram before transcatheter aortic valve implantation. World J Cardiol 2021. [DOI: 10.4330/wjc.v13.i8.362] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
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The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review. Int J Technol Assess Health Care 2020; 36:152-161. [DOI: 10.1017/s0266462320000100] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
BackgroundTranscatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.Materials and methodsA systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.ResultsA total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.ConclusionMany prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.
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Leclercq F, Robert P, Akodad M, Macia JC, Gandet T, Delseny D, Chettouh M, Schmutz L, Robert G, Levy G, Targosz F, Maupas E, Roubille F, Marin G, Nagot N, Albat B, Lattuca B, Cayla G. Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2020; 13:594-602. [DOI: 10.1016/j.jcin.2019.12.006] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/15/2019] [Revised: 11/06/2019] [Accepted: 12/03/2019] [Indexed: 10/24/2022]
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Akodad M, Lefèvre T, Lounes Y, Leclercq F. [TAVI simplification: A focus]. Ann Cardiol Angeiol (Paris) 2019; 68:418-422. [PMID: 31668597 DOI: 10.1016/j.ancard.2019.09.017] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/17/2019] [Accepted: 09/20/2019] [Indexed: 11/29/2022]
Abstract
After a first procedure carried out in 2002 by Pr Cribier's, Transcatheter Aortic Valve Replacement or TAVR revolutionized the management of aortic stenosis with a constant increase in the number of procedures performed worldwide. Experience of operators and teams and evolution of the technique has been accompanied by a drastic reduction in complications in patients at lower surgical risk. In parallel, the procedure was considerably simplified, carried out more and more under local anesthesia, with percutaneous femoral approach, secondary radial approach, prosthesis implantation without predilatation, rapid pacing on left ventricle wire and early discharge. Thus, the "simplified" TAVR adopted in most centers nowadays is a real revolution of the technique. However, simplified TAVR must be accompanied upstream by a rigorous selection of patients who can benefit from a minimalist procedure in order to guarantee its safety.
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Affiliation(s)
- M Akodad
- Service de cardiologie, centre hospitalier universitaire Arnaud-de-Villeneuve, 371, avenue du Doyen-Gaston-Giraud, 34090 Montpellier, France; PhyMed Exp, université de Montpellier, Inserm U1046, CNRS UMR 9214, 34295 Montpellier cedex 5, France.
| | - T Lefèvre
- Ramsay générale de santé, institut cardiovasculaire Paris Sud, 91300 Massy, France
| | - Y Lounes
- Service de chirurgie vasculaire, centre hospitalier universitaire Arnaud-de-Villeneuve, 34295 Montpellier, France
| | - F Leclercq
- Service de cardiologie, centre hospitalier universitaire Arnaud-de-Villeneuve, 371, avenue du Doyen-Gaston-Giraud, 34090 Montpellier, France; PhyMed Exp, université de Montpellier, Inserm U1046, CNRS UMR 9214, 34295 Montpellier cedex 5, France
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Dumonteil N, Terkelsen C, Frerker C, Collart F, Wöhrle J, Butter C, Hovorka T, Pinaud F, Baumgartner H, Tarantini G, Wendler O, Lefèvre T. Outcomes of transcatheter aortic valve replacement without predilation of the aortic valve: Insights from 1544 patients included in the SOURCE 3 registry. Int J Cardiol 2019; 296:32-37. [PMID: 31256993 DOI: 10.1016/j.ijcard.2019.06.013] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2019] [Revised: 06/05/2019] [Accepted: 06/09/2019] [Indexed: 10/26/2022]
Abstract
AIMS To investigate the impact of transcatheter aortic valve replacement (TAVR) without preliminary balloon aortic valvuloplasty (pre-BAV) on periprocedural outcomes in a large, real-world registry. METHODS AND RESULTS The SOURCE 3 registry was an observational, multi-center, single-arm study of patients with severe, symptomatic aortic stenosis at high surgical risk treated with the SAPIEN 3 transcatheter heart valve (THV). Procedural and 30-day outcomes were compared between two groups of 772 patients each (retrospectively matched) with or without pre-BAV. All baseline clinical, echocardiographic, and anatomical valve characteristics were comparable between groups except for Society of Thoracic Surgeons (STS) score, which was lower in the direct TAVR group (6.0 ± 5.9 vs 7.8 ± 8.3; p = 0.003). In the direct TAVR group, there were less post-dilatations (8.1% vs. 13.1%, p = 0.002), shorter procedural time (70.9 ± 39.8 min vs 73.0 ± 32.2 min, p = 0.033) and fluoroscopy time (13.4 ± 7.0 min vs 14.9 ± 7.4 min, p < 0.001). Other procedural outcomes and echocardiographic variables at 30 days did not differ significantly between the two groups: safety endpoint (10.4% with pre-BAV vs 13.5% with direct TAVR, p = 0.059), mortality (2.1% vs 2.3%, p = 0.730), disabling strokes (0.4% vs 0.5%, p = 0.704), and moderate to severe paravalvular leak (PVL) (3.2% vs 2.2%, p = 0.40). Unexpectedly, new permanent pacemaker implantation and life-threatening bleeds were less frequently observed with pre-BAV group than with direct TAVR (10.4% vs 13.9%, p = 0.032 and 3.5% vs 6.5%, p = 0.007, respectively). CONCLUSION In this large TAVR dataset, direct implantation of the SAPIEN 3 THV without pre-BAV was feasible and safe and resulted in shorter procedures, without impact on 30-day prosthesis function and PVL.
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Affiliation(s)
- Nicolas Dumonteil
- Groupe CardioVasculaire Interventionnel (GCVI), Clinique Pasteur, Toulouse, France.
| | | | | | | | - Jochen Wöhrle
- Department of Internal Medicine II - Cardiology, University Hospital of Ulm, Ulm, Germany
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Trend and Outcomes of Direct Transcatheter Aortic Valve Replacement from a Single-Center Experience. Cardiol Ther 2018; 7:191-196. [PMID: 30109506 PMCID: PMC6251825 DOI: 10.1007/s40119-018-0115-0] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2018] [Indexed: 12/26/2022] Open
Abstract
INTRODUCTION When transcatheter aortic valve replacement (TAVR) was introduced, pre-implantation balloon aortic valvuloplasty (BAV) was a routine part of the procedure. Smaller device profiles have resulted in selective use of BAV; however, there is a paucity of data about the trend in use of direct TAVR and the safety of this strategy. METHODS All patients who underwent TAVR at a Veterans Affairs Medical Center from September 2013 to November 2016 were included in this retrospective analysis. We reviewed angiography films and verified with procedure reports to assess if direct TAVR was performed. Troponin T was assessed within 72 h after the TAVR. Multivariate analysis examined the association between direct TAVR and periprocedural myocardial infarction (MI) or 1-year mortality. RESULTS Overall, 207 patients were available for analysis. The mean follow-up was 13.3 months. A balloon-expandable valve was used 93.2% of the time, and 35.3% of patients were treated with conscious sedation. Periprocedural MI or 1-year mortality occurred in 12.5% of the direct TAVR group versus 18.3% of the pre-implantation BAV group (p = 0.30). After controlling for potential confounding variables, direct TAVR was not associated with periprocedural MI or 1-year mortality. CONCLUSIONS Direct TAVR appears to be safe and is not associated with periprocedural MI or 1-year mortality. With current generation devices, this strategy can be considered for most patients undergoing TAVR.
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Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation. Am J Cardiol 2018; 122:477-482. [PMID: 29980272 DOI: 10.1016/j.amjcard.2018.04.025] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2018] [Revised: 03/31/2018] [Accepted: 04/03/2018] [Indexed: 12/20/2022]
Abstract
Balloon predilation (BPD) has been an integral part of transcatheter aortic valve implantation (TAVI) since inception. We sought to investigate the effect of avoiding BPD on outcomes of TAVI across different valve types. Articles were included if outcomes of TAVI without BPD were reported. Pooled meta-analysis used a random effects model and reported odds ratios (ORs). Twenty-one studies with 10,752 patients were pooled for analysis. Age and gender were well matched between NoBPD and BPD groups. There was no difference in mortality, stroke, bleeding, and acute kidney injury. NoBPD showed lower pacemaker rates (OR 0.84, 95% confidence interval [CI] 0.72 to 0.97), vascular complications (OR 0.77, 95% CI 0.62 to 0.95), and early safety at 30 days (OR 0.81, 95% CI 0.66 to 0.99). For balloon-expandable valves, lower rates of aortic regurgitation (OR 0.73, 95% CI 0.53 to 0.99) and early safety (OR 0.68, 95% CI 0.55 to 0.85) were seen. Self-expanding valves showed lower pacemaker (OR 0.80, 95% CI 0.66 to 0.97) and vascular complications (OR 0.70, 95% CI 0.50 to 0.99), with a trend toward higher postdilation (OR 1.51, 95% CI 0.85 to 2.67). TAVI without BPD is safe and effective. NoBPD is associated with fewer vascular complications, less aortic regurgitation, and fewer pacemaker requirements and composite early safety end points.
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Akodad M, Lefèvre T. TAVI: Simplification Is the Ultimate Sophistication. Front Cardiovasc Med 2018; 5:96. [PMID: 30087900 PMCID: PMC6066956 DOI: 10.3389/fcvm.2018.00096] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2018] [Accepted: 06/29/2018] [Indexed: 12/19/2022] Open
Abstract
Since its introduction in 2002, TAVI has evolved dramatically and is now standard of care for intermediate risk patients when the femoral approach can be implemented safely. The development of innovative transcatheter heart valves (THVs) and refinement of technical skills have contributed to the decrease in complication rates associated with TAVI4. Increased experience, smaller sheaths, rigorous pre-procedural planning and improved vascular closing techniques have resulted in markedly lower rates of vascular complications. The next step is the simplification of the procedure, which should contribute to a further decrease in complications, and also reduce procedural time, hospital stay as well as staff workload and costs. Moving to conscious sedation, no predilatation, no temporary pace maker and use of the radial approach as the contralateral approach are all instrumental in achieving this ultimate refinement.
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Affiliation(s)
- Mariama Akodad
- Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.,Centre Hospitalier Universitaire Arnaud de Villeneuve, Montpellier, France
| | - Thierry Lefèvre
- Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France
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Impact of Balloon Predilatation on Hemodynamics and Outcomes After Transcatheter Aortic Valve Implantation With the Self-Expanding CoreValve Prosthesis. Am J Cardiol 2018; 121:1358-1364. [PMID: 29680171 DOI: 10.1016/j.amjcard.2018.02.008] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2017] [Revised: 01/31/2018] [Accepted: 02/06/2018] [Indexed: 11/20/2022]
Abstract
The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.
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