Gender-based radiation exposure and clinical outcomes in peripheral endovascular intervention for limb ischemia: A prospective study

Abstract

BACKGROUND

Peripheral endovascular intervention (PEVI) is performed using radiation. Radiation has deleterious health consequences for patients and operators.

AIM

To investigate the gender radiation disparities and procedural outcomes in PEVI.

METHODS

A prospective observational study was performed in 186 consecutive patients (65 ± 12 years) at an academic medical center from January 2019 to April 2020 (mean follow-up of 3.9 ± 3.6 months) comparing the gender radiation disparity and outcomes of PEVI (n = 147 underwent intervention, 79.0%). Groups were divided into women (n = 99, 53.2%) and men (n = 87, 48.4%). Primary endpoints included air kerma, dose area product (DAP), fluoroscopy time, and contrast use. Secondary endpoints included all-cause mortality, acute myocardial infarction, acute kidney injury, stroke, repeat revascularization, major adverse limb event, and the composite of complications.

RESULTS

Men showed increased DAP compared with women (15221.2 ± 25858.5 µGy × m²vs 9251.7 ± 9555.3 µGy × m², P = 0.047), but no significant difference in air kerma or any other primary endpoints. In the secondary endpoints, no significant difference was found between gender.

CONCLUSION

Men had increased DAP indicating more radiation absorption in the exposed area. Gender outcomes showed no difference in complications. Thus, PEVI can be safely performed in men or women.

Key Words: Endovascular intervention; Peripheral arterial disease; Peripheral vascular disease; Radiation; Acute limb ischemia; Critical limb ischemia; Chronic total occlusion; Vascular access; Venous occlusion

Core Tip: Radiation is harmful to patients and operators. During peripheral angiogram and peripheral endovascular intervention (PEVI), radiation is produced. Our study showed that men had a greater dose area product compared with women, but no difference in procedural outcomes. These findings are important, so that we may consider more radiation prudent practices in men to minimize the patient’s and operator’s radiation exposure. Such a study has not been previously conducted in PEVI and provides important real-world information.

INTRODUCTION

Peripheral arterial disease (PAD) occurs in a substantial portion of the world’s population. In 2010, 202 million people were afflicted with PAD[1]. In a 2023 scientific statement from the American Heart Association, it was reported that PAD affects 200 million people worldwide and over 12 million Americans[2]. Treatment for PAD involves peripheral endovascular intervention (PEVI) using fluoroscopy, cine angiography, and digital subtraction angiography. It is associated with elevated levels of radiation from both the deterministic (more likely from high doses of radiation) and stochastic effects (occurs at any level of exposure with the severity being independent from the dose). Radiation can be pernicious with deterministic effects causing skin injury (erythema and/or skin necrosis) in patients and cataracts in operators. Stochastic effects can induce left sided brain tumors, genetic damage, and cancer[3-13]. Women undergoing PEVI have worse outcomes compared with men[14,15]. However, gender comparisons of radiation parameters such as air kerma, fluoroscopy time, and dose area product (DAP) have not been studied. Thus, we sought to evaluate if radiation disparities exist between women vs men undergoing PEVI and their outcomes in peripheral vascular disease (PVD) including acute limb ischemia (ALI) and critical limb ischemia (CLI)/chronic limb threatening ischemia.

MATERIALS AND METHODS

We conducted a prospective observational study of 186 consecutive patients (65 ± 12 years) between January 2019 to April 2020 at a university medical center and compared the radiation and gender outcomes of PEVI. PEVI was defined as any patient who underwent a PEVI with balloon angioplasty, drug-coated balloon angioplasty, and/or peripheral endovascular stent. The majority of patients (n = 160, 87.0%) underwent procedures using 7.5-10 frames/second (f/s) fluoroscopy and 7.5-10 f/s cine angiography. Radiation shielding, frame rate, and collimation adjustment was used at the discretion of the interventional cardiologist. All the interventional cardiologists were experienced and blinded to the study outcomes. Peripheral angiographic images were reviewed by the 4 interventional cardiologists performing the procedures. Figure 1 displays the study protocol. All procedures were performed using Siemens Artis CC X-ray equipment (Siemens Medical Solutions, United States) built in September 2010.

Figure 1  Gender protocol in the peripheral endovascular study with the primary and secondary outcomes displayed between men vs women.

The primary endpoints included air kerma, DAP, fluoroscopy time, and contrast use. In ionizing radiation air kerma is a measure of the kinetic energy released by air per unit mass. DAP is a calculated variable derived from air kerma multiplied by the irradiated area. DAP is the calculated total energy received by the patient during PEVI[16]. The x-ray equipment automatically calculated the radiation parameters. In fluoroscopic procedures, air kerma denotes the kinetic energy that is transferred to the electrons in air and the absorbed dose of radiation in that volume of air. DAP is an important variable for risk of radiation related malignancy (stochastic), whereas air kerma is an important measurement for tissue injury risk (deterministic effect)[17]. Secondary endpoints included all-cause mortality, cardiac mortality, acute myocardial infarction, stroke, acute kidney injury, repeat target lesion/repeat vessel revascularization, vessel dissection/perforation, major adverse limb event (MALE), composite of complications, and access site complications such as major bleeding, arteriovenous fistula, pseudoaneurysm, retroperitoneal bleeding, compartment syndrome, and limb amputation. Patient follow-up was performed via clinic evaluation. The university institutional review board approved our study and informed consent was obtained from patients.

Statistical analysis

Quantitative variables were summarized using mean and standard deviation. Categorical variables were summarized using frequency and percentages. The student’s t-test and χ² test were used in normal distributions and the Wilcoxon sum rank test was used for non-normal distributions. Variables not fitting the normal distribution were converted using a natural log transformation with P values representing the analysis of the log transformed variables. Comparison between groups were analyzed using χ² and Fisher’s exact test. The main outcome variables (fluoroscopy time, DAP, air kerma, and contrast) were analyzed using a linear regression model and compared across the radiation groups while correcting for age, gender, body mass index (BMI), and diabetes. The model also compensated for clustering effect caused by patients who underwent staged or repeat intervention. The study was powered to detect difference in radiation parameters. Data was considered significant at a P value less than 5%. The statistical analyses were performed by experienced statisticians at the university using Stata version 15 (Stata Corp LLC).

RESULTS

The baseline patient characteristics showed that women (n = 99, 53.2%, 65.5 ± 12.7 years) had lower body weight (73.2 ± 16.8 kg vs 80.1 ± 16.4 kg; P = 0.005) and height (158.8 ± 7.5 cm vs 169.4 ± 14.3 cm; P < 0.001) compared with men (n = 87, 46.8%, 64.4 ± 10.9 years). Women also had lower body surface area (1.8 ± 0.2 m²vs 1.9 ± 0.2 m²; P < 0.001). However, no significant difference was found between men or women in BMI (27.6 ± 5.4 kg/m²vs 29.0 ± 6.5 kg/m²; P = 0.11). Smoking was more common in men (n = 54, 62%) compared with women (n = 36, 36%, P < 0.001). The most common indications for PEVI were CLI (n = 89, 47.8%), ALI (n = 32, 17.2%), and intermittent claudication (n = 27, 14.5%) with no significant difference in the incidence between gender. Most of the patients underwent infrainguinal (n = 94, 50.5%) and infrapopliteal PEVI (n = 66, 35.4%). No significant gender difference was noted in the number of patients undergoing suprainguinal, infrainguinal, infrapopliteal, or chronic total occlusion (CTO) intervention.

Men had more symptomatic lesions with greater number of patients having Rutherford Grade III (n = 30, 34% vs n = 21, 21%; P = 0.043) and Fontaine Class IV lesions (n = 31, 36% vs n = 19, 19%; P = 0.012) compared with women. However, women had more complex lesions with greater number having Transatlantic Intersociety Consensus C lesions (TASC) than men (n = 36, 36% vs n = 20, 23%; P = 0.047). The most common risk factors included the following: Hypertension (n = 140, 75.3%), diabetes (n = 126, 67.7%), hyperlipidemia (n = 98, 52.7%), current or past history of smoking (n = 90, 48.4%), and history of coronary artery disease (n = 59, 31.7%). No significant difference in these risk factors was found between men vs women, except smoking. Patient characteristics are listed in Table 1. The TASC, Rutherford, and Fontaine classifications for PAD are listed in Table 1.

Table 1 Patient characteristics in men and women.

	Male, n = 87	Female, n = 99	P value
Age	64.4 ± 10.9	65.5 ± 12.7	0.52
Weight (kg)	80.1 ± 16.4	73.2 ± 16.8	0.005
Height (cm)	169.4 ± 14.3	158.8 ± 7.5	< 0.001
Body mass index (kg/m2)	27.6 ± 5.4	29.0 ± 6.5	0.11
Body surface area (m2)	1.9 ± 0.2	1.8 ± 0.2	< 0.001
Total fluoro time (minutes)	30.2 ± 25.6	24.1 ± 16.3	0.34
DAP (µGy × m2)	15221.2 ± 25858.5	9251.7 ± 9555.3	0.047
Air Kerma (mGy)	616.8 ± 1101.8	474.8 ± 493.2	0.38
Contrast (cc)	106.1 ± 62.1	98.4 ± 57.5	0.48
Follow-up (month)	3.5 ± 3.3	4.3 ± 3.8	0.18
Diabetes	53 (61)	73 (74)	0.062
Hypertension	63 (72)	77 (78)	0.40
Hyperlipidemia	44 (51)	54 (55)	0.59
Past medical history of CAD	25 (29)	34 (34)	0.41
History of MI/PCI	23 (26)	28 (28)	0.78
Atrial fibrillation/flutter	4 (5)	9 (9)	0.23
History of chronic kidney disease/end stage renal disease on hemodialysis	1 (1)	7 (7)	0.047
History of peripheral intervention	26 (30)	22 (22)	0.23
History of vascular surgery	3 (3)	2 (2)	0.55
History of acute limb ischemia/critical limb ischemia	14 (16)	17 (17)	0.84
Current/former smoker	54 (62)	36 (36)	< 0.001
History of amputation	13 (15)	15 (15)	0.97
Intermittent claudication	14 (16)	13 (13)	0.57
Critical limb ischemia	41 (47)	48 (48)	0.85
Acute limb ischemia	12 (14)	20 (20)	0.25
Lower extremity edema/deep venous thrombosis/may Thurner/chronic total occlusion vein	14 (16)	11 (11)	0.32
Venous stenosis	1 (1)	1 (1)	0.93
Re-look angiography	6 (7)	7 (7)	0.96
Left heart cath with peripheral angio	1 (1)	5 (5)	0.13
Peripheral aneurysm	4 (5)	0 (0)	0.031
Suprainguinal	20 (23)	21 (21)	0.77
Infrainguinal	42 (48)	52 (53)	0.56
Infrapopliteal	29 (33)	37 (37)	0.57
Intervention	71 (82)	75 (76)	0.33
Chronic total occlusion intervention	23 (26)	31 (31)	0.46
Staged intervention	10 (11)	8 (8)	0.43
Femoral access	70 (80)	88 (89)	0.11
Pedal	13 (15)	5 (5)	0.023
Retrograde	84 (97)	95 (96)	0.83
Antegrade	0 (0)	1 (1)	0.35
Brachial/radial	20 (23)	8 (8)	0.005
Venous intervention	12 (14)	7 (7)	0.13
Tasc A	7 (8)	9 (9)	0.80
Tasc B	33 (38)	23 (23)	0.029
Tasc C	20 (23)	36 (36)	0.047
Tasc D	6 (7)	7 (7)	0.96
Ruth grade I	12 (14)	15 (15)	0.79
Ruth grade II	22 (25)	35 (35)	0.14
Ruth grade III	30 (34)	21 (21)	0.043
Ruth grade IV	1 (1)	0 (0)	0.28
Fontaine I	0	0
Fontaine II	13 (15)	20 (20)	0.35
Fontaine III	12 (14)	25 (25)	0.051
Fontaine IV	31 (36)	19 (19)	0.012
Complications	17 (20)	21 (21)	0.78
Major adverse limb event	17 (20)	10 (10)	0.068
Myocardial infarction	3 (3)	1 (1)	0.25
Stroke	0 (0)	1 (1)	0.35
Hematoma	4 (5)	3 (3)	0.58
Dissection/perforation	6 (7)	12 (12)	0.23
Acute kidney injury	9 (10)	17 (17)	0.18
Repeat intervention/target lesion revascularization	12 (14)	8 (8)	0.21
Death	2 (2)	2 (2)	0.90

Data were showed as mean ± SD or n (%). DAP: Dose area product; CAD: Coronary artery disease; MI/PCI: Myocardial infarction/percutaneous coronary intervention; TASC: Transatlantic intersociety consensus.

In the entire study population (diagnostic and interventional procedures), men (mean follow-up 3.5 ± 3.3 months) compared with women (mean follow-up 4.3 ± 3.8 months) showed an increase in DAP (15221.2 ± 25858.5 µGy × m²vs 9251.7 ± 9555.3 µGy × m², P = 0.047), but no significant increase in air kerma (616.8 ± 1101.8 mGy vs 474.8 ± 493.2 mGy; P = 0.38), fluoroscopy time (30.2 ± 25.6 minutes vs 24.1 ± 16.3 minutes; P = 0.34), or contrast use (106.1 ± 62.1 cc vs 98.4 ± 57.5 cc; P = 0.48).

During PEVI (n = 147, 79.0%), men (n = 71, 48.3%) compared with women (n = 76, 51.7%) also had higher DAP (16371.7 ± 28148.2 µGy × m²vs 8916.7 ± 9855.1 µGy × m²; P = 0.005). None of the other primary endpoints differed between gender. No significant difference was found in the number of men vs women undergoing PEVI (n = 71 vs n = 75; P = 0.33), location of intervention (suprainguinal, infrainguinal, or infrapopliteal), or treatment for such lesions. CTO intervention was also performed without any difference between gender. Retrograde femoral access was the most common approach (n = 179, 96.2%). Patient characteristics of those who underwent PEVI are listed in Table 2.

Table 2 Patient gender characteristics in peripheral intervention.

	Male, n = 71	Female, n = 76	P value
Age	64.4 ± 11.6	65.8 ± 13.4	0.49
Weight (kg)	80.3 ± 16.2	73.6 ± 16.8	0.016
Height (cm)	169.7 ± 14.8	158.7 ± 7.9	< 0.001
Body mass index (kg/m2)	27.5 ±5.3	29.3 ± 6.5	0.069
Body surface area (m2)	1.9 ± 0.2	1.8 ± 0.2	< 0.001
Follow-up (month)	4.0 ± 3.5	4.0 ± 3.6	0.84
Diabetes	42 (59)	58 (76)	0.026
Hypertension	50 (70)	62 (82)	0.11
Hyperlipidemia	32 (45)	40 (53)	0.36
Past history of coronary artery disease	18 (25)	30 (39)	0.068
History of MI/PCI	16 (23)	25 (33)	0.16
Atrial fibrillation/flutter	4 (6)	8 (11)	0.28
History of chronic kidney disease/end stage renal disease on hemodialysis	1 (1)	5 (7)	0.11
History of peripheral intervention	23 (32)	19 (25)	0.32
History of vascular surgery	2 (3)	2 (3)	0.94
History of acute limb ischemia/critical limb ischemia	11 (15)	16 (21)	0.38
Current/former smoker	45 (63)	25 (33)	< 0.001
History of amputation	8 (11)	13 (17)	0.31
Intermittent claudication	7 (10)	10 (13)	0.53
Critical limb ischemia	37 (52)	39 (51)	0.92
Acute limb ischemia	11 (15)	19 (25)	0.15
Lower extremity edema/deep venous thrombosis/May Thurner/chronic total occlusion vein	14 (20)	7 (9)	0.069
Venous stenosis	0 (0)	1 (1)	0.33
Re-look angiography	5 (7)	5 (7)	0.91
Peripheral aneurysm	2 (3)	0 (0)	0.14
Suprainguinal	20 (28)	21 (28)	0.94
Infrainguinal	42 (59)	52 (68)	0.24
Infrapopliteal	29 (41)	37 (49)	0.34
Intervention	71 (100)	75 (99)	0.33
Chronic total occlusion intervention	23 (32)	31 (41)	0.29
Dissection/perforation	6 (8)	12 (16)	0.17
Femoral access	60 (85)	69 (91)	0.25
Pedal	11 (15)	5 (7)	0.083
Retrograde	68 (96)	73 (96)	0.93
Antegrade	0 (0)	1 (1)	0.33
Brachial/radial	12 (17)	3 (4)	0.010
Venous intervention	12 (17)	7 (9)	0.16
Tasc A	5 (7)	8 (11)	0.46
Tasc B	27 (38)	21 (28)	0.18
Tasc C	19 (27)	33 (43)	0.035
Tasc D	6 (8)	6 (8)	0.90
Ruth grade I	7 (10)	12 (16)	0.28
Ruth grade II	20 (28)	32 (42)	0.077
Ruth grade III	27 (38)	16 (21)	0.024
Ruth grade IV	1 (1)	0 (0)	0.30
Fontaine I	0	0
Fontaine II	7 (10)	17 (22)	0.040
Fontaine III	10 (14)	23 (30)	0.019
Fontaine IV	28 (39)	14 (18)	0.005
Staged intervention	9 (13)	8 (11)	0.68

Data were showed as mean ± SD or n (%). DAP: Dose area product; MI/PCI: Myocardial infarction/percutaneous coronary intervention; TASC: Transatlantic intersociety consensus.

In the secondary endpoints, no significant difference was found between gender in any complication or the composite of complications. The incidence of MALE, acute kidney injury, or death was not significantly different. Table 3 Lists the primary and secondary endpoints between gender.

Table 3 Primary and secondary endpoints of peripheral intervention.

Primary endpoints	Male	Female	P value
Total fluoro time (minute)	33.3 ± 25.4	26.9 ± 15.7	0.071
DAP (μGy × m2)	16371.7 ± 28148.2	8916.7 ± 9855.1	0.005
Air kerma (mGy)	661.2 ± 1198.5	470.8 ± 511.6	0.11
Contrast (cc)	114.2 ± 63.3	105.4 ± 58.9	0.39
Secondary endpoints complications	16 (23)	20 (26)	0.59
Major adverse limb event	17 (24)	10 (13)	0.091
MI	2 (3)	1 (1)	0.52
Stroke	0	0
Hematoma	3 (4)	2 (3)	0.59
Dissection/perforation	6 (8)	12 (16)	0.17
Acute kidney injury	9 (13)	14 (18)	0.34
Repeat intervention/target lesion revascularization	11 (15)	8 (11)	0.37
Death	2 (3)	2 (2)	0.52

Data were showed as mean ± SD or n (%). DAP: Dose area product; MI: Myocardial infarction.

DISCUSSION

PEVI is associated with elevated radiation which is detrimental to patients[3,6,7,9,13]. PEVI in aortoiliac lesions is associated with even higher radiation compared with the femoropopliteal or infrapopliteal regions[11,18,19]. Radiation is increased in PEVI so that tissue injury can develop in 1 out of 14 patients along with the inherent risk of malignancy[20]. The stochastic effects of radiation can induce genetic damage and cancer. Deterministic effects can induce patient skin injury and the development of cataracts in operators, specifically posterior subcapsular cataracts from ionizing radiation in the catheterization laboratory[21].

PEVI in women is associated with worse outcomes than men[14,15]. In the K-VIS registry[22], women had higher rates of death, myocardial infarction, major amputation, MALE, and procedural complications during PEVI than men. In the National Inpatient Sample database from 2002 to 2015, CLI outcomes between gender were evaluated for revascularization and in-hospital outcomes among 2400778 CLI hospitalizations (43.6% women). This retrospective study showed that women were older with a greater prevalence of hypertension, heart failure, obesity, and prior stroke. Also, women had lower incidence of any revascularization (34.7% vs 35.4%, P < 0.001). On multivariable analysis, women had a greater incidence of in-hospital mortality, bleeding, blood transfusion requirement, ischemic stroke, and postoperative infection[23].

In a post-hoc analysis of the EUCLID trial (Examining Use of Ticagrelor in PAD), sex specific differences in MACE and limb events were evaluated in 13885 patients (30-month follow-up) with PAD (28% women, n = 3888). Women had a lower risk of MACE [9.5% vs 11.2%; adjusted hazard ratio: 0.77; 95% confidence interval (95%CI): 0.68-0.88; P < 0.001] and all-cause-mortality (7.6% vs 9.7%; adjusted hazard ratio: 0.61; 95%CI: 0.53 to 0.71; P < 0.001). However, no differences occurred between women and men in MALE (2.6% vs 3.0%) and hospitalization for ALI (1.6% vs 1.7%)[24].

A retrospective analysis of the National Cardiovascular Data Registry Peripheral Vascular Intervention Registry from 2014-2017 (85 United States sites, n = 27119) found that 7.1% undergoing PEVI have the potential for tissue injury and are all exposed to the potential for subsequent malignancy. Multivariate logistic and linear regression models found that the most powerful predictors for DAP (DAP > 500 Gy × m² and increased overall DAP) was lesion location, procedure duration, BMI, male sex, bifurcation lesion, diabetes, and hypertension[20].

In a German population-based registry (2004-2015) of procedures performed by vascular surgeons, interventional cardiologists, interventional radiologists, and angiologists, DAP was higher in men and lower when performed by vascular surgeons[16]. This was a prospective study of 24000 patients who underwent PEVI for PAD in Germany[16]. However, no other radiation parameters were evaluated in the study.

Furthermore, no study has evaluated the radiation differences between men and women undergoing PEVI comparing air kerma, DAP, and fluoroscopy time, nor the discrepancy in contrast use. These are important outcomes due to the pernicious effects of radiation and to discover if more radiation precautions should be implemented in a particular gender. The KAR RAD study[25] evaluated the effects of low dose radiation during cardiac catheterization and percutaneous coronary intervention in a prospective observational study at an academic medical center. It showed a significant reduction in radiation using low dose radiation compared with standard dose radiation.

Our study showed that DAP was increased in men during PEVI, which may be secondary to their increased weight and height compared with women (Tables 1 and 2). Also, men had a significantly greater body surface area, which may have elevated their DAP. Procedural complexity was actually significantly more in women (more TASC C), so this cannot account for the increase in DAP. Moreover, PEVI techniques were performed and adjusted based on lesion findings and complexity. However, the air kerma was not significantly different nor was fluoroscopy time or contrast utilization. Thus, men who undergo PEVI with either normal BMI or elevated BMI, consideration should be given to reduce radiation parameters such as lowering the frame rate during fluoroscopy and cineangiography since their DAP was increased. Hence, men had increased radiation absorption over the irradiated area. Furthermore, the scatter radiation to the operator will increase, which is an important factor during PEVI for the operator and the catheterization staff. Consequently, the operator can contemplate reducing radiation parameters to minimize potential harm to the patient and also scatter radiation to the operator and catheterization staff. Monitoring the operator’s radiation dose during PEVI in men and especially with elevated BMI can be considered. Therefore, in men and particularly, men with high BMI, meticulous care should be instituted to monitor and control radiation during PEVI. Even though men had greater weight than women, they did not experience more complications suggesting safety. No study in PEVI has specifically evaluated radiation reduction strategies. In cardiac catheterization and percutaneous coronary intervention, the KAR RAD study[25] showed the benefits of radiation reduction techniques which significantly reduced the radiation endpoints of air kerma and DAP.

Women underwent similar treatment for PAD including CTO PEVI as men. Women had no significant difference in the number of PEVI procedures performed compared with men. Even though women were significantly lower in weight and height, they did not experience more complications than men. Moreover, the increased severity of lesions in women did not contribute to enhanced complications. Women may have developed more severe disease since they were less symptomatic. Nevertheless, women did not have more risk factors than men. In actuality, men had an additional risk factor - more commonly smokers. Men also had more severe symptomatic disease even though they had lesions which were less complex.

Our prospective study reports an important finding of increased DAP in men. The combined radiation endpoints of air kerma, DAP, fluoroscopy time, and contrast utilization has not been previously studied in PEVI, so it answers a critical knowledge gap. Our results are relevant to interventional cardiologists, general cardiologists, vascular surgeons, vascular medicine physicians, and interventional radiologists who either perform PEVI or manage these patients. Awareness of the medical community of the potentially increased DAP in men during PEVI can suggest the performance of staged PEVI and more meticulous monitoring for the detrimental deterministic or stochastic effects of radiation. Furthermore, in men undergoing PEVI, practicing radiation reduction techniques should be considered to reduce potential harm. Since patients may undergo multiple procedures or tests which expose them to radiation in their lifetime, mitigating radiation during PEVI should be considered, especially in men. Collimation, fluoroscopy frame rate, filtration, and shielding are techniques which should be implemented for radiation reduction.

The prospective study was performed in a single academic center so it may potentially lack generalizability. Long-term follow-up on radiation effects were not studied. Unmeasured confounders may be procedure time which can vary by operator. Nonetheless, this is a meaningful study since all patients were included for PEVI (all-comers study). Moreover, no patients were excluded for gender analyses, so it provides practical data on radiation parameters, gender outcomes, and complications in PEVI.

CONCLUSION

To our knowledge, this is the first prospective study comparing radiation differences in air kerma and DAP between women and men undergoing PEVI in PVD including ALI and CLI. Men had increased DAP compared with women, but no significant difference in air kerma, contrast use, or fluoroscopy time. Women underwent PEVI with similar outcomes as men even though they had lower body weight and more complex lesions. Men had more symptomatic PAD. No gender difference in complications was found, but men had an extra risk factor (smoking). Consequently, PEVI may be safely performed in men and women regardless of gender and lesion severity. However, DAP was higher in men so they should be monitored closely during the procedure to minimize radiation to the patient and operator. Moreover, radiation reduction techniques to decrease DAP in men should be considered, especially in men with elevated BMI. In conclusion, our study showed that PEVI is safe and effective regardless of gender. However, meticulous radiation monitoring and practices are necessary, particularly in men. Further clinical research on radiation disparity and their long-term outcomes may be worthwhile in a larger cohort study.

ACKNOWLEDGEMENTS

We would like to thank Alok Dwivedi, PhD, and Luis A. Alvarado, MS, for their statistical analyses.