Early vs. delayed mechanical circulatory support in patients with acute myocardial infarction and cardiogenic shock.

AIMS: Despite increased temporary mechanical circulatory support (tMCS) utilization for acute myocardial infarction complicated by cardiogenic shock (AMI-CS), data regarding efficacy and optimal timing for tMCS support are limited. This study aimed to describe outcomes based on tMCS timing in AMI-CS and to identify predictors of 30-day mortality and readmission. METHODS AND RESULTS: Patients with AMI-CS identified in the National Readmissions Database were grouped according to the use of tMCS and early (<24 h) vs. delayed (≥24 h) tMCS. The correlation between tMCS timing and inpatient outcomes was evaluated using linear regression. Multivariate logistic regression was used to identify variables associated with 30-day mortality and readmission. Of 294 839 patients with AMI-CS, 109 148 patients were supported with tMCS (8067 veno-arterial extracorporeal membrane oxygenation, 33 577 Impella, and 79 161 intra-aortic balloon pump). Of patients requiring tMCS, patients who received early tMCS (n = 79 906) had shorter lengths of stay (7 vs. 15 days, P < 0.001) and lower rates of ischaemic and bleeding complications than those with delayed tMCS (n = 32 241). Patients requiring tMCS had higher in-hospital mortality [odds ratio (95% confidence interval)] [1.7 (1.7-1.8), P < 0.001]. Among patients requiring tMCS, early support was associated with fewer complications, lower mortality [0.90 (0.85-0.94), P < 0.001], and fewer 30-day readmissions [0.91 (0.85-0.97), P = 0.005] compared with patients with delayed tMCS. CONCLUSION: Among patients receiving tMCS for AMI-CS, early tMCS was associated with fewer complications, shorter lengths of stay, lower hospital costs, and fewer deaths and readmissions at 30 days.

A non-interventional cardiologist's guide to coronary chronic total occlusions.

Coronary chronic total occlusions (CTO) are present in up to one-third of patients with coronary artery disease (CAD). It is thus essential for all clinical cardiologists to possess a basic awareness and understanding of CTOs, including optimal evaluation and management. While percutaneous coronary intervention (PCI) for CTO lesions has many similarities to non-CTO PCI, there are important considerations pertaining to pre-procedural evaluation, interventional techniques, procedural complications, and post-procedure management and follow-up unique to patients undergoing this highly specialized intervention. Distinct from other existing topical reviews, the current manuscript focuses on key knowledge relevant to non-interventional cardiologists.

Outcomes With Malignancy-Associated High-Risk Pulmonary Embolism: A Nationwide Analysis.

OBJECTIVE: To examine the characteristics and outcomes among patients with high-risk pulmonary embolism (PE) and malignancy. PATIENTS AND METHODS: The Nationwide Readmissions Database was used to identify hospitalizations with high-risk PE from January 1, 2016, to December 31, 2019. The main outcome was the difference in all-cause in-hospital mortality. RESULTS: Among 28,547 weighted hospitalizations with high-risk PE, 4,825 (16.9%) had malignancy. Admissions with malignancy had a lower prevalence of other comorbid conditions except for anemia and coagulopathy. The use of systemic thrombolysis, catheter-directed interventions, and surgical embolectomy was less common among admissions with malignancy, whereas the use of inferior vena cava filter was more common among those with malignancy. All-cause in-hospital mortality was higher among admissions with malignancy even after adjustment (adjusted odds ratio, 1.91; 95% CI, 1.72 to 2.11; P<.001). Metastatic genitourinary, gastrointestinal (other than colorectal), and lung malignancies were associated with the highest incidence of in-hospital mortality. The incidence of intracranial hemorrhage (3.9% vs 3.1%; P=.056) and the composite of non-intracranial hemorrhage bleeding (21.9% vs 20.6%; P=.185) was not different between admissions with and without malignancy. However, admissions with malignancy had higher incidence of gastrointestinal bleeding. CONCLUSION: In this nationwide analysis of patients admitted with high-risk PE, malignancy was independently associated with an increased risk of in-hospital mortality. The risk was highest among patients with metastatic genitourinary, gastrointestinal, and lung malignancies. Advanced therapies were less frequently used among patients with malignancy.

Extra-plaque rotational atherectomy for treating a balloon uncrossable ostial right coronary artery chronic total occlusion.

Performing atherectomy in the subintimal space remains controversial. We describe a case of successful ostial right coronary artery CTO recanalization using rotational atherectomy in subintimal space.

Retrograde stent target technique for left main chronic total Occlusion revascularization.

A 72-year-old woman presented with progressive angina and anterior ischemia on a nuclear stress test.

Radiation exposure during distal and traditional radial coronary angiography and percutaneous coronary intervention: a meta-analysis of randomized controlled trials.

OBJECTIVES: Previous studies show that the distal transradial approach (dTRA) is safe and effective for coronary angiography and percutaneous coronary intervention. However, the effect of dTRA on radiation exposure in the catheterization laboratory has not been characterized. The authors analyzed the available literature to compare the radiation exposure associated with dTRA vs the traditional radial approach (TRA). METHODS: A systematic review and meta-analysis of the scientific literature was conducted by using relevant terms to search the PubMed, Embase, and Cochrane Library databases from their inception until October 13, 2022, to identify randomized controlled trials (RCTs) comparing dTRA with TRA. The primary outcome was radiation exposure reported as fluoroscopy time, air kerma, or kerma-dose product. The standard mean difference (SMD) and its 95% confidence interval were used to summarize continuous variables. Random effect and meta-regression also were used for analyses. RESULTS: Among 484 studies identified, 7 were RCTs, with a total of 3427 patients (1712 dTRA, 1715 TRA). No difference was found between dTRA and TRA in radiation exposure quantified as fluoroscopy time (SMD -0.10 [-0.36, 0.15], P=.43) or air kerma (SMD -0.31 [-0.74, 0.13], P=.17). The overall estimate favored lower kerma-area product in the TRA (SMD 0.19 [0.08, 0.30], P=.0006). Meta-regression showed no correlation between fluoroscopy time and year of publication. CONCLUSIONS: Compared with TRA, dTRA was associated with significantly greater radiation exposure per the kerma-area product during interventional cardiology procedures, with no differences in fluoroscopy time and air kerma.

Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients With Previous Coronary Artery Bypass Graft Surgery.

The outcomes of chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) in patients with previous coronary artery bypass graft (CABG) surgery have received limited study. We examined the baseline characteristics and outcomes of CTO PCIs performed at 47 United States and non-United States centers between 2012 and 2023. Of the 12,164 patients who underwent CTO PCI during the study period, 3,475 (29%) had previous CABG. Previous CABG patients were older, more likely to be men, and had more comorbidities and lower left ventricular ejection fraction and estimated glomerular filtration rate. Their CTOs were more likely to have moderate/severe calcification and proximal tortuosity, proximal cap ambiguity, longer lesion length, and higher Japanese CTO scores. The first and final successful crossing strategy was more likely to be retrograde. Previous CABG patients had lower technical (82.1% vs 88.2%, p <0.001) and procedural (80.8% vs 86.8%, p <0.001) success, higher in-hospital mortality (0.8% vs 0.3%, p <0.001), acute myocardial infarction (0.9% vs 0.5%, p = 0.007) and perforation (7.0% vs 4.2%, p <0.001) but lower incidence of pericardial tamponade and pericardiocentesis (0.1% vs 1.3%, p <0.001). At 2-year follow-up, the incidence of major adverse cardiac events, repeat PCI and acute coronary syndrome was significantly higher in previous CABG patients, whereas all-cause mortality was similar. In conclusion, patients with previous CABG who underwent CTO PCI had more complex clinical and angiographic characteristics and lower success rate, higher perioperative mortality, and myocardial infarction but lower tamponade, and higher incidence of major adverse cardiac events with similar all-cause mortality during follow-up.

Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI.

BACKGROUND: Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES: This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. METHODS: Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed. RESULTS: Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. CONCLUSIONS: In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use.

Short Versus Long-Term Dual Antiplatelet Therapy in Patients at High Bleeding Risk Undergoing PCI in Contemporary Practice: A Systemic Review and Meta-analysis.

INTRODUCTION: Patients at high bleeding risk (HBR patients) represent an important subset of patients undergoing percutaneous coronary intervention (PCI). It remains unclear whether a shortened duration of dual antiplatelet therapy (DAPT) confers benefits compared with prolonged duration of DAPT in this patient population. The aim of this study was to investigate and compare bleeding and ischemic outcomes among HBR patients receiving short- versus long-term DAPT after PCI. METHODS: A meta-analysis of studies comparing short-term (1-3 months) and long-term (6-12 months) DAPT after PCI with second-generation drug-eluting stents in HBR patients was performed. RESULTS: Six studies [1 randomized controlled trial (RCT), 2 RCT subanalyses, and 3 prospective propensity-matched studies] involving 15,908 patients were included in the meta-analysis. During a follow-up of 12 months, short-term DAPT was associated with a reduction in major bleeding events [odds ratio (OR) 0.63, 95% confidence interval (CI) 0.42-0.95; p = 0.03, I2 = 71] and comparable definite/probable stent thrombosis, all-cause mortality, cardiovascular mortality, myocardial infarction (MI), and ischemic stroke, compared with long-DAPT. Single antiplatelet therapy (SAPT) with aspirin was comparable to SAPT with P2Y12 inhibitor, with no treatment-by-subgroup interaction for major bleeding events (p-interaction = 0.27). In studies including patients presenting with MI, a trend of more frequent MI was noted in the short-DAPT arm (OR 1.25, 95% CI 0.98-1.59; p = 0.07; I2 = 0). In a sensitivity analysis comparing 3- and 12-month DAPT, the 3-month DAPT strategy was associated with a higher risk of ischemic stroke (OR 2.37, 95% CI 1.15-4.87; p = 0.02, I2 = 0%). CONCLUSION: Short-term DAPT after PCI in HBR patients was associated a reduction in major bleeding events and similar ischemic outcomes. However, a higher risk of ischemic stroke and MI at 1 year of follow-up was seen in some subsets.

Intravascular Imaging Use in Percutaneous Coronary Interventions of Chronic Total Occlusions.

BACKGROUND: Intravascular ultrasound (IVUS) can assist percutaneous coronary intervention (PCI) of chronic total occlusions (CTO). METHODS: We analyzed 8,983 CTO PCIs performed in 8,771 patients between 2012 and 2022 at 39 centers. RESULTS: Overall, IVUS was used in 44.5% of the cases, for crossing in 11.5% and for stent optimization in 33.1%. IVUS for stent optimization was used more often for complex lesions with higher prevalence of calcification (51.2% vs 34.3%; P<.001); was associated with lower air kerma radiation dose (1.78 [1.00, 3.09] vs 2.30 (1.35, 3.91) min, P<.001) and contrast volume (190 [138, 258] vs 220 [160, 300] ml, P<.001). Among cases with successful guidewire crossing, those that used IVUS for stent optimization had higher technical (99.3% vs 96.3%; P<.001) and procedural (96.1% vs 94.6%, P=.002) success rates and similar major adverse complication event rates (2.04% vs 1.62%; P=.176). The use of IVUS for stent optimization significantly increased over time. CONCLUSION: In a contemporary, multicenter registry, IVUS was used in 44.5% and its use for stent optimization significantly increased over time. Cases where IVUS was used for stent optimization had higher technical and procedural success and similar risk of complications compared with cases where IVUS was not used for stent optimization.

The impact of moderate aortic stenosis in acute myocardial infarction: A multicenter retrospective study.

BACKGROUND: Aortic stenosis (AS) is associated with myocardial ischemia through different mechanisms and may impair coronary arterial flow. However, data on the impact of moderate AS in patients with acute myocardial infarction (MI) is limited. AIMS: This study aimed to investigate the impact of moderate AS in patients presenting with acute myocardial infarction (MI). METHODS: We conducted a retrospective analysis of all patients who presented with acute MI to all Mayo Clinic hospitals, using the Enterprise Mayo PCI Database from 2005 to 2016. Patients were stratified into two groups: moderate AS and mild/no AS. The primary outcome was all cause mortality. RESULTS: The moderate AS group included 183 (13.3%) patients, and the mild/no AS group included 1190 (86.7%) patients. During hospitalization, there was no difference between both groups in mortality. Patients with moderate AS had higher in-hospital congestive heart failure (CHF) (8.2% vs. 4.4%, p = 0.025) compared with mild/no AS patients. At 1-year follow-up, patients with moderate AS had higher mortality (23.9% vs. 8.1%, p < 0.001) and higher CHF hospitalization (8.3% vs. 3.7%, p = 0.028). In multivariate analysis, moderate AS was associated with higher mortality at 1-year (odds ratio 2.4, 95% confidence interval [1.4-4.1], p = 0.002). In subgroup analyses, moderate AS increased all-cause mortality in STEMI and NSTEMI patients. CONCLUSION: The presence of moderate AS in acute MI patients was associated with worse clinical outcomes during hospitalization and at 1-year follow-up. These unfavorable outcomes highlight the need for a close follow-up of these patients and for timely therapeutic strategies to best manage these coexisting conditions.

Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention of the Left Anterior Descending Artery.

The left anterior descending artery (LAD) subtends a large myocardial territory. The outcomes of LAD chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. We performed a retrospective analysis of all patients who underwent LAD CTO PCI at a high-volume single center. Outcomes included in-hospital and long-term major adverse cardiovascular events (MACEs) and changes in left ventricular ejection fraction (LVEF). We performed a subgroup analysis of patients with ischemic cardiomyopathy, defined as an LVEF of 40% or less. From December 2014 to February 2021, 237 patients underwent LAD CTO PCI. The technical success rate was 97.4%, and the in-hospital MACE rate was 5.4%, A landmark analysis after hospital discharge showed an overall survival of 92% and 85% MACE-free survival at 2 years. There was no difference in overall survival or MACE-free survival between those who had ischemic cardiomyopathy versus those who did not. In patients with ischemic cardiomyopathy, LAD CTO PCI was associated with significant improvement in LVEF (10.9% at 9 months), which was further pronounced when these patients had a proximal LAD CTO and were on optimal medical therapy (14% at 6 months). In a single high-volume center, LAD CTO PCI was associated with 92% overall survival at 2 years, with no difference in survival between patients with or without ischemic cardiomyopathy. LAD CTO PCI was associated with an absolute 10% increase in LVEF at 9 months in patients with ischemic cardiomyopathy.

Angiographic Features and Clinical Outcomes of Balloon Uncrossable Lesions during Chronic Total Occlusion Percutaneous Coronary Intervention.

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p < 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p < 0.001) and diabetes mellitus (50% vs. 42%, p < 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p < 0.001), moderate/severe calcification (68% vs. 40%, p < 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p < 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p < 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p < 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p < 0.001) and procedural (88% vs. 96%, p < 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p < 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions.

Outcomes with catheter-directed thrombolysis vs. catheter-directed embolectomy among patients with high-risk pulmonary embolism: a nationwide analysis.

AIMS: To examine the shot-term outcomes with catheter-directed thrombolysis (CDT) vs. catheter-directed embolectomy (CDE) for high-risk pulmonary embolism (PE). METHODS AND RESULTS: The Nationwide Readmissions Database was utilized to identify hospitalizations with high-risk PE undergoing CDE or CDT from 2016 to 2019. The main outcome was all-cause in-hospital mortality. Propensity score matching was used to compare the outcomes in both groups. Among 3216 high-risk PE hospitalizations undergoing catheter-directed interventions, 868 (27%) received CDE, 1864 (58%) received CDT, and 484 (15%) received both procedures. In the unadjusted analysis, the rate of all-cause in-hospital mortality was not different between CDE and CDT (39.6% vs. 34.2%, P = 0.07). After propensity score matching, there was no difference in the incidence of in-hospital mortality [adjusted odds ratio (aOR): 1.28, 95% confidence interval (CI): 0.95, 1.72, P = 0.10], intracranial haemorrhage (ICH) (adjusted OR 1.57, 95% CI: 0.75, 3.29, P = 0.23), or non-ICH bleeding (aOR: 1.17, 95% CI: 0.85, 1.62, P = 0.33). There were no differences in the length of stay, cost, and 30-day unplanned readmissions between both groups. CONCLUSION: In this contemporary observational analysis of patients admitted with high-risk PE undergoing CDT or CDE, the rates of in-hospital mortality, ICH, and non-ICH bleeding events were not different.

Impact of proximal cap ambiguity on the procedural techniques and outcomes of chronic total occlusion percutaneous coronary intervention: Insights from the PROGRESS-CTO Registry.

BACKGROUND: Proximal cap ambiguity is a key parameter in the global chronic total occlusion (CTO) percutaneous coronary intervention (PCI) crossing algorithm. METHODS: We examined the baseline characteristics and procedural outcomes of 9718 CTO PCIs performed in 9498 patients at 41 US and non-US centers between 2012 and 2022. RESULTS: Proximal cap ambiguity was present in 35% of CTO lesions. Patients whose lesions had proximal cap ambiguity were more likely to have had prior coronary artery bypass graft surgery (37% vs. 24%; p < 0.001). Lesions with proximal cap ambiguity were more complex with higher J-CTO score (3.1 ± 1.0 vs. 2.0 ± 1.2; p < 0.001) and lower technical (79% vs. 90%; p < 0.001) and procedural (77% vs. 89%; p < 0.001) success rates compared with nonambiguous CTO lesions. The incidence of major adverse cardiovascular events (MACE) was higher in cases with proximal cap ambiguity (2.5% vs. 1.7%; p < 0.001). The retrograde approach was more commonly used among cases with ambiguous proximal cap (50% vs. 21%; p < 0.001) and was more likely to be the final successful crossing strategy (29% vs. 13%; p < 0.001). The antegrade dissection and re-entry (ADR) "move-the-cap" techniques were also more common among cases with proximal cap ambiguity. CONCLUSIONS: Proximal cap ambiguity in CTO lesions is associated with higher utilization of the retrograde approach and ADR, lower technical and procedural success rates, and higher incidence of in-hospital MACE.

Meta-Analysis on Transcarotid Versus Transfemoral and Other Alternate Accesses for Transcatheter Aortic Valve Implantation.

Transcarotid access has emerged as the preferred access site for transcatheter aortic valve implantation (TAVI) in patients with prohibitive iliofemoral anatomy. This study aimed to compare outcomes with transcarotid with those of other accesses in patients who underwent TAVI. Cochrane, EMBASE, and MEDLINE databases were searched for all published studies that compared outcomes with transcarotid with those of other accesses (transfemoral, transaxillary/subclavian, transaortic, and transapical) in patients who underwent TAVI. The primary outcome was all-cause mortality. Secondary outcomes included major bleeding, major vascular complications, stroke, myocardial infarction, permanent pacemaker implantation, and peri-aortic valve insufficiency. We included 22 observational studies with a total of 11,896 patients. Outcomes were reported during hospitalization and at 1-month follow-up. The transcarotid approach had higher mortality at 1 month (3.7% vs 2.6%, p = 0.02) but lower major vascular complications during hospitalization (1.5% vs 3.4%, p = 0.04) than did transfemoral access. The transcarotid approach had lower major vascular complications (2% vs 2.3%, p = 0.04) than did the transaxillary/subclavian but higher major bleeding (5.3% vs 2.6%, p = 0.03). The transaortic approach was associated with higher in-hospital (11.7% vs 1.9%, p = 0.02) and 1-month mortality (14.4% vs 3.9%, p = 0.007) rates than was transcarotid access. The transcarotid approach numerically reduced mortality and the risk of major vascular complications and major bleeding compared with the transapical approach; however, this did not reach statistical significance. The transcarotid approach did not increase the risk of stroke compared with transfemoral or the other alternative accesses. In conclusion, the transcarotid or transaxillary/subclavian approach had associated comparable outcomes that were better than those of the transapical and transaortic approaches. There was no difference in stroke risk between transcarotid access and other accesses.

Outcomes with plug-based versus suture-based vascular closure device after transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis.

BACKGROUND: Studies comparing plug-based (i.e., MANTA) with suture-based (i.e., ProStar XL and ProGlide) vascular closure devices (VCDs) for large-bore access closure after transcatheter aortic valve replacement (TAVR) have yielded mixed results. AIMS: To examine the comparative safety and efficacy of both types of VCDs among TAVR recipients. METHODS: An electronic database search was performed through March 2022 for studies comparing access-site related vascular complications with plug-based versus suture-based VCDs for large-bore access site closure after transfemoral (TF) TAVR. RESULTS: Ten studies (2 randomized controlled trials [RCTs] and 8 observational studies) with 3113 patients (MANTA = 1358, ProGlide/ProStar XL = 1755) were included. There was no difference between plug-based and suture-based VCD in the incidence of access-site major vascular complications (3.1% vs. 3.3%, odds ratio [OR]: 0.89; 95% confidence interval [CI]: 0.52-1.53). The incidence of VCD failure was lower in plug-based VCD (5.2% vs. 7.1%, OR: 0.64; 95% CI: 0.44-0.91). There was a trend toward a higher incidence of unplanned vascular intervention in plug-based VCD (8.2% vs. 5.9%, OR: 1.35; 95% CI: 0.97-1.89). Length of stay was shorter with MANTA. Subgroup analyses suggested significant interaction based on study designs such that there was higher incidence of access-site vascular complications and bleeding events with plug-based versus suture-based VCD among RCTs. CONCLUSION: In patients undergoing TF-TAVR, large-bore access site closure with plug-based VCD was associated with a similar safety profile as suture-based VCD. However, subgroup analysis showed that plug-based VCD was associated with higher incidence of vascular and bleeding complications in RCTs.