Importance:In patients with asymptomatic severe aortic stenosis (AS), exercise stress testing is recommended to unmask symptoms and guide the timing of intervention, yet it is infrequently used in clinical practice. This registry-based follow-up of the Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (EARLY TAVR) trial evaluates how treadmill stress testing (TST), used during screening for EARLY TAVR to confirm asymptomatic status, informed subsequent aortic valve replacement and clinical outcomes. Objective:To evaluate clinical outcomes in patients with asymptomatic severe AS and a positive TST result and to identify predictors of a positive TST result. Design, Setting, and Participants:This prespecified TST registry of the EARLY TAVR trial involved 75 clinical sites across the US. Between July 2017 and December 2021, apparently asymptomatic patients with severe AS underwent standardized TST. Those with normal TST results were randomized to transcatheter aortic valve replacement or clinical surveillance, whereas those with positive TST results were invited to enroll in a prospective registry and were followed up with through 2 years. Of 1250 patients screened, 962 met trial criteria. Of these, 816 (84.8%) had a normal TST result and 146 (15.2%) had a positive TST result. Of these, 105 consented to enroll in the EARLY TAVR Treadmill Registry. Data were analyzed from August 2025 to January 2026. Exposure:Positive TST result. Main Outcomes and Measures:TST-related safety, 2-year all-cause mortality, and rates of subsequent aortic valve replacement (AVR). Baseline predictors of a positive TST result were identified using multivariable logistic regression models. Results:Of the 105 patients included in the present analysis, the mean (SD) age was 76.1 (6.5) years, and 80 participants (76.2%) were male. TST was found to be safe, with no reported deaths, syncope, or cardioversions. Multivariable baseline predictors of a positive TST included higher peak velocity, lower ejection fraction, prior coronary artery bypass, and prior stroke. The 2-year Kaplan-Meier rate for all-cause mortality was 5.7%. Among patients with positive TST results, the rates of AVR at 1 and 2 years were 79.9% and 85.9%, respectively. Rates of mortality and AVR were similar for patients who had a class I indication for AVR (symptoms during testing) and those with a class IIa indication (drop in systolic blood pressure). Conclusions and Relevance:In patients with asymptomatic severe AS, TST was found to be safe and identified symptoms and AVR indication in approximately 15% of patients. However, 20% of those patients remained untreated at 1 year, despite having an indication for prompt treatment. Trial Registration:ClinicalTrials.gov Identifier: NCT03042104.
Importance As transcatheter aortic valve replacement (TAVR) is considered for younger and lower-risk populations, the durability of bioprosthetic valves is increasingly important. Limited data exist on long-term (7 years and beyond) valve durability. Objective To report 7-year valve durability outcomes for low-risk patients with symptomatic severe aortic stenosis treated with TAVR vs surgery. Design, Setting, and Participants Between March 2016 and October 2017, a total of 1000 patients were enrolled at 71 centers in the US and Canada and randomized to undergo TAVR vs surgery. The patient population for the present analysis consisted of all patients who underwent valve implantation (495 with TAVR and 453 with surgery). The last 7-year follow-up occurred in March 2025. Interventions Patients were randomized to balloon-expandable TAVR with the SAPIEN 3 valve or surgery with any commercially available valve. Main Outcomes and Measures The main outcomes of this analysis were stage 2 or 3 bioprosthetic valve dysfunction (BVD) related to structural valve deterioration (SVD), thrombosis, or endocarditis; all-cause bioprosthetic valve failure (BVF); BVF related to SVD; and aortic valve reintervention at 7 years. Analyses are presented as cumulative incidence rates with death as a competing risk. Results The mean (SD) age of the study population was 73.5 (6.0) years, and 657 participants (69.3%) were male. Of 671 patients who were still alive and enrolled in the study at 7-year follow-up, 537 (80.0%) were available for echocardiographic analysis. Cumulative incidence rates of stage 2 or 3 SVD-related BVD (7.3% vs 7.6%; hazard ratio [HR], 0.96; 95% CI, 0.59-1.57; P = .88), all-cause BVF (6.9% vs 7.5%; HR, 0.91; 95% CI, 0.55-1.49; P = .69), SVD-related BVF (3.9% vs 5.3%; HR, 0.72; 95% CI, 0.39-1.36; P = .31), and valve reintervention (6.0% vs 5.5%; HR, 1.09; 95% CI, 0.62-1.90; P = .77) were low and similar for TAVR and surgery, respectively. Stage 2 or 3 thrombosis-related BVD (subclinical and clinical) occurred more frequently with TAVR (5.2% vs 0.9%; HR, 5.52; 95% CI, 1.92-15.85; P < .001), although most events occurred within 3 years and few progressed to BVF. Rates of stage 2 or 3 endocarditis-related BVD were also low and similar (0.4% in the TAVR group vs 0.5% in the surgery group; HR, 0.85; 95% CI, 0.12-6.07; P = .87). The proportion of patients alive and free of all-cause BVF was 73.4% (331/451) with TAVR vs 74.8% (288/385) with surgery ( P = .69). Conclusions and Relevance In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years. These findings may inform discussions of valve replacement strategies. Trial Registration ClinicalTrials.gov Identifier: NCT02675114
Importance In patients with asymptomatic severe aortic stenosis (AS), exercise stress testing is recommended to unmask symptoms and guide the timing of intervention, yet it is infrequently used in clinical practice. This registry-based follow-up of the Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (EARLY TAVR) trial evaluates how treadmill stress testing (TST), used during screening for EARLY TAVR to confirm asymptomatic status, informed subsequent aortic valve replacement and clinical outcomes. Objective To evaluate clinical outcomes in patients with asymptomatic severe AS and a positive TST result and to identify predictors of a positive TST result. Design, Setting, and Participants This prespecified TST registry of the EARLY TAVR trial involved 75 clinical sites across the US. Between July 2017 and December 2021, apparently asymptomatic patients with severe AS underwent standardized TST. Those with normal TST results were randomized to transcatheter aortic valve replacement or clinical surveillance, whereas those with positive TST results were invited to enroll in a prospective registry and were followed up with through 2 years. Of 1250 patients screened, 962 met trial criteria. Of these, 816 (84.8%) had a normal TST result and 146 (15.2%) had a positive TST result. Of these, 105 consented to enroll in the EARLY TAVR Treadmill Registry. Data were analyzed from August 2025 to January 2026. Exposure Positive TST result. Main Outcomes and Measures TST-related safety, 2-year all-cause mortality, and rates of subsequent aortic valve replacement (AVR). Baseline predictors of a positive TST result were identified using multivariable logistic regression models. Results Of the 105 patients included in the present analysis, the mean (SD) age was 76.1 (6.5) years, and 80 participants (76.2%) were male. TST was found to be safe, with no reported deaths, syncope, or cardioversions. Multivariable baseline predictors of a positive TST included higher peak velocity, lower ejection fraction, prior coronary artery bypass, and prior stroke. The 2-year Kaplan-Meier rate for all-cause mortality was 5.7%. Among patients with positive TST results, the rates of AVR at 1 and 2 years were 79.9% and 85.9%, respectively. Rates of mortality and AVR were similar for patients who had a class I indication for AVR (symptoms during testing) and those with a class IIa indication (drop in systolic blood pressure). Conclusions and Relevance In patients with asymptomatic severe AS, TST was found to be safe and identified symptoms and AVR indication in approximately 15% of patients. However, 20% of those patients remained untreated at 1 year, despite having an indication for prompt treatment. Trial Registration ClinicalTrials.gov Identifier: NCT03042104
Patients with aortoiliac occlusive disease may be asymptomatic or present with a full range of symptoms from mild claudication to limb-threatening ischemia. The initial assessment should include a physical examination for signs of peripheral ischemia, distal embolization, and the status of the peripheral pulses. Appropriate assessment of these patients includes a complete carotid, abdominal, and lower extremity vascular examination as well as appropriate screening and assessment for coronary artery disease. A complete cardiovascular assessment of the patient with aortoiliac occlusive disease should be performed, given the high incidence of associated atherosclerotic diseases. Since 1980, balloon angioplasty has been used successfully, in the terminal aorta. Stents are an attractive therapeutic option for the management of large artery occlusive disease to maintain or improve the arterial luminal patency after balloon angioplasty. The long-term patency of iliac vessels treated with balloon angioplasty is influenced by both clinical and anatomic variables.
Objectives “Clopidogrel resistance,” also defined as heightened platelet reactivity (HPR) while on clopidogrel therapy, may lead to a sub-optimal antiplatelet effect and a potential thrombotic event. There is limited literature addressing the prevalence of HPR in a large cohort of patients receiving either coronary or endovascular interventions. Methods In a large integrated healthcare system, patients with a P2Y12 reaction units (PRU) test were identified. HPR was defined as a PRU ≥ 200 during clopidogrel therapy. Vascular and coronary interventions were identified utilizing CPT codes, HPR prevalence was calculated, and Fischer’s exact test was used to determine significance. Results From an initial cohort of 2,405,957 patients (October 2014 to January 2020), we identified 3301 patients with PRU tests administered. Of these, 1789 tests had a PRU ≥ 200 (HPR overall prevalence, 54%). We then identified 1195 patients who underwent either an endovascular or coronary procedure and had a PRU measurement. This corresponded to 935 coronary and 260 endovascular interventions. In the coronary cohort, the HPR prevalence was 54% (503/935). In the vascular cohort, the HPR prevalence was 53% (137/260); there was no difference between cohorts in HPR prevalence ( p = 0.78). Conclusion “Clopidogrel resistance” or HPR was found to be present in nearly half of patients with cardiovascular disease undergoing intervention. Our data suggest HPR is more common in the cardiovascular patient population than previously appreciated. Evaluating patients for HPR is both inexpensive ($25) and rapid (< 10 min). Future randomized studies are warranted to determine whether HPR has a clinically detectable effect on revascularization outcomes.
INTRODUCTION:Multiple device closure (MDC) strategy has been used in treating of complex Atrial septal defects (ASDs) in adults. The safety profile of MDC compared to conventional single device closure (SDC) is unknown in this population. This report represents the first review examining the outcomes of single versus multiple device ASD closure in adults with ostium secundum defects. METHODS:Literature databases and manual search from their inception until June 30th, 2017 followed the Preferred Reporting Items of Systemic Review and Meta-Analysis (PRISMA) guideline. Main outcomes are 1) overall complication incidence, 2) arrhythmia incidence, 3) residual shunt rate. Each outcome profile was pooled by MDC and SDC, respectively and chi-square analysis was applied to examine statistical significance between MDC and SDC strategies (two-sided and p < .050). RESULTS:A total of 1806 + studies were initially screened, and 20 studies were finally selected (MDC group, 147 patients; SDC group, 1706 patients). There was no difference in overall complication incidence (χ2 = 1.269; p = .259) and arrhythmia incidence (χ2 = 0.325; p = .568) between MDC and SDC. There was no difference in residual shunt rate between the SDC (4.10 %; 70/1706) and MDC groups (6.80 %; 10/147; χ2 = 2.387; p = .122). CONCLUSIONS:The outcomes of percutaneous multiple ASD closure (MDC) seem to be safe and effective as compared to conventional single ASD (SDC) closure in terms of device - related complications and technical success of the procedure. Prospective registry data and randomized trials are needed to determine the long-term outcomes of percutaneous ASD closure using MDC.
Aortic stenosis is the most common valvulopathy requiring replacement by means of the surgical or transcatheter approach. Transcatheter aortic valve replacement (TAVR) has quickly become a viable and often preferred treatment strategy compared to surgical aortic valve replacement. However, transcatheter heart valve system deployment not infrequently injures the specialized electrical system of the heart, leading to new conduction disorders including high-grade atrioventricular block and complete heart block (CHB) necessitating permanent pacemaker implantation (PPI), which may lead to deleterious effects on cardiac function and patient outcomes. Additional conduction disturbances (e.g., new-onset persistent left bundle branch block, PR/QRS prolongation, and transient CHB) currently lack clearly defined management algorithms leading to variable strategies among institutions. This article outlines the current understanding of the pathophysiology, patient and procedural risk factors, means for further risk stratification and monitoring of patients without a clear indication for PPI, our institutional approach, and future directions in the management and evaluation of post-TAVR conduction disturbances. (c) 2021 Elsevier Inc. All rights reserved.
Aortic stenosis is the most common valvulopathy requiring replacement by means of the surgical or transcatheter approach. Transcatheter aortic valve replacement (TAVR) has quickly become a viable and often preferred treatment strategy compared to surgical aortic valve replacement. However, transcatheter heart valve system deployment not infrequently injures the specialized electrical system of the heart, leading to new conduction disorders including high-grade atrioventricular block and complete heart block (CHB) necessitating permanent pacemaker implantation (PPI), which may lead to deleterious effects on cardiac function and patient outcomes. Additional conduction disturbances (e.g., new-onset persistent left bundle branch block, PR/QRS prolongation, and transient CHB) currently lack clearly defined management algorithms leading to variable strategies among institutions. This article outlines the current understanding of the pathophysiology, patient and procedural risk factors, means for further risk stratification and monitoring of patients without a clear indication for PPI, our institutional approach, and future directions in the management and evaluation of post-TAVR conduction disturbances.
Background: Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valves that are detected up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be lower in percutaneous compared to surgical PVL repair. However, a direct comparison of PVL closure techniques has never been performed. Our study is the first to demonstrate that elective PVL closure with monitored anesthesia care can be achieved with high success and low complications rates resulting in short hospital stays. Methods: This is a retrospective cohort of patients admitted electively for catheter-based treatment of symptomatic prosthetic paravalvular regurgitation from Jan 2013 to April 2018. Both mitral and aortic PVLs were included. Patients' demographics, risk factors, procedural outcomes, In-hospital and thirty-day mortality were all reported. We followed the Valve Academic Research Consortium (VARC) criteria to define device and procedural technical success. In-hospital and 30- day outcomes were assessed by retrospective chart review. Results: A total of 54 PVLs in thirty-seven patients were repaired (65% aortic & 35% mitral). The mean-age in the mitral cohort was lower than the aortic cohort (61 vs 72 years, P 0.0001) but the two groups shared similar clinical risk factors (P 0.05). Average hospital stay was 1-2 days (<1.5 days overall cohort) which was significantly lower in the aortic compared to the mitral cohort (P = 0.009). All procedures were guided by TEE under conscious sedation with monitored anesthesia care. Procedural technical success defined as any significant residual shunt was 81% in the overall cohort and 88% in the aortic group. No procedural deaths were reported. Short-term mortality during the first 30 days was 5.4% (two patients). Conclusion: Elective catheter-based repair of symptomatic prosthetic paravalvular regurgitation appears to be safe and effective. The use of conscious sedation with monitored anesthesia care resulted in short hospital stay. (C) 2020 Published by Elsevier Inc.
Balloon aortic valvuloplasty (BAV) is commonly used in patients with severe decompensated aortic stenosis (AS) and provides symptomatic improvement without any benefit in overall survival [(1)][1]. Outcomes following BAV are often short-lived due to development of valvular restenosis [(2)][2], which
Stroke is the second-leading cause of death and a major cause of disability worldwide. The majority of strokes are ischaemic, and effective therapy to achieve reperfusion includes intravenous thrombolysis and, for proximal large vessel occlusion strokes, endovascular mechanical thrombectomy (MT). There has been a paradigm shift in acute stroke care, driven by a series of randomised controlled trials demonstrating that timely reperfusion with MT results in superior outcomes compared to intravenous thrombolysis in patients with large vessel occlusion strokes. There are significant geographic disparities in delivering acute stroke care because of the maldistribution of neurointerventional specialists. There are now several case series demonstrating the feasibility and safety of first medical contact MT by carotid stent-capable interventional cardiologists and noninvasive neurologists working on stroke teams, which is a solution to the uneven distribution of neurointerventionalists and allows stroke interventions to be delivered in local communities. We have featured as our Editor’s Pick for Interventional Cardiology 8.1 this discussion by White et al. of disparities in acute stroke care delivery due to regional service differences. Randomised studies in acute ischaemic stroke have demonstrated the superiority of mechanical thrombectomy over systemic thrombolysis in achieving reperfusion of large vessel occlusion. For more than four decades, interventional cardiologists have accumulated experience in treating acute coronary syndromes, and integration into stroke teams may help to achieve timely reperfusion and solve the disparities in access to specialised stroke centres, as shown in this article. Authors: *Christopher J. White, Jose D. Tafur, Tamunoinemi Bob-Manuel, Marloe Prince, Rajan A.G. Patel, J. Stephen Jenkins, Tyrone J. Collins, Stephen R. Ramee Ochsner Medical Center, New Orleans, Louisiana, USA *Correspondence to cwhite@ochsner.org Disclosure: The authors have declared no conflicts of interest.
Recent trials have shown impressive results in low-risk patients undergoing Transcatheter Aortic Valve Replacement (TAVR) with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days and have led to a Food and Drug Administration indication for TAVR in these patients.The long-term data on subclinical leaflet thrombosis, valve durability, effects of pacemaker implantation, right ventricular pacing, and progressive paravalvular leak is unclear. We describe clinical and procedural considerations for patient selection and introduce future potential procedural challenges. Finally, we discuss the importance of considering life expectancy and durability prior to TAVR in this low risk relatively young cohort and emphasize the importance of a heart team approach. (C) 2020 Published by Elsevier inc.
Recent trials have shown impressive results in low-risk patients undergoing Transcatheter Aortic Valve Replacement (TAVR) with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days and have led to a Food and Drug Administration indication for TAVR in these patients.The long-term data on subclinical leaflet thrombosis, valve durability, effects of pacemaker implantation, right ventricular pacing, and progressive paravalvular leak is unclear. We describe clinical and procedural considerations for patient selection and introduce future potential procedural challenges. Finally, we discuss the importance of considering life expectancy and durability prior to TAVR in this low risk relatively young cohort and emphasize the importance of a heart team approach. (C) 2020 Published by Elsevier inc.
There is an increasing need for alternative access in patients with prohibitive surgical risk who have unsuitable anatomy for transfemoral transcatheter aortic valve replacement (TAVR). Data on differences in periprocedural outcomes via alternative access sites are scarce. We performed a retrospective analysis of patients who underwent Transaxillary (TAX) or Transapical (TAP) TAVR at our center from 2012 to 2019. All data was summarized and displayed as mean +/- SD for continuous variables and number of patients in each group. A propensity score was created for each patient in the dataset to determine the probability of axillary vs apical access. We adjusted for propensity score using multivariate logistic regression. A total of 102 patients underwent TAVR via alternative access: 28 patients (27%) via TAX and 74 patients (73%) via transapical (TAP) access. The average time to extubation in the TAX group was 5.3 +/- 3.5 hours vs 9.1 +/- 8.8 hours in the TAP patients (P = 0.03). None of the TAX patients required reintubation compared to 23% of TAP TAVR (P = 0.003). The average hospital length of stay for TAX was 2.4 +/- 2.0 days compared to 6.9 +/- 3.3 days (P < 0.0001) for TAP. TAX TAVR patients had significantly lower re-intubation rates, shorter time to extubation and in-hospital length of stay, but higher pacemaker implantation rates. TAX TAVR had improved periprocedural outcomes compared to TAP TAVR and remains the preferred TAVR alternative access.
Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic heart valves that are detected in up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be overall low in percutaneous PVL repair. However, a direct comparison of the timing of the PVL closure to
Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is a safe and effective therapy for failed surgical bioprosthetic aortic valves in patients who are at high risk for surgery. Both balloon-expanding valves (BEVs) (Medtronic, Minneapolis, Minnesota) and self-expanding valves (SEVs) (