Search

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date., Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality., Results: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P <0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P <0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis., Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV., Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Background: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access., Objectives: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR., Methods: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed., Results: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers., Conclusions: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device., Background: The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device., Methods: The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2)., Results: A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%., Conclusions: TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: To assess the feasibility and safety of transcatheter aortic valve implantation (TAVI) through a left transcarotid approach in patients previously operated on for ipsilateral carotid endarterectomy (CEA)., Background: The healthcare impact of extracranial carotid artery disease is essential as stroke is the third-leading cause of death in industrialized nations and CEA is often present in the history of patients awaiting TAVI., Methods: The primary endpoint was to evaluate 30-day mortality and freedom from major TAVI-related complications in an observational analysis., Results: From December 2011 to February 2014, we performed 9 TAVI. The mean age was 84.6 years. The procedure was performed without any technical complication or vascular injury in every patient. There was neither intraoperative mortality nor intraoperative major complications. One (11.1%) patient experienced spatial-temporal disorientation but cerebral computed tomography did not show any sign of stroke. Two (22.2%) patients needed the implantation of a pacemaker due to third-degree atrioventricular block appearance. Three (33.3%) patients were transfused with packed red blood cells and 1 (11.1%) patient developed a groin hematoma. Only 1 (11.1%) patient showed a residual paravalvular regurgitation ≥ 2. At 30-day follow-up there was neither mortality nor other TAVI-related complications and echocardiography parameters remained stable., Conclusions: TAVI through a left transcarotid approach in patients previously operated on for ipsilateral CEA is feasible and safe. The presence of a previous ipsilateral CEA represents no more a limitation to the utilization of this promising access route. At short-term follow-up, mortality and major complications rates are low., (© 2014 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Several issues remain unresolved post-TAVR, including CVEs., Methods: The FRANCE-2 (French Aortic Nation CoreValve and Edwards-2) registry prospectively included all patients who underwent TAVR in France and Monaco from January 2010 to October 2011. A total of 3,191 patients were analyzed. Six-month follow-up data were obtained. Events were adjudicated according to Valve Academic Research Consortium (VARC)-1 definition., Results: Of the cohort, 3.98% experienced a CVE: 55% were major strokes, 14.5% minor strokes, and 30.5% transient ischemic attacks. The mean delay for CVE occurrence was 2 days (interquartile range: 0 to 7 days) with 48.5% of CVEs occurring within 2 days. There was no statistically significant difference in CVE rate with regard to the type of valve (p = 0.899) and the access route (p = 0.128). Patients with a CVE more frequently had new-onset paroxysmal atrial fibrillation (13.6% vs. 7.6%; p = 0.015). During follow-up, the unadjusted mortality rate was higher in patients with a CVE (26% vs. 16.5%; p = 0.002). By multivariate analysis, only advanced age (odds ratio: 1.05; 95% confidence interval: 1.02 to 1.08; p = 0.02) and having 2 valves implanted (odds ratio: 3.13; 95 confidence interval: 1.40 to 7.05; p = 0.006) were associated with a significant risk of CVEs., Conclusions: CVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Retrograde transfemoral artery catheterization is the most common way of implanting a percutaneous aortic valve. But in some cases, this access cannot be used and the subclavian artery access may represent an alternative to the femoral route, even offering certain advantages. This article describes prosthetic aortic valve implantation using the subclavian arterial approach and reports the findings., Methods: The valve prosthesis is a self-expandable, nitinol-based device (CoreValve; Medtronic Inc. Minneapolis, Minn). The axillary or subclavian artery was exposed with a small incision. Rapid ventricular pacing was used to reduce cardiac output while a routine aortic balloon valvuloplasty was performed. Then, an 18F sheath was inserted into the axillary artery down into the ascending aorta. By using this method, a prosthesis was implanted in 17 patients (aged 71±11 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications., Results: Subclavian arterial injury did not occur in any patient. The postprocedural aortic valve area increased from 0.6±0.3 cm2 to 1.44±0.35 cm2. A transient ischemic attack occurred in 1 patient. Two patients experienced transitory brachial plexus deficit. There were no intraprocedural deaths. Two deaths occurred in the 30-day follow-up period., Conclusions: This initial experience suggests that subclavian transarterial aortic valve implantation, in selected high-risk patients, is feasible and safe with satisfactory short-term outcomes., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)