5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis

ObjectivesThe purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).BackgroundThere is a paucity of evidence on long-term durability of currently available transcatheter heart valves.MethodsStarting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.ResultsAll-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported.ConclusionsTAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.     

Commissural Alignment After Balloon-Expandable Transcatheter Aortic Valve Replacement Is Associated With Improved Hemodynamic Outcomes

BackgroundTranscatheter aortic valve replacement (TAVR) is generally performed without control over the alignment of the bioprosthesis to the native aortic valve (AV) commissures. Data on the impact of commissural misalignment (CMA) on the clinical and hemodynamic outcome after TAVR are scarce.ObjectivesThe aim of this study was to investigate the impact of commissural misalignment (CMA) on the clinical and hemodynamic outcome in patients with severe tricuspid aortic stenosis undergoing TAVR using the balloon-expandable (BE) SAPIEN 3 valve (Edwards LifeSciences).MethodsClinical data of consecutive patients who underwent BE TAVR at Cedars-Sinai Medical Center (Los Angeles, California, USA) enrolled in the RESOLVE (Assessment of TRanscathetER and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation) registry were retrospectively analyzed to evaluate CMA, which was defined as a neocommissure position >30° compared with native commissures on computed tomography.ResultsA total of 324 patients (36.6% female, median Society of Thoracic Surgeons score of 3.9%) were included in the analysis. CMA was present in 171 individuals (52.8%). At 30 days, rates of aortic regurgitation greater than mild (5.6%) and a residual AV gradient ≥20 mm Hg (7.4%) were not different between CMA and non-CMA patients. Commissural orientation was independently associated with a relative AV mean gradient increase >50% from discharge to 30 days (per increase of 10° misalignment; OR: 1.3; 95% CI: 1.0-1.4; P = 0.01). The long-term composite outcome of death or stroke was not different between groups (log-rank P = 0.29).ConclusionsIn patients with severe tricuspid aortic stenosis who undergo SAPIEN 3 TAVR, the neocommissures align randomly. Our data demonstrate that commissural alignment may impact device performance and clinical outcomes in patients undergoing BE TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic VaLVve Dysfunction with Multimodality Imaging and Its TrEatment with Anticoagulation [RESOLVE]; NCT02318342)     

Impact of New York Heart Association Functional Class on Outcomes After Transcatheter Aortic Valve Implantation

BackgroundIn the current guidelines, indications for transcatheter aortic valve implantation (TAVI) are expanded to include several subgroups of asymptomatic patients with severe aortic stenosis (AS), and there is a paucity of data on the prognostic impact of New York Heart Association (NYHA) functional class in patients with severe AS undergoing TAVI.MethodsAmong 2588 patients enrolled in the OCEAN-TAVI registry, patients were divided into 4 groups according to baseline NYHA class (class I in 95 patients, class II in 1172 patients, class III in 1126 patients, and class IV in 195 patients).ResultsMedian follow-up was 729 days. The cumulative 2-year incidence of all-cause death was significantly higher in patients with NYHA class IV and III than in those with NYHA class II and I. (30.0%, 21.3%, 13.4%, and 11.2%, respectively, P < 0.001). After adjusting confounders, NYHA class IV and III, but not NYHA class II were independently associated with higher mortality compared with NYHA class I (reference) (adjusted HR: 3.43, 95%CI: 1.83–7.15, P < 0.001; adjusted HR: 2.07, 95%CI: 1.15–4.19, P = 0.013; and adjusted HR: 1.50, 95%CI: 0.83–3.04, P = 0.19, respectively). With increasing NYHA class, there was an incremental increase of heart failure hospitalization in the effect size relative to the reference (NYHA class I).ConclusionsThe long-term outcomes of patients with NYHA class I were better than those with NYHA class IV or III in some selected patients undergoing TAVI.     

Long-Term Outcomes After Transcatheter Aortic Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: The U.K. Transcatheter Aortic Valve Implantation Registry

ObjectivesThe U.K. Transcatheter Aortic Valve Implantation Registry reported 30-day and 1-year mortality rates of 7.1% and 21.4%, respectively, for patients who underwent transcatheter aortic valve replacement (TAVR) in the United Kingdom between 2007 and 2009. The study aim was to report long-term outcomes in this same cohort of patients.BackgroundThere are few data on outcomes beyond 3 years after TAVR in any notable number of patients.MethodsData from all TAVR procedures performed in the United Kingdom between January 2007 and December 2009 were prospectively collected. All-cause mortality status was reported in March 2014. Mortality tracking was achieved in 97.7% patients.ResultsThe minimal time from replacement to census was 4.1 years, and the maximal time was 7.0 years. The 3- and 5-year survival rates were 61.2% and 45.5%, respectively. Independent predictors of 3-year mortality were renal dysfunction (hazard ratio [HR]: 1.65), atrial fibrillation (HR: 1.36), logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥18.5 (HR: 1.33), respiratory dysfunction (HR: 1.28), and ventricular dysfunction (left ventricular ejection fraction <30%) (HR: 1.53). Coronary artery disease (HR: 1.28) and age (HR: 1.03) were additional independent predictors of mortality at 5 years. Stroke within 30 days of TAVR was the only independent procedural predictor of mortality at 3 and 5 years (HR: 2.17 at 3 years). Device type, access route, and paravalvular leak did not independently predict long-term outcome.ConclusionsIn the large U.K. Transcatheter Aortic Valve Implantation Registry, long-term outcomes after TAVR are favorable with 3- and 5-year survival rates of 61.2% and 45.5%, respectively. Long-term survival after TAVR is largely determined by intrinsic patient factors. Other than stroke, procedural variables, including paravalvular aortic leak, did not appear to be independent predictors of long-term survival.