Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

Abstract

BACKGROUND There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aorticvalve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.

Transcatheter aortic valve replacement (TAVR) as bridge therapy restoring eligibility for liver transplantation in cirrhotic patients

“…Aortic regurgitation was less frequent. 20 We have not observed recurrent AS and aortic insufficiency in our patients yet because of our relatively weak follow-up. Taking into account that the average 5-year graft-survival after a first LT is 66% in multidisciplinary workup involving interventional cardiologist, anesthesiologist, and hepatologist is mandatory to discuss this procedure at an individual level.…”

Kathetergestützte Aortenklappenimplantation

“…Eine Subgruppen-Analyse der transfemoralen Kohorte zeigte gar eine Überlegenheit des kathetergestützten Verfahrens (TAVI: 16,3 %, AKE: 20,0 %, p = 0,04). In den kürzlich publizierten 5-Jahresdaten kreuzten sich nach rund 3 Jahren die Ereigniskurven des primären Endpunkts, die Nicht-Unterlegenheit blieb aber formal bestehen [9]. Es zeigten sich nun erstmals höhere Raten der Gesamtsterblichkeit, von Myokardinfarkten, Reinterventionen und Rehospitalisationen zwischen 2 und 5 Jahren im TAVI-Arm, nachdem die Ergebnisse der ersten beiden Jahre zugunsten des kathetergestützten Verfahrens ausgefallen waren [8].…”

“…Longitudinale Echokardiografie-Daten aus den frühen randomisierten Studien zeigen eine stabile Prothesenfunktion über 5 Jahre, bei z. T. niedrigeren Raten eines Prothesen-Patienten-Mismatch im Vergleich zum AKE. Die Prävalenz einer residuellen Insuffizienz blieb allerdings nach kathetergestütztem Vorgehen weiterhin erhöht [9,23,24] und mit Morbidität und Mortalität verbunden [8]. Die publizierte Inzidenz von Prothesendegenerationen und Wiederholungseingriffen war bislang niedrig, die beobachteten Zeiträume aber auch zu kurz, um dies systematisch beurteilen zu können.…”

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement—Systematic review and meta‐analysis of randomized controlled trials and prospective‐matched cohorts

“…1,2 It was once limited to high-risk patients but was recently shown to be noninferior to surgical aortic valve replacement in lowintermediate risk patients. [3][4][5][6] However, balloon valvuloplasty is not without its drawback, mechanical complications and acute hemodynamic change due to rapid pacing are associated with the procedure. [7][8][9] As technology advances, the possibility of direct TAVR without preimplantation balloon valvuloplasty becomes more feasible.…”