Safety and Efficacy of Transcatheter Aortic Valve Implantation in Nonagenarian Patients (original) (raw)
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1-Year Outcomes After Transfemoral Transcatheter or Surgical Aortic Valve Replacement
Journal of the American College of Cardiology, 2015
BACKGROUND There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. OBJECTIVES This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. METHODS The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. RESULTS The unadjusted enrolled population (N ¼ 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 AE 9.2% vs. 9.5 AE 7.1%, SAVR vs. transfemoral TAVR; p ¼ 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p ¼ 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p ¼ 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. CONCLUSIONS The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.
Revista Portuguesa de Cardiologia (English Edition), 2012
Introduction: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement in patients with severe aortic stenosis (AS) and unacceptably high surgical risk. Methods: We present our first two years' experience with TAVI. A total of 76 AS patients were evaluated for TAVI and 23 of them underwent a TAVI procedure. These patients had a mean EuroSCORE of 22.4% and a mean age of 81.5 years, and were prospectively followed for a mean of 12.9±11 months. Results: The percutaneous aortic valve was successfully implanted in 100% of the patients. Mortality at 30 days was 4%. The most common complications were access site-related bleeding and transfusion (22%), followed by new permanent pacemaker implantation (9%). After a mean follow-up of 12.9 months, survival was 87%. In a maximum follow-up of 30 months there were no cases of prosthesis dysfunction or cardiovascular death.
American Heart Journal, 2010
Transcatheter aortic valve implantation (TAVI) is an alternative treatment option for patients with aortic stenosis deemed high risk or unsuitable for aortic valve replacement. The aim of this study was to assess the feasibility of TAVI in elderly patients, the delivery of this technology with a multidisciplinary approach, and the use of traditional surgical scoring systems. One hundred fifty-one consecutive patients (mean age 82.6 +/- 7.3 years) with severe aortic stenosis underwent TAVI with the Edwards Lifesciences (Irvine, CA) Sapien bioprosthesis using the transapical (n = 84; 56%) or transfemoral (n = 67; 44%) approach from August 2007 to September 2009 at King's Health Partners, London, United Kingdom. We analyzed procedural outcome, complications, functional status, and midterm outcome of patients. The multidisciplinary team comprised interventional cardiologists, cardiothoracic surgeons, imaging specialists, cardiac anesthetists, and specialist nurses. Seventy percent of patients were in New York Heart Association class III/IV, and logistic EuroSCORE was 21.6 +/- 11.9. Procedural success was achieved in 98%. Postoperative complications included stroke (6%), complete atrioventricular block (5.3%), renal failure requiring hemofiltration (9.3%), and vascular injury (8.6%). Overall 30-day mortality was 9.9% (n = 15). The logistic EuroSCORE was a predictor of short-term mortality (logistic regression model, P < .05). Thirty-day mortality post-TAVI for patients with logistic EuroSCORE <20, 20 to 40, and >40 was 5.4%, 13.2%, and 22.2%, respectively. Transcatheter aortic valve implantation is a feasible treatment option in this patient group with promising short/medium-term results. Renal failure is the commonest short-term complication, and the incidence of vascular complications remains high. Risk prediction/case selection remains challenging, and a multidisciplinary team approach appears to be helpful in appropriate patient selection.
Revista Brasileira de Cardiologia Invasiva English Version, 2013
Background: Transcatheter aortic valve implantation (TAVI) is a treatment option for patients with aortic valve stenosis (AS) and high or prohibitive surgical risk. We report our experience using the Medtronic CoreValve TM self-expending system. Methods: From 2009 to 2013, 51 consecutive patients with severe symptomatic AS and high or prohibitive surgical risk were submitted to TAVI. Results were analyzed according to the criteria of the Valve Academic Research Consortium (VARC) -2. Results: Mean age was 82 ± 6 years, 49% were female, 19% were diabetic, 21% had renal failure and the logistic EuroScore was 17.4 ± 11.4%. The success rate of the device was 84.3%. All of the patients had a significant decrease of transaortic gradients, which was maintained over time. Hospitalization time was 6 days (interquartile range: 5-8.8). In-hospital mortality at 30 days as 7.8% and 9.8%, respectively. Permanent pacemaker implantation was required in 32.6% of the cases; ischemic stroke was observed in 3.9% and major vascular complications in 6% of the patients. Survival at 6 months and 1 year was 86.3% and 84.4%, respectively. NYHA functional class improved significantly after TAVI and remained low in the medium-term follow-up. Conclusions: In this preliminary experience, the treatment of patients with AS and high or prohibitive surgical risk with TAVI, using the CoreValve TM self-expanding system was feasible and safe and