Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

Columbia University Medical Center/NewYork–Presbyterian Hospital, New York, NY 10032, USA.
New England Journal of Medicine (Impact Factor: 54.42). 10/2010; 363(17):1597-607. DOI: 10.1056/NEJMoa1008232
Source: PubMed

ABSTRACT Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.
We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.
A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.
In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; number, NCT00530894.).

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    • "Since the first transcatheter aortic valve implantation (TAVI) in 2002 [1], more than 100,000 procedures in more than 40 countries have been performed [2]. TAVI is currently considered the standard of care for the treatment of patients with severe symptomatic inoperable aortic stenosis [3] as well as an alternative treatment for high-risk surgical patients [4]. The benefits of TAVI include improvement in New York Heart Association functional class and quality of life, left ventricular ejection fraction, and short-and long-term survival [3,5–9]. "
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    ABSTRACT: Background The aim of this study is to evaluate the predictors of permanent pacemaker (PPM) implantation after TAVI. Methods Between January 2008 and February 2012, 418 patients with severe aortic stenosis underwent TAVI and were enrolled in a Brazilian multicenter registry. After excluding patients who died during the procedure and those with a previous PPM, 353 patients were included in the analysis. Results At 30 days, the overall incidence of PPM implantation was 25.2%. Patients requiring PPM were more likely to be older (82.73 vs. 81.10 years, p = 0.07), have pre-dilation (68.42% vs. 60.07%, p = 0.15), receive CoreValve (93.68% vs. 82.55%, p = 0.008), and have baseline right bundle branch block (RBBB, 25.26% vs. 6.58%, p < 0.001). On multivariable analysis, CoreValve vs. Sapien XT (OR, 4.24; 95% CI, 1.56–11.49; p = 0.005), baseline RBBB (OR, 4.41; 95% CI, 2.20–8.82; p < 0.001), and balloon pre-dilatation (OR, 1.75; 95% CI, 1.02–3.02; p = 0.04) were independent predictors of PPM implantation. Conclusion PPM implantation occurred in approximately one-fourth of cases. Pre-existing RBBB, balloon pre-dilatation, and CoreValve use were independent predictors of PPM after TAVI. The type of prosthesis used and pre-balloon dilatation should be considered in TAVI candidates with baseline RBBB.
    International Journal of Cardiology 08/2014; 175(2):248–252. DOI:10.1016/j.ijcard.2014.05.020 · 6.18 Impact Factor
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    • "During the past decade, transcatheter AVR (TAVR) has emerged as a minimally invasive alternative for high-risk patients [2] [3] [4]. Small, randomized studies confirmed acceptable outcomes for certain selected high-risk and inoperable patients [5] [6] for both the transvascular (TV) and the transapical (TA) approach, when compared with conservative or surgical management. "
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    ABSTRACT: The German Aortic Valve Registry (GARY) seeks to provide information on a real-world, all-comers basis for patients undergoing aortic valve interventions. This registry comprises patients undergoing the complete spectrum of transcutaneous and conventional surgical aortic valve interventions. The aim of this study was to use the GARY registry to evaluate conventional and catheter-based aortic valve interventions in several risk groups.
    European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 07/2014; DOI:10.1093/ejcts/ezu290 · 2.81 Impact Factor
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    • "Thus, TAVI might be a valid alternative therapy in this subset of patients. However, no definite data are present regarding the cardiovascular and overall outcome after TAVI in patients with low EF [3] [9] [28] [36] [37] [40], and accordingly, some experiences, including the original PARTNERS A and B [1] [2], did not identify a low EF as a predictor of mortality after TAVI, in the multivariable analyses [9] [10]. On the contrary, some other observational studies reported a higher mortality of patients with low EF following TAVI procedure [11] [12] [13] [14] [15] [16] [17] [18]. "
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    ABSTRACT: Background: There is conflicting evidence regarding the safety and efficacy of transcatheter aortic valve implantation (TAVI) procedures in patients with severe aortic stenosis and low left ventricular ejection fraction (EF). The primary aim of this study was to determine the impact of TAVI on short-and long-term mortality in patients with low EF (EF < 50%); the secondary aim was to analyze the impact of TAVI procedure on EF recovery in the same setting of patients. Methods and results: Twenty-six studies enrolling 6898 patients with severe aortic stenosis undergoing TAVI procedure were included in the meta-analysis and analyzed for 30-day, 6-month and 1-year all-cause and cardiovascular mortality; a further meta-analysis was also performed in patients with low EF to assess EF changes post TAVI. In low EF patients, both all-cause and cardiovascular short-and long-term mortality were significantly higher when compared to patients with normal EF (30-day-all-cause mortality: 0.13; 95% confidence interval [CI]: 0.01 to 0.25, I-2 = 49.65, Q = 21.85; 1-year-all-cause mortality: 0.25; 95% [CI]: 0.16 to 0.34, I-2 = 25.57, Q = 16.12; 30-day-cardiovascular mortality: 0.03; 95% [CI]: -0.31 to 0.36, I-2 = 66.84, Q = 6.03; 1-year-cardiovascular mortality: 0.29; 95% [CI]: 0.12 to 0.45, I-2 = 0.00, Q = 1.88). Nevertheless, in low EF patients TAVI was associated with a significant recovery of EF, which started at discharge and proceeded up to 1-year-follow-up. Conclusions: Patients with low EF severe aortic stenosis have higher mortality following TAVI compared to normal EF patients, despite a significant and sustained improvement in EF.
    International Journal of Cardiology 06/2014; 176(1). DOI:10.1016/j.ijcard.2014.06.017 · 6.18 Impact Factor
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