for the PARTNER Trial Investigators. 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: 55.87). 10/2010; 363(17):1597-607. DOI: 10.1056/NEJMoa1008232
Source: PubMed


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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    • "TAVR is most often performed on patients drawn from an elderly population with considerable comorbidities (Leon et al., 2010), and a major concern is that MH might be associated with adverse side effects. Infusion of cold saline is also a noninvasive cooling method (Kim et al., 2007; Erlinge et al., 2014), but in the TAVR population, impaired left ventricular ejection fraction (LVEF) and pulmonary hypertension (PAH) are common (Kamperidis et al., 2014), and rapid infusion of 1000–2000 mL cold saline could lead to increased risk of pulmonary edema and acute heart failure. "
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    ABSTRACT: The safety, feasibility, and hemodynamic effects of mild hypothermia (MH) induced by transnasal cooling were studied in transcatheter aortic valve replacement (TAVR). MH is a common therapy following cardiac arrest and seems to have favorable effects in myocardial infarction and on hemodynamic stability. In TAVR, hemodynamic instability is common during rapid pacing. Twenty subjects undergoing TAVR were randomized 1:1 to hypothermia or normothermia. Hemodynamic endpoints were mean arterial blood pressure and required dosage of vasoactive and inotropic drugs. Patients were followed up at 6 months. All patients in the MH group (n=10) reached the target temperature of 34°C before first rapid pacing. Tympanic and urinary bladder temperature remained significantly lower in the MH group during the procedure. No adverse effects of cooling were observed. Mean arterial pressure was higher in the MH group (90±20 mm Hg) than in the control group (71±13 mm Hg) at the start of the procedure, at first rapid pacing (94±19 vs. 80±16 mm Hg), and at balloon aortic valvuloplasty (90±17 vs. 73±14 mm Hg). Less norepinephrine was administered to the hypothermia group. Transnasal cooling during TAVR was safe and well tolerated. We observed a more stable hemodynamic profile in the MH group, indicated by higher blood pressure and lower levels of vasoactive drugs required. A larger study of patients with severe ventricular dysfunction is required to more comprehensively investigate the hemodynamic effects of transnasal cooling in TAVR.
    07/2015; DOI:10.1089/ther.2015.0011
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    • "As a result, a large cohort of elderly patients with symptomatic severe AS and elevated operative risk will require intervention and present a unique set of management challenges for the heart teams managing them. Transcatheter aortic valve implantation (TAVI) is the standard of care for managing elderly patients with high operative risk suffering from symptomatic severe aortic valve stenosis [4] [5]. While the benefits of TAVI are clear, recent guidelines have omitted patients with BiAVs from their recommendations [6] [7]. "
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    ABSTRACT: We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV). BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients. We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint - a composite of 30day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30days and 1year. A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%) - mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1year mortality rates were 8.3% and 16.9% respectively with AR≥3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30day or 1year mortality - Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants. In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    International Journal of Cardiology 04/2015; 189(1). DOI:10.1016/j.ijcard.2015.04.066 · 4.04 Impact Factor
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    • "Transcatheter aortic valve implantation (TAVI) is a new standard of care for patients who suffer from symptomatic aortic disease with a high perioperative mortality risk or those with contraindications for conventional surgery [1] [2] [3]. Treatment of aortic stenosis (AS) with TAVI improves patients' clinical outcome and has a beneficial effect on their quality of life [4] [5]. "
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    ABSTRACT: To determine whether the location of aortic valve calcium (AVC) influences the location of paravalvular regurgitation (PR). PR is an adverse effect of transcatheter aortic valve implantation (TAVI) with a negative effect on long-term patient survival. The relationship between AVC and the occurrence of PR has been documented. However, the relationship between the distribution of AVC and the location of PR is still sparsely studied. The purpose of this study was to correlate severity and location of AVC with PR in patients treated with TAVI. Fifty-six consecutive patients who underwent transaortic or transapical TAVI and had preoperative computed tomography scans were included in this retrospective study. The volume, mass and location of AVC was determined and compared between patients with and without PR using a non-parametric t-test. Postoperative echocardiography was performed to determine the presence and location of PR, which was associated with the cusp with highest AVC using a χ(2) test. Valve deployment was successful in all 56 patients. PR was present in 38 patients (68%) after TAVI. There was a non-significantly higher volume of AVC in the PR group [214 (70-418) vs 371 (254-606) cm(3), P = 0.15]. AVC mass was significantly higher in patients with PR than in patients without PR [282 (188-421) vs 142 (48-259) mg, respectively, P = 0.043]. The location of PR was determined in 36 of these patients. Of these 36 patients, PR occurred at the cusp with the highest AVC in 20 patients (56%, χ(2) P = 0.030). In our population, PR was associated with greater AVC mass. Moreover, the location of PR was associated with the cusp with the highest amount of AVC. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
    Interactive Cardiovascular and Thoracic Surgery 12/2014; 20(3). DOI:10.1093/icvts/ivu413 · 1.16 Impact Factor
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