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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Available from: Raj Makkar, Oct 18, 2015
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    • "However, patients who are not eligible for the open-heart surgery may receive a bioprosthetic valve through a TAVI. Even though the one-year mortality for TAVI recipient is comparable to the patients undergoing surgical aortic valve replacement [8,9], there is still limited information on the longevity of the TAVI valves [10]. One way to indirectly assess the TAVI valve longevity can be through the evaluation of the leaflet loading, which may provide such surrogate measures. "
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    ABSTRACT: The transcatheter aortic valve implantation (TAVI) valve is a bioprosthetic valve within a metal stent frame. Like traditional surgical bioprosthetic valves, the TAVI valve leaflet tissue is expected to calcify and degrade over time. However, clinical studies of TAVI valve longevity are still limited. In order to indirectly assess the longevity of TAVI valves, an estimate of the mechanical wear and tear in terms of valvular deformation and strain of the leaflets under various conditions is warranted. The aim of this study was, therefore, to develop a platform for noncontact TAVI valve deformation analysis with both high temporal and spatial resolutions based on stereophotogrammetry and digital image correlation (DIC). A left-heart pulsatile in vitro flow loop system for mounting of TAVI valves was designed. The system enabled high-resolution imaging of all three TAVI valve leaflets simultaneously for up to 2000 frames per second through two high-speed cameras allowing three-dimensional analyses. A coating technique for applying a stochastic pattern on the leaflets of the TAVI valve was developed. The technique allowed a pattern recognition software to apply frame-by-frame cross correlation based deformation measurements from which the leaflet motions and the strain fields were derived. The spatiotemporal development of a very detailed strain field was obtained with a 0.5 ms time resolution and a spatial resolution of 72 μm/pixel. Hence, a platform offering a new and enhanced supplementary experimental evaluation of tissue valves during various conditions in vitro is presented.
    Full-text · Article · Jan 2016
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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.
    Full-text · Article · Jul 2015
    • "Of 14 cohort studies, 8 studies [10, 11, 13, 14, 16, 17, 19, 22] used propensity score analysis. To assess the risk of severe AKI requiring dialysis in patients undergoing TAVR, we included 2 RCTs [7, 8] and 11 cohort studies910111516171819202122 in the meta-analysis. Within selected studies , 14 and 11 studies were included for the post hoc analysis assessing the short-term [ "
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    ABSTRACT: The objective of this meta-analysis was to evaluate the risk of acute kidney injury (AKI) in patients who underwent transcatheter aortic valve replacement (TAVR). A literature search was performed using MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and from inception through October, 2014. Studies that reported relative risks, ORs, or hazard ratios comparing the AKI risk in patients who underwent TAVR versus those who underwent surgical aortic valve replacement were included. We performed the pre-specified sensitivity analysis including only propensity score-based studies. Mortality risk was evaluated among the studies that reported AKI outcome. Pooled risk ratios (RRs) and 95% confidence interval (CI) were calculated using a random-effect, generic inverse variance method. Three randomized controlled trials (RCTs) with 1,852 patients and 14 cohort studies with 3,113 patients were analyzed to assess the AKI risk in patients undergoing TAVR. The pooled RRs of AKI in patients undergoing TAVR were 0.65 (95% CI 0.36-1.15, I(2) = 75%) in the analysis of RCTs and propensity score-based studies and 0.76 (95% CI 0.44-1.34, I(2) = 79%) in the analysis of observational studies. Sensitivity analysis in RCTs and propensity score-based studies using a standard AKI definition demonstrated a significant association between TAVR and lower AKI risk (RR 0.35, 95% CI 0.25-0.50, I(2) = 0%). Our meta-analyses of RCTs and propensity score-based studies did not find associations between TAVR and reduced risks of severe AKI requiring dialysis (RR 0.82, 95% CI 0.38-1.79, I(2) = 63%). Our meta-analysis demonstrates an association between TAVR and lower AKI risk. © 2015 S. Karger AG, Basel.
    No preview · Article · Jun 2015 · American Journal of Nephrology
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