In a randomized trial, 1468 patients with severe aortic stenosis who were at low risk for death with surgery were assigned to either transcatheter aortic-valve replacement with a self-expanding valve ...or surgical aortic-valve replacement. At 2 years, TAVR was noninferior to surgery with respect to death or disabling stroke.
To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical ...research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health.
Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials.
The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite endpoints for TAVI safety and effectiveness were also recommended.
Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes.
Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening ...(HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.
The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.
A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.
At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.
The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)
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Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of ...complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access.
The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed.
Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I–defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses.
Major morbidity and mortality rates SCA-TAVR are equivalent to TF-TAVR. The SCA should be the preferred secondary access site for TAVR because it offers procedural and clinical outcomes comparable to TF-TAVR and applies to most patients who are not TF candidates.
The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents ...(DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction TVMI, or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES).
This study sought to assess clinical outcomes through 3 years following BVS implantation.
Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years.
The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter <2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis.
In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial RCT ABSORB-III; NCT01751906).
In a randomized trial involving 2008 patients with coronary disease, an everolimus-eluting bioresorbable scaffold was noninferior to an everolimus-eluting cobalt–chromium stent with respect to ...target-lesion failure at 1 year.
Contemporary drug-eluting coronary stents have been associated with better clinical outcomes than have either bare-metal stents or first-generation drug-eluting stents, but ongoing risks of stent thrombosis and restenosis limit their long-term safety and efficacy.
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The development of late adverse events with permanent metallic stents may be related to persistent inflammation, loss of normal vessel curvature, impaired vasomotion, strut fracture, ongoing tissue growth within the stent frame, and neoatherosclerosis.
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Furthermore, 20 to 30% of patients have recurrent angina during the first year after implantation of a drug-eluting stent.
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In this context, stents that are fully bioresorbable have been . . .
Transcatheter aortic-valve replacement with a new self-expanding prosthesis was compared with surgical aortic-valve replacement in patients with aortic stenosis who were at high surgical risk. The ...rate of death from any cause at 1 year was lower in the TAVR group.
Aortic stenosis is a debilitating disease in elderly persons that carries a dismal prognosis after symptom onset.
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Although surgical aortic-valve replacement remains the standard treatment for aortic stenosis,
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many patients are not suitable candidates for surgical replacement owing to an increased risk of death during surgery.
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Transcatheter aortic-valve replacement (TAVR) with a balloon-expandable device improves survival, as compared with medical therapy, in patients with severe aortic stenosis who cannot undergo surgery.
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Balloon-expandable TAVR and surgical aortic-valve replacement are associated with similar survival rates at 1 year among patients considered to be at high surgical risk, although the frequency of . . .
Abstract Background Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. Objectives The goal of ...this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. Methods We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. perspective. Results Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years (QALY; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained. Conclusions In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. standards. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement Medtronic CoreValve U.S. Pivotal Trial; NCT01240902 )
Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.
The purpose of this study was to examine ...outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.
The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently.
In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points.
In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed.
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