We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic ...stenosis and an increased risk of death during surgery.
We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing.
A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.
In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).
Platelets play an essential role in the pathophysiology of atherothrombosis. Reticulated platelets (RPs) are the youngest platelet population in the circulation; their presence is an indicator of ...platelet turnover. Circulating levels of RPs are increased in patients with coronary artery disease and stroke. Preliminary indications are that the proportion of circulating RP is associated with the likelihood of ischaemic events such as acute coronary syndrome and stroke. Plausible mechanisms include: (1) increased participation of these platelets in thrombosis due to messenger ribonucleic acid that may be translated to active proteins, (2) lack of exposure to anti-platelet drugs since they are newly released from the bone marrow or (3) their presence is a non-specific marker of inflammation. In this state-of-the-art review, we discuss the implication of RP in coronary artery disease and in hypo-responsiveness to the most commonly used anti-platelet drugs.
Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make ...coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication.
We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of -0.04±0.24 W in comparison with -0.14±0.27 W for IABP (P=0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5-supported patients in comparison with IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.023 in the per protocol population, respectively.
The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5-supported patients at 90 days.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00562016.
Antiplatelet therapy is the mainstay of treatment for patients with cardiovascular disease. However, some patients experience adverse cardiac events despite treatment with single- or ...dual-antiplatelet (aspirin and clopidogrel) therapy. Some of those events could be caused by low responsiveness to aspirin or clopidogrel. The frequency of this phenomenon has been reported to range from 1% to 45% for the 2 drugs. This wide range arises from the lack of a “gold-standard” definition to assess antiplatelet drug response and differences in assays, agonist concentrations, and cut-off points. Regardless of the variability in the incidence of aspirin or clopidogrel low responsiveness, several studies have indicated a clear relation between clopidogrel or aspirin low responsiveness and cardiovascular events. The evidence for an association between adverse clinical events and the results of ex vivo platelet function tests is stronger for clopidogrel than for aspirin. Currently, there is no established therapeutic approach for managing low response to aspirin or clopidogrel that has been shown in large trials to have clinical benefit. This review focuses on laboratory testing of antiplatelet response to aspirin and clopidogrel, the prevalence of low response, potential mechanisms, clinical significance, and prognostic value of this phenomenon and alternative approaches to optimize treatment in patients with low response to the drugs.
Simply, they applied the SYNTAX score based on quantitative coronary angiography to patients enrolled in FAME, stratified the patients into tertiles of risk based on the score, and then reclassified ...the coronary lesions by including in the score only those lesions with impaired FFR. ...fewer lesions were scored, and the intraobserver variability was improved considerably. ...the authors were able to construct a functional SYNTAX score (FSS) in which 32% of patients originally judged to be at high or intermediate risk were moved to lower risk strata.
Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.
The ...authors report their early experience with TMVR using a new valve system.
The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).
Fifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed.
TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation – The Twelve Intrepid TMVR Pilot Study; NCT02322840)
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Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve ...replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% P = .0145 for death and 19.2% vs 8.5% P = .0008 for acute kidney injury). Conclusions In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.
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