Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.
Baylor University1, Ohio State University2, Vanderbilt University3, University of Michigan4, NorthShore University HealthSystem5, Baylor University Medical Center6, Cleveland Clinic7, Northwestern University8, University of Virginia9, Tufts Medical Center10, Medical University of South Carolina11, University of Maryland, Baltimore12, Duke University13, Cedars-Sinai Medical Center14, MedStar Health15, Columbia University Medical Center16
TL;DR: The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate‐to‐severe or severe SMR.
About: This article is published in American Heart Journal.The article was published on 2018-11-01. It has received 71 citations till now. The article focuses on the topics: MitraClip & Mitral valve.
Citations
More filters
Columbia University Medical Center1, Vanderbilt University2, Ohio State University3, Cedars-Sinai Medical Center4, University of Virginia5, Intermountain Medical Center6, Baylor University Medical Center7, Carolinas Medical Center8, Piedmont Hospital9, University of Colorado Hospital10, University of Missouri–Kansas City11, MedStar Health12, Scott & White Hospital13
TL;DR: Among patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy, transcatheter mitral‐valve repair resulted in a lower rate of hospitalization forHeart failure and lower all‐cause mortality within 24 months of follow‐up than medical therapy alone.
Abstract: Background Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor Transcatheter mitral-valve repair may improve their clinical outcomes Methods At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group) The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 880% Results Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 t
1,758 citations
1,300 citations
264 citations
TL;DR: The beneficial effect of TMVR compared with GDMT alone was consistent in all echocardiographic subgroups, independent of the severity of LV dysfunction, LV dilatation, pulmonary hypertension, severity of tricuspid regurgitation or individual MR characteristics.
140 citations
Scott & White Hospital1, Vanderbilt University2, Ohio State University3, Bakersfield Heart Hospital4, University of Virginia5, Kaiser Permanente6, Intermountain Medical Center7, Baylor University Medical Center8, Cleveland Clinic9, Piedmont Hospital10, University of Colorado Hospital11, University of California, Davis12, Columbia University13, University of Missouri–Kansas City14, Georgetown University15, Icahn School of Medicine at Mount Sinai16
TL;DR: In the COAPT trial, transcatheter mitral valve repair (TMVr) resulted in fewer heart failure hospitalizations (HFHs) and lower mortality at 24-months in patients with heart failure (HF) with mitral regurgitation (MR) secondary to left ventricular dysfunction compared with guideline-directed medical therapy (GDMT) alone as mentioned in this paper.
94 citations
References
More filters
TL;DR: In this article, Anderson et al. proposed a new FAHA Chair, Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect, Alice K. Jacobs et al., this article and Biykem Bozkurt.
11,386 citations
14 Apr 2005
TL;DR: Cardiac resynchronization has been shown to reduce symptoms and improve left ventricular function in patients with heart failure due to systolic dysfunction and cardiac dyssynchrony.
Abstract: background Cardiac resynchronization reduces symptoms and improves left ventricular function in many patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony We evaluated its effects on morbidity and mortality methods Patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony who were receiving standard pharmacologic therapy were randomly assigned to receive medical therapy alone or with cardiac resynchronization The primary end point was the time to death from any cause or an unplanned hospitalization for a major cardiovascular event The principal secondary end point was death from any cause results A total of 813 patients were enrolled and followed for a mean of 294 months The primary end point was reached by 159 patients in the cardiac-resynchronization group, as compared with 224 patients in the medical-therapy group (39 percent vs 55 percent; hazard ratio, 063; 95 percent confidence interval, 051 to 077; P<0001) There were 82 deaths in the cardiac-resynchronization group, as compared with 120 in the medical-therapy group (20 percent vs 30 percent; hazard ratio 064; 95 percent confidence interval, 048 to 085; P<0002) As compared with medical therapy, cardiac resynchronization reduced the interventricular mechanical delay, the end-systolic volume index, and the area of the mitral regurgitant jet; increased the left ventricular ejection fraction; and improved symptoms and the quality of life (P<001 for all comparisons) conclusions In patients with heart failure and cardiac dyssynchrony, cardiac resynchronization improves symptoms and the quality of life and reduces complications and the risk of death These benefits are in addition to those afforded by standard pharmacologic therapy The implantation of a cardiac-resynchronization device should routinely be considered in such patients
5,493 citations
Anschutz Medical Campus1, University of Southern California2, Pennsylvania State University3, Memorial Hospital of South Bend4, Johns Hopkins University5, University of California, San Francisco6, United States Department of Veterans Affairs7, Pfizer8, University of Wisconsin-Madison9, Boston Scientific Corporation10, Thomas Jefferson University11
TL;DR: In this paper, the authors tested the hypothesis that prophylactic cardiac-resynchronization therapy in the form of biventricular stimulation with a pacemaker with or without a defibrillator would reduce the risk of death and hospitalization among patients with advanced chronic heart failure and intraventricular conduction delays.
Abstract: background We tested the hypothesis that prophylactic cardiac-resynchronization therapy in the form of biventricular stimulation with a pacemaker with or without a defibrillator would reduce the risk of death and hospitalization among patients with advanced chronic heart failure and intraventricular conduction delays. methods A total of 1520 patients who had advanced heart failure (New York Heart Association class III or IV) due to ischemic or nonischemic cardiomyopathies and a QRS interval of at least 120 msec were randomly assigned in a 1:2:2 ratio to receive optimal pharmacologic therapy (diuretics, angiotensin-converting–enzyme inhibitors, beta-blockers, and spironolactone) alone or in combination with cardiac-resynchronization therapy with either a pacemaker or a pacemaker–defibrillator. The primary composite end point was the time to death from or hospitalization for any cause. results As compared with optimal pharmacologic therapy alone, cardiac-resynchronization therapy with a pacemaker decreased the risk of the primary end point (hazard ratio, 0.81; P=0.014), as did cardiac-resynchronization therapy with a pacemaker–defibrillator (hazard ratio, 0.80; P=0.01). The risk of the combined end point of death from or hospitalization for heart failure was reduced by 34 percent in the pacemaker group (P<0.002) and by 40 percent in the pacemaker–defibrillator group (P<0.001 for the comparison with the pharmacologic-therapy group). A pacemaker reduced the risk of the secondary end point of death from any cause by 24 percent (P=0.059), and a pacemaker–defibrillator reduced the risk by 36 percent (P=0.003). conclusions In patients with advanced heart failure and a prolonged QRS interval, cardiac-resynchronization therapy decreases the combined risk of death from any cause or first hospitalization and, when combined with an implantable defibrillator, significantly reduces mortality.
5,132 citations
4,790 citations
TL;DR: Cardiac resynchronization results in significant clinical improvement in patients who have moderate-to-severe heart failure and an intraventricular conduction delay.
Abstract: Background Previous studies have suggested that cardiac resynchronization achieved through atrial-synchronized biventricular pacing produces clinical benefits in patients with heart failure who have an intraventricular conduction delay. We conducted a double-blind trial to evaluate this therapeutic approach. Methods Four hundred fifty-three patients with moderate-to-severe symptoms of heart failure associated with an ejection fraction of 35 percent or less and a QRS interval of 130 msec or more were randomly assigned to a cardiac-resynchronization group (228 patients) or to a control group (225 patients) for six months, while conventional therapy for heart failure was maintained. The primary end points were the New York Heart Association functional class, quality of life, and the distance walked in six minutes. Results As compared with the control group, patients assigned to cardiac resynchronization experienced an improvement in the distance walked in six minutes (+39 vs. +10 m, P=0.005), functional clas...
4,329 citations