Assessment of a Cardiac Support Device (CSD) in Patients With Heart Failure - ACORN

Description:

The goal of the trial was to evaluate whether treatment with the CorCap Cardiac Support Device (CSD), a mesh wrap implanted around the heart to reduce wall stress and left ventricular (LV) remodeling, impacts heart failure outcomes compared with usual therapy in patients with heart failure and dilated cardiomyopathy.

Study Design

Study Design:

Patients Enrolled: 300
NYHA Class: Class III 81.3%, Class IV 3.7%
Mean Follow Up: Median 22 months
Mean Patient Age: Mean age 52.5 years
Female: 45

Patient Populations:

NYHA class III-IV heart failure, age 18-80 years, ejection fraction <35% and LV end-diastolic volume >60 m, six-minute walk test <450 m, and stable and optical medical therapy

Primary Endpoints:

Composite endpoint that classified patients as improved, same, or worsened with respect to the occurrence of death, major cardiac procedure indicative of heart failure progression, or change in NYHA class

Drug/Procedures Used:

Patients who were going to be treated with mitral valve repair or replacement (MVR) surgery (n=193) were randomized to either MVR alone (n=102) or MVR plus CSD (n=91). Patients who were going to be treated with medical therapy (n=107) were randomized to either medical therapy alone (n=50) or medical therapy plus CSD (n=57). The analysis reports the pooled CSD groups with the pooled control groups. The CSD mesh cap was placed via thoracotomy. New York Heart Association (NYHA) class assessment was made by a core laboratory blinded to treatment assignment.

Concomitant Medications:

Angiotensin-converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (97%), diuretic (98%), and beta-blockers (85%)

Principal Findings:

Optimal medical therapy use at baseline was high, with ACE inhibitors or angiotensin-receptor blockers used in 97% of patients, diuretic in 98%, and beta-blockers in 85%.

For the primary endpoint, more patients in the CSD group compared with the control group were classified as improved (38% vs. 27%), and fewer as worse (37% vs. 45%), for an odds ratio (OR) of 1.73 (95% confidence interval 1.07-2.79; p=0.02). There were fewer major cardiac procedures in the CSD group (19% vs. 33%, p=0.01). There was a trend for more patients in the CSD group to have had an improvement in NYHA class (52% vs. 43%; OR 1.64, p=0.12).

Additionally, there was a greater reduction in LV end-diastolic volume (p=0.009) and systolic volume (p=0.017) and a greater increase in LV sphericity index (p=0.026), a measure of favorable eliptical shape. Quality of life measures were improved when assessed by the Minnesota Living with HF measure (p=0.05) and the SF-36 score (p=0.015).

There was no difference in the frequency of any adverse event (81.1% in the CSD group vs. 77.6% in the control group), and there were no device-related adverse events.

Interpretation:

Among patients with heart failure and dilated cardiomyopathy treated with mitral valve surgery or medical management, use of the CSD mesh wrap was associated with an improvement in the primary composite clinical event compared with the control group. Additionally, use of the CSD mesh wrap was associated with reductions in major cardiac procedures, improvements in LV size and shape, and improvements in quality of life measures.

The present study is the first large-scale randomized trial using the CSD device. The device is experimental and not yet approved by the FDA.

References:

Presented by Douglas L. Mann at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Angiotensin Receptor Antagonists, Thoracotomy, Minnesota, Quality of Life, Diuretics, Heart Failure, Ventricular Remodeling, Mitral Valve, Cardiomyopathy, Dilated


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