Initial United States experience with the Paracor HeartNet* myocardial constraint device for heart failure

Objective: This study was undertaken to review the initial results and surgical safety data for the US Food and Drug Administration safety and feasibility trial of the Paracor HeartNet ( Paracor Medical, Inc, Sunnyvale, Calif.) myocardial constraint device. Methods: Patients with New York Heart Association functional class II or III heart failure underwent device implantation (n = 21) through a left minithoracotomy. Results: The average age was 53 years ( 31 - 72 years). There were 18 men and 3 women, and 17 patients had nonischemic etiology of heart failure. Mean heart failure duration was 8.3 years (1.4-18.8 years). Average ejection fraction was 22% (11%-33%), with an average left ventricular end-diastolic dimension of 74 mm (55-94 mm). Previous medical therapy included angiotensin-converting enzyme inhibitors, beta-blockers, diuretics, digoxin, and aldosterone receptor blockers. At implantation, 17 patients had implantable electronic devices: 1 biventricular pacemaker, 11 biventricular pacemakers with cardioverter-defibrillators, and 5 implantable cardioverter-defibrillators. Patient comorbidities included hypertension in 10 cases, diabetes mellitus in 8, myocardial infarction in 1, and ventricular tachycardia in 8. Mean operative time was 68 minutes ( 42 - 102 minutes), and implantation time averaged 15 minutes ( 5 - 51 minutes). The average time to ambulation was 1.6 days ( 1 - 4 days). The intensive care unit stay averaged 3.3 days ( 1 - 16 days), and hospital stay averaged 6.3 days ( 4 - 16 days). Atrial fibrillation occurred in 2 patients, and there were 2 in-hospital deaths. Conclusions: The Paracor device can be implanted in patients with heart failure and reduced left ventricular function with a high degree of success. Significant surgical complications were infrequent. The initial US experience supports the conduct of a randomized, controlled, pivotal trial.