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Worldwide surgical experience with the Paracor HeartNet cardiac restraint device
Charles T Klodell1, Juan M Aranda, David C McGiffin
1Department of Surgery, Division of Thoracic and Cardiovascular Surgery, University of Florida College of Medicine, Gainesville, Fla 32610, USA. Klodell@surgery.ufl.edu
The Journal of Thoracic and Cardiovascular Surgery
|January 9, 2008
Summary
The Paracor HeartNet device shows promise for improving heart failure symptoms and function in patients with severe dilated cardiomyopathy. Six-month data indicate significant benefits in exercise capacity and quality of life, supporting further trials.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Heart failure significantly impacts patient quality of life and prognosis.
- Standard therapies often leave patients with severe dilated cardiomyopathy symptomatic.
- Novel interventions are needed to improve clinical and functional status in these patients.
Purpose of the Study:
- To evaluate the safety and efficacy of the Paracor HeartNet device in patients with severe heart failure.
- To assess the device's impact on clinical and functional status at six months post-implantation.
- To hypothesize that the HeartNet device improves outcomes in patients with dilated cardiomyopathy.
Main Methods:
- A prospective study involving 51 patients with ejection fraction ≤35% and NYHA class II/III.
- Implantation of the HeartNet device via minithoracotomy.
- Evaluation at baseline and 6 months using echocardiography, 6-minute walk test, cardiopulmonary exercise testing, and quality of life questionnaires.
Main Results:
- Successful implantation in 98% of patients.
- Significant improvements observed in the 6-minute walk test and Minnesota Living with Heart Failure scores.
- Adverse events included pulmonary complications, arrhythmias, and epicardial laceration.
Conclusions:
- The Paracor HeartNet device is safely implantable in heart failure patients with reduced left ventricular function.
- Data suggest functional and clinical benefits, with a trend towards reverse remodeling.
- These findings support a randomized controlled pivotal trial for further validation.
