Background: Ventricular containment with custom-made polyester mesh is an evolving technique that has been studied in experimental animals with heart failure with good results.
Methods: Five patients with symptomatic heart failure and ischemic cardiomyopathy were enrolled in a Phase I study, and underwent ventricular containment with custom-made polyester mesh along with coronary artery bypass grafting. Four patients had additional ventricular reconstruction of large myocardial scars.
Results: All patients were in NYHA functional class III at the time of their operation with a mean ejection fraction of 27.4%+/-6.6%. There were no deaths. Mean postoperative ejection fraction was 35.1%+/-12.6% (p = 0.16). Left ventricular end-diastolic diameter fell from 63.2+/-1.6 mm preoperatively to 50.6+/-5 mm, postoperatively (p = 0.004). There was no evidence of diastolic dysfunction or pericardial constriction on intra- or postoperative echocardiography. At a mean follow-up of 180 days all patients were in NYHA class I with no readmissions for heart failure. Repeat coronary angiography at 6 months revealed patent grafts in all patients.
Conclusions: Ventricular containment with a customized mesh may be performed safely as an adjunct to conventional cardiac operation in patients with symptomatic heart failure. Longer follow-up with an expansion of the study will help delineate the long-term effects of this therapy.