Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study

BACKGROUND: Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. Thus, the materials adopted may make a difference. CARDIOROOT is a one-piece collagen-coated woven vascular graft with pseudo-sinuses, which was designed for use in the treatment of aortic root disease. We report the results of a prospective, multicenter, observational post-market surveillance study evaluating the safety and performance of the CARDIOROOT in patients requiring aortic root surgery. METHODS: Patients with aortic root disease suitable for treatment with a vascular graft with pseudo-sinuses CARDIOROOT graft were eligible for participation. The enrolled patients were assessed intraoperatively, post-operatively, at discharge and at 1-year. Sites assessed complications at each visit, and recorded any reported adverse events. The study endpoint was mortality and complications through 1-year post-procedure. RESULTS: Fifty-two patients were enrolled from 6 European centers. All procedures were technically successful. Operative mortality was 1.9%: one patient suffered hemorrhagic shock unrelated to the graft 1 day following surgery. At 1-year follow-up the survival rate was 96.2%, with a late death due to pneumonia 5 months post-procedure. Eleven serious adverse events occurred in 7 patients, which included cardiac complications (pericardial effusion, myocardial infarction and ventricular arrhythmia), infection (pericardial infection, deep sternal infection and superficial sternal infection), vascular disorders, including hemorrhagic shock and pleural effusion requiring drainage. Nine of the 11 events were deemed procedure-related by the local investigator, and all were deemed unrelated to the device. There were no reports of graft-related adverse events, infection, occlusion or graft failure. CONCLUSIONS: The results of this 1-year follow-up study showed that the CARDIOROOT vascular graft is safe and effective for the treatment of aneurysmal aortic root in immediate and mid-term follow-up. However, longer term follow-up is needed before conclusions can be made on the long-term safety and effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01609270. Registered 31 May 2012.