Abstract
BackgroundSparing 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.MethodsPatients 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.ResultsFifty-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.ConclusionsThe 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 registrationClinicalTrials.gov Identifier: NCT01609270. Registered 31 May 2012.
Highlights
Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root
A total of 54 complications occurred in 32 patients throughout the follow-up period; 96% of these occurred within 30 days of the CARDIOROOT implant surgery
Two patients suffered from sternal site infections, and required packing/irrigation and wound vacuum-assisted closure
Summary
Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. When the aortic root disease is treated by a valve sparing technique, achieving a precise relationship among all the components of the aortic root and to restore near normal anatomy and function is imperative, and the materials used contribute greatly. The woven technique consists of interlacing two sets of yarn (warp and weft) oriented at 90 degrees to one another This confers peculiar mechanical properties and features to the graft. The orthogonal arrangement of the yarn components yields a low radial compliance property This arrangement results in a graft less prone to dilate immediately after the operation, as well as over time, compared with those made by means of knitted technique [4, 6]
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