Transarterial Medtronic CoreValve System Implantation for Degenerated Surgically Implanted Aortic Prostheses

Abstract

Background— To assess the results of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve System (MCS), through the transarterial approach, in high-risk patients with degenerated surgically implanted aortic bioprostheses (SP). Methods and Results— Of 241 patients who underwent TAVI, 10 (4%) had a degenerated SP. The approach was percutaneous transfemoral in 9 cases and surgical transaxillary in 1. Patients were age 75±10 years of age. All were in New York Heart Association classes III or IV and at high risk for repeated surgery. Seven patients had stented, 2 stentless, and 1 homograft SP. The failure mode was predominant regurgitation in 7 cases and stenosis (aortic valve area, 0.7±0.2 cm 2 ; mean gradient, 58±16 mm Hg) in 3. Based on the echographic measurements, 8 patients received a 26-mm, and 2 a 29-mm-diameter MCS. Procedural success rate was 100%. There was 1 in-hospital death, 1 stroke with moderate sequelae, and 1 pacemaker implantation. There were no other adverse events at 30 days. The mean postimplantation transprosthetic gradient was 13±7 mm Hg; periprosthetic regurgitation was absent or trivial in 9 cases and grade 2 in 1. After a median follow-up of 5 months, there were no additional adverse events. All but 1 of the hospital survivors were in New York Heart Association classes I or II. Conclusions— These results suggest that transarterial MCS implantation in degenerated SP is feasible and may lead to hemodynamic and clinical improvement in patients who are poor candidates for repeated surgery, pending confirmation in larger series with longer follow-up.

Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves

“…8 -10 In recent years, several reports have suggested that the off-label use of TAVR within failed surgically inserted bioprosthetic valves (valve-in-valve [VIV]) is technically feasible. [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] However, all previous reports evaluating the VIV approach have included a small number of cases and are limited in providing measures of efficacy and safety. High postprocedural gradients and several potentially life-threatening complications, such as ostial coronary obstruction, were only reported anecdotally, and there was no comparison between different devices possibly applicable for VIV.…”

Homograft use in reoperative aortic root and proximal aortic surgery for endocarditis: A 12-year experience in high-risk patients

“…It is possible that the risks posed by structural deterioration of the valve in a homograft root will increasingly be ameliorated as the use of transcatheter aortic valve implantation becomes more common. [16][17][18]…”

Forming effective relationships between academia and the medical devices industry with a focus on launching a smart heart valve prosthesis for pediatric patients

“…To summarize the above-provided feedback, for the benefit of the academic inventor, while searching for interaction with Medtronic, the best way would be to approach a clinician that has a record of publications that describe the performance of Medtronic's, prosthesis [81][82][83][84][85]. He has carried out many collaborations with industry, has 7 patents, multiple licenses and many of his reagents/innovations have been licensed and commercialized.…”