First Successful Implant of a CoreValve Inside a Degenerative Aortic Bioprosthesis (Valve-in-Valve) in the United States

Surgical aortic valve replacement (SAVR) has long been the standard of care (SOC) treatment for patients with severe aortic stenosis. With the recent advent of transcatheter aortic valves, transcatheter aortic valve replacement (TAVR) is now accepted as the SOC for symptomatic aortic stenosis patients who are not candidates for SAVR.

Furthermore, TAVR may be the preferred alternative in the high-risk surgical patient. The CoreValve (Medtronic) is a porcine pericardial valve mounted on a self-expanding nitinol frame. The safety and efficacy of this valve in high- and extreme-risk aortic stenosis patients is currently being evaluated in the CoreValve U.S. Pivotal Trial, which completed enrollment in September 2012. 

In the U.S., exclusions to CoreValve implantation have included low gradient/low output aortic stenosis, end-stage renal disease, and moderate-
severe/severe mitral and tricuspid regurgitation. Recently, the FDA has approved an expanded use protocol (August 2012) to allow for treatment of these high-risk subsets of patients. Also included in this expanded use protocol (approved February 2013) has been the treatment of degenerative bioprosthetic aortic valves. 

Surgical bioprosthetic valves have known limited durability. Reoperative SAVR is frequently high or extreme risk, especially in the elderly and in patients with multiple comorbidities, leading to significant morbidity and mortality. Outside of the U.S., since 2010, CoreValve (valve-in-valve, ViV) implantation within a degenerative aortic bioprosthesis has been utilized as an alternative treatment in this cohort of patients. Under the FDA-approved expanded use protocol, the Structural Heart Team at Lenox Hill Heart and Vascular Institute-NSLIJ Health System has successfully implanted the first CoreValve inside a degenerative aortic bioprosthesis (ViV) in the U.S.

Case

The patient was an eighty-year-old male with multiple comorbidities, including hypertension, atrial fibrillation, diabetes, chronic renal insufficiency, coronary artery disease status post bypass surgery, cardiomyopathy with a severe reduced ejection fraction (< 15%), and aortic valve disease status post SAVR 1999 with a 21mm Carpentier-Edwards aortic bioprosthesis (Edwards Lifesciences). Transthoracic and transesophageal echocardiography revealed the aortic bioprosthesis to be a severely degenerated with a mean gradient of 53mmHg, even with a severely reduced ejection fraction. Despite medical therapy and implantation of a biventricular implantable cardioverter defibrillator (ICD), he remained in refractory New York Heart Association class IV congestive heart failure, with a systolic blood pressure of 80mmHg. 

Without treatment, this patient’s condition carried a poor prognosis and was life-threatening. SAVR had a calculated operative mortality risk of 22%, as deemed by Society of Thoracic Surgeons (STS) criteria. He was evaluated by two teams of cardiac surgeons and was considered to be inoperable. Carlos Ruiz, MD, Director of Congenital and Structural Heart Disease at Lenox Hill, and his structural heart team, in adherence to the FDA, sponsor, and local IRB regulations, offered to perform a transcatheter aortic ViV implantation. The patient successfully underwent 23mm CoreValve ViV implantation via a percutaneous transfemoral approach. Intraprocedural hemodynamics and post-procedural echocardiography revealed trivial paravalvular regurgitation, with a mean residual gradient of 13mmHg. The patient was discharged home on post-operative day 5 without issue. 

Michele Impreveduto, MPA, RNC, can be contacted at Mimprevedu@NSHS.edu.

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Behind the Scenes at the Structural and Congenital Heart Disease Program at Lenox Hill Heart and Vascular Institute-North Shore LIJ Health System