Outcomes after transcatheter valve-in-valve implantation using a balloon-expandable Edwards Sapien valve in patients with degenerated Freestyle aortic bioprosthesis

Abstract

Background: Transcatheter aortic valve-in-valve implantation (ViV TAVI) in degenerated Medtronic Freestyle aortic bioprosthesis (FSB) has been reported as being technically challenging. This study sought to evaluate procedural data and outcomes after ViV TAVI using a balloon-expandable Edwards valve in patients with failed FSB.Methods: Between August 2014 and December 2020, twenty-seven consecutive patients underwent ViV TAVI for symptomatic FSB failure at our institution using a Sapien XT (n=1) and Sapien 3 (n=26) valve, respectively. Endpoints were defined according to the Valve Academic Research Consortium-2 (VARC-2) criteria and were retrospectively analyzed.Results: Mean patient age was 75.7±8.2 years (female n=5, male n=22); Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.3%±6.2%. ViV implantation with correct positioning of the Edwards Sapien valve within the FSB was successful in all cases. Intraprocedural transesophageal echocardiography revealed none/trace paravalvular regurgitation in twenty-five patients (92.6%), mild paravalvular regurgitation was present in two patients (7.4%). Neither of the patients had a mean gradient ≥20.0 mmHg excluding significant patient-prosthesis mismatch. Three early deaths (≤ thirty days) occurred resulting in a device success rate of 88.8%. One-year and three-year survival rates for patients alive beyond day thirty after ViV TAVI were 95.8% and 70.0%, respectively. Conclusions:ViV TAVI with Edwards Sapien valves lead to acceptable functional results in high-risk patients with degenerated FSB but early complications must be considered particularly during hospital stay.

Transcatheter aortic valve‐in‐valve implantation within stentless landing zones: Procedural insights from a single‐center experience

“…Nevertheless, 20% of our cases required use of an additional valve, highlighting the technical challenges with stentless VIV‐TAVI. Our outcomes are generally comparable to those of other series of stentless VIV‐TAVI procedures, although these earlier series reported implantation failure, device embolization, coronary occlusion, and stroke 4–6,11,12,18–21 . To prevent these complications, we utilized a variety of strategies, such as multimodal preprocedural planning, pre‐ and postimplantation BAV, prophylactic coronary stenting, SENTINEL cerebral EPDs, and suprasternal access, that helped mitigate the high‐risk features of individual patients.…”

“…Transcatheter device choice is an important consideration for stentless VIV‐TAVI. Duncan et al 11 ( n = 22) and Wei Sang et al 20 ( n = 56) preferred the use of a self‐expanding valve in every patient in their series, whereas Bapat et al 18 ( n = 10) and Burgdorf et al 21 ( n = 27) exclusively used balloon‐expandable valves. We used a mix of both valve types (76% balloon‐expandable, 20% self‐expanding), with a preference toward balloon‐expandable valves, which may offer improved anchoring and lower risk of PVL 24 .…”

“…Our outcomes are generally comparable to those of other series of stentless VIV-TAVI procedures, although these earlier series reported implantation failure, device embolization, coronary occlusion, and stroke. [4][5][6]11,12,[18][19][20][21] To prevent these complications, we utilized a variety of strategies, such as multimodal preprocedural planning, pre-and postimplantation BAV, prophylactic coronary stenting, SENTINEL cerebral EPDs, and suprasternal access, that helped mitigate the high-risk features of individual patients. Despite the complex anatomy underlying these procedures, our data suggest that VIV-TAVI in the setting of surgically-implanted stentless valves is a safe and efficacious alternative to redo surgery, which has been associated with a significant operative mortality of up to approximately 10%.…”

“…In VSARR, the native aortic valve is re-suspended by suturing the proximal portion of the graft to the subannular muscular rim of the left ventricular outflow tract (LVOT). Similarly, in a homograft, the Hospital readmission, n (%) [N] 2 (9.5) [21] Echocardiography results…”