Author + information
- Fausto Castriota1,
- Joachim Schofer2,
- Stephan Windecker3,
- Roberto Nerla4,
- Christian Frerker5,
- Mohamed Abdel-Wahab6,
- Nicolas Van Mieghem7,
- Azeem Latib8,
- Ole De Backer9,
- Matheus Simonato dos Santos10 and
- Danny Dvir11
- 1GVM Care and Research, E. S. Health Science Foundation, Cotignola, Ravenna, Italy
- 2Medical Care Center Prof. Mathey, Prof. Schofer and Albertinen Heart Center, Hamburg, Hamburg, Germany
- 3University Hospital Bern, Bern, Switzerland
- 4GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy
- 5Asklepios Klinik St. Georg, Hamburg, Germany
- 6Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
- 7Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
- 8Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
- 9Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark
- 10Federal University of Sao Paulo, Sao Paulo, São Paulo, Brazil
- 11Centre for Heart Valve Innovation, St. Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada
We aimed to evaluate the performance of the Lotus Aortic Valve Replacement System in patients with a degenerated aortic bioprosthesis undergoing transcatheter valve-in-valve (ViV).
Data was collected as part of the VIVID (Valve in Valve International Data) Registry, including a total of 1944 patients that underwent aortic valve in valve from 142 centres. The patients had been referred to ViV intervention by local multidisciplinary heart team decision.
A total of 33 patients undergoing Lotus ViV (age 75.1 ± 11.8 years, 72.7% males, STS PROM 4.4 ± 3.1%) were evaluated. Surgical valve label size was 24.4 ± 1.6 mm and none of the devices were small (label size ≤ 21mm). A stented bioprosthesis was treated in the majority of cases (n = 26, 78.8%). Degeneration modes were pure regurgitation in 16 patients (48.5%), stenosis in 6 patients (18.2%) and a mixed failure in 11 patients (33.3%). Most cases were performed using transfemoral access (96.8%) under local anaesthesia (72.7%). Surgical valve predilation was performed in only 2 cases (6.5%), while postdilation was required in none of the cases. In 5 patients (15.6%) initial device position was deemed not satisfactory so that the device was retrieved and repositioned. There were no cases of coronary occlusion. Final positioning was satisfactory in all cases. Final aortic regurgitation was absent or mild (11.1%) in all patients. Post implantation mean gradient was 14.4 ± 5.6 mmHg. The rate of elevated post procedural gradient (mean ≥ 20mmHg) was 12.9%. Median (interquartile range) hospital length of stay was 6 days. No patient died within 30 days, however one patient (3.7%) was diagnosed with a major stroke. Major vascular complications occurred in 2 patients (6.5%), while no patients developed acute kidney injury. New permanent pacemaker rate at discharge was only 4.3%.
This is the first large data collection of Lotus implantation in patients with failed aortic bioprostheses. Clinical outcomes were reassuring with acceptable residual mean gradients, no significant paravalvular leaks and a low rate of new pacemakers.
STRUCTURAL: Valvular Disease: Aortic