July 6, 2020
Ten-Year Follow-Up Reported From a Single-Center Experience With Early TAVR Devices
July 6, 2020—Investigators assessed the clinical outcomes, rate of structural valve deterioration (SVD), and bioprosthetic valve failure (BVF) in patients after transcatheter aortic valve replacement (TAVR) to 10‐year follow‐up in patients treated at St. Paul's Hospital, University of British Columbia in Vancouver, British Columbia.
The findings were published by Janarthanan Sathananthan, MBChB, et al online ahead of print in Catheterization and Cardiovascular Interventions.
The study was composed of 235 consecutive patients undergoing TAVR for native aortic valve stenosis or failed aortic surgical bioprosthesis at St. Paul's Hospital between 2005 and 2009. Patients’ mean age at the time of procedure was 82.4 ± 7.9 years. All patients were judged to be high risk, with a Society of Thoracic Surgeons’ STS score > 8 in 53.6% of patients. Devices implanted were the Cribier‐Edwards (20.9%; Edwards Lifesciences), Sapien (77.4%; Edwards Lifesciences), or CoreValve (1.7%; Medtronic).
In Catheterization and Cardiovascular Interventions, the investigators reported the following:
- Mortality at 1, 5, and 10‐year follow‐up was 23.4%, 63%, and 91.6%, respectively.
- Of the total cohort, 15 patients had SVD/BVF with a cumulative incidence at 10‐years of 6.5% (95% CI, 3.3%-9.6%).
- The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively.
- Nine patients had moderate SVD.
- Six patients had severe SVD; of these, two patients had reintervention (one redo TAVR; one surgical aortic valve replacement).
- Survivors (n = 19) at 10‐year follow‐up had a mean gradient of 14.0 ± 7.6 mm Hg with aortic regurgitation ≥ moderate in 5% of these patients.
- Quality-of-life measures in 10‐year survivors demonstrated activities of daily living assessment of 6/6 in 43.8% patients, and ambulation without a mobility aid of 62.5% patients.
In showing that the use of early-generation balloon-expandable TAVR devices in a high‐risk population resulted in a low rate of structural valve deterioration and valve failure at 10‐year follow‐up, the study provided insights into the long‐term performance of transcatheter heart valves and patients self‐reported derived benefits, concluded the investigators in Catheterization and Cardiovascular Interventions.