Author + information
- Tanvir Bajwa1,
- Daniel P. O'Hair1,
- Mathew Williams2,
- Mubashir Mumtaz3,
- Hemal Gada4,
- Stanley Chetcuti5,
- G. Michael Deeb6 and
- Jeffrey J. Popma7
- 1Aurora Cardiovascular Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Milwaukee, Wisconsin, United States
- 2NYU Langone Medical Center, New York, New York, United States
- 3PinnacleHealth, Harrisburg, Pennsylvania, United States
- 4PinnacleHealth CardioVascular Institute, Wormleysburg, Pennsylvania, United States
- 5University of Michigan Health Center, Ann Arbor, Michigan, United States
- 6University of Michigan Hospitals, Ann Arbor, Michigan, United States
- 7Beth Israel Deaconess Medical Center, Boston, Massachusetts, United State
Transcatheter aortic valve (TAV) selection depends on valve/aortic annuli ratio guidance. Insufficient sizing has been associated with more PVL. We evaluated a new 34-mm self-expanding, repositionable valve.
Patients with symptomatic, severe AS at increased surgical risk were treated with the Evolut R 34-mm TAV (Medtronic, Minneapolis, MN) at 10 US centers from June to October 2016. The primary endpoints were death and disabling stroke at 30 days. Pre-procedural multi-slice CT was required to assess valve annulus and access vasculature. An independent Clinical Events Committee adjudicated all adverse events. An independent echo core lab assessed valve hemodynamics. The 34-mm valve is intended for aortic annuli from 26–30 mm in diameter (81.7 – 94.2 mm perimeters) and implanted via a 16-F equivalent sheath in access vessels ≥5.5 mm in diameter. We report safety and efficacy outcomes at 30 days and 6 months.
The 34-mm TAV was implanted in 60 patients. Mean age was 81.8±8.2 y, 96.7% were men, STS-PROM was 5.5±2.8% and 63.3% had >NYHA class II symptoms. Conscious sedation was used in 43.3%, all patients were implanted transfemorally, 62.7% underwent pre-TAVR BAV and 36.7% had post-BAV. Repositioning was attempted in 20 patients (33.3%); all successfully. The mean effective orifice area and AV gradient were 2.6±0.7 cm2 and 6.4±3.2 mmHg at 30 days and 2.3±0.7 cm2 and 6.7±3.5 mmHg at 6 months. At 30 days, 1 patient (1.7%) had moderate PVL (no severe) and at 6 months none had >mild PVL. Outcomes at 30 days and 6 months in the Table.
|No. of patients (Kaplan-Meier rates as precentages)||30 Days||6 Months|
|All-cause mortality||1 (1.7)||5 (8.3)|
|Disabling stroke||0 (0.0)||1 (1.7)|
|Major vascular complication||1 (1.7)||1 (1.7)|
|Life-threatening or disabling bleed||1 (1.7)||2 (3.4)|
|Acute kidney injury||0 (0.0)||0 (0.0)|
|Valve-related dysfunction requiring repeat procedure||0 (0.0)||0 (0.0)|
|Pacemaker||11 (18.4)||13 (21.8)|
|Coronary artery obstruction||0 (0.0)||0 (0.0)|
AS, aortic stenosis; BAV, balloon aortic valvuloplasty; MSCT, multi-slice computed tomography; NYHA, New York Heart Association; PVL, paravalvular leak; STS-PROM, Society of Thoracic Surgeons Predictor of Mortality; TAVR, transcatheter aortic valve replacement.
The Evolut-R 34-mm self-expanding TAV had an acceptable safety profile and was effective for the treatment of severe aortic stenosis through 6 months, with excellent hemodynamics in a primarily male study cohort.
STRUCTURAL: Valvular Disease: Aortic