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TAVR in Low-Risk Patients With Bicuspid Aortic Valve Stenosis
Quick Takes
- This pilot study demonstrated excellent procedural safety and efficacy outcomes among low-risk patients with bicuspid aortic valve stenosis undergoing TAVR using a self-expanding supra-annular valve.
- Device success was very high, with excellent hemodynamics, and no patients had more than mild aortic regurgitation at 30 days.
- Randomized clinical trials comparing TAVR with surgery with longer-term outcomes should be performed prior to any changes in clinical guidelines and widespread adoption of TAVR in low-risk patients with bicuspid severe aortic stenosis.
Study Questions:
What is the procedural safety, efficacy, and 30-day outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis at low surgical risk?
Methods:
The investigators conducted a prospective, single-arm trial (The Low Risk Bicuspid Study) with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018–October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.
Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements. The prespecified primary endpoint was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy endpoint was device success defined as the absence of procedural mortality, the correct position of bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation post-procedure.
Results:
A total of 150 patients underwent an attempted implant. Baseline characteristics included mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% confidence interval [CI], 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (standard deviation) aortic valve gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.
Conclusions:
The authors concluded that TAVR in low–surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.
Perspective:
This 150-patient pilot study demonstrated excellent procedural safety and efficacy outcomes among low-risk patients with bicuspid aortic valve stenosis undergoing TAVR using a self-expanding supra-annular valve with low adverse event rates at 30 days (1.3% mortality or disabling stroke). Furthermore, device success was very high, with excellent hemodynamics, and no patients had more than mild aortic regurgitation at 30 days. Given the nonrandomized nature of the study, lack of surgical control group, and the small sample size, randomized clinical trials comparing TAVR with surgery with longer-term outcomes should be performed prior to any changes in clinical guidelines and widespread adoption of TAVR in low-risk patients with bicuspid severe aortic stenosis.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Hemodynamics, Pacemaker, Artificial, Risk, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement
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