Low-risk TAVR for bicuspid valves yields few adverse events
In patients with bicuspid aortic valves at low risk for surgery who underwent transcatheter aortic valve replacement with a self-expanding valve, only 1.3% died or had a disabling stroke at 30 days, according to new data presented at the virtual American College of Cardiology Scientific Session.
In the nonrandomized, single-arm study of 150 patients (mean age, 70 years; 52% men), at 30 days, 0.7% of patients died, 0.7% had a disabling stroke, 3.3% had a nondisabling stroke, 1.3% had a major vascular complication, 15.1% required a permanent pacemaker, 0.7% had coronary artery obstruction and none had aortic dissection or annular rupture, according to the researchers.
The primary efficacy endpoint of device success, defined as absence of procedural mortality, correct position of one valve in the proper anatomical location and absence of worse-than-mild aortic regurgitation, was met in 95.3% of patients at 30 days, Basel Ramlawi, MD, attending cardiothoracic surgeon and chairman of The Heart
and Vascular Center at Valley Health System in Winchester, Virginia, said during a presentation.
All patients were aged at least 60 years, had CT-confirmed bicuspid aortic valve anatomy, had severe symptomatic or asymptomatic aortic stenosis and had a Society of Thoracic Surgeons Predicted Risk of Mortality of less than 3% (mean, 1.4%) as assessed by a heart team, and underwent TAVR with a self-expanding valve (Evolut R or Evolut Pro, Medtronic).
“To date, there have been no prospective studies assessing TAVR in low-risk patients with bicuspid aortic stenosis,” Ramlawi said, noting that such patients tended to be excluded from clinical trials due to a variety of concerns.
Most patients (91.3%) had pre-TAVR balloon dilatation, and a plurality (41.6%) required a 34-mm valve, Ramlawi said.
Patient-prosthesis mismatch did not occur in 87.1% of patients, he said.
Mean aortic valve gradient declined from 48 mm Hg at baseline to 7.6 mm Hg at 30 days, while mean effective orifice area increased from 0.8 cm2 at baseline to 2.3 cm2 at 30 days.
Aortic valve regurgitation was absent or at trace amounts in 59.6% of patients, and mild in the remainder, according to the researchers.
While only 2% of patients had NYHA Class I HF at baseline, it increased to 75.3% at 30 days, Ramlawi said.
“This clearly has clinical implications for treatment of bicuspid valve patients at low risk, with early 30-day results showing that TAVR with the Evolut platform was safe and effective,” Ramlawi said. “The choice between TAVR and surgery, however, should be based on a multidisciplinary heart team discussion that includes both anatomic, clinical and patient social factors for choice of therapy.”
Patients will be followed for 10 years, he said.
During a discussion, David H. Adams, MD, Marie-Josée and Henry R. Kravis Professor and system chairman of the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount Sinai Health System, said that despite your results, many patients in this population will be better off with surgery.
“If I am your patient, I would argue with TAVR that the death/stroke rate and the permanent pacemaker rate and the mild [aortic regurgitation] rate is much higher than if I come to you, Basel, for a surgical valve,” he said. “We don’t need a randomized trial to prove that, particularly when you consider this was a super-selective anatomic bicuspid population.”
Ramlawi said patient preference is a factor in choice of procedure, noting that “a lot of times, I am talking them out of TAVR.” – by Erik Swain
Reference:
Ramlawi B, et al. Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials. Presented at: American College of Cardiology Scientific Session; March 28-30, 2020 (virtual meeting).
Disclosures: The study was funded by Medtronic. Ramlawi reports he received research grants and consultant fees from AtriCure, LivaNova and Medtronic.
Perspective
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We have seen the evolution of TAVR over the past 15 years. We progressed from high-risk to intermediate-risk to low-risk patients, all of which were shown to very effective. The one population excluded from all those trials was the bicuspid valve group. That was for practical reasons, due to anatomical concerns. The construction of a bicuspid valve is such that it is difficult to try to fit a TAVR valve inside of it to get a good seal and avoid aortic regurgitation after the procedure. With the self-expanding valves used in this study, one of the two major platforms used in the U.S., the researchers were able to get good seating of the valve and good placement with minimal leakage in a successful prospective study. This is very encouraging. It was thought it would be too technically difficult to achieve a good result in this population. Now, we have found another category where TAVR is working well — as well as surgery when compared with historical data. It appears that in all groups, TAVR has been shown to be successful, with low complication rates at least equivalent to surgery.