Disclosures: The study was funded by the Ram and Sanjita Kalra Aavishqaar Fund through makeadent.org. Kalra reports serving as CEO and creative director for makeadent.org. The other authors report no relevant financial disclosures.
February 03, 2022
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TAVR tied to better in-hospital outcomes vs. surgical AVR for bicuspid aortic stenosis

Disclosures: The study was funded by the Ram and Sanjita Kalra Aavishqaar Fund through makeadent.org. Kalra reports serving as CEO and creative director for makeadent.org. The other authors report no relevant financial disclosures.
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Transcatheter aortic valve repair for bicuspid aortic valve stenosis was associated with lower in-hospital morbidity and mortality and similar 30-day and 6-month outcomes compared with surgical AVR, researchers reported.

According to data published in EuroIntervention, despite lower in-hospital risk and similar risk for 30-day and 6-month MACE with TAVR compared with surgical AVR, patients who underwent TAVR experienced greater risk for permanent pacemaker implantation.

Ankur Kalra

“The revised guidelines for valve disease do not comment on the ‘cuspidity’ of the valve, as in bicuspid aortic valve stenosis or tricuspid aortic valve stenosis. It just mentions aortic valve stenosis and gives a platform to both surgical AVR and TAVR. Historically ... patients with bicuspid aortic valve disease were excluded from randomized clinical trials because it’s a different morphology, it’s a different anatomy and it is uncertain as to whether the transcatheter valve would do an equally efficacious job in addressing aortic valve stenosis without requiring future intervention,” Ankur Kalra, MD, FACP, FACC, FSCAI, associate professor of clinical medicine at Indiana University School of Medicine and director of interventional cardiology quality and innovation at Indiana University Health, told Healio. “I’m not advocating for transcatheter techniques or that based on the study it should now be the treatment of choice. ... But you’ll have patients who will have multiple comorbidities, though this population tends to be younger, who have something in their history that precludes them from being a good surgical candidate. The study is relevant because these are real-world data from those kinds of patients.”

According to the study, bicuspid aortic valve is estimated to have a prevalence in the U.S. of 0.5% to 2% across the population and is commonly associated with complications, including aortic valve stenosis, regurgitation, endocarditis, aortic aneurysm and aortic dissection.

To elucidate differences in early outcomes between TAVR and surgical AVR for bicuspid aortic valve stenosis, researchers identified patients using the Nationwide Readmission Database. The primary outcome was in-hospital mortality. Secondary outcomes included 30-day and 6-month MACE.

Researchers included 17,068 patients who underwent TAVR or surgical AVR for bicuspid aortic valve stenosis from 2016 to 2018 (9.5% TAVR; 90.5% surgical AVR), identified 1,393 matched pairs with 30 days of follow-up and 848 matched pairs with 6 months of follow-up.

In-hospital outcomes

According to the study, more TAVR procedures were performed as a nonelective procedure compared with surgical AVR (23.7% vs. 18%; P < .001).

Researchers reported that TAVR for bicuspid aortic valve stenosis was associated with lower odds of in-hospital death compared with surgical AVR (0.7% vs. 1.8%; OR = 0.35; 95% CI, 0.13-0.93; P = .035).

Patients who underwent TAVR were more likely to be discharged to home rather than other facilities compared with those who underwent surgical AVR (74.2% vs. 34.9%; OR = 2.05; 95% CI, 1.79-2.34; P < .001).

Compared with surgical AVR for bicuspid aortic valve stenosis, TAVR was associated with lower odds of:

  • major bleeding (2.5% vs. 10.5%; OR = 0.22; 95% CI, 0.13-0.36; P < .001);
  • vascular complications (1.4% vs. 2.9%; OR = 0.47; 95% CI, 0.21-1.03; P = .059);
  • acute kidney injury (11.1% vs. 20.2%; OR = 0.48; 95% CI, 0.35-0.65; P < .001);
  • cardiorespiratory complications (8.1% vs. 20.1%; OR = 0.34; 95% CI, 0.24-0.48; P < .001); and
  • need for post-procedure cardiothoracic procedure (0.6% vs. 2.5%; OR = 0.21; 95% CI, 0.06-0.69; P = .01).

In addition, TAVR was associated with 43% shorter length of stay compared with surgical AVR (2 vs. 6 days; OR = 0.57; 95% CI, 0.49-0.65; P < .001).

However, TAVR was associated with greater odds of pacemaker implantation compared with surgical AVR (11.8% vs. 8.6%; OR = 1.55; 95% CI, 1.04-2.31; P = .033).

Researchers reported no difference between TAVR and surgical AVR for the odds of in-hospital stroke, valvular complication and procedural cost.

30-day and 6-month outcomes

According to the study, there was no difference in 30-day and 6-month MACE among patients who underwent TAVR compared with surgical AVR (OR at 30 days = 0.65; 95% CI, 0.27-1.58; P = .343; HR at 6 months = 0.86; 95% CI, 0.44-1.69; P = .674).

There was also no difference between TAVR and surgical AVR in risk for:

  • all-cause readmission (P at 30 days = .684; P at 6 months = .998);
  • CV hospitalization (P at 30 days = .093; P at 6 months = .996);
  • all-cause mortality (P at 30 days = .338; P at 6 months = .93);
  • stroke (P at 6 months = .206); and
  • valvular complication (P at 6 months = .613).

However, researchers reported that TAVR was associated with greater risk for pacemaker implantation at 30 days (2.2% vs. 0.2%; P = .006).

“In terms of short-term clinical outcomes, including mortality, mortality at 6 months, acute kidney injury, mechanical ventilation or vascular complications, one may argue that TAVR may perform better compared with surgical AVR in the short term,” Kalra told Healio. “Where surgery performed better is requirement for permanent pacemaker and then also paravalvular leak, or aortic regurgitation, which is something that we account for very seriously, because it has been shown to adversely affect outcomes in the long term.
“I don’t want to advertise that TAVR is the go-to technique for bicuspid aortic valve disease,” Kalra told Healio. “These patients are complex. They require an evaluation at a center of excellence or a comprehensive valve disease program, where you have the multimodality imaging cardiologist, the cardiac surgeon, the interventionalist, the cardiologist dedicated to taking care of patients with valve disease so that there is a multidisciplinary team decision as to how to proceed with these patients.”

For more information:

Ankur Kalra, MD, FACP, FACC, FSCAI, can be reached at kalramd.ankur@gmail.com.