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Post TAVR: Management of conduction disturbances and number of valve recapture and/or repositioning attempts – Optimize self-expanding transcatheter aortic valve replacement (TAVR) positioning reduced the need for permanent pacemaker (PPM) implants down the road

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 4/14/2021

A study with significant implications for the future of patient care is officially underway. Specialists at Penn Medicine in Philadelphia have reported completing the first procedure in a global head-to-head study comparing the safety and effectiveness of two leading transcatheter aortic valve replacement (TAVR) systems.

The Small Annuli Randomized to Evolut or Sapien (SMART) post-market trial is designed to compare the safety and effectiveness of self-expanding TAVR systems manufactured by Medtronic and balloon-expandable systems manufactured by Edwards Lifesciences when treating patients with small annuli. More than 90 different facilities are taking part in the trial, and approximately 700 patients with severe symptomatic aortic stenosis are expected to participate. A majority of study participants are expected to be women due to the trial’s focus on individuals with small annuli.

Howard C. Herrmann, MD, a professor of cardiovascular diseases at the University of Pennsylvania’s Perelman School of Medicine, is leading the trial.

“Penn Medicine has been in on the ground floor of many of the early and landmark trials in TAVR research since performing one of the first investigational procedures in 2007, and, since then, we have completed thousands of these procedures,” he said in a prepared statement. “Subsequently, multiple devices have been FDA approved, and the procedure has grown to become the predominant one for all patients with aortic stenosis. The outcome of this study will help cardiac teams to make more tailored decisions about which kind of valve to use on which patients.”

The SMART trial’s estimated primary completion date is May 2023. The estimated study completion date, meanwhile, is May 2028.

• The PPM rate dropped from 9.7% to 3.0% (P=0.035), according to a team led by Hasan Jilaihawi, MD, of NYU Langone Health in New York City.

• The rate of new left bundle branch block (LBBB) went down from 25.8% to 9.0% (P<0.001), 

• the PARTNER 3 and CoreValve Low Risk trials in patients at low surgical risk showed PPM implant rates of 17.4% with the Evolut line, 6.6% with the balloon-expandable Sapien 3, and 4.1%-6.1% with surgery.

• “The His bundle passes through the membranous septum, a few millimeters beneath the non-coronary/right coronary cusps. It is therefore not surprising that a deeper valve implantation increases the likelihood of mechanical damage of the His bundle leading to a transient or persistent conduction disturbance,” according to Rodés-Cabau.

To capture factors that contributed to need for PPM implantation, Jilaihawi and colleagues performed a detailed restrospective analysis on 248 consecutive Evolut recipients at Langone treated with the standard TAVR approach — aiming for 3-4 mm implant depth (in relation to the non-coronary cusp) and recapturing and repositioning when the device landed considerably lower. Patients with prior PPM implantation were excluded. Devices used were Medtronic’s Evolut R, Evolut Pro, and Evolut 34XL.

This analysis revealed that use of the large Evolut 34XL (OR 4.96, 95% CI 1.68-14.63) and implant depth exceeding membranous septum length (OR 8.04, 95% CI 2.58-25.04) were independent predictors of later PPM implantation.

From there, operators came up with the MIDAS technique and applied it prospectively to another 100 consecutive patients.

Besides bringing down the PPM implant rate to 3.0%, there were no more cases of valve embolization, dislocation, or need for a second valve.

The standard and MIDAS groups shared similar membranous septum lengths but diverged in average actual device depth, such that the standard group tended to have Evolut devices positioned deeper (3.3 mm vs 2.3 mm, P<0.001).

SOURCE

https://www.medpagetoday.com/cardiology/pci/81849