Is surgical backup still necessary during TAVR? Opinions are mixed as bailout risk decreases
Surgical bailout during transcatheter aortic valve replacement (TAVR) is becoming more rare as time goes on, according to new data published in JACC: Cardiovascular Complications, an American College of Cardiology journal.[1]
Does this trend mean on-site cardiac surgery backup should no longer be required at facilities that perform TAVR? That all depends on who you ask.
First, the new data: Researchers explored Medicare data from more than 400,000 patients who underwent TAVR from 2016 to 2024. Surgical bailout was needed during 0.56% of those procedures, or approximately 2,000 total TAVRs. The most common surgical procedures performed on these bailout patients were mediastinal hematoma evacuation, ventricular repair, surgical aortic valve replacement, coronary artery bypass graft surgery and aortic surgery.
Tracking the odds of surgical bailout over time, the group found that it was needed during 0.92% of TAVRs in 2016 and 0.40% of TAVRs in 2024.
“Multiple factors contribute to this decrease, including improved operator experience with TAVR and improvements in both the TAVR delivery system and prosthesis design, including the ability to recapture self-expanding prostheses,” wrote corresponding author Tsuyoshi Kaneko, MD, chair of cardiovascular disease at Washington University in St. Louis, and colleagues.
The 30-day mortality rate after TAVR bailout was 26.3%. That numbers highlights the fact that surgeons are able to “prevent approximately one death for every two surgical bailouts performed,” the authors wrote. TAVR patients not requiring surgical bailout at all had a 30-day mortality rate of 1.8%. One-year and five-year mortality rates were also higher for patients who required a bailout procedure.
The mean ages of the bailout and no-bailout groups were the same, 80 years old, but certain the study’s authors did identify some key differences. For example, patients in the bailout group were more likely to be women and more likely to present with chronic obstructive pulmonary disease or peripheral vascular disease.
Is it time for current TAVR policies to change?
Kaneko et al. pointed to the continued push to allow TAVR to be performed at hospitals without on-site cardiac surgical support. Due to current U.S. Centers for Medicare and Medicaid Services policies, the group was unable to truly study how such an approach may impact patient care. At the same time, these findings provide fresh insights as various stakeholders consider how that change could affect patients.
“Although our results show that cardiac surgeons prevent one death for every two TAVRs with complications that indicate surgical bailout, the assumption of 100% mortality had cardiac surgeons not been present must be interpreted with caution given there was no true comparator group,” the group wrote. “Analysis from select European centers has demonstrated similar in-hospital mortality of TAVR at hospitals with and without in-hospital cardiac surgical support. Limitations of these analyses include noncontemporary data of higher risk patients, TAVR with early generation devices, and less than 2,000 TAVRs performed in non–cardiac surgery centers—less than the minimum indicated by power calculations on our observed data. These findings should not be extrapolated to contemporary practice. At present, there are insufficient contemporary data on TAVR performed at centers without cardiac surgery to change the national coverage determination requirements or consensus guidelines for in-hospital cardiac surgical support during TAVR in the United States.”
The group noted that it is possible these policies will eventually change, due in part to the fact that expanding TAVR to more centers could help avoid prolonged wait times. However, they shared their belief that a better way to keep wait times to a minimum would be to make “system-level improvements” that can get patients treated earlier than they are today.
“Although healthcare providers have previously expressed anxiety about performing TAVR without in-hospital cardiac surgical backup, additional analysis of both patient and provider perspectives with contemporary data should be obtained,” they authors wrote.
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Editorials examine new data from different angles
Two related editorials in JACC: Cardiovascular Interventions looked at this topic of on-site cardiac surgery support from different angles.
Mayo Clinic cardiologist Benjamin Hibbert, MD, PhD, wrote in a solo opinion piece that this reduced risk of surgery bailout during TAVR shows that these procedures can safely, consistently be performed without on-site surgical backup.[2]
One key point in his editorial was the fact that most TAVR patients experiencing severe complications are now being rescued in the cath lab, not the operating room.
“The absence of an on-site surgeon is not the absence of rescue,” he wrote.
In addition, Hibbert noted that percutaneous coronary intervention (PCI) was once treated this same way, but large trials were eventually performed showing that PCI can be performed at facilities without on-site surgical backup.
“On the strength of that evidence, PCI without on-site surgery became standard, and the earlier restriction is now understood to have withheld timely care,” he explained.
Meanwhile, a trio of authors wrote an editorial in favor of TAVR only being performed at sites with surgical backup on hand.[3]
“As TAVR expands to younger and lower-risk patients, preserving immediate access to on-site cardiac surgery remains essential,” wrote senior author Gilbert H. Tang MD, MSc, MBA, a veteran surgeon with the Icahn School of Medicine at Mount Sinai, and colleagues.
Tang and his co-authors noted the advanced cardiac surgeries often required during these incidents “are not procedures that can be improvised.”
“Successful rescue requires the immediate availability of an experienced cardiac surgeon, perfusionist, a primed cardiopulmonary bypass circuit, sternotomy instruments, and an operating environment capable of performing emergency complex open-heart surgery,” they wrote.
The group also emphasized that “every minute matters” in the increasingly rare instances when surgical bailout is required during TAVR.
“If a spectator collapses from cardiac arrest in a stadium and dies because no trained personnel or automated external defibrillator is available, society would consider this unacceptable—despite the fact that such events are relatively rare,” they wrote. “In contrast, during TAVR we knowingly expose patients to a complication with a higher probability, where immediate surgical bailout may be life-saving—yet in some settings, this backup is not consistently available. This inconsistency is difficult to justify.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.