Surgical bailout during TAVR linked to poor outcomes
The need for surgical bailout in heart patients undergoing transcatheter aortic valve replacement (TAVR) is low, according to research published in JACC: Cardiovascular Interventions, but when it is performed outcomes are poor, reaching 50% mortality at 30 days.
Despite its popularity and proven efficacy—and recently expanded indication to low-risk patients—TAVR isn’t a home run for every patient with aortic stenosis, first author Andres M. Pineda, MD, and colleagues wrote in the journal. The intervention still carries a risk for major intraoperative complications, and emergent conversion to open heart surgery has been reported in up to 7.7% of cases.
The authors said current data suggests “an important learning curve with TAVR,” but, notably, rates of procedural success have improved and complications have ebbed over the years. They hypothesized the need for surgical bailout might have decreased in tandem, and pulled data from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry to analyze bailout rates in a population of 47,546 patients who underwent TAVR between 2011 and 2015.
Surgical bailout was rare in the cohort, performed in just 1.17% of cases, or 558 patients. The most frequent indications for bailout were valve dislodgement (22%), ventricular rupture (19.9%) and aortic valve annular rupture (14.2%), and the incidence of surgical bailout decreased over time, from 1.25% to 1.04%.
Pineda et al. said 30-day and 1-year incidence of major adverse cardiovascular events (MACE) and all-cause mortality were much higher in the bailout cohort compared to those whose TAVR was uneventful:
- MACE at 30 days: 54.6% in bailout cohort vs. 7.4% in control group
- MACE at 1 year: 63.9% vs. 20.3%
- All-cause death at 30 days: 50% vs. 4.9%
- All-cause death at 1 year: 59.8% vs. 17.1%
According to the data, female sex, hemoglobin, left ventricular ejection fraction, nonelective cases and nonfemoral access were all independent predictors of surgical bailout in the STS/ACC cohort. Body surface area was the sole independent predictor of survival after surgical bailout.
Outcomes for those who did undergo open heart surgery were grim, with Pineda and co-authors’ research revealing 50% mortality at 30 days for people who required surgical bailout during TAVR.
The 50% in-hospital mortality rate for these patients suggests a potential for improving mortality with onsite surgery of about 0.5%, Fabian Nietlispach, MD, PhD, and Osmund Bertel, MD, noted in a related comment.
“From a statistical perspective and given the fact that patients can now be transferred with mobile biventricular assist devices to nearby hospitals, surgical standby probably is no longer a justifiable requirement to perform TAVR,” the editorialists wrote. “From an individual standpoint, however, many of us would opt for surgical standby if we ourselves needed TAVR.”
Nietlispach and Bertel said Pineda et al.’s work has the potential to change practice in many ways, and one of those is by reminding us of the importance of shared decision-making. It’s imperative that physicians thoroughly discuss the option of surgical bailout with their patients before each procedure, they said, to avoid futile bailouts “prone to result in disastrous outcomes.”
They emphasized the fact that thoughtful patient selection is important not just for TAVR, but for surgical bailout as well if that’s what it comes to.
“We have come a long way with TAVR, from inoperable, to high-risk, to intermediate-risk and now low-risk patients,” the pair wrote. “Now that TAVR is indicated for the clear majority of patients with severe aortic stenosis, outcome research from real-world registries such as this study by Pineda et al. is extremely valuable to realize the potential to further improve the results of TAVR as a breakthrough interventional treatment.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.