Despite reduced need for “surgical bailout” during transcatheter aortic valve replacement (TAVR) in recent years, patients still face higher death rates from procedures, according to the findings of a new study.
More than one out of every hundred TAVR procedures requires the surgical team to convert to open heart surgery after experiencing unexpected complications. However, a study published in the September issue of the journal JACC: Cardiovascular Interventions indicates that number is an improvement over previous years.
Researchers from University of Florida College of Medicine Jacksonville used data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. They focused on the need for surgical bailout during TAVR procedure and evaluated one-year death rates and adverse events between November 2011 and September 2015.
TAVR is a type of heart procedure that allows the surgeon to replace the heart valve by threading it through an artery in the leg instead of via open chest surgery. It places the valve over the damaged aortic valve in a less invasive procedure.
Initially, TAVR was approved only in high risk patients who were frail or couldn’t undergo open heart surgery because the procedure carried such high risks. More so, the durability of the heart valves was untested for use in younger patients who would outlive the devices that were designed to last 10 years, not 30 or more years.
Surgical bailout occurs when a surgeon begins the TAVR procedure, and due to some type of complication must stop the TAVR procedure and convert to open heart surgery, which is much more invasive and often involves greater risk.
TAVR surgical bailout is often needed because of valve displacement, ventricular rupture, and aortic valve annular rupture, which are all issues that carry high risks of death. These side effects occurred more often in women, nonelective cases, and when leg artery access wasn’t available.
Bailout’s Decrease, But Still Deadly
In the new study, nearly 48,000 patients underwent TAVR during the study period and surgical bailout was necessary in 1.2% of the cases, or nearly 560 cases. The research indicated the need for surgical bailout decreased over time to 1.04% from 1.25%, after briefly peaking at 1.43%. However, despite the decrease in the overall need for surgical bailout, the risks associated with surgical bailout were still high, the researchers reported.
The 30-day death rates and one-year death rates for TAVR procedures were much higher among patients that underwent surgical bailout.
The 30-day bailout fatality rate increased from 55% to 64% indicating nearly two-thirds of patients died by the 30 day mark. The one-year death rate also increased from 7% to more than 20%. All cause death rates increased as well.
“In a large, nationally representative registry, the need for surgical bailout in patients undergoing TAVR is low, and its incidence has decreased over time,” the researchers wrote. “However, surgical bailout after TAVR is associated with poor outcomes, including 50% mortality at 30 days.”
A recent study indicated many TAVR complications could be avoided if imaging techniques, like multidetector computed topography (MDCT) were utilized. That study also found using an experienced surgeon and focusing on real-time ultrasound guidance could help prevent complications.
Other side effects of TAVR include the failure of a closure device, device embolization, coronary occlusion, and higher risk of stroke, putting many more patients at risk.