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WASHINGTON (Sep 16, 2019) -
Just 1 percent of patients undergoing the minimally invasive heart procedure transcatheter aortic valve replacement (TAVR) have complications that require open-heart surgery, according to a new study published in JACC: Cardiovascular Interventions.
TAVR patients who did require open-heart surgery (known as surgical bailout) had poor outcomes. The study found 50 percent of these patients had died within 30 days—more than 10-fold higher than patients who did not require surgical bailout during TAVR.
TAVR is a minimally invasive surgical procedure that replaces the aortic valve without removing the damaged valve. Instead, a catheter is used to deliver a replacement valve to the site of the old valve where the new valve begins regulating blood flow. It is generally reserved for patients whose poor health makes an open-heart valve replacement too risky.
During TAVR, doctors often access the heart through the femoral artery in the groin. In some cases, the doctor may conduct the procedure through a small incision in the chest and access the heart through the aorta or through the tip of the left ventricle.
The researchers in the new study used data from the STS/ACC TVT Registry, which collects data of all commercial TAVR cases in the United States. Between November 2011 and September 2015, a total of 47,546 patients underwent TAVR. Surgical bailout during TAVR was performed in 1.17 percent of the cases (558 patients). The most frequent reasons for surgical bailout were valve dislodgement (22 percent), rupture of the ventricle (19.9 percent) and rupture of the aortic valve (14.2 percent).
The study found certain patients were at higher risk of requiring surgical bailout, including those undergoing emergency instead of elective TAVR procedures, and those whose catheter was not inserted through the femoral artery. Female patients and those with a higher ejection fraction—a measurement of the percentage of blood leaving the heart each time it contracts—were also at increased risk, the study found.
“Knowing who might be at greater risk of surgical bailout is important because the complication rates and mortality in these patients is so high,” said lead author Andres M. Pineda, MD, assistant professor of medicine in the Division of Cardiology at the University of Florida College of Medicine in Jacksonville. “These findings will be helpful in the preprocedural planning, including deciding whether a full surgical team needs to be present along with the interventional cardiologist doing the TAVR procedure. It is also helpful in deciding whether the procedure should be done in an operating room or cardiac catheterization lab.”
The study found the incidence of surgical bailout decreased over time—from 1.25 percent at the beginning of the study to 1.04 percent at the end. Pineda attributed this decline to several factors, including better processes for selecting patients, improved device technology and that the use of procedures involving the femoral artery has increased to at least 85 percent of cases.
The findings also can help guide doctors in discussing the risks of TAVR with patients.
“If a patient is having an emergency procedure, or one that involves non-femoral access, physicians should tell the patient the risk of open-heart surgery may be higher,” Pineda said.
In an accompanying editorial, Fabian Nietlispach, MD, PhD, and Osmund Bertel, MD, of the
Hirslanden Klinik Im Park, Zurich, Switzerland, wrote, “This excellent study reminds us…that we should thoroughly discuss the option of surgical bailout with every patient and the next of kin upfront before going into the procedure to avoid futile surgical bailout procedures prone to result in a disastrous outcome and therefore adds only further harm to the patients and their families. Thoughtful patient selection is an issue not only for TAVR itself but also for surgical bailout when complications are met.”
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.
The Journal of the American College of Cardiology ranks among the top cardiovascular journals in the world for its scientific impact. JACC is the flagship for a family of journals—JACC: Cardiovascular Interventions, JACC: Cardiovascular Imaging, JACC: Heart Failure, JACC: Clinical Electrophysiology, JACC: Basic to Translational Science, JACC: Case Reports and JACC: CardioOncology—that prides themselves in publishing the top peer-reviewed research on all aspects of cardiovascular disease. Learn more at JACC.org.