Study Raises Concerns Over 2-Valve TAVR Surgical Procedure Risks

A new study suggests individuals requiring an emergency second valve placement while undergoing transcatheter aortic valve replacement (TAVR) surgical procedures face an increased risk of severe bleeding events, strokes, and death.

Cardiologists from Israel and across Europe published findings last week in The Journal of the American Medical Association (JAMA), raising concerns patients undergoing TAVR procedures requiring a supplemental valve are at a higher risk of complications and mortality within 30 days post-surgery.

TAVR is a type of heart procedure which 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 among high risk patients who were frail or could not undergo open heart surgery. The durability of the heart valves was also untested for use among younger patients, who may outlive the devices, which were originally designed to last 10 years, not 30 or more years.

While past research has highlighted a known series of risks associated with single TAVR procedures, researchers preformed a cohort study analyzing whether there is an increased risk of adverse health events and mortality associated with a secondary, or 2-valve TAVR (2V-TAVR).

Researchers reviewed data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019, in which 223 patients underwent 2V-TAVR procedures. Patient data among both 1V-TAVR and 2V-TAVR were evaluated at 30 days following the procedures to assign mortality hazard ratios.

According to the data, 80% of patients required a supplementary valve implant after experiencing residual aortic regurgitation due to the primary valve being positioned incorrectly.

Of all patients who required supplementary valves, 2.3% suffered coronary obstruction compared to 0.4% 1V-TAVR procedures, 4.6% suffered stroke while 1V-TAVR rate was 1.6%, and nearly 12% of 2V-TAVR patients experienced a major bleeding event compared to 5.5% of 1V-TAVR procedures.

Researchers also assigned hazard ratios for mortality, indicating 2V-TAVR patients had a higher mortality rate of 2.58 at 30 days post-surgery when compared to 1V-TAVR procedures.

Valve malposition was found to be the most common cause for 2V-TAVR, and while incident rates were only found in 1% of patients, the 30 days after a 2V-TAVR procedure carried a higher risk of severe adverse health events and death.

A study published in the September 2020 issue of the journal JACC: Cardiovascular Interventions indicated more than one out of every hundred TAVR procedures requires surgical bailout, in which the surgical team has to convert to open heart surgery after experiencing unexpected complications, highlighting the risk of TAVR surgical bailouts.

Just last month, a recent TAVR mortality study presented at the virtual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI) presented findings that even low-risk patients who underwent transcatheter aortic valve replacement (TAVR) may face an increased risk of death from inflammation developing in the heart’s inner lining.