Monday, December 6, 2004

STS Database: Higher Mortality Associated with SVR Surgery
By Julie McKeel

New data from the Society of Thoracic Surgeons (STS) National Cardiac Database suggest that across the US, mortality associated with surgical ventricular restoration (SVR) is higher than previously reported. The 30-day mortality was 9.3% in this review, compared with 5.3% in a recent report based on another study. The results were presented at the recent American Heart Association Scientific Sessions 2004.

Heart failure occurs when the heart’s lower chambers, the ventricles, become less efficient at pumping blood out to the lungs and the rest of the body. SVR is one way to reconstruct the ventricles for patients with heart failure. In this procedure, the ventricle is reshaped from a dilated, spherical shape to a more functional elliptical shape.

Adrian Hernandez, MD

"SVR is emerging as a surgical therapy for heart failure nationally," concluded DCRI’s Dr Adrian F. Hernandez in an interview with theheart.org. “It's possible that differences in patient selection and experience with the procedure as it is being adopted are having an impact on mortality rates in the broader population of patients receiving this procedure. Nevertheless, because it's a slightly higher mortality rate, it's important to understand what the long-term benefits are, as well as trying to improve the quality of care, either procedural performance or patient selection."

Observational studies at selected centers had shown some early benefits of SVR. Registry data from a trial completed earlier this year (RESTORE) reported 30-day mortality of 5.3% in about 1200 patients who underwent the procedure between 1998 and 2003 at 12 selected hospitals.

Hernandez’s team analyzed the STS outcomes data in 538 patients who underwent the SVR procedure between 2002 and 2003 at 118 of the 600 hospitals that participated in the STS national database. In 2002, 176 procedures were performed, increasing to 362 in 2003.

"Most hospitals have only started using the procedure, with 94 sites performing less than five procedures, whereas only 12 sites performed 10 or more," Hernandez told theheart.org.

The patients in the STS Database were similar in age and condition to the RESTORE patients. However, Hernandez‘s team found that 30-day mortality was 9.3% in this group as opposed to the 5.3% reported in the trial. The combined end point of death or major complications (additional surgery, stroke, renal failure, or prolonged ventilation) occurred in 34% of patients. The STS Database mortality numbers are higher than those reported in the trial, even taking into consideration the differences in number of procedures performed by the participating centers.

Eric Velazquez, MD

The findings, the mortality rates, and perioperative adverse outcomes reported outside of expert centers, reinforce the importance of the ongoing Surgical Treatment for Ischemic Heart Failure (STICH) trial, Dr Eric Velazquez, a coauthor on this paper and a STICH investigator, told theheart.org. "Before this restoration procedure becomes a standard in the management of heart failure, it needs to be evaluated for its long-term benefits."

DCRI outcomes leaders coordinate the STS Database, which offers outcome programs in the areas of adult cardiac, general thoracic and congenital surgery. The STS Database has served as the basis for a federally funded national quality improvement randomized trial, as well as research in targeted areas of cardiac surgery.