Higher mortality than previously reported with SVR surgery

Susan Jeffrey

December 02, 2004

New Orleans, LA - New data from the Society of Thoracic Surgeons (STS) National Cardiac Database suggest that across the US, periprocedural 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 another recent report. The results were presented at the recent American Heart Association Scientific Sessions 2004.


"SVR is emerging as a surgical therapy for heart failure nationally," concluded first author Dr Adrian F Hernandez (Duke Clinical Research Institute, Durham, NC). "Acute procedural risks are higher than previous studies, but emergent/salvage procedures accounted for the majority of the risk."

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, Hernandez told heart wire . "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."

One such outcomes trial, the Surgical Treatment for Ischemic Heart Failure (STICH) trial, is now under way.

Reducing the ventricle and the mortality

SVR is a ventricular reconstruction strategy for patients with heart failure first described by Dr Vincent Dor (Centre Cardiothoracique de Monaco) during the 1980s. Nonfunctional portions of the ventricle are excluded and the ventricle reshaped from a dilated spherical shape to a more functional elliptical shape. A stitch encircles the transitional zone between contractile and noncontractile myocardium, and a small patch is used to reestablish ventricular wall continuity.

Observational studies at selected centers have shown some early benefits of SVR in improving functional class, ejection fraction, and ventricular size and shape, the researchers note. Earlier this year, data from the Reconstructive Endoventricular Surgery Returning Torsion Original Radius Elliptical Shape to the Left Ventricle (RESTORE) registry reported 30-day mortality of 5.3% in about 1200 patients who underwent the procedure between 1998 and 2003 at 12 selected hospitals.[1]

In this study, Hernandez et al examined outcomes in 538 patients who underwent the 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 said.

Compared with the RESTORE patients, these patients had a similar mean age of about 63 years, a similar distribution of NYHA functional class (39% class 3, 30% class 4), but a slightly lower ejection fraction at 28%, vs 30% in RESTORE. Some 87% of patients underwent concomitant bypass surgery, 22% mitral valve repair, and 4% mitral valve replacement.

Hernandez et al report that 30-day mortality was 9.3% in this cohort. The combined end point of death and major complications (reoperation, stroke, renal failure, or prolonged ventilation) occurred in 34% of patients.

Overall morbidity and mortality with SVR

End point %
 Mortality 9.3
 Reoperation 14.4
 Stroke 3.0
Renal failure 7.7
Prolonged ventilation 20.8

 Major preoperative predictors of the combined end point included emergent/salvage surgery, three-vessel disease, female gender, worsening renal function, and increasing age.

Predictors of mortality and major complications with SVR

Predictor Odds ratio (95% CI) p
Emergent/salvage vs elective 4.8 (1.7-13.6) 0.004
3-vessel CAD 2.3 (1.5-3.5) <0.001
Female 1.9 (1.2-2.9) 0.005
 Creatinine (per 1 mg/dL increase) 1.6 (1.1-2.2) 0.005
 Age (per 10-yr increase) 1.2 (1.0-1.5) 0.048

 Procedural mortality rates by volume showed that those centers performing less than five procedures had a rate of 12.5%, compared with 7.3% in centers performing 10 or more, although this difference did not reach statistical significance, Hernandez said. If emergent and salvage procedures were excluded, the difference between these groups was less, 8.4% vs 7.3%. Still, he pointed out, all of these numbers are higher than those reported in the RESTORE registry.

The findings, the highest mortality rates and perioperative adverse outcomes reported outside of expert centers, reinforce the importance of the STICH trial, Dr Eric Velasquez (Duke University Medical Center, Durham, NC), a coauthor on this paper and a STICH investigator, told heart wire . "Before this restoration procedure becomes a standard in the management of heart failure, it needs to be evaluated for its long-term benefits."


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