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Mortality Rates Vary Widely for Comprehensive Stage 2 Procedure

Review of national data shows room for improvement in handling the hybrid approach for left ventricular physiology.

Nationwide Children’s Hospital performs by far the most Comprehensive Stage 2 procedures using the “hybrid approach” for single ventricle physiology and systemic ventricular outflow tract obstruction in the United States, and has reported mortality of just 4 percent.

By analyzing The Society of Thoracic Surgeons Congenital Heart Surgery Database, members of The Heart Center at Nationwide Children’s found a national operative mortality rate of 12.4 percent. Nationwide Children’s accounted for 81 of the 209 cases in their study, in The Annals of Thoracic Surgery; 48 other centers accounted for the rest.

“This shows us, first, that the hybrid approach, including the Comprehensive Stage 2, has become an important tool across the country for the management of patients with hypoplastic left heart syndrome and related issues,” says Mark Galantowicz, MD, co-director of The Heart Center at Nationwide Children’s, chief of the hospital’s Department of Cardiothoracic Surgery and senior author of the study. “It also shows there is plenty of room for improvement in how it is used.”

The Nationwide Children’s team has taken the lead in developing the hybrid approach since the late 1990s as an alternative to the traditional Norwood-Glenn-Fontan sequence of procedures for left ventricle physiology. Studies suggest the hybrid approach can ultimately produce better outcomes in some patient populations, but the second stage of the hybrid approach is more complicated than the Glenn procedure.

“The hybrid approach, including the Comprehensive Stage 2, has become an important tool for management of patients with hypoplastic left heart syndrome...”

– Mark Galantowicz, MD

Most centers continue to use the traditional pathway for typical left ventricle patients and reserve the hybrid approach for their highest-risk patients, says Dr. Galantowicz. That partially explains why other centers would have a higher mortality rate than Nationwide Children’s, which uses the hybrid approach for high-risk and standard-risk patients.

There is also a significant learning curve. An institution performing only a few of those procedures per year will have difficulty improving their performances, says Dr. Galantowicz.

By contrast, a 2016 study from The Heart Center at Nationwide Children’s documented a quality improvement project that reduced mortality and complications in the Stage 2 procedure.

“I think you will continue to see an evolution, and with each evolution, we hope to show others how useful the hybrid approach can be,” Dr. Galantowicz says.

Galantowicz M, Yates AR. Improved outcomes with the comprehensive stage 2 procedure after an initial hybrid stage 1. The Journal of Thoracic and Cardiovascular Surgery. 2016 Feb;151(2):424-9.

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