The National Mortality Rate for the Comprehensive Stage 2 Procedure

Most published outcomes data on the pediatric Comprehensive Stage 2 procedure come from the few institutions routinely using the “hybrid approach” for single ventricle physiology and systemic ventricular outflow tract obstruction.

Nationwide Children’s Hospital, as an example, performs far more Comprehensive Stage 2 procedures than any other hospital in the United States, and has reported mortality of just 4 percent.

To understand outcomes in the rest of the country, members of The Heart Center at Nationwide Children’s led a recent analysis of data from The Society of Thoracic Surgeons Congenital Heart Surgery Database.

The study, published in The Annals of Thoracic Surgery, show an overall operative mortality rate of 12.4 percent, including the relatively low rate from Nationwide Children’s. Nationwide Children’s accounted for 81 of the 209 cases in the study; the majority of 48 other centers considered by the study accounted for one or two cases each.

“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 us that there is plenty of room for improvement in how it is used.”

Dr. Galantowicz and the team at Nationwide Children’s have taken the lead in the development of the hybrid approach since the late 1990s as an alternative to the traditional Norwood-Glenn-Fontan sequence of procedures for left ventricle physiology. A number of studies have suggested the hybrid approach can ultimately produce better outcomes than the traditional Norwood pathway in some patient populations, but the second stage of the hybrid approach is more complicated than the Glenn procedure in the traditional approach.

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, who is also a professor at The Ohio State University College of Medicine. 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.

But there is also a significant learning curve, particularly for the Comprehensive Stage 2 procedure. An institution performing only a few of those procedures per year will inevitably have difficulty improving their performances, says Dr. Galantowicz.

“Those of us who routinely use the hybrid approach argue that others should too,” he says. “We have our own opportunities for improvement, however, and we might be able to make a more convincing argument as we continue to get better.”

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.

References:

1. Cua CL, McConnell PI, Meza JM, Hill KD, Zhang S, Hersey D, Karamlou T, Jacobs JP, Jacobs ML, Galantowicz M.  Hybrid palliation: outcomes after the Comprehensive Stage 2 procedure. The Annals of Thoracic Surgery. 2017 Dec 19. [Epub ahead of print]
2. 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.