Should Cardiothoracic Surgery Be Regionalized in the U.S.?

Concentrating care across the spectrum of cardiothoracic surgery to regional high-volume specialty centers would likely improve patient survival and promote more efficient use of resources. However, such a change might exacerbate accessibility issues and would face many obstacles in the U.S., including regulatory constraints, potential antitrust actions and difficulties balancing financial incentives.

Those are the conclusions of a group of national cardiothoracic surgery thought leaders in an invited expert opinion on the pros and cons of regionalization just published in the Journal of Thoracic and Cardiovascular Surgery.

“There are no easy answers to the complex questions of whether and how cardiothoracic surgery should be regionalized to specialty centers in the U.S.,” says lead author of the opinion paper, Tara Karamlou, MD, MSC, a pediatric and congenital heart surgeon in Cleveland Clinic’s Department of Thoracic and Cardiovascular Surgery. “Considerable evidence supports centralization to save lives and costs, but implementation is improbable for financial and social reasons.”

The case for regionalization: Higher volumes = better outcomes

Existing centralized services, such as for organ transplantation and transcatheter valve replacement, demonstrate that such a model makes sense for complex interventions.

Real-world studies, as well as theoretical models, indicate that patients treated at high-quality centers with larger volumes fare better. The opinion piece highlighted a recent analysis of nearly 9,000 patients with type A aortic dissection from the Centers for Medicare and Medicaid Services (CMS) database. Those treated at (or transferred to) a facility that performed at least 105 proximal aortic operations had a relative risk reduction for operative survival of 8.1% compared with patients treated at a lower-volume center.

In another example, when Sweden consolidated congenital heart surgery from four hospitals to the two best-performing facilities, 30-day mortality rates fell from 9.5% to 1.9%.

But Dr. Karamlou cautions that advocating for regionalization based on volumes alone is overly simplistic. “Increasing numbers must be accompanied by a commitment to continued innovation, high quality and patient safety within the institutions,” she comments. “Collaboration and communication between specialty centers and local hospitals must also be emphasized.”

The case against regionalization: Is it practical?

The article brings up several obstacles to regionalization in the U.S., including the following:

• Financial interests may conflict. The U.S. faces more challenges to reorganizing healthcare services than countries with single-payer healthcare systems. Although CMS and private insurers could alter reimbursements to favor hospitals that meet select criteria, national policy initiatives are limited by state-level Medicaid administration.
• The access gap may widen. Centralizing services may widen disparities in healthcare access along socioeconomic and/or racial lines, as local hospitals will offer fewer specialty services. The authors urge that healthcare delivery models be optimized by geospatial analysis with this in mind to minimize disparities.
• Antitrust actions may ensue. Although antitrust legislation was designed for businesses, actions have been brought against expanding hospital systems, with some justification: Single large systems run the risk of failure in specific aspects of patient care that could not easily be addressed if competitors were eliminated. Price escalation may also ensue should widespread consolidation occur.

Daunting data challenges

Dr. Karamlou and colleagues emphasize that while evaluating the benefits of regionalization requires good data, acquiring comparable outcomes data is particularly challenging in a specialty as complex as cardiothoracic surgery — a problem magnified in congenital cardiothoracic surgery. They note, for example, that the number of patients needed to adequately power studies of different congenital anomaly repairs is often impossibly high for single institutions to acquire. Risk adjustment is also an important concern when comparing smaller hospitals that likely have less-complex cases than larger institutions.

Another area where data are lacking involves the logistics of consolidation. Whether entire hospitals — as opposed to, say, personnel or selected resources — should be regionalized is an important issue that requires further study. Simulations that have been performed by Dr. Karamlou’s group could be harnessed to address these pragmatic issues.

Exploring alternatives to regionalization

The authors offer alternatives to regionalization that may prove more practical in the U.S. Examples include:

• Healthcare satellite systems. An increasingly common model consists of a large hospital that participates in specialty care for neighboring associated small hospitals. This model requires financial alignment and usually geographic proximity among the participants, as well as extensive care coordination that defines complexity thresholds for referral to the larger hospital.
• Increased use of telemedicine. While not a substitute for surgery, telehealth services can extend specialty care, assist with triage and improve continuity of care for patients in remote areas.

“The notion of ‘access versus excess’ is a continuing challenge as we seek to improve outcomes and increase resource efficiencies,” concludes Dr. Karamlou. “While full regionalization is probably impractical, thoughtful reorganization of some subspecialties and specific services may be our best strategy.”

Another perspective

“A decade ago, Dr. Karamlou and colleagues assessed outcomes of neonates admitted to hospitals across North America in inception studies of several rare congenital heart defects,” says Eugene Blackstone, MD, Head of Clinical Investigations in Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute. Among their findings (J Thorac Cardiovasc Surg. 2010;139:569-577), he notes, was that a volume-outcome relationship was far weaker than many other factors associated with outcomes, outcomes were highly variable across institutions, and the rank order of institutions with respect to outcomes varied according to specific defects being treated.

“Volume-outcomes relationships become meaningful, as does risk adjustment, when there are large numbers of cases — and specifically a large number of events, the effective sample size,” continues Dr. Blackstone. “Today, mortality is low even for quite complex defects, and variability across program sizes is considerably lower than it was a decade or more ago. This suggests that arguments for or against regionalization need to be based on metrics other than case volume and mortality. This new expert opinion from Dr. Karamlou and colleagues articulates several of these alternatives under both the pro and con arguments that need to be debated — or, better yet, implemented and assessed.”

The entire expert opinion is available here.