MASS COMM: Elective PCI Safely Performed Without Surgical Backup

March 12, 2013

SAN FRANCISCO, California — Nonemergent PCI can be safely performed in community hospitals without on-site cardiac surgery, with Massachusetts investigators reporting that there was no difference in major adverse cardiac events (MACE) at 30 days and 12 months when these patients were compared with those treated at hospitals with surgical capability [1].

The results of the study, known as MASS COMM, were presented today during the late-breaking clinical-trials session at the American College of Cardiology 2013 Scientific Sessions and published concurrently in the New England Journal of Medicine.

Dr Alice Jacobs

"We know that emergency coronary bypass surgery following PCI has become a rare event," said lead investigator Dr Alice Jacobs (Boston University School of Medicine, Boston, MA). "So it raises the question of whether cardiac surgery on site is still necessary for the safe and effective performance of PCI. Moreover, the need for timely access to primary PCI has justified the expansion of PCI to hospitals without on-site cardiac surgery, but controversy exists as to whether there should be a further expansion for nonemergent PCI to these hospitals where the risk/benefit ratio might be different and the need for timely access is less important to cardiovascular outcomes."

Volume Standards for Hospitals and Operators

In MASS COMM, the participating community hospitals and operators met strict requirements, participating in the Massachusetts Department of Public Health special project for primary PCI. The centers had to perform a minimum of 300 diagnostic procedures in each of the previous two years, including 36 primary PCI procedures annually. The hospitals were also required to have access to a hospital with 24/7 surgical backup (patient arrival within 60 minutes). Physicians were mandated to have performed a minimum of 75 PCI procedures annually to be included in the trial.

In total, 2774 patients undergoing coronary angiography at a hospital without on-site cardiac surgery underwent PCI, and 917 were transferred for PCI to a hospital with surgical backup. The average patient age was 64 years old, approximately one-third had diabetes, and 30% of patients had undergone prior PCI. While the baseline characteristics were not significantly different, 24.1% individuals revascularized at the center without surgical backup had a prior MI compared with 20.2% of individuals treated at a center with on-site surgery (p=0.015).

Overall, the study met the primary safety and effectiveness end points at 30 days and 12 months, respectively. In terms of the individual components of the safety and efficacy end points (death, MI, repeat revascularization, or stroke), there was no difference among those treated with and without surgery on site. Jacobs said these data are in line with the results of the Cardiovascular Patient Outcomes Research Team Elective (C-PORT E) study, a trial previously reported by heartwire.

MASS COMM: Clinical End Points

End point No on-site surgery, n=2774 (%) On-site surgery, n=917 (%) p (for noninferiority)
MACE (death, MI, repeat revascularization, stroke) at 30 d 9.5 9.4 <0.001
MACE at 1 y 17.3 17.8 <0.001

"PCI performed at hospitals without cardiac surgery on site was noninferior to PCI performed with cardiac surgery on site with respect to the 30-day safety and 12-month effectiveness end points," said Jacobs. "These data suggest that PCI can be safely performed at hospitals without surgery on site, albeit with formal programs and volume requirements, and that this could be an acceptable option for patients presenting to such hospitals."

Some Tempered Enthusiasm

Dr Neal Kleiman

Speaking during a morning press conference, Dr Neal Kleiman (Methodist DeBakey Heart and Vascular Center, Houston, TX) said the study shows that in well-trained community hospitals, PCI without surgical backup can be safely performed. However, he said the major take-home message is that the decision to perform elective PCI without surgical backup can't be undertaken by community hospitals lightly.

"This was not a haphazard decision to order some guiding catheters, to see how cheap you can get some stents and guidewires, and say hey, let's do it," said Kleiman. "This was a very rigorous program with a long training period for operators and a long training period for hospitals with very clearly defined pathways to manage the patients. Getting set up before this was done took a lot of work and a lot of organization on the part of participating hospitals. So the take-home message should be, yes, you can do this, and you can do it safely if you have learned to select patients, trained your operators, and established a safe and reliable system for doing all these things, such as managing the patients and preparing for some of the potential disasters that can occur."

A complication, he added, can quickly change the mood and tenor of any enthusiastic program without on-site surgical backup. To heartwire , he said there are concerns that high-volume clinical centers, those hospitals that have on-site surgical backup, might suddenly turn into low-volume centers by displacing patients to community hospitals. The concern is that doing so might not be in the best interests of patient care.

"If you suddenly take high-volume experienced centers and convert them to low-volume inexperienced centers, are you improving the aggregate outcome for patients undergoing stenting? I think the answer is no," said Kleiman. "I think the real question is not what's best for the hospitals or best for the practitioners, but what's best for the patients. If you're making outcomes worse for the sake of parking convenience or the fact that a hospital has a cafeteria, that's the wrong approach. Also, economically, what does this mean for the US? I think it means there will be more procedures done. Is that the right thing? I think it's an unanswered question."

Kleiman added that on-site surgery often serves as a surrogate for having other hospital services, including specialized care. "Truthfully, it's also a surrogate for having more mid-level practitioners seeing patients," he said. "It's more eyes on the patient and more discussion. These are programmatic issues that will have an impact on the national aspects of healthcare more than at the individual level."

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