Nonsurgical centers can match surgical centers' PCI results with proper support and coordination

Reed Miller

May 10, 2010

Stavanger, Norway - PCI programs should be established at adequately equipped nonsurgery hospitals, according to the authors of the first prospective randomized trial comparing health-related quality of life after PCI conducted at centers with and without surgical backup[1].

In the April 2010 issue of the European Journal of Cardiovascular Prevention and Rehabilitation, Dr Tor Melberg (Stavanger University Hospital, Norway) and colleagues present efficacy results from 609 consecutive nonemergency, low-risk patients who were randomized to PCI at either a community hospital without on-site surgery capabilities (Stavanger University Hospital) or a regional hospital about 130 miles away with on-site surgical backup (Haukeland University Hospital). A total of 576 patients remained in the study at the six-month follow-up.

This efficacy study is a follow-up to a 2006 study that showed that selected nonemergency, low-risk patients could safely undergo PCI at hospitals without cardiac surgery backup[2].

Melberg et al report that the procedural success rates and the changes in health-status measures were similar at both hospitals. The patients at both hospitals showed significant and similar improvements in nearly all multi-item and summary health-related quality-of-life scores, as measured by the Norwegian version of the SF-36 health survey, which measures individual components of physical and mental function and provides a summary mental-component score and a summary physical-component score. The mean Norwegian norm score for both the mental summary and physical summaries is 50.0.

From baseline to follow-up in the nonsurgical-hospital group, the average physical-component summary score improved from 37.0 to 44.5; in the surgical-hospital group, it improved from 37.1 to 43.5. The average mental-component summary score improved from 45.1 to 48.5 and from 45.2 to 48.0, respectively.

For both the summary mental and physical scores, the differences in the improvements between the groups were statistically insignificant.

Although the literature includes many reports on PCI outcomes at nonsurgical centers, most are retrospective reviews or prospective registries; this is the only prospective randomized trial and the first to report health-related quality-of-life outcomes after PCI conducted in a center without on-site surgical backup, according to the authors.

The multicenter PCI studies that have included health-related quality-of-life measurements did not report outcomes on the institutional level, but previous studies have shown that health-related quality-of-life outcomes are better at hospitals that provide an invasive treatment strategy instead of medical treatment only. Therefore, "after establishing an invasive service at the nonsurgical hospital, any health-related quality-of-life outcome difference, compared with the surgical hospital, might therefore be equalized," Melberg et al hypothesize.

Differences in TVR don't appear to make quality-of-life difference

The need for repeat revascularizations because of restenosis was higher in the group treated at the nonsurgical hospital than at the surgical hospital (7.8% vs 2.8%), but there were too few of these events for the difference to be statistically significant. A higher rate of repeat revascularization for PCI patients at nonsurgical centers appeared in a recent analysis of the Massachusetts Data Analysis Center (MASS-DAC) database. The authors of that study pointed out that the nonsurgical centers were more likely to treat patients with planned staged PCI procedures after the initial treatment for STEMI. That study found no difference in death or MI between the two patient groups.

Dr Michael Kutcher (Wake Forest University, Winston-Salem, NC), commenting on the study by Melberg et al, pointed out that the New York State registry of STEMI patients shows a lower target vessel revascularization (TVR) rate for PCI at surgical hospitals than at nonsurgical hospitals (12.1% vs 9.0%; p=0.003)[3]. "This suggestion of an increase in repeat revascularization for PCI patients at off-site centers is currently unexplained and warrants additional assessment and studies," Kutcher told heart wire .

Can these results be reproduced at other centers?

From their study results, Melberg et al conclude that "comparable procedural and health-status outcomes can be achieved with well-trained operators and good cooperation between a hospital with and without on-site cardiac surgical backup." For example, the centers in this trial are operated with a "satellite-center" model.

Dr Melissa Walton-Shirley (Cardiology Associates, Glasgow, KY), the heart.org blogger and a long-time advocate of expanding PCI services to more hospitals and more patients, said the results of this study are "completely intuitive." Previous studies have shown that PCI at nonsurgical centers is safe, "so naturally good outcomes will generally support good quality-of-life indicators."

However, some cardiologists are resisting the expansion of PCI to nonsurgery centers. "It is distressing that we still refuse to evenly distribute this technology throughout our country because we refuse to extrapolate data to other programs," Walton-Shirley told heart wire . "Although competition is usually healthy, when it comes to PCI technology, competition can be deadly. A few hospitals have blocked the rapid diffusion of this technology out of fear that they will lose a large portion of their referral base. Those political tactics are unethical and dangerous."

Kutcher agrees that the kind of coordination demonstrated in Norway is unfortunately still too uncommon. "Interhospital collaboration between off-site and on-site PCI centers is essential for the best patient care and outcomes," he said. "The only barriers to such collaboration are entrenched institutional, political, and economic rivalry issues. With the onslaught of healthcare reform, perhaps more interhospital collaboration will be encouraged and/or economically mandated."

Although it was a small study with only two centers, Kutcher said that Melberg et al's study "sets a standard for future outcomes studies using more comprehensive health-related quality-of-life tools." Large-scale randomized trials would probably be cost-prohibitive, but PCI data from the National Cardiac Data Registry and comprehensive "spoke-and-hub" models such as the Mayo Clinic's "offer the best hope for ongoing monitoring and assessment of the safety and effectiveness of PCI at off-site centers."

The study was supported by grants from the Western Norway health authority and the Western Norway Cardiology Society . The authors declared no other disclosures.

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