Survey says: Most cardiologists support elective PCI sans on-site CABG . . . with caveats

December 13, 2011

The US News & World Report story on these survey results can be found here: Cardiologists say patients can safely get angioplasty without surgeons on site

New York, NY and Washington DC - If resistance isn't futile, perhaps it's slipping?

In a survey conducted jointly this month by theheart.org and US News & World Report, two-thirds of respondents say that elective angioplasty at centers without cardiothoracic surgery on-site (SOS) can be done safely and effectively.

Of note, however, respondents were split as to who should decide what hospitals should have PCI capability, although almost all felt that outcomes monitoring and public reporting should be mandated for all sites performing elective procedures.

The nearly one-third of respondents who gave elective PCI without on-site surgery a thumbs down did so in spite of the survey's stipulations that such programs be "properly developed," adhere to strict patient-selection criteria, and have an annual volume of >200 cases; that they include only "AHA/ACC-qualified" operators; and that outcomes be monitored.

"It's all about the money. Period. Greed is king. Period," wrote one responder anonymously. Another, reflecting the tone taken by quite a few of the survey's minority respondents, provided a fairly dry take on it: "Ask any cardiologist where they would prefer their PCI to be performed."

But others, in support of elective PCI without on-site surgery pointed out that this had been done "for a very long time," as one respondent put it. "The whole subject is utterly superfluous and unnecessary to even discuss!"

A collaborative effort

 

The news organizations together surveyed more than 17 000 cardiologists who subscribe to theheart.org or are recognized as Top Doctors by US News and Castle Connolly Medical Ltd.  About 5200 cardiologists have been certified as angioplasty specialists, according to the Society for Cardiovascular Angiography and Interventions. A total of 350 responded to the survey.

A "no-brainer"?

The survey results may reflect some thawing in the US cardiology establishment's take on the practice also reflected in new guidelines on coronary revascularization unveiled last month[1]. Previously relegated to class 3 ("not useful/effective and may be harmful"), the practice was upgraded to class 2b ("may be considered"). Primary PCI at such centers, a different question, was upgraded to class 2a ("is reasonable to perform").

Remaining in class 3 (useless or harmful) was any kind of non-SOS PCI in the absence of "a proven plan for rapid transport to a cardiac surgery operating room in a nearby hospital or without appropriate hemodynamic support capability for transfer"—a condition some rural centers can't meet.

Perhaps, as well, many respondents had recently seen results of the Cardiovascular Patient Outcomes Research Team Elective (C-PORT E) study, reported at the AHA 2011 Scientific Sessions and covered by heartwire . With >18 500 patients undergoing elective PCI randomized at centers with or without SOS, the trial saw no significant mortality (<1% in both groups) or safety differences at six weeks. Emergency bypass surgery was needed in 0.2% of cases at centers with SOS and 0.1% of non-SOS centers.

 
Surgical backup is rarely needed and has not been a requirement in Europe for years.
 

"C-PORT E is likely to establish a new standard of care for PCI in the US. Surgical backup is rarely needed and has not been a requirement in Europe for years," wrote Dr Henry Altszuler (Robert Wood Johnson Medical School, New Brunswick, NJ) in response to the survey. "As a participant in the trial, I can attest to the benefits. . . . With intelligent case selection and experienced staff and physicians, [non-SOS elective PCI] is a seamless process and a 'win-win' for patients and hospitals."        

"This is a no-brainer," wrote Dr Martin Albornoz (MidAtlantic Cardiovascular Associates, Baltimore MD). "PCI can be safely performed at hospitals without SOS. Case selection, physician experience, and careful oversight are key."

Nearly all responders who commented favorably on the practice had caveats, which were generally consistent with those in the new guidelines.

Topping the list was the need for high-level operator experience and skill: "I have been doing PCI without surgical backup since 2003. I also perform PCI at a site with surgery on-site," wrote Dr Jean-Pierre Geagea (Tufts University, Boston, MA). "For a successful program, physicians need to know their limitations. This is the golden rule. Rule #2, the program needs to know that complications will happen, so they need to get familiar with how to deal with them (pressing the panic button will not help the program). A well-experienced interventionalist should be available 24/7 to lead every new program."

"PCI without surgical backup can be safe if cases are chosen carefully and there is a plan for emergent transfer to a facility with surgical support in the rare instance that there is a complication that requires urgent surgical intervention," wrote Dr Mark Friedman (University of Arizona Medical Center, Tucson).

 
Surgery at every PCI site degrades the volume of surgery to the point that it cannot be done with a high degree of competence.
 

Dr Timothy A Sanborn (North Shore University Health System, Evanston, IL) agreed: "If there is a multihospital healthcare system with a good plan for transfer to a hospital with cardiothoracic surgery, then selected cases of elective PCI should be allowed, provided there is participation in a national database such as the ACC [National Cardiovascular Data Registry] NCDR."

Others were concerned that an insistence on SOS would spread surgeons and their experience too thinly. "The safety of PCI in today's setting is very good. The surgical volume necessary to maintain reasonable team competence is such that surgery at every PCI site degrades the volume of surgery to the point that it cannot be done with a high degree of competence, particularly in the situation of an emergent patient coming out of the cath lab," according to Dr John C Alexander (North Shore University Health System, Evanston, IL).

Dr Kim Eagle (University of Michigan, Ann Arbor), responding to the survey, observed: "Volumes fall due to success of medical and preventive therapy; hospitals and cardiologists are desperate to do as many PCIs as possible. I believe that much of this is fueled by greed, not need. The geographic-access argument does not fly for the majority of those seeking to do this. Also, indication drift leading to 'discretionary' procedures is a real issue if and when this is opened up. By making PCI available at every hospital in the nation, we will not only drive up costs, we will reduce quality due to exposing patients to unnecessary risky procedures."

"The greatest factor that increased the number of surgical programs has been compliance with state regulations so that PCI can be done. These small surgical programs are expensive and fragment surgery in our communities," wrote Dr W Douglas Weaver (Henry Ford Hospital, Detroit, MI).

Family matters

More than a few skeptics of the strategy expressed their objections by making it personal. Most did this anonymously, including those who wrote, "If I ever needed a coronary intervention, I would choose a hospital with surgical backup available" and "Would you let your family have PCI without standby?"

But Dr George Broderick (Good Samaritan Hospital, Dayton, OH) owned what he wrote: "Ask the interventional cardiologists doing these procedures at hospitals without surgical backup to remember their last patient who had to go to emergency surgery after an unexpected complication, and then would they do that to their parents? We all have had these experiences, and the limited randomized trial that suggests this is not an issue is backing this activity up. Very spooky."

 
Would you let your family have PCI without standby?
 

According to Dr Scott Woodfield (Lowcountry Cardiology Associates, North Charleston, SC), "PCI needs to be more limited. Fewer facilities with more experience mean better outcomes."

Which hospitals? What outcomes? Whose oversight?

 

Other survey questions probed the issues of who should be performing elective PCIs in the absence of surgical backup, how their results should be tracked, and by whom.

In all, 36.6% of survey respondents said that professional groups like the ACC and AHA should decide which hospitals have elective PCI capability, 29.7% said that state and/or local regulators should be in charge of that decision, 27.4% said that job should fall to local physicians and hospitals; only 6.3% believed federal regulators should have final say.

A full 97.7% of respondents supported outcomes monitoring and public reporting, and of those, the majority (46.3%) said professional groups like the ACC and AHA should be responsible. Roughly 24% felt state policymakers should provide this oversight, with local physician input, while 18.3% said it should happen at a national level, with the help of the professional societies. Just 11.7% felt "individual hospitals" should oversee their own outcomes and reporting.

There were additional nuances provided in the comments section.

Dr James de Lemos (University of Texas Southwestern Medical Center, Dallas) said, "I support reporting of outcomes to regulators but not yet to the public."

Also, Dr Ralph Brindis (Oakland Kaiser Medical Center, CA) observed, "Ideally these stand-alone programs would be created due to local patient care needs rather than a financial driver per se. Close evaluation of outcomes and quality through participation and transparency of results from the NCDR registry is essential for quality oversight."

Of the non-SOS skeptics as well, 59.7% believed that at the non-SOS centers, referrals for inappropriate PCI "to keep institutional volume up" will increase. "A bad idea" that will "increase the number of nonindicated procedures," concurred Dr Jacob Shani (Heart Institute at Maimonides Medical Center, Brooklyn, NY). "Those hospitals rarely use [fractional flow reserve] FFR for confirmation of lesion severity. All the high-risk patients are referred out, creating an unfair burden on other institutions. . . . The only reason results are 'good' is patient selection, including angioplasty of vessels and lesions that should be treated medically." And at centers without SOS, he wrote, "operators don't have the same skill level as in the surgery-backed institutions."

Indeed, almost as popular a reason not to consider non-SOS elective PCI safe and effective, selected by 57.1% of respondents, was that the centers with cardiothoracic surgery "tend to attract the most highly qualified cardiologists."

"Judgment, the appropriate case mix, equipment, surgical decisions, and long-term outcomes all are derived from a combination of skill and experience," writes Dr Michael Kelberman (Mohawk Valley Heart Institute, Utica, NY) "Small stand-alone programs simply will fall short on most of these measures by virtue of their very nature. These are elective cases—there is no reason to subject patients to these risks."

The fourth most common response was that there are too many non-SOS programs already: "this will dilute the volume at established centers." That was selected by 37.8% of respondents.

Writes Dr Joseph Carrozza (St Elizabeth's Medical Center, Boston, MA), "Although the data suggest that PCI at non-SOS hospitals can be performed safely, low-volume operators in low-volume institutions perform consistently below appropriate thresholds."

"Volume and quality are closely linked. The problem is there are a lot of diagnostic-only cath labs that are trying to transition to unbacked PCIs," according to Dr David A Portugal (Cardiology of Houston, TX) "This is at a time that overall PCI volume is dropping. This divides the overall 'pie' of PCIs further, making it more difficult for quality centers to maintain their volume. There needs to be better regulation, limiting PCI centers to high-volume labs."

Anachronism or malpractice fears?

Dr Gary S Roubin (Lenox Hill Heart and Vascular Institute, New York, NY): "Backup CT surgery is an anachronism from the early days of coronary angioplasty before the era of the modern coronary stent."        

Dr Nate Lebowitz (Advanced Cardiology Institute, Fort Lee, NJ): "The only valid reason we have avoided performing PCI at a hospital without cardiac surgery is fear of malpractice and fear of local newspaper persecution. With an acute MI, you often do not know the patient and family [and] so are more likely to get sued."

And 31.1% of non-SOS center skeptics indicated that elective PCI raises healthcare expenses. "With careful selection, PCI without surgical backup can be safe, but it is increasing healthcare costs for no benefits to the healthcare system," wrote Dr Kenneth M Kent (Washington Hospital Center, Washington, DC).

Those who provided comments in the survey indicated some other reasons, not included as survey options, for coming down against a non-SOS strategy. Several touted the advantages of a team approach in many patients who need revascularization.

Kelberman also wrote, "There is an increasing push to make revascularization decisions in concert with surgeons, including for hybrid procedures. This is an important trend that is making all revascularization decisions safer and better for patients. It makes no sense to take a step backward and encourage an environment where this can simply not take place."

All about the money?

Survey participants were also asked their explanation for why there is "a push to allow PCI at more hospitals" without SOS. "The issue is much more about money and marketing than MDs and hospitals want to admit," commented one anonymously, although speaking for those giving the highest-ranked response, at 45.4%.

 
This is about cardiologists and hospitals wanting more money. Quality and patient care have a secondary, if any, role.
 

On the record, Dr Michael Nellestein (Heartland Health, St Joseph, MO) similarly wrote, "This is about cardiologists and hospitals wanting more money. Quality and patient care have a secondary, if any, role. Doctors want [relative value units] RVUs and hospitals want facility fees, period. It's all about the money."

Dr Howard C Herrmann (University of Pennsylvania, Philadelphia) added: "Although I think it is generally safe, the rare complications will likely have better outcomes at hospitals with surgical backup. I suspect most physicians would not choose to have their own PCI at a hospital without surgical backup. Although there are legitimate reasons to do PCI without surgery at remote hospitals where patients otherwise might not have local access, and in emergent situations, I believe that much of the driving pressure is financial by the hospitals that want to offer this profitable procedure."        

According to Dr Michael Mirro (Fort Wayne Cardiology, IN), "This is about money most places—small hospitals trying to compete and bottom-feeder interventionalists. Some rural areas in the West do need to do this but should be granted a waiver."

On that note, 35.7% of the respondents indicated that the push is at least partly about increasing access to PCI in areas of need. "The limitation of the number of centers in rural US able to do PCI (primary and lower-risk elective) I feel makes it imperative that more centers be available even without surgical backup," wrote Dr Richard A Leff (Marshall Hospital Center Sparks, NV).

"We have all known for a very long time that the data and real-world practice show that in appropriately selected patients and cases, there is no need for on-site surgical programs," wrote Dr Andrey Espinoza (Hunterdon Medical Center, Flemington, NJ).

"You have to remember that it is not as though if there is a major complication during an elective PCI, a surgical team is just sitting around ready to take the patient into an open room," he added. "Sometimes the delay can be just as lengthy as [with] a transferred patient."

There were several other comments along the same lines, including this one from a discouraged anonymous writer: "The last time I really needed surgical backup, it failed to appear."

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