The waivers permit the hospitals to perform elective therapeutic cardiac catheterizations – also known as percutaneous coronary interventions (PCIs) – for three years without having on-site open heart surgery programs in case of emergency complications, while medical researchers are not in agreement that the benefits to patients outweigh the increased risks associated with PCI without open heart backup on-site. Current guidelines by the American College of Cardiology and the American Heart Association (ACC/AHA) warn that the practice is still contraindicated based on the absence of compelling evidence from randomized trials of a favorable risk/benefit ratio.

As a condition of participation in the waiver program, the New Jersey Department of Health and Senior Services (DHSS) has required each of the nine hospitals – Bayonne Medical Center, Holy Name Hospital, Monmouth Medical Center, Muhlenberg Regional Medical Center, Raritan Bay Medical Center, RWJ University Hospital at Hamilton, Somerset Medical Center, Trinitas Hospital, and Virtua-West Jersey Hospital-Marlton – to perform elective PCI only on patients enrolled in a nationwide study led by Johns Hopkins University School of Medicine cardiologist and researcher Thomas Aversano, M.D., and conducted by the Atlantic Cardiovascular Patient Outcomes Research Team (CPORT). The 18,000-patient study is comparing elective PCI outcomes at hospitals with and without surgical backup and hopes to have its conclusions by 2008.

The waiver program drew fierce opposition last year, with the charge led by a group of cardiologists from tertiary institutions – the Committee for Safe Angioplasty – which placed ads showing a boy and his mother dressed in black standing beside a casket, with a headline reading, "Tell him New Jersey didn’t think his dad would need a heart surgeon." Aversano was quoted in the Philadelphia Inquirer last year as saying, "I have not seen the kind of newspaper advertisements and Web sites that have been really sort of smearing the study project and fear among potential patients in places other than New Jersey."

While Aversano is confident that his approach to studying the issue represents the most reliable way to prove whether elective PCI without surgery back-up is safe, some critics contend that the CPORT trial is not a well-designed and safe study.

Cardiac care experts advising the states of Maryland and Massachusetts rejected CPORT because of flawed research design and risk to patient safety, according to cardiologist Jan R. Weber, M.D., MBA, medical director of the New Jersey Heart Institute and chair of Our Lady of Lourdes Medical Center’s Institutional Review Board. In Massachusetts, concerns over CPORT included an absence of a track record of NIH funding of past work by Aversano, and the use of deaths as the only outcome measure of past work, with no consideration of complications or revascularizations, Weber notes.

Meanwhile, New Jersey’s nine waiver hospitals have begun to perform elective PCIs according to CPORT trial protocols designed to track safety and quality via outcomes. Although public acrimony may have quieted, tension among competing imperatives remain: enhancing access by patients in underserved regions to potentially lifesaving medical services, ensuring that proliferation of highly specialized clinical services does not erode quality of care or endanger patients, and satisfying the competing economic interests of community and tertiary hospitals.

Objections to the Waiver Project

Critics testifying before the New Jersey State Health Planning Board last October raised objections to the project on the basis of economics, safety, quality and access.

Representatives of various tertiary hospitals argued that allowing elective PCIs at community hospitals would negatively impact the revenues of tertiary hospitals, which rely on a diversity of payor mixes – i.e., Medicare or private insurance – to compensate for low-paying Medicaid or non-paying charity patients. Weber testified that Lourdes would lose between five to ten percent of its angioplasty volume – between 100 and 200 annual cases – to Virtua West, along with $2 million to $4 million in collected revenue (Medicare rates), which he said contributes to Lourdes’ ability to provide $6.3 million in unreimbursed charity care valued at Medicare rates in the City of Camden.

Several quality and safety objections were ticked off by William Anderson, M.D., a cardiac thoracic surgeon at Deborah Heart and Lung Center:

· Failed angioplasty, while less frequent than in the past, still occurs, and it is bad medicine to discharge a patient following a failed angioplasty from one hospital to an ambulance for a 20-mile ride through unforeseen traffic to another hospital to be operated on.

· Given the direct correlation between operator volume and outcome, adding low-volume centers to the system degrades likely outcome quality, while diluting volume at existing centers.

· Senior citizens, who represent a large proportion of candidates for angioplasty, are also a cohort of patients that will least tolerate hospital-to-hospital transfers, complications and delays when acutely ill.

Dave Knowlton, president and CEO of the independent foundation, New Jersey Health Care Quality Institute, testified that the benefit of timely access to elective PCI at sites without surgical back-up may outweigh the risk in states with significant geographic distances between cardiac surgery programs, or with insufficient cardiac surgery capacity – neither of which is the case in New Jersey, he said. Any market or business advantage that elective PCI programs are perceived to provide to hospitals that have them is an insufficient rationale for permitting such programs without demonstrating true need, and at the present time any risk, however small, associated with the provision of elective PCI at hospitals that do not provide on-site cardiac surgery is an unnecessary risk, Knowlton added.

Waiver Project Rationale

DHSS Commissioner Jacobs responded to most of those concerns in his decision letter sent last year to the 18 community hospitals that applied for the PCI waiver.

Demand for cardiac surgery and angioplasty in New Jersey has been moving in opposite directions, which poses challenges to the state’s ongoing Certificate of Need requirement that elective PCI may only be offered at a cardiac surgery center, Jacobs wrote. While demand for cardiac surgery has declined by 15 percent in NJ during 2000 to 2004, the number angioplasty procedures has increased by 26 percent, and Jacobs said the trends are projected to continue as angioplasty continues to substitute for heart surgery for the treatment of coronary artery disease.

The DHSS wrote that it has relied to a great extent on ACC/AHA clinical guidelines in developing its standards for hospital-based cardiac care, and it acknowledged that the scarcity of research data provides little scientific basis on which the ACC/AHA could consider changes to its current policy that elective PCI should be performed only in hospitals with cardiac surgery on site. When ACC/AHA guidelines changed after new research emerged on the safety of emergency (as opposed to elective) PCI at hospitals without on-site surgical backup, the DHSS said it subsequently modified the Certificate of Need rules to uncouple primary angioplasty from on-site cardiac surgery. "It is in this context, coupled with the Department’s need to respond to the public interest in expanding the availability of elective angioplasty in New Jersey, that the Department determined to contribute to the effort to create an objective basis for assessing this issue by calling for a demonstration project" to contribute to the evidence base nationally on the safety of PCI without on-site surgical backup, Jacobs wrote in his decision letter.

Hospitals approved for the demonstration project have to be able to meet CPORT trial protocol criteria – including achievement of 200 annual PCI volume; and physician, case and device selection criteria – as well as DHSS waiver program criteria, including representation of the state’s diverse regions and potential to increase access to care for minorities and the medically underserved. Jacobs wrote that he weighed this latter factor heavily in his selection decision, noting that applicants ranged from having a three percent to 71 percent minority share of their diagnostic caseload. "When forced to choose85between a record of high volume and a record of serving a higher proportion of minority and medically underserved patients," wrote Jacobs, "I have generally decided in favor of increasing minority access."

Access is a multifaceted issue. Even in the absence of geographical obstacles to access, "functional access" remains a problem with material consequences: patients needing tertiary treatments are not getting referred, for reasons that are not completely understood – perhaps they are resistant to being moved to hospitals and physicians they don’t know, says Aversano. He cites a Crusade Project study of nongovernmental hospitals in which high-risk patients with acute coronary syndromes that could potentially benefit from transfer to a tertiary hospital instead presented to a hospital with just a catheterization lab or one with no vascularization services at all. Only about 48 percent of the high-risk ACS patients in that project were actually transferred, while the mortality was as high as nine percent in the hospitals without interventional services, compared to four percent in the hospitals that had interventional services and to which those patients were then transferred.

Economic obstacles to transfer were not the only reason, as Aversano says the findings were repeated in the VA system, where patients who presented to the so-called spike hospitals in the VA system were not transferred to tertiary institutions.

The DHSS initially called for six waivers to be granted, in an attempt to generate a sufficient contribution of cases to the multi-state CPORT trial while allaying concerns that the demonstration might create an impression of its being a vehicle for widespread proliferation of elective angioplasty without on-site surgical backup.

Jacobs approved nine waivers, saying in his decision letter that restricting the demonstration to six tilted too far in the direction of trying to allay concerns about proliferation. Jacobs said that elective PCI at the waiver hospitals is prohibited on any patient not enrolled in CPORT, and noted that, since the trial requires one quarter of a hospital’s elective PCI patients be randomly assigned to have their procedure performed at a tertiary institution, a number of patients may not consent to participate in the study.

The participation of a larger number of hospitals in the demonstration would also generate a cushion for unanticipated circumstances under which a hospital failed to enroll, or dropped out of CPORT, which would require a time-consuming reissuance of a call for new participants and ramp-up of trial-related activities at those hospitals, Jacobs wrote. Adding three waiver hospitals also corrected a regional imbalance in participation, better representing the northeastern region of the state, which Jacobs noted is also the most densely populated region.

Safety and quality screening ran into a snag during the selection process. While mortality and complication rate data were collected from each applicant, DHSS staff did not disaggregate data for diagnostic (typically low-risk) versus emergency angioplasty cases (high-risk), and Jacobs wrote that he gave less weight to these data because their conflation makes the outcomes comparison among applicants problematic.

Department staff reviewed historical utilization of diagnostic catheterization services by the demonstration applicants and projected potential elective PCI case volume to be 30 percent of that total, as per federal benchmarks. Staff reviewed each applicant’s track record of compliance with licensure requirements for its existing cardiac services, the number of interventional cardiologists on their staff and their respective interventional case volume.

According to Jacobs, NJ hospitals are required to perform a minimum of 100 elective PCIs in their first year of CPORT trial participation to allow for patient enrollment and program ramp-up time, and a minimum of 200 for the following two years.

The DHSS also stipulated that the demonstration project would be terminated if the CPORT trial ended early because of early evidence convincingly indicating safety problems.

Opponents of the waiver program have greatly overstated its potential to reduce elective PCI volume at existing hospitals in a way that has an adverse economic impact on the delivery of health services in the state or in a region, particularly since the demand for elective PCI in the state is growing, Jacobs wrote. "I believe competition, particularly when it is competition based on quality of care, can be a positive force for enhancing services to patients," he noted.

"If the demand trend for elective angioplasty can be coupled with convincing evidence that this procedure may be provided safely in a community hospital setting, then there would be a very strong argument for the Department to promote the wide dispersal of this service," just as it did in 2001 when it allowed emergency PCIs for heart attack victims at community hospitals without on-site surgery back-up, Jacobs wrote. Given the relatively small volume of emergency PCIs at community hospitals, but high fixed costs of maintaining that capability – particularly given the strict program quality standards imposed by New Jersey’s licensure standards – Jacobs added that "it may well be that, over the longer term, the continued viability of emergency angioplasty programs may depend on their being coupled with safe elective angioplasty programs."

Aversano Trial Oversight

Solid evidence is lacking that elective PCI without on-site surgery is as safe as with on-site surgery, and only a prospective, randomized trial can produce meaningful comparisons among sites, says Aversano.

A statistic widely cited by opponents to PCI waiver project is derived from a study by Wennberg et al published in 2004 in the Journal of the American Medical Association, which compared outcomes of nearly 626,000 Medicare patients undergoing angioplasty, Jacobs wrote in his decision letter. The study found that the risk of death after elective PCI was 38 percent higher in hospitals without on-site surgical back-up, while there was no significant mortality difference for patients having emergency PCI.

An editorial in the same JAMA edition cautioned, however, that the study’s design – using data from an administrative registry – may be inadequate to adjust for important patient differences that could affect the findings, Jacobs wrote. Elective PCI patients who were admitted to hospitals without surgical back-up, for example, were more likely to have acute myocardial infarction (51 percent vs. 29 percent) than those who were admitted to hospitals with on-site surgery, and higher mortality would be expected in such patients. The editorial noted that the study’s lack of mortality difference in emergency PCI – a more difficult procedure – also calls into question whether patient differences influenced the findings.

An institution’s procedure volume remains an important surrogate measure of quality, and was a telling variable in the Wennberg study, says Aversano. Hospitals without on-site surgery that performed over 100 elective PCIs per year on Medicare patients (and over 200 per year on all elective PCI patients, assuming that the Medicare population is about half of the total population getting angioplasty) had no higher mortality than hospitals with on-site surgery, while the increase in mortality was confined to hospitals that performed fewer than 50 elective PCIs per year on Medicare patients (100 per year on all elective PCI patients), Aversano notes.

The CPORT trial errs on the conservative side of requiring some minimum elective PCI volume from each institution: at least 200 per year, says Aversano. ACC/AHA recommends that institutions (with cardiac surgery back-up) perform 400 PCIs per year, or 200 per year for geographically isolated institutions; once volume falls below 200, there is good data that outcomes will become worse, says Aversano. "That doesn’t mean that volume will become worse at a single institution, but outcomes at many sites below 200 are clearly worse," he adds. It is also difficult to assess quality in real-time at low-volume institutions because of the rarity of PCI complications which require cardiac surgery. It would take ten years for a center that performs 100 PCIs per year to experience a coronary perforation, which Aversano says happens once in 1,000 cases, on average.

To test the hypothesis that outcomes of elective PCI performed at hospitals without on-site cardiac surgery are not inferior to outcomes at hospitals with on-site surgery, Aversano’s trial is using mortality six weeks after PCI as its primary endpoint, and is also collecting and analyzing additional outcomes data for a nine-month interval, including the comparative incidence of death, heart attack, stroke, bleeding, heart failure, bypass surgery, vascular surgery, and target vessel revascularization; comparative incidence and classification of heart failure and angina; comparative angiographic and clinical success rates; and the comparative cost of care.

While designed to minimize the number of patients that are excluded from study, it does have case selection criteria, notes Aversano. Excluded from participation are patients who have unprotected critical left main coronary artery disease, patients who have poor heart function, and patients who are thought to require the use of niche devices that are generally unavailable at non-surgical cath labs – known in the industry as "rippers and scrapers," he says.

Interventional cardiologists who perform the elective PCIs must also meet ACC/AHA competency guidelines, including the minimum performance of 75 PCIs per year.

The patient’s informed consent form indicates that elective PCIs at hospitals without surgical back-up is not the prevailing standard of care, that it could increase the risk of complications – including death, and that they may need to be transferred to a hospital with cardiac surgery, says Aversano. CPORT requires that transfers be made within 60 minutes.

The CPORT trial is being monitored at three layers, Aversano explains: each participating hospital reports any adverse events to its own Institutional Review Board, to John’s Hopkins’ Institutional Review Board, and to an Independent Data Safety and Monitoring Board. Any of those three bodies can terminate the participation of a physician or hospital at any time for protocol violations, for example, if a site recruits a patient without obtaining informed consent, says Aversano.

The entire trial itself has "stopping rules" if the mortality difference between surgical and non-surgical sites exceeds a statistically significant threshold, Aversano notes.

The New Jersey DHSS also collects outcomes data – including PCI outcomes – and through its licensure enforcement authority can require a hospital to submit a corrective action plan to remedy quality concerns, such as being an outlier for statewide risk-adjusted mortality, says Jacobs. For incidents deemed to be noteworthy, the department can send a survey team to the hospital and suspend a service rapidly, as it did recently with Jersey City Medical Center’s Level II Trauma Center until it obtained the necessary national certification approval, adds Jacobs.

The DHSS has not detected any quality problems so far in the PCI waiver program, although the hospitals have only begun to perform the procedures in recent months – following trial ramp-up activities – and have thus far performed maybe 20 to 30 cases each, says Jacobs.

Preliminary Hospital Experience

Somerset Medical Center went through three to four months of preparation for the CPORT trial, including a visit from Aversano, training of staff, preparing the cath lab, and coordinating EKG technician availability, according to Steven Georgeson, M.D., Chief of Somerset’s Cardiology Section. Somerset started performing elective PCIs in the spring and has enrolled 23 patients in CPORT as of late September, five of whom were randomized to Robert Wood Johnson University Hospital as per trial protocol, he says.

None of the 18 cases performed at Somerset have suffered major adverse events or required emergency transfer, although one patient had bleeding because of medication given for the stents, which Georgeson says would have been no different if the procedure were performed at RWJ.

Because the CPORT trial is set up for relatively low-risk patients who generally do well, statistically speaking, Georgeson believes that it is a far less "experimental" than many trials, which test whether or not a procedure should be done, or a drug be given, in the first place.

Somerset performs about 800 diagnostic catheterizations a year and, its ability to perform elective PCI makes it more convenient and comfortable for patients who can be set up before the diagnostic procedure is done, often eliminating the need for a second puncture in the groin to perform the interventional procedure, he adds.

Raritan Bay Medical Center has enrolled 122 patients in CPORT as of mid-October, 30 of whom were randomized to RWJ and to UMDNJ, and has required no emergency transfers, according to Anthony Chiaramida, M.D., Medical Director of Cardiology.

Chiaramida also notes there is a lot to be said for the familiar surroundings and setting of a patient’s community hospital, and that many of his patients are not wealthy, with some taking busses to get to Raritan. Given the prevalence of acute coronary syndrome, he believes that the state has a vested interest in having excellent care for it all over the state.

Critics Continue Opposition

The Committee for Safe Angioplasty continues to oppose the waivers and some of its members have filed lawsuits against it, according to Weber.

The committee continues to challenge the project in a lawsuit before the New Jersey Supreme Court alleging dereliction of DHSS duties regarding rules on introducing new programs – specifically, that it approved the PCI waiver program without consulting its own independent expert panel, the Cardiovascular Health Advisory Panel, to evaluate the risk, benefits and scientific merits of the study, says Weber.

If the panel was consulted before the department issued its call for applications for the waiver project, Jacobs says he is not aware of it, and he notes that the call was made before he became health commissioner.

Weber also says that Lourdes and the Cooper Health System joined together to sue Virtua Health System over alleged deficiencies in their patient informed consent form for the CPORT trial: that it does not clearly explain to patients the extent to which PCI without surgical backup deviates from ACC/AHA’s standard of care, and does not specifically name the institutions to which a patient would be sent in the event of an emergency or for randomization.

"We’re being made unwilling co-conspirators in a trial we want nothing to do with," says Weber. "If a Virtua patient were to have a catastrophe, the law obligates us to take that patient as an emergency transfer. We refuse to participate as their partner in this trial we’re opposed to philosophically," he adds.

Late last month, the state Appellate Division upheld Virtua’s participation in the waiver.

The committee is also pushing legislation in the state’s General Assembly that would require patients to be informed in more detail about standard of care deviation, and would require the DHSS to approve one informed consent form to be used when the state does a multiple center trial, says Weber.

The DHSS opposes legislation on informed consent, and left the content of the CPORT patient informed consent up to hospitals’ Institutional Review Boards, which Jacobs believes have the most expertise on how to protect their institutions from liability.

Aversano notes that patients’ informed consent is guided by both the Johns Hopkins IRB and by the individual IRBs involved at each site. Whatever requirements the local IRB suggests or requires are included in the informed consent, as long as all critical elements of the model consent are included, and the CPORT study does not dictate to which institution(s) patients are transferred – the selection of which is guided by considerations such as the patient’s wishes, the requirements of third party payers, and proximity (temporal and geographic) in the event of an emergency.

Weber also points out the potential cost inflation of angioplasty proliferation, and he cites the finding of a recent peer-reviewed study that it costs $3,024 more to have an elective PCI performed at a center without surgical back-up than at a center with back-up (measured in actual cost, not charges) – primarily because of the volume purchasing power, resources and other efficiencies of high-volume centers. Assuming that New Jersey enrolls 1,800 patients in CPORT, the cost difference will total $5.4 million, Weber adds.

To critics who ask, "why take the risk" of allowing elective PCIs without on-site surgical back-up, Aversano responds that attempting to expand angioplasty services in a controlled, rational way can help to sustain and improve emergency angioplasty programs at community hospitals, prevent proliferation of elective PCI programs without the best evidence – which he says is already occurring around the country, help community hospitals attract the best cardiologists – who he says tend to favor hospitals that offer interventional services, and reduce the pressure on hospitals to create additional cardiac surgery programs just to back up angioplasty.

Aversano reaffirms the importance of his study by declaring that the issue goes well beyond angioplasty and impacts the overall quality of care at a hospital, as millions of Americans have coronary artery disease and interventional cardiology services have become increasingly important to manage them.

New Jersey may restructure its cardiac services altogether, as Gov. Corzine recently appointed Uwe E. Reinhardt, one of the nation’s leading authorities on health care economics to head the state’s Commission on Rationalizing Health Care Resources – which will work to ensure that the state’s supply of hospital and other health care services is best configured to appropriately respond to community needs, says Jacobs. "Cardiology is a very prominent part of that review," he adds.