A state decision on whether to allow hospitals to perform elective angioplasties without having a backup cardiac surgery unit onsite will be decided after a series of public hearings, state Health Commissioner Mary E. O’Dowd said on Tuesday.
Angioplasty is a procedure performed by specially trained cardiologists, typically to open a blocked or narrowed artery. With cardiac surgery, in contrast, the heart is operated on directly.
The State Health Planning Board will hold a series of regional hearings to gather information before the state issues new angioplasty regulations, O’Dowd said at a symposium hosted by the New Jersey Chapter of the American College of Cardiology.
The subject has sharply divided hospitals over the past decade, with 18 hospitals that have backup cardiac surgical capability opposing the expansion of elective angioplasties to other hospitals.
Currently, 11 hospitals without cardiac surgeries are allowed to offer elective angioplasties, due to their participation in a national study of the procedures. Dr. Thomas Aversano, the study’s lead author, said the report showed that the procedures can be done safely and effectively at hospitals without onsite surgeries.
Angioplasty is used to improve symptoms of coronary heart disease or to reduce heart muscle damage from a heart attack. Elective angioplasties are profitable procedures for hospitals. In addition, hospital officials point to the benefits to patients of making angioplasties available at their facilities.
O’Dowd said she intends to propose a state rule that would allow elective angioplasties to continue at the 11 hospitals without onsite cardiac surgeries that participated in the study, until new regulations governing all heart procedures are reviewed and adopted.
“This allows the facilities that have a system in place with individuals performing the procedure -- and it’s not just the physicians, it’s the nurses and the techs and the entire team of individuals that built this system -- it allows them to continue while the (Health) Department goes through this process with the public,” O’Dowd said.
The study that the 11 hospitals participated in is finished, which is why the regulation specifically addressing them is expiring.
The new rules may require hospitals to report quality indicators regarding the cardiac procedures they’re conducting, O’Dowd said. The rule may also revisit how the state regulates cardiac catheterization, a procedure in which a tube is inserted in an artery. The state has already received input from health officials on the rules.
“We’ll have to evaluate all of those various opinions and determine what’s the best case moving forward,” O’Dowd said.
O’Dowd anticipates heavy political lobbying over the issue. It’s an unusual step for the department, which usually includes in its rulemaking private meetings with smaller groups of stakeholders.
“My hope is to say, rather than this devolving into a political conversation and discussion, to really have an open, honest, public, transparent dialogue on all of the various issues that impact this decision-making,” O’Dowd said.
Eight doctors participated in a series of presentations as well as a panel at the symposium, moderated by Dr. Ken Kutscher, the ACC chapter governor.
Dr. Charles Dennis, whose Mount Laurel-based practice The Cardiology Group, was acquired by Virtua in July, noted that the number of cardiac surgeries has declined since stents became widely used in the 1990s. Stents are the small tubes used in catheterization and angioplasty procedures.
Dr. Thomas Wharton of Exeter, NH, described a recent example of a woman whose life was saved by having an angioplasty at a hospital without cardiac surgery.
Several of the doctors cited studies that found that angioplasties at hospitals without cardiac surgeries were as safe as those with surgeries, particularly if steps were taken to ensure that the doctors were experienced.
Dr. Gregory Dehmer of Texas A&M University said ensuring that angioplasty programs meet appropriate performance standards “is likely to save more lives” than requiring that the programs have onsite cardiac surgery teams.
Aversano said his study, in which the 11 New Jersey hospitals participated, found that the elective procedures were conducted safely at hospitals without cardiac surgery. He added that the study wasn’t designed to reach a conclusion about what is the best policy. He then said that adding angioplasties “raises all boats” at hospitals, helping specialists in other areas improve their care.
Dr. Ralph Brindis of the University of California, San Francisco, said the arguments in favor of angioplasties without onsite cardiac surgery include providing timely access to emergency procedures; ensuring quality of procedures by increasing the volume through elective procedures; avoiding the challenges with transferring patients to other hospitals; increasing convenience for patients and doctors; and providing hospitals with a financial benefit.
The disadvantages include reducing the volume at hospitals that provide heart surgeries; possibly reducing the safety of the procedures at larger hospitals; harming hospital income; and reducing the number of cases at teaching hospitals, he said.
David L. Knowlton, president and CEO of the Healthcare Quality Institute of New Jersey, opposes allowing hospitals without onsite cardiac surgery to perform elective angioplasties. He noted that professional organizations -- including the American College of Cardiology and the American Heart Association -- have been skeptical of the practice.
In guidelines issued in 2011, the organizations said that elective angioplasties “might be considered in hospitals without on-site cardiac surgery, provided that appropriate planning for program development has been accomplished and rigorous clinical” and patient-selection criteria are used.
The guidelines added: “Desires for personal or institutional financial gain, prestige, market share, or other similar motives are not appropriate considerations for initiation” of angioplasty programs without onsite cardiac surgery and that it would only be appropriate “if this program will clearly fill a void in the healthcare needs of the community.” Knowlton said there is no lack of access to hospitals with onsite cardiac surgery in New Jersey. He added that O’Dowd was wise to hold public hearings on the topic.
O’Dowd noted that while the symposium was focused on clinical research results, the hearings could also include equally important issues, including access to services, cost to the various parties, and quality.
Along with the 18 hospitals with cardiac surgeries and the 11 with elective angioplasties, there are other hospitals that currently have emergency angioplasties but would also like to offer elective procedures.
O’Dowd said she has heard economic arguments from all of the different hospital groups and that it will be a challenge to strike the right balance.
The regional hearings will be held in 2013, O’Dowd said.