Ohio-ACC Header
Dear Ohio-ACC Colleague,  Christopher Cooper, MD, FACC

 

We are sharing a special message with you to discuss the performance of percutaneous coronary interventions (PCI) at sites without onsite surgical backup.  Although Ohio does not license hospitals, it does have regulatory authority over several hospital services, including cardiac catheterization labs and cardiac surgical programs. Several Ohio institutions were given waivers to perform PCI without onsite surgical backup as participants in the Cardiovascular Patient Outcomes Research Team (C-PORT) study. Now that the C-PORT study is over, the Ohio Department of Health (ODH) is reviewing the regulations governing cardiac catheterization and has had three meetings with stakeholders to discuss the issues and options.

 

In preparation for the ODH discussions, the Ohio-ACC Board of Trustees, who represent each area of our state, had an extensive discussion about this matter. The Ohio Chapter-ACC takes seriously our charge to follow the mission of the ACC: "To transform cardiovascular care and improve heart health."  In the spirit of this mission, the Ohio-ACC trustees presented the following recommendations to the Ohio Department of Health:

  1. Quality patient care, not economics, should be the determining factor in the decision to permit PCI at sites without surgical backup. (Unanimous agreement.)
  2. Ohio-ACC endorses the 2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update. (22 in favor. 1 opposed.)
  3. Ohio-ACC strongly believes that sites performing PCI without backup must report data to a single quality database. The American College of Cardiology's NCDR registry should be considered strongly, given the long history and large experience. (Unanimous agreement.)
  4. Data monitoring, from reviewers external to and independent of the doctor, hospital, or healthcare system, is essential for insuring reliable and meaningful data. (Unanimous agreement.)
  5. Ohio-ACC opposes allowing sites to perform PCI without surgical backup if they are within a reasonable distance (30-60 miles) of an established PCI site that has surgical backup.
  6. Enhancing ST-segment elevation myocardial infarction (STEMI ) care, with coordination of transfer of care from EMS directly to STEMI centers, should be a focus of the Ohio Department of Health. Currently EMS providers in several areas of the state are coordinating care with local and regional STEMI centers. These efforts should be broadened statewide to provide all Ohioans access to high quality care.
  7. The agreed upon standards should be enforced. (Unanimous agreement.)

The Ohio-ACC Board of Trustees also acknowledged that PCI without on-site surgical backup may improve cardiovascular care in limited areas of the state that are geographically isolated, by providing patients with rapid access to STEMI PCI.  However, it was also discussed and acknowledged that a proliferation of sites and operators has the potential for serious and negative consequences:

  • Incentivize increased numbers of procedures to allow hospitals and physicians to maintain volume standards,
  • Move cases from well-established high quality sites to lower quality sites,
  • Failure to disclose to patients that option for care at sites with surgical backup during informed consent.

The Ohio-ACC takes seriously our responsibility to enhance the lives of cardiovascular patients and views the potential changes as important to our patients and our cardiovascular caregivers. We will keep you informed on this issue as things progress. Following are a series of brief commentaries that depict some of the ideas and positions on this topic.

 

Christopher J. Cooper, MD, FACC

President, Ohio Chapter of the American College of Cardiology

 

Chip Glass 

Health Services Policy Program Administrator

CON/Policy, Projects and Research

Division of Quality Assurance

Ohio Department of Health

 

Presently in Ohio, the performance of high risk cardiac catheterization procedures, including PCI, is permitted only at facilities that have an open heart surgical service on the same site as the catheterization lab.  The sole exception to this rule is for a limited number of hospitals (ten) to perform these procedures without on-site surgery services.  This exception was originally intended to allow these hospitals to participate in the CPORT-E study.

 

With the conclusion and publication of the CPORT-E study, the Director of Health, Ted Wymyslo, MD, began an informal review of the current prohibition in light of current national guidelines, recent studies and current practices in other states.  As part of that informal review process, Dr. Wymyslo convened the Interventional Cardiology Advisory Group (ICAG).  The ICAG is composed of representatives of various associations and professional organizations such as the Ohio Chapter of the American College of Cardiology, Mission: Lifeline, the Ohio Hospital Association, and the Ohio fellowship programs in interventional cardiology.  The purpose of the ICAG is to provide a forum for an interchange of ideas and thoughts on a variety of topics including the current state of interventional cardiology, patient safety concerns, and the relationship of procedural volume to quality outcomes.

 

The ICAG has met three times, including a briefing from the principal investigator of CPORT-E, Dr. Thomas Aversano.  The next step is for the Director of Health to review the information collected and decide whether to proceed with amendment of the existing rule or some other action.  If the Director decides to amend the rule, draft rules will be prepared by his staff and made available initially to the ICAG and possibly other stakeholders for comment.  After that, the rules will be made available for a public comment period and following that a public hearing.

 

After the public comment period, ODH must take the comments into consideration.  That may or may not result in changes to the rule.  Then a public hearing is held, at which written statements and testimony can be presented.  Again, ODH must consider that information and may or may not make changes.  Assuming ODH still wants to go forward with rule changes after all of this, the rules are considered by the Joint Committee on Agency Rule Review (JCARR).  If JCARR does not vote to recommend invalidation to the General Assembly, the rules go into effect.  At any point in this process and after, a dissatisfied party may seek legislative action such as removing ODH's authority over health services in general or cardiac catheterization in particular.

 


Dean Kereiakes, MD

Dean J. Kereiakes, MD, FACC, FSCAI

Medical Director, The Christ Hospital Heart and Vascular Center / The Lindner Research Center

Professor of Clinical Medicine, Ohio State University
Chair, Ohio Mission:Lifeline Steering Committee 

 

Ohio Mission:Lifeline (M:L) supports the development and implementation of regionalized programs to improve efficient access to expert primary percutaneous intervention (PPCI) therapy for patients with ST-segment elevation myocardial infarction (STEMI) with focus on emergency medical system (EMS) integration, early diagnosis of STEMI using pre-hospital ECG at the point of first medical contact and transport of the STEMI patient to an established STEMI center of excellence for performance of PPCI.  Ohio M:L believes that a strategy of EMS integration with existing PCI centers will provide better and more cost-effective clinical outcomes than will a strategy of PCI center proliferation.  EMS integration with existing centers acknowledges both the link between annual per-center PCI volumes with procedural outcomes as well as existing limitations in physician, nursing and ancillary personal manpower resource availability.  Ohio M:L acknowledges the potential need to establish a new PCI center for the rare circumstance that geographic isolation impedes timely access (>60 minutes ground transport) to PPCI at an existing PCI center.  Ohio M:L  does not support the establishment of new PCI centers, especially those with no cardiac surgical facilities on site, within a 30 minute ground transportation time of an existing PCI center.  Ohio M:L believes that existing PCI facilities should: 1) adhere to current physician and facility procedural volume and credentialing requirements as set forth by ACC/AHA/SCAI guidelines; 2) provide 24/7/365 PPCI for STEMI; 3) provide both technology and expertise for hemodynamic resuscitation and support of circulatory compromise due to STEMI (minimum of intra-aortic balloon counter-pulsation), as well as anatomic (intravascular ultrasound) and/or physiologic (fractional flow reserve) assessment of coronary lesion severity prior to the performance of non-STEMI culprit stenosis PCI.

 

These recommendations are made in the context of both the C-PORT PPCI trial as well as the more recently published C-PORT ELECTIVE (E) trial.  C-PORT PPCI evaluated the relative safety and efficacy of PPCI versus fibrinolytic therapy at centers with no SOS.  C-PORT PPCI was prematurely terminated due to lack of trial financing when <20% of the prospectively projected sample size had been enrolled.  The composite primary endpoint of death, recurrent MI and stroke at 6 weeks trended lower in subjects (n=225) randomly assigned to PPCI (10.7%) compared with those (n=226) assigned to fibrinolytic therapy (17.7%; p=0.03).  The importance of this observation is diminished by the facts that:  1) the study is grossly underpowered and thus, the threshold for statistical significance should have been set higher (~p<0.01) due to premature study termination; 2) the relatively high rates of stroke (4.0%) and reinfarction (10.6%) observed in the small fibrinolytic treatment arm are unprecedented and may have occurred by chance; and 3) a large portion of subjects (138/451; 31%) were enrolled at a single center.  Thus, the results of C-PORT PPCI are not definitive, should be considered hypothesis generating and await confirmation in a larger, adequately powered multicenter trial.

 

In C-PORT E, which evaluated the relative safety and efficacy of elective PCI in centers with versus those without SOS, 75% of consented patients were not randomized due to multiple trial exclusion criteria including clinical/angiographic risk predictors.  Thus, despite the fact that the resultant study population was largely "low risk," both the per patient and per lesion success rates of PCI were significantly lower among patients receiving PCI at no-SOS centers.  Furthermore the requirement for repeat revascularization procedures (target vessel revascularization) was significantly more frequent by both intention to treat (20% relative increase; p=0.0098) as well as per protocol (actually treated, 35% relative increase; p<0.001) analyses among those patients receiving PCI at no-SOS facilities.  Similarly, the composite incidence of major adverse cardiovascular events was higher in no-SOS facility treated subjects by both intention to treat (p=0.0977) and per protocol (p=0.0030) analyses.  Interestingly, although use of drug-eluting stents (versus bare metal stents) was less frequent in no-SOS facilities, the requirement for target vessel revascularization was increased to a similar degree (33%) following deployment of either drug-eluting or bare metal stents at no-SOS facilities.  Finally, PCI at no-SOS facilities was less cost effective (compared with SOS facilities) particularly in those "low volume" facilities which performed <200 PCI/year. 

 

In summary, the results of C-PORT E were predictable in that the incidence of death to 6 weeks as a primary endpoint would not be expected to be different between the randomly assigned PCI groups.  Indeed, large scale trials such as COURAGE have demonstrated no difference in mortality between PCI and medical therapy in patients with stable ischemic heart disease.  Despite the relatively low risk profile of patients enrolled in C-PORT E, PCI success rates were lower and repeat revascularization at follow-up was higher in those subjects treated at no-SOS centers.  Lastly, cost per patient was increased in no-SOS centers, particularly those performing <200 PCI /year.  In this regard, it is noteworthy that 6 of 10 C-PORT centers in Ohio fall into this "low volume" category and that 5 of 10 are within a 15 minute drive of a pre-existing PCI facility with SOS.

 

Daniel Simon, MD

Daniel I. Simon, MD, FACC, FAHA, FSCAI

Chief, Division of Cardiovascular Medicine

Director, Harrington Heart & Vascular Institute

University Hospitals Case Medical Center

Herman K. Hellerstein Professor of Cardiovascular Research

Case Western Reserve University School of Medicine
 

I am a practicing interventional cardiologist and Director of the University Hospitals Harrington Heart & Vascular Institute.  I was invited to be a member of the Ohio Department of Health Interventional Cardiology Advisory Group (ICAG) as a representative of a CPORT waiver hospital performing elective and emergency PCI without on-site cardiac surgery.  University Hospitals is an integrated health system in Northeast Ohio that includes an academic medical center, six wholly-owned community medical centers, two joint venture community medical centers, and 20 ambulatory centers. 

 

Recognizing the superiority of primary PCI over thrombolysis for acute ST-segment elevation myocardial infarction (STEMI), and the importance of minimizing door-to-balloon (or "double" door-to-balloon for patients presenting to a non-PCI capable hospital) times to optimize myocardial salvage, we explored opportunities to improve STEMI care in our health system, which spans 22 counties and more  than 7,800 square miles. Our Emergency Medical Services Institute provides medical command to greater than 60 squads with two helicopters.  Adopting the recommendations of Dr. Harlan Kromholz and colleagues (New England Journal Medicine 2008), a "lean six sigma-like" approach that identified 6 independent predictors of door-to-balloon time, we dramatically improved our STEMI performance over a 12-24 month period.  Median door-to-balloon time dropped to 47 min with 100% of patients undergoing revascularization under the ACC/AHA/SCAI standard of 90 min.  This is a truly outstanding performance by a multi-disciplinary team that was featured in a cover story in the Wall Street Journal in 2012.

 

However, opportunities to improve the treatment of STEMI patients presenting to non-PCI capable hospitals were identified.  Double door-to-balloon times typically ranged from 120 to 150 minutes, outside of the optimal recommended treatment window.  It is with this background that we focused on exploring participation in the C-PORT elective and emergency PCI without on-site cardiac surgery clinical trial program for UH Geauga Medical Center.  This 144-bed community hospital, which is the only hospital in Geauga county, provides primary and secondary healthcare services for five surrounding rural counties with a high prevalence of atherothrombotic cardiovascular disease, including MI and stroke.  Six cardiologists are devoted to serving this community and have built robust practices that have generated greater than 900 cardiac (diagnostic only), peripheral (diagnostic and interventional), and electrophysiology procedures in a "low risk" cardiac catheterization laboratory.  Review of acute coronary syndrome transfers indicated that the hospital could support 30-40 primary PCI procedures for STEMI annually by participating in C-PORT.  The principle motivation for establishing a PCI program was to provide 24/7 emergency PCI for STEMI in a geographically-isolated, rural region serving the Amish community that is also challenged by many "no-fly" days due to adverse weather conditions.

 

Performance of elective PCI at hospitals without on-site cardiac surgery is generally considered to be necessary to promote the development of skillful and efficient interventional cardiology teams for emergency procedures.  Evidence supporting the safety of performing such elective PCI procedures was limited.  The clinical outcomes of elective PCI at hospitals with or without on-site cardiac surgery were reported recently by Aversano and colleagues (New England Journal of Medicine 2012) in the landmark CPORT-E (Cardiovascular Patient Outcomes Research Team-Elective) study.  A total of 18,867 patients were randomly assigned in a 3:1 ratio to undergo elective PCI at a hospital without on-site cardiac surgery (14,149 patients) or with on-site cardiac surgery (4,718 patients).  The trial had two primary end points: 6-week mortality and 9-month incidence of major adverse cardiac events (MACE, the composite of death, Q-wave myocardial infarction, or target-vessel revascularization).  The 6-week mortality rate was 0.9% at hospitals without on-site surgery versus 1.0% at those with on-site surgery (95% confidence interval [CI], −0.31 to 0.23; P = 0.004 for noninferiority). The 9-month rates of MACE were 12.1% and 11.2% at hospitals without and those with on-site surgery, respectively (95% CI, 0.04 to 1.80; P = 0.05 for noninferiority). The rate of target-vessel revascularization was higher in hospitals without on-site surgery (6.5% vs. 5.4%, P = 0.01).  Thus, PCI performed at hospitals without on-site cardiac surgery was noninferior to PCI performed at hospitals with on-site cardiac surgery with respect to mortality at 6 weeks and MACE at 9 months.

 

Members of the Ohio Department of Health Interventional Cardiology Advisory Group strongly support quality performance measures for PCI hospitals without on-site cardiac surgery.  Clinical performance may be monitored through national databases, such as ACC/NCDR, or state-sponsored data registries that generate risk-adjusted mortality and MACE models and report institution and/or operator-specific outcomes (e.g., California and Massachusetts).  Auditing of data and independent angiographic review of a sample of PCI procedures are strongly encouraged.  Institutional and operator volume are often used as surrogates for quality.  The relationship between volume and quality for PCI without on-site cardiac surgery is uncertain.  The ACC/AHA PCI guidelines have recommended a minimum annual volume of 200 cases.  The SCAI has recognized that a minimum volume of 150 cases per year may be sufficient as long as quality oversight is rigorous.  CPORT-E provides important new information regarding the relationship between volume and quality for PCI without on-site cardiac surgery.  While the institutional volume goal for CPORT-E was 200 PCIs per year, the actual median case volume was 150 PCIs per year with 25% of hospitals performing less than 99, 25% performing 100-150, 25% performing 151-216, and 25% performing more than 216 PCIs per year.  Importantly, there was no apparent relationship between volume and outcome in the CPORT-E study.  Therefore, it seems reasonable to consider a volume requirement in the 100-150 PCIs per year range.

 

Finally, we are proud of our PCI without on-site cardiac surgery program at UH Geauga Medical Center.  Since 2010, we have performed greater than 350 elective and emergency PCIs with 0% in-hospital elective PCI mortality rate and no emergency CABG procedures.  The performance of the 10 Ohio CPORT hospitals, that collectively have performed nearly 4,000 procedures, was reviewed and found to be commendable by Dr. Thomas Aversano during his presentation to the Ohio Department of Health Interventional Cardiology Advisory Group. The revised 2013 STEMI guidelines highlight the importance of treating STEMI patients at PCI capable hospitals.  The performance of PCI without on-site cardiac surgery will expand the access of primary PCI for many patients in Ohio.  The PCI Working Group had diverse representation from physicians, hospitals (academic and community medical centers), and societies (ACC, AHA, STS) and engaged in lively and spirited debate that we all hope will be useful in assisting the Director and staff of the Ohio Department of Health in formulating a rule change that will permit PCI without on-site cardiac surgery outside of a waiver mechanism.  The Ohio-ACC has and will continue to play a pivotal role in this process, and we thank you for your consideration.

 


Anthony DeRiso, MD

Anthony J. DeRiso II, MD, FACS, FACC, FCCP

Cardiothoracic Surgeon, Lakeside Heart and Lung Center

Director, Firelands Regional Medical Center Heart Institute

Practicing Cardiac Surgeon at Firelands Regional Medical Center in Sandusky and
Mercy Regional Medical Center in Lorain 

 

I am pleased to have been selected to be part of the Ohio Department of Health's ICAG to represent non-CPORT waiver community based hospitals and physicians.  In light of the fact that, according to a national healthcare ratings system, the State of Ohio currently has one of the best cardiac care success rates in the country and that the CPORT-E trial found no economic benefit was derived from programs performing non-primary PCI without surgical backup, the chief question is should this be allowed on a large scale basis?   It appears that there may be a consensus building to sanction such a rule as long as sufficient guidelines are established to ensure that the lessons learned from the CPORT-E trial of non-primary PCI on low risk coronary lesions and patients performed by seasoned cardiologist can safely be extrapolated to the general population.  If the expansion of the rules is approved, my greatest concern is for the .3 to .4% of the patients who will require emergent CABG after a failed PCI.  This means that at a center performing 1000 PCI's annually at least three or four patients each year will require emergent transfer for the complication of acute STEMI from dissection or rupture of a coronary vessel.  Since every patient deserves the best possible care, major consideration is being given to the usage of the established critical total ischemic time goal of ninety-minutes.  This can be called the "dissection to cardiopulmonary bypass" time goal, which is analogous to the "door to balloon" time goal.  Every facility that decides to develop a stand-alone PCI program will need to develop a plan to deal with transportation issues and establish a transfer agreement with the closest cardiac surgical center that complies with the ninety-minute "dissection to cardiopulmonary bypass" total time goal. 

 

Currently, the SCAI guidelines recommend that transport vehicles be able to respond to the PCI catheterization table within twenty minutes.  In a patient having an acute STEMI from a ruptured or dissected vessel, there is a fair probability that the patient will be intubated with an IABP in place.  Thus, at a minimum, an additional twenty minutes should be allotted to load the patient onto the ambulance. The guidelines would then require that the nearest possible cardiac surgical center that is willing to enter into a transfer agreement be utilized, preferably within thirty miles (or 30 minute ambulance time).  Careful consideration should be given to any transfer agreement by both institutions, since these patients may represent a significant challenge to transport within the required time frame and may constitute a substantial burden on the accepting center.  Finally, twenty minutes is allocated to get the patient into the operating room and onto emergent cardiopulmonary bypass to decompress the ischemic ventricle.   In summary, the state may be inclined to expand the availability of non-primary PCI to community hospitals at non-cardiac surgical centers if the appropriate guidelines are established and monitored to ensure patient safety.  While this approach addresses the basic patient safety issues, it does not address the reassuring effect on an interventional cardiologist and on a patient in knowing that a cardiac surgeon is on site.  In addition, the stand-alone concept is contrary to the national trend of promoting collaborative heart team care by cardiologists and cardiac surgeons.

 

 

 

Letter sent to Theodore Wymyslo, M.D., Director, Ohio Department of Health

 

RE:  Future of percutaneous coronary intervention (PCI) without on-site open heart surgery services

 

Dear Director Wymyslo:

 

This letter is submitted on behalf of the ten hospitals, formerly participants in the Johns Hopkins C-Port and C-Port-E research trials, following the final Interventional Cardiology Advisory Group (ICAG) meeting held at the department on January 9.  The purpose of this letter is to share the position of the ten hospitals based upon evidence and related discussion presented during the ICAG proceedings.  The undersigned firmly believe that continuation of the PCI services provided by the ten hospitals is in the best interests of the communities they serve and the citizens of Ohio.

 

ICAG deliberations expressed consensus on some points and seemingly a majority viewpoint on others.  For example, everyone appeared to agree that:

  • Timely access to affordable, quality PCI saves lives.

There appeared to be a virtual consensus that American College of Cardiology Guidelines should be followed as guidelines, but with recognition that ACC Guidelines are regularly revised-such as with an updated cardiac catheterization laboratory operator competency document soon to be published.  The undersigned suggest the ICAG expressed a consensus or near consensus that:

  • The ACC Guidelines should be considered as guidelines.

A considerable amount of ICAG meeting time involved discussion or presentations regarding the safety of PCI at hospitals without open heart surgery services.  ICAG members appeared to agree, based on recent studies (e.g., published findings of the C-Port-D trial), the recent experience of other states (e.g., California), and reported quality and outcomes at the ten Ohio C-Port hospitals, that:

  • PCI is safe under certain conditions at hospitals without open heart surgery services and outcomes are non-inferior to hospitals with open heart surgery services.

PCI volume, particularly institutional, figured prominently in ICAG discussion.  Recently published studies (e.g., C-Port) and other states' experience (e.g., California) appear to show that PCI is safe (viz., "noninferior") at volumes lower than recommended in the 1990s and early 2000s.  Operator minimum PCI volume guidelines have settled on 75 procedures averaged over two years.  Additionally, today's technology enables direct measurement of PCI quality and outcomes, leading a number of ICAG members to opine that such quality measures are more important than a minimum volume threshold.  Based on these considerations, the undersigned recommend that:

  • The primary requirement for authorizing PCI at hospitals without open heart services should be quality measures and outcomes comparable to tertiary care centers.

ICAG discussion included concern that setting any minimum volume number would put an emphasis on achieving that number when the primary focus should be medical results.  While the undersigned believe that regulatory criteria should focus on quality measures and outcomes,should the department determine that a minimum PCI volume requirement is necessary, recent literature, experience of other states, and experience of the ten Ohio C-Port hospitals indicate that:

  • A minimum annual aspirational PCI volume-averaged over two years-should not exceed 75 for operators and 100 for the institution.  The department should have the authority to perform a quality review of an operator or hospital performing fewer procedures.

As indicated above, PCI quality and outcomes are important.  ODH currently does not have the statutory authority or resources to actively monitor quality and outcomes of hospitals performing PCI, nor does the department actively monitor the quality of a variety of other important healthcare procedures (e.g., open heart, cancer, or trauma surgery).  However several entities were identified during ICAG deliberations, including OHA's Quality Institute and perhaps the ACC, which could perform a quality monitoring function.  The undersigned support the concept that:

  • Outcome and quality monitoring should be done by a qualified entity outside of ODH and under arrangements satisfactory to ODH, with reasonable expenses paid by PCI hospitals.

Some members of ICAG expressed concern regarding the medical appropriateness of PCI, worrying that mandated PCI volume numbers for hospitals and operators might promote unnecessary procedures.  Some states (e.g., California) include an auditing function in their regulatory oversight of PCI services.  It was also reported that ACC is developing an audit process to ensure the integrity of data reported to its National Cardiovascular Data Registry.  It should also be recognized that a variety of other entities already exercise or have the authority to exercise an auditing function:  e.g., hospital peer and quality review processes, government and commercial third party payors, and law enforcement authorities enforcing state and federal fraud and abuse law (e.g., The False Claims Act).  Ohio's Attorney General, as a more specific example, has the authority to investigate Medicaid patients for "medical necessity" of medical services, and both CMS and the U.S. Justice Department can mount similar investigation of services provided to Medicare patients.  The undersigned support the concept that:

  • A random, reasonable auditing function could be included in the responsibilities of a peer review entity, under arrangements satisfactory to ODH and with reasonable expenses paid by PCI hospitals.

Concern was expressed by some ICAG members that a regulatory change in Ohio might result in a proliferation of PCI services in a manner that would unnecessarily increase aggregate health care costs and threaten quality of care.  While this is a legitimate concern, there is also evidence (e.g., California) that low volume open heart services will close if given the option to perform PCI without on-site open heart surgery services, and there is anecdotal evidence that the same would occur in Ohio.  Moreover, regulatory requirements as described above, a mandate that PCI be offered 24/7, quality/outcome monitoring, auditing expense, and infrastructure costs would be obstacles to unwarranted proliferation of PCI services.  The undersigned believe that:

  • Proliferation of PCI services is unlikely, given the regulatory, financial and operational obstacles, and requirement for 24/7 availability of PCI services.

Finally, there appeared to be a consensus of ICAG members that resolution of the PCI issue should be governed by focusing on timely access of patients to affordable quality care.  Nonetheless, it cannot be ignored that PCI services bring benefits to the hospital offering PCI services and the community it serves.  Life-saving treatment is offered, well-credentialed physicians and other healthcare workers are added to the hospital staff, employee and community spirit are enhanced, and profit from PCI services supports other hospital services that are particularly valuable in rural and underserved areas (e.g., where a number of hospitals have closed maternity and newborn units for financial reasons).  As the ten Ohio C-Port hospitals can demonstrate empirically and anecdotally, the undersigned firmly believe that:

  • Lives will be saved, and other patients will continue to live productive lives, if the ten C-Port hospitals are able to continue offering primary and elective PCI.

Thank you for consideration of the above comments.  Please contact OHA or any of the undersigned for more information.

 

Sincerely,

 

Phil Ennen, President and CEO, Community Hospitals & Wellness Centers, Chair-Elect, Board of Directors, Ohio Hospital Association; Dr. Damoder R. Kesireddy, Medical Director Cardiac Catheterization Services, Community Hospitals & Wellness Centers; Jennifer Swenson, President, Fort Hamilton Hospital; Dr. Raja Nawaz, Medical Director Cath Lab, Fort Hamilton Hospital; Bruce White, CEO, Knox Community Hospital; Dr. Barry S. George, Director of Advanced Catheter-Based Therapies and Structural Heart Disease, Associate Clinical Professor of Medicine, The Ohio State University; Robert Montagnese, President & CEO, Licking Memorial Health Systems; Dr. Craig B. Cairns, Vice President Medical Affairs, Licking Memorial Health Systems; Scott Cantley, President, Memorial Health System; Dr. Joseph Mayo, Medical Director, Cardiac Cath Lab, Marietta Memorial Hospital; Claus von Zychlin, President & CEO, Mount Carmel Health System; Dr. Richard Streck, Chief Medical Officer, Mount Carmel Health System; Elizabeth Seely, Executive Director, The Ohio State University Hospital East; Dr. Vincent J. Pompili, Professor of Internal Medicine, Director, Interventional Cardiovascular Medicine & Cardiac Catheterization Laboratories, The Richard M. Ross Heart Hospital, The Ohio State University; Russ Wetherell, President and CEO, Southview Medical Center; Steve Jones, President, University Hospitals Geauga Medical Center; Dr. Daniel I. Simon, Director, Harrington Heart & Vascular Institute, Chief, Division of Cardiovascular Medicine, University Hospitals Case Medical Center; Dr. Kevin J. Joseph, President and CEO, West Chester Hospital, Senior Vice-President, UC Health, Assistant Professor, UC College of Medicine; Dr. Imran Arif, Medical Director, Cardiac Cath Lab, West Chester Hospital; Dr. Greg Rouan, 

Gordon & Helen Hughes Taylor Professor of Medicine, Chairman, Department of Internal Medicine, 

University of Cincinnati College of Medicine

 
Joseph Cacchione, MD

Joseph G. Cacchione, MD, FACC 

Chairman, Operations and Strategy

Heart and Vascular Institute 

Cleveland Clinic

As a "newcomer" to Ohio, I was privileged to be part of the advisory board to ODH on cardiac cath labs and PCI without surgical backup (waivers).  I was in Pennsylvania for 18 years prior to my arrival here and I had served on a similar committee in Pennsylvania.  The approach of the two respective departments is quite similar; however, I hope that the promise of transparency will be better than my past experience in Pennsylvania. 

 

As with all these committees, we "advise only."  In Pennsylvania, we had made very specific recommendations about waivers for PCI without backup (in the pre-CPORT era), however we were largely ignored.  At that time, the Pennsylvania Department of Health stated it was political maneuvering that pushed it through. The waivers granted were before the CPORT data existed and before we understood how these programs best function.  Also, Pennsylvania had laid the groundwork that PCI waiver hospitals should be for better access in remote areas.  Contrary to that premise, most of the waivers were granted in the Pittsburgh and Philadelphia markets.  The state did mandate that the ACC CathPCI Registry for all waiver labs which was to be monitored at set time intervals; little auditing of the data occurred.  Consequently, there were those that functioned with less than optimal outcomes when these programs were reviewed in detail. 

 

As a part of the push for transparency and public trust, all cath labs -- not just waiver programs -- will likely be subject to public reporting.  The progress toward public reports, whether state-based or federally mandated, for all cath labs, not just waiver hospitals, should be embraced by cardiologists.  States such as New York, Massachusetts, and Pennsylvania have been reporting for years.  The optimal data should be clinical not claims based, audited, real-time, and risk-adjusted.  To that end, waivers by state in the era of CPORT are likely to expand; hopefully the process of monitoring these programs and others will be informed by the large databases such as the ACC CathPCI Registry, which fulfill these criteria.  The ACC will be announcing a partnership on public reporting for the CathPCI Registry later this year.  Hopefully, Ohio and other states will utilize this registry for monitoring cath lab outcomes.