Talk Title SURGICAL BACK-UP IS NOT REQUIRED FOR PRIMARY PCI Mark A. Turco, MD, FACC, FSCAI Director, Center for Cardiac and Vascular Research Washington Adventist Hospital Takoma Park, Maryland Medical Director, Cardiac Cath Lab Frederick Memorial Hospital Frederick, Maryland Talk Title Name Institution

Mark A. Turco, MD Advisory Committee Abbott Vascular Medtronic, Inc. Boston Scientific Corporation Honoraria Daiichi Sankyo Eli Lilly and Company Grants/Contracted Research Cordis Corporation

Background Over the last 10 years, as a result of improvements in technology and pharmacology: The incidence of emergency CABG surgery for failed PCI is now very infrequent (0.3-0.6%) Seshadri N et al. Circulation 2002;106:2346-50. Yang EH et al. J Am Coll Cardiol 2005;2004-20. Primary PCI has been shown to be superior to fibrinolytic therapy for the treatment of STEMI Keely et al. Lancet 2003;361:13-20.

Need for Cardiac Surgery Dissection Post-Stent

Lesion Pre-PCI Perforation Post Stent Graft

Short-term Clinical Outcomes: Primary PCI vs Thrombolytic Therapy Summary of 23 Randomized Trials (n = 7739) PCI p < 0.0001 Lytic p = 0.0003 p < 0.0001 p = 0.0004 Keeley and Grines Lancet 2003

Effect of Time to Presentation on 30 Day Mortality with Primary PCI vs Lytic Therapy Analysis of 10 Randomized Trials Lytic PCI < 2 2-4 > 4 Zijlstre Eur Hear J 2002

Guidelines and Government Role in Reducing Infarct Size

Background The safety and efficacy of performing primary PCI in facilities without on site surgical back-up has been documented in several trials. Wharton TP Jr. et al. J Am Coll Cardiol 1999;33:1257-65. Aversano T el. C-PORT trial. JAMA 2002;287:1943-51. Wharton TP Jr. et al. PAMI-NoSOS Study. J Am Coll Cardiol 2004;43:1943-50. There have been numerous observational reports that extend the Off-Site concept to both primary and elective PCI.

Motivation for PCI Without On-Site Surgery Sustain primary PCI programs Improve utilization and access to PCI services Expand Cardiovascular Centers of Excellence Reduce pressure to create new open heart programs Improve ACS Driven Guideline Care

Regionalization and CAD Unintended Consequences in the Real World Regionalization may not make sense for a disease of epidemic proportion reduce access to revascularization and may increase the mortality of patients with CAD create second-tier facilities “Centers-of-Less-Than-Excellence” recruitment and retention effect on non-cardiology services

Approving a medical experiment that increases mortality 38% What were those N. J. bureaucrats thinking?

Heart Attack: Amazing Progress

Potential Disadvantages of Primary PTCA Excessive delay in establishing reperfusion Lack of availability

Improved Care for AMI Shorter delay for access to hospital care (D2B). Hospitals that have the ability to perform 24/7 PCI with experienced teams.

DANAMI-2: Treatment Times Local Lytics 105 64 169 minutes Symptoms to ED Door-to-Needle 55 Minute Delay Transfer For Primary PCI 107 50 32 26 224 minutes Symptoms to ED Transit In-door to Out-door Door - to - Balloon Anderson NEJM 2003

Primary PTCA at a Community Hospital Without Cardiac Surgery on Site

ACC/AHA MI Guidelines for Primary PTCA (continued) “More widespread availability of angioplasty for… acute infarction would potentially provide improved care for some patients… Circulation 88: 2987, 1993

Primary PTCA at Community Hospitals Without Surgical Backup is Performed as Effectively and With Less Delay Compared to Tertiary Care Center James D. Johnston, William W. O’Neill, Paul Slota, Thomas P. Wharton, Mark A. Turco, Gregg W. Stone, Bruce R. Brodie, Mark Barsamian, Mariann Graham, Lorelei L. Grines, Cindy L. Grines The No Surgery on Site Registry Centers and William Beaumont Hospital, Royal Oak, MI Dr.Feit, Dr.Mehran, ladies and gentleman: Prospectively collected information comparing patients treated with primary PTCA at hospitals without surgical back-up versus tertiary care centers has yet to be reported. Today, I would like to report the first prospective report comparing primary PTCA at community hospitals without surgical back-up to tertiary care centers.

Air PAMI Hospitals Without On-Site Surgery NO Primary PTCA Capability? Primary Angioplasty: No SOS vs Tertiary Centers Air PAMI Hospitals Without On-Site Surgery NO Primary PTCA Capability? YES HIGH RISK MI* Lytic Eligible RANDOMIZE No S.O.S.! The Air PAMI study, which is currently ongoing, was designed by Dr. Cindy Grines who reasoned that the risk and delay associated with transfer to a PTCA center may be off set by the added benefit of intervention. In hospitals with PTCA capability, without on-site surgery, a randomized registry, PAMI No-SOS was developed postulating that patients would show similar outcomes to the transferred group. Transfer for PTCA (ground or air) IV Lytics (no routine transfer) Primary PTCA (on site, no transfer)

Results: Treatment Times Primary Angioplasty: No SOS vs Tertiary Centers Results: Treatment Times Results demonstrated statistically significant differences between the No SOS centers versus tertiary centers for ER to cath lab, ER to Angio, and ER to balloon times. Mean ER to cath lab times were 84 minutes vs 95 minutes, ER to Angio 98 min vs 114 min and ER to balloon 119 min vs 134 min. CP onset to ER was not significantly different for the two groups. p=NS p=0.02 p=0.0001 p=0.0005

Atlantic CPORT TRIAL Dr. Thomas Aversano

Atlantic C-Port Trial Enrollment 7/96 – 6/99 Institutions in MD and MA (11 total) Percutaneous Coronary Intervention (PCI) vs Thrombolytic therapy at hospitals without Cardiac Surgery on Site Primary Endpoint: Composite of death, recurrent MI, or stroke at 6-months

451 Patient 11 Community Hospitals Without On-Site Cardiac Surgery Thrombolytic Therapy 226 Catheterization & PTCA 225 A pilot study was begun in July 1996 to demonstrate feasibility. Despite great efforts on the part of many, the C-PORT trial could not be funded and so was terminated prematurely in June 1999 after 453 patients were recruited from 11 community hospitals in the pilot trial. Despite representing only 18% of specified study population, the C-PORT trial represents the second largest prospective, randomized trial comparing these two alternative forms of therapy and the only one conducted exclusively in community hospitals without on-site cardiac surgery. Composite 6 week & 6 Month Endpoint Death, Non-fatal MI, Stroke Composite 6 week & 6 Month Endpoint Death, Non-fatal MI, Stroke

Outcomes at 6 Weeks P=0.03

Conclusions In hospitals without on-site cardiac surgery that participate in a formal PCI-development program and whose outcomes are monitored primary PCI can be performed safely and effectively Extension of primary PCI capability to hospitals without SOS is a viable way of improving access to the best form of reperfusion therapy for STEMI

Primary PCI without on-site cardiac surgery Risk Benefit

Non-Primary PCI without on-site cardiac surgery Risk Benefit

C-PORT Elective Patient for Diagnostic Cath Registry Catheterization Informed consent Registry Refuse Catheterization Exclusion criteria Meets inclusion criteria PCI no SOS PCI with SOS

Journal of the American College of Cardiology 2009; 54:16-24 Percutaneous Coronary Interventions in Facilities without Cardiac Surgery On Site: A Report from the National Cardiovascular Data Registry (NCDR) Journal of the American College of Cardiology 2009; 54:16-24 Dr. Michael A. Kutcher Wake Forest University

Study Population

Risk Adjusted Outcomes

TEAM EFFORT Outstate Hospital EMS Transport Tertiary Center

Equipment Selection & Patient Selection Remember Angioplasty “It’s always an away game!”

Arctic Sun Energy Transfer Pad ™ Placement

Impella 2.5

Conclusion Surgical backup is not needed for Primary PCI. Still must have high volume, skilled operators and staff with a administrative commitment to the program. We need to be sure that patients at outlying centers without on-site cardiac surgery who receive treatment are getting the same level of care they would receive at a surgical center.