1. 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

2. 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

5. 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 ( %)
Seshadri N et al. Circulation 2002;106:
Yang EH et al. J Am Coll Cardiol 2005;
Primary PCI has been shown to be superior to fibrinolytic therapy for the treatment of STEMI
Keely et al. Lancet 2003;361:13-20.

6. Need for Cardiac Surgery
Dissection
Post-Stent

7. Lesion Pre-PCI
Perforation
Post Stent Graft

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

9. 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

10. Guidelines and Government Role in Reducing Infarct Size

11. 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:
Aversano T el. C-PORT trial. JAMA 2002;287:
Wharton TP Jr. et al. PAMI-NoSOS Study. J Am Coll Cardiol 2004;43:
There have been numerous observational reports that extend the Off-Site concept to both primary and elective PCI.

12. 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

13. 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

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

15. Heart Attack: Amazing Progress

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

17. 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.

20. 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

21. Primary PTCA at a Community Hospital Without Cardiac Surgery on Site

22. 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

23. 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.

24. 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)

25. 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

26. Atlantic CPORT TRIAL
Dr. Thomas Aversano

27. 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

28. 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

29. Outcomes at 6 Weeks
P=0.03

30. 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

31. Primary PCI without on-site cardiac surgery
Risk
Benefit

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

33. 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

34. 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

35. Study Population

36. Risk Adjusted Outcomes

37. TEAM EFFORT
Outstate Hospital
EMS Transport
Tertiary Center

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

39. Arctic Sun Energy Transfer Pad ™ Placement

41. Impella 2.5

42. 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.