This document summarizes several studies and meta-analyses examining the safety of performing percutaneous coronary interventions (PCI) without on-site cardiac surgery. The studies found: 1) For ST-elevation myocardial infarction (STEMI) patients, there was no difference in in-hospital mortality or need for emergency CABG between facilities with and without on-site surgery. 2) For non-primary/elective PCI patients, most studies found no difference in outcomes. One meta-analysis found a possible small increase in mortality for facilities without on-site surgery. 3) Ensuring all PCI programs meet quality metrics is important to patient safety, rather than solely requiring on-site surgery. The quality of a program depends

1. PCI Without On-Site Cardiac Surgery
Recent Meta-analyses
Gregory J. Dehmer, MD, FACC, FACP, FAHA, FSCAI
Director, Cardiology Division
Scott & White Healthcare
Professor of Medicine, Texas A&M University Health Science Center College of Medicine
Past President, Society for Cardiovascular Angiography and Interventions
Board of Trustees, American College of Cardiology
We are all somewhat conflicted on this topic
I perform PCIs at facilities with and without onsite cardiac surgery

2. PCI Without On-Site Surgery
There are really two questions
1. Is it safe to perform elective PCI
without on-site surgery?

3. Studies on PCI Without On-Site Backup
Over 50 published peer-reviewed studies
• Most are retrospective reviews or prospective registries with a few
non-blinded randomized trials
• Some only primary PCI, some only elective PCI, some mixed
– Primary PCI: 1993 through 2008
– Elective PCI: 1990 through 2012
– Changing treatment paradigms
• Fibrinolytic therapy before PCI; GPIIb/IIIa inhibitors; Stents
• Simple aggregation or meta-analysis can be problematic
– All subject to unintentional bias or methodological concerns (changing
treatment paradigms)
– Many do not discriminate between
• Emergency CABG for failed PCI vs. CABG during
• CABG after unsuccessful PCI vs. index admission
• Urgent CABG for “discovered anatomy”

4. Singh M, et al. JAMA - 12/14/11

5. Singh M, et al. JAMA - 12/14/11
Characteristics of study
• Used established guidelines (MOOSE*)
for identifying studies
• Data extraction well-described
• Used an established tool (STROBE**)
for evaluating the quality of the studies
• Only studies with a control group
considered
• Heterogeneity of effect size evaluated
• Publication bias examined
• Effect of outliers evaluated
Examined in-hospital mortality
Rate of emergency CABG
* Meta-analysis Of Observational Studies in Epidemiology
**Strengthening the Reporting of Observational Studies in
Epidemiology

6. Singh M, et al. JAMA - 12/14/11
1988
to Mixed
N=15 International 2007
n=124,074 n=914,288

7. STEMI Patients - Mortality
Key Points
• 11 studies
• Ave. mortality
• No onsite surgery = 4.6%
• Onsite surgery = 5.1%
No difference in mortality
OR = 0.96 (CI 0.88 – 1.05)

8. Non-primary PCI - Mortality
Key Points
• 9 studies
• Ave. mortality
• No onsite surgery = 0.9%
AfterOnsite surgery = 0.8%
• adjustment for publication bias
Mortality was 25% higher at sites
without on-site surgery
OR = 1.25 (CI 1.01 – 1.53), p = 0.04

9. STEMI & Non-primary PCI - CABG
STEMI
n=7
Non-primary
n=6
STEMI patients: Lower incidence of emergency CABG at facilities without onsite surgery
Non-primary patients: No difference

10. Summary and Conclusions - STEMI
• In-hospital mortality and the need for emergency CABG
were not increased at sites without onsite surgery
– In fact the need for emergency CABG was lower at sites without
onsite surgery
• Possible Interpretation:
– Concern that borderline stable patients may not be transferred
out for CABG, but then mortality should be higher at facilities
without onsite surgery and it was not
– Alternatively, higher CABG rates at facilities with onsite surgery
may reflect a lower threshold to opt for surgery if the results are
suboptimal

11. Summary and Conclusions – Non-Primary PCI
• In-hospital mortality was not significantly different, but
after adjustment for publication bias was 25% higher
(barely) at facilities without onsite surgery
• Rate of emergency CABG was very low and not different
• Possible Interpretation:
– Studies did not differentiate truly low risk elective patients from higher
risk patients with unstable angina or NSTEMI
– Patients in studies that adhered to all structure and process
recommendations tend to do better
– Patients at sites without onsite surgery or PCI capability are less likely
to receive guideline recommended therapies1,2
– The issue of volume-outcome relationship mentioned
1. Pride YB, et al. Circ Cardiovasc Qual Outcomes. 2009;2(6):574-582.
2. Pride YB, et al. JACC Cardiovasc Interv. 2009; 2(10):944-952.

12. Post PN, et al. Eur Heart J 2010

13. Post PN, et al. Eur Heart J 2010
Characteristics of study
• Screened 1624 potential papers
resulting in 10 PCI studies
• 1746 facilities; 1,322,342 patients
• Used established guidelines
(MOOSE) for identifying studies
• Data extraction well-described
• Heterogeneity of effect size
evaluated; publication bias
examined
• Outcome variable: in-hospital
mortality
• Cut point for high vs. low volume
cases differed but in most studies
used was > 400 annually

14. Post PN, et al. Eur Heart J 2010
OR 0.87
Corrections for heterogeneity and eliminating certain studies failed to alter the OR
of the result
Consideration of stent used did not affect the results either

15. Surgery Onsite in the NCDR
• 1298 facilities About 4% of
reporting in the the PCIs
NCDR
• 49% ≤ 400 PCIs
annually
• 26% ≤ 200 PCIs
annually
• Preponderance of
sites without
surgery are lower
volume sites (22%
≤ 200 annually
Dehmer GJ, et al. JACC Nov 13, 2012

16. Zia MI, et al. Can J Cardiol - 2011

17. Zia MI, et al. Can J Cardiol -2011
Characteristics of study
• Data extraction well-described and used
established methods
• Randomized studies and those without a
control group considered
• Heterogeneity of effect size evaluated
• Publication bias examined, but none
found
n=11
• Effect of outliers evaluated
Examined in-hospital mortality
n=18
Rate of emergency CABG

18. STEMI Patients
Key Points
In-hospital Mortality Early CABG
• 9 studies ( 6 same as Singh)
• 8607 pts. without and
97,386 with onsite surgery
• Ave. mortality
• No onsite surgery = 6.1%
• Onsite surgery = 7.6%
No difference in mortality
OR = 0.93 (CI 0.83 – 1.05)
• Early CABG
• No onsite surgery = 3.0%
• Onsite surgery = 3.4%
No difference in early CABG
OR = 0.87 (CI 0.68 – 1.11)

19. Non-Primary PCI Patients
Key Points
In-hospital Mortality Early CABG
• 6 studies (6 same as Singh)
• 28,552 pts. without and
881,261 with onsite surgery
• Ave. mortality
• No onsite surgery = 1.6%
• Onsite surgery = 2.1%
No difference in mortality
OR = 1.03 (CI 0.64 – 1.66)
• Early CABG
• No onsite surgery = 1.0%
• Onsite surgery = 0.9%
No difference in early CABG
OR = 1.38 (CI 0.65 – 2.95)
However, heterogeneity of results noted

20. Summary and Conclusions – Zia Meta-analysis
• STEMI patients: No difference in the in-hospital mortality
or early CABG among sites with and without onsite
surgery
• Non-primary PCI: Overall, no difference in the in-hospital
mortality or early CABG among sites with and without
onsite surgery
– But, substantial variation in outcomes among sites
– Although centers with and without onsite surgery can achieve
similar outcomes, monitoring to ensure safety and efficacy of
each PCI center without cardiac surgery is of paramount
importance.
•

21. Singh PP, et al. Am J Therapeutics - 2011
American J Therapeutics 2011; 18:e22-e28.

22. Singh PP, et al. Am J Therapeutics - 2011
Characteristics of study
• Data extraction well-described and
used established methods
• Heterogeneity evaluated, but none
found
• Only studies with a comparison group
considered
• Publication bias not evaluated
• 4 studies (n = 6,817 patients)
Examined:
1. All cause in-hospital death
2. Non-fatal MI
3. Emergency CABG (unplanned surgery
within 48 hours)

23. Singh PP, et al. Am J Therapeutics - 2011
Summary of Analysis
2 studies
4 studies
2 studies

24. PCI Without On-Site Surgery
There are really two questions
1. Is it safe to perform PCI without on-site
surgery?
• STEMI patients - YES
• No difference in mortality or CABG
• Non-primary patients – PROBABLY YES
• No difference in CABG, possible signal of
increased mortality in one meta-analysis

25. PCI Without On-Site Surgery
There are really two questions
1. Is it safe to perform PCI without
on-site surgery?
2. What is the right way to
provide PCI services in New
Jersey and the US?

26. The “Real” Bottom Line
• This is really about developing a quality-driven system of
care for patients needing PCI
– The quality of a program is not determined solely by the
presence of absence of a surgeon
– The decision to operate a program should be based on the
needs of patients and the community
– “Ensuring that all PCI programs meet appropriate
performance metrics is likely to save more lives than
requiring all PCI
Released February 5, 2007 Full document at: www.scai.org
programs to have
on-site cardiac surgery”