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PCI Without On-Site Cardiac Surgery
Recent Meta-analyses
Gregory J. Dehmer, MD, FACC, FACP, FAHA, FSCAIDirector, Cardiology Division
Scott & White HealthcareProfessor 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
PCI Without On-Site Surgery
1. Is it safe to perform elective PCI without on-site surgery?
There are really two questions
Studies on PCI Without On-Site BackupOver 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 after unsuccessful PCI vs.• Urgent CABG for “discovered anatomy”
CABG duringindex admission
Singh M, et al. JAMA - 12/14/11
Singh M, et al. JAMA - 12/14/11
• 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
* Meta-analysis Of Observational Studies in Epidemiology**Strengthening the Reporting of Observational Studies in Epidemiology
Examined in-hospital mortality Rate of emergency CABG
Characteristics of study
Singh M, et al. JAMA - 12/14/11
N=15 International
1988 to
2007Mixed
n=124,074 n=914,288
STEMI Patients - Mortality
Key Points• 11 studies• Ave. mortality
• No onsite surgery = 4.6%• Onsite surgery = 5.1%
No difference in mortalityOR = 0.96 (CI 0.88 – 1.05)
Non-primary PCI - Mortality
Key Points• 9 studies• Ave. mortality
• No onsite surgery = 0.9%• Onsite surgery = 0.8%After adjustment for publication biasMortality was 25% higher at sites
without on-site surgeryOR = 1.25 (CI 1.01 – 1.53), p = 0.04
STEMI & Non-primary PCI - CABG
n=7
n=6
STEMI
Non-primary
STEMI patients: Lower incidence of emergency CABG at facilities without onsite surgeryNon-primary patients: No difference
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
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.
Post PN, et al. Eur Heart J 2010
Post PN, et al. Eur Heart J 2010
• 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
Characteristics of study
Post PN, et al. Eur Heart J 2010
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
OR 0.87
Surgery Onsite in the NCDR
• 1298 facilities reporting in the 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
About 4% of the PCIs
Zia MI, et al. Can J Cardiol - 2011
Zia MI, et al. Can J Cardiol -2011
• 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
• Effect of outliers evaluated
Examined in-hospital mortality Rate of emergency CABG
Characteristics of study
n=11
n=18
STEMI Patients
Key Points• 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%
• Early CABG• No onsite surgery = 3.0%• Onsite surgery = 3.4%
No difference in mortalityOR = 0.93 (CI 0.83 – 1.05)
In-hospital Mortality Early CABG
No difference in early CABGOR = 0.87 (CI 0.68 – 1.11)
Non-Primary PCI Patients
Key Points• 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%
• Early CABG• No onsite surgery = 1.0%• Onsite surgery = 0.9%
In-hospital Mortality Early CABG
No difference in early CABGOR = 1.38 (CI 0.65 – 2.95)
No difference in mortalityOR = 1.03 (CI 0.64 – 1.66)
However, heterogeneity of results noted
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.
Singh PP, et al. Am J Therapeutics - 2011
American J Therapeutics 2011; 18:e22-e28.
Singh PP, et al. Am J Therapeutics - 2011
• 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 death2. Non-fatal MI3. Emergency CABG (unplanned surgery within 48 hours)
Characteristics of study
Singh PP, et al. Am J Therapeutics - 2011
Summary of Analysis
4 studies
2 studies
2 studies
PCI Without On-Site Surgery
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
There are really two questions
PCI Without On-Site Surgery
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?
There are really two questions
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 programs to have on-site cardiac surgery”
Released February 5, 2007 Full document at: www.scai.org