dehmer final--pci without onsite surgery-recent meta-analyses -final

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


• 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


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


• 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



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


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%


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)


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.


• 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)



Summary of Analysis

4 studies

2 studies

2 studies


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



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?


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

dehmer final--pci without onsite surgery-recent meta-analyses -final

Documents