Nonemergency PCI at Hospitals with or without On-Site Cardiac Surgery

Abstract

Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).

SCAI/ACC/AHA Expert Consensus Document

“…Since 2006, 11 original studies and 3 meta-analyses on the topic of PCI without on-site surgery have been identified by a computerized systematic literature search using Medline (PubMed and Ovid) and Cochrane Databases [9,[11][12][13][14][15][16][17][18][19][20][21][22][23].…”

“…The 9-month rates of major adverse cardiac events were 11.2% and 12.1% at hospitals with and without on-site surgery, respectively (P ¼ 0.05 for noninferiority). A similar, but smaller randomized study of nonemergency PCI was performed in Massachusetts hospitals [11]. The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P < 0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P < 0.001 for noninferiority).…”

“…In 1 meta-analysis, after adjusting for publication bias, the mortality rate for nonprimary PCI was 25% higher at centers without on-site surgery compared with centers that had on-site surgery (OR, 1.25; 95% CI, 1.01-1.53; P ¼ 0.04) [20]. However, it is important to note that these meta-analyses preceded the publication of the 2 randomized trials [9,11]. Therefore, based on these [2,24,25].…”

“…Both CPORT-E and MASS-COMM studies provide guidance contained in their on-line supplementary materials [9,11]. Both require a transport vehicle to be available to begin transport within 30 min and arrival at the surgical hospital within 60 min of the decision to declare the need for emergency surgery.…”

The Challenges of Success

“…In recent years, this proliferation has been aided, in part, by data suggesting that PCI can be performed safely without on-site cardiac surgery. 9,10 Given the aforementioned association between PCI volume and outcomes, the net effect of any such growth is likely to represent a complex balance between improved access and decreasing procedural volumes (both for hospitals and operators).…”