SCAI: PCI equally safe with or without on-site surgery access
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PCI without surgery on-site is as safe as PCI at centers with on-site surgery across randomized controlled trials, observational studies and international experiences, according to an expert consensus statement.
The statement, an update of 2014 guidance published in the Journal of the Society for Cardiovascular Angiography and Interventions and JACC: Cardiovascular Interventions, noted that adequate operator experience, appropriate clinical judgment and case selection, and facility preparation are essential to a safe and successful PCI program with no surgery on-site.
Data were derived from Grines CL, et al. J Soc Cardiovasc Angiography. 2023;doi:10.1016/j.jscai.2022.100560.
“We are liberalizing the 2014 criteria,” Cindy L. Grines, MD, MSCAI, FACC, past president of SCAI and chief scientific officer of Northside Hospital Cardiovascular Institute in Atlanta, told Healio. “We are allowing centers to perform more complex PCI cases. It does not matter which cath lab you look at — patients are older, have more calcified lesions and more diffuse disease. Despite those comorbidities, patients do well regardless of where they are treated. That said, we do not want everyone to perform these procedures without surgical backup unless they are very experienced. We cannot emphasize that enough.”
New considerations
Since SCAI published the last consensus statement in 2014, same-day discharge after elective PCI has increased to 28.6% of all PCIs and 39.7% of radial PCIs in the U.S., Grines said. Elective PCI in settings with no on-site surgery have increased in volume and complexity.
“The 2014 statement was pretty conservative in terms of the types of lesions treated at hospitals that did not have surgery on-site,” Grines said in an interview. “Many physicians were concerned that if they started a procedure and found they needed to perform an atherectomy or use special devices, they couldn’t do it, and it was harmful to the patient to not be able to use those technologies if necessary. At the same time, there has been a recent consolidation of cardiovascular services. Instead of independent hospitals, there are huge health systems. Cardiothoracic surgery has been taken out of many of those hospitals and funneled into a single institution. Hospitals used to performing complex angioplasty were all of a sudden left with very little. That was not desirable for the physician or the patient.”
The updated consensus statement reconsiders the types of cases that could be undertaken without on-site surgical backup, reviews data regarding which patients are at higher risk and recommends patient selection criteria based on patient risk, operator experience and facility capabilities.
“Importantly, as PCI with no surgery-on-site is often the predominant mode of delivery globally, we expanded the document to include international experience, perspectives and outcomes,” the researchers wrote in the statement.
Complication rates remain low
The rates of emergent bypass performed for a periprocedural complication after PCI have remained extremely low, the researchers noted. Data from the MASS COMM trial found no difference in the need for emergency surgery among patients randomly assigned to PCI at facilities with or without on-site cardiac surgery, with an incidence of 0.3% vs. 0.1%, respectively. Data from the British Cardiovascular Intervention Society between 2006 and 2012 showed emergency surgery was required for 0.04% of patients at centers with no surgery on-site compared with 0.1% at centers with on-site surgery. In a propensity-matched comparison of nonprimary PCI, researchers found that surgery was performed in 0.5% of patients at centers with surgery and in 0.3% of patients at centers without.
“In summary, the most recent data fail to find any clinically significant differences in outcomes of PCI at surgical vs. nonsurgical on-site PCI centers,” the researchers wrote.
Economic benefits with no on-site surgery
The United States has been leading the migration of PCI outside of the hospital, driven by market forces and reimbursement policies. PCI outside the hospital setting may be performed in a freestanding ASCs or in office-based laboratories.
“The economic benefits of PCI with no surgery on-site have driven and will continue to drive payers toward the migration of PCI to the ambulatory setting,” the researchers wrote. “This expert consensus statement summarizes the evidence supporting PCI with no surgery on-site and provides the community with the guidance necessary for this transition.”
For more information:
Cindy L. Grines, MD, MSCAI, FACC, can be reached at cgrines@yahoo.com.
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