SCAI/ACC/AHA Statement: PCI Without Surgical Backup Safe When Done According to Protocol
Newly updated recommendations from the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), and American Heart Association (AHA), affirm that percutaneous coronary intervention (PCI) performed at a hospital lacking onsite surgical backup can be done in both urgent and elective cases without increasing the risk of mortality or emergency bypass surgery.
The consensus document, published online March 17, 2014, ahead of print in Catheterization and Cardiovascular Interventions, reviews the literature since the issue was last assessed in 2007 and provides recommendations for hospitals that do not provide cardiac surgery should complications occur.
Gregory J. Dehmer, MD, of Baylor Scott & White Health, Central Texas (Temple, TX), and colleagues cite the fact that as PCI technology and experience has advanced since 2007, “the volume of PCI procedures peaked in 2006 and has declined by over 30%.” Because of this, they say, “many operators and hospitals now have low-volume practices.” For example:
- Sixty-one percent of interventional cardiologists performed 40 or fewer Medicare fee-for-service PCIs annually since 2008
- Forty-nine percent of facilities performed 400 or fewer PCIs, and 26% performed 200 or fewer annually
- About 33% of facilities had no on-site surgical backup, and among these, 65% had an annual case volume of 200 or fewer PCIs
The authors highlight 7 studies and 2 meta-analyses on primary PCI, none of which showed a difference in mortality between sites that did or did not offer surgical backup; only 1 meta-analysis showed a higher likelihood of emergency CABG at sites lacking backup.
In regards to elective procedures, the statement reviews the outcomes of both the CPORT-E and MASS COMM randomized trials. The former included more than 18,000 patients and demonstrated noninferiority regarding 6-week mortality and 9-month MACE for PCI with or without surgical backup; the latter, a smaller study, showed noninferiority with regard to MACE at 30 days and 1 year without a difference in the individual rates of death, MI, repeat revascularization, or stroke.
Thus the authors infer “based on these recent studies, there is no indication of increased mortality or a greater need for emergency CABG for either primary or nonprimary PCI at sites without onsite cardiac surgery.”
New Recommendations Adapt to Novel Technologies
The current recommendations are a composite of the 2007 SCAI expert consensus statement, 2011 PCI guidelines, 2012 expert consensus document on cardiac catheterization laboratory standards, 2013 PCI competency statement and recommendations from the policy statement of the AHA, and requirements for the Mission Lifeline program and D2B Alliance, as well as new suggestions.
In a telephone interview, Dr. Dehmer told TCTMD that the writing committee placed a greater emphasis on the presence of quality review programs for facilities and operators. Two suggestions added to the consensus document, he pointed out, have to do with the use of novel imaging modalities and definition of optimal geographic placement for PCI programs.
Many older documents said “it would be really nice if you had [IVUS and FFR] in a cath lab that did PCI without onsite surgery,” Dr. Dehmer explained. “Now it’s a requirement because of all the emphasis on lesion assessment using FFR. It’s no longer just a nice thing to have, and it’s basically essential in any cath lab now.”
Another addition was a clear definition of the term ‘geographic isolation,’ so often used in past guidelines to justify the building of a new PCI facility without onsite surgery, he said. “On purpose, it was never very crisply defined what they meant by geographic isolation,” Dr. Dehmer observed. “We tried to get a little more granular about it. We shifted and instead of talking about it in terms of distance, we talked about it in terms of time.” The recommendation now states that geographic isolation exists if the emergency transport time to another facility for a STEMI patient is more than 30 minutes, in accordance with that standard door-to-balloon time of 90 minutes.
This change was inspired by a writing committee member from New York City, where “at the height of rush hour traffic you can see another hospital off in the distance, but it can take more than 30 minutes to get there,” he explained.
Other new recommendations include:
- Adding the heart team approach to the personnel interactions section
- Stressing the need for consent for PCI to be obtained before the procedure and before any sedatives are given
- Adding chronic total occlusions to the list of situations in which intervention should be avoided
- Highlighting the importance of operator consideration in the event of high-risk lesions and STEMI patients resuscitated from sudden cardiac death
- Cautioning against a recently trained interventional cardiologist starting a new PCI program
Emphasis Now on ‘Distribution of PCI Services’
“For the future, the focus must now shift to developing a rational plan for the distribution of PCI services,” the authors write. “Small PCI programs with large fixed costs are inefficient and unnecessary if they do not improve access in areas of need. However, it is unlikely that issues of system-wide efficiency will be addressed without central planning on the state or federal level,” they conclude.
Dr. Dehmer said that he hopes the statement will be a “source document that will be as current as it can possibly be [and will be available for] a facility that is engaged in PCI without onsite surgery.”
Facilities with existing cath labs and those thinking about building new cath labs will have many issues to consider in the coming years, he commented. “As a center sees… volume going down, that has to be balanced against what is basically the financial bottom line for the institution,” Dr. Dehmer said. “A cath lab is a very expensive thing to buy, it is also very costly to maintain, and it is also very costly to maintain the inventory necessary… to really treat anyone who walks in the door…. If the volume of cases is going down, reimbursement for facilities is also gradually drifting downward, and those things need to be watched.”
For now though, the question of whether PCI can be safe without onsite surgical backup is answered, he concluded. “The real challenging question moving forward [will be the appropriateness of] where we are providing the access to PCI facilities,” Dr. Dehmer said.
Dehmer GJ, Blankenship JC, Cilingiroglu M, et al. SCAI/ACC/AHA expert consensus document: 2014 update on percutaneous coronary intervention without on-site surgical backup. Cath Cardiovasc Interv. 2014;Epub ahead of print.
- Dr. Dehmer reports no relevant conflicts of interest.