Left Main PCI in Interventional Labs Without On-Site Surgery: When is High Risk Too High?

When is high risk too high? Read the article below and then click here to listen to a discussion as Dr. Morton Kern and his expert colleagues review the complexity of left main intervention in a lab without on-site surgery.

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There are many interventional labs in the United States that operate without the benefit of on-site surgery, with agreements in place for emergency transfers and other safety procedures as outlined in the 2014 Society for Cardiovascular Angiography and Interventions (SCAI) consensus document on percutaneous coronary intervention (PCI) in labs without surgery on site (SOS).¹ As PCI technique progresses and new aspects of stenting, chronic total occlusion (CTO) procedures, and complex interventions become more routine for large, full-service centers, many experienced operators are bringing their expertise to labs without SOS. This expansion in sites of care prompted a revision of the 2014 SCAI consensus statement, released this month, headed by chairperson Dr. Cindy Grines and co-chair Dr. Arnold Seto.²

The issue of what constitutes safe practice in the no-SOS labs is not trivial. Before I present a summary of the revised consensus statement, I thought I would stimulate our thinking by providing a real case from our lab, what my colleagues said about the case, and the issues around the no-SOS lab transfer approach.

The Case

A 72-year-old patient with stable exertional angina on appropriate medical therapy was brought to the cath lab after a positive preoperative screening stress test (electrocardiogram [ECG] ST depressions) for cataracts. (Usually, cataract surgery doesn’t get screening stress tests, but sometimes it is done.) On angiography, we found an 80% irregular, ulcerated-appearing left main artery narrowing and total right coronary artery (RCA) with left-to-right collaterals (Figure 1). Echocardiography showed a left ventricular ejection fraction (LVEF) of 45%. After discussions with the patient and surgical colleagues at our nearby referring hospital, we planned to transfer this patient urgently after the procedure for coronary artery bypass graft (CABG) surgery. However, there were no beds available for surgery at any of our three potential referral sites. This delay in needed care could be a bigger problem if the patient destabilizes and needs urgent revascularization. Fortunately, and for a majority of our patients, we are able to treat the patient conservatively with heparin and anti-ischemic meds until a bed opens up.

While transfer is a standard approach for many sites without SOS, in these post-COVID days of tight bed availability, transfer for CABG is often is not timely.

My question to the group was, what to do now that there are no beds available?

1. Do you admit for observation following the procedure while awaiting transfer?

2. Although the patient is entirely asymptomatic for the last week, do you insert an intra-aortic balloon pump (IABP)? His blood pressure, heart rate (HR), and sats are normal after the procedure. I doubt anyone would place an Impella (Abiomed) left ventricular assist device at this juncture.

3. Should we proceed with high-risk PCI without surgical standby?

Before we hear about what we did and what our expert cath lab colleagues said, let’s review the guidelines and consensus statements information on PCI in centers without SOS.

Outpatient PCI in 2014?

In 2014, most PCI patients were still observed overnight, sometimes for clinical reasons, sometimes for billing reasons. Concerns about the femoral access and late bleeding might have contributed to the situation. Outpatient PCI was not reimbursed at the same rate as short stay or full admission status.  These scenarios and recommendations for outpatient PCI and for centers with no SOS were summarized in the SCAI consensus document.¹ Since the publication of the 2014 consensus statement, same-day discharge after elective PCI has increased (29% of all PCIs).³ Forty percent of radial access PCI procedures in the United States underwent same-day discharge by 2017.³ The volume and complexity of PCI in no-SOS sites have also increased, with many interventional cardiologists performing PCI in ambulatory surgery centers (ASCs). Several studies from around the world subsequently demonstrated that PCIs at no-SOS centers have low rates of complications, with similar outcomes compared to PCIs performed at centers with SOS. Fast forward to 2023.

PCI of Complex Lesions in No-SOS Centers

The 2023 SCAI consensus document² reviews the state of the art and provides data regarding patient selection criteria based on patient risk, operator experience, and facility capabilities and administrative lab requirements. Although a detailed and expert report, there are limited data regarding PCI outcomes for high-risk lesion subsets in outpatient settings. Several large datasets are cited. The Victorian Cardiac Outcomes Registry in Australia reported that 19% of unprotected left main procedures were undertaken in no-SOS centers.^2,4 Of interest, patients treated at no-SOS sites had a higher prevalence of left ventricular dysfunction, ST-elevation myocardial infarction (STEMI), and/or cardiogenic shock or required intubation, and had higher mortality and major adverse cardiac event (MACE) rates. Many of these patients, of course, are not elective interventions, but rather potentially life-saving emergencies.  Importantly, on-site cardiac surgery was not independently associated with in-hospital mortality or 30-day mortality. In the United Kingdom, a series of 40,744 left main PCIs reported 37% were performed at no-SOS centers. There was no association between surgery backup and risk of death, major adverse cardiac and cerebrovascular events (MACCE), or emergency CABG. Noteworthy was that bleeding complications were lower at no-SOS centers (probably in large part due to use of the radial approach).

There have been no comparative studies in other complex subgroups such as CTO and atherectomy; however, observational data suggests that CTO procedures are feasible with experienced operators, but with higher complication rates than with other anatomic subsets.

The 2023 consensus document makes a strong case for judicious patient selection for the safe performance of ambulatory PCI. The difference among these settings is compared in Table 1. Ambulatory centers do not generally receive high-risk acute coronary syndrome (ACS) patients, but hospital-based labs with no SOS can manage STEMI and other ACS patients. Patient comorbidities, particularly those that would favor the hospital setting, are shown on Table 2. The personnel and facility requirements for PCI programs without on-site surgical backup are summarized in Table 3.  Requirements for primary PCI and emergency CABG at hospitals without on-site cardiac surgery are also provided in Table 4.

Our Left Main Patient

Our lab is a hospital-based PCI/electrophysiology lab without SOS. Here is what we did. Although the patient was very stable after the angiogram, given the ulcerated image of the left main (LM), we had concern that urgent surgery was needed (flow chart, Figure 2). We found that we could not transfer the patient that day due to lack of outside bed availability. We admitted him to the intermediate monitored care unit, initiated heparin infusion, and continued his home medications while awaiting a surgical bed at one of our referral CABG facilities. It took 2 days to transfer the patient. He then had his surgery without any complications and was discharged home.

As for the risk for PCI at our no-SOS center, we use the same criteria as described in the SCAI expert consensus document of 2023,² but an unprotected LM with RCA CTO was deemed too high risk for us. We cannot risk our program on a complication in a patient like this. As for the question about need for IABP, since he remained rock stable and never changed clinical status, we saw no indication.

My colleagues (below) agreed with management and commented on the challenges of transfer of patients to tertiary referral centers.

Chris White, New Orleans, Louisiana: Just a comment on transfers during the pandemic being slow. The knock-on effect has been the increases in labor costs (agency nursing), resulting in many hospitals not being able to afford to staff all of their beds. There are plenty of beds, but not enough nurses to open them. We are currently experiencing a contraction of available beds from pre-pandemic levels, so I would expect that transfer delays may get worse will be with us for a while.

Kirk Garratt, Newark, Delaware: I heard a healthcare economist recently say we are currently short 400k RNs nationwide. The really bad news: things are expected to worsen, with a shortage of 450k expected by 2025.

Bonnie Weiner, Worcester, Massachusetts: Thanks, Kirk. These numbers don’t really surprise me. What concerns me, though, is the sense I have that just like physician workforce issues, the need here is for “bedside” nurses and the trend recently has been for increasing specialization and “advancement” to advance practice and administrative roles. A lower percentage of nurses are actually doing or staying in direct patient care roles. Not sure we have the tools to change the trend.

Kirk Garratt, Newark, Delaware: You’re absolutely right, Bonnie. The bedside and some specialty nurses seem to be in shortest supply, so they are getting really mind-bending compensation offers. I heard an unsubstantiated rumor that some OR RNs are getting $300/hour. RNs often work 36 hours/week. At 1872 work hours/year, that comes out to a salary competitive with an interventional cardiologist!! I might be an outlier here, but I also feel part of our overall workforce problem is our failure to use the advanced practice clinicians (APCs) properly. Too many APCs function as handmaidens and manservants to the doctors. That’s totally wrong and financially backwards. We talk about having APCs work at top of license, but we fail all too often, contributing further to excess cost. APCs are here to stay and talented RNs will continue to move in that direction. If we use APCs to work in team-based models and improve care efficiency, we have a shot at containing costs, which will help (among other things) sustain physician salaries. Without changes like this, physician compensation will suffer.

Bonnie Weiner, Worcester, Massachusetts: Thanks, Kirk. I agree with your comments about the APCs as well. Too often, I hear of them “waiting for the attending” to do consults or stress tests, for example. They should be quite capable of doing these things in the majority of cases. Knowing that an MD is going to follow after or is available for questions, they should be freeing up time for MDs to do more complex activities and other things such as teaching or research, where appropriate. It’s definitely not always happening that way.

The Bottom Line

PCI with no SOS is as safe as PCI at centers with on-site surgery. Adequate operator experience, appropriate clinical judgment and case selection, and facility preparation are essential to a successful PCI program with no SOS. The expert consensus statement summarizes the evidence supporting PCI with no SOS and provides the community with the guidance necessary for this transition. Lastly, many other centers like ours will have to accept the fact that transfers during the triple pandemic will be slow. 

References

1. 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. Catheter Cardiovasc Interv. 2014;84(2):169-187. doi: 10.1002/ccd.25371

2. Grines CL, Box LC, Mamas MA, et al. SCAI expert consensus statement on percutaneous coronary intervention without on-site surgical backup. JACC Cardiovasc Interv. 2023 Jan 24: S1936-8798(22)02297-X. doi: 10.1016/j.jcin.2022.12.016

3. Bradley SM, Kaltenbach LA, Xiang K, et al. Trends in use and outcomes of same-day discharge following elective percutaneous coronary intervention. JACC Cardiovasc Interv. 2021 Aug 9; 14(15): 1655-1666. doi: 10.1016/j.jcin.2021.05.043

4. Hanson L, Vogrin S, Noaman S, et al; Victorian Cardiac Outcomes Registry Investigators. Long-term outcomes of unprotected left main percutaneous coronary intervention in centers without onsite cardiac surgery. Am J Cardiol. 2022 Apr 1; 168: 39-46. doi: 10.1016/j.amjcard.2021.12.051

Morton J. Kern, MD, MSCAI, FACC, FAHA

Clinical Editor; Chief of Cardiology, Long Beach VA Medical Center, Long Beach, California; Professor of Medicine,

University of California, Irvine Medical Center, Orange, California

Disclosures: Dr. Morton Kern reports he is a consultant for Abiomed, Abbott Vascular, Philips Volcano, ACIST Medical, and Opsens Inc.

Dr. Kern can be contacted at mortonkern2007@gmail.com

On Twitter @MortonKern

More From Dr. Kern:

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What Should a New Team Member Do on Day 1 in the Cath Lab?

Managing Urgency During a Cardiac Cath