Source/Disclosures
Source:

Box LC, et al. SCAI Clinical Documents. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).

Box LC, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28991.
Disclosures: Box reports no relevant financial disclosures. Mahmud reports he received clinical trial research support from Abbott Vascular, Cardiovascular Systems Inc. and Corindus; consulted for Abiomed and Medtronic; and holds equity in Abiomed. Please see the document for the other authors’ relevant financial disclosures.
May 20, 2020
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SCAI document identifies patients appropriate for PCI in ASCs

Source/Disclosures
Source:

Box LC, et al. SCAI Clinical Documents. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).

Box LC, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28991.
Disclosures: Box reports no relevant financial disclosures. Mahmud reports he received clinical trial research support from Abbott Vascular, Cardiovascular Systems Inc. and Corindus; consulted for Abiomed and Medtronic; and holds equity in Abiomed. Please see the document for the other authors’ relevant financial disclosures.
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Lyndon C. Box

CMS in January commenced reimbursement for PCI procedures performed in ASCs. However, existing PCI guidelines assume the procedure occurs in a hospital, so the Society for Cardiovascular Angiography and Interventions released a position statement identifying appropriate patients to undergo PCI in an ASC and advising on requirements for starting a PCI program in such a center.

“CMS anticipates a $20 million annual savings in costs and about $5 million saved in copays if only 5% of PCIs are relocated to ambulatory surgical centers,” Lyndon C. Box, MD, FSCAI, director of the Cardiovascular Service Line, West Valley Medical Center, Caldwell, Idaho, said during a presentation at the virtual SCAI Scientific Sessions. “Some of the drawbacks are that, currently, we do not have any safety data on PCI performed in an ambulatory surgical center, and there is a big concern that there is going to be an increase in ambulatory procedures because of the potential financial gain for doing procedures in this setting. There is also a concern about harm to the system by shifting resources away from hospitals, making it more difficult for them to care for higher-risk patients or patients without insurance. It is critical that patients in the ambulatory surgical center environment receive the same quality of care as those in the hospital setting.”

CMS approved reimbursement codes for standard PCI in ASCs, but not for chronic total occlusion PCI, PCI for STEMI, bypass grafts or atherectomy, Box said.

“Unfortunately, IVUS, OCT and [fractional flow reserve] codes were not included,” he said. “They are bundled in. SCAI’s Government Relations Committee has lobbied for this and will continue to lobby very hard for this in the future.”

The regulation requires that “all equipment necessary for performing PCI and for dealing with emergencies should be available” at the ASC, Box said during the presentation. “This includes things like a pericardiocentesis tray, echocardiography or ultrasound capable of assessing for pericardial effusion, temporary transvenous pacemakers, covered stents, intra-aortic balloon pumps and advanced cardiac life support supplies including a defibrillator and a ventilator.”

ASCs beginning a PCI program should follow the SCAI 2016 Best Practices in the Cardiac Catheterization Laboratory document, Box said, including having a minimal annual volume of at least 50 PCI cases per operator.

“SCAI also cautions against newly trained interventional cardiologists performing PCI in an ASC setting,” he said. “Ideally, operators would have a career experience of greater than 500 cases. Additionally, a credentialing process must be in place.”

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Patient selection

Appropriate patients include those who would qualify for same-day discharge from a hospital and for PCI without surgical backup, Box said.

“This is different because you don’t have the easy option of converting someone to an overnight stay,” he said. “For example, if you attempt bifurcation and lose a side branch, you will have to transfer that patient for observation.”

According to an algorithm included with the statement, patients selected for PCI in an ASC should have adequate social support and access to follow-up care, favorable clinical features and no complex or high-risk anatomy.

Unfavorable clinical features inappropriate for PCI at an ASC include decompensated congestive HF, stroke or transient ischemic attack within 8 weeks, left ventricular ejection fraction less than 30%, chronic kidney disease, anemia, ACS, severe pulmonary hypertension or pulmonary disease, unprotected left main stenosis, three-vessel CAD, signs of clinical instability, severe aortic stenosis, severe contrast allergy and other conditions as identified by the operator, according to the document.

Anatomical characteristics inappropriate for the ASC setting include bifurcation lesions with significant side branch involvement, severely calcified lesions, extreme angulation or tortuosity, bypass graft lesions, CTOs, anything that might interfere with stent deployment, thrombus in the target vessel or lesion, unprotected left main lesions, last remaining conduit status and possible need for upfront mechanical circulatory support, the authors wrote.

Box noted that “much of the ethical concerns involve finances. Physicians must remain cognizant of the potential for clinical decisions to be unduly influenced. Likewise, this increases the responsibility for full disclosure of the potential for financial influence to affect their care.”

Low-risk outpatients

Ehtisham Mahmud

Implementation “is going to vary state by state,” Ehtisham Mahmud, MD, FACC, FSCAI, division chief of cardiovascular medicine, executive director of medicine at the Cardiovascular Institute, director of the Interventional Cardiology and Cardiac Cath Lab and professor of medicine at the University of California, San Diego, and immediate past president of SCAI, said during a panel discussion. “Ultimately, what I think will happen is that there will be a portion of very low-risk outpatients that get diagnostic caths and relatively straightforward PCI in an ASC. Will this impact hospitals adversely? I don’t think so. We should already be using our hospital resources for patients who need more complex interventional therapy.”

The document was published in Catheterization and Cardiovascular Interventions along with a companion document on optimal PCI therapy for complex CAD. – by Erik Swain

References:

Box LC, et al. SCAI Clinical Documents. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).

Box LC, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28991.

Disclosures: Box reports no relevant financial disclosures. Mahmud reports he received clinical trial research support from Abbott Vascular, Cardiovascular Systems Inc. and Corindus; consulted for Abiomed and Medtronic; and holds equity in Abiomed. Please see the document for the other authors’ relevant financial disclosures.