Complex PCI: Who and where?
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Recently, there has been renewed interest in the treatment of higher-risk patients undergoing PCI for complex CAD. Novel techniques and equipment have expanded operators’ ability to treat patients with increasingly complicated lesion types.
But how does one define “complex” or “higher-risk”? Currently, there is no formalized definition, and there are widely varying opinions on what constitutes complex and higher-risk procedures. Although there are a handful of risk calculators for coronary revascularization (eg, SYNTAX I and II, EuroSCORE I and II, Society of Thoracic Surgeons), they are based predominantly on anatomic or physiologic aspects of coronary anatomy and fail to fully incorporate all aspects of patient risk.
A white paper in 2016 first attempted to define the complex and higher-risk population as well as highlight the unmet need for their treatment. The patient population was defined as one that had a composite of three areas: specific complex coronary anatomic subsets, patient comorbidities that increased periprocedural risk and advanced technical skillsets required to treat this complex anatomy in the setting of these comorbidities (Figure). It is the total risk derived from all three areas that leads to the cumulative procedural risk profile of any individual patient for whom revascularization is considered.
Although there is risk inherent to the patient’s own anatomic and clinical factors, there also exists risk contingent upon the skill and experience of the treating interventionalist. For example, an operator with an extensive experience in chronic total occlusion (CTO) PCI has been shown to have higher success and lower complication rates compared with lower-volume operators. Moreover, interventionalists using best practices based on evidence-based medicine can mitigate periprocedural and long-term risk compared with those who do not.
Fundamental principles
To address the growing problem of operators not always using evidence-based best practices, a societal document from the Society for Cardiovascular Angiography and Interventions (SCAI) published in May focuses on the state-of-the art clinical evidence regarding PCI in patients with higher-risk features. It provides procedural guidance to achieve optimal outcomes for this patient population based on several fundamental principles.
No. 1, the use of scoring systems such as SYNTAX II and Society of Thoracic Surgeons can be helpful in delineating some aspects of procedural risk and to help inform optimal revascularization strategies. These scores can be utilized in the framework of a local heart team approach to obtain ideal care delivery.
No. 2, intravascular imaging and physiology are crucial to obtaining durable long-term results. Physiological assessment of intermediate coronary lesions should be considered to be a part of diagnostic coronary angiography so clinicians can make a proper diagnosis, which will ultimately shape treatment patterns for each patient, regardless of their modality of revascularization.
No. 3, coronary calcium requires both intravascular imaging for diagnostic purposes and various advanced treatment strategies — such as specialty balloons, atherectomy and/or lithoplasty — to allow appropriate stent expansion.
No. 4, as CTO PCI procedural success rates have significantly improved at dedicated centers, saphenous vein graft PCI is transitioning from a higher-risk procedure to a bailout procedure when the native vessel is unable to be treated. Mounting data support improved long-term target lesion and vessel patency for CTO PCI compared with bypass graft interventions. It is unclear whether more diffuse training in CTO PCI is needed as opposed to referral of these patients to specialized centers of excellence, but the data remain clear that CTO PCI is a preferred option for this patient group. This idea more broadly extends to treating left main disease and bifurcation lesions, where the data clearly show that higher-volume operators have improved outcomes with lower major adverse event rates compared with lower-volume operators. Improving technical education options and/or establishment of centers of excellence for complex PCI can hopefully bridge this gap.
Finally, there is a dearth of information regarding the use of mechanical circulatory support during PCI. There are some novel data regarding improving outcomes from cardiogenic shock due to acute MIs though the use of intravascular axial flow devices, but otherwise the data remain relatively scarce.
PCIs in ASCs
Our ability to treat patients with complex CAD illustrates how far PCI has advanced since its early days. At the inception of coronary intervention, it was not uncommon to experience an abrupt vessel closure rate of more than 10%. Therefore, cardiothoracic surgical backup was required to support interventional procedures. Since that time, with advances in technology, technique and pharmacology, the technical success rates of PCI have increased drastically, with a commensurate decrease in complication rates. In fact, PCI is now increasingly performed with same-day discharge, with several studies and registries demonstrating excellent safety profiles and cost reduction. Societal guidelines have also changed their recommendation from class III to class IIA for PCI without surgical backup.
Source: Riley RF, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28994. Reprinted with permission.
Due to the improved safety profile of PCI in general, along with greater use of same-day discharge, there has been increasing interest in performing PCI in outpatient ASCs. Potential benefits of ASCs may be greater patient access to PCI, reduced overall cost, greater efficiency and improved patient satisfaction. On Jan. 1, CMS allowed for reimbursements of PCI in ASC settings. However, given the varying complexity of PCI cases, which types of cases should be performed in ASC and which should be performed in the hospital setting?
SCAI in May published a position statement to provide guidance regarding the performance of PCI in the ASC setting. The document highlights the need for high-quality standards for patients undergoing PCI in ASCs, as well as impressing upon the need for patient safety.
At present, complex PCI subsets such as interventions of bypass grafts, CTOs and procedures on patients with ACS or those requiring atherectomy will not be reimbursed by CMS at an ASC. Other lesion subsets that should be considered for deferral to the hospital setting would be bifurcation lesions with risk for side branch loss, unprotected left main lesions, last remaining conduits, concurrent severe valvular disease and need for mechanical circulatory support. Given the increased potential for life-threatening complications, need for emergent cardiac surgery, and overnight monitoring for peri- and postprocedural complications, ASCs would not be adequately equipped to address such issues.
Complex patients need hospital setting
In conclusion, we have made great strides in the percutaneous treatment of patients with complex CAD during the past decade. The recent explosion of novel techniques and equipment have allowed us to treat this growing patient group with excellent success rates and reasonable safety profiles. We are also moving toward performing some PCIs in nontraditional settings such as ASCs.
Nevertheless, we still have a long way to go in terms of evaluating the safety of PCI in ASCs and improving our ability to treat complex CAD across the board. As we begin to amass safety data regarding outcomes for lower-risk patients undergoing PCI at ASCs, it is clear that complex and higher-risk patients should clearly undergo PCI in the hospital setting, as suggested in recent guidelines. This will allow us to optimize outcomes and safety for our patients, which is ultimately the goal of any treatment strategy, regardless of the setting in which it is delivered.
References:
Basir MB, et al. Catheter Cardiovasc Interv. 2019;doi:10.1002/ccd.28307.
Box LC, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28991.
Choi KH, et al. JACC Cardiovasc Interv. 2019;doi:10.1016/j.jcin.2019.01.227.
Colleran R, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.03.456.
Escaned J, et al. Eur Heart J. 2017;doi:10.1093/eurheartj/ehx512.
Kinnaird T, et al. Circ Cardiovasc Interv. 2020;doi:10.1161/CIRCINTERVENTIONS.119.008782.
Kirtane AJ, et al. Circulation. 2016;doi:10.1161/CIRCULATIONAHA.116.022061.
Riley RF, et al. Catheter Cardiovasc Interv. 2020;doi:10.1002/ccd.28994.
Shahian DM, et al. Ann Thorac Surg. 2018;doi:10.1016/j.athoracsur.2018.03.002.
Xaplanteris P, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1803538.
Young MN, et al. Circ Cardiovasc Interv. 2019;doi:10.1161/CIRCINTERVENTIONS.119.007877.
Young MN, et al. J Am Heart Assoc. 2020;doi:10.1161/JAHA.119.014738.
- For more information:
- Darshan Doshi, MD, MS, is an interventional cardiologist in the division of cardiology at Massachusetts General Hospital and faculty at Harvard Medical School. He can be reached at darshan_doshi@mgh.harvard.edu; Twitter: @drdarshandoshi.
- For more information:
- Robert F. Riley, MD, MS, is research and medical director for the Complex Coronary Therapeutics Program at The Christ Hospital Health Network in Cincinnati. He can be reached at robert.riley@thechristhospital.com.
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