SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers.

The Centers for Medicare & Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed.

Preliminary Results of the Outpatient Endovascular and Interventional Society National Registry.

PURPOSE: To present a new outcomes-based registry to collect data on outpatient endovascular interventions, a relatively new site of service without adequate historical data to assess best clinical practices. Quality data collection with subsequent outcomes analysis, benchmarking, and direct feedback is necessary to achieve optimal care. MATERIALS AND METHODS: The Outpatient Endovascular and Interventional Society (OEIS) established the OEIS National Registry in 2017 to collect data on safety, efficacy, and quality of care for outpatient endovascular interventions. Since then, it has grown to include a peripheral artery disease (PAD) module with plans to expand to include cardiac, venous, dialysis access, and other procedures in future modules. As a Qualified Clinical Data Registry approved by the Centers for Medicare and Medicaid Services, this application also supports new quality measure development under the Quality Payment Program. All physicians operating in an office-based laboratory or ambulatory surgery center can use the Registry to analyze de-identified data and benchmark performance against national averages. Major adverse events were defined as death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery. RESULTS: Since Registry inception in 2017, 251 participating physicians from 64 centers located in 18 states have participated. The current database includes 18,134 peripheral endovascular interventions performed in 12,403 PAD patients (mean age 72.3±10.2 years; 60.1% men) between January 2017 and January 2020. Cases were performed primarily in an office-based laboratory (85.1%) or ambulatory surgery center setting (10.4%). Most frequently observed procedure indications from 16,086 preprocedure form submissions included claudication (59%), minor tissue loss (16%), rest pain (9%), acute limb ischemia (5%), and maintenance of patency (3%). Planned diagnostic procedures made up 12.2% of cases entered, with the remainder indicated as interventional procedures (87.6%). The hospital transfer rate was 0.62%, with 88 urgent/emergent transfers and 24 elective transfers. The overall complication rate for the Registry was 1.87% (n=338), and the rate of major adverse events was 0.51% (n=92). Thirty-day mortality was 0.03% (n=6). CONCLUSION: This report describes the current structure, methodology, and preliminary results of OEIS National Registry, an outcomes-based registry designed to collect quality performance data with subsequent outcome analysis, benchmarking, and direct feedback to aid clinicians in providing optimal care.

LumenRECON Guidewire: Pilot Study of a Novel, Nonimaging Technology for Accurate Vessel Sizing and Delivery of Therapy in Femoropopliteal Disease.

BACKGROUND: Proper vessel sizing during endovascular interventions is crucial to avoid adverse procedural and clinical outcomes. LumenRECON (LR) is a novel, nonimaging, 0.035-inch wire-based technology that uses the physics-based principle of Ohm's law to provide a simple, real-time luminal size while also providing a platform for therapy delivery. This study evaluated the accuracy, reliability, and safety of the LR system in patients presenting for a femoropopliteal artery intervention. METHODS AND RESULTS: This multicenter, prospective pilot study of 24 patients presenting for peripheral intervention compared LR measurements of femoropopliteal artery size to angiographic visual estimation, duplex ultrasound, quantitative angiography, and intravascular ultrasound. The primary effectiveness and safety end point was comparison against core laboratory adjudicated intravascular ultrasound values and major adverse events, respectively. Additional preclinical studies were also performed in vitro and in vivo in swine to determine the accuracy of the LR guidewire system. No intra- or postprocedure device-related adverse events occurred. A balloon or stent was successfully delivered in 12 patients (50%) over the LR wire. Differences in repeatability between successive LR measurements was 2.5±0.40% (R2=0.96) with no significant bias. Differences in measurements of LR to other modalities were 0.5±1.7%, 5.0±1.8%, -1.5±2.0%, and 6.8±3.4% for intravascular ultrasound core laboratory, quantitative angiography, angiographic, and duplex ultrasound, respectively. CONCLUSIONS: This study demonstrates that through a physics-based principle, LR provides a real-time, safe, reproducible, and accurate vessel size of the femoropopliteal artery during intervention and can additionally serve as a conduit for therapy delivery over its wire-based platform.

Optical coherence tomography: guided therapy of in-stent restenosis for peripheral arterial disease.

Approximately 27 million people in Europe and North America currently have peripheral arterial disease (PAD). The endovascular treatment of stenosis or blocked peripheral arteries in PAD include percutaneous transluminal angioplasty with or without a drug coated balloon (DCB), atherectomy (rotational, directional, orbital or laser), and stenting. The development of next generation peripheral stents and drug-coated stents have led to the improved treatment of complex superficial femoral artery (SFA) lesions, and consequently increased their usage. Additionally, the technologies developed for PAD intervention have further improved the overall adoption of endovascular procedures leading to increased utilization of stents to address procedural dissections (bailout stenting), as support scaffolding for complex lesions, and to prevent preventing elastic recoil post balloon angioplasty. For example, bail-out stenting after DCB angioplasty has been reported to be as high as 40% in long lesions and as high as 46% in chronic total occlusions lesions. In total, approximately 200,000 stents are placed annually in the femoral and popliteal arteries in PAD patients in the USA, with 30% to 40% of these stents expected to develop in-stent restenosis within 2-3 years of implantation. Accordingly, the treatment of in-stent restenosis (ISR) remains a substantial healthcare burden. Few technologies reported on improved ISR patency rates as compared to PTA treatment alone, including drug-eluting stents and balloons, laser atherectomy or covered stents. However, the reported longer-term patency for ISR remains suboptimal creating a cyclical treatment pattern that burdens patients and providers. In this review, we present the rational and clinical evidence for utilizing OCT-guided therapies for the treatment of ISR for PAD.