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Re-Evaluating the Center for Medicare and Medicaid Services (CMS) High Risk Criteria for Carotid Artery Revascularization
*Sabrina Straus, *Daniel Willie-Permor, *Ann Gaffey, Mahmoud B. Malas
Vascular Surgery, UCSD, La Jolla, CA

Objective: Identifying high-risk criteria for carotid endarterectomy (CEA) is crucial to provide the proper treatment for at-risk patients. However, existing literature has revealed inconsistencies with CMS risk guidelines. With recent CMS approval for Transcarotid Artery Revascularization (TCAR) and Transfemoral Carotid Artery Stenting (TFCAS) in high and standard risk patients, we aim to assess and update CMS guidelines using national data to identify true high-risk indicators for CEA.
Methods: Data was collected from the Vascular Quality Initiative (2016-2023) for carotid stenosis patients undergoing CEA, TFCAS, or TCAR. We used inverse probability weighting to adjust for confounders and compare in-hospital stroke or death across procedures for the following high-risk criteria: contralateral occlusion (CLO), prior CEA, prior CAS, radiation, prior neck surgery, moderate-severe CHF, severe COPD (on home O2), unstable angina, recent MI (<6 mo.), and age (>75 y/o).
Results: A total of 122,737 (62%) patients underwent CEA, 50,095 (25%) underwent TCAR, and 26,218 (13%) underwent TFCAS. In line with CMS criteria, TCAR had lower odds of stroke/death compared to CEA for patients with CLO (2.0% vs 2.8%; aOR=0.73 [95%CI:0.55-0.98] P=0.035) and radiation (0.7% vs 2.4%; aOR=0.44[95%CI:0.23-0.82] P=0.01). When comparing TFCAS with CEA, CLO patients performed similarly, but TFCAS radiation patients had lower odds of stroke/death (1.0% vs 2.4%; aOR=0.42[95%CI:0.23-0.74] P=0.003). When comparing to TCAR, TFCAS CLO patients had higher odds of stroke/death (3.4% vs 2.0%; aOR=1.69[95%CI:1.24-2.32] P<0.001), but there was no statistical difference for radiation patients. Contrary to CMS criteria, CEA patients did not have higher stroke/death for prior CEA, prior CAS, prior neck surgery, moderate-severe CHF, severe COPD, unstable angina, recent MI, or age (>75) compared to TCAR and TFCAS. TFCAS even had higher odds of stroke/death compared to CEA and TCAR for patients with prior CEA (2.2% vs 1.6%; aOR=1.37[95%CI:1.09-1.73] P=0.007; 2.2% vs 1.3%; aOR=1.68[95%CI:1.29-2.18] P<0.001), recent MI (6.7% vs 3.5%; aOR=1.99[95%CI:1.24-3.18] P=0.004; 6.7% vs 3.9%; aOR=1.79[95%CI:1.10-2.92] P=0.019), and age >75 (3.2% vs 1.7%; aOR=1.95[95%CI:1.70-2.24] P<0.001; 3.2% vs 1.7%; aOR=1.96[95%CI:1.68-2.28] P<0.001) (Table I).
Conclusions: While the previously mentioned criteria have been conventionally recognized as high-risk factors for CEA, only patients with CLO or radiation would benefit more from TCAR over CEA. In contrast, patients with prior CEA, moderate-severe CHF, recent MI, or age (>75) had worse outcomes with TFCAS compared to both TCAR and CEA, suggesting that CEA should remain a viable treatment option for these patients. While future prospective studies are needed to confirm findings, the definition of high-risk criteria for CEA may warrant reconsideration. Consequently, results of this study will be sent to CMS for potential revision to current guidelines.

In-hospital stroke-death rates by high-risk criteria comparing TCAR vs CEA and tfCAS vs CEA (Reference: CEA)
 TCAR vs CEATFCAS vs CEATFCAS vs TCAR
 CEATCARaOR [CI]P valueTFCASaOR [CI]P valueaOR [CI]P value
Contralateral Occlusion2.8%2.0%0.73 (0.55-0.98)0.0353.4%1.24 (0.93-1.66)0.151.69 (1.24-2.32)<.001
Prior CEA1.6%1.3%0.82 (0.66-1.02)0.0752.2%1.37 (1.09-1.73)0.0071.68 (1.29-2.18)<.001
Prior CAS2.5%1.1%0.45 (0.20-1.02)0.0561.7%0.68 (0.29-1.55)0.41.51 (0.97-2.36)0.068
Radiation2.4%0.7%0.30 (0.17-0.54)<.0011.0%0.42 (0.23-0.74)0.0031.37 (0.72-2.61)0.3
Prior Neck Surgery2.0%1.3%0.63 (0.37-1.07)0.0891.5%0.73 (0.41-1.29)0.31.15 (0.57-2.33)0.7
Moderate-Severe CHF (Class III, IV)3.2%2.3%0.69 (0.44-1.09)0.114.6%1.44 (0.92-2.25)0.112.08 (1.27-3.41)0.004
Severe COPD (on home O2)2.2%2.5%1.12 (0.73-1.72)0.62.7%1.24 (0.76-2.03)0.41.11 (0.67-1.85)0.7
Unstable Angina2.6%2.0%0.75 (0.37-1.52)0.43.8%1.45 (0.73-2.90)0.31.94 (0.91-4.17)0.088
Recent MI (<6 mo.)3.5%3.9%1.11 (0.70-1.77)0.76.7%1.99 (1.24-3.18)0.0041.79 (1.10-2.92)0.019
Age (>75 years old)1.7%1.7%1.00 (0.88-1.13)>0.93.2%1.95 (1.70-2.24)<.0011.96 (1.68-2.28)<.001

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