Abstract
Abstract Background Patients with symptomatic/severe carotid disease (recent carotid related TIA/stroke and/or high-risk plaque) and unstable, surgery-requiring cardiac disease (multivessel coronary artery disease-CAD and/or severe valvular heart disease-VHD) constitute a major decision-making and logistics challenge. Intervention limited to cardiac-only or carotid-only pathology may significantly increase the risk of serious/fatal complications arising primarily from "the other" (untreated) condition. Purpose To assess safety and feasibility of simultaneous, neuroprotected carotid artery stenting (CAS) under open-chest extracorporeal circulation (ECC) standby combined with urgent cardiac surgery in extreme risk patients with non-ST elevation myocardial infarction –(NSTEMI)/unstable angina (UA) and/or severe VHD (NYHA III) coexisting with symptomatic (recent stroke/TIA) carotid stenosis or high-risk lesion. Methods CAS and cardiac surgery were performed (multidisciplinary neurovascular team decision) in a hybrid room, during same anaesthetic setting (absence of delay). After chest opening and ECC stand-by connection, neuroprotected CAS was performed using transfemoral or direct carotid route with an immediate switch to ECC as required. Cardiac surgery followed immediately. Patients were on acetylsalicylic acid pre-procedurally. CAS heparinization was ACT-guided and was followed by ECC large-dose heparinization (protamine reversal). Clopidogrel (300 mg) was given within 12h, if surgical drainage was decreasing. Analysis was intention to treat (ITT). Results Over 60 months, 44 patients (age 71.2y, 81.8% male) meeting inclusion criteria were enrolled (ITT group), all in American Society of Anesthesiologists grade IV. Of those, 43 underwent treatment (1 death in transportation), 35 (79.5%) were treated per-protocol. Of the remaining 8 patients 5 with severe pulmonary disease/severe obesity/severely impaired ejection fraction/seriously impaired mobility were not cleared for surgery by anaesthesia ("too-sick for surgery"), in 3 cases hybrid room was not immediately available. 100% CAS were neuroprotected and all involved plaque sequestration with micronet-covered stent. CAS procedures (n=42, one lesion severity not confirmed) were 100% technically successful. Iv. inotropics were administered routinely, need for immediate switch to ECC occurred in 4 patients. The valve procedures in this study were due to severe aortic stenosis. For further details see Table. Patients "too-sick for surgery" (11.4%) underwent total endovascular treatment. On 30-day Carotid Doppler-Duplex ultrasound no in-stent restenosis/thrombosis occurred. Conclusions This study shows that truly simultaneous CAS+cardiac surgery in extremely high-risk, heamodynamically unstable patients is feasible and safe. Stent patency at 30 days and low 30-day death/MI/stroke rate (5.7% as per protocol) suggest efficacy of this novel strategy.
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