Melhem J. Sharafuddin

Objective: To assess the clinical use of the UltraScore balloon in a real-world setting. Methods: This is a prospective, multicenter, single-arm, real-world study to assess the clinical use of the UltraScore balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal and below-the-knee (BTK) arteries. A total of 350 subjects were treated with the study device and follow-up was performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure. The primary endpoints were technical success and optimal PTA, defined as ≤30% residual stenosis without major flow-limiting dissection. Secondary endpoints included rate of bail-out stenting, freedom from target lesion revascularization (TLR), freedom from major amputation and clinical improvement measurements. Results: Technical success was 100% and optimal PTA was 72.8%. The rate of bail-out stenting was 4.0%; freedom from TLR was 100% at 30 days, 93.5% at 6 months and 88.2% at 12 months. Freedom from major amputation was 97.4% at 30 days, 94.7% at 6 months and 93.4% at 12 months. Conclusions: This study supports the feasibility and potential clinical utility of the UltraScore balloon when used during the endovascular treatment of stenotic and calcified lesions in the SFA, popliteal and BTK arteries.

BACKGROUND: Cerebral hemodynamic impairment in patients with asymptomatic high-grade (>70%) internal carotid artery (ICA) stenosis is associated with risk of stroke and cognitive decline, but correlations between the degree of stenosis and hemodynamic impairment are derived from small case series. Using baseline data from 242 participants in the CREST-H study (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis–Hemodynamics), we hypothesized that the degree of stenosis in the ICA would correlate with time-to-peak (TTP) delay in ipsilateral cerebral blood flow using MR/CT perfusion scans, adjusting for demographic and cardiovascular risk variables. METHODS: From all participants, ICAs were insonated using a 7 to 10 MHz probe for peak systolic velocity (PSV) and end diastolic velocity. Dynamic contrast perfusion imaging was standardized across 61 CREST-H sites, using standard sequential T2*-weighted perfusion imaging. CT perfusion used standard clinical protocols. TTP delay was calculated in the ipsilateral versus contralateral hemispheres. In cross-sectional analysis, linear regression was used to model TTP delay as the outcome variable and PSV, end diastolic velocity, and PSV ICA/common carotid artery ratio on the index and nonindex side as primary predictor variables in 6 separate models, adjusting for covariates, followed by automated backward elimination model reduction. RESULTS: Among 392 CREST-H participants, the 242 with complete data for all variables were included in the regression analysis (age, 70±7.6; 62% M). End diastolic velocity on the index side correlated with TTP delay (β=0.003, P =0.005). PSV had a similar correlation but did not reach significance (β=0.001, P =0.099), nor did ICA/common carotid artery ratio (β=0.003, P =0.126). Nonindex side PSV, end diastolic velocity, and ICA/common carotid artery ratio showed no correlation with TTP delay ( P =0.268, P =0.495, P =0.380, respectively). Circle of Willis completeness did not correlate with TTP. CONCLUSIONS: In this large cohort of patients with high-grade asymptomatic carotid stenosis, higher end-diastolic flow velocities correlated with greater TTP delays, supporting a definition of hemodynamically significant stenosis. Our findings have implications for the management of asymptomatic carotid stenosis, which will be tested in the CREST-H study. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03121209.

Objectives: Scarring from prior bypass surgery and irradiation may compromise revascularization options in critical ischemia due to underlying occlusive disease. Occlusive disease of the axillo-brachial artery is particularly difficult to revascularize under such hostile conditions. Method: We present a case of a 58-year-old woman presenting with a painful, pulseless, and cool left upper extremity. The patient had a known history of left upper extremity occlusive disease which was managed by subclavian–axillary artery stenting with re-occlusion and subsequent extra-anatomic left carotid-to-proximal brachial artery prosthetic bypass, which was complicated by stroke. The patient had a history of left mastectomy, axillary node dissection, and external beam radiation therapy. When considering revascularization options, the combination of post-radiation changes and scarring of the conventional operative zones for revascularization posed a high risk for complications. We describe a novel approach for such revascularization, where the inflow source was the terminal brachiocephalic artery, outflow to the upper left brachial artery, with anatomic intrathoracic-to-axillary tunneling through the thoracic outlet after verifying the lack of dynamic extrinsic compression at that level. Result: The procedure resulted in resolution of the symptoms and the patient continued to do well 2 years later. Conclusion: This case shows that anatomic tunneling through the thoracic outlet can be a viable option for upper extremity revascularization when hostile conditions preclude other anatomic tunneling routes or extra-anatomic options.

Objectives: Despite two decades of experience, no dedicated classification system exists to document and prognosticate patterns of endoleak encountered after endovascular therapy of type-B aortic dissection. This nomenclature gap has led to inconsistent management and underreporting of significant findings associated with adverse outcomes after endovascular treatment of type-B aortic dissection. Our goal was to propose a reproducible and prognostically relevant classification. Methods: A multidisciplinary team of seven experienced open and endovascular aortic surgeons was assembled to provide consensus opinion. Extensive literature review was conducted. Deficiencies in the current classification approach of the various patterns of persistent filling of false lumen after endovascular therapy were identified. Results: Our focus was to categorize high-risk and low-risk subgroups within endoleaks after endovascular treatment of type-B aortic dissection. In this classification, type-Ia endoleak refers to persistent filling of the false lumen in an antegrade manner. Causes include failure to cover the primary entry tear and sizing or technical related proximal seal failure. False lumen filling via distal entry tears is classified as type Ib endoleak, which is further sub-classified into b1 (major branch-related tears), and b2 (multiple small branches related tears). Retrograde ascending aortic dissection and stent graft-induced new entry were classified as type-I endoleaks (type-Ir and type-Is, respectively). Another focus was reclassification type-II endoleaks, with type-IIa endoleak referring to conventional retroleak from one or more posterior branches and type-IIx referring to retroleak from major branches (visceral or left subclavian arteries). Conclusions: The majority of endoleaks after endovascular treatment of type-B aortic dissection are related to persistent or new filling of the false lumen. We propose a new false lumen-based classification schema for endoleaks occurring after endovascular therapy of type-B aortic dissection.