Multi-Center Experience with Intravascular Lithotripsy for Treatment of Severe Calcification during TCAR for High-Risk Patients.

OBJECTIVES: Transcarotid artery revascularization (TCAR) offers a safe alternative to carotid endarterectomy (CEA), but severe calcification is currently considered a contraindication in carotid artery stenting. This study aims to describe the safety and effectiveness of TCAR with intravascular lithotripsy (IVL) in patients with traditionally prohibitive calcific disease. METHODS: All consecutive patients who underwent TCAR+IVL from 2018-2022 at nine institutions were identified. IVL was combined with pre-dilatation angioplasty to treat calcified vessels before stent deployment. The primary outcome was a new ipsilateral stroke within 30 days. Secondary outcomes included any new ipsilateral neurologic event (stroke/TIA) at 30 days, technical success, and <30% residual stenosis. RESULTS: Fifty-eight patients (62% Male, mean age 78±6.6 years) underwent TCAR+IVL, with 22 (38%) for symptomatic disease. Fifty-seven patients (98%) met high-risk anatomical or physiologic criteria for CEA. Forty-seven patients had severely calcific lesions. Fourteen patients (30%) had isolated eccentric plaque, 20 patients (43%) had isolated circumferential plaque, and 13 had eccentric and circumferential calcification (27%). Mean procedure and flow reversal times were 87±27 and 25±14 minutes. The median number of lithotripsy pulses per case was 90 (range 30-330), and mean contrast usage was 29 mL. No patients had EEG changes or new deficits observed intraoperatively. Technical success was achieved in 100% of cases, with 98% having <30% residual stenosis on completion angiography. One patient had an in-hospital post-procedural stroke (1.72%). Four patients total had any new ipsilateral neurologic event (stroke/TIA) within 30 days for an overall rate of 6.8%. One TIA and one stroke occurred during the index hospitalization, and two TIAs occurred after discharge. Preoperative mean stenosis in patients with any post-operative neurologic event was 93% (versus 86% in non-stroke/TIA patients, p=.32), and chronic renal insufficiency was higher in patients who had a new neurologic event (75% vs. 17%, p=.005). No differences were observed in calcium, procedural, or patient characteristics between the two groups. The mean follow-up was 132 days (range 19-520). Three stents developed recurrent stenosis (5%) on follow-up duplex; the remainder were patent without issue. There were no reported interventions for recurrent stenosis during the study period. CONCLUSIONS: IVL sufficiently remodels calcified carotid arteries to facilitate TCAR effectively in patients with traditionally prohibitive calcific disease. One patient (1.7%) suffered a stroke within 30 days, though four patients (6.8%) sustained any new neurological event (stroke/TIA). These results raise concerns about the risks of TCAR + IVL and whether it is an appropriate strategy for patients who could potentially undergo CEA.

In situ laser fenestration of aortic septum to bridge false and true lumen during endovascular repair of aortic dissection.

Fenestration of the septum between the true and false lumen might be necessary after aortic dissection. We report the technical aspects of in situ laser fenestration of the aortic dissection septum. Two illustrative cases are provided: a 56-year-old man with false lumen deployment of a frozen elephant trunk graft, and a 67-year-old man who underwent fenestrated endovascular aortic repair with a target branch vessel off the false lumen. In both cases, the septum was crossed using in situ laser fenestration. This technique is a precise option to enable passage between true and false lumens during endovascular repair of an aortic dissection.

Use of Iliac Branch Endoprosthesis to Rescue Inadvertent False Lumen Deployment of the Innominate Branch Stent During Physician-Modified Fenestrated-Branched Aortic Arch Repair.

A 70-year-old male with a history of 3 prior median sternotomies and on anticoagulation presented with acute chest and back pain associated with a pseudoaneurysm of the ascending and aortic arch in the setting of residual dissection involving the innominate, proximal right carotid, and subclavian arteries. A physician-modified triple vessel fenestrated-branched arch endograft was deployed. The innominate branch stent was deployed from the right carotid cut down, while the left carotid and left subclavian branch stents were placed from a femoral approach. Postoperatively, the innominate branch was found to be deployed in the false lumen of the dissected native innominate artery, leading to continued pressurization of the pseudoaneurysm. This was rescued by placing a Gore Iliac Branch Endoprosthesis (IBE) into the innominate branch through a temporary conduit sewn to the right carotid artery with a right subclavian branch placed via a brachial artery cut down into the internal iliac gate. The use of IBE allowed branch stent extension past the dissected native vessels. The patient had an uneventful recovery without neurologic complications. At 3-month follow-up, the patient remains well with an excluded pseudoaneurysm, and patent bifurcated innominate, bilateral carotid, and subclavian artery branches. A Gore IBE can be utilized in a dissected innominate artery to create an innominate branch device during fenestrated-branched endovascular arch repair.

Aortic rupture during STABILISE (stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair) technique.

The STABILISE (stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair) technique has shown promising results for treating type B aortic dissections, but the potential exists for fatal adverse effects. We present a case of infrarenal aortic rupture while using a compliant balloon to balloon mold the true lumen inside previously placed bare metal stents during the STABILISE technique. Caution is advised for providers who wish to perform the STABILISE technique, and we recommend using a semi-compliant balloon sized to the smallest total aortic diameter to mitigate the risk of rupture.

Sandwich thoracic branch endoprosthesis technique for endovascular repair of thoracic aortic aneurysm with aberrant right subclavian artery.

Subclavian artery coverage is frequently required to achieve an adequate proximal seal during thoracic endovascular aortic repair. The thoracic branch endoprosthesis (TBE; W.L. Gore & Associates) is the first U.S. Food and Drug Administration-approved branched device for thoracic endovascular aortic repair, designed for left subclavian artery incorporation. However, anatomic suitability of the TBE has been shown to be limited. In the present report, we describe a novel technique using the TBE in a sandwich periscope configuration to allow for emergent repair of a ruptured thoracic aortic aneurysm with a highly angulated proximal seal zone and aberrant right subclavian artery.

Medial arterial calcification score is associated with increased risk of major limb amputation.

OBJECTIVE: The pedal medial arterial calcification (MAC) score has been associated with risk of major limb amputation in patients with chronic limb-threatening ischemia. This study aimed to validate the pedal MAC scoring system in a multi-institutional analysis to validate its usefulness in limb amputation risk prediction. METHODS: A multi-institution, retrospective study of patients who underwent endovascular or open surgical infrainguinal revascularization for chronic limb-threatening ischemia was performed. MAC scores of 0 to 5 were assigned based on visible calcified arteries on foot X ray then trichotomized (0-1, 2-4, 5) for analysis. The primary outcome was major limb amputation at 6 months. Adjusted Kaplan-Meier models were used to analyze time-to-major amputation across groups. RESULTS: There were 176 patients with 184 affected limbs (mean age, 66 years; 61% male; 60% White), of whom 97% presented with a wound. The MAC score was 0 in 41%, 1 in 9%, 2 in 13%, 3 in 11%, 4 in 13%, and 5 in 13% of the limbs. There were 26 major amputations (14%) and 16 deaths (8.7%) within 6 months. Patients with MAC 5 had a significantly higher risk of major limb amputation than both the 0 to 1 and 2 to 4 groups (P = .001 and P = .044, respectively), and lower overall amputation-free survival (log-rank P = .008). CONCLUSIONS: Pedal MAC score is a reproducible and generalizable measure of inframalleolar arterial disease that can be used with Wound, Ischemia, and foot Infection staging to predict major limb amputation in patients with chronic limb-threatening ischemia.

Comparative outcomes of physician-modified fenestrated-branched endovascular repair of post-dissection and degenerative complex abdominal or thoracoabdominal aortic aneurysms.

OBJECTIVE: Fenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs. METHODS: A single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention. RESULTS: Of the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23). CONCLUSIONS: PM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up.

Risk of Stroke with Thoracic Endovascular Aortic Repair of the Aortic Arch.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) involving the aortic arch is increasingly being performed and novel endografts have been developed for this procedure, but the association of stroke and relative risk of procedural techniques remains unclear. This study evaluates the procedural risk factors for stroke and mortality with zone 0-2 TEVAR. METHODS: The Society for Vascular Surgery Vascular Quality Initiative registry was queried for patients who underwent TEVAR with proximal landing in zone 0-2 from 2013 to 2022. Emergent and ruptured cases were excluded. Primary exposure variables included proximal seal zone (0-2) and branch vessel revascularization technique: open debranching/bypass, total endovascular incorporation, or combination (at least 1 branch open and 1 branch endovascular). The primary outcome was perioperative inhospital stroke and the secondary outcome was inhospital mortality. Univariable and multivariable regression analyses were performed. RESULTS: In total, 4,355 cases were analyzed with 350 in zone 0 (8%), 513 in zone 1 (12%), and 3,492 in zone 2 (80%). For zone 0, 1, and 2, the stroke rates were 11.1%, 5.3% and 4.7% (P < 0.0001) and inhospital mortality rates were 6.9%, 5.3% and 3.5% (P = 0.002), respectively. Branch vessel revascularization technique was associated with stroke in zone 0 with a 3-fold higher stroke rate for total endovascular incorporation of branches compared to combination and open techniques (P = 0.002). On multivariable analysis, zone 0 was independently associated with a greater than 2-fold increased odds of stroke compared to zone 2 (95% CI 1.4-3.2, P = 0.0008). CONCLUSIONS: Stroke rate was 2-3 times higher for zone 0 TEVAR compared to zones 1 and 2. Within zone 0, total endovascular branch incorporation was associated with a 3-fold higher stroke rate than open and combination techniques. Future device design modifications and novel endovascular strategies for stroke prevention are required to make total endovascular repair of the aortic arch an acceptable alternative to combination and open debranching/bypass techniques.

Use of retrograde left subclavian branch portal of Gore TAG thoracic branch endoprosthesis for physician-modified fenestrated branched endovascular repair of thoracoabdominal aortic aneurysm.

A 75-year-old man who had undergone zone 2 thoracic endovascular repair of a symptomatic penetrating aortic ulcer using a Gore TAG thoracic branch endoprosthesis (TBE) device (W.L. Gore & Associates) 5 years before had presented with an enlarging extent I thoracoabdominal aortic aneurysm. A physician-modified five-vessel fenestrated-branched endograft repair was performed using preloaded wires. The visceral renal vessels were sequentially catheterized from the left brachial access via the TBE portal, and the endograft was deployed in staggered fashion. At 1 year of follow-up, imaging studies demonstrated a stable aneurysm sac, patent visceral renal branches, and no endoleak. The retrograde portal of Gore TAG TBE can facilitate fenestrated-branched endovascular repair of thoracoabdominal aortic aneurysms.

Racial and ethnic disparities in clinical trials and peripheral artery disease.

As peripheral artery disease (PAD) continues to affect many people in our population, the search continues for medical advances to improve the treatment algorithms for this debilitating disease. Prior research studies have more than adequately documented the disparity that exists in the outcomes of patients with PAD based on race and ethnicity. One of the paths to clinical improvement and removal of the disparate outcomes is through application of the studied variables in a well-constructed clinical trial. Unfortunately, the groups that are known for worse outcomes are also those with limited enrollment into clinical trials, which exacerbates the problem. This article evaluates the issue of underrepresentation of racial and ethnic minority populations in clinical trials, addresses factors contributing to the problem, and provides possible pathways to a viable solution.

Techniques of antegrade in situ laser fenestration for endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

Antegrade in situ laser fenestration allows for incorporation of visceral and renal arteries during endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. This technique can be particularly useful for urgent and emergent cases and for centers without access to manufactured fenestrated-branched endovascular aneurysm repair devices. In the present report, we have described two techniques of antegrade in situ fenestration, the common pitfalls, and the anatomic considerations for each technique.

Bilateral renal forniceal rupture due to retroperitoneal hematoma after femoral venous access.

Retroperitoneal hematoma is a potential complication of femoral venous access that rarely leads to bilateral ureteral obstruction. We present the case of a 73-year-old woman who underwent an ablation procedure for atrial fibrillation complicated by laceration of an aberrant obturator artery during femoral venous cannulation, leading to a compressive retroperitoneal hematoma, bilateral ureteral obstruction, acute renal failure, and renal forniceal rupture. The patient was successfully treated with embolization of the inferior epigastric artery and aberrant obturator artery, hematoma evacuation, and ureteral stent placement. This case illustrates a rare complication of arterial laceration during femoral venous access without ultrasound guidance.