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.

Postoperative Outcomes and One-Year Mortality of Patients on Chronic Anticoagulation Medications Undergoing Infrainguinal Bypass.

BACKGROUND: Patients requiring open infrainguinal bypass (IIB) frequently are taking chronic anticoagulation (AC) medications. Taking these medications in the preoperative setting may affect the outcomes of surgery. This study aims to evaluate postoperative outcomes and 1-year mortality of patients taking chronic AC medications that undergo IIB. METHODS: Using data obtained from the Vascular Quality Initiative from January 2011 to October 2021, patients on warfarin or any direct oral anticoagulants (DOAC) within 30 days of IIB were compared with patients not taking chronic AC medications. The primary outcomes were in-hospital, 30-day, and 1-year mortality. The secondary outcomes included total procedure time, need for perioperative packed red blood cell transfusion, prolonged length of hospital stay, postoperative myocardial infarction or stroke, and graft patency at discharge. A subgroup analysis was performed comparing patients taking warfarin with those taking DOACs. Univariate analyses and multivariate logistic regression, Kaplan Meier survival, and Cox regression analyses were used to analyze the data for postoperative and 1-year outcomes, respectively. RESULTS: A total of 55,076 patients underwent IIB during the study period, and 11,547 (20.97%) were on chronic AC prior to surgery. The 2 cohorts differed significantly in almost every demographic and clinical characteristic. Multivariate analyses adjusting for 45 potential confounders revealed that there was no significant difference in in-hospital, 30-day, and 1-year mortality. The total procedure time for the chronic AC cohort was on average 11.46 ± 2.16 min longer (P ≤ 0.001) and there was a greater risk of prolonged length of stay in the hospital (adjusted odds ratio [aOR]: 1.19, 95% confidence interval [CI]: 1.13-1.26, P < 0.001). These patients also returned to the operating room (OR) at a greater rate (aOR: 1.12, 95% CI: 1.05-1.19; P = 0.016) and demonstrated a significantly lower rate of graft patency at discharge (aOR: 0.73, 95% CI: 0.62-0.86, P = 0.001). On subgroup analysis, multivariate analysis demonstrated lower 30-day mortality for the DOAC group in comparison to the warfarin group (aOR: 0.74, 95% CI: 0.57-0.94, P = 0.015), but no significant differences in in-hospital and 1-year mortality. CONCLUSIONS: Patients taking AC medications within 30 days prior to IIBs may require more perioperative red blood cell transfusions, longer hospitalizations, and return to the OR at a greater rate. They are also at an increased risk for loss of graft patency at discharge. However, these patients are not at increased risk of in-hospital, 30-day, or 1-year mortality. IIB can, therefore, be performed safely in patients taking chronic AC medications.

Initial experience with a modified "candy-plug" technique for false lumen embolization in chronic type B aortic dissection.

Background: Persistent distal false lumen (FL) perfusion after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) can lead to aneurysmal degeneration and an increased risk of rupture. We have presented our initial experience using a modified "candy-plug" (CP) technique for FL embolization. Methods: From February 2021 to July 2022, we treated six patients using the modified CP technique. All the patients had undergone prior or simultaneous TEVAR for chronic TBAD with persistent FL perfusion and aneurysm expansion. Bilateral common femoral artery access was obtained, and intravascular ultrasound was used to confirm wire access in the true lumen (TL) and FL. A conformable TAG device (W.L. Gore & Associates, Flagstaff, AZ) was used in four cases and an Excluder aortic cuff (W.L. Gore & Associates) in two cases. The device was modified by placing a constraining "napkin-ring" suture through the middle segment of the device. Femoral sheaths were placed in the TL and FL. A standard TL TEVAR extension was performed at the level of the celiac artery (zone 5). Next, the CP device was advanced and deployed in the FL, distally aligning it with the TL device. An appropriately sized Amplatzer II plug (Abbot Vascular, Santa Clara, CA) was then deployed in the constrained segment of the modified stent graft. Completion angiography was performed to confirm successful FL embolization. Results: Technical success was defined as successful deployment of the CP device in the FL. The technical success rate was 100% (six of six patients). Clinical success was defined as the cessation of aneurysm growth on follow-up computed tomography angiography. No 30-day mortality, myocardial infarction, stroke, spinal cord ischemia, access site complications, or aortic-related reinterventions occurred. Surveillance imaging at a mean follow-up of 10 months confirmed clinical success (stable aneurysm size or shrinkage) for all five patients with follow-up data available. Conclusions: The modified CP embolization technique is a promising solution for persistent distal FL perfusion after TEVAR for TBAD. Further investigation is required to determine the long-term durability of this technique as an adjunct to TEVAR to promote aortic remodeling.

Interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease.

Endovascular treatment of peripheral arterial disease has emerged as a minimally-invasive alternative to surgical intervention and has often become the first-line therapy. The patency of these interventions has shown promise but has remained variable depending upon the location, length of lesion and device used for a particular treatment. Specifically, one of the most common locations that is treated with endovascular means for chronic-limb threatening ischemia is the femoropopliteal region. This area of the arterial tree is highly exposed to movements such as flexion, extension, and rotational torque; as such, placing metallic stents can result in kinking and damage to the stent, and subsequently the artery, over time. Stent characteristics are defined according to the metal property that composes them. Nitinol has been experimented with for use in the arterial tree since the 1980s namely because of its uniquely elastic mechanical properties, which were ideal for sustaining its shape within an anatomic area prone to positional variability. More recently, nitinol stents were introduced in an interwoven fashion, the design of which creates a scaffold of structure for the elastic property of the metal to remain reinforced within highly flexible arteries. This review article discusses the available literature and evidence behind the use of these interwoven nitinol stents in lower extremity peripheral arterial interventions.

Perioperative and long-term outcomes after open conversion of endovascular aneurysm repair versus primary open aortic repair.

BACKGROUND: The use of endovascular abdominal aortic aneurysm repair (EVAR) has superseded that of open aneurysm repair (OAR) as the procedure of choice for abdominal aortic aneurysm repair. However, significant rates of late reintervention and aneurysm rupture have been reported after EVAR, resulting in the need for conversion to OAR (C-OAR). To assess the relative effects of C-OAR on patients, we compared the outcomes of these patients to those of patients who had undergone P-OAR. METHODS: The data from all patients who had undergone C-OAR and P-OAR in the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database from 2003 to 2018 were queried. Multivariable logistic regression and Kaplan-Meier survival and Cox proportional hazard regression analyses were used to assess the perioperative long-term outcomes. RESULTS: A total of 4763 patients were included (91.4%, P-OAR; 8.6%, C-OAR). C-OAR was associated with a significant increase in the odds of perioperative mortality (odds ratio, 1.7; 95% confidence interval [CI], 1.1-2.7; P = .027) and renal complications (odds ratio, 1.5; 95% CI, 1.1-2; P = .004) vs P-OAR. At 5 years, conversion was associated with a higher risk of mortality (hazard ratio [HR], 1.5; 95% CI, 1.3-1.9; P < .001), aneurysmal rupture (HR, 1.9; 95% CI, 1.2-3.1; P = .007), and reintervention (HR, 1.4; 95% CI, 1.05-1.97; P = .022) compared with P-OAR. These results also persisted at 10 years, with conversion associated with a higher risk of mortality (HR, 1.5; 95% CI, 1.2-1.8; P < .001), rupture (HR, 1.8; 95% CI, 1.1-2.8; P = .018), and reintervention (HR, 1.5; 95% CI, 1.1-2.1; P = .010). CONCLUSIONS: The results from the present study have demonstrated that C-OAR is associated with a significantly higher risk of perioperative morbidity and mortality compared with P-OAR. We found a significant increase in mortality, aneurysm rupture, and reintervention at 5 and 10 years of follow-up.

Arterial spin labeling magnetic resonance imaging quantifies tissue perfusion around foot ulcers.

Objective: Tools that quantify tissue perfusion of the foot are deficient, contributing to the uncertainty in predicting ulcer healing potential. This pilot study aims to quantify peri-wound foot perfusion at various tissue depths using a novel application of pseudo-continuous arterial spin labeling magnetic resonance imaging. Methods: Ten diabetic patients with neuropathic wounds and 20 healthy volunteers without wounds were recruited. Wounds were graded according to the Wound, Ischemia, Foot Infection (WIfI) system. All subjects underwent a noncontrasted ASL MRI of the foot for perfusion measurements. For healthy volunteers, perfusion was compared at rest and during sustained toe flexion between four regions: lateral plantar, medial plantar, lateral calcaneal, and medial calcaneal. Evaluations of diabetic volunteers compared perfusion between four zones: wound, near border, far border, and remote. Remote zone perfusion in diabetics was compared with perfusion in the plantar foot of healthy volunteers. Results: There were 11 wounds, which were located over the metatarsal heads in five, the stump of a transmetatarsal amputation in three, the heel in two, and the mid foot in one. The median WIfI stage was 2. One patient had a WIfI ischemia grade of 1; the remaining patients' grades were 0. The mean ankle-brachial index was 1.0 ± 0.3. There were two patients with a WIfI foot infection grade of 1; the remaining patients' grades were 0. In healthy volunteers, plantar foot perfusion with sustained toe flexion was 43.9 ± 1.7 mL/100g/min and significantly higher than perfusion at rest (27.3 ± 2.7 mL/100g/min; P < .001). In diabetic patients, perfusion at the wound, near border, far border, and remote regions was 96.1 ± 10.7, 92.7 ± 9.4, 73.4 ± 8.2, and 62.8 ± 2.7 mL/100g/min. Although this perfusion pattern persisted throughout the depth of the wound, perfusion decreased with tissue depth. In the near border, perfusion at 20% of the wound depth was 124.0 ± 35.6 mL/100g/min and 69.9 ± 10.1 mL/100g/min at 100% (P = .006). Lastly, remote perfusion in diabetics was 2.3 times the plantar perfusion in healthy volunteers (27.3 ± 2.7 mL/100g/min; P < .001). Conclusions: The pattern of resting tissue perfusion around nonischemic diabetic foot ulcers was successfully quantified with arterial spin labeling magnetic resonance imaging. Diabetic patients with wounds were hyperemic compared with healthy volunteers. There was a 1.5-fold increase in peri-wound tissue perfusion relative to the rest of the foot. This study is the first step in developing a tool to assess the perfusion deficit in ischemic wounds.

Contemporary management and outcomes of peripheral venous aneurysms: A multi-institutional study.

OBJECTIVE: Extremity venous aneurysms result in the risk of pulmonary embolism (PE) and chronic venous insufficiency. At present, owing to the rarity of these aneurysms, no consensus for their treatment has been established. The purpose of the present study was to review the presentation, natural history, and contemporary management of extremity venous aneurysms. METHODS: We performed a retrospective, multi-institutional review of all patients with extremity venous aneurysms treated from 2008 to 2018. A venous aneurysm was defined as saccular or fusiform with an aneurysm/vein ratio of >1.5. RESULTS: A total of 66 extremity aneurysms from 11 institutions were analyzed, 40 of which were in a popliteal location, 14 iliofemoral, and 12 in an upper extremity or a jugular location. The median follow-up was 27 months (range, 0-120 months). Of the 40 popliteal venous aneurysms, 8 (20%) had presented with deep vein thrombosis (DVT) or PE, 13 (33%) had presented with pain, and 19 had been discovered incidentally. The mean size of the popliteal venous aneurysms presenting with DVT or PE was larger than that of those presenting without thromboembolism (3.8 cm vs 2.5 cm; P = .003). Saccular aneurysm morphology in the lower extremity was associated with thromboembolism (30% vs 9%; P = .046) and fusiform aneurysm morphology with a thrombus burden >25% (45% vs 3%). Patients presenting with thromboembolism were more likely to have had a thrombus burden >25% in their lower extremity venous aneurysm compared with those who had presented without thromboembolism (70% vs 9%). Approximately half of all the patients underwent immediate intervention, and half were managed with observation or antithrombotic regimen. In the non-operative cohort, three patients subsequently developed a DVT. Eight patients in the medically managed cohort went on to require surgical intervention. Of the 12 upper extremity venous aneurysms, none had presented with DVT or PE, and only 2 (17%) had presented with pain. Of the 66 patients in the entire cohort, 41 underwent surgical intervention. The most common indication was the absolute aneurysm size. Nine patients had undergone surgery because of a DVT or PE, and 11 for pain or extremity swelling. The most common surgery was aneurysmorrhaphy in 21 patients (53%), followed by excision and ligation in 14 patients (35%). Five patients (12%) had undergone interposition bypass grafting. A postoperative hematoma requiring reintervention was the most common complication, occurring in three popliteal vein repairs and one iliofemoral vein repair. None of the patients, treated either surgically or medically, had reported post-thrombotic complications during the follow-up period. CONCLUSIONS: Large lower extremity venous aneurysms and saccular aneurysms with thrombus >25% of the lumen are more likely to present with thromboembolic complications. Surgical intervention for lower extremity venous aneurysms is indicated to reduce the risk of venous thromboembolism (VTE) and the need for continued anticoagulation. Popliteal aneurysms >2.5 cm and all iliofemoral aneurysms should be considered for repair. Upper extremity aneurysms do not have a significant risk of VTE and warrant treatment primarily for symptoms other than VTE.

Midterm Results of the Supera Stent for the Treatment of Femoropopliteal Occlusive Disease.

BACKGROUND: The Supera (Abbott Vascular, Santa Clara, CA) stent is an interwoven nitinol, shape-memory stent with high strength and flexibility characteristics which are purported to increase resistance to kinking and compression. The purpose of this study was to review single-center outcomes of the use of this stent in the femoropopliteal segment. METHODS: We performed a single-center, retrospective analysis of patients who underwent Supera stent placement for femoropopliteal occlusive disease from 2016-2019. Data was collected on patient demographics and procedural details. Follow-up imaging data, including duplex imaging and ankle-brachial indices, and clinical data were abstracted from encounter notes. RESULTS: Sixty-two patients with 72 unique Supera stent placements were identified. Mean age was 76 and 69% were male. 56% of patients had severe calcification and 11% had moderate calcification. 48% of lesions were Trans-Atlantic Inter-Society Consensus Document C or D lesions. Primary patency rates at 12, 24, and 36 months were 85%, 82%, and 75%, respectively. Primary patency was not affected significantly by lesion length, degree of calcification, number of outflow vessels, concomitant interventions, or stent size. CONCLUSIONS: These results demonstrate sustained primary patency with the Supera stent over a 3-year interval in treatment of patients with femoropopliteal occlusive disease, including in the setting of severely calcified vessels.

Preoperative thrombolysis is associated with improved vein patency and functional outcomes after first rib resection in acute Paget-Schroetter syndrome.

INTRODUCTION: Most patients with acute Paget-Schroetter syndrome (PSS) present in one of two manners: (1) thrombosis managed initially with thrombolysis and anticoagulation and then referred for surgery, and (2) initial treatment with anticoagulation only and later referral for surgery. Definitive benefits of thrombolysis in the acute period (the first 2 weeks after thrombosis) over anticoagulation alone have not been well reported. Our goal was to compare patients managed with early thrombolysis and anticoagulation followed by first rib resection (FRR) and later postoperative venography with venoplasty (PTA) with those managed with anticoagulation alone followed by FRR and PTA using vein patency assessed with venography and standardized outcome measures. METHODS: We reviewed a prospectively collected database from 2000 to 2019. Two groups were compared: those managed with early thrombolysis at our institution (Lysis) and those managed with anticoagulation alone (NoLysis). All patients underwent FRR. Venography was routinely performed before and after FRR. Standardized outcome measures included Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores and Somatic Pain Scale. RESULTS: A total of 50 Lysis and 50 NoLysis patients were identified. Pre-FRR venography showed that thrombolysis resulted in patency of 98% of veins, whereas 78% of NoLysis veins were patent. After FRR, postoperative venography revealed that 46 (92%) patients in the Lysis group and 37 (74%) patients in the NoLysis group achieved vein patency. Thrombolysis was significantly associated with final vein patency (odds ratio: 17 [4-199]; P < .001). Lysis patients had a trend toward lower QuickDASH scores from pre-FRR to post-FRR compared with NoLysis patients with a mean difference of -16.4 (±19.7) vs -5.2 (±15.6) points (P = .13). The difference in reduction of Somatic Pain Scale scores was not statistically significant. CONCLUSIONS: Thrombolysis as initial management of PSS, combined with anticoagulation, followed by FFR and VenoPTA resulted in improved final vein patency and may lead to an improved functional outcome measured with QuickDASH scores. Therefore, clinical protocols using thrombolysis as initial management should be considered when planning the optimal treatment strategy for patients with acute PSS.

Embolic Protection Devices are Not Associated with Improved Outcomes of Atherectomy for Lower Extremity Revascularization.

BACKGROUND: Atherectomy is associated with a risk of distal embolization, but the role of embolic protection devices (EPDs) during atherectomy is not well-defined. This study examines the utilization and impact of EPD on the outcomes of atherectomy during peripheral vascular interventions (PVIs). METHODS: The annual trend in utilization of EPD during atherectomy in the Vascular Quality Initiative PVI files (2010-2018) was derived. Patients with concomitant open surgery, acute limb ischemia, emergent-status, concomitant thrombolysis, missing indication, missing EPD use, and missing long-term follow-up data were excluded. The characteristics of patients undergoing atherectomy with and without EPD were compared. Propensity matching based on age, gender, race, chronic obstructive pulmonary disease, coronary artery disease, end-stage renal disease, prior PVI, indication, urgent-status, TransAtlantic interSociety Consensus classification, and anatomical location of lesion was performed. The perioperative and 1-year outcomes of the matched groups were compared. RESULTS: EPD was used in 23.3% of atherectomy procedures (n = 5,013/21,500). The utilization of EPD with atherectomy increased from 8.8% to 22.7% (P = 0.003) during the study period. Patients undergoing atherectomy without EPD were more likely to have ESRD (7.8% vs. 5.2%; P < 0.001), tissue loss (31% vs. 23.1; P < 0.001), tibial intervention (39.6% vs. 23.3%; P < 0.001), higher number of arteries treated (1.78 ± 0.92 vs. 1.68 ± 0.93; P = 0.001), and longer length of lesion (21.15 ± 21.14 vs. 19 ± 20.27 cm; P = 0.004). Conversely, patients undergoing atherectomy with EPD were more likely to be White (81.1% vs. 74%; P < 0.001), have a history of smoking (80.6% vs. 74.5%; P < 0.001), chronic obstructive pulmonary disease (24.8% vs. 21.6%; P < 0.037), coronary artery disease (38.5% vs. 33.2%; P = 0.002), prior percutaneous coronary intervention (24.3% vs. 19.9%, P = 0.005), prior coronary artery bypass grafting (32.3% vs. 24.9%; P < 0.001), and prior PVI (49.2% vs. 45.1%; P = 0.023). After propensity matching, there were 1,007 patients in each group with no significant difference in baseline characteristics. There was no significant difference in short-term outcomes including the rate of distal embolization, technical success, dissection, perforation, discharge to home, and 30-day mortality. The use of EPD was, however, associated with longer fluoroscopy time. At 1-year, there was also no difference in primary patency, ipsilateral minor or major amputation, ankle brachial index improvement, reintervention, or mortality rate between patients who underwent atherectomy with and without EPD. CONCLUSIONS: EPD has been increasingly used in conjunction with atherectomy especially in patients with claudication and femoropopliteal disease. However, the use of EPD during atherectomy does not seem to impact the outcomes. Further research is needed to justify the additional cost and fluoroscopy time associated with the use of EPD during atherectomy.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.

Trainee Experience in Simulation-Based Education of Open Vascular Surgery.

BACKGROUND: Simulation continues to be an important adjunct to vascular surgery training, yet the optimal implementation of simulation to complement conventional surgical training continues to evolve. This study aims to find areas for improvement in current simulation-based training of open vascular skills by characterizing the experience of vascular trainees attending a national simulation-based course. METHOD: This was a survey study conducted at the simulation course of the Annual UCLA/SVS Symposium: A Comprehensive Review and Update of What's New in Vascular and Endovascular Surgery, a national vascular surgery meeting. The survey consisted of 17 questions and was administered on paper or electronically via the Audience Response System, before the start of the course. The survey assessed the participants' experience in formal training, simulation training, and comfort with open surgical procedures. RESULTS: Between 2013 and 2018, the survey was completed by 150 participants of which 65% were vascular fellows. Only 48% of the participants had formal training in suturing and surgical instruments. Most participants had formal training in basic vascular techniques and advanced vascular operations. In 71%, simulation was incorporated into basic technique training and 60% in open surgical training. Simulation training was most commonly utilized in learning anastomotic techniques and open abdominal aortic aneurysm repair. Simulation skills were deemed translatable to the operating room by 59% of participants. Most participants were comfortable performing open vascular procedures. However, 68% of participants were uncomfortable performing an abdominal aortic aneurysm repair. CONCLUSIONS: There continues to be a significant portion of trainees who do not undergo a simulation-based education. Current simulation training is being targeted to meet trainee needs in open vascular surgery, specifically open aneurysm repair. Nonetheless, trainees continue to have doubts regarding applicability of simulation-based skills to the operating theater. Further studies investigating access to simulation education as well as its translatability are needed.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

OBJECTIVE: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF. METHODS: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed. RESULTS: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality. CONCLUSIONS: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population.

Adjunctive techniques to minimize thrombotic complications following microfoam sclerotherapy of saphenous trunks and tributaries.

OBJECTIVE: Thrombus extension into the deep venous system following superficial vein chemical ablation with Varithena polidocanol microfoam has been reported. The objective of this study was to assess the effect of intraoperative improved techniques during treatment for patients with symptomatic varicose veins and their impact on extension of thrombus into deep veins. METHODS: A retrospective review of a prospectively maintained database was performed. All patients who underwent endovenous chemical ablation with polidocanol microfoam (Varithena, Boston Scientific, Marlborough, Mass) for symptomatic superficial axial and tributary vein reflux were identified. Patients had postoperative duplex (48-72 hours) scanning after the procedure; those who did not adhere to the recommended follow-up were excluded. Demographic data, CEAP Classification, Venous Clinical Severity Score, procedure details, and follow-up data were abstracted. RESULTS: Between April 2018 and August 2020, 157 limbs in 122 patients were treated with Varithena microfoam; 129 limbs in 99 patients met our inclusion criteria. Veins treated included the great saphenous vein (n = 89), anterior accessory saphenous vein (n = 15), small saphenous vein (n = 14), and tributary veins (n = 56). Adjunctive techniques during treatment included intraoperative elevation of the limb to greater than 45°, ultrasound mapping and digital occlusion of large perforator veins, limitation of foam volume per session, injection of sterile saline before treatment, and compression of the limb in the elevated position. The preoperative Venous Clinical Severity Score was 11.4 and decreased after treatment to 9.7. The immediate closure rate was 95% with 81% overall symptomatic relief at last follow-up. The mean follow-up was 113.5 days for the entire cohort; two limbs (1.5%) required postoperative anticoagulation for thrombus extension into the deep venous system (common femoral vein n = 1; popliteal vein n = 1) postoperatively for a mean of 22 days. Both resolved with anticoagulation. One asymptomatic limb developed a femoral vein deep venous thrombosis and one symptomatic late deep venous thrombosis was noted 4 months after the procedure. Postoperative pain and phlebitis were reported in 15.6% and 14.8% of patients, respectively, and all had resolved at last follow-up. No pulmonary emboli were noted and no neurologic or visual adverse events were recorded. CONCLUSIONS: Adjunctive techniques during microfoam ablation decreased thrombotic complications in our series compared with those reported in earlier phase III clinical trials. Excellent early closure and symptomatic improvement were also noted. Endovenous microfoam ablation with Varithena is a safe and effective nontumescent, nonthermal alternative to laser and radiofrequency ablation.

Nationwide comparison of the medical complexity of patients by surgical specialty.

OBJECTIVE: Intuitively, the chronic disease burden of surgical patients varies considerably by surgical specialty, although sparse evidence in the literature supports this notion. We sought to characterize the medical complexity of surgical patients by surgical specialty and to quantify the association between medical complexity and outcomes. METHODS: The National Inpatient Sample, an all-payer inpatient database representative of 97% of all U.S. hospitalizations, was used to identify adults undergoing surgery between 2005 and 2014. The most commonly performed operations that constituted 80% of each surgical specialty's practice were abstracted. The previously validated Elixhauser Comorbidity Index (ECI) was calculated per year by surgical specialty as a measure of medical complexity. Outcomes and resource utilization were assessed by comparing mortality rate, length of stay, and cost. RESULTS: An estimated 53,232,144 patients underwent operations in one of nine surgical specialty categories. Surgical specialties were ranked by ECI, with cardiac surgery (3.56), vascular surgery (3.49), and thoracic surgery (2.86) having the highest mean ECI (all P values <.0001 compared with vascular surgery). Whereas the high ECI scores in cardiac surgery were driven by arrhythmias and hypertension, vascular patients had a more uniform distribution of comorbidities. The average ECI for all surgical patients increased during the study period from 2.03 in 2005 to 2.65 in 2014 (P < .001), with a similar trend for all specialties considered. Unlike the two specialties with the lowest burden of comorbidities (orthopedic surgery and endocrine surgery), cardiac surgery and vascular surgery exhibited significantly higher inpatient mortality, LOS, and costs. CONCLUSIONS: Although all surgical patients have exhibited an increase in comorbidities during the past decade, candidates for cardiac and vascular operations appear to carry the largest burden of chronic conditions. Despite caring for patients with the highest burden of comorbidities for emergent operations, vascular surgery did not have the highest mortality, inpatient costs, or length of stay compared with some of the other specialties. The intensity of care and assumed risk in treating medically complex vascular patients should be taken into consideration in deciding health policy, reimbursement, and hospital resource allocation.

Managing central venous access during a health care crisis.

OBJECTIVE: During the COVID-19 pandemic, central venous access line teams were implemented at many hospitals throughout the world to provide access for critically ill patients. The objective of this study was to describe the structure, practice patterns, and outcomes of these vascular access teams during the COVID-19 pandemic. METHODS: We conducted a cross-sectional, self-reported study of central venous access line teams in hospitals afflicted with the COVID-19 pandemic. To participate in the study, hospitals were required to meet one of the following criteria: development of a formal plan for a central venous access line team during the pandemic; implementation of a central venous access line team during the pandemic; placement of central venous access by a designated practice group during the pandemic as part of routine clinical practice; or management of an iatrogenic complication related to central venous access in a patient with COVID-19. RESULTS: Participants from 60 hospitals in 13 countries contributed data to the study. Central venous line teams were most commonly composed of vascular surgery and general surgery attending physicians and trainees. Twenty sites had 2657 lines placed by their central venous access line team or designated practice group. During that time, there were 11 (0.4%) iatrogenic complications associated with central venous access procedures performed by the line team or group at those 20 sites. Triple lumen catheters, Cordis (Santa Clara, Calif) catheters, and nontunneled hemodialysis catheters were the most common types of central venous lines placed by the teams. Eight (14%) sites reported experience in placing central venous lines in prone, ventilated patients with COVID-19. A dedicated line cart was used by 35 (59%) of the hospitals. Less than 50% (24 [41%]) of the participating sites reported managing thrombosed central lines in COVID-19 patients. Twenty-three of the sites managed 48 iatrogenic complications in patients with COVID-19 (including complications caused by providers outside of the line team or designated practice group). CONCLUSIONS: Implementation of a dedicated central venous access line team during a pandemic or other health care crisis is a way by which physicians trained in central venous access can contribute their expertise to a stressed health care system. A line team composed of physicians with vascular skill sets provides relief to resource-constrained intensive care unit, ward, and emergency medicine teams with a low rate of iatrogenic complications relative to historical reports. We recommend that a plan for central venous access line team implementation be in place for future health care crises.

Aortoesophageal fistula treated with staged aortic stent graft and subsequent homograft interposition.

Aortoesophageal fistula (AEF) is a rare complication of esophageal interventions. We present a 49-year-old woman who underwent Roux-en-Y gastric bypass with a recurrent gastrojejunal anastomotic leak requiring covered esophageal stent placement. She presented 1 month later with abdominal pain, leukocytosis, and hematemesis. A computed tomography scan demonstrated migration of the esophageal stent with aortic erosion concerning for AEF. She underwent emergent endovascular exclusion of an AEF to the descending thoracic aorta with subsequent esophageal resection and diversion and aortic endograft explant, resection, and homograft repair on postoperative day 6 allowing for staged removal of prosthetic material and maintenance of inline flow.

Investigating uncommon vascular diseases using the Vascular Low Frequency Disease Consortium.

BACKGROUND: Standardized databases such as the Vascular Quality Initiative and National Surgical Quality Improvement Project assess the quality of care related to common vascular surgery procedures, but are not designed for uncommon vascular diseases. We describe a method of assessing uncommon vascular diseases using a multi-institutional collaboration, the Vascular Low Frequency Disease Consortium (VLFDC). METHODS: Uncommon vascular diseases are identified through a systematic literature review. A disease-specific database is developed and tested at a single institution, then refined and circulated to participating VLFDC investigators. Detailed inclusion and exclusion criteria and data point definitions are provided, allowing for standardized data collection across institutions. Each participating institution identifies all patients over a specific time period and enters the data into a VLFDC-provided database. The data are then de-identified and transmitted to our centralized data center for analysis. RESULTS: Since 2003, the VLFDC has conducted and published nine studies and enrolled 4532 patients, involving 232 institutions and 271 investigators. The studies include renal artery aneurysms, isolated femoral artery aneurysms, spontaneous mesenteric dissection, adventitial cystic disease, carotid body tumors, and vascular Ehlers-Danlos syndrome. Each published study reported on a minimum of 10 times the number of patients collected in previously published studies over the same time period, allowing stronger conclusions to be drawn from the larger sample size. Each study both confirmed previous management principles, which were based on small single-institution experiences, and challenged conventional management paradigms. CONCLUSIONS: When only small clinical series exist to provide guidance in managing uncommon vascular diseases, and/or where conflicting recommendations are made on the treatment of uncommon vascular diseases, a multi-institutional consortium can provide high-volume standardized data that either confirm or changes prior management principles.