Percutaneous thrombectomy for acute limb ischemia is associated with equivalent limb and mortality outcomes compared with open thrombectomy.

BACKGROUND: Acute limb ischemia (ALI) carries a 15% to 20% risk of combined death or amputation at 30 days and 50% to 60% at 1 year. Percutaneous mechanical thrombectomy (PT) is an emerging minimally invasive alternative to open thrombectomy (OT). However, ALI thrombectomy cases are omitted from most quality databases, limiting comparisons of limb and survival outcomes between PT and OT. Therefore, our aim was to compare in-hospital outcomes between PT and OT using the National Inpatient Sample. METHODS: We analyzed survey-weighted National Inpatient Sample data (2015-2020) to include emergent admissions of aged adults (50+ years) with a primary diagnosis of lower extremity ALI undergoing index procedures within 2 days of hospitalization. We excluded hospitalizations with concurrent trauma or dissection diagnoses and index procedures using catheter-directed thrombolysis. Our primary outcome was composite in-hospital major amputation or death. Secondary outcomes included in-hospital major amputation, death, in-hospital reintervention (including angioplasty/stent, thrombolysis, PT, OT, or bypass), and extended length of stay (eLOS; defined as LOS >75th percentile). Adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) were generated by multivariable logistic regression, adjusting for demographics, frailty (Risk Analysis Index), secondary diagnoses including atrial fibrillation and peripheral artery disease, hospital characteristics, and index procedure data including the anatomic thrombectomy level and fasciotomy. A priori subgroup analyses were performed using interaction terms. RESULTS: We included 23,795 survey-weighted ALI hospitalizations (mean age: 72.2 years, 50.4% female, 79.2% White, and 22.3% frail), with 7335 (30.8%) undergoing PT. Hospitalization characteristics for PT vs OT differed by atrial fibrillation (28.7% vs 36.5%, P < .0001), frequency of intervention at the femoropopliteal level (86.2% vs 88.8%, P = .009), and fasciotomy (4.8% vs 6.9%, P = .006). In total, 2530 (10.6%) underwent major amputation or died. Unadjusted (10.1% vs 10.9%, P = .43) and adjusted (aOR = 0.96 [95% CI, 0.77-1.20], P = .74) risk did not differ between the groups. PT was associated with increased odds of reintervention (aOR = 2.10 [95% CI, 1.72-2.56], P < .0001) when compared with OT, but this was not seen in the tibial subgroup (aOR = 1.31 [95% CI, 0.86-2.01], P = .21, Pinteraction < .0001). Further, 79.1% of PT hospitalizations undergoing reintervention were salvaged with endovascular therapy. Lastly, PT was associated with significantly decreased odds of eLOS (aOR = 0.80 [95% CI, 0.69-0.94], P = .005). CONCLUSIONS: PT was associated with comparable in-hospital limb salvage and mortality rates compared with OT. Despite an increased risk of reintervention, most PT reinterventions avoided open surgery, and PT was associated with a decreased risk of eLOS. Thus, PT may be an appropriate alternative to OT in appropriately selected patients.

Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials.

BACKGROUND: Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. METHODS: RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30 months after the completion date, the date the final participant was examined, allowing time for publication. RESULTS: Of 108 RCT (n = 37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR = 0.18, (95% CI 0.05-0.71), P = 0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. CONCLUSIONS: Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.

Left internal mammary artery access for embolization of the left subclavian artery in a patient with type II endoleak after thoracic endovascular aortic repair for a ruptured right-sided aortic arch aneurysm.

A 65-year-old woman had presented with a ruptured type B intramural hematoma associated with a right-sided aortic arch aneurysm, a large Kommerell diverticulum (KD) and an aberrant left subclavian artery (LSA). She underwent total aortic arch replacement with elephant trunk, thoracic endovascular aortic repair, and LSA ligation distal to the left vertebral artery. She subsequently developed a brisk type II endoleak into the KD via retrograde flow from the left vertebral artery. Percutaneous access of the left internal mammary artery with coil embolization of the proximal LSA and KD was performed. At 5 years, computed tomography angiogram showed complete thoracic aortic remodeling without an endoleak. The results from the present case have illustrated the novel use of the left internal mammary artery as an alternative access for LSA embolization in patients with type II endoleak and limited access options.

Impact of thoracic endovascular aortic repair timing on aortic remodeling in acute type B aortic intramural hematoma.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) is increasingly utilized in the management of acute type B aortic intramural hematoma (TBIMH). Optimal timing for intervention has not been described. The aim of this study was to evaluate TEVAR timing on postoperative aortic remodeling. METHODS: A retrospective chart review was performed on patients who underwent TEVAR for TBIMH from January 2008 to September 2018. Imaging was reviewed pre- and postoperatively. Primary data points included true lumen diameter (TLD) and total aortic diameter (TAD) at the site of maximal pathology. Primary endpoint was aortic remodeling evidenced by a TAD/TLD ratio closest to 1.0. Secondary outcome was occurrence of aortic-related adverse events and mortality (AREM): aortic rupture, aortic-related death, progression to dissection, or need for aortic reintervention within 12 months. Patients undergoing emergent TEVAR (within 24 hours, 'eTEVAR') were compared with the remainder - delayed TEVAR ('dTEVAR'). RESULTS: We analyzed 71 patients that underwent TEVAR for TBIMH; 25 underwent emergent TEVAR and 46 patients underwent dTEVAR (median, 5.5 days; range, 2-120 days). There were no differences in demographics and comorbidities, and patients did not differ in presenting IMH thickness (12.6 ± 3.1 vs 11.3 ± 4.1 mm; P = .186) nor presenting TAD/TLD ratio (1.535 ± 0.471 vs 1.525 ± 0.397; P = .928) for eTEVAR and dTEVAR groups, respectively. eTEVAR patients had larger average presenting maximal descending aortic diameter (45.8 ± 14.3 vs 38.2 ± 7.5 mm; P = .018) and higher incidence of penetrating aortic ulcer on presenting computed tomography angiography (52.0% vs 21.7%; P = .033). Thirty-day mortality was 2 of 25 (8.0%) for eTEVAR and 2 of 45 (4.4%) for dTEVAR (P = .602). Postoperative aortic remodeling was more complete in the dTEVAR group (1.23 ± 0.12 vs 1.33 ± 0.15; P = .004). Case-control matching (controlling for presenting descending aortic diameter and penetrating aortic ulcer) on 30 patients still showed better aortic remodeling in the dTEVAR group (1.125 ± 0.100 vs 1.348 ± 0.42; P < .001). The incidence of AREM was higher in the eTEVAR (6/25; 24.0%) group compared with the dTEVAR group (2/46; 4.3%). At 12 months, freedom from AREM was higher in the dTEVAR group (95.7% vs 76.0%; P = .011). Postoperative TAD/TLD ratio was the best predictor for late aortic-related adverse events (area under the receiver operator characteristic = 0.825; P = .003). CONCLUSIONS: TEVAR for acute TBIMH within 24 hours of admission is associated with lower aortic remodeling and higher occurrence of late AREM. Delaying TEVAR when clinically possible could improve aortic remodeling and aortic-related outcomes.

A more proximal landing zone is preferred for thoracic endovascular repair of acute type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has become first-line therapy for complicated acute type B aortic dissection (aTBAD). However, the strategy for optimal proximal landing zone remains to be determined. We compared early outcomes and late aortic-related adverse events in patients undergoing TEVAR for complicated aTBAD with endograft deployment in proximal landing zone 2 vs 3. METHODS: We performed a retrospective chart review of adult patients undergoing TEVAR for complicated aTBAD within 6 weeks of diagnosis from January 2008 to December 2018. We excluded patients with connective tissue disorders and prior type A repair. Patients were divided into landing zone 2 TEVAR (Z2T) and zone 3 TEVAR (Z3T) groups. Z2 patients were divided between left subclavian artery (LSA) revascularization (Z2R) vs LSA coverage without revascularization (Z2C). Groups were compared for the need for aortic reintervention within 36 months of initial admission and freedom from aortic-related adverse events and mortality (AREM), defined as the need for aortic reintervention, aortic-related death, or rupture. RESULTS: Eighty-three patients underwent TEVAR for complicated aTBAD within a mean of 4.1 ± 7.8 days; 89.5% of patients had less than 2 cm of healthy proximal descending thoracic aorta. The landing zone was Z3T in 35 patients and 48 underwent Z2T: 10 Z2C and 38 Z2R. There were no differences between Z2T and Z3T in time from diagnosis to TEVAR, demographics, comorbidities, and diameter aortic measurements. The 30-day survival was 87.8%-89.5% for Z2R, 88.6% for Z3, and 80.0% for Z2C (P = .610). The postoperative spinal cord ischemia rate was 3.7%-2.7% for Z2R, 0% for Z3T, and 20.0% for Z2C (P = .012). The postoperative thoracic aortic rupture was 2.2% in Z2 and 0 in Z3. The need for aortic reintervention at 36 months after TEVAR was lower for Z2T (10.4%) vs Z3T (31.4%; P = .025). Freedom from AREM at 36 months was higher in Z2T vs Z3T (87.5% vs 68.6%; P = .048). The freedom from proximal reintervention was higher in Z2T (95.8%) compared with Z3T (80.0%; P = .019). Z3T deployment was predictive for AREM (odd ratio, 3.648; 95% confidence interval, 1.161-11.465; P = .027) and need for proximal reintervention (odds ratio, 5.542; 95% confidence interval, 1.062-28.927; P = .042). CONCLUSIONS: Most patients with aTBAD have less than 2 cm of proximal healthy descending thoracic aorta. In patients treated for complicated aTBAD, Z2T is associated with a lower need for aortic reintervention and aortic-related adverse events than Z3T. Patients may benefit from a more aggressive proximal landing zone with similar perioperative morbidity when Z2T is done with LSA revascularization.

Percutaneous Closure of Iatrogenic Ascending Aortic Pseudoaneurysms Following Surgical Aortic Repair.

We present a case series of 4 iatrogenic ascending aortic pseudoaneurysms that were all successfully repaired with a percutaneous approach. Pre-procedural imaging, device selection, and procedural techniques are described. With careful preparation and patient selection, catheter closure of iatrogenic ascending aortic pseudoaneurysms can be performed reliably and safely. (Level of Difficulty: Advanced.).

A novel approach to high-grade carotid stenosis with concomitant extracranial carotid aneurysms using transcarotid artery revascularization.

We present the novel application of transcarotid artery revascularization (TCAR) in two high-risk patients with high-grade internal artery stenosis and concomitant atherosclerotic extracranial carotid artery aneurysms (ECAAs). ECAAs account for <1% of arterial aneurysms and are usually clinically silent at presentation. Historically, the treatment of ECAAs has been via open reconstruction or stent grafting. TCAR is an effective alternative for carotid revascularization in high-risk patients with high-grade carotid stenosis, but has not been widely used for aneurysmal management. We report two cases to describe our management of concomitant carotid stenoses and ECCA with TCAR.

Distal Revascularization and Interval Ligation for the Management of Dialysis Access Steal Syndrome.

BACKGROUND: Treatment options for dialysis access steal syndrome (DASS) include distal revascularization with interval ligation (DRIL), proximalization of arterial inflow (PAI), access banding, and access ligation. This study examines the efficacy of DRIL in treating DASS and reports short-term bypass patency, access patency, and wound infection rates. METHODS: A retrospective analysis was performed on adults diagnosed with DASS following hemo-dialysis access creation who underwent DRIL procedures between January 1, 2009 and May 11, 2017. Patients <18 years and those with lower extremity accesses or HeRO grafts that developed DASS were excluded. Data was obtained using electronic medical records and analyzed using SPSS software. Residual steal was defined as reintervention for DASS within 60 days of DRIL. Recurrent steal was defined as reintervention beyond 60 days. RESULTS: Eighty-nine DRIL procedures were performed for correction of DASS. Population included 59.6% female (n = 53), 47.2% current/former smokers (n = 42), 76.4% diabetic (n = 68), and 79.8% AVF (n = 71). Symptom resolution was complete for 69.7% (n = 62), and partial for 25.8% (n = 23), with no improvement in 4.5% (n = 4). Following DRIL, mean DBI improved from 0.43 to 0.67 (P= 0.002). Mean steal classification improved from 3.04 to 0.64 (P< 0.001). Five patients required a subsequent procedure for DASS symptoms - 3 for residual steal and 2 for recurrent steal. Bypass patency at 6 months post DRIL was 93.3% (n = 83) primary, 97.8% (n = 87) primary-assisted, and 100% (n = 89) secondary patency. Access patency at 6 months post DRIL was 78.7% (n = 70) primary, 91% (n = 81) primary-assisted, and 94.4% (n = 84) secondary. Twenty-one patients (23.5%) had 24 cases of surgical site infections, with 70.8% (n = 17) occurring at the saphenectomy site. Wound infections re-solved within 60 days postoperatively in 23 out of 24 patients. CONCLUSIONS: DRIL is highly effective in relieving symptoms of DASS and has excellent rates of short-term access and bypass patency. However, consideration must be given to the high wound infection rate and the potential need for subsequent procedures.

Optimal In Situ Fenestration Technique With Laser Perforation and Balloon Dilation for Aortic Stent-Grafts.

PURPOSE: To evaluate the response of various stent-grafts after laser fenestration and dilation with noncompliant balloons to determine the optimal therapeutic combination for this treatment technique. MATERIALS AND METHODS: Five aortic stent-grafts were evaluated ex vivo: the Bolton RelayPlus, Jotec E-vita Thoracic 3G, Medtronic Valiant, Cook Zenith Alpha, and Vascutek Anaconda. Small holes were created using an excimer laser with the grafts submerged in saline. Five rows of 5 fenestrations were created, 4 holes in each row were dilated once with a 6-, 8-, 10-, or 12-mm-diameter noncompliant balloon to the specified nominal pressure (one hole served as the control). The saline solution from each stent-graft was collected and qualitatively analyzed for debris. The fenestrations were evaluated under light and scanning electron microscopes. The maximum diameter and area for each fenestration were measured. The direction and length of tears were assessed. RESULTS: The fenestration was feasible and reproducible in all the stent-grafts. The mean area of fenestration ranged from 7.63±1.63 to 14.75±0.73 mm2 when using balloons of 6- and 8-mm diameter, respectively. The 10- and 12-mm-diameter balloons caused a significant increase in area, variability, and tearing. The Anaconda graft tended to tear in the weft direction, while the other devices tore in the warp direction when using the 10- and 12-mm-diameter balloons. Dilation of the RelayPlus and Anaconda grafts with 6- and 8-mm-diameter balloons provided minimal tearing and precise fenestrations. Melted fiber remnants were observed after filtration of the saline solution for all devices. CONCLUSION: Laser fenestration and dilation with noncompliant balloons is a relatively simple and reproducible option for revascularization in urgent, complex aortic endovascular repairs. In our model, large balloons (ie, >10 mm) increased the destruction and tearing of the fabric. The maximum dilation recommended is 6 to 8 mm to avoid significant tears. Development of stent-grafts or novel fabrics designed explicitly for fenestration is needed to reduce potential complications.

Postoperative complications affect long-term outcomes after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for colorectal peritoneal carcinomatosis.

BACKGROUND AND OBJECTIVES: Morbidity after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) for colorectal peritoneal carcinomatosis (PC) may negatively affect survival. The objective was to determine the impact of postoperative complications (CX) on survival in patients undergoing CRS + HIPEC for colorectal PC. METHODS: All patients undergoing laparotomy for planned CRS + HIPEC for colorectal PC at a single institution from 1999 to 2014 were included. Patients were divided into three groups: CRS + HIPEC without CX (+HIPEC-CX); CRS + HIPEC with postoperative complication (+HIPEC + CX); and aborted CRS and HIPEC due to unresectable disease (-HIPEC). Postoperative morbidity were defined as Clavien II+ complications. Kaplan-Meier survival analyses and multivariable Cox proportional hazard modeling were used to describe the disease-free (DFS) and overall survival (OS). RESULTS: One hundred and twenty-two patients were included in the analysis (50 +HIPEC - CX, 40 +HIPEC + CX, 32-HIPEC). Overall complication rate was 42%. OS at 1-, 3-, and 5-years in patients undergoing successful CRS + HIPEC were 97%, 67%, and 45%. CX after successful CRS + HIPEC was independently associated with worsened OS (HR1.58, 95%CI, 1.19-1.97) but not DFS (HR1.11, 95%CI, 0.56-2.20). PCI also independently predicted worsened DFS (HR1.12, 95%CI, 1.06-1.18) and OS (HR1.08, 95%CI, 1.04-1.12). Patients with unresectable disease had significantly worse OS (HR6.50, 95%CI, 1.37-7.01). CONCLUSIONS: CX after CRS + HIPEC significantly affect OS. Patient selection and perioperative care are of paramount importance in the management of CRS + HIPEC for colorectal PC.