Prosthetic outcomes after amputation and the impact of mobility level on survival.

OBJECTIVE: Lower extremity amputation continues to be necessary in a significant number of patients with peripheral vascular disease. The 5-year survival following lower limb loss is markedly reduced. Many of these patients are never fitted with a prosthesis, and there is a dearth of knowledge regarding the barriers to prosthetic attainment. The goal of this study was to identify the risk factors for not receiving a prosthesis and the effect of mobility level on survival following major amputation. METHODS: This was a retrospective analysis of all patients that underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to December 31, 2019. Abstracted data included: age, sex, race, body mass index, comorbidities, American Society of Anesthesiologists score, statin use, level of amputation, stump revision, fitting for prosthesis, type of prosthesis, and the United States' Medicare Functional Classification Level, also called K level. Survival was determined using a combination of sources, including the Social Security Death Master File, searches of multiple genealogic registries, and general internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis attainment. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: A total of 464 patients were included in this study. The mean age was 65 years, and mean body mass index was 27 kg/m2. The majority of patients were male (68%), White (56%), diabetic (62%), and hypertensive (76%), and underwent below-the-knee amputation (69%). Prosthetic attainment occurred in 185 (40%). On multivariable analysis, age >81 years and current tobacco use were associated with no prosthetic fitting. Overall 5-year survival was 41.9% (95% confidence interval [CI], 37.6%-46.6%) (below-the-knee amputation, 47.7% [95% CI, 42.5%-53.5%]; above-the-knee amputation, 28.7% [95% CI, 22.1%-37.2%]). On multivariable analysis, age >60 years, congestive heart failure, above-the-knee amputation, and no prosthetic attainment were associated with decreased survival. Increasing K level was incrementally associated with improved survival. CONCLUSIONS: This study has identified several patient factors associated with prosthetic attainment, as well as multiple factors predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. The Medicare Functional Classification Level K level predicts survival. More research is needed to determine the barriers to prosthetic attainment and if improving a patients K level will improve survival.

Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. METHODS: From August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. RESULTS: The 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. CONCLUSIONS: Data herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.

Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD). METHODS: From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years. RESULTS: We identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years. CONCLUSIONS: Results at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

Multi-center experience with intravascular lithotripsy for treatment of severe calcification during transcarotid artery revascularization for high-risk patients.

OBJECTIVE: 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/transient ischemic attack [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 (27%) had eccentric and circumferential calcification. Mean procedure and flow reversal times were 87 ± 27 minutes 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 electroencephalogram 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 postoperative neurologic event was 93% (vs 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 days). 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, although 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.

Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair.

BACKGROUND: Left subclavian artery (LSA) revascularization has been recommended for patients undergoing elective thoracic endovascular aortic repair (TEVAR) with a proximal zone 2 landing requiring coverage of the LSA. The clinical standard of care remains surgical LSA revascularization. However, recently, the feasibility of using branched endografts has been demonstrated. We compared the perioperative and mid-term outcomes of these approaches. METHODS: We performed a retrospective review of consecutive patients who underwent TEVAR with a proximal zone 2 landing at a single center from 2014 to 2020. The patients were divided into cohorts for comparison: those who underwent surgical revascularization (SR-TEVAR group) and those who underwent thoracic branched endografting with an investigational device (TBE group). Those patients who did not undergo LSA revascularization were excluded. Perioperative outcomes, including procedural success, death, stroke, limb ischemia, and length of stay, were compared. Kaplan-Meier survival curves were compared using the log-rank test. The cumulative incidence of device-related endoleak (types I and III) and device-related reintervention, accounting for death as a competing hazard, were compared using the Fine-Gray test. RESULTS: A total of 55 patients were included: 31 (56%) in the SR-TEVAR group and 24 (44%) in the TBE group. The preoperative demographics and comorbidities were similar between the two groups. Procedural success was 100% in both cohorts, with no periprocedural strokes or left upper extremity ischemic events. One operative or 30-day death (TBE, 4.2%; vs SR-TEVAR, 3.2%; P = .99) occurred in each cohort. The total operative time (TBE, 203 ± 79 minutes; vs SR-TEVAR, 250 ± 79 minutes; P = .03) and total length of stay (TBE, 5.2 ± 3.6 days; vs SR-TEVAR, 9.9 ± 7.2 minutes; P = .004) were both significantly shorter in the TBE group. No difference was found in mid-term survival (log-rank test, P = .50) nor the cumulative incidence of device-related endoleak (Fine-Gray test, P = .51) or reintervention (Fine-Gray test, P = .72). No occlusions of the TBE graft or surgical bypass or transpositions had occurred after a mean follow-up of 28 ± 16 and 34 ± 24 months, respectively. CONCLUSIONS: TBE can be performed with procedural success rate and safety profile comparable to those of TEVAR with surgical revascularization, with a decreased total length of stay, for patients requiring proximal zone 2 coverage. The mid-term outcomes for each approach were also similar. Prospective, randomized comparisons of these techniques are warranted.

Machine learning analysis of multispectral imaging and clinical risk factors to predict amputation wound healing.

OBJECTIVE: Prediction of amputation wound healing is challenging due to the multifactorial nature of critical limb ischemia and lack of objective assessment tools. Up to one-third of amputations require revision to a more proximal level within 1 year. We tested a novel wound imaging system to predict amputation wound healing at initial evaluation. METHODS: Patients planned to undergo amputation due to critical limb ischemia were prospectively enrolled. Clinicians evaluated the patients in traditional fashion, and all clinical decisions for amputation level were determined by the clinician's judgement. Multispectral images of the lower extremity were obtained preoperatively using a novel wound imaging system. Clinicians were blinded to the machine analysis. A standardized wound healing assessment was performed on postoperative day 30 by physical exam to determine whether the amputation site achieved complete healing. If operative revision or higher level of amputation was required, this was undertaken based solely upon the provider's clinical judgement. A machine learning algorithm combining the multispectral imaging data with patient clinical risk factors was trained and tested using cross-validation to measure the wound imaging system's accuracy of predicting amputation wound healing. RESULTS: A total of 22 patients undergoing 25 amputations (10 toe, five transmetatarsal, eight below-knee, and two above-knee amputations) were enrolled. Eleven amputations (44%) were non-healing after 30 days. The machine learning algorithm had 91% sensitivity and 86% specificity for prediction of non-healing amputation sites (area under curve, 0.89). CONCLUSIONS: This pilot study suggests that a machine learning algorithm combining multispectral wound imaging with patient clinical risk factors may improve prediction of amputation wound healing and therefore decrease the need for reoperation and incidence of delayed healing. We propose that this, in turn, may offer significant cost savings to the patient and health system in addition to decreasing length of stay for patients.

Drug-Coated Balloon Angioplasty for Carotid Artery In-Stent Restenosis: Case Series.

OBJECTIVES: Few case reports have demonstrated promising results of drug-coated balloons (DCBs) as an emerging management for carotid artery in-stent restenosis (CAISR). Herein, we report 6 cases of CAISR which were treated with a DCB with or without new stent deployment. BACKGROUND: Carotid artery in-stent restenosis is a high-risk condition with an estimated incidence rate that varies widely from 6% to 40%. Several strategies are available now for the management of the CAISR including conventional balloon angioplasty, plaque modification balloon angioplasty, and new stent placement. METHODS: A retrospective review of consecutive patients with a diagnosis of severe CAISR at Baylor Scott & White The Heart Hospital Plano from 2011 to 2021 was performed. This study was approved by the Baylor Scott & White Research Institute institutional review board. RESULTS: Six patients underwent DCB angioplasty with or without stent placement under an embolic protection device. Resolution of CAISR was achieved in all cases with 0% to 10% residual stenosis in all cases. Following the procedure, 1 patient had a brief episode of syncope with balloon inflation with immediate recovery on deflation of the balloon. There were otherwise no significant neurological or cardiac events prior to discharge. All patients were asymptomatic at their follow-up visit with no neurological or cardiac events reported at 12, 24, and 36 months following the procedure. CONCLUSION: While CAISR treatment remains a challenging condition, our study shows that the use of DCB with or without stent placement is a feasible and promising treatment option when compared with other conventional treatment options. CLINICAL IMPACT: Carotid artery in-stent restenosis treatment remains a challenging condition. Our study shows that the use of drug coated balloon with or without stent placement is a feasible and promising treatment option when compared with current conventional treatment options.

Differences in Mid-Term Outcomes Between Patients Undergoing Thoracic Endovascular Aortic Repair for Aneurysm or Acute Aortic Syndromes: Report From the Global Registry for Endovascular Aortic Treatment.

PURPOSE: To analyze differences in baseline characteristics, overall mortality, device-related mortality, and re-intervention rates in patients who underwent thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) with atherosclerotic/degenerative cause or acute aortic syndrome (AAS), using the Global Registry For Endovascular Aortic Treatment (GREAT). MATERIALS AND METHODS: Patients submitted to TEVAR for AAS or DTAA, included in GREAT, were eligible for this analysis. Primary outcome was 30-day all-cause mortality rate. Secondary outcomes were 30-day aorta-related mortality and re-intervention rate, 1-year and 3-year all-cause mortality, aorta-related mortality and re-intervention rate. RESULTS: Five-hundred and seventy-five patients were analyzed (305 DTAA and 270 AAS). Thirty-day mortality rate was 1.3% and 1.8% for DTAA and AAS, respectively (p=0.741). One-year and 3-year mortality rates were 6.2% versus 9.3 and 17.3% versus 15.9% for DTAA and AAS, respectively (p=0.209 and p=0.655, respectively). Aorta-related mortality rates at 30 days, 1 year and 3 years were 1.3%, 1.3%, and 2.6% for DTAA, 1.8%, 4.2%, and 4.2% for AAS (p=ns). Re-intervention rates at 30 days, 1 year, and 3 years were 1.3%, 4.3%, and 7.5% for DTAA, 3.3%, 8.1%, and 10.7% for AAS (p=ns). Furthermore, a specific analysis with similar outcomes was performed dividing follow-up in 3 periods (1-30 days, 31-365 days, 366-1096 days) and describing mutual differences between 2 groups and temporal trends in each group. CONCLUSION: Patients who underwent TEVAR for DTAA or AAS experienced different mortality and re-intervention rates among years during mid-term follow-up. Although all-cause related deaths within 30 days were TEVAR-related, aorta-related deaths were more common for AAS patients within 1 year. A greater re-intervention rate was described for AAS patients, although only 1 year after TEVAR.

Sex, age, and other barriers for prosthetic referral following amputation and the impact on survival.

BACKGROUND: Despite advances in peripheral vascular disease treatment, lower extremity amputation continues to be necessary in a significant number of patients. Up to 80% of amputees are not referred for prosthetic fitting. The factors contributing to referral decisions have not been adequately investigated, nor has the impact of prosthetic referral on survival. We characterized differences between patients who were successfully referred to our in-house prosthetists and those who were not, and identified factors associated with prosthetic referral and predictive of survival. METHODS: This was a retrospective analysis of all patients who underwent lower extremity amputation by surgeons in our practice from January 1, 2010, to June 30, 2017. Data regarding age, sex, race, body mass index (BMI), diabetes, hypertension, hyperlipidemia, end-stage renal disease, prior coronary artery bypass graft surgery, congestive heart failure, tobacco use, American Society of Anesthesiologists (ASA) score, previous arterial procedure, chronic obstructive pulmonary disease, statin use, postoperative ambulatory status, level of amputation, stump revision, and referral for prosthesis were collected. Survival was determined from a combination of sources, including the Social Security Death Master Index, multiple genealogic registries, and internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis referral. Multivariable Cox proportional hazard regression with time-dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: There were 293 patients included in this study. Mean age was 66 years, and mean BMI 27 kg/m2. The majority of patients were male (69%), white (53%), with diabetes (65.4%) and hypertension (77.5%), and underwent below-the-knee amputation (BKA) (73%). Prosthetic referral occurred in 123 (42.0%). Overall 5-year survival was 61.7% (95% confidence interval [CI], 55.9%-68.1%) (BKA 64.7% [95% CI, 57.9%-72.3%]; above-the-knee amputation 53.8% [95% CI, 43.4%-66.6%]). On multivariate analysis, age >70 years, female sex, diabetes, ASA score 4 or 5, and current tobacco use were associated with no referral for prosthetic fitting. Patients with BMI 25 to 30, a previous arterial procedure, BKA, and history of stump revision were more likely to be referred. Factors associated with decreased survival were increasing age, higher ASA class, black race, and BMI; prosthetic referral was seen to be protective. CONCLUSIONS: We identified multiple patient factors associated with prosthetic referral, as well as several characteristics predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. Further research is needed to determine whether the factors identified as associated with nonreferral are markers for patient characteristics that make them clinically unsuitable for prosthetic fitting or if they are symptoms of unconscious bias or of the patient's access to care.

Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the GREAT Registry.

BACKGROUND: Arterial access and device delivery in endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have evolved from open femoral or iliac artery exposure to selective percutaneous arterial access. Although regional application of percutaneous access for these 2 procedures varies widely, the use of this technique continues to increase. Currently, differences in the use of percutaneous access between EVAR and TEVAR have not been well explored. The Gore Global Registry for Endovascular Aortic Treatment (GREAT) registry collected relevant data for evaluation of these issues and the comparative results between open and percutaneous approaches in regard to complication rates and length of stay (LOS). METHODS: This study was performed via a retrospective review of patients from the GREAT registry (Clinicaltrials.gov no. NCT01658787). The primary variable of this study was access site complications including postoperative hematoma, vessel dissection, and pseudoaneurysm. Patients were categorized by abdominal (EVAR) and thoracic (TEVAR) aortic procedures using percutaneous-only, cutdown-only, and combined vascular access techniques for a total of 6 groups. Standard statistical methodology was used to perform single-variable and multivariable analysis of a variety of covariates including LOS, geographical location of procedure, procedural success rate, and access sheath size. RESULTS: Of 4,781 patients from the GREAT registry, 3,837 (80.3%) underwent EVAR and 944 (19.7%) underwent TEVAR with percutaneous-only access techniques being used in 2,017 (42.2%) and cutdown-only in 2,446 (51.2%). There was variable application of percutaneous access by geographic region with Australia and New Zealand using this technique more frequently and Brazil using percutaneous access the least. No significant difference in the rate of access site complications was detected between the 6 groups of patients in the study; however, significantly lower rates of access site complications were associated with percutaneous-only compared with both cutdown-only and combined techniques (P = 0.03). In addition, associated with significantly higher rates of access site complications was longer LOS (P < 0.01). Average LOS was 5.2 days and was higher in the TEVAR group (10.1 days) than that in EVAR (4.0 days, P < 0.05). Increased sheath size does not appear to increase the risk of access site complication. CONCLUSIONS: There was no significant difference found in the complication rate between percutaneous and cutdown access techniques. This analysis demonstrates that percutaneous-only access is safe, has low complication rates, and has lower LOS compared with open access or combined access techniques.

Outcomes from the Gore Global Registry for Endovascular Aortic Treatment in patients undergoing thoracic endovascular aortic repair for type B dissection.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective multicenter registry collecting real-world data on the performance of W. L. Gore (Flagstaff, Ariz) aortic endografts. The purpose of the present study was to analyze the implementation and outcomes of thoracic endovascular aortic repair (TEVAR) in GREAT patients with type B aortic dissection (TBAD). METHODS: From 2010 to 2016, >5000 patients were enrolled in the GREAT from 113 centers in 14 countries across 4 continents. The study population comprised those treated for TBAD. The primary outcomes of interest were mortality and freedom from aortic events (AEs). RESULTS: A total of 264 patients (80% male; mean age, 62 years) underwent TEVAR for the treatment of 170 (64%) acute and 94 (36%) chronic cases of TBAD. Chronic TBAD patients required significantly longer endograft coverage than did acute TBAD patients (P = .05). Early postoperative complications occurred in 9% of patients, with no difference in chronic vs acute dissection (P = .11). The 30-day aortic mortality and all-cause mortality were 1.5% and 2.3%, respectively, with no differences based on chronicity. During a mean follow-up of 26 months, the total aortic mortality was 2.7% and the total all-cause mortality was 12.5%. The all-cause mortality was significantly greater for chronic vs acute TBAD (19.2% vs 8.8%, respectively; P = .02). On multivariate analysis, patients with acute uncomplicated dissections had significantly improved overall survival compared with all other categories of dissections (93% vs 83% at 2 years; P < .05). A proximal landing zone diameter >40 mm was associated with an increased risk of retrograde type A dissection (18% vs 2%; P = .02). Patients undergoing left subclavian artery (LSA) coverage experienced a twofold greater rate of AEs compared with noncoverage patients (P < .01). Patients who underwent LSA revascularization experienced a 1.5-fold greater rate of AEs compared with patients covered without revascularization (P = .04). CONCLUSIONS: TEVAR for TBAD using the conformable GORE TAG thoracic endoprosthesis device can be performed with a low incidence of aortic mortality and complications. Acute uncomplicated TBAD patients had a significantly lower mortality rate than that of other patients. Larger proximal landing zones were associated with more frequent retrograde type A dissection. LSA involvement (coverage and/or revascularization) was associated with an increased risk of AEs during follow-up.

Case Report: An Innovative Endovascular Technique for Repair of Descending Thoracic Aortic Aneurysm following an Open Coarctation Repair.

It was once postulated that open surgical repair of coarctation of the aorta during childhood patients was cured. However, long-term follow-up has been significant for late problems such as an aneurysm. The incidence of such aneurysm after open surgical coarctation repair is 11-24%. If such an aneurysm is left untreated, patients are at a high risk of morbidity and mortality. Prior to the endovascular era, patients would require a redo open repair which in itself is a highly morbid operation. Currently, thoracic endovascular aortic repair (TEVAR) has been reported as a feasible and safe alternative to open surgical reprocedures in this context. However, TEVAR might be challenging due to the proximity of the pathology to supraaortic vessels and the ongoing presence of the coarctation. We are reporting a unique case of a 48-year-old male undergoing TEVAR due to aortic aneurysm after previous surgical coarctation treatment and successful closure of the coarctation with a vascular plug device.

Limited Clinical Relevance of Vertebral Artery Injury in Blunt Trauma.

BACKGROUND: Blunt cerebrovascular injury (BCVI), although rare, is more common than previously thought and carries a substantial stroke and mortality risk. The purpose of our study was to evaluate the differences between blunt carotid artery (CA) and vertebral artery (VA) injuries, assess the stroke and death rates related to these injuries, and identify the relationship of Injury Severity Score (ISS) with stroke and mortality in BCVI. METHODS: Using a retrospective review of the trauma registry at a level I trauma center, we identified patients with BCVI. The study period began in January 2003 and ended in July 2014. Demographics, injuries reported, investigative studies performed, and outcomes data were obtained and analyzed. Radiographic images of both blunt CA and VA injuries were reviewed and graded by an independent radiologist, according to the current classification of blunt CA injuries. RESULTS: BCVI involving 114 vessels was identified in 103 patients. This population consisted of 65 males and 38 females with an average age of 45 years (15-92, range). The average ISS was 22 (4-75, range). Cervical spine fracture occurred in 80% of VA injuries (64 total patients). Injuries involved the CA in 33, the VA in 59, and both in 11. The CA group had a higher incidence of traumatic brain injury (61% vs. 46%), ISS (27 vs. 18), and stroke (24% vs. 3%), compared to the VA group. Mortality in the CA group was 30% compared to 3% in the VA group. Patients with high ISS (≥25) had increased stroke rates compared to those with lower (<25) ISS (19% vs. 6.7%). All mortalities occurred with ISS >25. Logistic regression revealed that vessel injured, ISS, and Glasgow Coma Scale (GCS) were significant risk factors for mortality. Multivariate analysis demonstrated carotid injury, and lowest GCS were independently associated with mortality. CONCLUSIONS: In this comparison of CA and VA injuries in BCVI, VA injuries were more common and more frequently found with cervical spine fractures than CA injuries. However, VA injuries had a lower incidence of CVA and mortality. A high ISS was associated with stroke and mortality while carotid injury and lowest GCS were independently associated with increased mortality.

Managing claudication in the community setting.

Advances made in medical management and treatment options in addressing lower extremity claudication and vascular disease have skyrocketed during the last decade. Given the recent advances in treatment options, there is often the perception within the medical community and general community that to get the most "cutting edge" treatment, one must go to an academic center or practitioner. The goal of this portion of the discussion is to explore the question of what differences in treatment options there are between a community practice and an academic practice within those members of the vascular surgery specialty. Are there really any differences in the types of treatments offered or availability of the different modalities, and what drives us as practitioners to one over the other?

Case Report: A Durable Open Repair of a Rare Profunda Aneurysm.

Profunda femoris artery aneurysms (PFAAs) are rare and difficult to diagnose in the early stages of development due to location and encasement in the deep thigh musculature. We report the case of a 74-year-old male who was discovered to have a right PFAA during evaluation for progressively worsening short distance claudication. He had undergone an angioplasty of the left iliofemoral system several months ago with no improvement of his symptoms. The PFAA was diagnosed through computed tomography angiography and repaired via syndactylization of profunda femoris branches and interposition grafting with a polytetrafluoroethylene stretch graft. The imaging features are described in the article. Although PFAAs are rare clinical presentations, their development should be considered, in particular when symptoms such as progressive or unchanging claudication are present in a patient following an angioplasty of the affected iliofemoral system.

The incidence and outcome of endothermal heat-induced thrombosis after endovenous laser ablation.

BACKGROUND: Endovenous laser ablation (EVLA) of the saphenous vein has become one of the preferred treatments for treating saphenous vein reflux that has resulted in symptomatic lower extremity venous insufficiency or varicose veins. This procedure was noted during initial reports to have a low incidence of postoperative thrombosis of the femoral or popliteal vein adjacent to the treated great saphenous vein (GSV) or small saphenous vein (SSV). Later clinical experience suggested that the actual incidence of this event is higher and it was subsequently termed endothermal heat-induced thrombosis (EHIT). METHODS: We reviewed the office records and the pre- and post-treatment ultrasounds of patients undergoing EVLA in our office from 2005 to 2010 to determine the frequency of EHIT in patients we had treated and then graded them according to a previously published classification. RESULTS: There were 528 veins treated in 192 men and 336 women. The clinical, etiology, anatomy, pathophysiology (CEAP) class for these patients was 1 (0), 2 (291), 3 (65), 4 (104), 5 (26), and 6 (40), respectively. The GSV was treated in 496 patients, the SSV in 22, and both were treated in 10 patients. EHIT occurred in 29 of the legs treated for an incidence of 5.1%. The EHIT in the femoral vein were of level 3 (3), 4 (7), 5 (12), and 6 (3), respectively. Two patients developed EHIT in the popliteal vein after EVLA of the SSV. Treatment for the EHIT consisted of observation (13), anticoagulation (9), antiplatelet therapy (2), and nonsteroidal anti-inflammatory agents (1). Duration of therapy was usually 1 week, but 7 patients were treated for periods ranging from 1 to 7 weeks. No pulmonary emboli occurred in any of these patients. The EHIT resolved completely in all patients. CONCLUSIONS: EHIT after EVLA occurs frequently and mainly consists of low-risk level 3, 4, and 5 deep vein thrombosis. The risk of pulmonary embolism is low and the EHIT typically resolves after 1 week. It can be treated with a short course of antiplatelet or anticoagulation therapy, although observation appears to be sufficient as well for lesser grades of EHIT.

Clinical Outcomes of Non-Stent-Based Interventions for Symptomatic Below-the-Knee Peripheral Artery Disease in the Excellence in Peripheral Artery Disease (XLPAD) Registry.

For endovascular treatment of below-the-knee (BTK) peripheral artery disease (PAD), independently adjudicated real-world outcomes comparing non-stent-based balloon angioplasty (percutaneous transluminal angioplasty) and adjunctive treatments with or without a concomitant ipsilateral femoropopliteal (FP) artery intervention are scarce. A total of 1,060 patients from the multicenter XLPAD registry who underwent non-stent-based BTK PAD intervention between 2006 and 2021 were included. The primary outcome was the 1-year incidence of major adverse limb events (MALEs), a composite of all-cause death, any amputation, or clinically driven repeat revascularization. A total of 566 patients underwent BTK and 494 BTK + FP interventions; 72% were men, with a mean age of 68.4 ± 10.9 years. Diabetes mellitus was more prevalent in the BTK-only group (76.5% vs 69%, p = 0.006). Mean Rutherford class was 4.2 ± 1.18; chronic limb-threatening ischemia was more frequent in the BTK group (55.3% vs 49%, p = 0.040). Moderate to severe calcification was more frequent in the BTK + FP group (21.2% vs 27.1%, p = 0.024), as was lesion length (110.6 ± 77.3 vs 135.4 ± 86.3 mm, p <0.001). Nearly 81% of lesions were treated with percutaneous transluminal angioplasty. Drug-coated balloon (1.6% vs 14%, p <0.001) and atherectomy (38% vs 58.5%, p <0.001) use was more frequent in the BTK + FP group. The rate of procedural success was higher in the BTK + FP group (86% vs 91%, p = 0.009), with amputation being the most common complication at 3.3% within 30 days after the procedure. The rates of 1-year MALE (21.2% vs 22.3%, p = 0.675) and mortality (4.6% vs 3.4%, p = 0.3) were similar between the BTK and BTK + FP groups. Nonstent treatment for BTK PAD with concomitant FP intervention leads to high procedural success and similar rates of 1-year MALE compared with isolated BTK intervention. Condensed Abstract: The vast majority of below-the-knee (BTK) peripheral artery disease (PAD) interventions are performed with balloon angioplasty. Presence of inflow femoropopliteal PAD in patients who undergo BTK interventions can affect the outcome of the procedure. This report explores immediate procedural success and major adverse limb events at 1 year after balloon angioplasty treatment for isolated BTK PAD and in patients who underwent an additional femoropopliteal PAD intervention.

Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial.

PURPOSE: To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency. MATERIALS AND METHODS: In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio< 2.5. RESULTS: At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P<.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized<20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by>20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%. CONCLUSIONS: The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes.

Effect of a pulmonary embolism response team on the management and outcomes of patients with acute pulmonary embolism.

OBJECTIVE: We aimed to evaluate the effects of a multidisciplinary pulmonary embolism (PE) response team (PERT) on the management and outcomes of patients with acute PE. METHODS: We retrospectively reviewed all patients presenting to our institution with a diagnosis of PE from July 2020 to April 2022. The primary outcome measures were in-hospital mortality, major bleeding events defined by the International Society on Thrombosis and Haemostasis, and use of catheter-directed interventions (CDIs). The secondary outcome measures included 30-day and 12-month mortality, hospital and intensive care unit (ICU) lengths of stay, vasopressor requirement, and cardiac arrest. Continuous variables were assessed using the Mann-Whitney U test and categorical variables using the χ2 or Fisher exact test, as appropriate. RESULTS: A total of 279 patients with acute PE were identified, of whom 79 (28%), 173 (62%), and 27 (10%) were considered to have low risk, intermediate risk, and high risk, respectively. The PERT was activated for 133 patients (47.7%). Saddle and main pulmonary artery embolisms (P < .001), right ventricular strain (P= .001), right ventricular dysfunction (P < .001), coexisting deep vein thrombosis (P < .001), and dyspnea as a presenting symptom (P = .008) were significantly associated with PERT activation. Patients evaluated by the PERT were more likely to undergo CDI (49% vs 27%; P < .001) across all risk groups and less likely to have an inferior vena cava filter placed (1% vs 5%; P = .04). PERT consultation showed numerical, but nonstatistically significant, trends toward reduced in-hospital (2% vs 5%; P = .2) and 30-day (2% vs 8%; P = .06) mortality but similar rates of 12-month mortality (7% vs 8%; P = .7). PERT activation was also associated with a trend toward reduced rates of major bleeding (2% vs 7%), cardiac arrest (2% vs 7%), and vasopressor requirement (9% vs 18%). PERT consultations decreased the median number of ICU days by one half; however, we did not observe any differences in the total hospital length of stay between the groups. CONCLUSIONS: At our institution, PERT consultations were associated with significantly higher usage of CDIs and improved clinical outcomes, including reduced mortality and a lower rate of major bleeding events. PERT consultations were also associated with fewer ICU days, suggesting a possible economic benefit for implementing PERTs, although further research is needed to confirm that conclusion.

Extracorporeal membrane oxygenation for large pulmonary emboli.

Massive and submassive pulmonary emboli (PE) are increasingly being treated with percutaneous lytic and embolectomy procedures. While these procedures are overwhelmingly safe, patients with significant right ventricular strain are at risk for hemodynamic compromise requiring extracorporeal membrane oxygenation (ECMO). We conducted a retrospective study of all patients requiring ECMO support for PE from 2014 through 2022. The primary outcome was survival. Secondary outcomes included commonly encountered ECMO complications. From 2014 to 2022, 10 patients with submassive or massive PE required ECMO support. All 10 patients (100%) had right ventricular strain on echocardiography, 7 (70%) had a saddle PE, and 3 (30%) had extensive bilateral PE. Six (60%) patients required cardiopulmonary resuscitation prior to ECMO cannulation, and 4 (40%) were undergoing cardiopulmonary resuscitation while being cannulated. Nine (90%) patients were placed on venoarterial ECMO through the femoral vessels, while 1 (10%) was cannulated with right atrial to pulmonary artery ECMO. The median duration of support was 4 [3-8] days. During their course, 5 patients underwent percutaneous embolectomy, 1 underwent surgical embolectomy, and 4 underwent percutaneous lytic therapy. All patients (100%) survived to ECMO decannulation, and 6 (60%) survived to discharge. With a mean follow-up of 496 days, there were no postdischarge mortalities. In conclusion, although therapy for large PE is well tolerated, a small number of patients will experience periprocedural hemodynamic collapse requiring ECMO support. ECMO for PE patients is associated with acceptable morbidity and mortality. Further investigation is warranted to better characterize which patients are likely to require ECMO support.