Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.

BACKGROUND: The Relay Thoracic Stent-Graft with Plus Delivery System (RelayPlus; Terumo Aortic, Sunrise, Fla) was designed to handle the curvature and tortuosity of the thoracic aorta. It was approved by the Food and Drug Administration in 2012; the postapproval study was stopped early because of adequate safety and efficacy data, and no difference was identified in experienced vs first-time users of RelayPlus. The purpose of this study was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers (PAUs) undergoing thoracic endovascular aortic repair (TEVAR) with RelayPlus. METHODS: This is a prospective, multicenter, nonrandomized postapproval study that required the use of novice implanters in the United States. Primary and secondary end points included device-related adverse events (deployment failure, conversion to open repair, endoleaks, migration, rupture, and mortality) and major adverse events (stroke, paraplegia/paraparesis, renal failure, respiratory failure, and myocardial infarction), respectively. Continuous and categorical covariates were reported in means or medians and percentages, respectively. Kaplan-Meier survival estimates were used to report long-term TEVAR-related mortality, all-cause mortality, and reinterventions at 3 years. RESULTS: A total of 45 patients with mean age (standard deviation [SD]) of 73.5 (±7.20) years were treated for descending thoracic fusiform aneurysm (56%) or saccular aneurysm/PAU (44%). The patients were predominantly white (80.0%) and male (68.9%). Mean (SD) proximal neck, distal neck, and lesion lengths were 38.2 (±37) mm, 42.1 (±28) mm, and 103.8 (±74) mm, respectively. Mean (SD) aneurysm, proximal neck, and distal neck diameters were 53.9 (±13) mm, 31.3 (±4) mm, and 31.7 (±6) mm, respectively. Technical success was 100%. TEVAR-related mortality at 30 days was 4.4%; two patients died postoperatively, one of shock and the second of bilateral hemispheric stroke. No patient in the study had any conversion to open repair or post-TEVAR rupture. Two patients experienced three major adverse events, which included stroke (2.2%), paraplegia (2.2%), and respiratory failure (2.2%) at 30 days. Three-year freedom from TEVAR-related mortality, all-cause mortality, and reinterventions was 95.6%, 84.0%, and 97.2%, respectively. There were two type I endoleaks at 3 years: one type IB associated with no migration or aneurysm sac increase and one type IA associated with caudal migration of proximal neck and expansion of the proximal aorta. CONCLUSIONS: The RelayPlus postapproval study reported low operative mortality and morbidity and supported use of the device as a safe and effective thoracic aortic aneurysm and PAU endovascular treatment. Early midterm follow-up showed sustained freedom from TEVAR-related mortality in real-world practice. Follow-up continues to evaluate the durability of this endograft.

Short Duration Catheter-directed Thrombolysis for Acute Pulmonary Embolism Rapidly Improves Acute Cardiac Function.

BACKGROUND: Treatment of massive and submassive pulmonary embolism (PE) has been shown to be a valuable therapeutic modality. However, a paucity of data exists, regarding length and guidelines for treatment and typically these patients are treated by other than vascular surgery specialists. The aim of this study is to evaluate the effectiveness and safety of short duration treatment of massive and submassive PE, exclusively by vascular surgeons, without routine follow-up pulmonary angiography. METHODS: Retrospective analysis of prospectively collected data at a single-institution treating massive and submassive PE with catheter-directed thrombolysis (CDT). Internal review board approval was obtained. Descriptive statistical analysis was performed from the data set. Continuous covariates were presented in mean (SD) or median (IQR) and categorical covariates as number (percentage). For continuous variables, a paired t test was used to measure results against the baseline. P value less than 0.05 was defined as statistically significant. STATA® statistical software was used for analysis. RESULTS: From January of 2013 to December of 2016, 28 consecutive patients were treated for massive and submassive PE with CDT. All patients had evidence of right heart strain on echocardiogram, as evidence by a right ventricular to left ventricular (RV/LV) diameter ratio of >0.9. Of the 28 patients, 19 (68%) had hemodynamic derangement with either systolic blood pressure (SBP) less then 90 or tachycardia (HR > 100). The mean RV/LV ratio before CDT was 1.18. After therapy, RV/LV ratio was reduced to 0.86 at 48 hr (P < 0.0001). In addition, mean right ventricular systolic pressure (RVSP) before CDT treatment was 53 mm Hg, and after treatment, RVSP was reduced to 40 mm Hg at 48-hr (P value = 0.0001). There was complete resolution of hypotension in hemodynamically unstable patients (i.e., SBP <90) after CDT. Mean HR before therapy was 102. After 24 hr of CDT, mean HR reduced to 84 (P < 0.0001). From 2013 to 2016, there was a significant decrease in mean hospital length of stay from 8 days to 4 days (P = 0.05). Mean t-PA dose used decreased, as well, from 2014 (21.7 mg) to 2016 (14.9 mg), but this was not statistically significant (P = 0.13). There was no major bleeding complications or CDT-related death in any of the patients treated during the study period. CONCLUSIONS: CDT treatment of massive and submassive PE is safe and highly efficacious at reducing right heart strain acutely. Significant hemodynamic improvement was shown in our cohort throughout the study period. Improvement in tachycardia and resolution of hypotension were seen within 24 hr of CDT. Tissue plasminogen activator dosage decreased throughout the study period as a more restrictive approach to follow-up angiography was used without adverse safety or patient outcomes.

Endovascular Treatment of Concomitant Carotid Fibromuscular Dysplasia and Atherosclerotic Disease After Failed Open Surgical Treatment.

We describe a case of concomitant fibromuscular dysplasia (FMD) and atherosclerotic internal carotid artery (ICA) disease in a symptomatic patient. Sixty-eight-year-old female presented for evaluation of a transient ischemic attack. Imaging revealed severe proximal >80% ICA stenosis with severe FMD to mid and distal ICA. Planned hybrid approach with left carotid endarterectomy (CEA) and balloon angioplasty was aborted intraoperatively due to lack of back bleeding. Open gradual rigid dilation was then performed with resumption of back bleeding. Completion angiogram revealed widely patent flow through CEA patch with no residual defects. Patient awoke from operation neurologically intact. At 6-month follow-up, carotid duplex revealed severe recurrent ICA stenosis. Endovascular intervention was performed with balloon dilation to the proximal and mid-ICA with stenting of a moderate 60% ostial common carotid stenosis. She recovered well from procedure with 3-month carotid duplex showing widely patent common carotid stent and ICA with no areas of stenosis. Informed consent has been obtained from the patient for publication of the case report and accompanying images.

Acute pancreatitis after percutaneous mechanical thrombectomy: case report and review of the literature.

PURPOSE: We describe a case of severe acute pancreatitis after percutaneous mechanical thrombectomy (PMT) and review the literature for the occurrence of this complication. MATERIALS AND METHODS: A 53-year-old man with a history of bilateral external iliac artery stent placement sought care for acute onset of lifestyle-limiting left claudication. Angiography confirmed left external iliac stent occlusion, and PMT with the AngioJet Xpeedior catheter (Possis Medical, Minneapolis MN) was performed. RESULTS: After PMT of the occluded external iliac artery, a residual in-stent stenosis required the placement of a second iliac stent. The procedure was complicated by severe acute pancreatitis. Other causes of pancreatitis were eliminated during the patient's hospital stay. A literature review revealed nine cases of acute pancreatitis after PMT. CONCLUSION: Although rare, pancreatitis can be a devastating complication of PMT. The development of pancreatitis seems to be related to the products of extensive hemolysis triggering an inflammatory process. To prevent this complication, we recommend that close attention be paid to the duration and extent of PMT, thereby avoiding extensive hemolysis and subsequent complications.

Brachial versus basilic vein dialysis fistulas: a comparison of maturation and patency rates.

OBJECTIVES: Although the performance of basilic vein transpositions for dialysis access is well established, the utility and patency rates of brachial vein transpositions are poorly characterized. The brachial vein is being used increasingly as an alternative vein for transposition in an effort to increase the percentage of autogenous fistula utilization. The purpose of this study was to review a single-center comparative experience with these fistulas. METHODS: A retrospective chart review was performed on 59 patients who received basilic and brachial vein transpositions between January 2000 and December 2006. Patient demographics, comorbidities, mortality, and morbidity were evaluated. Patency rates were calculated using Kaplan-Meier life-table analysis. RESULTS: Of 59 vein transpositions, there were 42 basilic (71%) and 17 brachial (29%). The 30-day mortality was 0%. Maturation rates were 74% for basilic vein transpositions and 47% for brachial (P = .049). The mean time to maturation was 11.9 +/- 8.8 weeks. Primary patency rates at 12 months were 50% for basilic vein transpositions vs 40% for brachial (P = .115). The mean vein size was 4.9 +/- 0.9 mm. The mean basilic vein transposition diameter of 4.9 +/- 1.0 mm and brachial vein transposition diameter of 5.0 +/- 0.8 mm were not significant (P = .39). CONCLUSIONS: Despite a higher rate of initial maturation in basilic vein transpositions, brachial and basilic vein transpositions had comparable patency rates at 12 months. These preliminary results require further follow-up and a larger cohort of patients for confirmation. Broader use of the brachial vein transposition for dialysis appears justified and can increase the overall percentage of autogenous fistula placement.

Long-term postplacement cost after endovascular aneurysm repair.

BACKGROUND: Previous studies have demonstrated that the initial hospital cost associated with endovascular aneurysm repair (EVAR) is approximately $20,000. However, the cost of long-term surveillance and secondary procedures is poorly characterized. METHODS: Between December 1998 and June 2006, 259 patients underwent EVAR for infrarenal aneurysms at a single institution. Follow-up costs were calculated using a relative value unit based hospital cost accounting system, which incorporates departmental direct and indirect costs. Institutional overhead costs were included using a conversion factor. Costs for professional services were determined by a cost-to-charge ratio, and outpatient visits were calculated with a time-based formula. Year 2006 costs were applied to prior years. To minimize costs associated with the early learning curve, the initial 50 EVAR patients between December 1995 and 1998 were excluded. Patients with <1 year follow-up were also excluded. Data are expressed as mean +/- standard error. RESULTS: The mean follow-up after EVAR for 136 patients was 34.7 +/- 1.8 months. The cumulative 5-year postplacement cost per patient was $11,351. The 27 patients (19.9%) who required secondary procedures had a 5-year cumulative cost of $31,696 compared with $3668 for 109 patients without secondary procedures (8.6-fold increase, P < .05). The 5-year cost for patients with endoleak was $26,739 compared with $5706 for those without endoleak (4.7-fold increase, P < .05). Overall, major cost components were 57.4% for secondary procedures and 32.5% for radiologic studies. CONCLUSIONS: During a 5-year period, the postplacement cost of EVAR increases the global cost by 44%. The subgroups of patients with endoleaks and those requiring secondary procedures generate a disproportionate share of postplacement costs. Efforts at minimizing cost should emphasize technical and device modifications aimed at reducing endoleaks and the need for secondary procedures.

Current management of peripheral arterial occlusive disease: a review of pharmacologic agents and other interventions.

Peripheral arterial occlusive disease (PAOD) of the lower extremities is becoming more prevalent worldwide. Nonsurgical treatment options provide the foundation for management. Lifestyle and risk factor modification should be emphasized in this patient population because of the associated adverse cardiovascular events. This includes implementation of a regular walking and smoking-cessation programs, aggressive control of hyperlipidemia, hypertension and diabetes mellitus, and treatment of hyperhomocysteinemia. Antiplatelet agents such as aspirin (acetylsalicylic acid) or clopidogrel are not specifically indicated for claudication but these drugs should be used in all patients with PAOD to prevent secondary ischemic events. Currently, cilostazol is the only US FDA approved agent that appears effective for the treatment of claudication symptoms. Several agents have been used with success outside of the US and others are still undergoing testing. Definitive recommendations cannot be made on the use of these drugs until further evaluation is completed. Ongoing research with new strategies for angiogenesis and the use of progenitor cells has yielded encouraging results, particularly for patients with critical limb ischemia and limited options. Advances in endovascular technology over the last several years have greatly enhanced the ability to diagnose and treat specific anatomic lesions that previously would have required open surgical correction. The use of percutaneous transluminal angioplasty and stents in the lower extremities has had considerable success when following specific guidelines such as those set forth by the TransAtlantic Inter-Society Consensus Working Group.

Endovascular repair of an iliac artery aneurysm in a patient with Ehlers-Danlos syndrome type IV.

Ehlers-Danlos type IV (EDS-IV) is an inherited condition most notable for its associated vascular complications. Patients are prone to aneurysm formation, arterial dissection, and spontaneous vessel rupture. Intervention for the vascular pathology of EDS-IV carries high morbidity and mortality. We describe a case of a 57-year-old man with EDS-IV and an expanding iliac aneurysm who underwent successful endovascular repair with a stent-graft. Endovascular aneurysm repair is feasible and should be considered for patients with EDS-IV.

The thoracic endograft: a minimally invasive treatment option for aortic diseases.

BACKGROUND: Thoracic endografts provide a less invasive surgical option for treatment of descending aortic pathology. We present our early thoracic endograft experience with endovascular management of aneurysms, penetrating aortic ulcers, and traumatic injuries. METHODS: Fifteen consecutive patients scheduled for endograft placement at a single institution were evaluated on an intent-to-treat basis. Retrospective record review was used to determine patient demographics, surgical indications, operative, and follow-up care. RESULTS: Fourteen of 15 patients (93.3%) had successful endograft implantation. Thirty-day survival was 100%, with a 0% rate of spinal cord ischemia. Morbidity included access complications in two patients (13.3%) and a myocardial infarction in one patient (6.7%). CONCLUSIONS: Descending thoracic aortic pathology can be treated with low morbidity and mortality using endografts, even in high-risk patients. Continued post-placement surveillance is necessary.