Long-Term Outcomes of a Japanese Prospective Multicenter Registry Using a Heparin-Bonded Expanded Polytetrafluoroethylene Graft for Above-the-Knee Femoropopliteal Bypasses.

BACKGROUND: Despite the widespread use of PROPATEN®, a bioactive heparin-bonded expanded polytetrafluoroethylene graft, in bypass surgery, there are only a few reports of long-term results. We evaluated the long-term results of PROPATEN®use for above-knee femoropopliteal bypass (AKFPB).Methods and Results: After PROPATEN®-based AKFPB, patients were prospectively registered at 20 Japanese institutions between July 2014 and October 2017 to evaluate long-term results. During the median follow-up of 76 months (interquartile range 36-88 months) for 120 limbs (in 113 patients; mean [±SD] age 72.7±8.1 years; 66.7% male; ankle-brachial index [ABI] 0.45±0.27; lesion length 26.2±5.7 cm; chronic limb-threatening ischemia in 45 limbs), there were 8 major amputations; however, clinical improvement was sustained (mean [±SD] ABI 0.87±0.23) and the Rutherford classification grade improved in 105 (87.5%) limbs at the latest follow-up. At 8 years, the primary patency, freedom from target-lesion revascularization, secondary patency, survival, and amputation-free survival, as estimated by the Kaplan-Meier method, were 66.3±4.8%, 71.5±4.4%, 86.5±3.4%, 53.1±5.0%, and 47.4±5.3%, respectively. CONCLUSIONS: This multicenter prospective registry-based analysis showed sustained excellent clinical improvement and secondary patency for up to 8 years following PROPATEN®-based AKFPB. PROPATEN®constitutes a durable and good revascularization option for complex superficial femoral artery lesions, especially when endovascular treatment is inappropriate or an adequate venous conduit is unavailable.

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery.

OBJECTIVE: We assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). METHODS: The present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. RESULTS: Of the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier-estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. CONCLUSIONS: Stent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

[Treatment Strategy for Aortic Arch Aneurysms to Minimize the Complications:Which should be Chosen, Endovascular Treatment or Open Repair?]

The technologies of endovascular treatment for aortic pathologies have progressed rapidly, and endovascular treatment for thoracic pathologies has gained widespread acceptance, and there has been a significant increase in the number of thoracic pathologies treated by thoracic endovascular aortic repair (TEVAR) over the last decade. The initial results of TEVAR such as operative mortality and morbidities have been good and acceptable. Therefore, indication of TEVAR has expanded along with the improvement of techniques and devices. However, as its mid-term and long-term results became available, complications including stroke, endoleaks and consequent aneurysm rupture have become apparent. Open repair is still the important treatment option because its results are acceptable and durable. This article provides an treatment strategy of aortic arch aneurysms to minimize the complications.

A Novel Shaggy Aorta Scoring System to Predict Embolic Complications Following Thoracic Endovascular Aneurysm Repair.

OBJECTIVE: The aim of this study was to investigate the correlation between shaggy aorta and embolic complications during thoracic endovascular aneurysm repair (TEVAR), based on a shaggy aorta scoring system. METHODS: The entire aorta was assessed based on 5 mm slice computed tomography (CT) from the sinotubular junction to the aortic bifurcation using a three dimensional workstation. One shaggy point (shaggy score) was given when the following conditions were met: 1) ulcer like thrombus, 2) maximum thrombus thickness ≥ 5 mm, and 3) mural thrombus occupies more than two thirds of the circumference of the aortic diameter on reconstructed CT of the axial statue. Subsequently, each point was added to obtain the total shaggy score. RESULTS: The outcomes of 301 patients undergoing TEVAR were evaluated. Post-operative embolic complications including stroke, acute renal failure, and distal embolisation, were identified in 21 cases (7.0%). The average shaggy score for the entire cohort was 2.4 ± 5.6 points, whereas it was 7.9 ± 7.1 in those patients with embolic complications (E group) and 2.0 ± 5.3 in those without embolic complications (N group, p = .001). There were no statistical differences in 30 day mortality (p = .70), but overall survival at two years was significantly lower in the E group (E: 58.8%, N: 93.3%, p < .001). Multivariable analysis revealed that the predictors of post-operative embolic complication were past history of cerebrovascular disease (p = .001, OR 5.90, 95% CI 2.14-16.29) and shaggy score (p < .001, OR 1.13, 95% CI 1.06-1.19). The area under the ROC curve was 0.77, and the cut off value of the shaggy score using the Youden index was 3 points (sensitivity: 71.4%, specificity: 81.4%). CONCLUSION: This shaggy score is a useful method to predict post-operative embolic complications following TEVAR. Because the risk of embolic complications was relatively high in patients with a high shaggy score, the indication for TEVAR in such patients should be considered carefully.

Midterm Results of a Japanese Prospective Multicenter Registry of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Above-the-Knee Femoropopliteal Bypass.

BACKGROUND: This study prospectively analyzed the midterm results of above-the-knee femoropopliteal bypass (AKb) using bioactive heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft in patients with femoropopliteal occlusive disease.Methods and Results:This prospective, multicenter, non-randomized study reviewed limbs undergoing AKb with HB-ePTFE graft for femoropopliteal lesion in 20 Japanese institutions between July 2014 and October 2017. Primary efficacy endpoints were primary, primary assisted, and secondary graft patency. Safety endpoints included any major adverse limb event and perioperative mortality. During the study period, 120 limbs of 113 patients (mean age, 72.7 years) underwent AKb with HB-ePTFE grafts. A total of 45 patients (37.5%) had critical limb ischemia and 17 (15.0%) were on hemodialysis (HD). Median duration of follow-up was 16 months (range, 1-36 months). Estimated 1- and 2-year primary, primary assisted, and secondary graft patency rates were 89.4% and 82.7%, 89.4% and 87.2%, and 94.7% and 92.5%, respectively. On univariate analysis of 2-year primary graft patency, having 3 run-off vessels, cuffed distal anastomoses, no coronary artery disease, and no chronic kidney disease requiring HD were significantly associated with favorable patency. CONCLUSIONS: AKb using HB-ePTFE grafts achieved favorable 2-year graft patency. AKb using HB-ePTFE grafts may therefore be an acceptable, highly effective treatment option for femoropopliteal artery lesions.

Mid-Term Results of Thoracic Endovascular Aneurysm Repair with Intentional Celiac Artery Coverage for Crawford Type I Thoracoabdominal Aortic Aneurysms with the TX2 Distal Component Endograft.

BACKGROUND: Anatomically suitable Crawford type I (C-I) thoracoabdominal aortic aneurysm (TAAA) can be treated by thoracic endovascular aneurysm repair (TEVAR) with intentional celiac artery (CA) coverage to ensure distal seal. We report on mid-term results of TEVAR with intentional CA coverage for C-I TAAA. METHODS: Between August 2010 and July 2017, we treated 16 cases of C-I TAAA by TEVAR with intentional CA coverage using the Zenith TX2 Thoracic Distal Component Endograft. The primary end point was aneurysm shrinkage. Secondary end points were technical success, aneurysm-related death (ARD), and major adverse events (MAEs) including stroke, paraplegia, visceral ischemia, endoleak, and secondary intervention. RESULTS: The preoperative mean aneurysm size was 57.7 ± 8.0 mm. The technical success rate was 100%. There was no aneurysm-related mortality; however, one patient suffered from superior mesenteric artery embolization, which required an open laparotomy. The mean observational period was 40.5 months, and aneurysm shrinkage of >5 mm was observed in 10 cases (62.5%). At 12, 36, and 60 months after the procedure, freedom from ARD was 100%, 100%, and 100%, respectively, whereas freedom from MAE including secondary intervention was 86.7%, 86.7%, and 77.0%, respectively. CONCLUSIONS: Mid-term results of TEVAR with intentional CA coverage for C-I TAAA were acceptable.

Outcomes of Chimney Thoracic Endovascular Aortic Repair for an Aortic Arch Aneurysm.

BACKGROUND: Chimney thoracic endovascular aneurysm repair (TEVAR) has advantages that include no requirements for special devices; however, problems have been identified such as gutter leaks. The aim of this study is to evaluate the short- and mid-term results of TEVAR with chimney technique including the safety, efficacy, and risk factors for occurrence of gutter endoleak in this technique. METHODS: A retrospective single-center study was conducted on 55 consecutive patients who underwent first-time chimney TEVAR for arch aneurysms in the past 7 years. This consisted of 33 cases of single-chimney (SC) TEVAR and 22 cases of double-chimney (DC) TEVAR. The outcomes of these 55 cases of SC-TEVAR and DC-TEVAR were retrospectively examined. Risk factors for endoleaks in chimney TEVAR were also examined. RESULTS: Operative mortalities of 3.0% and 4.5% were observed in SC-TEVAR and DC-TEVAR, respectively. Incidences of stroke were 12.1% in the SC-TEVAR and 4.5% in the DC-TEVAR, resulting in endoleaks in 16 patients (48.5%) in SC-TEVAR and 6 patients (27.3%) in DC-TEVAR. Only 1 of the 77 chimney grafts was occluded, with a patency rate of 98.7%. SC-TEVAR and small distance from the common carotid artery were the risk factors of type I endoleaks. Overall survival rates over a period of 1, 3, and 5 years were 82.3%, 78.0%, and 57.7%, respectively, in the SC-TEVAR group and 95.2%, 89.3%, and 76.5%, respectively, in the DC-TEVAR group. Freedom from aneurysm-related death over 1, 3, and 5 years was 82.3%, 69.0%, and 57.7%, respectively, in the SC-TEVAR group and 95.2%, 89.3%, and 89.3% in the DC-TEVAR group. Freedom from secondary intervention over 1, 3, and 5 years was 80.2%, 64.7%, and 47.2%, respectively, in the SC-TEVAR group and 95.0%, 74.0%, and 74.0%, respectively, in the DC-TEVAR group. CONCLUSIONS: The short- and mid-term results of chimney TEVAR were worse than expectation. Especially, the results of SC-TEVAR were not acceptable because of extremely high incidence of type I endoleak and high incidence of stroke.

Risk factors and treatment outcomes for stent graft infection after endovascular aortic aneurysm repair.

OBJECTIVE: We aimed to retrospectively analyze incidence, risk factors, and management of postoperative stent graft (SG) infection after endovascular aneurysm repair (EVAR). METHODS: We evaluated patients who underwent EVAR for infrarenal abdominal aortic aneurysm at our institution between July 2006 and December 2014. The primary end point was SG infection. We compared patients' demographics between the infection (group I) and noninfection (group NI) groups and reviewed management and outcomes in group I. A risk factor for SG infection was assessed by multivariable logistic regression. Patients without aortoenteric fistula (AEF) were treated with conservative therapy for SG infection. RESULTS: A total of 1202 patients underwent EVAR for infrarenal abdominal aortic aneurysm. During a mean follow-up of 43.9 ± 30.4 months, SG infection occurred in 15 cases (incidence, 3.5/1000 person-years). The median time between initial EVAR and detection of infection was 30 months (range, 14 days-86 months). Freedom from SG infection at 1 year, 3 years, and 5 years was 99.5%, 99.2%, and 98.2%, respectively. There were no differences in age, sex, comorbidities, and SG type between the groups. Coil embolization of the hypogastric artery was more frequent in group I (60% vs 31%). During follow-up before infection, type II endoleak (47% vs 24%), sac enlargement (40% vs 16%), and multiple reinterventions (13% vs 2%) were significantly higher in group I; however, after multivariate analysis, only coil embolization of the hypogastric artery (odds ratio, 3.22; 95% confidence interval, 1.12-9.24; P = .029) remained a significant predictor. Among the 15 patients, four had AEF and six bacteriologic species were detected in five patients (33%). Twelve patients (80%) were treated with conservative therapy; three underwent surgical therapy (two patients with SG resection, omentum patching, and extra-anatomic bypass with fistula closure or partial duodenectomy and one patient with graft preservation, irrigation, omentum patching, and aneurysmorrhaphy). In-hospital mortality occurred in three cases; two cases were due to sepsis after conservative therapy, and one case was due to aortic stump rupture after surgical therapy. Excluding in-hospital mortality cases, during a median follow-up of 31 (range, 2-76) months, five patients were lost because of cancer or senility. There was no aneurysm-related death or recurrence of SG infection. CONCLUSIONS: Concomitant coil embolization was a risk factor for SG infection. For patients with AEF, surgical therapy remains the first-line treatment of SG infection after EVAR; however, conservative therapy is a viable option for SG infection in patients without AEF, particularly considering patients' comorbidities and limited life expectancy.

Hybrid Surgery for Multiple Visceral Artery Aneurysms: A Case Report.

BACKGROUND: We present a case with multiple visceral artery aneurysms that were treated with a hybrid approach involving both surgical and endovascular treatment. CASE REPORT: The patient was a 48-year-old female. She was diagnosed with multiple visceral artery aneurysms including 2 splenic artery aneurysms, celiac artery aneurysm, and bilateral renal artery aneurysms during an examination for loss of appetite. With regard to 2 splenic artery aneurysms, the proximal aneurysm was treated surgically, whereas the peripheral aneurysm that was located deeply in the abdomen was treated with coil embolization. The celiac artery aneurysm located at the bifurcation of the common hepatic artery and splenic artery, an intracranial aneurysm clip was used. The left and right renal aneurysms were resected and renal arteries were reconstructed surgically. The postoperative course was uneventful. The pathological diagnosis of all aneurysms was segmental arterial mediolysis. The reconstructed vessels were patent without stenosis or recurrence at 1 year after the operation. CONCLUSIONS: Hybrid treatment involving surgical resection, endovascular coil embolization, and obliteration with clips was useful in the treatment of multiple visceral artery aneurysms.

Risk Factor Analyses of Abdominal Aortic Aneurysms Growth in Japanese Patients.

BACKGROUND: This study aimed to retrospectively demonstrate the growth rate (mm/year) of abdominal aortic aneurysm (AAA) diameters (ADs) and to analyze risk factors for AAA expansion. METHODS: We retrospectively investigated the clinical data of 319 patients with AAAs who were followed up as outpatients for >2 years after their initial visit and who underwent computed tomography >4 times. RESULTS: The mean follow-up period was 3.7 ± 1.5 years. The annual average growth rates according to varying ADs were as follows: 1.9 ± 0.8 (AD 30-34 mm), 2.6 ± 1.2 (AD 35-39 mm), 2.8 ± 1.1 (AD 40-44 mm), 3.1 ± 1.3 (AD 45-49 mm), 3.4 ± 1.6 (AD 50-54 mm), and 3.5 ± 1.4 mm (AD ≥55 mm). Factors associated with AAA expansion were smoking (P = 0.017), hypertension (P < 0.001), and ADs (P < 0.001). In the subgroup analysis, data regarding growth rates of ≥3 mm were extracted, and a statistically significant difference between smoking status and ADs of ≥40 mm was observed. CONCLUSIONS: Factors associated with AAA expansion in Japanese patients included smoking, hypertension, and ADs, and a statistically significant difference was observed between smoking status and ADs of ≥40 mm.

[Initial Clinical Experience of the Herbal Medicine Inchinkoto for Refractory Hyperbilirubinemia Following Open-heart Surgery].

We retrospectively assessed our initial clinical experience of the herbal medicine Inchinkoto for refractory hyperbilirubinemia following open-heart surgery. Six patients developed hyperbilirubinemia in an acute phase after surgery and their maximum total bilirubin levels were 6.4~26.4 mg/dl( mean:13.1± 8.2 mg/dl). They were initially treated with ursodeoxycholic acid and/or Stronger Neo-Minophagen C containing monoammonium glycyrrhizinate, glycine, aminoacetic acid, and L-cysteine hydrochloride hydrate. These treatments, however, were ineffective, and Inchinkoto was introduced at 5~34 day (mean:13.3±11.3 days) after surgery. Hyperbilirubinemia improved in all patients after the introduction of Inchinkoto:1 day after in 1 case, 2 days after in 2 cases, 3 days after in 2 cases, and 4 days after in 1 case. These results indicate the potential of Inchinkoto to attenuate refractory hyperbilirubinemia following cardiac surgery with cardiopulmonary bypass.

Outcomes of mini-incision eversion carotid endarterectomy combined with nontouch isolation technique of the internal carotid artery.

OBJECTIVE: We developed a mini-incision eversion carotid endarterectomy (CEA) procedure (the Jikei method CEA) to prevent perioperative embolic stroke. The aim of this study was to retrospectively analyze perioperative and midterm outcomes after the Jikei method CEA. METHODS: We evaluated patients with the Jikei method CEA at our institution between January 2006 and June 2014. The primary end point was a major adverse event, which included death, stroke, intracranial hemorrhage, and myocardial infarction, within 30 days of CEA. Secondary end points were postoperative ipsilateral stroke and restenosis. RESULTS: We retrospectively studied 120 lesions in 110 patients. The mean age was 72.2 ± 8.0 years. With regard to the 120 lesions, 56 lesions (46.7%) were symptomatic and 73 lesions (60.8%) showed ≥90% severe stenosis. The mean length of the skin incision was 3.2 ± 0.5 cm. The mean operative time, volume of blood loss, and internal carotid artery clamp time were 171.0 ± 50.7 minutes, 161.6 ± 110.8 mL, and 35.7 ± 10.8 minutes, respectively. There were three perioperative major adverse events (2.5%), including two strokes (1.7%) and one intracranial hemorrhage (0.8%) resulting from hyperperfusion syndrome. The median postoperative hospital stay was 6 days (range, 2-303 days). The mean follow-up was 3.9 ± 2.2 years. There was no case of ipsilateral stroke during the follow-up period. The freedom from ipsilateral stroke at 5 years was 98.3%. Three lesions (2.5%) developed restenosis. The freedom from restenosis was 97.2% at 5 years. The freedom from reintervention at 5 years was 99.0% because carotid artery stent placement was necessary in one patient with severe restenosis. CONCLUSIONS: The Jikei method CEA was safe and effective in preventing perioperative and midterm stroke.

Result of Thoracic Endovascular Aortic Repair for Patients with Esophageal Cancer.

BACKGROUND: Bleeding from the thoracic aorta is potentially fatal in patients with advanced esophageal cancer. Thoracic endovascular aortic repair (TEVAR) was recently applied for aortic invasion by esophageal cancer. However, only a few case reports have been published. This study was performed to clarify the effectiveness and safety of TEVAR for patients with advanced esophageal cancer. METHODS: We retrospectively reviewed 18 patients who underwent TEVAR for esophageal cancer. We also performed a literature search and reviewed 21 similar cases. RESULTS: From 2007 to 2016, 10 patients were treated on an emergent basis for aortic hemorrhage (salvage group) and 8 patients underwent urgent prophylactic surgery (prophylactic group). Hemostasis was achieved in all cases. One (10%) patient in the salvage group died of aspiration pneumonia on postoperative day 1, while all patients in the prophylactic group survived for >1 month. The median survival period in the salvage and prophylactic group was 3.25 and 11.10 months, respectively. The longest survivor was still alive 9 years after TEVAR and chemoradiotherapy. No fatal adverse events or negative impacts on subsequent treatment for esophageal cancer occurred. CONCLUSIONS: TEVAR is feasible, safe, and effective in preventing fatal aortic hemorrhage secondary to esophageal cancer invasion, although it is palliative in most cases. Because the outcomes of emergent TEVAR after bleeding tended to be worse in the salvage than in prophylactic group, prophylactic TEVAR may be considered a viable treatment option for patients with aortic invasion by advanced esophageal cancer.

Clinical Outcomes of Total Endovascular Aneurysm Repair for Aortic Aneurysms Involving the Proximal Anastomotic Aneurysm following Initial Open Repair for Infrarenal Abdominal Aortic Aneurysm.

BACKGROUND: To evaluate initial and midterm clinical outcomes of aortic aneurysms involving the proximal anastomotic aneurysm (AAPAAs) following initial open repair for infrarenal abdominal aortic aneurysm. METHODS: Between July 2006 and August 2015, 24 patients underwent elective endovascular repair for the treatment of AAPAAs at our institution. AAPAA classification has been categorized as 3 types. Type I AAPAA is the most extensive, extending from the descending aorta to the prior proximal anastomosis as similar to Crawford type II or III thoracoabdominal aortic aneurysm. Type II AAPAA is limited to the aortic aneurysm below the diaphragm including the abdominal visceral arteries. Finally, similar to pararenal abdominal aortic aneurysm, type III AAPAA involves the renal origins, but does not extend to the celiac and superior mesenteric arteries. Total endovascular aneurysm repair (t-EVAR) consisted of fenestrated EVAR (f-EVAR), multibranched EVAR (t-Branch), and snorkel EVAR (s-EVAR) were performed for patients with high-risk open surgical repair. We retrospectively analyzed 24 cases, which were categorized with 3 types of AAPAA. RESULTS: F-EVAR, t-Branch, and s-EVAR for AAPAAs were performed in 15 patients (62.5%), 5 patients (20.8%), and 4 patients (16.7%), respectively. Type I and type II AAPAA were identified in 13 patients (54.2%) and 7 patients (29.2%), and type III AAPAA was identified in 4 patients (16.7%). Technical success was 95.8%, and clinical success was 79.2% with t-EVAR. Spinal cord ischemia was identified in 2 patients (8.3%) of type I AAPAA, the 30-day mortality rate was 4.2% (n = 1, type I AAPAA). Type II and III endoleaks occurred in 1 (4.2%, type III AAPAA) and 3 patients (12.5%, each case of type I, II, and III AAPAA), respectively. There was no open conversion or aneurysm rupture in the late follow-up period. The estimated overall survival rates of t-EVAR after 1 and 3 years were 95.6% and 76.2%, respectively. Rates of freedom from aneurysm-related death and secondary intervention of t-EVAR at 3 years were 90.1% and 89.7%, respectively. Finally, rates of target vessel patency at 1 and 3 years were 95.3% and 88.8%, respectively. CONCLUSIONS: Our initial to midterm results of t-EVAR for the treatment of AAPAA were generally good with low rates of perioperative mortality and aneurysm-related death. However, more attentions should be paid for the treatment of type I AAPAA with high incidence of major adverse events.

Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions.

OBJECTIVE: The objective of this study was to assess 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (≥10 cm) in the superficial femoral artery (SFA) as a substitute for above-knee open bypass surgery. METHODS: This prospective, multicenter (15 hospitals) study assessed heparin-coated stent grafts for the treatment of long SFA lesions in Japanese subjects with peripheral arterial disease. Inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), ankle-brachial index ≤0.9, and color flow duplex ultrasound-assessed SFA lesions with cumulative length ≥10 cm and ≥50% stenosis. Main efficacy and safety outcomes were primary assisted patency and adverse events, respectively. Secondary outcomes included primary patency using the surgical bypass definition, that is, blood flow through a device without requiring target lesion revascularization (TLR) to maintain or to restore flow. For comparison with prior endovascular studies, primary patency-interventional was defined as peak systolic velocity ratio <2.5 without TLR in treated lesions. Other outcomes included freedom from TLR and Vascular Quality of Life questionnaire scoring. General anesthesia avoidance and hospitalization duration were compared with historical data from 68 consecutive patients (n = 51 Rutherford 2/3 claudicants and 17 Rutherford 4/5 subjects) who underwent above-knee bypass surgery at study sites between 2002 and 2012 and met study enrollment criteria. RESULTS: Of 103 enrollees (74.2 ± 7.0 years old; 17.5% female; 97.1% claudicants), 100 subjects were evaluated through postoperative 12 months. Average lesion length was 21.8 ± 5.8 cm, and 65.7% were totally occluded. The whole-cohort Kaplan-Meier estimated primary assisted patency rate was 94.1% (95% confidence interval [CI], 87.3%-97.3%) at 12 months. The primary patency-surgical rate was 92.1% (95% CI, 84.8%-96.0%), the primary patency-interventional rate was 88.1% (95% CI, 80.0%-93.1%), and freedom from TLR was 93.1% (95% CI, 86.1%-96.7%). Mean ankle-brachial index increased from 0.64 ± 0.12 to 0.98 ± 0.12 at 1 month after intervention and 0.94 ± 0 .17 at 12 months (P < .0001 at both follow-ups). Target vessel revascularization, major amputation, or death did not occur through postoperative 30 days. No life- or limb-threatening intraoperative or perioperative adverse events and no acute limb ischemia cases were observed during follow-up. Vascular Quality of Life questionnaire score increased from 58.6% ± 15.7% to 72.9% ± 18.6% at 12 months (P < .0001). No stent fractures were detected. No stent graft participant required general anesthesia, and median postoperative hospital stay was 2.0 days (mean, 3.4 ± 2.9 days) in the Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) claudicant subgroup, values that were significantly lower than the 76.5% general anesthesia rate (P < .0001) and 11.0 days median hospitalization stay (mean, 12.7 ± 5.3 days; P < .0001) in the 51 open bypass claudicant subjects. CONCLUSIONS: Stent grafting appears to be a safe and less invasive alternative to above-knee bypass surgery, providing 88% to 92% primary patency at 12 months in long, complex lesions.

Analysis of Risk Factors for Early Type I Endoleaks After Thoracic Endovascular Aneurysm Repair.

PURPOSE: To evaluate risk factors for early (<30 days) type I endoleak following thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective study was conducted of 439 consecutive patients (mean age 74.0±10.0 years; 333 men) who underwent TEVAR at a single center between June 2006 and June 2013. Pathologies included 237 aortic arch aneurysms and 202 descending thoracic aortic aneurysms (dTAA). Maximum TAA diameter was 63.6±13.7 mm. Among the distal aortic arch aneurysms, 124 required coverage of the left subclavian artery (LSA), while the remaining 113 arch aneurysms had debranching (n=40), the chimney technique (n=52), and a branched stent-graft (n=13). Eight patients with dilatation of the ascending aorta underwent arch replacement with elephant trunk prior to TEVAR. Predictive factors for type I endoleak were explored in univariate analysis and examined for each outcome using logistic regression models; results are given as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: Among 439 TEVAR cases, 37 (8.4%) had type I endoleaks on imaging at 1 month; 31 were in the 237 arch cases (13.1%). Endoleak investigation by site indicated a low incidence (3.0%) for dTAAs and markedly low (1.4%) in zone 4. Significantly more endoleaks were observed in zones 0-2 than in zone 4 (p<0.001). On univariate analysis, significant associations were found between endoleak and LSA coverage (OR 5.8, 95% CI 2.4 to 14.4, p<0.001), operative time ≥240 minutes (OR 3.7, 95% CI 1.5 to 6.2, p=0.002), and ≥270 mL of contrast (OR 2.8, 95% CI 1.4 to 5.8, p=0.004). Among the aortic branch reconstruction procedures, the chimney technique was the only maneuver associated with a significant risk of endoleak (OR 5.3, 95% CI 2.3 to 11.2, p<0.001). Arch state was not correlated with endoleaks, but ≥38-mm proximal neck diameter (OR 3.6, 95% CI 1.2 to 10.8, p=0.023), stent-graft diameter ≥40 mm (OR 9.9, 95% CI 1.4 to 30.5, p=0.015), and excessively oversized (≥14%) stent-grafts (OR 3.5, 95% CI 1.2 to 10.3, p=0.020) were; the proximal neck length was not correlated with endoleaks if a proximal neck length >10 mm can be secured. CONCLUSION: Risks for early type I endoleaks after TEVAR for aneurysm were landing zone 0-2, LSA coverage, large proximal neck and stent-graft diameters, excessive oversizing, and the use of the chimney technique.

Repair of Chronic Aneurysmal Aortic Dissection Using a Stent Graft and an Amplatzer® Vascular Plug: A Case Study.

We report a case in which a stent graft and an Amplatzer® vascular plug (AVP) were effective for the treatment of chronic aneurysmal aortic dissection. The patient was a 52-year-old man. At 45 years of age, he developed acute aortic dissection, for which he underwent surgery 4 times with prosthetic graft replacement in the abdominal aorta, descending thoracic, ascending aorta (without neck branch reconstruction), and thoracoabdominal aorta with the reconstruction of the celiac, superior mesenteric, and bilateral renal arteries. At the time of thoracoabdominal aortic surgery, strong adhesion was evident, particularly in the thoracoabdominal area. The adhesion was dissected in a part of the chest, and prosthetic graft replacement was performed the following day. Subsequently, the dissection of the residual distal aortic arch enlarged, and the patient was examined at our hospital. Computed tomography (CT) revealed a small intimal tear at the site of anastomosis distal to the graft in the ascending aorta and a large intimal tear in the descending thoracic aorta with a maximum diameter of 67 mm. Furthermore, open repair by prosthetic graft replacement seemed difficult; therefore, treatment with stent grafting was considered. Because the prosthetic graft in the abdomen was extremely tortuous, stent-graft insertion via the femoral artery seemed to be impossible. The planned treatment involved the placement of a thoracic stent graft using the chimney technique which included reconstruction of the brachiocephalic artery and left common carotid arteries using chimney stent graft and coverage of the left subclavian artery. The thoracic stent graft was planned to be inserted via the abdominal prosthetic graft site because the abdominal prosthetic graft was crooked and was located close to the body surface. However, a small intimal tear distal to the graft in the ascending aorta which had not been revealed by intraoperative aortography was detected by the selective angiography, and closure with an AVP was attempted for this. The site was successfully closed using an AVP with a wire passing through the tear and into the false lumen. Thereafter, the large tear in the descending thoracic aorta was closed using a stent graft. The patient made good postoperative progress without evidence of paraplegia, and complete thrombosis of the false lumen was confirmed by postoperative CT. CT at 1 year after thoracic endovascular aneurysm repair (TEVAR) showed complete thrombosis of false lumen and aneurysm shrinkage.

Comparison between Open and Endovascular Repair for the Treatment of Juxtarenal Abdominal Aortic Aneurysms: A Single-Center Experience with Midterm Results.

BACKGROUND: To evaluate the optimal treatment for juxtarenal abdominal aortic aneurysm (JAAA), we compared the outcomes of open surgical repair (OSR) with endovascular aortic repair (EVAR) using a variety of fenestrated and snorkel EVARs. METHODS: We evaluated overall survival, aneurysm-related death, reintervention, and renal impairment in 152 JAAAs retrospectively, excluding cases of aortic dissection and rupture. Cox models were used to assess survival and assessed postoperative dialysis rates following surgery. RESULTS: OSR and EVAR were performed in 81 and 71 patients, respectively. The mean age was significantly higher in the EVAR group (overall, 74.5 years; OSR, 71 years; and EVAR; 77 years). High preoperative serum creatinine levels, cerebrovascular disease, and chronic obstructive pulmonary disease were more prevalent in the EVAR group. Mean operative time, hospital stay, and perioperative blood loss were significantly greater in the OSR group (P < 0.001 for all). The overall 30-day mortality was 1.9% with no statistical difference between 2 groups. The reintervention rate was significantly higher in the EVAR group (P = 0.01). Overall survival rates at 1, 3, 5, and 7 years were 97.4%, 91.6%, 86.3%, and 82.9%, respectively, with no significant difference between groups. Mortality in EVAR was associated with over 3.0 mg/dL of postoperative creatinine, and postoperative dialysis following OSR was associated with operative time and volume of bleeding. CONCLUSIONS: Acceptable outcomes were observed with OSR and EVAR. However, reintervention was more frequently required following EVAR. OSR appears to be the most appropriate first-line treatment for JAAA in good-risk patients; however, EVAR may represent an alternative option in high-risk patients.

Concomitant Coil Embolization for Gutter Leak during Endovascular Aortic Repair with the Snorkel Technique.

Snorkel endovascular aortic repair (SEVAR) is reported to be effective for the treatment of pararenal or juxtarenal aortic aneurysms. SEVAR can be performed with an off-the-self device, which is applied for emergency cases. However, there is a concern that SEVAR lead to gutter leak due to insertion of multiple stents. Previously, we performed 2-staged treatment for gutter leak after SEVAR. However, the gutter leaks can also occur late, and it is often difficult to close. Therefore, if a significant gutter leak is identified intraoperatively, performing concomitant gutter coil embolization at the time of the initial surgery may be reasonable.

Clinical Outcomes of Spinal Cord Ischemia after Fenestrated and Branched Endovascular Stent Grafting during Total Endovascular Aortic Repair for Thoracoabdominal Aortic Aneurysms.

BACKGROUND: In this single-center study, we assessed the clinical outcomes of fenestrated endovascular aortic repair (f-EVAR) and branched EVAR on morbidity and mortality during total endovascular aortic repair for thoracoabdominal aortic aneurysms (TAAAs). METHODS: Between July 2006 and June 2015, elective f-EVAR and multibranched EVAR (t-Branch) for TAAAs were performed in 99 patients at our institution (Crawford classification types I [7], II [13], III [6], IV [55], and V [18]). We retrospectively analyzed 44 patients, excluding those with Crawford type IV TAAAs, and compared 30 patients treated with f-EVAR and 14 treated with t-Branch. Multivariate analysis was performed to determine the factors associated with perioperative spinal cord ischemia (SCI). RESULTS: Technical success was 96.7% with f-EVAR and 100% with t-Branch, and the 30-day mortality rate was 3.3% with f-EVAR and 7.1% with t-Branch (P = 0.646). The incidences of perioperative SCI were higher with t-Branch (n = 5, 35.7%) than those with f-EVAR (n = 2, 6.7%; P = 0.04). Endoleaks were more prevalent with f-EVAR (n = 9, 30.0%) than with t-Branch (n = 1, 7.1%; P = 0.046). Rates of freedom from aneurysm-related death after 1 year for f-EVAR and t-Branch were 96.7 and 92.9%, respectively, and those after 3 years were 88.8 and 92.9% (P = 0.982), respectively. The risk of SCI remarkably increased in the presence of risk factors such as procedure (t-Branch), maximum short axis of ≥65 mm, coverage length of ≥360 mm, internal iliac artery occlusion, and ≥ 5 sacrificed intercostal arteries. CONCLUSIONS: Our initial to mid-term results of f-EVAR and t-Branch were good with low rates of perioperative mortality and high rates of freedom from aneurysm-related death. SCI incidence with t-Branch was significantly high; it is important to develop additional SCI prevention methods for patients with high-risk factors.