One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study.

PURPOSE: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. MATERIALS AND METHODS: Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. RESULTS: The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). CONCLUSIONS: The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. CLINICAL IMPACT: This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.

Surgeon-modified endovascular grafts for treating ruptured arch aneurysm due to proximal endograft failure after thoracic endovascular aneurysm repair combined with total debranching.

Generally, proximal endograft failure after total arch debranching and thoracic endovascular repair (TEVAR) is one of the most difficult problems because re-sternotomy poses extremely high risks to patients with high surgical risk. Herein, we report an endovascular technique using surgeon-modified endovascular grafts for a patient with ruptured arch aneurysm caused by type Ia endoleak following total arch debranching and TEVAR.

Treatment Strategy of Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysm Based on the Fitzgerald Classification.

BACKGROUND: The Fitzgerald classification expresses the extension of hematoma from the ruptured abdominal aortic aneurysm (rAAA) and is related to a patient's preoperative status. The objective of this study was to propose a new decision-making method for emergency surgeries, endovascular aortic repair (EVAR), or open repair (OR) for rAAA based on the Fitzgerald classification using preoperative computed tomography images. MATERIALS AND METHODS: A multicenter observational study was performed with a questionnaire survey of rAAA from August 2010 to July 2015 in Hokkaido, Japan, and sent to 20 institutions participating in the Hokkaido Society of Aortic Stent Graft. We included 205 patients who could be stratified by the Fitzgerald classification as the subjects of this study. We categorized these patients into Fitzgerald classes I and II (first category, n = 72) and classes III and IV (second category, n = 133). The short-term results of both EVAR and OR cases were examined in the 2 categories. RESULTS: In the first category, patients in the EVAR group were older than those in the OR group. Nonetheless, the in-hospital mortality rate was lower in the EVAR group than in the OR group (0% vs. 18%; P = 0.019). In the second category, there was no difference in preoperative factors between the groups. The EVAR group showed a higher incidence rate of postoperative abdominal compartment syndrome than the OR group (12% vs. 2%; P = 0.042). The in-hospital mortality rate was comparable between the groups (24% vs. 25%; P = 0.80). Although there were no deaths in the EVAR group without preoperative shock, in-hospital mortality in the EVAR group of the second category with shock was 41% (vs. 28% in the OR group; P = 0.27). Furthermore, mortality in the EVAR group with Fitzgerald class IV was 100% (vs. 29% in the OR group; P = 0.049). CONCLUSIONS: EVAR is recommended in Fitzgerald class I or II and also in Fitzgerald class III or IV without shock because the results of EVAR were better than those of OR. Because all patients who underwent EVAR died in Fitzgerald class IV, OR would be beneficial in this patient population.

[Surgery for Flail Chest with Titanium Plates after Cardiopulmonary Resuscitation;Report of a Case].

A 74-year-old woman was admitted for the management of nausea with hyponatremia. On the 19th day of hospitalization, the patient developed cardiac arrest and needed cardiopulmonary resuscitation (CPR). CPR was successful but the patient developed multiple rib fractures with flail chest by CPR. Because of persistent dyspnea, surgery for fixing of the fractured ribs was performed using 4 titanium plates, with prompt improvement of the flail chest after the operation.

Hybrid Aortic Arch Repairs.

Hybrid aortic arch repair (HAAR) consists of thoracic stent-graft repair and procedures to maintain cerebral blood flow. Several hybrid techniques have been used, including arch artery debranching, parallel graft technique, fenestration or branching of endograft, or a combination of these. We provided an overview of HAAR by presenting literature reviews as well as our clinical experience. The experience consisted of 172 patients who had undergone HAAR. The 30-day mortality was 3% (5/172). Persistent neurologic deficits occurred in 7 patients (4%), respiratory failure in 5 (3%), de novo aortic dissection in 3 and spinal cord injury in 2. 17% of the patients experienced type Ia endoleak. Seventeen patients required redo thoracic endovascular aortic repair. Fifty-six late deaths occurred during the follow-up period, including aortic-related death in 9 patients. In conclusion, hybrid arch debranching repair should be performed for elderly or high-surgical-risk patients. However, refining techniques and device technology is likely to reduce late endograft-related events. (This is a translation of Jpn J Vasc Surg 2018; 27: 385-391.).

Predictive Factors for Abdominal Aortic Aneurysm Shrinkage One Year after Successful Endovascular Aneurysm Repair.

BACKGROUND: Often, we experience cases of aneurysm shrinkage and no aneurysm shrinkage after successful endovascular aortic aneurysm repair, without postoperative endoleaks. We studied these cases to ascertain the predictive factors for aneurysm shrinkage. METHODS: From 2007 to 2014, we selected 255 cases that comprised aneurysm shrinkage (>4 mm) and no-shrinkage cases (shrinkage from 0 to 4 mm). Excluding 36 cases of endoleaks, 43 cases without 1-year follow-up computed tomography scan, and 3 cases of aortic dissection, we assessed 93 cases of aneurysm shrinkage (S group) and 80 cases of no aneurysm shrinkage (N group) at 1-year follow-up. RESULTS: No significant differences were found in sex, comorbidities (diabetes mellitus, chronic kidney disease, hemodialysis, and malignancy), and medications (antiplatelet drugs, anticoagulant drugs, steroids, and statins). Advanced age was a strong negative predictive factor for aneurysm shrinkage (N: 75.0 ± 1.0 vs. S: 72.1 ± 0.9 years; P = 0.023), and intraoperative endoleaks were more frequent in the N group (N: 31.3 vs. S: 9.7%; P = 0.001). Neck thrombus was more likely in the N group (N: 17.5 vs. S: 7.5%; P = 0.045), but it had a strong correlation with intraoperative endoleaks (P = 0.008). In the multivariate analysis, patient age and intraoperative endoleaks were predictive factors for aneurysm shrinkage. CONCLUSIONS: Advanced age and intraoperative endoleaks were negative predictive factors for aneurysm shrinkage at 1-year follow-up after successful endovascular treatment without postoperative endoleaks.

Anatomical repair for Kommerell diverticulum with deep site in-situ fenestration.

An 83-year-old woman with a Kommerell diverticulum was treated by anatomical endovascular repair with a deep site in-situ fenestration instead of complex debranching techniques. The main component of the thoracic stent-graft was deployed just distal to the third cervical branch to completely exclude the Kommerell diverticulum. A deep site in-situ fenestration was made on the main component using a radiofrequency needle through the left subclavian artery, and a stent-graft was deployed to bridge the main component to the left subclavian artery. Six months postoperatively, the Kommerell diverticulum was completely excluded with excellent left subclavian artery patency.

Outcome From a Randomized Controlled Clinical Trial　- Improvement of Peripheral Arterial Disease by Granulocyte Colony-Stimulating Factor-Mobilized Autologous Peripheral-Blood-Mononuclear Cell Transplantation (IMPACT).

BACKGROUND: The clinical usefulness of peripheral blood (PB) mononuclear cell (MNC) transplantation in patients with peripheral arterial disease (PAD), especially in those with mild-to-moderate severity, has not been fully clarified.Methods and Results:A randomized clinical trial was conducted to evaluate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF)-mobilized PBMNC transplantation in patients with PAD (Fontaine stage II-IV and Rutherford category 1-5) caused by arteriosclerosis obliterans or Buerger's disease. The primary endpoint was progression-free survival (PFS). In total, 107 subjects were enrolled. At baseline, Fontaine stage was II/III in 82 patients and IV in 21, and 54 patients were on hemodialysis. A total of 50 patients had intramuscular transplantation of PBMNC combined with standard of care (SOC) (cell therapy group), and 53 received SOC only (control group). PFS tended to be improved in the cell therapy group than in the control group (P=0.07). PFS in Fontaine stage II/III subgroup was significantly better in the cell therapy group than in the control group. Cell therapy-related adverse events were transient and not serious. CONCLUSIONS: In this first randomized, large-scale clinical trial of G-CSF-mobilized PBMNC transplantation, the cell therapy was tolerated by a variety of PAD patients. The PBMNC therapy was significantly effective for inhibiting disease progression in mild-to-moderate PAD.

[Infectious Endocarditis due to Methicillin-sensitive Bovine Staphylococcus aureus;Report of a Case].

A 19-year-old male patient was admitted to our hospital after developing infectious endocarditis associated with methicillin-sensitive bovine Staphylococcus aureus septicemia. Brain magnetic resonance imaging confirmed occipital lobe cerebral bleeding. An echocardiogram showed severe mitral regurgitation with vegetation on the posterior mitral leaflet. We performed mitral valve replacement. However, a hepatic artery aneurysm and a ruptured splenic artery aneurysm was found on the 5th postoperative day and coil embolization was accordingly performed. The patient suffered repeated cerebral bleeding and received external decompression. He was discharged on the 92nd day after the valve replacement. Our case is rare in that methicillin-sensitive bovine Staphylococcus aureus isolated from human is extremely unusual especially complicated by multiple peripheral aneurysms. This is the 1st reported case of methicillin-sensitive bovine Staphylococcus aureus isolated from human in the Japanese literature.

Homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions.

OBJECTIVE: The aim of this retrospective analysis was to evaluate the outcomes of homemade fenestrated stent-grafts for thoracic endovascular aortic repair of zone 2 aortic lesions. METHODS: From November 2013 to January 2017, 24 patients underwent thoracic endovascular aortic repair with left subclavian artery revascularization using a homemade fenestrated stent-graft to preserve the patency of the left subclavian artery. Elective cases accounted for 54% (n = 13) of the sample. Indications included acute complicated type B aortic dissection (n = 9), degenerative aneurysm (n = 9), penetrating aortic ulcer (n = 5), and intramural hematoma (n = 1). Routine postoperative follow-up imaging with computed tomography angiography was performed to assess thoracic endovascular aortic repair and left subclavian artery fenestration patency and endoleak. RESULTS: Median duration for stent-graft modification was 16 minutes (range, 14-17 minutes). The technical success rate was 100%. One patient had a distal type I endoleak requiring additional stent-graft placement. One patient had partial coverage of the left common carotid artery requiring left common carotid artery stenting. One patient had a stroke without permanent sequelae (4.1%). Overall mortality was 0%. All left subclavian arteries were patent. Two type III endoleaks required additional left subclavian artery covered stent placement. One type II endoleak is currently observed. During a mean follow-up of 13.2 ± 2 months, there were no conversions to open surgical repair, aortic rupture, paraplegia, or retrograde dissection. CONCLUSIONS: The use of a homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions is both feasible and effective for left subclavian artery revascularization during thoracic endovascular aortic repair involving a spectrum of thoracic aortic pathology. Durability concerns will need to be assessed in additional studies with long-term follow-up.

Physician-Modified Thoracic Stent-Grafts for the Treatment of Aortic Arch Lesions.

PURPOSE: To evaluate outcomes of physician-modified thoracic stent-grafts for the treatment of aortic arch aneurysms. METHODS: A retrospective dual-center analysis was performed involving 36 patients (mean age 74.7±9 years, range 58-91; 27 men) with an aortic arch lesion who were treated between November 2013 and June 2016 using physician-modified thoracic stent-grafts. Half of the patients had a degenerative aneurysm; the remainder had type B dissection (n=9), traumatic transection (n=3), type Ia endoleak after previous endografting (n=5), or aortoesophageal fistula (n=1). All patients were considered to be at high surgical risk. Patients were treated using an aortic arch stent-graft with a single fenestration (n=24) or a proximal scallop (n=12); zone 0 was involved in 16 patients, zone 1 in 9, and zone 2 in 11. The modified thoracic stent-graft was deployed after supra-aortic branch revascularization in 24 (67%) patients. RESULTS: Mean time required for stent-graft modifications was 18 minutes (range 14-21). Technical success was obtained in all cases with no type I endoleak. One (3%) patient had a stroke without permanent sequelae. The 30-day mortality was 6%. During a mean follow-up of 11.4±6 months (range 2-36), there were no conversions to open repair. The overall mortality was 14%; aorta-related mortality was 6%. CONCLUSION: Our experience suggests that physician-modified thoracic stent-grafts are feasible for aortic arch lesions and provide encouraging results in the short term. Durability concerns will need to be assessed.

[Echographic Examination for Leg Vein Thromboembolism in Thoracic Surgery].

Echographic examination for leg vein thromboembolism was carried out in 123 patients scheduled for thoracic surgery. Preventive measures for thromboembolism were conducted after the risk assessment. Echography was done after surgery in 72 cases, most of which were cases of lung malignant tumors, and thromboembolism was detected in 4 cases. Thus, the incidence rate of venous thromboembolism was 5.6%( 4/72). There was no patients who developed pulmonary thromboembolism during the examination period, suggesting reasonable risk assessment and preventive measures in our procedure.

[Examination of the postoperative change of pedicled pericardial fat pad for reinforcement of bronchial sutures by computed tomography].

A pedicled pericardial fat pad (PPFP) is often used in pulmonary resection to reinforce bronchial sutures. Here, we assessed the significance of PPFP by serial chest computed tomography (CT). Ten cases in which bronchial stump were covered with a PPFP in the past 6 years were reviewed. The procedures were pneumonectomy (3), lobectomy (6), and a segmentectomy. According to the CT value evaluated serially PPFP was recognized as fat tissue until 1~2 postoperative months. No cases of bronchopleural fistulae was encountered in this series. The coverage of the sutures with the PPFP was thought to contribute to the prevention of bronchial fistula by staying around bronchial stump for at least 1 to 2 months.

[Total debranching through mini-sternotomy].

Aneurysms of the aortic arch are technically challenging to repair with thoracic endovascular aneurysm repair (TEVAR). Various optional techniques such as debranching or hybrid TEVAR enable landing zones to extend, however, there is still room for improvement. We have performed total debranching to facilitate TEVAR with adequate central neck length more than 2.5 cm. In summary our procedure has 3 features:mini-thoracotomy to minimize its surgical stress which might cause post-operative respiratory failure, side-to-side anastomosis of trifurcated graft with ascending aorta to avoid its kinking after chest closure, and the usage of Pruitt-Inahara shunt tube during anastomoses of the carotid artery.

[Simultaneous operation for ischemic heart disease combined with Leriche syndrome].

A 63-year-old male patient was admitted to the hospital complaining of chest pain. He had undergone aorto-bifemoral bypass and percutaneous coronary intervention due to Leriche syndrome and ischemic heart disease. Radiological examination revealed complete obstruction of the right coronary artery(#2) as well as the bypass graft. He was successfully treated with the simultaneous operation of coronary artery bypass grafting( CABG) and ascending aorta to bifemoral artery bypass.

Example of evoked potential monitoring for a neurogenic tumor positioned high in the mediastinum.

Excision of a neurogenic tumor of the brachial plexus positioned high in the mediastinal space could potentially result in a functional disorder of the arm. We report on a case in which we performed evoked potential monitoring on a tumor located high in the mediastinum. We found large potential changes in the median and ulnar nerve areas and had a concern that the excision might injure the brachial plexus. We did a biopsy and intraoperative rapid histological diagnosis, which promptly revealed that the tumor was not malignant. Thus, we decided not to excise the tumor because the procedure could possibly injure nerves in the arm.

[Idiopathic pulmonary trunk aneurysm].

Pulmonary trunk aneurysm is generally associated with congenital cardiac defects, pulmonary hypertension, or infection. Idiopathic pulmonary trunk aneurysm without any associated diseases is a rare lesion and has seldom been reported. Here, we report a case of a 68-year-old woman with idiopathic pulmonary trunk aneurysm. The maximum diameter of the aneurysm was 53 mm while she was 142 cm in height. We successfully performed aneurysmorrhaphy and her postoperative course was uneventful. Aneurysmorrhaphy was an effective technique for idiopathic pulmonary trunk aneurysm without pulmonary hypertention.