Five-year outcomes of the Bi- versus Trimodular EndurantTM stent-graft in 100 patients with infrarenal abdominal aortic repair.

BACKGROUND: Recent studies on the Endurant™ endografts mainly compared outcomes of the bimodular stent-graft to other manufacturer's endografts or reported results for cases outside manufacturer's instructions for use (IFU), while data on the experience of standard endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysms (AAA) inside manufacturer's IFU comparing the bi- with the trimodular device is limited. METHODS: Inclusion criteria were: 1) infrarenal aneurysms (>50 mm diameter) treated by EndurantTM II (END II) or EndurantTM IIs (END IIs) stent-graft inside manufacturer's IFU; 2) available CTA with 1 mm reconstruction of the entire aorta prior to intervention. Endpoints comparing the devices included technical success, 30-day mortality, rate of complications (bleeding with conversion to open repair, stent-graft stenosis/occlusion, acute distal embolism, infection or postprocedural necessity of dialysis), endoleaks and reinterventions (5-year follow-up). Aneurysm sac diameters were compared between baseline preinterventional CTA and last post-interventional CTA. RESULTS: One hundred patients (90% male, mean age 74 years) treated with END II (N.=66) or END IIs (N.=34) were included. Technical success was 99%. One procedure-related active bleeding occurred ending up in surgical conversion (END II N.=1). 30d mortality was 0%. No initial type I/III endoleaks were present. Re-interventions were required in 19/100 (19%) of patients (END II N.=10; END IIs N.=9, P=0.17). The outcome of EVAR including technical success, 30d mortality, rate of complications, endoleaks and re-interventions showed no significant differences comparing END II/IIs. CONCLUSIONS: Five-year outcomes of EVAR show consistently safe and effective results for either END II or IIs device.

[Robot-assisted Distal Pancreatectomy with En Bloc Celiac Axis Resection (Modified Appleby Procedure) after Neoadjuvant Therapy]. / Robotisch assistierte Resektion eines zentralen neoadjuvant behandelten Pankreaskarzinoms mit En-bloc-Resektion des Truncus coeliacus (modifizierte Appleby-Operation).

Pancreatic carcinoma in the body and on the left side of the mesentericoportal axis is often only detected in late stages owing to unspecific or even missing clinical symptoms. In approximately 20% of the cases, there is already infiltration of the tumour into the surrounding arteries or veins. Despite locally advanced growth, 30% of patients do not have distant metastases and would potentially qualify for local resection. Arterial resections and vascular reconstruction are associated with an almost 9-fold increase in postoperative mortality compared with resections without vascular reconstruction. The Appleby procedure is a complex surgical technique originally developed for advanced gastric cancer. The technique has been further developed for patients with advanced pancreatic body and tail tumours with infiltration of the coeliac trunk (modified Appleby procedure). The advantage of the procedure is that technically, no reconstruction of the resected arteries is required. This is because a natural internal anastomosis in the pancreatic head between the A. mesenterica superior and the A. hepatica via branches of the A. gastroduodenalis is used to maintain liver perfusion and gastric blood flow. However, the surgical procedure is also associated with high morbidity and mortality, with comparably poor oncological results (R0 rates of approximately 60%). Therefore, the procedure was not recommended until a few years ago, and patients were considered inoperable. With developments in neoadjuvant therapy for pancreatic carcinoma, the Appleby procedure is being performed more frequently, with the goal of improving oncological outcomes in the context of multimodal treatment. With developments in robotics in visceral surgery, the previous limitations of minimally invasive pancreatic surgery can be overcome, and significantly more patients may benefit from the advantages of this minimally invasive surgery, such as faster convalescence. The use of robotic surgical techniques allows the extension of minimally invasive techniques into the field of complex vessel resection and reconstruction. In this video contribution, we describe a robot-assisted modified Appleby procedure using the Da Vinci Xi Surgical System in a patient with advanced pancreatic carcinoma of the pancreatic body, after neoadjuvant therapy.

Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon for revascularization of complex femoro-popliteal lesions.

To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II-III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-("LL"; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions ("ULL"; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5-96.9%) and 92.0% (95% CI 84.7-100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8-92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3-100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.

Acute Hemoptysis Following Cryoballoon Pulmonary Vein Isolation: A Multicenter Study.

OBJECTIVES: This study sought to assess the incidence, procedural characteristics, contributing factors, and clinical outcome of cryoballoon-based pulmonary vein isolation (CB-PVI)-related hemoptysis in a multicenter study. BACKGROUND: Hemoptysis has been described as a rare complication of CB-PVI. However, the precise mechanism and the etiology of this complication are poorly characterized. METHODS: Consecutive patients undergoing CB-PVI for paroxysmal or persistent atrial fibrillation at 4 German hospitals were included in this observational analysis. RESULTS: A total of 4,331 CB-PVI procedures were performed between 2006 and 2019. Fifteen patients (9 men, mean age 68.1 ± 9.8 years) developed acute hemoptysis during or within 24 h after CB-PVI, resulting in a hemoptysis frequency of 0.35%. Hemoptysis occurred in 6 of 720 procedures using the first-generation CB (0.83%) and in 9 of 3,611 procedures using the second-, third-, or fourth-generation CB (0.25%) (p = 0.015). Bronchoscopy was performed in 8 patients and showed bleeding exclusively due to mucosal injury or due to a coagulum at a bronchus adjacent to the ablation site. Hemoptysis resolved spontaneously without any long-term sequelae in all patients, except for a 92-year-old patient who died 13 days after CB-PVI due to pneumonia. No specific endobronchial treatment was necessary. CONCLUSIONS: Acute hemoptysis after CB-PVI is a rare but potentially life-threatening complication that is usually self-limiting. Direct thermal injury of bronchi adjacent to a pulmonary vein seems to be the most likely mechanism.

Correction: Analysis of Tyrosine Kinase Inhibitor-Mediated Decline in Contractile Force in Rat Engineered Heart Tissue.

[This corrects the article DOI: 10.1371/journal.pone.0145937.].

Initial Experience with the E-liac® Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm.

PURPOSE: Occlusion of internal iliac arteries during endovascular treatment (EVAR) of abdominal aortic (AAA) and common iliac artery aneurysms might be associated with ischemic pelvic complications. This study evaluates technical and clinical success, safety and mid-term results of a novel iliac branch device (IBD) for revascularization of the internal iliac artery (IIA) during EVAR. MATERIALS AND METHODS: Retrospectively, we identified 21 men (mean age 73.3 ± 6.2 years) treated for aorto-iliac aneurysms by use of a novel IBD (E-liac®, Jotec Hechingen, Germany). We analyzed safety (30-day survival), technical (no type I and III endoleaks, "EL"), clinical (no ischemic complications) success, mid-term patency of this IBD, peri-procedural complications, occurrence of type II ELs, rate of re-interventions and additional treatment of the revascularized IIA for landing zone preparation. RESULTS: Twenty-three IBDs were implanted. Aneurysms of the ipsilateral IIA were present in 6/23 IIAs (26.1%). Super-selective branch embolization was performed in these patients and the landing zone for the iliac sidebranch stent-graft was within the superior gluteal artery. Mean follow-up was 341 days (range 4-1103 days). Technical success and 30-day survival were 100%. Clinical success was 95.2%. Primary patency of the IBDs was 100% at 12 months. Peri-procedural complications occurred in 3/21 patients (14.3%), none of them related to the IBD. AAA-related type II ELs were found in 6 patients (28.6%), IBD-related ELs in 4/23 IBDs (17.4%) (two type Ib, two type II endoleaks). Overall re-intervention rate was 23.8%, IBD-related 8.7%. CONCLUSION: Utilization of the E-liac® IBD is safe and effective for the treatment of aorto-iliac aneurysms.

Analysis of Tyrosine Kinase Inhibitor-Mediated Decline in Contractile Force in Rat Engineered Heart Tissue.

INTRODUCTION: Left ventricular dysfunction is a frequent and potentially severe side effect of many tyrosine kinase inhibitors (TKI). The mode of toxicity is not identified, but may include impairment of mitochondrial or sarcomeric function, autophagy or angiogenesis, either as an on-target or off-target mechanism. METHODS AND RESULTS: We studied concentration-response curves and time courses for nine TKIs in three-dimensional, force generating engineered heart tissue (EHT) from neonatal rat heart cells. We detected a concentration- and time-dependent decline in contractile force for gefitinib, lapatinib, sunitinib, imatinib, sorafenib, vandetanib and lestaurtinib and no decline in contractile force for erlotinib and dasatinib after 96 hours of incubation. The decline in contractile force was associated with an impairment of autophagy (LC3 Western blot) and appearance of autophagolysosomes (transmission electron microscopy). CONCLUSION: This study demonstrates the feasibility to study TKI-mediated force effects in EHTs and identifies an association between a decline in contractility and inhibition of autophagic flux.