Brachial artery aneurysm after hemodialysis fistula ligation: Case reports and review of literature.

INTRODUCTION: Brachial artery aneurysm (BAA) following long-standing arteriovenous fistula (AVF) ligation after renal transplantation is odd. CASE PRESENTATION: Two cases of brachial artery aneurysm treated with bypass (a saphenous vein graft and a PTFE graft). In the first patient no complications were recorded whereas an infection was diagnosed after 6 months from the procedure in the second treatment. CLINICAL DISCUSSION: Multiple factors activated by stress on the vessel wall followed by fistula ligation are the cause of vascular remodeling of the three layers making up the wall with possible evolution in aneurysmatic lesions. In literature the gold standard for this lesion is the surgical approach, only one endovascular procedure is reported. The traditional surgical approach uses the autologous vein or prosthetic PTFE grafts. CONCLUSION: Brachial artery aneurysm is a complication that affects patients undergoing renal transplantation who have already undergone AVF ligation. In our experience autologous vein graft represented the best solution.

Trans-limb embolization for treatment of Type 2 endoleak post EVAR: Case report.

INTRODUCTION: Type 2 endoleaks (T2EL) occur after 10%-25% of endovascular abdominal aortic aneurysm repairs and increase the risk factor of endograft repair failure and rupture. Herein we report a case of endovascular treatment of T2EL where we performed a trans-limb embolization. PRESENTATION OF CASE: A 63-years-old male previously treated for AAA with endovascular aortic aneurysms repair (EVAR), showed an angio-CT scan followup with a type 2 endoleak fed from inferior mesenteric artery (AMI) with growth of AAA greater of 1 cm than preoperative CT-scan and increase of chronic lumbar pain. Due to high risk of rupture was performed a trans-limb embolization with complete sealing. The 6 months CT-angiography showed complete type 2 endoleak exclusion without changes of AAA. DISCUSSION: The risk of aneurysm rupture in the presence of an isolated T2EL is exceptionally low. However, when a persistent T2EL is associated with a significant sac size increase, commonly considered as at least 5 mm over 6 months, should be treated. Detachable coils are repositionable, allowing an extremely precise deployment and subsequent embolization of different targets. CONCLUSION: In this experience trans-limb embolization was feasible and this tool should be taken in account especially when no other surgical options exists.

Transcervical approach for carotid artery stenting with transitory reversal flow: Case report.

INTRODUCTION: Carotid artery stenting (CAS) has been indicated as an alternative to carotid endarterectomy in high risk patients. Sometimes, an aortic arch can be anatomically unfavourable for CAS. Herein we report our experience in a case of CAS with transcervical approach. PRESENTATION OF CASE: A 77-year-old male was referred to our hospital for severe subtotal occlusion of the left internal carotid artery. He had a past medical history of radiation to the head and neck for laryngeal cancer. Previous CT-angiography had shown a type III aortic with bovine arch. CAS via transcervical approach was performed with transitory reversal flow during the placement of RX Spider Filter 6 Fr (Medtronic, Minneapolis, MN). After release of 7 × 30 mm RX Xact carotid stent (Abbott Vascular, Chicago, IL) and ballooning with a 5.5 × 30 mm Rx Submarine balloon catheter (Medtronic Minneapolis, MN), angiography check showed a good result. DISCUSSION: The transcervical approach is an innovative technique where usually a shunt is created, either between the common carotid artery and the internal jugular vein or between the common carotid artery and the common femoral vein. This flow reversal reduces the risk of periprocedural embolic events. In our experience a short proximal clamping with transitory reversal flow, reduces the invasiveness of procedure with good outcomes. CONCLUSION: Transcervical carotid access with transitory reversal flow is a valid alternative in complicated patient with anatomy unfit for CAS.

Penetrating aortic ulcer post migration of thoracic aortic endoprosthesis: Case report.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) is the first treatment option for many thoracic aortic pathologies. Especially after aortic dissections, it is possible to have progression during follow-up with appearance of new lesions on arterial wall. Herein, we report a case of Penetrating Aortic Ulcer (PAU) post release of Thoracic endoprosthesis. PRESENTATION OF CASE: A 67-years-old male with hypertension and diabetes mellitus was followed at our hospital after an emergency procedure for Type B aortic dissection (TBAD) complicated by symptomatic large infrarenal AAA and treated with a proximal TEVAR plus chimney for left subclavian artery and PETTICOAT with EVAR for abdominal aortic disease. Follow up at 15 months showed a deep PAU with partial crush of stent in Left Subclavian Artery. Thus, we performed a left carotid-subclavian bypass and subsequently a TEVAR procedure with release of Bolton Relay endoprosthesis (Terumo Aortic, Sunrise, Florida, United States). DISCUSSION: In literature there are few studeis that focus on migration after TEVAR during follow-up. Elongation, changes of tortuosity on thoracic aorta after TEVAR, can help to determine a migration of prosthesis. In this case Bolton Relay endoprosthesis (Terumo Aortic, Sunrise, Florida, United States) has permitted to improve precision and quality of procedure. CONCLUSION: In literature there are few studies reporting complications of TEVAR post prosthesis migration. In this case, Bolton Relay endoprosthesis was useful and safe.

TEVAR and periscope graft technique to treatment of huge aneurysm of aortic isthmus: Case report.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) has revolutionized the treatment of thoracic aortic aneurysms. Innovative techniques as chimney and periscope grafts can improve the outcomes of procedure. Herein, we report a case in emergency of huge Thoracic aortic aneurism. PRESENTATION OF CASE: An 86-year-old male with hypertension, diabetes mellitus, was referred to our hospital for chest pain. CT-angiography showed a huge aneurysm of aortic isthmus with signs of rupture. The patient was considered unfit for open surgery and an endovascular approach was chosen. This patient underwent endovascular repair with TEVAR, using the periscope graft technique to preserve patency in left subclavian artery (LSA). DISCUSSION: Symptomatic ischemia from LSA coverage has been reported to occur in only a modest 6-10% of patients and is often sacrificed with impunity given coverage rates between 10 and 50%. In this case reported the lack of revascularization of LSA increased the risk of neurological manifestations or stroke. Periscope technique is feasible and safe to maintain perfusion to the subclavian artery, with a 93% primary patency at 2 years. CONCLUSIONS: Our experience using TEVAR with periscope graft technique as solution to address thoracic aneurysm of aortic isthmus was feasible and safe.

Multilevel diabetic foot revascularization in COVID 19 patient: Case report.

INTRODUCTION: Coronavirus 2019 (COVID-19) has been associated with endothelial dysfunction. This hypercoagulable state coming from the endothelial injury pones COVID-19 patients to a higher risk for thrombosis. COVID 19 diabetic patients are more exposed to peripheral vascular disease progression. Multilevel peripheral arterial disease is the main cause of critical limb ischemia. Vascular interventions are required to increase distal blood flow and reduce the risk of amputation. PRESENTATION OF CASE: We report a case of complex revascularization in a diabetic patient with aggressive right foot lesions evolution after COVID-19 infection. The patient presenting a Peripheral arterial ischemic involving the infrarenal aorta, iliac, femoral. The simultaneous intervention consisted of an endovascular aortic stent-graft placement and angioplasty of femoral artery. DISCUSSION: Diabetes is a risk factor of severity and deaths in patients infected with pulmonary viruses. In our experience, COVID 19 virus can accelerate the ulcers generation and progression in diabetic patient. Hybrid interventions can be performed simultaneously or staged with benefit given by the complementary role of endovascular and surgical treatments. In the reported case, a complex simultaneous treatment in a patient presenting Multilevel peripheral arterial disease in association to COVID 19 infection was feasible in the same operation. CONCLUSION: Hybrid procedures are safe with high degree of efficacy in terms of revascularization, reduced morbidity and shorter intensive care. In our experience, the use of a hybrid procedure is technically feasible and allowed the treatment of complicated diabetic COVID-19 patient with a good outcome.

Composite femoro-tibial bypass as alternative solution in complicated revascolarization: Case report.

INTRODUCTION: Peripheral Arterial Disease (PAD) in diabetic patients is a significant cause of Morbility. Long arterial occlusion in patient previously treated can require unusual and complex solution. Herein we report a case of complicated bypass in diabetic patient with history of bypass for bilateral popliteal aneurysm. PRESENTATION OF CASE: A 51-year-old male, smoker, with hypertension and diabetes mellitus was referred to our hospital for rest pain in left limb and peripheral cyanosis. Ultrasound doppler (US) showed an occlusion after common femoral artery with patency of Anterior-tibial artery (ATA) two centimeters after the origin. The unavailability of adequate autologous conduit necessitated an alternative solution and was chosen a composite femoro-anterior tibial artery bypass with successive ATA angioplasty to ensure the patency of graft. DISCUSSION: The autogenous vein is the preferred conduit in below-knee vascular reconstructions but in redo-procedures in the absence of vein, synthetic or biologic vascular prostheses must be considered as graft material. In these cases tibial angioplasty can improve the outflow and the patency. CONCLUSION: Composite Femoro-ATA bypass with tibial angioplasty is an alternative technique for critically ischemic legs with limited autologous vein material. In our experience this approach was safe and effective.

Mechanical rotational thrombectomy in long femoropopliteal artery and stent occlusion in COVID-19 patient: Case report.

INTRODUCTION: Coronavirus disease-19 (COVID-19) has been increasingly associated with thromboembolic complications. COVID-19 infection has a thrombogenic potential for stents. Herein, we report a case of stent thrombosis in diabetic obese patient COVID-19 positive where was previously released a Multilayer Flow Modulator stent (MFM) for large popliteal aneurysm. CASE REPORT: A 78-year-old male was referred to our hospital for fever and acute pain in the left leg. At history, the same patient had endovascular procedure for a large symptomatic popliteal aneurysm, treated through release of three MFM. The pulmonary CT scan showed COVID-19 infection with confirm of rhino-laryngeal swab. Duplex ultrasound and CT-angiography showed complete thrombosis of stents. The treatment consisted of mechanical thrombectomy using an 8Fr catheter Rotarex plus release of Vibahn stent-graft. DISCUSSION: COVID-19 patients can present arterial occlusion. In literature are not reported cases about thrombosis peripheral stent. Minimally invasive approaches in redo-procedure reduce risk of infection. Rotarex device was used in revascularization of acute and subacute iliac and femoropopliteal arteries. The goal is to have a debulking, to avoid an incomplete deployment of stent-graft. In our precedent experience, MFM and stent-graft to treatment of popliteal aneurism were safe. It is important to monitor these patients for early identification of failure and rapprochement. In this case, the COVID-19 infection was determinant in promoting thrombosis. CONCLUSIONS: COVID-19 increases risk of thrombosis stent. In our experience debulking through Rotarex and stenting, were decisive factors for revascularization and limb salvage.

Iliac-femoral stent-graft infection after hybrid procedure redo: Case report.

INTRODUCTION: Stent-graft infection in peripheral arteries is rare and potentially dangerous. The use of hybrid procedures, in complicated patients previously treated, involves an increase of infective risk especially in no collaborative patients. PRESENTATION OF CASE: We report a case of rare stent-graft infection in a patient treated for a Rutherford IV Multiple Peripheral Arterial Disease (MPAD) involving the right iliac-femoral axis with stenosis on deep femoral artery due to a previously stenting procedure for Superficial Femoral artery (SFA) stenosis. The first simultaneous hybrid intervention consisted of an endovascular iliac stent-graft placement and a surgical common femoral patch angioplasty. After two months the patient was readmitted to our unit for a purulent secretion through a fistulous channel and a suspect infection of stent-graft. Subsequently, the stent-graft was completely removed without possibility to have a surgical revascularization. An amputation major amputation was needed for irreversible ischemia of right leg. DISCUSSION: The incidence of stent-graft infection after endovascular aortic aneurysm repair had been reported as 0.4-1.0% while Aortoiliac graft infection occurs in 2-6% of patients. Hybrid procedures are secure and need close follow-up for cases of redo and patient with comorbidities. CONCLUSIONS: Graft infection is a rare complication after endovascular treatments. Hybrid procedures outcomes are good with less morbidity but in patient with high risk of infection is important a close follow-up.

Staged acute mesenteric and peripheral ischemia treatment in COVID-19 patient: Case report.

INTRODUCTION: COVID-19 is an infectious disease that has been associated not only with respiratory complications. The COVID-19 disease includes, also damage to other organ systems as well as coagulopathy. The present report describes a case of COVID-19 presenting with acute mesenteric ischemia (AMI) and subsequent acute limb ischemia (ALI). PRESENTATION OF CASE: An 84-years old hospitalized female patient presenting diabetes and recent COVID-19 reported acute onset of abdominal pain and typical findings of AMI. The CT-angiography confirmed the AMI secondary to a superior mesenteric artery (SMA) occlusion. The patient was managed through an endovascular approach using a SMA mechanical thrombectomy and stenting with a good result. DISCUSSION: Treatment of this life-threatening condition includes surgical resection of the necrotic bowel, restoration of blood flow to the ischemic intestine and supportive measure - gastrointestinal decompression, fluid resuscitation, hemodynamic support. Endovascular management of AMI is preferred over the standard surgical approach due to a reduced mortality and morbidity rates. Imaging findings of intestinal necrosis, however, represent an indication for AMI surgical treatment with explorative laparotomy. Different endovascular solutions have been employed to address AMI including mechanical thrombectomy, local thrombolysis, and PTA-stenting. CONCLUSION: COVID-19 clinical presentation can be atypical, including gastrointestinal symptoms. If a first embolic event occurs, an aggressive anticoagulation treatment could be inefficient to reduce the risk of subsequent embolization events. The limited life expectancy of such revascularization procedures should orientate towards less invasive treatments.

Type 1A endoleak detachable coil embolization after endovascular aneurysm sealing: Case report.

INTRODUCTION: Endovascular aneurysm sealing (EVAS) with the Nellix system was introduced to reduce endovascular aneurysm repair (EVAR) perioperative complications, especially endoleaks. Herein we report a case of successful type 1A endoleak managed with detachable coils embolization after EVAS. PRESENTATION OF CASE: A 77-year-old male was referred for abdominal pain. The angio-CT scan confirmed the previous EVAS procedure and showed a type Is2 endoleak below the right renal artery resulting in a 2.5 cm aortic blister with contrast medium filling the space between the aortic wall and the endobags. The patient was considered unfit for conventional open surgery and an endovascular approach with coil embolization Concerto Helix Detachable Coil System was chosen under local anesthesia. After intervention, a complete abdominal pain regression was registered. The 12- month CT follow-up showed endoleak sealing and Nellix system stability. DISCUSSION: EVAS has been associated to a high endoleaks and complications incidence when compared to EVAR. The EVAS different device concept led to a different endoleak classification and management. Endoleak management main options include the Nellix system explantation or the Nellix in Nellix application, however these are nearly always not applicable, respectively, due to the high surgical risk condition and the Nellix system availability, especially in emergent setting. Despite the use of coil embolization is controversial, this tool is off-the-shelf and leads to a disease resolution in most of patients without other surgical options. CONCLUSION: Proximal type Is2 embolization after EVAS is feasible with limited invasiveness.

A Single-Center Experience on Below-The-Knee Endovascular Treatment in Diabetic Patients.

Diabetic ulceration of the foot is a major global medical, social and economic problem and is the most frequent end-point of diabetic complications. A retrospective analysis from February 2017 to May 2019 of diabetic patients presenting below-the-knee artery disease (PAD) was carried out. Only patients treated with endovascular techniques as first choice treatment were evaluated. Outcome measured was perioperative mortality and morbidity. Freedom from occlusion, secondary patency and amputation rate were all registered. Additional maneuvers including stenting or angioplasty with drug eluting balloon (DEB) were reported. A total of 167 (101 male/66 female) patients with a mean age of 71 years were included in the study. A Rutherford 3, 4, 5 and 6 categories were reported in 5, 7, 110 and 45 patients, respectively. No perioperative mortality was reported. Morbidity occurred in 4 (4.4%) cases and consisted of pseudoaneurysm. Additional stenting during first procedure was required in 7 (4%) patients, drug eluting balloon was needed in 56 (33%) patients. At 1-year follow-up, estimated freedom from occlusion and secondary patency was 70% and 80% respectively. Major amputation rate was 2.4%, minor amputation rate was 41.9%. In our experience, extreme revascularization in search of distal direct flow reduce the rate of amputations with an increase in ulcer healing. New materials and techniques such as drug eluting technology, used properly, can improve outcome.

Endovascular Treatment with Drug-Eluting Balloon for Severe Subclavian Artery Stenosis Involving the Origin of the Vertebral Artery.

The first line approach for subclavian steal syndrome is PTA-stenting of subclavian artery. When the ipsilateral vertebral artery origin is involved or in closed proximity of the atherosclerotic lesion in the subclavian artery PTA-stenting is at risk of ipsilateral vertebral artery coverage. Herein we report our experience with DEB to address lesions involving the subclavian artery and the origin of the ipsilateral vertebral artery. From January 2017 to February 2019, patients presenting subclavian artery lesion involving the origin of the ipsilateral vertebral artery and treated using primary DEB, were included. Three patients, with left subclavian steal syndrome, were identified. The perioperative mortality and morbidity were outcomes evaluated. Freedom from occlusion, secondary patency, amputation rate was registered. A total of 3 (2 female) patients were included in the study. No complication, symptoms recurrence, restenosis or occlusion were reported at duplex scan during 12-month follow-up. Indication for stenting was arterial dissection. In our limited experience, the use of DEB in association to embolic protection device in the treatment of atherosclerotic subclavian lesion involving the origin of the vertebral artery was safe and technically feasible.

Treatment of de novo femoro-popliteal lesions with a new Drug Coated Balloon: early experience of a single Center in the first 50 patients.

Angioplasty with drug-coated balloon (DCB) is an emerging and reliable method for the treatment of femoro-popliteal lesions. We report our experience with the Stellarex™ DCB in the first 50 patients. METHODS: From July 2015 to November 2017, 50 patients (41 M, 9F), medium age (64 ± 7.4 year) were subject to 33 angioplasties (PTAs) for femoro-popliteal lesions with a paclitaxel-coated balloon (Stellarex™). Based upon clinical data sixteen patients had severe claudication (56% - Rutherford class 3); ten patients suffered from ischemic rest pain (34% - Rutherford class 4); and five presented minor tissue loss (10% - Rutherford class 5). 42% of patients showed femoro-popliteal lesion TASC-II B, and 58% presented lesions pertaining to TASC-II C. RESULTS: Immediate technical success was 100% without perioperative complications. Primary patency rate was 94% at twelve months. In three cases restenosis (6%) was detected within a year from procedure, and a further PTA DCB was performed with primary assisted patency rates of 100% at twelve months. Two patients underwent major lower limb amputation. Three patients died during follow-up and one patient was lost at follow-up. CONCLUSION: DCB angioplasty with Stellarex™ is a viable alternative to traditional endovascular procedures proving satisfactory primary patency rates at twelve months. Based on our experience, treatment with DCB is a first choice technique for non-complex de novo lesions of the femoro - popliteal tract.

Mid-term Results of Chimney and Periscope Grafts in Supra-aortic Branches in High Risk Patients.

PURPOSE: Report mid-term outcomes of thoracic endovascular aneurysm repair (TEVAR) with chimney and periscope grafts (CPG) in supra-aortic branches (SAB). METHODS: Retrospective analysis, from October 2009 to May 2014, of patients with aneurysms requiring TEVAR with zone 0/1/2 proximal landing in association with at least one CPG in the SAB. All patients were considered at high risk for conventional surgery. Peri-operative mortality and morbidity, retrograde type A dissection, maximum aortic transverse diameter (TD) and its post-operative evolution, endoleak, survival, freedom from cardiovascular re-interventions, and CPG freedom from occlusion during the follow-up were analysed. RESULTS: Forty-one patients (28.05% EuroScore II) with thoraco-abdominal aortic aneurysm (17%), arch aneurysm (39%), descending aneurysm (34%), and aneurysm extending from the arch to the visceral aorta (10%) were included. Fifteen (37%) patients were treated non-electively. Fifty-nine SABs were treated with the CPG technique: one, two, three, and four CPG were employed in 71%, 19%, 5%, and 5% of patients, respectively. The proximal landing was in zone 0 in 49% of patients, zone 1 in 17%, and zone 2 in 34%. Technical success was 95%. Peri-operative complications and neurological events were registered in six (14.6%) patients and there were 5 deaths (12%). At a median follow-up of 21.2 (mean 22, SD 18; range 0-65) months, type I/III endoleaks were registered in three (7%) cases and re-intervention in six (15%) patients. A significant aneurysm sac shrinkage (p<.001) was reported at mean follow-up and no significant aneurysm sac increase (>5 mm). The estimated 2 year survival, freedom from re-intervention, freedom from endoleak, and freedom from branch occlusion were 75%, 77%, 86%, and 96%, respectively. CONCLUSION: The chimney and periscope grafts technique was shown to be safe in aortic aneurysm disease involving the supra aortic branches, even in an emergency setting using off the shelf devices. Mid-term follow-up results in this high risk population are good, but longer follow-up is mandatory before this technique is used in intermediate-risk patients.

Mid- and Longer-term Follow up of Chimney and/or Periscope Grafts and Risk Factors for Failure.

OBJECTIVE: The aim was to report on chimney and periscope grafts (CPGs) and their mid- and longer-term outcomes when they are used to preserve reno-visceral artery (RVA) perfusion in endovascular repair of pararenal (PRAAs) or thoraco-abdominal aortic aneurysm (TAAAs). In addition, factors associated with CPG failure are presented. Limited data exist on the outcomes of CPGs, and mid- and long-term results are generally not reported. METHODS: This was a prospective study in a cohort of 100 patients with PRAA (69) or TAAA (31). A total of 224 (mean 2.24 per patient) RVAs were preserved with 136 (61%) chimney and 88 (39%) periscope grafts. CPGs were constructed mainly using self expandable stent grafts. Patients were followed by clinical examination, CTA (82%), and/or duplex (18%). Data were collected until February 2015. RESULTS: CPG immediate technical success was 99% (222/224 branches). Mean follow up was 29 months (range 0-65; SD 17); 59% patients were followed > 2 years, 30% > 3 years, and 16% > 4 years. Post-operatively, CPG occlusion was observed early (≤30 days) in three (1.3%) branches and during follow up in 10 (4.5%). At 36 and 48 months, the estimated primary patency was 93% and 93%. After corrective percutaneous (10) or surgical (3) re-interventions, the estimated secondary patency was 96% and 96%. Thirty day mortality was 2%; at 36 and 48 months the estimated patient survival was 79%. Significant shrinkage (72 [SD 23] vs. 62 [SD 24] mm; p < .001) was observed, with a substantial reduction (>5 mm) in 55 patients, and sac enlargement in four. Incomplete aneurysm sac sealing was treated successfully by a secondary intervention in 15 patients. CONCLUSIONS: Self expandable CPGs have proved to be a highly successful and durable treatment for RVA preservation up to 5 years. Incomplete CPG expansion, inadequate length, and CPG use in small and diseased target arteries were risk factors for occlusion. These mid- and longer-term results support CPG use to treat PRAAs or TAAAs in patients unfit for open surgery or fenestrated/branched stent grafts.

How to diagnose and treat abdominal compartment syndrome after endovascular and open repair of ruptured abdominal aortic aneurysms.

Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) are frequently encountered in patients treated for ruptured abdominal aortic aneurysms (rAAA) and carry a high morbidity and mortality risk. Despite these facts, IAH/ACS are still overlooked by many physicians, timely diagnosis is missed and treatment often inadequate. All staff involved in the treatment of rAAA should be aware of the risk factors predicting IAH/ACS, the profound implications and derangements on all organ systems, the clinical presentation, the appropriate measurement of intra-abdominal pressure to detect IAH/ACS and the current treatment options for these detrimental syndromes. This comprehensive review provides contemporary knowledge that should help to improve patient survival and long-term outcome.

The integration of the risk management process with the lifecycle of medical device software.

OBJECTIVES: The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. METHODS: A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. RESULTS: This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. CONCLUSIONS: Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

Less invasive (common) femoral artery aneurysm repair using endografts and limited dissection.

OBJECTIVE: We report our experience with the treatment of femoral artery aneurysms (FAAs) under local anaesthesia with limited dissection, using endografts to facilitate the proximal anastomosis and some distal anastomoses. METHOD: Between January 2006 and December 2010, six males, mean age 72 years (range, 65-80 years) with FAAs were treated at the University Hospital of Zurich. All operations were performed under local anaesthesia with analgosedation, except for one performed under spinal anaesthesia. After limited dissection and puncture of the anterior wall of the FAA, a sheath and a self-expanding endograft were introduced over a guide wire and with fluoroscopy they were guided intraluminally into the proximal normal neck of the FAA and deployed. Proximal arterial control was achieved with a balloon catheter introduced through the endograft. Then the FAAs were opened and distal arterial control is obtained with balloon catheters. The distal end of the stent graft was then sutured to the normal-sized distal arteries or to stent grafts placed within them. RESULTS: Of the six FAAs, four were true and two were false anastomotic aneurysms. Mean FAA diameter was 5.0 cm (range, 3.0-6.5 cm). Four patients also had aneurysmal involvement of the external iliac artery, one patient also had deep femoral aneurysms, but deep femoral circulation was always preserved. In three of the patients, the distal anastomosis was created to the femoral artery bifurcation, in two patients to the deep femoral artery when the superficial femoral artery (SFA) was chronically occluded and in one patient to the SFA. Immediate technical success was achieved in all six patients, and graft patency was observed from 9 to 48 months (mean 29 months). There were no amputations, complications or deaths. CONCLUSION: This technique for repair of FAAs can be performed under local anaesthesia, minimises dissection and complications and simplifies exclusion of these lesions. It is of particular value in high-risk patients with large FAAs.