Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study.

BACKGROUND: The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™. METHODS AND DESIGN: This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months. DISCUSSION: The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD. TRIAL REGISTRATION: #DRKS00029947 (who.int). PROTOCOL APPROVAL ID: #22-0047(Ethics Committee at Ludwig-Maximilians-University Munich).

Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™".

PURPOSE: To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. METHODS: This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. RESULTS: Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46-91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20-70 cm) with a median diameter of 5.0 mm (range 3-6 mm) and 4.0 mm (range 2-6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). CONCLUSION: The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD.

[Atherectomy with a Novel Device Offering Wider Options]. / Atherektomie mit einem neuen System, das noch mehr kann.

Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of multifunctional atherectomy devices for complex lesion morphologies, with moderate material use. This is then thus an alternative to bypass surgery, although a direct comparison is lacking.The results of the ByCross approval study were compared to technical and clinical data from various atherectomy systems in terms of range of indication, limitations as defined by the manufacturer, the success and complication rate and the instructions for use. As in many recent studies, a residual stenosis ≤ 50% after atherectomy and ≤ 30% in the completion imaging was defined as the primary endpoint and proof of technical success.Lesions recruited for the ByCross study were more complex than in other studies, with respect to the lesion length (124.7 mm vs. 34 mm in the EASE study and 67.2 mm in the VISION study) and the degree of stenosis (99.4% vs. 88.5% in the EASE and 78,7% in the VISION study). Calcification was also more severe - as defined by the PACSS (Peripheral Artery Calcification Severity Score). ByCross allowed recanalisation of lesions without wire passage prior to atherectomy (26.82%), which is a must for all other systems. The variable tip diameter of the ByCross can achieve a lumen gain of 4.7 mm without tip or wire exchange or run time limits. The 0% rate of embolic events, which is unique for atherectomy device approval studies, can be explained by the working principle and the high aspiration rate. No vessel injuries occurred, and the 6-month follow-up results showed 0% revascularisation rate.New generation atherectomy systems offer safe and effective enlargement of the endovascular portfolio. The ByCross device is an atherectomy, thrombectomy and crossing device free from investment and has a wider range of indications for the iliac and the femorodistal segments, which supports ByCross atherectomy as an alternative for bypass surgery.

German nation-wide in-patient treatment of abdominal aortic aneurysm-trends between 2005 and 2019 and impact of the SARS-CoV-2 pandemic.

PURPOSE: Aim of this study was to analyze hospitalizations due to ruptured and non-ruptured abdominal aortic aneurysms (rAAA, nrAAA) in Germany between 2005 and 2021 to determine long-term trends in treatment and the impact of the SARS-CoV-2 pandemic. MATERIALS AND METHODS: Fully anonymized data were available from the research data center (RDC) of the German Federal Statistical Office (Destatis). All German hospitalizations with the ICD-10 code "I71.3, rAAA" and "I71.4, nrAAA" in 2005 and 2010-2021 were analyzed. RESULTS: We report data of a total of 202,951 hospitalizations. The number of hospitalizations increased from 2005 to 2019 (14,075 to 16,051, + 14.0%). The rate of open repair (OR) constantly decreased, whereas the rate of endovascular aortic repair (EVAR) increased until 2019. During the pandemic, the number of hospitalizations due to nrAAA dropped from 13,887 (86.5%) in 2019 to 11,278 (85.0%) in 2021. The strongest decrease of hospitalizations for AAA was observed during the first wave of the SARS-CoV-2-pandemic in spring 2020 (-25.5%). CONCLUSION: Over the past decades, we observed an increasing number of hospitalizations due to AAA accompanied by a shift from OR to EVAR especially for nrAAA. During the lockdown measures due to the SARS-CoV-2-pandemic, a decrease in hospitalizations for nrAAA (but not for rAAA) was shown in 2020 and furthermore in 2021 with no rebound of treatment of nrAAA suggesting an accumulation of untreated AAA with a potentially increased risk of rupture.

Combining Endovascular Aneurysm Sealing with Chimney Grafts - 5 Year Follow-Up after 47 Procedures.

BACKGROUND: To evaluate longer-term results of a cohort treated with primary chimney endovascular aneurysm sealing (ChEVAS) for complex abdominal aortic aneurysms or secondary ChEVAS after failed endovascular aneurysm repair/endovascular aneurysm sealing. METHODS: A single-center study was conducted of 47 consecutive patients (mean age 72 ± 8 years, range 50-91; 38 men) treated with ChEVAS from February 2014 to November 2016 and followed through December 2021. The main outcome measures were all-cause mortality (ACM), aneurysm-related mortality, occurrence of secondary complications and conversion to open surgery. Data are presented as the median (interquartile range [IQR]) and absolute range. RESULTS: 35 patients received a primary ChEVAS (=group I) and 12 patients a secondary ChEVAS (=group II). Technical success was 97% (group I) and 92% (group II); 30-day mortality was 3% and 8%, respectively. The median proximal sealing zone length was 20.5 mm (IQR 16, 24; range 10-48) in group I and 26 mm (IQR 17.5, 30; range 8-45) in group II, respectively. During a median time of follow-up of 62 months (range 0-88), ACM amounted to 60% (group I) and 58% (group II); aneurysm mortality was 29% and 8%, respectively. An endoleak was seen in 57% (group I: 15 type Ia endoleaks, four isolated type Ib, and 1 endoleak type V) and 25% (group II: 1 endoleak type Ia, one type II, and 2 type V), aneurysm growth in 40% and 17%, migration in 40% and 17%, resulting in 20% and 25% conversions in group I and II, respectively. Overall a secondary intervention was performed in 51% (group I) and 25% (group II), respectively. The occurrence of complications did not significantly differ between the 2 groups. Neither the number of chimney grafts, nor the thrombus ratio significantly affected the occurrence of abovementioned complications. CONCLUSIONS: While initially delivering a high technical success rate, ChEVAS fails to provide acceptable longer-term results both in primary and secondary ChEVAS, resulting in high rates of complications, secondary interventions and open conversions.

Strategies for Avoiding Typical Drug-Drug Interactions and Drug-Related Problems in Patients with Vascular Diseases.

Background and objectives: Drug-drug interactions and drug-related problems in patients with vascular diseases are common. To date, very few studies have focused on these important problems. The aim of the present study is to investigate the most common drug-drug interactions and DRPs in patients with vascular diseases. Materials and Methods: The medications of 1322 patients were reviewed manually in the time period from 11/2017 to 11/2018; the medications of 96 patients were entered into a clinical decision support system. Potential drug problems were identified, and a read-through consensus was reached between a clinical pharmacist and a vascular surgeon during the clinical curve visits; possible modifications were implemented. The focus was on additional dose adjustment and drug antagonization on drug interactions. Interactions were classified as contraindicated/high-risk combination (drugs must not be combined), clinically serious (interaction can be potentially life-threatening or have serious, possibly irreversible consequences), or potentially clinically relevant and moderate (interaction can lead to therapeutically relevant consequences). Results: A total of 111 interactions were observed. Of these, 6 contraindicated/high-risk combinations, 81 clinically serious interactions, and 24 potentially clinically relevant and moderate interactions were identified. Furthermore, 114 interventions were recorded and categorized. Discontinued use of the drug (36.0%) and drug dose adjustment (35.1%) were the most common interventions. Mostly, antibiotic therapy was continued unnecessarily (10/96; 10.4%), and the adjustment of the dosage to kidney function was overlooked in 40/96; 41.7% of the cases. In the most common cases, a dose reduction was not considered necessary. Here, unadjusted doses of antibiotics were found in 9/96, 9.3% of the cases. Notes for medical professionals summarized information that did not require direct intervention but rather increased attention on the part of the ward doctor. It was usually necessary to monitor laboratory parameters (49/96, 51.0%) or the patients for side effects (17/96, 17.7%), which were expected with the combinations used. Conclusions: This study could help identify problematic drug groups and develop prevention strategies for drug-related problems in patients with vascular diseases. A multidisciplinary collaboration between the different professional groups (clinical pharmacists and surgeons) might optimize the medication process. Collaborative care could have a positive impact on therapeutic outcomes and make drug therapy safer for patients with vascular diseases.

Technical aspects of percutaneous endovascular arteriovenous fistula creation with the Ellipsys® Vascular Access System. Preliminary results after 16 patients.

PURPOSE: Technical aspects are crucial for planning and performing endovascular arteriovenous fistula (AVF) creation. The Ellipsys® Vascular Access System represents a minimal invasive method for the creation of a proximal forearm fistula. This report summarizes the essential elements for AVF creation with the Ellipsys® Vascular Access System and investigates feasibility, efficacy, and safety procedures conducted on 16 patients. MATERIALS AND METHODS: We performed a retrospective analysis of patients who underwent endovascular AVF creation with the Ellipsys® Vascular Access System between May 2020 and March 2022 at a tertiary referral center. RESULTS: The median age was 67.5 years (47-86 years). The mean BMI was 31.4 kg/m2. AV fistula was created on 15/16 patients on their left arm. The technical success was 100%. The mean operation time was 24.2 min. There were no complications associated with the procedure. All patients were examined after 30 days (± 5 days). Primary patency after 30 days was 94% (15/16). The mean fistula flow was 681.1 mL/min and the mean AVF diameter was 6.1 mm. Thirteen out of 15 patients met the criteria for potential hemodialysis. CONCLUSION: With the Ellipsys Vascular Access System exist an additional possibility of an AV fistula creation. Based on above findings, the Ellipsys® Vascular Access System represents a feasible, safe, and effective method for AVF creation.

Open Conversion After Endovascular Aneurysm Sealing: Technical Features and Clinical Outcomes in 44 Patients.

PURPOSE: To evaluate the technical features and clinical results after open conversion for complications following endovascular aneurysm sealing (EVAS). MATERIALS AND METHODS: From July 2013 to February 2020, 44 patients (mean age 72±8 years; 36 men) underwent an open conversion due to EVAS complications in a single center. Data were collected on patient characteristics, reasons for conversion, characteristics and duration of the procedure, condition of the polymer, blood loss, time in the intensive care unit (ICU), and intra/postoperative complications. The main outcome measure was mortality at 30 days and in follow-up. Data are presented as the median (IQR) and absolute range. RESULTS: On average, the open conversion took place 3 years after the initial EVAS implantation [median 37 months (IQR 23, 50); range 0-64]. Most patients were converted due migration (82%), aneurysm growth (77%), and/or endoleak (75%), with 21 patients (48%) having all 3 events. Less frequent diagnoses were aneurysm rupture (n=7), aortic infection (n=3), technical failure during implantation (n=2), and graft thrombosis (n=1). The majority of patients (n=26) were asymptomatic and converted electively, but 9 were operated on urgently and 9 emergently (7 late rupture and 2 due to technical failure). The median procedure duration was 178 minutes (IQR 149, 223; range 87-417), the median blood loss was 1100 mL (IQR 600, 2600; range 300-5000). Polymer degradation was mentioned in the operative reports of 18 cases (41%). Patients stayed a median of 3 days (IQR 2, 7; range 1-35) in the ICU, while the median length of stay in the hospital was 14 days (IQR 10, 20; range 0-93). The 30-day mortality was 23% (n=10). During a median follow-up of 3 months (IQR 0, 11; range 0-38), no additional deaths occurred, but 12 patients suffered from an adverse event. There were 3 cases of wound dehiscence after laparotomy, 2 cases of leg ischemia, 2 cases of renal failure, and individual cases of urinary obstruction, urinoma, paralytic ileus, gastrointestinal bleeding, and postoperative delirium. A non-elective setting was associated with a significantly increased mortality of 33% in urgent cases and 56% in emergent cases (p=0.007). Based on these results an algorithm for the management of EVAS complications was developed. CONCLUSION: The significantly increased mortality associated with nonelective conversions highlights the need for active surveillance. The presented algorithm offers a structured tool to avoid emergency conversions.