Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany.

BACKGROUND: Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. METHODS: Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph's Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. DISCUSSION: Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05665101. Registered on 23 December 2022.

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.

The prevalence of vascular complications in SARS-CoV-2 infected outpatients.

BACKGROUND: The risk of thromboembolic events is increased for coronavirus disease (COVID)-19 inpatients. For severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected outpatients, only few data are available so far. METHODS: In our prospective single-center study, 461 SARS-CoV-2-infected outpatients were screened for the presence of deep vein thrombosis. RESULTS: Two outpatients had suffered a deep vein thrombosis. An association with previously known risk factors, such as preexisting thrombosis in the medical history or cardiovascular risk factors, could not be proven. CONCLUSION: General thromboprophylaxis in SARS-CoV-2-infected outpatients is still not recommended.

Two-year follow-up after treatment of an aortic transection in the presence of an aberrant right subclavian artery.

OBJECTIVES: An aberrant right subclavian artery (ARSA) is one of the most common anatomic variants of the aortic arch. The combination of an ARSA and a transection is naturally rare. METHODS: This case report describes the treatment of a transection in the presence of an ARSA and the follow-up of two years. RESULTS: We successfully treated the contained rupture with a stentgraft. Both subclavian arteries had to be covered in the emergency setting. At the two-year follow-up, the patient did not suffer from any neurological impairment. CONCLUSIONS: In emergency settings, primary cover of both subclavian arteries with a stentgraft can be performed in individual cases after risk assessment. Severe complications such as development of upper limb ischaemia, ASAS or reduced perfusion of the posterior cerebral circulation should be considered in treatment planning.

Determination of the influence of weather and air constituents on aortic aneurysm ruptures.

In this article, we present a method to determine the influence of meteorology and air pollutants on ruptured aortic aneurysm (rAA). In contrast to previous studies, our work takes into account highly resolved seasonal relationships, a time-lagged effect relationship of up to two weeks, and furthermore, potential confounding influences between the meteorological and air-hygienic variables are considered and eliminated using a cross-over procedure. We demonstrate the application of the method using the cities of Augsburg and Munich in southern Germany as examples, where a total of 152 rAA can be analyzed for the years 2010-2019. With the help of a Wilcoxon rank-sum test and the analysis of the atmospheric circulation, typical weather situations could be identified that have an influence on the occurrence of rAA in the southern German region. These are a rainy northwest wind-type in spring, humid weather in summer and warm southwest wind-type weather in autumn and winter.

Iatrogenic injury of the popliteal artery in orthopedic knee surgery: clinical results and development of a therapeutic algorithm.

PURPOSE: Intraoperative injury to the popliteal artery is a rare complication of orthopedic surgery, however, it can have serious consequences, including major amputation. Recommendations for a standard approach are lacking. The aim of this study was to develop an interdisciplinary therapeutic algorithm to assist in complication management. METHODS: From 01/11 to 12/20, 16 arterial injuries after knee surgery were analyzed in a retrospective single-center study. Four cases involved recurrent orthopedic surgery. Procedures performed included eleven total knee arthoplasties (TKA), two TKA replacements, one arthroscopy, and two high tibial osteotomies. Clinical presentation of patients was hemorrhage (n = 2), ischemia (n = 7), the combination of both (n = 4), or pseudoaneurysm formation (n = 3). RESULTS: Ten patients underwent endovascular treatment, some as combined procedures: (stent)-PTA (n = 6), aspiration thrombectomy (n = 5), thrombin injection (n = 1), and embolization (n = 1). Six patients were treated surgically: four with bypass/interposition and one with a patch plasty and one as a hybrid procedure, respectively. Only autologous great saphenous vein was used. All extremities could be preserved. Functional impairment remained in six cases. CONCLUSION: Both endovascular and surgical procedures can be used to treat arterial injuries after knee surgery. Efficient standardized diagnosis and the involvement of vascular expertise are essential to prevent functional impairment or limb loss, as suggested in the algorithms.

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.

Preliminary outcome of Nellix-in-Nellix extensions in patients treated with failed endovascular aneurysm sealing.

BACKGROUND: The 1-year results of the use of the Nellix (Endologix Inc, Irvine, Calif) endovascular aneurysm sealing (EVAS) device were initially promising. However, midterm complications including migration and aneurysm growth occurred more frequently than expected, which provided an incentive to refine the instructions for use. Strategies for the management of complications arising after endovascular aneurysm repair are often not applicable for EVAS, given the unique configuration of the Nellix device, and new techniques are needed. This study analyzes the clinical outcomes of both elective and emergency deployment of a new Nellix device within a primarily placed device, for failure of EVAS, which we refer to as a Nellix-in-Nellix application (NINA). METHODS: This is a global, retrospective, observational cohort study focusing on the early outcome of NINA for failed EVAS, including data from 11 European institutions and 1 hospital in New Zealand. RESULTS: A total of 41 patients were identified who underwent a NINA procedure. Of these, 32 (78%) were placed electively and 9 (22%) were placed on an emergency basis. Seven patients were initially treated with chimney EVAS (n = 5 in the elective NINA group and n = 2 in the emergency NINA group). The average time between the primary EVAS procedure and NINA was 573 days (interquartile range, [IQR] 397-1078 days) and 478 days (IQR, 120-806) for the elective and emergency groups, respectively. The indication for elective NINA was endoleak with migration (50%), endoleak without migration (25%), migration without endoleak (16%), and other (9%). Chimney grafts were used in 21 of 32 patients in the elective group and 3 of 9 patients in the emergency group. Technical success was achieved in 94% of patients in the elective group and 100% of patients in the emergency group. At latest follow-up (median, 104 days; IQR, 49-328 days), there were three aneurysm-related deaths (9%), no ruptures, and five device-related reinterventions (16%) within the elective group. In the emergency group (median follow-up, 23 days; IQR, 7-61 days), there were four aneurysm-related deaths and three aneurysm-related reinterventions. CONCLUSIONS: In conclusion, a NINA can be used to treat late failures of EVAS with an acceptable technical success rate and can be used when more established treatment options are unfeasible or contraindicated. The durability of this technique needs to be further reviewed.