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1.
J Vasc Surg ; 79(5): 1179-1186.e1, 2024 May.
Article in English | MEDLINE | ID: mdl-38145634

ABSTRACT

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.


Subject(s)
Aortic Aneurysm, Abdominal , Arterial Occlusive Diseases , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Popliteal Artery Aneurysm , Male , Humans , Female , Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Blood Vessel Prosthesis Implantation/adverse effects , Arterial Occlusive Diseases/surgery , Popliteal Artery/diagnostic imaging , Popliteal Artery/surgery , Treatment Outcome , Retrospective Studies , Risk Factors
2.
Vasa ; 53(2): 129-134, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38319124

ABSTRACT

Background: Smoking represents the well-known enemy of vascular well-being. Numerous previous studies emphasised the important role of smoking on the development and progression of atherosclerotic cardiovascular disease. The current study aimed to identify hurdles and barriers for an insufficient implementation of secondary prevention in the treatment of lower extremity peripheral arterial disease (PAD). Methods: All members of the German Society for Vascular Surgery and Vascular Medicine (DGG) with valid email addresses were invited to participate in an electronic survey on smoking. Results are descriptively presented. Results: Amongst 2716 invited participants, 327 (12%) submitted complete responses, thereof 33% women and 80% between 30 and 59 years old (87% board certified specialists). 83% were employed by hospitals (56% teaching hospital, 14% university, 13% non-academic) and 16% by outpatient facilities. 6% are active smokers (63% never) while a mean of five medical education activities on smoking cessation were completed during the past five years of practice. Only 27% of the institutions offered smoking cessation programs and 28% of the respondents were aware of local programs while a mean of 46% of their patients were deemed eligible for participation. 63% of the respondents deemed outpatient physicians primarily responsible for smoking cessation, followed by medical insurance (26%). Conclusions: The current nationwide survey of one scientific medical society involved in the care of patients with vascular disease revealed that smoking cessation, although being commonly accepted as important pillar of comprehensive holistic care, is not sufficiently implemented in everyday clinical practice.


Subject(s)
Peripheral Arterial Disease , Smoking Cessation , Surgeons , Humans , Female , Adult , Middle Aged , Male , Smoking Cessation/methods , Risk Factors , Smoking/adverse effects , Smoking/epidemiology , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/epidemiology , Peripheral Arterial Disease/surgery
3.
Vascular ; 31(4): 644-653, 2023 Aug.
Article in English | MEDLINE | ID: mdl-35404720

ABSTRACT

OBJECTIVES: The objective is to evaluate the feasibility and interobserver agreement of a Mixed Reality Viewer (MRV) in the assessment of aortoiliac vascular anatomy of abdominal aortic aneurysm (AAA) patients. METHODS: Fifty preoperative computed tomography angiographies (CTAs) of AAA patients were included. CTAs were assessed in a mixed reality (MR) environment with respect to aortoiliac anatomy according to a standardized protocol by two experienced observers (Mixed Reality Viewer, MRV, Brainlab AG, Germany). Additionally, all CTAs were independently assessed applying the same protocol by the same observers using a conventional DICOM viewer on a two-dimensional screen with multi-planar reconstructions (Conventional viewer, CV, GE Centricity PACS RA1000 Workstation, GE, United States). The protocol included four sets of items: calcification, dilatation, patency, and tortuosity as well as the number of lumbar and renal arteries. Interobserver agreement (IA, Cohen's Kappa, κ) was calculated for every item set. RESULTS: All CTAs could successfully be displayed in the MRV (100%). The MRV demonstrated equal or better IA in the assessment of anterior and posterior calcification (κMRV: 0.68 and 0.61, κCV: 0.33 and 0.45, respectively) as well as tortuosity (κMRV: 0.60, κCV: 0.48) and dilatation (κMRV: 0.68, κCV: 0.67). The CV demonstrated better IA in the assessment of patency (κMRV: 0.74, κCV: 0.93). The CV also identified significantly more lumbar arteries (CV: 379, MRV: 239, p < 0.01). CONCLUSIONS: The MRV is a feasible imaging viewing technology in clinical routine. Future efforts should aim at improving hologram quality and enabling accurate registration of the hologram with the physical patient.


Subject(s)
Aortic Aneurysm, Abdominal , Augmented Reality , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Observer Variation , Feasibility Studies , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Blood Vessel Prosthesis Implantation/methods , Treatment Outcome , Retrospective Studies
4.
Vasa ; 52(3): 160-168, 2023 May.
Article in English | MEDLINE | ID: mdl-36891667

ABSTRACT

Background: To investigate the usability of Mixed-Reality (MR) during patient education in patients scheduled for abdominal aortic aneurysm (AAA) repair. Patients and methods: Consecutive patients scheduled for elective AAA repair were block-randomized in either the Mixed-Reality group (MR group) or the conventional group (control group). Patients of both groups were educated about open and endovascular repair of their respective AAA. The MR group was educated using a head-mounted display (HMD) demonstrating a three-dimensional virtual reconstruction of the respective patient's vascular anatomy. The control group was educated using a conventional two-dimensional monitor to display the patient's vasculature. Outcomes were informational gain as well as patient satisfaction with the educational process. (DRKS-ID: DRKS00025174). Results: 50 patients were included with 25 patients in either group. Both groups demonstrated improvements in scores in the Informational Gain Questionnaire (IGQ) when comparing pre- and post-education scores. (MR group: 6.5 points (±1.8) versus 7.9 points (±1.5); Control group: 6.2 points (±1.8) versus 7.6 points (±1.6); p<0.01) There was no significant difference between the MR group and the control group either in informational gain (MR group: 1.4±1.8; Control group: 1.4±1.8; p=0.5) nor in patient satisfaction scores (MR group: mean 18.3 of maximum 21 points (±3.7); Control group: mean 17 of 21 points (±3.6); p=0.1) Multiple regression revealed no correlation between the use of MR and informational gain or patient satisfaction. Usability of the system was rated high, and patients' subjective assessment of MR was positive. Conclusions: The use of MR in patient education of AAA patients scheduled for elective repair is feasible. While patients reported positively on the use of MR in education, similar levels of informational gain and patient satisfaction can be achieved with MR and conventional methods.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/etiology , Blood Vessel Prosthesis Implantation/adverse effects , Elective Surgical Procedures , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Patient Education as Topic , Retrospective Studies , Risk Factors , Treatment Outcome
5.
J Endovasc Ther ; 29(3): 370-380, 2022 06.
Article in English | MEDLINE | ID: mdl-34632839

ABSTRACT

OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHODS: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6-67.0) and was completed in 91.2% (177/194) of patients. RESULTS: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76-0.70]) and 56.6% (95% CI = [0.57-0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07-0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21-0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004-0.05]) and 3.9% (95% CI = [0.007-0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. CONCLUSIONS: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Diseases , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aortic Aneurysm, Thoracic/complications , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Diseases/diagnostic imaging , Aortic Diseases/surgery , Blood Vessel Prosthesis/adverse effects , Humans , Male , Middle Aged , Postoperative Complications/etiology , Retrospective Studies , Stents/adverse effects , Time Factors , Treatment Outcome
6.
J Endovasc Ther ; : 15266028221109455, 2022 Jul 12.
Article in English | MEDLINE | ID: mdl-35822261

ABSTRACT

PURPOSE: The objective of this systematic review was to report the cumulative incidence of endograft migration (EM), as well as the morbidity, reintervention rates, and mortality related to EM. This study aimed to provide evidence-based data on patient-relevant sequelae of EM after thoracic endovascular aortic repair (TEVAR) performed using contemporary aortic endografts. MATERIALS AND METHODS: A systematic electronic search of literature in MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials was performed. The pooled synthesis of outcomes was performed using the inverse variance method. RESULTS: Seven prospective non-randomized and 4 retrospective studies, including a total of 1783 patients presenting 70 EMs, were considered for the quantitative analysis. The pooled rate of EM was 4% (95% CI, 2%-7%; range, 0.2%-11%; I2=82%); pooled morbidity rate was 31% (95% CI, 12%-59%; range, 0%-100%; I2=64%) and pooled reintervention rate was 32% (95% CI, 15%-56%; range, 0%-100%; I2=55%). The pooled mortality rate due to EM was 5% (95% CI, 1%-21%; range, 0%-40%; I2=24%). CONCLUSION: For the first time, this meta-analysis provides pooled reference estimates of EM after TEVAR. Thus, the results hold the potential to further characterize EM after TEVAR. The clinical relevance of EM is underlined by its association with high rates of endoleak-related morbidity, reintervention, and mortality. Close standardized surveillance after TEVAR for early detection of EM and prophylaxis of its sequelae is essential.

7.
Eur J Vasc Endovasc Surg ; 64(4): 407-415, 2022 10.
Article in English | MEDLINE | ID: mdl-35963514

ABSTRACT

OBJECTIVE: New onset aspirin resistance during surgery, known as peri-operative aspirin resistance, is observed in up to 30% of vascular surgery patients and is associated with post-operative myocardial damage; questioning aspirin effectiveness towards peri-operative cardiovascular events. The objective of this study was to prospectively evaluate whether peri-operative aspirin resistance in vascular surgery is associated with an adverse cardiovascular outcome. METHODS: Based on a sample size calculation, 194 adult elective vascular or endovascular surgery patients receiving aspirin were analysed in this prospective, single centred, non-interventional cohort study. Platelet function was measured before surgery, one hour after incision, four hours post-operatively, and on the morning of the first and second post-operative days using the Multiplate analyser. The primary outcome was myocardial injury after non-cardiac surgery (MINS). Secondary outcomes included major bleeding, admission to intensive care unit, length of hospital stay, and major adverse cardiac and cerebrovascular events. Subgroup analyses were performed for patients with different cardiovascular risk and for patients who underwent endovascular surgery. RESULTS: Peri-operative aspirin resistance was observed in 27.8% of patients but was not associated with MINS (27.8% vs. 32.1%, aspirin resistance vs. no aspirin resistance, OR 0.812, 95% CI 0.406 - 1.624, p = .56) or with any of the secondary endpoints (all p > .050). In nine of the 10 subgroup analyses, aspirin resistance was not associated with a difference in MINS rate. However, in patients with a low cardiovascular risk profile (RCRI 0-2), MINS occurred more frequently in patients without aspirin resistance (p = .049). CONCLUSION: This study confirmed previous reports demonstrating that peri-operative aspirin resistance is common in patients undergoing vascular or endovascular surgery. However, in patients who continue aspirin throughout the peri-operative period, aspirin resistance is a phenomenon, which does not appear to be related to MINS. Measuring peri-operative platelet function using the Multiplate analyser with the intention to identify and potentially prevent or treat peri-operative aspirin resistance seems to be dispensable.

8.
Thorac Cardiovasc Surg ; 70(4): 314-322, 2022 06.
Article in English | MEDLINE | ID: mdl-33580489

ABSTRACT

BACKGROUND: The treatment of extensive thoracic/thoracoabdominal aortic pathologies with arch involvement remains a challenging task in aortic surgery. The introduction of the frozen elephant trunk (FET) technique offered a link between open surgery and thoracic endovascular aortic repair (TEVAR). Despite a decade of experience, data on the complementary use of these techniques are scant. The aim of this study was to evaluate TEVAR following FET in clinical reality. METHODS: Between November 2006 and June 2018, 20 patients (9 females; median age of 69 years) underwent endovascular second-stage completion after FET. The clinical outcomes, technical feasibility, and morphological findings were analyzed retrospectively. RESULTS: Eleven of the 20 interventions were intended "rendezvous procedures" in a multistage approach; 4 were elective reinterventions, and 5 were emergency complication repairs. The median interval between FET and TEVAR was 231 days (11 days-7.4 years). The technical success rate was 100%. During a median follow-up (FU) period of 58.3 months, the overall survival rate was 95%, with one in-hospital death. Neurological complications occurred in three cases (spinal cord injury: n = 1; stroke: n = 2). Computed tomography angiography showed overall regression in the median diameter of the proximal descending aorta (from 57 to 48.5 mm). CONCLUSION: TEVAR as a second-stage intervention after FET is a feasible option, with satisfactory results at medium-term FU. In extensive thoracoabdominal aortic disease without proximal landing zones, the complementary use of both techniques in a multistage approach should be considered.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Female , Hospital Mortality , Humans , Retrospective Studies , Treatment Outcome
9.
Zentralbl Chir ; 147(5): 472-479, 2022 Oct.
Article in German | MEDLINE | ID: mdl-32207122

ABSTRACT

BACKGROUND: Multidisciplinary aortic boards (mAB) are a valuable tool for decision making in patients with aortic pathologies. The aim of this study was to evaluate the mAB of a maximum care hospital with regards to total patient volume and discipline-specific presentations. Furthermore, the indications for conservative/surgical treatment and the patients' allocation were reviewed. METHODS: A retrospective analysis was performed of all patients discussed in the mAB of Heidelberg University Hospital (Department of Vascular and Endovascular Surgery [VS]/Department of Cardiac Surgery [CS]/Department of Radiology), between 01/2014 and 12/2018. RESULTS: Within a five-year period, 344 patients (median of 71 patients/year) were discussed. Of those, 262 (76%) were presented by VS, mostly recruited from the outpatient sector. Another 63 cases (18%), originated from CS and 19 patients (6%) from other disciplines. An indication for surgical treatment was defined in 153 of 344 patients (45%), whereas 191 of 344 cases (55%) were treated in a conservative fashion. Procedures performed by VS were indicated in 85/153 (55%) cases, including 25% (22/85) of non-VS-patients. Procedures performed by CS were indicated in 68/153 (45%) cases containing 84% (57/68) of non-CS-patients. Despite a dedicated indication for surgery, 59/153 patients (39%) did not receive the recommended therapy. CONCLUSION: mAB maintenance is highly dependent on the outpatient sector. With respect to patient selection, the mAB has an important filter function towards conservative treatment. The nearly balanced distribution between VS and CS underlines the importance of a multidisciplinary approach to aortic surgery. Given the relevant number of untreated patients, a central management office with an in-hospital registry seems crucial in order to improve mAB performance.


Subject(s)
Conservative Treatment , Endovascular Procedures , Endovascular Procedures/methods , Humans , Patient Selection , Registries , Retrospective Studies , Treatment Outcome
10.
Zentralbl Chir ; 147(5): 439-446, 2022 Oct.
Article in German | MEDLINE | ID: mdl-36220066

ABSTRACT

BACKGROUND: "Mixed reality" (MR) allows the projection of virtual objects into the user's field of view through a head-mounted display (HMD). In the interventional and surgical treatment of vascular diseases MR applications could be of future benefit. The following scoping review aims to provide orientation on the current application of the aforementioned technologies in the field of vascular surgery and to define research goals for the future. METHODS: A systematic literature search was performed in PubMed (MEDLINE) using the search terms "aorta", "intervention", "endovascular intervention", "vascular surgery", "aneurysm", "endovascular", "vascular access", each in combination with "mixed reality" or "augmented reality". The search was performed according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines for scoping reviews. RESULTS: From 547 references 8 relevant studies were identified. The search results could be classified into two categories: (1) MR aimed at information management and improving periprocedural ergonomics (n = 3) and (2) MR aimed at intraoperative navigation (n = 5). The registration of the physical patient with the virtual object and the tracking of instruments in the MR environment for intraoperative navigation is currently the focus of scientific interest and could be demonstrated on phantom and animal models with technical success. However, the methods presented so far are associated with high infrastructural costs and important limitations. CONCLUSION: The use of MR in the field of vascular surgery is promising. For the future, alternative, pragmatic registration methods with appropriate quantification of the positional error should be aimed at. The developed software and hardware solutions should be adapted to the requirements of vascular surgery. Electromagnetic instrument tracking appears to be a useful complementary technology for the implementation of MR-assisted navigation.


Subject(s)
Surgery, Computer-Assisted , Animals , Software , Surgery, Computer-Assisted/methods , Vascular Surgical Procedures
11.
J Vasc Surg ; 74(3): 738-745.e3, 2021 09.
Article in English | MEDLINE | ID: mdl-33639234

ABSTRACT

OBJECTIVE: To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic disease. METHODS: In this retrospective observational study, all patients treated with EVAS between March 2013 and January 2018 for abdominal aortic aneurysm (AAA) or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, and procedural and clinical surveillance outcomes. Furthermore, patients treated within the original instructions for use (IFU-group) were compared with patients treated outside the IFU (non-IFU-group) with regard to survival, reintervention-free survival, freedom from type I endoleak, and freedom from stent graft migration. RESULTS: Seventy patients were included (67 male; median age, 72.5 years). Sixty-five patients were treated for AAA and 5 patients for abdominal penetrating aortic ulcer. Sixty-nine cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow-up was 50.5 months (interquartile range, 29.3-62.7 months) with a median computed tomography angiographic follow-up of 38.5 months (interquartile range, 17.1-60.2 months). There were five deaths during the study period (7.1%), four of which were aneurysm related (5.7%). Five secondary AAA ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly owing to thrombotic complications (18.6%), stent graft migration (17.1%), and type I endoleak (12.9%). Fifteen patients were treated outside of the IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days and 1, 3, and 5 years was 94.3%, 88.5%, 72%, and 56.9%, respectively. Freedom from stent graft migration at 1, 3, and 5 years was 98.6%, 82.0%, and 47.3%, respectively. The estimated freedom from type I endoleak at 30 days and 1, 3, and 5 years in the IFU-group was 100%, 100%, 94.9% and, 91.1% and significantly different when compared with the non-IFU-group with 79.5%, 72.2%, 72.2%, and 72.2% (P = .012). CONCLUSIONS: Although the technical and initial results were satisfying, the mid-term results were disappointing. The enforcement of a close follow-up protocol for all patients treated with EVAS, especially vigilant for stent graft migration to prevent secondary type I endoleak and rupture, is strongly recommended.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/etiology , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/etiology , Endovascular Procedures/adverse effects , Foreign-Body Migration/etiology , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnostic imaging , Aortic Rupture/mortality , Aortic Rupture/therapy , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Endoleak/diagnostic imaging , Endoleak/mortality , Endoleak/therapy , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Foreign-Body Migration/diagnostic imaging , Foreign-Body Migration/mortality , Foreign-Body Migration/therapy , Humans , Male , Middle Aged , Progression-Free Survival , Retreatment , Retrospective Studies , Risk Assessment , Risk Factors , Stents , Time Factors
12.
Ann Vasc Surg ; 72: 664.e7-664.e9, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33227461
13.
Vascular ; 29(4): 486-498, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33131466

ABSTRACT

OBJECTIVE: To describe the outcome of thoracic endovascular aortic repair (TEVAR) in thoracic aortic aneurysm and penetrating aortic ulcer with respect to instructions for use status. METHODS: Between October 2009 and September 2017, a total of 532 patients underwent TEVAR; of which 195 have been treated using the Conformable GORE® TAG® thoracic endoprosthesis (CTAG). Fifty-six patients of this cohort underwent TEVAR for thoracic aortic aneurysm/penetrating aortic ulcer using the CTAG. Depending on the preoperative computed tomography angiography findings, patients were classified as inside or outside the device's instructions for use. All inside instruction for use patients underwent postoperative reclassification regarding the instructions for use status. Study endpoints included TEVAR-related reintervention, exclusion of the pathology (endoleak type I/III), TEVAR-related mortality, and graft-related serious adverse events. The median duration of follow-up was 29.7 months (range: 0-109.4 months). RESULTS: Of the 56 patients, 17 were primarily classified as outside instruction for use, and in additional 13 patients, TEVAR was performed outside instruction for use, leading to 30 outside instruction for use patients (53.6%). Twenty-six patients (46.4%) were treated inside instruction for use. Reintervention-free survival was lower in outside instruction for use patients (P = 0.016) with a hazard ratio of 9.74 (confidence interval 1.2-80.2; P = 0.034) for TEVAR-related reintervention. With respect to endoleak type I/III, relevant difference was detected between inside/outside instruction for use status (P = 0.012). The serious adverse event rate was 30.4%, mainly in outside instruction for use patients (P = 0.004). Logistic regression analysis indicated an association between graft-related serious adverse event/instructions for use status (odds ratio 6.11; confidence interval 1.6-30.06; P = 0.012). In-hospital death was seen more frequently in outside instruction for use patients (P = 0.12) as was procedure-related death (log-rank test: P = 0.21). CONCLUSION: TEVAR for thoracic aortic aneurysm/penetrating aortic ulcer is frequently performed outside instruction for use despite preoperative inside instruction for use eligibility, leading to important consequences for technical/clinical outcome. Instructions for use adherence in TEVAR should be of interest for further large-scale studies.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Clinical Decision-Making , Endovascular Procedures/instrumentation , Patient Selection , Ulcer/surgery , Aged , Aged, 80 and over , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Databases, Factual , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/surgery , Product Labeling , Prosthesis Design , Reoperation , Retrospective Studies , Time Factors , Treatment Outcome , Ulcer/diagnostic imaging , Ulcer/mortality
14.
Vasa ; 50(3): 217-223, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33435742

ABSTRACT

Background: Isolated femoral artery revascularisation (iFAR) represents a well-established surgical method in the treatment of peripheral arterial disease (PAD) involving common femoral artery disease. Data for iFAR in multilevel PAD are inconsistent, particularly in patients with critical limb ischemia (CLI). The aim of the study was to evaluate the outcome of iFAR in CLI regarding major amputation and reintervention and to identify associated risk factors for this outcome. Patients and methods: The data used have been derived from the German Registry of Firstline Treatment in Critical Limb Ischemia (CRITISCH). A total of 1200 patients were enrolled in 27 vascular centres. This sub-analysis included patients, which were treated with iFAR with/without concomitant iliac intervention. For detection of risk factors for the combined endpoint of major amputation and/or reintervention, selection of variables for multiple regression was conducted using stepwise forward/backward selection by Akaike's information criterion. Results: 95 patients were included (mean age: 72 years ± 10.82; 64.2% male). Of those, 32 (33.7%) participants reached the combined endpoint. Risk factor analysis revealed continued tobacco use (odds ratio [OR] 2.316, confidence interval [CI] 0.832-6.674), TASC D-lesion (OR: 2.293, CI: 0.869-6.261) and previous vascular intervention in the trial leg (OR: 2.720, CI: 1.037-7.381) to be associated with reaching the combined endpoint. Conclusions: iFAR provides a reasonable, surgical option to treat CLI. Lesion length (TASC D) seems to have a negative impact on outcome. Further research is required to better define the future role of iFAR for combined femoro-popliteal lesions in CLI - best in terms of a randomised controlled trial.


Subject(s)
Femoral Artery , Peripheral Arterial Disease , Aged , Amputation, Surgical , Critical Illness , Female , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Humans , Ischemia/diagnostic imaging , Ischemia/surgery , Limb Salvage , Male , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Risk Factors , Treatment Outcome
15.
J Vasc Surg ; 63(5): 1170-1181.e1, 2016 05.
Article in English | MEDLINE | ID: mdl-26921004

ABSTRACT

OBJECTIVE: This study reports the long-term results after thoracic endovascular aortic repair (TEVAR) in thoracic aortic aneurysms (TAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: Between 1997 and 2010, 269 patients were treated with TEVAR, 100 of them (72 male; mean age, 68.3 years) for aneurysmal disease. An intact TAA (iTAA) was present in 49 patients and an intact TAAA (iTAAA) in 18. In 25 patients, there was a ruptured TAA or ruptured TAAA (rTAA). Eight patients were admitted with a post-traumatic TAA (pTAA). Retrospective analysis was performed from a prospectively maintained database. Primary end points were 5-year all-cause and TEVAR-related mortality. Secondary end points were causes of death, complications, and reinterventions (RIs). A 5-year follow-up was complete in all cases. RESULTS: The overall 5-year mortality rate was 50% (40.8% in iTAA, 80% in rTAA, 12.5% in pTAA, and 50% in iTAAA, respectively; log-rank test, P = .00012). The overall procedure-related mortality was 21% (10.2% [n = 5] in iTAA, 40% [n = 10] in rTAA, 33% [n = 6] in iTAAA, and 0 in pTAA, respectively; log-rank test, P = .00013). Freedom from complication was 52%, 47.2%, and 47.2% at 1, 3, and 5 years, respectively. There were a total of 30 RIs in 25 patients. Freedom from RI was 82%, 77.8%, and 71.2% at 1, 3, and 5 years. Stepwise forward logistic regression analysis revealed rTAA and occurrence of complications were risk factors for survival (odds ratios, 7.7 and 4.2, respectively). CONCLUSIONS: Long-term results after TEVAR for aneurysmatic aortic disease demonstrate considerable overall and procedure-related mortality in both elective and urgent indications. Complications and RIs occur still as late events and emphasize the necessity for long-term follow-up.


Subject(s)
Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Adult , Aged , Aged, 80 and over , Aorta, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/mortality , Aortic Rupture/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Cause of Death , Disease-Free Survival , Elective Surgical Procedures , Emergencies , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Germany , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Odds Ratio , Postoperative Complications/etiology , Postoperative Complications/mortality , Postoperative Complications/therapy , Retreatment , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
16.
J Vasc Surg ; 64(6): 1569-1579.e2, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27575808

ABSTRACT

OBJECTIVE: The aim of this study was to analyze the outcome of thoracic endovascular aortic repair (TEVAR) and medical therapy in patients with aortic intramural hematoma type B (IMHB). METHODS: Between January 2004 and January 2014, 41 IMHB patients were treated; 28 underwent TEVAR (16 male; median age, 69 years; group I) plus best medical therapy (BMT), whereas 13 had BMT alone (6 male; median age, 69 years; group II). Study end points were assessment of indications for TEVAR and BMT, clinical outcome, and evaluation of aortic morphology over time. Median follow-up was 32 months for group I and 40 months for group II. RESULTS: In group I, TEVAR was immediately performed in 7 of 28 cases because of pain and imaging results (penetrating aortic ulcers, n = 4; intramural blood pools, n = 3). In 21 of 28 cases, TEVAR was undertaken because of clinical or radiologic signs of progression at a median of 10 days (range, 2-223 days). The median number of stent grafts implanted was two (range, 1-3). The median length of covered aorta was 15 cm (range, 9.5-33.4 cm). Technical success was achieved in 25 of 28. In-hospital mortality was 1 of 28 in group I and 0 of 13 in group II. Survival in group I was 81.5%, 77.8%, and 67% at 1, 2, and 4 years. There was no death in group II during follow-up. Aortic reinterventions were performed in 6 of 28 group I cases, including 2 open conversions for retrograde type A dissection. Aortic diameter decreased during follow-up in 10% in group I (vs 3% in group II; P = .039). In group I, complete remodeling was seen in 7 of 27, regression in the remaining 20. In group II, complete remodeling was seen in 3 of 12; regression was seen in 9 of 12. No patient in group II required invasive treatment. CONCLUSIONS: BMT is justified in uncomplicated IMHB. However, IMHB becomes complicated in the majority of patients within 20 days. TEVAR in complicated IMHB is feasible but associated with a substantial aortic reintervention rate, reflecting technical challenges and fragile aortic wall conditions.


Subject(s)
Aorta, Thoracic/surgery , Aortic Diseases/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Hematoma/surgery , Adult , Aged , Aged, 80 and over , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/physiopathology , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , Aortic Diseases/physiopathology , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Computed Tomography Angiography , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Germany , Hematoma/diagnostic imaging , Hematoma/mortality , Hematoma/physiopathology , Hospital Mortality , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/mortality , Retrospective Studies , Risk Factors , Stents , Time Factors , Treatment Outcome , Vascular Remodeling
18.
Ann Vasc Surg ; 29(5): 1019.e7-1019.e10, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25765639

ABSTRACT

BACKGROUND: The aim of this study was to report the occurrence of a type IIIb endoleak after endovascular repair of a thoracic aortic aneurysm caused by endoanchor dislocation. CASE REPORT: An 84-year-old female patient underwent thoracic endovascular repair for aneurysmal disease of her thoracic aorta. The procedure included primary left subclavian artery revascularization and the placement of endoanchors to enhance fixation of the endograft within the aortic arch. Dislocation of one of the endoanchors resulted in a graft defect leading to a type IIIb endoleak and aortic diameter expansion. CONCLUSIONS: Endoanchors represent a promising adjunct in endovascular repair settings. However, their use requires careful procedure planning and special attention during follow-up.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Endoleak/etiology , Endovascular Procedures/adverse effects , Foreign-Body Migration/complications , Suture Anchors , Suture Techniques/adverse effects , Aged, 80 and over , Aortic Aneurysm, Thoracic/diagnosis , Aortography , Blood Vessel Prosthesis , Endoleak/diagnosis , Endoleak/surgery , Female , Foreign-Body Migration/diagnosis , Foreign-Body Migration/surgery , Humans , Imaging, Three-Dimensional , Prosthesis Failure , Reoperation , Suture Techniques/instrumentation , Tomography, X-Ray Computed
19.
Indian J Thorac Cardiovasc Surg ; 40(1): 86-90, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38125333

ABSTRACT

Long-term outcome after thoracic endovascular aortic repair (TEVAR) of acute type B aortic dissection (aTBAD) is still underreported in current literature. This case report shows persistence of aortic remodeling without secondary complication or need of reintervention 13 years after TEVAR. A 45-year-old woman was referred to the emergency room with aTBAD. Due to early diameter progression in combination with therapy-refractory pain and uncontrolled hypertension, TEVAR was performed. Hereafter, the patient showed complete remodeling of the descending thoracic aorta without persistent false lumen perfusion in this segment and with stable true and false lumen diameter in the untreated abdominal segment for a 13-year period. No aortic-related reintervention was needed. With contemporary devices and adapted therapy, TEVAR seems able to treat complex thoracic disease. Long-term follow-up (FU) is mandatory to monitor the efficacy and durability of endovascular treatment in aortic disease.

20.
J Imaging ; 10(4)2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38667974

ABSTRACT

Mixed reality (MxR) enables the projection of virtual three-dimensional objects into the user's field of view via a head-mounted display (HMD). This phantom model study investigated three different workflows for navigated common femoral arterial (CFA) access and compared it to a conventional sonography-guided technique as a control. A total of 160 punctures were performed by 10 operators (5 experts and 5 non-experts). A successful CFA puncture was defined as puncture at the mid-level of the femoral head with the needle tip at the central lumen line in a 0° coronary insertion angle and a 45° sagittal insertion angle. Positional errors were quantified using cone-beam computed tomography following each attempt. Mixed effect modeling revealed that the distance from the needle entry site to the mid-level of the femoral head is significantly shorter for navigated techniques than for the control group. This highlights that three-dimensional visualization could increase the safety of CFA access. However, the navigated workflows are infrastructurally complex with limited usability and are associated with relevant cost. While navigated techniques appear as a potentially beneficial adjunct for safe CFA access, future developments should aim to reduce workflow complexity, avoid optical tracking systems, and offer more pragmatic methods of registration and instrument tracking.

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