Publications by authors named "Sebastian E Debus"

22 Publications

  • Page 1 of 1

Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial.

Eur Heart J 2021 10;42(39):4040-4048

CPC Clinical Research, 2115 N Scranton Street, Suite 2040, Aurora, CO, USA.

Aims: In this secondary analysis of the VOYAGER trial, rivaroxaban 2.5 mg twice/day plus aspirin 100 mg/day was assessed in older adults. Advanced age is associated with elevated bleeding risk and unfavourable net benefit for dual antiplatelet therapy in chronic coronary artery disease. The risk-benefit of low-dose rivaroxaban in patients ≥75 years with peripheral artery disease (PAD) after lower extremity revascularization (LER) has not been described.

Methods And Results: The primary endpoint was a composite of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death. The principal safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding analysed by the pre-specified age cut-off of 75 years. Of 6564 patients randomized, 1330 (20%) were >75 years. Absolute 3-year Kaplan-Meier cumulative incidence rates for primary efficacy (23.4% vs. 19.0%) and safety (3.5% vs. 1.5%) endpoints were higher in elderly vs. non-elderly patients. Efficacy of rivaroxaban (P-interaction 0.83) and safety (P-interaction 0.38) was consistent irrespective of age. The combination of intracranial and fatal bleeding was not increased in patients >75 years (2 rivaroxaban vs. 8 placebo). Overall, benefits (absolute risk reduction 3.8%, number needed to treat 26 for the primary endpoint) exceeded risks (absolute risk increase 0.81%, number needed to harm 123 for TIMI major bleeding).

Conclusion: Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed. This suggests that low-dose rivaroxaban combined with aspirin should be considered in PAD after LER regardless of age.
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http://dx.doi.org/10.1093/eurheartj/ehab408DOI Listing
October 2021

The Association of Periodontitis and Peripheral Arterial Occlusive Disease in a Prospective Population-Based Cross-Sectional Cohort Study.

J Clin Med 2021 May 11;10(10). Epub 2021 May 11.

Department of Vascular Medicine, University Heart and Vascular Center UKE Hamburg, Research Group GermanVasc, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany.

Objectives: Peripheral arterial occlusive disease (PAOD) and periodontitis are common chronic diseases, which together affect almost 1 billion people worldwide. There is growing evidence suggesting a relationship between chronic inflammatory conditions such as periodontitis and PAOD. This study aims to determine an association between both entities using high quality research data and multiple phenotypes derived from an epidemiological cohort study.

Design: This population-based cross-sectional cohort study included data from 3271 participants aged between 45 and 74 years enrolled in the Hamburg City Health Study (NCT03934957).

Material & Methods: An ankle-brachial-index below 0.9, color-coded ultrasound of the lower extremity arteries, and survey data was used to identify participants with either asymptomatic or symptomatic PAOD. Periodontitis data was collected at six sites per tooth and included the probing depth, gingival recession, clinical attachment loss, and bleeding on probing index. Multivariate analyses using logistic regression models were adjusted for variables including age, sex, smoking, education, diabetes, and hypertension.

Results: The baseline characteristics differed widely between participants neither affected by periodontitis nor PAOD vs. the group where both PAOD and severe periodontitis were identified. A higher rate of males, higher age, lower education level, smoking, diabetes, and cardiovascular disease was observed in the group affected by both diseases. After adjusting, presence of severe periodontitis (odds ratio 1.265; 97.5% CI 1.006-1.591; = 0.045) was independently associated with PAOD.

Conclusion: In this cross-sectional analysis of a prospective cohort study, an independent association between periodontitis and PAOD was revealed. The results of the current study emphasize a potential for preventive medicine in an extremely sensitive target population. Future studies should determine the underlying factors modifying the relationship between both diseases.
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http://dx.doi.org/10.3390/jcm10102048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8152001PMC
May 2021

The Vascular Textbook is Dead: Long Live Virtual Vascular.

Eur J Vasc Endovasc Surg 2020 Oct;60(4):499

Gloucestershire, Hospitals NHS Foundation Trust, Gloucester, United Kingdom.

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http://dx.doi.org/10.1016/j.ejvs.2020.08.023DOI Listing
October 2020

Endovascular Repair of a Large Ilioiliac Fistula Using a Reversed Iliac Limb Endograft.

Ann Vasc Surg 2019 Apr 27;56:354.e11-354.e15. Epub 2018 Nov 27.

Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, Hamburg, Germany.

Ilioiliac fistulae are a rare condition, for which diagnosis and treatment can be challenging. In this report, we describe the case of a 74-year-old patient with a high-flow fistula between the left common iliac artery and the ipsilateral common iliac vein presenting with heart failure. The fistula was probably iatrogenic, caused by prostatic surgery 1 year earlier. We describe imaging findings on computed tomography angiography and the treatment by 2 back-table reversed stent grafts. The satisfactory results demonstrated in our case and those in the literature suggest that an endovascular treatment for this rare condition should be considered as the first-line therapy.
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http://dx.doi.org/10.1016/j.avsg.2018.08.104DOI Listing
April 2019

Intentional Targeted False Lumen Occlusion after Aortic Dissection: A Systematic Review of the Literature.

Ann Vasc Surg 2019 Apr 26;56:317-329. Epub 2018 Nov 26.

German Aortic Center, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.

Background: Residual patent false lumen (FL) after chronic type B aortic dissection (cTBAD) or type A aortic dissection (TAAD) treatment is independently associated with poor long-term outcomes. The aim of our study was to present endovascular techniques and the existing experience with targeted FL thrombosis after cTBAD or TAAD treatment.

Material And Methods: A systematic review was performed (Preferred Reporting Items for Systematic reviews and Meta-Analyses) searching in MEDLINE, CENTRAL, and Cochrane databases for studies reporting on targeted FL occlusion after cTBAD or TAAD treatment.

Results: One hundred one patients either after open repair of a TAAD (n = 40; 3 case reports and 3 retrospective studies) or after cTBAD (n = 61; 13 case reports and 6 retrospective studies) underwent an endovascular procedure for intentional FL occlusion (2 studies reported on both procedures). Among TAAD patients, 27 of 40 (68%) had previous open repair, whereas 48 of 61 (79%) with cTBAD had a previous endovascular repair. Thirty-one (78%) patients with TAAD and fifty-one (83%) with cTBAD were treated electively. Four main techniques were used: (1) the candy-plug (19/101), (2) the knickerbocker (3/91), (3) the "cork in the bottle neck" technique (2/101), and (4) FL embolization with combined use of coils, onyx, plugs, and glue (77/101). The technical success rate was 100%, with a 30-day mortality rate of 2.5% (1/40) in TAAD and 0% in cTBAD patients. During follow-up (ranging: 2 to 63 months), the mortality rate was 0% (0/31) and 7.1% (4/61) in TAAD and cTBAD patients, respectively. The FL remained completely thrombosed in 78% (31/40) of TAAD and 62% (38/61) of cTBAD patients, whereas it was partially thrombosed in 3 and 2 patients, respectively (no report for 22 patients).

Conclusions: Intentional FL occlusion seems to be a feasible less invasive approach after cTBAD or TAAD treatment, which is not broadly used. Future larger studies with longer follow-up duration may demonstrate the apparent benefit in terms of aortic remodeling or stabilization of the disease progression.
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http://dx.doi.org/10.1016/j.avsg.2018.08.086DOI Listing
April 2019

Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms.

J Vasc Surg 2019 02 29;69(2):357-366. Epub 2018 Oct 29.

Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, Hamburg, Germany.

Objective: The aim of our study was to analyze the incidence of spinal cord ischemia (SCI) in patients presenting with complex aortic aneurysms treated with endovascular aneurysm repair (EVAR) and to identify risk factors associated with this complication.

Methods: A retrospective study was undertaken of prospectively collected data including patients presenting with complex aortic aneurysm (pararenal abdominal aortic aneurysm and thoracoabdominal aortic aneurysm) treated with fenestrated EVAR (F-EVAR) or branched EVAR (B-EVAR). The primary end point was the incidence of SCI and the assessment of any associated factors.

Results: Between January 2011 and August 2017, a total of 243 patients (mean aneurysm diameter, 65.2 ± 15.3 mm; mean age, 72.4 ± 7.5 years; 73% male) were treated with F-EVAR or B-EVAR. Asymptomatic patients were treated in 73% of the cases (177/243, in contrast to 27% urgent), and 52% (126/243) were treated for thoracoabdominal aortic aneurysm (in contrast to 48% for pararenal abdominal aortic aneurysm). F-EVAR (mean number of fenestrations, 3.3/case) and B-EVAR (mean number of branches, 3.7/case) were undertaken in 67% (164/243) and 33% (79/243), respectively. The total incidence of SCI was 17.7% [43/243; paraplegia in 4% (10/243) and paraparesis in 13.7% (33/243)]. Most of the patients with SCI presented with immediate postoperative symptoms (72% [31/43]). A spinal drain was preoperatively placed in 53% (130/243) and was associated with the prevention of SCI (SCI with spinal drainage, 12% [16/130]; SCI without spinal drainage, 24% [27/113]; P = .018). The 30-day mortality rate was 9% (21/243). After multiple logistic regression analysis, SCI was associated with preoperative renal function (SCI with preoperative glomerular filtration rate <60 mL/min/1.73 m: odds ratio [OR], 2.43; 95% confidence interval [CI], 1.18-4.99; P = .016) and the number of vertebral segments covered (SCI with higher position of proximal stent in terms of vertebra: OR, 1.2; 95% CI, 1.1-1.3; P = .000). A similar outcome was derived when the height of the proximal end of the stent graft was replaced by the total length of aortic coverage (SCI with preoperative glomerular filtration rate <60 mL/min/1.73 m: OR, 2.36 [95% CI, 1.11-5.00; P = .025]; SCI with longer length of aortic coverage: OR, 1.01 [95% CI, 1.003-1.009; P = .000]).

Conclusions: The majority of SCI incidence after F-EVAR or B-EVAR of complex aortic aneurysms is manifested immediately postoperatively. The use of preoperative spinal drainage may prevent SCI. Patients with GRF <60 mL/min/1.73 m and with longer aortic stent graft coverage are at higher risk of SCI.
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http://dx.doi.org/10.1016/j.jvs.2018.05.216DOI Listing
February 2019

Branched endografts in the aortic arch following open repair for DeBakey Type I aortic dissection.

Eur J Cardiothorac Surg 2018 09;54(3):517-523

Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, University Hospital Eppendorf, Hamburg, Germany.

Objectives: DeBakey Type I aortic dissections are frequently treated by an ascending aortic tube graft or hemiarch replacement with the residual dissection remaining untreated. We investigated the outcomes of branched thoracic endovascular repair for post-dissection aneurysms of the aortic arch.

Methods: We conducted a retrospective, single-centre evaluation of 20 consecutive patients with a false-lumen aneurysm after a DeBakey I aortic dissection treated with branched thoracic endovascular repair. The indication for endovascular repair was agreed on in an interdisciplinary case conference. Study end points were technical success, 30-day mortality rate, complications and late complications and reinterventions.

Results: Between 2012 and 2016, 20 patients (14 men, age 65 ± 9 years) were treated for false-lumen aneurysm formation after a DeBakey Type I aortic dissection. All patients had undergone open ascending aortic repair either isolated (n = 16) or with partial arch repair (n = 4). Technical success was achieved in 19 of 20 cases. The 30-day mortality rate and incidence of stroke were each 5% (1/20). Simultaneous procedures to exclude false-lumen perfusion included implantation of a Knickerbocker graft in 3 (15%) patients and a candy-plug graft in 7 (35%) patients. Early postoperative computed tomography angiography revealed persistent false-lumen perfusion in 10 cases that required secondary interventions in 6 cases. During 17 ± 14 months of mean follow-up, there was 1 aortic-related death and 2 deaths of non-aortic reasons. The estimated overall survival was 89 ± 7% and 75 ± 15% at 12 and 36 months, respectively.

Conclusions: Treatment of residual aortic arch dissections with branched thoracic endovascular repair appears feasible and safe with few deaths and low stroke rates. A high rate of secondary procedures is required to achieve thoracic false-lumen occlusion.
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http://dx.doi.org/10.1093/ejcts/ezy133DOI Listing
September 2018

Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany.

J Vasc Surg 2018 10 27;68(4):956-964. Epub 2018 Mar 27.

Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, Hamburg, Germany.

Objective: The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany.

Methods: A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow-up, freedom from reintervention, rupture, and failure mode were also assessed.

Results: Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty-seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30-day mortality rate was 0% and 2.5%, respectively. The mean follow-up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow-up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively.

Conclusions: The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30-day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.
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http://dx.doi.org/10.1016/j.jvs.2018.01.037DOI Listing
October 2018

Fenestrated-branched endografts and visceral debranching plus stenting (hybrid) for complex aortic aneurysm repair.

J Vasc Surg 2018 06 1;67(6):1684-1689. Epub 2018 Mar 1.

German Aortic Center Hamburg, University Heart Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

Objective: The aim of this study was to assess the immediate postoperative and midterm outcome of complex aortic aneurysm treatment necessitating four-vessel revascularization with either a total endovascular approach (fenestrated-branched stent graft [FBSG]) or a hybrid technique of visceral debranching plus stenting.

Methods: The clinical data of consecutively treated patients presenting with a complex aortic aneurysm that necessitated four-vessel revascularization between 2010 and 2015 were retrospectively analyzed.

Results: There were 98 patients (65 men [68%]) with a mean age of 70.65 ± 4 years who presented with aortic aneurysm (Crawford type I, 12; type II, 18; type III, 12; type IV, 24; type V, 6; and juxtarenal and suprarenal, 26) and were treated with either FBSG (76/98 [77.5%]) or hybrid repair (22/98 [22.4%]). Twenty-six patients were symptomatic (16, pain; 10, contained rupture). The mean maximum aneurysm diameter was 65 ± 15 mm, and 53% of the patients had a prior aortic intervention. In FBSG-treated patients, 15 off-the-shelf multibranched stent grafts, 3 surgeon-modified fenestrated stent grafts, and 58 custom-made devices tailored to the patient's anatomy were used. Four fenestrations, four branches, and their combination were used in 38 cases, 30 cases, and 8 cases, respectively. A total of 304 target vessels were addressed, with technical success rate of 96% (292/304). In most hybrid cases (18/22 [82%]), a two-stage procedure was undertaken. All target vessels were successfully revascularized with 88 bypasses. The 30-day mortality was 15.3% (15/98), and the early target vessel occlusion was 9.1% (2 in FBSG, 7 in hybrid). After multivariate analysis, type of procedure (hybrid) was independently associated with higher early mortality (odds ratio, 6.3; P = .01). The morbidity was mainly attributed to pulmonary complications (16.3%), lower extremity weakness (16.3%), mesenteric ischemia (6.1%), dialysis on discharge (6.1%), and complete paraplegia (4.3%). Acute renal failure (2.6% vs 18%; P = .03) and mesenteric ischemia (3% vs 23%; P = .001) presented more commonly in the hybrid group. The mean follow-up was 16.4 ± 5 months, and the mortality rate was 19.4% (12% in the FBSG group vs 45% in the hybrid group; P = .05). The graft and stent graft patency rate was 87.8% (three branches and nine bypasses were occluded).

Conclusions: FBSG and hybrid technique seem to be feasible treatment options for complex aortic aneurysms that necessitate four-vessel revascularization. FBSG may be associated with lower mortality and morbidity rates in comparison to the hybrid procedure. FBSG should be the treatment of choice for complex aneurysms in patients with comorbidities, whereas hybrid repair should be considered for acute cases unsuitable for endovascular repair.
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http://dx.doi.org/10.1016/j.jvs.2017.09.049DOI Listing
June 2018

The Presence of Gas in Aneurysm Sac during Early Postoperative Period Is Associated to the Type of Endograft and Perfused Lumen's Size.

Ann Vasc Surg 2018 Jul 23;50:173-178. Epub 2018 Feb 23.

German Aortic Center Hamburg, University Heart Center, University Hospital Hamburg Eppendorf, Hamburg, Germany.

Background: The aim of the present study was to examine the frequency of gas within the aneurysm sac following endovascular aneurysm repair (EVAR) on early postoperative computed tomography (CT) scans, to measure its volume, record the location, and analyze anatomical and procedural risk factors of its presence.

Methods: A retrospective analysis of prospectively collected data of patients undergoing standard, fenestrated, or branched EVAR between January 2013 and December 2015 was undertaken. The presence, position, and size of gas in the postoperative computed tomography angiography (CTA) (within 10 days) was examined, classified as (1) gas near aortic wall; (2) between aortic wall and endograft; and (3) near endograft and further analyzed in terms of anatomical and procedural risk factors associated with its presence.

Results: From a total of 241 (85% males, 204/241 and 15% females, 37/241) patients who were treated with EVAR, CTA within 10 days was available in 211 patients with mean age of 73 ± 8.3 years. Gas was present on postoperative CT scan in 83 of 211 (39%) patients; 59/83 (71%) standard, 19/83 (23%) fenestrated, and 5/83 (6%) branched EVAR. The location of the gas was more frequently near the aortic wall (a) (46/83; 55.4%), with the mean gas volume to be 0.41 mL (range 0.01-2.74). Endoleak type II was diagnosed in 31.2% (66/211) of the cases and was not associated with the presence of gas (20/83; presence vs. 46/128; absence of gas; P = 0.069). The presence of gas was associated with larger preoperative diameter of the aortic perfused lumen (P = 0.013). The type of graft was correlated to the presence of gas on postoperative CTA (more frequent in standard EVAR [odds ratio 8; 95% confidence interval {CI} 2.01-31.25] and fenestrated [odds ratio 5.81; 95% CI 1.41-23.81]). In standard EVAR patients, the presence of gas was more frequently identified in early CTA (<5 days) than in later one (6-10 days) (P = 0.000). During the first month follow-up, no patient demonstrated any signs of infection in clinical and radiological assessment.

Conclusions: The presence of gas in the aneurysm sac after EVAR is a frequent finding on postoperative CTA and not related to infection or endoleak. Type of stent graft and size of the perfused lumen is associated with the presence of gas.
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http://dx.doi.org/10.1016/j.avsg.2017.11.067DOI Listing
July 2018

Endovascular treatment of para-anastomotic aneurysms after open abdominal aortic surgery.

J Cardiovasc Surg (Torino) 2020 Apr 8;61(2):159-170. Epub 2018 Feb 8.

Department of Vascular Surgery, School of Health Sciences, Faculty of Medicine, University Hospital of Larissa, Larissa, Greece.

Introduction: The repair of long-term complications of open abdominal aortic repair such as para-anastomotic aneurysm (PAA) and pseudoaneurysm (PSA) is very challenging. The aim of this study was to assess the outcomes of endovascular repair of PAA/PSA after previous open aortic surgery for aneurismal or occlusive disease.

Evidence Acquisition: A systematic review was undertaken; a search was performed (PRISMA) in MEDLINE, CENTRAL, Cochrane databases and key references of all studies of endovascular treatment of PAA/PSA after open aortic surgery.

Evidence Synthesis: Eighteen studies included totally 433 patients (86.3% males) with mean age of 71±2.5 years were identified. Most of the patients were asymptomatic (76%) and diagnosed with PAA (60.5%), while 81.6% had history of open aortic reconstruction for aneurismal disease. The mean diameter of para-anastomotic aneurysms was 59.7 mm (from 23 mm to 110 mm) and the mean duration until their diagnosis was 10±2 years. Standard bifurcated (23.7%), fenestrated (23.4%) and aorto-uni-iliac stent-grafts (16.3%) were mostly used. The technical success rate was 97.8% (391/400) with 1.4% (6/433) 30 day-mortality rate and mean hospital stay of 6±3 days. The mean 1- and 2- year survival rate was 87.8% and 78.8%, respectively. The follow-up ranged from 9 to 43 months, with presenting complications such as endoleak type I (24/378; 6.3%), type II (15/354; 4.3%), type III (3/378;0.8%), migration (4/378; 1%) and limb occlusion (5/310;1.6%). Additionally, 5.7% (19/332) of the patients underwent open conversion, while the total re-intervention rate was 11.4% (39/340; time of reintervention ranged from 7 to 30 months). In cases in which a stent was used for splanchnic vessels (renal artery: 188, superior mesenteric artery: 98, celiac artery: 64), the primary patency rate was 97.4% (341/350).

Conclusions: Endovascular treatment of PAAs and PSAs after previous open aortic surgery is a feasible and efficient option with high technical success rate, low 30-day mortality and good mid-term outcomes.
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http://dx.doi.org/10.23736/S0021-9509.18.10145-5DOI Listing
April 2020

Total endovascular arch repair is the procedure of the future.

J Cardiovasc Surg (Torino) 2018 Aug 19;59(4):559-571. Epub 2018 Jan 19.

Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, Hamburg, Germany.

Introduction: This study evaluates the current experience on endovascular repair of the aortic arch pathologies, the feasibility and safety of the procedure.

Evidence Acquisition: A systematic review was performed. MEDLINE, CENTRAL, and Cochrane databases were searched with PRISMA methodology for published studies reporting on endovascular repair of aortic arch pathologies from 2000 to 2018.

Evidence Synthesis: Thirteen non-randomized retrospective studies (either single or multicenter), two multicenter Registries and one multicenter non-randomized interventional study were included in the systematic review. The total number of patients who underwent total endovascular repair of the aortic arch pathology with either fenestrated, branched, or a combination of those devices or chimney technique was 952 patients (73%; 634/872 males, mean age ranging from 51 to 78 years). The technical success rate was 96.7% (921/952), while the 30-day mortality rate was 3.3% (32/952). The most common adverse events were endoleak type I (13.5%; 35/259), stroke (5.1%; 49/952), spinal cord ischemia (1.4%; 14/952) and retrograde dissection (1%; 8/952). During the follow-up period (mean ranging: 16.9 to 41.4 months; median ranging: 9 to 44.8 months) the total number of deaths was 31 (4.4%; 31/693). The total loss of supra-aortic vessel patency rate was 1.7% (14/803) and a re-intervention was needed in 50 patients (9%; 50/559; 11 open conversion).

Conclusions: Endovascular repair of aortic arch pathologies is a feasible treatment option with good early and reasonable mid-term outcomes. This treatment modality approaches a level of maturity and may be considered as a solid alternative method of treatment.
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http://dx.doi.org/10.23736/S0021-9509.18.10412-5DOI Listing
August 2018

Durability of fenestrated endovascular aortic repair for juxta-renal abdominal aortic aneurysm repair.

J Cardiovasc Surg (Torino) 2018 Apr 9;59(2):213-224. Epub 2018 Jan 9.

German Aortic Center Hamburg, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.

Background: The aim of this study was to evaluate the long term durability of fenestrated endovascular aortic aneurysm repair (F-EVAR) of juxta-renal aortic aneurysms (JAAAs) in terms of mortality, target visceral vessel (TVV) patency and Reintervention rates.

Evidence Acquisition: A systematic review and meta-analysis was performed. MEDLINE, CENTRAL, and Cochrane databases were searched with PRISMA methodology for studies reporting on F-EVAR of JAAA presenting follow-up >36 months. Articles with <15 patients, follow-up <36 months, comparison of F-EVAR with other treatment modalities were excluded.

Evidence Synthesis: Seven non-randomized retrospective studies of prospectively collected data were analysed including 772 patients (mean age and diameter ranging from 71.5 to 74 years and from 60 to 65mm, respectively) underwent F-EVAR for JAAA during 2001-2015. The pooled mortality rates during 12, 24, 36, 48 and 60 months were 0.080 (0.060-0.106), 0.129 (0.097-0.169), 0.211 (0.158-0.277), 0.279 (0.193-0.386) and 0.405 (0.303-0.517), respectively. The pooled Reintervention rates during 12, 24, 36 and 48 months were 0.097 (0.066-0.140), 0.131 (0.082-0.203), 0.281 (0.182-0.406) and 0.244 (0.103-0.477), respectively. The pooled loss of TVV patency rates during 12, 24, 36, 48 and 60 months were 0.046 (0.035-0.060), 0.081 (0.058-0.110), 0.088 (0.060-0.127), 0.123 (0.067-0.214) and 0.132 (0.081-0.207).

Conclusions: F-EVAR for the treatment of patients with JAAA is a durable procedure with good long term outcomes in terms of mortality and visceral vessels patency. During long term period the need for a Reintervention continues to exists, thus follow-up of those cases may be important for preserving the good results.
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http://dx.doi.org/10.23736/S0021-9509.18.10341-7DOI Listing
April 2018

Systematic review of laparoscopic ligation of inferior mesenteric artery for the treatment of type II endoleak after endovascular aortic aneurysm repair.

J Vasc Surg 2017 12 16;66(6):1878-1884. Epub 2017 Aug 16.

German Aortic Center Hamburg, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.

Objective: Type II endoleak after endovascular aneurysm repair (EVAR) is frequently caused by persistent flow from the inferior mesenteric artery (IMA). The aim of this study was to assess the perioperative and midterm efficacy of laparoscopic ligation of the IMA for treatment of endoleak.

Methods: MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane databases and key references were searched with Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology for studies reporting on laparoscopic ligation of the IMA for treatment of type II endoleak after EVAR.

Results: Eight case studies and one study of a retrospective nature were identified. In total, 20 patients (18 men; mean age, 73.6 ± 2 years; with a mean abdominal aortic aneurysm diameter of 64.3 ± 10 mm) who underwent post-EVAR laparoscopic ligation of the IMA for type II endoleak were analyzed. The mean time from EVAR until intervention ranged from 6 to 18 months. All but one patient were asymptomatic; in 9, the aneurysm sac was enlarged, and in 11, the endoleak was considered persistent without sac enlargement. The mean procedural duration was 99 ± 24 minutes, with technical success rate of 90% (18/20); in two cases, the patients were successfully reoperated on laparoscopically in 24 hours. The mean hospitalization was 3.6 ± 1.2 days, with 0% (0/20) perioperative and 30-day mortality. No patient underwent open conversion or showed signs of intestinal ischemia. During follow-up of 32.6 ± 12 months, 13 of 20 patients had aneurysm sac regression, whereas the rest had a stable sac diameter without evidence of persistent type II endoleak.

Conclusions: Laparoscopic ligation of the IMA for treatment of type II endoleak after EVAR is a feasible and safe technique in specialized centers with high technical success rate and good midterm outcomes.
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http://dx.doi.org/10.1016/j.jvs.2017.07.066DOI Listing
December 2017

Back-Table Surgeon Modification of a t-Branch.

Ann Vasc Surg 2017 Nov 21;45:330-335. Epub 2017 Jul 21.

Department of Vascular Medicine, University Heart Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: Surgeon modification of commercially available aortic stent grafts represents a salvage option to treat complex aortic pathologies in high-risk patients.

Technique: A 68-year-old male was referred to our hospital with a contained rupture of the visceral aorta. The patient was previously treated with an infrarenal tube graft 16 years earlier as well as with a Crawford procedure with island patch of the celiac trunk (TC) and the superior mesenteric artery (SMA) and bypasses to both renal arteries 6 years before admission. The computed tomography demonstrated a "blowout aneurysm" of the TC and SMA patch. The bypass to the left renal artery originated from the level of the TC. We therefore modified a commercially available t-branch (Cook Medical, Bloomington, IN) with surgeon-made fenestrations for both renal arteries. The procedure was successful, and the patient could be discharged to home on the seventh postoperative day.

Conclusions: The use of surgeon-modified "off-the-shelf" t-branches broadens the possibilities of treating even anatomically very challenging aortic pathologies otherwise not suitable for the t-branch.
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http://dx.doi.org/10.1016/j.avsg.2017.07.011DOI Listing
November 2017

Primary aorto-enteric fistula as a rare cause of massive gastrointestinal haemorrhage.

Vasa 2017 Oct 30;46(6):425-430. Epub 2017 Jun 30.

3 Institute for Legal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

The incidence of primary aorto-enteric fistula (PAEF) is low with only few case reports and case series published. Depending on the location of the PAEF, the perforation leads to upper or lower gastrointestinal haemorrhages. We conducted a MEDLINE search according to the PRISMA statement. Articles with publication dates from 2000 to 2016 were included and present an own case report. We considered all case reports and series reporting on PAEF and identified 85 individual patients from 32 case reports and five case series. The majority of PAEF is associated with atherosclerotic or aneurysmatic findings of the aorta and in particular with inflammatory aortic diseases. Most commonly, the duodenum (64 %) was mentioned as location of the perforation. Other cases involved the jejunum (< 10 %) and the colon (5 %). Almost all patients were diagnosed either with gastrointestinal haemorrhage, abdominal or back pain, or anaemia due to bleeding. The immediate and correct diagnosis of this entity remains difficult. Therefore, treatment is delayed leading to an extraordinary high mortality of almost 100 % in untreated cases. Duplex ultrasound and contrast-enhanced CT angiography have high diagnostic sensitivity and specificity to rule out acute abdominal aortic pathologies. New endovascular approaches can help to lower mortality.
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http://dx.doi.org/10.1024/0301-1526/a000646DOI Listing
October 2017

Prevalence of cardiovascular risk factors among 28,000 employees.

Vasa 2017 May 3;46(3):203-210. Epub 2017 Feb 3.

1 Department of Vascular Medicine, University Heart Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: Cardiovascular diseases are the leading cause of death in Germany. The knowledge of causal risk factors and their distribution is of utmost importance to design screening programs.

Probands And Methods: In this cross-sectional study design we used STROBE criteria to achieve the highest comparability possible. Anthropometric measures (height and weight), total cholesterol, glucose level, and blood pressure were measured. Probands' history was collected by using a standardized questionnaire. The data was age- and gender-adjusted for the working population 16 to 70 years of age, derived from the micro census, the 1 %-sample census of the German statistical office. For each study year weight factors were calculated. Logistic regression analysis was conducted regarding the cardiovascular risk factors: smoking, arterial hypertension, diabetes, hypercholesterolemia, and obesity.

Results: Between 2006 and 2015 a total of 28,293 employees took part in the ongoing company screenings. The mean age was 42.3 years for both sexes (median: 43 years). The mean body mass index (BMI) was 25.6 kg/m (men: 26.5 kg/m, women: 24.7 kg/m). A history of hypertension was present in 16 % of the employees (men: 17.8 %, women: 13.8 %). Of the respondents 2 % suffered from diabetes (men: 2.4 %, women: 1.6 %). Lipid-lowering drugs were taken by 2.8 % of all employees (3.6 % men and 1.9 % women). 23.3 % of the men and women indicated to be active smokers. In the regression analysis obesity was associated with a four times higher risk of hypertension and a three times higher risk of elevated glucose levels, thus manifesting as main contributor for vascular diseases. Meanwhile the risk for obesity was 140 % higher in probands who are former smokers.

Conclusions: We regard obesity as the number one cardiovascular risk which should be assessed by various medical, legislative, and socio-economic actions to limit future mortality and health-care costs in Germany.
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http://dx.doi.org/10.1024/0301-1526/a000611DOI Listing
May 2017

Tips and tricks in vascular access for (T)EVAR.

J Cardiovasc Surg (Torino) 2017 Apr 22;58(2):194-203. Epub 2016 Dec 22.

Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, Hamburg-Eppendorf University Hospital, Hamburg, Germany -

Endovascular repair has become the treatment of choice for thoracic and abdominal aortic pathologies in the last decades, and is associated with excellent results in terms of perioperative, mid- and long-term morbidity and mortality. Access vessels play a central role in these procedures since access-related issues can increase the rates of technical failures and determine clinical complications for the patient. Therefore, accurate preoperative clinical evaluation and review of the preoperative images are mandatory. In this review, we report on the access-related issues that can be encountered during EVAR and TEVAR, and present solutions and strategies to minimize access-related adverse outcomes.
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http://dx.doi.org/10.23736/S0021-9509.16.09835-9DOI Listing
April 2017

Hyperbaric oxygen therapy for chronic wounds.

Cochrane Database Syst Rev 2015 Jun 24(6):CD004123. Epub 2015 Jun 24.

Department of Anaesthesia and Critical Care, University of Würzburg, Oberdürrbacher Str. 6, Würzburg, Germany, 97080.

Background: Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.

Objectives: To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.

Search Methods: For this second update we searched the Cochrane Wounds Group Specialised Register (searched 18 February 2015); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 1); Ovid MEDLINE (1946 to 17 February 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 17 February 2015); Ovid EMBASE (1974 to 17 February 2015); and EBSCO CINAHL (1982 to 17 February 2015).

Selection Criteria: Randomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).

Data Collection And Analysis: Three review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.

Main Results: We included twelve trials (577 participants). Ten trials (531 participants) enrolled people with a diabetic foot ulcer: pooled data of five trials with 205 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.19 to 4.62; P = 0.01) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We identified one trial (30 participants) which enrolled patients with non-healing diabetic ulcers as well as venous ulcers ("mixed ulcers types") and patients were treated for 30 days. For this "mixed ulcers" there was a significant benefit of HBOT in terms of reduction in ulcer area at the end of treatment (30 days) (MD 61.88%, 95% CI 41.91 to 81.85, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.

Authors' Conclusions: In people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.
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http://dx.doi.org/10.1002/14651858.CD004123.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055586PMC
June 2015

Vascunet registry validated.

Vasa 2014 Mar;43(2):86-7

Department for Vascular Medicine, University Heart Center, University Clinics Hamburg-Eppendorf, Germany.

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http://dx.doi.org/10.1024/0301-1526/a000334DOI Listing
March 2014

Hyperbaric oxygen therapy for chronic wounds.

Cochrane Database Syst Rev 2012 Apr 18(4):CD004123. Epub 2012 Apr 18.

Department of Anaesthesia and Critical Care, University of Würzburg, Würzburg,

Background: Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.

Objectives: To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.

Search Methods: For this first update we searched the Cochrane Wounds Group Specialised Register (searched 12 January 2012); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4); Ovid MEDLINE (1950 to January Week 1 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 11 July 2012); Ovid EMBASE (1980 to 2012 Week 01); and EBSCO CINAHL (1982 to 6 January 2012).

Selection Criteria: Randomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).

Data Collection And Analysis: Three review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.

Main Results: We included nine trials (471 participants). Eight trials (455 participants) enrolled people with a diabetic foot ulcer: pooled data of three trials with 140 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 5.20, 95% confidence interval (CI) 1.25 to 21.66; P = 0.02) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.

Authors' Conclusions: In people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.
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http://dx.doi.org/10.1002/14651858.CD004123.pub3DOI Listing
April 2012

Endoscopic ultrasound-guided transrectal biopsies of pelvic tumors.

J Gastrointest Surg 2002 May-Jun;6(3):342-6

Department of Surgery, University School of Medicine, Wuerzburg, Germany.

The aim of this study was to evaluate the feasibility, safety, and diagnostic accuracy of endorectal ultrasound-guided biopsies in patients with extrarectal lesions. Data from all patients with suspicious pelvic pathology who underwent endorectal ultrasound-guided biopsies were collected prospectively. To evaluate the accuracy of the diagnosis, all patients with benign histology but primary suspicion of a malignant lesion were followed up for at least 12 months. A total of 48 patients whose median age was 66 years were evaluated. Apart from one postbiopsy hemorrhage, which was managed conservatively, no other complications were encountered. Sufficient tissue was removed to allow histologic examination in all cases. A large variety of diagnoses including primary and secondary malignancies (n = 25) as well as benign pathologies (n = 23) could be established. There were no false positive but three false negative histologies in patients with proven local recurrence of a malignant tumor during the follow-up period. This results in a sensitivity of 88%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 89%. It is concluded that endoscopic ultrasound-guided transrectal biopsy is a safe method with a high diagnostic accuracy in the assessment of pelvic tumors.
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http://dx.doi.org/10.1016/s1091-255x(01)00012-9DOI Listing
August 2002
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