Dittmar Böckler

Universität Heidelberg, Heidelburg, Baden-Württemberg, Germany

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Publications (331)571.41 Total impact

  • No preview · Article · Apr 2016 · Intensivmedizin up2date
  • [Show abstract] [Hide abstract] ABSTRACT: Background: The aim of the study was to analyze the use of contrast-enhanced cone beam computed tomography (ceCBCT) during endovascular aneurysm repair (EVAR) and to compare this imaging modality with standard completion digital subtraction angiography (cDSA) and postoperative computed tomography angiography (CTA) regarding the detection of endograft-associated complications. Methods: Between September 2012 and April 2015, ceCBCT was used in 98 EVAR patients in addition to cDSA and CTA. Endoleaks, intraluminal thrombus and limb stenoses, contrast agent use, and radiation exposure were recorded for all modalities. Results: cDSA detected 16 (16.3%) endoleaks; ceCBCT, 35 (35.7%) endoleaks; and CTA, 22 (22.4%) endoleaks. All endoleaks identified by cDSA or CTA were also seen on ceCBCT. ceCBCT detected intraluminal thrombus in three patients (none in cDSA or CTA) and previously undetected limb stenoses in three patients. It prompted intraoperative interventions in 7 of 98 patients (7.1%). Replacing cDSA and CTA by ceCBCT would have caused a 39% reduction of in-hospital contrast agent volume in this cohort. Conclusions: ceCBCT can reliably detect all endograft-associated complications during EVAR. It offers the chance for immediate revision of remediable problems in a relevant proportion of patients and could thus reduce early reintervention rates. ceCBCT can safely replace early follow-up CTA and thereby reduce in-hospital use of contrast media.
    No preview · Article · Apr 2016 · Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter
  • [Show abstract] [Hide abstract] ABSTRACT: Background: Ruptured abdominal aortic aneurysm (rAAA) represents one of the most challenging emergencies in surgery. Open repair (OR) is associated with relevant morbidity and mortality and has not been reduced significantly over the last decade. The introduction of endovascular aneurysm repair (EVAR) and its meanwhile common use in the treatment of rAAA has raised the demand for randomised controlled trials (RCTs) in order to resolve a potential superiority of either OR or EVAR. Purpose: This review discusses the current treatment strategies in rAAA repair including diagnostics, peri-operative management and results of OR and EVAR, focussing on RCTs comparing both modalities. Results: Thirty-day mortality after OR and EVAR shows no significant difference in published RCTs. In particular with respect to OR, 30-day mortality was much lower than anticipated throughout all RCTs ranging from 18 to 37 %. EVAR for rAAA resulted in reduced in-hospital stay. Limitations of all except one RCT are low patient recruitment and exclusion of haemodynamically unstable patients. Conclusions: OR and EVAR need to be provided for rAAA. Despite lacking evidence, EVAR is the first choice treatment in experienced high-volume vascular centres. Low mortality rates in all RCTs raise the question if aortic surgery should be centralised.
    No preview · Article · Apr 2016 · Langenbeck s Archives of Surgery
  • No preview · Article · Apr 2016
  • A Steuwe · P Geisbüsch · C Schulz · D Böckler · H Kauczor · W Stiller
    No preview · Article · Mar 2016 · RöFo - Fortschritte auf dem Gebiet der R
  • [Show abstract] [Hide abstract] ABSTRACT: Purpose: Abdominal aortic aneurysm is a common degenerative vascular disorder associated with sudden death due to aortic rupture. This review describes epidemiology, predisposing factors, and biology of ruptured abdominal aortic aneurysms (rAAAs). Methods: Based on a selective literature search in Medline (PubMed), original publications, meta-analyses, systematic reviews, and Cochrane reviews were evaluated for rAAA. Results: The hospital admission rate for rAAA is decreasing and is now in the range of approximately 10 per 100,000 population in men. Smoking contributes to about 50 % of population risk for rupture or surgically treated AAA. AAA rupture is a multifaceted biological process involving biochemical, cellular, and proteolytic influences, in addition to biomechanical factors. AAA rupture occurs when the stress (force per unit area) on the aneurysm wall exceeds wall strength. Proteolytic activities of matrix metalloproteinases have been implicated in aneurysm wall weakening and rupture. Aneurysm diameter is the most prominent predisposing factor for aneurysm growth and rupture. Wall stress, aneurysm shape and geometry, intraluminal thrombus, wall thickness, calcification, and metabolic activity influence the rupture risk. Conclusion: The best conservative option to avoid AAA rupture consists in smoking cessation and control of hypertension. Many biological factors influence rupture risk.
    No preview · Article · Mar 2016 · Langenbeck s Archives of Surgery
  • [Show abstract] [Hide abstract] ABSTRACT: Purpose An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). Methods Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15–96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists’ (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. Results Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) Conclusions Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.
    No preview · Article · Mar 2016 · Langenbeck s Archives of Surgery
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    [Show abstract] [Hide abstract] 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.
    Full-text · Article · Feb 2016 · Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter
  • Carola M Wieker · M Spazier · Dittmar Boeckler
    [Show abstract] [Hide abstract] ABSTRACT: The benefits, safety and efficacy of endovascular aortic aneurysm repair (EVAR) is well documented and intensively reported in multiple randomized trials and metaanalysis. Therefore, EVAR became the first choice of abdominal aortic aneurysms (AAA) treatment in almost 70-100% of patients. Consecutively, open repair (OR) is performed less frequently in morphologically preselected patients. Anatomical condition remains the most important factor for indication for OR. Especially unfavorable infrarenal landing zone based on difficult neck anatomy like very short neck or excessive neck angulation is still the most predictive factor. Furthermore patients presenting additional iliac aneurysms, aortoiliac occlusive disease or variations of renal arteries are recommended for OR. Randomized trials like EVAR 1, DREAM and OVER from the year 2004/2005 and 2009 showed lower 30-day mortality rates in EVAR compared to OR. However, the late mortality rates after two years became equal in both treatment options. Furthermore reinterventions after EVAR occur more frequently than after OR. Analysis from our own data showed a higher 30-day mortality in the patients who underwend OR in the endovascular era (15% vs 2.5%), however the number of emergency open AAA repair because of ruptured aneurysms was much higher in the endovascular era (32.5% vs 5%). In conclusion, treatment of AAA has changed in the past decade. Nevertheless OR of AAA still remains as a safe and durable method in experienced surgeons even in the endovascular era. High volume centers are needed to offer the best patients ́ treatment providing the best postoperative outcome. Therefore OR must remain a part of fellowship training in the future. To decide the best treatment option many facts like patients ́ fitness and preference or finally the anatomic suitability for endovascular repair have to be considered.
    No preview · Article · Jan 2016 · The Journal of cardiovascular surgery
  • [Show abstract] [Hide abstract] ABSTRACT: Bleeding and vascular infections are serious potential complications during abdominal general surgery. The management of bleeding depends on the extent and localization and can range from the application of hemostatics to vascular sutures, interpositioning and ligatures. The use of prosthetic biomaterials implanted endoluminally or during open reconstruction permits palliation of potentially fatal conditions. The overall incidence of infections involving vascular prostheses is relatively low because of routine antibiotic prophylaxis prior to surgery, refinements in sterilization and packaging of devices and careful adherence to aseptic procedural and surgical techniques. When infections occur detection and definitive therapy of the vascular prosthesis are often delayed and the management is complex and tedious. Infections involving vascular prostheses are difficult to eradicate and in general, surgical therapy is required often coupled with excision of the prosthesis. Keys to success include accurate diagnostics to identify the organism and extent of graft infections, specific long-term antibiotic therapy and well-planned surgical interventions to excise and replace the infected graft and sterilize the local tissue. Regardless of the technique used to eradicate graft infections, success is measured by patient survival, freedom from recurrent infection and patency of revascularization. Even when treatment is successful, the morbidity associated with vascular graft infections is considerable. Aortoenteric fistulas (AEF) are a rare (incidence < 1.5 %) but often fatal complication. Primary diagnosis of AEF remains difficult. Computed tomography (CT) and fluorodeoxyglucose positron emission tomography CT (FDG-PET-CT) are the diagnostic tools of choice. Therapy consists of an urgent individualized interdisciplinary surgical approach with primary axillofemoral bypass and secondary prosthesis explantation or in situ replacement and subsequent bowel resection. Endovascular aortic repair (EVAR) is reserved for primary aortoenteric fistulas in patients with no signs of infection or in emergency cases as a bridging method.
    No preview · Article · Jan 2016 · Der Chirurg
  • [Show abstract] [Hide abstract] ABSTRACT: Purpose: To determine abdominal aortic expansion after thoracic endovascular aortic repair (TEVAR) in patients with aortic dissection type B and 36 months minimum follow-up. Methods: Retrospective study of 18 TEVAR patients with follow-up >36 months. Abdominal aortic diameters at celiac trunk (location B) and infrarenal aorta (location C) were recorded on the first and last imaging after TEVAR. False lumen thrombosis was determined at level of endograft (A) and at B and C. Aortic expansion was defined as diameter increase of 5 mm or 15%. Correlation analyses were performed to investigate potential determinants of expansion. Results: Median follow-up was 75.2 months. Sixteen of 18 patients (88.9%) demonstrated abdominal expansion. Mean expansion was 9.9 ± 6.1 mm at B and 11.7 ± 6.5 mm at C, without a difference between acute and chronic dissections. Critical diameters of 55 mm were reached in two patients treated for chronic dissection (11.1%). Annual diameter increase was significantly greater at locations with baseline diameters >30 mm (2.1 ± 1.1 mm vs. 1.0 ± 0.6 mm, p = 0.009). Baseline diameters were greater in patients with chronic dissections. Conclusion: Abdominal aortic expansion can be frequently recognized after TEVAR for aortic dissection type B and occurs independently from thoracic false lumen thrombosis. Clinical significant abdominal aortic expansion may occur more frequently in patients treated with TEVAR for chronic dissection.
    No preview · Article · Jan 2016 · Vascular
  • No preview · Article · Jan 2016 · Gefässchirurgie
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    [Show abstract] [Hide abstract] ABSTRACT: Objective . Glyoxalase-1 is an enzyme detoxifying methylglyoxal (MG). MG is a potent precursor of advanced glycation endproducts which are regarded to be a key player in micro- and macrovascular damage. Yet, the role of Glo1 in atherosclerosis remains unclear. In this study, the effect of Glo1 on mouse metabolism and atherosclerosis is evaluated. Methods . Glo1 knockdown mice were fed a high fat or a standard diet for 10 weeks. Body weight and composition were investigated by Echo MRI. The PhenoMaster system was used to measure the energy expenditure. To evaluate the impact of Glo1 on atherosclerosis, Glo1 KD mice were crossed with ApoE-knockout mice and fed a high fat diet for 14 weeks. Results . Glo1 activity was significantly reduced in heart, liver, and kidney lysates derived from Glo1 KD mice. Yet, there was no increase in methylglyoxal-derived AGEs in all organs analyzed. The Glo1 knockdown did not affect body weight or body composition. Metabolic studies via indirect calorimetry did not show significant effects on energy expenditure. Glo1 KD mice crossed to ApoE −/− mice did not show enhanced formation of atherosclerosis. Conclusion . A Glo1 knockdown does not have major short term effects on the energy expenditure or the formation of atherosclerotic plaques.
    Full-text · Article · Jan 2016 · Journal of Diabetes Research
  • [Show abstract] [Hide abstract] ABSTRACT: Objectives: Regional anesthesia for patients undergoing carotid endarterectomy is associated with improved intraoperative hemodynamic stability compared with general anesthesia. The authors hypothesized that the reported advantages might be related to attenuated ipsilateral baroreflex control of blood pressure, caused by chemical denervation of the carotid bulb baroreceptor nerve fibers. Design: A prospective cohort study. Setting: Single-center university hospital. Participants: The study included 46 patients undergoing carotid endarterectomy using superficial cervical block. Interventions: A noninvasive computational periprocedural measurement of baroreceptor sensitivity was performed in all patients. Two groups were formed, depending on the patients' subjective response to surgical stimulation regarding the necessity of additional intraoperative local anesthesia (LA) administration on the carotid bulb. Group A (block alone) included 23 patients who required no additional anesthesia, and group B (block + LA) consisted of 23 patients who required additional anesthesia. Measurements and main results: Baroreceptor sensitivity showed no significant change after application of the block in both groups (group A: median [IQR], 5.19 [3.07-8.54] v 4.96 [3.1-9.07]; p = 0.20) (group B: median [IQR], 4.47 [3.36-8.09] v 4.53 [3.29-8.01]; p = 0.55). There was a significant decrease in baroreceptor sensitivity in group B after intraoperative LA administration (median [IQR], 4.53 [3.29-8.01] v 3.31 [2.26-7.31]; p = 0.04). Conclusions: Standard superficial cervical plexus block did not impair local baroreceptor function, and, therefore, it was not related to improved cerebral perfusion in awake patients undergoing carotid endarterectomy. However, direct infiltration of the carotid bulb was associated with the expected attenuation of baroreflex sensitivity.
    No preview · Article · Dec 2015 · Journal of cardiothoracic and vascular anesthesia
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    [Show abstract] [Hide abstract] ABSTRACT: Purpose: To assess the feasibility and safety of the endovascular aneurysm sealing (EVAS) technique in the treatment of acute abdominal aortic aneurysm (AAA). Methods: A retrospective, multicenter, observational study was conducted at 8 centers (7 European and 1 in New Zealand) experienced with EVAS in the elective setting. From February 2013 to April 2015, 58 patients (mean age 74±9 years; 46 men) with an acute AAA were treated (28 ruptured and 30 symptomatic). The primary endpoint of the study was 30-day mortality; secondary endpoints included endoleak, reinterventions, and 30-day morbidity. Results: The overall intensive care unit and hospital stays were 2.2±6.6 days and 9.7±11.4 days, respectively. Thirty-day mortality rates were 32% (9/28) for the ruptured group and 7% (2/30) for the symptomatic group, with morbidity rates of 57% and 17%, respectively. Early endoleak was present in only 2 (3%) patients, one in each group; both leaks were type Ia. Reinterventions within 30 days were performed in 8 patients in the ruptured group; in the symptomatic patients, the only perioperative reintervention was embolization a type Ia endoleak. The mean follow-up was 9.3±3.1 months in the ruptured group and 12.4±5.4 months in the symptomatic group. The mean aneurysm diameter at 30-day follow-up was 71.8±16.0 mm compared with 74.7±15.7 mm preoperatively in the ruptured group and 66.1±13.5 mm compared with 65.8±13.0 mm in the symptomatic group. Conclusion: EVAS in the acute setting appears safe and feasible and concordant with the literature for endovascular aneurysm repair. More robust prospective and comparative data are required to establish the position of the technique in the treatment algorithm of acute AAA.
    Full-text · Article · Dec 2015 · Journal of Endovascular Therapy
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    [Show abstract] [Hide abstract] ABSTRACT: Endovascular aneurysm sealing (EVAS) using the Nellix system is a new and different method of abdominal aortic aneurysm repair. Normal postoperative imaging has unique appearances that change with time; complications also have different and specific appearances. This consensus document on the imaging findings after Nellix EVAS is based on the collective experience of the sites involved in the Nellix EVAS Global Forward Registry and the US Investigational Device Exemption Trial. The normal findings on computed tomography (CT), duplex ultrasound, magnetic resonance imaging, and plain radiography are described. With time, endobag appearances change on CT due to contrast migration to the margins of the hydrogel polymer within the endobag. Air within the endobag also has unique appearances that change over time. Among the complications after Nellix EVAS, type I endoleak usually presents as a curvilinear area of flow between the endobag and aortic wall, while type II endoleak is typically small and usually occurs where an aortic branch artery lies adjacent to an irregular aortic blood lumen that is not completely filled by the endobag. Procedural aortic injury is an uncommon but important complication that occurs as a result of overfilling of the endobags during Nellix EVAS. The optimum imaging surveillance algorithm after Nellix EVAS has yet to be defined but is largely CT-based, especially in the first year postprocedure. However, duplex ultrasound also appears to be a sensitive modality in identifying normal appearances and complications.
    Full-text · Article · Nov 2015 · Journal of Endovascular Therapy
  • [Show abstract] [Hide abstract] ABSTRACT: Objective: To evaluate accuracy and feasibility of fusion imaging during thoracic endovascular aortic repair (TEVAR). Methods: From January 2013 to January 2015 fusion imaging was used in 18 TEVAR procedures. Patients were prospectively enrolled for the survey and informed consent was obtained. Planning of the procedure and computed tomography (CT) angiography (CTA) segmentation with determination of all relevant surgical landmarks that should be displayed on fusion imaging was done using the preoperative CTA data. The registration was done with an intraoperative noncontrast-enhanced cone beam CT and CTA (three-dimensional [3D]-3D registration; n = 15) or with two fluoroscopic images in anteroposterior and lateral projection and the CTA (two-dimensional-3D registration; n = 3). An intraoperative digital subtraction angiography was performed to adjust fusion imaging and to allow accuracy measurement. Results: Fusion imaging was possible in all included patients. The median dose for noncontrast-enhanced cone beam CT imaging was 28.6 Gy/cm(2) (range, 17.9-43.3) and 0.46 Gy cm(2) for two fluoroscopic images in the two-dimensional-3D group. Full accuracy was achieved in two cases (11%), with a median deviation of 11.7 mm (range, 0.0-37.2). Manual realignment was possible in all cases. Conclusions: This early experience shows that fusion imaging is feasible in TEVAR procedures using different registration methods. However, it shows a significant deviation in thoracic procedures because of different sources of error, making confirmation of fusion overlay with a digital subtraction angiography necessary in any case.
    No preview · Article · Nov 2015 · Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter
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    [Show abstract] [Hide abstract] ABSTRACT: Objectives: To analyse early and long-term results of thoracic endovascular aortic repair (TEVAR) in patients with pseudoaneurysms after open aortic coarctation (CoA) repair. Methods: A total of 11 patients of 418 patients who had been treated with TEVAR during the period from January 1998 to April 2015 (8 males; median age 53 years) were retrospectively analysed. Dacron patch aortoplasty was primarily performed in 9 patients and sub-clavian flap aortoplasty in 2 patients. Seven of the 11 patients had asymptomatic pseudoaneurysms (median diameter 56 mm, range 20-65 mm) diagnosed by routine screening. Symptomatic patients presented with haemoptysis, lower limb ischaemia, haemodynamic collapse and back pain and underwent emergency repair (4/11). Adjunctive procedures at the proximal landing zone were required in 7/11 patients. The median number of implanted endoprostheses per patient was 1 (range: 1-5). The median follow-up was 60 months (range 6-161 months). Results: Technical success was achieved in 91% (10/11; 1 secondary elective open conversion). The 30-day mortality was 0%. The stroke rate was 18% (2 non-disabling strokes). In 2 patients (20%), stent-graft displacement during deployment was observed. The reintervention rate was 33% (Type Ib endoleak, left arm claudication, partial coverage of the left common carotid artery). Clinical success during follow-up was achieved in 10/11 patients. In 9/10 patients, aneurysm sac shrinkage was observed. The Type II endoleak rate was 10% (1/10; intercostal artery). The overall mortality rate was 9% (1 patient died of amyotrophic lateral sclerosis). Conclusions: Endovascular treatment of post-coarctation pseudoaneurysms is feasible in elective and emergency cases, yielding durable results in the long term. Due to anatomical specifics, implantation may be challenging and requires careful procedural planning. On-site cardiothoracic surgery backup is essential in case open conversion is required.
    Full-text · Article · Oct 2015 · Interactive Cardiovascular and Thoracic Surgery
  • [Show abstract] [Hide abstract] ABSTRACT: Purpose: To associate regions of highest local rupture risk from finite element analysis (FEA) to subsequent rupture sites in abdominal aortic aneurysms (AAA). Methods: This retrospective multicenter study analyzed computed tomography angiography (CTA) data from 13 asymptomatic AAA patients (mean age 76 years; 8 men) experiencing rupture at a later point in time between 2005 and 2011. All patients had CTA scans before and during the rupture event. FEA was performed to calculate peak wall stress (PWS), peak wall rupture risk (PWRR), rupture risk equivalent diameters (RRED), and the intraluminal thrombus volume (ILTV). PWS and PWRR locations in the prerupture state were compared with subsequent CTA rupture findings. Visible contrast extravasation was considered a definite (n=5) rupture sign, while a periaortic hematoma was an indefinite (n=8) sign. A statistical comparison was performed between the 13-patient asymptomatic AAA group before and during rupture and a 23-patient diameter-matched asymptomatic AAA control group that underwent elective surgery. Results: The asymptomatic AAAs before rupture showed significantly higher PWRR and RRED values compared to the matched asymptomatic AAA control group (median values 0.74 vs 0.52 and 77 vs 59 mm, respectively; p<0.0001 for both). No statistical differences could be found for PWS and ILTV. Ruptured AAAs showed the highest maximum diameters, PWRR, and RRED values. In 7 of the ruptured AAAs (2 definite and 5 indefinite rupture signs), CTA rupture sites correlated with prerupture PWRR locations. Conclusion: The location of the PWRR in unruptured AAAs predicted future rupture sites in several cases. Asymptomatic AAA patients with high PWRR and RRED values have an increased rupture risk.
    No preview · Article · Oct 2015 · Journal of Endovascular Therapy
  • [Show abstract] [Hide abstract] ABSTRACT: Objective: The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. Methods: Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length ≥10 mm and angle to the sac ≤60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter ≤6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine level ≤2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). Results: Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). Conclusions: In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.
    No preview · Article · Oct 2015 · Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter

Publication Stats

3k Citations
571.41 Total Impact Points

Institutions

  • 2004-2016
    • Universität Heidelberg
      • Department of Vascular Surgery (Mannheim)
      Heidelburg, Baden-Württemberg, Germany
  • 2013
    • University of Pittsburgh
      Pittsburgh, Pennsylvania, United States
  • 2012
    • Friedrich-Alexander Universität Erlangen-Nürnberg
      Erlangen, Bavaria, Germany
  • 2008-2009
    • Ethianum Klinik Heidelberg
      Heidelburg, Baden-Württemberg, Germany
    • University of Tuebingen
      Tübingen, Baden-Württemberg, Germany
  • 2007
    • Vascular and Endovascular Surgery Institute of São Paulo
      San Paulo, São Paulo, Brazil
  • 2005
    • German Cancer Research Center
      • Division of Radiology
      Heidelberg, Baden-Wuerttemberg, Germany