Thomas Umscheid

Percutaneous endovascular aortic aneurysm repair: a prospective evaluation of safety, efficiency, and risk factors.

Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72±6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n=16) or late (n=7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p<0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p<0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p<0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p<0.05). Obesity was not a risk factor for any complication. Conclusion: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.

Fenestrated endografting for aortic aneurysm repair: a 7-year experience.

PURPOSE To present a 7-year single-center clinical experience with fenestrated endografts and side branches. METHODS Between April 1999 and August 2006, 63 patients (57 men; mean age 70.5+/-11.6 years, range 25-89) received custom-designed Zenith fenestrated endoprostheses for a variety of aneurysms (59 abdominal, 1 thoracoabdominal, and 3 thoracic). They were all unsuitable for standard EVAR owing to short aortic necks and high risk for open surgery. RESULTS Nineteen tube grafts and 44 composite bifurcated grafts with a total of 122 fenestrations and 58 side branches were used. Technical success was achieved in 55 (87.3%) patients and in 118 (96.7%) vessels. Treatment success was 93.7%. The mean follow-up was 23+/-18 months (median 14, range 6-77). Overall, 9 (7.4%) visceral branches were lost: 4 intraoperative, 2 perioperative, and 3 late. There were 12 (19.0%) endoleaks identified: 5 (7.9%: 4 type Ia and 1 fenestration-related type III) primary and 7 (11.1%: 4 type II, 1 type I, and 2 type III) secondary endoleaks; 4 resolved, 4 were treated, and 4 are under observation. At 77 months, 75.3% of patients were free of a reintervention. All reinterventions were performed within the first 14 months. Fourteen cases of renal impairment were seen [6 permanent (only 1 on dialysis) and 8 transient]. One (1.6%) conversion and 1 (1.6%) rupture were recorded; aneurysm-related mortality was 4.8% (3/63). CONCLUSION The favorable outcomes in this study, which encompasses the teams learning curve with fenestrated endografts and side branches, support the use of these devices in selected patients.

Secondary Procedures After Aortic Aneurysm Repair With Fenestrated and Branched Endografts

Purpose To investigate the secondary procedures in patients with previous endovascular aortic repair by fenestrated or branched stent-grafts for aneurysms involving the renal and visceral vessels. Methods Between January 2001 and May 2010, 107 consecutive high-risk patients (97 men; mean age 73 years, range 50–86) with aortic aneurysms involving the renal and visceral arteries were treated with endovascular techniques. A custom-made Zenith graft was used in all patients. All secondary graft-related procedures performed in the perioperative period and during follow-up were analyzed. Estimates of survival, freedom from migration/type I endoleak, and freedom from any device-related secondary procedures were assessed with Kaplan-Meier analyses. Results The 30-day mortality rate was 1.9%. During follow-up (mean 25 months, range 1–94), 34 secondary procedures were performed in 28 (26.2%) patients for 6 (17.6%) limb graft stenoses/thromboses (5.6% of 107 cases), 8 (23.5%) in-stent visceral vessel stenoses/ occlusions (7.5% of 107 cases), 8 (23.5%) migrations/type I endoleaks with/without visceral stent fractures (7.5% of 107 cases), and 12 (35.3%) type III endoleaks (9.3% of 107 cases). The mean interval between the primary and secondary procedures was 12.9 months (range 1?68). In 26 (76.5%) of 34 cases, a secondary endovascular procedure was performed; in the remaining 8 (23.5%) cases, the complication was treated surgically. The secondary procedure was unsuccessful in 9 cases of visceral vessel compromise (failure to cannulation, stent fracture/migration, in-stent stenosis/occlusion). Estimated 3-year survival was 77%, while the 3-year rate for freedom from any device-related secondary procedure was 75.5%. Conclusion The incidence of early and late complications requiring a secondary procedure after treatment with fenestrated or branched devices was not negligible. Endoleak type III represented the most common cause for reintervention during follow-up. Secondary procedures performed for visceral vessel compromise had high rates of treatment failure. Accurate preoperative planning, the advent of new materials/techniques, and strict follow-up could be the key factors to improving the results of fenestrated or branched stent-graft interventions and to reduce the rate of secondary procedures.

Fenestrated and Branched Grafts for Para-Anastomotic Aortic Aneurysm Repair

Purpose: To investigate the use of fenestration and branch artery stenting during endovascular stent-graft repair of para-anastomotic aneurysms (PAA). Methods: A retrospective review was conducted of 9 patients (all men; mean age 71 years, range 60–80) who received custom-designed fenestrated endoprostheses for PAA repair. Eight tubular fenestrated devices and 1 composite device (fenestrated tube plus modular bifurcated body) with a total of 31 fenestrations were used. Results: The mean operating time was 318±93 minutes (range 220–485); the mean fluoroscopy time was 77±38 minutes (range 39–158), during which a mean 121±81 mL (range 33–300) of contrast was used. Technical success was achieved in all cases. Over a mean follow-up of 12±5.5 months (range 6–24), 1 secondary intervention was carried out due to a break in a side branch stent-graft; 2 transient renal impairments and 1 permanent renal insufficiency unrelated to renal artery patency were observed. So far, no vessel loss has emerged. Conclusion: Conventional repair of PAA has been a standard procedure for many years, though it carries high surgical risk as well as perioperative mortality. Fenestrated endografts may be a promising alternative in selected patients.

Hemangiosarcoma after Endovascular Aortic Aneurysm Repair

Purpose: To report a rare case of hemangiosarcoma after endovascular aneurysm repair (EVAR). Case Report: A 50-year-old man with Klinefelter syndrome presented 5 years after EVAR with a mass at the infrarenal aorta outside the stent-graft. Radiomorphologic and clinical signs were misleading because there had been evidence of an inflammatory process for more than a year. The stent-graft with the surrounding aorta was removed and replaced by a conventional tube graft. Systemic chemotherapy followed. The tumor recurred after 12 months, with pulmonary metastases and tumor embolic occlusion of his left femoral artery. Thrombectomy was performed, and a second course of chemotherapy was administered. The patient died 24 months after the conversion procedure. Conclusion: Morphological changes of the aneurysm wall seen on computed tomographic scans of EVAR patients may not be incidental or signs of infection; rather, a malignant tumor of the aorta or lymphatic disease, although rare, have to be taken into consideration as well.

Hybrid Thoracoabdominal Aneurysm Repair with Simultaneous Antegrade Visceral Revascularization and Supra-Aortic Debranching from the Ascending Aorta

Purpose: To describe a hybrid technique involving combined antegrade revascularization of both supra-aortic and visceral arteries and complete exclusion of a dissecting thoracoabdominal aortic aneurysm (TAAA). Technique: A 46-year-old man had a dissecting TAAA involving the left subclavian artery (LSA) and the descending thoracic and abdominal aorta down to the left common iliac artery. The ascending aorta was the only feasible source of inflow to the cerebral and visceral vessels. Via a median thoracolaparotomy, the supra-aortic and visceral arteries were dissected, and an octopus graft was implanted using 3 bifurcated Dacron grafts. An 18-×9-mm bifurcated Dacron graft was anastomosed in an end-to-side fashion to the ascending aorta, the brachiocephalic trunk, and the left common carotid artery. A 16-×8-mm bifurcated Dacron graft was sutured end-to-side to the celiac artery and superior mesenteric artery. A third 12-×7-mm bifurcated graft was sutured to both renal arteries. In a second step, 3 tapered custom-made thoracic Zenith T×2 endografts were used to repair the thoracic and the thoracoabdominal aorta. A bifurcated Zenith AAA device was used to treat the aneurysm at the level of the infrarenal aorta and both iliac arteries. Despite covering the LSA and all intercostal and lumbar arteries, the patient developed only a temporary paresis of the left leg. Computed tomography showed complete exclusion of the aneurysm and normal flow to the supra-aortic and visceral arteries. Conclusion: In selected cases, this hybrid approach using the ascending aorta for antegrade revascularization of cerebral and visceral arteries is feasible, with acceptable perioperative morbidity. However, its role for the treatment of complex thoracoabdominal aortic disease must be evaluated further.

Qualitätsmanagement Bauchaortenaneurysma der Deutschen Gesellschaft für Gefäßchirurgie (DGG) – Ergebnisse 2000

ZusammenfassungIntention des Qualitätsmanagements “Aortenaneurysma” ist die Erfassung und Auswertung von Eingriffen bei Patienten mit Bauchaortenaneurysma (BAA) in Deutschland mit der Option einer vergleichenden, externen Qualitätssicherung.Die Teilnahme an der Erhebung ist freiwillig und beinhaltet strukturierte Angaben in einem maschinenlesbaren Erfassungsbogen. Die Sammlung und Auswertung der Daten erfolgt über eine unabhängige Firma. Dabei werden die Angaben der einzelnen Institutionen dem Durchschnittswert aller beteiligten vergleichend gegenübergestellt.Für das Jahr 2000 wurden 3265 Patienten erfasst. 102 Kliniken beteiligten sich an der Erhebung.81,7% der Patienten wurden konventionell, 18,2% endovaskulär behandelt. 86% der Patienten wurden elektiv offen und 96% elektiv interventionell behandelt. Die Anteil der rupturierten Aneurysmen betrug 14% bzw. 4%. Die Letalität lag bei 3,4% für das offene Verfahren und bei 1,0% beim interventionellen. Im Stadium der Ruptur lag sie bei 43% bei der konventionellen Therapie. Eine Aussage für das interventionelle Verfahren ist nicht möglich. Die Letalität hängt neben Alter und ASA-Score von der Operationsfrequenz der einzelnen Kliniken ab.Obwohl nur etwa ein Viertel aller geschätzten Eingriffe an der infrarenalen Aorta erfasst werden, sind aufschlussreich Daten aus dem Datenpool zu extrahieren. Die Ergebnisse der BAA-Chirurgie entsprechen dem internationalen Standard, zum Teil sind sie sogar besser. Die endovaskuläre Therapie nimmt mit einem Fünftel aller Operationen einen breiten Raum ein und zeigt perioperativ bessere Ergebnisse. Wünschenswert wäre eine weitere Steigerung der Teilnehmer in Zukunft, um noch bessere Aussagen machen zu können.AbstractThe intention of quality management concerning treatment of infrarenal aortic aneurysms is to document procedures for external quality control.Participation in the program is voluntary, not on an intention-to-treat basis, and contains data from a structured questionnaire. Data collection and statistics are performed by an independent company in an anonymous manner.In 2000, 3265 patients were registered involving 102 hospitals or departments. Results: 81.7% of the patients were treated with an open procedure and 18.2% by intervention. Of the open procedures performed, 86% were elective cases, whereas 96% of the interventions were elective. The rate of ruptured aneurysms was 14% and 4%, respectively. Perioperative mortality was 3.4% for open surgery and 1.0% for interventions. In ruptured cases mortality was 43% for open procedures. Due to the low incidence of ruptured aneurysms in interventional surgery no statistical analysis was performed.More differentiated interpretations were possible regarding age and mortality, blood consumption, intensive care stay, or mortality and workload of the hospital.Although only one-fourth of all procedures performed on the infrarenal aorta in Germany could be registered and although participation was voluntary, the results show that aortic procedures in Germany meet international standards. Endovascular procedures account for one-fifth of all operations, showing better perioperative results.The main aims for the future are enlargement of the number of participants to improve the quality of the statements and inclusion of a majority of institutions treating aortic aneurysms.

Double Tube Stent-Grafts for Infrarenal Aortic Aneurysm: A New Concept

Purpose: To present the concept of double tube stent-grafts and examine the indications for and results achieved with these devices. Methods: From January 1, 2000, to December 31, 2005, 759 patients who underwent endovascular repair of infrarenal aortic aneurysms at 2 centers. Of these, 45 (5.9%) patients received a double tube stent-graft; complete operative and follow-up data were available for retrospective analysis in 41 patients (33 men; mean age 73.1±8.9 years). Diameters measured before stent-graft implantation and at follow-up (12, 24, 36, and 48 months) with clinical examination, 2-phase computed tomographic angiography, duplex sonography, and biplanar abdominal radiography were tested for significant changes using ANOVA with the Bonferroni-Dunn correction. Late outcomes (clinical success and endoleak) were analyzed by the Kaplan-Meier method. Results: The postoperative complication rate was 12.2%, with 2.4% systemic complications (1 patient with angina pectoris); the early mortality rate was 0%. Mean follow-up was 21.9±12.8 months (range 12–61) for the 41 patients. Four (9.8%) patients died during follow-up of cardiac causes (n=2), lung cancer (n=1), and bowel ischemia (n=1). Four (9.8%) endoleaks were observed during follow-up: 1 distal type I, 2 type II, and 1 type III. Maximum aneurysm diameters shrank from 52.0±9.5 mm preoperatively to 44.0±10.8 mm (p<0.0001) postoperatively at the latest available follow-up. Conclusion: Our study supports the use of this double tube technique for repair of appropriate saccular infrarenal aortic aneurysms. The double tube stent-graft method appears safe in terms of endoleaks and migration, so we recommend that it be considered an option of endovascular aortic aneurysm therapy.

Weiterbildung in endovaskulären Techniken mit der privaten Akademie der DGG

ZusammenfassungDie endovaskulären Techniken sind integraler Bestandteil gefäßchirurgischer Tätigkeit. Sie sind in diesem Fachgebiet tief verwurzelt, aber noch nicht flächendeckend gleichmäßig verbreitet. Die Sektion „Endovaskuläre Techniken“ der Akademie für Forschung und Weiterbildung der DGG hat deshalb das Konzept einer strukturierten Weiterbildung in diesen Techniken entwickelt und mit einem Kurssystem hinterlegt, dass Gefäßchirurgen die komplette diesbezügliche Weiterbildung ermöglicht. Der Nachweis der erreichten Kompetenz kann durch die Zertifizierung zum „Endovaskulären Chirurgen“ oder „Endovaskulären Spezialisten“ geführt werden. Konzept, Kurssystem und der Weg zur Zertifizierung werden dargelegt.AbstractEndovascular techniques are integrated into vascular surgery. Vascular surgeons are deeply involved in using these techniques, but the techniques are not being spread everywhere. Therefore, members of the section for endovascular techniques of the private Academy for Research and Education of the German Society for Vascular Surgery developed a concept for structured education concerning endovascular activities. A system of workshops was developed to render this education feasible. To prove full endovascular competence, a vascular surgeon can achieve certification as an endovascular surgeon or endovascular specialist. The concept, workshops, and method of achieving certification are herein explained.

Ergebnisqualität in der Gefäßchirurgie

ZusammenfassungHintergrund. Zur Beurteilung der Ergebnisqualität ist die Ermittlung und Wertung interner und externer Behandlungsdaten erforderlich. Die Gefäßchirurgie zeichnet sich in ihren Kernbehandlungsbereichen wie Karotisstenosen, Bauchaortenaneurysmen (BAA), der peripheren arteriellen Verschlusskrankheit (pAVK) und der Varikose durch klar definierte Ergebnisindikatoren aus. Trotzdem ist die Ermittlung der Ergebnisqualität erschwert durch unterschiedliche Indikationen, Therapiekonzepte und Datenvalidität. Methode. Die Qualitätssicherungskommission der Deutschen Gesellschaft für Gefäßchirurgie hat zur externen, vergleichenden Qualitätssicherung nach § 137 SGB V Programme zum “Qualitätsmanagement für die Carotis TEA und das abdominelle Aortenaneurysma” aufgelegt sowie einen Qualitätserfassungsbogen zur Behandlung der Varikose entwickelt. Ergebnisse. Die Auswertung aller an ein unabhängiges Institut eingesandten Erfassungsbögen ermöglicht jeder Abteilung eine umfassende Evaluation der eigenen Ergebnisqualität und den Vergleich mit einem definierten Qualitätswert (Benchmarking) und den landesweiten Ergebnissen. Schlussfolgerung. Die Erfassung der eigenen Ergebnisqualität stellt für jeden therapeutisch tätigen Arzt ein fundamentales Anliegen dar, das durch gesundheitspolitische Rahmenbedingungen zunehmend Bedeutung gewinnt.AbstractIntroduction. For the assessment of outcome quality, the acquisition and evaluation of internal and external treatment data is necessary. Vascular surgery is characterized in main topics of treatment such as carotid stenoses, aortic aneurysms, peripheral arterial disease, and varicose veins by clearly defined outcome indicators. Nevertheless, the determination of the quality of outcome is difficult because of the differing standards. Methods. For an external, comparative quality assurance, the quality assurance commission of the German Society for Vascular Surgery has established a program, “Quality Management for the carotid TEA and the BAA” according to § 137 SGB V, and has developed a questionnaire for recording the quality of treatment of varicose veins. Results. The evaluation of all the questionnaires submitted to an independent institute enables the participating departments to have a comprehensive evaluation of their own quality of outcome and provides a tool to compare it with defined quality levels (benchmarking). Conclusion. For every physician, the perception of his own quality of outcome represents a fundamental requirement, which continues to gain importance within the context of future health policies.