Beate Hugl

Effect of the dual endothelin receptor antagonist bosentan on Raynaud’s phenomenon secondary to systemic sclerosis: a double-blind prospective, randomized, placebo-controlled pilot study

OBJECTIVE To investigate the efficacy of the endothelin receptor antagonist, bosentan, in patients with RP secondary to SSc without pre-existing digital ulcers. METHODS Single-centre, randomized, prospective, double-blinded comparison of bosentan and placebo. Patients received either 62.5 mg bosentan twice daily for 4 weeks, followed by 125 mg twice daily for 12 weeks or matching doses of placebo. RESULTS Of the 17 patients enrolled, 16 completed the study and 1 withdrew from the study due to the reversible development of peripheral oedema. Compared with placebo, bosentan did not improve the frequency, duration, pain or severity of RP attacks. However, in contrast to placebo, bosentan significantly improved the functional scores. With respect to baseline, the scleroderma HAQ disability index changes were in favour of bosentan at Weeks 12 (P = 0.03) and 20 (P = 0.01), and the United Kingdom functional score changes at Weeks 8 (P = 0.038) and 16 (P = 0.039). CONCLUSIONS Bosentan is not effective in SSc-related RP without pre-existing digital ulcers, but it might benefit functional impairment in those patients. TRIAL REGISTRATION European Union Drug Regulating Authorities Clinical Trials, https://eudract.emea.europa.eu, EudraCT-Nr 2004-002686-21.

Endovascular repair or medical treatment of acute type B aortic dissection? A comparison

INTRODUCTION The aim of this retrospective study was to compare the outcome of thoracic endovascular aortic repair (TEVAR) to that of medical therapy in patients with acute type B aortic dissection (TBD). MATERIALS AND METHODS From July 1996 to April 2008, 88 patients presenting with acute TBD underwent either TEVAR (group A, n=38) or medical therapy (group B, n=50). Indications for TEVAR were intractable pain, aortic branch compromise resulting in end-organ ischemia, rapid aortic dilatation and rupture. Follow-up was performed postinterventionally, at 3, 6 and 12 months and yearly thereafter and included clinical examinations and computed tomography (CT), as well as aortic diameter measurements and assessment of thrombosis. RESULTS Mean follow-up was 33 months in group A and 36 months in group B. The overall mortality rate was 23.7% in group A and 24% in group B, where 4 patients died of late aortic rupture. In group A, complications included 9 endoleaks and 4 retrograde type A dissections, 3 patients were converted to open surgery and 2 needed secondary intervention. None of the patients developed paraplegia. In group B, 4 patients were converted to open surgery and 2 to TEVAR. The maximal aortic diameter increased in both groups. Regarding the extent of thrombosis, our analyses showed slightly better overall results after TEVAR, but they also showed a tendency towards approximation between the two groups during follow-up. CONCLUSION TEVAR is a feasible treatment option in acute TBD. However, several serious complications may occur during and after TEVAR and it should therefore be reserved to patients with life-threatening symptoms.

Endovascular Repair of Isolated Iliac Artery Aneurysms

Purpose: To retrospectively evaluate a 12-year experience with endovascular repair of isolated iliac artery aneurysm (IAA). Methods: From August 1997 through July 2009, 91 patients (81 men; mean age 71 years, range 31–90) underwent endovascular treatment for isolated IAA at our department. Of these, 77 patients received stent-grafts either alone or in combination with coils or an Amplatzer vascular plug (n=2); 1 patient received a Smart stent combined with coils, and 13 patients were treated with coil embolization only. The aneurysms were classified according to location: type I=common iliac artery (CIA), type II=internal iliac artery (IIA), type III5CIA and IIA, and type IV=external iliac artery with/without CIA and/or IIA involvement. Results: Primary technical success was 90.1% for all aneurysm types and 93.6%, 80%, 88.8%, and 93.3% for types I, II, III, and IV, respectively. Secondary technical success was 96.7% for all types and 97.8%, 95%, 100%, and 93.3%, respectively, for each type. Clinical success was 93.4% for all types and 97.8%, 85%, 100%, and 86.7%, respectively, by type. Complications in 18 (19.8%) patients included 7 type I endoleaks, 3 type II endoleaks, 2 enlarged aneurysm sacs (incomplete embolization), 5 cases of buttock claudication, and 2 stent-graft thromboses. Two patients were converted to open surgery; 10 underwent secondary interventions. Mortality rates were 1.1% (n=1) at 30 death days and 23.1% (n=21) over a mean follow-up of 45.9 months (no aneurysm-related death). Cumulative overall survival was 97.7% at 1 year and 47.6% at 10 years. Freedom from aneurysm-related complications was 88.6% at 1 year and 83.5% at 5 years. Conclusion: Endovascular repair of isolated IAA is a safe and minimally invasive alternative to surgery. However, it may be associated with several complications and must, therefore, be carefully planned.

Endovascular Repair of Acute Type B Aortic Dissection: Midterm Results

Purpose: To evaluate midterm results of endovascular stent-graft placement for acute Stanford type B dissection (TBD). Methods: A retrospective review was conducted of 35 consecutive patients who were treated with stent-graft implantation for acute TBD between July 1996 and July 2007. Computed tomographic (CT) volumetric analysis of the true lumen (TL) and false lumen (FL) changes in 23 patients was performed, as well as evaluation of the influence of re-entry points and length of stent-graft coverage on volume changes. In addition, complications were evaluated. Follow-up was performed at 6 and 12 months and yearly thereafter Results: The technical success rate was 82.7%, and the 30-day mortality rate was 8.5%. Mean follow-up was 34 months. The overall survival rate at 5 years was 78.4%. Complications included retrograde type A dissections in 3 patients during the perioperative period and in 1 patient during midterm follow-up. In addition, 5 early and 3 late endoleaks were observed. Three patients were converted to open surgery and 2 needed secondary interventions. In the stented segment, stabilization of the aorta was achieved even during midterm follow-up, with a TL volume increase of 59% at 5 years and nearly stable FL volume. The segment from the distal end of the stent-graft to the celiac artery, however, showed unstable TL and FL volumes, with high standard deviations after the first postinterventional year and circumferential aneurysmal dilatation of the aorta immediately adjacent to the stent-graft in 5 patients. The abdominal aorta showed no substantial volume changes over time. The length of stent-graft coverage and the occurrence of reentries greatly influenced FL volume changes distal to the stent-graft. Conclusion: Serious complications can occur during and after endovascular repair of TBD. Therefore, it should be reserved for high-risk patients.

Evaluation of volumetric measurements in patients with acute type B aortic dissection – thoracic endovascular aortic repair (TEVAR) vs conservative

OBJECTIVE The aim of this retrospective study was to evaluate aortic volume changes in patients with acute type B aortic dissection (TBD), treated either by thoracic endovascular aortic repair (TEVAR) or conservatively. MATERIALS AND METHODS From July 1996 through March 2008, 76 patients presenting with acute TBD were referred to our department. To ensure a follow-up of at least 24 months, only 64 of them were included in the present study, with the cut-off for inclusion being March 2006. Twenty-nine of these patients underwent TEVAR and 35 patients underwent conservative treatment. Indications for TEVAR were life-threatening symptoms. Follow-up was performed postinterventionally in patients after TEVAR and at 3, 6, and 12 months, and yearly thereafter in both groups. It included clinical examinations, computed tomography (CT) scans, analysis of volume changes in true thoracic lumen (TTL), false thoracic lumen (FTL), thoracic lumen (TL), abdominal lumen (AL), and aortic diameter measurements. In addition, the extent of thrombosis and its influence on volume changes were assessed. RESULTS Mean follow-up was 41 months after TEVAR and 46 months in the conservatively-treated patients. At 60 months, cumulative rates of freedom from dissection-related death and rupture-free survival were 82.6% and 93.1% in the TEVAR group, respectively. They were 74.9% and 88.5% in the conservatively-treated group, respectively. In the conservatively-treated patients, 3 patients died of late aortic rupture, 4 were converted to open surgery, and 2 to TEVAR. Evaluation of volume changes showed better results in the TEVAR group within 24 months. However, within 60 months the difference between the two groups was no longer relevant. Relating to thrombosis of the FTL, analyses showed slightly better overall results and promotion of thrombus formation after TEVAR. However, at 60 months the results showed a tendency towards approximation between the two groups. CONCLUSION Our data suggest that TEVAR seems to delay the natural course of the disease but not to stop it.