Jens-Rainer Allenberg

30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.

BACKGROUND Carotid endarterectomy is effective in stroke prevention for patients with severe symptomatic carotid-artery stenosis, and carotid-artery stenting has been widely used as alternative treatment. Since equivalence or superiority has not been convincingly shown for either treatment, we aimed to compare the two. METHODS 1200 patients with symptomatic carotid-artery stenosis were randomly assigned within 180 days of transient ischaemic attack or moderate stroke (modified Rankin scale score of < or =3) carotid-artery stenting (n=605) or carotid endarterectomy (n=595). The primary endpoint of this hospital-based study was ipsilateral ischaemic stroke or death from time of randomisation to 30 days after the procedure. The non-inferiority margin was defined as less than 2.5% on the basis of an expected event rate of 5%. Analyses were on an intention-to-treat basis. This trial is registered at Current Controlled Trials with the international standard randomised controlled trial number ISRCTN57874028. FINDINGS 1183 patients were included in the analysis. The rate of death or ipsilateral ischaemic stroke from randomisation to 30 days after the procedure was 6.84% with carotid-artery stenting and 6.34% with carotid endarterectomy (absolute difference 0.51%, 90% CI -1.89% to 2.91%). The one-sided p value for non-inferiority is 0.09. INTERPRETATION SPACE failed to prove non-inferiority of carotid-artery stenting compared with carotid endarterectomy for the periprocedural complication rate. The results of this trial do not justify the widespread use in the short-term of carotid-artery stenting for treatment of carotid-artery stenoses. Results at 6-24 months are awaited.

Hybrid procedures for thoracoabdominal aortic aneurysms and chronic aortic dissections – A single center experience in 28 patients

OBJECTIVE We report our 6-year experience with the visceral hybrid procedure for high-risk patients with thoracoabdominal aortic aneurysms (TAAA) and chronic expanding aortic dissections (CEAD). METHODS Hybrid procedure includes debranching of the visceral and renal arteries followed by endovascular exclusion of the aneurysm. A series of 28 patients (20 male, mean age 66 years) were treated between January 2001 and July 2007. Sixteen patients had TAAAs type I-III, one type IV, four thoracoabdominal placque ruptures, and seven patients CEAD. Patients were treated for asymptomatic, symptomatic, and ruptured aortic pathologies in 20, and 4 patients, respectively. Two patients had Marfans syndrome; 61% had previous infrarenal aortic surgery. The infrarenal aorta was the distal landing zone in 70%. In elective cases, simultaneous approach (n = 9, group I) and staged approach (n = 11, group II) were performed. Mean follow-up is 22 months (range 0.1-78). RESULTS Primary technical success was achieved in 89%. All stent grafts were implanted in the entire thoracoabdominal aorta. Additionally, three patients had previous complete arch vessel revascularization. Left subclavian artery was intentionally covered in three patients (11%). Thirty-day mortality rate was 14.3% (4/28). One patient had a rupture before the staged endovascular procedure and died. Overall survival rate at 3 years was 70%, in group I 80%, and in group II 60% (P = .234). Type I endoleak rate was 8%. Permanent paraplegia rate was 11%. Three patients required long-term dialysis (11%). Peripheral graft occlusion rate was 11% at 30 days. Gut infarction with consecutive bowel resection occurred in two patients. There was no significant difference between group I and II regarding paraplegia and complications. CONCLUSIONS Early results of visceral hybrid repair for high-risk patients with complex and extended TAAAs and CEADs are encouraging in a selected group of high risk patients in whom open repair is hazardous and branched endografts are not yet optional.

Renal artery aneurysm: surgical indications and results.

The clinical course of 23 patients with 28 renal artery aneurysms (RAAs) is reported. The RAAs were recorded over a period of 10 years. Thirty-five per cent of the RAAs (eight of 23 patients) were detected during the investigation of hypertension, whereas 26% (six of 23 patients) were discovered incidentally while imaging atherosclerotic arterial disease in the aorto-iliac region by angiography. Twenty-two aneurysms were treated surgically and primary nephrectomy was necessary in one case. The surgical technique used was excision of the aneurysm with bypass grafting in 13 cases (seven Dacron, five vein, one arterial bypass), a running suture following aneurysm excision in four cases and an end-to-end anastomosis in two cases. The results (for a period of 1-10 years) were excellent in all but three cases: two early graft occlusions (vein interposition) and one late occlusion (Dacron bypass) in the course of a re-operation which had become necessary because of a ruptured aneurysm of the gastro-epiploic artery after 3 months. Three of 23 patients were treated by embolisation of four intraparenchymal aneurysms. The follow-up of a non-treated saccular aneurysm showed a total thrombosis of the aneurysm within 4 years and fixed renal hypertension developed later in this patient. We suggest surgical repair of an RAA regardless of its size and the clinical symptoms, in order to prevent microembolism into the renal parenchyma and to avoid the development of fixed renal hypertension. Intrarenal aneurysms can be treated by embolisation to stop severe haematuria thus preserving the kidney.(ABSTRACT TRUNCATED AT 250 WORDS)

The Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs. Endarterectomy Trial

The Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) Trial is investigating if both treatment modalities are equivalent in the treatment of severe symptomatic carotid stenoses. Patients with symptomatic (transient ischaemic attack or minor stroke) stenosis (above 50% following the North American Symptomatic Endarterectomy Trial criteria) eligible for both methods can be recruited into this trial. The primary endpoint is the incidence of an ipsilateral stroke or death between randomisation and day 30 after treatment. Surgeons as well as the interventionalists have to demonstrate their expertise prior to participation in the trial. Funding is mostly by public institutions (Federal Ministry of Education and Research and German Research Foundation). An external monitoring is applied. Thirty-two centres are currently taking part in the SPACE Trial that has been running in Germany, Austria and Switzerland for 3 years, and they have been able to recruit a total of around 670 patients. The definitive results of this study cannot be expected before 3–5 years.

Peripheral Arterial Disease as an Independent Predictor for Excess Stroke Morbidity and Mortality in Primary-Care Patients: 5-Year Results of the getABI Study

Background:There is controversial evidence with regard to the significance of peripheral arterial disease (PAD) as an indicator for future stroke risk. We aimed to quantify the risk increase for mortality and morbidity associated with PAD. Methods:In an open, prospective, noninterventional cohort study in the primary care setting, a total of 6,880 unselected patients ≧65 years were categorized according to the presence or absence of PAD and followed up for vascular events or deaths over 5 years. PAD was defined as ankle-brachial index (ABI) <0.9 or history of previous peripheral revascularization and/or limb amputation and/or intermittent claudication. Associations between known cardiovascular risk factors including PAD and cerebrovascular mortality/events were analyzed in a multivariate Cox regression model. Results:During the 5-year follow-up [29,915 patient-years (PY)], 183 patients had a stroke (incidence per 1,000 PY: 6.1 cases). In patients with PAD (n = 1,429) compared to those without PAD (n = 5,392), the incidence of all stroke types standardized per 1,000 PY, with the exception of hemorrhagic stroke, was about doubled (for fatal stroke tripled). The corresponding adjusted hazard ratios were 1.6 (95% confidence interval, CI, 1.1–2.2) for total stroke, 1.7 (95% CI 1.2–2.5) for ischemic stroke, 0.7 (95% CI 0.2–2.2) for hemorrhagic stroke, 2.5 (95% CI 1.2–5.2) for fatal stroke and 1.4 (95% CI 0.9–2.1) for nonfatal stroke. Lower ABI categories were associated with higher stroke rates. Besides high age, previous stroke and diabetes mellitus, PAD was a significant independent predictor for ischemic stroke. Conclusions:The risk of stroke is substantially increased in PAD patients, and PAD is a strong independent predictor for stroke.

Endovascular aortic arch reconstruction with supra-aortic transposition for symptomatic contained rupture and dissection: early experience in 8 high-risk patients.

Purpose: To report our initial experience with total and subtotal endovascular aortic arch reconstruction combined with supra-aortic vessel transposition in high-risk patients and to present a new morphological classification of thoracic aortic lesions for patient and procedure selection. Methods: Among 80 patients treated with thoracic stent-grafts at our department between 1997 and 2003, 8 patients (6 men; mean age 71 years, range 45–81) unfit for open repair were not candidates for standard endovascular repair due to inadequate proximal landing zones on the aortic arch. Commercially available endografts (Excluder, Zenith, Endofit, Talent) were used to repair the arch after supra-aortic vessel transposition was performed. The endograft was implanted transfemorally or via an iliac Dacron conduit graft with standardized endovascular techniques and deployed during intravenous adenosine-induced asystole. The imaging data from all thoracic endograft patients was analyzed to classify thoracic and thoracoabdominal lesions according to a 4-level anatomical system. Results: Deployment success was 100% after staged supra-aortic vessel transposition, but 1 patient died of endograft-related rupture of the proximal aortic arch. There was no neurological complication. Mean follow-up was 16 months (range 1–36). Patency of all endografts and conventional bypasses was 100%, and no migration was observed. One minor type II endoleak was demonstrated. Conclusions: Initial results are encouraging for endovascular aortic arch repair in combination with supra-aortic transposition in selected high-risk patients with complex aortic pathologies.

Surgical Therapy of Extracranial Carotid Artery Aneurysms: Long-Term Results over a 24-Year Period

BACKGROUND To evaluate long-term results of surgical therapy of extracranial carotid artery aneurysms (ECCA) and to provide a morphologic classification for individual surgical reconstruction techniques. PATIENT AND METHODS This retrospective analysis includes 57 patients (43 male, mean age 61.9 years.) with 64 carotid reconstructions for ECCA between 1980 and 2004. In 29 (50.9%) of the patients there was found a cerebral ischemic event as an initial symptom (18 transient ischemic attacks, 11 strokes). In patients without cerebral events, the presenting symptom was pulsatile cervical mass in 19 and cranial nerve dysfunction in 3 cases. ECCA was morphologically stratified in Type I=isolated aneurysms of the internal carotid artery (n=25), Type II=aneurysms of the complete internal carotid artery with involvement of the bifurcation (n=8), Type III=aneurysms of the carotid bifurcation (n=20), Type IV=combined aneurysm of the internal and common carotid artery (n=5) and Type V=isolated aneurysm of the common carotid artery (n=6). RESULTS Perioperative stroke rate was 1.6%. 4 patients suffered from transient ischemic attacks (6.3%). Permanent and transient cranial nerve injury rate was 6.3% and 20.3% respectively. After 5, 10, 15 and 20 years the actuarial survival was 90%, 77%, 65% and 57%. The ipsilateral stroke-free time was 96%, 96%, 93% and 87%, respectively. CONCLUSIONS Surgical reconstruction of extracranial carotid aneurysms is a safe procedure with good long-term results. The risk of a permanent, perioperative cerebral neurological deficit is low, but there is a considerable risk of cranial nerve injury.

Carotid endarterectomy and intracranial thrombolysis: Simultaneous and staged procedures in ischemic stroke

PURPOSE The feasibility and safety of combining carotid surgery and thrombolysis for occlusions of the internal carotid artery (ICA) and the middle cerebral artery (MCA), either as a simultaneous or as a staged procedure in acute ischemic strokes, was studied. METHODS A nonrandomized clinical pilot study, which included patients who had severe hemispheric carotid-related ischemic strokes and acute occlusions of the MCA, was performed between January 1994 and January 1998. Exclusion criteria were cerebral coma and major infarction established by means of cerebral computed tomography scan. Clinical outcome was assessed with the modified Rankin scale. RESULTS Carotid reconstruction and thrombolysis was performed in 14 of 845 patients (1.7%). The ICA was occluded in 11 patients; occlusions of the MCA (mainstem/major branches/distal branch) or the anterior cerebral artery (ACA) were found in 14 patients. In three of the 14 patients, thrombolysis was performed first, followed by carotid enarterectomy (CEA) after clinical improvement (6 to 21 days). In 11 of 14 patients, 0.15 to 1 mIU urokinase was administered intraoperatively, ie, emergency CEA for acute ischemic stroke (n = 5) or surgical reexploration after elective CEA complicated by perioperative intracerebral embolism (n = 6). Thirteen of 14 intracranial embolic occlusions and 10 of 11 ICA occlusions were recanalized successfully (confirmed with angiography or transcranial Doppler studies). Four patients recovered completely (Rankin 0), six patients sustained a minor stroke (Rankin 2/3), two patients had a major stroke (Rankin 4/5), and two patients died. In one patient, hemorrhagic transformation of an ischemic infarction was detectable postoperatively. CONCLUSION Combining carotid surgery with thrombolysis (simultaneous or staged procedure) offers a new therapeutic approach in the emergency management of an acute carotid-related stroke. Its efficacy should be evaluated in interdisciplinary studies.

Emergency Carotid Endarterectomy

Objective: Evaluation of the therapeutical efficacy of emergency carotid endarterectomy (CEA) in neurologically unstable patients. Patients and Methods: Three groups of a consecutive series of 71 emergency CEAs performed from 1980 to July 1998 were classified: (1) acute onset of severe stroke (n = 16), (2) progressive stroke/stroke in evolution (n = 34), and (3) crescendo transient ischemic attacks (n = 21). Cerebral coma, cerebral haemorrhage, and major ischemic stroke established in cranial computed tomography scans were contraindications for surgery. The neurological outcome was assessed by the modified Rankin scale. Long-term survival and long-term stroke recurrences were analyzed. Results: The recovery/minor stroke rates (Rankin 0–3) in acute stroke, progressive stroke, and crescendo transient ischemic attacks were 56.3, 76.4 and 80.9%, respectively; the combined major stroke/mortality rates (Rankin 4–6) were 43.7, 23.6 and 19.1%, respectively. Intraoperative angiography in 39 patients detected early carotid reocclusions in 2 and intracranial embolism in 7 patients. Local application of thrombolytic agents (n = 5) may contribute to a better neurological outcome in emergency CEA. Life table probabilities of major strokefree survival were 74.5, 71.6, and 53.7% after 1, 2, and 5 years, respectively (including perioperative strokes). Life table probabilities to suffer no stroke recurrence during follow-up were 96.7, 96.7 and 85.3%, respectively (perioperative strokes excluded). Conclusions: Emergency CEA may be worthwhile in selected patients. Completion angiography is mandatory. Emergency CEA should be included in therapeutic strategies for ischemic stroke.

Are elevated homocysteine plasma levels related to peripheral arterial disease? Results from a cross‐sectional study of 6880 primary care patients

Background  It is still unclear whether the strength of the association between elevated plasma homocysteine (HC) levels and peripheral arterial disease (PAD), coronary artery disease (CAD) and cerebrovascular disease (CVD) is similar.