Pirkka Vikatmaa

Clopidogrel Plus Aspirin Versus Warfarin in Patients With Stroke and Aortic Arch Plaques

Background and Purpose— Severe atherosclerosis in the aortic arch is associated with a high risk of recurrent vascular events, but the optimal antithrombotic strategy is unclear. Methods— This prospective randomized controlled, open-labeled trial, with blinded end point evaluation (PROBE design) tested superiority of aspirin 75 to 150 mg/d plus clopidogrel 75 mg/d (A+C) over warfarin therapy (international normalized ratio 2–3) in patients with ischemic stroke, transient ischemic attack, or peripheral embolism with plaque in the thoracic aorta >4 mm and no other identified embolic source. The primary end point included cerebral infarction, myocardial infarction, peripheral embolism, vascular death, or intracranial hemorrhage. Follow-up visits occurred at 1 month and then every 4 months post randomization. Results— The trial was stopped after 349 patients were randomized during a period of 8 years and 3 months. After a median follow-up of 3.4 years, the primary end point occurred in 7.6% (13/172) and 11.3% (20/177) of patients on A+C and on warfarin, respectively (log-rank, P=0.2). The adjusted hazard ratio was 0.76 (95% confidence interval, 0.36–1.61; P=0.5). Major hemorrhages including intracranial hemorrhages occurred in 4 and 6 patients in the A+C and warfarin groups, respectively. Vascular deaths occurred in 0 patients in A+C arm compared with 6 (3.4%) patients in the warfarin arm (log-rank, P=0.013). Time in therapeutic range (67% of the time for international normalized ratio 2–3) analysis by tertiles showed no significant differences across groups. Conclusions— Because of lack of power, this trial was inconclusive and results should be taken as hypothesis generating. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00235248.

Editor's Choice – Treatment of Aortic Prosthesis Infections by Graft Removal and In Situ Replacement with Autologous Femoral Veins and Fascial Strengthening

INTRODUCTIONnAortic prosthetic graft infection (AGI) is a major challenge in vascular surgery. Eradicating the infection requires prosthetic material removal, debridement, and lower limb revascularization. For the past 15 years, we have used femoral veins for aorto-iliac reconstruction and tensor fascia lata to strengthen the upper anastomosis.nnnOBJECTIVEnThe purpose of this single institution retrospective study is to present results regarding in situ replacement of infected aortic grafts with autologous femoral veins (FVs).nnnMETHODSnFrom October 2000 to March 2013, patients treated for AGI with graft removal and autologous FV reconstruction at Helsinki University Hospital were included. Primary outcome measures were 30 day mortality, long-term treatment related mortality, and re-infection rate. Secondary outcome measures were long-term all cause mortality and event free survival (graft rupture, re-intervention, major amputation).nnnRESULTSnDuring a 13 year period 55 patients (42 male, 13 female) were operated on using a venous neo-aorto-iliac system for AGI. The mean follow up was 32 months (1-157 months). The 30 day mortality rate was 9% (5) and overall treatment related mortality 18% (10). All cause mortality during follow up was 22 (40%) and overall Kaplan-Meier survival was 90.7% at 30 days, 81.5% at 1 year, and 59.3% at 5 years. Graft rupture occurred in three (5%) cases, two of which were caused by graft re-infection (4%). Four patients required major amputation, one of them on arrival and three (5%) during the post-operative period. Nine (16%) patients needed interventions for the vein graft, and two graft limbs occluded during follow up.nnnCONCLUSIONnIn situ reconstruction for aortic graft infection with autologous FV presents acceptable rates of morbidity and mortality, and remains the treatment of choice for AGI at Helsinki University Hospital.

Compression Therapy Versus Surgery in the Treatment of Patients With Varicose Veins: A RCT

OBJECTIVEnSuperficial venous reflux and varicose veins are common. The aim of this randomized controlled trial was to assess effectiveness of compression therapy compared with surgery for superficial venous reflux.nnnMETHODSn153 patients with CEAP class C2-C3 and superficial venous reflux were randomized to receive either conservative treatment (compression stockings) (n = 77) or surgery (n = 76). Clinical examination including duplex ultrasound (DUS) was performed at entry and 1 and 2 years after randomization (compression group) or surgery (surgery group). Venous Clinical Severity Score without compression stockings (VCSS-S), Venous Segmental Disease Score (VSDS), Venous Disability Score (VDS), and health-related quality of life (HRQoL) were assessed at entry and at the follow-ups. Data were analysed on an intention-to-treat basis and according to the actual treatment performed.nnnRESULTSnAt 2 years, 70/76 patients in the surgery group and 11/77 patients in the compression group had been operated on. VCSS-S decreased from 4.6 to 3.5 in the compression group (p < .01) and from 4.8 to 0.6 in the surgery group (p < .001). VSDS decreased from 7.7 to 7.0 in the compression group and from 8.2 to 0.9 in the surgery group (p < .0001). HRQoL did not change in the compression group, but improved significantly in the surgery group.nnnCONCLUSIONnThe surgical elimination of non-complicated superficial venous reflux is an effective treatment when compared with providing compression stockings only.

Strategies for Free Flap Transfer and Revascularisation with Long-term Outcome in the Treatment of Large Diabetic Foot Lesions

OBJECTIVE/BACKGROUNDnTo analyse the impact of ischaemia and revascularisation strategies on the long-term outcome of patients undergoing free flap transfer (FFT) for large diabetic foot lesions penetrating to the tendon, bone, or joint.nnnMETHODSnFoot lesions of 63 patients with diabetes (median age 56 years; 70% male) were covered with a FTT in 1991-2003. Three groups were formed and followed until 2009: patients with a native in line artery to the ulcer area (nxa0=xa019; group A), patients with correctable ischaemia requiring vascular bypass (nxa0=xa032; group B), and patients with uncorrectable ischaemia lacking a recipient vessel in the ulcer area (nxa0=xa012; group C).nnnRESULTSnThe respective 1, 5, and 10 year amputation free survival rates were 90%, 79%, and 63% in group A; 66%, 25%, and 18% in group B; and 50%, 42%, and 17%, in group C. The respective 1, 5, and 10 year leg salvage rates were 94%, 94%, and 87% in group A; 71%, 65%, and 65% in group B; and 50%, 50%, and 50% in group C. In 1 year, 43%, 45%, and 18% of the patients in groups A, B, and C, respectively, achieved stable epithelisation for at least 6 months. The overall amputation rate was associated with smoking (relative risk [RR] 3.09, 95% confidence interval [CI] 1.8-5.3), heel ulceration (RR 2.25, 95% CI 1.1-4.7), nephropathy (RR 2.24, 95% CI 1.04-4.82), and an ulcer diameter of >10xa0cm (RR 2.08, 95% CI 1.03-4.48).nnnCONCLUSIONnDespite diabetic comorbidities, complicated foot defects may be covered by means of an FFT with excellent long-term amputation free survival, provided that a patent native artery feeds the ulcer area. Ischaemic limbs may also be salvaged with combined FFT and vascular reconstruction in non-smokers and in the absence of very extensive heel ulcers. Occasionally, amputation is avoidable with FFT, even without the possibility of direct revascularisation.

Carotid Embolectomy and Endarterectomy for Symptomatic Complete Occlusion of the Carotid Artery as a Rescue Therapy in Acute Ischemic Stroke

Emergency endarterectomy of an occluded internal carotid artery (ICA) has not been investigated as an option of rescue therapy for severe acute ischemic stroke in the era of intravenous (IV) thrombolysis treatment neither as a primary treatment nor after failed IV thrombolysis. Data from the pre-IV thrombolysis era are conflicting and therefore emergency endarterectomy has not been recommended. The number of patients reaching the emergency room within the IV thrombolysis time window has vastly grown due to advanced acute stroke treatment protocols. The efficacy of mechanical thrombectomy as a primary or add-on to IV thrombolysis therapy option is being actively investigated. We herein report 2 cases of acute ischemic stroke with computerized tomography (CT) angiography-documented occlusion of an ICA that were treated with emergency carotid endarterectomy and embolectomy to restore cerebral blood flow. Both cases presented with severe stroke symptoms and signs not responding to IV thrombolysis and showed severe CT-perfusion deficits mainly representing ischemic penumbra. Blood flow was surgically restored after 5 h of symptom onset. Both patients achieved a favorable outcome. We conclude that timely surgical approach of acute ICA occlusion after failed thrombolysis as a rescue therapy may be a viable option in well-selected patients.

Perioperative Myocardial Infarction in Non-Cardiac Surgery Patients: A Prospective Observational Study

Background and Aims: Perioperative myocardial infarction is an underdiagnosed complication causing morbidity, mortality, and considerable costs. However, evidence of preventive and therapeutic options is scarce. We investigated the incidence and outcome of perioperative myocardial infarction in non-cardiac surgery patients in order to define a target population for future interventional trials. Material and Methods: We conducted a prospective single-center study on non-cardiac surgery patients aged 50u2009years or older. High-sensitivity troponin T and electrocardiograph were obtained five times perioperatively. Perioperative myocardial infarction diagnosis required a significant troponin T release and an ischemic sign or symptom. Perioperative risk calculator was used for risk assessment. Results: Of 385 patients with systematic ischemia screening, 27 patients (7.0%) had perioperative myocardial infarction. The incidence was highest in vascular surgery—19 of 172 patients (11.0%). The 90-day mortality was 29.6% in patients with perioperative myocardial infarction and 5.6% in non–perioperative myocardial infarction patients (pu2009<u20090.001). Perioperative risk calculator predicted perioperative myocardial infarction with an area under curve of 0.73 (95% confidence interval: 0.64–0.81). Conclusion: Perioperative myocardial infarction is a common complication associated with a 90-day mortality of 30%. The ability of the perioperative risk calculator to predict perioperative myocardial infarction was fair supporting its routine use.

Efficacy of endovascular treatment for pelvic congestion syndrome.

BACKGROUNDnChronic pelvic pain is not a rare health problem among women. One of the most common causes of chronic pelvic pain is pelvic congestion syndrome (PCS). We have reviewed all medical literature on the endovascular treatment of PCS and hereby provide a brief overview of the anatomy, pathophysiology, and clinical aspects of ovarian and pelvic varices. We describe the technique of transcatheter embolization, the complications thereof and the clinical results of the treatment.nnnMETHODSnA literature search was performed using PubMed, Science Direct, Google Scholar, and Scopus to identify case series on the endovascular treatment of PCS up until the end of Novemberxa02014.nnnRESULTSnTwenty studies with a total of 1081 patients were included in the review. There were no randomized trials, and only one study included a control group. The immediate technical success rate in the occlusion of the affected veins was 99%. Seventeen studies reported the 1- to 3-month clinical success of 641 patients. Of these, 88.1% reported moderate to significant relief in the symptoms and 11.9% reported little or no relief. In 17 studies, long-term results were reported, and the follow-up varied between 7.3xa0months and 5xa0years. In late follow-up, 86.6% reported relief of the symptoms and 13.6% experienced little or no relief.nnnCONCLUSIONSnThe immediate success rate for the endovascular treatment of PCS is good and the complication rate low. Most patients report relief in the symptoms for up to 5xa0years after the procedure. However, there are no randomized or high-quality controlled trials, and the level of evidence therefore remains atxa0C.

Medical treatment of carotid endarterectomy patients requires attention

Abstract Objectives: The benefits of prophylactic carotid endarterectomy (CEA) together with best medical treatment (BMT) are well-established. Early initiation of proper medical treatment reduces the risk of new strokes as waiting periods for CEA operation can be considerably long. We investigated: (1) preoperative medical treatment of CEA patients at our hospital and (2) how well the present medical treatment coheres with national and international secondary prevention guidelines and other CEA cohorts. Methods: A retrospective study cohort of 135 consecutive patients planned for CEA in a tertiary center because of symptomatic (nu200a=u200a100) or asymptomatic (nu200a=u200a35) carotid artery stenosis during a 14-month period (2007–2008). Results: One hundred and twenty-six of 135 (93·3%) patients received antiplatelet therapy at the time of surgery, 125/135 (92·6%) were on statin, and 121/135 (89·6%) used antihypertensive medications. Ten of the 100 symptomatic patients had recurrence or progression in their ischemic symptoms while waiting for the operation, with a median time of 8·5 days (range 1–30 days). Discussion: Carotid artery stenosis patients are considered high-risk patients regardless of symptomatology. The high proportion of medication use exceeds the use in the past proof-of-concept randomized controlled trials on the benefit of CEA+BMT over BMT. Nevertheless, there is room for improvement.

Treatment of Paget-Schroetter syndrome with a three-stage approach including thoracoscopic rib resection at the second stage

OBJECTIVEnYoung, active persons may suffer lifelong consequences of subclavian vein thrombosis, but the best treatment options remain unclear. On introduction of more active pharmacomechanical thrombus removal and thoracoscopic rib resection in our institution, we planned a diagnostic and treatment protocol and aimed to analyze the early, midterm, and intermediate-term results.nnnMETHODSnThe study included 72 patients who were diagnosed with an upper limb deep venous thrombosis and underwent phlebography between 2006 and 2013. After the initial treatment, control phlebography was performed and a thoracoscopic first rib resection was considered. Postoperative balloon angioplasty was performed when appropriate, and 1-year follow-up phlebography was carried out.nnnRESULTSnAfter the initial thrombus removal, 60 patients were treated with thoracoscopic first rib resection and subsequent phlebography with or without balloon angioplasty. The median time from symptom to surgery was 124xa0days, and six (10%) patients had a reocclusion before surgery. Ten (16.7%) patients experienced complications, which were treated mainly with a chest tube (nxa0= 3) or thoracoscopic re-exploration (nxa0= 4). Three months after surgery, 98.3% (59/60) experienced an overall relief of symptoms. No recurrence of clinical thrombosis or residual compression due to incomplete rib resection was seen, and 96.6% (56/58) of the patients reported an overall improvement of symptoms at 13xa0months. Two patients (3.4%) were treated for chronic pain and had electroneuromyography-verified nerve plexus damage. In both cases, the pain was relieved in the long run.nnnCONCLUSIONSnA combination of early thrombus removal, thoracoscopic first rib resection, and postoperative venous balloon angioplasty seems to yield acceptable intermediate-term results after Paget-Schroetter thrombosis.

The effects of baroreflex activation therapy on blood pressure and sympathetic function in patients with refractory hypertension: the rationale and design of the Nordic BAT study*

Abstract Objective: To explore the effects of baroreflex activation therapy (BAT) on hypertension in patients with treatment resistant or refractory hypertension. Methods: This investigator-initiated randomized, double-blind, 1:1 parallel-design clinical trial will include 100 patients with refractory hypertension from 6 tertiary referral hypertension centers in the Nordic countries. A Barostim Neo System will be implanted and after 1 month patients will be randomized to either BAT for 16 months or continuous pharmacotherapy (BAT off) for 8 months followed by BAT for 8 months. A second randomization will take place after 16 months to BAT or BAT off for 3 months. Eligible patients have a daytime systolic ambulatory blood pressure (ABPM) of u2009≥145u2009mm Hg, and/or a daytime diastolic ABPM of u2009≥95u2009mm Hg after witnessed drug intake (including u2009≥3 antihypertensive drugs, preferably including a diuretic). Results: The primary end point is the reduction in 24-hour systolic ABPM by BAT at 8 months, as compared to pharmacotherapy. Secondary and tertiary endpoints are effects of BAT on home and office blood pressures, measures of indices of cardiac and vascular structure and function during follow-up, and safety. Conclusions: This academic initiative will increase the understanding of mechanisms and role of BAT in the refractory hypertension.