Klas Österberg

Very Urgent Carotid Endarterectomy Confers Increased Procedural Risk

Background and Purpose— Current Swedish guidelines recommend that carotid endarterectomy should be performed within 14 days of a qualifying neurological event, but it is not clear if very urgent surgery after an event is associated with increased perioperative risk. The aim of this study was to determine how the time between the event and carotid endarterectomy affects the procedural risk of mortality and stroke. Methods— We prospectively analyzed data on all patients who underwent carotid endarterectomies for symptomatic carotid stenosis between May 12, 2008, and May 31, 2011, with records in the Swedish Vascular Registry (Swedvasc). Patients were divided according to time between the qualifying event and surgery (0–2 days, 3–7 days, 8–14 days, 15–180 days). Stroke rate and mortality at 30 days postsurgery were determined. Results— We analyzed data for 2596 patients and found that the combined mortality and stroke rate for patients treated 0 to 2 days after qualifying event was 11.5% (17 of 148) versus 3.6% (29 of 804), 4.0% (27 of 677), and 5.4% (52 of 967) for the groups treated at 3 to 7 days, 8 to 14 days, and 15 to 180 days, respectively. In a multivariate analysis, time was an independent risk factor for perioperative complications: patients treated at 0 to 2 days had a relative OR of 4.24 (CI, 2.07–8.70; P<0.001) compared with the reference 3- to 7-day group. Conclusions— In this study of patients treated for symptomatic carotid disease, it was safe to perform surgery as early as Day 3 after a qualifying neurological event in contrast to patients treated within 0 to 2 days, which has a significantly increased perioperative risk.

Improved Quality of Life After One Year With an Invasive Versus a Non-Invasive Treatment Strategy in Claudicants: One Year Results of the IRONIC Trial

Background—The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. Methods and Results—After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improv...Background— The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. Methods and Results— After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group. Overall, Vascular Quality of Life Questionnaire score (P<0.01) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group. Intermittent claudication distance improved significantly in the invasive (+124 m) versus the noninvasive (+50 m) group (P=0.003), whereas the change in maximum walking distance was not significantly different between groups. Conclusions— An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management. Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01219842.

Improved Quality of Life After 1 Year With an Invasive Versus a Noninvasive Treatment Strategy in Claudicants One-Year Results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial

Background—The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. Methods and Results—After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improv...Background— The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. Methods and Results— After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group. Overall, Vascular Quality of Life Questionnaire score (P<0.01) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group. Intermittent claudication distance improved significantly in the invasive (+124 m) versus the noninvasive (+50 m) group (P=0.003), whereas the change in maximum walking distance was not significantly different between groups. Conclusions— An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management. Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01219842.

Walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication--a prospective randomised trial.

OBJECTIVES Despite limited scientific evidence for the effectiveness of invasive treatment for intermittent claudication (IC), revascularisation procedures for IC are increasingly often performed in Sweden. This randomised controlled trial compares the outcome after 2 years of primary invasive (INV) versus primary non-invasive (NON) treatment strategies in unselected IC patients. MATERIALS/METHODS Based on arterial duplex and clinical examination, IC patients were randomised to INV (endovascular and/or surgical, n = 100) or NON (n = 101). NON patients could request invasive treatment if they deteriorated during follow-up. Primary outcome was maximal walking performance (MWP) on graded treadmill test at 2 years and secondary outcomes included health-related quality of life (HRQL), assessed with Short Form (36) Health Survey (SF-36). RESULTS MWP was not significantly (p = 0.104) improved in the INV versus the NON group. Two SF-36 physical subscales, Bodily Pain (p < 0.01) and Role Physical (p < 0.05) improved significantly more in the INV versus the NON group. There were 7% crossovers against the study protocol in the INV group. CONCLUSIONS Although invasive treatment did not show any significant advantage regarding MWP, the HRQL improvements associated with invasive treatment tentatively suggest secondary benefits of this regimen. On the other hand, a primary non-invasive treatment strategy seems to be accepted by most IC patients.

National experience with extracranial carotid artery aneurysms: epidemiology, surgical treatment strategy, and treatment outcome.

OBJECTIVE Extracranial carotid artery aneurysms (CAAs) are rare but confer risk of stroke, rupture, and local symptoms. Few cases have been reported, even from large centers, and therefore knowledge of the disease is limited. The purpose of this study was to review epidemiology, surgical treatment, and outcomes of CAAs in a nationwide setting using the Swedish National Registry for Vascular Surgery (Swedvasc). METHODS Data on all surgical interventions for CAAs from January 1997 to December 2011 were retrieved from the Swedvasc registry. Additional clinical information was collected from hospital records. RESULTS A total of 48 cases of CAAs were identified. The cause was atherosclerosis in 34 cases, infection in 2, and pseudoaneurysm in 12. The most common presentation was a pulsatile mass with or without local symptoms. Aneurysms isolated to the internal carotid artery predominated. Resection with end-to-end anastomosis was the most common technique used for treatment. Among true aneurysms, 24% had a known synchronous aneurysm elsewhere. Stroke-free survival (n = 48) was 90% after 30 days and 85% after 1 year. A total of 12.5% patients experienced permanent cranial nerve injury and 33% experienced any complication. CONCLUSIONS CAAs are rare entities in vascular surgery. In terms of stroke-free survival, the Swedish national results approach reports from large volume centers. The relatively high risk for permanent cranial nerve injury advocates caution when performing surgery on CAAs.

Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication

Intermittent claudication is associated with significant impairment of health‐related quality of life. The use of revascularization techniques to improve health‐related quality of life remains controversial.

Endovascular Technique for Arterial Shunting to Prevent Intraoperative Ischemia

OBJECTIVES The use of an intraoperative shunt is an established technique used to reduce the ischemic time after acute arterial obstruction or in the prevention of hypoperfusion due to complex open vascular or endovascular operative procedures. To date, described methods of temporary extremity blood perfusion have required open surgical techniques. METHODS An endovascular shunt (ES) was formed by connecting two introducer sheaths to each other, one positioned proximal and one distal to an arterial obstruction. The ES method was used in patients considered to be at high risk for prolonged lower limb ischemia in conjunction with a vascular procedure and where shunt creation by open surgical technique was not considered to be a practical alternative. The flow capacity of the ES was defined in a desktop model. RESULTS The ES method was used clinically in 15 vascular interventions including eight complex endovascular aortic procedures, three open aortic operations, and four procedures for acute limb ischemia. The shunts were functional in all patients and there were no shunt occlusions. Postoperatively, there were no evident clinical reperfusion injuries. Flow analysis revealed that the ES had a flow capacity of 73% flow capacity compared to a Pruitt-Inahara shunt. CONCLUSION A new method of temporary blood shunting in connection to vascular procedures has been demonstrated.

Response to Correspondence by de Borst re: 'The True Risk of Early Recurrent Stroke: Importance of Cohort Composition and Index Event Definition'.

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Response to Letter Regarding Article, “Improved Quality of Life After 1 Year With an Invasive Versus a Noninvasive Treatment Strategy in Claudicants: One-Year Results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial”

We thank the authors for their interest in our study. The pragmatic real-life design applied the 2 main treatment options for claudicants used in our clinical practice. We also included a large proportion of consecutive patients with intermittent claudication1 to safeguard the external validity of our results. Our study was not designed to evaluate the efficacy of different pharmacotherapies or exercise therapies. We acknowledge that short-term supervised exercise training on the graded treadmill, in comparison with walk advice, improves walking distance on the graded treadmill. Despite available evidence, supervised exercise training is still largely unavailable,2 probably in part because the long-term efficacy is not firmly established.3 A systematic review indicated poor long-term adherence,4 and, in …

Response to Letter Regarding Article, “Very Urgent Carotid Endarterectomy Confers Increased Procedural Risk”

Response: Thank you for your interest in our study1 regarding procedural risk with acute carotid endarterectomy. First we would like to emphasize that one of the main findings of our study is that procedural risk is not increased even if the time from the index event to surgery is reduced to as few as 3 days (804 patients with carotid endarterectomy 3–7 days after an index event had 3.6% procedural risk). Many surgical centers still find it difficult to reduce the time to intervention to <1 week, and our study stresses the importance of continuing …