| 1. |
- Amlani, Vishal, et al.
(författare)
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The current status of drug-coated devices in lower extremity peripheral artery disease interventions
- 2021
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Ingår i: Progress in Cardiovascular Diseases. - : Elsevier BV. - 0033-0620. ; 65, s. 23-28
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Tidskriftsartikel (refereegranskat)abstract
- Lower limb peripheral artery disease is a leading cause of cardiovascular disease morbidity and mortality. Endovascular revascularization is often indicated to improve walking function and to prevent limb loss but restenosis in the treated vessel segment remains a concern that limits the overall effectiveness of the treatment. The most promising technique to prevent restenosis is the use of drug-coated devices, and the most common drug used to coat lower limb balloon angioplasty balloons and stents is paclitaxel. A systematic review and meta analysis in 2018 reported a possible increase in late mortality attributable to paclitaxel-coated devices. Since then, their use has been brought into question. Here, we present an update of data focusing on the efficacy and safety of paclitaxel-coated devices in lower limb treatment applications. While paclitaxel-coated devices appear to reduce restenosis rates it is still unclear how these surrogate marker improvements translate to direct patient benefits and uncertainty remains as to whether paclitaxel-coated devices confer an increased risk of long-term mortality. Available randomized clinical data is hampered by trial heterogeneity, insufficient power, potential attrition bias and the lack of a plausible mechanistic explanation. An important step forward is that the ongoing trials that were temporarily halted due to the Katsanos et al. report have now both commenced recruitment and may ultimately resolve this clinical dilemma by virtue of their larger sample sizes. Other possible ways forward are the ongoing investigation of alternative anti-proliferative coating agents and use of new sophisticated vascular imaging techniques to more clearly identify patients at risk of restenosis already in the preoperative setting. (c) 2021 Elsevier Inc. All rights reserved.
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| 2. |
- Baubeta Fridh, Erik, 1982, et al.
(författare)
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Amputation Rates, Mortality, and Pre-operative Comorbidities in Patients Revascularised for Intermittent Claudication or Critical Limb Ischaemia : A Population Based Study
- 2017
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : W B SAUNDERS CO LTD. - 1078-5884 .- 1532-2165. ; 54:4, s. 480-486
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aims of this population based study were to describe mid-to long-term amputation risk, cumulative incidence of death or amputation, and differences in pre-operative comorbidities in patients revascularised for lower limb peripheral artery disease (PAD).Methods: This was an observational cohort study. Data from the Swedish National Quality Registry for Vascular Surgery (Swedvasc) were combined with mandatory national health care registries and patient medical records. All patients who underwent revascularisation in Sweden between May 2008 and May 2013 for intermittent claudication (IC) or critical limb ischaemia (CLI), aged 50 years and older, were identified through the Swedvasc database. The mandatory national health care registries and medical records provided data on comorbidities, mortality, and major amputations.Results: A total of 16,889 patients with PAD (IC, n = 6272; CLI, n = 10,617) were studied. The incidence of amputations in IC patients was 0.4% (range 0.3%-0.5%) per year. Among CLI patients, the amputation rate during the first 6 months following revascularisation was 12.0% (95% CI 11.3-12.6). Thereafter, the incidence declined to approximately 2% per year. The cumulative combined incidence of death or amputation 3 years after revascularisation was 12.9% (95% CI 12.0-13.9) in IC patients and 48.8% (95% CI 47.7-49.8) in CLI patients. Among CLI patients, compared with IC patients, the prevalence of diabetes, ischaemic stroke, heart failure, and atrial fibrillation was approximately doubled and renal failure was nearly tripled, even after age standardisation.Conclusion: The risk of amputation is particularly high during the first 6 months following revascularisation for CLI. IC patients have a benign course in terms of limb loss. Mortality in both IC and CLI patients is substantial. Revascularised CLI patients have different comorbidities from IC patients.
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| 3. |
- Baubeta Fridh, Erik, et al.
(författare)
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Comparison of Magnetic Resonance Angiography and Digital Subtraction Angiography for the Assessment of Infrapopliteal Arterial Occlusive Lesions, Based on the TASC II Classification Criteria
- 2020
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Ingår i: Diagnostics (Basel). - : MDPI. - 2075-4418. ; 10:11
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Tidskriftsartikel (refereegranskat)abstract
- This paper aimed to study the agreement and repeatability, both intra- and interobserver, of infrapopliteal lesion assessment with magnetic resonance angiography (MRA), using the TransAtlantic Inter-Society Consensus (TASC) II criteria, with perioperative digital subtraction angiography (DSA) as a reference. Sixty-eight patients with an MRA preceding an endovascular infrapopliteal revascularization were included. Preoperative MRAs and perioperative DSAs were evaluated in random order by three independent observers using the TASC II classification. The results were analyzed using visual grading characteristics (VGC) analysis and Krippendorffs alpha. No systematic difference was found between modalities: area under the VGC curve (AUC(VGC)) = 0.48 (p = 0.58) or intraobserver; AUC(VGC) for Observer 1 and 2 respectively, 0.49 (p = 0.85) and 0.53 (p = 0.52) for MRA compared with 0.54 (p = 0.30) and 0.49 (p = 0.81) for DSA. Interobserver differences were seen: AUC(VGC) of 0.63 (p < 0.01) for DSA and 0.80 (p < 0.01) for MRA. These results were confirmed using Krippendorffs alpha for the three observers showing 0.13 (95% confidence interval (CI) -0.07-0.31) for MRA and 0.39 (95% CI 0.23-0.53) for DSA. Poor interobserver agreement was also found in the choice of a target vessel on preoperative MRA: Krippendorffs alpha = 0.19 (95% CI 0.01-0.36). In conclusion, infrapopliteal lesions can be reliably determined on preoperative MRA, but interobserver variability regarding the choice of a target vessel is a major concern that appears to affect the overall TASC II grade.
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| 4. |
- Baubeta Fridh, Erik, 1982, et al.
(författare)
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Editor's Choice - Impact of Comorbidity, Medication, and Gender on Amputation Rate Following Revascularisation for Chronic Limb Threatening Ischaemia
- 2018
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 56:5, s. 681-688
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Tidskriftsartikel (refereegranskat)abstract
- Objective/background: Chronic limb threatening ischaemia (CLTI) has a high risk of amputation and mortality. Increased knowledge on how sex, comorbidities, and medication influence these outcomes after revascularisation may help optimise results and patient selection. Methods: This population based observational cohort study included all individuals revascularised for CLTI in Sweden during a five year period (10,617 patients in total). Data were retrieved and merged from mandatory national healthcare registries, and specifics on amputations were validated with individual medical records. Results: Mean age at revascularisation was 76.8 years. Median follow up was 2.7 years (range 0-6.6 years). Male sex (hazard ratio [HR] 1.20, 95% confidence interval [CI] 1.09-1.33), renal insufficiency (HR 1.57, 95% CI 1.32-1.87), diabetes (HR 1.45, 95% CI 1.32-1.60), and heart failure (HR 1.17, 95% CI 1.05-1.31) were independently associated with an increased amputation rate, whereas the use of statins (HR 0.71, 95% CI 0.64-0.78) and low dose acetylsalicylic acid (HR 0.77, 95% CI 0.70-0.86) were associated with a reduced amputation rate. For the combined end point of amputation or death, an association with increased rates was found for male sex (HR 1.25, 95% CI 1.18-1.32), renal insufficiency (HR 1.94, 95% CI 1.75-2.14), heart failure (HR 1.50, 95% CI 1.40-1.60), and diabetes (HR 1.31, 95% CI 1.23-1.38). The use of statins (HR 0.74, 95% CI 0.67-0.82) and low dose acetylsalicylic acid (HR 0.82, 95% CI 0.77-0.881) were related to a reduced risk of amputation or death. Conclusions: Renal insufficiency is the strongest independent risk factor for both amputation and amputation/ death in revascularised CLTI patients, followed by diabetes and heart failure. Men with CLTI have worse outcomes than women. These results may help govern patient selection for revascularisation procedures. Statin and low dose acetylsalicylic acid are associated with an improved limb outcome. This underlines the importance of preventive medication to reduce general cardiovascular risk and increase limb salvage. (C) 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
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| 5. |
- Baubeta Fridh, Erik, 1982, et al.
(författare)
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Impact of Preoperative Symptoms and Revascularized Arterial Segment in Patients With Chronic Limb-Threatening Ischemia
- 2019
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Ingår i: Vascular and Endovascular Surgery. - : SAGE Publications. - 1538-5744 .- 1938-9116. ; 53:5, s. 365-372
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Tidskriftsartikel (refereegranskat)abstract
- Background: Little is known about the relative impact of the preoperative symptoms rest pain and tissue loss, and of the arterial segment revascularized, on amputation rate and mortality in patients with chronic limb-threatening ischemia (CLTI). We wanted to investigate this topic further. Method: This population-based observational cohort study involved 10 419 patients revascularized for CLTI in Sweden, 2008 to 2013. Data were collected from health-care registries and medical records. The effect of preoperative symptoms and revascularized arteries was determined using Cox regression models. A competing risk analysis was used to determine the effect of symptoms on the combined endpoint "amputation or death". Results: The amputation rate during a mean follow-up of 2 years was 7.5% in patients with rest pain, 15.6% in patients with tissue loss only, and 20.1% when both symptoms were present. Mortality was 39% lower in patients with rest pain only than in those with both symptoms. Revascularizations targeted the aortoiliac, femoropopliteal, and infrapopliteal segments in 19.4%, 76.8%, and 30.6%, respectively. Distal revascularizations were associated with a higher amputation rate, but this difference disappeared after adjustment for comorbidities. Aortoiliac revascularizations were associated with high mortality. Competing risk analysis showed that mortality became the major determinant of amputation-free survival outcomes from 1 year after revascularization. Conclusions: Tissue loss implies a clearly worse prognosis compared to rest pain for patients with CLTI. Most revascularizations for CLTI are done in the femoropopliteal segment. Infrapopliteal procedures are associated with a higher amputation rate, whereas aortoiliac revascularizations are associated with higher mortality.
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| 6. |
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| 7. |
- Cervin, Anne, 1971-, et al.
(författare)
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Results After Open and Endovascular Repair of Popliteal Aneurysm: A Matched Comparison Within a Population Based Cohort
- 2021
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Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884 .- 1532-2165. ; 61:6, s. 988-997
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To identify factors affecting the outcome after open surgical (OSR) and endovascular (ER) repair of popliteal artery aneurysm (PA) in comparable cohorts. Methods: A matched comparison in a national, population based cohort of 592 legs treated for PA (2008 - 2012), with long term follow up. Registry data from 899 PA patients treated in 2014 - 2018 were analysed for time trends. The 77 legs treated by ER were matched, by indication, with 154 legs treated with OSR. Medical records and imaging were collected. Analysed risk factors were anatomy, comorbidities, and medication. Elongation and angulations were examined in a core lab. The main outcome was occlusion. Results: Patients in the ER group were older (73 vs. 68 years, p = .001), had more lung disease (p = .012), and were treated with dual antiplatelet therapy or anticoagulants more often (p < .001). The hazard ratio (HR with 95% confidence intervals) for occlusion was 2.69 (1.60 - 4.55, p < .001) for ER, but 3.03 (1.26 - 7.27, p = .013) for poor outflow. For permanent occlusion, the HR after ER was 2.47 (1.35 - 4.50, p = .003), but 4.68 (1.89 - 11.62, p < .001) for poor outflow. In the ER subgroup, occlusion was more common after acute ischaemia (HR 2.94 [1.45 - 5.97], p = .003; and poor outflow HR 14.39 [3.46 - 59.92], p < .001). Larger stent graft diameter reduced the risk (HR 0.71 [0.54 - 0.93], p = .014). In Cox regression analysis adjusted for indication and stent graft diameter, elongation increased the risk (HR 1.020 per degree [1.002 - 1.033], p = .030). PAS treated for acute ischaemia had a median stent graft diameter of 6.5 mm, with those for elective procedures being 8 mm (p < .001). Indications and outcomes were similar during both time periods (2008 - 2012 and 2014 - 2018). Conclusion: In comparable groups, ER had a 2.7 fold increased risk of any occlusion, and 2.4 fold increased risk of permanent occlusion, despite more aggressive medical therapy. Risk factors associated with occlusion in ER were poor outflow, smaller stent graft diameter, acute ischaemia, and angulation/elongation. An association between indication, acute ischaemia, and small stent graft diameter was identified.
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| 8. |
- De La Motte, L., et al.
(författare)
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Is EVAR a durable solution? Indications for reinterventions
- 2018
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Ingår i: Journal of Cardiovascular Surgery. - 0021-9509. ; 59:2, s. 201-212
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCION: Indications for reinterventions after endovascular aneurysm repair (EVAR), as well as their occurrence in number and time, are important to establish in order to optimize patient selection, postprocedure surveillance and also to guide improvements in endograft designs. The aim of this report was to present an overview of current data on reinterventions after elective EVAR. EVIDENCE ACQUISITION: Qualitative review of studies reporting on reinterventions after elective EVAR, identified by a systematic literature search in MEDLINE, EMBASEand the Cochrane Library for publications from 2010 to 13th of November 2017. EVIDENCESYNTHESIS: Twenty-Three studies reporting on 83,307 patients met the inclusion criteria. Index procedures were performed between 1996-2014. There was wide heterogeneity in reporting standards. Type Iendoleaks were reported in 0.6%-13% and type IIIendoleaks in 0.9-2.1% with a significant improvement for newer devices. Migration rates varied between 0-4%. Endoleak type II was the most common indication for re-intervention ranging from 14-25.3% although the majority resolved without intervention. Rupture rates ranged from 0-5.4% and carried a high mortality (60-67%). Ruptures occurred at any time after the index procedure. Limb ischemia rates were reported at 0.4-11.9% with re-intervention rates between 0.06-11.9%. Wound related complications and related re-interventions were the indication in 0.5-14% and 0.3-6.5%, respectively. Endograft infection carried a high risk of mortality and was described in 0.3-3.6%, often related to graft-enteric fistula and the majority had an open explantation of the endograft. CONCLUSIONS: This review showed that the rates of complications and techniques for reintervention developed over time with a tendency towards better outcomes considering the aneurysm related indications. Significant factors that led to subsequent secondary interventions were migration, rupture, infections and type Iand IIendoleaks. Patients treated with earlier generation endografts are still alive and need continued surveillance to detect these severe complications before they lead to rupture. © 2018 Edizioni Minerva Medica.
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| 9. |
- Delle, M., et al.
(författare)
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Celiac trunk coverage in endovascular aneurysm repair
- 2010
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Ingår i: Scandinavian Journal of Surgery. - : SAGE Publications. - 1457-4969. ; 99:4, s. 226-229
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND AIMS: This retrospective study was undertaken to examine the risks associated with obstruction of the coeliac trunk in the process of treating aneurysms with endografting. MATERIAL AND METHODS: 120 patients were treated by endografting for aneurysmal disease. Of these, a subgroup of 9 patients had their celiac trunk covered. If possible, a preoperative angiography was performed to evaluate collateral flow from the superior mesenteric artery. This was considered to predict the risk for ischemia. RESULTS: None of the patients had any severe clinical event of the celiac trunk occlusion or clinical signs of intestinal ischemia. Three patients had transient increase of liver enzymes. CONCLUSIONS: In cases where the distal landing zone of the descending thoracic aorta is to short for endografting, covering of the celiac trunk may be an option if no other surgical alter-native is apparent. Preoperative angiography to visualise the presence of collateral vessels from the superior mesenteric artery is recommended.
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| 10. |
- Djerf, Henrik, et al.
(författare)
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Absence of Long-Term Benefit of Revascularization in Patients with Intermittent Claudication: Five-Year Results from the IRONIC Randomized Controlled Trial
- 2020
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Ingår i: Circulation: Cardiovascular Interventions. - 1941-7640 .- 1941-7632. ; 13:1
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Tidskriftsartikel (refereegranskat)abstract
- © 2020 Lippincott Williams and Wilkins. All rights reserved. Background: The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. Methods: The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. Results: Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). Conclusions: After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.
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