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- Blomgren, Lena, 1957-, et al.
(författare)
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Changes in superficial and perforating vein reflux after varicose vein surgery
- 2005
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Ingår i: Journal of Vascular Surgery. - : Elsevier BV. - 0741-5214 .- 1097-6809. ; 42:2, s. 315-320
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES:This prospective duplex study was conducted to study the effect of current surgical treatment for primary varicose veins on the development of venous insufficiency < or = 2 years after varicose vein surgery.METHODS:The patients were part of a randomized controlled study where surgery for primary varicose veins was planned from a clinical examination alone or with the addition of preoperative duplex scanning. Postoperative duplex scanning was done at 2 months and 2 years.RESULTS:Operations were done on 293 patients (343 legs), 74% of whom were women. The mean age was 47 years. In 126 legs, duplex scanning was done preoperatively, at 2 months and 2 years, and at 2 months and 2 years in 251 legs. Preoperative perforating vein incompetence (PVI) was present in 64 of 126 legs. Perforator ligation was not done on 42 of these; at 2 months, 23 of these legs (55%) had no PVI, and at 2 years, 25 legs (60%) had no PVI. Sixty-one legs had no PVI preoperatively, 5 (8%) had PVI at 2 months, and 11 (18%) had PVI at 2 years. In the group of 251 legs, reversal of PVI between 2 months and 2 years was found in 28 (41%) of 68 and was more common than new PVI, which occurred in 41 (22%) of 183 (P = .003). After 2 years, the number of legs without venous incompetence in which perforator surgery was not performed was 11 (26%) of 42 legs with preoperative PVI and 18 (30%) of 61 legs without preoperative PVI, (P = .713). After 2 years, new vessel formation was more common in the surgically obliterated saphenopopliteal junction (SPJ), 4 (40%) of 10, than in the saphenofemoral junction (SFJ), 17 (11%) of 151(P = .027), and new incompetence in a previously normal junction was more common in the SFJ, 11 (18%) of 63, than in the SPJ, 3 (1%) of 226 (P < .001). Reflux in the great saphenous vein (GSV) below the knee was abolished after stripping above the knee in 17 (34%) of 50 legs at 2 months and in 22 legs (44%) after 2 years.CONCLUSIONS:Varicose vein surgery induces changes in the remaining venous segments of the legs that continue for several months. In most patients, perforators and the GSV below the knee can be ignored at the primary surgery. A substantial number of recurrences in the SFJ and SPJ are unavoidable with present surgical knowledge because they stem from new vessel formation and progression of disease.
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- Blomgren, Lena, 1957-, et al.
(författare)
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Late follow-up of a randomized trial of routine duplex imaging before varicose vein surgery
- 2011
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Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 98:8, s. 1112-1116
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Tidskriftsartikel (refereegranskat)abstract
- Background: Routine preoperative duplex examination led to an improvement in results 2 years after surgery for primary varicose veins. The aim of the present study was to evaluate the impact of preoperative duplex imaging after 7 years, in relation to other risk factors for varicose vein recurrence. Methods: Patients with primary varicose veins were randomized to operation with (group 1), or without (group 2) preoperative duplex imaging. The same patients were invited to attend follow-up with interview, clinical examination and duplex imaging. Quality of life (QoL) was measured with the Short Form 36 questionnaire. Results: Some 293 patients (343 legs) were included initially; after 7 years 227 were interviewed, or their records reviewed: 114 in group 1 and 113 in group 2. One hundred and ninety-four legs (95 in group 1 and 99 in group 2) were examined clinically and with duplex imaging. Incompetence was seen at the saphenofemoral junction and/or saphenopopliteal junction in 14 per cent of legs in group 1 and 46 per cent in group 2 (P < 0.001). QoL was similar in both groups. After a mean follow-up of 7 years (and including patients who underwent surgery after the review), 15 legs in group 1 needed reoperation and 38 in group 2 (P = 0.001). Conclusion: Routine preoperative duplex imaging improved the results of surgery for primary varicose veins for at least 7 years.
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- Blomgren, Lena, 1957-, et al.
(författare)
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Randomized clinical trial of routine preoperative duplex imaging before varicose vein surgery
- 2005
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Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 92:6, s. 688-694
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND:Duplex imaging is used increasingly for preoperative evaluation of varicose veins, but its value in terms of the long-term results of surgery is not clear.METHODS:Patients with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery.RESULTS:Two hundred and ninety-three patients (343 legs) had varicose vein surgery after duplex imaging (group 1; 166 legs) or no imaging (group 2; 177 legs). In 44 legs (26.5 per cent), duplex examination suggested a different surgical procedure than had been considered on clinical grounds; the procedure was changed accordingly for 29 legs. At 2 months, incompetence was detected at the saphenofemoral or saphenopopliteal junction (or both) in 14 legs (8.8 per cent) in group 1 and in 44 legs (26.5 per cent) in group 2 (P < 0.001). At 2 years, two legs (1.4 per cent) had undergone or were awaiting reoperation in group 1, and 14 legs (9.5 per cent) in group 2 (P = 0.002). In the remainder, major incompetence was found in 19 legs (15.0 per cent) in group 1 and in 53 (41.1 per cent) in group 2 (P < 0.001).CONCLUSION:Routine preoperative duplex examination led to an improvement in results 2 years after surgery for patients with primary varicose veins.
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- Sigvant, Birgitta, et al.
(författare)
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Differences in presentation of symptoms between women and men with intermittent claudication
- 2011
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Ingår i: BMC Cardiovascular Disorders. - : BioMed Central. - 1471-2261 .- 1471-2261. ; 11:39
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Tidskriftsartikel (refereegranskat)abstract
- Background: More women than men have PAD with exception for the stage intermittent claudication (IC). The purpose of this study was to evaluate differences in disease characteristics between men and women when using current diagnostic criteria for making the diagnosis IC, defined as ABI less than 0.9 and walking problems. Study Design: Cohort study Methods: 5040 elderly (median age 71) subjects participated in a point-prevalence study 2004. They had their ABI measured and filled out questionnaires covering medical history, current medication, PAD symptoms and walking ability. The prevalence of IC was 6.5% for women and 7.2% for men (P = 0.09). A subset of subjects with IC (N = 56) was followed up four years later with the same procedures. They also performed additional tests aiming to determine all factors influencing walking ability. Results: Men with IC had more concomitant cardiovascular disease and a more profound smoking history than women. Women, on the other hand, reported a lower walking speed (P less than 0.01) and more joint problems (P = 0.018). In the follow up cohort ABI, walking ability and amount of atherosclerosis were similar among the sexes, but women more often reported atypical IC symptoms. Conclusion: Sex differences in the description of IC symptoms may influence diagnosis even if objective features of PAD are similar. This may influence accuracy of prevalence estimates and selection to treatment.
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- Sigvant, Birgitta, et al.
(författare)
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Risk factor profile and use of cardiovascular drugprevention in women and men with peripheral artery disease
- 2009
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Ingår i: European Journal of Cardiovascular Prevention & Rehabilitation. - 1741-8267 .- 1741-8275. ; 16:1, s. 39-46
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Tidskriftsartikel (refereegranskat)abstract
- Objective To determine cardiovascular comorbidities and use of cardiovascular disease preventive drugs in patients with peripheral arterial disease (PAD), with special attention to sex differences. Design A cross-sectional point-prevalence study. Patients A population sample of patients that are 60-90 years old. Setting Primary care areas in four Swedish regions. Main outcome measures Prevalence of PAD stages, comorbidities and medication use. Results The prevalence of any type of PAD was 18.0% (range 16-20), of asymptomatic peripheral arterial disease (APAD) was 11.1% (range 9-13), intermittent claudication was 6.8% (range 6.5-7.1), and of critical limb ischemia (CLI) was 1.2% (range 1.0-1.5). APAD and CLI were more common in women. Statins were used by 17.5% (range 16.9-18.2), 29.4% (range 29.0-30.1), and 30.3% (range 29.9-30.8) of the patients with APAD, intermittent claudication, and CLI, respectively, and antiplatelet therapy was reported by 34.1% (range 33.7-34.3), 47.6% (range 47.3-47.9), and 60.2% (range 59.1-60.7). The odds ratio for having APAD was 1.7 (range 1.2-2.4) for women with a smoking history of 10 years in relation to nonsmokers. This association was observed only in men who had smoked for at least 30 years or more. Preventive drug use was more common in men with PAD. Compared with women they had an odds ratio of 1.3 (range 1.1-1.5) for lipid-lowering therapy, 1.3 (range 1.0-1.7) for β-blockers or angiotensin-converting enzyme inhibitors, and 1.5 (range 1.2-1.9) for antiplatelet therapy. Conclusion The patients' risk factor profiles differed among the PAD stages. Smoking duration already seemed to be a risk factor for women with PAD after 10 years of smoking, as compared with 30 years for men, and fewer women reported use of preventive medication. These observations may partly explain the sex differences in prevalence that were observed.
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- Schulman, S., et al.
(författare)
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Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients
- 2010
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Ingår i: Journal of Thrombosis and Haemostasis. - : Elsevier BV. - 1538-7933 .- 1538-7836. ; 8:1, s. 202-204
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Tidskriftsartikel (refereegranskat)abstract
- The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.
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| 10. |
- Schulman, S, et al.
(författare)
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Response to rebuttal, definition of major bleeding in surgery: an anaesthesiologist's point of view.
- 2010
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Ingår i: Journal of thrombosis and haemostasis. - : Elsevier BV. - 1538-7836 .- 1538-7933. ; 8:6, s. 1443-1444
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Tidskriftsartikel (refereegranskat)abstract
- See also Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W. Definition of major bleeding in clinical investigations of anti-hemostatic medicinal products in surgical patients. J Thromb Haemost 2010; 8: 202–4; Rosencher N, Zufferey P, Samama C-M. Definition of major bleeding in surgery: an anesthesiologist's point of view: a rebuttal. This issue, pp 1442–3. We read with interest the comments by Rosencher et al. about our definition of major bleeding in surgical patients. The component of our definition that is the focus of this discussion is criterion 5, i.e. the unexpected bleeding with some additional requirements [1]. We are aware that anesthesiologists frequently make use of more detailed calculations of blood loss. Their way of calculating blood loss is certainly more accurate than the criterion of a defined drop in hemoglobin or the need for 2 or more units of blood transfusion. In theory, such calculations are physiologically relevant for the decision to give a blood transfusion and may, therefore, result in more appropriate and hopefully reduced use of blood transfusions as indicated in the OSTHEO study [2]. However, criteria that are based on blood loss calculations have never been used for recognition of major bleeding. One of us (B.E.) evaluated blood loss, transfusion requirement and delta-hemoglobin in phase II studies on desirudin and melagatran. These variables had a lower sensitivity than the surgeon’s subjective view of ’serious bleeding‘ or ’overt bleeding‘ in the dose response of these anticoagulants. There is thus insufficient evidence to propose that calculated blood loss could be superior to differentiate between drug-induced and surgical bleeding. The European Medicines Agency (EMEA) guideline from 2007 (printed 2008) [3] is the one we want to improve and correct with our set of definitions. That guideline primarily uses the criteria defined by ISTH for medical patients. As additional support, calculated blood loss is in the middle of a long list of examples. In our work with the ISTH guidelines, we have tried to consider the important factors for both the surgeon and the patient. At the same time, it was necessary to create a definition that could not only be applied to most types of surgery represented in clinical trials using new anticoagulants, but also to keep it comparatively simple. The fact that both European and North American orthopedic and general surgeons could agree on these criteria was a big step forward. Although we admit that criterion no. 5 remains partly subjective, we find that the criterion suggested by Rosencher et al., ’all abnormal bleeding notified by the local investigator‘ is highly subjective and susceptible to influence by the knowledge that the patient is taking part in a trial with a new hemostatic agent. In trials, the local investigator is frequently not the operating surgeon. Who better than the surgeon present in the operating theatre, can assess what is unexpected (for the circumstances) and what represents prolonged bleeding? Some of us have been members of multiple committees for central event-adjudication for these studies, and we have often found that advice from the surgeon is the most helpful for gauging the seriousness of the wound bleeding and any likely association to study drug rather than to other bleeding risk factors. We, therefore, feel that the ISTH guideline for surgical patients is workable, in line with standard clinical practice and acceptable in any multicenter trial. A completely scientific and evidence-based process to develop ideal guidelines should select different strict criteria and prospectively evaluate their sensitivity for clinically important outcomes, including long-term function.
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