| 1. |
- Ragnarsson, Sigurdur, et al.
(författare)
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No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial
- 2020
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Ingår i: American Heart Journal. - : MOSBY-ELSEVIER. - 0002-8703 .- 1097-6744. ; 224, s. 17-24
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Tidskriftsartikel (refereegranskat)abstract
- The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the "no-touch" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration.
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| 2. |
- Weiss, Marc Gjern, et al.
(författare)
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Clinical Outcomes After Surgical Revascularization Using No-Touch Versus Conventional Saphenous Vein Grafts : Mid-Term Follow-Up of Propensity Score Matched Cohorts
- 2021
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Ingår i: Seminars in Thoracic and Cardiovascular Surgery. - : Elsevier. - 1043-0679 .- 1532-9488. ; 35:2, s. 228-236
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Tidskriftsartikel (refereegranskat)abstract
- Previous studies have demonstrated superior patency of no-touch as compared to conventional saphenous vein grafts in coronary artery bypass grafting. We aimed to compare mid-term clinical outcomes of both techniques in a large cohort of routine patients. We identified all patients undergoing nonemergent primary coronary artery bypass grafting with either no-touch or conventional saphenous vein grafts at our institution between 2000 and 2020. Propensity score matching was used to create adjusted cohorts based on 5288 eligible patients. The primary outcome was the combined endpoint of all-cause mortality and repeat revascularization. Secondary outcomes were individual rates of all-cause mortality and repeat revascularization, surgical complications, and short-term mortality. Propensity score matching resulted in cohorts of no-touch (n = 923) and conventional (n = 923) saphenous vein grafted patients with comparable baseline characteristics. Mean follow-up time was significantly shorter for the no-touch compared to the conventional cohort (4.9 ± 2.3 vs 8.3 ± 2.6 years, P < 0.001). Up to 7-year follow-up, neither the rate of the primary composite endpoint nor death differed significantly between the cohorts. The rate of repeat revascularization was significantly higher in patients in the no-touch cohort (12.9% vs 9.3% at 7-year follow-up, P = 0.022. Post-hoc analysis of percutaneous coronary intervention during follow-up revealed comparable rates of saphenous vein graft failure (no-touch 42/923 (4.6%) vs conventional 32/923 (3.5%), P = 0.286). In this large propensity score matched registry study, coronary artery bypass with no-touch compared to conventional saphenous vein grafting did neither enhance mid-term survival nor reduce the rate of repeat revascularization.
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| 3. |
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| 4. |
- Bagge, L., et al.
(författare)
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Haemostasis at low heparin dosage during cardiopulmonary bypass with heparin-coated circuits pigs
- 1997
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Ingår i: Scandinavian Cardiovascular Journal. - 1401-7431 .- 1651-2006. ; 31:6, s. 275-281
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Recension (övrigt vetenskapligt/konstnärligt)abstract
- Cardiopulmonary bypass (CPB) causes activation of cascade systems. Although heparin coating of CPB circuits improves biocompatibility, the effects on coagulation remain controversial. Theoretically, heparin coating should permit the reduction of systemic anticoagulation during CPB. We investigated influences on haemostatic variables in animal CPB, comparing heparin-coated circuits and reduced systemic heparinization (group HC) with uncoated circuits and full heparinization (group C). Twenty pigs underwent 2-h CPB. Seven (HC, n = 4; C, n = 3) were weaned from CPB and studied for up to 4 h. Total administered heparin was 470 +/- 6 IU/kg (mean +/- SEM) in group C and 100 +/- 0 IU/kg in group HC. Protamine dosage was significantly reduced in group HC. In group C, levels of prothrombin complex, factor VIII and adhesive platelets were reduced significantly during CPB, and postoperatively there were significantly lower values of prothrombin complex, fibrinogen antithrombin III, factor VIII and adhesive platelets but a significantly increased concentration of von Willebrand factor and cumulative bleeding after 4 h. In conclusion, heparin-coated CPB circuits combined with lowered heparin dosage reduced coagulation factor consumption and preserved platelet function, possibly contributing to improved postoperative haemostasis.
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| 5. |
- Bagge, Louise, et al.
(författare)
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Quality of life is not improved aftermitral valve surgery combined with epicardial left atrial cryoablation as compared with mitral valve surgery alone : a substudy of the double blind randomized SWEDish Multicentre Atrial Fibrillation study (SWEDMAF)
- 2018
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 20, s. F343-F350
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Tidskriftsartikel (refereegranskat)abstract
- Aims: Concomitant surgical ablation of atrial fibrillation (AF) in patients undergoing mitral valve surgery (MVS) has almost become routine despite lack of convincing information about improved quality-of-life (QOL) and clinical benefit. Quality-of-life was therefore assessed after MVS with or without epicardial left atrial cryoablation. Methods and results: Sixty-five patients with permanent AF randomized to MVS with or without left atrial cryoablation, in the doubleblinded multicentre SWEDMAF trial, replied to the Short Form 36 QOL survey at 6 and 12 months follow-up. The QOL scores at 12month follow-up did not differ significantly between patients undergoing MVS combined with cryoablation vs. those undergoing MVS alone regarding Physical Component Summary mean 42.8 (95% confidence interval 38.3-47.3) vs. mean 44.0 (40.1-47.7), P =0.700 or Mental Component Summary mean 53.1 (49.7-56.4) vs. mean 48.4 (44.6-52.2), P=0.075. All patients, irrespective of allocated procedure, reached the same QOL after surgery as an age-matched Swedish general population. The Physical Component Summary in patients with sinus rhythm did also not differ from those in AF at 12months; mean 45.4 (42.0-48.7) vs. mean 40.5 (35.5-45.6), P=0.096) nor was there a difference in Mental Component Summary; mean 51.0 (48.0-54.1) vs. mean 49.6 (44.6-54.5), P=0.581). Conclusion: Left atrial cryoablation added to MVS does not improve health-related QOL in patients with permanent AF, a finding that raises concerns regarding recommendations made for this combined procedure.
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| 6. |
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| 7. |
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| 8. |
- Blomström-Lundqvist, Carina, et al.
(författare)
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A randomized double-blind study of epicardial left atrial cryoablation for permanent atrial fibrillation in patients undergoing mitral valve surgery: the SWEDish Multicentre Atrial Fibrillation study (SWEDMAF).
- 2007
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Ingår i: European heart journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 28:23, s. 2902-8
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: The efficacy of epicardial left atrial (LA) cryoablation in eliminating atrial fibrillation (AF) in patients undergoing mitral valve surgery (MVS) is unknown. We hypothesized that MVS combined with LA cryoablation is superior to MVS alone. METHODS AND RESULTS: Sixty-nine patients with permanent AF, included at four centres, underwent MVS with or without epicardial LA cryoablation. The primary endpoint was regained sinus rhythm. Risk factors for failed AF cryoablation were elucidated. Sixty-five out of 69 patients reached the primary endpoint. At 6 and 12 months follow-up, 73.3% of patients who underwent cryoablation had regained sinus rhythm at both follow-ups, compared with 45.7 and 42.9% of patients, respectively, who underwent MVS alone (group differences, at 6 months P = 0.024, after 12 months P = 0.013). The in-hospital complication rate was 11.4% in the MVS group and 26.5% in the cryoablation group (P = 0.110). Risk factors for failed elimination of AF by cryoablation were duration of permanent AF (P = 0.012) and presence of coronary artery disease (P = 0.047), according to multiple logistic regression analysis. CONCLUSION: This first prospective randomized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone.
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| 9. |
- Borowiec, Jan, et al.
(författare)
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Biocompatibility reflected by haemostasis variables during cardiopulmonary bypass using heparin-coated circuits
- 1997
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Ingår i: The thoracic and cardiovascular surgeon. - : Georg Thieme Verlag KG. - 0171-6425 .- 1439-1902. ; 45:4, s. 163-167
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Recension (övrigt vetenskapligt/konstnärligt)abstract
- Cardiopulmonary bypass (CPB) is associated with haemostatic disturbances and signs of acute inflammatory response, most likely related to poor biocompatibility of the artificial surfaces. Some haemostatic variables are known as markers of acute-phase reaction, blood cell trauma, and endothelial damage. The aim of the study was to evaluate the effect of heparin-coating of artificial surfaces on those variables of hemostasis. 14 patients operated on with elective coronary artery revascularization were randomized into two groups. In group H (n = 7), heparin-coated CPB circuits and in control group C (n = 7), noncoated CPB sets were used. Patients in group C received normal heparinization, e.g. bolus 300 IU/kg and additional doses to maintain activated coagulation time (ACT) over 400 sec during CPB. In group H, a bolus heparin dose was reduced by 25% (to 225 IU/kg) in order to compensate for the amount of heparin immobilized on circuit surfaces and the corresponding ACT limit was 300 sec. There were significant increases of the von Willebrand factor (vWf), plasminogen activator inhibitor-1 (PAI) and tissue-plasminogen activator (tPA) starting at CPB end and rising to about twice the baseline levels postoperatively. This reaction was less evident in group H, as indicated by significantly lower levels of tPA compared to group C at CPB end (135% +/- 9 in group H versus 241% +/- 15 in group C, p < 0.0005) and at two hours postoperatively. The rates of tPA and vWF increase were lower in group H, also indicating reduced endothelial damage in this group. Marginally significant, a higher value of PAI was found in the C group early after CPB onset. Group H showed significantly lower concentrations of circulating complex between elastase and alpha 1-antitrypsin at CPB end and postoperatively, implicating a reduced granulocyte activation (60 min after protaminization 41 micrograms/L +/- 5 in group H versus 256 micrograms/L +/- 55 in group C, p < 0.05). It was concluded that the heparin-coated CPB circuits demonstrated improved biocompatibility which may be related to less disturbed haemostasis.
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| 10. |
- Borowiec, Jan, et al.
(författare)
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Decreased blood loss after cardiopulmonary bypass using heparin-coated circuit and 50% reduction of heparin dose
- 1992
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Ingår i: Scandinavian journal of thoracic and cardiovascular surgery. - 0036-5580. ; 26:3, s. 177-185
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Tidskriftsartikel (refereegranskat)abstract
- In a randomized, double-blind study of patients undergoing elective coronary artery grafting, the effect of heparin-coated circuit combined with 50% reduction of systemic heparin bolus was investigated. Ten patients comprised group HC (heparin-coated) and ten group C (controls). The mean total doses of heparin were 172 IU/kg in group HC and 416 IU/kg in group C and the respective protamine doses were 0.96 and 3.96 mg/kg (both p < 0.001). Activated clotting times during cardiopulmonary bypass were significantly shorter in group HC, and both intra- and postoperative bleeding was significantly less than in group C (7.7 vs. 11.7 ml/kg, p = 0.036, and 6.9 vs. 9.7 ml/kg, p = 0.004). Hemoglobin loss via the drains was 22.5 g in group HC and 43.7 g in group C (p < 0.005). Hemolysis at the end of bypass was significantly greater in group C. Apart from one perioperative myocardial infarction in group HC the postoperative course was uneventful. Use of a heparin-coated circuit is concluded to permit complication-free reduction of heparin and protamine doses and to decrease both intra- and postoperative bleeding, which may favorably influence the outcome of coronary artery grafting.
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