Nils-Einar Kløw

Catheter‐directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short‐term patency

Summary.  Background: Approximately one in four patients with acute proximal deep vein thrombosis (DVT) given anticoagulation and compression therapy develop post‐thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase patency and prevent PTS. Objectives: To assess short‐term efficacy of additional catheter‐directed thrombolysis (CDT) compared with standard treatment alone. Patients and methods: Open, multicenter, randomized, controlled trial. Patients (18–75 years) with iliofemoral DVT and symptoms < 21 days were randomized to receive additional CDT or standard treatment alone. After 6 months, iliofemoral patency was investigated using duplex ultrasound and air‐plethysmography assessed by an investigator blinded to previous treatment. Results: One hundred and three patients (64 men, mean age 52 years) were allocated additional CDT (n = 50) or standard treatment alone (n = 53). After CDT, grade III (complete) lysis was achieved in 24 and grade II (50%–90%) lysis in 20 patients. One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 32 (64.0%) in the CDT group vs. 19 (35.8%) controls, corresponding to an absolute risk reduction (RR) of 28.2% (95% CI: 9.7%–46.7%; P = 0.004). Venous obstruction was found in 10 (20.0%) in the CDT group vs. 26 (49.1%) controls; absolute RR 29.1% (95% CI: 20.0%–38.0%; P = 0.004). Femoral venous insufficiency did not differ between the two groups. Conclusions: After 6 months, additional CDT increased iliofemoral patency from 36% to 64%. The ongoing long‐term follow‐up of this study will document whether patency is related to improved functional outcome.

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease

BACKGROUND Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life. METHODS We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life. RESULTS At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups. CONCLUSIONS In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).

Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial

BACKGROUND Post-thrombotic syndrome is a common complication after acute proximal deep vein thrombosis (DVT) and is associated with reduced quality of life and a substantial cost burden. In the 2-year results of the CaVenT study, additional catheter-directed thrombolysis reduced the risk of post-thrombotic syndrome by 14% compared with conventional therapy, but did not affect quality of life. In this study we report results at the 5-year follow-up, aiming to assess whether findings for post-thrombotic syndrome and quality of life have persisted. METHODS Between Jan 3, 2006, and Dec 22, 2009, we recruited patients aged 18-75 years with a first-time high proximal leg DVT from 20 hospitals in the Norwegian southeastern health region. With sealed envelopes, participants were randomly assigned (1:1) to standard treatment with compression stockings and anticoagulants (control group) or to standard treatment plus catheter-directed thrombolysis with alteplase within 21 days from symptom onset. Pre-specified outcomes in this analysis were post-thrombotic syndrome at 5 years as assessed with the Villalta score and scores for quality of life at 5 years with EQ-5D and the disease-specific VEINES-QOL/Sym. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00251771. FINDINGS At 5 year follow-up (last date Oct 14, 2014), data were available for 176 patients (84% of the 209 patients originally randomised)--87 originally assigned to catheter-directed thrombolysis and 89 originally assigned to the control group. 37 patients (43%; 95% CI 33-53) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, compared with 63 (71%; 95% CI 61-79) allocated to the control group (p<0·0001), corresponding to an absolute risk reduction of 28% (95% CI 14-42) and a number needed to treat of 4 (95% CI 2-7). Four (5%) patients assigned to catheter-directed thrombolysis and one (1%) to standard treatment had severe post-thrombotic syndrome (Villalta score ≥ 15 or presence of an ulcer). Quality-of-life scores with either assessment scale did not differ between the treatment groups. INTERPRETATION Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit during follow-up for up to 5 years, supporting the use of additional catheter-directed thrombolysis in patients with extensive proximal DVT. However, allocation to this therapy did not lead to better quality of life. The optimal endovascular thrombolytic approach needs further investigation. FUNDING Southeastern Norway Regional Health Authority, the Research Council of Norway, University of Oslo, Oslo University Hospital.

MRI of the small bowel with oral contrast or nasojejunal intubation in Crohn's disease: randomized comparison of patient acceptance.

Objective. Magnetic resonance imaging of the small bowel with an oral contrast (MRI per os) is believed to generate fewer adverse symptoms compared with installation of the contrast in a nasojejunal catheter (MRE). However, there is very little evidence to support this assumption. The aim of this study was to evaluate the compliance of patients examined with both of these MRI methods. Material and methods. Patients with suspected or known Crohns disease referred for MRI of the small bowel underwent both MRI per os and MRE within 7 days. A questionnaire was answered immediately and 24 h after the procedure. Adverse symptoms were graded on a visual analogue scale (VAS). Responses were compared with paired and independent sample t-tests and signed-rank tests. Correlation of each symptom to the overall discomfort was evaluated with Spearmans correlation coefficient. Results. Thirty-eight patients (18 F, 20 M) were included in the analysis. Abdominal pain and discomfort were lower with MRI per os than with MRE (mean VAS pain score immediately after: 10 mm and 33 mm, respectively, p<0.001; mean VAS discomfort score 24 h after: 18 mm and 62 mm, respectively, p<0.001). Nausea and abdominal pain were correlated with overall discomfort after MRI per os (r=0.56 for both, p<0.001). No symptoms were significantly correlated with discomfort experienced with MRE. More patients accepted repeat MRI per os examination (n=36) than MRE (n=22, p=0.001). Conclusion. Patients preferred and experienced less abdominal pain and discomfort with MRI per os than with MRE.

Radiation-Induced Skin Injury after Percutaneous Transluminal Coronary Angioplasty Case Report

A 58-year-old man underwent percutaneous transluminal coronary angioplasties in June 1992 and May 1993. Approximately 3 weeks after the last procedure, a cutaneous lesion developed into an ulcer over the right scapular region. The ulcer failed to heal with conservative treatment; therefore, surgical excision was performed. The localization and the course of the development indicated injury caused by radiation, and this was confirmed by the histologic examination. To avoid such injury in interventional procedures with long fluoroscopic time, several precautions should be taken. These include continuous surveillance of the X-ray dosage, the use of different projections to avoid exposure to one skin area throughout the whole procedure, keeping the irradiated area as small as possible, and good planning of the procedure.

Percutaneous Transluminal Renal Artery Angioplasty Using the Coaxial Technique Ten years of experience from 591 procedures in 419 patients

Purpose: To evaluate the angiographic and clinical results of all percutaneous transluminal renal angioplasties (PTRAs) performed at one centre in Norway since the introduction of the method. Most of the PTRAs were performed with the coaxial technique (guiding-catheter-assisted angioplasty). Material and Methods: In 419 patients, 595 PTRAs of 552 stenoses were performed from 1982 to 1993. the cases included 295 patients with arteriosclerotic vascular disease (AVD), 49 with fibromuscular dysplasia (FMD), and 74 transplantation patients (TX). Angiographic and clinical follow-up were undertaken. Results: Initial angiographic success was obtained in 92% of the patients and another 3% improved. the rates of immediate success were 92%, 98% and 84% for AVD, FMD and TX respectively. the corresponding rates for primary patency were 57%, 67% and 54%, and for secondary patency (after 1 to 6 angioplasties) 77%, 93% and 64%. Lower long-term results were obtained for: recanalized vessels; long lesions; bifurcation stenoses; stenoses in patients with abdominal aortic aneurysm; smaller vessels; and segmental branches in native and TX kidneys. of 252 patients with hypertension, 8% were cured and another 58% improved. of 215 patients with reduced renal function, 38% were normalized or improved and 42% unchanged. Major complications including 2 deaths were seen in 2.9% of the procedures and other complications in 4.7%. Conclusion: PTRA with a guiding catheter can be performed in most patients with a high success rate and a low complication rate. This study points to two major problems with PTRA: the high restenosis rate and the low response to treatment of hypertension. the careful selection of patients for PTRA is important for increasing the success rate, and follow-up to detect restenosis is mandatory.

Transcatheter arterial embolization in the management of bleeding duodenal ulcers : A 5.5-year retrospective study of treatment and outcome

Objective. The mortality rate associated with bleeding duodenal ulcer disease is about 10%. Primary endoscopic hemostasis is successful in over 90% of patients, but in 15–25%, the bleeding cannot be controlled endoscopically or the patient rebleeding, requiring alternative treatment. Percutaneous transcatheter arterial embolization (TAE) has been proposed as an alternative to surgery and was introduced at Ullevål University Hospital in Oslo, Norway, in June 2000. In this study we report our experiences in 36 patients. Material and methods. A retrospective review identified all patients admitted to Ullevål University Hospital with hematemesis and/or melena and endsocopically verified duodenal ulcer from June 2000 to 2005. The indication for TAE was endoscopically unmanageable bleeding/rebleeding or rebleeding after surgery. Technical success was defined as acute hemostasis. Clinical success was defined as technical success without rebleeding within 30 days. Results. A total of 278 patients (mean age 73 years) were included in the study. Primary endoscopic hemostasis failed in 13 patients (5%) and 53 patients (20%) experienced rebleeding. An attempt was made to treat 36 patients with TAE. Technical success in the TAE group was 92% and clinical success was 72%. In total, 10 patients underwent surgery, 3 because of rebleeding after TAE. The 30-day mortality was 10% for all patients, 19% in the TAE group, and 20% in the surgical group. Conclusions. High technical and clinical success was obtained with TAE in patients with bleeding duodenal ulcer after failure of endoscopic treatment. TAE appears to be a treatment alternative to surgery in this group of patients.

Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial.

OBJECTIVE: To compare clinical outcome 6 months after treatment with bilateral laparoscopic occlusion of the uterine artery versus uterine leiomyoma embolization. METHODS: Sixty-six premenopausal women with symptomatic uterine leiomyomata were randomized to treatment with either laparoscopic occlusion of uterine arteries or uterine leiomyoma embolization. The primary outcome was reduction of blood loss from pretreatment to 6 months postoperatively, measured by a Pictorial Bleeding Assessment Chart. Secondary outcomes included patients’ own assessment of symptom reduction, postoperative pain assessed using visual analog scales, ketobemidone used postoperatively, complications, secondary interventions, and failures. RESULTS: Fifty-eight women were included; 6-month follow-up data were available for 28 participants in each group. The percentage reduction in Pictorial Bleeding Assessment Chart scores did not differ between the treatment groups (52% after uterine leiomyoma embolization and 53% after laparoscopy, P=.96). The study had 52% power to detect a 20% difference on the Pictorial Bleeding Assessment Chart. Fewer participants in the group treated with uterine leiomyoma embolization complained of heavy bleeding after 6 months (4% compared with 21%, P=.044). The postoperative use of ketobemidone was higher after uterine leiomyoma embolization (46 mg compared with 12 mg, P<.001). CONCLUSION: Both laparoscopic occlusion of uterine vessels and embolizaton of uterine leiomyoma improved clinical symptoms in the majority of patients. Participants with the laparoscopic procedure had less postoperative pain but heavier menstrual bleeding 6 months after treatment. A larger study and longer follow-up is necessary before a definite conclusion can be made regarding the most effective treatment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT 00277680 LEVEL OF EVIDENCE: I

Effect of Ischemic Postconditioning on Infarct Size in Patients With ST-Elevation Myocardial Infarction Treated by Primary PCI Results of the POSTEMI (POstconditioning in ST-Elevation Myocardial Infarction) Randomized Trial

Background Reduction of infarct size by ischemic postconditioning (IPost) has been reported in smaller proof‐of‐concept clinical studies, but has not been confirmed in other smaller studies. The principle needs to be evaluated in larger groups of ST‐elevation myocardial infarction (STEMI) patients before being implemented in clinical practice. This study assessed the effect of ischemic postcoditioning (IPost) on infarct size in patients with STEMI treated by primary percutaneous coronary intervention (PCI). Methods and Results Patients with first‐time STEMI, <6 hours from symptom onset, referred to primary PCI were randomized to IPost or control groups. IPost was administered by 4 cycles of 1‐minute reocclusion and 1‐minute reperfusion, starting 1 minute after opening, followed by stenting. In the control group, stenting was performed immediately after reperfusion. The primary endpoint was infarct size measured by cardiac magnetic resonance after 4 months. A total of 272 patients were randomized. Infarct size (percent of left ventricular mass) after 4 months (median values and interquartile range) was 14.4% (7.7, 24.6) and 13.5% (8.1, 19.3) in the control group and IPost group, respectively (P=0.18). No significant impact of IPost was found when controlling for baseline risk factors of infarct size in a multivariate linear regression model (P=0.16). The effects of IPost on secondary endpoints, including markers of necrosis, myocardial salvage, and ejection fraction, as well as adverse cardiac events during follow‐up, were consistently neutral. Conclusions In contrast to several smaller trials reported previously, we found no significant effects of IPost on infarct size or secondary study outcomes. Clinical Trial Registration URL: http://www.clinicaltrials.gov Unique identifier: NCT.No.PO1506.

Bowel magnetic resonance imaging of pediatric patients with oral mannitol

The purpose of this study was to assess the sensitivity, specificity, and diagnostic accuracy of magnetic resonance imaging (MRI) in pediatric patients with clinical suspicion of inflammatory bowel disease (IBD) by comparing MRI and ultrasound (US) to endoscopy, the gold standard. A median volume of 300 ml of mannitol in a 15% [corrected] watery solution were ingested by 43 children prior to examination. The 53 MRI examinations were compared with 20 endoscopies and 41 US of the terminal ileum. The outcomes were MRI quality; pathologic findings; level of adverse events; and concordance between endoscopy, MRI, and US estimated by kappa statistics. The ileum and terminal ileum were very good or excellently imaged in approximately 80% of cases. Wall thickening and enhancement were most frequent in the terminal ileum. MRI compared with endoscopy had a sensitivity of 81.8% [95% confidence interval (CI)], specificity of 100%, diagnostic accuracy of 90%, and kappa value of 0.80 (95% CI), indicating a good degree of concordance. A similar degree of concordance was achieved between US and endoscopy. In spite of the frequent adverse reactions, such as diarrhea and nausea, half of the patients were prepared to repeat the examination. The results of MRI are concordant with endoscopy and US of the terminal ileum.