94 research outputs found
Cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain:12-month and cost-effectiveness results from the multicenter COCOGEN trial
No full textBackground Radiofrequency (RF) treatment of the genicular nerves reduces chronic knee pain in patients with osteoarthritis (OA) or persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The objective of this study is to compare long-term outcomes of cooled and conventional RF and perform an economic evaluation. Methods The COCOGEN trial is a double-blinded, non-inferiority, pilot, randomized controlled trial that compared the effects up to 12 months of cooled and conventional RF in patients with chronic knee pain suffering from OA or PPSP after TKA following a 1:1 randomization rate. Outcomes were knee pain, functionality, quality of life, emotional health, medication use, and adverse events. A trial-based economic evaluation was performed with a 12-month societal perspective. Here, the primary outcome was the incremental costs per quality-adjusted life year (QALY). Results 41 of the 49 included patients completed the 12-month follow-up. One patient in the PPSP cooled RF group had substantial missing data at 12-month follow-up. The proportion of patients with ≥50% pain reduction at 12 months was 22.2% (4/18) in patients treated with conventional RF versus 22.7% (5/22) in patients treated with cooled RF (p>0.05). There was a statistically significant difference in the mean absolute numerical rating scale at 12 months after cooled RF and conventional RF in patients with PPSP (p=0.02). Differences between other outcomes were not statistically significant. The health economic analysis indicated that cooled RF resulted in lower costs and improved QALYs compared with conventional RF in PPSP but not in OA. There were no serious adverse events. Conclusions Both RF treatments demonstrated in approximately 22% of patients a ≥50% pain reduction at 12 months. In patients with PPSP, contrary to OA, cooled RF seems to be more effective than conventional RF. Additionally, cooled RF has in patients with PPSP, as opposed to OA, greater effectiveness at lower costs compared with conventional RF.</p
Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial
No full textBACKGROUND: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasoundguided puncture is unclear. AIMS: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation. METHODS: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions. RESULTS: A total of 544 patients undergoing complex PCI mandating large-bore (>= 7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopyguided access and 2.6% for ultrasound-guided access (p=0.32). CONCLUSIONS: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for largebore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access. ClinicalTrials.gov identifier: NCT04837404Maatschap Cardiologie Zwolle (sponsor) TOP Medical Consultancy B.V. (unrestricted grant
Clinical Implications of Distal Vessel Stenosis After Successful Coronary Chronic Total Occlusion Recanalization
No full textsee www.pubmed.go
Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial)
No full textBackground Radiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking.Methods This double blind, non-inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty. Patients were randomized following a 1:1 rate. The primary outcome was the proportion of patients with >= 50% pain reduction at 3 months postintervention. Other outcomes were knee pain, functionality, quality of life, emotional health, and adverse events up to 6 months postintervention. Conventional RF treatment was tested for non-inferiority to cooled in reducing knee pain at 3 months follow- up. Results Forty- nine of 70 patients were included, of which 47 completed a 3- month follow- up. The primary outcome was achieved in 4 of 23 patients treated with conventional RF (17%) vs in 8 of 24 with cooled (33%) (p=0,21). Results from the non-inferiority comparison were inconclusive in relation to the non-inferiority margin. There was no statistically significant difference between secondary outcomes. There were no serious adverse events.Conclusions Both conventional and cooled RF treatment reduced pain in the osteoarthritis and persistent postsurgical pain population. This pilot study did not demonstrate statistically significant differences in the proportion of patients experiencing >= 50% pain reduction between techniques. The non-inferiority analysis was inconclusive. These results warrant further research
Broadcast And Surveillance TechnologIes Over Networks
No full textMark Verhoeven (Axon), Willem-Jan Dirks (Axon), Egwin Wesselink (Axon), Teun Selten (Axon), Sander van Kolck (Axon),Jochem Herrmann (Adimec), Adriaan Umans (Adimec), Joost van Kuijk (Adimec), Marcel Dijkema (Adimec),Klaas Jan Damstra (GVN), John Hommel (GVN), Robert Pot (GVN), Joost Uijtdehaag (GVN),Patrick Henckes (Caeleste), Bart Dierickx (Caeleste), Bert Luyssaert (Caeleste),Pascal Douine (e2v), Jean-Luc Diverchy (e2v), Alain Prevost (e2v), Philippe Kuntz (e2v),Christophe Guettier (Sagem), Marc Bousquet (Sagem), Romuald Perinelle (Sagem), François Gendry (Sagem),Corinne Ancourt (Armines), François Irigoin (Armines), Claude Tadonki (Armines),Peter Brookes (Altera/Intel)International audienceThe main objective of the BASTION project is to research and develop new applications for the Broadcast Market, and for theSecurity and Surveillance Markets. Both applications will be built on top of the Internet Protocol network, which will allow distributing the applications over several physical sites. The cameras will be located on one or more sites, and the monitoring/control room will be on a separate site. The main benefit of this distribution is that it will enable increasing the efficiency for producing live Broadcast content by a factor of 2-3, by sending only camera personnel to remote sites, and having the main production team in the home studio to do several programs in a single day. Integrating high-quality and high-resolution (HD and higher) image sensors in a networked infrastructure to detect, recognize and identify Surveillance and Security issues when observing long distance or large-scale events
Rationale and design of POPular-TAVI: AntiPlatelet therapy for Patients undergoing Transcatheter Aortic Valve Implantation
No full textBackground Despite improving experience and techniques, ischemic and bleeding complications after transcatheter aortic valve implantation (TAVI) remain prevalent and impair survival. Current guidelines recommend the temporary addition of clopidogrel in the initial period after TAVI to prevent thromboembolic events. However, explorative studies suggest that this is associated with a higher rate of major bleeding without a decrease in thromboembolic complications. Methods The POPular TAVI trial is a prospective randomized, controlled, open-label multicenter clinical trial to test the hypothesis that monotherapy with aspirin or oral anticoagulation (OAC) after TAVI is safer than the addition of clopidogrel for 3 months, without compromising clinical benefit. This trial encompasses 2 cohorts: cohort A, patients are randomized 1:1 to aspirin vs aspirin + clopidogrel, and cohort B, patients on OAC therapy are randomized 1:1 to OAC vs OAC + clopidogrel. Primary outcome is freedom from non-procedure-related bleeding at 1 year. Secondary net-clinical benefit outcome is freedom from the composite of cardiovascular death, non-procedural-related bleeding, myocardial infarction, or stroke at 1 year. The primary outcome is analyzed for superiority, whereas the secondary outcome is analyzed for noninferiority. Recruitment began in February 2014, and the trial will continue until a total of 1,000 patients (684 expected in cohort A and 316 in cohort B) are included and followed up for 1 year. Summary The POPular TAVI trial (NCT02247128) is the first large randomized controlled trial to test if monotherapy with aspirin or OAC vs additional clopidogrel after TAVI reduces bleeding with a favorable net-clinical benefit
Response to comment on: “perioperative blood glucose monitoring and control in major vascular surgery patients”
No full textULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial
No full textINTRODUCTION: Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date. METHODS AND ANALYSIS: A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by the local Ethics Committee (‘Medisch Ethische Toetsing Commissie Isala Zwolle’) for all Dutch sites, ‘Comité Medische Ethiek Ziekenhuis Oost-Limburg’ for Hospital Oost-Limburg, ‘Comité d’éthique CHU-Charleroi—ISPPC’ for Centre Hospilatier Universitaire de Charleroi and ‘Ethik Kommission de Ärztekammer Nordrhein’ for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752. REGISTRATION DETAILS: ClinicalTrials.gov identifier: NCT03846752
Polyvascular Atherosclerotic disease: Echocardiographic and metabolic determinants of adverse cardiac outcome
No full textPeripheral Arterial Disease (PAD) is a multifactorial syndrome that most commonly
affects people over 60 years of age. With the aging of the population, the
prevalence of atherosclerotic disease and its associated adverse outcomes will
increase. It has to be noted that the process of established atherothrombosis is not
limited to a single arterial location, giving it the character of a systemic and
generalized disease. The Reduction of Atherothrombosis for Continued Health
(REACH) registry demonstrated that one out of six patients with (i) PAD, (ii)
cerebrovascular disease, or (iii) coronary artery disease had involvement of one or
two other arterial beds. Importantly, the presence of multiple affected arterial
territories, called polyvascular disease, has been demonstrated to be an
independent predictor of long-term cardiovascular outcome in the general
population.
In response to studies demonstrating the adverse prognosis of
atherosclerotic disease, the need for adequate risk factor stratification and
reduction has emerged. The importance of risk factor reduction in patients with
PAD has resulted in universally recommended atherothrombotic risk factor
reduction, with the objective of decreasing the high incidence of heart disease and
cerebrovascular disease associated with PAD. In patients with PAD scheduled for
vascular surgery, risk factor stratification is directed at the detection of
(a)symptomatic atherosclerotic disease in other vascular beds than the primary
symptomatic arterial location. Early detection of polyvascular atherosclerotic
disease has important consequences for risk factor reduction strategies, including
life-style interventions and medical therapy
Long-term outcome of ablative therapy of postoperative supraventricular tachycardias in patients with univentricular heart: a European multicenter study
No full textBACKGROUND: Catheter ablation has evolved as a possible curative treatment modality for supraventricular tachycardias (SVT) in patients with univentricular heart. However, the long-term outcome of ablation procedures is unknown. We evaluated the procedural and long-term outcome of ablative therapy of late postoperative SVT in patients with univentricular heart. METHODS AND RESULTS: Patients with univentricular heart (n=19, 11 male; age, 29+/-9 years) referred for ablation of SVT were studied. Ablation was guided by 3D electroanatomic mapping in all but 2 procedures. A total of 41 SVT were diagnosed as intra-atrial reentrant tachycardia (n=30; cycle length, 310+/-68 ms), typical atrial flutter (n=4; cycle length, 288+/-42 ms), focal atrial tachycardia (n=6; cycle length, 400+/-60 ms), and atrial fibrillation (n=1). Ablation was successful in 73% of intra-atrial reentrant tachycardia, 75% of atrial flutter, and all focal atrial tachycardia and focal atrial fibrillation. During the follow-up period of 53+/-34 months, 2 patients were lost to follow-up, 3 died of heart failure, 2 underwent heart transplantation, and 1 underwent conduit replacement. Of the remaining group, 8 had sinus rhythm and 3 had SVT. CONCLUSIONS: Focal and reentrant mechanisms underlie postoperative SVT in patients with univentricular heart. Successive SVT developing over time may be caused by different mechanisms. Ablative therapy is potentially curative, with a procedural success rate of 78%. In patients who had multiple ablation procedures, the SVT originated from different atrial sites, suggesting that these new SVT were caused by progressive atrial disease. Despite recurrent SVT, sinus rhythm at the end of the follow-up period was achieved in 72%
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