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301 result(s) for "Søndergaard, Lars"
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Reduced Leaflet Motion after Transcatheter Aortic-Valve Replacement
In a trial, patients who had undergone successful TAVR were assigned to rivaroxaban or antiplatelet therapy. In this substudy in patients who underwent CT, leaflet thickening and reduced leaflet motion at 90 days were less common with rivaroxaban. However, in the main trial, rivaroxaban was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding.
Five-Year Outcomes of PFO Closure or Antiplatelet Therapy for Cryptogenic Stroke
In the initial report of the Gore REDUCE trial of patent foramen ovale closure, with a median follow-up of 3.2 years, 18 patients had stroke recurrence (6 in the PFO closure group and 12 in the antiplatelet-only group). After a median follow-up of 5 years, 20 patients had stroke recurrence, with the two additional strokes occurring in the PFO closure group.
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement
Patients who had undergone successful TAVR were randomly assigned to receive either a rivaroxaban-based antithrombotic regimen or an antiplatelet-based antithrombotic regimen. At 17 months, the primary outcome of death or thromboembolic complications occurred more frequently with rivaroxaban.
Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients
Among patients at intermediate risk for aortic-valve surgery, transcatheter aortic-valve replacement (TAVR) was noninferior to standard surgery, although each procedure had a different pattern of adverse events. Transcatheter aortic-valve replacement (TAVR) with the use of a self-expanding prosthesis is superior to medical therapy in patients with severe, symptomatic aortic stenosis in whom surgical aortic-valve replacement has been associated with prohibitive risk. 1 Among patients who are at high risk for standard surgery, TAVR may be the preferred option. 2 – 4 The adoption of TAVR in patients with aortic stenosis at high risk for surgery has been rapid, as shown by enrollment in the ongoing Society of Thoracic Surgeons–American College of Cardiology Transcatheter Valve Therapy Registry. 5 The comparative efficacy of TAVR and surgery has been less well studied among patients . . .
Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study
Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33–281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p<0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).
ERNICA guidelines for the management of rectosigmoid Hirschsprung’s disease
Background Hirschsprung’s disease (HSCR) is a serious congenital bowel disorder with a prevalence of 1/5000. Currently, there is a lack of systematically developed guidelines to assist clinical decision-making regarding diagnostics and management. Aims This guideline aims to cover the diagnostics and management of rectosigmoid HSCR up to adulthood. It aims to describe the preferred approach of ERNICA, the European Reference Network for rare inherited and congenital digestive disorders. Methods Recommendations within key topics covering the care pathway for rectosigmoid HSCR were developed by an international workgroup of experts from 8 European countries within ERNICA European Reference Network from the disciplines of surgery, medicine, histopathology, microbiology, genetics, and patient organization representatives. Recommendation statements were based on a comprehensive review of the available literature and expert consensus. AGREE II and GRADE approaches were used during development. Evidence levels and levels of agreement are noted. Results Thirty-three statements within 9 key areas were generated. Most recommendations were based on expert opinion. Conclusion In rare or low-prevalence diseases such as HSCR, there remains limited availability of high-quality clinical evidence. Consensus-based guidelines for care are presented.
Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves
Reduced leaflet motion was detected on computed tomography in 22 patients in a clinical trial of transcatheter aortic-valve replacement (TAVR) and in 17 patients in two registries. The condition resolved with anticoagulation. Transcatheter aortic-valve replacement (TAVR) is a recent innovation in the management of aortic stenosis. The efficacy and safety of this therapeutic intervention have been studied in several randomized clinical trials. 1 – 6 The Portico Re-sheathable Transcatheter Aortic Valve System U.S. Investigational Device Exemption (PORTICO IDE) study is an ongoing, prospective clinical trial to evaluate TAVR with either a Portico valve (St. Jude Medical) or a commercially available valve. As specified in the PORTICO IDE protocol, computed tomography (CT) was performed in a subgroup of patients to assess the stent frame of the implanted valve. A finding of reduced leaflet motion on . . .
Transcatheter mitral valve repair: an overview of current and future devices
The field of transcatheter mitral valve repair (TMVr) for mitral regurgitation (MR) is rapidly evolving. Besides the well-established transcatheter mitral edge-to-edge repair approach, there is also growing evidence for therapeutic strategies targeting the mitral annulus and mitral valve chordae. A patient-tailored approach, careful patient selection and an experienced interventional team is crucial in order to optimise procedural and clinical outcomes. With further data from ongoing clinical trials to be expected, consensus in the Heart Team is needed to address these complexities and determine the most appropriate TMVr therapy, either single or combined, for patients with severe MR.
Short- and Long-Term Mortality and Stroke Risk After Transcatheter Aortic Valve Implantation
No published studies have compared the outcome after transcatheter aortic valve implantation (TAVI) with the outcome in the general population. Thus, it is unknown whether TAVI restores normal life expectancy and stroke risk. Furthermore, despite the increasing use of TAVI, only little is known about the temporal trends for TAVI regarding patient characteristics and outcomes. We identified all Danish patients treated with TAVI from 2006 to 2014 (n = 1,631) and 9,737 general population controls matched by gender, age, and co-morbidity. The primary end point was a composite end point of all-cause mortality and stroke. During the first 90 days, the risk of the combined end point, the stroke risk, and mortality were significantly higher among TAVI patients compared with controls (9.4%, 7.5%, and 2.5%, respectively, in TAVI patients compared with 2.0%, 1.6%, and 0.5% in controls). After 90 days, there were no differences (adjusted mortality rate ratio, stroke rate ratio, and mortality or stroke rate ratio 0.92 [0.79 to 1.06], 1.32 [0.98 to 1.78], and 1.00 [0.90 to 1.10], respectively). During the study period, there were small changes in the characteristics of patients treated with TAVI; however, more patients were treated by transfemoral access; fewer needed blood transfusions, hospital stays were shorter, and the overall mortality rate decreased. In conclusion, 90 days after TAVI, the stroke risk and mortality of the TAVI patients were comparable with the stroke risk and mortality of the general population. Over time, the patient risk profiles have remained largely unchanged; however, outcomes have improved substantially, including lower short- and long-term mortality.
Simplification and optimization of transcatheter aortic valve implantation – fast-track course without compromising safety and efficacy
Transcatheter aortic valve implantation (TAVI) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis. Ageing of the Western and Asian population and expansion of indications for TAVI will lead to a substantial increase in the number of TAVI procedures performed worldwide within the next decades. In line with the maturation of TAVI over the past few years, there has also been a significant simplification and optimisation of the TAVI procedure. A minimalist TAVI procedure and fast-track TAVI course have been shown to have distinct advantages over the more traditional TAVI approach. The aim of this manuscript is to discuss strategies of TAVI simplification and optimization, with special focus on fast-track TAVI, without compromising safety and efficacy.