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result(s) for
"Betts, Tim"
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Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing
by
Brouwer, Tom F.
,
Boersma, Lucas V.A.
,
Wilde, Arthur A.M.
in
Death, Sudden, Cardiac - prevention & control
,
Defibrillators, Implantable
,
Electric Countershock - adverse effects
2019
In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates.
The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm.
The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning.
Journal Article
Expert consensus document: Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment
by
Guasch, Eduard
,
Cartlidge, David
,
Bucklar-Suchankova, Gabriela
in
Animals
,
Atrial Fibrillation - diagnosis
,
Atrial Fibrillation - epidemiology
2016
Despite remarkable advances in antiarrhythmic drugs, ablation procedures, and stroke-prevention strategies, atrial fibrillation (AF) remains an important cause of death and disability in middle-aged and elderly individuals. Unstructured management of patients with AF sharply contrasts with our detailed, although incomplete, knowledge of the mechanisms that cause AF and its complications. Altered calcium homeostasis, atrial fibrosis and ageing, ion-channel dysfunction, autonomic imbalance, fat-cell infiltration, and oxidative stress, in addition to a susceptible genetic background, contribute to the promotion, maintenance, and progression of AF. However, clinical management of patients with AF is currently guided by stroke risk parameters, AF pattern, and symptoms. In response to this apparent disconnect between the known pathophysiology of AF and clinical management, we propose a roadmap to develop a set of clinical markers that reflect the major causes of AF in patients. Thereby, the insights into the mechanisms causing AF will be transformed into a format that can underpin future personalized strategies to prevent and treat AF, ultimately informing better patient care.
Journal Article
Real‐world evidence in a national health service: results of the UK CardioMEMS HF System Post‐Market Study
2022
Aims The CardioMEMS HF System Post‐Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic‐guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. Methods and results COAST is a prospective, international, multicentre, open‐label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic‐guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system‐related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72–88%] than the previous 12 months (0.27 vs. 1.52 events/patient‐year, respectively, P < 0.0001). Freedom from device/system‐related complications and pressure sensor failure at 2 years was 100% and 99%, respectively. Conclusions Remote haemodynamic‐guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic‐guided HF management was safe and significantly reduced hospitalization in a group of high‐risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: ClinicalTrials.gov identifier: NCT02954341.
Journal Article
Substrate Utilization by the Failing Human Heart by Direct Quantification Using Arterio-Venous Blood Sampling
2009
Metabolic substrate utilization of the human failing heart is an area of controversy. The purpose of this study is to directly quantify myocardial substrate utilization in moderately severe heart failure, type 2 diabetes and healthy controls using simultaneous coronary sinus and arterial blood sampling. Patients with heart failure (n = 9, mean NYHA 2.7+/-0.5), with type 2 diabetes (n = 5) and with normal heart function (n = 10) were studied after an overnight fast in connection with electrophysiological investigations/treatments.A systemic infusion of [(2)H(2)]palmitate allowed for the calculation of absolute palmitate extraction across the heart. Blood samples were analysed for non-esterified fatty acids, triacylglycerol, glycerol, glucose, pyruvate, lactate, 3-hydroxybutyrate, and blood gases after simultaneous sampling of arterial and coronary sinus blood. Arterio-coronary sinus metabolite concentration differences and fractional extractions for all substrates were similar between the groups. The absolute NEFA uptakes assessed by [(2)H(2)]palmitate extraction were also similar between the groups. Using direct measurements of metabolic substrate uptake by arterio-venous difference technique, the compensated human failing heart does not appear to have reduced myocardial fatty acid uptake.
Journal Article
Inappropriate shocks from a subcutaneous implantable cardioverter-defibrillator due to oversensing during periods of rate-related bundle branch block
2017
Abstract The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a novel technology with proven efficacy in sudden cardiac death prevention; however, there is a lack of long-term safety data. We describe the case of a 55-year-old female patient implanted with an S-ICD due to idiopathic ventricular fibrillation, who subsequently presented with inappropriate shocks leading to ventricular fibrillation that was successfully terminated by another shock. Inappropriate shocks were due to intermittent T wave oversensing during periods of rate-dependent right bundle branch block. Assessment of the S-ICD electrograms during an exercise test allowed successful reprogramming of the device׳s sensing vector with no further events.
Journal Article
Left Atrial Appendage Occlusion: British Cardiovascular Intervention Society and British Heart Rhythm Society Position Statement
by
Betts, Tim R
,
Graham, Lee N
,
Calvert, Patrick A
in
Anticoagulants
,
Associations, institutions, etc
,
Blood clots
2024
Percutaneous left atrial appendage occlusion aims to reduce the risk of stroke in patients with AF, particularly those who are not good candidates for systemic anticoagulation. The procedure has been studied in large international randomised trials and registries and was approved by the National Institute for Health and Care Excellence in 2014 and by NHS England in 2018. This position statement summarises the evidence for left atrial appendage occlusion and presents the current indications. The options and consensus on best practice for pre-procedure planning, undertaking a safe and effective implant and appropriate post-procedure management and follow-up are described. Standards regarding procedure volume for implant centres and physicians, the role of multidisciplinary teams and audits are highlighted.
Journal Article
Electrical synchronization achieved by multipoint pacing combined with dynamic atrioventricular delay
2021
PurposeMultipoint pacing (MPP) improves left ventricular (LV) electrical synchrony in cardiac resynchronization therapy (CRT). SyncAV automatically adjusts atrioventricular delay (AVD) according to intrinsic AV intervals and may further improve synchrony. Their combination has not been assessed. The objective was to evaluate the improvement in electrical synchrony achieved by SyncAV combined with MPP in an international, multicenter study.MethodsPatients with LBBB undergoing CRT implant with a quadripolar lead (Abbott Quartet™) were prospectively enrolled. QRS duration (QRSd) was measured by blinded observers from 12-lead ECG during: intrinsic conduction, BiV pacing (conventional biventricular pacing, nominal static AVD), MPP (2 LV cathodes maximally spaced, nominal static AVD), BiV + SyncAV, and MPP + SyncAV. All SyncAV offsets were individualized for each patient to yield the narrowest QRSd during BiV pacing. QRSd changes were compared by ANOVA and post hoc Tukey-Kramer tests.ResultsOne hundred and three patients were enrolled (65.7 ± 12.1 years, 67% male, 37% ischemic, EF 26.4 ± 6.5%, PR 190.3 ± 39.1 ms). Relative to intrinsic conduction (QRSd of 165 ± 16 ms), BiV reduced QRSd by 11.9% to 145 ± 18 ms (P < 0.001 vs intrinsic), and MPP reduced QRSd by 13.3% to 142 ± 19 ms (P < 0.001 vs intrinsic). However, enabling SyncAV with a patient-optimized offset nearly doubled this QRSd reduction. BiV + SyncAV reduced QRSd by 22.0% to 128 ± 13 ms (P < 0.001 vs BiV), while MPP + SyncAV reduced QRSd further by 25.6% to 122 ± 14 ms (P < 0.05 vs BiV + SyncAV).ConclusionSyncAV can significantly improve acute electrical synchrony beyond conventional CRT, with further improvement achieved by superimposing MPP.
Journal Article
Acute electrical and hemodynamic effects of endocardial biventricular pacing using the WiSE CRT system and conventional epicardial biventricular pacing
by
Leo, Milena
,
Betts, Tim R.
,
Webster, David
in
acute hemodynamic response
,
Anticoagulants
,
Atrial fibrillation
2018
Wireless left ventricular endocardial pacing with the WiSE CRT system has recently become available as alternative to conventional epicardial CRT pacing. We report the first comparison of the acute electrical and hemodynamic response produced by the two CRT pacing modalities in a patient undergoing WiSE CRT implant after a failed conventional CRT procedure. WiSE CRT pacing showed an additive acute benefit compared with conventional CRT. These findings could potentially translate into long‐term clinical benefit and introduce the potential for tri‐ventricular pacing using both systems simultaneously.
Journal Article
Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment
by
Guasch, Eduard
,
Cartlidge, David
,
Bucklar-Suchankova, Gabriela
in
Atrial fibrillation
,
Care and treatment
,
Development and progression
2016
Despite remarkable advances in anti-arrhythmic drugs, ablation procedures, and stroke-prevention strategies, atrial fibrillation (AF) remains an important cause of death and disability in middle-aged and elderly individuals. Unstructured management of patients with AF sharply contrasts with our detailed, although incomplete, knowledge of the mechanisms that cause AF and its complications. Altered calcium homeostasis, atrial fibrosis and ageing, ion-channel dysfunction, autonomic imbalance, fat-cell infiltration, and oxidative stress, in addition to a susceptible genetic background, contribute to the promotion, maintenance, and progression of AF. However, clinical management of patients with AF is currently guided by stroke risk parameters, AF pattern, and symptoms. In response to this apparent disconnect between the known pathophysiology of AF and clinical management, we propose a roadmap to develop a set of clinical markers that reflect the major causes of AF in patients. Thereby, the insights into the mechanisms causing AF will be transformed into a format that can underpin future personalized strategies to prevent and treat AF, ultimately informing better patient care.
Journal Article
Subcutaneous or Transvenous Defibrillator Therapy
by
Alings, Marco
,
van der Stuijt, Willeke
,
Mittal, Suneet
in
Aged
,
Arrhythmias, Cardiac - therapy
,
Cardiac arrhythmia
2020
Patients with an indication for an implantable cardioverter–defibrillator but no indication for pacing were randomly assigned to a subcutaneous or a transvenous ICD. At 49 months, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.
Journal Article