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1.
Article in English | MEDLINE | ID: mdl-38544812

ABSTRACT

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.

2.
Interv Cardiol ; 19: e02, 2024.
Article in English | MEDLINE | ID: mdl-38532943

ABSTRACT

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.

3.
J Physiol ; 601(18): 4013-4032, 2023 09.
Article in English | MEDLINE | ID: mdl-37475475

ABSTRACT

The best pharmacological treatment for each atrial fibrillation (AF) patient is unclear. We aim to exploit AF simulations in 800 virtual atria to identify key patient characteristics that guide the optimal selection of anti-arrhythmic drugs. The virtual cohort considered variability in electrophysiology and low voltage areas (LVA) and was developed and validated against experimental and clinical data from ionic currents to ECG. AF sustained in 494 (62%) atria, with large inward rectifier K+ current (IK1 ) and Na+ /K+ pump (INaK ) densities (IK1 0.11 ± 0.03 vs. 0.07 ± 0.03 S mF-1 ; INaK 0.68 ± 0.15 vs. 0.38 ± 26 S mF-1 ; sustained vs. un-sustained AF). In severely remodelled left atrium, with LVA extensions of more than 40% in the posterior wall, higher IK1 (median density 0.12 ± 0.02 S mF-1 ) was required for AF maintenance, and rotors localized in healthy right atrium. For lower LVA extensions, rotors could also anchor to LVA, in atria presenting short refractoriness (median L-type Ca2+ current, ICaL , density 0.08 ± 0.03 S mF-1 ). This atrial refractoriness, modulated by ICaL and fast Na+ current (INa ), determined pharmacological treatment success for both small and large LVA. Vernakalant was effective in atria presenting long refractoriness (median ICaL density 0.13 ± 0.05 S mF-1 ). For short refractoriness, atria with high INa (median density 8.92 ± 2.59 S mF-1 ) responded more favourably to amiodarone than flecainide, and the opposite was found in atria with low INa (median density 5.33 ± 1.41 S mF-1 ). In silico drug trials in 800 human atria identify inward currents as critical for optimal stratification of AF patient to pharmacological treatment and, together with the left atrial LVA extension, for accurately phenotyping AF dynamics. KEY POINTS: Atrial fibrillation (AF) maintenance is facilitated by small L-type Ca2+ current (ICaL ) and large inward rectifier K+ current (IK1 ) and Na+ /K+ pump. In severely remodelled left atrium, with low voltage areas (LVA) covering more than 40% of the posterior wall, sustained AF requires higher IK1 and rotors localize in healthy right atrium. For lower LVA extensions, rotors can also anchor to LVA, if the atria present short refractoriness (low ICaL ) Vernakalant is effective in atria presenting long refractoriness (high ICaL ). For short refractoriness, atria with fast Na+ current (INa ) up-regulation respond more favourably to amiodarone than flecainide, and the opposite is found in atria with low INa . The inward currents (ICaL and INa ) are critical for optimal stratification of AF patient to pharmacological treatment and, together with the left atrial LVA extension, for accurately phenotyping AF dynamics.


Subject(s)
Amiodarone , Atrial Fibrillation , Humans , Atrial Fibrillation/drug therapy , Flecainide/pharmacology , Flecainide/therapeutic use , Heart Atria , Amiodarone/pharmacology , Amiodarone/therapeutic use , Action Potentials/physiology
4.
Europace ; 25(3): 914-921, 2023 03 30.
Article in English | MEDLINE | ID: mdl-36734247

ABSTRACT

AIMS: The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting. METHODS AND RESULTS: Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak <3 mm, 2.4 (4/169) had leak ≥3 mm to ≤5 mm, and 0% had >5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295). CONCLUSION: The WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Humans , Male , Aged , Aged, 80 and over , Female , Platelet Aggregation Inhibitors/therapeutic use , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Treatment Outcome , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/complications , Stroke/etiology , Stroke/prevention & control , Anticoagulants/adverse effects , Cardiac Catheterization/adverse effects , Echocardiography, Transesophageal
5.
J Cardiovasc Electrophysiol ; 33(4): 741-750, 2022 04.
Article in English | MEDLINE | ID: mdl-35118767

ABSTRACT

BACKGROUND: Insertable cardiac monitors (ICMs) are essential for ambulatory arrhythmia diagnosis. However, definitive diagnoses still require time-consuming, manual adjudication of electrograms (EGMs). OBJECTIVE: To evaluate the clinical impact of selecting only key EGMs for review. METHODS: Retrospective analyses of randomly selected Abbott Confirm Rx™ devices with ≥90 days of remote transmission history were performed, with each EGM adjudicated as true or false positive (TP, FP). For each device, up to 3 "key EGMs" per arrhythmia type per day were prioritized for review based on ventricular rate and episode duration. The reduction in EGMs and TP days (patient-days with at least one TP EGM), and any diagnostic delay (from the first TP), were calculated versus reviewing all EGMs. RESULTS: In 1000 ICMs over a median duration of 8.1 months, at least one atrial fibrillation (AF), tachycardia, bradycardia, or pause EGM was transmitted by 424, 343, 190, and 325 devices, respectively, with a total of 95 716 EGMs. Approximately 90% of episodes were contributed by 25% of patients. Key EGM selection reduced EGM review burden by 43%, 66%, 77%, and 50% (55% overall), while reducing TP days by 0.8%, 2.1%, 0.2%, and 0.0%, respectively. Despite reviewing fewer EGMs, 99% of devices with a TP EGM were ultimately diagnosed on the same day versus reviewing all EGMs. CONCLUSION: Key EGM selection reduced the EGM review substantially with no delay-to-diagnosis in 99% of patients exhibiting true arrhythmias. Implementing these rules in the Abbott patient care network may accelerate clinical workflow without compromising diagnostic timelines.


Subject(s)
Atrial Fibrillation , Delayed Diagnosis , Atrial Fibrillation/diagnosis , Bradycardia/diagnosis , Humans , Retrospective Studies , Tachycardia/diagnosis
6.
ESC Heart Fail ; 9(1): 48-56, 2022 02.
Article in English | MEDLINE | ID: mdl-34882989

ABSTRACT

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.


Subject(s)
Heart Failure , State Medicine , Aged , Aged, 80 and over , Blood Pressure Monitoring, Ambulatory/methods , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/therapy , Humans , Male , Middle Aged , Prospective Studies , United Kingdom/epidemiology
7.
J Cardiovasc Electrophysiol ; 33(3): 458-463, 2022 03.
Article in English | MEDLINE | ID: mdl-34968010

ABSTRACT

BACKGROUND: The rate of left ventricular (LV) lead displacement after cardiac resynchronization therapy (CRT) remains high despite improvements in lead technology. In 2017, a novel quadripolar lead with active fixation technology became available in the UK. METHODS: This was a retrospective, observational study analyzing device complications in 476 consecutive patients undergoing successful first-time implantation of a CRT device at a tertiary center from 2017 to 2020. RESULTS: Both active (n = 135) and passive fixation (n = 341) quadripolar leads had similar success rates for implantation (99.3% vs. 98.8%, p = 1.00), although the pacing threshold (0.89 [0.60-1.25] vs. 1.00 [0.70-1.60] V, p = .01) and lead impedance (632 [552-794] vs. 730 [636-862] Ohms, p < .0001) were significantly lower for the active fixation lead. Patients receiving an active fixation lead had a reduced incidence of lead displacement at 6 months (0.74% vs. 4.69%, p = .036). There was no significant difference in the rate of right atrial (RA) and right ventricular (RV) lead displacement between the two groups (RA: 1.48% vs. 1.17%, p = .68; RV: 2.22% vs. 1.76%, p = .72). Reprogramming the LV lead after displacement was unsuccessful in most cases (successful reprogramming: Active fix = 0/1, Passive fix = 1/16) therefore nearly all patients required a repeat procedure. As a result, the rate of intervention within 6 months for lead displacement was significantly lower when patients were implanted with the active fixation lead (0.74% vs. 4.40%, p = .049). CONCLUSION: The novel active fixation lead in our study has a lower incidence of lead displacement and re-intervention compared to conventional quadripolar leads for CRT.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/methods , Cardiac Resynchronization Therapy Devices , Electrodes, Implanted/adverse effects , Heart Failure/diagnosis , Heart Failure/therapy , Humans , Postoperative Complications/therapy , Retrospective Studies , Treatment Outcome
8.
J Interv Card Electrophysiol ; 61(3): 453-460, 2021 Sep.
Article in English | MEDLINE | ID: mdl-32740689

ABSTRACT

PURPOSE: Multipoint 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. METHODS: Patients 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. RESULTS: One 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). CONCLUSION: SyncAV can significantly improve acute electrical synchrony beyond conventional CRT, with further improvement achieved by superimposing MPP.


Subject(s)
Cardiac Resynchronization Therapy , Heart Failure , Cardiac Resynchronization Therapy Devices , Electrocardiography , Female , Heart Failure/diagnostic imaging , Heart Failure/therapy , Heart Ventricles , Humans , Male , Treatment Outcome
10.
N Engl J Med ; 383(6): 526-536, 2020 08 06.
Article in English | MEDLINE | ID: mdl-32757521

ABSTRACT

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies. METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks. RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12). CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).


Subject(s)
Arrhythmias, Cardiac/therapy , Defibrillators, Implantable/adverse effects , Aged , Cardiomyopathies/therapy , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/prevention & control , Electrodes, Implanted/adverse effects , Equipment Failure , Female , Follow-Up Studies , Heart Diseases/therapy , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Prosthesis Design
13.
Am Heart J ; 214: 167-174, 2019 08.
Article in English | MEDLINE | ID: mdl-31220775

ABSTRACT

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. STUDY DESIGN: 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. CONCLUSION: 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.


Subject(s)
Defibrillators, Implantable , Electric Countershock/adverse effects , Equipment Safety , Death, Sudden, Cardiac/prevention & control , Humans , Monitoring, Physiologic , Patient Selection , Prospective Studies
14.
J Am Heart Assoc ; 7(15): e009218, 2018 08 07.
Article in English | MEDLINE | ID: mdl-30371239

ABSTRACT

Background Atrial fibrillation ( AF ) is associated with myocardial infarction, and patients with AF and no obstructive coronary artery disease can present with symptoms and evidence of cardiac ischemia. We hypothesized that microvascular coronary dysfunction underlies these observations. Methods and Results Myocardial blood flow ( MBF ) at baseline and during adenosine stress and left ventricular and left atrial function were evaluated by magnetic resonance in 49 patients with AF (25 paroxysmal, 24 persistent) with no history of epicardial coronary artery disease or diabetes mellitus, before and 6 to 9 months after ablation. Findings were compared with those obtained in matched controls in sinus rhythm (n=25). Before ablation, patients with AF had impaired left atrial function and left ventricular ejection fraction and strain indices (all P<0.05 versus controls). MBF was impaired in patients both under baseline conditions (1.21±0.24 mL/min per g·[mm Hg·bpm/104]-1 versus 1.34±0.28 mL/min per g·[mm Hg·bpm/104]-1 in controls, P=0.044) and during adenosine stress (2.29±0.48 mL/min per g versus 2.73±0.37 mL/min per g in controls, P<0.001). Under baseline conditions, MBF correlated with left ventricular strain and left atrial function (all P≤0.001), so that cardiac function was most impaired in patients with the lowest MBF . Baseline and stress MBF remained unchanged postablation (both P=ns), and baseline MBF showed similar correlations with functional indices to those present preablation (all P≤0.001). Conclusions Baseline and stress MBF are significantly impaired in patients with AF but no epicardial coronary artery disease. Reduction in MBF is proportional to severity of left ventricular and left atrial dysfunction, even after successful ablation. Coronary microvascular dysfunction may be a relevant pathophysiological mechanism in patients with a history of AF .


Subject(s)
Atrial Fibrillation/metabolism , Coronary Circulation/physiology , Microvessels/physiopathology , Myocardial Ischemia/metabolism , Aged , Atrial Fibrillation/surgery , Atrial Function, Left , Case-Control Studies , Catheter Ablation , Coronary Vessels , Exercise Test , Female , Humans , Magnetic Resonance Imaging , Magnetic Resonance Imaging, Cine , Male , Middle Aged , Myocardial Ischemia/diagnostic imaging , Myocardial Ischemia/physiopathology , Myocardial Perfusion Imaging , Ventricular Dysfunction/diagnostic imaging , Ventricular Dysfunction/metabolism , Ventricular Dysfunction/physiopathology , Ventricular Function, Left
15.
JACC Clin Electrophysiol ; 4(7): 860-868, 2018 07.
Article in English | MEDLINE | ID: mdl-30025684

ABSTRACT

OBJECTIVES: This study hypothesized that guided implants, in which the optimal left ventricular endocardial (LVENDO) pacing location was identified and targeted, would improve acute markers of contractility and chronic markers of cardiac resynchronization (CRT) response. BACKGROUND: Biventricular endocardial (BiVENDO) pacing may offer a potential benefit over standard CRT; however, the optimal LVENDO pacing site is highly variable. Indiscriminately delivered BiVENDO pacing is associated with a reverse remodeling response rate of between 40% and 60%. METHODS: Registry of centers implanting a wireless, LVENDO pacing system (WiSE-CRT System, EBR Systems, Sunnyvale, California); John Radcliffe Hospital (Oxford, United Kingdom), Guy's and St. Thomas' Hospital (London, United Kingdom), and The James Cook University Hospital (Middlesbrough, United Kingdom). Centers used a combination of preprocedural imaging and electroanatomical mapping the identify the optimal LVENDO site. RESULTS: A total of 26 patients across the 3 centers underwent a guided implant. Patients were predominantly male with a mean age of 68.8 ± 8.4 years, the mean LV ejection fraction was 34.2 ± 7.8%. The mean QRS duration was 163.8 ± 26.7 ms, and 30.8% of patients had an ischemic etiology. It proved technically feasible to selectively target and deploy the pacing electrode in a chosen endocardial segment in almost all cases, with a similar complication rate to that observed during indiscriminate BiVENDO. Ninety percent of patients met the definition of echocardiographic responder. Reverse remodeling was observed in 71%. CONCLUSIONS: Guided endocardial implants were associated with a higher degree of chronic LV remodeling compared with historical nonguided approaches.


Subject(s)
Cardiac Resynchronization Therapy Devices , Heart Ventricles , Hemodynamics/physiology , Surgery, Computer-Assisted/methods , Aged , Cardiac Resynchronization Therapy , Electrocardiography , Electrodes, Implanted , Female , Heart Ventricles/diagnostic imaging , Heart Ventricles/physiopathology , Heart Ventricles/surgery , Humans , Male , Middle Aged , Wireless Technology
16.
Europace ; 20(12): 1997-2002, 2018 12 01.
Article in English | MEDLINE | ID: mdl-29868905

ABSTRACT

Aims: Endocardial left ventricular (LV) pacing is a viable alternative in patients with failed coronary sinus (CS) lead implantation. However, long-term thrombo-embolic risk remains unknown. Much of the data have come from a small number of centres. We examined the safety and efficacy of endocardial LV pacing to determine the long-term thrombo-embolic risk. Methods and results: Registries from four UK centres were combined to include 68 patients with endocardial leads with a mean follow-up of 20 months. These were compared to a matched 1:2 control group with conventional CS leads. Medical records were reviewed, and patients contacted for follow-up. Ischaemic stroke occurred in four patients (6%) in the endocardial arm providing an annual event rate (AER) of 3.6% over a 20 month follow-up; compared to 9 patients (6.6%) amongst controls with an AER of 3.4% over a 23-month follow-up. Regression analyses showed a significant association between sub-therapeutic international normalized ratio and stroke (P = 0.0001) in the endocardial arm. There was no association between lead material and mode of delivery (transatrial/transventricular) and stroke. Mortality rate was 12 and 15 per 100 patient years in the endocardial and control arm respectively with end-stage heart failure being the commonest cause. Conclusion: Endocardial LV lead in heart failure patients has a good success rate at 1.6 year follow-up. However, it is associated with a thrombo-embolic risk (which is not different from conventional CS leads) attributable to sub-therapeutic anticoagulation. Randomized control trials and studies on non-vitamin K antagonist oral anticoagulants are required to ascertain the potential of widespread clinical application of this therapeutic modality.


Subject(s)
Brain Ischemia/etiology , Cardiac Pacing, Artificial/adverse effects , Endocardium/physiopathology , Heart Failure/therapy , Heart Ventricles/physiopathology , Stroke/etiology , Thromboembolism/etiology , Ventricular Function, Left , Administration, Oral , Aged , Aged, 80 and over , Anticoagulants/administration & dosage , Blood Coagulation/drug effects , Brain Ischemia/blood , Brain Ischemia/diagnosis , Brain Ischemia/prevention & control , Cardiac Pacing, Artificial/methods , Female , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , International Normalized Ratio , Male , Middle Aged , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/blood , Stroke/diagnosis , Stroke/prevention & control , Thromboembolism/blood , Thromboembolism/diagnosis , Thromboembolism/prevention & control , Time Factors , Treatment Outcome , United Kingdom
17.
J Arrhythm ; 34(1): 87-89, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29721121

ABSTRACT

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.

18.
Europace ; 20(12): 1989-1996, 2018 12 01.
Article in English | MEDLINE | ID: mdl-29688340

ABSTRACT

Aims: The optimal site for biventricular endocardial (BIVENDO) pacing remains undefined. Acute haemodynamic response (AHR) is reproducible marker of left ventricular (LV) contractility, best expressed as the change in the maximum rate of LV pressure (LV-dp/dtmax), from a baseline state. We examined the relationship between factors known to impact LV contractility, whilst delivering BIVENDO pacing at a variety of LV endocardial (LVENDO) locations. Methods and results: We compiled a registry of acute LVENDO pacing studies from five international centres: Johns Hopkins-USA, Bordeaux-France, Eindhoven-The Netherlands, Oxford-United Kingdom, and Guys and St Thomas' NHS Foundation Trust, London-UK. In all, 104 patients incorporating 687 endocardial and 93 epicardial pacing locations were studied. Mean age was 66 ± 11 years, mean left ventricular ejection fraction 24.6 ± 7.7% and mean QRS duration of 163 ± 30 ms. In all, 50% were ischaemic [ischaemic cardiomyopathy (ICM)]. Scarred segments were associated with worse haemodynamics (dp/dtmax; 890 mmHg/s vs. 982 mmHg/s, P < 0.01). Delivering BiVENDO pacing in areas of electrical latency was associated with greater improvements in AHR (P < 0.01). Stimulating late activating tissue (LVLED >50%) achieved greater increases in AHR than non-late activating tissue (LVLED < 50%) (8.6 ± 9.6% vs. 16.1 ± 16.2%, P = 0.002). However, the LVENDO pacing location with the latest Q-LV, was associated with the optimal AHR in just 62% of cases. Conclusions: Identifying viable LVENDO tissue which displays late electrical activation is crucial to identifying the optimal BiVENDO pacing site. Stimulating late activating tissue (LVLED >50%) yields greater improvements in AHR however, the optimal location is frequently not the site of latest activation.


Subject(s)
Action Potentials , Cardiac Resynchronization Therapy/methods , Endocardium/physiopathology , Heart Failure/therapy , Heart Rate , Heart Ventricles/physiopathology , Myocardial Contraction , Ventricular Dysfunction, Left/therapy , Ventricular Function, Left , Aged , Europe , Female , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Male , Middle Aged , Reaction Time , Registries , Time Factors , Treatment Outcome , Ventricular Dysfunction, Left/diagnosis , Ventricular Dysfunction, Left/physiopathology , Ventricular Pressure
19.
Heart Rhythm ; 15(7): 1017-1022, 2018 07.
Article in English | MEDLINE | ID: mdl-29501668

ABSTRACT

BACKGROUND: Cardiac resynchronization therapy (CRT) is an effective treatment for selected patients with heart failure, but it can be limited by the inability to place the left ventricular (LV) lead via the coronary sinus. OBJECTIVE: The purpose of this study was to develop an alternative approach, placing the LV lead endocardially via an interventricular septal puncture, and to assess the feasibility and safety of this technique. METHODS: All patients were anticoagulated with warfarin (international normalized ratio 2.5-3.5). A superior approach ventricular transseptal puncture using radiofrequency energy was performed. An active fixation pacing lead was delivered to the mapped site of latest electrical activation on the endocardial LV. RESULTS: Twenty patients were recruited, 15 with failed transvenous LV lead placement and 5 nonresponders to CRT. Mean (± SD) age was 67 ± 12, with 80% male, QRS duration 157 ± 14 ms, ischemic etiology 45%, New York Heart Association functional class 2.9 ± 0.4, and LV ejection fraction 28% ± 7%. The procedure was successful in all, with no serious complications. Clinical composite score improved at 6 months in 65% and worsened in 35%. LV ejection fraction improved >5% in 88%, from 28% ± 7% to 41% ± 9%. Six-minute walking distance improved >10% in 64%, from 248 ± 125 m to 316 ± 109 m. One patient suffered a lacunar ischemic stroke after 5 months with partial neurological recovery, associated with labile international normalized ratios. After 2.0 ± 1.0 years of follow-up, 3 patients died (2 pneumonia, 1 heart failure), and 2 patients suffered transient ischemic attacks. CONCLUSION: LV endocardial pacing via interventricular septal puncture in patients for whom standard CRT is not possible is similarly effective and durable, with significant but potentially acceptable risks.


Subject(s)
Cardiac Catheterization/methods , Cardiac Resynchronization Therapy/methods , Heart Failure/therapy , Pacemaker, Artificial , Ventricular Function, Left/physiology , Aged , Electrocardiography , Endocardium , Feasibility Studies , Female , Follow-Up Studies , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Male , Patient Selection , Pilot Projects , Treatment Outcome , Ventricular Septum
20.
JACC Clin Electrophysiol ; 3(2): 107-116, 2017 02.
Article in English | MEDLINE | ID: mdl-28280785

ABSTRACT

OBJECTIVES: The objective of this study was to evaluate the cost-effectiveness of quadripolar versus bipolar cardiac resynchronization defibrillator therapy systems. BACKGROUND: Quadripolar left ventricular (LV) leads for cardiac resynchronization therapy reduce phrenic nerve stimulation (PNS) and are associated with reduced mortality compared with bipolar leads. METHODS: A total of 606 patients received implants at 3 UK centers (319 Q, 287 B), between 2009 and 2014; mean follow-up was 879 days. Rehospitalization episodes were costed at National Health Service national tariff rates, and EQ-5D utility values were applied to heart failure admissions, acute coronary syndrome events, and mortality data, which were used to estimate quality-adjusted life-year differences over 5 years. RESULTS: Groups were matched with regard to age and sex. Patients with quadripolar implants had a lower rate of hospitalization than those with bipolar implants (42.6% vs. 55.4%; p = 0.002). This was primarily driven by fewer hospital readmissions for heart failure (51 [16%] vs. 75 [26.1%], respectively, for quadripolar vs. bipolar implants; p = 0.003) and generator replacements (9 [2.8%] vs. 19 [6.6%], respectively; p = 0.03). Hospitalization for suspected acute coronary syndrome, arrhythmia, device explantation, and lead revisions were similar. This lower health-care utilization cost translated into a cumulative 5-year cost saving for patients with quadripolar systems where the acquisition cost was <£932 (US $1,398) compared with bipolar systems. Probabilistic sensitivity analysis results mirrored the deterministic calculations. For the average additional price of £1,200 (US $1,800) over a bipolar system, the incremental cost-effective ratio was £3,692 per quality-adjusted life-year gained (US $5,538), far below the usual willingness-to-pay threshold of £20,000 (US $30,000). CONCLUSIONS: In a UK health-care 5-year time horizon, the additional purchase price of quadripolar cardiac resynchronization defibrillator therapy systems is largely offset by lower subsequent event costs up to 5 years after implantation, which makes this technology highly cost-effective compared with bipolar systems.


Subject(s)
Cardiac Resynchronization Therapy Devices/economics , Defibrillators, Implantable/economics , Acute Coronary Syndrome/economics , Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/therapy , Aged , Arrhythmias, Cardiac/economics , Arrhythmias, Cardiac/mortality , Arrhythmias, Cardiac/therapy , Cardiac Pacing, Artificial/economics , Cardiac Pacing, Artificial/mortality , Cardiac Resynchronization Therapy/economics , Cardiac Resynchronization Therapy/mortality , Cost-Benefit Analysis , Female , Heart Failure/economics , Heart Failure/mortality , Heart Failure/therapy , Hospitalization/economics , Humans , Male , Prosthesis Design , Quality-Adjusted Life Years , Registries , United Kingdom/epidemiology
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