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  • 1
    In: EP Europace, Oxford University Press (OUP), ( 2019-10-30)
    Abstract: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men. Methods and results A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P  〈  0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P  〈  0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401–9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024–1.065; P  〈  0.001), number of generator replacements (OR 1.029, CI 1.005–1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422–15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404–5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069–1.212; P  〈  0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098). Conclusion The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
    detail.hit.zdb_id: 2002579-8
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  • 2
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 148, No. 11 ( 2023-09-12), p. 862-871
    Abstract: Ventricular arrhythmia is an important cause of mortality in patients with ischemic left ventricular dysfunction. Revascularization with coronary artery bypass graft or percutaneous coronary intervention is often recommended for these patients before implantation of a cardiac defibrillator because it is assumed that this may reduce the incidence of fatal and potentially fatal ventricular arrhythmias, although this premise has not been evaluated in a randomized trial to date. METHODS: Patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium were randomly assigned to receive either percutaneous coronary intervention (PCI) plus optimal medical and device therapy (OMT) or OMT alone. The composite primary outcome was all-cause death or aborted sudden death (defined as an appropriate implantable cardioverter defibrillator therapy or a resuscitated cardiac arrest) at a minimum of 24 months, analyzed as time to first event on an intention-to-treat basis. Secondary outcomes included cardiovascular death or aborted sudden death, appropriate implantable cardioverter defibrillator (ICD) therapy or sustained ventricular arrhythmia, and number of appropriate ICD therapies. RESULTS: Between August 28, 2013, and March 19, 2020, 700 patients were enrolled across 40 centers in the United Kingdom. A total of 347 patients were assigned to the PCI+OMT group and 353 to the OMT alone group. The mean age of participants was 69 years; 88% were male; 56% had hypertension; 41% had diabetes; and 53% had a clinical history of myocardial infarction. The median left ventricular ejection fraction was 28%; 53.1% had an implantable defibrillator inserted before randomization or during follow-up. All-cause death or aborted sudden death occurred in 144 patients (41.6%) in the PCI group and 142 patients (40.2%) in the OMT group (hazard ratio, 1.03 [95% CI, 0.82–1.30]; P =0.80). There was no between-group difference in the occurrence of any of the secondary outcomes. CONCLUSIONS: PCI was not associated with a reduction in all-cause mortality or aborted sudden death. In patients with ischemic cardiomyopathy, PCI is not beneficial solely for the purpose of reducing potentially fatal ventricular arrhythmias. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01920048.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 1466401-X
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  • 3
    In: Circulation: Cardiovascular Quality and Outcomes, Ovid Technologies (Wolters Kluwer Health), Vol. 17, No. 1 ( 2024-01)
    Abstract: Percutaneous coronary intervention (PCI) is frequently undertaken in patients with ischemic left ventricular systolic dysfunction. The REVIVED (Revascularization for Ischemic Ventricular Dysfunction)-BCIS2 (British Cardiovascular Society-2) trial concluded that PCI did not reduce the incidence of all-cause death or heart failure hospitalization; however, patients assigned to PCI reported better initial health-related quality of life than those assigned to optimal medical therapy (OMT) alone. The aim of this study was to assess the cost-effectiveness of PCI+OMT compared with OMT alone. METHODS: REVIVED-BCIS2 was a prospective, multicenter UK trial, which randomized patients with severe ischemic left ventricular systolic dysfunction to either PCI+OMT or OMT alone. Health care resource use (including planned and unplanned revascularizations, medication, device implantation, and heart failure hospitalizations) and health outcomes data (EuroQol 5-dimension 5-level questionnaire) on each patient were collected at baseline and up to 8 years post-randomization. Resource use was costed using publicly available national unit costs. Within the trial, mean total costs and quality-adjusted life-years (QALYs) were estimated from the perspective of the UK health system. Cost-effectiveness was evaluated using estimated mean costs and QALYs in both groups. Regression analysis was used to adjust for clinically relevant predictors. RESULTS: Between 2013 and 2020, 700 patients were recruited (mean age: PCI+OMT=70 years, OMT=68 years; male (%): PCI+OMT=87, OMT=88); median follow-up was 3.4 years. Over all follow-ups, patients undergoing PCI yielded similar health benefits at higher costs compared with OMT alone (PCI+OMT: 4.14 QALYs, £22 352; OMT alone: 4.16 QALYs, £15 569; difference: −0.015, £6782). For both groups, most health resource consumption occurred in the first 2 years post-randomization. Probabilistic results showed that the probability of PCI being cost-effective was 0. CONCLUSIONS: A minimal difference in total QALYs was identified between arms, and PCI+OMT was not cost-effective compared with OMT, given its additional cost. A strategy of routine PCI to treat ischemic left ventricular systolic dysfunction does not seem to be a justifiable use of health care resources in the United Kingdom. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01920048.
    Type of Medium: Online Resource
    ISSN: 1941-7713 , 1941-7705
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
    detail.hit.zdb_id: 2453882-6
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  • 4
    In: MethodsX, Elsevier BV, Vol. 6 ( 2019), p. 1343-1352
    Type of Medium: Online Resource
    ISSN: 2215-0161
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 2830212-6
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  • 5
    In: Pacing and Clinical Electrophysiology, Wiley, Vol. 44, No. 9 ( 2021-09), p. 1616-1630
    Abstract: Epicardial ICD systems and CRT‐Ds using high voltage coils represent an alternative to transvenous systems in patients without central venous access and prior device complications including infection. Objective We present a case series in the adult population of epicardial ICD/CRTD systems using high voltage epicardial coils. We summarize the existing data regarding techniques, efficacy, and safety. Methods A retrospective board approved medical record review was conducted for all patients undergoing epicardial ICD/CRTD placement at our institution between January 2010 and May 2020. The literature was reviewed for prior published trials, case reports, and case series of epicardial high voltage coil insertions. Results Eleven patients (six female, mean age 48 years) underwent epicardial ICD/CRTD implant including 5/11 completely epicardial CRTD systems. The procedure was performed via median sternotomy in eight patients, left anterior thoracotomy in two patients, and sub‐xiphoid approach in one patient. After a mean follow up of 35 months, appropriate successful shocks were delivered in two (18%) patients and no patients received an inappropriate shock. Three of five (60%) patients had volumetric remodeling with CRT with significant improvement of LV EF. Device‐related complications requiring a surgical/percutaneous revision or another DFT test occurred in six patients (54%). One patient died during follow up due to refractory heart failure. No cases of epicardial device infection, coronary artery compression, constrictive pericarditis, or erosion of defibrillator coils into intrathoracic organs were reported. No randomized studies comparing safety and efficacy of traditional transvenous or subcutaneous ICD systems and epicardial ICD systems using contemporary high voltage coils were found nor any studies directly comparing epicardial defibrillator patches versus epicardial coils. Thirteen case series and 24 single case reports published between 2004 and 2020 were identified describing in total a heterogenous group of 188 patients with ICD systems incorporating one or more epi‐ or pericardially positioned shock coils. Conclusion The use of epicardial defibrillation coils for ICD/CRT‐D is a feasible treatment option for patients with either failed or contraindicated transvenous ICD systems. Dedicated epicardial high voltage leads with integrated pace‐sense electrodes and specialized delivery tools for minimal invasive implantations may improve longer term outcomes.
    Type of Medium: Online Resource
    ISSN: 0147-8389 , 1540-8159
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2037547-5
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  • 6
    In: European Heart Journal - Case Reports, Oxford University Press (OUP), Vol. 5, No. 11 ( 2021-11-01)
    Abstract: Left bundle branch area pacing (LBBAP) is a novel form of conduction system pacing which can reverse left bundle branch block and deliver cardiac resynchronization therapy (CRT). The WiSE-CRT system delivers leadless endocardial pacing with symptomatic and left ventricular (LV) remodelling improvements following intervention. We report the technical feasibility of delivering leadless LBBAP using the WiSE-CRT system. Case summary In Case 1, a 57-year-old male with ischaemic cardiomyopathy and complete heart block underwent implantation of the WiSE-CRT system, using a retrograde transaortic approach, after failed conventional CRT. Temporary left bundle stimulation from the LV septum achieved superior electrical resynchronization and equivalent haemodynamic response compared to endocardial pacing at the lateral LV wall. In Case 2, an 82-year-old gentleman with tachyarrhythmia-induced cardiomyopathy underwent WiSE-CRT implantation via a trans-septal inter-atrial approach, with the endocardial electrode successfully deployed in the LV septum. Discussion Here we report the first case of deployment of the WiSE-CRT endocardial electrode in the LV septum and demonstrate the technical feasibility of leadless LBBAP. Entirely leadless CRT is an attractive option for patients with venous access issues or recurrent lead complications and has previously been successful using the WiSE-CRT system and a leadless pacemaker in the right ventricle. Further studies are required to assess long-term efficacy and safety of leadless LBBAP.
    Type of Medium: Online Resource
    ISSN: 2514-2119
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2948381-5
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  • 7
    In: European Journal of Cardio-Thoracic Surgery, Oxford University Press (OUP), Vol. 63, No. 1 ( 2022-12-02)
    Abstract: OBJECTIVES Atrial fibrillation (AF) is common and can cause significant morbidity and detriment to quality of life. Success rates for conventional catheter ablation are suboptimal in persistent AF (PsAF), especially when longstanding. Convergent hybrid ablation combines endoscopic surgical epicardial and endocardial catheter ablation. It offers promise in treating PsAF. We aimed to evaluate outcomes at our centre following convergent ablation. METHODS We conducted an observational study of patients undergoing ablation from 2012 to 2019 at a London cardiac centre. Sixty-seven patients underwent convergent ablation entailing epicardial ablation, mostly via sub-xiphoid access, followed by endocardial left atrial catheter ablation. Baseline and follow-up data were obtained retrospectively from clinical records. Primary outcome was freedom from AF on/off anti-arrhythmic drugs after 12-month follow-up. Secondary outcomes included freedom from AF over the entire follow-up, freedom from anti-arrhythmic drugs, freedom from atrial arrhythmias, symptom status, repeat ablation and complications. RESULTS At baseline, 80.6% had PsAF & gt;1 year (80.6%), 49.3% had body mass index & gt;30 kg/m2 at baseline and 19.4% had left ventricular ejection fraction of 40% or less. The median follow-up was 2.3 (1.4–3.7) years. Freedom from AF recurrence was 81.3% at 1 year and 61.5% over overall follow-up. Eleven patients (16.4%) required redo AF ablation. Prolonged AF duration was associated with increased recurrence at 12 months and duration & gt;5 years with a shorter time to recurrence on Kaplan–Meier analysis, but this and other factors did not significantly impact the AF recurrence during the overall follow-up period. CONCLUSIONS Convergent ablation had good 1-year and overall success rates for treating PsAF. Our results in a diverse, real-world population support the potential of convergent ablation in patients with challenging to treat PsAF.
    Type of Medium: Online Resource
    ISSN: 1873-734X
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 1500330-9
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  • 8
    In: Pacing and Clinical Electrophysiology, Wiley, Vol. 42, No. 10 ( 2019-10), p. 1355-1364
    Abstract: Transvenous lead extraction (TLE) may be performed by superior approach using the original implant vein or via a femoral approach; however, limited comparative data exists. We compare outcomes between femoral versus nonfemoral TLE approaches and determine predictors of bailout transfemoral lead extraction in patients undergoing initial TLE via the original implant vein by a superior approach. Methods All consecutive TLEs between October 2000 and March 2018 were prospectively collected ( n  = 1052). Patients were dichotomized into femoral ( n  = 118) and nonfemoral ( n  = 934) groups. Results Demographics were balanced between femoral vs nonfemoral groups. Patients in the femoral group had significantly higher mean lead dwell times (11.6 ± 9.7 vs 6.6 ± 6.6 years, P  〈  .001), mean number of leads extracted (2.7 ± 1.3 vs 2.0 ± 1.0, P  〈  .001), 30‐day procedure related major complications (including deaths) (8.5% vs 1.1%, P  〈  .001) and emergency thoracotomy rates (4.2% vs 0.7%, P  = .007). All‐cause 30‐day mortality rates were similar between groups (3.4% vs 2.0%, P  = .315). Prolonged lead dwell time and increased number of leads extracted were predictive of a bailout transfemoral approach at multivariable analysis. Conclusion Femoral approach TLE is associated with increased risk of 30‐day procedure related major complications but not 30‐day all‐cause mortality. Prolonged lead dwell time and increased number of leads extracted are independent predictors for bailout transfemoral lead extraction. Such patients should be considered high risk of major complications and performed by high‐volume lead extraction centers with experience in multiple approaches and techniques including experience with transfemoral lead extraction.
    Type of Medium: Online Resource
    ISSN: 0147-8389 , 1540-8159
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2037547-5
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  • 9
    In: Heart Rhythm, Elsevier BV, Vol. 18, No. 9 ( 2021-09), p. 1566-1576
    Type of Medium: Online Resource
    ISSN: 1547-5271
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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  • 10
    In: Heart Rhythm, Elsevier BV, Vol. 18, No. 8 ( 2021-08), p. S413-
    Type of Medium: Online Resource
    ISSN: 1547-5271
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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