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1. Shared Decision-making in Breast Cancer Reconstructive Surgery: Experience in a Leading Hospital

Author

María Herrera de la Muela, MD, PhD, Santiago Sanz Medrano, MD, Francisco Leyva, MD, PhD, Inmaculada Masa Jurado, MD, PhD, Ana I. Membrilla Ortiz, NP, Juana Brenes Sánchez, MD, PhD, Miriam de la Puente Yagüe, MD, PhD, Jorge Ruiz Rodríguez, MD, PhD, and Javier Buendía Pérez, MD

Subjects
Surgery, RD1-811
Abstract

Background:. The paradigm of healthcare has evolved toward patient-centered approaches, where shared decision-making (SDM) plays a pivotal role. This study aimed to explore the implementation of SDM during breast cancer reconstruction consultations and assess its impact on patient satisfaction and the decision-making process as a whole. Methods:. A total of 102 female patients undergoing breast reconstruction were included in a multidisciplinary breast pathology unit. A streamlined SDM model involving choice introduction, option description, and preference exploration was implemented. A validated Spanish version of the nine-item Shared Decision Making Questionnaire was used alongside a complementary questionnaire. Data analysis was carried out using electronic data capture software. Results:. The nine-item Shared Decision Making Questionnaire results indicate strong agreement in presenting various options and explaining their advantages and disadvantages. Patients were less confident about their participation in decision-making. The Complementary Shared Decision Making Questionnaire highlighted high satisfaction with interview times and language clarity but areas for improvement in consultation space and therapeutic choice participation. Conclusions:. Integrating SDM into breast reconstruction consultations empowers patients in the decision-making process and enhances satisfaction. Decision aids prove effective in this context, facilitating patients’ comprehension and reducing decisional conflict. There are areas for improvement within the SDM strategy, and they are detectable through scales. Although challenges in information transmission and patient involvement persist, adopting an SDM model has potential benefits that warrant further investigation.

Published
2024
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2. Arrhythmic Risk Stratification in Non-ischemic Cardiomyopathy Based on Cardiovascular Magnetic Resonance Measures of Myocardial Fibrosis and Gray Zone Fibrosis

Author

Daniel Hammersley, MD, Abbasin Zegard, MD, Emmanuel Androulakis, MD, Richard Jones, MD, PhD, Osita Okafor, MD, Suzan Hatipoglu, MD, Lukas Mach, MD, Amrit Lota, MD, PhD, Zohya Khalique, MD, PhD, Antonio De Marvao, MD, PhD, Resham Baruah, MD, PhD, Kaushik Guha, James Ware, PhD, Upasana Tayal, MD, PhD, Dudley Pennell, MD, FSCMR, Brian Halliday, MD, PhD, BSc, Tian Qiu, Sanjay Prasad, MD, PhD, and Francisco Leyva, MD, PhD

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Published
2024
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3. Diagnostic yield of a heart failure referral pathway using N-terminal pro-brain natriuretic peptide

Author

Tamara Naneishvili, Francisco Leyva, Alex Zaphiriou, Peysh A Patel, Tian Qiu, Berthold Stegemann, Abbasin Zegard, Ravi Viyapurapu, Purushottam Desai, and Sam White

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Objective To determine the diagnostic yield of a ‘high’ N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients with suspected heart failure (HF) referred from primary to secondary care.Methods In this retrospective study, cardiac diagnoses were quantified in consecutive patients with an NT-proBNP>400 ng/L referred from primary care centres to a specialist HF service.Results Among 654 consecutive patients (age: 78.5±9.72 years; 45.9% men; left ventricular ejection fraction (LVEF): 55.4±12.5% (mean±SD)), the primary diagnoses were: valvular disease (39.4%), HF (29.2%; 13.3% with LVEF400 ng/L referred through a primary care HF pathway, most patients had valve disease or AF rather than HF. NT-proBNP cannot discriminate among HF, valve disease and AF. On this basis, NT-proBNP may be best employed in detecting cardiac disease in general rather than HF per se.

Published
2023
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4. Cardiac device implantation and device usage in Fabry and hypertrophic cardiomyopathy

Author

Ravi Vijapurapu, William Bradlow, Francisco Leyva, James C. Moon, Abbasin Zegard, Nigel Lewis, D. Kotecha, Ana Jovanovic, Derralynn A. Hughes, Peter Woolfson, Richard P. Steeds, and Tarekegn Geberhiwot

Subjects
Fabry, Hypertrophic cardiomyopathy, Arrhythmia, Defibrillator, Prognosis, Risk, Medicine
Abstract

Abstract Background Fabry disease (FD) is a treatable X-linked condition leading to progressive cardiac disease, arrhythmia and premature death. We aimed to increase awareness of the arrhythmogenicity of Fabry cardiomyopathy, by comparing device usage in patients with Fabry cardiomyopathy and sarcomeric HCM. All Fabry patients with an implantable cardioverter defibrillator (ICD) implanted in the UK over a 17 year period were included. A comparator group of HCM patients, with primary prevention ICD implantation, were captured from a regional registry database. Results Indications for ICD in FD varied with 72% implanted for primary prevention based on multiple potential risk factors. In FD and HCM primary prevention devices, arrhythmia occurred more frequently in FD over shorter follow-up (HR 4.2, p

Published
2022
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5. A multicenter prospective randomized controlled trial of cardiac resynchronization therapy guided by invasive dP/dt

Author

Manav Sohal, MBBS, Shoaib Hamid, MD, Giovanni Perego, MD, Paolo Della Bella, MD, Shaumik Adhya, MD, John Paisey, MD, Tim Betts, MD, Ravi Kamdar, MD, Pier Lambiase, MD, Francisco Leyva, MD, Janet M. McComb, MD, Jonathan Behar, MD, Thomas Jackson, MD, Simon Claridge, MD, Vishal Mehta, MD, Mark Elliott, MD, Steven Niederer, PhD, Reza Razavi, MD, and C. Aldo Rinaldi, MD, FHRS

Subjects
Acute hemodynamic response, Cardiac resynchronization therapy, Heart failure, LV reverse remodeling, Targeted lead placement, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: No periprocedural metric has demonstrated improved cardiac resynchronization therapy (CRT) outcomes in a multicenter setting. Objective: We sought to determine if left ventricular (LV) lead placement targeted to the coronary sinus (CS) branch generating the best acute hemodynamic response (AHR) results in improved outcomes at 6 months. Methods: In this multicenter randomized controlled trial, patients were randomized to guided CRT or conventional CRT. Patients in the guided arm had LV dP/dtmax measured during biventricular (BIV) pacing. Target CS branches were identified and the final LV lead position was the branch with the best AHR and acceptable threshold values. The primary endpoint was the proportion of patients with a reduction in LV end-systolic volume (LVESV) of ≥15% at 6 months. Results: A total of 281 patients were recruited across 12 centers. Mean age was 70.8 ± 10.9 years and 54% had ischemic etiology. Seventy-three percent of patients in the guided arm demonstrated a reduction in LVESV of ≥15% at 6 months vs 60% in the conventional arm (P = .02). Patients with AHR ≥ 10% were more likely to demonstrate a reduction of ESV ≥ 15% (84% of patients with an AHR ≥10% vs 28% with an AHR

Published
2021
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6. Acute Hemodynamic Effects of Simultaneous and Sequential Multi-Point Pacing in Heart Failure Patients With an Expected Higher Rate of Sub-response to Cardiac Resynchronization Therapy: Results of Multicenter SYNSEQ Study

Author

Maciej Sterliński, Joanna Zakrzewska-Koperska, Aleksander Maciąg, Adam Sokal, Joaquin Osca-Asensi, Lingwei Wang, Vasiliki Spyropoulou, Baerbel Maus, Francesca Lemme, Osita Okafor, Berthold Stegemann, Richard Cornelussen, and Francisco Leyva

Subjects
heart failure, biventricular pacing, quadripolar lead for left ventricle pacing, multipoint pacing, acute hemodynamic effect, cardiac resynchronization therapy, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

The aim of the SYNSEQ (Left Ventricular Synchronous vs. Sequential MultiSpot Pacing for CRT) study was to evaluate the acute hemodynamic response (AHR) of simultaneous (3P-MPP syn) or sequential (3P-MPP seq) multi-3-point-left-ventricular (LV) pacing vs. single point pacing (SPP) in a group of patients at risk of a suboptimal response to cardiac resynchronization therapy (CRT). Twenty five patients with myocardial scar or QRS ≤ 150 or the absence of LBBB (age: 66 ± 12 years, QRS: 159 ± 12 ms, NYHA class II/III, LVEF ≤ 35%) underwent acute hemodynamic assessment by LV + dP/dtmax with a variety of LV pacing configurations at an optimized AV delay. The change in LV + dP/dt max (%ΔLV + dP/dt max) with 3P-MPP syn (15.6%, 95% CI: 8.8%-22.5%) was neither statistically significantly different to 3P-MPP seq (11.8%, 95% CI: 7.6-16.0%) nor to SPP basal (11.5%, 95% CI:7.1-15.9%) or SPP mid (12.2%, 95% CI:7.9-16.5%), but higher than SPP apical (10.6%, 95% CI:5.3-15.9%, p = 0.03). AHR (defined as a %ΔLV + dP/dt max ≥ 10%) varied between pacing configurations: 36% (9/25) for SPP apical, 44% (11/25) for SPP basal, 54% (13/24) for SPP mid, 56% (14/25) for 3P-MPP syn and 48% (11/23) for 3P-MPP seq.Fifteen patients (15/25, 60%) had an AHR in at least one pacing configuration. AHR was observed in 10/13 (77%) patients with a LBBB but only in 5/12 (42%) patients with a non-LBBB (p = 0.11). To conclude, simultaneous or sequential multipoint pacing compared to single point pacing did not improve the acute hemodynamic effect in a suboptimal CRT response population.Clinical Trial RegistrationClinicalTrials.gov, identifier: NCT02914457.

Published
2022
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7. A randomised controlled trial evaluating arrhythmia burden, risk of sudden cardiac death and stroke in patients with Fabry disease: the role of implantable loop recorders (RaILRoAD) compared with current standard practice

Author

Ravi Vijapurapu, Rebecca Kozor, Derralynn A. Hughes, Peter Woolfson, Ana Jovanovic, Patrick Deegan, Rosemary Rusk, Gemma A. Figtree, Michel Tchan, David Whalley, Dipak Kotecha, Francisco Leyva, James Moon, Tarekegn Geberhiwot, and Richard P. Steeds

Subjects
Fabry, Arrhythmia, ILR, Cardiomyopathy, Medicine (General), R5-920
Abstract

Abstract Background Fabry disease (FD) is a genetic disorder caused by a deficiency in the enzyme alpha-galactosidase A, leading to an accumulation of glycosphingolipids in tissues across the body. Cardiac disease is the leading cause of morbidity and mortality. Advanced disease, characterised by extensive left ventricular hypertrophy, ventricular dysfunction and fibrosis, is known to be associated with an increase in arrhythmia. Data identifying risk factors for arrhythmia are limited, and no Fabry-specific risk stratification tool is available to select those who may benefit from initiation of medical or device therapy (implantable cardiac defibrillators). Current monitoring strategies have a limited diagnostic yield, and implantable loop recorders (ILRs) have the potential to change treatment and clinical outcomes. Aim The aim of this study is to determine whether ILRs can (1) improve arrhythmia detection in FD and (2) identify risk predictors of arrhythmia. Methods A prospective, 5-year, open-label, international, multi-centre randomised controlled trial of a minimum of 164 participants with genetically or enzymatically confirmed FD (or both) who have evidence of cardiac disease will be recruited from five centres: Queen Elizabeth Hospital, Birmingham, UK; Salford Royal Hospital, Salford, UK; Royal Free Hospital, London, UK; Addenbrookes Hospital, Cambridge, UK; and Westmead Hospital, Sydney, Australia. Participants will be block-randomised (1:1) to two study arms for cardiac monitoring (i) control arm: standard of care with annual 24 h or 5-day Holter monitor or (ii) treatment arm: continuous cardiac monitoring with ILR implantation plus standard of care. Participants will undergo multiple investigations—blood/urine biomarkers, 12-lead and advanced electrocardiogram (ECG) recording, echocardiography and cardiovascular magnetic resonance (CMR) imaging—at baseline and 6–12 monthly follow-up visits. The primary endpoint is identification of arrhythmia requiring initiation or alteration in therapy. Secondary outcome measures include characterising the risk factors associated with arrhythmia and outcome data in the form of imaging, ECG and blood biomarkers. Discussion This is the first study evaluating arrhythmia burden and the use of ILR across the spectrum of risk profiles in Fabry cardiomyopathy. This will enable detailed characterisation of arrhythmic risk predictors in FD and ultimately support formulation of Fabry-specific guidance in this high-risk population. Trial registration ClinicalTrials.gov (NCT03305250). Registered on 9 October 2017.

Published
2019
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8. Assessment of myocardial viability using a minimally invasive laser Doppler flowmetry on pig model

Author

Karina Litvinova, Berthold Stegemann, and Francisco Leyva

Subjects
beating heart, rf ablation, perfusion real-time monitoring, myocardial microcirculation, Technology, Optics. Light, QC350-467
Abstract

The intra-operative real-time assessment of tissue viability can potentially improve therapy delivery and clinical outcome in cardiovascular therapies. Cardiac ablation therapy for the treatment of supraventricular or ventricular arrhythmia continues to be done without being able to assess if the intended lesion and lesion size have been achieved. Here, we report a method for continuous measurements of cardiac muscle microcirculation to provide an instrument for real-time ablation monitoring. We performed two acute open chest animal studies to assess the ability to perform real-time monitoring of creation and size of ablation lesion using a standard RF irrigated catheter. Radiofrequency ablation and laser Doppler were applied to different endocardial areas of alive open-chest pig. We performed two experiments at three different RF ablation energy setting and different ablation times. Perfusion signals before and after ablation were found extensively and distinctively different. By increasing the ablation energy and time, the perfusion signal was decreasing. In vivo assessing the local microcirculation during RF ablation by laser Doppler can potentially be useful to differentiate between viable and nonviable ablated beating heart in real time.

Published
2021
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9. Sex‐Specific Differences in Survival and Heart Failure Hospitalization After Cardiac Resynchronization Therapy With or Without Defibrillation

Author

Francisco Leyva, Tian Qiu, Abbasin Zegard, David McNulty, Felicity Evison, Daniel Ray, and Maurizio Gasparini

Subjects
cardiac resynchronization therapy, female sex, implantable cardioverter defibrillator, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Women are underrepresented in cardiac resynchronization therapy (CRT) trials. Some studies suggest that women fare better than men after CRT. We sought to explore clinical outcomes in women and men undergoing CRT‐defibrillation or CRT‐pacing in real‐world clinical practice. Methods and Results A national database (Hospital Episode Statistics for England) was used to quantify clinical outcomes in 43 730 patients (women: 10 890 [24.9%]; men: 32 840 [75.1%]) undergoing CRT over 7.6 years, (median follow‐up 2.2 years, interquartile range, 1–4 years). In analysis of the total population, the primary end point of total mortality (adjusted hazard ratio [aHR], 0.73; 95% CI, 0.69–0.76) and the secondary end point of total mortality or heart failure hospitalization (aHR, 0.79, 95% CI 0.75–0.82) were lower in women, independent of known confounders. Total mortality (aHR, 0.73; 95% CI, 0.70–0.76) and total mortality or heart failure hospitalization (aHR, 0.79; 95% CI, 0.75–0.82) were lower for CRT‐defibrillation than for CRT‐pacing. In analyses of patients with (aHR, 0.89; 95% CI, 0.80–0.98) or without (aHR, 0.70; 95% CI, 0.66–0.73) a myocardial infarction, women had a lower total mortality. In sex‐specific analyses, total mortality was lower after CRT‐defibrillation in women (aHR, 0.83; P=0.013) and men (aHR, 0.69; P

Published
2019
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10. Changes in QRS Area and QRS Duration After Cardiac Resynchronization Therapy Predict Cardiac Mortality, Heart Failure Hospitalizations, and Ventricular Arrhythmias

Author

Osita Okafor, Abbasin Zegard, Peter van Dam, Berthold Stegemann, Tian Qiu, Howard Marshall, and Francisco Leyva

Subjects
cardiac resynchronization therapy, left bundle branch block, QRS area, QRS duration, vectorcardiography, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Predicting clinical outcomes after cardiac resynchronization therapy (CRT) and its optimization remain a challenge. We sought to determine whether pre‐ and postimplantation QRS area (QRSarea) predict clinical outcomes after CRT. Methods and Results In this retrospective study, QRSarea, derived from pre‐ and postimplantation vectorcardiography, were assessed in relation to the primary end point of cardiac mortality after CRT with or without defibrillation. Other end points included total mortality, total mortality or heart failure (HF) hospitalization, total mortality or major adverse cardiac events, and the arrhythmic end point of sudden cardiac death or ventricular arrhythmias with or without a shock. In patients (n=380, age 72.0±12.4 years, 68.7% male) undergoing CRT over 7.7 years (median follow‐up: 3.8 years [interquartile range 2.3–5.3]), preimplantation QRSarea ≥102 μVs predicted cardiac mortality (HR: 0.36; P

Published
2019
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11. Long‐Term Outcomes of Cardiac Resynchronization Therapy Using Apical Versus Nonapical Left Ventricular Pacing

Author

Francisco Leyva, Abbasin Zegard, Robin J. Taylor, Paul W. X. Foley, Fraz Umar, Kiran Patel, Jonathan Panting, Peter van Dam, Frits W. Prinzen, Howard Marshall, and Tian Qiu

Subjects
cardiac resynchronization therapy, lead position, mortality, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background Experimental evidence indicates that left ventricular (LV) apical pacing is hemodynamically superior to nonapical LV pacing. Some studies have shown that an LV apical lead position is unfavorable in cardiac resynchronization therapy. We sought to determine whether an apical LV lead position influences cardiac mortality after cardiac resynchronization therapy. Methods and Results In this retrospective observational study, the primary end point of cardiac mortality was assessed in relation to longitudinal (basal, midventricular, or apical) and circumferential (anterior, lateral, or posterior) LV lead positions, as well as right ventricular (apical or septal), assigned using fluoroscopy. Lead positions were assessed in 1189 patients undergoing cardiac resynchronization therapy implantation over 15 years. After a median follow‐up of 6.0 years (interquartile range: 4.4–7.7 years), an apical LV lead position was associated with lower cardiac mortality than a nonapical position (adjusted hazard ratio: 0.74; 95% confidence interval, 0.56–0.99) after covariate adjustment. There were no differences in total mortality or heart failure hospitalization. Death from pump failure was lower with apical than nonapical positions (adjusted hazard ratio: 0.69; 95% confidence interval, 0.51–0.94). Compared with a basal position, an apical LV position was also associated with lower risk of sudden cardiac death (adjusted hazard ratio: 0.34; 95% confidence interval, 0.13–0.93). No differences emerged between circumferential LV lead positions or right ventricular positions with respect to any end point. Conclusions In recipients of cardiac resynchronization therapy, an apical LV lead position was associated with better long‐term cardiac survival than a nonapical position. This effect was due to a lower risk of pump failure and sudden cardiac death.

Published
2018
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12. Cardiac Resynchronization Therapy Using Quadripolar Versus Non‐Quadripolar Left Ventricular Leads Programmed to Biventricular Pacing With Single‐Site Left Ventricular Pacing: Impact on Survival and Heart Failure Hospitalization

Author

Francisco Leyva, Abbasin Zegard, Tian Qiu, Edmund Acquaye, Gaetano Ferrante, Jamie Walton, and Howard Marshall

Subjects
arrhythmia, bipolar lead, cardiac resynchronization therapy, heart failure, quadripolar lead, sudden cardiac death, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

BackgroundIn cardiac resynchronization therapy (CRT), quadripolar (QUAD) left ventricular (LV) leads are less prone to postoperative complications than non‐QUAD leads. Some studies have suggested better clinical outcomes. Methods and ResultsClinical events were assessed in 847 patients after CRT‐pacing or CRT‐defibrillation using either QUAD (n=287) or non‐QUAD (n=560), programmed to single‐site site LV pacing. Over a follow‐up period of 3.2 years (median [interquartile range, 1.90–5.0]), QUAD was associated with a lower total mortality (adjusted hazard ratio [aHR]: 0.32, 95% confidence interval [CI], 0.20–0.52), cardiac mortality (aHR: 0.36, 95% CI, 0.20–0.65), and heart failure (HF) hospitalization (aHR: 0.62, 95% CI, 0.39–0.99), after adjustment for age, sex, New York Heart Association class, HF etiology, device type (CRT‐pacing or CRT‐defibrillation), comorbidities, atrial rhythm, medication, left ventricular ejection fraction, and creatinine. Death from pump failure was lower with QUAD (aHR: 0.33; 95% CI, 0.18–0.62), but no group differences emerged with respect to sudden cardiac death. There were no differences in implant‐related complications. Re‐interventions for LV displacement or phrenic nerve stimulation, which were lower with QUAD, predicted total mortality (aHR: 1.68, 95% CI, 1.11–2.54), cardiac mortality (aHR: 2.61, 95% CI, 1.66–4.11) and HF hospitalization (aHR: 2.09, 95% CI, 1.22–3.58). ConclusionsCRT using QUAD, programmed to biventricular pacing with single‐site LV pacing, is associated with a lower total mortality, cardiac mortality, and HF hospitalization. These trends were observed for both CRT‐defibrillation and CRT‐pacing, after adjustment for HF cause and other confounders. Re‐intervention for LV lead displacement or phrenic nerve stimulation was associated with worse outcomes.

Published
2017
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13. Is Cardiac Resynchronisation Therapy Proarrhythmic?

Author

Francisco Leyva and Paul WX Foley

Subjects
cardiac resynchronisation therapy, arrhythmias, mortality, heart failure, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

It is well established that cardiac resynchronisation therapy (CRT) using biventricular pacing prolongs survival by its effects on pump failure. The rate of sudden cardiac death in patients undergoing CRT, however, remains high. Animal and human studies have shown that reversal of normal sequence of myocardial activation during epicardial pacing, as applied during CRT, increases the transmural dispersion of repolarisation (TDR), a substrate for ventricular arrhythmias. Cohort studies in humans suggest that CRT has a differential effect on the arrhythmogenic substrate, antiarrhythmic in some and proarrhythmic in others. This review the focuses on the possibility that CRT may, under certain circumstances, promote arrhythmogenesis.

Published
2008

14. Auditoría médica concurrente de certificados de incapacidad temporal para el trabajo

Author

Fernando Llanos Zavalaga, Francisco Leyva Hurtado, Juan J. Miranda Montero, Julio Mayca Pérez, and Carlos Zeballos Palacios

Subjects
Auditoría, auditoría médica, atención del paciente, Medicine
Abstract

La auditoría médica, busca identificar las irregularidades y disfunciones médicas y administrativa con miras a proponer alternativas que permitan mejorar la calidad. Objetivo: Identificar y analizar las causas de la emisión de los Certificados de Incapacidad Temporal para el Trabajo (CITT). Material y Métodos: El estudio se realizó en 17 centros asistenciales de EsSalud de Lima y Callao, en 1996. Se auditaron 41,918 CITT, excluyendo aquellos emitidos para descanso pre y post natal, y por los servicios médicos PAAD (Programa de Atención Ambulatoria y Domiciliaria). Se establecieron 8 criterios para determinar la adecuada emisión de los mismos. Resultados: Del total de CITT auditados 52.93% presentaron observaciones. La mayor parte de las observaciones fueron de tipo administrativo, las relacionadas a la práctica médica fueron escasas. Las observaciones más frecuentes fueron: "No estar registrado en la historia clínica" (45.46% de CITT observados), "No estar la consulta registrada en la historia clínica" (16.61%) y "No coincidir la fecha registrada en la historia clínica con la fecha del CITT" (10.82%). Conclusiones: Muchos de los errores encontrados que justificaron la observación técnica de los CITT estaban relacionados con problemas administrativos, producto generalmente del llenado inadecuado de los documentos (historias clínicas y CITT). Se recomienda la implementación de un sistema autosostenible de auditoría concurrente, y diseños de programas de educación y capacitación en este tema. (Rev Med Hered 2002; 13: 26-31).

Published
2002

15. Cateterismo venoso central y perforación de miocardio: presentación de un caso

Author

Antonio Ormea Villavicencio and Francisco Leyva Hurtado

Subjects
Intensive care, catheter, cardiac tamponade, pericardial effusion, Medicine
Abstract

The use of central venous catheters has a wide use in our hospitals, but it is not exempt from complications. We report a 18 years old woman who had one of this life involved complication. The patient died and necropsy she was diagnosed as follow: perforation of miocardium and pericardial tamponade. The possible mechanism of perforation it was a gradual form which has several causes. It is very important to understand the different forms of perforation and also to evaluate frequently every central venous catheter to prevent all these fatal ocurrences. ( Rev Med Hered 1998; 9:119-122 ).

Published
1998

16. Mannose-Binding Lectin Promoter Polymorphisms and Gene Variants in Pulmonary Tuberculosis Patients from Cantabria (Northern Spain)

Author

J.-Gonzalo Ocejo-Vinyals, Lucía Lavín-Alconero, Pablo Sánchez-Velasco, M.-Ángeles Guerrero-Alonso, Fernando Ausín, M.-Carmen Fariñas, and Francisco Leyva-Cobián

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Mannose-binding lectin is a central molecule of the innate immune system. Mannose-binding lectin 2 promoter polymorphisms and structural variants have been associated with susceptibility to tuberculosis. However, contradictory results among different populations have been reported, resulting in no convincing evidence of association between mannose-binding lectin 2 and susceptibility to tuberculosis. For this reason, we conducted a study in a well genetically conserved Spanish population in order to shed light on this controversial association. We analysed the six promoter and structural mannose-binding lectin 2 gene variants in 107 patients with pulmonary tuberculosis and 441 healthy controls. Only D variant and HYPD haplotype were significantly more frequents in controls which would indicate that this allele could confer protection against pulmonary tuberculosis, but this difference disappeared after statistical correction. Neither the rest of alleles nor the haplotypes were significantly associated with the disease. These results would indicate that mannose-binding lectin promoter polymorphisms and gene variants would not be associated with an increased risk to pulmonary tuberculosis. Despite the slight trend of the D allele and HYPD haplotype in conferring protection against pulmonary tuberculosis, susceptibility to this disease would probably be due to other genetic factors, at least in our population.

Published
2012
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18. Comprehensive Phenotypic Characterization of Late Gadolinium Enhancement Predicts Sudden Cardiac Death in Coronary Artery Disease

Author

Richard E. Jones, Hassan A. Zaidi, Daniel J. Hammersley, Suzan Hatipoglu, Ruth Owen, Gabriel Balaban, Antonio de Marvao, François Simard, Amrit S. Lota, Ciara Mahon, Batool Almogheer, Lukas Mach, Francesca Musella, Xiuyu Chen, John Gregson, Laura Lazzari, Andrew Ravendren, Francisco Leyva, Shihua Zhao, Ali Vazir, Pablo Lamata, Brian P. Halliday, Dudley J. Pennell, Martin J. Bishop, and Sanjay K. Prasad

Subjects
Radiology, Nuclear Medicine and imaging, Cardiology and Cardiovascular Medicine
Abstract

Background Late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR) offers the potential to noninvasively characterize the phenotypic substrate for sudden cardiac death (SCD). Objectives The authors assessed the utility of infarct characterization by CMR, including scar microstructure analysis, to predict SCD in patients with coronary artery disease (CAD). Methods Patients with stable CAD were prospectively recruited into a CMR registry. LGE quantification of core infarction and the peri-infarct zone (PIZ) was performed alongside computational image analysis to extract morphologic and texture scar microstructure features. The primary outcome was SCD or aborted SCD. Results Of 437 patients (mean age: 64 years; mean left ventricular ejection fraction [LVEF]: 47%) followed for a median of 6.3 years, 49 patients (11.2%) experienced the primary outcome. On multivariable analysis, PIZ mass and core infarct mass were independently associated with the primary outcome (per gram: HR: 1.07 [95% CI: 1.02-1.12]; P = 0.002 and HR: 1.03 [95% CI: 1.01-1.05]; P = 0.01, respectively), and the addition of both parameters improved discrimination of the model (Harrell’s C-statistic: 0.64-0.79). PIZ mass, however, did not provide incremental prognostic value over core infarct mass based on Harrell’s C-statistic or risk reclassification analysis. Severely reduced LVEF did not predict the primary endpoint after adjustment for scar mass. On scar microstructure analysis, the number of LGE islands in addition to scar transmurality, radiality, interface area, and entropy were all associated with the primary outcome after adjustment for severely reduced LVEF and New York Heart Association functional class of >1. No scar microstructure feature remained associated with the primary endpoint when PIZ mass and core infarct mass were added to the regression models. Conclusions Comprehensive LGE characterization independently predicted SCD risk beyond conventional predictors used in implantable cardioverter-defibrillator (ICD) insertion guidelines. These results signify the potential for a more personalized approach to determining ICD candidacy in CAD.

Published
2023
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19. Declining Risk of Sudden Cardiac Death in Heart Failure: Fact or Myth?

Author

Francisco Leyva, Carsten W. Israel, and Jagmeet Singh

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Abstract

The notion that the risk of sudden cardiac death (SCD) in patients with heart failure (HF) is declining seems to be gaining traction. Numerous editorials and commentaries have suggested that SCD, specifically arrhythmic SCD, is no longer a significant risk for patients with HF on guideline-directed medical therapy. In this review, we question whether the risk of SCD has indeed declined in HF trials and in the real world. We also explore whether, despite relative risk reductions, the residual SCD risk after guideline-directed medical therapy still suggests a need for implantable cardioverter defibrillator therapy. Among our arguments is that SCD has not decreased in HF trials, nor in the real world. Moreover, we argue that data from HF trials, which have not adhered to guideline-directed device therapy, do not obviate or justify delays to implantable cardioverter defibrillator therapy. In this context, we underline the challenges of translating the findings of HF randomized, controlled trials of guideline-directed medical therapy to the real world. We also make the case for HF trials that adhere to current guideline-directed device therapy so that we can better understand the role of implantable cardioverter defibrillators in chronic HF.

Published
2023
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20. Effects of haemodynamically atrio‐ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure ( <scp>HOPE‐HF</scp> ) randomized, double‐blind, cross‐over trial

Author

Zachary I. Whinnett, Matthew J. Shun‐Shin, Mark Tanner, Paul Foley, Badri Chandrasekaran, Philip Moore, Shaumik Adhya, Norman Qureshi, Amal Muthumala, Rebecca Lane, Aldo Rinaldi, Sharad Agarwal, Francisco Leyva, Jonathan Behar, Sukh Bassi, Andre Ng, Paul Scott, Rachana Prasad, Jon Swinburn, Joseph Tomson, Amarjit Sethi, Jaymin Shah, Phang Boon Lim, Andreas Kyriacou, Dewi Thomas, Jenny Chuen, Ravi Kamdar, Prapa Kanagaratnam, Myril Mariveles, Leah Burden, Katherine March, James P. Howard, Ahran Arnold, Pugazhendhi Vijayaraman, Berthold Stegemann, Nicholas Johnson, Emanuela Falaschetti, Darrel P. Francis, John G.F. Cleland, and Daniel Keene

Subjects
Cardiology and Cardiovascular Medicine
Published
2023
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25. Device implantation complicated by a retrosternal goiter.

Author

Elshafie, Sally, Tariq, Abu Taher, and Leon, Francisco Leyva

Subjects
GOITER diagnosis, ENDOCRINOLOGY, GOITER, COMPLICATIONS of prosthesis, BLOOD vessels, COMPUTED tomography, CHEST X rays, NURSING, ELECTROCARDIOGRAPHY, VENOGRAPHY, IMPLANTABLE cardioverter-defibrillators, CARDIAC pacing, HEART block, LEFT ventricular dysfunction
Abstract

Central venous obstruction in the cardiac implantable electronic devices (CIED) population is commonly due to thrombosis and fibrosis secondary to the passage of pre‐existing leads. However, vein occlusion before CIED implantation is uncommon, and one cause is retrosternal goiters. We report a case where the failure of the initial implantation of a primary CIED led to an unusual implantation route without goiter excision. The patient had an indication for cardiac resynchronization therapy (CRT) given his left ventricular (LV) function was impaired and had second‐degree heart block Mobitz Type II; however, he had occluded bilateral subclavian veins due to a sizeable retrosternal goiter. This obstruction led to the implantation of a single lead pacemaker via the right femoral vein after multiple failed attempts at CRT, dual chamber pacemaker and left bundle branch area pacing (LBBaP). [ABSTRACT FROM AUTHOR]

Published
2024
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27. The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure

Author

Leor Perl, David Meerkin, Domenico D'amario, Binyamin Ben Avraham, Tuvia Ben Gal, Tatyana Weitsman, Tal Hasin, Hüseyin Ince, Sebastian Feickert, Giuseppe D'ancona, Ulrich Schaefer, Horst Sievert, Francisco Leyva, Zachary I. Whinnett, Carlo Di Mario, Michael Jonas, Michael Glikson, Manhal Habib, Oren Caspi, Oran Koren, William T. Abraham, Ran Kornowski, and Filippo Crea

Subjects
Cardiology and Cardiovascular Medicine
Published
2022
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28. Timing of cardiac resynchronization therapy implantation

Author

Francisco Leyva, Abbasin Zegard, Peysh Patel, Berthold Stegemann, Howard Marshall, Peter Ludman, Jamie Walton, Joseph de Bono, Giuseppe Boriani, and Tian Qiu

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Abstract

AimsThe optimum timing of cardiac resynchronization therapy (CRT) implantation is unknown. We explored long-term outcomes after CRT in relation to the time interval from a first heart failure hospitalization (HFH) to device implantation.Methods and resultsA database covering the population of England (56.3 million in 2019) was used to quantify clinical outcomes after CRT implantation in relation to first HFHs. From 2010 to 2019, 64 968 patients [age: 71.4 ± 11.7 years; 48 606 (74.8%) male] underwent CRT implantation, 57% in the absence of a previous HFH, 12.9% during the first HFH, and 30.1% after ≥1 HFH. Over 4.54 (2.80–6.71) years [median (interquartile range); 272 989 person-years], the time in years from the first HFH to CRT implantation was associated with a higher risk of total mortality [hazard ratio (HR); 95% confidence intervals (95% CI)] (1.15; 95% CI 1.14–1.16, HFH (HR: 1.26; 95% CI 1.24–1.28), and the combined endpoint of total mortality or HFH (HR: 1.19; 95% CI 1.27–1.20) than CRT in patients with no previous HFHs, after co-variate adjustment. Total mortality (HR: 1.67), HFH (HR: 2.63), and total mortality or HFH (HR: 1.92) (all P < 0.001) were highest in patients undergoing CRT ≥2 years after the first HFH.ConclusionIn this study of a healthcare system covering an entire nation, delays from a first HFH to CRT implantation were associated with progressively worse long-term clinical outcomes. The best clinical outcomes were observed in patients with no previous HFH and in those undergoing CRT implantation during the first HFH.Condensed abstractThe optimum timing of CRT implantation is unknown. In this study of 64 968 consecutive patients, delays from a first heart failure hospitalization (HFH) to CRT implantation were associated with progressively worse long-term clinical outcomes. Each year from a first HFH to CRT implantation was associated with a 21% higher risk of total mortality and a 34% higher risk of HFH. The best outcomes after CRT were observed in patients with no previous HFHs and in those undergoing implantation during their first HFH.

Published
2023
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29. Non-invasive three-dimensional electrical activation mapping to predict cardiac resynchronization therapy response: site of latest left ventricular activation relative to pacing site

Author

Leonor Parreira, Alexey Tsyganov, Elena Artyukhina, Kevin Vernooy, Claudio Tondo, Pedro Adragao, Ciro Ascione, Pedro Carmo, Salomé Carvalho, Matthias Egger, Antonio Ferreira, Mohammed Ghossein, Magnus Holm, Vitaly Kalinin, Maria Malakhova, Mathias Meine, Silvia Nunes, Dmitry Podolyak, Amiran Revishvili, Albina Shapieva, Vera Stepanova, Antonius van Stipdonk, Irina Taymasova, Philippe Wouters, Stepan Zubarev, Francisco Leyva, Angelo Auricchio, Niraj Varma, MUMC+: MA Cardiologie (3), RS: Carim - H01 Clinical atrial fibrillation, RS: Carim - H06 Electro mechanics, Cardiologie, MUMC+: MA Med Staf Spec Cardiologie (9), and MUMC+: MA Med Staf Artsass Cardiologie (9)

Subjects
Cardiac resynchronization therapy, Non-invasive 3D electrical activation mapping, Ischaemic cardiomyopathy, Dilated cardiomyopathy, Electrocardiographic imaging, Heart failure, PATIENT, LEAD, Physiology (medical), PLACEMENT, HEART-FAILURE, ECGI, Cardiology and Cardiovascular Medicine, ECHOCARDIOGRAPHY
Abstract

Aims Pacing remote from the latest electrically activated site (LEAS) in the left ventricle (LV) may diminish response to cardiac resynchronization therapy (CRT). We tested whether proximity of LV pacing site (LVPS) to LEAS, determined by non-invasive three-dimensional electrical activation mapping [electrocardiographic Imaging (ECGI)], increased likelihood of CRT response. Methods and results Consecutive CRT patients underwent ECGI and chest/heart computed tomography 6–24 months of post-implant. Latest electrically activated site and the distance to LVPS (dp) were assessed. Left ventricular end-systolic volume (LVESV) reduction of ≥15% at clinical follow-up defined response. Logistic regression probabilistically modelled non-response; variables included demographics, heart failure classification, left bundle branch block (LBBB), ischaemic heart disease (IHD), atrial fibrillation, QRS duration, baseline ejection fraction (EF) and LVESV, comorbidities, use of CRT optimization algorithm, angiotensin-converting enzyme inhibitor(ACE)/angiotensin-receptor blocker (ARB), beta-blocker, diuretics, and dp. Of 111 studied patients [64 ± 11 years, EF 28 ± 6%, implant duration 12 ± 5 months (mean ± SD), 98% had LBBB, 38% IHD], 67% responded at 10 ± 3 months post CRT-implant. Latest electrically activated sites were outside the mid-to-basal lateral segments in 35% of the patients. dp was 42 ± 23 mm [31 ± 14 mm for responders vs. 63 ± 24 mm non-responders (P < 0.001)]. Longer dp and the lack of use of CRT optimization algorithm were the only independent predictors of non-response [area under the curve (AUC) 0.906]. dp of 47 mm delineated responders and non-responders (AUC 0.931). Conclusion The distance between LV pacing site and latest electrical activation is a strong independent predictor for CRT response. Non-invasive electrical evaluation to characterize intrinsic activation and guide LV lead deployment may improve CRT efficacy.

Published
2023
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30. CI-452767-4 NON-INVASIVE 3D ELECTRICAL ACTIVATION MAPPING TO PREDICT CRT RESPONSE: SITE OF LATEST LV ACTIVATION RELATIVE TO PACING SITE

Author

Leonor Parreira, Alexey Tsyganov, Elena Artyukhina, Kevin Vernooy, Claudio Tondo, Pedro Adragao, Ciro Ascione, Pedro Carmo, Maria Carvalho, Matthias Egger, António Ferreira, Mohammed A. Ghossein, Magnus C. Holm, Vitaly Kalinin, Maria Malakhova, Mathias Meine, Sílvia Nunes, Dmitry Podolyak, Amiran S. Revishvili, Albina Shapieva, Vera Stepanova, Antonius van Stipdonk, Irina Taymasova, Philippe Wouters, Stepan Zubarev, Francisco Leyva, Angelo Auricchio, and Niraj Varma

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Published
2023
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33. Effects of haemodynamically atrio-ventricular optimized His-pacing on heart failure symptoms and exercise capacity: The His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomised, double-blind, cross-over trial

Author

Zachary I, Whinnett, Matthew J, Shun-Shin, Mark, Tanner, Paul, Foley, Badri, Chandrasekaran, Philip, Moore, Shaumik, Adhya, Norman, Qureshi, Amal, Muthumala, Rebecca, Lane, Aldo, Rinaldi, Sharad, Agarwal, Francisco, Leyva, Jonathan, Behar, Sukh, Bassi, Andre, Ng, Paul, Scott, Rachana, Prasad, Jon, Swinburn, Joseph, Tomson, Amarjit, Sethi, Jaymin, Shah, Phang Boon, Lim, Andreas, Kyriacou, Dewi, Thomas, Jenny, Chuen, Ravi, Kamdar, Prapa, Kanagaratnam, Myril, Mariveles, Leah, Burden, Katherine, March, Ahran, Arnold, Pugazhendhi, Vijayaraman, Berthold, Stegemann, Nicholas, Johnson, Emanuela, Falaschetti, Darrel P, Francis, John Gf, Cleland, and Daniel, Keene

Abstract

Excessive prolongation of PR interval impairs coupling of AV contraction, which reduces left ventricular pre-load and stroke volume, and worsens symptoms. His-bundle pacing allows AV-delay shortening while maintaining normal ventricular activation. HOPE-HF evaluated whether AV-optimized His pacing is preferable to no-pacing, in double-blind cross-over fashion, in patients with heart failure, left ventricular ejection fraction (LVEF) ≤40%, PR interval ≥200ms and either QRS ≤140ms or right BBB.Patients had atrial and His-bundle leads implanted (and an ICD lead if clinically indicated) and were randomized, to 6-months of pacing and 6-months of no-pacing utilizing a cross-over design. The primary outcome was peak oxygen uptake during symptom-limited exercise. Quality of life, LVEF and patients' holistic symptomatic preference between arms were secondary outcomes. 167 patients were randomized: 90% men, 69±10 years, QRS duration 124±26ms, PR interval 249±59ms, LVEF 33±9%. Neither peak VOHis-bundle pacing did not increase peak oxygen uptake but, under double-blind conditions, significantly improved quality of life and was symptomatically preferred by the clear majority of patients. Ventricular pacing delivered via the His bundle did not adversely impact ventricular function during the 6 months. This article is protected by copyright. All rights reserved.

Published
2022

34. Greyzone myocardial fibrosis and ventricular arrhythmias in patients with a left ventricular ejection fraction >35%

Author

Lucy Hudsmith, Abbasin Zegard, Francisco Leyva, Berthold Stegemann, Richard P. Steeds, T. Qiu, Mauro Lencioni, Manish Kalla, Howard Marshall, Joseph de Bono, and Osita Okafor

Subjects
medicine.medical_specialty, Magnetic Resonance Imaging, Cine, Ventricular tachycardia, Coronary artery disease, Greyzone scar, Ventricular Function, Left, Sudden cardiac death, Interquartile range, Clinical Research, Physiology (medical), Internal medicine, Myocardial fibrosis, medicine, Clinical endpoint, Humans, AcademicSubjects/MED00200, cardiovascular diseases, Sudden death and ICDs, Ventricular fibrillation, Aged, Retrospective Studies, Ejection fraction, business.industry, Myocardium, Arrhythmias, Cardiac, Stroke Volume, Middle Aged, medicine.disease, Fibrosis, Death, Sudden, Cardiac, Cardiology, cardiovascular system, Cardiovascular magnetic resonance, Cardiology and Cardiovascular Medicine, business
Abstract

Aims To determine whether myocardial fibrosis and greyzone fibrosis (GZF) on cardiovascular magnetic resonance (CMR) is associated with ventricular arrhythmias in patients with coronary artery disease (CAD) and a left ventricular ejection fraction (LVEF) >35%. Methods and results In this retrospective study of CAD patients, GZF mass using the 3SD method (GZF3SD) and total fibrosis mass using the 2SD method (TF2SD) on CMR were assessed in relation to the primary, combined endpoint of sudden cardiac death, ventricular tachycardia, ventricular fibrillation, or resuscitated cardiac arrest. Among 701 patients [age: 65.8 ± 12.3 years (mean ± SD)], 28 (3.99%) patients met the primary endpoint over 5.91 years (median; interquartile range 4.42–7.64). In competing risks analysis, a GZF3SD mass ≥5.0 g was strongly associated with the primary endpoint [subdistribution hazard ratio (sHR): 17.4 (95% confidence interval, CI 6.64–45.5); area under receiver operator characteristic curve (AUC): 0.85, P 35%, GZF3SD mass was strongly associated with the arrhythmic endpoint. These findings hold promise for its use in identifying patients with CAD and an LVEF >35% at risk of arrhythmic events., Graphical Abstract Late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR) was used to detect myocardial fibrosis in patients with coronary artery disease (CAD). As shown in the horizontal long axis (left upper panel) and short-axis views (left lower panel) of the left ventricle, areas of greyzone fibrosis are typically heterogeneous, often harbouring ‘channels’ in between areas of myocardial fibrosis. As shown in the survival curves (right upper panel), the proportional risk of the primary endpoint increased with increasing greyzone fibrosis mass using the 3SD method (GZF3SD). In comparison to left ventricular ejection fraction (LVEF) and total fibrosis mass, this risk, expressed in terms of subdistribution hazard ratios (sHRs) from competing risks analyses, was much higher for GZF3SD than for total fibrosis mass using the 2SD method, or LVEF (right lower panel). LV, left ventricle; RV, right ventricle.

Published
2021

36. Right ventricular function and long-term clinical outcomes after cardiac resynchronization therapy: A cardiovascular magnetic resonance study

Author

Abbasin Zegard, Osita Okafor, William Moody, Howard Marshall, Tian Qiu, Berthold Stegemann, Roger Beadle, and Francisco Leyva

Subjects
Aged, 80 and over, Heart Failure, Male, Magnetic Resonance Spectroscopy, Ventricular Dysfunction, Right, Stroke Volume, General Medicine, Middle Aged, Ventricular Function, Left, Cardiac Resynchronization Therapy, Treatment Outcome, Ventricular Function, Right, Humans, Female, Cardiology and Cardiovascular Medicine, Cardiomyopathies, Aged, Retrospective Studies
Abstract

Right ventricular (RV) dysfunction has been linked to a poor response to cardiac resynchronization therapy (CRT). We sought to determine whether cardiovascular magnetic resonance (CMR)-derived measures of RV function influence clinical outcomes after CRT.In this retrospective study, we used CMR to assess pre-implant RV volumes and RV ejection fraction (RVEF) in relation to clinical outcomes after CRT implantation.Among 243 patients (age: 70.3 ± 10.8 years [mean ± SD]; 68.7% male; 121 [49.8%]) with ischemic cardiomyopathy and 122 (50.2%) with nonischemic cardiomyopathy, 141 (58%) after CRT-defibrillation (CRT-D) and 102 (42%) after CRT-pacing (CRT-P), 101 (41.6.0%) patients died, 61 (25.1%) from cardiac causes and 24 (9.88%) from noncardiac causes, over 5.87 years (median; interquartile range: 4.35-7.73). Two (0.82%) patients underwent cardiac transplantation and four (1.64%) had a left ventricular assist device (LVAD). A total of 41 (16.9%) met the composite endpoint of sudden cardiac death (SCD), ventricular tachycardia, or ventricular fibrillation. In univariate analyses, no measure of RV function was associated with total mortality or the arrhythmic endpoint. RVEF was associated with cardiac mortality on univariate analyses (HR per 10%: 0.82, 95% CI 0.70-0.96), but not on multivariate analyses that included left ventricular ejection fraction.There is no relationship between measures of RV function, such as RV volumes and RVEF, and the long-term clinical outcome of CRT. These findings indicate that such measures should not be considered in patient selection.

Published
2022

37. Myocardial fibrosis predicts ventricular arrhythmias and sudden death after cardiac electronic device implantation

Author

Francisco Leyva, Abbasin Zegard, Osita Okafor, Paul Foley, Fraz Umar, Robin J. Taylor, Howard Marshall, Berthold Stegemann, William Moody, Richard P. Steeds, Brian P. Halliday, Daniel J. Hammersley, Richard E. Jones, Sanjay K. Prasad, and Tian Qiu

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Abstract

Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted educational grants Background Increasing evidence supports a link between myocardial fibrosis (MF) and ventricular arrhythmias. We sought to determine whether presence of MF on visual assessment (MFVA) and gray zone fibrosis (GZF) mass predicts SCD and ventricular fibrillation / sustained ventricular tachycardia after cardiac implantable electronic device (CIED) implantation. Methods In this prospective study, total fibrosis and GZF mass, quantified using cardiovascular magnetic resonance, was assessed in relation to the primary endpoint of sudden cardiac death (SCD) and the secondary, arrhythmic endpoint of SCD or ventricular arrhythmias after CIED implantation. Results Among 700 patients (age 68.0 ± 12.0yrs [mean ± SD]), 27 (3.85%) experienced a SCD and 121 (17.3%) met the arrhythmic endpoint over 6.93 yrs (median; interquartile range 5.82-9.32). MFVA predicted SCD (hazard ratio [HR]: HR:26.3 [95% confidence interval [CI] 3.70-3337]; negative predictive value: 100%). In competing risks analyses, MFVA also predicted the arrhythmic endpoint (subdistribution [sHR]: 19.9 [95% CI 6.40-61.9]; negative predictive value:98.6%). Compared with no MFVA, a GZF mass measured with the 5SD method (GZF5SD) > 17 g was associated with highest risk of SCD (HR: 44.6;95% CI 6.12-5685) and the arrhythmic endpoint (sHR: 30.3 [95% CI 9.60-95.8]). Adding GZF5SD mass to MFVA led to reclassification of 39% for SCD and 50.2% for the arrhythmic endpoint. In contrast, LVEF did not predict either endpoint. Conclusions In CIED recipients, MFVA excluded patients at risk of SCD and virtually excluded ventricular arrhythmias. Quantified GZF5SD mass added predictive value in relation to SCD and the arrhythmic endpoint.

Published
2022
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38. Myocardial Fibrosis as a Predictor of Sudden Death in Patients With Coronary Artery Disease

Author

T. Qiu, Abbasin Zegard, Manish Kalla, Lucy Hudsmith, Osita Okafor, Richard P. Steeds, Berthold Stegemann, Joseph DeBono, Francisco Leyva, Howard Marshall, and M Lencioni

Subjects
medicine.medical_specialty, Objective (goal), medicine.medical_treatment, 030204 cardiovascular system & hematology, Ventricular tachycardia, Sudden death, Sudden cardiac death, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Physiology (medical), Internal medicine, medicine, In patient, cardiovascular diseases, 030212 general & internal medicine, Ejection fraction, business.industry, Hazard ratio, Coronary arteriosclerosis, medicine.disease, Implantable cardioverter-defibrillator, Ventricular fibrillation, cardiovascular system, Cardiology, Myocardial fibrosis, Cardiology and Cardiovascular Medicine, business
Abstract

Funding Acknowledgements Type of funding sources: None. BACKGROUND The ‘grayzone’ of myocardial fibrosis (GZF) on cardiovascular magnetic resonance may be a substrate for ventricular arrhythmias (VAs). OBJECTIVES To determine whether GZF predicts SCD and VAs (ventricular fibrillation or sustained ventricular tachycardia) in patients with coronary artery disease (CAD) and a wide range of LVEFs. METHODS In this retrospective study of CAD patients, myocardial fibrosis presence on visual assessment (MFVA) and GZF mass in patients with MFVA was assessed in relation to SCD and the composite, arrhythmic endpoint of SCD or VAs. RESULTS Among 979 patients (age: 65.8 ± 12.3 yrs [mean ± SD]), 29(2.96%) suffered a SCD and 80(8.17%) met the arrhythmic endpoint over 5.82 years (median; interquartile range: 4.1-7.3). In the whole cohort, MFVA was strongly associated with SCD (hazard ratio [HR]:10.1, 95% CI 1.42-1278.9) and the arrhythmic endpoint (HR:28.0, 95% CI 4.07-3525.4). In competing risks analyses, associations between LVEF 5.0 g was strongly associated with SCD (sHR:10.8, 95% CI 3.74-30.9) and the arrhythmic endpoint (sHR:7.40, 95% CI 4.29-12.8). Associations between LVEF CONCLUSIONS In CAD patients, MFVA plus quantified GZF3SD mass was more strongly associated with SCD and VAs than LVEF. In selecting patients for implantable cardioverter defibrillators, assessment of MFVA followed by quantification of GZF3SD mass may be preferable to LVEF. Abstract Figure.

Published
2021
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39. UK multicenter retrospective comparison of novel active versus conventional passive fixation coronary sinus leads

Author

Ihab Diab, Ian Williams, Waqas Ullah, Anthony Chow, Francisco Leyva, Ross J. Hunter, Andrew J. Turley, and Dimitrios Gerontitis

Subjects
Pacemaker, Artificial, medicine.diagnostic_test, business.industry, Coronary Sinus, Retrospective cohort study, 030204 cardiovascular system & hematology, United Kingdom, Confidence interval, Electrodes, Implanted, 03 medical and health sciences, 0302 clinical medicine, Physiology (medical), Clinical endpoint, Humans, Medicine, Fluoroscopy, 030212 general & internal medicine, Implant, Cardiology and Cardiovascular Medicine, business, Nuclear medicine, Lead (electronics), Coronary sinus, Retrospective Studies, Fixation (histology)
Abstract

Background A novel active fixation coronary sinus (CS) lead, Attain Stability (AS), has been released aiming to improve targeted lead positioning. Rather than being wedged into the distal vessel, it relies on a side helix for fixation. We aimed to compare implant procedure parameters and electromechanical stability of the AS lead with passive CS leads. Methods A retrospective study involving six major UK cardiac centers. Patients who received active fixation leads were compared with passive fixation lead recipients in a 1:2 ratio. The primary outcome was total lead displacements (combined macrodisplacement/microdisplacement, defined as displacements requiring repositioning procedures, an increase in threshold ≥0.5 V or pulse width ≥0.5 ms, or a change in pacing polarity). Results A total of 761 patients were included (253 AS leads and 508 passive fixation leads), of which 736 had follow-up data. The primary endpoint rate was 31% (75/241) in the active and 43% (214/495) in the passive group (p = .002). Six patients (2.5%) in the active group and 14 patients (2.8%) in the passive group required CS lead repositioning procedures (p = 0.981). On multivariable analysis, active leads were associated with a reduction in lead displacements, odds ratio 0.66 (95% confidence interval: 0.46-0.95), p = .024. There were differences in favor of passive leads in procedure duration, 120 (96-149) versus 127 (105-155) min (p = .008), and fluoroscopy time, 17 (11-26) versus 18.5 (13-27) min (p = .0022). The median follow-up duration was similar (active vs. passive): 31 (17-47) versus 34 (16-71) weeks, (p = .052). Conclusion AS CS leads had improved electromechanical stability compared with passive fixation leads, with only minimal increases in implant procedure and fluoroscopy times.

Published
2020
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40. Variability in the Management of Adults With Pulmonary Nontuberculous Mycobacterial Disease

Author

Patricia L. Winokur, Nora Watson, Getahun Abate, Ravi P. Nayak, Shanda Phillips, Kay M. Tomashek, Jack T. Stapleton, Marcia Sokol-Anderson, Buddy Creech, Lisa A. Jackson, Nicholas A Turner, Jason E. Stout, Sharon E. Frey, Francisco Leyva, Naomi Prashad Kown, Ghina Alaaeddine, Nadine Rouphael, Joan Siegner, Edward Charbek, Aaron S. Miller, Melinda Tibbals, Elizabeth Guy, Arthur W. Baker, Greta Dahlberg, Emmanuel B. Walter, Hana M. El Sahly, Katherine Sokolow, and Nour Beydoun

Subjects
Adult, Lung Diseases, Microbiology (medical), medicine.medical_specialty, Mycobacterium Infections, Nontuberculous, Disease, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, 030212 general & internal medicine, Ethambutol, Retrospective Studies, Lung, biology, business.industry, Medical record, Nontuberculous Mycobacteria, Retrospective cohort study, Odds ratio, Mycobacterium avium Complex, bacterial infections and mycoses, biology.organism_classification, Infectious Diseases, medicine.anatomical_structure, 030228 respiratory system, Amikacin, Nontuberculous mycobacteria, business, medicine.drug
Abstract

Background The increasing global prevalence of pulmonary nontuberculous mycobacteria (NTM) disease has called attention to challenges in NTM diagnosis and management. This study was conducted to understand management and outcomes of patients with pulmonary NTM disease at diverse centers across the United States. Methods We conducted a 10-year (2005–2015) retrospective study at 7 Vaccine and Treatment Evaluation Units to evaluate pulmonary NTM treatment outcomes in human immunodeficiency virus–negative adults. Demographic and clinical information was abstracted through medical record review. Microbiologic and clinical cure were evaluated using previously defined criteria. Results Of 297 patients diagnosed with pulmonary NTM, the most frequent NTM species were Mycobacterium avium-intracellulare complex (83.2%), M. kansasii (7.7%), and M. abscessus (3.4%). Two hundred forty-five (82.5%) patients received treatment, while 45 (15.2%) were followed without treatment. Eighty-six patients had available drug susceptibility results; of these, >40% exhibited resistance to rifampin, ethambutol, or amikacin. Of the 138 patients with adequate outcome data, 78 (56.5%) experienced clinical and/or microbiologic cure. Adherence to the American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) treatment guidelines was significantly more common in patients who were cured (odds ratio, 4.5, 95% confidence interval, 2.0–10.4; P Conclusions Despite ATS/IDSA Guidelines, management of pulmonary NTM disease was heterogeneous and cure rates were relatively low. Further work is required to understand which patients are suitable for monitoring without treatment and the impact of antimicrobial therapy on pulmonary NTM morbidity and mortality.

Published
2020
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42. European Society of Cardiology Quality Indicators for the care and outcomes of cardiac pacing: developed by the Working Group for Cardiac Pacing Quality Indicators in collaboration with the European Heart Rhythm Association of the European Society of Cardiology

Author

Cecilia Linde, Haran Burri, Niraj Varma, Jens Cosedis Nielsen, Michael R. Gold, Jens Brock Johansen, Francisco Leyva, David J. Slotwiner, Inga Drossart, Dan Foldager, Pascal Defaye, Yoav Michowitz, Mads Brix Kronborg, Jean-Claude Deharo, Carina Blomström-Lundqvist, Amr Abdin, Torkel Steen, Chris P Gale, Giuseppe Boriani, Kevin Vernooy, Suleman Aktaa, Stylianos Tzeis, Elena Arbelo, José María Tolosana, Michael Glikson, Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Cardiologie, MUMC+: MA Med Staf Spec Cardiologie (9), RS: Carim - H01 Clinical atrial fibrillation, and RS: Carim - H06 Electro mechanics

Subjects
Adult, Pacemaker, Artificial, medicine.medical_specialty, Cardiac pacing, [SDV]Life Sciences [q-bio], medicine.medical_treatment, media_common.quotation_subject, Advisory Committees, Cardiology, Cardiac resynchronization therapy, Quality indicators, THERAPY, Cardiac pacemaker, Cardiac Resynchronization Therapy, Physiology (medical), Internal medicine, medicine, Humans, AcademicSubjects/MED00200, Quality (business), COHORT, Cardiac and Cardiovascular Systems, ESC GUIDELINES, Cardiac device, Quality Indicators, Health Care, media_common, COMPLICATIONS, Kardiologi, business.industry, Task force, Guideline, RESYNCHRONIZATION THERAPY, ELECTROPHYSIOLOGY, Clinical practice guidelines, Heart Rhythm, RISK-FACTORS, Cardiology and Cardiovascular Medicine, business, INFARCTION, POSITION PAPER, EHRA Position Paper, TASK-FORCE
Abstract

Aims To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing. Methods and results Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy. Conclusion By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers.

Published
2022
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44. Cardiac device implantation and device usage in Fabry and hypertrophic cardiomyopathy

Author

Derralynn Hughes, Dipak Kotecha, Ana Jovanovic, William Bradlow, Richard P. Steeds, Nigel Lewis, Peter Woolfson, Abbasin Zegard, Ravi Vijapurapu, Francisco Leyva, Tarekegn Geberhiwot, and James C. Moon

Subjects
Risk, medicine.medical_specialty, Defibrillator, Risk Factors, Internal medicine, Medicine, Humans, Pharmacology (medical), Cardiac device, Genetics (clinical), business.industry, Research, Hypertrophic cardiomyopathy, Arrhythmias, Cardiac, General Medicine, Cardiomyopathy, Hypertrophic, medicine.disease, Prognosis, Device Usage, Defibrillators, Implantable, Fabry, Cardiology, Tachycardia, Ventricular, Fabry Disease, business, Arrhythmia
Abstract

Background Fabry disease (FD) is a treatable X-linked condition leading to progressive cardiac disease, arrhythmia and premature death. We aimed to increase awareness of the arrhythmogenicity of Fabry cardiomyopathy, by comparing device usage in patients with Fabry cardiomyopathy and sarcomeric HCM. All Fabry patients with an implantable cardioverter defibrillator (ICD) implanted in the UK over a 17 year period were included. A comparator group of HCM patients, with primary prevention ICD implantation, were captured from a regional registry database. Results Indications for ICD in FD varied with 72% implanted for primary prevention based on multiple potential risk factors. In FD and HCM primary prevention devices, arrhythmia occurred more frequently in FD over shorter follow-up (HR 4.2, p p = 0.002). Immediate shock therapy for sustained VT was also more common (HR 2.5, p p = 0.004, NSVT: HR 3.1, p Conclusion This study demonstrates arrhythmia burden and ICD usage in FD is high, suggesting that Fabry cardiomyopathy may be more ‘arrhythmogenic’ than previously thought. Existing risk models cannot be mutually applicable and further research is needed to provide clarity in managing Fabry patients with cardiac involvement.

Published
2022

46. The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring

Author

Leor, Perl, David, Meerkin, Domenico, D'amario, Binyamin Ben, Avraham, Tuvia Ben, Gal, Tatyana, Weitsman, Tal, Hasin, Hüseyin, Ince, Sebastian, Feickert, Giuseppe, D'ancona, Ulrich, Schaefer, Horst, Sievert, Francisco, Leyva, Zachary I, Whinnett, Carlo, Di Mario, Michael, Jonas, Michael, Glikson, Manhal, Habib, Oren, Caspi, Oran, Koren, William T, Abraham, Ran, Kornowski, and Filippo, Crea

Subjects
Heart Failure, Cardiac Catheterization, Atrial Pressure, Humans, Stroke Volume, Prospective Studies
Abstract

Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlicDiastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076).The V-LAP left atrium monitoring system appears to be safe and accurate.

Published
2021

47. Time trends in sudden cardiac death risk in heart failure patients with cardiac resynchronization therapy: a systematic review

Author

Rodrigue Garcia, Eloi Marijon, Sérgio Barra, Sharad Agarwal, Serge Boveda, Francisco Leyva, Wayne C. Levy, Xavier Jouven, Véronique L. Roger, Rudolf Duehmke, Kumar Narayanan, Rui Providência, and Clinical sciences

Subjects
medicine.medical_specialty, Time Factors, genetic structures, medicine.medical_treatment, Population, Electric Countershock, Cardiac resynchronization therapy, 030204 cardiovascular system & hematology, Sudden death, Ventricular Function, Left, Sudden cardiac death, Cardiac Resynchronization Therapy, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, education, Death, Sudden, Cardiac/epidemiology, Cause of death, Heart Failure, education.field_of_study, Ejection fraction, business.industry, Stroke Volume, Implantable cardioverter-defibrillator, medicine.disease, Defibrillators, Implantable, Death, Sudden, Cardiac, Treatment Outcome, Heart Failure/complications, Heart failure, cardiovascular system, Cardiology, Cardiology and Cardiovascular Medicine, business, circulatory and respiratory physiology
Abstract

Aims While data from randomized trials suggest a declining incidence of sudden cardiac death (SCD) among heart failure patients, the extent to which such a trend is present among patients with cardiac resynchronization therapy (CRT) has not been evaluated. We therefore assessed changes in SCD incidence, and associated factors, in CRT recipients over the last 20 years. Methods and results Literature search from inception to 30 April 2018 for observational and randomized studies involving CRT patients, with or without defibrillator, providing specific cause-of-death data. Sudden cardiac death was the primary endpoint. For each study, rate of SCD per 1000 patient-years of follow-up was calculated. Trend line graphs were subsequently constructed to assess change in SCD rates over time, which were further analysed by device type, patient characteristics, and medical therapy. Fifty-three studies, comprising 22 351 patients with 60 879 patient-years of follow-up and a total of 585 SCD, were included. There was a gradual decrease in SCD rates since the early 2000s in both randomized and observational studies, with rates falling more than four-fold. The rate of decline in SCD was steeper than that of all-cause mortality, and accordingly, the proportion of deaths which were due to SCD declined over the years. The magnitude of absolute decline in SCD was more prominent among CRT-pacemaker (CRT-P) patients compared to those receiving CRT-defibrillator (CRT-D), with the difference in SCD rates between CRT-P and CRT-D decreasing considerably over time. There was a progressive increase in age, use of beta-blockers, and left ventricular ejection fraction, and conversely, a decrease in QRS duration and antiarrhythmic drug use. Conclusion Sudden cardiac death rates have progressively declined in the CRT heart failure population over time, with the difference between CRT-D vs. CRT-P recipients narrowing considerably.

Published
2019
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48. Spectral Stability of Traveling Fronts for Reaction Diffusion-Degenerate Fisher-KPP Equations

Author

Ramón G. Plaza, J. Francisco Leyva, and Luis López Ríos

Subjects
Physics, Equilibrium point, 010102 general mathematics, Essential spectrum, Degenerate energy levels, Mathematical analysis, Monotonic function, Eigenfunction, 01 natural sciences, 010101 applied mathematics, Monotone polygon, Reaction–diffusion system, 0101 mathematics, Analysis, Weighted space
Abstract

This paper establishes the spectral stability of monotone traveling front solutions for reaction-diffusion equations where the reaction function is of Nagumo (or bistable) type and with diffusivities which are density dependent and degenerate at zero (one of the equilibrium points of the reaction). Spectral stability is understood as the property that the spectrum of the linearized operator around the wave, acting on an exponentially weighted space, is contained in the complex half plane with non-positive real part. Three different types of monotone waves are studied: (i) stationary diffusion-degenerate fronts, connecting the two stable equilibria of the reaction; (ii) traveling diffusion-degenerate fronts connecting zero with the unstable equilibrium; and, (iii) non-degenerate fronts. In the first two cases, the degeneracy is responsible of the loss of hyperbolicity of the asymptotic coefficient matrices of the spectral problem at one of the end points, precluding the application of standard techniques to locate the essential spectrum. This difficulty is overcome with a suitable partition of the spectrum, a generalized convergence of operators technique, the analysis of singular (or Weyl) sequences and the use of energy estimates. The monotonicity of the fronts, as well as detailed descriptions of the decay structure of eigenfunctions on a case by case basis, are key ingredients to show that all traveling fronts under consideration are spectrally stable in a suitably chosen exponentially weighted $L^2$ energy space.

Published
2019
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49. Renal function and the long‐term clinical outcomes of cardiac resynchronization therapy with or without defibrillation

Author

Kiran Patel, Jonathan Panting, Shajil Chalil, Abbasin Zegard, Fraz Umar, Paul W.X. Foley, Charles J. Ferro, Francisco Leyva, Robin J. Taylor, Howard Marshall, and Tian Qiu

Subjects
Male, medicine.medical_specialty, implantable cardioverter defibrillator, genetic structures, medicine.medical_treatment, Cardiac resynchronization therapy, Renal function, cardiac resynchronization therapy, heart failure, 030204 cardiovascular system & hematology, Lower risk, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Devices, Humans, 030212 general & internal medicine, cardiovascular diseases, Aged, business.industry, Hazard ratio, General Medicine, Implantable cardioverter-defibrillator, medicine.disease, Defibrillators, Implantable, Hospitalization, Treatment Outcome, Cardiovascular Diseases, Heart failure, Cardiology, cardiovascular system, Kidney Failure, Chronic, Female, Cardiology and Cardiovascular Medicine, business, chronic kidney disease, Kidney disease, Glomerular Filtration Rate
Abstract

BACKGROUND AND AIMS Patients with moderate-to-severe chronic kidney disease (CKD) are underepresented in clinical trials of cardiac resynchronization therapy (CRT)-defibrillation or CRT-pacing (CRT-P). We sought to determine whether outcomes after CRT-D are better than after CRT-P over a wide spectrum of CKD. METHODS AND RESULTS Clinical events were quantified in relation to pre-implant estimated glomerular filtration rate (eGFR) after CRT-D (n = 410 [39.2%]) or CRT-P (n = 636 [60.8%]) implantation. Over a follow-up period of 3.7 years (median, interquartile range: 2.1-5.7), the eGFR

Published
2019

50. Long‐term outcomes of cardiac resynchronization therapy in adult congenital heart disease

Author

Lucy Hudsmith, Paul Clift, Tian Qiu, Howard Marshall, Joseph de Bono, Francisco Leyva, Sara Thorne, and Abbasin Zegard

Subjects
Male, Adult, Heart Defects, Congenital, medicine.medical_specialty, Heart disease, medicine.medical_treatment, Cardiomyopathy, Cardiac resynchronization therapy, heart failure, 030204 cardiovascular system & hematology, Cardiac Resynchronization Therapy, 03 medical and health sciences, QRS complex, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Devices, adult congenital heart disease, Humans, 030212 general & internal medicine, Cardiac Resynchronization Therapy Devices, Aged, Retrospective Studies, Univariate analysis, business.industry, Hazard ratio, General Medicine, Middle Aged, medicine.disease, mortality, Treatment Outcome, England, Heart failure, Cardiology, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Background and Aims Randomized, controlled trials of cardiac resynchronization therapy (CRT) excluded patients with adult congenital heart disease (ACHD). We sought to explore long‐term clinical outcomes. Methods and Results In this single‐center, observational study, events were collected from hospital records on patients with structural ACHD (sACHD) and adults with ischemic (ICM) or nonischemic (NICM) cardiomyopathy undergoing CRT. Patients with sACHD (n = 23, age: 41.6 ± 13.5 years [mean ± standard deviation]) and adults with ICM (n = 533) or NICM (n = 458) were followed‐up for 4.1 years (median; interquartile range: 2.2‐6.1). Total mortality was 5/23 (21.7%; 4.4 per 100 person‐years) in sACHD, 221/533 (41.5%; 11.8 per 100 person‐years) in ICM, and 154/458 (33.6%; 9.7 per 100 person‐years) in NICM. In univariate analyses, total mortality in sACHD was lower than in ICM (hazard ratio [HR]: 0.38; 95% confidence interval [CI] 0.15‐0.91), but similar to NICM (HR: 0.48, 95% CI 0.20‐1.16). Cardiac mortality in sACHD was similar to ICM (HR: 0.78, 95% CI 0.32‐1.92) and NICM (HR: 1.12, 95% CI 0.45‐2.78). Heart failure (HF) hospitalization rates were similar to ICM (HR: 0.44, 95% CI 0.11‐1.77) and NICM (HR: 0.75, 95% CI 0.18‐3.08). In multivariate analyses, no differences emerged in total mortality, cardiac mortality, or HF hospitalization between sACHD and NICM or ICM, after adjustment for age, sex, New York Heart Association class, diabetes, atrial rhythm, QRS duration, QRS morphology, systemic ventricular ejection fraction, and medical therapy. Conclusion Total mortality, cardiac mortality, and HF hospitalization after CRT in patients with sACHD was similar to adults with ICM or NICM.

Published
2019

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