Background
Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long‐term follow‐up. Existing international guidelines lack detailed ...instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single‐chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm.
Methods
A panel of experts, including interventional and non‐interventional cardiologists, used the Research ANd Development/University of California at Los Angeles (RAND/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable.
Results
This consensus statement, based on available literature and the experts’ opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm.
Conclusions
Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.
Coronary artery spasm (CAS) is associated with ventricular arrhythmias (VA). Much controversy remains regarding the best therapeutic interventions for this specific patient subset. We aimed to ...evaluate the clinical outcomes of patients with a history of life-threatening VA due to CAS with various medical interventions, as well as the need for ICD placement in the setting of optimal medical therapy.
A multicentre European retrospective survey of patients with VA in the setting of CAS was aggregated and relevant clinical and demographic data was analysed. Forty-nine appropriate patients were identified: 43 (87.8%) presented with VF and 6 (12.2%) with rapid VT. ICD implantation was performed in 44 (89.8%). During follow-up 59 (17-117) months, appropriate ICD shocks were documented in 12. In 8/12 (66.6%) no more ICD therapies were recorded after optimizing calcium channel blocker (CCB) therapy. SCD occurred in one patient without ICD. Treatment with beta-blockers was predictive of appropriate device discharge. Conversely, non-dihydropyridine CCB therapy was significantly protective against VAs.
Patients with life-threatening VAs secondary to CAS are at particularly high-risk for recurrence, especially when insufficient medical therapy is administered. Non-dihydropyridine CCBs are capable of suppressing episodes, whereas beta-blocker treatment is predictive of VAs. Ultimately, in spite of medical intervention, some patients exhibited arrhythmogenic events in the long-term, suggesting that ICD implantation may still be indicated for all.
About 30% of patients treated with cardiac resynchronization therapy (CRT) do not respond to treatment. The aim of this study was to identify clinical predictors of lack of improvement in patients ...receiving CRT. From 197 consecutive patients scheduled to receive CRT, 143 fulfilled the inclusion criteria. Mean age was 68 ± 7 years and 79% were men. Heart failure was due to ischemic heart disease in 49 patients (34%). Mean QRS duration was 165 ± 26 ms, and left ventricular ejection fraction was 27 ± 7%. Nonresponder patients were defined as those who died of heart failure, underwent heart transplantation, or did not increase the distance walked in 6 minutes >10%. At 6-month follow-up, there were 28 nonresponders (20%). Among nonresponders, 2 patients received a heart transplantation and 9 patients died of heart failure. In logistic regression analysis, independent predictors of lack of response to CRT were ischemic heart disease (odds ratio OR 2.9, 95% confidence interval CI 1.2 to 7; p = 0.023), severe mitral regurgitation (OR 3.5, 95% CI 1.3 to 9; p = 0.014), and left ventricular end-diastolic diameter ≥75 mm (OR 3.1, 95% CI 1.1 to 8; p = 0.026). Patients with these 3 predictors had a probability response of 27%.
Introduction: Echocardiography is widely used to optimize CRT programming, but it is time‐consuming. This study aimed to correlate the optimal interventricular pacing (V‐V) interval obtained by echo ...with the optimal V‐V interval obtained by a simpler method based on the surface ECG.
Methods and Results: Three V‐V intervals were tested: LV preactivation at –30 ms, simultaneous biventricular pacing (0 ms), and RV preactivation at +30 ms. The one that achieved the best LV synchrony was chosen as the optimal V‐V. This result was then compared with two different ECG measurements. The first ECG method considered the best V‐V to be that which achieved the narrowest QRS. The second V‐V method consisted in measuring the interval from the pacing spike to the beginning of the fast deflexion of the QRS complex in leads V1, V2, first pacing from the LV (T1), and after from the RV (T2). The T2‐T1 interval was considered as a surrogate measurement of interventricular delay and defined as the best V‐V. A cohort of 31 consecutive patients treated with CRT was studied. Optimal V‐V interval obtained by echo was –30 ms in 25 patients (80%), +30 ms in three patients (10%), and 0 ms in the remaining three patients (10%). Echo results had 32% coincidence with the first ECG method (r = 0.2, P = NS) and 83% coincidence with the second ECG method (r = 0.81 P< 0.001).
Conclusions: The time difference in the fast ventricular depolarization observed between RV and LV stimulation in the surface ECG shows a good correlation with the V‐V optimization chosen according to echo.
Pacing and Cardiac Resynchronization Therapy (CRT) procedural training for novice operators usually takes place in-vivo and methods vary across countries/institutions. No common system exists to ...objectively assess trainee ability to perform required tasks at predetermined performance levels prior to in-vivo practice. We sought to characterize and validate with experts a reference approach to pacing/CRT implants based on objective and explicit performance quality metrics, for the development of a reproducible, simulation-based, training curriculum aiming to operator proficiency.
Three experienced CRT implanters, a behavioural scientist and two engineers performed a detailed task deconstruction of the pacing/CRT procedure and identified the performance metrics (phases, steps, errors, critical errors) that constitute an optimal CRT implant for training purposes. The metrics were stress tested to determine reliability and score-ability and then subjected to detailed systematic review by an international panel of 15 expert implanters in a modified Delphi process.
Thirteen procedure phases were identified, consisting of 196 steps, 122 errors, 50 critical errors. The expert panel deliberation added 16 metrics, deleted 12, and modified 43. Unanimous panel consensus on the resulting CRT procedure metrics was obtained, which verified face and content validity.
A reference pacing/CRT procedure and metrics created by a core group of experts accurately characterize the essential components of performance and were endorsed by an international panel of experienced peers. The metrics will underpin quality-assured novice implanter training.
•Performance metrics underpin simulation-based training curriculum to proficiency.•Detailed CRT reference procedure and performance metrics were defined.•Metrics identified phases, steps and errors constituting optimal CRT implant.•International expert consensus panel concurred with the performance metrics.•The CRT performance metrics are valid and can be objectively and reliably scored.
This study was conducted to investigate the clinical impact of cardiac resynchronization device optimization. A series of 100 consecutive patients received cardiac resynchronization therapy. In the ...first 49 patients, an empirical atrioventricular delay of 120 ms was set, with simultaneous biventricular stimulation (interventricular VV interval = 0 ms). In the next 51 patients, systematic atrioventricular optimization was performed. VV optimization was also performed, selecting 1 VV delay: right or left ventricular preactivation (+30 or −30 ms) or simultaneous (VV interval = 0 ms), according to the best synchrony obtained by tissue Doppler–derived wall displacement. At follow-up, patients who were alive without cardiac transplantation and showed improvement of ≥10% in the distance walked in the 6-minute walking test were considered responders. There were no differences between the 2 groups at baseline. Left ventricular ejection fraction improved in the 2 groups, but left ventricular cardiac output improved only in the optimized group. At 6 months, patients with optimized devices walked slightly further in the 6-minute walking test (497 ± 167 vs 393 ± 123 m, p <0.01), with no differences in New York Heart Association functional class or quality of life compared with nonoptimized patients. Overall, the number of nonresponders were similar in the 2 groups (27% vs 23%, p = NS). In conclusion, the echocardiographic optimization of cardiac resynchronization devices provided a slight incremental clinical benefit at midterm follow-up. Simple and rapid methods to routinely optimize the devices are warranted.
Background
We sought to assess the efficacy of high‐energy shocks to restore rhythm and predictors of success in patients with sustained ventricular arrhythmias and implantable cardioverter ...defibrillator (ICD).
Methods and results
Data from 162 patients included in the UMBRELLA study that experienced one or more episodes of ventricular tachycardia (VT) for which ICD shocks of at least 30 Joules were delivered (appropriate high‐energy shocks) were analyzed. In total, 456 ventricular arrhythmia episodes were registered. Forty four episodes (9.6%) from 39 patients (24%) had at least one ineffective high‐energy shock delivered. Hypertrophic cardiomyopathy was more frequent among patients with unsuccessful shocks (10.3% vs 2.4%). Patients with ineffective shocks had higher proportion of sustained monomorphic ventricular arrhythmias (86.4%; the other 13.6% were sustained polymorphic and ventricular fibrillation VF) compared with patients with all their shocks effective (62.9%, P = 0.02). No statistical differences were found between groups in time from detection to the high‐energy shock delivery, in tachycardia cycle length, or in antitachycardia pacing, but patients with ineffective high‐energy shocks had higher proportion of previously ineffective low‐energy shock (9.1% vs 0.5%, P = 0.01).
Conclusion
We found a substantial rate of ineffective high‐energy shocks for the treatment of VT or VF in patients with ICD. High‐energy shock efficacy seems to be reduced by hypertrophic cardiomyopathy and by the administration of previous low‐energy shocks.
This article presents the findings of the 2012 Spanish Catheter Ablation Registry.
Data were collected in 2 ways: retrospectively using a standardized questionnaire, and prospectively using a central ...database. Each participating center selected its own preferred method of data collection.
Seventy-four Spanish centers voluntarily contributed data to the survey. A total of 11 042 ablation procedures were analyzed, averaging 149 (103) per center. The 3 main conditions treated were atrioventricular nodal reentrant tachycardia (n=2842; 25.7%), cavotricuspid isthmus (n=2485; 23%), and accessory pathways (n=1999; 18%). Atrial fibrillation was the fourth most common substrate treated (n=1852; 17%), representing a slight increase. The number of ventricular arrhythmia ablation procedures was similar to that of 2011, but there was a decrease in procedures for ventricular tachycardia associated with postinfarction scarring. The overall success rate was 94.9%, major complications occurred in 1.9%, and the overall mortality rate was 0.04%.
Data from the 2012 registry show that the number of ablations performed continued to increase. Overall, they also show a high success rate and a low number of complications. Ablation of complex substrates continued to increase, particularly in the case of atrial fibrillation.
Se detallan los resultados del Registro Nacional de Ablación del año 2012.
La recogida de datos se llevó a cabo mediante dos sistemas. De manera retrospectiva con la cumplimentación de un formulario y de manera prospectiva a través de una base de datos común. La elección de una u otra fue voluntaria para cada uno de los centros.
Se recogieron datos de 74 centros. El número total de procedimientos de ablación fue 11.042, con una media de 149±103 procedimientos. Los tres sustratos abordados con más frecuencia fueron la taquicardia intranodular (n=2.842; 25,7%), la ablación del istmo cavotricuspídeo (n=2.485; 23%) y las vías accesorias (n=1.999; 18%). El cuarto sustrato fue la ablación de fibrilación auricular (n=1.852; 17%), que mostró un incremento del 21% con respecto a los datos de 2011. La ablación de arritmias ventriculares ha permanecido estable, pero han disminuido los procedimientos sobre las asociadas a cicatriz tras infarto. La tasa total de éxito fue del 94,9%; la de complicaciones mayores, del 1,9% y la de mortalidad, del 0,04%.
El registro del año 2012 mantiene una línea de continuidad ascendente en el número de ablaciones realizadas y muestran, en líneas generales, una elevada tasa de éxito y bajo número de complicaciones. Continúa el aumento del abordaje de sustratos más complejos, especialmente de la fibrilación auricular.
HeartLogic is a multiparametric algorithm incorporated into implantable cardioverter-defibrillators (ICD). The associated alerts predict impending heart failure (HF) decompensations. Our objective ...was to analyze the association between alerts and clinical events and to describe the implementation of a protocol for remote management in a multicenter registry.
We evaluated study phase 1 (the investigators were blinded to the alert state) and phases 2 and 3 (after HeartLogic activation, managed as per local practice and with a standardized protocol, respectively).
We included 288 patients from 15 centers. In phase 1, the median observation period was 10 months and there were 73 alerts (0.72 alerts/patient-y), with 8 hospitalizations and 2 emergency room admissions for HF (0.10 events/patient-y). There were no HF hospitalizations outside the alert period. In the active phases, the median follow-up was 16 (95%CI, 15-22) months and there were 277 alerts (0.89 alerts/patient-y); 33 were associated with HF hospitalizations or HF death (n=6), 46 with minor decompensations, and 78 with other events. The unexplained alert rate was 0.39 alerts/patient-y. Outside the alert state, there was only 1 HF hospitalization and 1 minor HF decompensation. Most alerts (82% in phase 2 and 81% in phase 3; P=.861) were remotely managed. The median NT-proBNP value was higher within than outside the alert state (7378 vs 1210 pg/mL; P <.001).
The HeartLogic index was frequently associated with HF-related events and other clinically relevant situations, with a low rate of unexplained events. A standardized protocol allowed alerts to be safely and remotely detected and appropriate action to be taken on them.
HeartLogic es un algoritmo multiparamétrico incorporado a desfibriladores automáticos implantables (DAI). La alerta asociada predice descompensaciones de insuficiencia cardiaca (IC). Nuestro objetivo es analizar la asociación entre alertas y eventos clínicos bajo un protocolo de seguimiento común en un registro multicéntrico.
Se evaluaron la fase 1 (investigadores ciegos al estado de la alerta) y las fases 2 y 3 (tras la activación de HeartLogic, según práctica local y un protocolo común respectivamente).
Se incluyó a 288 pacientes en 15 centros. En fase 1, tras una media de observación de 10 meses, hubo 73 alertas (0,72 alertas/paciente-año), con 8 hospitalizaciones y 2 visitas a urgencias por IC (0,10 eventos/año-paciente). No hubo hospitalizaciones fuera del periodo de alerta. Las fases activas tuvieron una media de seguimiento de 16 (IC95%, 15-22) meses, con 277 alertas (0,89 alertas/año-paciente); 33 se asociaron con hospitalizaciones o muerte por IC, 46 con descompensaciones menores y 78 con otros eventos. La tasa de alertas inexplicables fue 0,39/año-paciente. Fuera del estado de alerta solo hubo una hospitalización y una descompensación menor. La mayoría de las alertas (el 82% en fase 2 y el 81% en fase 3; p=0,861) se gestionaron a distancia. La mediana de NT-proBNP fue superior en estado de alerta que fuera de él (7.378 frente a 1.210 pg/ml; p <0,001).
El índice HeartLogic se asoció con descompensaciones de IC y otros eventos relevantes, con baja tasa de alertas inexplicables. Un protocolo estandarizado permitió detectar y actuar a distancia con seguridad sobre las alertas.
Multiparametric scores have been designed for better risk stratification in Brugada syndrome (BrS). We aimed to validate 3 multiparametric approaches (the Delise score, Sieira score and the Shanghai ...BrS Score) in a cohort with Brugada syndrome and electrophysiological study (EPS).
We included patients diagnosed with BrS and previous EPS between 1998 and 2019 in 23 hospitals. C-statistic analysis and Cox proportional hazard regression models were used.
A total of 831 patients were included (mean age, 42.8±13.1; 623 75% men; 386 46.5% had a type 1 electrocardiogram (ECG) pattern, 677 81.5% were asymptomatic, and 319 38.4% had an implantable cardioverter-defibrillator). During a follow-up of 10.2±4.7 years, 47 (5.7%) experienced a cardiovascular event. In the global cohort, a type 1 ECG and syncope were predictive of arrhythmic events. All risk scores were significantly associated with events. The discriminatory abilities of the 3 scores were modest (particularly when these scores were evaluated in asymptomatic patients). Evaluation of the Delise and Sieira scores with different numbers of extra stimuli (1 or 2 vs 3) did not substantially improve the event prediction c-index.
In BrS, classic risk factors such as ECG pattern and previous syncope predict arrhythmic events. The predictive capabilities of the EPS are affected by the number of extra stimuli required to induce ventricular arrhythmias. Scores combining clinical risk factors with EPS help to identify the populations at highest risk, although their predictive abilities remain modest in the general BrS population and in asymptomatic patients.
Se han desarrollado puntuaciones multiparamétricas para una mejor estratificación del riesgo en el síndrome de Brugada (SBr). Nuestro objetivo es validar 3 abordajes multiparamétricos (las escalas Delise, Sieira y Shanghai BrS) en una cohorte de pacientes con síndrome de Brugada y estudio electrofisiológico (EEF).
Pacientes diagnosticados de SBr y con un EEF previo entre 1998-2019 en 23 hospitales. Se utilizaron análisis mediante estadístico C y modelos de regresión de riesgos proporcionales de Cox.
Se incluyó en total a 831 pacientes con una media de edad de 42,8±13,1 años; 623 (75%) eran varones; 386 (46,5%) tenían patrón electrocardiográfico (ECG) tipo 1; 677 (81,5%) estaban asintomáticos y 319 (38,4%) tenían un desfibrilador automático implantable. Durante un seguimiento de 10,2±4,7 años, 47 (5,7%) sufrieron un evento cardiovascular. En la cohorte total, un ECG tipo 1 y síncope fueron predictivos de eventos arrítmicos. Todas las puntuaciones de riesgo se asociaron significativamente con los eventos. Las capacidades discriminatorias de las 3 escalas fueron discretas (particularmente al aplicarlas a pacientes asintomáticos). La evaluación de las puntuaciones de Delise y Sieira con diferente número de extraestímulos (1 o 2 frente a 3) no mejoró sustancialmente el índice c de predicción de eventos.
En el SBr, los factores de riesgo clásicos como el ECG y el síncope previo predicen eventos arrítmicos. El número de extraestímulos necesarios para inducir arritmias ventriculares influye en las capacidades predictivas del EEF. Las escalas que combinan factores de riesgo clínico con EEF ayudan a identificar las poblaciones con más riesgo, aunque sus capacidades predictivas siguen siendo discretas tanto en población general con SBr como en pacientes asintomáticos.
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