Impact of Sacubitril/Valsartan on the Long-Term Incidence of Ventricular Arrhythmias in Chronic Heart Failure Patients

El‐Battrawy, Ibrahim; Pilsinger, Christina; Liebe, Volker; Lang, Siegfried; Kuschyk, Jürgen; Zhou, Xiaobo; Borggrefe, Martin; Röger, Susanne; Akın, İbrahim

doi:10.3390/jcm8101582

Cited by 35 publications

(30 citation statements)

References 12 publications

(16 reference statements)

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“…Our study adds some novel findings on this topic; in particular, we firstly showed a statistically significant reduction in atrial fibrillation episodes on sacubitril/valsartan treatment in DCM patients with reduced ejection fraction and ICD. These data, in contrast with the results of the Paradigm HF Trial [1] and other real-world experiences [6][7][8], may be explained by the electro-mechanical atrial reverse remodeling [13], since significant reduction in atrial volumes, as well an improvement in electrocardiographic indexes of heterogeneity in atrial conduction, were observed in our study population after sacubitril/valsartan treatment. Our findings expand the recently described positive effect of sacubitril/valsartan treatment on atrial volumes [14,15] and among atrial electrical parameters, suggesting the hypothesis of a complete electro-mechanical atrial reverse remodeling.…”

Section: Discussioncontrasting

confidence: 98%

“…There are few real-world data about the clinical performance of sacubitril/valsartan among patients with heart failure and implantable cardioverter defibrillators [2][3][4]. Therefore little is known about the effect of sacubitril/valsartan on device-detected arrhythmias, both ventricular and atrial [2][3][4][5][6][7][8], and there are no reliable data on ICD electrical parameters among patients with heart failure on sacubitril/valsartan treatment.…”

Section: Discussionmentioning

confidence: 99%

“…Sacubitril/valsartan therapy demonstrated superiority in reducing the risks of death and hospitalization for heart failure (HF) among patients with reduced ejection fraction (HFrEF) when compared to guideline recommended doses of enalapril; however, no information about the mechanism leading to sudden cardiac death (SCD) was provided in the randomized control trial [1]. There are few and contrasting real-world data about the incidence of device detected tachyarrhythmias in HFrEF patients with implantable cardioverter defibrillators (ICD) treated with sacubitril/valsartan [2][3][4], and its possible direct antiarrhythmic effect is still debated [5][6][7][8][9][10]. Moreover, there are no clinical data about the effect of sacubitril/valsartan therapy on measured ICD electrical parameters, such as atrial/ventricular electrograms sensing and pacing threshold.…”

Section: Introductionmentioning

confidence: 99%

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The Effect of Sacubitril/Valsartan on Device Detected Arrhythmias and Electrical Parameters among Dilated Cardiomyopathy Patients with Reduced Ejection Fraction and Implantable Cardioverter Defibrillator

Russo

Bottino

Rago

et al. 2020

JCM

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Sacubitril/valsartan therapy reduces sudden cardiac death (SCD) among patients with reduced ejection fraction (HFrEF) when compared to guidelines recommended doses of enalapril, however the mechanism is still not clear. There are few, contrasting results about the effect of sacubitril/valsartan on arrhythmias in the clinical context of dilated cardiomyopathy (DCM) and there are no clinical data about its effect on measured implantable cardioverter defibrillator (ICD) electrical parameters, such as atrial/ventricular electrograms sensing and pacing threshold. We conducted a 12 month follow-up observational study in 167 ischemic and nonischemic DCM patients (mean age 68.1 ± 11.6 years; 85% male), with dual-chamber ICD on sacubitril/valsartan treatment, to evaluate the incidence of device detected tachyarrhythmia events, both atrial and ventricular, and the change in measured ICD electrical parameters. We collected data on clinical, electrocardiographic and echocardiographic parameters to find a possible electro-mechanical correlation within results. Our results show that DCM patients with reduced ejection fraction and ICD on sacubitril/valsartan treatment experienced a reduction in both atrial and ventricular arrhythmias incidence and an improvement in ICD electrical atrial parameters. The findings might be explained by the electro-mechanical cardiac reverse remodeling induced by sacubitril/valsartan therapy.

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Section: Discussioncontrasting

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Effect of Sacubitril/Valsartan on Device Detected Arrhythmias and Electrical Parameters among Dilated Cardiomyopathy Patients with Reduced Ejection Fraction and Implantable Cardioverter Defibrillator

Russo

Bottino

Rago

et al. 2020

JCM

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“…Different reports showed a clear temporal association between initiation of ARNI and early occurrence of ventricular arrhythmias [25][26]. Furthermore, an increased incidence of ventricular arrhythmias was recently reported in the first 12 months after initiation of sacubitril/valsartan, particularly in patients with ischaemic cardiomyopathy (11% versus 37%, p = 0.04) [27].…”

Section: Discussionmentioning

confidence: 95%

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Gatti

Antonazzo

Diemberger

et al. 2020

European Journal of Preventive Cardiology

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Aims The aim of this study was to characterise clinical priority of adverse events with sacubitril/valsartan for targeting preventive measures. Methods We used the US Food and Drug Administration adverse event reporting system (worldwide pharmacovigilance database) to compare adverse events recording sacubitril/valsartan as suspect with other cardiovascular drugs. Disproportionality analyses were performed by calculating the reporting odds ratios, deemed significant when the lower limit of the 95% confidence interval was greater than 1. Clinical priority was assigned to adverse events with significant disproportionality by scoring (range 0–10 points) five features (number of events, magnitude of the lower limit of the 95% confidence interval, mortality frequency, important/designated medical event, biological plausibility). Results Sacubitril/valsartan was recorded in 20,021 reports, with 178 adverse events associated with significant disproportionality: 71.9%, 25.9% and 2.2% were classified as weak, moderate and strong clinical priorities, respectively. Increased reporting emerged for several cardiovascular adverse events, including ‘renal failure’ ( N = 388; lower limit of the 95% confidence interval 2.26), ‘hyperkalaemia’ (314; 2.42) and ‘angioedema’ (309; 1.56). Sudden cardiac death (priority score 9 points) was the only designated medical event with strong clinical priority. Notably, sudden cardiac death occurred early after sacubitril/valsartan administration (average onset 124 days), with concomitant drugs known for pro-arrhythmic potential (e.g. amiodarone, escitalopram, mirtazapine, loop diuretics) in 26.2% of records. Conclusion The increased cardiovascular reporting of sacubitril/valsartan in the real world was largely predictable from pre-approval evidence, underlying disease and likely patients’ comorbidities. The unexpected reporting of sudden cardiac death occurred well before the complete development of positive electrical remodelling induced by sacubitril/valsartan, and calls for stringent clinical monitoring (to reduce the pro-arrhythmic burden related to co-medications), and further investigation on appropriate combination with other preventive measures.

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“…В крупном рандомизированном исследовании сакубитрила/валсартана у больных с СН со сниженной ФВ ЛЖ PARADIGM-HF [15] антиаритмический эффект сакубитрила/валсартана не был первичной конечной точкой, что следует признать важным ограничением, снижающим статистическую достоверность влияния препарата на риск внезапной сердечной смерти. Более того, некоторые исследователи наблюдали отсутствие каких-либо признаков подавления желудочковых аритмий при 12-месячном лечении систолической СН с применением сакубитрила/валсартана [16]. Не получено доказательств позитивного влияния сакубитрила/ валсартана на риск возникновения фибрилляции предсердий [15].…”

Section: обсуждение полученных результатовunclassified

Sacubitril/valsartan versus candesartan in women with heart failure receiving adjuvant therapy for breast cancer - is there any antiarrhythmic effect?

Канорский

Павловец

2020

Vestnik aritmologii

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Purpose. To compare the effects of sacubitril/valsartan and candesartan on the occurrence and course of heart arrhythmias in the standard treatment of heart failure (HF) in patients with breast cancer receiving anthracycline antibiotics as part of adjuvant polychemotherapy. Methods. The study involved 127 women aged 53 to 65 who received radical surgical and subsequent treatment for breast cancer in the MAMME clinic in Krasnodar in 2017-2020. Patients were prescribed adjuvant polychemotherapy, including anthracyclines, from 6 cycles. After randomization, standard HF therapy was carried out simultaneously with chemotherapy using sacubitril/valsartan (n=63) or candersartan (n=64). Initially, after the first, third and last courses of special cancer therapy, the heart rate was assessed using standard electrocardiography, 24-hour Holter monitoring of the electrocardiogram, transthoracic echocardiography, a 6-minute walk test were performed, and the level of the N-terminal pro-B type natriuretic peptide and high-sensitivity cardiac troponin I, the Minnesota Quality of Life Questionnaire for patients with chronic HF was completed.Results. According to the 24-hour Holter monitoring of the electrocardiogram, the burden of ventricular premature contraction significantly decreased in the sacubitril/valsartan group (p=0.018), but not in candesartan group (p=0.326). The proportion of patients with persisting episodes of unstable ventricular tachycardia was also significantly reduced in patients randomized to take sacubitril/valsartan (p=0.027), but practically did not change in the candesartan group (p=0.785). Physical exercise tolerance, a 6-minute walk distance, and a quality of life indicator significantly improved only in the sacubitril/valsartan group. According to echocardiography, sacubitril/valsartan improved systolic function of the left ventricle, and candesartan only prevented its decline under the influence of the damaging effects of chemotherapy.Conclusion. The efficacy and safety of treating patients who received cardiotoxic adjuvant chemotherapy for breast cancer, a decrease in the burden of ventricular arrhythmias, noted in the sacubitril/valsartan group, were a consequence of the intensification of treatment for HF. The cardiotoxic effect of anthracyclines can be overcome thanks to the pronounced positive neurohumoral effects of modern pharmacotherapy of HF using sacubitril/valsartan, which leads to a limitation of myocardial remodeling.

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Impact of Sacubitril/Valsartan on the Long-Term Incidence of Ventricular Arrhythmias in Chronic Heart Failure Patients

Cited by 35 publications

References 12 publications

The Effect of Sacubitril/Valsartan on Device Detected Arrhythmias and Electrical Parameters among Dilated Cardiomyopathy Patients with Reduced Ejection Fraction and Implantable Cardioverter Defibrillator

The Effect of Sacubitril/Valsartan on Device Detected Arrhythmias and Electrical Parameters among Dilated Cardiomyopathy Patients with Reduced Ejection Fraction and Implantable Cardioverter Defibrillator

Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system

Sacubitril/valsartan versus candesartan in women with heart failure receiving adjuvant therapy for breast cancer - is there any antiarrhythmic effect?

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