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Abstract Aims Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. Conclusions For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.

Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug treatment. Although the number of these devices is growing, only few are supported by robust evidence. Current devices aim to improve haemodynamics, improve reverse remodelling, or provide electrical therapy. A number of these devices have guideline recommendations and some have been shown to improve outcomes such as cardiac resynchronization therapy, implantable cardioverter‐defibrillators and long‐term mechanical support. For others, more evidence is still needed before large‐scale implementation can be strongly advised. Of note, devices and drugs can work synergistically in HF as improved disease control with devices can allow for further optimization of drug therapy. Therefore, some devices might already be considered early in the disease trajectory of HF patients, while others might only be reserved for advanced HF. As such, device therapy should be integrated into HF care programmes. Unfortunately, implementation of devices, including those with the greatest evidence, in clinical care pathways is still suboptimal. This clinical consensus document of the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) describes the physiological rationale behind device‐provided therapy and also device‐guided management, offers an overview of current implantable device options recommended by the guidelines and proposes a new integrated model of device therapy as a part of HF care. [ABSTRACT FROM AUTHOR]

Aims: Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results: A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. Conclusions: For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality. [ABSTRACT FROM AUTHOR]

Abstract Aims Heart failure with reduced ejection fraction (HFrEF) is associated with excessive sympathetic and impaired parasympathetic activity. The Barostim Neo™ device is used for electronical baroreflex activation therapy (BAT) to counteract autonomic nervous system dysbalance. Randomized trials have shown that BAT improves walking distance and reduces N‐terminal prohormone of brain natriuretic peptide (NT‐proBNP) levels at least in patients with only moderate elevation at baseline. Its impact on the risk of heart failure hospitalization (HFH) and death is not yet established, and experience in clinical routine is limited. Methods and results We report on patient characteristics and clinical outcome in a retrospective, non‐randomized single‐centre registry of BAT in HFrEF. Patients in the New York Heart Association (NYHA) Classes III and IV with a left ventricular ejection fraction (LVEF) 1600 pg/mL, or estimated glomerular filtration rate (eGFR)

Atrial fibrillation (AF) is common in patients with hypertrophic cardiomyopathy (HCM) and can be challenging to manage. Atrioventricular nodal (AVN) ablation may be an effective management strategy for AF in these patients. The purpose of this study was to assess the efficacy of AVN ablation in HCM patients who have failed medical therapy and/or catheter ablation for AF. A multicenter study with retrospective analysis of a prospectively collated HCM registry was performed. AVN ablation patients were identified. Baseline characteristics and device and procedural indications were collected. Symptoms defined by New York Heart Association and European Heart Rhythm Association classification and echocardiographic findings during follow-up were assessed. Fifty-nine patients were included in the study. Indications for AVN ablation were 6 (10.2%) inappropriate implantable cardioverter-defibrillator shock, 35 (59.3%) ineffective rate control, and 18 (30.5%) to regularize rhythm for symptom improvement. During post-AVN ablation follow-up of 79.4 ± 61.1 months, left ventricular ejection fraction (LVEF) remained stable (pre-LVEF 48.9% ± 12.6% vs post-LVEF 50.1% ± 10.1%; P =.29), even in those without a cardiac resynchronization therapy (CRT) device (pre-LVEF 54.3% ± 8.0% vs post-LVEF 53.8% ± 8.0%; P =.65). Forty-nine patients (83.1%) reported an improvement in symptoms regardless of AF type (17/21 [81.0%] paroxysmal vs 32/38 [84.2%] persistent; P = 1.00), presence of baseline left ventricular impairment (22/26 [84.6%] LVEF ≤50% vs 27/33 [81.8%] LVEF ≥50%; P = 1.00) or CRT device (27/32 [84.4%] CRT vs 22/27 [81.5%] no CRT; P = 1.00). Symptoms improved in 16 patients (89.0%) who underwent AVN ablation to regularize rhythm. AVN ablation improved symptoms without impacting left ventricular function in the majority of patients. The data suggest that AVN ablation is an effective and safe management approach for AF in HCM and should be further evaluated in larger prospective studies. [ABSTRACT FROM AUTHOR]

Aims: Heart failure with reduced ejection fraction (HFrEF) is associated with excessive sympathetic and impaired parasympathetic activity. The Barostim Neo™ device is used for electronical baroreflex activation therapy (BAT) to counteract autonomic nervous system dysbalance. Randomized trials have shown that BAT improves walking distance and reduces N‐terminal prohormone of brain natriuretic peptide (NT‐proBNP) levels at least in patients with only moderate elevation at baseline. Its impact on the risk of heart failure hospitalization (HFH) and death is not yet established, and experience in clinical routine is limited. Methods and results: We report on patient characteristics and clinical outcome in a retrospective, non‐randomized single‐centre registry of BAT in HFrEF. Patients in the New York Heart Association (NYHA) Classes III and IV with a left ventricular ejection fraction (LVEF) <35% despite guideline‐directed medical therapy were eligible. Symptom burden, echocardiography, and laboratory testing were assessed at baseline and after 12 months. Clinical events of HFH and death were recorded at routine clinical follow‐up. Data are shown as number (%) or median (inter‐quartile range). Between 2014 and 2020, 30 patients were treated with BAT. Median age was 67 (63–77) years, and 27 patients (90%) were male. Most patients (83%) had previous HFH. Device implantation was successful in all patients. At 12 months, six patients had died and three were alive but did not attend follow‐up. NYHA class was III/IV in 26 (87%)/4 (13%) patients at baseline, improved in 19 patients, and remained unchanged in 5 patients (P < 0.001). LVEF improved from 25.5 (20.0–30.5) % at baseline to 30.0 (25.0–36.0) % at 12 months (P = 0.014). Left ventricular end‐diastolic diameter remained unchanged. A numerical decrease in NT‐proBNP [3165 (880–8085) vs. 1001 (599–3820) pg/mL] was not significant (P = 0.526). Median follow‐up for clinical events was 16 (10–33) months. Mortality at 1 (n = 6, 20%) and 3 years (n = 10, 33%) was as expected by the Meta‐Analysis Global Group in Chronic Heart Failure risk score. Despite BAT, event rate was high in patients with NYHA Class IV, NT‐proBNP levels >1600 pg/mL, or estimated glomerular filtration rate (eGFR) <30 mL/min at baseline. NYHA class and eGFR were independent predictors of mortality. Conclusions: Patients with HFrEF who are selected for BAT are in a stage of worsening or even advanced heart failure. BAT appears to be safe and improves clinical symptoms and—to a modest degree—left ventricular function. The risk of death remains high in advanced disease stages. Patient selection seems to be crucial, and the impact of BAT in earlier disease stages needs to be established. [ABSTRACT FROM AUTHOR]

The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM). Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers. One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3–6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents. Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL. [ABSTRACT FROM AUTHOR]

With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.

Klevin Roger L Reyes, Florian Rader Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USACorrespondence: Florian Rader, Hypertension Center of Excellence, 127 San Vincente Blvd. AHSP A3408, Los Angeles, CA, 90048, USA, Tel +1 310 423-3880, Fax +1 310 967-3805, Email Florian.Rader@cshs.orgAbstract: Hypertension is the most potent modifiable risk factor for the development of cardiovascular morbidity and mortality worldwide. Nevertheless, blood pressure (BP) control on a broad scale appears to be insurmountable and has even worsened in the US. Barriers to sustained hypertension control are multifactorial and although lack of patient awareness and socioeconomic barriers to healthcare access may play a role, medication non-compliance and therapeutic inertia are major causes. Renal denervation (RDN) is a minimally invasive procedure that has been the subject of interest in clinical trials for more than a decade and although the first sham-controlled trial could not detect group difference between treated and untreated hypertensives, subsequent, better designed sham-controlled trials clearly demonstrated the BP lowering effect of RDN, as well as its safety. While to-date, RDN is not available for routine clinical practice, one major requirement for broad implementation is that the BP lowering effect is durable. Therefore, this review will summarize the available long-term data of the different RDN modalities with respect to both effectiveness and safety.Keywords: hypertension, renal denervation, device therapy, blood pressure device, resistant hypertension

Background: The number of young patients receiving ICDs or CRT-Ds has been increasing in recent decades and understanding the key characteristics of this special population is paramount to optimized patient care. Methods: The DEVICE I+II registry prospectively enrolled patients undergoing ICD/CRT-D implantation or revision from 50 German centers between 2007 and 2014 Data on patient characteristics, procedural outcome, adverse events, and mortality during the initial stay and 1-year follow-up were collected. All patients under the age of 45 years were identified and included in a comparative analysis with the remaining population. Results: A total number of 5313 patients were enrolled into the registry, of which 339 patients (6.4%) were under the age of 45 years. Mean age was 35.0 ± 8.2 vs. 67.5 ± 9.7 years, compared to older patients (≥45 years). Young patients were more likely to receive an ICD (90.9 vs. 69.9%, p < 0.001) than a CRT-D device (9.1 vs. 30.1%). Coronary artery disease was less common in younger patients (13.6 vs. 63.9%, p < 0.001), whereas hypertrophic cardiomyopathy (10.9 vs. 2.7%, p < 0.001) and primary cardiac electrical diseases (11.2 vs. 1.5%, p < 0.001) were encountered more often. Secondary preventive ICD was more common in younger patients (51.6 vs. 39.9%, p < 0.001). Among those patients, survival of sudden cardiac death (66.7 vs. 45.4%, p < 0.001) due to ventricular fibrillation (60.6 vs. 37.9%, p < 0.001) was the leading cause for admission. There were no detectable differences in postoperative complications requiring intervention (1.5 vs. 1.9%, p = 0.68) or in-hospital mortality (0.0 vs. 0.3%, p = 0.62). Median follow-up duration was 17.9 [13.4–22.9] vs. 16.9 [13.1–23.1] months (p = 0.13). In younger patients, device-associated complications requiring revision were more common (14.1 vs. 8.3%, p < 0.001) and all-cause 1-year-mortality after implantation was lower (2.9 vs. 7.3%, p = 0.003; HR 0.39, 95%CI: 0.2–0.75) than in older patients. Conclusions: Young patients < 45 years of age received defibrillator therapy more often for secondary prevention. Rates for periprocedural complications and in-hospital mortality were very low and without differences between groups. Young patients have lower mortality during follow-up but experienced a higher rate of postoperative complications requiring revision, potentially due to a more active lifestyle.

This review provides a contemporary overview of HF management and highlights the key studies which have informed recent European HF guidelines. [ABSTRACT FROM AUTHOR]

The incidence of heart failure (HF) continues to grow and burden our health care system. Electrophysiological aberrations are common amongst patients with heart failure and can contribute to worsening symptoms and prognosis. Targeting these abnormalities with cardiac and extra-cardiac device therapies and catheter ablation procedures augments cardiac function. Newer technologies aimed to improvement procedural outcomes, address known procedural limitations and target newer anatomical sites have been trialled recently. We review the role and evidence base for conventional cardiac resynchronisation therapy (CRT) and its optimisation, catheter ablation therapies for atrial arrhythmias, cardiac contractility and autonomic modulation therapies. [ABSTRACT FROM AUTHOR]

Tricuspid regurgitation is a widely recognised phenomenon in patients with transvenous cardiac rhythm management (CRM) devices. If tricuspid valve repair or replacement is to be considered, what to do with the existing CRM system requires scrutiny with multidisciplinary input. We present a case of multifactorial tricuspid regurgitation in a 48‐year‐old female with giant cell myocarditis and a transvenous implantable cardioverter‐defibrillator (ICD). Key considerations in management and alternative CRM options are discussed. [ABSTRACT FROM AUTHOR]

For this reason, the presence of severe right valve insufficiency represents a relative contraindication to CCM therapy; however, in carefully selected cases of functional tricuspid regurgitation, CCM therapy-induced right ventricular reverse remodeling could induce a reduction of the degree of tricuspid regurgitation. Therefore, in patients with HFrEF and HFmrEF, CCM therapy should be considered, as an add-on therapy, after 3 months of optimizing disease-modifier drug therapy [[14]]. In randomized controlled trials, CCM therapy improves functional capacity (i.e. VO2 peak at cardiopulmonary exercise test) [[6]]; also, in a real-world registry, CCM therapy is associated with a lower rate of HF-related hospitalizations [[7]]. Keywords: Cardiac contractility modulation; device therapy; tailored therapy; heart failure with reduced ejection fraction; heart failure with mildly reduced ejection fraction EN Cardiac contractility modulation device therapy tailored therapy heart failure with reduced ejection fraction heart failure with mildly reduced ejection fraction 525 528 4 06/20/23 20230701 NES 230701 1. [Extracted from the article]

Background: It is unclear if the location of implantation of the leadless pacemaker (LP) makes a difference in the incidence of pacing‐induced cardiomyopathy (PICM). Aim: The aim of this study was to compare the incidence of PICM based on the location of implantation of LP. Methods: A total of 358 consecutive patients [women: 171 (48%), mean age: 73 ± 15 years] with left ventricular ejection fraction (EF) > 50%, who received an LP (Micra) between January 2017 and June 2022, formed the study cohort. Micra‐AV and Micra‐VR were implanted in 122 (34%) and 236 (66%) patients, respectively. Fluoroscopically, the location of implantation of LP in the interventricular septum (IS) was divided into two equal halves (apex/apical septum [AS] and mid/high septum [HS]). During follow‐up, PICM was defined as an EF drop of ≥10%. Results: LP was implanted in 109 (34%) and 249 (66%) patients at AS and HS locations, respectively. During a mean 18 ± 8 months follow‐up, 28 patients (7.8%) developed PICM. Among the 249 patients with HS placement of LP, 10 (4%) developed PICM, whereas among the 109 patients with AS placement of LP, 18 (16.5%) developed PICM (p =.002). AS location was associated with a higher risk of PICM compared to HS locations (adjusted hazard ratio: 4.42, p <.001). Conclusion: AS location of LP was associated with a higher risk of PICM compared to HS placement. Larger randomized studies are needed to confirm our findings. [ABSTRACT FROM AUTHOR]

Heart failure (HF) is one of the leading causes of global health impairment. Current drugs are still limited in their effectiveness in the treatment and reversal of HF: for example, drugs for acute HF (AHF) help to reduce congestion and relieve symptoms, but they do little to improve survival; most conventional drugs for HF with preserved ejection fraction (HFpEF) do not improve the prognosis; and drugs have extremely limited effects on advanced HF. In recent years, progress in device therapies has bridged this gap to a certain extent. For example, the availability of the left ventricular assist device has brought new options to numerous advanced HF patients. In addition to this recognizable device, a range of promising novel devices with preclinical or clinical trial results are emerging that seek to treat or reverse HF by providing circulatory support, repairing structural abnormalities in the heart, or providing electrical stimulation. These devices may be useful for the treatment of HF. In this review, we summarized recent advances in novel devices for AHF, HFpEF, and HF with reduced ejection fraction (HFrEF) with the aim of providing a reference for clinical treatment and inspiration for novel device development. [ABSTRACT FROM AUTHOR]

Background: The left atrial assist device (LAAD) is a novel pump that was developed specifically for the treatment of heart failure with preserved ejection fraction. The device is surgically implanted in the mitral position. This study aimed to characterize the various device‐fitting configurations in the mitral annular position. Methods: Rapidly prototyped LAAD models (n = 5) were fabricated with five different driveline configurations: (A) annulus level/intra‐cuff running; (B) supra‐cuff/below coronary sinus (CS); (C) infra‐cuff; (D) supra‐annulus/supra‐CS; (E) left ventricular free wall level. The 3D‐printed models were implanted in extracted fresh porcine hearts (80–100 kg, adult, healthy porcine) and the proximity of anatomical structures between the driveline and CS and coronary artery (CA) were measured. Results: All five device configurations were evaluated for fitting. For the purpose of preventing blood clot formation around the driveline, the mitral annulus (MA) as a driveline pass‐way (configuration A) has been considered advantageous with the current device, in that the driveline exposure to blood has been avoided. The CS does not exist at exactly the same level as the MA, and there is less risk of injuring it than using the left atrial free wall. However, there is an inevitable risk of damaging the CA, so careful visual inspection before inserting the driveline is needed. Conclusions: Several options of driveline exteriorization were demonstrated, and the safety of each configuration was evaluated. Using the MA as a pathway for the driveline exit is considered to be a reasonable and safe method. [ABSTRACT FROM AUTHOR]

Cardiac resynchronisation therapy (CRT) has become the cornerstone of heart failure (HF) treatment. Despite the obvious benefit from this therapy, an estimated 30% of CRT patients do not respond (“non-responders”). The cause of “non-response” is multi-factorial and includes suboptimal device settings. To optimise CRT settings, echocardiography has been considered the gold standard but has limitations: it is user dependent and consumes time and resources. CRT proprietary algorithms have been developed to perform device optimisation efficiently and with limited resources. In this review, we discuss CRT optimisation including the various adopted proprietary algorithms and conduction system pacing.

Aims: This pilot study aimed to assess the potential benefits of cardiac contractility modulation (CCM) in patients with heart failure with preserved ejection fraction (HFpEF). Methods and results: This was a prospective, multicentre, single‐arm, pilot study of CCM therapy in patients with HFpEF and New York Heart Association (NYHA) class II or III. Echocardiographic parameters were measured by an echo core laboratory to determine study eligibility. After CCM device implantation, patients were followed for 24 weeks. Overall, 47 patients (mean age 74.3 ± 4.4 years, 70.2% female) were enrolled, with left ventricular ejection fraction of 59 ± 4.4%, 63.8% with hypertension, 46.8% with atrial fibrillation, 40.4% with diabetes, 31.9% with at least one heart failure hospitalization in the prior year, 61.7% in NYHA class III, and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of 48.9 ± 21.7. The primary efficacy endpoint (mean change in the KCCQ overall summary score) improved by 18.0 ± 16.6 points (p < 0.001) and there was an event‐free rate of 93.6% for the primary safety endpoint (device‐ and procedure‐related complications), as adjudicated by an independent physician committee. Conclusion: This pilot study demonstrates that the benefits of CCM may extend to the HFpEF patient population. The significant improvement in health status observed, with no obvious impact on safety, suggests that utilization of CCM for patients with HFpEF could prove to be promising. [ABSTRACT FROM AUTHOR]

Copyright of Zeitschrift für Herz-, Thorax- und Gefaesschirurgie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with refractory systolic heart failure and normal QRS width. Randomized trials demonstrated benefits of CCM primarily for patients with severe heart failure (> NYHA class II). Purpose: To better understand individualized indication in clinical practice, we compared the effect of CCM in patients with baseline NYHA class II vs. NYHA class III or ambulatory IV over the 5-year period in our large clinical registry (MAINTAINED Observational Study). Methods: Changes in NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP level, and KDIGO chronic kidney disease stage were compared as functional parameters. In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic heart failure risk score. Results: A total of 172 patients were included in the analyses (10% with NYHA class II). Only patients with NYHA class III/IV showed a significant improvement in NYHA class over 5 years of CCM (II: 0.1 ± 0.6; p = 0.96 vs. III/IV: − 0.6 ± 0.6; p < 0.0001). In both groups, LVEF improved significantly (II: 4.7 ± 8.3; p = 0.0072 vs. III/IV: 7.0 ± 10.7%; p < 0.0001), while TAPSE improved significantly only in NYHA class III/IV patients (II: 2.2 ± 1.6; p = 0.20 vs. III/IV: 1.8 ± 5.2 mm; p = 0.0397). LVEF improvement was comparable in both groups over 5 years of CCM (p = 0.83). NYHA class II patients had significantly lower NT-proBNP levels at baseline (858 [175/6887] vs. 2632 [17/28830] ng/L; p = 0.0044), which was offset under therapy (399 [323/1497] vs. 901 [13/18155] ng/L; p = 0.61). Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p = 0.0038 for NYHA class III/IV patients). Conclusions: NYHA class III/IV patients experienced more direct and extensive functional improvements with CCM and a survival benefit compared with the predicted risk. However, our data suggest that NYHA class II patients may also benefit from the sustained positive effects of LVEF improvement. [ABSTRACT FROM AUTHOR]

Purpose of Review: Cardiac implantable electronic device implant numbers are continually increasing due to the expanding indications and ageing population. This review explores the complications associated with device therapy and discusses ways to minimise and manage such complications. Recent Findings: Complications related to device therapy contribute to mortality and morbidity. Recent publications have detailed clear guidelines for appropriate cardiac device selection, as well as consensus documents discussing care quality and optimal implantation techniques. There have also been advances in device technologies that may offer alternative options to patients at high risk of/or already having encountered a complication. Summary: Adherence to guidelines, appropriate training, and selection of device, in addition to good surgical technique are key in reducing the burden of complications and improving acceptability of device therapy. [ABSTRACT FROM AUTHOR]

Background There are few US Food and Drug Administration (FDA)–approved devices specifically aimed at the pediatric patient with arrhythmia. This has led to a high off‐label utilization of devices in this vulnerable population. The Pediatric and Congenital Electrophysiology Society (PACES), the international organization representing pediatric and congenital heart disease arrhythmia specialists, developed a task force to comprehensively address device development issues relevant to pediatric patients with congenital arrhythmia. Methods and Results As a first step, the taskforce developed a 26‐question survey for the pediatric arrhythmia community to assess providers’ understanding of the FDA approval process, specifically in regard to pediatric labeling. There were 92/211 respondents (44%) with a >90% completion rate. The vast majority of respondents believed there was a paucity of devices available for children (96%). More than 60% of respondents stated that they did not understand the FDA regulatory process and were not aware of whether the devices they used were labeled for pediatric use. Conclusions Pediatric electrophysiologists are keenly aware of the deficit of available pediatric devices for their patients. The majority do not understand the FDA approval process and could benefit from additional educational resources regarding this. A collaborative forum including PACES, FDA, patients and their families, and Industry would be an important next step in clarifying opportunities and priorities to serve this vulnerable population.

Device therapy for severe heart failure (HF) has shown efficacy both in acute and chronic settings. Recent percutaneous device innovations have pioneered a field known as interventional HF, providing clinicians with a variety of options for acute decompensated HF that are centered on nonsurgical mechanical circulatory support. Other structural-based therapies are aimed at the pathophysiology of chronic HF and target the underlying etiologies such as functional mitral regurgitation, ischemic cardiomyopathy, and increased neurohumoral activity. Remote hemodynamic monitoring devices have also been shown to be efficacious for the ambulatory management of HF. We review the current data on devices and investigational therapies for HF management whereby pharmacotherapy falls short. [ABSTRACT FROM AUTHOR]

Cardiac amyloidosis (CA) results in symptoms of heart failure, atrial and ventricular arrhythmias, conduction disturbances, and profound autonomic dysfunction. These symptoms present unique management challenges as compared with patients without CA, and can be very debilitating. Thus, management of the cardiovascular symptoms of these patients plays a central role in their care. This review presents an overview of the typical cardiovascular manifestations encountered in patients with CA and highlights the key management considerations for each. [ABSTRACT FROM AUTHOR]

Copyright of Archives of the Turkish Society of Cardiology / Türk Kardiyoloji Derneği Arşivi is the property of KARE Publishing and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background Patients with a systemic right ventricle (sRV) in the context of transposition of the great arteries (TGA) late after atrial switch are prone to heart failure. Complications like tricuspid valve regurgitation (TR) can further aggravate sRV dysfunction. Tricuspid valve regurgitation is usually secondary to annular dilatation and restriction. Criteria for cardiac resynchronization therapy (CRT) in this patient group are not well defined and should be considered on a case-by-case basis. Case summary We present a case of a 42-year-old male with sRV failure and TR in the context of TGA after atrial switch. Patient had progressive reduction in exercise capacity. Electrocardiogram showed a wide QRS complex (right bundle branch block configuration). Echocardiography showed significant TR and signs of electromechanical dyssynchrony of the failing sRV with severely reduced systolic function. He underwent heart catheterization and invasive haemodynamic evaluation to assess the potential benefit of CRT. During sequential atrial-sRV pacing, 20% increase in Dp / Dt was measured, suggesting that he would be a CRT responder. Concomitant angiography showed no baffle leakage nor obstructive coronary artery disease. Hybrid CRT-defibrillator implantation resulted in successful resynchronization and improved sRV function, reduced TR and better exercise capacity. Discussion Invasive haemodynamic contractility evaluation can help assess the potential benefit of CRT in patients with systemic right ventricular failure in the context of transposition of TGA after atrial switch. Successful CRT can result in improved sRV function, reduced TR and improved exercise capacity. [ABSTRACT FROM AUTHOR]

In the year 2021, the universal definition and classification of heart failure (HF) was published that defines HF as a clinical syndrome with symptoms and/or signs caused by a cardiac abnormality and corroborated by elevated natriuretic peptide levels or objective evidence of cardiogenic congestion. This definition and the classification of HF with reduced ejection fraction (HFrEF), mildly reduced, and HF with preserved ejection fraction (HFpEF) is consistent with the 2021 ESC Guidelines on HF. Among several other new recommendations, these guidelines give a Class I indication for the use of the sodium–glucose co-transporter 2 (SGLT2) inhibitors dapagliflozin and empagliflozin in HFrEF patients. As the first evidence-based treatment for HFpEF, in the EMPEROR-Preserved trial, empagliflozin reduced the composite endpoint of cardiovascular death and HF hospitalizations. Several reports in 2021 have provided novel and detailed analyses of device and medical therapy in HF, especially regarding sacubitril/valsartan, SGLT2 inhibitors, mineralocorticoid receptor antagonists, ferric carboxymaltose, soluble guanylate cyclase activators, and cardiac myosin activators. In patients hospitalized with COVID-19, acute HF and myocardial injury is quite frequent, whereas myocarditis and long-term damage to the heart are rather uncommon. [ABSTRACT FROM AUTHOR]

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Cardiac contractility modulation (CCM) is an FDA-approved device-based therapy for patients with systolic heart failure and normal QRS width who are symptomatic despite optimal drug therapy. The purpose of this study was to compare the long-term therapeutic effects of CCM therapy in patients with ischemic (ICM) versus non-ischemic cardiomyopathy (NICM). Changes in NYHA class, KDIGO CKD stage, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), and NT-proBNP levels were compared as functional parameters. Moreover, observed mortality rates at 1 and 3 years were compared to those predicted by the MAGGIC heart failure risk score, and observed mortality rates were compared between groups for the entire follow-up period. One hundred and seventy-four consecutive patients with chronic heart failure and CCM device implantation between 2002 and 2019 were included in this retrospective analysis. LVEF was significantly higher in NICM patients after 3 years of CCM therapy (35 ± 9 vs. 30 ± 9%; p = 0.0211), and after 5 years, also TAPSE of NICM patients was significantly higher (21 ± 5 vs. 18 ± 5%; p = 0.0437). There were no differences in other effectiveness parameters. Over the entire follow-up period, 35% of all patients died (p = 0.81); only in ICM patients, mortality was lower than predicted at 3 years (35 vs. 43%, p = 0.0395). Regarding improvement of biventricular systolic function, patients with NICM appear to benefit particularly from CCM therapy. • Under CCM therapy, patients with NICM have more pronounced improvement in LVEF and TAPSE than patients with ICM in the long term. • Patients with more severely impaired LVEF of 20 to 25% also benefit from CCM therapy. • Safety events related to the device are rare with this therapy. [ABSTRACT FROM AUTHOR]

Objective: Despite recommendations from heart failure guidelines on the use of pharmacologic and device therapy in patients with heart failure with reduced ejection fraction (HFrEF), important inconsistencies in guideline adherence persist in practice. The aim of this study was to assess adherence to guideline-directed medical and device therapy for the treatment of patients with chronic HFrEF (left ventricular ejection fraction ≤40%). Methods: The Adherence to guideline-directed medical and device Therapy in outpAtients with HFrEF (ATA) study is a prospective, multicenter, observational study conducted in 24 centers from January 2019 to June 2019. Results: The study included 1462 outpatients (male: 70.1%, mean age: 67+-11 years, mean LVEF: 30%+-6%) with chronic HFrEF. Renin–angiotensin system (RAS) inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and ivabradin were used in 78.2%, 90.2%, 55.4%, and 12.1% of patients, respectively. The proportion of patients receiving target doses of medical treatments was 24.6% for RAS inhibitors, 9.9% for beta-blockers, and 10.5% for MRAs. Among patients who met the criteria for implantable cardioverter–defibrillator (ICD) and cardiac resynchronization therapy (CRT), only 16.9% of patients received an ICD (167 of 983) and 34% (95 of 279) of patients underwent CRT (95 of 279). Conclusion: The ATA study shows that most HFrEF outpatients receive RAS inhibitors and beta-blockers but not MRAs or ivabradin when the medical reasons for nonuse, such as drug intolerance or contraindications, are taken into account. In addition, most eligible patients with HFrEF do not receive target doses of pharmacological treatments or guideline-recommended device therapy.

Abstract Background The ANZACS‐QI Cardiac Implanted Device Registry (ANZACS‐QI DEVICE) collects nationwide data on cardiac implantable electronic devices in New Zealand (NZ). We used the registry to describe contemporary NZ use of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT). Methods All ICD and CRT Pacemaker implants recorded in ANZACS‐QI DEVICE between 1 January 2014 and 31 December 2017 were analyzed. Results Of 1579 ICD implants, 1152 (73.0%) were new implants, including 49.0% for primary prevention and 51.0% for secondary prevention. In both groups, median age was 62 years and patients were predominantly male (81.4% and 79.2%, respectively). Most patients receiving a primary prevention ICD had a history of clinical heart failure (80.4%), NYHA class II‐III symptoms (77.1%) and LVEF ≤35% (96.9%). In the secondary prevention ICD cohort, 88.4% were for sustained ventricular tachycardia or survived cardiac arrest from ventricular arrhythmia. Compared to primary prevention CRT Defibrillators (n = 155), those receiving CRT Pacemakers (n = 175) were older (median age 74 vs 66 years) and more likely to be female (38.3% vs 19.4%). Of the 427 (27.0%) ICD replacements (mean duration 6.3 years), 46.6% had received appropriate device therapy while 17.8% received inappropriate therapy. The ICD implant rate was 119 per million population with regional variation in implant rates, ratio of primary prevention ICD implants, and selection of CRT modality. Conclusion In contemporary NZ practice three‐quarters of ICD implants were new implants, of which half were for primary prevention. The majority met current guideline indications. Patients receiving CRT pacemaker were older and more likely to be female.

Background : The number of young patients receiving ICDs or CRT-Ds has been increasing in recent decades and understanding the key characteristics of this special population is paramount to optimized patient care. Methods : The DEVICE I+II registry prospectively enrolled patients undergoing ICD/CRT-D implantation or revision from 50 German centers between 2007 and 2014 Data on patient characteristics, procedural outcome, adverse events, and mortality during the initial stay and 1-year follow-up were collected. All patients under the age of 45 years were identified and included in a comparative analysis with the remaining population. Results : A total number of 5313 patients were enrolled into the registry, of which 339 patients (6.4%) were under the age of 45 years. Mean age was 35.0 ± 8.2 vs. 67.5 ± 9.7 years, compared to older patients (≥45 years). Young patients were more likely to receive an ICD (90.9 vs. 69.9%, p < 0.001) than a CRT-D device (9.1 vs. 30.1%). Coronary artery disease was less common in younger patients (13.6 vs. 63.9%, p < 0.001), whereas hypertrophic cardiomyopathy (10.9 vs. 2.7%, p < 0.001) and primary cardiac electrical diseases (11.2 vs. 1.5%, p < 0.001) were encountered more often. Secondary preventive ICD was more common in younger patients (51.6 vs. 39.9%, p < 0.001). Among those patients, survival of sudden cardiac death (66.7 vs. 45.4%, p < 0.001) due to ventricular fibrillation (60.6 vs. 37.9%, p < 0.001) was the leading cause for admission. There were no detectable differences in postoperative complications requiring intervention (1.5 vs. 1.9%, p = 0.68) or in-hospital mortality (0.0 vs. 0.3%, p = 0.62). Median follow-up duration was 17.9 [13.4-22.9] vs. 16.9 [13.1-23.1] months ( p = 0.13). In younger patients, device-associated complications requiring revision were more common (14.1 vs. 8.3%, p < 0.001) and all-cause 1-year-mortality after implantation was lower (2.9 vs. 7.3%, p = 0.003; HR 0.39, 95%CI: 0.2-0.75) than in older patients. Conclusions : Young patients < 45 years of age received defibrillator therapy more often for secondary prevention. Rates for periprocedural complications and in-hospital mortality were very low and without differences between groups. Young patients have lower mortality during follow-up but experienced a higher rate of postoperative complications requiring revision, potentially due to a more active lifestyle.

The regulatory landscape for device-based heart failure (HF) therapies has seen a major shift in the last 7 years. In 2013, the U.S. Food and Drug Administration released guidance for early feasibility and first-in-human studies, thereby encouraging device innovation, and in 2016 the U.S. Congress authorized the Breakthrough Devices Program to expedite access for Americans to innovative devices indicated for diagnosis and treatment of serious illnesses, such as HF. Since December 2016, there has been an increase in the number of HF devices for which manufacturers are seeking approval through the breakthrough designation pathway. This has led to a rapid uptake in the development and evaluation of device-based HF therapies. This article reviews the current and future landscape of device therapies for chronic HF and associated comorbidities and the regulatory environment that is driving current and future innovation. [ABSTRACT FROM AUTHOR]

These practice guidelines on the management of arterial hypertension are a concise summary of the more extensive ones prepared by the Task Force jointly appointed by the European Society of Hypertension and the European Society of Cardiology. These guidelines have been prepared on the basis of the best available evidence on all issues deserving recommendations; their role must be educational and not prescriptive or coercive for the management of individual subjects who may differ widely in their personal, medical and cultural characteristics. The members of the Task Force have participated independently in the preparation of these guidelines, drawing on their academic and clinical experience and by objective examination and interpretation of all available literature. A disclosure of their potential conflict of interest is reported on the websites of the ESH and the ESC.

Purpose: The conventional surgical treatment for postinfarction left ventricular aneurysm (LVA) is open-heart repair with cardiopulmonary bypass. However, the risk of the open-heart surgery under cardiopulmonary bypass may result in an unacceptable risk for many patients with multiple comorbidities. Here, we reported a new off-pump repair technique for postinfarction apical LVA., Methods: A new off-pump repair technique, circular banding and occlusion technique, was applied to repair the postinfarction apical LVA in 12 patients. Clinical data of all those 12 patients were retrospectively reviewed. Patients were followed up prospectively by direct interviews and echocardiographic examination., Results: The new repair technique was successfully performed in all these 12 patients. Acute reduction of the LVA mouth diameter, the left ventricular (LV) end-diastolic volume and end-systolic volume, and an increase in the LV ejection fraction (EF) were immediately obtained after the repair. Patients had an uneventful postoperative course. They were in New York Heart Association class 1-2, and the LV volume and EF detected by echocardiography remained unchanged during an average 28.4 ± 9.9 months (range 13 to 45 months) follow-up., Conclusions: Circular banding and occlusion is a simple, safe, and effective off-pump repair technique for postinfarction apical LVA. It can allow effective LV remodeling and improve heart function.

Elevated left atrial pressure during exercise is a hallmark of heart failure (HF) and is associated with adverse left atrial remodeling and poor outcomes. To decompress the pressure-overloaded left atrium in patients with HF, several device-based approaches have been developed to create a permanent, pressure-dependent, left-to-right interatrial shunt. Such approaches are currently in various stages of investigations in both HF with reduced ejection fraction (EF) and HF with preserved EF. This review discusses the evolution of the concept of left atrial decompression and summarizes the current landscape of device-based approaches used for left atrial decompression., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The subcutaneous implantable cardioverter-defibrillator (S-ICD) consists of a large generator and is implanted near the left breast. This might lead to discomfort and problems with self-perception and sexuality, especially in the female population. We aimed to assess the issues that female S-ICD patients experience and to provide practical guidance for cardiologists and implanters on minimizing these issues. For this retrospective single-center study, we conducted semi-structured interviews with four female S-ICD patients and processed their experiences into a questionnaire. This consisted of three open questions and 17 statements that participants could answer through a five-point Likert scale. The questionnaire was subsequently sent to all female adult patients who received an S-ICD between February 2009 and November 2018 in our tertiary centre in Amsterdam, the Netherlands. The response rate of the questionnaire was 73%, with 52 female respondents (mean age 47.4 ± 12.5 years, mean time since implant 4.6 ± 3.1 years). Postoperative pain exceeded the expectation of 54% of the respondents. Furthermore, 14 out of 49 respondents (29%) expressed an unpleasant feeling during intimate contact with their sexual partner since the implant. Many women (44%) reported daily discomfort caused by their bra and preferred a more cranial and posterior position of the S-ICD generator. Finally, a smaller design of the generator is desired by a great majority (63%) of female S-ICD patients Female S-ICD patients experience a variety of issues with a substantial impact on their daily life. Most issues that we identified would benefit from adequate counseling and implanter awareness. • Female patients have a strong wish for a smaller and flatter S-ICD generator. • After S-ICD implant, females experience a variety of physical and esthetical issues. • With awareness and counseling, health care professionals could amend these issues. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 39-year-old man with the evaluation of dyspnea on exertion. Topics include patient developing symptoms of heart failure, documenting complete AVB, and severe left ventricular systolic dysfunction; and atrial and biventricular paced rhythm being observed after the effective shock therapy.

In contrast to the wealth of proven therapies for heart failure with reduced ejection fraction (HFrEF), therapeutic efforts in the past have failed to improve outcomes in heart failure with preserved ejection fraction (HFpEF). Moreover, to this day, diagnosis of HFpEF remains controversial. However, there is growing appreciation that HFpEF represents a heterogeneous syndrome with various phenotypes and comorbidities which are hardly to differentiate solely by LVEF and might benefit from individually tailored approaches. These hypotheses are supported by the recently presented PARAGON-HF trial. Although treatment with LCZ696 did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among HFpEF patients, subanalyses suggest beneficial effects in female patients and those with an LVEF between 45 and 57%. In the future, prospective randomized trials should focus on dedicated, well-defined subgroups based on various information such as clinical characteristics, biomarker levels, and imaging modalities. These could clarify the role of LCZ696 in selected individuals. Furthermore, sodium-glucose cotransporter-2 inhibitors have just proven efficient in HFrEF patients and are currently also studied in large prospective clinical trials enrolling HFpEF patients. In addition, several novel disease-modifying drugs that pursue different strategies such as targeting cardiac inflammation and fibrosis have delivered preliminary optimistic results and are subject of further research. Moreover, innovative device therapies may enhance management of HFpEF, but need prospective adequately powered clinical trials to confirm safety and efficacy regarding clinical outcomes. This review highlights the past, present, and future therapeutic approaches in HFpEF. [ABSTRACT FROM AUTHOR]

Objective: Despite recommendations from heart failure guidelines on the use of pharmacologic and device therapy in patients with heart failure with reduced ejection fraction (HFrEF), important inconsistencies in guideline adherence persist in practice. The aim of this study was to assess adherence to guideline-directed medical and device therapy for the treatment of patients with chronic HFrEF (left ventricular ejection fraction =40%). Methods: The Adherence to guideline-directed medical and device Therapy in outpAtients with HFrEF (ATA) study is a prospective, multicenter, observational study conducted in 24 centers from January 2019 to June 2019. Results: The study included 1462 outpatients (male: 70.1%, mean age: 67±11 years, mean LVEF: 30%±6%) with chronic HFrEF. Renin-angiotensin system (RAS) inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and ivabradin were used in 78.2%, 90.2%, 55.4%, and 12.1% of patients, respectively. The proportion of patients receiving target doses of medical treatments was 24.6% for RAS inhibitors, 9.9% for beta-blockers, and 10.5% for MRAs. Among patients who met the criteria for implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT), only 16.9% of patients received an ICD (167 of 983) and 34% (95 of 279) of patients underwent CRT (95 of 279). Conclusion: The ATA study shows that most HFrEF outpatients receive RAS inhibitors and beta-blockers but not MRAs or ivabradin when the medical reasons for nonuse, such as drug intolerance or contraindications, are taken into account. In addition, most eligible patients with HFrEF do not receive target doses of pharmacological treatments or guideline-recommended device therapy. [ABSTRACT FROM AUTHOR]