Implantable Device Therapy Research Articles

Taurolidine-containing solution for reducing cardiac implantable electronic device infection-early report from the European TauroPace™ registry.

Infection is a significant complication of cardiac implantable electronic device (CIED) therapy. The European TauroPace™ Registry investigates the safety and efficacy of TauroPace™ (TP), an antimicrobial solution containing taurolidine, designed to prevent CIED infections. This multicenter study included patients undergoing CIED procedures at participating centers where TP was used as a disinfectant for external hardware surfaces and an antiseptic for irrigating surgical sites. All patients eligible for CIED placement with adjunctive TP as the standard of care were included. Other aspects of CIED procedures adhered to current guidelines. Data on CIED-related infective endocarditis, CIED pocket infection, device and procedure-related complications, adverse events, and all-cause mortality were prospectively collected for 12 months. In cases of revision, the previous procedure was censored, and a new procedure was created. Binomial and Kaplan-Meier statistics were employed to analyze event rates. From January 2020 to November 2022, TP was used in 822 out of 1170 CIED procedures. Among patients who completed the 3-month follow-up, no CIED pocket infections were observed, and one case of CIED-related infective endocarditis was reported. In the 12-month follow-up cohort, two additional local pocket CIED infections were observed, resulting in a total of three major CIED infections within 1 year after the CIED placement procedure. The 3-month and 12-month major CIED infection rates were 0.125% and 0.51%, respectively. During the observation a complication rate of 4.4% was reported. No adverse events related to TP were observed. TP appears to be effective and safe in preventing CIED infections. gov Identifier: NCT04735666.

Integration of implantable device therapy in patients with heart failure. A clinical consensus statement from the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC).

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.

Lead and generator dysfunction in children and adolescents with epicardial pacemaker and implantable cardioverter defibrillator systems: The challenge of early recognition.

A major issue of cardiac implantable electronic device therapy in pediatric patients is the high incidence of lead dysfunctions and associated reinterventions. This study aims to analyze the timing and mode of generator and lead dysfunction. Retrospective single-center analysis of 283 children and young adults with an epicardial pacemaker or implantable cardioverter defibrillator therapy from 1998 to 2018. Mean age at implant was 6.1 years (SD±5.8 years) and median follow-up 6.4 years (IQR, 3.4-10.4 years) with a total of 1998.1 patient-years of cardiac device therapy. A total of 120 lead-related complications were observed in 82 patients (29.0%). They were detected by device interrogation (n=86), symptoms (n=13), intraoperative findings (n=7), routine chest radiography (n=5), routine ECG (n=4), patient alert sound by device (n=3), and physical examination (n=2). It was possible to find the date of the event on the device memory in 21 out of 120 lead dysfunctions (18%) with a median time interval between occurrence and detection of 1.3 months (IQR, 0.2-5.0 months). Moreover, 20 generator-related complications were found in 13 patients. Early recognition of lead and generator dysfunction remains challenging in pediatric patients. As symptoms are relatively rare conditions in the context of PM and ICD dysfunction, close patient monitoring is mandatory, even in asymptomatic patients with a good clinical course. To further improve the safety of pediatric pacing systems, more durable epicardial electrodes are desirable.

Discontinuation of cardiac implantable electronic device therapy after transvenous lead extraction.

Patients with cardiac implantable electronic devices (CIEDs) may no longer be eligible for continued therapy. The study aimed to assess the circumstances under which CIED reimplantation may not be necessary after transvenous lead extraction (TLE). A retrospective analysis of 3646 TLE procedures was performed with assessment of indications for device reimplantation. Reimplantation was not performed immediately after TLE in 169 (4.6%) and, in long-term follow-up, in 146 (4.0%) of patients. No further need for CIED reimplantation was mostly associated with establishment of stable sinus rhythm (2.4%), conversion of sinus node dysfunction to chronic atrial fibrillation (AF; 1.4%), or improvement in left ventricular ejection fraction (LVEF) (0.9%). Independent prognostic factors were in the pacing groups: LVEF (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.05; P <0.001), AF (OR, 3.8; 95% CI, 2.4-15.7; P <0.001), patients' age during first CIED implantation (OR, 0.97; 95% C, 0.96-0.98; P <0.001), and New York Heart Association (NYHA) class (OR, 0.616; 95% CI, 0.43-0.86; P <0.01); in the cardioverter-defibrillator group: LVEF (OR, 1.06; 95% CI, 1.04-1.09; P <001). Non-reimplanted patients had more complex procedures and more frequent complications, but survival after TLE was better in this group of patients. Reassessment of the need for continuation of CIED therapy should be considered in all patients following lead extraction and also before planned device replacement as TLE delay increases implant duration, complexity, and procedural risk. The predictors of non-reimplantation are a younger age during the first CIED implantation, lower NYHA class, presence of AF, and higher LVEF in pacemaker carriers, and, in the defibrillator group, only higher LVEF. A decision not to reimplant does not negatively affect the long-term prognosis.

Zero to minimal fluoroscopy for cardiac electronic device implantation: A systematic review and meta-analysis.

Fluoroscopy is conventionally performed for cardiac implantable electronic device (CIED) therapy and carries radiation drawback for both patients and medical workers. Recently, zero to minimal fluoroscopy (ZMF) approach is introduced to reduce radiation exposure of fluoroscopy. This study compares the feasibility and safety of ZMF approach to fluoroscopy for CIEDs therapy in adults. A systematic literature search was conducted on PubMed, ScienceDirect, and Web of Science in March 2023. All observational or experimental studies comparing ZMF approach to fluoroscopy for adult CIEDs therapy were included. Reviews, case report/series, animal studies, and non-English articles were excluded. The success rate, procedural time, fluoroscopy time, radiation dose, and complications rate were compared for each approach. Seven articles for permanent and three articles for temporary CIEDs were included for analysis. The success rate of ZMF for permanent CIEDs was similar to fluoroscopy method (OR: 0.77, 95% CI: 0.33-4.15). The procedural time of ZMF was similar to fluoroscopy for both permanent and temporary CIEDs (standardized mean difference [SMD]: 0.10, 95% CI: -0.35 to 0.55 and SMD: -0.71, 95% CI: -1.87-0.44, respectively). However, ZMF approach markedly reduced the fluoroscopy time and radiation exposure for permanent CIEDs (SMD: -1.80, 95% CI: -2.49 to -1.12 and SMD: -1.26, 95% CI: -2.24 to -0.29). The complication rate was similar for permanent CIEDs (OR: 1.08, 95% CI: 0.41-2.84), yet lowered for temporary CIEDs (OR: 0.34, 95% CI: 0.20-0.59). ZMF had similar success rate, procedural time, and sum complication rate for permanent CIEDs implantation with a significant reduction of fluoroscopy time and radiation exposure.

PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT-HF) study design and enrolment.

The HeartLogic multisensor index has been found to be a sensitive predictor of worsening heart failure (HF). However, there is limited data on this index's association and its constituent sensors with HF readmissions. The PREEMPT-HF study is a global, multicentre, prospective, observational, single-arm, post-market study. HF patients with an implantable defibrillator device or cardiac resynchronization therapy with defibrillator with HeartLogic capabilities were eligible if sensor data collection was turned on and the HeartLogic feature was not enabled. Thus, the HeartLogic Index/alert and heart sounds sensor trends were unavailable via the LATITUDE remote monitoring system to clinicians (blinded). Evaluation of subject medical records at 6months and a final in-clinic visit at 12months was required for collection of all-cause hospitalizations and HF outpatient visits. The purpose of this study is exploratory, no formal hypothesis tests are planned, and no adjustment for multiple testing will be performed. A total of 2183 patients were enrolled at 103 sites between June 2018 and June 2020. A significant proportion of the patients were implanted with implantable defibrillator devices (39%) versus cardiac resynchronization therapy with defibrillator (61%); were female (27%); over 65 (61%); New York Heart Association class I (13%), II (53%), and III (33%); ejection fraction<25% (21%); ischaemic (50%); and with a history of renal dysfunction (23%). The PREEMPT study will provide clinical data and blinded sensor trends for the characterization of sensor changes with HF readmission, tachyarrhythmias, and event subgroups. These data may help to refine the clinical use of HeartLogic and to improve patient outcomes.

Transvenous lead extraction versus surgical lead extraction or conservative treatment for cardiac implantable electronic device infections: Propensity score-weighted analyses of a nationwide claim-based database.

Infection is one of the most important complications associated with cardiac implantable electronic device (CIED) therapy. The number of reports comparing the outcomes of transvenous lead extraction (TLE), surgical lead extraction, and conservative treatment for CIED infections using a real-world database is limited. This study investigated the association between the treatment strategies for CIED infections and their outcomes. We performed a retrospective analysis of 3605 patients with CIED infections admitted to 681 hospitals using a nationwide claim-based database collected between April 2012 and March 2018. We divided the 3605 patients into TLE (n=938 [26%]), surgical lead extraction (n=182 [5.0%]), and conservative treatment (n=2485 [69%]) groups. TLE was performed more frequently in younger patients and at larger hospitals (p for trend<.001 for both). The rate of TLE increased during the study period, whereas that of surgical lead extraction decreased (p for trend<.001 for both). TLE was associated with lower in-hospital mortality (vs. surgical lead extraction: odds ratio [OR], 0.20; 95% CI, 0.06-0.70; vs. conservative treatment: OR, 0.45; 95% CI: 0.22-0.94) and lower 30-day readmission rates (vs. surgical lead extraction: OR, 0.18; 95% CI: 0.06-0.56; vs. conservative treatment: OR, 0.06; 95% CI, 0.03-0.13) in propensity score-weighted analyses. Only 26% of patients hospitalized for CIED infections received TLE. TLE was associated with significantly lower in-hospital mortality and 30-day recurrence rates than surgical lead extraction and conservative treatment, suggesting that TLE should be more widely recommended as a first-line treatment for CIED infections.

NL-EVDR: Netherlands-ExtraVascular Device Registry.

Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with asignificant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. ADutch registry-based study seems to be aunique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands-ExtraVascular Device Registry (NL-EVDR), aDutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR's device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As afirst step, apilot project has started in selected centres in October 2022 to optimise data collection.

Differences in patient characteristics, clinical practice and outcomes of cardiac implantable electric device therapy between Japan and the USA: a cross-sectional study using data from nationally representative administrative databases

ObjectivesTo identify differences in patient characteristics, clinical practice and outcomes of cardiac implantable electronic device (CIED) therapy between Japan and the USA.DesignA cross-sectional study.SettingNationally representative administrative databases from Japan and...

Efficacy of the antibacterial envelope to prevent cardiac implantable electronic device infection in a high-risk population.

Infection is a serious complication of cardiac implantable electronic device (CIED) therapy. An antibiotic-eluting absorbable envelope has been developed to reduce the infection rate, but studies investigating the efficacy and a reasonable number needed to treat in high-risk populations for infections are limited. One hundred and forty-four patients undergoing CIED implantation who received the antibacterial envelope were compared with a matched cohort of 382 CIED patients from our institution. The primary outcome was the occurrence of local infection, and secondary outcomes were any CIED-related local or systemic infections, including endocarditis, and all-cause mortality. The results were stratified by a risk score for CIED infection, PADIT. The envelope group had a higher PADIT score, 5.9 ± 3.1 vs. 3.9 ± 3.0 (P < 0.0001). For the primary endpoint, no local infections occurred in the envelope group, compared with 2.6% in the control group (P = 0.04), with a more pronounced difference in the stratum with a high (>7 points) PADIT score, 0 vs. 9.9% (P = 0.01). The total CIED-related infections were similar between groups, 6.3% compared with 5.0% (P = 0.567). Mortality after 1600 days of follow-up did not differ between groups, 22.9 vs. 26.4%, P = 0.475. Our study confirms the clinical efficacy of an antibacterial envelope in the prevention of local CIED infection in patients with a higher risk according to the PADIT score. In an effort to improve cost-benefit ratios, ration of use guided by the PADIT score is advocated. Further prospective randomized studies in high-risk populations are called for.

The response to cardiac resynchronization therapy in LMNA cardiomyopathy.

Cardiac implantable electronic device (CIED) therapy is fundamental to the management of LMNA cardiomyopathy due to the high frequency of atrioventricular block and ventricular tachyarrhythmias. We aimed to define the role of cardiac resynchronization therapy (CRT) in impacting heart failure in LMNA cardiomyopathy. From nine referral centres, LMNA cardiomyopathy patients who underwent CRT with available pre- and post-echocardiograms were identified retrospectively. Factors associated with CRT response were identified (defined as improvement in left ventricular ejection fraction [LVEF] ≥5% 6 months post-implant) and the associated impact on the primary outcome of death, implantation of a left ventricular assist device or cardiac transplantation was assessed. We identified 105 patients (mean age 51 ± 10 years) undergoing CRT, including 70 (67%) who underwent CRT as a CIED upgrade. The mean change in LVEF ∼6 months post-CRT was +4 ± 9%. A CRT response occurred in 40 (38%) patients and was associated with lower baseline LVEF or a high percentage of right ventricular pacing prior to CRT in patients with pre-existing CIED. In patients with a European Society of Cardiology class I guideline indication for CRT, response rates were 61%. A CRT response was evident at thresholds of LVEF ≤45% or percent pacing ≥50%. There was a 1.3year estimated median difference in event-free survival in those who responded to CRT (p=0.04). Systolic function improves in patients with LMNA cardiomyopathy who undergo CRT, especially with strong guideline indications for implantation. Post-CRT improvements in LVEF are associated with survival benefits in this population with otherwise limited options.

Percutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post Myocardial Infarction: One-Year Evaluation of the Heartech First-in-man Study

BackgroundThis is first-in-man investigation of an implantable Heartech left ventricular partitioning device (LVPD) therapy for chronic heart failure (HF) after a myocardial infarction. Methods and ResultsInitially, 16 patients were chosen from 3 cardiac centers within China. All patients were treated with percutaneous ventricular restoration involving the Heartech LVPD implantation. Major adverse cardiovascular and cerebrovascular events were documented. Functional status, echocardiograph evaluation, European five-dimensional health scale, 6-minute walk test before the procedure and at postoperative follow-ups were recorded. We demonstrated successful implantation and device function with a success rate of 93.75%. One patient suffered a fatal myocardial infarction within the 12 ± 1 month follow-up. However, other patients did not report any major adverse cardiovascular and cerebrovascular events at their 12 ± 1 month follow-ups. After the operation, the average left ventricular end-systolic volume index decreased dramatically (66.00 mL/m2, interquartile range [IQR] 63.00–89.00 mL/m2 vs 48.00 mL/m2, IQR 32.25–68.25 mL/m2, P = .001), along with the left ventricular end-diastolic volume index (105.00 mL/m2, IQR 90.00–130.00 mL/m2 vs 76.50 mL/m2, IQR 57.75–120.25 mL/m2, P = .002). The left ventricular ejection fraction (35.00%, IQR 27.00–38.00% vs 42.50%, IQR 34.75–50.25%, P = .003), 6-minute walk test (383.13 ± 108.70 m vs 491.17 ± 118.44 m, P = .01), and European five-dimensional health scale (65.93 ± 11.25 vs 82.50 ± 5.44, P < .001), in turn, improved significantly. ConclusionsIn our study, the Heartech LVPD was demonstrated as both safe and effective in reducing LV volume, enhancing LV function after implantation. These results remain constant at least till the 12 month follow-up. (Trial Registration: NCT 02938637.)

Cardiovascular implantable electronic device therapy in patients with left ventricular assist devices: insights from TRAViATA

BackgroundThere is conflicting observational data on the survival benefit cardiac implantable electronic devices (CIED) in patients with LVADs. MethodsPatients in whom an LVAD was implanted between January 2008 and April 2017 in the multinational Trans-Atlantic Registry on VAD and Transplant (TRAViATA) registry were separated into four groups based on the presence of CIED prior to LVAD implantation: none (n = 146), implantable cardiac defibrillator (ICD) (n = 239), cardiac resynchronization without defibrillator (CRT-P) (n = 28), and CRT with defibrillator (CRT-D) (n = 111). ResultsA total of 524 patients (age 52 years ±12, 84.4% male) were followed for 354 (interquartile range: 166–701) days. After multivariable adjustment, there were no differences in survival across the groups. In comparison to no device, only CRT-D was associated with late right ventricular failure (RVF) (hazard ratio 2.85, 95% confidence interval [CI] 1.42–5.72, p = 0.003). There was no difference in risk of early RVF across the groups or risk of ICD shocks between those with ICD and CRT-D. ConclusionIn a multinational registry of patients with LVADs, there were no differences in survival with respect to CIED subtype. However, patients with a pre-existing CRT-D had a higher likelihood of late RVF suggesting significant long-term morbidity in those with devices capable of LV‑lead pacing post LVAD implantation.

Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.

Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005-December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [<50 years], young intermediate [50-69 years], older intermediate [70-79 years], and octogenarian [≥80 years]. Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1%vs. 33.2%, respectively, p<.01). High-voltage leads were extracted most frequently from young patients, less frequently from octogenarians (31.6%vs. 10%, p<.001), while the opposite was evident for pacemaker leads (p<.001). Rotational sheath use was equally prevalent across all patient groups (p=.79). Minor and major complications across all the age groups were statistically similar, as was procedural success; the 30-day mortality was most significant in the octogenarian and least in the young patients (4.9%vs. 0.4%, p=.005). Propensity matching multivariate analysis found systemic infection, lead dwell time, and patient age (p=.013, OR 1.064 [1.013-1.116]) increased risk of 30-day mortality. TLE is safe and effective across all age groups. 30-day mortality risk is significantly higher in the older patients.

Heart involvement in type 1 and type 2 myotonic dystrophy. Insights from a 10-year follow-up study

Abstract Background and aim Myotonic Dystrophy (MD) is the most common inherited muscular dystrophy of the adult. Cardiac manifestation, including arrhythmias and conduction disorders, contributes significantly to the morbidity and mortality of the disease. The transition from a subclinical form of cardiac involvement to potentially life-threating manifestations is highly variable and not yet entirely understood. Aim of this work is to evaluate whether PQ interval (PQi) prolongation could be a reliable marker to predict left and right ventricle impairment and the necessity of a stricter monitoring. Methods In this retrospective cohort study, we selected all consecutive patients with a confirmed diagnosis of MD (type 1 and type 2) referred to our Centre. We performed clinical, laboratoristic and instrumental assessments (every 3, 6 or 12 months), tailored on each patient's features. Every patient was treated according to the latest guidelines for pharmacological and device therapy. ECG (recorded at 25 and 50 mm/sec), 24h ECG Holter and transthoracic echocardiography were performed at least yearly. Cardiac Magnetic Resonance was requested to better stratify intermediate risk patients to implantable device therapy. Results A total of 72 patients (age 48±15 years, 39% female) were included in the analysis. Patients with MD type 1 and type 2 were referred to our Centre after a mean period of 12 years (SD ±8 years) from initial diagnosis. After a mean follow-up of 5 years (±4 years), 8 patients died (mean age at death: 60±12.4 years), all of them for respiratory insufficiency. We evaluated PQ interval (PQi) evolution and type I AVB onset. No statistically significant differences emerged when stratifying for type I AVB. Nevertheless, a PQi increase of more than 20 ms during the follow-up (even if PQ &amp;lt;200 ms) is significantly associated with lower values of TAPSE and greater LVEDD, while no differences emerged for LVEF, dyastolic function and other echocardiographic parameters. Moreover, the evolution of PQ interval is associated with an increasing number of supraventricular arrhythmias and a worse prognosis (shorter interval from first cardiac symptom to death, p 0.025), despite optimal medical therapy. Conclusions Although relatively rare, MD is a challenge for present Cardiologists. How and when to treat those patients is not codified in guidelines or consensus papers. This study suggests PQi variation as a proxy for critical evolution of MD cardiac involvement. ECG and its modification during lifetime seem pivotal for these patients' care, qualifying as a red flag for stringent follow-up. Further evidences, on larger cohorts, are needed to validate these findings. Funding Acknowledgement Type of funding source: None

Treatment of Central Sleep Apnea in Heart Failure Patients

Background Central sleep apnea (CSA) is a neurological breathing disorder, resulting from intermittent disruptions in the neural drive to breath. CSA differs substantially from the more prevalent Obstructive Sleep Apnea (OSA), which occurs as a result of muscles relaxing in the upper airway and preventing the passage of airflow. Sleep apnea is classified as when over 50% of the apnea-hypopnea index (AHI) is driven by central events. CSA is a common and serious comorbidity in patients with heart failure (HF), with a prevalence of 30-50% in patients with a reduced left ventricular ejection fraction LVEF 45%. Patients with HF and untreated CSA suffer from poor outcomes, including increased morbidity and mortality as well as increased hospitalizations. Historically, CSA patients have received the same treatment options as patients suffering from OSA, including positive airway pressure (PAP) devices, nocturnal oxygen, and pharmacological treatments. However, recently published data has highlighted safety and mortality concerns with some forms of PAP therapy on patients with HF, CSA and reduced LVEF. A new FDA-approved implantable device therapy, phrenic nerve stimulation (PNS), has been designed specifically to treat CSA. Unlike positive airway pressure devices that use pressure to overcome obstructions and inflate the lungs, PNS activates the diaphragm to create negative pressure in the chest - mimicking the physiologic mechanism of natural breathing. In our institution we have developed a care pathway with a nurse practitioner designated as care coordinator responsible for initial screening, coordination of testing, and facilitation of treatment plan, whether that be with a sleep physician PAP device or electrophysiologist for implantable treatment. Objectives Describe a methodology and pathway to identify and treat HF patients with CSA. Methodology Guideline directed therapy for patients with HF now recommends sleep testing due to the deleterious effects of untreated sleep disordered breathing. With no clear patient characteristic that is predictive of CSA in patients with HF, clinicians should consider broadly testing patients with HF using polysomnography (PSG) or a home sleep apnea test (HSAT) with the ability to differentiate CSA from OSA. Results Clinical patient information from sleep (e.g. AHI) and cardiology (e.g. LVEF) should be used when determining a treatment plan. Implantable treatment options for CSA necessitate a robust pathway that requires communication across specialties (Figure 1). PNS requires collaboration among three clinical specialties: heart failure, sleep, and electrophysiology. Typically, heart failure identifies patients, sleep diagnoses, and electrophysiology implants the device. Providers also need to make a decision on how to best manage the CSA patient following the implant procedure for therapy titration and long-term patient follow-up. Regardless of which specialty manages the patient's CSA therapy long-term, success in treating patients with heart failure and CSA depends on collaboration and communication among the clinicians. Conclusions Given newly available treatment options for CSA and the risks associated with some forms of PAP therapy for HF patients with reduced LVEF, providers should design a robust treatment pathway across sleep, heart failure, and EP to manage treatment of patients with CSA and HF.

Takotsubo syndrome and cardiac implantable electronic device therapy

Recent studies have reported that takotsubo syndrome (TTS) patients are suffering from life-threatening arrhythmias. The aim of our study was to understand the short and long-term usefulness of cardiac implantable electronic devices in TTS patients.We constituted a collective of 142 patients in a bi-centric study diagnosed with TTS between 2003 and 2017. The patient groups, divided according to the treatment with (n = 9, 6.3%) or without cardiac devices (n = 133, 93.7%), were followed-up to determine the importance of devices and its complications. One patient was treated with a permanent pacemaker, five patients with a wearable cardioverter defibrillator, two patients with a subcutaneous defibrillator and one patient with a transvenous defibrillator. Regular device check-up was documented in all patients, presenting an ongoing high-degree AV-block. Neither device complications nor life-threatening tachyarrhythmias were documented after acute TTS event. However, patients comprising the device group suffered significantly more often from a highly reduced EF (30 ± 7.7% versus 39.1 ± 9.7%; p < 0.05), cardiogenic shock with use of inotropic agents (66.6% versus 16.6%; p < 0.05) and cardiopulmonary resuscitation (44.4% versus 5.3%; p < 0.05). Our data confirm the usefulness of pacemaker in TTS patients. However, the cardioverter defibrillator including wearable cardioverter defibrillator may not be recommended.

The role of implantable cardioverter-defibrillators and sudden cardiac death prevention: indications, device selection, and outcome.

Multiple randomized multicentre clinical trials have established the role of the implantable cardioverter-defibrillator (ICD) as the mainstay in the treatment of ventricular tachyarrhythmias and sudden cardiac death (SCD) prevention. These trials have focused mainly on heart failure patients with advanced left ventricular dysfunction and were mostly conducted two decades ago, whereas a more recent trial has provided conflicting results. Therefore, much remains to be determined on how best to balance the identification of patients at high risk of SCD together with who would benefit most from ICD implantation in a contemporary setting. Implantable cardioverter-defibrillators have also evolved from the simple, defibrillation-only devices implanted surgically to more advanced technologies of multi-chamber devices, with physiologic bradycardic pacing, including cardiac resynchronization therapy, atrial and ventricular therapeutic pacing algorithms, and subcutaneous ICDs. These multiple options necessitate individualized approach to device selection and programming. This review will focus on the current knowledge on selection of patients for ICD treatment, device selection and programming, and future directions of implantable device therapy for SCD prevention.

Device Therapy and Arrhythmia Management in Left Ventricular Assist Device Recipients: A Scientific Statement From the American Heart Association.

Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure with reduced ejection fraction. Although these devices effectively improve survival, atrial and ventricular arrhythmias are common, predispose these patients to additional risk, and complicate patient management. However, there is no consensus on best practices for the medical management of these arrhythmias or on the optimal timing for procedural interventions in patients with refractory arrhythmias. Although the vast majority of these patients have preexisting cardiovascular implantable electronic devices or cardiac resynchronization therapy, given the natural history of heart failure, it is common practice to maintain cardiovascular implantable electronic device detection and therapies after LVAD implantation. Available data, however, are conflicting on the efficacy of and optimal device programming after LVAD implantation. Therefore, the primary objective of this scientific statement is to review the available evidence and to provide guidance on the management of atrial and ventricular arrhythmias in this unique patient population, as well as procedural interventions and cardiovascular implantable electronic device and cardiac resynchronization therapy programming strategies, on the basis of a comprehensive literature review by electrophysiologists, heart failure cardiologists, cardiac surgeons, and cardiovascular nurse specialists with expertise in managing these patients. The structure and design of commercially available LVADs are briefly reviewed, as well as clinical indications for device implantation. The relevant physiological effects of long-term exposure to continuous-flow circulatory support are highlighted, as well as the mechanisms and clinical significance of arrhythmias in the setting of LVAD support.

Moderated ePosters 15: Implantable device therapy : the good, the bad and the ugly

Moderated ePosters 15: Implantable device therapy : the good, the bad and the ugly