Abstract Aims Remote monitoring (RM) of thoracic impedance represents an early marker of pulmonary congestion in heart failure (HF). Chronic kidney disease (CKD) may promote fluid overload in HF patients. We investigated whether concomitant CKD affected the efficacy of impedance‐based RM in the OptiLink HF trial. Methods and results Among HF patients included in the OptiLink HF trial, time to the first cardiovascular hospitalization and all‐cause death according to the presence of concomitant CKD was analysed. CKD was defined as GFR < 60 mL/min/1.73 m2 at enrolment. Of the 1002 patients included in OptiLink HF, 326 patients (33%) had HF with concomitant CKD. The presence of CKD increased transmission of telemedical alerts (median of 2 (1‐5) vs. 1 (0–3); P = 0.012). Appropriate contacting after alert transmission was equally low in patients with and without CKD (57% vs. 59%, P = 0.593). The risk of the primary endpoint was higher in patients with CKD compared with patients without CKD (hazard ratio (HR), 1.62 [95% confidence interval (CI), 1.16–2.28]; P = 0.005). Impedance‐based RM independently reduced primary events in HF patients with preserved renal function, but not in those with CKD (HR 0.68 [95% CI, 0.52–0.89]; P = 0.006). Conclusions The presence of CKD in HF patients led to a higher number of telemedical alert transmissions and increased the risk of the primary endpoint. Inappropriate handling of alert transmission was commonly observed in patients with chronic HF and CKD. Guidance of HF management by impedance‐based RM significantly decreased primary event rates in patients without CKD, but not in patients with CKD.

BackgroundHeart failure (HF) is associated with development of depressive symptoms and reduced quality of life (QoL). Patients with HF and an implantable cardioverter-defibrillator (ICD) were evaluated regarding depressive symptoms and QoL. MethodsThe present study included 446 patients with HF and an ICD. Depressive symptoms were assessed using the Patient Health Questionnaire 9 (PHQ-9), QoL was evaluated using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Functional ability and exercise tolerance were assessed at inclusion and after 6 months with help of the 6-min walking test (6MWT). ResultsPatients included in the study had a mean age of 65.8 years and were predominantly male (83.6%), with mostly ischemic (n = 277; 62.1%) or dilated (n = 150; 33.6%) cardiomyopathy. One hundred ninety-three (43.2%) patients had depressive symptoms, of whom 75 patients (16.8%) were classified as moderate to severe depression according to the PHQ-9 at baseline. Depressive symptoms were associated with low QoL independent of NYHA functional class. High NYHA functional class, high PHQ-9 score, age and body mass index (BMI) were associated with a lower 6MWT at enrollment, while depressive symptoms (expressed as higher PHQ-9 score) and age were associated with a lower 6MWT after 6 months. Patients with history of smoking and a higher BMI showed higher PHQ-9 scores after 6 months. Patients under antidepressant medication showed improved PHQ-9 score after 6 months, indicating controlled/treated depression. However, patients with low QoL at inclusion remained with low QoL after 6 months. ConclusionDepressive symptoms correlate with low QoL and lower long-term functional status in patients with HF and an ICD. Depressive symptoms are associated with smoking and obesity, which themselves are risk factors for a poor prognosis in HF. Only a small fraction of patients with HF and ICD showing depressive symptoms receives appropriate treatment. Assessing depressive symptoms and lifestyle factors should be part of a multimodal treatment plan in patients with HF and an ICD.

BACKGROUND:In the OptiLink heart failure study, timely and appropriate reactions to telemedicine alerts improved clinical outcomes in heart failure patients. This analysis investigates the relation between the weekday of alert transmission and the subsequent patient contact. METHODS:In patients enrolled in the intervention arm of the OptiLink heart failure study (n = 505, age 66.1 ± 10.1, 77.2% male, left-ventricular ejection fraction 26.7% ± 6.1%), fluid index threshold crossing alerts were analysed according to the weekday of the transmission. Transmissions on Mondays-Thursdays were categorized as TD1, Fridays-Sundays as well as public holidays as TD2. RESULTS:Of 1365 transmitted alerts, 867 (63.5%) were categorized as TD1 and 498 (36.5%) as TD2. Same day telephone contacts were more frequent in TD1 (46.2%) than in TD2 (18.3%; p < 0.001). Accordingly, the median time to contact was significantly longer in TD2 compared with TD1 (2(1-3) vs 0(0-1) days; p < 0.001). Rates of no telephone contact were no different between the groups (12.1% vs 12.4%; p = 0.866). Although signs of worsening heart failure were prevalent in 32.4% in TD1 versus 32.1% in TD2 (p = 0.996), initiation of a pharmacological intervention occurred more likely in TD1 compared with TD2 (27.9% vs 22.9%; p = 0.041). No differences existed concerning hospitalization for heart failure within 30 days after alert transmission (3.9% vs 3.4%; p = 0.636). CONCLUSION:Alert transmissions during weekends and public holidays were less likely associated with timely patient contacts and initiation of pharmacological interventions than during the week. Telemedical centres providing 24/7 remote monitoring service and specific education programmes for physicians might help to optimize patient care.

BACKGROUND:In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), intracardiac impedance measured by dedicated CRT-D software may be used to monitor hemodynamic changes. We investigated the relationship of hemodynamic parameters assessed by intracardiac impedance and by echocardiography in a controlled clinical setting. METHODS:The study enrolled 68 patients (mean age, 66 ± 9 years; 74% males) at 12 investigational sites. The patients had an indication for CRT-D implantation, New York Heart Association class II/III symptoms, left ventricular ejection fraction 15%-35%, and a QRS duration ≥150 ms. Two months after a CRT-D implantation, hemodynamic changes were provoked by overdrive pacing. Intracardiac impedance was recorded at rest and at four pacing rates ranging from 10 to 40 beats/min above the resting rate. In parallel, echocardiography measurements were performed. We hypothesized that a mean intra-individual correlation coefficient (rmean) between stroke impedance (difference between end-systolic and end-diastolic intracardiac impedance) measured by CRT-D and the aortic velocity time integral (i.e., stroke volume) determined by echocardiography would be significantly larger than 0.65. RESULTS:The hypothesis was evaluated in 40 patients with complete data sets. The rmean was 0.797, with a lower confidence interval bound of 0.709. The study hypothesis was met (p = 0.007). A stepwise reduction of stroke impedance and stroke volume was observed with increasing heart rate. CONCLUSIONS:Intracardiac impedance measured by implanted CRT-Ds correlated well with the aortic velocity time integral (stroke volume) determined by echocardiography. The impedance measurements bear potential and are readily available technically, not requiring implantation of additional material beyond standard CRT-D system.

Background: Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink heart failure (HF) trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians’ inappropriate reactions to alerts. Methods: We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial (Optimization of Heart Failure Management Using OptiVol™ Fluid Status Monitoring and CareLink™). Appropriate contacts had to meet the following criteria: (1) initial telephone contact within 2 working days after FTC transmission, (2) follow-up contacts according to study protocol, and (3) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or HF hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care. Results: In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared with usual care, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary end point (hazard ratio, 0.61 [95% CI, 0.39–0.95]; P =0.027). Conclusions: RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators.

In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups. Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition. The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58–0.91). Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

Patients receiving dual-chamber implantable cardioverter-defibrillator (DR-ICD) therapy are at risk of developing atrial arrhythmia because of the increased rate of ventricular pacing and the progression of heart failure. Remote monitoring (RM) may identify the patients at highest risk of adverse events such as atrial arrhythmias. A total of 283 patients with 91,632 remote transmissions during a 15-month follow-up (FU) period enrolled in the LION registry were analysed. The parameters retrieved included the pacing mode, lower rate limit, percentage of atrial (%AP) and ventricular pacing (%VP), and percentage of atrial arrhythmia burden (%AB). In 92.7% of patients, the devices were initially programmed in DDD(R) or DDI(R), with changes of the pacing mode in 19.3% only. The lower rate limit remained stable in 80.4% of patients. At the first transmission, 8.7% of patients suffered from RM-detected atrial arrhythmia, which reached 36% during FU. The %AP was not associated with increased AB (p = 0.67), but the %VP was different in patients developing RM-detected atrial arrhythmia (26.9% vs. 13.7%, p < 0.00001). The %VP increased in 105 patients (significance level of α = 0.05), and 11 patients crossed the border of 50% VP. The LION substudy supports the concept of using RM in a real-world DR-ICD population. Remote monitoring of DR-ICDs allows for the quantification of the course of the pacing parameters and AB. Based on these observations, device parameters can be adjusted and optimized.

Electromagnetic interferences between implantable cardioverter/defibrillators (ICD) and left ventricular assist devices (LVAD) impacting telemetry have been described in previous generations of ICD as well as LVAD, but have been predominantly overcome in current ICD generations. After introduction of a new fully magnetically levitated centrifugal continuous-flow circulatory pump, we report a case of tenacious telemetry interference between the HeartMate 3 LVAD and an ICD after battery exchange to an Iforia 5. Initialization of the initial telemetry handshake was only possible using several specific maneuvers simultaneously. In order to exclude device–device interference, we suggest to place the ICD above the LVAD before implantation and to test for possible telemetry interferences.

HomeCirculation: Arrhythmia and ElectrophysiologyVol. 9, No. 11Subcutaneous Implantable Cardioverter-Defibrillator Shocks After Left Ventricular Assist Device Implantation Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBSubcutaneous Implantable Cardioverter-Defibrillator Shocks After Left Ventricular Assist Device Implantation Tobias J. Pfeffer, MD, Thorben König, MD, David Duncker, MD, Roman Michalski, MD, Stephan Hohmann, MD, Hanno Oswald, MD, Jan D. Schmitto, MD and Christian Veltmann, MD Tobias J. PfefferTobias J. Pfeffer From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. , Thorben KönigThorben König From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. , David DunckerDavid Duncker From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. , Roman MichalskiRoman Michalski From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. , Stephan HohmannStephan Hohmann From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. , Hanno OswaldHanno Oswald From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. , Jan D. SchmittoJan D. Schmitto From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. and Christian VeltmannChristian Veltmann From the Department of Cardiology and Angiology (T.J.P., T.K., D.D., R.M., S.H., H.O., C.V.) and Department of Cardiac, Thoracic, Transplantation and Vascular Surgery (J.D.S.), Hannover Medical School, Germany. Originally published28 Oct 2016https://doi.org/10.1161/CIRCEP.116.004633Circulation: Arrhythmia and Electrophysiology. 2016;9:e004633Case ReportA 42-year-old man experiencing nonischemic cardiomyopathy with severely reduced left ventricular function and advanced heart failure met the criteria for primary prophylactic implantation of an implantable cardioverter-defibrillator (ICD). A subcutaneous ICD (S-ICD; EMBLEM; Boston Scientific, Marlborough, MA) was implanted at a secondary center in November 2015 with the lead (3401; Boston Scientific) tunnelled in left parasternal position. Before implantation, surface ECG screening was performed following the manufacturer's instructions.A few weeks later, the patient was transferred to Hannover Medical School because of heart failure deterioration (New York Heart Association class IV). After careful evaluation, a continuous-flow left ventricular assist device (LVAD; HeartMate 3; Thoratec, Pleasanton, CA) was implanted using conventional sternotomy.1 Approximately 1 hour after LVAD implantation, the patient received 31 S-ICD shocks. The device was immediately deactivated. Interrogation of the S-ICD revealed normal sinus rhythm during the shocks. However, R waves were diminished and superimposed by electric noise caused by the LVAD. Oversensing of electromagnetic interference led to all S-ICD shocks (Figure 1). Manually, all 3 sensing vectors, primary, secondary, and alternate at all available gain settings, were tested for adequate R wave sensing. In not a single configuration, the S-ICD was able to differentiate between R wave and T wave. Even flutter waves (F waves) were discriminated as R waves by the S-ICD (Figure 2). Thus, after LVAD implantation, S-ICD therapy was not feasible any more.Download figureDownload PowerPointFigure 1. Subcutaneous implantable cardioverter-defibrillator (ICD) ECG with primary sensing vector showing inappropriate ICD shock because of oversensing of electric noise caused by the left ventricular assist device.Download figureDownload PowerPointFigure 2. Subcutaneous implantable cardioverter-defibrillator (ICD) ECG with alternate sensing vector showing oversensing of flutter waves and T waves. In this vector, no electromagnetic interference could be observed.Surface ECG screening was repeated after LVAD implantation. Both left and right parasternal electrode placement showed low R wave amplitudes and confirmed the inability of the S-ICD to differentiate between F, R, and T wave (Figure 3).Download figureDownload PowerPointFigure 3. Screening ECG after left ventricular assist device implantation. The ECG showed atrial flutter with low voltage of the R waves. Lead I indicates the alternate sensing vector, lead II the secondary sensing vector, and lead III the primary sensing vector. (paper speed 25 mm/s).After completion of rehabilitation period, the S-ICD was explanted and a conventional transvenous single-chamber ICD was implanted. During a follow-up of 6 months, the ICD showed a regular device function. Up to now, no oversensing or inappropriate therapy occurred.DiscussionThis case report illustrates inappropriate S-ICD shocks because of changes in R wave morphology and amplitude after LVAD implantation. Changes in ECG morphology after LVAD implantation have been described previously.2 However, these consequences need special consideration when surface ECG–based systems like the S-ICD are used.There are only few case reports dealing with the combination of S-ICD and LVAD therapy. One case describes successful combination of an LVAD (HeartMate II; Thoratec) and an S-ICD (SQ-RX pulse generator model 1010; Boston Scientific) without any electromagnetic interference.3Saeed et al4 reported a case in which electromagnetic interference between the S-ICD and the LVAD (HVAD; HeartWare International, Inc, Framingham, MA) was observed. Two out of 3 sensing vectors showed electromagnetic interference after LVAD implantation. The electromagnetic noise was correctly classified by the S-ICD and did not lead to inappropriate shocks.To our knowledge, this report describes the first case with inappropriate S-ICD shocks after LVAD implantation. The S-ICD shocks were caused by electromagnetic interference, changes in R wave morphology, and a decreased R wave amplitude after LVAD implantation.Low voltage of R wave is commonly observed after LVAD implantation.2 Because the device automatically adjusts its sensing threshold to the amplitude of the last sensed events, postoperative low voltage increases the risk of ventricular oversensing.ConclusionsOn the basis of our experience, we recommend deactivation of the antitachycardia therapy of the S-ICD before LVAD implantation. After recovery from surgery and before reactivation of the device, all sensing vectors should be evaluated with respect to adequate sensing and differentiation of R wave and T wave.Because of sparse and inconsistent data about the combination of S-ICDs and LVADs, we recommend to avoid this combination until data have become more conclusive. If a combination of S-ICD and LVAD cannot be avoided, postoperative follow-up should be performed with great caution and under close surveillance, as proposed above.DisclosuresD. Duncker has received a fellowship grant and travel support from Boston Scientific. C. Veltmann has received honoraria for speeches and presentations from Boston Scientific. The other authors report no conflicts.FootnotesCorrespondence to Christian Veltmann, MD, Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie, Carl-Neuberg-Str.1, 30625 Hannover, Germany. E-mail [email protected]References1. Schmitto JD, Hanke JS, Rojas SV, Avsar M, Haverich A. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III).J Heart Lung Transplant. 2015; 34:858–860. doi: 10.1016/j.healun.2015.03.001.CrossrefMedlineGoogle Scholar2. Martinez SC, Fansler D, Lau J, Novak EL, Joseph SM, Kleiger RE. Characteristics of the electrocardiogram in patients with continuous-flow left ventricular assist devices.Ann Noninvasive Electrocardiol. 2015; 20:62–68. doi: 10.1111/anec.12181.CrossrefMedlineGoogle Scholar3. Raman AS, Shabari FR, Kar B, Loyalka P, Hariharan R. No electromagnetic interference occurred in a patient with a HeartMate II left ventricular assist system and a subcutaneous implantable cardioverter-defibrillator.Tex Heart Inst J. 2016; 43:183–185. doi: 10.14503/THIJ-14-4795.CrossrefMedlineGoogle Scholar4. Saeed D, Albert A, Westenfeld R, Maxhera B, Gramsch-Zabel H, O'Connor S, Lichtenberg A, Winter J. Left ventricular assist device in a patient with a concomitant subcutaneous implantable cardioverter defibrillator.Circ Arrhythm Electrophysiol. 2013; 6:e32–e33. doi: 10.1161/CIRCEP.113.000240.LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Gordon J, Maynes E, O'Malley T, Pavri B and Tchantchaleishvili V (2021) Electromagnetic interference between implantable cardiac devices and continuous-flow left ventricular assist devices: a review, Journal of Interventional Cardiac Electrophysiology, 10.1007/s10840-020-00930-8, 61:1, (1-10), Online publication date: 1-Jun-2021. Zormpas C, Eiringhaus J, Hillmann H, Hohmann S, Müller-Leisse J, Schmitto J, Veltmann C and Duncker D (2020) Eligibility for subcutaneous implantable cardioverter-defibrillator in patients with left ventricular assist device, Journal of Interventional Cardiac Electrophysiology, 10.1007/s10840-020-00810-1, 60:2, (303-311), Online publication date: 1-Mar-2021. Jin C, Hsu J, Frenkel D, Jacobson J, Iwai S and Ferrick A (2021) Unique technique to relieve left ventricular assist device electromagnetic interference with an implantable cardioverter defibrillator, Journal of Cardiovascular Electrophysiology, 10.1111/jce.14840, 32:2, (551-553), Online publication date: 1-Feb-2021. Braun O (2021) Management of Implantable Cardioverter Defibrillators in Patients with a Left Ventricular Assist Device Case-Based Device Therapy for Heart Failure, 10.1007/978-3-030-70038-6_15, (255-264), . Zormpas C, Eiringhaus J, Hillmann H, Hohmann S, Müller‐Leisse J, Schmitto J, Veltmann C and Duncker D (2020) A novel screening tool to unmask potential interference between S‐ICD and left ventricular assist device, Journal of Cardiovascular Electrophysiology, 10.1111/jce.14769, 31:12, (3286-3292), Online publication date: 1-Dec-2020. Reichert W, Tomaiko E, Kalya A, Kusne S, Lockhart C and Su W (2020) De novo subcutaneous implantable cardioverter-defibrillator in patient with left ventricular assist device, HeartRhythm Case Reports, 10.1016/j.hrcr.2020.07.020, 6:10, (774-776), Online publication date: 1-Oct-2020. Black-Maier E, Lewis R, Barnett A, Pokorney S, Sun A, Koontz J, Daubert J and Piccini J (2020) Subcutaneous implantable cardioverter-defibrillator troubleshooting in patients with a left ventricular assist device: A case series and systematic review, Heart Rhythm, 10.1016/j.hrthm.2020.04.019, 17:9, (1536-1544), Online publication date: 1-Sep-2020. Gordon J, Maynes E, Choi J, Wood C, Weber M, Morris R, Massey H and Tchantchaleishvili V (2020) Ventricular arrhythmias following continuous‐flow left ventricular assist device implantation: A systematic review, Artificial Organs, 10.1111/aor.13665, 44:8, Online publication date: 1-Aug-2020. Ishida Y, Payne J, Field M and Gold M (2020) Electromagnetic interference from left ventricular assist devices in patients with subcutaneous implantable cardioverter‐defibrillators, Journal of Cardiovascular Electrophysiology, 10.1111/jce.14431, 31:5, (1195-1201), Online publication date: 1-May-2020. Gomes J (2020) Ventricular Tachycardia Associated with Left Ventricular Assist Device Heart Rhythm Disorders, 10.1007/978-3-030-45066-3_15, (221-228), . Ellenbogen K, Kalahasty G and Leffler J (2020) Subcutaneous Implantable Cardioverter Defibrillator Therapy with a Left Ventricular Assist Device Cardiac Electrophysiology, 10.1007/978-3-030-28533-3_147, (607-610), . Boulet J, Massie E, Mondésert B, Lamarche Y, Carrier M and Ducharme A (2019) Current Review of Implantable Cardioverter Defibrillator Use in Patients With Left Ventricular Assist Device, Current Heart Failure Reports, 10.1007/s11897-019-00449-8, 16:6, (229-239), Online publication date: 1-Dec-2019. López-Gil M, Fontenla A, Delgado J, Rodríguez-Muñoz D, Papageorgiou N, Iliodromitis K, D'Amario D, Vamvakidou A and Camm C (2019) Subcutaneous implantable cardioverter defibrillators in patients with left ventricular assist devices: case report and comprehensive review, European Heart Journal - Case Reports, 10.1093/ehjcr/ytz057, 3:2, Online publication date: 1-Jun-2019. Johnson V, Hamm C and Schmitt J (2019) Device-Device-InteraktionDevice-device interaction, Herzschrittmachertherapie + Elektrophysiologie, 10.1007/s00399-019-0617-z, 30:2, (183-190), Online publication date: 1-Jun-2019. Gopinathannair R, Cornwell W, Dukes J, Ellis C, Hickey K, Joglar J, Pagani F, Roukoz H, Slaughter M and Patton K (2019) Device Therapy and Arrhythmia Management in Left Ventricular Assist Device Recipients: A Scientific Statement From the American Heart Association, Circulation, 139:20, (e967-e989), Online publication date: 14-May-2019. Karnik A, Helm R and Monahan K (2019) Mechanisms and management of inappropriate therapy in subcutaneous implantable cardioverter defibrillators, Journal of Cardiovascular Electrophysiology, 10.1111/jce.13831, 30:3, (402-409), Online publication date: 1-Mar-2019. Zormpas C, Mueller-Leisse J, Koenig T, Schmitto J, Veltmann C and Duncker D (2019) Electrocardiographic changes after implantation of a left ventricular assist device – Potential implications for subcutaneous defibrillator therapy, Journal of Electrocardiology, 10.1016/j.jelectrocard.2018.11.002, 52, (29-34), Online publication date: 1-Jan-2019. Gabriels J, Donnelly J, Willner J, Beldner S, Patel A, Lima B and Epstein L (2018) Subcutaneous defibrillator lead management in a patient undergoing a sternotomy, Pacing and Clinical Electrophysiology, 10.1111/pace.13457, 41:12, (1681-1683), Online publication date: 1-Dec-2018. Afzal M, Ahmed A, Prutkin J, Saba S, Cha Y, Friedman P, Knight B, Kanwar M, Lampert B and Weiss R (2018) Multicenter Experience of Concomitant Use of Left Ventricular Assist Devices and Subcutaneous Implantable Cardioverter-Defibrillators, JACC: Clinical Electrophysiology, 10.1016/j.jacep.2018.05.002, 4:9, (1261-1262), Online publication date: 1-Sep-2018. Ho G, Braun O, Adler E, Feld G, Pretorius V and Birgersdotter-Green U (2018) Management of Arrhythmias and Cardiac Implantable Electronic Devices in Patients With Left Ventricular Assist Devices, JACC: Clinical Electrophysiology, 10.1016/j.jacep.2018.04.014, 4:7, (847-859), Online publication date: 1-Jul-2018. Parikh V, Sauer A, Friedman P and Sheldon S (2018) Management of cardiac implantable electronic devices in the presence of left ventricular assist devices, Heart Rhythm, 10.1016/j.hrthm.2018.01.017, 15:7, (1089-1096), Online publication date: 1-Jul-2018. Migliore F, Cavalli G, Bottio T, De Franceschi P, Bertaglia E, Gerosa G and Iliceto S (2018) Subcutaneous implantable cardioverter defibrillator in patients awaiting cardiac transplantation or left ventricular assist device for refractory heart failure: a feasible alternative to transvenous device?, ESC Heart Failure, 10.1002/ehf2.12255, 5:3, (218-221), Online publication date: 1-Jun-2018. Saini H, Saini A, Leffler J, Eddy S and Ellenbogen K (2018) Subcutaneous implantable cardioverter defibrillator (S-ICD) shocks in a patient with a left ventricular assist device, Pacing and Clinical Electrophysiology, 10.1111/pace.13273, 41:3, (309-311), Online publication date: 1-Mar-2018. Ahmed A, Patel P, Bagga S, Gilge J, Schleeter T, Lakhani B, Ravichandran A, Donnelley S, Allavatam V, Prystowsky E and Padanilam B (2018) Troubleshooting electromagnetic interference in a patient with centrifugal flow left ventricular assist device and subcutaneous implantable cardioverter defibrillator, Journal of Cardiovascular Electrophysiology, 10.1111/jce.13433, 29:3, (477-481), Online publication date: 1-Mar-2018. Weinstock J and Madias C (2017) The Subcutaneous Defibrillator, Cardiac Electrophysiology Clinics, 10.1016/j.ccep.2017.08.007, 9:4, (775-783), Online publication date: 1-Dec-2017. Raffa G, Morsolini M, Gentile G, Coppola G and Sciacca S (2017) Should subcutaneous implantable cardioverter-defibrillators be implanted in patients who are candidates for continuous flow left ventricular assist device?, European Journal of Internal Medicine, 10.1016/j.ejim.2017.05.004, 43, (e30-e32), Online publication date: 1-Sep-2017. November 2016Vol 9, Issue 11 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.116.004633PMID: 27793958 Manuscript receivedAugust 30, 2016Manuscript acceptedSeptember 9, 2016Originally publishedOctober 28, 2016 Keywordsdefibrillators, implantableheart-assist deviceheart failurenoiseshockcardiomyopathiesPDF download Advertisement SubjectsCatheter Ablation and Implantable Cardioverter-DefibrillatorSudden Cardiac Death

Introduction: The wearable cardioverter/defibrillator (WCD) has been shown to be a safe and effective tool to allow secured risk stratification for sudden arrhythmic death. We present a single-centre analysis of consecutive patients wearing the WCD.

Abstract Aims One option to improve cardiac resynchronization therapy (CRT) responder rates lies in the optimization of pacing intervals. A haemodynamic sensor embedded in the SonRtip atrial lead measures cardiac contractility and provides a systematic automatic atrioventricular and interventricular delays optimization. This multi-centre study evaluated the safety and performance of the lead, up to 1 year. Methods and results A total of 99 patients were implanted with the system composed of the lead and a CRT-Defibrillator device. Patients were followed at 1, 3, 6, and 12 months post-implant. The primary safety objective was to demonstrate that the atrial lead complication free rate was superior to 90% at 3-months follow-up visit. A lead handling questionnaire was filled by implanting investigators. Lead electrical performances and the performance of the system to compute AV and VV delays were evaluated at each study visit over 1 year. The complication free rate at 3 months post-implant was 99.0% [95%CI 94.5–100.0%], P < 0.001. Electrical performances of the lead were adequate whatever the atrial lead position and remained stable over the study period. The optimization algorithm was able to compute AV and VV delays in 97% of patients, during >75% of the weeks. Conclusion The atrial lead is safe to implant and shows stable electrical performance over time. It therefore offers a promising tool for automatic CRT optimization to further improve responder rates to CRT.

AIMS:Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients.METHODS AND RESULTS:Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention.CONCLUSION:Among ICD patients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field.

A 46-year old man was implanted with a totally subcutaneous implantable defibrillator, after having a documented episode of cardiac arrest due to idiopathic ventricular fibrillation. During the 4‑month follow-up, an episode of inappropriate triple counting due to P‑ and T‑wave oversensing was detected. Although preoperative screening, high detection rates, and the INSIGHT(TM) discrimination algorithm have reduced the incidence of oversensing-related implantable cardioverter defibrillator (ICD) shocks, continuous evaluation of appropriate sensing vectors at rest, during positional maneuver, and exercise, seems to be mandatory at each follow-up visit.

Background: Improvements in cardiac care of children with congenital heart disease have led to an increasing number of long-term survivors reaching adulthood. Transposition of the great arteries entails the highest incidence of sudden cardiac arrest among congenital heart defects. Purpose of the study was to analyze the efficacy and safety of ICD therapy in grown-up patients with transposition of the great arteries. Methods and results: 14 ICD carriers (8 male, mean age 31 ± 15 years) with surgically corrected dextro-transposition of the great arteries or congenitally corrected transposition were analyzed. Past medical history and ICD follow-up data were obtained retrospectively from hospital records. Median follow-up duration was 5.0 years (interquartile range [2.2, 15.1] years), cumulative 113.5 patient-years. One patient was lost to follow-up due to moving to another follow-up center. A total of 177 ventricular episodes occurred in 9 patients. In 128 (72%) at least one burst of antitachycardic pacing (ATP) was delivered. ATP was successful in 102 episodes (80% of episodes treated with ATP). 69 (39%) episodes were treated by high voltage shock, either as first-line treatment or after failed ATP. All shocks were successful in terminating the ventricular tachyarrhythmia. 5 slowVTs below the cut-off rate were not treated by the ICD, however they were hemodynamically tolerated by the patients. Mean cycle length of the ventricular tachyarrhythmias was 310 ± 72 msec. Estimated marginal means (± standard error) of the ventricular tachycardia cycle lengths were significantly longer on class I antiarrhythmic drugs (324 ± 15 msec) or amiodarone (406 ± 11 msec) than without any medication (254 ± 9 msec). No significant difference in cycle length was observed between episodes with successful ATP and those with ATP failure. Comparing individual antiarrhythmic drugs in a logistic regression model, no antiarrhythmic drug conferred a significant odds ratio for ATP success. 31 episodes of supraventricular tachycardia in 5 Patients (ventricular cycle length 247 ± 29 msec) caused inappropriate therapies, of which 28 led to inappropriate shocks. No difference in inappropriate shock burden was observed between dual and single chamber devices. Conclusion: ICD therapy is safe and effective in grown-ups with transposition of the great arteries, although a high burden of inappropriate shocks due to supraventricular tachycardia was observed. ATP is highly effective in these patients. This might be important when considering risks and benefits of transvenous versus totally subcutaneous ICDs, as the latter might be favorable in such patients with altered anatomy but lack ATP capabilities.

BackgroundCardiac resynchronization therapy (CRT) relies on sufficient left ventricular (LV) pacing with safety margin to phrenic nerve stimulation (PNS). Previous studies introduced LV vector reprogramming in bipolar coronary sinus leads to optimize LV pacing and avoid PNS. We investigated the efficacy and reliability of quadripolar leads in CRT.MethodsThe EffaceQ study enrolled 344 patients with de novo CRT implantation with a quadripolar LV lead in an observational, prospective multicenter study. The study was powered to demonstrate that in at least 90% of patients with an implanted quadripolar LV lead, a viable LV pacing configuration (LVPC) is available (primary end point: LV pacing threshold ≤2.5 V/0.5 ms, sufficient PNS margin).ResultsQuadripolar leads were successfully implanted in 96% of patients. A total of 278 of 299 (93.0%) patients with complete data met the criteria for viable LVPC. With the use of traditional LVPCs, a viable LVPC would have been available (268 of 299 patients; P = 0.002) in significantly fewer patients (89.6%). In any LVPC, PNS was inducible in 65.0% of patients and 22.6% of patients reported PNS during ambulatory 3‐month follow‐up. LVPC reprogramming was performed in 49.8% of patients. PNS inducibility decreased from distal to proximal electrodes, whereas LV pacing thresholds increased from distal to proximal. At prehospital discharge, 5.9 ± 2.8 viable LVPCs were observed, stable during follow‐up. The quadripolar electrode offered significantly more LVPC for LV optimization and PNS avoidance.ConclusionQuadripolar LV leads yield high numbers of patients with viable LVPCs and alternatives for noninvasive repositioning of LV pacing.

BACKGROUND:Reduced cognitive performance and high prevalence of depression have been reported in patients with congestive heart failure (CHF) and severe left ventricular dysfunction. However, effects of contemporary device therapy on cognitive performance and depression symptoms have not been studied thoroughly.METHODS:Seventy-four consecutive CHF patients-45 receiving a biventricular defibrillator (CRT-D) and 29 receiving an implantable single or dual-chamber defibrillator (ICD) as a control group-were enrolled in this investigator-initiated, prospective, controlled, and investigator-blinded study. A set of neuropsychological tests (mini-mental state examination, DemTect, age-concentration test, and Beck depression inventory) was performed before, at 3 and at 6 months after device implantation.RESULTS:DemTect-score improved significantly (F = 7.8; P = 0.007) after CRT-D-implantation compared with ICD. Age-concentration test revealed better concentration ability after CRT-D-implantation (F = 8.3; P = 0.005) compared with ICD. Under CRT-D mini-mental state examination showed a significant improvement (F = 4.2; P = 0.043). CRT with defibrillator therapy also improved depression revealed by beck depression inventory (F = 14.7; P< 0.001) compared with ICD.CONCLUSION:This prospective study is the first to demonstrate psycho-cognitive improvement by resynchronization therapy in CHF patients with severe left ventricular dysfunction. In contrast to ICD therapy, the beneficial effect of CRT-D on psycho-cognitive performance might be attributed to improved cardiac function and haemodynamics.

AIMS:Intracardiac electrograms (IEGMs) are essential for the assessment of implantable cardioverter-defibrillator (ICD) function. The Biotronik Home Monitoring systems transmit an 'IEGM Online' that is shorter than the full-length programmer IEGM due to technical constrains. The aim of this study was to evaluate the accuracy of the physician's classification of the underlying rhythm based on the second-generation IEGM Online.METHODS AND RESULTS:In total, 1533 patients treated with single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators were enrolled at 67 investigational sites and followed for 15 months. The investigators classified the rhythm shown in IEGM Online as ventricular tachycardia, ventricular fibrillation, atrial fibrillation, other supraventricular tachyarrhythmia, oversensing due to lead failure, T-wave oversensing, or other rhythm. At the next in-office follow-up, the investigators classified independently the rhythm seen in the corresponding programmer IEGM. The two rhythm classifications were compared thereafter. Both IEGM Online and programmer IEGM were available in 2099 arrhythmic or oversensing events, of which 146 (7.0%) were classified as other rhythm or artefacts and were excluded as inconclusive or atypical. The remaining 1953 events, affecting 352 patients (23.0%), were classified correctly in 1803 cases (92.3%). The accuracy of rough rhythm classification as ventricular, supraventricular, or oversensing was 97.2%.CONCLUSION:The Lumax and IEGM Online HD Evaluation study demonstrates that remote IEGM analysis is reasonably accurate in a remote monitoring system that transmits shorter IEGM than the full-length programmer IEGM for the sake of frequent, fully automatic data transmission.