The patient perspective on remote monitoring of implantable cardiac devices.

Aims: Remote monitoring for patients with cardiac implantable electronic devices (CIEDs) is well established in clinical routine and recommended by current guidelines. Nevertheless, data regarding patients' perceptions are limited. Therefore, this study aims to analyze the patient perspectives on the remote monitoring of cardiac devices in Germany. Methods and results: Patients with CIEDs and remote monitoring of all current manufacturers from three German centers were asked to participate. The questionnaire consisted of 37 questions regarding the patients' individual use and perspectives on remote monitoring. Survey participation was anonymous and on a voluntary basis. A total of 617 patients (71.6% men) participated. Most patients reported feeling well informed (69.3%) and reported having unchanged or improved coping (98.8%) since the start of remote monitoring. At least 39.7% of patients experienced technical problems regarding the transmitter, whereas most patients (60.3%) reported that they never noted technical issues. Older patients had significantly less interest than younger patients in using their own smartphones for data transfer (p < 0.001). Conclusion: Patients with remote follow-up of CIED reported that they felt well informed about the remote monitoring approach. Remote monitoring can support coping with their disease. With remote monitoring, patients experienced a prolongation of intervals of in-person follow-up visits, and especially younger patients would appreciate smartphone-based data transfer of their CIEDs.

[Structural requirements and prerequisites for outpatient implantation of defibrillators, devices for cardiac resynchronization and event recorders]. / Strukturmerkmale und Voraussetzungen zur ambulanten Implantation von implantierbaren Defibrillatoren, Geräten zur kardialen Resynchronisation und Ereignisrekordern.

The possibility of outpatient implantation of defibrillators, devices for cardiac resynchronization, and event recorders (collectively called cardiac implantable electronic devices, CIEDs) is becoming increasingly important. In Germany, only a few options for outpatient implantation are currently realized. Furthermore, there is a lack of uniform, recognized, and binding quality criteria. This article provides insight into the current contract constellations for outpatient surgery and defines a first, holistic quality concept for outpatient implantations of CIEDs. The present works aims to initiate a discourse in the specialist society in order to define a coordinated, binding quality concept. Then, this should serve as the basis for future outpatient implantation services, enabling comparability and to contribute long-term evidence.

Sudden cardiac death after implantation of a cardiac resynchronization therapy pacemaker: a case report illustrating that not always less is more.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves symptoms and survival in selected patients with systolic heart failure and ventricular conduction delay. In subjects without prior life-threatening ventricular arrhythmia, clinicians have to select between implanting a CRT pacemaker (CRT-P) or a more complex device with additional defibrillator capability (CRT-D). This individual decision can be challenging in light of the available evidence and the potential risks and benefits. CASE SUMMARY: A 76-year-old male with non-ischaemic cardiomyopathy, heart failure New York Heart Association Class III, left bundle branch block (QRS duration 185 ms) and a left ventricular ejection fraction of 30% despite optimal medical therapy was indicated for CRT. In light of the patient characteristics and clinical condition, a CRT-P device was implanted. No complication occurred, and the patient was discharged after an appropriate device function was confirmed. Despite the clinical improvement, he died suddenly without prior symptoms approximately 2 months thereafter. Post-mortem device interrogation provided no evidence for device malfunction and confirmed sudden cardiac death (SCD) due to spontaneous ventricular fibrillation. DISCUSSION: Patients indicated for CRT often have overlapping internal cardioverter defibrillator indication for the primary prevention of SCD. By weighing individual risks and potential benefits, clinicians have to decide whether to implant a CRT-P (less is more) or a more complex and costly CRT-D device. Despite careful consideration of patient characteristics and clinical conditions, however, SCD can occur in subjects categorized as low risk and implanted with a CRT-P. More data from randomized clinical trials are needed to better support physicians in the often challenging process of selecting the most appropriate device for CRT.

[Safety and efficiency of interventional electrophysiology utilizing the German "Belegarztsystem"]. / Effizienz und Sicherheit einer interventionellen Elektrophysiologie im kooperativen Belegarztsystem.

INTRODUCTION: Electrophysiology study (EPS) and catheter ablation (abl.), in particular for atrial fibrillation, are increasingly performed in Germany. Therefore, measures and steps to ensure quality assurance are indicated. Most of the procedures are performed by physicians employed by hospitals; however, some are also carried out by attending cardiologists on contract in private practice, applying the so-called Belegarztsystem. The aim of this study was to determine the safety and efficiency of an interventional electrophysiology performed in a German Belegarztsystem. METHODS: Based on a prospective registry, we analyzed procedure-related data from 1400 consecutive EPS/abl. performed at our center between 2014 and 2018. One-year follow-up data (arrhythmia recurrences, complications, deaths) were collected for all procedures carried out during the first 2 years. RESULTS: In the total study cohort, no periprocedural death occurred, and there was a low cumulative incidence of groin complications (0.9%). The most common procedure (n = 772) was complex ablation for atrial fibrillation/flutter (55%). In this group, the success rate was 98% (acute) and 65% (1 year), and the cumulative rate of complications was 5.0% (transient ischemic attack/stroke 0.1%, pericardial tamponade 0.4%, relevant pericarditis/pericardial effusion 1.1%, groin complication 1.5%, other 1.9%). For the other procedures, rates for success and complications were comparable, and procedure times and x­ray doses tended to be lower in our analysis as compared to prior reports. CONCLUSION: Interventional electrophysiology, carried out by experienced operators and qualified staff, can be performed safely and effectively by attending physicians in a Belegarztsystem.

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact).

BACKGROUND: In heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes. METHODS: InContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only. RESULTS: Two hundred and ten patients underwent randomisation (telemetry n = 102; personal contact n = 108 [remote+phone: n = 53; visit: n = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care (p > 0.999), remote+phone (p = 0.937) or visit (p = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups (p = 0.832/p = 0.645), as were HF-hospitalisation rates (11.0% overall; p = 0.605/p = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients. CONCLUSION: In HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage. TRIAL REGISTRATION: clinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).

[Malignant bileaflet mitral valve prolapse syndrome in otherwise idiopathic ventricular fibrillation]. / Malignes Mitralklappenprolapssyndrom bei "idiopathischem" Kammerflimmern.

A 32-year-old, otherwise healthy woman was admitted after successful out-of-hospital resuscitation due to ventricular fibrillation. Established cardiac, pulmonary, metabolic, and toxicological causes were excluded. However, persisting (biphasic) negative T waves in the inferior ECG leads and premature ventricular contractions (PVC) were noted. PVC morphology indicated a focus alternating between the posterior papillary muscle/the left posterior fascicle and the left ventricular outflow tract region/anterior papillary muscle. Echocardiography revealed a bileaflet mitral prolapse with mild mitral valve regurgitation. This case is a typical presentation of the recently described malignant bileaflet mitral valve prolapse syndrome. The patient was discharged without overt neurological deficit after implantation of a cardioverter-defibrillator.

[Permanent junctional reciprocating tachycardia causing cardiomyopathy in an adult woman]. / Permanente junktionale Reentrytachykardie als Kardiomyopathie-Ursache bei einer erwachsenen Frau.

A 35-year-old female was referred with progressive dyspnoea and elevated heart rate. Surface electrocardiography (ECG) showed supraventricular tachycardia (SVT) with long RP interval and inverse P waves. ECG revealed left ventricular dilation and severe systolic dysfunction. An electrophysiological (EP) examination was performed due to incessant SVT despite betablocker medication. Permanent junctional reciprocating tachycardia (PJRT) was diagnosed and successfully ablated. During follow-up, the patient's symptoms abated and ECG parameters normalized. PJRT is usually found in infants and children, but should also be considered as a rare cause of incessant SVT and tachycardiomyopathy in adults.

Device malfunction caused by "auto-oversensing" of transthoracic impedance measurement test pulses in a modern minute ventilation dual-chamber pacemaker.

Oversensing of physiologic and non-physiologic electrical signals is a relevant cause of malfunctions in subjects with CIED. Physicians taking care of CIED patients must be aware of the potential causes of oversensing and their pattern in EGMs. The present case describes an uncommon source and unique underlying root cause for oversensing in a modern dual-chamber MV rate-adaptive pacemaker.

Rationale and design of the SPICE study-septal positioning of ventricular ICD electrodes.

AIM: Detrimental effects of right ventricular apical pacing have prompted the search for alternative pacing sites. Data from pacemaker studies suggest that the mid-septum may be a hemodynamically favorable pacing site within the right ventricle. However, data on the safety of implantable cardioverter defibrillator (ICD) lead placement in this location are limited. The aim of the SPICE study is to ascertain that implantation of a ventricular ICD lead at the mid-septum is not inferior to the traditional apical site in terms of feasibility and safety. METHODS: In total, 286 patients with the indication for ICD implantation will be included in the study and stratified in a 1:1 ratio to have the lead placed in the right ventricular apex or the mid-septum. Primary outcome measure of this randomized, prospective study is the event-free survival of lead-related complications at 3 months. The combined end point includes the feasibility to reach the randomized pacing site in combination with the achievement of adequate pacing, sensing, and defibrillation thresholds. Data analysis and sample size calculation are based on a non-inferiority design. CONCLUSION: This trial will primarily assess the feasibility, safety, and efficacy of right ventricular ICD lead positioning in the mid-septum compared to the traditional apical position. Documentation of non-inferiority of the novel lead position in terms of applicability and safety will be the prerequisite for potential further trials that may evaluate long-term clinical effects associated with mid-septal lead positions.

Analysis of interaction of acute atrial overdrive pacing with sleep-related breathing disorder.

Dose-related effects of atrial overdrive pacing (AOP) on sleep-related breathing disorder (SRBD) were studied. Fourteen patients with pacemakers with moderate to severe SRBD (mean screening apnea-hypopnea index [AHI] 35.2 +/- 21.9 events/hour) were randomized to 3 levels of pacing (50, 10, and 20 beats/min greater than the mean nocturnal heart rate) and studied by polysomnography, observing for changes in AHI. At the 2 AOP levels, no significant change was observed in the primary end point of reduction in AHI. Additionally, there was no observed impact on secondary end points of the study. Cyclic variation of heart rate was progressively abolished with higher levels of AOP without affecting AHI. Large variations were observed between the screening and control studies in SRBD indexes in a number of patients. In conclusion, AOP demonstrated no benefit to predominantly obstructive SRBD disorder of at least moderate severity.

Feasibility of automated detection of advanced sleep disordered breathing utilizing an implantable pacemaker ventilation sensor.

OBJECTIVES: This study tested the feasibility of automatically detecting advanced sleep disordered breathing (SDB) from a pacemaker trans-thoracic impedance sensor. BACKGROUND: SDB is prevalent yet under-diagnosed in patients with cardiovascular disease. The potential for automated detection of SDB in patients receiving pacemakers with respiration sensors has not been fully explored. We hypothesized that the trans-thoracic impedance sensor could be utilized for automatic detection of advanced SDB. METHODS: Patients underwent overnight polysomnography (PSG). The pacemaker trans-thoracic impedance signal was simultaneously recorded and time synchronized with the polysomnograph. Cardiovascular health variables were abstracted from medical records. Apnea was defined as cessation of inspiratory airflow lasting 10 seconds or longer. Hypopnea was defined as a reduction of tidal volume of at least 30% from baseline tidal volume, lasting 10 seconds or more. A computer algorithm (PM-A) was developed to automatically detect SDB from the pacemaker impedance sensor data. The performance of automated SDB detection was compared against PSG. RESULTS: Sixty patients (aged 69 +/- 12 years, 45 males) were studied. Advanced SDB (moderate or severe) was diagnosed in 40 patients. Severe SDB (apnea-hypopnea index [AHI]> or = 30) was diagnosed in 32 patients (53%), but only 5 patients had prior diagnosis of the disease. Moderate SDB (30 > AHI > 15) was diagnosed in 8 patients of whom only two were previously diagnosed. Cardiovascular health variables did not predict the presence of advanced SDB. PM-A derived AHI correlated with that of the PSG (r = 0.80, P < 0.01). The algorithm identified patients with advanced SDB with 82% sensitivity and 88% specificity. CONCLUSIONS: It is feasible to automatically measure SDB severity using a pacemaker trans-thoracic impedance sensor. Advanced SDB was frequently undiagnosed in this cohort of pacemaker patients.