BackgroundPatient satisfaction with remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) seems to be high, yet knowledge on long‐term patient experiences is limited. The European REMOTE‐CIED study explored patients' experiences with RPM, examined patient's preferences for ICD follow‐up, and identified determinants of patient's preferences in the first 2 years postimplantation.MethodsEuropean heart failure patients (N = 300; median age = 66 years [interquartile range (IQR) = 59‐73], and 22% female) with a first‐time ICD received a Boston Scientific LATITUDE RPM system (Marlborough, MA, USA) and had scheduled in‐clinic follow‐ups once a year. Patients completed questionnaires at 1‐2 weeks and also at 3, 6, 12, and 24 months postimplantation and clinical data were obtained from their medical records. Patient evaluation data were analyzed descriptively, and Student's t‐tests/Man‐Whitney U tests or Chi‐square tests/Fisher's exact tests were performed to examine determinants of patient preferences.ResultsAt 2 years postimplantation, the median patient satisfaction score with the RPM system was 9 out of 10 (IQR = 8‐10), despite 53% of the patients experiencing issues (eg, failure to transmit data). Of the 221 patients who reported their follow‐up preferences, 43% preferred RPM and 19% preferred in‐clinic follow‐up. Patients with a preference for RPM were more likely to be higher educated (P = 0.04), employed (P = 0.04), and equipped with a new LATITUDE model (P = 0.04), but less likely to suffer from chronic obstructive pulmonary disease (P = 0.009).ConclusionIn general, patients were highly satisfied with RPM, but a subgroup preferred in‐clinic follow‐up. Therefore, physicians should include patients’ concerns and preferences in the decision‐making process, to tailor device follow‐up to individual patients’ needs and preferences.
Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence.
In CRT recipients, midseptal RV lead position was not superior with respect to improvement of echocardiographic parameters or paced QRS width. It did not predispose to ventricular arrhythmias or ICD therapy. The finding that midseptal lead position was associated with a longer time to first heart failure event and a longer survival time deserves further investigation.
Background
Critically ill patients with cardiogenic shock could benefit from ventricular assist device support using the Impella microaxial blood pump. However, recent studies suggested Impella not to improve outcomes. We, therefore, evaluated outcomes and predictors in a real-world scenario.
Methods
In this retrospective single-center trial, 125 patients suffering from cardiac arrest/cardiogenic shock between 2008 and 2018 were analyzed. 93 Patients had a prior successful cardiopulmonary resuscitation. The primary endpoint was hospital mortality. Associations of covariates with the primary endpoint were assessed by univariable and multivariable logistic regression. Adjusted odds ratios (aOR) and optimal cut-offs (using Youden index) were obtained.
Results
Hospital mortality was high (81%). Baseline lactate was 4.7mmol/L [IQR = 7.1mmol/L]. In multivariable logistic regression, only age (aOR 1.13 95%CI 1.06–1.20; p<0.001) and lactate (aOR 1.23 95%CI 1.004–1.516; p = 0.046) were associated with hospital mortality, and the respective optimal cut-offs were >3.3mmol/L and age >66 years.
Patients were retrospectively stratified into three risk groups: Patients aged ≤66 years and lactate ≤3.3mmol (low-risk; n = 22); patients aged >66 years or lactate >3.3mmol/L (medium-risk; n = 52); and patients both aged >66 years and lactate >3.3mmol/L (high-risk, n = 51). Risk of death increased from 41% in the low-risk group, to 79% in the medium risk group and 100% in the high-risk group. The predictive abilities of this model were high (AUC 0.84; 95% 0.77–0.92).
Conclusion
Mortality was high in this real-world collective of severely ill cardiogenic shock patients. Better patient selection is warranted to avoid unethical use of Impella. Age and lactate might help to improve patient selection.
There is a paucity of information on the influence of selected overdrive parameters on the clinical efficacy and tolerance of atrial overdrive algorithms to suppress atrial tachyarrhythmias. Data from a completed clinical trial investigating a new DDD+ overdrive algorithm implemented in a permanent pacemaker were analyzed. One-hundred patients with standard pacing indications and atrial tachyarrhythmias were enrolled and followed for 6 months in DDD and 6 months in DDD+ mode in a randomized, crossover fashion. The overdrive step size was programmed at the discretion of the investigators between 4 and 12 beats/min, overdrive plateau length between 10 and 32 beats, and maximum overdrive rate between 100 and 160 beats/min. The effects of DDD+ versus DDD mode on burden and incidence of atrial tachyarrhythmias stored in the mode switch memory were examined as a function of the programmed overdrive parameters. An overdrive step size between 7 and 12 beats/min, and higher a maximum overdrive rate between 121 and 160 beats/min were slightly more effective than lower programmed values, though > 500 randomized, crossover observations would have been necessary to verify statistical significance. Overdrive pacing related symptoms mandated early manual deactivation of overdrive pacing in 4.7% of 85 evaluated patients. Overdrive was disabled without testing tolerability of less aggressive overdrive values. There was no link between patient symptoms and programmed overdrive step size or overdrive plateau length values.
In this retrospective single-center trial, we analyze 109 consecutive patients (female: 27.5%, median age: 69 years, median left ventricular ejection fraction: 20%) who survived sudden cardiac death (SCD) and needed hemodynamic support from an Impella assist device between 2008 and 2018. Rhythm monitoring is investigated in this population and associations with hospital survival are analyzed. Hospital mortality is high, at 83.5%. Diverse cardiac arrhythmias are frequently registered during Impella treatment. These include atrial fibrillation (AF, 21.1%) and ventricular tachycardia (VT, 18.3%), as well as AV block II°/III° (AVB, 7.3%), while intermittent asystole (ASY) is the most frequently observed arrhythmia (42.2%). Nevertheless, neither ventricular nor supraventricular tachycardias are associated with patients’ survival. In patients who experience intermittent asystole, a trend towards a fatal outcome is noted (p = 0.06). Conclusions: Mortality is high in these severely sick patients. While cardiac arrhythmias were frequent, they did not predict hospital mortality in this population. The hemodynamic support of the pump seems to counterbalance the adverse effects of these events.
Background
Registry data add important information to randomized controlled trials (RCT) on real‐life aspects of implantable cardioverter‐defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT‐D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT.
Methods
The German Device registry (DEVICE) prospectively collected data on ICD and CRT‐D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow‐up.
Results
DEVICE included n = 4384 first ICD/CRT‐D implantations (29.3% CRT‐D devices). We found a strong adherence to guidelines with over 90% of patients being on ß‐blocker and ACE‐inhibitor medication and adequate QRS width in the majority of CRT‐D patients. Patients receiving a CRT‐D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT‐D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1‐year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2‐fold higher risk of 1‐year mortality.
Conclusion
Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real‐world registry data and the impact of comorbidities on mortality of ICD and CRT‐D recipients.
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