Refined heart failure detection algorithm for improved clinical reliability of OptiVol alerts in CRT-D recipients

   Background: The reliability of intrathoracic impedance monitoring for prediction of heart failure (HF) by implantable cardiac devices is controversial. Despite using additional device-based parameters described in the PARTNERS HF study, such as new onset of arrhythmias, abnormal autonomics, low biventricular pacing rate or patient activity level, the predictive power of device diagnostic algorithm is still in doubt. The objective of this study was to compare the device diagnostic algorithm described in the PARTNERS HF study to a newly developed algorithm applying refined diagnostic criteria. Methods: Fourty two patients were prospectively enrolled who had been implanted with an intrathoracic impedance and remote monitoring capable implantable cardiac defibrillator with a cardiac resychroniza­tion therapy (CRT-D) device in this observational study. If a remote OptiVolTM alert occurred, patients were checked for presence of HF symptoms. A new algorithm was derived from the original PARTNERS HF criteria, considering more sensitive cut-offs and changes of patterns of the device-based parameters. Results: During an average follow-up of 38 months, 722 remote transmissions were received. From the total of 128 transmissions with OptiVol alerts, 32 (25%) corresponded to true HF events. Upon multivariate discriminant analysis, low patient activity, high nocturnal heart rate, and low CRT pacing (< 90%) proved to be independent predictors of true HF events (all p < 0.01). Incorporating these three refined criteria in a new algorithm, the diagnostic yield of OptiVol was improved by increasing specific­ity from 37.5% to 86.5%, positive predictive value from 34.1% to 69.8% and area under the curve from 0.787 to 0.922 (p < 0.01), without a relevant loss in sensitivity (96.9% vs. 93.8%). Conclusions: A refined device diagnostic algorithm based on the parameters of low activity level, high nocturnal heart rate, and suboptimal biventricular pacing might improve the clinical reliability of OptiVol alerts.  

Association of remote monitoring with survival in heart failure patients undergoing cardiac resynchronization therapy: Retrospective observational study

Background: Remote monitoring is an established, guideline-recommended technology with unequivocal clinical benefits; however, its ability to improve survival is contradictory. Objective: The aim of our study was to investigate the effects of remote monitoring on mortality in an optimally treated heart failure patient population undergoing cardiac resynchronization defibrillator therapy (CRT-D) implantation in a large-volume tertiary referral center. Methods: The population of this single-center, retrospective, observational study included 231 consecutive patients receiving CRT-D devices in the Medical Centre of the Hungarian Defence Forces (Budapest, Hungary) from January 2011 to June 2016. Clinical outcomes were compared between patients on remote monitoring and conventional follow-up. Results: The mean follow-up time was 28.4 (SD 18.1) months. Patients on remote monitoring were more likely to have atrial fibrillation, received heart failure management at our dedicated heart failure outpatient clinic more often, and have a slightly lower functional capacity. Crude all-cause mortality of remote-monitored patients was significantly lower compared with patients followed conventionally (hazard ratio [HR] 0.368, 95% CI 0.186-0.727, P=.004). The survival benefit remained statistically significant after adjustment for important baseline parameters (adjusted HR 0.361, 95% CI 0.181-0.722, P=.004). Conclusions: In this single-center, retrospective study of optimally treated heart failure patients undergoing CRT-D implantation, the use of remote monitoring systems was associated with a significantly better survival rate

Implantation of the Micra transcatheter pacing system: Single Polish center experience with the real costs of hospitalization analysis

Background: The Micra transcatheter pacing system (TPS) is a miniaturized, single-chamber pacemaker system. Study reported herein is an initial experience with implantation of the Micra TPS. Methods: The leadless pacemaker was implanted in 10 patients with standard indications for a permanent pacemaker implantation. All hospitalization costs were calculated for all patients. Results: The mean age of the patients was 75 ± 7.1 years, 6 were men and 4 were women. Four patients had permanent atrial fibrillation as the basal rhythm and 6 patients had sinus rhythm. All patients had at least one relative contraindication that precluded the use of a traditional pacing system. Mean intraoperative ventricular sensing amplitude was 10.6 ± 5.4 mV, impedance 843 ± 185 ohms, and pacing threshold at 0.24 ms was 0.56 ± 0.23 V. At discharge, those values were 13.9 ± 5.6 mV, 667 ± 119 ohms and 0.47 ± 0.17, respectively. The mean duration of implantation procedure was 82 min, while mean fluoroscopy time was 3.5 min. Two patients developed hematoma at the groin puncture site post-implantation. In 1 case there was a need for erythrocyte mass transfusion and surgical intervention. Mean total time of hospitalization was 26 days and time from procedure to discharge 12 days. Average cost of hospitalization per 1 patient was 11,260.15 EUR minimal cost was 9,052.68 EUR, while maximal cost was 16,533.18 EUR. Conclusions: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Hospitalization costs vary for individual patients in wide range

Risk of cardiac arrhythmias after electrical accident: a single-center study of 480 patients

Objective: Patients with electrical injury are considered to be at high risk of cardiac arrhythmias. Due to the small number of studies, there is no widely accepted guideline regarding the risk assessment and management of arrhythmic complications after electrical accident (EA). Our retrospective observational study was designed to determine the prevalence of ECG abnormalities and cardiac arrhythmias after EA, to evaluate the predictive value of cardiac biomarkers for this condition and to assess in-hospital and 30-day mortality. Methods: Consecutive patients presenting after EA at the emergency department of our institution between 2011 and 2016 were involved in the current analysis. ECG abnormalities and arrhythmias were analyzed at admission and during ECG monitoring. Levels of cardiac troponin I, CK and CK-MB were also collected. In-hospital and 30-day mortality data were obtained from hospital records and from the national insurance database. Results: Of the 480 patients included, 184 (38.3%) had suffered a workplace accident. The majority of patients (96.2%) had incurred a low-voltage injury ( 100 bpm, n = 21, 4.4%). Other detected arrhythmias were as follows: newly diagnosed atrial fibrillation (n = 1); frequent multifocal atrial premature complexes (n = 1); sinus arrest with atrial escape rhythm (n = 2); ventricular fibrillation terminated out of hospital (n = 1); ventricular bigeminy (n = 1); and repetitive nonsustained ventricular tachycardia (n = 1). ECG monitoring was performed in 182 (37.9%) patients for 12.7 ± 7.1 h at the ED. Except for one case with regular supraventricular tachycardia terminated via vagal maneuver and one other case with paroxysmal atrial fibrillation, no clinically relevant arrhythmias were detected during the ECG monitoring. Cardiac troponin I was measured in 354 (73.8%) cases at 4.6 ± 4.3 h after the EA and was significantly elevated only in one resuscitated patient. CK elevation was frequent, but CK-MB was under 5% in all patients. Both in-hospital and 30-day mortality were 0%. Conclusions: Most of cardiac arrhythmias in patients presenting after EA can be diagnosed by an ECG on admission, thus routine ECG monitoring appears to be unnecessary. In our patient cohort cardiac troponin I and CK-MB were not useful in risk assessment after EA. Late-onset malignant arrhythmias were not observed

Clinical Impact of Digitalis Therapy in a Large Multicenter Cohort of CRT-Recipients

(1) Introduction: Digitalis use in patients with severe heart failure is controversial. We assessed the effects of digitalis therapy on mortality in a large, observational study in recipients of cardiac resynchronization therapy (CRT). (2) Methods: Consecutive patients receiving a CRT-defibrillator in three European tertiary referral centers were enrolled and followed-up for a mean 37 months ± 28 months. Digitalis use was assessed at the time of CRT implantation. A multivariate Cox-regression model and propensity score matching were used to determine all-cause mortality as the primary endpoint. CRT-response (defined as improvement of ≥1 NYHA class), echocardiographic improvement (defined as improvement of LVEF of ≥ 5%) and incidence of ICD shocks and rehospitalization were assessed as secondary endpoints in a subgroup of patients. (3) Results: The study comprised 552 CRT-recipients with standard indications, including 219 patients (40%) treated with digitalis. Compared to patients without digitalis, they had more often atrial fibrillation, poorer LVEF and a higher NYHA class (all p ≤ 0.002). Crude analysis of all-cause mortality demonstrated a similar relative risk of death for patients with and without digitalis (HR = 1.14; 95% CI 0.88–1.5; p = 0.40). After adjustment for independent predictors of mortality, digitalis therapy did not alter the risk for death (adjusted HR = 1.04; 95% CI 0.75–1.45; p = 0.82). Furthermore, in comparison to 286 propensity-score-matched patients, mortality was not affected by digitalis intake (propensity-adjusted HR = 1.11; 95% CI 0.72–1.70; p = 0.64). A CRT-response was predominant in digitalis non-users, concerning both improvement of HF symptoms and LVEF (NYHA p p p = 0.01); although, rehospitalization for cardiac reasons was significantly lower among digitalis users compared to digitalis non-users (HR = 0.58; 95% C. I. 0.40–0.85; p = 0.01). (4) Conclusions: Digitalis therapy had no effect on mortality, but was associated with a reduced response to CRT and increased susceptibility to ventricular arrhythmias requiring ICD shock treatment. Although, digitalis administration positively altered the likelihood for cardiac rehospitalization during follow-up

Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial.

BACKGROUND: Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. OBJECTIVE: The purpose of this study was to describe the natural history of acute elevated Micra vs traditional transvenous lead thresholds. METHODS: Micra study VVI patients with threshold data (at 0.24 ms) at implant (n = 711) were compared with Capture study patients with de novo transvenous leads at 0.4 ms (n = 538). In both cohorts, high thresholds were defined as \u3e1.0 V and very high as \u3e1.5 V. Change in pacing threshold (0-6 months) with high (1.0 to ≤1.5 V) or very high (\u3e1.5 V) thresholds were compared using the Wilcoxon signed-rank test. RESULTS: Of the 711 Micra patients, 83 (11.7%) had an implant threshold of \u3e1.0 V at 0.24 ms. Of the 538 Capture patients, 50 (9.3%) had an implant threshold of \u3e1.0 V at 0.40 ms. There were no significant differences in patient characteristics between those with and without an implant threshold of \u3e1.0 V, with the exception of left ventricular ejection fraction in the Capture cohort (high vs low thresholds, 53% vs 58%; P = .011). Patients with an implant threshold of \u3e1.0 V decreased significantly (P \u3c .001) in both cohorts. Micra patients with high and very high thresholds decreased significantly (P \u3c .01) by 1 month, with 87% and 85% having 6-month thresholds lower than the implant value. However, when the capture threshold at implant was \u3e2 V, only 18.2% had a threshold of ≤1 V at 6 months and 45.5% had a capture threshold of \u3e2 V. CONCLUSIONS: Pacing thresholds in most Micra patients with elevated thresholds decrease after implant. Micra device repositioning may not be necessary if the pacing threshold is ≤2 V