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.

Physical activity detection in patients with intracardiac leadless pacemaker.

INTRODUCTION: The Micra Transcatheter Pacing System provides a rate adaptive pacing using an individually programmable three-axis accelerometer. We evaluated the short- and mid-term performance of the Micra activity sensor by testing all three available activity vectors during the exercise tests. METHODS AND RESULTS: Implantation and follow-up data were prospectively collected from the patients undergoing Micra implantation at our institution. Patients underwent a 5-minute exercise test for each vector at predischarge (initial testing) and at scheduled in-office visits (repeat testing). On the basis of measurements of activity counts during the test, vectors were categorized to be adequate (excellent or acceptable) or poor. A total of 278 tests with 818 vector measurements were analyzed in 51 patients during follow-up (median duration was 18 months). Initial testing revealed the adequate quality of the nominal Vector 1 in 74.5% of the patients. Upon repeated testing at subsequent in-office visits, Vectors 1 and 3 were comparable (adequate quality in 64.7% vs 68.6% of the patients; P = 0.65) but better compared with Vector 2 (51.0%; P = 0.10 vs Vector 1, P = 0.01 vs Vector 3). In a subgroup of 45 patients programmed to VVIR mode, Vector 1 was selected in 46.7% of the patients after the initial test (Vector 2, 8.9%; Vector 3, 44.4%). Vector change was performed in 10 patients (22.2%) following repeated tests within 3 months of postimplantation. CONCLUSION: The three-axis accelerometer-based rate adaptive pacing feature proved to be feasible after manual selection of an adequate activity vector. Vector testing in Micra patients with chronotropic incompetence appears to be beneficial compared with the use of nominal Vector 1.

Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta-Analysis.

INTRODUCTION: Two leadless pacemaker (PM) systems were recently developed to avoid pocket- and lead-related complications. As leadless PMs are implanted with a large delivery catheter, cardiac perforation remains a major safety concern. We aimed to provide a literature review on incidence of cardiac perforation with conventional and with leadless PM systems. METHODS AND RESULTS: A systematic review over the last 25 years for studies reporting data on PM lead perforation was performed. Findings were synthesized descriptively. Where control groups were available, data were meta-analyzed to identify important clinical risk factors. A total of 28 studies comprising 60,744 patients undergoing conventional PM implantation were analyzed. The incidence of lead perforation ranged from 0% to 6.37% (mean 0.82%, weighted mean 0.31%, median of 0.40%). There was no significant difference in perforation risk between atrial and ventricular electrodes (POR 0.72, 95% confidence interval [CI], 0.28-1.87, P = 0.50) and between MRI conditional and conventional leads (POR 5.93, 95% CI, 0.72-48.76, P = 0.10). The use of active fixation leads (POR 4.25, 95% CI, 1.00-17.95, P = 0.05) and utilization of DDD versus VVI PM systems (POR 3.50, 95% CI, 1.48-8.28, P < 0.01) were associated with higher rates of perforation. In the 2 leadless PM studies, the incidence of cardiac perforation was 1.52% for each. CONCLUSION: PM lead perforation rates vary in individual studies with an overall low incidence. Leadless PMs seem to be associated with a slightly higher perforation risk, most likely reflecting a learning curve effect of this novel technology.

Needle aspiration for treating iatrogenic pneumothorax after cardiac electronic device implantation: a pilot study.

PURPOSE: Pneumothorax (PTX) following cardiac implantable electronic device procedures is traditionally treated with chest tube drainage (CTD). We hypothesized that, in a subset of patients, the less invasive needle aspiration (NA) may also be effective. We compared the strategy of primary NA with that of primary CTD in a single-center observational study. METHODS: Of the 970 procedures with subclavian venous access between January 2016 and June 2018, 23 patients had PTX requiring intervention. Beginning with March 2017, the traditional primary CTD (9 cases) has been replaced by the "NA first" strategy (14 patients). Outcome measures were procedural success rate and duration of hospitalization evaluated both as time to event (log-rank test) and as a discrete variable (Wilcoxon-Mann-Whitney test). RESULTS: Needle aspiration was successful in 8/14 (57.1%) of the cases (95% CI 28.9-82.3%), whereas PTX resolved in all patients after CTD was 9/9 (100%, 95% CI 66.4-100.0%, p = 0.0481). Regarding length of hospital stay, intention to treat time to event analysis showed no difference between the two approaches (p = 0.73). Also, the median difference was not statistically significant (- 2.0 days, p = 0.17). In contrast, per protocol evaluation revealed reduced risk of prolonged hospitalization for NA patients (p = 0.0025) with a median difference of - 4.0 days (p = 0.0012). Failure of NA did not result in a meaningful delay in discharge timing as median difference was 1.5 days (p = 0.28). CONCLUSIONS: Our data suggest that in a number of patients iatrogenic PTX may be successfully treated with NA resulting in shorter hospitalization without the risk of meaningful discharge delay in unsuccessful cases.

[Possible role of selected IGR and SLC22A4/SLC22A5 loci in development of inflammatory bowel diseases]. / Az 5q31 IBD5-régióban található IGR és SLC22A4/SLC22A5 variánsok lehetséges szerepe a gyulladásos bélbetegség kialakulásában.

UNLABELLED: The IBD5 locus (MIM#606348) on chromosome 5q31 has been demonstrated to confer increased risk for inflammatory bowel disease. Controversial reports have been published about the significance of individual loci located in this region. Here we investigated the possible genetic association of inflammatory bowel diseases with C1672T of SLC22A4 and G-207C SLC22A5 alleles, and with IGR2096a_1 (rs12521868) and IGR2198a_1 (rs11739135) susceptibility variants of the IBD5 region located on chromosome 5q31. PATIENTS AND METHODS: Total of 440 patients, 206 with Crohn's disease, 234 with ulcerative colitis, and 279 controls were studied by PCR-RFLP methods. RESULTS: Neither the C1672T, and G-207C alleles, nor the TC haplotype were found to confer risk for Crohn's disease or ulcerative colitis. By contrast, both of the minor allele frequencies of IGR2096a_1 T (48.1%) and IGR2198a_1 C (46.1%) were increased in Crohn's disease subjects as compared with the controls (38.5% and 38.4%, respectively; p<0.05). Using regression analysis adjusted to age and gender these alleles were found to confer risk for Crohn's disease (OR=1.694, 95% CI: 1.137-2.522; p=0.010 for T allele, OR=1.644, 95% CI=1.103-2.449; p=0.015 for C allele of IGRs). In UC no such associations were found. CONCLUSIONS: Our results revealed the susceptibility nature of the examined IGR minor alleles in Hungarians, which nation differs historically from the surrounding Caucasian populations in origin of the founders of the state.

Effects of implantation of quadripolar left ventricular leads on CRT response.

BACKGROUND: The use of quadripolar (QP) left ventricular leads for cardiac resynchronization therapy (CRT) is intended to improve outcomes compared with conventional bipolar leads (BP). Hence, the number of implanted quadripolar CRT systems is increasing despite limited long-term data. PURPOSE: The aim of this study is to evaluate clinical response and long-term outcomes of CRT recipients who were implanted with quadripolar versus bipolar left ventricular leads. METHODS: Data from consecutive patients receiving a CRT defibrillator in one German and one Hungarian tertiary referral center were retrospectively collected. Long-term survival and response to CRT were analyzed. RESULTS: A total of 536 patients with structural heart disease and a mean left ventricular ejection fraction (LVEF) of 25% received a CRT defibrillator (CRT-D) system for primary (79%) or secondary (21%) prevention of sudden death. Comorbidities did not differ significantly between patients receiving a QP (n = 123) or a BP lead (n = 413). Procedure (101 vs. 120 min) and fluoroscopy times (14 vs. 20 min) were shorter in patients implanted with QP compared with BP (both p < 0.001). At 6 months follow-up, QP patients were more likely to respond to CRT measured as improvement in the New York Heart Association (NYHA) functional class (77% vs. 63%; p < 0.001). Use of QP left ventricle/left ventricular (LV) leads was associated with greater reduction in QRS duration compared with patients implanted with BP LV leads (- 21 ± 30 vs. - 8 ± 35 ms, p = 0.004). Mortality was not significantly different between patients with QP and patients with BP LV leads at a mean follow-up of 39 ± 31 months. CONCLUSION: Implantation of quadripolar left ventricular leads was associated with better CRT response compared with bipolar left ventricular leads.

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 resychroniza-tion 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 specific-ity 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.

A novel algorithm increases the delivery of effective cardiac resynchronization therapy during atrial fibrillation: The CRTee randomized crossover trial.

BACKGROUND: Cardiac resynchronization therapy (CRT) requires a high percentage of ventricular pacing (%Vp) to maximize its clinical benefits. Atrial fibrillation (AF) has been shown to reduce %Vp in CRT due to competition with irregular intrinsic atrioventricular (AV) conduction. We report the results of a prospective randomized crossover trial evaluating the amount of effective CRT delivered during AF with a novel algorithm (eCRTAF). OBJECTIVE: The purpose of this study was to determine whether eCRTAF increases the amount of effective CRT delivered during AF compared to a currently available rate regularization algorithm. METHODS: Patients previously implanted with a cardiac resynchronization therapy-defibrillator and with a history of AF and intact AV conduction received up to 4 weeks of control (Conducted AF Response) and up to 4 weeks of eCRTAF in a randomized sequence. The percent effective CRT (%eCRT) pacing, which excludes beats without left ventricular capture, %Vp, and mean heart rate (HR) were recorded during AF and sinus rhythm. RESULTS: The eCRTAF algorithm resulted in a significantly higher %eCRT during AF than control (87.8% ± 7.8% vs 80.8% ± 14.3%; P <.001) and %Vp during AF than control (90.0% ± 5.9% vs 83.2% ± 11.9%; P <.001), with a small but statistically significant increase in mean HR of 2.5 bpm (79.5 ± 9.7 bpm vs 77.0 ± 9.9 bpm; P <.001). CONCLUSION: In a cohort of CRT patients with a history of AF, eCRTAF significantly increased %eCRT pacing and %Vp during AF with a small increase in mean HR. This algorithm may represent a novel noninvasive method of significantly increasing effective CRT delivery during AF, potentially improving CRT response.

Effects of Upgrade Versus De Novo Cardiac Resynchronization Therapy on Clinical Response and Long-Term Survival: Results from a Multicenter Study.

BACKGROUND: Benefits of cardiac resynchronization therapy (CRT) on morbidity and mortality in selected patients are well known. Although the number of upgrade procedures from single- or dual-chamber devices to CRT is increasing, there are only sparse data on the outcomes of upgrade procedures compared with de novo CRT. This study aimed to evaluate clinical response and survival in patients receiving de novo versus upgrade CRT defibrillator therapy. METHODS AND RESULTS: Prospectively collected outcome data were compared in patients undergoing de novo or upgrade CRT defibrillator implantation at 3 implant centers in Germany and Hungary. Clinical response was defined as an improvement by at least one New York Heart Association (NYHA) functional class. CRT implantation was performed in 552 consecutive patients of whom 375 underwent a de novo and 177 an upgrade procedure. Upgrade patients were more often implanted for secondary prevention, suffered more often from atrial fibrillation, chronic kidney disease, diabetes mellitus, and dyslipidemia, and had more often a non-LBBB (left bundle branch block) wide QRS complex, and lower left ventricular ejection fraction. Upgrade procedures were associated with a lower response rate compared to the de novo group (57% versus 69%, P univariate=0.008, P multivariate=0.021). During the follow-up of 37±28 months, survival was worse after upgrade compared with de novo CRT defibrillator implantations (hazard ratio, 1.65; 95% confidence interval, 1.22-2.24; P=0.001) even after careful adjustment for important baseline variables (adjusted hazard ratio, 1.68; 95% confidence interval, 1.20-2.34; P=0.002) and after propensity-score matching (propensity-adjusted hazard ratio, 1.79; 95% confidence interval, 1.08-2.95; P=0.023). CONCLUSIONS: Both clinical response and long-term survival were less favorable in patients undergoing CRT upgrade compared to de novo implantations.