Cardiac Resynchronization Therapy Defibrillator Research Articles

The incidence, clinical significance of depression and its clinical course after a cardac device implantation in patients with severe heart failure

Abstract Aim To assess the incidence, clinical significance of depression and the impact of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) implantation on psychiatric status in patients with heart failure (HF). Methods The prospective, single-center study encompassed 575 consecutive HF patients implanted with a CRT-D or ICD. Finally, the study population consisted of 494 subjects (186 ICD and 308 CRT-D patients), as 81 patients taking antidepressants were excluded from the analysis. All patients underwent psychiatric examination at the time of implantation, and the assessment of psychiatric status was repeated after 3, 6, 12 and 24 months. The study population was divided into 4 groups: Group 1 encompassed 101 (20.4%) patients with persistent depression, Group 2 constituted of 95 (19.2%) patients with depression that developed after ICD/CRT-D implantation, whereas 43 (8.7%) patients with remission of depression comprised Group 3, and Group 4 encompassed 255 (51.6%) patients with never diagnosed depression. Data on long-term follow-up (median 34.1 months) were screened to identify patients who developed a composite endpoint defined as death or hospitalization for decompensated HF. Results The cumulative incidence of depression at the baseline assessment was 39.1%. Depression developed in 95 (27.1%) patients, whereas remission of depression was observed in 43 (29.9%) subjects after ICD/CRT-D implantation. ICD intervention (HR 3.3) and increase in NYHA class by at least one class (HR 2.6) were the independent risk factors for depression development, whereas mitral regurgitation reduction (HR 1.9), as well as improvement in NYHA class by at least one class (HR 2.4) were the independent predictors for depression remission. Patients with persistent depression (Group 1) and those with newly developed depression (Group 2) were at significantly higher risk of a composite endpoint compared to patients in Group 3 and Group 4 (Table 1). Conclusions Depression is a common comorbidity associated with HF, as it affects 4 of 10 HF patients. ICD intervention and HF worsening are the strongest predictors for depression development after ICD/CRT-D implantation. Depression is a strong, independent risk factor of poor outcomes in HF population. Funding Acknowledgement Type of funding source: None

Sacubitril/valsartan reduces atrial fibrillation and supraventricular arrhythmias in patients with HFrEF and remote monitoring: preliminary data from the SAVE THE RHYTHM

Abstract Background Sacubitril/valsartan, the first combined angiotensin receptor-neprilysin inhibitor, has demonstrated a significant benefit compared to angiotensin inhibitor in decreasing ventricular arrhythmias and appropriate implantable cardioverter defibrillator (ICD) shocks in patients with heart failure with reduced ejection fraction (HFrEF). At present, there is no study which evaluates the effect of sacubitril/valsartan on the supraventricular arrhythmic burden in HFrEF patients with an ICD or cardiac resynchronisation therapy-defibrillator (CRT-D) and remote monitoring. Purpose To evaluate the effect of sacubitril/valsartan on the supraventricular arrhythmic burden in HFrEF patients with an ICD or CRTD and remote monitoring. Methods The SAVETHERHYTHM ((SAacubitril Valsartan rEal-world registry evaluating THE arRHYTHMia burden in HFrEF patients with implantable cardioverter defibrillator) is a multicentre, observational, prospective registry enrolling all patients with HFrEF, ICD or CRT-D actively followed through remote monitoring and starting treatment with sacubitril/valsartan. All patients are followed-up for at least one year after sacubitril/valsartan start. The primary endpoint is the mean number of sustained atrial tachycardia or atrial fibrillation (AT/AF) episodes per month. Secondary endpoints include the total burden of AT/AF (defined as the percentage of time in AT/AF per day), the mean number of premature ventricular contractions (PVC) per hour and the percentage of biventricular pacing per day (in patients with CRT-D). All primary and secondary endpoints are collected through remote monitoring. Results At the time of the first ad interim analysis, 60 patients (85.2% male, age 69±10 years) were consecutively enrolled. After treatment with sacubitril/valsartan, patients with at least one episode of AT/AF per month decreased from 32.8% to 21.3% (p=0.015). A significant decrease in number of AT/AF episodes (from 4.3 to 1.2 per year), in AT/AF burden (from 12% to 9%) and in number of PVC (from 83 to 74 per hour) were seen in patients with a previous diagnosis of paroxysmal or persistent AF (n=15; all p<0.05). Patients with permanent AF (n=7) experienced no benefits from sacubitril/valsartan therapy in terms of arrhythmic burden reduction. Patients with no previous history of AF (n=38) showed a decrease in number of AT/AF episodes (from 2.0 to 0.8 per year) and in number of PVC (from 77 to 49 per hour, all p<0.05). No new diagnosis of clinical AF was made after starting treatment with sacubitrl/valsartan, and patients with subclinical AT/AF episodes decreased from 8% to 3%. Conclusions Preliminary data suggest that therapy with sacubitril/valsartan could decrease arrhythmic burden in patients with non-permanent AF and reduce subclinical AT/AF episodes in patients with no history of AF. No positive effect has been noted in patients with permanent AF. Funding Acknowledgement Type of funding source: None

Real world experience with heart failure risk status generated by cardiac resynchronisation therapy defibrillators: high heart failure risk status incidence, causes and timing of remote transmissions

Abstract Background Proactive patient monitoring is of paramount importance in effective management of heart failure (HF) patients. Cardiac implantable electronic devices (CIEDs) used in HF patients are able to derive long-term trends in physiologic parameters and provide timely warning to clinicians. Little is known, however, on the real-world experience with device-generated HF risk-stratifying algorithms. Purpose Heart Failure Risk Score (HFRS) takes into account nine parameters and is calculated automatically based on long-term clinical trends. Remote transmissions provide information on the risk of HF event in next 30 days categorized as low, medium or high based on a maximum daily risk status in prior 30 days. We aimed to evaluate the ability of HFRS to alert HF specialists on the actual HF risk status. Methods The prospective registry included all patients with CIEDs featuring integrated Heart Failure Risk Score (HFRS) followed via Medtronic CareLink remote monitoring system and enabled for Co-management (CM) from May 2015 to August 2019 in a tertiary centre. High HFRS does not trigger automatic alert transmission. Study follow-up spanned between start of CM and last transmission in 2019. Inclusion criteria were CRT-D in situ, active Home Monitor, switched on OptiVol 2.0 remote alert and transmission data available on CareLink following study period completion. Transmissions were scheduled 3-monthly. Results Out of 229 consecutive patients, 132 met study criteria. Mean age was 74±10 years, 18% were female. Median follow-up duration was 2.7 years (IQR 1.3). Total number of transmissions was 2652, median per patient was 18 (IQR 13); scheduled, unscheduled and care alerts constituted 42%, 44% and 14%, respectively. One third of transmissions were automatically sent for CM review. There were 398 high HFRS episodes. OptiVol fluid index was below the threshold throughout 128 (32%) episodes. Missed episodes (not transmitted within 30 days from the final day of high HFRS) amounted to 130 (33%) and the reasons behind this included OptiVol alerting before the first day of high HFRS or persistently elevated when HFRS changed from low/medium to high (52%), low OptiVol index during the episode (38%) or other (10%). Median duration of high HFRS was 7 days (IQR 12, range, 1–187). Among timely picked-up high HFRS episodes, 38% were transmitted during the relevant episode and 62% afterwards with median delay of 10 days (IQR 15) from the last day of high HFRS; 21% of transmissions showing high HFRS were not highlighted for CM review which correlated with low OptiVol index, P<0.001. The factors contributing to high HFRS included: raised OptiVol (60%), patient activity (83%), AT/AF (46%), ventricular rate (VR) during AF (6%), % of VP (40%), shocks (2%), treated VT/VF (2%), night VR (72%) and HR variability (34%). Conclusions In a real-world clinical setting high HFRS was frequently under-reported. The investigation into clinical implications is warranted. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Our department has benefited from unrestricted grants from Boston Scientific and Medtronic Inc during the last 5 years.

Temporal characteristics of an integrated diagnostics risk score before and after heart failure hospitalizations in a large real-world population of patients with implantable devices

Abstract Background Diagnostic parameters measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) have been shown to change before and after heart failure (HF) events with fluid overload. Purpose We investigated the temporal characteristics of an integrated diagnostic risk score before and after HF events in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a de-identified database of aggregated electronic health record (EHR) data (2007–2017) to a manufacturer's device database with continuous diagnostic monitoring data. Patients with ICD/CRTD implants with intra-thoracic impedance diagnostic feature were included for this study. The previously defined integrated diagnostic risk score was derived by combining daily diagnostic data, including intra-thoracic impedance, night-time heart rate, activity, heart rate variability, and atrial fibrillation (AF) burden, ventricular rate during AF, CRT pacing, ventricular tachycardia episodes and shocks, in a Bayesian Belief Network framework. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretic administration. Temporal average of daily risk score across all patients in the 60 days pre and post HF events were compared in HF events with and without readmission within 60 days and with no HF event during pre and post follow-up days. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6±12.3 years, with 72% being males, and 51% with ICD devices. The average integrated diagnostics risk score in HF events with and without readmission and with no events is shown in Figure. A total of 1174 patients had 1425 HF events with no readmission for HF within 60 days and 282 patients had 295 HF events which were followed by readmission for HF within 60 days. A total of 17,839 patients had no HF events over 86,858 follow-up months. The average daily risk score across all patients was higher on all 60 days pre and post HF event with readmission compared to HF events with no readmission (p<0.001) and both were higher compared to follow-up period with no events (p<0.001). The risk score recovers less often after HF events which are followed by readmission within 60 days compared to HF events with no readmission. Conclusions In a large real-world population of patients with ICD/CRTD devices, the average integrated diagnostics risk score was higher before and after HF events with readmission compared to HF events with no readmission. Re-admissions are more likely in patients with smaller risk score recovery after HF events. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic Plc

Impact of an adaptive CRT optimization algorithm on the risk of life-threatening ventricular arrythmias of heart failure patients

Abstract Introduction Adaptive cardiac resynchronization therapy (aCRT) algorithm provides ambulatory CRT optimization and synchronized left-ventricular pacing instead of conventional biventricular pacing. Purpose To analyze the impact of aCRT on the risk of life-threatening ventricular arrythmia (VA) in patients with concomitant defibrillator therapy. Methods Symptomatic HF patients, in sinus rhythm, with LVEF ≤35% and QRS complex ≥130 ms undergoing first CRT-defibrillator (CRT-D) implant were collected from the multicentre, prospective and nationwide UMBRELLA study (2012–2017). All device information was automatically stored and collected through the remote monitoring system. An experts committee analysed in a blinded manner all electrograms. The endpoint was first appropriate therapy (AT) delivered within ventricular fibrillation zone at 12-months follow-up. Results 206 patients were collected (66.1±8.7 years; 73.3% male). Fifty nine patients composed the aCRT group and 147 composed the non-aCRT group. At implant, LBBB was present in 93% of patients, functional class III or IV in 69.9%, non-ischemic HF in 63.1% of patients and mean LVEF was 26.5±5.6%. Optimal medical treatment was achieved in a majority (B-blockers in 92%; RAASi in 89% and MRA in 72.2%). The percentage of ventricular pacing through 12 months was 96.1±9.4% in non-aCRT patients and 97.5±2.7% in aCRT patients (p=0.261). At 1-year of follow-up, 16 patients were delivered an AT (event rate: 7.8%). Most of these episodes (n=14) were due to sustained monomorphic ventricular tachycardia while the rest were caused by sustained polymorphic ventricular tachycardia/VF. A lower incidence of AT was observed in aCRT patients (3.4%) compared to non-aCRT patients (9.5%) but with no statistical differences (OR=0.33, CI 0.07–1.51, p=0.155). Conclusions In patients undergoing CRT provided by aCRT algorithm the risk of malign VA after 1-year of follow-up was low. Randomized studies are needed to clarify the impact of this dynamic algorithm on the arrhythmic risk of HF patients. Funding Acknowledgement Type of funding source: None

10-year outcomes of triple-site versus standard cardiac resynchronization therapy randomized trial (TRUST CRT)

Abstract Background Triple-Site versus Standard Cardiac Resynchronization Therapy Randomized Trial (TRUST CRT) was initiated in 2009 to verify the hypothesis whether triple-site (single right, double left) cardiac resynchronization therapy (CRT) may be superior to conventional, biventricular resynchronization in patients with advanced heart failure. Objectives To report 6-month outcomes and 10-year survival in TRUST CRT. Methods 100 consecutive patients with moderate to severe heart failure, ejection fraction of 35% or less, electrical and mechanical dyssynchrony, were randomly assigned in a 1:1 fashion to triple-site CRT defibrillator (TRIV) or to conventional CRT-D. The primary objective evaluated response-rate, defined as the 6-month's combined end point of alive status, freedom from hospitalization for heart failure or heart transplantation, relative≥10% increase in ejection fraction, ≥10% in peak oxygen consumption, and ≥10% in 6-minute walking distance. The secondary objective was to assess the occurrence of major adverse cardiovascular events (hospitalization for exacerbated heart failure requiring modification of pharmacotherapy, heart transplant or death) at month 6 and during remote observation. Results At month 6, the response-rate was higher in triple-site than conventional CRT-D group (51.1 vs. 26.5%, P=0.014). There were 2 deaths or heart failure events in the triple-site group (4%) as compared with 8 in the group assigned to conventional CRT-D (16%). A triple-site resynchronization resulted in 12% absolute risk reduction for secondary end point (hazard ratio 0.25; 95 percent confidence interval, 0.05 to 1.17, P=0.056, in comparison with the conventional CRT-D group). After 10 years of observation (median follow up of 7.1 years; range: 1.2–10.4) 57 patients (58.2%) died: 24 (53.3%) in the triple-site group, 31 (60.8%) in the conventional group (P=0.46) and 2 patients with and ICD (failed CRT implantation) [Figure]. Conclusions In patients with advanced heart failure, triple-site resynchronization combined with an ICD did not result in better survival than conventional resynchronization therapy in a median observation of 7.1 years. Figure 1 Funding Acknowledgement Type of funding source: None

Evaluation of the effectiveness of infusion of bone marrow derived cell in patients with heart failure: A network meta-analysis of randomized clinical trials and cohort studies.

Background: The aim of this study was to investigate the effectiveness of bone marrow-derived cells (BMC) technology in patients with heart failure and compare it with alternative therapies, including drug therapy, cardiac resynchronization therapy pacemaker (CRT-P), cardiac resynchronization therapy defibrillator (CRT-D). Methods: A systematic review study was conducted to identify all clinical studies published by 2017. Using keywords such as "Heart Failure, BMC, Drug Therapy, CRT-D, CRT-P" and combinations of the mentioned words, we searched electronic databases, including Scopus, Cochrane Library, and PubMed. The quality of the selected studies was assessed using the Cochrane Collaboration's tool and the Newcastle-Ottawa. The primary and secondary end-points were left ventricular ejection fraction (LVEF) (%), failure cases (Number), left ventricular end-systolic volume (LVES) (ml), and left ventricular end-diastolic volume (LVED) (ml). Random-effects network meta-analyses were used to conduct a systematic comparison. Statistical analysis was done using STATA. Results: This network meta-analysis covered a total of 57 final studies and 6694 patients. The Comparative effectiveness of BMC versus CRT-D, Drug, and CRT-P methods indicated the statistically significant superiority of BMC over CRT-P (6.607, 95% CI: 2.92, 10.29) in LVEF index and overall CRT-P (-13.946, 95% CI: -18.59, -9.29) and drug therapy (-4.176, 95% CI: -8.02, -.33) in LVES index. In addition, in terms of LVED index, the BMC had statistically significant differences with CRT-P (-10.187, 95% CI: -18.85, -1.52). BMC was also dominant to all methods in failure cases as a final outcome and the difference was statistically significant i.e. BMC vs CRT-D: 0.529 (0.45, 0.62) and BMC vs Drug: 0.516 (0.44, 0.60). In none of the outcomes, the other methods were statistically more efficacious than BMC. The BMC method was superior or similar to the other methods in all outcomes. Conclusion: The results of this study showed that the BMC method, in general, and especially in terms of failure cases index, had a higher level of clinical effectiveness. However, due to the lack of data asymmetry, insufficient data and head-to-head studies, BMC in this meta-analysis might be considered as an alternative to existing treatments for heart failure.

Subclinical atrial fibrillation in patients with cardiac resynchronization therapy caused heart failure hospitalization

Current study reported that early detection and early rhythm control therapy in patient with Atrial Fibrillation (AF) was associated with a lower risk of cardiovascular outcomes than usual care for AF. Early detection and early treatment for AF is important. However, subclinical AF is likely to go undetected and untreated, because patients with subclinical AF had no symptoms. It is unclear the relationship subclinical AF and Heart Failure (HF). This review summarizes the relationship between subclinical AF and HF hospitalization in patients with cardiac dysfunction using Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Tissue Doppler-Derived Left Ventricular Systolic Velocity Is Associated with Lethal Arrhythmias in Cardiac Device Recipients Irrespective of Left Ventricular Ejection Fraction

Life-threatening arrhythmias (LTAs) can trigger sudden cardiac death or provoke implantable cardioverter-defibrillator (ICD) discharges that escalate morbidity and mortality. Longitudinal myofibrils predominate in the subendocardium, which is uniquely sensitive to arrhythmogenic triggers. In this study, we test the hypothesis that mitral annular systolic velocity (S'), a simple routinely obtained tissue Doppler index of LV long-axis systolic function, might predict lethal arrhythmias irrespective of left ventricular ejection fraction (LVEF). This is a retrospective analysis of data from 302 patients (mean age, 68years; LVEF, 32%; 77% male; 52% ischemic; 35% primary prevention; and 53% cardiac resynchronization therapy defibrillator [CRT-D]) who were followed up (median, 15months) at two centers after receipt of an ICD or CRT-D for diverse indications. S', averaged from tissue Doppler-derived medial and lateral mitral annular velocities, was correlated with the primary outcome of time to sustained ventricular tachycardia (VT) or fibrillation (VF) needing device therapy. The median S' was 5.1 (interquartile range, 4.0-6.2) cm/sec and lower in CRT-D than ICD subjects (4.5 [3.8-5.6] cm/sec vs 5.5 [4.8-6.8] cm/sec, P<.001). Fifty-six (19%) subjects had LTA. Each 1cm/sec higher S' correlated to a 30% decreased risk of LTA (hazard ratio=0.70; 95% CI, 0.57-0.87; P=.001) independently of age, sex, β-blocker use, center, ICD use, and LVEF. Adding S' to the baseline Cox model improved net reclassification (P=.02). An S' > 5.6cm/sec was the best cutoff and linked to a 58% lower LTA risk than an S' ≤ 5.6cm/sec (95% CI, 0.23-0.85; P=.02). A higher S' is associated with a reduced probability of LTA in cardiac device recipients irrespective of LVEF and may have the potential to be used clinically to titrate medical, device, and ablative therapies to mitigate future arrhythmic risk.

Effective Use of Keishibukuryogan in Subcutaneous Hematoma after Implantable Cardiac Device Surgery in Two Cases.

Keishibukuryogan is a Kampo medicine that induces vasodilation and improves the blood flow velocity in subcutaneous blood vessels. We herein report two cases in which keishibukuryogan completely diminished subcutaneous hematoma after cardiac resynchronization therapy pacemaker implantation and defibrillator battery replacement within a month. Keishibukuryogan can be a good option for treating or preventing subcutaneous hematoma after surgical procedures for devices.

PREDICTORS OF IN-HOSPITAL MORTALITY IN PATIENTS WITH SARCOIDOSIS WITH CARDIOMYOPATHY

SESSION TITLE: Cardiovascular Disease SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: We sought to determine the predictors of in-hospital mortality using charlson co-morbidity variables among patients with sarcoidosis with cardiomyopathy (SCM) METHODS: The Nationwide Inpatient Sample was queried from 2010 to 2014 using ICD-9 diagnosis code (135) for sarcoidosis among patients >18 years. We combined it with code 425.8 for cardiomyopathy in other diseases including sarcoid and sarcoid heart muscle disease. We excluded patients with a history of prior myocardial infarction, percutaneous coronary intervention and coronary artery bypass graft. RESULTS: From 2010 to 2014, we identified 9,063 patients with SCM (Mean age = 53.11 ± 11.28 years; men 51.8% and black 52.5%). The overall in-hospital mortality rate was 2.5%. Various arrhythmias include atrial fibrillation (AF) 18.4%, ventricular fibrillation (VF) 2.5%, ventricular tachycardia (VT) 24.7%, complete heart block (CHB) 1.5% and second degree Mobitz type II 0.5%. Rates of implantable cardiac devices included implantable cardioverter-defibrillator (ICD) 9.7%, Cardiac Resynchronization Therapy Defibrillator (CRT-D) 3.6%, permanent pacemaker (PPM) 1.9%. Rate of endomyocardial biopsy (EMB) was found to be 2.8%. Rates of heart failure, cardiogenic shock, orthotropic heart transplantation (OHT), and catheter ablation were 100%, 2.6%, 1.4%, and 4.4%, respectively. Overall rate of sudden cardiac arrest (SCA) was found to be 1.8%. Based on a multivariate analysis, significant predictors of in-hospital mortality were age (AOR = 1.047, 95% CI [1.033, 1.061]), peripheral vascular disease (AOR = 0.297, 95% CI [0.173, 0.509]), COPD (AOR = 0.568, 95% CI [0.419, 0.771]), mild liver disease (AOR = 0.242, 95% CI [0.160, 0.367]), hemiplegia or paraplegia (AOR = 12.223, 95% CI [5.637, 26.506]), renal disease (AOR = 0.451, 95% CI [0.328, 0.619]), AF (AOR = 2.686, 95% CI [1.963, 3.675]), VF (AOR = 0.453, 95% CI [0.250, 0.821]), and SCA (AOR = 0.023, 95% CI [0.015, 0.036]). CONCLUSIONS: Patients with co-morbidities such as peripheral vascular disease, COPD, mild liver disease, hemiplegia or paraplegia, and renal disease were associated with higher in-hospital mortality. Among complications AF, VF, and SCA were predictors of in-hospital mortality. CLINICAL IMPLICATIONS: This study sheds light on clinical factors that could play a role in predicting mortality in patients with SCM. Possible identification and appropriate management of these factors may improve outcomes. DISCLOSURES: No relevant relationships by Abhijit Bhattaru, source=Web Response No relevant relationships by Akhil Gade, source=Web Response No relevant relationships by Karthik Gonuguntla, source=Web Response No relevant relationships by Pranav Karambelkar, source=Web Response No relevant relationships by Shivaraj Patil, source=Web Response No relevant relationships by Chaitanya Rojulpote, source=Web Response

Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices.

To explore the safety and clinical utility of MRI in participants with non-MRI-conditional cardiac implantable electronic devices, by establishing the Patient Registry of Magnetic Resonance Imaging in Non-Approved DEvices (PROMeNADe). From September 2015 to June 2019, 532 participants (211 women) with a mean age of 69 years ± 14 (standard deviation) were enrolled prospectively in the PROMeNADe registry (ClinicalTrials.gov identifier: NCT03081364) and underwent a total of 608 MRI examinations (61 cardiac MRI examinations). All participants had device interrogations performed before and after each MRI. Pacemaker-dependent patients received asynchronous pacing. Patients with an implantable cardioverter defibrillator (ICD) had tachycardia therapies disabled during the MRI. An electrophysiology nurse monitored participants for any hemodynamic or rhythm abnormalities. Referring physicians were surveyed regarding the clinical utility of the MRI. Standard descriptive analyses included summary statistics with percentages and means. Cardiac devices included pacemakers (46%), ICDs (30%), cardiac resynchronization therapy (CRT) pacemakers (4%), and CRT defibrillators (17%), as well as abandoned leads (2%). Pacemaker-dependent patients comprised 27% of all MRI examinations. There were no patient- or device-related complications. Clinical utility surveys of MRI examinations were completed by 150 physicians. According to the survey responses, these MRI examinations changed the suspected diagnosis 25% of the time and changed suspected prognosis in 26% of participants, with planned medical or surgical treatment being changed 42% of the time. This registry demonstrates that MRI examinations, including thoracic MRI examinations, can be performed safely in patients who have non-MRI-conditional devices, in pacemaker-dependent patients with ICDs, and in patients with abandoned leads. These MRI examinations can have a substantial impact on patient care, justifying the extensive resources used to perform them.Supplemental material is available for this article.© RSNA, 2020See also the commentary by Peshock in this issue.

Complications of cardiac implantable electronic device placement in public and private hospitals.

Few safety data exist comparing clinical outcomes in Australian public and private hospitals. We hypothesised that differences could exist between public and private hospitals due to differences in acuity and patient-level co-morbidities. To report comparative complications of cardiac implantable electronic device (CIED) placement in public and private hospitals. We conducted an observational cohort study of outcomes of patients aged >18 years from 2010 to 2015 undergoing a new permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy pacemaker or defibrillator (CRT-D/P) implant in NSW and Queensland public and private hospitals. The primary endpoint was major CIED-related complications occurring in-hospital or within 90 days of discharge. The independent effect of hospital sector was determined using multiple logistic regression, adjusting for covariates, including age, sex, co-morbidities and procedural acuity. A total of 32 364 new CIED implants (PPM 23 845, ICD 5361 and CRT-D/P 3158) were included (49% in private hospitals). Overall, 8.0% of private hospital procedures and 9.6% public hospital procedures experienced at least one complication. After adjustment, the overall risk of CIED complications was similar in private and public hospitals (OR: 0.92, 95% CI: 0.84-1.00, P = 0.06). In analysis of individual complications, adjusted all-cause in-hospital mortality was higher in private hospitals, (OR: 1.49, 95% CI: 1.03-2.16, P = 0.036) primarily driven by an excess mortality in acute cases. The adjusted risk of in-hospital generator operation (OR: 0.53, 95% CI: 0.30-0.94, P = 0.03) and post-discharge infection (OR: 0.61, 95% CI: 0.46-0.81, P < 0.001) was lower in private hospitals. These data identify important similarities and differences in safety outcomes of CIED implantation between Australian public and private hospitals.

CLINICAL CASE OF NON-COMPACTION CARDIOMYOPATHY IN A PATIENT WITH PKP2 GENE MUTATION

The features of the clinical course of non-compaction cardiomyopathy, its prognosis and even its diagnosis are still the subject of discussion. The variety of phenotypes of this disease and genetic heterogeneity dictates the need for detailed clinical and molecular genetic examination of patients with this pathology. The article presents a clinical observation of a patient with a dilated phenotype of left ventricular non-compaction, progression of chronic heart failure, as well as the presence of ventricular rhythm and conduction disorders that required the implantation of cardiac resynchronization therapydefibrillator (CRT-D). The patient was found to have a missense mutation c. 1892A&gt;G (p.Tyr631Cys, rs1060501183) in PKP2 gene in a heterozygous state. The issues of differential diagnostics with arrhythmogenic right ventricular cardiomyopathy and treatment strategies for the disease were discussed.

Relationship between device-detected subclinical atrial fibrillation and heart failure in patients with cardiac resynchronization therapy defibrillator.

BackgroundAtrial fibrillation (AF) is a leading preventable cause of heart failure (HF) for which early detection and treatment is critical. Subclinical‐AF is likely to go untreated in the routine care of patients with cardiac resynchronization therapy defibrillator (CRT‐D).HypothesisThe hypothesis of our study is that subclinical‐AF is associated with HF hospitalization and increasing an inappropriate therapy.MethodsWe investigated 153 patients with an ejection fraction less than 35%. We divided into three groups, subclinical‐AF (n = 30), clinical‐AF (n = 45) and no‐AF (n = 78). We compared the baseline characteristics, HF hospitalization, and device therapy among three groups. The follow‐up period was 50 months after classification of the groups.ResultsThe average age was 66 ± 15 years and the average ejection fraction was 26 ± 8%. Inappropriate therapy and biventricular pacing were significantly different between subclinical‐AF and other groups (inappropriate therapy: subclinical‐AF 13% vs clinical‐AF 8.9% vs no‐AF 7.7%: P = .04, biventricular pacing: subclinical‐AF 81% vs clinical‐AF 85% vs no‐AF 94%, P = .001). Using Kaplan‐Meier method, subclinical‐AF group had a significantly higher HF hospitalization rate as compared with other groups. (subclinical‐AF 70% vs clinical‐AF 49% vs no‐AF 38%, log‐rank: P = .03). In multivariable analysis, subclinical‐AF was a predictor of HF hospitalization.ConclusionsSubclinical‐AF after CRT‐D implantation was associated with a significantly increased risk of HF hospitalization. The loss of the biventricular pacing and increasing an inappropriate therapy might affect the risk of HF hospitalization.

Dose-response association of implantable device-measured physical activity with long-term cardiac death and all-cause mortality in patients at high risk of sudden cardiac death: a cohort study

BackgroundCardiovascular implantable electronic devices (CIEDs) with physical activity (PA) recording function can continuously and automatically collect patients’ long-term PA data. The dose-response association of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRTD)-measured PA with cardiovascular outcomes in patients at high risk of sudden cardiac death (SCD) was investigated.MethodsIn total, 822 patients fulfilling the inclusion criteria were included and divided into three groups according to baseline PA tertiles: tertile 1 (< 8.04%, n = 274), tertile 2 (8.04–13.24%, n = 274), and tertile 3 (> 13.24%, n = 274). The primary endpoint was cardiac death, the secondary endpoint was all-cause mortality.ResultsDuring a mean follow-up of 59.7 ± 22.4 months, cardiac death (18.6% vs 8.8% vs 5.5%, tertiles 1–3, P < 0.001) and all-cause mortality (39.4% vs 20.4% vs 9.9%, tertiles 1–3, P < 0.001) events decreased according to PA tertiles. Compared with patients younger than 60 years old, older patients had a lower average PA level (9.6% vs 12.8%, P < 0.001) but higher rates of cardiac death (13.2% vs 8.1%, P = 0.024) and all-cause mortality (28.4% vs 16.7%, P < 0.001) events. Adjusted multivariate Cox regression analyses showed that a higher tertile of PA was associated with a lower risk of cardiac death (hazard ratio (HR) 0.41, 95% confidence interval (CI): 0.25–0.68, tertile 2 vs tertile 1; HR 0.28, 95% CI: 0.15–0.51, tertile 3 vs tertile 1, Ptrend < 0.001). Similar results were observed for all-cause mortality. The dose-response curve showed an inverse non-linear pattern, and a significant reduction in endpoint risk was observed at the low-moderate PA level. The HR for cardiac death was reduced by half with 12.32% PA (177 min), and the HR for all-cause mortality was reduced by half with 11.92% PA (172 min). Subgroup analysis results indicated that older adults could benefit from PA and the range for achieving optimal benefits might be lower.ConclusionsPA monitoring may aid in long-term management of patients at high risk of SCD. More PA will generate better survival benefits, but even low-moderate PA is already good especially for older adults, which is relatively easy to achieve.

Improved 30day heart failure rehospitalization prediction through the addition of device-measured parameters.

AimsThis study aimed to improve in‐person clinical evaluation on the day of heart failure (HF) hospitalization discharge by adding device‐measured parameters to predict 30 day HF rehospitalization risk in cardiac resynchronization therapy‐defibrillator (CRT‐D) patients.Methods and resultsIn a cohort of Medicare patients with CRT‐Ds, the independent prognostic value of four device‐measured parameters was assessed relative to typical clinical parameters associated with rehospitalization risk. Medicare registry, claims, and Medtronic CareLink® Network data for these patients were analysed using logistic regression modelling and net reclassification methods. Among 1563 CRT‐D patients, 411 patients had 607 HF hospitalization events during a median 6.3 years of follow‐up. Compared with clinical variables alone, impedance measurements resulted in a 28% improvement between the predicted probabilities of having vs. not having a 30 day HF rehospitalization (relative integrated discrimination improvement = 0.28) and a net 42% improvement in the classification of 30 day HF rehospitalization events and non‐events after an index HF hospitalization (net reclassification index = 0.42; 95% CI: 0.10, 0.74).ConclusionsIn CRT patients, intrathoracic impedance measurements improve prediction of 30 day HF rehospitalization over clinical characteristics alone. The present study provides supportive data for the routine evaluation of intrathoracic impedance prior to discharge in patient with CRT devices. Furthermore, the models developed in this study could be used to design interventions to improve compliance with Medicare reimbursement guidelines regarding 30 day HF rehospitalization.

Seventeen-year trend (2001–2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups

AimsTo analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD). MethodsFrequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50–79, ≥80 years). ResultsFrom 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator – CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD).ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy. ConclusionSince 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population.

Safety of magnetic resonance imaging scanning in patients with cardiac resynchronization therapy–defibrillators incorporating quadripolar left ventricular leads

Magnetic resonance imaging (MRI) scanning of magnetic resonance (MR)-conditional cardiac implantable cardioverter-defibrillators (ICDs) can be performed safely following specific protocols. MRI safety with cardiac resynchronization therapy-defibrillators (CRT-Ds) incorporating quadripolar left ventricular (LV) leads is less clear. The purpose of this study was to evaluate the safety and effectiveness of ICDs and CRT-D systems with quadripolar LV leads after an MRI scan. The ENABLE MRI Study included 230 subjects implanted with a Boston Scientific ImageReady ICD (n = 39) or CRT-D (n=191) incorporating quadripolar LV leads undergoing nondiagnostic 1.5-T MRI scans (lumbar and thoracic spine imaging) a minimum of 6 weeks postimplant. Pacing capture thresholds (PCTs), sensing amplitudes (SAs), and impedances were measured before and 1 month post-MRI using the same programmed LV pacing vectors. The ability to sense/treat ventricular fibrillation (VF) was assessed in a subset of patients. A total of 159 patients completed a protocol-required MRI scan (MRI Protection Mode turned on) with no scan-related complications. All right ventricular (RV) and left LV PCT and SA effectiveness endpoints were met: RV PCT 99% (145/146 patients), LV PCT 100% (120/120), RV SA 99% (145/146), and LV SA 98% (116/118). In no instances did MRI result in a change in pacing vector or lead revision. All episodes of VF were appropriately sensed and treated. This first evaluation of predominantly CRT-D systems with quadripolar LV leads undergoing 1.5-T MRI confirmed that scanning was safe with no significant changes in RV/LV PCT, SA, programmed vectors, and VF treatment, thus suggesting that MRI in patients having a device with quadripolar leads can be performed without negative impact on CRT delivery.

Heart failure hospitalizations and costs in ICD/CRT-D recipients following replacement or upgrade: the DECODE registry.

AimsThe aim of this study is to report heart failure hospitalization (HFH) rates and associated costs within 12 months following implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT‐D) device replacement or upgrade from ICD to CRT‐D.Methods and resultsThe DEtect long‐term COmplications after icD rEplacement (DECODE) was a prospective, single‐arm, multicentre cohort study that explored complications in ICD/CRT‐D recipients. All clinical and survival data at 12 months were prospectively analysed. For each adjudicated HFH, admission and discharge dates and ICD‐9‐CM diagnosis and procedure codes were recorded. The reimbursement for each HFH was calculated for each diagnosis‐related group code. Between 2013 and 2015, 983 patients (mean age 71 years, male 76%, mean left ventricular ejection fraction 35%, and New York Heart Association Class I/II 75.6%) were enrolled. Patients underwent device replacement (900; 91.6%, 446 ICD/454 CRT‐D) or ICD upgrade to CRT‐D (83; 8.4%). Post‐replacement hospitalizations occurred in 220 patients, with the primary discharge diagnosis identifying cardiovascular causes in 175 patients (80%). Fifty‐five (5.6%) patients experienced at least one HFH. Overall, 91 HFH events occurred (9.6% event rate, 95% confidence interval: 7.7–11.7) in 70 patients; 66 (6.7%) patients died, 40 (60.6%) of cardiovascular causes. The HFH rate was significantly higher following upgrades, and the occurrence of HFH was associated with an 11‐fold increased mortality risk (95% confidence interval: 5.9–20.5, P < 0.0001). Medical diagnosis‐related group accounted for 91.2% of HFH; the mean cost per HFH was €5662 ± 9497, and the mean cost per patient was €9369 ± 12 687. On multivariate analysis, predictors of HFH were atrial fibrillation, chronic kidney disease, and all‐cause hospitalization within 30 days prior to the procedure.ConclusionsIn the DECODE registry, HFH and mortality rates in the year following ICD/CRT‐D replacement or upgrade were low. In this particular subset, underlying cardiac disease was the main driver of HFH, mortality, and higher healthcare expenditures.