Cardiac Resynchronization Therapy Pacemaker Research Articles

Long-term mortality in cardiac resynchronization therapy upgrade procedures compared with de novo implantations - a nationwide cohort study

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Danish Cardiovascular Academy Background Patients with an implanted pacemaker (PM) or implantable cardioverter-defibrillator (ICD) who develop heart failure (HF) and have frequent right ventricular (RV) pacing, may be upgraded to a Cardiac Resynchronization Therapy (CRT) device. Such upgrades constitute approximately one fourth of CRT implantations. Limited research has been devoted to long-term outcomes after upgrade implantations and diverging results have been reported. Purpose We aimed to investigate long-term mortality in patients undergoing upgrade to CRT after previous PM or ICD implantation and patients undergoing CRT de novo implantation. Methods This was a nationwide register-based cohort study. The patient cohort was identified via the Danish Pacemaker and ICD Registry and consisted of consecutive Danish patients undergoing a CRT de novo implantation or an upgrade to CRT, from 01.01.2000 to 31.08.2018. Upgrade from a CRT pacemaker to a CRT defibrillator, and simple device replacement procedures were not included. Data were cross-linked with the Danish Patient Registry via the unique central person registration number. The endpoint was total mortality. Unadjusted- and adjusted Cox proportional hazard regression was used to assess the association between the procedure type (upgrade or de novo), baseline characteristics and total mortality. Results We identified 8,880 patients of whom 6,685 (75.3%) underwent de novo CRT implantation and 2,195 (24.7%) underwent upgrade to CRT from a previous PM or ICD. The median (IQR) follow-up time was 3.9 years (5.3) and 4.6 years (4.3) for upgrade and de novo implantations respectively. At baseline, patients who underwent upgrade to CRT were older (median 71.9 vs. 69.3 years) and more likely to have ischemic heart disease (66.8% vs. 57.1%), atrial fibrillation or atrial flutter (57.5% vs. 33.4%) and chronic kidney disease (10.3% vs. 7.2%) compared to patients who had de novo implantation. The proportion of males was larger among patients who underwent upgrade to CRT compared to de novo implantation (84.1% vs. 74.9%). Upgrade implantations were associated with higher minimally adjusted (age and sex) total mortality (HR 1.13, [95% CI 1.05;1.21], p<0.001) compared to de novo implantations. There was no difference in total mortality between upgrade and de novo implantations after adjusting for age, sex, diabetes, hypertension, chronic ischemic heart disease, atrial fibrillation or atrial flutter, chronic obstructive pulmonary disease, and chronic kidney disease (HR 1.03, [95% CI 0.96;1.10], p=0.46). Conclusion There are major differences in co-morbidities among patients undergoing upgrade to CRT and patients undergoing CRT de novo implantation. When adjusting for these differences, there was no difference in total mortality between the two populations. This suggests that CRT is equally beneficial in both de novo and upgrade implantations.

Risk of complications following external cardioversion in cardiovascular implantable electronic devices with and without generator replacement

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Karl G. Andersen Foundation Introduction External cardioversion (ECV) with transthoracic shock is a standard procedure to control atrial fibrillation and flutter in patients regardless of whether cardiovascular implantable electronic devices (CIED) are in situ. Studies have demonstrated infrequent ECV-related CIED malfunction, requiring device re-interventions, but the mechanisms seem heterogeneous. We hypothesized, that replaced CIED generators are more vulnerable to ECV procedures, maybe caused by insulation defects. The aim of this study is to investigate the long-term risk of complications following ECV in CIEDs with or without previous generator replacement. Methods All CIED implants and re-operations in Denmark were identified in the Danish Pacemaker and ICD Register and ECVs were identified in the Danish National Patient Registry from January 2010 to February 2019. We identified CIED patients with and without previous generator replacement. Inclusion was at the time of first ECV. Time to generator replacement with the same type and lead re-intervention with the same lead type after ECV were calculated independently, using Cox regression with death, generator extraction, and system up-/down-grade being competing events. The cause-specific hazard ratios (HR) were calculated using inverse probability of treatment balancing patient age and sex and stratified for the different types of CIED and lead, allowing different baseline hazard functions (1). Results We identified 515 CIED patients with previous generator replacement and 1,878 CIED patients without generator replacement. Mean age of patients at inclusion was 68.7±11.7 years with 74% men and the median generator and lead implant times were 1.6 years (0.9 years without replacement) and 3.0 years (0.7 years without replacement) before ECV. The types of CIED included 50% of pacemakers, 30% of Implantable Cardioverter Defibrillators, 6% of Cardiac Resynchronization Therapy-Pacemaker, and 14% of Cardiac Resynchronization Therapy-Defibrillators. During the first 3 years of follow-up, 92 (18%) of the patients with replaced generator had an additional generator replacement compared to 161 (9%) of the patients without generator replacement. The type of leads included 38% atrial leads, 26% right ventricle leads, 13% left ventricle leads, and 23% high voltage leads. During the first 3 years of follow-up, 71 (8%) of the patients with a replaced generator had lead re-intervention compared to 191 (5%) of the patients without a replaced generator. The HR of generator replacement was 2.00 (95%CI:1.51;2.64, p<0.001) and 1.60 (95%CI:1.21;2.12, p=0.001) balancing generator implant time. The HR of lead re-intervention was 1.62 (95%CI:1.21;2.16, p=0.001). Conclusion Wearing a contemporary cardiovascular implantable electronic device with a prior generator replacement is associated with a two-fold increased risk of additional generator replacement and an increased risk of lead re-intervention following external cardioversion.

Telemonitoring heart failure in a remote region: data from cardiac implantable electronic devices

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Heart failure (HF) represents an important burden to the medical system attending to its high prevalence and high risk of hospital admissions by decompensations. Remote monitoring (RM) systems using invasive and non-invasive parameters were developed to anticipate clinical deterioration in patients with cardiac implantable electronic devices (CIEDs). Objective To characterize a cohort of patients with HF and CIEDs in an outermost region. We aimed to accessed data from monitoring device algorithms and to analyze the real impact in clinical decompensations, hospital admissions and all-cause mortality. Methods Retrospectively multicenter cohort study included 211 patients with HFrEF and CIEDs, between 2010 and 2020. This study population was divided into two specific groups: Group A including patients with RM data and Group B including patients who receive usual care at regular hospital consultations. RM technology applied used different parameters to access the risk of worsening HF and stablishing an alert threshold. Results Out of 211 patients enrolled, 75% were male and 44.8% were in NYHA functional class II at the time of device implantation. One-hundred and twenty (56.9%) received in-home monitoring system (89% Latitude® and 10.8% Carelink®), corresponding to the Group A. The remaining 91 patients (43.1%) were included in Group B. Forty-nine patients (40.8%) had transvenous implantable cardioverter defibrillator (ICD), 13 (10.8%) had a subcutaneous ICD, 54 (45%) a cardiac resynchronization therapy (CRT) defibrillator and 4 (3.3%) a CRT pacemaker. Group A patients did not have coronary artery disease (p 0.047) and were younger than patients in Group B (median age 66 years, IQR 55 – 73; median age 70 years, IQR 63 – 77). No other statistically differences in main comorbidities were detected between groups. The number of atrial fibrillation (AF) episodes and AF burden was higher in Group A during the follow-up (p 0.006) as well as non-sustained ventricular tachycardia episodes (p 0.016). However, no differences were accessed in emergency department (ED) admissions or heart failure hospitalizations (HFH) by decompensation for patients in group A who received alerts versus patients who not received (p 0.178 and p 0.748, respectively) nor between group A and B (p 0.921 and p 0.213, respectively). Patients in group A had a lower all-cause mortality rate (p < 0.001) and cardiovascular mortality (p 0.002), but no difference in life-threatening ventricular events occurred. Conclusion In our cohort of HF patients, remote monitoring allowed the premature detection and the correct quantification of arrhythmic events but did not reflect any difference in ED nor HFH by decompensation. Instead, RM system demonstrates ability to reduce global mortality when compared to conventional care. More data about the application of this system and the ideal tracking algorithms are necessary.

PO-03-054 OPTIMIZING REMOTE MONITORING ALERTS FOR CIED PATIENTS TO REDUCE RESOURCE UTILIZATION WITHOUT COMPROMISING CLINICAL CARE

The benefits of remote monitoring (RM) have been demonstrated in multiple clinical studies and have become the standard of care for patients with cardiovascular implantable electronic devices (CIEDs). Benefits include fewer hospitalizations, reduction in mortality and improved clinical workflow by reducing in-office visits. As RM utilization increases, the amount of transmitted data can become a resource burden for responsible caregivers. To evaluate RM alert burden from actively monitored CIED patients within US-based integrated healthcare system to identify opportunities to optimize RM and a reduction of provider workload. We conducted an epidemiologic descriptive study using data from 9,781 CIED Patients from 7 healthcare centers within Kaiser Permanent who were monitored using BIOTRONIK Home Monitoring® (HM) from 1/1/22 through 7/31/22. Frequencies and proportions were used to describe alerts during the study period, as well as occurrence by device type. Patterns were identified that suggest specific alert programming differences leading to unnecessary alerts from a given healthcare centers or device type. In total, 9,781 active CIED patients enrolled in HM were analyzed. A total of 8,519 (87%) patients had ≥1 alert in the given timeframe. The distribution of device types in the patient population with an alert was: 5,725 (67%) implantable pulse generator (IPG), 132 (2%) cardiac resynchronization therapy pacemaker (CRT-P), 1,718 (20%) implantable cardioverter-defibrillator (ICD), 715 (8%) cardiac resynchronization therapy defibrillator (CRT-D) and 229 (3%) implantable cardiac monitors (ICM). A breakdown of alerts per patient per month shows that the majority (65%) of all alerts are generated by a minority of patients (20%). In conjunction with this finding, the alert per patient rate in this timeframe was the highest for ICM (15/patient) and CRT-D (13/patient) which represents 10% of all patients. Alert optimization is essential to reduce the work burden associated with RM. As shown in this analysis a limited number of patients (20%) are responsible for a significant portion of the overall alert burden (65%). We plan to target those high-volume alert sites as well as the specific alerts and specific patients to create server-based alert “templates” to optimize patient care and decrease alert burden for clinicians. A subsequent analysis will determine impact on patient outcomes and reduction in the burden of work.

Performance of alert transmissions from cardiac implantable electronic devices to the CareLink network: A retrospective analysis

Remote monitoring of cardiac implantable electric devices improves patient outcomes and experiences. Alert-based systems notify physicians of clinical or device issues in near real-time, but their effectiveness is contingent upon device connectivity. To assess patient connectivity by analyzing alert transmission times from patient transceivers to the CareLink network. Alert transmissions were retrospectively gathered from a query of the United States de-identified Medtronic CareLink database. Alert transmission time was defined as the duration from alert occurrence to arrival at the CareLink network and was analyzed by device type, alert event, and alert type. Using data from previous studies, we computed the benefit of daily connectivity checks. The mean alert transmission time was 14.8 hours (median = 6 hours), with 90.9% of alert transmissions received within 24 hours. Implantable pulse generators (17.0 ± 40.2 hours) and cardiac resynchronization therapy-pacemakers (17.2 ± 42.5 hours) had longer alert transmission times than implantable cardioverter-defibrillators (13.7 ± 29.5 hours) and cardiac resynchronization therapy-defibrillators (13.5 ± 30.2 hours), but the median time was 6 hours for all 4 device types. There were differences in alert times between specific alert events. Based on our data and previous studies, daily connectivity checks could improve daily alert transmission success by 8.5% but would require up to nearly 800 additional hours of staff time on any given day. Alert transmission performance from Medtronic devices was satisfactory, with some delays likely underscored by patient connectivity issues. Daily connectivity checks could provide some improvement in transmission success at the expense of increased clinic burden.

Acute and long-term outcomes of quadripolar IS-4 versus bipolar IS-1 left ventricular leads in cardiac resynchronization therapy: A retrospective registry study.

The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary. In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint. Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = .002). The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs. 22.4%; p = .003; 4.5% vs. 17.9%; p = .015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = .029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = .036). In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU.

TCTAP C-193 A Case of Acute Decompensated Heart Failure Due to Leadless Pacemaker Induced Dyssynchrony After TAVR Which Was Dramatically Improved by Cardiac Resynchronization Therapy Pacemaker

TCTAP C-193 A Case of Acute Decompensated Heart Failure Due to Leadless Pacemaker Induced Dyssynchrony After TAVR Which Was Dramatically Improved by Cardiac Resynchronization Therapy Pacemaker

Long-term risk of cardiovascular implantable electronic device reinterventions following external cardioversion of atrial fibrillation and flutter: A nationwide cohort study

External cardioversion (ECV) is an essential part of rhythm control of atrial fibrillation and flutter in patients with and without cardiovascular implantable electronic devices (CIEDs). Long-term follow-up data on ECV-related CIED dysfunctions are limited. The purpose of this study was to investigate the risk of CIED reintervention following ECV in a nationwide cohort. We identified CIED implants and surgical reinterventions from 2005 to 2021 in the Danish Pacemaker and ICD Register. We included CIED patients undergoing ECV from 2010 to 2019 from the Danish National Patient Registry. For each ECV-exposed generator, 5 matched generators without ECV were identified, and for each ECV-exposed lead, 3 matched leads were identified. The primary endpoints were generator replacement and lead reintervention. We compared 2582 ECV-exposed patients with 12,910 matched patients with a pacemaker (47%), implantable cardioverter-defibrillator (ICD) (29%), cardiac resynchronization therapy-pacemaker (6%), or cardiac resynchronization therapy-defibrillator (18%). During 2 years of follow-up, 210 ECV-exposed generators (8.1%) vs 670 matched generators (5.2%) underwent replacements, and 247 ECV-exposed leads (5.6%) vs 306 matched leads (2.3%) underwent reintervention. Unadjusted hazard ratios were 1.61 (95% confidence interval [CI] 1.37-1.91; P <.001) for generator replacement and 2.39 (95% CI 2.01-2.85; P <.001) for lead reintervention. One-year relative risks were 1.73 (95% CI 1.41-2.12; P <.001) for generator replacement and 2.85 (95% CI 2.32-3.51; P <.001) for lead reintervention, and 2-year relative risks were 1.39 (95% CI 1.19-1.63; P <.001) and 2.18 (95% CI 1.84-2.57; P <.001), respectively. ECV in patients with a CIED is associated with a higher risk of generator replacement and lead reintervention. The risks of reinterventions were more pronounced within the first year after cardioversion.

Renal denervation for resistant hypertension and heart failure with a reduced ejection fraction

Hypertension is a risk factor for the development of heart failure and has a negative impact on the survival of these patients. Although patients with these two conditions usually take different antihypertensive medications, some patients do not achieve adequate blood pressure control and their hypertension becomes resistant or refractory. In this scenario, percutaneous renal denervation has emerged in recent years as an alternative to achieve blood pressure control goals. We present the case of a 53-year-old woman with a medical history of essential hypertension, hypercholesterolemia, unipolar depression, and diabetes, who was diagnosed with dilated cardiomyopathy with reduced left ventricular ejection fraction (33%). Despite the initiation of multiple antihypertensive medications and placement of a cardiac resynchronization therapy pacemaker, the patient remained hypertensive with a left ventricular ejection fraction of 40%. At that time, percutaneous renal denervation was performed without complications, and one year after the procedure, the patient had improved better blood pressure control and the left ventricular ejection fraction increased to 51%. This case illustrates one of the clinical scenarios in which it has been suggested that renal denervation may be more beneficial, as in the situation of patients with refractory hypertension and heart failure.

Device-detected atrial fibrillation in a large remote-monitored cohort: implications for anticoagulation and need for new pathways of service delivery

BackgroundRemote monitoring (RM) can facilitate early detection of subclinical and symptomatic atrial fibrillation (AF), providing an opportunity to evaluate the need for stroke prevention therapies. We aimed to characterize the burden of RM AF alerts and its impact on anticoagulation of patients with device-detected AF.MethodsConsecutive patients with a cardiac implantable electronic device, at least one AF episode, undergoing RM were included and assigned an estimated minimum CHA2DS2-VASc score based on age and device type. RM was provided via automated software system, providing rapid alert processing by device specialists and systematic, recurrent prompts for anticoagulation.ResultsFrom 7651 individual, 389,188 AF episodes were identified, 3120 (40.8%) permanent pacemakers, 2260 (29.5%) implantable loop recorders (ILRs), 987 (12.9%) implantable cardioverter defibrillators, 968 (12.7%) cardiac resynchronization therapy (CRT) defibrillators, and 316 (4.1%) CRT pacemakers. ILRs transmitted 48.8% of all AF episodes. At twelve-months, 3404 (44.5%) AF < 6 min, 1367 (17.9%) 6 min–6 h, 1206 (15.8%) 6–24 h, and 1674 (21.9%) ≥ 24 h. A minimum CHA2DS2-VASc score of 2 was assigned to 1704 (63.1%) of the patients with an AF episode of ≥ 6 h, 531 (31.2%) who were not anticoagulated at 12-months, and 1031 (61.6%) patients with an AF episode duration of ≥ 24 h, 290 (28.1%) were not anticoagulated.ConclusionsDespite being intensively managed via RM software system incorporating cues for anticoagulation, a substantial proportion of patients with increased stroke risk remained unanticoagulated after a device-detected AF episode of significant duration. These data highlight the need for improved clinical response pathways and an integrated care approach to RM.Trial registrationAustralian New Zealand Clinical Trial Registry: ACTRN12620001232921.Graphical

Predicting the survival benefit of cardiac resynchronization therapy with defibrillator function for non-ischemic heart failure-Role of the Goldenberg risk score.

Primary prevention of sudden cardiac death (SCD) in non-ischemic heart failure (HF) patients remains a topic of debate at cardiac resynchronization therapy (CRT) implantation requiring individual risk assessment. Using the Goldenberg SCD risk score, we aimed to predict, which non-ischemic HF patients will benefit from the addition of an implantable cardioverter defibrillator (ICD) to CRT at long-term. Between 2000 and 2018 non-ischemic HF patients undergoing CRT implantation were collected into our retrospective registry. The Goldenberg risk score (GRS) was calculated by the presence of atrial fibrillation, New York Heat Association (NYHA) class > 2, age > 70 years, blood urea nitrogen > 26 mg/dl and QRS > 120 ms. The primary endpoint was all-cause mortality, heart transplantation or left ventricular assist device implantation. From 667 patients, 347 (52%) underwent cardiac resynchronization therapy-pacemaker (CRT-P), 320 (48%) cardiac resynchronization therapy-defibrillator (CRT-D) implantations. During the median follow up time of 4.3 years, 306 (46%) patients reached the primary endpoint (CRT-D 37% vs. CRT-P 63%; p < 0.001). CRT-D patients were younger (64 vs. 69 years; p < 0.001), infrequently females (26 vs. 39%; p < 0.001), and had a lower ejection fraction (27 vs. 29%; p < 0.01) compared to CRT-P patients. After GRS calculation, patients were dichotomized by low (< 3) and high (≥ 3) scores. CRT-D patients with low GRS showed a mortality benefit compared to CRT-P (HR 0.68; 95% CI 0.48-0.96; p = 0.03), high-risk patients did not (HR 0.84; 95% CI 0.62-1.13; p = 0.26). In our non-ischemic cohort, patients with low GRS showed a clear long-term mortality benefit by adding ICD to CRT, however, in high-risk patients no further benefit could be observed.

Subclinical hypothyroidism and its relationship with therapy failure in patients underwent cardiac resynchronization therapy.

Cardiac resynchronization therapy (CRT) is used in patients with heart failure (HF), an important problem in cardiology practice, with reduced left ventricular systolic dysfunctions and left ventricular dyssynchrony to improve morbidity and mortality. Thyroid diseases have undeniable effects on cardiac functions. So, we aimed to evaluate the effect of subclinical hypothyroidism on CRT response in HF patients in this study. After the exclusion, 386 consecutive patients who received first-time CRT-defibrillator (CRT-D) or CRT-pacemaker (CRT-P) were retrospectively included. Known overt hypothyroidism or hyperthyroidism patients were excluded. The response of CRT was defined as a relative increase (≥15%) or absolute increase (≥10%) in left ventricular ejection fraction (LVEF) from implantation to one-year after follow-up. Diabetes mellitus, atrial fibrillation and coronary artery disease ratios were similar between responder vs. non-responder groups. Thyroid stimulating hormone (TSH) levels were higher (p <0.005) in non-responder group. Responder group had higher baseline LVEF (p <0.001), and follow-up LVEF (p <0.001) and longer baseline QRS interval (p =0.004), but similar post-implant QRS interval duration (p >0.005) with non-responder group. Baseline QRS interval (p =0.002), baseline LVEF (p <0.001) and the presence of subclinical hypothyroidism (SCH) (p =0.001) were independent predictors of CRT response. Adding SCH as a risk factor to our baseline risk modelling has an independent prognostic impact to predict non-responder patients (p =0.01). Presence of the SCH may be an important predictor of non-response in patients undergoing CRT. Evaluating the risk factors associated with non-response to CRT may be logical in identifying patients who obtain maximum benefit from CRT treatment.

Ventricular arrhythmia events in heart failure patients with cardiac resynchronization therapy with or without a defibrillator for primary prevention.

It is uncertain whether cardiac resynchronization therapy with a defibrillator (CRT-D) provides better survival benefits than a CRT-pacemaker (CRT-P) in heart failure patients with a reduced ejection fraction (≦35%, HFrEF) treated with contemporary HF therapy. We retrospectively analyzed the ventricular arrhythmia (VAs; sustained ventricular tachycardia/fibrillation) events in HFrEF patients who underwent CRT without a prior history of VAs or aborted sudden cardiac death before the CRT implantation. Between January/2010 and December/2020, a CRT device was implanted in 79 HFrEF patients (mean age: 69 ± 12 years, male: 57, ischemic cardiomyopathy: 16). CRT-D and CRT-P devices were implanted in 50 and 29 patients, respectively, at each physician's discretion. CRT-Ds were indicated in younger patients than were CRT-Ps (66 ± 12 vs. 73 ± 12 years, p=0.03), but the gender distribution did not differ (female, 24% [12 of 50] vs. 35% [10 of 29], p=0.44). The VA events during a median follow-up of 3.5-years (interquartile range [IQR]:1.6-5.5) and their predictors were analyzed. VA events occurred in 9 patients with CRT-Ds (18%) and one with a CRT-P (3%, p=0.08). The VA event rate was significantly lower in patients without a prior non-sustained ventricular tachycardia (NSVT: ≥3 beats; rate, ≥120 bpm; lasting <30 s, HR 0.05; 95% CI 0.01-0.30; p < 0.01) and females (HR 0.11; 95% CI 0.01-0.93; p=0.04). Of note, no female patients without a prior history of NSVT experienced VA events. HFrEF CRT candidates without a prior history of NSVT and females may obtain less benefit from a primary preventive defibrillator indication.

Low proportion of biventricular pacing in acardiac resynchronization therapy pacemaker device: what is the mechanism?

Low proportion of biventricular pacing in acardiac resynchronization therapy pacemaker device: what is the mechanism?

The benefits of adding a defibrillator to cardiac resynchronization therapy – systematic review and meta-analysis

Abstract Background There is an long-standing debate whether cardiac resynchronisation therapy-defibrillation (CRT-D) is preferred over CRT-pacemaker (CRT-P). No randomised controlled trials have been designed to compare these treatments. However, several observational studies have been performed so far providing controversial results. Methods PubMed, CENTRAL and Embase until October 2021 were screened for studies comparing CRT-P and CRT-D, focusing on all-cause mortality, cardiovascular mortality, sudden cardiac death, and non-cardiac death. Conference abstracts were excluded. Odds ratio with 95% confidence interval (CI) was calculated, data from the selected studies were pooled using a random effect model (Mantel-Haenszel method, where more than 5 studies with Hartung-Knapp adjustment). τ2 was estimated by Paule-Mandel method with CI calculated by Q profile method. Statistical heterogeneity was assessed by Cochrane Q test and I2 test. Results were summarized by Forest and drapery plots. Results Altogether 20 observational retrospective studies (69,124 patients) were included (CRT-P: 37,461, CRT-D: 31,663). CRT-D was superior to CRT-P regarding all-cause mortality in multivariate analysis (aHR: 0.79; 95% CI: 0.69–0.88; p&amp;lt;0.01). Based on propensity matched studies (25,040 patients; 12,520 CRT-P, 12,520 CRT-D) CRT-D showed significantly better survival compared to CRT-P (HR: 0.83; 95% CI: 0.79–0.87; p&amp;lt;0.001). Three studies (47,846 patients, CRT-P: 27,344, CRT-D: 20,502) compared cardiovascular mortality between CRT-D and CRT-P. Univariate analysis showed a significantly lower rate of cardiovascular mortality in patients implanted with a CRT-D device compared to patients with a CRT-P device (HR: 0.61; 95% CI: 0.50–0.73; p=0.002). Three studies (4,623 patients. CRT-P: 2,518, CRT-D: 2,105) reported on heart failure death, where CRT-D was associated with decreased heart failure mortality compared to CRT-P (HR: 0.68; 95% CI: 0.41–0.95; p=0.008). Five studies (6,434 patients. CRT-P: 3,475, CRT-D: 2,959) were analyzed for sudden cardiac death, CRT-D was superior in univariate analysis (HR: 0.33; 95% CI: 0.28–0.89; p=0.03). Three studies (48,770 patients, CRT-P: 28,398, CRT-D: 20,372) reported on non-cardiac death, CRT-D showed significantly better survival than CRT-P (HR: 0.58; 95% CI: 0.55–0.60; p&amp;lt;0.001). Conclusion Our meta-analysis demonstrated that patients with CRT-D had a lower risk of all-cause mortality compared to CRT-P based on those studies that used multivariate analysis and propensity score matching. Univariate analysis showed a significantly lower rate of cardiovascular heart failure mortality, sudden cardiac death, and non-cardiac death in patients implanted with a CRT-D device compared to patients with a CRT-P. However, due to the heterogeneity of the articles coming from the selection bias of patients for CRT-D/CRT-P implantation, this question requires further analysis. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The research presented here, carried out by Semmelweis University was supported by Semmelweis 250+ Excellence Scholarship (EFOP-3.6.3-VEKOP-16-2017-00009)as well as the Centre for Translational Medicine, Semmelweis University. This work was financed by the Thematic Excellence Programme (2020-4.1.1.-TKP2020) of the Ministry for Innovation and Technology in Hungary, within the framework of the Therapeutic Development and Bioimaging thematic programmes of the Semmelweis University. - I agree that this information can be anonymised and then used for statistical purposes only

Physical activity and heart failure: a forgotten indicator

Abstract Introduction Low physical activity may be associated with comorbidities, sedentary lifestyle or clinical worsening in heart failure (HF) patients. Cardiovascular implantable electronic devices (CIEDs) detect and analyse physical activity data that is often integrated in multifactorial algorithms for predicting HF decompensations, but its potential is probably underestimated. Purpose We hypothesized that low physical-activity levels, obtained from remote monitoring of CIEDs, help predict clinical outcomes in HF patients, independently from multifactorial algorithms. Methods We retrospectively evaluated consecutive patients with HF and CIEDs through clinical assessments and remote monitoring (two monitoring systems were used). Low activity was defined as &amp;lt;1 hour/day of physical activity and two groups of patients were defined: patients with low activity alerts (group 1) and patients without low activity alerts (group 2). Primary outcome was defined as death by all causes and secondary outcome as HF hospitalizations and sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes. Results From 121 patients with RPM, physical activity data was obtained in 104 (85,9%). Mean age was 63,98±12,44 years, 70,2% were males and follow-up was 59,19±38,491 months. Fifty-four (51,9%) had implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D), 46 (44,2%) transvenous implantable cardioverter defibrillator (ICD), and 4 (3,8%) CRT pacemaker (CRT-P). The aetiology was idiopathic in 42,5% and ischemic in 40,2%. Mean left ventricular ejection fraction was 34,08±11,40% and mean physical activity duration was 2,25±1,84 hours/day. Forty-eight (53,7%) had low activity alerts (group 1) and 56 (46,3%) had no low activity alerts (group 2). In group 1 mean period of low activity was 52,978±15,75 days/year. Patients from group 1 were older (p=0,001), had more oncological disease (p=0,041) and peripheral artery disease (p=0,028). Three deaths occurred in total, all in group 1 (p=0,039) and HF hospitalizations were more frequent in group 1 (1,68±2,59 vs 0,69±1,32, p=0,005). Low activity burden was also associated with atrial fibrillation burden (r=0,473, p&amp;lt;0,05) and number of episodes of VT or VF (r=0,267, p=0,007). A decrease of 50% or more in mean duration of physical activity, but above 1 hour/day, was associated with increase HF hospitalizations (1,83±2,13 vs 1,05±1,95, p=0,006). Conclusion Low physical activity data obtained from CIEDs was associated with HF hospitalizations, arrhythmic events and death by all causes, independently of multifactorial algorithms. A decrease in basal activity even above alert threshold, was associated with HF hospitalizations and may be an even earlier sign of HF decompensations. Funding Acknowledgement Type of funding sources: None.

Biventricular or left univentricular pacing in heart failure patients: is there a better strategy

Abstract Background Cardiac resynchronization therapy (CRT) is a cornerstone in treatment of heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and ventricular dyssynchrony. Biventricular (BiV) pacing is often the preferred method and corrects electrical and mechanical dyssynchrony but Left ventricular (LV) preferential pacing is may preserve conduction via the right bundle branch, preventing deleterious effects from right ventricular. The evidence is sparse and there is doubts whether which programming strategy is better. Purpose We hypothesized that BiV is non-inferior to preferential LV pacing in HF patients with reduced LVEF and CRT devices in cardiovascular death and HF hospitalizations. Methods We retrospectively evaluated 147 patients with HF patients with reduced LVEF and CRT devices. Two groups were defined: LV pacing (group 1) and BiV pacing (group 2). Primary outcome was defined as cardiovascular death and secondary outcome as HF hospitalizations and NYHA class after CRT. Results Mean age was 70,26±10,6 years, 68,1% were males and follow-up was 52,22±44,51 months. One hundred and twenty six (85,7%) patients had implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D) and 21 (14,3%) CRT pacemaker (CRT-P). Mean LVEF was 31,1±8,5% and mean QRS duration before CRT implantation was 149,5±48,6 ms. Thirty-nine (36,4%) patients were in NYHA III–IV. HF aetiology was idiopathic in 51 (47,2%), ischemic in 36 (33,3%) and alcoholic cardiomyopathy in 9 (8,3%). Forty-five (40,5%) patients had atrial fibrillation and 37 (35,6%) coronary disease. Patients in group 2 were more frequently males than group 1 patients (46 (78,0%) vs 32 (56,1%) respectively, p=0,012). There were no differences in regard to age, LVEF, HF aetiology or other comorbidities between groups. In 57 (49,1%) CRT was programming in preferential LV pacing and 50 (50,9%) in BiV pacing. There were 2 deaths in group 1 and 3 in group 2 (OR 0.80, 95% CI 0.27–2.40). There were 0,98±3,17 hospitalizations per patient and there were no differences in HF hospitalizations between groups (OR 1.01, 95% CI 0.92–1.18) or NYHA after 6 months of CRT (p=0,364). Conclusion BiV pacing was not inferior to LV-only pacing in regard to cardiovascular death, HF hospitalizations and NYHA class improvement. There was no clear advantage for one pacing strategy over the other but more studies are still required. Funding Acknowledgement Type of funding sources: None.

Feasibility and image quality of myocardial perfusion imaging by CMR in patients with conditional and non-conditional cardiac devices

Abstract Purpose First, to determine image quality using different cardiovascular magnetic resonance (CMR) perfusion protocols in patients with all available active device types in a real-world setting, including non-conditional devices. Second, to demonstrate feasibility of high-quality perfusion imaging using spoiled gradient echo (sGE) protocols for non-invasive stress-testing. Methods From August 2020 to March 2022, N=222 patients with active cardiac implantable electronic devices (CIED) were scanned on a 1.5-T MR scanner (Philips Ingenia and Ambition). Our CMR scanning protocol was tailored to the clinical indication, and whenever myocardial perfusion imaging was possible, both a conventional steady-state-free-precession (SSFP)-based and a modified sGE-perfusion protocol were applied. Such a tailored perfusion protocol was performed in N=119 patients (70% men) with exclusively left-sided devices (pacemaker (PM), n=45; implantable cardioverter-defibrillator (ICD), n=46; subcutaneous ICD (S-ICD), n=15 and cardiac resynchronization therapy-pacemaker (CRT-P, n=5) or -defibrillator (CRT-D, n=8) with a percentage of 10% non-conditional devices. For assessment of image quality, a semi-quantitative 4-point grading scale was used based on a standard 16-segment model. Results A total of N=33 stress-tests with either regadenosone, adenosine or dobutamine and N=86 rest perfusion protocols were performed. Asynchronous pacing was required in 34% of the patients due to a heart rate of &amp;lt;40bpm. Device interrogation before and after CMR scanning showed no significant changes. Image quality was substantially better in sGE-based perfusion protocols compared to conventional SSFP-based perfusion in ICD, CRT-D and S-ICD patients (p&amp;lt;0.001). In patients with PM/ CRT-P image quality was neither significantly impaired in SSFP- nor in sGE-based protocols. Most device artefacts were located primarily in the anterior myocardial segments (1, 7, 13) in transvenous implanted devices and lateral in SICD-patients. A significant relationship between the extent of device artefacts and the parameters LVEDV (p=0.03), LVESV (p=0.005) and non-conditional devices (p=0.029) in SSFP-perfusion protocols were found in patients with PM/CRT-P. In contrast, there was no correlation between clinical and CMR-parameters in patients with ICD/ CRT-D. In S-ICD-patients, there was an inverse relationship between the extent of device artefact and age (p=0.006), BMI (p=0.001) in sGE-perfusion. Conclusion Myocardial perfusion imaging by CMR is safe and feasible with high image-quality in patients with all kinds of CIEDs – including MR-conditional as well as non-conditional devices. When performing CMR-based myocardial perfusion imaging in patients with left-sided ICD/CRT-D/S-ICD, a sGE-based perfusion-protocol should be preferred compared to conventional SSFP-based perfusion protocols in order to achieve artefact-free and well interpretable images. Funding Acknowledgement Type of funding sources: None.

Implantable defibrillator therapy and mortality in patients with non-ischaemic dilated cardiomyopathy : Anupdated meta-analysis and effect on Dutch clinical practice by the Task Force of the Dutch Society of Cardiology.

Primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with non-ischaemic cardiomyopathy (NICMP) remains controversial. This study sought to assess the benefit of ICD therapy with or without cardiac resynchronisation therapy (CRT) in patients with NICMP. In addition, data were compared with real-world clinical data to perform arisk/benefit analysis. Relevant randomised clinical trials (RCTs) published in meta-analyses since DANISH, and in PubMed, EMBASE and Cochrane databases from 2016 to 2020 were identified. The benefit of ICD therapy stratified by CRT use was assessed using random effects meta-analysis techniques. Six RCTs were included in the meta-analysis. Among patients without CRT, ICD use was associated with a24% reduction in mortality (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.62-0.93; P = 0.008). In contrast, among patients with CRT, aCRT-defibrillator was not associated with reduced mortality (HR: 0.74, 95% CI 0.47-1.16; P = 0.19). For ICD therapy without CRT, absolute risk reduction at 3‑years follow-up was 3.7% yielding anumber needed to treat of27. ICD use significantly improved survival among patients with NICMP who are not eligible for CRT. Considering CRT, the addition of defibrillator therapy was not significantly associated with mortality benefit compared with CRT pacemaker.

A long-term cost-effectiveness analysis of cardiac resynchronisation therapy with or without defibrillator based on health claims data

BackgroundIn Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, most patients would also be eligible for the less expensive CRT pacemaker (CRT-P). We conducted a cost-effectiveness analysis for CRT-P devices compared to CRT-D devices from a German payer’s perspective.MethodsLongitudinal health claims data from 3569 patients with de novo CRT implantation from 2014 to 2019 were used to parametrise a cohort Markov model. Model outcomes were costs and effectiveness measured in terms of life years. Transition probabilities were derived from multivariable parametric survival regression that controlled for baseline differences of CRT-D and CRT-P patients. Deterministic and probabilistic sensitivity analyses were conducted.ResultsThe Markov model predicted a median survival of 84 months for CRT-P patients and 92 months for CRT-D patients. In the base case, CRT-P devices incurred incremental costs of € − 13,093 per patient and 0.30 incremental life years were lost. The ICER was € 43,965 saved per life year lost. In the probabilistic sensitivity analysis, uncertainty regarding the effectiveness was observed but not regarding costs.ConclusionThis modelling study illustrates the uncertainty of the higher effectiveness of CRT-D devices compared to CRT-P devices. Given the difference in incremental costs between CRT-P and CRT-D treatment, there would be significant potential cost savings to the healthcare system if CRT-D devices were restricted to patients likely to benefit from the additional defibrillator.