Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial.

OBJECTIVES: Assess safety and performance of novel quadripolar preshaped left ventricular (LV) leads: NAVIGO 4LV 2D ('S shaped') and NAVIGO 4LV ARC ('U shaped'). METHODS: Patients indicated for cardiac resynchronisation therapy were enrolled in a multicentre, prospective, controlled study (NAVIGATOR, NCT03279484). Patients were implanted with either a NAVIGO 4LV 2D or ARC lead, and assessed at 10 weeks, 6, 12 and 24 months post-implant. Co-primary safety and performance endpoints were assessed at 10 weeks. Safety endpoint was the patients' rate free from lead-related complications. Performance endpoint was the rate of patients with successful lead performance, defined as LV pacing threshold ≤2.5 V at 0.5 ms on at least one pacing vector, and the absence of phrenic nerve stimulation at the final programmed configuration. Lead-related complications and electrical parameters were monitored throughout study. RESULTS: A NAVIGO 4LV lead was successfully implanted in 211 out of 217 patients (97.2%). The safety endpoint was met, with 100% and 96.1% of patients free from complications for NAVIGO 4LV 2D and ARC, respectively. The performance endpoint was met with 98.1% and 98.9% of patients with a successful lead performance for NAVIGO 4LV 2D and ARC, respectively. Over 12 months, the global complication-free rate for both leads was 97.1% (95% CI: 93.71% to 98.70%), with a mean pacing capture threshold of 1.23 V±0.73 V and a mean impedance of 951 Ω±300.1 Ω. CONCLUSION: A high implantation success rate and low complication rate was reported for the novel NAVIGO 4LV 2D and ARC leads, along with successful performance up to 12 months.

Indications for Cardiac Resynchronization Therapy in Patients with Congenital Heart Disease.

Heart failure in patients with congenital heart disease (CHD) stems from unique causes compared with the elderly. Patients with CHD face structural abnormalities and malformations present from birth, leading to altered cardiac function and potential complications. In contrast, elderly individuals primarily experience heart failure due to age-related changes and underlying cardiovascular conditions. Cardiac resynchronization therapy (CRT) can benefit patients with CHD, although it presents numerous challenges. The complexities of CHD anatomy and limited access to appropriate venous sites for lead placement make CRT implantation demanding.

Progression of Device-Detected Atrial High-Rate Episodes and the Risk of All-Cause Mortality.

Atrial high-rate episodes (AHREs) are prevalent in approximately 1/3 of patients with cardiac implanted electronic devices and are associated with an increased risk of several adverse outcomes. This study aimed to explore the factors associated with AHRE progression and the risk of all-cause mortality. At least 1 day with AHRE burden ≥15 minutes was identified in 124 of 343 recipients (36.2%) of an implantable cardioverter defibrillator or cardiac resynchronization therapy device. We included patients whose AHRE burden at the time of first detection was ≥15 minutes but <24 hours (n = 107). Various cut-off values (15 minutes, 6 hours, and 24 hours) of daily AHRE burden were analyzed. During an average follow-up of 4.2 years, 60 patients (56.1%) experienced ≥1 progression to greater AHRE burden. Patients with hypertension or greater AHRE burden at first detection were associated with faster progression. In addition, 27 deaths (45%) occurred among 60 patients with AHRE progression, compared with 25.5% (12 of 47) for those without progression. After multivariable adjustment, AHRE progression was independently associated with all-cause mortality (hazard ratio 2.56, 95% confidence interval 1.23 to 5.35, p = 0.012). Notably, AHRE progression within 1 month after their first detection was associated with an increased risk for all-cause mortality (hazard ratio 4.01, 95% confidence interval 1.76 to 9.16, p = 0.001) compared with patients without progression. However, a similar risk was not observed among patients with AHRE progression occurring after 1 month after their first detection. In conclusion, >1/2 of the patients with AHRE progressed to a greater burden over time. Continuous monitoring of the AHRE burden may help identify patients at great risk for death.

Long-term cardiovascular outcomes among immigrants and non-immigrants in cardiac resynchronization therapy: a nationwide study.

AIMS: To date, potential differences in outcomes for immigrants and non-immigrants with a cardiac resynchronization therapy (CRT), in a European setting, remain underutilized and unknown. Hence, we examined the efficacy of CRT measured by heart failure (HF)-related hospitalizations and all-cause mortality among immigrants and non-immigrants. METHODS AND RESULTS: All immigrants and non-immigrants who underwent first-time CRT implantation in Denmark (2000-2017) were identified from nationwide registries and followed for up to 5 years. Differences in HF related hospitalizations and all-cause mortality were evaluated by Cox regression analyses. From 2000 to 2017, 369 of 10 741 (3.4%) immigrants compared with 7855 of 223 509 (3.5%) non-immigrants with a HF diagnosis underwent CRT implantation. The origins of the immigrants were Europe (61.2%), Middle East (20.1%), Asia-Pacific (11.9%), Africa (3.5%), and America (3.3%). We found similar high uptake of HF guideline-directed pharmacotherapy before and after CRT and a consistent reduction in HF-related hospitalizations the year before vs. the year after CRT (61% vs. 39% for immigrants and 57% vs. 35% for non-immigrants). No overall difference in 5-year mortality among immigrants and non-immigrants was seen after CRT [24.1% and 25.8%, respectively, P-value = 0.50, hazard ratio (HR) = 1.2, 95% confidence interval (CI): 0.8-1.7]. However, immigrants of Middle Eastern origin had a higher mortality rate (HR = 2.2, 95% CI: 1.2-4.1) compared with non-immigrants. Cardiovascular causes were responsible for the majority of deaths irrespective of immigration status (56.7% and 63.9%, respectively). CONCLUSION: No overall differences in efficacy of CRT in improving outcomes between immigrants and non-immigrants were identified. Although numbers were low, a higher mortality rate among immigrants of Middle Eastern origin was identified compared with non-immigrants.

Clinical predictors of incomplete coronary sinus lead removal during transvenous lead extraction in patients with cardiac resynchronization therapy.

BACKGROUND: Reports of coronary sinus (CS) lead removal include small studies with short implant durations. Procedural outcomes for mature CS leads removed with long duration implantation are unavailable. OBJECTIVE: The purpose of this study was to examine the safety, efficacy, and clinical predictors of incomplete CS lead removal by transvenous lead extraction (TLE) in a large long implant duration cardiac resynchronization therapy patient cohort. METHODS: Consecutive patients with cardiac resynchronization therapy devices in the Cleveland Clinic Prospective TLE Registry who had TLE between 2013 and 2022 were included in the analysis. RESULTS: CS leads (N = 231; implant duration 6.1 ± 4.0 years) removed from 226 patients were included, using powered sheaths for 137 leads (59.3%). Complete CS lead extraction success was achieved in 95.2% of leads (n = 220) and in 95.6% of patients (n = 216). Major complications occurred in 5 patients (2.2%). Patients who had the CS lead extracted first had significantly higher incomplete removal rates than when the other leads were first removed. Multivariable analysis showed that older CS lead age (odds ratio 1.35; 95% confidence interval 1.01-1.82; P = .03) and removal of the first CS lead (odds ratio 7.48; 95% confidence interval 1.02-54.95; P = .045) were independent predictors of incomplete CS lead removal. CONCLUSION: The complete and safe lead removal rate of long implant duration CS leads by TLE was 95%. However, CS lead age and the order in which leads were extracted were the independent predictors of incomplete CS lead removal. Therefore, before the CS lead is extracted, physicians should first extract the leads from the other chambers and use powered sheaths.

Upgrades from Previous Cardiac Implantable Electronic Devices Compared to De Novo Cardiac Resynchronization Therapy Implantations: Results from CRT Survey-II in the Turkish Population.

OBJECTIVE: Cardiac resynchronization therapy is the guideline-directed treatment option in selected heart failure with reduced left ventricular ejection fraction patients. Data regarding the contemporary clinical practice of cardiac resynchronization therapy in Turkey have been published recently. This sub-study aims to compare clinical and periprocedural characteristics between cardiac resynchronization therapy upgrade and de novo implantations. METHODS: Turkish arm of the Cardiac Resynchronization Therapy Survey-II was conducted between October 1, 2015, and December 31, 2016, at 16 centers. All consecutive patients who underwent an upgrade to cardiac resynchronization therapy system (n=60) or de novo cardiac resynchronization therapy implantation (n=335) were eligible. RESULTS: Distribution of age, gender, and heart failure etiology were similar in the 2 groups. Atrial fibrillation, valvular heart disease, and chronic kidney disease were more common in cardiac resynchronization therapy upgrade patients. Narrow intrinsic QRS duration and left ventricular ejection fraction being 75% in both groups, and only beta-blockers were prescribed at rates of >90% in both groups. CONCLUSION: Cardiac resynchronization therapy upgrades are performed with high procedural success rates and without excess periprocedural complication risk. Feared complications of cardiac resynchronization therapy upgrades due to the pre-existing device should not delay the procedure if indicated.

An unprecedented cause of cardiac resynchronization with defibrillator (CRT-D) malfunction "A beheaded generator assembly".

Cardiac resynchronization with defibrillator (CRT-D) malfunction can be due to various reasons, including wire injury, insulation break, battery problems, or patient factors. Undesired outcomes can be dramatically elevated in those settings, prompting early detection and proper troubleshooting. To diagnose, clinical correlation and device interrogation are vital. However, it is not uncommon to find general troubleshooting options insufficient, as highlighted in this case report. Here, we presented an unusual "head assembly separation," as the main reason for abnormal device parameters.

One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?

PURPOSE: The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients. METHODS: We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry. RESULTS: We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models. CONCLUSION: In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods.

Remote monitoring data from cardiac implantable electronic devices predicts all-cause mortality.

AIMS: To determine if remotely monitored physiological data from cardiac implantable electronic devices (CIEDs) can be used to identify patients at high risk of mortality. METHODS AND RESULTS: This study evaluated whether a risk score based on CIED physiological data (Triage-Heart Failure Risk Status, 'Triage-HFRS', previously validated to predict heart failure (HF) events) can identify patients at high risk of death. Four hundred and thirty-nine adults with CIEDs were prospectively enrolled. Primary observed outcome was all-cause mortality (median follow-up: 702 days). Several physiological parameters [including heart rate profile, atrial fibrillation/tachycardia (AF/AT) burden, ventricular rate during AT/AF, physical activity, thoracic impedance, therapies for ventricular tachycardia/fibrillation] were continuously monitored by CIEDs and dynamically combined to produce a Triage-HFRS every 24 h. According to transmissions patients were categorized into 'high-risk' or 'never high-risk' groups. During follow-up, 285 patients (65%) had a high-risk episode and 60 patients (14%) died (50 in high-risk group; 10 in never high-risk group). Significantly more cardiovascular deaths were observed in the high-risk group, with mortality rates across groups of high vs. never-high 10.3% vs. <4.0%; P = 0.03. Experiencing any high-risk episode was associated with a substantially increased risk of death [odds ratio (OR): 3.07, 95% confidence interval (CI): 1.57-6.58, P = 0.002]. Furthermore, each high-risk episode ≥14 consecutive days was associated with increased odds of death (OR: 1.26, 95% CI: 1.06-1.48; P = 0.006). CONCLUSION: Remote monitoring data from CIEDs can be used to identify patients at higher risk of all-cause mortality as well as HF events. Distinct from other prognostic scores, this approach is automated and continuously updated.

Clinical Heart Failure Among Patients With and Without Severe Mental Illness and the Association With Long-Term Outcomes.

BACKGROUND: Patients with severe mental illness (SMI) including schizophrenia, bipolar disorder, and severe depression have earlier onset of cardiovascular risk factors, predisposing to worse future heart failure (HF) compared with the general population. We investigated associations between the presence/absence of SMI and long-term HF outcomes. METHODS: We identified patients with HF with and without SMI in the Duke University Health System from 2002 to 2017. Using multivariable Cox regression, we examined the primary outcome of all-cause mortality. Secondary outcomes included rates of implantable cardioverter defibrillator use, cardiac resynchronization therapy, left ventricular assist device implantation, and heart transplantation. RESULTS: We included 20 906 patients with HF (SMI, n=898; non-SMI, n=20 008). Patients with SMI presented clinically 7 years earlier than those without SMI. We observed an interaction between SMI and sex on all-cause mortality (P=0.002). Excess mortality was observed among men with SMI compared with men without SMI (hazard ratio, 1.36 [95% CI, 1.17-1.59]). No association was observed among women with and without SMI (hazard ratio, 0.97 [95% CI, 0.84-1.12]). Rates of implantable cardioverter defibrillator use, cardiac resynchronization therapy, left ventricular assist device implantation, and heart transplantation were similar between patients with and without SMI (6.1% versus 7.9%, P=0.095). Patients with SMI receiving these procedures for HF experienced poorer prognosis than those without SMI (hazard ratio, 2.12 [95% CI, 1.08-4.15]). CONCLUSIONS: SMI was associated with adverse HF outcome among men and not women. Despite equal access to procedures for HF between patients with and without SMI, those with SMI experienced excess postprocedural mortality. Our data highlight concurrent sex- and mental health-related disparities in HF prognosis, suggesting that patients with SMI, especially men, merit closer follow-up.

Influence of the type of pathogen on the clinical course of infectious complications related to cardiac implantable electronic devices.

The specific role of the various pathogens causing cardiac implantable electronic devices-(CIEDs)-related infections requires further understanding. The data of 1241 patients undergoing transvenous lead extraction because of lead-related infective endocarditis (LRIE-773 patients) and pocket infection (PI-468 patients) in two high-volume centers were analyzed. Clinical course and long-term prognosis according to the pathogen were assessed. Blood and generator pocket cultures were most often positive for methicillin-sensitive Staphylococcus aureus (MSSA: 22.19% and 18.13% respectively), methicillin-sensitive Staphylococcus epidermidis (MSSE: 17.39% and 15.63%) and other staphylococci (11.59% and 6.46%). The worst long-term prognosis both in LRIE and PI subgroup was in patients with infection caused by Gram-positive microorganisms, other than staphylococci. The most common pathogens causing CIED infection are MSSA and MSSE, however, the role of other Gram-positive bacteria and Gram-negative organisms is also important. Comparable, high mortality in patients with LRIE and PI requires further studies.

Subclinical cardiac perforation by cardiac implantable electronic device leads detected by cardiac computed tomography.

BACKGROUND: The relationship between the characteristics of cardiac implantable electronic device (CIED) leads and subclinical cardiac perforations remains unclear. This study aimed to evaluate the incidence of subclinical cardiac perforation among various CIED leads using cardiac computed tomography (CT). METHODS: A total of 271 consecutive patients with 463 CIED leads, who underwent cardiac CT after CIED implantation, were included in this retrospective observational study. Cardiac CT images were reviewed by one radiologist and two cardiologists. Subclinical perforation was defined as traversal of the lead tip past the outer myocardial layer without symptoms and signs related to cardiac perforation. We compared the subclinical cardiac perforation rates of the available lead types. RESULTS: A total of 219, 49, and 3 patients had pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy, respectively. The total subclinical cardiac perforation rate was 5.6%. Subclinical cardiac perforation by screw-in ventricular leads was significantly more frequent than that caused by tined ventricular leads (13.3% vs 3.3%, respectively, p = 0.002). There were no significant differences in the incidence of cardiac perforation between atrial and ventricular leads, screw-in and tined atrial leads, pacing and defibrillator ventricular leads, nor between magnetic resonance (MR)-conditional and MR-unsafe screw-in ventricular leads. Screw-in ventricular leads were significantly associated with subclinical cardiac perforation [odds ratio, 4.554; 95% confidence interval, 1.587-13.065, p = 0.005]. There was no case subclinical cardiac perforation by septal ventricular leads. CONCLUSIONS: Subclinical cardiac perforation by screw-in ventricular leads is not rare. Septal pacing may be helpful in avoiding cardiac perforation.

Cardiovascular implantable electronic devices and native arteriovenous fistula in hemodialysis patients: novel perspectives.

The benefits from cardiovascular implantable electronic devices (CIED) implantation in hemodialysis (HD) patients are still far to be thoroughly defined, especially on primary prevention. In addition, CIED placement is not a risk-free procedure, because it could be followed by a not negligible burden of complications that could compromise the health and the vascular access of HD patients. In fact, the arteriovenous fistula (AVF) dysfunction following CIED implantation is usually due to a hemodynamically significant alteration of blood flow. This condition could lead to a potential decrease of dialysis efficacy and a raised risk of thrombosis of both the central vein and the efferent vein of the AVF.The pathological pathway that leads to AVF dysfunction after CIED implantation may involve the irritating actions of the CIED and their leads to the vascular wall in HD patients that are more prone to show previous vascular diseases.The aim of this review is to focus the physiopathology of the CIED-induced AVF dysfunction, the current treatment strategies and the novel perspectives that could be taken into consideration and offered to the HD population to preserve both their AVF and their quality of life.

The fatal consequence of inappropriate therapy in a single VF zone primary prevention defibrillator.

We report a case of inappropriate implantable cardioverter defibrillator (ICD) therapy due to single ventricular fibrillation (VF) zone programming leading to patient death. A remote transmission was received from a patient with a cardiac resynchronization therapy-defibrillator showing sinus tachycardia in the VF detection zone initiating inappropriate shocks and resulting in shock refractory VF. This case report highlights the importance of manufacturer specific ICD programming. In devices without discrimination in the VF zone, a higher rate single VF detection zone and/or addition of a ventricular tachycardia zone with supraventricular tachycardia discrimination should be considered.

Comparative Analysis of Procedural Outcomes and Complications Between De Novo and Upgraded Cardiac Resynchronization Therapy.

OBJECTIVES: This study compared rates of procedural success and complications between de novo cardiac resynchronization therapy (CRT) implantation versus upgrade, including characterization of technical challenges. BACKGROUND: CRT upgrade is common, but data are limited on the incidence of procedural success and complications as compared to de novo implantation. METHODS: All patients who underwent a transvenous CRT procedure at a single institution between 2013 and 2018 were reviewed for procedure outcome, 90-day complications, reasons for unsuccessful left ventricular lead delivery, and the presence of venous occlusive disease (VOD) that required a modified implantation technique. RESULTS: Among 1,496 patients, 947 (63%) underwent de novo implantation and 549 (37%) underwent device upgrade. Patients who received a device upgrade were older (70 ± 12 years vs. 68 ± 13 years; p < 0.01), with a male predominance (75% vs. 66%; p < 0.01) and greater prevalence of comorbidities. There was no difference in the rate of procedural success between de novo and upgrade CRT procedures (97% vs. 96%; p = 0.28) or 90-day complications (5.1% vs. 4.6%; p = 0.70). VOD was present in 23% of patients who received a device upgrade and was more common among patients with a dual-chamber versus a single-chamber device (26% vs. 9%; p < 0.001). Patients with and without VOD had a similar composite outcome of procedural failure or complication (8.0% vs. 7.8%; p = 1.0). CONCLUSIONS: Rates of procedural success and complications were no different between de novo CRT implantations and upgrades. VOD frequently increased procedural complexity in upgrades, but alternative management strategies resulted in similar outcomes. Routine venography before CRT upgrade may aid in procedural planning and execution of these strategies.

Pacemaker-mediated tachycardia in a dual-lead CRT-D: What is the mechanism?

A 73-year-old gentleman with dilated cardiomyopathy, left bundle branch block and a left ventricular (LV) ejection fraction of 20% was implanted with two LV leads in a tri-ventricular cardiac resynchronisation therapy defibrillator (CRT-D) trial. As a part of the trial he was programmed with fusion-based CRT therapy with dual LV lead only pacing. The patient presented to local heart failure service 12 years after implant, after a positive response to CRT therapy, with increase in fatigue, shortness of breath and bilateral pitting oedema. The patient sent a remote monitoring transmission that suggested loss of capture on one of the LV leads. This coupled with atrial ectopics was producing a high burden of pacemaker-mediated tachycardia (PMT) that was not seen when both LV leads had been capturing. What is the mechanism for this? Dual LV-lead tri-ventricular leads have been shown to have variable improvements in CRT response but with an increased complexity of implant procedure. This is the first case report of PMT-induced heart failure exacerbation in a tri-ventricular device following loss of LV capture of one lead.