Cardioneuroablation for the management of patients with recurrent vasovagal syncope and symptomatic bradyarrhythmias: the CNA-FWRD Registry.

BACKGROUND: Cardioneuroablation has been emerging as a potential treatment alternative in appropriately selected patients with cardioinhibitory vasovagal syncope (VVS) and functional AV block (AVB). However the majority of available evidence has been derived from retrospective cohort studies performed by experienced operators. METHODS: The Cardioneuroablation for the Management of Patients with Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias (CNA-FWRD) Registry is a multicenter prospective registry with cross-over design evaluating acute and long-term outcomes of VVS and AVB patients treated by conservative therapy and CNA. RESULTS: The study is a prospective observational registry with cross-over design for analysis of outcomes between a control group (i.e., behavioral and medical therapy only) and intervention group (Cardioneuroablation). Primary and secondary outcomes will only be assessed after enrollment in the registry. The follow-up period will be 3 years after enrollment. CONCLUSIONS: There remains a lack of prospective multicentered data for long-term outcomes comparing conservative therapy to radiofrequency CNA procedures particularly for key outcomes including recurrence of syncope, AV block, durable impact of disruption of the autonomic nervous system, and long-term complications after CNA. The CNA-FWRD registry has the potential to help fill this information gap.

Temporal trends in anticoagulation use and clinical outcomes among medicare beneficiaries with non-valvular atrial fibrillation.

PURPOSE: Oral anticoagulants effectively prevent stroke/systemic embolism among patients with non-valvular atrial fibrillation but remain under-prescribed. This study evaluated temporal trends in oral anticoagulant use, the incidence of stroke/systemic embolism and major bleeding, and economic outcomes among elderly patients with non-valvular atrial fibrillation and CHA2DS2-VASc scores ≥ 2. METHODS: Retrospective analyses were conducted on Medicare claims data from January 1, 2012 through December 31, 2017. Non-valvular atrial fibrillation patients aged ≥ 65 years with CHA2DS2-VASc scores ≥ 2 were stratified by calendar year (2013-2016) of care to create calendar-year cohorts. Patient characteristics were evaluated across all cohorts during the baseline period (12 months before diagnosis). Treatment patterns and clinical and economic outcomes were evaluated during the follow-up period (from diagnosis through 12 months). RESULTS: Baseline patient characteristics remained generally similar between 2013 and 2016. Although lack of oral anticoagulant prescriptions among eligible patients remained relatively high, utilization did increase progressively (53-58%). Among treated patients, there was a progressive decrease in warfarin use (79-52%) and a progressive increase in overall direct oral anticoagulant use (21-48%). There were progressive decreases in the incidence of stroke/systemic embolism 1.9-1.4 events per 100 person years) and major bleeding (4.6-3.3 events per 100 person years) as well as all-cause costs between 2013 and 2016. CONCLUSIONS: The proportions of patients with non-valvular atrial fibrillation who were not prescribed an oral anticoagulant decreased but remained high. We observed an increase in direct oral anticoagulant use that coincided with decreased incidence of clinical outcomes as well as decreasing total healthcare costs.

Appropriateness of implantable cardioverter-defibrillator device implants in the United States.

BACKGROUND: The appropriate use criteria (AUCs) are a diverse group of indications aimed to better evaluate the benefits of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy. OBJECTIVE: The purpose of this study was to quantify the proportion of ICD and cardiac resynchronization therapy with defibrillator (CRT-D) implants as appropriate, may be appropriate (MA), or rarely appropriate (RA) on the basis of the AUC guidelines. METHODS: This is a multicenter retrospective study of patients within the National Cardiovascular Data Registry undergoing ICD implantation between April 2018 and March 2019 at >1500 US hospitals. The appropriateness of ICD implants was adjudicated using the AUC. RESULTS: Of 309,318 ICDs, 241,438 were primary prevention implants (78.1%) and 67,880 secondary prevention implants (21.9%); 243,532 (79%) were mappable to the AUC. For primary prevention, 185,431 ICDs (96.4%) were appropriate, 5660 (2.9%) MA, and 1205 (0.6%) RA. For secondary prevention, 47,498 ICDs (92.7%) were appropriate, 2581 (5%) MA, and 1157 (2.3%) RA. A significant number of RA devices were implanted in patients with New York Heart Association class IV heart failure who were ineligible for advanced therapies (53.9%) and those with myocardial infarction within 40 days (18.1%). The appropriateness of the pacing lead was more variable, with 48,470 dual-chamber ICD implants (62%) being classified as appropriate, 29,209 (37.4%) MA, and 448 (0.6%) RA. Among CRT-D implants, 63,848 (82.2%) were appropriate, 9900 (12.7%) MA, and 3940 (5.1%) RA for left ventricular pacing. A total of 99,754 implants were deemed appropriate but excluded from Centers for Medicare & Medicaid Services National Coverage Determination. More than 92% of hospitals had an RA implant rate of <4%. CONCLUSION: In this large national registry, 95% of mappable ICD and CRT-D implants were considered appropriate, with <2% of RA implants. Nearly 100,000 appropriate implants are excluded by Centers for Medicare & Medicaid Services National Coverage Determination.

Colchicine for the Prevention of Recurrent Arrhythmia After Catheter Ablation of Atrial Fibrillation: Results of a Single-Center, Retrospective Study.

BACKGROUND: There is evidence to suggest that colchicine reduces the risk of recurrent atrial fibrillation (AF) after catheter ablation; however, the tolerability and safety of colchicine in routine practice is unknown. METHODS: Patients undergoing catheter ablation for AF who received colchicine after ablation were matched 1:1 to patients who did not by age, sex, and renal function. Recurrent AF was compared between groups categorically at 12 months and via propensity weighted Cox proportional hazards models with and without a 3-month blanking period. RESULTS: Overall, 180 patients (n = 90 colchicine and n = 90 matched controls) were followed for a median (Q1, Q3) of 10.3 (7.0, 12.0) months. Mean age was 65.3 ± 9.1 years, 33.9% were women, mean CHA2DS2-VASc score was 2.9 ± 1.5, and 51.1% had persistent AF. Most patients (70%) received colchicine 0.6 mg daily for a median of 30 days. In the colchicine group, 55 patients (61.1%) were receiving at least one known interacting medication with colchicine. After ablation, one patient required colchicine dose reduction and four patients required discontinuation. After adjusting for covariate imbalance using propensity weighting, no significant association between colchicine use and AF recurrence was identified (adjusted hazard ratio 0.94, 95% confidence interval [CI] 0.48-1.85; p = 0.853). No significant association was found between colchicine use and all-cause hospitalizations (adjusted odds ratio 0.74, 95% CI 0.28-1.96; p = 0.548). CONCLUSION: Despite the frequent presence of drug-drug interactions, a 30-day course of colchicine is well-tolerated after AF ablation; however, we did not observe any association between colchicine and lower rates of AF recurrence or hospitalization.

Geographic variation in clinical outcomes and anticoagulation among medicare beneficiaries with non-valvular atrial fibrillation.

Oral anticoagulants (OACs) have been used to prevent stroke/systemic embolism (SE) among patients with non-valvular atrial fibrillation (NVAF). To evaluate baseline clinical characteristics, incidence rates of stroke/SE and hospitalization for bleeding, and OAC use among elderly patients with NVAF in the US by geographic region. Patients with NVAF were selected from the US Centers for Medicare & Medicaid Services claims database (01JAN2013-31DEC2016). Twelve months of health plan enrollment was required before and after the NVAF diagnosis to evaluate baseline characteristics and outcomes, respectively. Each patient was assigned to a 3-digit zip code based on their primary residence, and geographic variation was visualized using ArcGIS Pro software. Over 2.8 million patients with NVAF were identified. Large geographic variation was observed in clinical characteristics, stroke/SE, hospitalization for bleeding, and OAC use among patients across the US. The zip codes with the highest mean CHA2DS2-VASc scores and frequency of prior bleeding also had the highest incidence of stroke/SE and hospitalization for bleeding. Across 3-digit zip codes, 35-63% of patients were untreated. Overall, the incidence of stroke/SE and hospitalization for bleeding were higher and OAC treatment was less frequent in zip codes located in the Southern US. Baseline clinical characteristics, incidence rates of stroke/SE and hospitalization for bleeding, and OAC usage vary considerably by 3-digit zip code in the US. The additional granularity provided in this study may help clinicians to identify small regions with high-risk of stroke/SE and hospitalization for bleeding and low use of OAC that may benefit from targeted care strategies.

Electrocardiographic parameters associated with pacemaker induced cardiomyopathy.

BACKGROUND: Chronic right ventricular (RV) pacing can induce left ventricular (LV) dyssynchrony and cause pacemaker induced cardiomyopathy (PiCM). Identifying which patients are at risk for PiCM is limited. METHODS: Patients receiving RV-only permanent pacemakers (PPMs) at Duke University Medical Center between 2011 and 2017 who had normal baseline ejection fractions (EFs) were identified. Patients who developed a subsequent decrease in EF, died, or underwent cardiac resynchronization therapy, left ventricular assist device, or heart transplant without a competing cause were considered as the primary endpoint. Pre-PPM and post-PPM electrocardiograms (ECGs) were analyzed to extract scalar measurements including the lead one ratio (LOR) as well as advanced-ECG (A-ECG) features to identify predictors of PiCM. Traditional and penalized Cox regression were used to identify variables predictive of the primary endpoint. RESULTS: Pre-PPM ECGs were evaluated for 404 patients of whom 140 (35%) experienced the primary endpoint. Predictors included female sex (hazard ratio [HR] 1.14), a T' wave in V6 (HR 1.31), a P' wave in aVL (HR 0.88), and estimated glomerular filtration rate (HR 0.88). Post-PPM ECGs were evaluated for 228 patients for whom 94 (41%) experienced the primary endpoint. Predictors included female sex (HR 0.50), age (HR 1.06), and a history of congestive heart failure (HR 1.63). Neither LOR nor A-ECG parameters were strong predictors of the primary endpoint. CONCLUSIONS: Baseline and paced ECG data provide limited insight into which patients are at high risk for developing PiCM.

Acute echocardiographic and hemodynamic response to his-bundle pacing in patients with first-degree atrioventricular block.

BACKGROUND: Atrial pacing and right ventricular (RV) pacing are both associated with adverse outcomes among patients with first-degree atrioventricular block (1°AVB). His-bundle pacing (HBP) provides physiological activation of the ventricle and may be able to improve both atrioventricular (AV) and inter-ventricular synchrony in 1°AVB patients. This study evaluates the acute echocardiographic and hemodynamic effects of atrial, atrial-His-bundle sequential (AH), and atrial-ventricular (AV) sequential pacing in 1°AVB patients. METHODS: Patients with 1°AVB undergoing atrial fibrillation ablation were included. Following left atrial (LA) catheterization, patients underwent atrial, AH- and AV-sequential pacing. LA/left ventricular (LV) pressure and echocardiographic measurements during the pacing protocols were compared. RESULTS: Thirteen patients with 1°AVB (mean PR 221 ± 26 ms) were included. The PR interval was prolonged with atrial pacing compared to baseline (275 ± 73 ms, p = .005). LV ejection fraction (LVEF) was highest during atrial pacing (62 ± 11%), intermediate with AH-sequential pacing (59 ± 7%), and lowest with AV-sequential pacing (57 ± 12%) though these differences were not statistically significant. No significant differences were found in LA or LV mean pressures or LV dP/dT. LA and LV volumes, isovolumetric times, electromechanical delays, and global longitudinal strains were similar across pacing protocols. CONCLUSION: Despite pronounced PR prolongation, the acute effects of atrial pacing were not significantly different than AH- or AV-sequential pacing. Normalizing atrioventricular and/or inter-ventricular dyssynchrony did not result in acute improvements in cardiac output or loading conditions.

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.

Association between vectorcardiographic QRS area and incident heart failure diagnosis and mortality among patients with left bundle branch block: A register-based cohort study.

BACKGROUND: QRS duration and morphology including left bundle branch block (LBBB) are the most widely used electrocardiogram (ECG) markers for assessing ventricular dyssynchrony and predicting heart failure (HF). However, the vectorcardiographic QRS area may more accurately identify delayed left ventricular activation and HF development. OBJECTIVE: We investigated the association between QRS area and incident HF risk in patients with LBBB. METHODS: By crosslinking data from Danish nationwide registries, we identified patients with a first-time digital LBBB ECG between 2001 and 2015. The vectorcardiographic QRS area was derived from a 12­lead ECG using the Kors transformation method and grouped into quartiles. The endpoint was a composite of HF diagnosis, filled prescriptions for loop diuretics, or death from HF. Cause-specific multivariable Cox regression was used to compute hazard ratios(HR) with 95% confidence intervals(CI). RESULTS: We included 3316 patients with LBBB free from prior HF-related events (median age, 72 years; male, 40%). QRS area quartiles comprised Q1, 36-98 µVs; Q2, 99-119 µVs; Q3, 120-145 µVs; and Q4, 146-295 µVs. During a 5-year follow-up, 31% of patients reached the composite endpoint, with a rate of 39% in the highest quartile Q4. A QRS area in quartile Q4 was associated with increased hazard of the composite endpoint (HR:1.48, 95%CI:1.22-1.80) compared with Q1. CONCLUSIONS: Among primary care patients with newly discovered LBBB, a large vectorcardiographic QRS area (146-295 µVs) was associated with an increased risk of incident HF diagnosis, filling prescriptions for loop diuretics, or dying from HF within 5-years.

Segment Length in Cine Strain Analysis Predicts Cardiac Resynchronization Therapy Outcome Beyond Current Guidelines.

BACKGROUND: Patients with a class I recommendation for cardiac resynchronization therapy (CRT) are likely to benefit, but the effect of CRT in class II patients is more heterogeneous and additional selection parameters are needed in this group. The recently validated segment length in cine strain analysis of the septum (SLICE-ESSsep) measurement on cardiac magnetic resonance cine imaging predicts left ventricular functional recovery after CRT but its prognostic value is unknown. This study sought to evaluate the prognostic value of SLICE-ESSsep for clinical outcome after CRT. METHODS: Two hundred eighteen patients with a left bundle branch block or intraventricular conduction delay and a class I or class II indication for CRT who underwent preimplantation cardiovascular magnetic resonance examination were enrolled. SLICE-ESSsep was manually measured on standard cardiovascular magnetic resonance cine imaging. The primary combined end point was all-cause mortality, left ventricular assist device, or heart transplantation. Secondary end points were (1) appropriate implantable cardioverter defibrillator therapy and (2) heart failure hospitalization. RESULTS: Two-thirds (65%) of patients had a positive SLICE-ESSsep ≥0.9% (ie, systolic septal stretching). During a median follow-up of 3.8 years, 66 (30%) patients reached the primary end point. Patients with positive SLICE-ESSsep were at lower risk to reach the primary end point (hazard ratio 0.36; P<0.001) and heart failure hospitalization (hazard ratio 0.41; P=0.019), but not for implantable cardioverter defibrillator therapy (hazard ratio, 0.66; P=0.272). Clinical outcome of class II patients with a positive ESSsep was similar to those of class I patients (hazard ratio, 1.38 [95% CI, 0.66-2.88]; P=0.396). CONCLUSIONS: Strain assessment of the septum (SLICE-ESSsep) provides a prognostic measure for clinical outcome after CRT. Detection of a positive SLICE-ESSsep in patients with a class II indication predicts improved CRT outcome similar to those with a class I indication whereas SLICE-ESSsep negative patients have poor prognosis after CRT implantation.

Early Increased Physical Activity, Cardiac Rehabilitation, and Survival After Implantable Cardioverter-Defibrillator Implantation.

BACKGROUND: Increased physical activity (PA) through cardiac rehabilitation (CR) improves outcomes in patients with heart failure and coronary disease, but CR referral remains infrequent. Implantable cardioverter-defibrillators (ICDs) can provide daily PA measurements to patients that may motivate them to increase PA, but it remains unclear if increased ICD measured PA is associated with improved outcomes with and without CR. METHODS: This is a retrospective observational study of 41 731 Medicare beneficiaries with ICD implantation between January 1, 2014 and December 31, 2016. We linked daily ICD PA measurements and Medicare claims data to determine if increased PA is associated with a reduction in the likelihood of death or heart failure hospitalization. To determine if CR participation altered the effect of PA on outcomes, we performed two additional analyses matching CR participants and nonparticipants using propensity scores. The first match included demographics, comorbidities, and baseline PA measurements. The second match also included the change in PA measured during CR or the same time frame after ICD implant among nonparticipants. RESULTS: The mean age was 75 (SD, 10) years, 30 182 beneficiaries (72.3%) were male, and 1324 (3%) participated in CR. Increased ICD detected PA was associated with improved survival. CR participants had a mean PA change of +9.7 (SD, 57.8) min/d, whereas nonparticipants had a mean change of -1.0 (SD, 59.7) min/d (P<0.001). After matching for demographics, comorbidities and baseline PA, CR participants had significantly lower 1- to 3-year mortality (hazard ratio, 0.76 [95% CI, 0.69-0.85], P=0.03). After additionally matching for the ICD measured change in PA during CR there were no differences in mortality with and without CR (hazard ratio, 1.00 [95% CI, 0.82-1.21], P=0.87). Every 10 minutes of increased daily PA was associated with a 1.1% reduction in all-cause mortality in both groups. CONCLUSIONS: Among Medicare beneficiaries with ICDs, small increases in PA were associated with significant reductions in all-cause mortality.

Association Between ECG Abnormalities and Fatal Cardiovascular Disease Among Patients With and Without Severe Mental Illness.

Background ECG abnormalities are associated with adverse outcomes in the general population, but their prognostic significance in severe mental illness (SMI) remains unexplored. We investigated associations between no, minor, and major ECG abnormalities and fatal cardiovascular disease (CVD) among patients with SMI compared with controls without mental illness. Methods and Results We cross-linked data from Danish nationwide registries and included primary care patients with digital ECGs from 2001 to 2015. Patients had SMI if they were diagnosed with schizophrenia, bipolar disorder, or severe depression before ECG recording. Controls were required to be without any prior mental illness or psychotropic medication use. Fatal CVD was assessed using hazard ratios (HRs) with 95% CIs and standardized 10-year absolute risks. Of 346 552 patients, 10 028 had SMI (3%; median age, 54 years; male, 45%), and 336 524 were controls (97%; median age, 56 years; male, 48%). We observed an interaction between SMI and ECG abnormalities on fatal CVD (P<0.001). Severe mental illness was associated with fatal CVD across no (HR, 2.17; 95% CI, 1.95-2.43), minor (HR, 1.90; 95% CI, 1.49-2.42), and major (HR, 1.40; 95% CI, 1.26-1.55) ECG abnormalities compared with controls. Across age- and sex-specific subgroups, SMI patients with ECG abnormalities but no CVD at baseline had highest standardized 10-year absolute risks of fatal CVD. Conclusions ECG abnormalities conferred a poorer prognosis among patients with SMI compared with controls without mental illness. SMI patients with ECG abnormalities but no CVD represent a high-risk population that may benefit from greater surveillance and risk management.

Left bundle-branch block is associated with asimilar dyssynchronous phenotype in heart failure patients with normal and reduced ejection fractions.

BACKGROUND: Few therapies improve outcomes in patients with heart failure with preserved ejection fraction (HFpEF). If left bundle-branch block (LBBB) is associated with left ventricular dyssynchrony and impaired cardiac performance in HFpEF, cardiac resynchronization therapy could be a promising treatment. METHODS: We performed a cross-sectional analysis of selected patients with HFpEF (ejection fraction ≥50%) with and without LBBB (normal conduction, NC) and patients with HFrEF and LBBB who were suitable cardiac resynchronization therapy candidates to describe and contextualize the mechanical phenotype of LBBB in HFpEF. Systolic and diastolic isovolumic times, ejection time(ET), and diastolic filling time(DFT) were measured on spectral tissue Doppler echocardiographic images and indexed to the heart rate. Dyssynchrony pattern was assessed using speckle-tracked longitudinal strain patterns. Comparisons were performed using analysis of variance and χ2 test with posthoc pairwise comparisons as indicated. RESULTS: Eighty-two HFpEF (50 with NC, 32 with LBBB) and 149 HFrEF (all with LBBB) patients met criteria. Overall, 84.4% with HFpEF/LBBB and 91.3% with HFrEF/LBBB had demonstrable mechanical dyssynchrony compared to 0% with HFpEF/NC. Compared to HFpEF/NC, HFpEF/LBBB had significantly prolonged isovolumetric contraction time (ICT), isovolumetric relaxation time (IRT), and total isovolumetric time and significantly shorter ET (all indexed). LBBB/HFrEF patients, compared to LBBB/HFpEF patients, had increased ICT and IRT with decreased DFT but similar ET. CONCLUSIONS: Patients with HFpEF and LBBB frequently have an LBBB dyssynchrony phenotype, prolonged ICT and IRT, and reduced ET compared to HFpEF patients with NC. The electromechanical dyssynchrony and disordered cardiac timing of HFpEF with LBBB are similar to HFrEF with LBBB.

Economic Evaluation of Catheter Ablation of Atrial Fibrillation in Patients with Heart Failure With Reduced Ejection Fraction.

BACKGROUND: Randomized clinical trials have demonstrated that catheter ablation for atrial fibrillation in patients with heart failure with reduced ejection fraction may improve survival and other cardiovascular outcomes. METHODS: We constructed a decision-analytic Markov model to estimate the costs and benefits of catheter ablation and medical management in patients with symptomatic heart failure with reduced ejection fraction (left ventricular ejection fraction ≤35%) and atrial fibrillation over a lifetime horizon. Evidence from the published literature informed the model inputs, including clinical effectiveness data from meta-analyses. Probabilistic and deterministic sensitivity analyses were performed. A 3% discount rate was applied to both future costs and benefits. The primary outcome was the incremental cost-effectiveness ratio assessed from the US health care sector perspective. RESULTS: Catheter ablation was associated with 6.47 (95% CI, 5.89-6.93) quality-adjusted life years (QALYs) and a total cost of $105 657 (95% CI, $55 311-$191 934; 2018 US dollars), compared with 5.30 (95% CI, 5.20-5.39) QALYs and $63 040 (95% CI, $37 624-$102 260) for medical management. The incremental cost-effectiveness ratio for catheter ablation compared with medical management was $38 496 (95% CI, $5583-$117 510) per QALY gained. Model inputs with the greatest variation on incremental cost-effectiveness ratio estimates were the cost of ablation and the effect of catheter ablation on mortality reduction. When assuming a more conservative estimate of the treatment effect of catheter ablation on mortality (hazard ratio of 0.86), the estimated incremental cost-effectiveness ratio was $74 403 per QALY gained. At a willingness-to-pay threshold of $100 000 per QALY gained, atrial fibrillation ablation was found to be economically favorable compared with medical management in 95% of simulations. CONCLUSIONS: Catheter ablation in patients with heart failure with reduced ejection fraction patients and atrial fibrillation may be considered economically attractive at current benchmarks for societal willingness-to-pay in the United States.

VVI pacing with normal QRS duration and ventricular function: MOST trial findings relevant to leadless pacemakers.

BACKGROUND: Leadless pacemakers (LPs) provide ventricular pacing without the risks associated with transvenous leads and device pockets. LPs are appealing for patients who need pacing, but do not need defibrillator or cardiac resynchronization therapy. Most implanted LPs provide right ventricular pacing without atrioventricular synchrony (VVIR mode). The Mode Selection Trial in Sinus Node Dysfunction (MOST) showed similar outcomes in patients randomized to dual-chamber (DDDR) versus ventricular pacing (VVIR). We compared outcomes by pacing mode in LP-eligible patients from MOST. METHODS: Patients enrolled in the MOST study with an left ventricular ejection fraction (LVEF) >35%, QRS duration (QRSd) <120 ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population). Cox proportional hazards models were used to test the association between pacing mode and death, stroke or heart failure (HF) hospitalization and atrial fibrillation (AF). RESULTS: Of the 2010 patients enrolled in MOST, 1284 patients (64%) met inclusion criteria. Baseline characteristics were well balanced across included patients randomized to DDDR (N = 630) and VVIR (N = 654). Over 4 years of follow-up, there was no association between pacing mode and death, stroke or HF hospitalization (VVIR HR 1.28 [0.92-1.75]). VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], P = .007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], P < .001). CONCLUSION: In patients without reduced LVEF or prolonged QRSd who would be eligible for LP, DDDR, and VVIR pacing demonstrated similar rates of death, stroke or HF hospitalization; however, VVIR pacing significantly increased the risk of AF development.

Concomitant changes in ventricular depolarization and repolarization and long-term outcomes of biventricular pacing.

BACKGROUND: Biventricular (BiV) pacing increases transmural repolarization heterogeneity due to epicardial to endocardial conduction from the left ventricular (LV) lead. However, limited evidence is available on concomitant changes in ventricular depolarization and repolarization and long-term outcomes of BiV pacing. Therefore, we investigated associations of BiV pacing-induced concomitant changes in ventricular depolarization and repolarization with mortality (i.e., LV assist device, heart transplantation, or all-cause mortality) and sustained ventricular arrhythmia endpoints. METHODS: Consecutive BiV-defibrillator recipients with digital preimplantation and postimplantation electrocardiograms recorded between 2006 and 2015 at Duke University Medical Center were included. We calculated changes in QRS duration and corrected JT (JTc) interval and split them by median values. For simplicity, these variables were named QRSdecreased (≤ -12 ms), QRSincreased (> -12 ms), JTcdecreased (≤22 ms), and JTcincreased (> 22 ms) and subsequently used to construct four mutually exclusive groups. RESULTS: We included 528 patients (median age, 68 years; male, 69%). No correlation between changes in QRS duration and JTc interval was observed (P = .295). Compared to QRSdecreased /JTcincreased , increased risk of the composite mortality endpoint was associated with QRSdecreased /JTcdecreased (hazard ratio [HR] = 1.62; 95% confidence interval [CI] = 1.09-2.43), QRSincreased /JTcdecreased (HR = 1.86; 95% CI = 1.27-2.71), and QRSincreased /JTcincreased (HR = 2.25; 95% CI = 1.52-3.35). No QRS/JTc group was associated with excess sustained ventricular arrhythmia risk (P = .400). CONCLUSION: Among BiV-defibrillator recipients, QRSdecreased /JTcincreased was associated with the most favorable long-term survival free of LV assist device, heart transplantation, and sustained ventricular arrhythmias. Our findings suggest that improved electrical resynchronization may be achieved by assessing concomitant changes in ventricular depolarization and repolarization.

Predicting the Development of Reduced Left Ventricular Ejection Fraction in Patients With Left Bundle Branch Block.

Left bundle branch block (LBBB) increases the likelihood of developing reduced left ventricular (LV) ejection fraction (EF) but predicting which patients with LBBB and normal LVEF will develop decreased LVEF remains challenging. Fifty patients with LBBB and normal LVEF were retrospectively identified. Clinical, electrocardiographic, and echocardiographic variables were compared between patients who developed a decreased LVEF and those who did not. A total of 16 of 50 patients developed reduced LVEF after 4.3 (SD = 2.8) years of follow-up. Baseline patient and electrocardiographic variables were similar between patients who did and did not develop decreased LVEF. Baseline LVEF was lower in patients who developed decreased LVEF than in those who did not (51.9% [SD = 2.2%] vs 54.9% [SD = 4.4%], p <0.01). Diastolic filling time (DFT) accounted for a significantly smaller percentage of the cardiac cycle in patients who developed decreased LVEF than in those who did not (35.9%, [SD = 6.9%] vs 44.4% [SD = 4.5%] p <0.01). In univariable logistic regression, DFT had a C-statistic of 0.86 (p <0.0001) for prediction of development of decreased LVEF. In conclusion, patients in whom DFT accounted for <38% of the cardiac cycle had a relative risk of developing decreased LVEF of 7.0 (95% confidence interval 3.0 to 16.0) compared to patients with DFT accounting for ≥38% of the cardiac cycle.