Novel Method for Assessment of His Bundle Pacing Morphology Using Near Field and Far Field Device Electrograms.

BACKGROUND: The 12-lead ECG is considered the gold standard to differentiate between selective (S), nonselective (NS) His bundle pacing (HBP), and right ventricular septal capture in routine clinical practice. We sought to assess the utility of device EGM recordings as a tool to identify the type of HBP morphology. METHODS: One hundred forty-eight consecutive patients underwent HBP with a 3830 Select Secure lead (Medtronic, Inc) at 3 centers between October 2016 and October 2017. The near field V-EGM morphology (NF EGM), near field V-EGM time to peak (NFTime to peak), and far-field EGM QRS duration (QRSd) were recorded while pacing the His lead with simultaneous 12-lead ECG rhythm strips. RESULTS: Indications for HBP were sinus node dysfunction, atrioventricular conduction disease, and cardiac resynchronization therapy in 68 (46%), 56 (38%), and 24 (16%) patients, respectively. Baseline QRSd was 108±38 ms with QRSd >120 ms in 57 (39%) patients (27 right bundle branch block, 18 left bundle branch block, and 12 intraventricular conduction delay). S-HBP was noted in 54 (36%) patients. A positive NFEGM and NFTime to peak >40 ms were highly sensitive (94% and 93%, respectively) and specific (90% and 94%) for S-HBP irrespective of baseline QRSd. All 3 parameters (+NFEGM, NFTime to peak >40 ms, and far-field EGM QRSd <120 ms) had high negative predictive value (97%, 95%, and 92%). A novel device-based algorithm for S-HBP was proposed. EGM transitions correlated with ECG transitions during threshold testing and can help accurately differentiate between S-HBP, NS-HBP, and right ventricular septal pacing with a cumulative positive predictive value of 91% (positive predictive value =100% in patients with baseline QRSd <120 ms). CONCLUSIONS: We propose a novel and simple criteria for accurate differentiation between S-HBP, NS-HBP, and right ventricular septal capture morphologies by careful analysis of device EGMs alone. This study paves the way for future studies to assess autocapture algorithms for devices with HBP.

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads.

BACKGROUND: The transvenous implantable cardioverter-defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database. METHODS AND RESULTS: Data from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5-year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications. CONCLUSIONS: Incidence of mechanical and infectious complications of transvenous ICD leads over long-term follow-up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

Thirty-day readmissions after cardiac implantable electronic devices in the United States: Insights from the Nationwide Readmissions Database.

BACKGROUND: Limited data are available regarding true estimates of individual complications contributing to readmissions after cardiac implantable electronic device (CIED) implantation. OBJECTIVE: The purpose of this study was to identify predictors of 30-day readmission in patients admitted for CIED implantation. METHODS: The study cohort consisted of patients who underwent CIED implantation in 2014, identified from the National Readmission Database. Readmission was defined as a subsequent hospital admission within 30 days after the discharge day of index admission. If patients had more than 1 readmission within 30 days, only the first readmission was included. RESULTS: Our final cohort consisted of 70,223 cases, 61,738 (88%) in the no-readmission group and 8485 patients (12%) in the readmission group. Female gender (odds ratio [OR] 1.09; 95% confidence interval [CI] 1.04-1.14; P = .001), atrial fibrillation/flutter (OR 1.23; 95% CI 1.17-1.29, P <.001), acute renal failure (OR 1.65; 95% CI 1.56-1.74; P <.001), coronary artery disease (OR 1.09; 95% CI 1.03-1.14; P = .002), length of stay (OR 1.70; 95% CI 1.51-1.89; P <.001), device placement on the day of admission (OR 0.87; 95% CI 0.80-0.95, P = .001), and fourth quartile of hospital procedure volume (OR 0.91; 95% CI 0.84-0.99; P = .03; first quartile of hospital procedure volume as reference) were independent predictors of 30-day readmissions. The 30-day readmission resulted in additional median charges of $30,692 per patient. Device-related complications were seen in 10.7% of readmitted patients. The most common complications were mechanical (2.8%) and infectious (2.6%). CONCLUSION: Several patient and hospital-related factors were identified to be independent predictors of 30-day readmission, accounting for increased health care cost.

Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: Results from the Cryo-DOSING Study (Cryoballoon-ablation DOSING Based on the Assessment of Time-to-Effect and Pulmonary Vein Isolation Guidance).

BACKGROUND: There are no recommendations on the optimal dosing for cryoablation of atrial fibrillation (Cryo-AF). OBJECTIVE: The purpose of this study was to develop and prospectively test a Cryo-AF dosing protocol guided exclusively by time-to-pulmonary vein (PV) isolation (TT-PVI) in patients undergoing a first-time Cryo-AF. METHODS: In this multicenter study, we examined the acute/long-term safety/efficacy of Cryo-AF using the proposed dosing algorithm (Cryo-AFDosing; n = 355) against a conventional, nonstandardized approach (Cryo-AFConventional; n = 400) in a nonrandomized fashion. RESULTS: Acute PV isolation was achieved in 98.9% of patients in Cryo-AFDosing (TT-PVI = 48 ± 16 seconds) vs 97.2% in Cryo-AFConventional (P = .18). Cryo-AFDosing was associated with shorter (149 ± 34 seconds vs 226 ± 46 seconds; P <.001) and fewer (1.7 ± 0.8 vs 2.9 ± 0.8; P <.001) cryoapplications, reduced overall ablation (16 ± 5 minutes vs 40 ± 14 minutes; P <.001), fluoroscopy time (13 ± 6 minutes vs 29 ± 13 minutes; P <.001), left atrial dwell time (51 ± 14 minutes vs 118 ± 25 minutes; P <.001), and total procedure time (84 ± 23 minutes vs 145 ± 49 minutes; P <.001) but similar nadir balloon temperature (-47°C ± 8°C vs -48°C ± 6°C; P = .41) and total thaw time (43 ± 27 seconds vs 45 ± 19 seconds; P = .09) as compared to Cryo-AFConventional. Adverse events (2.0% vs 2.7%; P = .48), including persistent phrenic nerve palsy (0.6% vs 1.2%; P = .33) and 12-month freedom from all atrial arrhythmias (82.5% vs 78.3%; P = .14), were similar between Cryo-AFDosing and Cryo-AFConventional. However, Cryo-AFDosing was specifically associated with fewer atypical atrial flutters/tachycardias during long-term follow-up (8.5% vs 13.5%; P = .02) as well as fewer late PV reconnections at redo procedures (5.0% vs 18.5%; P <.001). CONCLUSION: A novel Cryo-AF dosing algorithm guided by TT-PVI can help individualize the ablation strategy and yield improved procedural endpoints and efficiency as compared to a conventional, nonstandardized approach.

Benefit of the Wearable Cardioverter-Defibrillator in Protecting Patients After Implantable-Cardioverter Defibrillator Explant: Results From the National Registry.

OBJECTIVES: This study reports on the time course of reimplantation and benefits of the wearable cardioverter-defibrillator (WCD) in patients post implantable cardioverter-defibrillator (ICD) explantation. BACKGROUND: The WCD is used to treat patients at high risk for ventricular tachycardia (VT) and ventricular fibrillation (VF), including patients with ICD-related infections who undergo device removal and cannot be immediately reimplanted. METHODS: This retrospective study included consecutive patients from 2002 to 2014 who underwent ICD removal because of device-related infection and were prescribed a WCD. WCD-stored electrocardiograms were reviewed. Event outcome was assessed through either the manufacturer WCD registry or the Social Security death index search. RESULTS: A total of 8,058 patients (mean age 62 ± 14 years, 75% male) were included in the analysis. Median time to reimplantation of an ICD was 50 days (interquartile range: 24 to 83 days). While wearing the WCD, 334 patients (4%) experienced 406 VT/VF events, of which 348 events were treated. Shocks were averted in 54 events by conscious patients. The overall 24-h survival, both treated and nontreated, was 93% (312 of 334). VT/VF occurrence was the highest in the initial weeks after ICD removal (0.9%, 0.7%, and 0.7% per week for weeks 1, 2, and 3, respectively). The 12-month cumulative event rate was 10%. For all patients, the 30-day post-event survival was 81%. An ICD was reimplanted in 80% of patients. CONCLUSIONS: The risk of VT/VF reaches 4% during the first 2 months and 10% at 1 year after ICD removal. WCD demonstrated a high efficacy for protecting patients from VT/VF. Clinicians may use the WCD as an ICD alternative when reimplantation is medically delayed.

Assessment of exit block following pulmonary vein isolation: far-field capture masquerading as entrance without exit block.

BACKGROUND: Complete electrical isolation of pulmonary veins (PVs) remains the cornerstone of ablation therapy for atrial fibrillation. Entrance block without exit block has been reported to occur in 40% of the patients. Far-field capture (FFC) can occur during pacing from the superior PVs to assess exit block, and this may appear as persistent conduction from PV to left atrium (LA). OBJECTIVE: To facilitate accurate assessment of exit block. METHODS: Twenty consecutive patients with symptomatic atrial fibrillation referred for ablation were included in the study. Once PV isolation (entrance block) was confirmed, pacing from all the bipoles on the Lasso catheter was used to assess exit block by using a pacing stimulus of 10 mA at 2 ms. Evidence for PV capture without conduction to LA was necessary to prove exit block. If conduction to LA was noticed, pacing output was decreased until there was PV capture without conduction to LA or no PV capture was noted to assess for far-field capture in both the upper PVs. RESULTS: All 20 patients underwent successful isolation (entrance block) of all 76 (4 left common PV) veins: mean age 58 ± 9 years; paroxysmal atrial fibrillation 40%; hypertension 70%, diabetes mellitus 30%, coronary artery disease 15%; left ventricular ejection fraction 55% ± 10%; LA size 42 ± 11 mm. Despite entrance block, exit block was absent in only 16% of the PVs, suggesting persistent PV to LA conduction. FFC of LA appendage was noted in 38% of the left superior PVs. FFC of the superior vena cava was noted in 30% of the right superior PVs. The mean pacing threshold for FFC was 7 ± 4 mA. Decreasing pacing output until only PV capture (loss of FFC) is noted was essential to confirm true exit block. CONCLUSIONS: FFC of LA appendage or superior vena cava can masquerade as persistent PV to LA conduction. A careful assessment for PV capture at decreasing pacing output is essential to exclude FFC.

Assessment of a novel device-based diagnostic algorithm to monitor patient status in moderate-to-severe heart failure: rationale and design of the CLEPSYDRA study.

AIMS: Monitoring systems integrated into electronic implantable devices for heart failure (HF) have significantly expanded the possibility of obtaining diagnostic information and can be used to enhance patient follow-up. The ability to obtain advance warning of worsening HF is currently being explored using a variety of diagnostic parameters. A novel device-based algorithm, physiological diagnostic (PhD), combines data from minute ventilation and accelerometer sensors to provide an indicator of the overall status of HF patients and detect clinically relevant acute HF events. The objective of this study was to evaluate the effectiveness of the PhD algorithm for detecting HF events in patients with HF. METHODS: CLEPSYDRA is a multicentre, prospective, non-randomized, single-arm double-blinded study in 62 centres in Europe, the USA, and Canada. Patients with moderate-to-severe HF, on stable optimal pharmacological therapy, QRS≥120 ms, and ejection fraction≤0.35% will be included. Patients will be followed at 3-month intervals until study end, or for a minimum of 13 months. The primary endpoint is the sensitivity of the PhD (proportion of HF-related clinical events occurring within a 4-week period after a PhD HF indication). Secondary endpoints include the sensitivity of PhD with regard to HF events related to oral treatment modification, and adverse events. The first patient was included in October 2009. At the time of manuscript submission (Week 26, 2010), 214 patients had been enrolled. Study results are expected in 2012. PERSPECTIVE: CLEPSYDRA will provide essential data on the utility of the PhD algorithm in a HF population with blinded investigators and patients. A successful outcome will demonstrate the potential for the algorithm to be implemented in clinical practice. This would improve clinical management and further the ability to generate dynamic and reliable risk profiles for patients with HF.

The effect of device advisories on implantable cardioverter-defibrillator therapy.

Implantable cardioverter-defibrillators have been shown to improve survival by terminating life-threatening ventricular tachyarrhythmias. As the devices have become more complex, there has been an increase in the incidence of device and lead malfunction. The device manufacturers issue advisories and recalls to alert physicians of the potential for malfunction. When patients are faced with a recalled device or lead, the initial question is whether or not to replace it. A rational approach to evaluating these patients and the associated advisory can help gauge the competing risks of elective device removal or extraction versus keeping the device in place. It is important to keep in mind that the risks of replacing devices or extracting leads are not insignificant and may outweigh the risks of death from malfunction. Despite the increasing number of advisories and attention to device and lead failure, the overall reliability and efficacy of these devices for appropriate patients remains high. In general, patients should be counseled prior to implant of the potential for device and lead malfunction, and careful consideration must be employed when decisions are made to replace generators or extract leads.

Clinical judgment versus decision analysis for managing device advisories.

INTRODUCTION: Implantable cardioverter-defibrillator (ICD) and pacemaker (PM) advisories may have a significant impact on patient management. Surveys of clinical practice have shown a great deal of variability in patient management after a device advisory. We compared our management of consecutive patients in a single large university practice with device advisories to the "best" patient management strategy predicted by a decision analysis model. METHODS: We performed a retrospective review of all patients who had implanted devices affected by an advisory at our medical center between March 2005 and May 2006 and compared our actual patient management strategy with that subsequently predicted by a decision analysis model. RESULTS: Over 14 months, 11 advisories from three different manufacturers affected 436 patients. Twelve patients (2.8%) were deceased and 39 patients (8.9%) were followed at outside facilities. Management of the 385 remaining patients varied based on type of malfunction or potential malfunction, manufacturer recommendations, device dependency, and patient or physician preferences. Management consisted of the following: 57 device replacements (15.2%), 44 devices reprogrammed or magnets issued (11.7%), and 268 patients underwent more frequent follow-up (71.3%). No major complications, related to device malfunction or device replacement, occurred among any patient affected with a device advisory. Concordance between the decision analysis model and our management strategy occurred in 57.1% of cases and 25 devices were replaced when it was not the preferred treatment strategy predicted by the decision model (43.9%, 37.3% when excluding devices replaced based on patient preference). The decision analysis favored replacement for all patients with PM dependency, but only for four patients with ICDs for secondary prevention. No devices were left implanted that the decision analysis model predicted should have been replaced. CONCLUSIONS: We found that despite a fairly conservative device replacement strategy for advisories, we still replaced more devices when it was not the preferred device management strategy predicted by a decision analysis model. This study demonstrates that even when risks and benefits are being considered by experienced clinicians, a formal decision analysis can help to develop a systematic evidence based approach and potentially avoid unnecessary procedures.

Benefit of primary prevention implantable cardioverter-defibrillators in the setting of chronic kidney disease: a decision model analysis.

INTRODUCTION: Primary prevention ICD trials have excluded patients with CKD. Comorbidities and lower life expectancy in patients with CKD make the benefit of primary prevention ICD implantation uncertain. METHODS: A decision analysis model was devised to evaluate the risks and benefits of implantable cardioverter-defibrillators (ICD) implantation in patients with chronic kidney disease (CKD) who meet current criteria for a primary prevention ICD. Published data capturing event rates, infection risks, and overall survival in CKD patients with and without ICDs were utilized. Variables included patient's age, GFR and stage of CKD, probability of sudden cardiac death (SCD), and device implantation mortality. RESULTS: The benefit of an ICD for primary prevention of SCD in patients with CKD depends primarily on the patient's age and stage of kidney disease. With stages 1 and 2 CKD, ICD implantation reduces mortality. However, in patients with more advanced stages of CKD, the benefit is less significant and age-dependent. This is attributed to patients with advanced CKD having a higher procedural risk and decreased life expectancy. With average procedural mortality, ICD implantation is favored at ages <80 for stage 3, ages <75 for stage 4, and ages <65 for stage 5. As procedural mortality rates increase, age thresholds for ICD implantation decrease. CONCLUSIONS: Our model shows that benefit from primary prevention ICD implantation is determined by the patient's age and stage of kidney disease. While there is limited impact with lower stages of CKD, careful consideration of ICD implantation is suggested for older patients with more advanced stages of kidney disease.

Gender disparity in the use of cardiac resynchronization therapy in the United States.

BACKGROUND: Although several studies have shown the effectiveness of cardiac resynchronization therapy (CRT) for advanced congestive heart failure (CHF), gender differences in utilization of CRT are not known. METHODS: We used the Healthcare Cost and Utilization Project (HCUP) to study national rates for admissions due to CHF along with procedures for initial CRT implantation, including both CRT-defibrillator (CRT-D) and CRT-pacemakers (CRT-P) during the years of 2002-2004. Chi-square tests were used for comparison between number of women and men. A P < 0.05 was considered significant. RESULT: Women had consistently higher rates of admission for CHF during each year (574,037 (54%) vs 482,005 (46%), 2002; 601,181 (54%) vs 517,202 (46%), 2003; and 580,913 (53%) vs 521,280 (47%), 2004). The number of initial CRT device implantations (both CRT-D and CRT-P) was significantly lower during each year for women compared to men (659 (25%) vs 1,931 (75%), 2002; 6,928 (26%) vs 19,646 (74%), 2003; and 11,286 (27%) vs 42,196 (73%), 2004; P < 0.01 for all). Both CRT-P and CRT-D were used less frequently in women compared to men; however, this difference was consistently less prominent during each year with CRT-P compared to CRT-D (301 (41%) CRT-P vs 358 (19%) CRT-D, 2002; 659 (39%) CRT-P vs 2,530 (28%) CRT-D, 2003; and 2,891 (39%) CRT-P vs 8,395 (24%) CRT-D, 2004; P < 0.05). CONCLUSION: Our data clearly demonstrate a significant gender disparity in utilization of CRT devices. Further studies are needed to find possible reasons behind this disparity.

Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model.

CONTEXT: Limited information exists to direct clinical management after an implantable device has been put under advisory. A better understanding of the risks and benefits of device replacement compared with continued clinical follow-up would be helpful to clinicians. OBJECTIVE: Using the tools of decision analysis, to determine the best management approach (immediate device replacement vs continued monitoring) in the setting of a device advisory. DESIGN: A decision model was constructed to evaluate the risks and benefits associated with immediate device replacement compared with continued monitoring. MAIN OUTCOME MEASURES: Variables considered included indications for device implantation, anticipated course following device failure, device failure rates from the advisory ranging from 0.0001% to 1.0% per year, and device replacement mortality rates ranging from 0.10% to 1.00% per procedure. Device replacement was preferred to continued follow-up when replacement led to greater patient survival. RESULTS: The decision to replace a recalled device depends primarily on the advisory's estimated device failure rate and the likely effects of device failure on mortality. Procedural mortality is an important secondary factor, while patient age and remaining generator life have the least influence on the decision. For pacemaker-dependent patients, advisory device failure rates exceeding 0.3% warrant device replacement in most situations. In patients with implantable cardioverter-defibrillators for primary or secondary prevention, a failure rate associated with an advisory of 3.0% is needed to favor replacement in most cases, decreasing to close to 1.0% as procedural mortality rates decrease to 0.1% or risk of fatal arrhythmias increase to near 20% per year. In cases of pacemaker implantation for non-life-threatening situations (eg, carotid sinus hypersensitivity), most device advisories do not warrant device replacement. CONCLUSIONS: The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.

Clinical assessment and management of patients with implanted cardioverter-defibrillators presenting to nonelectrophysiologists.

All physicians increasingly will encounter patients who have implanted cardioverter-defibrillators (ICDs) for protection from ventricular arrhythmias. This advisory provides a concise summary relevant to the assessment and management of patients with ICDs, including those who present to primary care or emergency department physicians with symptoms suggesting arrhythmia or ICD malfunction and those who require cardiac or surgical procedures.