Radiographic Identification of Cardiac Implantable Electronic Device Manufacturer: Smartphone Pacemaker-ID Application Versus X-ray Logo.

Radiographic identification of the cardiac implantable electronic device (CIED) manufacturer facilitates urgent interrogation of an unknown CIED. In the past, we relied on visualizing a manufacturer-specific X-ray logo. Recently, a free smartphone application ("Pacemaker-ID") was made available. A photograph of a chest X-ray was subjected to an artificial intelligence (AI) algorithm that uses manufacturer characteristics (canister shape, battery design) for identification. We sought to externally validate the accuracy of this smartphone application as a point-of-care (POC) diagnostic tool, compare on-axis to off-axis photo accuracy, and compare it to X-ray logo visualization for manufacturer identification. We reviewed operative reports and chest X-rays in 156 pacemaker and 144 defibrillator patients to visualize X-ray logos and to test the application with 3 standard (on-axis) and 4 non-standard (off-axis) photos (20° cranial; caudal, leftward, and rightward). Contingency tables were created and chi-squared analyses (P < .05) were completed for manufacturer and CIED type. The accuracy of the application was 91.7% and 86.3% with single and serial application(s), respectively; 80.7% with off-axis photos; and helpful for all manufacturers (range, 85.4%-96.6%). Overall, the application proved superior to the X-ray logo, visualized in 56% overall (P < .0001) but varied significantly by manufacturer (range, 7.7%-94.8%; P < .00001). The accuracy of the Pacemaker-ID application is consistent with reports from its creators and superior to X-ray logo visualization. The accuracy of the application as a POC tool can be enhanced and maintained with further AI training using recent CIED models. Some manufacturers can enhance their X-ray logos by improving placement and design.

Right ventricular dilatation and systolic dysfunction and relationship to QRS duration in patients with left bundle branch block and cardiomyopathy.

BACKGROUND: Marked QRS widening in patients with left bundle branch block (LBBB) may reduce efficacy of cardiac resynchronization therapy (CRT). We hypothesized that extreme QRS prolongation may accompany right ventricular (RV) dilatation/systolic dysfunction (RVD/RVsD) as well as left ventricular dilatation/systolic dysfunction (LVD/LVsD). METHODS: We assessed rates of both ventricular dilatation and systolic dysfunction according to widening of QRS duration (QRSd) in 100 consecutive cardiomyopathy patients with true LBBB (QRSd ≥ 130 ms in female or ≥140 ms in male, QS or rS in leads V1/V2, and mid-QRS notching/slurring in ≥2 contiguous leads of I, aVL, and V1/V2/V5/V6). Ventricular dimensions and function were measured by cardiac magnetic resonance imaging. RESULTS: There was a trend toward an increase in the prevalence of LVD (13%, 20%, and 90%), LVsD (67%, 77%, and 90%), RVD (23%, 27%, and 50%), RVsD (27%, 27%, and 40%), RVD plus RVsD (13%, 17%, and 40%), or RVD/RVsD (37%, 37%, and 50%) according to the degree of QRS prolongation (<150 ms, n = 30; 150-180 ms, n = 60; and ≥180 ms, n = 10). Similarly, patients in the highest quartile of QRSd (QRSd ≥ 168 ms, n = 26) showed greater rates of RVD (23% vs. 44%, p = .069), RVsD (22% vs. 48%, p = .032), RVD plus RVsD (10% vs. 30%, p = .040), or RVD/RVsD (33% vs. 57%, p = .050) compared to those in the remaining quartiles (n = 74). QRSd ≥ 180 ms was identified as an independent predictor for the presence of RVD plus RVsD. CONCLUSION: The rates of RVD and/or RVsD increased with QRS widening, particularly when QRSd exceeded 180 ms. This may diminish anticipated CRT response rates in cardiomyopathy patients with LBBB.

Cardiac Resynchronization Therapy With or Without Defibrillation in Patients With Nonischemic Cardiomyopathy: A Systematic Review and Meta-Analysis.

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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.

Clinical Outcomes and Characteristics With Dofetilide in Atrial Fibrillation Patients Considered for Implantable Cardioverter-Defibrillator.

BACKGROUND: Dofetilide is one of the only anti-arrhythmic agents approved for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF). However, postapproval data and safety outcomes are limited. In this study, we assessed the incidence and predictors of LVEF improvement, safety, and outcomes in patients with AF with LVEF ≤35% without prior implantable cardioverter defibrillator, cardiac resynchronization therapy, or AF ablation. METHODS: An analysis of 168 consecutive patients from 2007 to 2016 was performed. Incidences of adverse events, drug continuation, implantable cardioverter defibrillator and cardiac resynchronization therapy implantation, LVEF improvement (>35%) and recovery (≥50%), AF recurrence, and AF ablation were determined. Multivariable regression analysis to identify predictors of LVEF improvement/recovery was performed. RESULTS: The mean age was 64±12 years. Dofetilide was discontinued before hospital discharge in 46 (27%) because of QT prolongation (14%), torsades de pointe or polymorphic ventricular tachycardia/fibrillation (6% [sustained 3%, nonsustained 3%]), ineffectiveness (5%), or other causes (3%). At 1 year, 43% remained on dofetilide. Freedom from AF was 42% at 1 year, and 40% underwent future AF ablation. LVEF recovered (≥50%) in 45% and improved to >35% in 73%. Predictors of LVEF improvement included presence of AF during echocardiogram (odds ratio, 4.22 [95% CI, 1.71-10.4], P=0.002), coronary artery disease (odds ratio, 0.35 [95% CI, 0.16-0.79], P=0.01), left atrial diameter (odds ratio, 0.52 per 1 cm increase [95% CI, 0.30-0.90], P=0.01), and LVEF (odds ratio, per 1% increase, 1.09 [95% CI, 1.02-1.16], P=0.006). The C statistic was 0.78. CONCLUSIONS: In patients with LVEF ≤35%, who are potential implantable cardioverter defibrillator candidates, treated with dofetilide as an initial anti-arrhythmic strategy for AF, drug discontinuation rates were high, and many underwent future AF ablation. However, most patients had improvement in LVEF, obviating the need for primary prevention implantable cardioverter defibrillator.

Predictors of long-term outcomes greater than 10 years after cardiac resynchronization therapy implantation.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in patients with medically refractory heart failure and wide QRS duration. While much is known about predictors of left ventricular (LV) remodeling after CRT implantation and short-term mortality, limited data exist on long-term outcomes after CRT placement. METHODS: We retrospectively reviewed all patients undergoing CRT implantation at our center between 2003 and 2008 and examined mortality using institutional electronic records, social security death index, and online obituary search. We included only patients with preimplant echoes with LV ejection fraction (LVEF) 35% or below. Variable selection was performed using stepwise regression and models were compared using goodness-of-fit criteria. A final model was validated with the bootstrap regression method. RESULTS: Out of the 877 CRT patients undergoing implantation during this time, 287 (32.7%) survived longer than 10 years. Significant (P < .05) predictors of survival in our multivariate model were age, left ventricular diastolic diameter, sex, presence of nonischemic vs ischemic cardiomyopathy, QRS duration, atrial fibrillation, BNP levels, and creatinine levels at the time of CRT implantation. A model using the odds ratios from these variables had a receiver operating curve with an area under the curve score of 0.816 (standard error, 0.019) at predicting survival or freedom from LVAD or heart transplant for longer than 10 years after CRT implantation. The specificity for factors 3 or above and 5 or above was 68% and 77%, respectively. CONCLUSION: A large proportion of patients are still alive 10 years after CRT implantation. Variables at the time of CRT implant can help provide prognostic information to patients and electrophysiologists to determine the long-term benefit and survival of patients after CRT implantation.

The gap between what patients know and desire to learn about their cardiac implantable electronic devices.

BACKGROUND: Advancement of digital technology now allows patients to have access to data from their cardiac implantable electronic devices (CIEDs). However, patients' understanding regarding CIED data and perceived personal usability remain unclear. The present study is a prospective survey to examine patients' understanding of their CIEDs and their perception of what is important. METHODS: We screened 400 patients between July and December 2018 who presented to our outpatient clinic for a CIED interrogation. Patients received a one-page questionnaire asking baseline demographics, their perception about their own knowledge about their device, and multiple-choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks received. We compared these answers to their interrogation reports to assess accuracy. We also asked participants what they would like to be aware of regarding their CIED. RESULTS: From this cohort, 344 of 400 (86%) (62.9 ± 12.8 years and 64 % males) agreed to take the survey and were included in the analysis. At baseline, 63.2% agreed or strongly agreed that they were knowledgeable about their devices. The overwhelming majority of patients demonstrated CIED knowledge deficits in at least one content area (n = 294, 86%), or more than two content areas (n = 176, 51%). Patients agreed or strongly agreed that they had a desire to have information regarding each of the following: battery life (84%), activity level (79%), heart rate trend (75%), and ventricular arrhythmias (74%). CONCLUSION: There is a large discrepancy in patients' level of knowledge regarding their CIEDs and their wish to know more details. Future technologies should satisfy providers' goals to educate their patients with basic information and fulfill patients' desire to obtain more data from their CIEDs.

Baseline Right Ventricular Dysfunction Predicts Worse Outcomes in Patients Undergoing Cardiac Resynchronization Therapy Implantation.

INTRODUCTION: Cardiac resynchronization therapy (CRT) has been shown to improve survival in patients with systolic heart failure, wide QRS duration, and left-bundle-branch-block. However, CRT outcomes stratified by right ventricular (RV) function at implant have not been well studied. METHODS: We retrospectively reviewed patients at Cleveland Clinic who underwent CRT implantation (n = 777) from 2003 to 2011 with a diagnosis of heart failure, echocardiography with both pre-CRT left ventricular ejection fraction (LVEF) ≤35% and available post-CRT echocardiography at 6 months post-implant. CRT response was defined as LVEF improvement ≥5%. Patients were separated into 2 groups: normal or mild RV dysfunction (n = 570) labeled Normal RV; moderate to severe dysfunction (n = 207) labeled RV DYSFXN based on qualitative echocardiography assessment. Survival was calculated as time from CRT implant to death, left ventricular assist device implant, or heart transplant. RESULTS: CRT response was significantly higher in patients with Normal RV (67%) compared with patients with RV DYSFXN (56%; P = .006). Kaplan-Meier analysis showed that CRT patients with Normal RV had significantly greater survival compared with patients with RV DYSFXN (P < .001). In multivariable Cox regression accounting for a priori covariates, RV DYSFXN was associated with worse survival (HR 1.41 [95% CI: 1.14-1.75], P = .002) and lower CRT response (HR 0.66 [95% CI: 0.44-0.97], P = .03). CONCLUSION: Baseline RV dysfunction at CRT implant is an important predictor of worsened left ventricular remodeling and survival in CRT patients.

Effect of Cardiac Resynchronization Therapy on Left Ventricular Remodeling in Patients With Cardiac Sarcoidosis.

Cardiac resynchronization therapy (CRT) has been shown to be beneficial in patients with medically refractory heart failure. Although it has been found to be effective in a wide range of etiologies for nonischemic cardiomyopathy, its role in improving remodeling and survival of patients with cardiac sarcoidosis (CS) remains undefined. We performed a retrospective review of all patients at our institution with CS who underwent implantation of a CRT device from 2007 to 2017. The outcomes of this population were compared with the outcomes of a cohort of patients with nonischemic cardiomyopathy with an etiology other than sarcoidosis. Nineteen patients in our institution with CS underwent CRT implantation during the time period. This group was compared with 311 consecutive patients with other etiologies of nonischemic cardiomyopathy who underwent CRT implantation. CRT improved left ventricular ejection fraction (LVEF) from 28.8% to 35.9% (p <0.05) in CS, whereas it improved LVEF from 25% to 36.6% (p <0.01) in non-CS group (difference in means of 0.13). CRT significantly improved diastolic and systolic LV diameters, mitral regurgitation, and right ventricular systolic function in non-CS patients but failed to improve same parameters in CS patients. In conclusion, CRT significantly improved LVEF in patients with CS. There is no significant evidence that survival outcomes of CRT patients with CS are significantly worse than other etiologies of nonischemic cardiomyopathy.

Incidence and predictors of late atrioventricular conduction recovery among patients requiring permanent pacemaker for complete heart block after cardiac surgery.

BACKGROUND: New-onset complete heart block (CHB) commonly complicates cardiac surgery, for which some patients require a permanent pacemaker (PPM). Little is known regarding late atrioventricular (AV) conduction recovery. OBJECTIVE: The purpose of this study was to characterize the incidence and predictors of late AV conduction recovery among patients requiring PPM after cardiac surgery. METHODS: Consecutive patients receiving PPM for CHB after cardiac surgery at a high-volume U.S. center from 2000 to 2014 were evaluated. The primary outcome was late AV conduction recovery, defined as a reduction in ventricular pacing requirement to <10% beyond 1 month postimplant. Regression analysis was performed to evaluate predictors of AV recovery. RESULTS: Among 301 patients evaluated over 4 ± 4 years of follow-up, the incidence of late AV conduction recovery was 12% (n = 37), for whom the median ventricular pacing requirement decreased from 96% at implant to <1% at 6 months and persisted throughout study follow-up. AV recovery was less common when preoperative conduction abnormalities were present, including no recovery among patients with preoperative PR >200 ms and QRS >120 ms (n = 42). Multivariable analysis identified only female sex and transient AV conduction postoperatively as independent predictors of recovery (odds ratio 3.5; P <.01 for each). Neither cardiac surgery subtype nor PPM implant timing postoperatively was significantly associated with recovery. CONCLUSION: Late AV conduction recovery is not uncommon after cardiac surgery, occurring in 1 of 8 patients within 6 months postoperatively. Preoperative AV conduction abnormalities were associated with decreased recovery, whereas female sex and transient postoperative AV conduction were associated with increased recovery.

Incidence and predictors of right ventricular pacing-induced cardiomyopathy in patients with complete atrioventricular block and preserved left ventricular systolic function.

BACKGROUND: Right ventricular (RV) pacing may worsen left ventricular cardiomyopathy in patients with reduced left ventricular ejection fraction (LVEF) and advanced atrioventricular block. OBJECTIVE: The objectives of this study were to calculate incidence and identify predictors of RV pacing-induced cardiomyopathy (PICM) in complete heart block (CHB) with preserved LVEF and to describe outcomes of subsequent cardiac resynchronization therapy (CRT) upgrade. METHODS: An analysis of consecutive patients receiving permanent pacemaker (PPM) from 2000 to 2014 for CHB with LVEF >50% was performed. PICM was defined as CRT upgrade or post-PPM LVEF ≤40%. PICM association was determined via multivariable regression analysis. CRT response was defined by LVEF increase ≥10% or left ventricular end-systolic volume decrease ≥15%. RESULTS: Of the 823 study patients, 101 (12.3%) developed PICM over the mean follow-up of 4.3 ± 3.9 years, with post-PPM LVEF being 33.7% ± 7.4% in patients with PICM vs 57.6% ± 6.1% in patients without PICM (P < .001). In multivariable analysis, lower pre-PPM LVEF (hazard ratio [HR] 1.047 per 1% LVEF decrease; 95% confidence interval [CI] 1.002-1.087; P = .042) and RV pacing % both as a continuous (HR 1.011 per 1% RV pacing; 95% CI 1.002-1.02; P = .021) and as a categorical (<20% or ≥20% RV pacing) (HR 6.76; 95% CI 2.08-22.0; P = .002) variable were independently associated with PICM. Only 29 patients with PICM (28.7%) received CRT upgrade despite an 84% responder rate (LVEF increase 18.5% ± 8.1% and left ventricular end-systolic volume decrease 45.1% ± 15.0% in responders). CRT upgrade was associated with greater post-PPM LVEF decrease, lower post-PPM LVEF, and post-PPM LVEF ≤35% (P = .006, P = .004, and P = .004, respectively). CONCLUSION: PICM is not uncommon in patients receiving PPM for CHB with preserved LVEF and is strongly associated with RV pacing burden >20%. CRT response rate is high in PICM, but is perhaps underutilized.

Exercise-induced syncope in a sedentary woman.

Vasovagal (neurocardiogenic) syncope, a subtype of reflex syncope, has many well-known triggers. However, we found no previous report of vasovagal exercise-induced syncope in a sedentary person. We present the case of a 35-year-old sedentary woman who experienced vasovagal syncope as she underwent an exercise stress test. Results of evaluations, including resting and stress electrocardiography and echocardiography, were normal. Her presentation is highly unusual: syncope has typically not been associated with exercise except in young athletes, people with structural heart abnormalities, or people with a prolonged QT syndrome. To our knowledge, this is the first report of vasovagal syncope associated with exercise in a sedentary patient who had normal cardiac and electrophysiologic function. We suggest possible physiologic mechanisms and diagnostic strategies.