The impact of supraventricular arrhythmias on the outcomes of guideline-compliant implantable cardioverter defibrillator programming.

INTRODUCTION: Several implantable cardioverter defibrillators (ICD) programming strategies are applied to minimize ICD therapy, especially unnecessary therapies from supraventricular arrhythmias (SVA). However, it remains unknown whether these optimal programming recommendations only benefit those with SVAs or have any detrimental effects from delayed therapy on those without SVAs. This study aims to assess the impact of SVA on the outcomes of ICD programming based on 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement and 2019 focused update on optimal ICD programming and testing guidelines. METHODS: Consecutive patients who underwent ICD insertion for primary prevention were classified into four groups based on SVA status and ICD programming: (1) guideline-concordant group (GC) with SVA, (2) GC without SVA, (3) nonguideline concordant group (NGC) with SVA, and (4) NGC without SVA. Cox proportional hazard models were analyzed for freedom from ICD therapies, shock, and mortality. RESULTS: Seven hundred and seventy-two patients (median age, 64 years) were enrolled. ICD therapies were the most frequent in NGC with SVA (24.0%), followed by NGC without SVA (19.9%), GC without SVA (11.6%), and GC with SVA (8.1%). Guideline concordant programming was associated with 68% ICD therapy reduction (HR 0.32, p = .007) and 67% ICD shock reduction (HR 0.33, p = .030) in SVA patients and 44% ICD therapy reduction in those without SVA (HR 0.56, p = .030). CONCLUSION: Programming ICDs in primary prevention patients based on current guidelines reduces therapy burden without increasing mortality in both SVA and non-SVA patients. A greater magnitude of reduced ICD therapy was found in those with supraventricular arrhythmias.

Association between symptoms, affect and heart rhythm in patients with persistent or paroxysmal atrial fibrillation: an ambulatory pilot study.

Symptoms in atrial fibrillation are generally assumed to correspond to heart rhythm; however, patient affect - the experience of feelings, emotion or mood - is known to frequently modulate how patients report symptoms but this has not been studied in atrial fibrillation. In this study, we investigated the relationship between affect, symptoms and heart rhythm in patients with paroxysmal or persistent atrial fibrillation. We found that presence of negative affect portended reporting of more severe symptoms to the same or greater extent than heart rhythm.

Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART).

BACKGROUND: Sarcoidosis is an inflammatory disease characterized by the formation of granulomas, which involve the heart in up to 25% of patients. Cardiac sarcoidosis can lead to life threatening arrhythmias and heart failure. While corticosteroids have been used as a treatment for over 50 years, they are associated with hypertension, diabetes, and weight gain, further increasing cardiovascular risk. Interleukin-1 (IL-1) is the prototypical proinflammatory cytokine that works to activate the nuclear transcription factor NF-kB, one of the targets of glucocorticoids. IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis. METHODS: Building on a network of research collaborators developed in the Cardiac Sarcoidosis Consortium, we will investigate the feasibility and tolerability of treatment of CS with anakinra at two National Institute of Health Clinical and Translational Science Award (CTSA) hubs with expertise in cardiac sarcoidosis. In this pilot study, up to 28 patients with cardiac sarcoidosis will be recruited to compare the administration of an IL-1 blocker, anakinra, 100 mg daily on top of standard of care versus standard of care only for 28 days and followed for 180 days. Utilizing surrogate endpoints of changes in systemic inflammatory biomarkers and cardiac imaging, we aim to determine whether IL-1 blockade with anakinra can combat systemic and cardiac inflammation in patients with cardiac sarcoidosis. DISCUSSION: The current trial demonstrates an innovative collaborative approach to clinical trial development in a rare, understudied disease that disproportionately affects females and minorities. Trial Registration The trial was registered prospectively with ClinicalTrials.gov on July 12, 2019, identifier NCT04017936.

Lead damage after cardiac implantable device replacement procedure: Comparison between electrical plasma tool and electrocautery.

BACKGROUND: Lead damage is a complication caused by lead manipulation or heating damage from conventional electrocautery (EC) after cardiovascular implantable electronic device (CIED) replacement. Application of electrical plasma (PEAK PlasmaBlade) is a new technology that reportedly reduces this risk. OBJECTIVES: This study was designed to compare the effect of EC versus PEAK PlasmaBlade on lead parameters and complications after generator replacement procedures. METHODS: We retrospectively studied 410 consecutive patients (840 leads) who underwent CIED replacement using EC (EC group) and 410 consecutive patients (824 leads) using PEAK PlasmaBlade (PlamaBlade group). Pacing lead impedance, incidence of lead damage, and complications were compared between both groups. RESULTS: Lead impedance increased in 393 leads (46.8%) in the EC group versus 282 leads (34.2%) in the PlasmaBlade group (p < .01) with average percent changes of 6.7% and 4.0% (p < .01), respectively. Lead impedance decreased in 438 leads (52.1%) in the EC group versus 507 leads (61.5%) in the PlasmaBlade group (p < .01) with average percent changes of -5.7% and -7.1% (p < .01), respectively. Lead damage requiring lead revision occurred in five leads (0.6%) or after five procedures (1.2%) in the EC group compared to three leads (0.4%, p = .50) or after three procedures (0.7%, p = .48) in the PlasmaBlade group. There were no significant differences in the procedural-related complications between the EC group (nine patients, 2.2%) and the PlasmaBlade group (five patients, 1.2%, p = .28). CONCLUSION: Conventional electrocautery can potentially damage lead insulations. However, this study shows that when used carefully electrocautery is as safe as the PEAK PlasmaBlade™.

Predicting atrial fibrillation episodes with rapid ventricular rates associated with low levels of activity.

BACKGROUND: Rapid and irregular ventricular rates (RVR) are an important consequence of atrial fibrillation (AF). Raw accelerometry data in combination with electrocardiogram (ECG) data have the potential to distinguish inappropriate from appropriate tachycardia in AF. This can allow for the development of a just-in-time intervention for clinical treatments of AF events. The objective of this study is to develop a machine learning algorithm that can distinguish episodes of AF with RVR that are associated with low levels of activity. METHODS: This study involves 45 patients with persistent or paroxysmal AF. The ECG and accelerometer data were recorded continuously for up to 3 weeks. The prediction of AF episodes with RVR and low activity was achieved using a deterministic probabilistic finite-state automata (DPFA)-based approach. Rapid and irregular ventricular rate (RVR) is defined as having heart rates (HR) greater than 110 beats per minute (BPM) and high activity is defined as greater than 0.75 quantile of the activity level. The AF events were annotated using the FDA-cleared BeatLogic algorithm. Various time intervals prior to the events were used to determine the longest prediction intervals for predicting AF with RVR episodes associated with low levels of activity. RESULTS: Among the 961 annotated AF events, 292 met the criterion for RVR episode. There were 176 and 116 episodes with low and high activity levels respectively. Out of the 961 AF episodes, 770 (80.1%) were used in the training data set and the remaining 191 intervals were held out for testing. The model was able to predict AF with RVR and low activity up to 4.5 min before the events. The mean prediction performance gradually decreased as the time to events increased. The overall Area under the ROC Curve (AUC) for the model lies within the range of 0.67-0.78. CONCLUSION: The DPFA algorithm can predict AF with RVR associated with low levels of activity up to 4.5 min before the onset of the event. This would enable the development of just-in-time interventions that could reduce the morbidity and mortality associated with AF and other similar arrhythmias.

THE EFFICACY AND SAFETY OF CO-ADMINISTRATION OF SITAGLIPTIN WITH METFORMIN IN PATIENTS WITH TYPE 2 DIABETES AT HOSPITAL DISCHARGE.

OBJECTIVE: Few randomized controlled trials have focused on the optimal management of patients with type 2 diabetes (T2D) during the transition from the inpatient to outpatient setting. This multicenter open-label study explored a discharge strategy based on admission hemoglobin A1c (HbA1c) to guide therapy in general medicine and surgery patients with T2D. METHODS: Patients with HbA1c ≤7% (53 mmol/mol) were discharged on sitagliptin and metformin; patients with HbA1c between 7 and 9% (53-75 mmol/mol) and those >9% (75 mmol/mol) were discharged on sitagliptinmetformin with glargine U-100 at 50% or 80% of the hospital daily dose. The primary outcome was change in HbA1c at 3 and 6 months after discharge. RESULTS: Mean HbA1c on admission for the entire cohort (N = 253) was 8.70 ± 2.3% and decreased to 7.30 ± 1.5% and 7.30 ± 1.7% at 3 and 6 months ( P<.001). Patients with HbA1c <7% went from 6.3 ± 0.5% to 6.3 ± 0.80% and 6.2 ± 1.0% at 3 and 6 months. Patients with HbA1c between 7 and 9% had a reduction from 8.0 ± 0.6% to 7.3 ± 1.1% and 7.3 ± 1.3%, and those with HbA1c >9% from 11.3 ± 1.7% to 8.0 ± 1.8% and 8.0 ± 2.0% at 3 and 6 months after discharge (both P<.001). Clinically significant hypoglycemia (<54 mg/dL) was observed in 4%, 4%, and 7% among patients with a HbA1c <7%, 7 to 9%, and >9%, while a glucose <40 mg/dL was reported in <1% in all groups. CONCLUSION: The proposed HbA1c-based hospital discharge algorithm using a combination of sitagliptin-metformin was safe and significantly improved glycemic control after hospital discharge in general medicine and surgery patients with T2D. ABBREVIATIONS: BG = blood glucose; DPP-4 = dipeptidyl peptidase-4; eGFR = estimated glomerular filtration rate; HbA1c = hemoglobin A1c; T2D = type 2 diabetes.

Programming of implantable cardioverter defibrillators for primary prevention: outcomes at centers with high vs. low concordance with guidelines.

BACKGROUND: While ICD therapy reduction programming strategies are recommended in current multi-society guidelines, concerns remain about a possible trade-off between the benefits of ICD therapy reduction and failure to treat episodes of ventricular arrhythmias. The study is to evaluate the outcomes of primary prevention patients followed in centers with high and low concordance with the 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement and 2019 focused update on optimal ICD programming and testing guidelines. METHODS: Consecutive patients with primary prevention ICD implantation from two centers between 2014 and 2016 were included. One center was classified as high guideline concordance center (HGC) with 47% (146/310) of patients with initial ICD concordant with the guidelines, and the other center was classified as low guideline concordance center (LGC) with only 1% (2/178) of patients with guideline-concordant initial ICD programming. Cox proportional hazard models were used to assess risk of first ICD therapy (ATP or shock), first ICD shock, and mortality. RESULTS: A total of 488 patients were included (mean age, 66 ± 13 years). During a mean follow-up of 1.9 ± 0.9 years, patients followed at HGC were 63% less likely to receive any ICD therapy (adjusted HR [aHR] 0.37, 95% CI 0.42-0.99). There were no significant differences in the rate of first ICD shock (aHR 0.72, 95% CI 0.34-1.52) or mortality (aHR 1.19, 95% CI, 0.47-3.05). CONCLUSIONS: Compared to primary prevention patients followed at LGC, primary prevention ICD patients followed at HGC received a significantly lower rate of ICD therapy, mainly from ATP reduction, without a difference in mortality during follow-up.

Outcomes in patients with electrocardiographic left ventricular dyssynchrony following transcatheter aortic valve replacement.

BACKGROUND: Left bundle branch block (LBBB) and atrioventricular (AV) conduction abnormalities requiring permanent pacemaker (PPM) implantation occur frequently following transcatheter aortic valve replacement (TAVR). The resultant left ventricular (LV) dyssynchrony may be associated with adverse clinical events. OBJECTIVES: The purpose of this study was to assess the adverse outcomes associated with LV dyssynchrony due to high-burden right ventricular (RV) pacing or permanent LBBB following TAVR in patients with preserved left ventricular ejection fraction (LVEF). METHODS: Consecutive TAVR patients at the University of Michigan from January 2012 to June 2017 were included. Pre-existing cardiac implantable electronic device, previous LBBB, LVEF <50%, or follow-up period <1 year were excluded. The primary outcome was all-cause mortality. Secondary outcomes included cardiomyopathy (defined as LVEF ≤45%), a composite endpoint of cardiomyopathy or all-cause mortality, and the change in LVEF at 1-year follow-up. RESULTS: A total of 362 patients were analyzed (mean age 77 years). LV dyssynchrony group (n = 91 [25.1%]) included 56 permanent LBBB patients, 12 permanent LBBB patients with PPM, and 23 non-LBBB patients with PPM and high-burden RV pacing. Remaining patients served as control (n = 271 [74.9%]). After adjusted analysis, LV dyssynchrony had significantly higher all-cause mortality (adjusted hazard ratio [HR] 2.16; 95% confidence interval [CI] 1.07-4.37) and cardiomyopathy (adjusted HR 14.80; 95% CI 6.31-14.69). The LV dyssynchrony group had mean LVEF decline of 10.5% ± 10.2% compared to a small increase (0.5% ± 7.7%) in control. CONCLUSION: Among TAVR patients with preserved LVEF and normal AV conduction, development of postprocedural LV dyssynchrony secondary to high-burden RV pacing or permanent LBBB was associated with significantly higher risk of death and cardiomyopathy at 1-year follow-up.

Programming implantable cardioverter-defibrillator in primary prevention: Guideline concordance and outcomes.

BACKGROUND: Inappropriate therapy is a common adverse effect in patients with an implantable cardioverter-defibrillator (ICD) that may be prevented by appropriate programming. OBJECTIVE: The purpose of this study was to assess the outcomes of device programming based on a 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement and a 2019 focused update on optimal ICD programming and testing. METHODS: Consecutive patients who underwent ICD insertion for primary prevention from 2014-2016 at 3 centers were included in the retrospective analysis. Patients were classified into 2 groups based on the tachycardia programming at the time of implant: guideline concordant group (GC) and non-guideline concordant group (NGC). Kaplan-Meier analysis and Cox proportional hazard models were used to estimate freedom from ICD therapy (antitachycardia pacing or shock), ICD shock, and death. RESULTS: A total of 772 patients were included in the study (mean age 63.3 ± 13.8 years). Of this total, 258 patients (33.4%) were in the GC group and 514 patients (66.6%) were in the NGC group. During mean follow-up of 2.02 ± 0.91 years, guideline concordant programming was associated with a 53% reduction in ICD therapy (P <.01) and 50% reduction in ICD shock (P = .02). There were no significant differences in mortality (6% in GC group vs11% in NGC group; P = .22). CONCLUSION: Only one-third of the studied population had an ICD device programmed in concordance with current guidelines. ICD programming based on the current guidelines was associated with a significantly lower rate of ICD therapy and shock without changes in mortality during intermediate-term follow-up.

Significance of clinical ventricular tachycardias induced by antitachycardia pacing in patients with prior myocardial infarction.

BACKGROUND: In patients with implantable cardioverter-defibrillator (ICD), ventricular tachycardia (VT) can occur spontaneously or as a result of antitachycardia pacing (ATP) that changes, rather than terminates, a spontaneous VT to a different VT. The relevance of ATP-induced VTs is uncertain. OBJECTIVE: The purpose of this study was to assess the clinical relevance of ATP-mediated VTs in patients undergoing VT ablation procedures. METHODS: Stored ICD electrograms of 162 consecutive patients with prior myocardial infarction referred for VT ablation (mean age 67.5 ± 9.2 years; 150 men; median ejection fraction 25% [IQR 20%-35%]) were reviewed. Clinical VTs were classified as spontaneous or ATP-induced. All VTs were targeted during the ablation procedures. RESULTS: Of 554 ICD-recorded clinical VTs, 157 (28%) were ATP-induced (63 patients) and 397 (72%) were spontaneous. ATP-induced VTs were faster (cycle length 316 ± 62 ms vs 369 ± 83 ms; P < .001), less commonly inducible with invasive programmed stimulation (35% vs 52%; P < .001), and less commonly had identifiable target sites (21% vs 40%; P < .001) than were spontaneous VTs. During a median follow-up of 368 days [IQR: 68-1106] postablation, 71 VTs recurred (39 patients), none of which was a previously documented ATP-induced VT. A history of ATP-induced VT was associated with an increase in VT recurrence. CONCLUSION: ATP-induced VTs occur frequently in patients with prior myocardial infarction presenting for VT ablation procedures. The presence of ATP-induced VT is associated with a higher VT recurrence rate postablation. None of the ATP-induced VTs recorded before the ablation procedure recurred postablation, and therefore ATP-induced VTs represent a marker rather than the cause of VT recurrence.

Targeting Noninducible Clinical Ventricular Tachycardias in Patients With Prior Myocardial Infarctions Based on Stored Electrograms.

BACKGROUND: Ablation of postinfarction ventricular tachycardia (VT) has been shown to reduce VT recurrence and decrease mortality. However, VT recurrence can occur despite extensive ablation procedures. The lack of inducibility of clinical VTs during ablation procedures remains problematic and may be in part responsible for VT recurrences. In this prospective study, we targeted documented but noninducible clinical VTs based on stored implantable cardioverter-defibrillator (ICD) electrograms. METHODS: Radiofrequency ablation was performed in a consecutive group of 66 postinfarction patients (mean age, 67.5±9.2 years; men, 61; mean left ventricular ejection fraction, 25.1±10.8%) in whom clinical VTs were not inducible during an ablation procedure. In the first 33 patients (control group), only inducible VTs were targeted, and in the second 33 patients, noninducible clinical VTs were also targeted by pace-mapping based on stored ICD-electrograms (ICD-electrogram-guided ablation group). Procedural and clinical outcomes were compared at 24 months post-ablation. RESULTS: VT recurred in 5 patients (15%) in whom the ICD-electrogram-guided approach was performed and in 13 patients (39%) in the control group. Freedom from recurrent VT was higher (log-rank P=0.04) in the ICD-electrogram-guided group, but there was no difference in ventricular fibrillation or in total mortality between both groups. CONCLUSIONS: Ablation guided by pace-mapping of noninducible postinfarction clinical VTs based on ICD-electrograms is feasible and reduces the risk of recurrent VT.

Type 2 diabetes specialty clinic model for the accountable care organization era.

AIMS: A third of the patients with Type 2 diabetes have an advance disease that requires complex pharmacotherapies and advanced expertise, dependent on multiple clinical interactions. Unfortunately, limited providers availability enables only sporadic interactions. Additionally, the expanding Accountable Care Organization (ACO) concept enhances providers' compensation when clinical performance is improving while limiting face-to-face clinic visits. METHODS: We developed an advanced type 2 specialty clinic model, geared toward frequent remote clinical interventions while limiting face-to-face clinic visits. The model was tested in a 1-year, prospective, randomized controlled clinical trial. N=60, patients were randomized 1:1, to the experimental or standard endocrinology clinics. RESULTS: Average A1c in the experimental arm decreased from 9.6±0.9% to 7.9±1.3%(p<0.0001). Whereas in the control it decreased from 8.9±0.8% to 8.6±1.9%(non-significant). More patients were treated with statins in the experimental arm compared to the control (93.3% vs. 66.7%; p=0.01). Face-to-face clinic visits occurred 1.5±0.7 times per year in the experimental arm compared to 3.6±4.0 in the control (p<0.0001). CONCLUSIONS: We believe that the presented model for a modified type 2 diabetes specialty clinic may enhance providers accessibility and patients' outcomes while improving reimbursement in the ACO model.

Feasibility and Usability of a Mobile Application to Assess Symptoms and Affect in Patients with Atrial Fibrillation: A Pilot Study.

BACKGROUND: Atrial fibrillation (AF) is the most prevalent arrhythmia leading to hospital admissions. The majority of patients with AF report symptoms that are believed to be associated with the arrhythmia. The symptoms related to AF traditionally are collected during a clinic visit that is influenced by biases associated with recalling the experience over a limited period of time. PURPOSE: We designed this pilot study to assess the usability and feasibility of a mobile application to assess symptoms in patients with AF. METHODS: We designed a mobile application (miAfib) to assess symptoms (chest pain, palpitation, shortness of breath, fatigue, dizziness/lightheadedness), positive affect (happy, excited, content) and negative affect (worried, angry, sad) on multiple occasions throughout the day based on iOS platform. We performed a four-week feasibility trial to examine user adherence, acceptance and experiences with the mobile application. We administered questionnaires to assess factors affecting usage and self-reported acceptance of the application based on a five-point Likert scale with zero representing strongly disagree and 5 representing strongly disagree with. RESULTS: We included ten patients with paroxysmal and persistent AF. The mean number of completed assessments each day was 2.81 ± 1.59 with 94.7% of days with at least one assessment. The users found the application easy to use (4.75±0.46), intended to use it in the future (4.37±1.06) and found it easy to integrate into daily routine (4.5±1.07). CONCLUSION: In this pilot study, we found participants in this four-week trial reliably used the application and were able to use the app to report their daily symptoms and affect regularly. Participants reported that they found the application easy to use and would consider using the application in the future.

Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study.

OBJECTIVE: This study investigated the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2 diabetes (T2D) in general medicine and surgery patients. RESEARCH DESIGN AND METHODS: In this pilot, multicenter, open-label, randomized study, patients (n = 90) with a known history of T2D treated with diet, oral antidiabetic agents, or low total daily dose of insulin (≤0.4 units/kg/day) were randomized to receive sitagliptin alone or in combination with glargine insulin (glargine) or to a basal bolus insulin regimen (glargine and lispro) plus supplemental (correction) doses of lispro. Major study outcomes included differences in daily blood glucose (BG), frequency of treatment failures (defined as three or more consecutive BG >240 mg/dL or a mean daily BG >240 mg/dL), and hypoglycemia between groups. RESULTS: Glycemic control improved similarly in all treatment groups. There were no differences in the mean daily BG after the 1st day of treatment (P = 0.23), number of readings within a BG target of 70 and 140 mg/dL (P = 0.53), number of BG readings >200 mg/dL (P = 0.23), and number of treatment failures (P > 0.99). The total daily insulin dose and number of insulin injections were significantly less in the sitagliptin groups compared with the basal bolus group (both P < 0.001). There were no differences in length of hospital stay (P = 0.78) or in the number of hypoglycemic events between groups (P = 0.86). CONCLUSIONS: Results of this pilot indicate that treatment with sitagliptin alone or in combination with basal insulin is safe and effective for the management of hyperglycemia in general medicine and surgery patients with T2D.