Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports.

AIMS: Cardiac resynchronization therapy (CRT) is an important treatment for heart failure that requires constant ventricular pacing, placing a high energy burden on CRT defibrillators (CRT-D). Longer battery life reduces the need for device changes and associated complications, thereby affecting patient outcomes and cost of care. We therefore investigated the time to battery depletion of CRT-D from different manufacturers and compared these results with manufacturers' published product performance reports (PPRs). METHODS AND RESULTS: All CRT-D recipients at our institution between January 2008 and December 2010 were included in this study cohort. The patients were followed up to the endpoint of battery depletion and were otherwise censored at the time of death, last follow-up, or device removal for any reason other than battery depletion. A total of 621 patients [173 Boston Scientific (BSC), 391 Medtronic (MDT), and 57 St. Jude Medical (SJM)] were followed up for a median of 3.7 (IQR 1.6-5.0) years, during which time 253 (41%) devices were replaced for battery depletion. Compared with MDT devices, battery depletion was 85 and 54% less likely to happen with BSC and SJM devices, respectively (P < 0.001 for pairwise comparisons). Product performance reports from all manufacturers significantly overestimated battery longevity by more than 20% 6 years after device implantation. CONCLUSIONS: Large differences in CRT-D battery longevity exist between manufacturers. Industry-published PPRs significantly overestimate device longevity. These data have important implications to patients, healthcare professionals, hospitals, and third-party payers.

Risk of Stroke and Death in Atrial Fibrillation by Type of Anticoagulation: A Propensity-Matched Analysis.

BACKGROUND: We examined the effect of novel oral anticoagulants (NOACs) compared to warfarin on the risk of death or stroke in atrial fibrillation (AF) patients in every day clinical practice. METHODS: We examined a cohort of 2,836 AF patients, of whom 2,253 were prescribed warfarin and 583 were prescribed an NOAC. Patients with glomerular filtration rate < 30 mg/mL or history of significant valvular heart disease were excluded. Patients were followed to primary end points of death or stroke. Propensity matching was used to adjust for differences in baseline characteristics between the groups. RESULTS: Compared to patients in the NOAC group, patients on warfarin had more comorbidities and higher CHADS2 and CHA2 DS2 -VASc scores (1.7 vs 1.3 for CHADS2 , 2.8 vs 2.2 for CHA2 DS2 -VASc, P < 0.0001 for both). After adjusting for differences in baseline characteristics, NOAC use was associated with significant reduction in all-cause mortality compared to warfarin (hazard ratio [HR] = 0.47, 95% confidence interval [CI; 0.3-0.8], P = 0.006) but not stroke, over a median follow-up of 42.5 months. The difference in mortality persisted after propensity score matching (HR = 0.51, 95% CI [0.28-0.93], P = 0.03). CONCLUSIONS: Compared to warfarin, NOAC use is associated with decreased all-cause mortality but not stroke risk. These data from real-life clinical practice add to existing evidence for decreased mortality among patients prescribed NOACs compared to warfarin.

Battery longevity in cardiac resynchronization therapy implantable cardioverter defibrillators.

AIMS: Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) deliver high burden ventricular pacing to heart failure patients, which has a significant effect on battery longevity. The aim of this study was to investigate whether battery longevity is comparable for CRT-ICDs from different manufacturers in a contemporary cohort of patients. METHODS AND RESULTS: All the CRT-ICDs implanted at our institution from 1 January 2008 to 31 December 2010 were included in this analysis. Baseline demographic and clinical data were collected on all patients using the electronic medical record. Detailed device information was collected on all patients from scanned device printouts obtained during routine follow-up. The primary endpoint was device replacement for battery reaching the elective replacement indicator (ERI). A total of 646 patients (age 69 ± 13 years), implanted with CRT-ICDs (Boston Scientific 173, Medtronic 416, and St Jude Medical 57) were included in this analysis. During 2.7 ± 1.5 years follow-up, 113 (17%) devices had reached ERI (Boston scientific 4%, Medtronic 25%, and St Jude Medical 7%, P < 0.001). The 4-year survival rate of device battery was significantly worse for Medtronic devices compared with devices from other manufacturers (94% for Boston scientific, 67% for Medtronic, and 92% for St Jude Medical, P < 0.001). The difference in battery longevity by manufacturer was independent of pacing burden, lead parameters, and burden of ICD therapy. CONCLUSION: There are significant discrepancies in CRT-ICD battery longevity by manufacturer. These data have important implications on clinical practice and patient outcomes.

Perioperative Cardiac Considerations in the Surgical Patient.

The ability to identify and guide evaluation of the patient with cardiac disease represents a necessary skill for success in surgery of the foot and ankle. Common risk factors, such as diabetes and peripheral arterial disease, are encountered in podiatric practice. Recognition of patients at risk for cardiac disease and a predilection for sustaining a major adverse cardiac event perioperatively advocates for preoperative cardiology consultation. Identification of risk factors, assessment of functional capacity, and appropriate work-up mitigate any untoward cardiac events surrounding surgery. This optimization results from appropriate medical and interventional treatment plans directed at minimizing or eliminating identified risks factors.

Developing a panel of biomarkers and miRNA in patients with myocardial infarction for early intervention strategies of heart failure in West Virginian population.

BACKGROUND: Myocardial infarction is the most common cause of heart failure. MI has been intricately linked to ventricular remodeling, subsequently leading to the reduction in the cardiac ejection fraction causing HF. The cumulative line of evidence suggests an important role of several biomarkers in modulating the cardiac vasculature, further contributing towards the progression of post-MI complications. Studies have demonstrated, yet not fully established, that an important biomarker, IL-10, has a causal relationship with MI and associated cardiac dysfunction. HYPOTHESIS: This study aims to establish the role of IL-10 as a prognostic marker for the cardiovascular outcomes and to develop a panel of biomarkers and circulating miRNAs that could potentially result in the early detection of HF resulting from MI, allowing for early intervention strategies. METHODS AND RESULTS: Blood was withdrawn and echocardiography assessment was performed on a total of 43 patients that were enrolled, within 24 hours of the incidence of MI. Patients were divided in three main groups, based on the ejection fraction measurement from echocardiography: control (n = 14), MI with normal EF (MI+NEF, n = 13) and MI with low EF (MI+LEF, n = 16). Our results showed that TGFß-1, TNF-α, IL-6 and MMP-9 were upregulated significantly in MI+NEF group and more so in MI+LEF group, as compared to control group (p<0.01). The circulating levels of miR-34a, miR-208b and miR-126 were positively correlated and showed elevated levels in the MI+NEF group, even higher in MI+LEF group, while levels of miR-24 and miR-29a were reduced in MI+NEF, and much lower in MI+LEF, as compared to the control group (p<0.01). Our results also demonstrated a direct correlation of IL-10 with the ejection fraction in patients with MI: IL-10 was elevated in MI+NEF group, however, the levels were significantly low in MI+LEF group suggesting an important role of IL-10 in predicting heart failure. Importantly, our study confirmed the correlation of IL-10 with EF by our follow-up echocardiography assessment that was performed 2 months after the incidence of MI. CONCLUSION: Our results support the clinical application of these serum biomarkers to develop a panel for appropriate prognosis and management of adverse cardiac remodeling and development of heart failure post-myocardial infarction.

Frequency and characteristics of skin cancers diagnosed at Ayub Medical College, Abbottabad Pakistan from 1995-2003.

BACKGROUND: Our histopathology laboratory serves mountainous area of Hazara Division in Northern Pakistan. This study is an analysis of the records of skin cancers reported over a nine years period to develop local statistics about frequency and characteristics of skin cancers. METHODS: Data from 1995-2003 record of cancers reported by Department of Pathology, Ayub Medical College, Abbottabad were analysed to calculate cumulative and year wise frequency of skin cancers and their major types. Frequency distribution with reference to gender and age was also calculated. RESULTS: Skin cancers were 220 (1.04%) out of the total 21075 cancers recorded during this period. Squamous cell carcinoma was diagnosed in 118 (53.6%), Basal cell carcinoma in 88 (40%) and Malignant melanoma in 14 (6.4%) cases. The mean age for all skin cancers considered together was 58.75 +/- 15.21. Non Melanoma Skin Cancer (NMSC) were seen in all age groups (minimum 15, maximum 103 years), while no malignant melanoma patient was under 35 years of age. Gender difference in distribution was negligible with slight male preponderance (23:21). Malignant melanoma was significantly (p < 0.05) more in males (71.4%), while distribution of both the types of NMSC was non-significantly in favour of males. We found no significant rise or fall in total skin cancers or any type of skin cancer in this 9 years period. CONCLUSIONS: At present the frequency of skin cancer is stable at around 1% of total cancers reported at Ayub Medical College, reflecting a stable very low incidence rate of skin cancer in Hazara Division of Pakistan.

Comparative effectiveness of antiarrhythmic drugs for rhythm control of atrial fibrillation.

INTRODUCTION: Although there are many different antiarrhythmic drugs (AADs) approved for rhythm management of atrial fibrillation (AF), little comparative effectiveness data exist to guide drug selection. METHODS: We followed 5952 consecutive AF patients who were prescribed amiodarone (N=2266), dronedarone (N=488), dofetilide (N=539), sotalol (N=1718), or class 1C agents (N=941) to the primary end point of AF recurrence. RESULTS: Median follow-up time was 18.2 months (range 0.1-101.6 months). Patients who were prescribed amiodarone had the highest, while patients on class 1C agents had the lowest baseline CHA2DS2-VASc score, Charlson comorbidity index, and burden of comorbid illnesses including coronary artery disease, congestive heart failure, diabetes mellitus, hyperlipidemia, chronic obstructive lung disease, chronic kidney disease, or cancer (p<0.05 for all comparisons). After adjusting for baseline characteristics, using dronedarone as benchmark, amiodarone [hazard ratio (HR) 0.58, p<0.001], class 1C agents (HR 0.70, p<0.001), and sotalol (HR 0.79, p=0.008), but not dofetilide (HR 0.87, p=0.178) were associated with less AF recurrence. In addition, compared to dronedarone, amiodarone and class 1C agents were associated with lower rates of admissions for AF (HR 0.55, p<0.001 for amiodarone; HR 0.71, p=0.021 for class 1C agents) and all-cause mortality was lowest in patients treated with class 1C agents (HR 0.42, p=0.018). The risk of stroke was similar among all groups. CONCLUSION: Compared with dronedarone, amiodarone, class 1C agents, and sotalol are more effective for rhythm control, while dofetilide had similar efficacy. These findings have important implications for clinical practice.

Mortality risk of long-term amiodarone therapy for atrial fibrillation patients without structural heart disease.

BACKGROUND: Amiodarone is often prescribed in the management of atrial fibrillation (AF) but is known to cause significant end-organ toxicities. In this study, we examined the impact of amiodarone on all-cause mortality in AF patients with structurally normal hearts. METHODS: We performed a retrospective cohort analysis of all AF patients with structurally normal hearts who were prescribed antiarrhythmic drugs (AAD) for rhythm control of AF at our institution from 2006 to 2013 (n = 2,077). Baseline differences between the amiodarone (AMIO: n = 403) and other AADs (NON-AMIO: n = 1,674) groups were corrected for using propensity score matching. RESULTS: Amiodarone use as first-line therapy decreased significantly with a higher degree of prescriber specialization in arrhythmia management (31%, 22%, and 9% for primary care physicians, general cardiologists and cardiac electrophysiologists, respectively, p < 0.001). After propensity score matching, baseline comorbidities were balanced between the AMIO and NON-AMIO groups. Over a median follow-up of 28.2 months (range 6.0-100.9 months), amiodarone was associated with increased all-cause (HR 2.41, p = 0.012) and non-cardiac (HR 3.55, p = 0.008) mortality, but not cardiac mortality. AF recurrence and cardiac hospitalizations were similar between the two study groups. CONCLUSIONS: Amiodarone treatment of AF is associated with increased mortality in patients without structural heart disease and therefore should be avoided or only used as a second-line therapy, when other AF therapies fail. Adherence to guideline recommendations in the management of AF patients impacts clinical outcome.

Patient outcomes according to adherence to treatment guidelines for rhythm control of atrial fibrillation.

BACKGROUND: Although guidelines for antiarrhythmic drug therapy in atrial fibrillation (AF) were published in 2006, it remains uncertain whether adherence to these guidelines affects patient outcomes. METHODS AND RESULTS: We retrospectively evaluated the records of 5976 consecutive AF patients who were prescribed at least 1 antiarrhythmic drug between 2006 and 2013. Patients with 1 or more prescribed antiarrhythmic drugs that did not comply with guideline recommendations comprised the non-guideline-directed group (=2920); the remainder constituted the guideline-directed group (=3056). Time to events was assessed using the survival analysis method and adjusted for covariates using Cox regression. Rates of adherence to the guidelines increased significantly with a higher degree of prescriber specialization in arrhythmias (49%, 55%, and 60% for primary care physicians, general cardiologists, and cardiac electrophysiologists, respectively, P=0.001) for the first prescribed antiarrhythmic drug. Compared to the non-guideline-directed group, the guideline-directed group had higher rates of heart failure, but lower baseline CHADS2-VASc scores (P<0.001) and lower rates of coronary artery disease, valvular disease, hypertension, hyperlipidemia, pulmonary disease, and renal insufficiency (P<0.05 for all). During 45 ± 26 months follow-up, the guideline-directed group had a lower risk of AF recurrence (hazard ratio=0.86, 95% CI=0.80 to 0.93), fewer hospital admissions for AF (hazard ratio=0.87, 95% CI=0.79 to 0.97), and fewer procedures for recurrent AF, including electrical cardioversion, pacemaker implantation, and atrioventricular nodal ablation (P<0.01 for all). The mortality and stroke risks were similar between the groups. CONCLUSIONS: Adherence to published guidelines in the antiarrhythmic management of AF is associated with improved patient outcomes.

Outcomes of Sprint Fidelis and Riata lead extraction: Data from 2 high-volume centers.

BACKGROUND: The Sprint Fidelis (SF) and the Riata (RT) implantable cardioverter-defibrillator leads have been recalled for premature failure. OBJECTIVE: Data on SF and RT extractions are limited; therefore, we performed a pooled analysis to compare the safety and efficacy of lead extraction for the SF and RT lead families. METHODS: We retrospectively reviewed consecutive patients undergoing transvenous extraction of SF and RT leads at Emory University and the University of Pittsburgh Medical Center from January 2007 to October 2013. Patients were placed into 2 groups based on the presence of an SF or RT lead. The primary endpoint was a major procedural complication, defined as death, need for urgent cardiac surgery, and hemopericardium or hemothorax that required an intervention. RESULTS: A total of 462 patients underwent extraction of recalled leads (SF, n = 360; RT, n = 102). The mean number of leads extracted in the RT group was higher than in the SF group (1.8 ± 0.9 vs 1.3 ± 0.7, P < .001), and there was a longer implantation time in the RT group (5.5 ± 2.5 vs 4.3 ± 2.0 years, P < .001). Complete procedural success was higher in the SF group (99.4% vs 96.1%, P =.024). Clinical success was similar (SF 99.4% vs RT 97.1%, P = .075). There were 6 major procedural complications in the entire cohort (1.3%). The rate of major complications was not different between the SF and RT groups (SF 1.1% vs RT 2.0%, P = .618). Total mortality was 0.65%, with no difference between the groups CONCLUSION: Our data from 2 high-volume centers suggest that extraction of SF and RT leads is associated with excellent clinical success and a similar rate of major procedural complications.

Effect of echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy on mortality and risk of defibrillator therapy for ventricular arrhythmias in heart failure patients (from the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region [STARTER] trial).

Echocardiography-guided left ventricular (LV) lead placement at the site of latest mechanical activation improves heart failure outcomes in patients receiving a cardiac resynchronization therapy defibrillator (CRT-D). In this study, we test the hypothesis that a strategy of echocardiography-guided LV lead placement improves patient survival rate free from appropriate CRT-D therapy for ventricular arrhythmias. Patients enrolled in the prospective, randomized Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial and treated with a CRT-D device (108 with the echo-guided strategy and 75 with the routine strategy) were followed to the end point of death or first appropriate CRT-D therapy. Over a follow-up period of 3.7 ± 2.1 years, 62 patients (33%) died and 40 (22%) received appropriate CRT-D therapy. Compared with the routine group, patients in the echo-guided group had improved CRT-D therapy-free survival rate (hazard ratio = 0.64, 95% confidence interval = 0.42 to 0.98, p = 0.038). Patients randomized to the echo-guided LV lead placement were more likely to resynchronize their LV compared with the routine group (72% vs 48%, respectively, p = 0.006). Patients whose LV did resynchronize after CRT-D had improved therapy-free survival rate compared with those whose LV did not resynchronize (hazard ratio = 0.49, 95% confidence interval = 0.28 to 0.86, p = 0.012). In conclusion, a strategy of echo-guided LV lead placement improved the patient survival rate free from defibrillator therapy in CRT-D recipients.

Influence of QRS duration on outcome of death or appropriate defibrillator therapy by strategy of left ventricular lead placement in cardiac resynchronization therapy recipients.

PURPOSE: Echocardiography-guided (EG) lead placement at the site of latest left ventricular (LV) mechanical activation improves outcome in patients receiving a cardiac resynchronization therapy (CRT) defibrillator (D). The purpose of this study is to examine whether a strategy of EG LV lead placement equally improves outcome in CRT recipients with wide (≥150 ms) versus intermediate (120-149 ms) QRS duration. METHODS: Patients treated with a CRT-D in the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region (STARTER) prospective, randomized trial (108 EG strategy and 75 routine strategy) were followed to the endpoint of death or first appropriate CRT-D therapy. Of the patients enrolled in STARTER, 115 had QRS ≥ 150 ms and 68 had 120 < QRS ≤ 149 ms. RESULTS: Over a mean follow-up period of 3.7 ± 2.1 years, 62 (33 %) patients died and 40 (22 %) received appropriate CRT-D therapy. Compared to patients with QRS ≥ 150 ms, patients with intermediate QRS had meaningfully worse survival free from ICD therapy (HR = 1.48, p = 0.056). CRT-D therapy-free survival was significantly worse in patients with intermediate QRS duration randomized to the routine LV lead placement strategy, compared to patients with intermediate QRS duration randomized to the EG LV lead placement strategy or patients with wide QRS duration regardless of LV implantation strategy (HR = 2.08, 95 % confidence interval = 1.21-3.56, P = 0.008). This finding was independent in type of cardiomyopathy. CONCLUSION: A strategy of EG LV lead placement improves survival free from defibrillator therapy in patients with QRS between 120-149 ms to levels comparable to those of patients with QRS ≥ 150 ms.

Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy in ischemic vs nonischemic cardiomyopathy patients.

BACKGROUND: Echocardiography-guided (EG) left ventricular (LV) lead placement at the site of latest mechanical activation improves outcome in heart failure (HF) patients receiving a cardiac resynchronization therapy (CRT)-defibrillator (CRT-D). OBJECTIVE: The purpose of this study was to examine the effect of a strategy of EG LV lead placement in each of ischemic (ICM) vs nonischemic (NICM) cardiomyopathy patients. METHODS: Patients enrolled in the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region (STARTER) prospective, randomized trial who were treated with a CRT-D device (108 EG strategy and 75 routine strategy) were followed to the end-points of death, appropriate CRT-D therapy, or HF hospitalization. RESULTS: Of the patients enrolled in STARTER, 115 had ICM and 68 had NICM. Over mean follow-up of 3.7 ± 2.1 years, 62 patients died, 40 received appropriate CRT-D therapy, and 67 had HF hospitalizations. Compared to NICM patients, patients with ICM had worse survival (P = .0003), worse survival free from implantable cardioverter-defibrillator therapy (P = .004), and survival free from HF hospitalization (P = .0001). A strategy of EG LV lead placement improved the outcome of CRT-D therapy-free survival primarily in ICM patients and the outcome of HF hospitalization-free survival in both ICM and NICM patients. Achieving LV resynchronization was most critical in ICM patients in whom arrhythmic and HF outcomes improve with resynchronization to levels comparable to those of NICM patients. CONCLUSION: A strategy of EG LV lead placement improves HF-free survival equally in ICM and NICM patients and CRT-D therapy-free survival more favorably in ICM patients to levels comparable to those of NICM patients.

A fatal case of nafcillin-induced hepatotoxicity: a case report and the literature review.

Background. Drug-induced hepatotoxicity (DIH) is quite common, and there are several recommendations for its treatment based upon its etiology. DIH may range from mild and subclinical to fulminant liver failure and death. Even though there is extensive list of drugs causing DIH, antibiotics, as a class of drugs, are the most common cause of DIH. Here, we present a fatal case of nafcillin-induced hepatotoxicity confirmed by liver biopsy, with total bilirubin peaking to 21.8 mg/dl and subsequent further extensive evaluation for hepatic injury turning out to be negative.