Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial.

BACKGROUND: Current expert consensus recommends remote monitoring for cardiac implantable electronic devices, with at least annual in-office follow-up. We studied safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for 2 years. METHODS: In Japan, consecutive pacemaker patients committed to remote monitoring were randomized to either RFU or conventional in-office follow-up (conventional follow-up) at twice yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after 2 years. The primary end point was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was noninferiority with 5% margin. RESULTS: Of 1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (Conventional follow-up) patients reached either the primary end point or 24 months follow-up. The primary end point occurred in 10.9% and 11.8%, respectively (P=0.0012 for noninferiority). The median (interquartile range) number of in-office follow-ups was 0.50 (0.50-0.63) in RFU and 2.01 (1.93-2.05) in conventional follow-up per patient-year (P<0.001). Insurance claims for follow-ups and directly related diagnostic procedures were 18 800 Yen (16 500-20 700 Yen) in RFU and 21 400 Yen (16 700-25 900 Yen) in conventional follow-up (P<0.001). Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable. CONCLUSIONS: Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01523704.

Major bleeding complications related to combined antithrombotic therapy in atrial fibrillation patients 12 months after coronary artery stenting.

BACKGROUND AND PURPOSE: Many patients with atrial fibrillation (AF) and coronary artery stent deployment are given both antiplatelet drug and warfarin. Little information is available as to the relationship between the antithrombotic therapies in the late phase after stenting and the clinical outcomes of these patients. We examined the clinical outcomes of AF patients 12 months after coronary artery stenting. METHODS: We retrospectively examined 146 patients and classified them into three groups according to the antithrombotic therapies [dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT) plus warfarin, and DAPT plus warfarin] 12 months after stenting. We defined the primary endpoint as Thrombolysis in Myocardial Infarction major bleeding and the secondary endpoint as a composite of adverse events (CAE: all-cause death, nonfatal myocardial infarction, intracranial bleeding, and cerebral infarction). RESULTS: During a median follow-up of 37 months, major bleeding and CAE were observed in 14 (9.6%) and 46 (31.5%) patients, respectively. DAPT plus warfarin was an independent risk factor for major bleeding in a multivariate Cox hazard regression model after adjustment for age, gender, and the type of AF (hazard ratio: 4.20; 95% confidence interval: 1.13-17.27; p=0.033). No significant clinical variables were found for CAE. CONCLUSIONS: Prolonged use of DAPT with warfarin significantly increases the risk of major bleeding in AF patients after coronary artery stenting. Individualized antithrombotic treatment is required in these patients to prevent major bleeding.

Association between clinical outcome and antiarrhythmic treatment in heart failure patients who have atrial fibrillation upon admission to the hospital.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) are associated with significant mortality and morbidity. We sometimes encounter patients who have AF upon admission to the hospital, but it spontaneously converts to sinus rhythm within several days (i.e. converter). PURPOSE: We examined the association between the outcome and types of strategy for AF treatment in converters. METHODS: From January 2000 to December 2005, we identified 95 converters (age 69 ± 12 years) presenting with worsening HF and AF upon admission, in which sinus rhythm was restored within 7 days without either electrical or pharmacological cardioversion. The patients were classified into three groups according to the antiarrhythmic drug (AAD) therapy used: class I AAD, class III AAD, and rate-control drug. The patients were followed for 36 ± 23 months. RESULTS: The left ventricular ejection fraction (LVEF) significantly improved with conversion to sinus rhythm (38 ± 14% vs. 47 ± 13%, p<0.05). Those receiving class I AAD had a trend toward a well-preserved LVEF (50 ± 13%, n=35) as compared to those receiving class III AAD (43 ± 12%, n=24) or rate-control drug (47 ± 14%, n=36). In the patients receiving class I AAD, the rate of all-cause death increased 1.9-fold (p=0.009) compared to those receiving class III AAD, and 1.7-fold (p=0.010) compared to those taking rate-control drug. A hospitalization for HF was observed in 49 (52%) patients, however there was no significant difference in the rate of hospitalization among the three groups (p=0.890). Those receiving rate-control drugs had a 50% lower rate of the development of persistent AF than those taking class III AAD (p=0.019). CONCLUSIONS: A rate-control strategy should be the primary approach for converters to reduce mortality and development of persistent AF.

Prognostic significance of T-wave amplitude in lead aVR in heart failure patients with narrow QRS complexes.

BACKGROUND: Prolonged duration of the QRS complex is a prognostic marker in patients with heart failure (HF), whereas electrocadiographic markers in HF with narrow QRS complex remain unclear. We evaluated the prognostic value of the T-wave amplitude in lead aVR in HF patients with narrow QRS complexes. METHODS: We examined 331 patients who were admitted to our hospital for worsening HF (68 ± 15 years, mean ± standard deviation) from January 2000 to October 2004 who had sinus rhythm and QRS complex <120 ms. The patients were categorized into three groups according to the peak T-wave amplitude from baseline in lead aVR: negative (<-0.1 mV; n = 209, 63%), flat (-0.1-0.1 mV; n = 64, 19%), and positive (>0.1 mV; n = 58, 18%). RESULTS: During a mean follow-up of 33 months, 113 (34%) patients had all-cause death, the primary end point. After adjusting for clinical covariates, flat T wave (hazard ratio [HR] 1.86, 95% confidence interval [CI] 1.42-2.46), and positive T wave (HR 6.76, 95% CI 3.92-11.8) were independent predictors of mortality, when negative T wave was considered a reference. CONCLUSIONS: As the peak T-wave amplitude in lead aVR becomes less negative, there was a progressive increase in mortality. The T wave in lead aVR provides prognostic information for risk stratification in HF patients with narrow QRS complexes.

Prognostic significance of circadian variability of RR and QT intervals and QT dynamicity in patients with chronic heart failure.

BACKGROUND: In patients with chronic heart failure (CHF), circadian variability of RR and QT intervals may be altered because of neurohumoral activation and functional and structural remodeling of the heart. OBJECTIVE: The aim of this study was to evaluate the prognostic significance of circadian variability of the RR and QT intervals and QT dynamicity (QT/RR slope) in CHF patients. METHODS: We prospectively enrolled 121 patients with stable CHF in sinus rhythm (age 67 +/- 14 years, mean +/- SD; range 34 to 87 years). The RR, QT, and rate-corrected QT (QTc) intervals and the QT/RR slope measured from 24-hour Holter electrocardiogram were fitted by cosine curves. RESULTS: During the follow-up period of 34 +/- 17 months, 40 (33%) patients died of cardiac causes, 10 of which were sudden. All patients showed significant circadian rhythms in the RR, QT, and QTc intervals and the QT/RR slope by cosine-curve fitting. In addition to the expected higher heart rate, longer QT interval, and steeper QT/RR slope, we found that patient who died of cardiac causes had reduced circadian variability of QT interval (10 +/- 10 ms vs 21 +/- 13 ms) and a later maximum RR interval (4.1 +/- 0.9 AM vs 2.3 +/- 2.1 AM) compared with survivors, among many other statistically significant circadian parameter differences. These 2 parameters were independent predictors of cardiac death in multivariate Cox proportional hazards regression analysis. CONCLUSION: Circadian variability analyses of Holter-derived RR and QT intervals may provide prognostic information beyond that provided by 24-hour averages of these parameters.

High-sensitivity C-reactive protein is predictive of successful cardioversion for atrial fibrillation and maintenance of sinus rhythm after conversion.

BACKGROUND: Cardioversion for atrial fibrillation (AF) is the most effective treatment for the restoration of sinus rhythm (SR). Recently, an elevated level of hs-CRP has been shown to be associated with AF burden, suggesting that inflammation increases the propensity for persistence of AF. We examined whether the level of high-sensitivity C-reactive protein (hs-CRP) was predictive of the outcome of cardioversion for AF. METHODS AND RESULTS: One hundred and six patients with a history of symptomatic AF lasting > or =1 day (age 63+/-14 years, mean+/-S.D.) underwent cardioversion. Echocardiography and hs-CRP assay were performed immediately prior to cardioversion. SR was restored in 84 patients (79%). By using selected cutoff values, multiple discriminant analysis revealed significant associations between successful cardioversion and a shorter duration of AF (AF duration< or =36 days, odds ratio (OR), 0.98; 95% confidence interval (CI), 0.97-0.99), smaller left atrial diameter (left atrial diameter< or =40 mm, OR 0.82, 95% CI 0.71-0.94), better-preserved left ventricular ejection fraction (left ventricular ejection fraction> or =60%, OR 0.92, 95% CI 0.86-0.99), and lower hs-CRP level (hs-CRP< or =0.12 mg/dL, OR 0.33, 95% CI 0.21-0.51). During a follow-up period of 140+/-144 days, AF recurred in 64 patients (76%). By using a cutoff value of hs-CRP> or =0.06 mg/dL, Cox proportional-hazards regression model found that only hs-CRP level was an independent predictor of AF recurrence (OR 5.30, 95% CI 2.46-11.5) after adjustment for coexisting cardiovascular risks. When patients were divided by the hs-CRP level of 0.06 mg/dL, percentage of maintenance of SR below and above the cutoff was 53% and 4%, respectively (log-rank test, p<0.0001). CONCLUSIONS: hs-CRP level determined prior to cardioversion represents an independent predictor of both successful cardioversion for AF and the maintenance of SR after conversion.