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Aims Use of implantable cardioverter-defibrillators (ICD) for primary prevention of sudden cardiac death (SCD) in heart failure with reduced ejection fraction (HFrEF) is limited. We aimed to investigate barriers to ICD use in HFrEF while considering the predicted risk of mortality and SCD. Method and results Patients from the SwedeHF registered in 2011-2018 and with an indication for primary prevention ICD were analysed. The Seattle Proportional Risk and Seattle Heart Failure Models were used to predict the proportional SCD and all-cause mortality risk, respectively. A multivariable logistic regression model was fitted to identify independent predictors of ICD use/non-use; Cox regression models to evaluate the interaction between predicted SCD/mortality risk and ICD use for mortality. Of 13 475 patients, only 15.5% had an ICD. Those with higher predicted proportional SCD risk (>45%) had an similar to 80% higher likelihood to have an ICD. Other predictors of non-use were follow-up in primary versus specialty care, higher comorbidity burden and lower socioeconomic status. ICD use was associated with lower mortality only in patients with higher predicted SCD and lower mortality risk (34% and 37% relative risk reduction for 3-year all-cause and cardiovascular mortality, respectively). In this subgroup of patients, underuse of ICD was 81.8%. Conclusion In a contemporary registry, only 15.5% of patients with an indication for primary prevention ICD received the device. While a high predicted proportional SCD risk was appropriately linked to ICD use, the lack of specialized follow-up, higher comorbidity burden, and lower socioeconomic status were major unjustified impediments to implementation. Our findings suggest areas for improving ICD use for primary prevention of SCD in clinical practice. Funding Agencies|Boston Scientific; EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking BigData@Heart grant [116074]

Aims The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value. Methods and results The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years. Conclusions The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.

Background Spinal cord stimulation (SCS) reduces sympathetic activity in animal models of heart failure with reduced ejection fraction (HF) but limited data exist of SCS in patients with HF. The aim of the present study was to test the primary hypothesis that SCS reduces cardiac sympathetic nerve activity in HF patients. Secondary hypotheses were that SCS improves left ventricular function and dimension, exercise capacity, and clinical variables relevant to HF. Methods HF patients with a SCS device previously participating in the DEFEAT-HF trial were included in this crossover study with 6-week intervention periods (SCS-ON and SCS-OFF). SCS (50 Hz, 210-μs pulse duration, aiming at T2–T4 segments) was delivered for 12 hours daily. Indices of myocardial sympathetic neuronal function (heart-to-mediastinum ratio, HMR) and activity (washout rate, WR) were assessed using 123I-metaiodobenzylguanidine (MIBG) scintigraphy. Echocardiography, exercise testing, and clinical data collection were also performed. Results We included 13 patients (65.3 ± 8.0 years, nine males) and MIBG scintigraphy data were available in 10. HMR was not different comparing SCS-ON (1.37 ± 0.16) and SCS-OFF (1.41 ± 0.21, P = 0.46). WR was also unchanged comparing SCS-ON (41.5 ± 5.3) and SCS-OFF (39.1 ± 5.8, P = 0.30). Similarly, average New York Heart Association class (2.4 ± 0.5 vs 2.3 ± 0.6, P = 0.34), quality of life score (24 ± 16 vs 24 ± 16, P = 0.94), and left ventricular dimension and function as well as exercise capacity were all unchanged comparing SCS-ON and SCS-OFF. Conclusion In patients with HF, SCS (12 hours daily, targeting the T2–T4 segments of the spinal cord) does not appear to influence cardiac sympathetic neuronal activity or function as assessed by MIBG scintigraphy.

Aims Symptom severity assessed by NYHA functional class and QRS duration are essential criteria for selection of heart failure (HF) patients for CRT. This study assessed the relationship between NYHA class, QRS duration, and survival in a nationwide HF registry. Methods and results We studied 13 423 patients with HF in NYHA class II–IV and LVEF

Background Decompensation is frequent in heart failure (HF) patients and predicts poor prognosis. Hypothesis Volume-overload events in HF patients are preceded by changes in intrathoracic impedance (Z) and body weight (BW); monitoring these parameters may be useful to predict decompensation. Methods Forty-three HF patients (LVEF 25% ± 12%) with a recent HF event and an implantable cardioverter-defibrillator providing daily Z were equipped with telemonitoring scales submitting daily BW. Changes in BW and Z 30 days prior to major (HF hospitalization) and minor (ambulatory adjustment of diuretics) were analyzed. Results During median of 427 days follow-up 25 major and 41 minor events occurred. Z decreased by −4.8 (95% confidence interval [CI]: CI −6.7 to −3.0) and −4.3 (95% CI: −5.5 to −3.2) within 30 days prior to major and minor events respectively (P

Aims Implantable device telemonitoring (DTM) is a diagnostic adjunct to traditional face-to-face hospital visits. Remote device follow-up and earlier diagnoses facilitated by DTM should reduce healthcare utilization. We explored whether DTM reduces healthcare utilization over standard of care (SoC), without compromising patient outcomes. Methods and results This systematic review and meta-analysis of 11 randomized controlled trials on DTM in patients with heart failure consisted of 5702 patients, with a median of 117 [interquartile range (IQR) 76–331] patients per study [age 65 years (IQR 63–67)] and follow-up range of 12–36 months. DTM was associated with a reduction in total number of visits [planned, unplanned, and emergency room (ER)] [relative risk (RR) 0.56; 95% confidence interval (CI) 0.43–0.73, P < 0.001]. Rates of cardiac hospitalizations (RR 0.96; 95% CI 0.82–1.12, P = 0.60) and the composite endpoints of ER, unplanned hospital visits, or hospitalizations (RR 0.99; 95% CI 0.68–1.43, P = 0.96) was similar between the DTM and the SoC groups. An increase in the total number of ER or unscheduled visits (RR 1.37; 95% CI 1.11–1.70, P = 0.004) was observed. This effect was consistent and statistically significant for all studies. Total and cardiac mortality were similar between the groups (DTM RR 0.90; 95% CI 0.69–1.16, P = 0.41; and DTM RR 0.93; 95% CI 0.51–1.69, P = 0.80). Monetary costs favoured DTM (10–55% reduction in five studies). Conclusions Compared with SoC, DTM is associated with a marked reduction in planned hospital visits. In addition, DTM was associated with lower monetary costs, despite a modest increase in unplanned hospital and ER visits. DTM did not compromise survival.

Objective: To establish the diagnostic accuracy of the transesophageal ventriculo-atrial (VA) interval in patients with paroxysmal supraventricular tachycardia (PSVT) and normal baseline electrocardiogram (ECG). Methods: The transesophageal VA interval during tachycardia was recorded in 318 patients (age 45 ± 17 years, 58% female) with PSVT and a normal surface ECG between attacks. Subsequently, all patients underwent an ablation procedure establishing the correct tachycardia diagnosis. Results: AV nodal reentrant tachycardia (AVNRT), AV reentrant tachycardia through a concealed accessory pathway (AVRT), and ectopic atrial tachycardia (EAT) were found in 213, 95, and 10 cases, respectively. Receiver operating characteristic curve analysis identified an optimal cutoff for a binary categorization of AVNRT versus AVRT/EAT at ≤80 ms (area under the curve 0.891). Owing to a biphasic distribution, AVNRT was very likely at VA intervals ≤90 ms with a sensitivity, specificity, and positive predictive value (PPV) of 87%, 91%, and 95%. In the range 91–160 ms the corresponding values for AVRT were 88%, 95%, and 88% (90%, 99%, and 98% in male patients). In the small group with VA intervals >160 ms (n = 29), the diagnosis was less clear (PPV of 67% for AVNRT). Conclusions: In patients with sudden onset regular tachycardia and a normal ECG during sinus rhythm, a transesophageal VA interval of ≤80 ms has the highest diagnostic accuracy to diagnose AVNRT versus AVRT/EAT. Overall, the biphasic distribution of VA intervals suggests considering AVNRT at 90 ms and below and AVRT between 91 and 160 ms (in particular in male patients) while the diagnosis is vague at VA intervals above 160 ms. Ann Noninvasive Electrocardiol 2011;16(4):327–335

Aims To compare haemodynamic responses during the 6-min walk test (6MWT) and daily living activities in heart failure (HF) patients. Methods and results Eighteen HF patients received an implantable haemodynamic monitor, which continuously measured heart rate (HR), estimated pulmonary artery diastolic pressure (ePAD), and several right ventricular (RV) pressure parameters. During the 6MWT, haemodynamics were assessed at rest and peak exercise. Ambulatory values were measured as the daily minimum, maximum, and median, averaged over the 14-day period surrounding each 6MWT. During the 6MWT, HR increased from 71 ± 17 to 101 ± 20 b.p.m. and ePAD from 20 ± 5 to 34 ± 8 mmHg. Daily minimum values were significantly lower and daily maximum values higher compared with rest and peak exercise. Patients with a walked distance above the median (402 m) had lower resting HR (64 ± 10 vs. 77 ± 20, P = 0.001) and ePAD (18 ± 4 vs. 21 ± 7, P = 0.022) compared to patients with walked distances below the median; values at peak exercise were similar. This pattern was also observed during the ambulatory periods. Conclusion Ranges of HR and RV pressures are significantly larger during daily living activities compared with 6MWT in HF patients. Haemodynamic characteristics of patients with greater exercise capacity include lower resting HR and RV pressures and are similar during the 6MWT and daily life.

Aims: To evaluate the long-term clinical outcome and device performance of cardiac resynchronization therapy in a consecutive sample of patients with moderate to severe heart failure. Methods and Results: Between 1998 and 2000, forty consecutive patients with drug-refractory heart failure due to ischemic or idiopathic dilated cardiomyopathy were selected for cardiac resynchronization therapy (CRT). After successful implantation of the coronary sinus lead (n = 35, 88%), patients were followed every sixth month by New York Heart Association (NYHA) functional class, the 6-minute walking test (6´ walk), quality of life (QoL, Minnesota), and pacemaker control. NYHA-class and 6´ walk were significantly improved after 6 months and continued to improve gradually until 36 months of follow-up. The QoL improvement at 6 months was sustained over 3 years. After 3 years, the β-blocker dose could be increased in 10/23 patients as compared to baseline. Nine patients had to be re-operated. Coronary sinus lead thresholds were stable over time. Conclusion: The clinical improvements by CRT are sustained over 3 years of follow-up. In the setting of a University Medical Center, CRT can be applied in clinical routine with excellent clinical outcome, acceptable implantation success, and stable device performance over time.

The health care costs for heart failure are substantial. Studies indicate that hospital treatment constitutes 65-75% of these. The aim of this study was to assess total and heart failure related hospital days as well as safety and efficacy of biventricular pacing in 16 patients with severe heart failure and delayed intraventricular conduction (QRS duration150 ms). They were implanted with a biventricular pacemaker and followed by NYHA class, 6-min walk test and quality of life for a mean of 291+/-76 days. Total number of hospital days and the need for hospitalisations were monitored. Thirteen responders improved by at least one functional class. After 6 months of pacing the 6-min walk test improved from 375+/-83 m to 437+/-73 m (P0.001) and Minnesota Living with Heart Failure quality of life score from 41+/-19 to 24+/-17 (P0.001) compared to baseline. The need for hospital care decreased significantly after biventricular pacing. The total number of hospital days in all patients was 253 the year before compared to 45 the year after biventricular pacing (P0.01). For heart failure related hospital days the corresponding figures were 183 and 39 days, respectively (P0.01). Biventricular pacing improved 13/16 patients with severe heart failure and wide QRS complexes in this open study. The improvement resulted in a reduced need for hospital care.