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AIMS: The objective of this paper is to assess whether cardiac contractility modulation (via the Optimizer System) plus standard of care (SoC) is a cost-effective treatment for people with heart failure [New York Heart Association (NYHA) III, left ventricular ejection fraction of 25-45%, and narrow QRS] compared against SoC alone from the perspective of the English National Health Service. METHODS AND RESULTS: We developed a regression equation-based cost-effectiveness model, using individual patient data from three randomized control trials (FIX-HF-5 Phases 1 and 2, and FIX-HF-5C) to populate the majority of parameters. A series of regression equations predicted NYHA class over time, mortality, all-cause hospitalization rates, and health-related quality of life. We conducted the analysis in line with the National Institute for Health and Care Excellence reference case, modelling costs from an English National Health Service perspective, and considering outcomes in quality-adjusted life years (QALYs) over a patient lifetime perspective. Our base case analysis produced an incremental cost per additional QALY of GBP22 988 (€25 750) when comparing Optimizer + SoC to SoC alone. This result was not sensitive to parameter uncertainty but was sensitive to the time horizon over which costs and QALYs were captured and the duration over which a survival benefit with Optimizer + SoC can be assumed to apply. CONCLUSIONS: Cardiac contractility modulation is likely to be cost-effective in people with heart failure with reduced ejection fraction, NYHA III, and narrow QRS, provided that the treatment benefit can be maintained beyond the duration of the existing clinical trial follow-up. This analysis supports the current recommendations of the European Society of Cardiology that this therapy may be considered for such patients. peerReviewed

BACKGROUND Optimization of cardiac resynchronization therapy (CRT) is often time-consuming and therefore underused in a clinical setting. Novel device-based algorithms aiming to simplify optimization include a dynamic atrioventricular delay (AVD) algorithm (SyncAV, Abbott) and multipoint pacing (MPP, Abbott). This study examines the acute effect of SyncAV and MPP on electrical synchrony in patients with newly and chronically implanted CRT devices. METHODS Patients with SyncAV and MPP enabled devices were prospectively enrolled during implant or scheduled follow-up. Blinded 12-lead electrocardiographic acute measurements of QRS duration (QRSd) were performed for intrinsic QRSd (Intrinsic), bi-ventricular pacing (BiV), MPP, BiV with SyncAV at default offset 50 ms (BiVSyncAVdef ), BiV with SyncAV at patient-specific optimised offset (BiVSyncAVopt ), MPP with SyncAV at default offset 50 ms (MPPSyncAVdef ), and MPP with SyncAV at patient-specific optimised offset (MPPSyncAVopt ). RESULTS Thirty-three patients were enrolled. QRSd for Intrinsic, BiV, MPP, BiVSyncAVdef , BiVSyncAVopt , MPPSyncAVdef , MPPSyncAVopt were 160.4 ± 20.6 ms, 141.0 ± 20.5 ms, 130.2 ± 17.2 ms, 121.7 ± 20.9 ms, 117.0 ± 19.0 ms, 121.2 ± 17.1 ms, 108.7 ± 16.5 ms respectively. MPPSyncAVopt led to greatest reduction of QRSd relative to Intrinsic (-31.6 ± 11.1%; p

Multipoint pacing [Multipoint™ Pacing (MPP), Abbott] via a single left ventricular lead (Quartet™ LV lead, Abbott) improves acute left ventricular (LV) function and response to cardiac resynchronization therapy (CRT). Aim of this study was to examine additional benefits in terms of LV reverse remodeling and CRT response by activating MPP in responders and non-responders to conventional biventricular pacing (CONV). 43 consecutive patients receiving CRT (Quadra Assura MP™, Abbott) received LV dP/dtmax optimized CONV programming for 6 months. MPP programming with large anatomical electrode separation (> 30 mm) and basal LV1 pacing location was activated afterwards. Echocardiographic and clinical parameters were obtained at baseline, 6- and 12-month follow-up (FU). The response was defined as an improvement of LVESV ≥ 15% and super-response as improvement ≥ 30% relative to baseline. 41 patients completed FU (one died of non-cardiac cause and one was lost to FU) and after 6 months CONV, 26 patients (63%) were classified as CRT responders. With MPP, the response rate increased to 90% (p

Background:Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective.Methods:This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed.Results:In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively.Conclusion:Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.

Introduction The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. Methods Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. Results Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. Conclusions This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.

The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR.Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed.Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months.TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.

ObjectiveIn implantable cardiac defibrillators (ICDs), long-detection times safely reduce unnecessary and inappropriate therapies. We aimed to evaluate ICD treatment of ventricular arrhythmias in women, compared with men, also taking into account ICD detection.MethodsThe Advance III trial randomised patients implanted with an ICD for primary or secondary prevention in two arms—long and nominal ventricular arrhythmias detection times before therapy delivering (number of intervals needed to detect (NID) 30/40 and 18/24, respectively). The main endpoint of this post hoc analysis was the incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models.ResultsOverall, 1902 patients (304 women, 65±11 years) were randomised. Women showed a lower risk of ICD therapy (HR 0.63, 95% CI 0.43 to 0.93, p=0.022); this difference was observed only in the long-detection arm (HR 0.37, p=0.013) and not in the short detection arm (HR 0.82, p=0.414). No significant sex differences were observed concerning inappropriate therapies and mortality rate. Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).ConclusionsIn patients with ICDs, the strategy of setting a long-detection time to treat ventricular arrhythmias (NID 30/40) reduces overall delivered therapies, both in women and men, when compared with nominal setting (NID 18/24). The reduction was significantly higher in women. Overall, women were less likely to experience ICD therapies than men; this result was only observed in the long-detection arm.Clinical trial registrationNCT00617175.

Aims A long-detection interval (LDI) (30/40 intervals) has been proved to be superior to a standard-detection interval (SDI) (18/24 intervals) in terms of reducing unnecessary implantable cardioverter defibrillator (ICD) therapies. To better evaluate the different impact of LDI and anti-tachycardia pacing (ATP) on reducing painful shocks, we assessed all treated episodes in the ADVANCE III trial. Methods and results A total of 452 fast (200 ms < cycle length ≤ 320 ms) arrhythmic episodes were recorded: 284 in 138 patients in the SDI arm and 168 in 82 patients in the LDI arm (106/452 inappropriate detections). A total of 346 fast ventricular tachycardias (FVT) were detected in 169 patients: 208 in 105 patients with SDI and 138 in 64 patients with LDI. Setting LDI determined a significant reduction in appropriate but unnecessary therapies [208 in SDI vs. 138 in LDI; incidence rate ratio (IRR): 0.61 (95% CI 0.45–0.83), P = 0.002]. Anti-tachycardia pacing determined another 52% reduction in unnecessary shocks [208 in SDI with hypothetical shock-only programming vs. 66 in LDI with ATP; IRR: 0.37 (95% CI 0.25–0.53, P < 0.001)]. The efficacy of ATP in terminating FVT was 63% in SDI and 52% in LDI ( P = 0.022). No difference in the safety profile (acceleration/degeneration and death/cardiovascular hospitalizations) was observed between the two groups. Conclusion The combination of LDI and ATP during charging is extremely effective and significantly reduces appropriate but unnecessary therapies. The use of LDI alone yielded a 39% reduction in appropriate but unnecessary therapies; ATP on top of LDI determined another 52% reduction in unnecessary shocks. The strategy of associating ATP and LDI could be considered in the majority of ICD recipients.

Aims Cardiac Contractility Modulation (CCM) is a treatment for heart failure based on electrical signals applied during the absolute refractory period. CCM improves myocardial molecular and biochemical characteristics of heart failure and improves exercise tolerance and quality of life. However, the long term impact on survival has not been described. Methods and results Survival was determined retrospectively from a cohort of 68 consecutive heart failure cases with NYHA II or III symptoms and QRS duration ≤130ms, implanted with a CCM device between May 2002 and July 2013 in either Bochum or Ludenscheid, Germany. Results were compared with predicted survival (Seattle Heart Failure Model; SHFM) pre-implant for each patient. Mean follow-up was 4.5years (range 0.25–10.3years). Baseline characteristics were as follows: mean age 61years, 88% male, 68% with ischemic heart disease, 78% with an ICD, mean NYHA class 2.9±0.3, LVEF 26%±6% (range 15–40%) and mean QRS duration 106±11ms. Mortality rates (Kaplan–Meier analysis) at 1-, 2- and 5-years were lower with CCM than predicted by SHFM for the cohort (0% with CCM vs. 6.1% per SHFM, 3.5% vs. 11.8%, and 14.2% vs. 27.7%, respectively, p=0.007). Conclusions Long-term mortality rates in heart failure patients with NYHA (II–III) and QRS≤130ms are lower when treated by CCM than predicted for the cohort. These findings warrant substantiation in a prospective study.

Background: Persons of lower socio-economic status are at higher risk of disease, especially with respect to severe and chronic illnesses. To date, there have not been any studies with large case numbers regarding acute medical emergencies in this population. Methods: In a retrospective study, data were obtained on all cases treated by emergency physicians in Bochum, Germany, in 2014/2015, including the diagnoses that were made by the emergency physicians. There were a total of 16 767 cases. The local unemployment rate was taken as an indicator of the socioeconomic situation of a neighborhood; it was defined as the percentage of registered unemployed persons among persons aged 15 to 64 with their domicile in the neighborhood. 12 168 cases were grouped by emergency medical diagnosis and analyzed with respect to the three most heavily represented diagnostic categories (cardiovascular, neurological, and pulmonary emergencies), which accounted for nearly two-thirds of all diagnoses. Results: The overall rates of deployment involving emergency physicians were found to be positively correlated with the unemployment rate. After adjustment for age, sex, and possible confounders, this correlation was statistically significant (p

Background The survival of in-hospital cardiac arrest (8–25%) has not changed substantially in the past. Until now, most hospitals in Germany had no standardized protocols available for a course of action in case of emergency, and there are no continuous registry data for in-hospital cardiac arrest and survival. Objective Our aim was to improve survival and receive outcomes data, so we implemented a structured hospital-wide automated first-responder system in the hospital. Here our 5-year experience with 443 emergency calls is outlined. Methods Throughout the hospital, 15 automated external defibrillator (AED) “access spots,” which can be easily reached within 30 s, were identified. AEDs were then installed at these locations (Lifepak 500 and Lifepak 1000, Medtronic equipped with a Biolog 3000i portable ECG monitor). At the same time, a training program was initiated in which the employees of the hospital participated once a year. Participants learned how to apply and activate an AED in case of cardiac arrest even before the designated Cardiac Arrest Team arrived at the scene. Results A witnessed cardiac arrest event was confirmed in 126 cases. In 56 of the 126 cases, the primary arrest rhythm was either ventricular tachycardia or ventricular fibrillation and the AED delivered a shock. In this group, spontaneous circulation was reached in 44 cases (79%) and 23 patients (41%) were discharged. In 44% (24 from 55 patients) of the cases, a shock was recommended by AED and delivered by the first responders before the rescue team arrived. Conclusions The first-responder AED program successfully gave training lessons to the hospital staff. The training included how to initiate the cardiac arrest call, how to use the AED, and how to start immediate resuscitation. As a result, a higher survival rate after in-hospital cardiac arrest can be accomplished.

Aims Right ventricular (RV) septum is a non-apical site targeted during lead implantation. Electrocardiographic (ECG) recognition of mid-septal lead location is challenging. The aim of the study is to determine ECG correlates of RV mid-septal pacing. Methods and results The present study is a pre-specified analysis of a prospective, multicenter study, which randomized recipients of an implantable cardioverter defibrillator to an apical vs. mid-septal RV lead positioning. Following implantation, a 12-lead ECG was recorded during intrinsic rhythm and RV pacing. In total, 227 patients, 121 in the apical group (76.9% males, 67.1 ± 11.3 years) and 106 in the mid-septal group (82.1% males, age 64.7 ± 12.7 years) were included. Apically as compared with septally paced patients had significantly longer paced QRS duration (177.0 ± 25.0 vs. 170.4 ± 21.7, respectively, P = 0.03) and significantly more leftward paced QRS axis (−71.6 ± 33.3° vs. 9.4 ± 86.5°, respectively, P < 0.001). A significantly higher proportion of patients in the mid-septal as compared with the apical group displayed predominantly positive QRS in lead V6 (62.3 vs. 4.1%, P < 0.001), predominantly positive QRS in any of the inferior leads (53.8 vs. 4.1%, P < 0.001), and a QR pattern in lead aVL (53.3 vs. 3.3%, P < 0.001). These ECG correlates were incorporated in a stepwise algorithm with total sensitivity of 87% and specificity of 90% for the identification of a mid-septal lead location. Conclusion A mid-septal lead location may be identified using a simple stepwise algorithm, based on the presence of positive QRS in lead V6, positive QRS in any of the inferior leads, and a QR pattern in lead aVL.

Background Left bundle branch block (LBBB) and QT prolongation both are associated with a worse prognosis. LBBB lengthens the QT interval. To date it is not known whether QT prolongation during LBBB differs in repolarization from QT prolongation during narrow QRS. Objective The purpose of the present proof-of-concept-study was to develop a formula that allows comparison of the adjusted QT interval during LBBB with reference values and thereby allows interpretation of the QT interval irrespective of QRS widening. Methods Sixty consecutive patients with sinus rhythm (SR) and narrow QRS underwent electrophysiologic study for ablation. In all patients, the intrinsic QRS ,QT, and JT times were measured during SR, and ventricular pacing from both the right ventricular apex (RVA) and the right ventricular outflow tract (RVOT) caused LBBB. We determined prolongation of the QT during as compared to SR (ΔQT). ΔQT was then divided by the QRS length during pacing QRS (QRSb). This describes the percentage of the QRS duration at LBBB, which must be subtracted from the measured QT (QTb) to determine the modified QT interval (QTm). Results The ratio of ΔQT to paced QRS was calculated as 48.3% (RVA) and 48.8% (RVOT) (mean 48.5%). The ratio intrinsic of JTi to paced JT was 1.0055 (RVA) and 1.0087 (RVOT). There was no significant difference in intrinsic JT vs paced JT (P = .2). Conclusion Right ventricular pacing causes prolongation of the QT due to a paced LBBB without prolongation of the JT time. In our study, we showed that QT prolongation caused by LBBB constitutes 48.5% of the QRS width. This is the value that must be subtracted from the measured QT in LBBB in order to estimate the modified QT. Thus, the resulting formula for "modified QT" estimation in LBBB is QTm=QTb – 48.5% * (QRSb).

Electrocardiographic (ECG) identification of prior myocardial infarction (MI) during right ventricular (RV) pacing is of clinical importance. Proposed ECG criteria have been evaluated only during apical pacing. We evaluated the effect of pacing site on the predictive performance of ECG signs of prior MI.The present study is a secondary analysis of a prospective, multicenter study which randomized recipients of an implantable cardioverter defibrillator to an apical versus septal RV lead positioning. ECGs of patients with or without prior MI were analyzed for the presence of the following criteria: Cabrera sign, Chapman sign, QR pattern in leads I, aVL, V5 or V6, QR in inferior leads and notching in the descending slope of the QRS complex in inferior leads.The MI group included 89 patients (55.1% apically paced), while 99 patients had no prior MI (50.5% apically paced). In the total population, the Cabrera sign presented the highest specificity (97%) and diagnostic accuracy (62.2%), with a sensitivity of 23.6%. The Cabrera sign was the only significant predictor of a prior MI [OR=9.9, (95%CI:2.8-34.5), p0.001], among all ECG markers. Pacing site did not significantly influence the sensitivity and specificity of the Cabrera sign for detection of prior MI.In our study, the Cabrera sign was the only ECG marker that predicted the presence of prior MI during ventricular paced rhythm. Septal RV lead positioning did not affect the predictive performance of the Cabrera sign.

Acute treatment of in-hospital cardiac arrest (IHCA) is challenging and overall survival rates are low. However, data on the use of public-access automated external defibrillators (AEDs) for IHCA remain controversial. The aim of our study was to evaluate characteristics of patients experiencing IHCA and feasibility of public-access AED use for resuscitation in a university hospital.IHCA events outside the intensive care unit were analysed over a period of 21 months. Patients' characteristics, AED performance, return of spontaneous circulation (ROSC) and 24 h survival were evaluated. Outcomes following adequate and inadequate AED use were compared.During the study period, 59 IHCAs occurred. AED was used in 28 (47.5%) of the cases. However, AED was adequately used in only 42.8% of total AED cases. AED use was not associated with an increased survival rate (12.9 vs. 10.7%, p = 0.8) compared to non-AED use. However, adequate AED use was associated with a higher survival rate (25 vs. 0%, p = 0.034) compared to inadequate AED use. Time from emergency call to application of AED3 min was the most important factor of inadequate AED use. Adequate AED use was more often observed between 7:30 and 13:30 and in the internal medicine department.AEDs were applied in less than 50% of the IHCA events. Furthermore, AED use was inadequate in the majority of the cases. Since adequate AED use is associated with improved survival, AEDs should be available in hospital areas with patients at high risk of shockable rhythm.HINTERGRUND: Im Fall eines innerklinischen Herzstillstands (IHCA) sind die Gesamtüberlebensraten niedrig und die Daten zur Verwendung von öffentlich zugänglichen automatischen externen Defibrillatoren (AED) im Fall eines IHCA weiter kontrovers. Das Ziel unserer Studie war es, die Charakteristika von Patienten mit IHCA und die Durchführbarkeit von öffentlichen zugänglichen AED-Anwendungen zur Wiederbelebung außerhalb der Intensivstation in einem Universitätsklinikum zu evaluieren.In einen Zeitraum von 21 Monaten wurden alle IHCA analysiert und die AED-Anwendung (unterschieden in adäquate und inadäquate AED-Anwendung), das Erreichen eines Kreislaufs (ROSC) und das 24 h-Überleben evaluiert.Während des Untersuchungszeitraums traten 59 IHCA auf. AED wurde in 28 Fällen (47,5 %) eingesetzt. Der AED wurde jedoch nur in 42,8 % der gesamten AED-Fälle angemessen eingesetzt. Die AED-Anwendung war nicht mit einer erhöhten Überlebensrate (12,9 vs. 10,7 %, p = 0,8) im Vergleich zur Nicht-AED-Anwendung verbunden. Eine adäquate AED-Anwendung war im Vergleich zu einer inadäquaten AED-Anwendung mit einer höheren Überlebensrate verbunden (25 vs. 0 %, p = 0,034). Eine adäquate AED-Anwendung wurde häufiger zwischen 07.30 Uhr und 13.30 Uhr und in Abteilungen der inneren Medizin beobachtet. Die inadäquate AED-Anwendung war gehäuft mit einer Zeit von3 min zwischen Notruf und AED-Anwendung assoziiert.AED wurden in weniger als 50 % der IHCA angewendet. Außerdem war die Verwendung von AED in der Mehrzahl der Fälle inadäquat. Da allerdings eine adäquate AED-Anwendung mit einem verbesserten Überleben verbunden ist, sollten AED in Krankenhausbereichen mit Patienten mit einem hohen Risiko für einen schockbaren Rhythmus vorgehalten werden. Kriterien, die diese Bereiche charakterisieren und damit die Wahrscheinlichkeit einer adäquaten AED-Nutzung erhöhen, müssen durch weitere Untersuchungen evaluiert werden.

This study sought to evaluate the effects of programming a long detection in single-chamber (VVI) implantable cardioverter-defibrillators (ICDs) in the multicenter prospective ADVANCE III (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III) trial.Programming strategies may reduce unnecessary ICD shocks and their adverse effects but to date have been described only for dual-chamber ICDs.A total of 545 subjects (85% male; atrial fibrillation 25%, left ventricular ejection fraction 31%, ischemic etiology 68%, secondary prevention indications 32%) receiving a VVI ICD were randomized to long detection (30 of 40 intervals) or standard programming (18 of 24 intervals) based on device type, atrial fibrillation history, and indication. In both arms, antitachycardia pacing (ATP) therapy during charging was programmed for episodes with cycle length 320 to 200 ms and shock only for cycle length 200 ms. Wavelet and stability functions enabled. Therapies delivered were compared using a negative binomial regression model.A total of 267 patients were randomized to long detection and 278 to the control group. Median follow-up was 12 months. One hundred twelve therapies (shocks and ATP) occurred in the long detection arm versus 257 in the control arm, for a 48% reduction with 30 of 40 intervals (95% confidence interval [CI]: 0.36 to 0.76; p = 0.002). In the long detection arm, overall shocks were reduced by 40% compared to the control arm (48 vs. 24; 95% CI: 0.38 to 0.94; p = 0.026) and appropriate shocks by 51% (34 vs. 74; 95% CI: 0.26 to 0.94; p = 0.033). Syncopal events did not differ between arms, but survival improved in the long detection arm.Among patients implanted with a VVI ICD, programming with the long detection interval significantly reduced appropriate therapies, shocks, and all-cause mortality. (Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III [ADVANCEIII]; NCT00617175).

Background Detrimental effects of right ventricular (RV) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum. As safety data are scarce for implantable cardioverter defibrillator (ICD) recipients the study aims to evaluate ICD lead performance in the mid-septal position. Methods and results A total of 299 ICD recipients (79% male, aged 65.2±12.1years, 83% primary prevention of sudden cardiac death) were randomized to receive the RV ICD electrode either in a mid-septal (n=145) or apical (n=154) location. Event-free survival was evaluated at 3 (primary endpoint) and 12months (secondary endpoint). Events included a composite of lead revision, suboptimal right ventricular electrode performance (including defibrillation thresholds (DFT)>25J) or lead position not in accordance with randomized location. Event-free survival at 3 (12) months was observed in 80.6% (72.3%) of patients randomized to a mid-septal and in 82.2% (72.1%) of patients randomized to an apical lead position, p=0.726 (p=0.969). Pre-defined margins for non-inferiority were not reached at 3 or 12months. High DFT was found in 7 patients (5.0%) of the mid-septal and in 3 (2.2%) patients of the apical group (p=0.209). Conclusion In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision, suboptimal right ventricular electrode performance or non-randomized lead position. Non-inferiority of the mid-septal lead location cannot be concluded. This should be taken into consideration when a mid-septal lead position is pursued. Clinical trial registration ClinicalTrials.gov identifier NCT00745745.

Cardiac contractility modulation (CCM) is an electrical stimulation treatment for symptomatic heart failure (HF) patients. The procedure involves implantation of two ventricular leads for delivery of CCM impulses. The purpose of this study is to compare the efficacy and safety of CCM when the signal is delivered through one vs. two ventricular leads.This prospective blinded randomized trial enrolled 48 patients. Eligible subjects had symptoms despite optimal HF medications, left ventricular ejection fraction40% and peakVOFollowing 6 months, similar and significant (p0.05) improvements from baseline in NYHA (-0.7±0.5 vs. -0.9±0.7) and MLWHFQ (-14±20 vs. -16±22) were observed in Group A and in Group B. PeakVOThe efficacy and safety of CCM in this study were similar when the signal was delivered through either one or two ventricular leads. These results support the potential use of a single ventricular lead for delivery of CCM.

Aims Cardiac resynchronization therapy (CRT) requires effective left ventricular (LV) pacing (i.e. sufficient energy and appropriate timing to capture). The AdaptivCRT™ (aCRT) algorithm serves to maintain ventricular fusion during LV or biventricular pacing. This function was tested by comparing the morphological consistency of ventricular depolarizations and percentage effective LV pacing in CRT patients randomized to aCRT vs. echo-optimization. Methods and results Continuous recordings (≥20 h) of unipolar LV electrograms from aCRT ( n = 38) and echo-optimized patients ( n = 22) were analysed. Morphological consistency was determined by the correlation coefficient between each beat and a template beat. Effective LV pacing of paced beats was assessed by algorithmic analysis of negative initial EGM deflection in each evoked response. The %CRT pacing delivered, %effective LV pacing (i.e. % of paced beats with effective LV pacing), and overall %effective CRT (i.e. product of %CRT pacing and %effective LV pacing) were compared between aCRT and echo-optimized patients. Demographics were similar between groups. The mean correlation coefficient between individual beats and template was greater for aCRT (0.96 ± 0.03 vs. 0.91 ± 0.13, P = 0.07). Although %CRT pacing was similar for aCRT and echo-optimized (median 97.4 vs. 98.6%, P = 0.14), %effective LV pacing was larger for aCRT [99.6%, (99.1%, 99.9%) vs. 94.3%, (24.3%, 99.8%), P =0.03]. For aCRT vs. echo-optimized groups, the proportions of patients with ≥90% effective LV pacing was 92 vs. 55% ( P = 0.002), and with ≥90% effective CRT was 79 vs. 45%, respectively ( P = 0.018). Conclusion AdaptivCRT™ significantly increased effective LV pacing over echo-optimized CRT.

AB Purpose: Maternal obesity is known to predispose the offspring to impaired glucose metabolism and obesity associated with low-grade inflammation and hypothalamic dysfunction. Because preventive approaches in this context are missing to date, we aimed to identify molecular mechanisms in the offspring that are affected by maternal exercise during pregnancy. Methods: Diet-induced obese mouse dams were divided into a sedentary obese (high-fat diet [HFD]) group and an obese intervention (HFD-running intervention [RUN]) group, which performed voluntary wheel running throughout gestation. Male offspring were compared with the offspring of a sedentary lean control group at postnatal day 21. Results: HFD and HFD-RUN offspring showed increased body weight and white adipose tissue mass. Glucose tolerance testing showed mild impairment only in HFD offspring. Serum interleukin-6 (IL-6) levels, hypothalamic and white adipose tissue IL-6 gene expressions, and phosphorylation of signal transducer and activator of transcription 3 in HFD offspring were significantly increased, whereas HFD-RUN was protected against these changes. The altered hypothalamic global gene expression in HFD offspring showed partial normalization in HFD-RUN offspring, especially with respect to IL-6 action. Conclusion: Maternal exercise in obese pregnancies effectively reduces IL-6 trans-signaling and might be the underlying mechanism for the amelioration of glucose metabolism at postnatal day 21 independent of body composition.

Right bundle branch block (RBBB) configuration is an unexpected finding during right ventricular (RV) pacing that raises the suspicion of inadvertent left ventricular lead positioning. The aim of this study was to evaluate the prevalence of paced RBBB pattern in relation to RV lead location. This is a secondary analysis of a prospective, multicenter study, which randomized implantable cardioverter defibrillator recipients to an apical versus midseptal defibrillator lead positioning. A 12-lead electrocardiogram was recorded during intrinsic rhythm and RV pacing. Paced RBBB-like pattern was defined as positive (0.05 mV) net amplitude of QRS complex in leads V1 and/or V2. In total, 226 patients (65.6 ± 12.0 years, 20.8% women, 53.1% apical site) were included in the study. The prevalence of paced RBBB pattern in the total population was 15.5%. A significantly lower percentage of patients in the midseptal group demonstrated RBBB-type configuration during RV pacing compared with the apical group (1.9% vs 27.5%, p0.001). Baseline RBBB, prolonged QRS duration during intrinsic rhythm, and reduced ejection fraction were not associated with increased likelihood of paced RBBB. In the subgroup of patients with RBBB type during pacing, 91.4% of patients had a paced QRS axis from -30° to -90°, whereas 100% of patients displayed a negative QRS vector at lead V3. In conclusion, RBBB configuration is encountered in a considerable percentage of device recipients during uncomplicated RV pacing. Midseptal lead positioning is associated with significantly lower likelihood of paced RBBB pattern compared with apical location.

Background: Cardiac contractility modulation (CCM) signals are non-excitatory electrical signals delivered during the absolute refractory period intended to improve contraction and cardiac function. Clinical trials have shown that CCM treatment significantly improves exercise tolerance and quality of life in symptomatic heart failure patients. Studies with CCM therapy typically include CCM delivery for 3, 5 or 7 h per day, although other configurations are also commonly used. Each has been associated with improved outcomes in heart failure, but it is not clear whether different application durations are associated with the various degrees of benefit. The purpose of the current pilot evaluation study was to evaluate the quality of life, exercise tolerance, and cardiac function, over a 6-month period when CCM was delivered for 5 h/day vs. 12 h/day. Increasing the daily CCM therapy duration is safe and as good as the standard CCM periods of application per day. Methods: This single center pilot evaluation study involved 19 medically refractory symptomatic patients with heart failure and reduced left ventricular function who underwent implantation of an Optimizer™ system (Impulse Dynamics, Orangeburg, NY, USA). Patients were randomized into one of two treatment groups; 5 h/day CCM treatment or 12 h/day CCM treatment. Subjects and evaluating physicians were blinded to the study group. Subjects returned to the hospital after 12 and 24 weeks. Efficacy evaluations included changes from baseline to 24 weeks in Minnesota Living With Heart Failure Questionnaire score (MLWHFQ), maximal oxygen consumption in the cardio-pulmonary stress test (peak VO2), New York Heart Association classification (NYHA), 6-min walk distance (6MWD), and ejection fraction (EF). Results: At the end of 24 weeks, clinical improvement was observed in the entire cohort in all efficacy measures (mean change from baseline of –17.1 in MLWHFQ, –0.86 in NYHA, and improvement trend of 1.48 mL O2/kg/min in peak VO2, 31.3 m in 6MWD, and 2.25% in EF). There were no significant differences, either clinically or statistically, between the groups receiving CCM for 5 h/day vs. 12 h/day. Three subjects were voluntarily withdrawn before completing the study. One subject died from pneumonia after 125 days, and 6 serious adverse events were reported, none of which was classified as related to either the device or the procedure. Conclusions: Together with previously reported experience with CCM, delivery of CCM therapy is equally safe and appears similarly effective over the range of shorter (5 h) to longer (12 h) daily periods of application. Given the small sample size, further studies are warranted.

The impact of right ventricular (RV) lead location on clinical end points in patients undergoing cardiac resynchronization therapy (CRT) is unclear. We evaluated the impact of different RV lead locations on clinical outcome in CRT patients enrolled in the Septal Positioning of ventricular implantable cardioverter-defibrillator (ICD) Electrodes (SPICE) trial, which randomized recipients of implantable cardioverter defibrillators to apical versus midseptal RV lead positioning.Ninety-eight CRT recipients were included in the multicenter SPICE trial and followed for 12 months: Fifty-three patients were randomized to receive an apical (A) and 45 to receive a midseptal (S) lead position. We compared echocardiographical and electrocardiographical parameters and outcome.Echocardiographic response with respect to improvement of left ventricular ejection fraction (A: +15.8 ± 14.6%, S: +9.7 ± 12.6%, P = 0.156) and reduction of left ventricular end-diastolic diameter (A: -4.2 ± 10.7 mm, S: -7.5 ± 10.7 mm, P = 0.141) was comparable in apical and midseptal groups. Paced QRS width neither differed at prehospital discharge (A: 129 ± 21 ms, S: 135 ± 21 ms, P = 0.133) nor at 12-month follow-up (A: 131 ± 23 ms, S: 134 ± 28 ms, P = 0.620). No differences were found with respect to the risk of ventricular tachyarrhythmia or ICD therapy. Septal RV lead position, however, was associated with a significant longer time to a first heart failure event (P = 0.040) and a longer survival time (P = 0.019).In CRT recipients, midseptal RV lead position was not superior with respect to improvement of echocardiographic parameters or paced QRS width. It did not predispose to ventricular arrhythmias or ICD therapy. The finding that midseptal lead position was associated with a longer time to first heart failure event and a longer survival time deserves further investigation.

The aim of this prospective study was to determine the impact of plasma B-type natriuretic peptide (BNP) on long-term outcome in patients undergoing transcatheter aortic valve implantation (TAVI).TAVI was performed either transfemorally or transaxillary using either the CoreValve prosthesis or Edwards SAPIEN prosthesis in 226 patients with symptomatic severe aortic valve stenosis and at high surgical risk. The examinations included measurements of plasma BNP and echocardiography before and at 30 days after TAVI. The primary study end-point was death from any cause after TAVI; the secondary end-point was defined as cardiovascular death.During a mean follow up of 728 ± 549 days, 72 patients died; 52 deaths were cardiovascular-related. Those patients who died had higher preprocedural plasma BNP levels compared to those who survived (1,305 ± 1,238 pg/ml versus 716 ± 954 pg/ml; p0.001). Plasma BNP was the strongest independent predictor of all-cause mortality (BNP475 pg/ml, hazard risk [HR] 3.049; 95% confidence interval [CI] 1.804-5.151; p0.001) and cardiovascular mortality (BNP475 pg/ml, HR 3.479; 95% CI 1.817-6.662; p0.001). In surviving patients, plasma BNP levels were decreased by 30 days after TAVI (pre-TAVI 874 ± 1,122 pg/ml; post TAVI 471 ± 569 pg/ml; p0.001). A plasma BNP level328 pg/ml at 30 days postoperatively was also associated with all-cause mortality (HR 8.125; 95% CI 3.097-21.318; p0.001).In patients undergoing TAVI, plasma BNP is the strongest independent predictor of all-cause mortality and cardiovascular mortality. Plasma BNP levels at 30 days after TAVI may provide prognostic information that should, potentially, lead to a more intensive therapy of these patients.

The cardio-circulatory system of chronotropic incompetent patients is unable to adapt heart rate adequately to the level of strain. A common therapy is the implantation of a pacemaker that stimulates the heart at a rate derived from a strain related sensor signal. The paper describes a new pacemaker concept that uses a well-defined time interval in the electrogram as a sensor parameter, the atrioventricular conduction time (AVCT). Identification experiments with patients delivered the stationary and dynamic behaviour of AVCT subject to variations in the exercise rate and the pacing frequency. Furthermore, it was demonstrated that AVCT is perturbed by respiratory activity. The new rate-responsive algorithm, which uses the internal model control principle, explicitly takes into account the closed-loop nature of the underlying system. The major design objectives were: extended range of the individual heart rate; effective attenuation of the respiratory-related disturbance; and stability. Seven patients undergoing incremental exercise were paced with this AVCT-based algorithm. The experiments confirmed the suitability of this concept with respect to the design goals. The patients' peak intrinsic heart rate at exercise was 100 +/- 20min(-1). When paced with the AVCT algorithm, the paced heart rate was 126 +/- 12min(-1). The increase was significant (26 +/- 13min(-1); 15 to 53 min(-1)), which clearly demonstrated the potential of this concept to restore chronotropic competence.

Background— Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator (ICD) therapy in primary prevention patients. Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) was the only trial that enrolled both primary and secondary prevention patients. Methods and Results— Of the 1902 patients enrolled in the ADVANCE III trial, 477 received a defibrillator for secondary prevention; 248 patients were randomly assigned to a long detection setting (30 of 40 intervals) and 229 to the nominal setting (18 of 24 intervals) for ventricular arrhythmias with cycle length ≤320 ms. Eight-five percent of patients were men, with a mean age of 65±12 years, a previous history of ventricular fibrillation in 37% of the cases, and a mean ejection fraction of 38±13%. The ICD device mix was 37% single chamber, 47% dual chamber, and 16% triple chamber. Over a median period of 12 months, the long detection period was associated with a 25% reduction in the number of overall therapies (115.6 versus 86.8 per 100 patient-years; incidence rate ratio, 0.75; 95% confidence interval, 0.61–0.93; P =0.008) and a 34% reduction in the number of shocks (rate per 100 patient-years, 51.2 versus 38.1; incidence rate ratio, 0.66; 95% confidence interval, 0.48–0.89; P =0.007). Appropriate therapies (89.7 versus 67.7; incidence rate ratio, 0.77; 95% confidence interval, 0.60–0.97; P =0.029) and appropriate shocks (37.1 versus 28.1; incidence rate ratio, 0.64; 95% confidence interval, 0.45–0.93; P =0.018) were also reduced. Conclusions— ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients. These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging. Clinical Trial Registration— URL: http://www/clinicaltrials.gov . Unique identifier: NCT00617175.

There is little known about the long-term results of the CoreValve prosthesis. The aim of this study was to assess the 3-year clinical and hemodynamic outcomes of the CoreValve prosthesis. One hundred fifty consecutive patients with severe aortic stenosis successfully underwent transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. The primary study end point was death from any cause after TAVI. The secondary end points were defined as (1) cardiovascular death and (2) prosthesis-related mortality and morbidity. At 1 to 3 years, all-cause mortality rates were 25%, 32%, and 41%, respectively, and cardiovascular mortality rates were 14%, 21%, and 27%, respectively. Before TAVI, 95% of patients were in New York Heart Association class III or IV. Of the surviving patients, rates of New York Heart Association class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively. There was an annual decrease of the valve area of approximately 0.1 cm². Aortic restenosis occurred in 2 patients. Moderate or severe aortic regurgitation (AR) occurred in 15% of patients immediately after TAVI. Twenty patients (13%) had a slight worsening of AR within 3 years. New severe AR did not occur. The incidence of prosthesis-related endocarditis was 0.66% per year. Overall, 7 patients (incidence of 1.5% per year) had a clinically relevant problem of the prosthesis. In conclusion, TAVI with the CoreValve prosthesis had favorable effects on symptoms and outcomes even after 3 years. These results are clouded by side effects, such as AR and prosthesis-related mortality and morbidity.

Background Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatment of late-life depression (GermanIMPACT trial) in the German primary care context. GermanIMPACT was developed as an adaptation of a successful and widely used American model. The aim of the study is to evaluate the model’s applicability to the German primary care setting and its cost-effectiveness. Methods/Design The study will be conducted as a cluster-randomized controlled trial comparing the development of depressive symptoms in primary care patients who either receive treatment as usual (control arm) or treatment according to the GermanIMPACT model (intervention arm). In two German cities (Freiburg and Hamburg), a total of 60 general practice offices will be selected and randomized. Each general practice office will be asked to enroll five patients into the trial who are 60 years of age or older and who show moderate depressive symptoms in the scope of a diagnosed depressive episode, recurrent depressive disorder, or dysthymia. General practices in the control arm will provide treatment as usual; general practices in the intervention arm will work closely with a specially trained care manager and a supervising mental health specialist. Evidence-based elements of the treatment plan manual include patient education, identification and integration of positive activities into the daily routine, relapse prevention, and training of problem-solving techniques as needed. The intervention period per patient will be one year. Data will be collected at baseline, 6, and 12 months. Primary outcome is the patient-reported change of depressive symptoms (Patient Health Questionnaire, PHQ-9). Secondary outcomes include measures of quality of life, anxiety, depression-related behavior, problem-solving skills, resilience, and an overall economic evaluation of the program. Discussion The GermanIMPACT trial will provide evidence about the effectiveness, feasibility, and cost-effectiveness of collaborative stepped care in treating late-life depression in German primary care. Positive results will be a first step toward integrating specialized depression care managers into the primary care setting. Trial registration German Clinical Trials Register: DRKS00003589 (September 2012).

The evaluation of the heart rate response to exercise is important for the diagnosis of chronotropic incompetence and the assessment of a rate responsive algorithm of sensor-controlled pacemakers. The aim of the present study was to examine a classification of the chronotropic response at an individually moderate exercise level. Sixteen pacemaker patients (patient group, age 62.9 +/- 7.6 years) with sick sinus syndrome and 15 age-matched healthy subjects (control group, age 57.6 +/- 9.4 years) underwent a maximum cardiopulmonary exercise test on a treadmill after a protocol with individually selected incremental steps. To analyze the patients' intrinsic heart rate response, the rate responsive mode of the pacemaker was switched off. Chronotropic incompetence was diagnosed in eight patients whose maximal heart rate was < 80% of the age-predicted heart rate. The heart rate at the anaerobic threshold was significantly lower in the chronotropically incompetent subgroup than in the chronotropically competent patients and the healthy subjects (85.9 +/- 6.6 beats/min vs 100.3 +/- 9.9 beats/min and 112.9 +/- 11.7 beats/min, respectively). The chronotropic slope of the heart rate reserve as a function of the metabolic reserve was significantly higher in the control group than in the patient groups with either mild or severe chronotropic incompetence (0.94 +/- 0.17 vs 0.64 +/- 0.08 and 0.43 +/- 0.14, respectively). Furthermore, the chronotropically incompetent response could be divided into a linear type with and without a threshold, an exponential, and a logarithmic type. The anaerobic threshold was an objectively detectable breakpoint at an individually moderate exercise level that could be used for characterization of chronotropic function. At the anaerobic threshold, a physiological heart rate response was about 220--age--50 beats/min. A deviation of more than 10 beats/min below this physiological value characterized chronotropic incompetence.

Survival rates after sudden cardiac arrest could be increased if bystanders could be encouraged to perform CPR until emergency services arrive. This should be initiated by the dispatcher at the emergency control facility who receives the call. For the first time the ERC guidelines of 2010 included instructions to be given to untrained rescuers by the dispatcher. Rapid recognition of cardiac arrest and initiation of emergency measures is assured by means of specific training for the dispatchers.The aim of this investigation was to determine whether the time between an emergency call and beginning of cardiopulmonary resuscitation (CPR) could be shortened using a simple protocol and whether a relationship exists between the intensity of phone contact between dispatcher and caller and if this improves the results.In known cases of unconsciousness, group 1 (45 persons) received short CPR instructions via the phone, where the dispatcher was on the phone for continuous advice until emergency services arrived. Group 2 (45 persons) received identical phone instructions like group 1, but the phone call was terminated by the dispatcher after the information was provided. Group 3 (29 persons) only received instructions to start CPR.On average, all test persons in group 1 started reanimation after 68.0 ± 33.5 s, in group 2 after 68.3 ± 25.2 s, and in group 3 after 64.9 ± 34.4 s. The compression frequency on average was 98.3/min in group 1, 84.8/min in group 2, and 85.2/min in group 3; therefore, all groups reached an average frequency of 80/min. The correct compression depth was achieved by 47.8 % of test persons in group 1, by 44.2 % in group 2, and by 30.2 % in group 3. All volunteers felt well supported. Of the 90 people, 70 did not feel that they were missing instructions.There were no significant differences between the groups regarding the target variables. The results show that already extremely short instructions or advice by the dispatcher to start CPR is sufficient to encourage bystanders to give assistance in an emergency. Continuous support over the phone does not appear to be necessary.

The aim of this study was to evaluate the relationship between left ventricular (LV) ejection fraction and clinical outcome to cardiac resynchronization therapy (CRT) in mild heart failure patients enrolled in MADIT-CRT [corrected].Left ventricular ejection fraction (LVEF) is a surrogate marker of heart failure (HF) status and associated risk. Data on the effectiveness of cardiac resynchronization therapy with defibrillator (CRT-D) in patients with mild HF and better LVEF are limited.In the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) study, the echocardiography core laboratory assessed baseline LVEF independent of the enrolling centers and identified a range of LVEFs, including those30% (i.e., beyond the eligibility criteria). Echocardiographic response with CRT, defined as percent change in left ventricular end-diastolic volume (LVEDV), was analyzed in 3 prespecified LVEF groups:30%, 26% to 30%, and ≤25%. The primary endpoint was HF or death. Secondary endpoint included all-cause mortality.LVEF was evaluated in 1,809 study patients. There were 696 (38%) patients with LVEF30% (in the range of 30.1% to 45.3%); 914 patients (50.5%) with LVEF 26% to 30%; and 199 patients with LVEF ≤25% (11%). The mean reduction in LVEDV with CRT-D therapy at the 1-year follow-up was directly related to increasing LVEF (LVEF30%: 22.3%; LVEF 26% to 30%: 20.1%; and LVEF ≤25%: 18.7% reduction, respectively [p = 0.001]). CRT-D treatment similarly reduced the risk of HF/death in patients with LVEF30% (hazard ratio [HR]: = 0.56 [95% confidence interval (CI): 0.39 to 0.82], p = 0.003), LVEF 26% to 30% (HR: 0.67: [95% CI: 0.50 to 0.90], p = 0.007), and LVEF ≤25% (HR: 0.57 [95% CI: 0.35 to 0.95], p = 0.03; all p values for LVEF-by-treatment interactions0.1).In MADIT-CRT, the clinical benefit of CRT was evident regardless of baseline LVEF, including those with LVEF30%, whereas the echocardiographic response was increased with increasing LVEF, indicating that CRT might benefit patients with better LVEF. (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy [MADIT-CRT]; NCT00180271).

Background: For preventive interventions in general practice to succeed, patients' points of view must be taken into account in addition to those of GPs. Objective: To explore patients' views and beliefs about the importance of lifestyle and preventive interventions, to assess their readiness to make changes to their lifestyle and their willingness to receive support from GPs. Methods: Cross-sectional survey conducted by EUROPREV in primary care practices in 22 European countries. Patients were consecutively selected and interviewed from September 2008 to September 2009. Results: Seven thousand nine hundred and forty-seven participants, 52.2% females. Only 30.5% of risky drinkers think they need to change, as opposed to 64% of smokers, 73.5% of patients with unhealthy eating habits and 73% with lack of physical activity. Risky drinkers reported that GPs initiated a discussion on alcohol consumption less often (42%) than on smoking (63%), eating habits (59%) or physical activity (55%). Seventy-five per cent, 66% and 63% of patients without hypertension, diabetes or hypercholesterolaemia, respectively, think blood pressure, blood sugar and serum cholesterol should be checked yearly. Women (80%) think they should be screened with the cervical smear test and 72.8% of women aged 30-49 years with mammography, yearly or every 2 years. Conclusions: A high proportion of patients attending primary care with unhealthy lifestyles (especially risky drinkers) do not perceive the need to change their habits, and about half the patients reported not having had any discussion on healthy lifestyles with their GPs. Patients overestimate their need to be screened for cardiovascular risk factors and for cancer., peer-reviewed

To assess the efficacy of a comprehensive program of secondary prevention of cardiovascular disease in general practice.A cluster randomized clinical trial was carried out in a regular general practice setting. Male and female patients aged under 86 years with a diagnosis of ischemic heart disease, stroke or peripheral artery disease were recruited between January 2004 and May 2005. Study participants were seen at 42 health centers throughout the whole of Spain. The primary endpoint was the combination of all-cause mortality and hospital cardiovascular readmission at 3-year follow-up.In total, 1224 patients were recruited: 624 in the intervention group and 600 in the control group. The primary endpoint was observed in 29.9% (95% confidence interval [CI], 25.5-34.8%) in the intervention group and 25.6% (22.3-29.2%) in the control group (P=.15). At the end of follow-up, 8.5% (6.3-11.3%) in the intervention group and 11% (7.4-16%) in the control group were smokers (P=.07). The mean waist circumference of patients in the intervention and control groups was 100.44 cm (95% CI, 98.97-101.91 cm) and 102.58 cm (95% CI, 100.96-104.21 cm), respectively (P=.07). Overall, 20.9% (15.6-27.7%) of patients in the intervention group and 29.6% (23.9-36.1%) in the control group suffered from anxiety (P=.05), and 29.6% (22.4-37.9%) in the intervention group and 41.4% (35.8-47.3%) in the control group had depression (P=.02).A comprehensive program of secondary prevention of cardiovascular disease in general practice was not effective in reducing cardiovascular morbidity and mortality. However, some factors associated with a healthy lifestyle were improved and anxiety and depression were reduced.

Background This multicenter, prospective, randomized, controlled, parallel trial compares the efficacy of biventricular (BIV) versus right ventricular (RV) antitachycardia pacing (ATP) in terminating all kinds of ventricular tachycardia (VT). Methods Five hundred twenty-six patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device were enrolled and randomized 1:1 to either BIV (266) or RV (260) ATP (single burst 8 pulse, 88% coupling interval) and were followed up for 12 months. Results During 12 months' follow-up, 1,077 ventricular episodes in 180 patients were detected and classified: 634 true VTs divided into 69 ventricular fibrillation (VF) (11%), 202 fast ventricular tachycardia (FVT) (32%), and 363 VT (57%). A comparable first ATP efficacy (BIV 65% vs RV 68%, P = .59) was observed in FVT + VT, in VT zone (BIV 62% vs RV 71%, P = .25), and in FVT zone (BIV 71% vs RV 61%, P = .34). A trend toward lower accelerations during ATP applied to FVT was observed in the BIV group (3.5% BIV vs 10.2% RV, P = .163). No syncope/presyncope occurred during ATP for FVT in the BIV group versus 4 events (3.2%) in the RV group ( P = .016). biventricular ATP was more effective in treating FVT in coronary artery disease (CAD) patients ( P = .032), whereas both modalities presented similar efficacy in patients with non-CAD etiology ( P = .549). Conclusions Antitachycardia pacing is effective in patients implanted with a CRT-D device. No significant differences in efficacy emerged between BIV- and RV-delivered ATP in the general population, whereas BIV ATP seems to present a safer profile in ischemic patients.

Purpose The purpose of the trial was to quantify and compare the efficacy of two different sequences of burst anti-tachycardia pacing (ATP) strategies for the termination of fast ventricular tachycardia. Methods The trial was prospective, multicenter, parallel and randomized, enrolling patients with an indication for implantable cardioverter-defibrillator implantation. Results From February 2004, 925 patients were randomized and followed-up for 12 months. Eight pulses ATP terminated 64% of episodes vs. 70% in the 15-pulse group (p = 0.504). Fifteen pulses proved significantly better in patients without a previous history of heart failure (p = 0.014) and in patients with LVEF ≥ 40% (p = 0.016). No significant differences between groups were observed with regard to syncope/near-syncope occurrence. Conclusion In the general population, 15-pulse ATP is as effective and safe as eight-pulse ATP. The efficacy of ATP on fast ventricular arrhythmias confirmed once more the striking importance of careful device programming in order to reduce painful shocks.

OBJECTIVES: To assess the efficacy of a comprehensive secondary prevention programme to reduce morbidity and mortality in patients who have suffered a cardiovascular (CV) event; to control CV risk factors and prophylactic treatment in order to prevent recurrence; and to improve the quality of life of patients with cardiovascular disease. DESIGN: Randomised, pragmatic, open clinical trial in primary care. SETTING: A total of 42 primary care centres of 8 different areas in Spain. PARTICIPANTS: Men and women below 86 years old, diagnosed with coronary disease and/or stroke and/or peripheral vascular disease in the preceding year, and who have no serious or terminal disease. INTERVENTION: Primary care centres will be randomised to following usual care (control group), or to following a comprehensive programme of secondary prevention (intervention group). MAIN MEASUREMENTS: Cardiovascular fatal events, cardiovascular non-fatal events, total mortality and health-related quality of life (SF-36).

OBJECTIVE: Disease prevention and health promotion are important tasks in the daily practice of all general practitioners (GPs). The objective of this study was to explore the knowledge and attitudes of European and Spanish GPs in implementing evidence-based health promotion and disease prevention recommendations in primary care, to describe GPs’ perceived barriers to implementing these recommendations, and to assess how GPs’ own health behaviors affect their work with their patients. DESIGN: A postal multinational survey was carried out from June 2000 to May 2001. SETTING: A random sample of GPs listed from national colleges of each country. PARTICIPANTS: A total of 2082 GPs from 11 European countries participated in the survey. In Spain a total of 270 GPs participated. RESULTS: Spanish GPs carried out more frequently most of the health promotion or disease prevention activities than the European GPs. Spanish GPs carried out less often those no evidence-based activities. The most important barrier reported was heavy workload/lack of time. Associations between personal health behaviour and attitudes to health promotion or activities in prevention were found. GPs who smoked felt less effective in helping patients to reduce tobacco consumption than non-smoking GPs (39.34% vs 48.18%; P

Background: Most of the national colleges of general practitioners (GPs) do not have their own dietary/nutritional tools, and GPs and nurses do not have the time, knowledge, or skills to advise their patients about desirable dietary practices. Objective: To assess the usefulness of a simple and practical guide on healthy diet to be used by European GPs and nurses. Design: A postal survey was mailed to 171 GPs and nurses from 12 European countries to obtain information about the usefulness of a guide on healthy diet developed by EUROPREV. Results: The perception of health professionals is that the main source of information on healthy diet for the population was the media. In all, 95% of GPs and nurses reported that the guide was useful; 93, 95, and 82% reported that the concepts were concise, easy to understand, and realistic, respectively. Also, 77% reported that the type of counselling recommended was feasible and could be applied, 94% reported that the implementation measures proposed could be effective and 88% reported that the Traditional Mediterranean Diet Pyramid is useful, but some concerns about the content were mentioned. Conclusions: GPs and nurses from Europe think that a practical guide on healthy diet developed by EUROPREV could be used to advise patients in primary care, although the Traditional Mediterranean Diet Pyramid should be modified.

Background: General practitioners (GPs) can promote good nutrition to patients and advise them about desirable dietary practices for specific conditions. Objective: The objective was to assess GPs' knowledge and attitudes in implementing preventive and health promotion activities and to describe tools used by European GPs in advising patients about dietary practices. Design: A postal survey was mailed to 1976 GPs from 10 GP national colleges to obtain information about beliefs and attitudes in prevention and health promotion, and an e-mail survey was sent to 15 GPs representing national colleges to obtain information about dietary guideline. Results: In the postal survey, 45% of GPs reported estimating body mass in clinical practice, and 60% reported advising overweight patients to lose weight. Fifty-eight percent answered that they felt minimally effective or ineffective in helping patients achieve or maintain normal weight. In the e-mail survey, only 4 colleges out of 15 reported that they had published their own dietary tools, although 10 out of 15 answered that GPs use some nutritional/dietary recommendations in the office when seeing patients. Eleven out of 15 answered that both the nurse and the GP advise patients about dietary practices, with 4 answering that GPs were the only ones who advise patients. Only 5 delegates answered that they can refer their patients to trained nutrition specialists. Conclusions: GPs think that obesity is not easy to handle in practice. Most GPs have dietary tools in the office and think that nurses play an important role in advising patients.

Primary tumors of the heart are very rare. We report a case of a 28-year old female patient in whom a tumor of the left ventricle was first diagnosed by transthoracic echocardiography. Angiography, nuclear magnetic resonance imaging and fasting positron emission tomography with 18-fluorodesoxyglucose suggested the diagnosis of a well vascularized tumor. The tumor was subtotally excised during heart surgery under total cardiopulmonary bypass and histological examination identified a predominantly vascular hamartoma.

Using more intervals to detect ventricular tachyarrhythmias has been associated with reducing unnecessary implantable cardioverter-defibrillator (ICD) therapies.To determine whether using 30 of 40 intervals to detect ventricular arrhythmias (VT) (long detection) during spontaneous fast VT episodes reduces antitachycardia pacing (ATP) and shock delivery more than 18 of 24 intervals (standard detection).Randomized, single-blind, parallel-group trial that enrolled 1902 primary and secondary prevention patients (mean [SD] age, 65 [11] years; 84% men; 75% primary prevention ICD) with ischemic and nonischemic etiology undergoing first ICD implant at 1 of 94 international centers (March 2008-December 2010).Patients were randomized 1:1 to programming with long- (n = 948) or standard-detection (n = 954) intervals.Total number of ATPs and shocks delivered for all episodes (primary outcomes) and inappropriate shocks, mortality, and syncopal rate (secondary outcomes).During a median follow-up of 12 months (interquartile range, 11-13), long-detection group had 346 delivered therapies (42 therapies per 100 person-years, 95% CI, 38-47) vs 557 in the standard-detection group (67 therapies per 100 person-years [95% CI, 62-73]; incident rate ratio [IRR], 0.63 [95% CI, 0.51-0.78]; P.001). The long- vs the standard-detection group experienced 23 ATPs per 100 person-years (95% CI, 20-27) vs 37 ATPs per 100 person-years (95% CI, 33-41; IRR, 0.58 [95% CI, 0.47-0.72]; P.001); 19 shocks per 100 person-years (95% CI, 16-22) vs 30 shocks per 100 person-years (95% CI, 26-34; IRR, 0.77 [95% CI, 0.59-1.01]; P = .06), with a significant difference in the probability of therapy occurrence (P.001); and a reduction in first occurrence of inappropriate shock (5.1 per 100 patient-years [95% CI, 3.7-6.9] vs 11.6 [95% CI, 9.4-14.1]; IRR, 0.55 [95% CI, 0.36-0.85]; P = .008). Mortality (5.5 [95% CI, 4.0-7.2] vs 6.3 [95% CI, 4.8-8.2] per 100 patient-years; HR, 0.87; P = .50) and arrhythmic syncope rates (3.1 [95% CI, 2.6-4.6] vs 1.9 [95% CI, 1.1-3.1] per 100 patient-years; IRR, 1.60 [95% CI, 0.76-3.41]; P = .22) did not differ significantly between groups.Among patients receiving an ICD, the use of a long- vs standard-detection interval resulted in a lower rate of ATP and shocks, and inappropriate shocks. This programming strategy may be an appropriate alternative.clinicaltrials.gov Identifier: NCT00617175.

Background Immediate bystander cardiopulmonary resuscitation (CPR) significantly improves survival after a sudden cardiopulmonary collapse. This study assessed the basic life support (BLS) knowledge and performance of high school students before and after CPR training. Methods This study included 132 teenagers (mean age 14.6 ± 1.4 years). Students completed a two-hour training course that provided theoretical background on sudden cardiac death (SCD) and a hands-on CPR tutorial. They were asked to perform BLS on a manikin to simulate an SCD scenario before the training. Afterwards, participants encountered the same scenario and completed a questionnaire for self-assessment of their pre- and post-training confidence. Four months later, we assessed the knowledge retention rate of the participants with a BLS performance score. Results Before the training, 29.5% of students performed chest compressions as compared to 99.2% post-training (P < 0.05). At the four-month follow-up, 99% of students still performed correct chest compressions. The overall improvement, assessed by the BLS performance score, was also statistically significant (median of 4 and 10 pre- and post-training, respectively, P < 0.05). After the training, 99.2% stated that they felt confident about performing CPR, as compared to 26.9% (P < 0.05) before the training. Conclusions BLS training in high school seems highly effective considering the minimal amount of previous knowledge the students possess. We observed significant improvement and a good retention rate four months after training. Increasing the number of trained students may minimize the reluctance to conduct bystander CPR and increase the number of positive outcomes after sudden cardiopulmonary collapse.

Dominant autosomal polycystic renal disease (DAPRD) is the most common cystic nephropathy, with multiorgan expression in many cases. Chronic irreversible renal failure is its major complication. Its clinical presentation is variable and it may remain symptom-free; therefore, it is important to know its many renal and extrarenal features which may suggest the diagnosis together with the family history, and also indicate the diagnostic and therapeutic possibilities. The primary care physician may also play a role in prevention, with the early diagnosis of the involved patients and genetic counseling with information of the implications. We report 5 cases of DAPRD with a clinical evaluation and family study, and also a succinct literature review.

41 patients with inferior myocardial infarction underwent both exercise stress testing and coronary arteriography. Coronary arteriography of 15 patients showed high-degree stenosis as well as occlusions of the right coronary artery and/or of the R. circumflexus of the left coronary artery alone. In 14 of these 15 cases exercise stress testing showed a normal result, in one case results were abnormal. However, we detected additional high-degree stenosis of R. interventricularis anterior and/or of R. diagonalis and/or of R. marginalis in the other 26 patients. In 22 of these 26 cases exercise stress testing showed an abnormal result, in 4 cases it was normal. Because of a sensitivy of 84,6% and a specificity of 93,3% we can assume, that abnormal results of exercise stress testing suggest additional high-degree stenosis of the RIVA-vessel system in patient after inferior myocardial infarction. Considering an eventual bypass operation it is possible to narrow the indication for coronary arteriography.

To carry out an audit of clinical records in our center for the evaluation of the quality of care before the introduction of protocols, several prevalent conditions were selected, and among them urinary tract infections (UTI). Another aim of the study was to evaluate the autochthonous flora responsible for UTI and its resistence to commonly used antimicrobials. A series of acceptable criteria and standards were set as quality controls, and the real index was found below the preselected one in all cases. The most commonly isolated organism was E. coli, followed by Proteus, which were resistent to trimetoprim-sulfamethoxazole in 56% and 71.4% of cases, respectively. Problems of organization and knowledge, and a high resistence rate to common antimicrobials were detected; the following were suggested as measures for improvement: introduction of a protocol, need for continuing education, reduction in the care demand, health education and improvement in the antibiotic policy.

The development and systematic use of microserological techniques have allowed to identify the etiology of a higher number of respiratory diseases, that could hardly have been considered some years ago and that now are known to play a more common role in clinical practice than usually thought. In the present study, the clinical, radiological and epidemiological features of seven patients are reported; they were seen in our health center during a 16 month period and the diagnosis of Chlamydia psittaci pneumonia was made by serological studies. All patients were treated with erithromycin, with favorable clinical and radiological outcome. Psittacosis is a condition that should be considered as a cause of community acquired pneumonia even in the absence of suggestive epidemiological background.