Specific Risk Factors for Fatal Outcome in Critically Ill COVID-19 Patients: Results from a European Multicenter Study.

(1) Background: The aim of our study was to identify specific risk factors for fatal outcome in critically ill COVID-19 patients. (2) Methods: Our data set consisted of 840 patients enclosed in the LEOSS registry. Using lasso regression for variable selection, a multifactorial logistic regression model was fitted to the response variable survival. Specific risk factors and their odds ratios were derived. A nomogram was developed as a graphical representation of the model. (3) Results: 14 variables were identified as independent factors contributing to the risk of death for critically ill COVID-19 patients: age (OR 1.08, CI 1.06-1.10), cardiovascular disease (OR 1.64, CI 1.06-2.55), pulmonary disease (OR 1.87, CI 1.16-3.03), baseline Statin treatment (0.54, CI 0.33-0.87), oxygen saturation (unit = 1%, OR 0.94, CI 0.92-0.96), leukocytes (unit 1000/µL, OR 1.04, CI 1.01-1.07), lymphocytes (unit 100/µL, OR 0.96, CI 0.94-0.99), platelets (unit 100,000/µL, OR 0.70, CI 0.62-0.80), procalcitonin (unit ng/mL, OR 1.11, CI 1.05-1.18), kidney failure (OR 1.68, CI 1.05-2.70), congestive heart failure (OR 2.62, CI 1.11-6.21), severe liver failure (OR 4.93, CI 1.94-12.52), and a quick SOFA score of 3 (OR 1.78, CI 1.14-2.78). The nomogram graphically displays the importance of these 14 factors for mortality. (4) Conclusions: There are risk factors that are specific to the subpopulation of critically ill COVID-19 patients.

Impact of COVID-19 outbreak on regional STEMI care in Germany.

AIMS: To assess the impact of the lockdown due to coronavirus disease 2019 (COVID-19) on key quality indicators for the treatment of ST-segment elevation myocardial infarction (STEMI) patients. METHODS: Data were obtained from 41 hospitals participating in the prospective Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) study, including 15,800 patients treated for acute STEMI from January 2017 to the end of March 2020. RESULTS: There was a 12.6% decrease in the total number of STEMI patients treated at the peak of the pandemic in March 2020 as compared to the mean number treated in the March months of the preceding years. This was accompanied by a significant difference among the modes of admission to hospitals (p = 0.017) with a particular decline in intra-hospital infarctions and transfer patients from other hospitals, while the proportion of patients transported by emergency medical service (EMS) remained stable. In EMS-transported patients, predefined quality indicators, such as percentages of pre-hospital ECGs (both 97%, 95% CI = - 2.2-2.7, p = 0.846), direct transports from the scene to the catheterization laboratory bypassing the emergency department (68% vs. 66%, 95% CI = - 4.9-7.9, p = 0.641), and contact-to-balloon-times of less than or equal to 90 min (58.3% vs. 57.8%, 95%CI = - 6.2-7.2, p = 0.879) were not significantly altered during the COVID-19 crisis, as was in-hospital mortality (9.2% vs. 8.5%, 95% CI = - 3.2-4.5, p = 0.739). CONCLUSIONS: Clinically important indicators for STEMI management were unaffected at the peak of COVID-19, suggesting that the pre-existing logistic structure in the regional STEMI networks preserved high-quality standards even when challenged by a threatening pandemic. CLINICAL TRIAL REGISTRATION: NCT00794001.

Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial.

BACKGROUND: Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial. METHODS: Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility. RESULTS: Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%-11.9%) and in BMT patients by 7.3% (4.3%-10.3%; P=0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients. CONCLUSIONS: The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00652522.

Determinants of inappropriate implantable cardioverter-defibrillator shocks: the German Device Registry perspective.

BACKGROUND: In the present study, we have focused upon rates and clinical determinants of inappropriate shock (IS) after implantable cardioverter-defibrillator (ICD). METHODS: Data were collected prospectively in the German Device II Registry. RESULTS: A total of 783 patients were included. Three sub-groups were identified: non-shock (NS) included 725 patients (92.6%), IS 24 (3.1%), and appropriate shock (AS) 34 (4.3%). IS patients were younger (AS 68 (58-77); IS 59 (51-68); NS 66 (56-75) years; p = 0.03), had been mainly referred for primary prophylaxis (AS 42.4%; IS 70.8%; NS 67.3%; p = 0.01), had a higher resting heart rate (AS 70 (63-80); IS 80 (71-98); NS 70 (60-81) BPM; p = 0.003), had more often atrial fibrillation (AF) (AS 14.7%; IS 45.8%; NS 18.8%; p = 0.006), and shorter QRS duration (AS 100 (90-120); IS 95 (90-100); NS 120 (98-150) msec.; p = 0.001). VVI-ICD was more common in IS (AS 64.7%; IS 83.3%; NS 49.8%; p = 0.002). At a follow-up of 18.2 months (75% IQR 13.6-22.4), no deaths were observed in the IS group, one (2.9%) in the AS, and 36 (4.9%) in the NS (p = 0.9). At logistic regression, VVI-ICD implantation was the strongest IS independent determinant (OR 5.0; 95% CI 1.6-15.9; p = 0.004) together with age < 70 years (OR 4.6; CI 1.4-14.7; p = 0.009), AF at time of ICD implantation (OR 3.5; CI 1.3-9.1; p = 0.01), and resting heart rate > 70/min (OR 2.8; CI 1.0-7.3; p = 0.03). CONCLUSION: In a contemporary setting, some specific conditions such as VVI-ICD, younger age, and faster resting heart rates remain important IS determinants after ICD implantation.

Can we rely on Danish? Real-world data on patients with nonischemic cardiomyopathy from the German Device Registry.

According to current guidelines prophylactic implantable cardioverter-defibrillator (ICD) therapy is recommended in patients with significantly impaired left ventricular systolic function. However, the recently published DANISH trial did not find a significantly lower long-term rate of death from any cause compared with usual clinical care in patients with non-ischemic cardiomyopathy. We investigated whether registry data from a multi-center 'real-life' registry on patients with non-ischemic cardiomyopathy are similar to this trial. The German Device Registry (DEVICE) is a nationwide, prospective registry with one-year follow-up investigating 5451 patients receiving device implantations in 50 German centers. The present analysis of DEVICE focused on patients with non-ischemic cardiomyopathy and a left ventricular ejection fraction ≤35% who received a prophylactic ICD. Out of 779 patients with symptomatic heart failure and nonischemic cardiomyopathy, 33.1% received a single chamber ICD (VVI), while 11.0% were implanted with a dual-chamber ICD (DDD), and 55.8% received a defibrillator system for cardiac resynchronization therapy. Median follow-up was 16.1 months. 90.7% were alive at follow-up, 9.3% had died during this period. Overall mortality after one year was 5.4%. Overall mortality one year after implantation was significantly increased in patients 68 years and older(7.9%) as compared to younger patients (59-68 years: 2.5%; < 59 years: 3.8%; p < 0.015). Data from the present registry support the recently published results of the DANISH trial. In particular the influence of an increased age as proven in the DANISH trial might also play a role in the present collective. This limits the potential beneficial effect of ICD therapy in particular in the elderly population.

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact).

BACKGROUND: In heart failure (HF) patients with implantable cardioverter defibrillators (ICD) or cardiac resynchronisation therapy defibrillators (CRT-D), remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits. We aimed to provide further evidence for this effect, and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes. METHODS: InContact was a prospective, randomised, multicentre study. Subjects receiving quarterly automated follow-up only (telemetry group) were compared to those receiving personal physician contact. Personal contact patients were further divided into those receiving automated follow-up plus a telephone call (remote+phone subgroup) or in-clinic visits only. RESULTS: Two hundred and ten patients underwent randomisation (telemetry n = 102; personal contact n = 108 [remote+phone: n = 53; visit: n = 55]). Baseline characteristics were comparable between groups and subgroups. Over 12 months, 34.8% of patients experienced deterioration of their Packer Clinical Composite Response, with no significant difference between the telemetry group and personal care (p > 0.999), remote+phone (p = 0.937) or visit (p = 0.940) patients; predefined non-inferiority criteria were met. Mortality rates (5.2% overall) were comparable between groups and subgroups (p = 0.832/p = 0.645), as were HF-hospitalisation rates (11.0% overall; p = 0.605/p = 0.851). The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups (42.2 and 45.3%) compared to the visit group (29.1%). Overall, ≥ 1 ICD therapy was delivered to 15.2% of patients. CONCLUSION: In HF patients with ICDs/CRT-Ds, quarterly remote follow-up only over 12 months was non-inferior to regular personal contact. Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage. TRIAL REGISTRATION: clinicaltrials.gov: NCT01200381 (retrospectively registered on September 13th 2010).

Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial.

Aims: The aim of this study was to investigate the effect of contact-to-balloon time on mortality in ST-segment elevation myocardial infarction (STEMI) patients with and without haemodynamic instability. Methods and results: Using data from the prospective, multicentre Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) trial, we assessed the prognostic relevance of first medical contact-to-balloon time in n = 12 675 STEMI patients who used emergency medical service transportation and were treated with primary percutaneous coronary intervention (PCI). Patients were stratified by cardiogenic shock (CS) and out-of-hospital cardiac arrest (OHCA). For patients treated within 60 to 180 min from the first medical contact, we found a nearly linear relationship between contact-to-balloon times and mortality in all four STEMI groups. In CS patients with no OHCA, every 10-min treatment delay resulted in 3.31 additional deaths in 100 PCI-treated patients. This treatment delay-related increase in mortality was significantly higher as compared to the two groups of OHCA patients with shock (2.09) and without shock (1.34), as well as to haemodynamically stable patients (0.34, P < 0.0001). Conclusions: In patients with CS, the time elapsing from the first medical contact to primary PCI is a strong predictor of an adverse outcome. This patient group benefitted most from immediate PCI treatment, hence special efforts to shorten contact-to-balloon time should be applied in particular to these high-risk STEMI patients. Clinical Trial Registration: NCT00794001.

Activation of remote monitoring for cardiac implantable electronic devices: small dog for tall weeds.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has been popularized as a precious patients' management tool. We have investigated RM within the premises of a multicenter, prospective, real-world registry, i.e., the German Device II. METHODS: We have focused on: (1) CIEDs with RM capabilities implantation rate and (2) actual rate of RM features activation. RESULTS: A cohort of 1223 CIEDs patients were treated from 04/11 to 02/14. Of these, 720 (58.8%) were implanted with RM-capable devices and were presenting significantly more often a clinical diagnosis of dilatative cardiomyopathy and an indication for cardiac resynchronization. At discharge, the RM feature was activated in only 12.6% (91/720) of the total number of patients implanted with RM-capable CIEDs. After adjusting for implanting center, there was no significant correlation between any of the patient clinical characteristics and RM activation. One-year estimated mortality was 9.0% in patients with activated RM, 5.6% in those with not activated RM, and 7.7% in those without RM capability (p = 0.3). The RM feature was still activated in 13.8% of the patients surviving at follow-up. Patients undergoing RM had a trend for higher re-hospitalization rate and less visits in the device outpatient clinic. CONCLUSIONS: Although RM in CIEDs may be a clinically valuable technological armamentarium, its activation does not reflect patients' clinical profile. In fact, RM is often not activated, most probably because it is still recognized as a source of increased workload in a reality where reimbursement plans for dedicated human resources are not yet optimized.

Long-term outcomes after event-free cardioverter defibrillator implantation: comparison between patients discharged within 24 h and routinely hospitalized patients in the German DEVICE registry.

AIMS: To analyse the long-term safety of implantable cardioverter defibrillators (ICDs) in patients discharged within 24 h or after 2- 5-day hospitalization, respectively, after complication-free implantation, in circumstances of actual care. METHODS AND RESULTS: Patients in the multicentre, nationwide German DEVICE registry were contacted 12-15 months after their first ICD implantation or device replacement. Data were collected on complications, potential arrhythmic events, syncope, resuscitation, ablation procedures, cardiac events, hospitalizations, heart failure status, change of medication, and quality of life. Of 2356 patients from 43 centres, 527 patients were discharged within 24 h and 1829 were hospitalized routinely for >24 h after complication-free implantations. The disease profiles and rates of co-morbidities were similar at baseline for both cohorts. During between 384 and 543 days of follow-up, there were no significant differences between the groups in terms of complications, hospitalizations, or quality of life. One-year rates of death were 4.5% in patients discharged early compared with 7.2% in hospitalized patients (hazard ratio 0.65; 95% confidence interval 0.42-1.02; P = 0.052). Rates of major adverse cardiovascular events or defibrillator events were not higher in patients discharged after 24 h. In both groups, a high rate of patients declared that they would opt for the procedure again in the same situation. CONCLUSION: Data from a large-scale registry reflecting current day-to-day practice in Germany suggest that most patients can be discharged safely within 24 h of successful ICD implantation if there are no procedure-related events. Follow-up data up to 1.5 years after implantation did not raise long-term safety concerns.

Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study.

INTRODUCTION: Reliable detection and monitoring of atrial fibrillation (AF) is essential for accurate clinical decision making, which can now be done continuously with the introduction of implantable cardiac monitors (ICM) The DETECT AF study evaluated the performance of the Confirm DM2102 ICM (St. Jude Medical, St. Paul, MN, USA) to accurately detect and monitor AF. METHODS: Ninety patients previously implanted with the ICM and with either suspected or known paroxysmal AF were enrolled at 12 centers in Germany and The Netherlands. At least 2 weeks after ICM implant, patients wore a Holter monitor for 4 days, while the ICM monitored for AF episodes lasting at least 2 minutes. Holter monitor data was analyzed by a blinded, independent core laboratory and compared to the ICM AF detections. Patient and episode sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive (NPV) were calculated using standard analysis and a generalized estimation equation method where appropriate. RESULTS: A total of 79/90 subjects (61% male, 65.7 ± 9.6 years old) were included in the analysis, totaling 6,894 hours of Holter monitoring. Using a per patient analysis SE was 100%, PPV was 64.0%, SP was 85.7%, and NPV was 100%. Using a per episode analysis, SE was 94.0% and PPV was 64.0%. With an AF duration analysis, the SE was 83.9%, PPV was 97.3%, SP was 99.4% with an NPV of 98.5%. CONCLUSION: The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length.

Development of radiation exposure in patients undergoing pulmonary vein isolation in Germany between 2007 and 2014: great potential to minimize radiation dosage.

AIM: The aim of this study was to analyze the radiation usage in patients undergoing pulmonary vein isolation (PVI) in Germany and to evaluate the possibility to reduce radiation dose. METHODS AND RESULTS: A total of 6617 patients with atrial fibrillation (AF) from the German ablation registry and the FREEZEplus registry (control group), who underwent first PVI between 2007 and 2014, were analyzed. In the second step, the effect of optimized conventional fluoroscopy and optimized 3D mapping use was evaluated in 526 consecutive patients with AF who underwent first PVI at the Klinikum Ludwigshafen (optimized group) between 2007 and 2014. In the control group, the median dose area product (DAP) for PVI was 34 Gy cm(2), and the median DAP rate was 1.3 Gy cm(2)/min. The DAP decreased from 37 to 28 Gy cm(2), whereas the DAP rate increased from 1.3 to 1.6 Gy cm(2)/min between 2007 and 2014. In the optimized group, optimized radiation application and use of 3D mapping resulted in a continuous decrease in the DAP from 67 to 2 Gy cm(2) and DAP rate from 1.0 to 0.2 Gy cm(2)/min. CONCLUSION: Currently, the median radiation exposure during PVI in Germany is 28 Gy cm(2). Optimized fluoroscopy by simple means can safely reduce the radiation dose to about 2 Gy cm(2) or even lower when using 3D mapping. Before introducing novel expensive technologies for radiation reduction optimizing of the conventional fluoroscopy is mandatory.

Catheter ablation of atrial fibrillation in the young: insights from the German Ablation Registry.

INTRODUCTION: Catheter ablation of paroxysmal atrial fibrillation (PAF) has been suggested as first-line treatment for selected patients (pts). However, patient characteristics, procedural data, and complication rate in the group of young patients remain undetermined. METHODS: The German Ablation Registry has been designed as a multi-center prospective registry. AF ablation data were collected from 51 German centers between March 2007 to September 2012 and 2 groups were defined (group A: ≤45 years, group B: >45 years). Data were analyzed according to patient characteristics, procedural data, and complications. To calculate differences between both groups CHI2 or Mann-Whitney-Wilcoxon tests was utilized. RESULTS: A total of 7243 patients undergoing AF ablation were included (group A: 593, 8.2 %; group B: 6650, 91.8 %). Male gender and PAF were significantly more often present in group A. Patient characteristic revealed decreased co-morbidities in the young. In both groups circumferential pulmonary vein isolation represented the procedural cornerstone, whereas substrate modification was significantly more often performed in group B. Procedure-, and fluoroscopy-time was similar but there was a shorter hospital stay and a favorable complication profile in the young. After 12 months AF recurrence and use of antiarrhythmic drugs were less common in group A. CONCLUSION: The young AF ablation patient has typically paroxysmal AF and less comorbidities. In this group, catheter ablation of AF is associated with a lower major complication rate, shorter hospitalization, and a favorable clinical outcome.

Comparison between atrial fibrillation-triggered implantable cardioverter-defibrillator (ICD) shocks and inappropriate shocks caused by lead failure: different impact on prognosis in clinical practice.

INTRODUCTION: Recent studies suggest a worse impact of inappropriate shock therapies on the outcome of patients with an implantable cardioverter-defibrillator (ICD). However, it is not known whether the worse impact is attributed to the ICD shock itself or due to the underlying heart disease. The aim of the study was to evaluate the impact of inappropriate ICD shocks on clinical outcome by comparing ICD shocks triggered by atrial fibrillation (AF) with shocks caused by lead failure. METHODS AND RESULTS: A total of 1,411 consecutive patients of the prospective single-center ICD-registry Ludwigshafen who underwent an ICD implantation between 1992 and 2008 for primary or secondary prevention of sudden cardiac death were analyzed. During the median follow-up of 3 years, 297 (21%) patients experienced inappropriate ICD shocks. Sixty percent of patients had inappropriate shocks due to AF and 24% due to lead defect or T-wave oversensing. Multiple ICD shocks (≥2) triggered by AF were associated with a worse prognosis, whereas a single shock due to AF or 1 or multiple shocks resulting from lead failure were not. ICD shocks caused by AF occurred more often in tandem with a serious adverse event than in patients with a lead failure (15% vs 6%, P < 0.05). CONCLUSION: Multiple ICD shocks triggered by AF are associated with a worse prognosis in ICD patients, whereas a single shock due to AF or shocks resulting from lead failure are not. These data support that the ICD shock itself has no worse impact on the outcome of ICD patients.

First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead.

AIMS: Cardiac resynchronization therapy (CRT) is sometimes complicated by elevated pacing thresholds and phrenic nerve stimulation (PNS), both of which may require that the coronary sinus lead be repositioned. The purpose of this study was to evaluate the performance of a novel quadripolar electrode lead and cardiac resynchronization therapy-defibrillator (CRT-D) device that enables electrical repositioning, potentially obviating a lead reposition procedure. METHODS AND RESULTS: Patients indicated for CRT were enrolled and received a quadripolar electrode lead and CRT-D device (Quartetmodel 1458Q and Promote Q; St Jude Medical, Sylmar, CA, USA). Electrical data, and the presence of PNS during pacing from each left ventricular (LV) configuration, were documented at pre-hospital discharge and at 1 month. Seventy-five patients were enrolled and 71 were successfully implanted with a Quartetlead. Electrical measurements were stable over the follow-up period. Ninety-seven per cent (64 of 66) of patients had one or more programmable configurations with a threshold < 2.5 V and no PNS vs. 86% (57 of 66) if only conventional bipolar configurations were considered. Physicians were able to use the increased programming options to manage threshold changes and PNS. CONCLUSION: The new quadripolar electrode LV lead provides more programming options to address common problems faced when managing CRT patients. Electrical measurements from new vectors are comparable with conventional configurations. Furthermore, 11% of patients in the study suffered PNS on all conventional bipolar vectors.

Impact of moderate exercise workload on predicted optimal AV and VV delays determined by an intracardiac electrogram-based method for optimizing cardiac resynchronization therapy.

AIMS: Aim of this study is to evaluate reproducibility, consistency and the impact of moderate exercise workload on optimized PV and VV delays as determined by the IEGM-based QuickOpt™ method (St. Jude Medical), that was shown to produce hemodynamic performance similar to that obtained by echo-guided aortic VTI maximization. METHODS: Sixty patients with CRT-ICD (65 ± 9 years, 12% female, LVEF 28 ± 9%, 48% CAD and 52% DCM) were enrolled. IEGM-based PV/VV optimization was conducted six times: twice at rest, twice immediately after a 6-min walk test and twice following a 3-min recovery period. Timing cycle delays were programmed in accordance with the optimization results. Follow-up was performed after 1 year. RESULTS: Although significant difference in heart rate was reached [68 ± 9 bpm (REST) vs. 79 ± 12 (6MWT), p < 0.001], differences were not observed between IEGM-based optimized PV/VV delays: PV(opt) = 128 ± 14 ms (REST) versus 130 ± 17 ms (6MWT) versus 129 ± 16 ms (RECOV); VV(opt) = 15 ± 24 ms (REST) versus 15 ± 22 ms (6MWT) versus 16 ± 24 ms (RECOV). During 1-year follow-up PV(opt) and VV(opt) remained stable (ΔPV(opt) = 10 ± 10 ms, ΔVV(opt) = 9 ± 11 ms). CONCLUSION: Optimized IEGM-based timing cycle delays are independent of moderate exercise status within a particular patient but varied between patients. This supports the use of PV/VV optimization in each CRT patient.

Impact of left ventricular lead position on the incidence of ventricular arrhythmia and clinical outcome in patients with cardiac resynchronization therapy.

PURPOSE: The aim of the study was to evaluate the incidence of ventricular arrhythmia and clinical outcome in patients receiving a cardiac resynchronization therapy (CRT) depending on the left ventricular (LV) lead position. METHODS: A total of 187 consecutive patients with advanced heart failure who received a CRT-implantable cardioverter defibrillator were analyzed. Forty patients (21%) had a LV lead in the anterior/apical (anterior) and 147 patients (79%) in the posterior/posterolateral (posterior) region. The total median follow-up time was 644 days. RESULTS: The incidence of ventricular arrhythmia was 35% in patients with an anterior LV lead versus 30% in patients with a posterior LV lead (p = 0.53). The 1- and 2-year mortality in the anterior LV lead group was 19% and 22%, as compared with 0.7% and 3.2%, respectively, in the posterior LV lead group (p < 0.001). In a multivariable analysis, an anterior LV lead was independently associated with an increased mortality (hazard ratio 5.88, 95% confidence interval 2.22-16.67). The major cause of death was end-stage heart failure whereas the incidence of sudden cardiac death was not different between both groups. CONCLUSIONS: Thus, biventricular pacing with an anterior LV lead seems to have no impact on the incidence of ventricular arrhythmia but may be associated with an increased mortality rate due to worsening heart failure.

Prevalence of bacterial colonization of generator pockets in implantable cardioverter defibrillator patients without signs of infection undergoing generator replacement or lead revision.

AIMS: This study was designed to evaluate the prevalence of bacterial colonization of generator pockets in implantable cardioverter defibrillator (ICD) patients without signs of infection and to analyse the impact of bacterial colonization on the incidence of device infection during follow-up. METHODS AND RESULTS: In 122 ICD patients undergoing generator replacement or surgical lead revision between January 2006 and July 2008, microbiological cultures of generator pockets and extracted leads were consecutively obtained. Patients with clinical evidence of a device infection were excluded. Positive cultures from the generator pocket and leads were found in 40 (33%) patients. The most common bacteria isolated were coagulase negative staphylococci (68%). During a median follow-up time of 203 days after the revision device infection occurred in three [7.5%, confidence interval (CI) 1.6-20.4%] patients with a positive culture vs. two (2.4%, CI 0.3-8.5%) patients with a negative culture (P = 0.33). Time from revision to infection was 108 +/- 73 days in patients with positive culture vs. 60 +/- 39 days in patients with negative culture (P = 0.50). CONCLUSION: A third of ICD patients undergoing generator replacement or lead revision have an asymptomatic bacterial colonization of generator pockets. After revision 7.5% of these patients develop a device infection with the same species of microorganism.

Prevalence of left atrial thrombus and dense spontaneous echo contrast in patients with short-term atrial fibrillation < 48 hours undergoing cardioversion: value of transesophageal echocardiography to guide cardioversion.

BACKGROUND: The aim of this study was to investigate the value of transesophageal echocardiography (TEE)-guided cardioversion (CV) to prevent thromboembolic complications in patients with short-term atrial fibrillation (AF) < 48 hours in duration. METHODS: This single-center, observational study comprised 366 consecutive, unselected patients with short-term AF < 48 hours in duration. During the first 2 years, CV was performed using the conventional approach without TEE. Thereafter, CV guided by TEE was performed in consecutive patients. RESULTS: TEE revealed left atrial thrombi in 1.4% and left atrial dense spontaneous echo contrast in 10% of patients with short-term AF (n = 207), of whom 63% were receiving anticoagulation therapy. Patients without prior anticoagulation had a 4% prevalence of left atrial thrombi. A low ejection fraction and an enlarged left atrium tended to be associated with an increased prevalence of thrombus or dense spontaneous echo contrast. During the first month after CV, there were no significant differences in the rate of embolic events between the two treatment groups. CONCLUSIONS: These results underline the need for further studies on the usefulness of TEE-guided CV in patients with short-term AF who are not therapeutically anticoagulated at presentation.

Defibrillator implantation early after myocardial infarction.

BACKGROUND: The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone. METHODS: This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. RESULTS: During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). CONCLUSIONS: Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)

Reperfusion therapy for acute ST-elevation and non ST-elevation myocardial infarction: what can be achieved in daily clinical practice in unselected patients at an interventional center?

BACKGROUND: In the year 2000 a new definition of acute myocardial infarction (AMI) was introduced, now differentiating ST segment elevation AMI (STEMI) from non-ST segment elevation AMI (NSTEMI). The characterization of AMI patients according to this definition is still incomplete. METHODS AND RESULTS: 888 consecutive AMI patients at a single interventional center were included: 493 (55.5%) STEMI and 395 (44.5%) NSTEMI patients. Median age of STEMI patients was four years lower compared to NSTEMI patients (62.8 versus 66.6 years, P<0.001). STEMI patients more often presented in cardiogenic shock (11.0% versus 2.0%, P<0.001) and after pre-hospital resuscitation (4.9% versus 0.8%, P<0.001). Catheterization was performed in 98.4% of STEMI and in 95.9% of NSTEMI patients (P<0.001). The circumflex artery was more often the culprit lesion in NSTEMI patients compared to STEMI patients (58.3% versus 48%, P=0.003). They also showed significantly more often a 3 vessel disease (41.4% versus 29.9%, P=0.002). Out of STEMI patients 10.1% were treated with medical therapy only compared to 27.2% of NSTEMI patients (P<0.001). Whereas PCI was performed more often in STEMI patients (84.3% versus 57.8%, P<0.001), CABG was used more often in NSTEMI patients (21.6% versus 9.1%, P<0.001). In-hospital death was 8.7% in STEMI compared to 4.8% in NSTEMI patients (P<0.001). CONCLUSIONS: In clinical practice STEMI and NSTEMI seem to occur with similar frequency. Invasive strategies were applied in a high percentage in both groups, however with different therapeutic consequences. In-hospital mortality was twice as high in STEMI compared to NSTEMI patients.