Long-Term Technical Performance of the Osypka QT-5® Ventricular Pacemaker Lead.

BACKGROUND: Lead-associated complications and technical issues in patients with cardiac implantable electronic devices are common but underreported in the literature. METHODS: All patients undergoing implantation of the Osypka QT-5® ventricular lead at the University Clinic St. Pölten between 1 January 2006 and 31 December 2012 were retrospectively analyzed (n = 211). Clinical data including pacemaker follow-up examinations and the need for lead revisions were assessed. Kaplan-Meier analysis to estimate the rate of lead dysfunction during long-term follow-up was conducted. RESULTS: Patients were followed for a median of 5.2 years (interquartile range (IQR) 2.0-8.7). R-wave sensing properties at implantation, compared to last follow-up, remained basically unchanged: 9.9 mV (IQR 6.8-13.4) and 9.6 mV (IQR 5.6-12.0), respectively). Ventricular pacing threshold significantly increased between implantation (0.5 V at 0.4 ms; IQR 0.5-0.8) and the first follow-up visit (1.0 V at 0.4 ms; IQR 0.8-1.3; p < 0.001) and this increase persisted throughout to the last check-up (0.9 V at 0.4 ms; IQR 0.8-1.2). Impedance significantly declined from 1142 Ω (IQR 955-1285) at implantation to 814 Ω (IQR 701-949; p < 0.001) at the first check-up, followed by a further decrease to 450 Ω (IQR 289-652; p < 0.001) at the last check-up. Overall, the Osypka QT-5® ventricular lead was replaced in 36 patients (17.1%). CONCLUSIONS: This report shows an unexpected high rate of technical issues of the Osypka QT-5® ventricular lead during long-term follow-up.

Cutting fertility? Effects of cesarean deliveries on subsequent fertility and maternal labor supply.

Despite the growing incidence of cesarean deliveries (CDs), procedure costs and benefits continue to be controversially discussed. In this study, we identify the effects of CDs on subsequent fertility and maternal labor supply by exploiting the fact that obstetricians are less likely to undertake CDs on weekends and public holidays and have a greater incentive to perform them on Fridays and days preceding public holidays. To do so, we adopt high-quality administrative data from Austria. Women giving birth on different days of the week are pre-treatment observationally identical. Our instrumental variable estimates show that a non-planned CD at parity 0 decreases lifecycle fertility by almost 13.6%. This reduction in fertility translates into a temporary increase in maternal employment.

A case report of a 40-year-old woman with endomyocardial fibrosis in a non-tropical area: from initial presentation to high urgent heart transplantation.

BACKGROUND: Endomyocardial fibrosis (EMF) represents the most common cause of restrictive cardiomyopathy worldwide. Despite a high prevalence in tropical regions, it occasionally occurs in patients who have never visited these areas. While researches have proposed various possible triggers for EMF, etiology and pathogenesis remain largely unknown. Diagnosis is based on patient history, heart failure symptoms, and echocardiographic signs of restrictive ventricular filling, atrioventricular valve regurgitation and frequently apical thrombus. Following is a case report of an Austrian patient with EMF who eventually had to undergo a heart transplant. This case report strives to promote awareness for this in non-tropical areas uncommon but nevertheless detrimental disease. CASE PRESENTATION: A 40-year-old woman was presented at our emergency department with chest pain and fever up to 38.1° Celsius. Plasma troponin-T levels and inflammatory markers were slightly elevated, but the echocardiogram was without pathological findings. The patient was hospitalized on the suspicion of acute myocarditis and discharged soon after improvement. Eight months later, she was presented again with chest pain and symptoms of heart failure. The echocardiogram showed normal systolic left ventricular (LV) function with LV wall thickening and severe restrictive mitral regurgitation as well as aortic and tricuspid regurgitation. Coronary angiogram was normal but right heart catheterization showed pulmonary hypertension due to left heart disease. Further diagnostic workup with cardiac magnetic resonance imaging revealed subendocardial late enhancement and apical thrombus formation in the left ventricle compatible with the diagnosis of EMF. A comprehensive diagnostic workup showed no evidence of infection, systemic immunologic or hematological disease, in particular hypereosinophilic syndrome. After a multidisciplinary consideration of several therapeutic options, the patient was listed for heart transplantation. On the waiting list, she deteriorated rapidly due to progressive heart failure and finally underwent a heart transplantation. Histological examination confirmed the diagnosis of EMF. Six years after her heart transplantation, the patient was presented in an excellent clinical condition. CONCLUSIONS: Even in non-tropical regions, the diagnosis of EMF should always be considered in restrictive cardiomyopathy. Knowledge of the distinct phenotype of EMF facilitates diagnosis, but comprehensive workup and therapeutic management remain challenging and require a multidisciplinary approach.

Comparison of transcatheter aortic valve implantation with other approaches to treat aortic valve stenosis: a systematic review and meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVI) is an alternative treatment for patients with symptomatic severe aortic stenosis ineligible for surgical aortic valve replacement (SAVR) or at increased perioperative risk. Due to continually emerging evidence, we performed a systematic review and meta-analysis comparing benefits and harms of TAVI, SAVR, medical therapy, and balloon aortic valvuloplasty. METHODS: We searched MEDLINE, Embase, and Cochrane CENTRAL from 2002 to June 6, 2017. We dually screened abstracts and full-text articles for randomized controlled trials (RCTs) and propensity score-matched observational studies. Two investigators independently rated the risk of bias of included studies and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). If data permitted, we performed meta-analyses using random- and fixed-effects models. RESULTS: Out of 7755 citations, we included six RCTs (5862 patients) and 13 observational studies (6376 patients). In meta-analyses, patients treated with SAVR or TAVI had similar risks for mortality at 30 days (relative risk [RR] 1.05; 95% confidence interval [CI] 0.82 to 1.33) and 1 year (RR 1.02; 95% CI 0.93 to 1.13). TAVI had significantly lower risks for major bleeding but increased risks for major vascular complications, moderate or severe paravalvular aortic regurgitation, and new pacemaker implantation compared to SAVR. Comparing TAVI to medical therapy, mortality did not differ at 30 days but was significantly reduced at 1 year (RR 0.51; 95% CI 0.34 to 0.77). CONCLUSIONS: Given similar mortality risks but different patterns of adverse events, the choice between TAVI and SAVR remains an individual one.

ECMO and cytokine removal for bridging to surgery in a patient with ischemic ventricular septal defect - a case report.

Even in the modern era of percutaneous coronary intervention, postinfarction ventricular septal defect (VSD) remains a serious and often lethal complication. Whether or not immediate surgical repair or delaying surgery a few days aided by intra-aortic counterpulsation provides the optimal strategy remains a matter of debate. An interdisciplinary approach of intensivists and cardiac surgeons in this setting is mandatory. We report the use of veno-arterial extracorporeal membrane oxygenation and extracorporeal blood purification therapy (CytoSorb®) as bridging to surgical closure in a patient with an ischemic VSD leading to protracted cardiogenic shock after posterior myocardial infarction.

Outcome after Elective Percutaneous Coronary Intervention Depends on Age in Patients with Stable Coronary Artery Disease - An Analysis of Relative Survival in a Multicenter Cohort and an OCT Substudy.

BACKGROUND: Age is a strong predictor of survival in patients with coronary artery disease. In elder patients with increasing co-morbidities percutaneous coronary intervention (PCI) is associated with more complications and worse outcome. The calculation of relative survival rates adjusts for the "background" mortality in the general population by correcting for age and gender. We analyzed if elder patients after elective PCI have a worse relative survival compared to younger patient groups. METHODS: A total of 8,342 patients who underwent elective PCI at two high volume centers between 1998 and 2009 were analyzed. RESULTS: The survival of our patients after PCI (observed survival) was slightly lower compared to the general population (expected survival) resulting in a slightly decreasing relative survival curve. In a multivariate Cox regression model age amongst others was a strong predictor of survival. Stratifying patients according to their age the relative survival curves of younger patients (Quartile 1: <58 years; 2,046 patients), elder patients (Quartile 3: 66-73 years; 2,090 patients) and very old patients (Quartile 4: >73 years; 2,307 patients) were similar. The relative survival of mid-aged patients (Quartile 2: 58-65 years; 1,899 patients) was better than that of all other patient groups. The profile of cardiovascular risk factors differs between the various groups resulting in different composition and burden of coronary plaques in an optical coherence tomography sub-study. CONCLUSION: Patients after elective PCI have a slightly worse long-term survival compared to the age- and sex-matched general population. This is also true for different groups of age except for mid-aged patients between 58 and 63 years. Elder patients between 66 and 73 years and above 73 years have a similar relative survival compared to younger patients below 58 years, and might therefore have similar benefit from elective PCI.

A detailed view on pacemaker lead parameters remotely transmitted after magnetic resonance.

BACKGROUND: The purpose of this study was to analyze potential influences of magnetic resonance (MR) on the course of automatically device-based assessed lead parameters remotely transmitted in patients who were implanted with MR-conditional permanent pacemakers (PMs) and who had nondiagnostic brain and lumbar spine MR (1.5T) within the ProMRI single center pilot study. METHODS: The ProMRI study evaluated the feasibility of the Evia PMs with Safio S leads (Biotronik SE&Co KG, Berlin, Germany) in the MR environment. All patients were equipped with remote monitoring on the day of MR. Atrial (RA) und ventricular (RV) lead parameters (sensing, pacing capture threshold [PCT], pacing impedance) were automatically assessed and remotely transmitted on a daily or event-triggered basis for 3 months post MR. Remotely transmitted data were normalized for potential differences between at-daytime (in-office) and at-night-time (remotely) assessed parameters using the 1-month follow-up data for each patient. Confidence intervals of continuous data were calculated day-wise with one sample t-tests of post-MR/pre-MR differences, respectively. RESULTS: A total of 2,428 data sets (mean 80 ± 20 per patient) were transmitted. Mean values for the different lead parameters were (RA/RV) 3.3 ± 2.0/14.4 ± 6.9 mV for sensing, 0.65 ± 0.17/0.78 ± 0.23 V/0.4 ms for PCT, and 516 ± 60/607 ± 47 Ω for pacing impedance. No significant differences were found compared with pre-MR measurements. No atrial PCT increases ≥0.5 V compared with pre-MR were observed, and in only one patient the ventricular PCT increased by ≥0.5 V from day 76 post-MR, presumably based on new antiarrhythmic therapy with amiodarone. CONCLUSION: Our analyses of automatically assessed and remotely transmitted PM lead parameters after MR show that sensing amplitudes, PCTs, and pacing impedances are not affected in a clinically relevant way by MR.

Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: the safety issue of the ESTIMATE study.

BACKGROUND: No published data exist about the safety of diagnostic magnetic resonance (MR) of the heart performed in a larger series of patients implanted with MR conditional pacemakers (PM). The purpose of our study is to analyse safety and potential alterations of electrical lead parameters in patients implanted with the EnRhythm/Advisa MRI SureScan PM with 5086MRI leads (Medtronic Inc.) during and after MR of the heart at 1.5 Tesla. METHODS: Patients enrolled in this single center pilot study who underwent non-clinically indicated diagnostic MR of the heart were included in this analysis. Heart MR was performed for analyses of potential changes in right and left ventricular functional parameters under right ventricular pacing at 80 and 110 bpm. Atrial/ventricular sensing, atrial/ventricular pacing capture threshold [PCT], and pacing impedances were assessed immediately before, during, and immediately after MR, as well at 3 and 15 months post MR. RESULTS: Thirty-six patients (mean age 69 ± 13 years; high degree AV block 18 [50%]) underwent MR of the heart. No MR related adverse events occurred during MR or thereafter. Ventricular sensing differed significantly between the FU immediately after MR (10.3 ± 5.3 mV) and the baseline FU (9.8 ± 5.3 mV; p < 0.05). Despite PCT [V/0.4ms] was not significantly different between the FUs (baseline: 0.84 ± 0.27; in-between MR scans: 0.82 ± 0.27; immediately after MR: 0.84 ± 0.24; 3-month: 0.85 ± 0.23; 15-month: 0.90 ± 0.67; p = ns), 7 patients (19%) showed PCT increases by 100% (max. PCT measured: 1.0 V) at the 3-month FU compared to baseline. RV pacing impedance [Ω/5V] differed significantly at the FU in-between MR scans (516 ± 47), and at the 15-month FU (482 ± 58) compared to baseline (508 ± 75). CONCLUSION: The results of our study suggest MR of the heart to be safe in patients with the MR conditional EnRhythm/Advisa system, albeit although noticeable but clinically irrelevant ventricular PCT changes were observed.

Implantable defibrillators with enhanced detection algorithms: detection performance and safety results from the PainFree SST study.

BACKGROUND: Implantable defibrillators (ICD) are highly effective in reducing arrhythmia-related mortality. ICD shock therapy has been shown to increase psychological distress, health care utilization, and is associated with increased mortality. The Protecta ICDs (Medtronic Inc., Minneapolis, MN, USA) have algorithms designed to reduce unnecessary and inappropriate shock therapy. METHODS AND RESULTS: The PainFree SmartShock™ Technology (PainFree SST) study is a prospective, multicenter, clinical trial with two consecutive phases, a premarket phase safety study and a postmarket phase effectiveness study. We report the results of the PainFree SST safety study. The premarket phase aimed to investigate safety in the first year postimplant, and to determine if the novel algorithms (T-wave discrimination, right ventricular lead noise discrimination and confirmation+) affect appropriate ventricular fibrillation (VF) detection. Patients (total: n = 246 [male 78%, mean age 63 year, primary prevention indication in 76%]) were implanted either with a Protecta XT dual-chamber ICD (n = 114 [46%]) or a defibrillator with cardiac resynchronization therapy (n = 132 [54%]). Appropriate VF detection was measured during VF induction at implantation when the novel algorithms were programmed ON. A two-second delay in VF detection was classified as clinically significant. No delay in VF detection was observed with all algorithms programmed ON. No unanticipated serious adverse device effects occurred during first year postimplant. CONCLUSION: The results of the premarket phase of the PainFree SST trial demonstrate the safety of the Protecta XT defibrillators. Detection of induced VF was not delayed with SmartShock™ algorithms ON.

Benefit of immediate beta-blocker therapy on mortality in patients with ST-segment elevation myocardial infarction.

OBJECTIVES: Despite the recommendations to initiate ß-blockade to all patients with an ST-segment elevation myocardial infarction, data concerning the timing of the administration of ß-blockers are controversially discussed. In view of these controversies, we analyzed the effect of immediate vs. delayed ß-blockade on all-cause mortality of patients with ST-segment elevation myocardial infarction in the Lower Austrian Myocardial Infarction Network. DESIGN: Nonrandomized, prospective observational cohort study. SETTING: Myocardial infarction network including the out-of-hospital emergency services, five primary-care hospitals and a percutaneous coronary intervention-capable hospital in the western part of Lower Austria. PATIENTS: The data of all patients with ST-segment elevation myocardial infarction defined according to the American Heart Association criteria and treated according to the treatment protocol of the network were consecutively collected. For the purpose of survival analyses, the baseline survival time was set to 48 hours after the first electrocardiogram, and in all patients with recurrent MI within the observational period, only the first MI was regarded. INTERVENTIONS: The treatment protocol recommended either the immediate oral administration of 2.5 mg bisoprolol (within 30 min after the first electrocardiogram) or 24 hours after acute myocardial infarction (delayed ß-blockade). MEASUREMENTS AND MAIN RESULTS: In total, out of the 664 patients with ST-segment elevation myocardial infarction, 343 (n = 52%) received immediate ß-blockade and 321 (48%) received delayed ß-blockade. The probability of any death (baseline survival time: 48 hours after first electrocardiogram; 640 patients) was 19.2% in the delayed treatment group and 10.7% in the immediate treatment group (p = 0.0022). Also the probability of cardiovascular mortality was significantly lower in the immediate ß-blocker treatment group (immediate treatment group: 9 (5.2%); delayed treatment group: 30 (13.4%); p = 0.0002). Multivariable Cox regression analysis identified immediate ß-blocker therapy to be independently protective against death of any cause (odds ratio: 0.55, p = 0.033). CONCLUSION: Immediate ß-blocker administration in the emergency setting is associated with a reduction of all-cause and cardiovascular mortality in patients with ST-segment elevation myocardial infarction and seems to be superior to a delayed ß-blockade in our patient cohort.

Monocenter feasibility study of the MRI compatibility of the Evia pacemaker in combination with Safio S pacemaker lead.

BACKGROUND: The purpose of this study was to evaluate the feasibility of the magnetic resonance (MR) conditional pacemaker (PM) system (Evia SR-T and DR-T with Safio S leads) under MR conditions. METHODS: Patients with standard PM indications and Evia PM were eligible for enrollment in this single center prospective non-randomized pilot study. Patients underwent MR of the brain and lower lumbar spine at 1.5 Tesla. Atrial (RA) und ventricular (RV) lead parameters (sensing, pacing threshold [PTH], pacing impedance) were assessed immediately before (baseline follow-up [FU]) and immediately after MRI (1st FU), after 1 month (2nd FU) and 3 months (3rd FU). The effect of MR on serious adverse device effect (SADE) free-rate, on atrial and ventricular sensing (AS/VS; mV) and atrial (RA) and ventricular (RV) pacing thresholds (PTH; V/0.4 ms) were investigated between baseline and 2nd FU. Continuous variables are expressed as mean ± SD and were compared using paired Student's t-test. A p < 0.05 was considered significant. RESULTS: Thirty-one patients were enrolled. One patient had to be excluded because of an enrollment violation. Therefore, data of 30 patients (female 12 [40%], age 73 ± 12 years, dual chamber PM 15 [50%]) were included in this analysis. No MR related SADE occurred. Lead measurements were not statistically different between the baseline FU and the 2nd FU (AS/VS at baseline 3.2 ± 2.1/15.0 ± 6.0, at 2nd FU 3.2 ± 2.1/14.9 ± 6.5; p = ns. RA-PTH/RV-PTH at baseline 0.68 ± 0.18/0.78 ± 0.22, at 2nd FU 0.71 ± 0.24/0.78 ± 0.22; p = ns). The presence of the permanent pacemakers led to MR imaging artifacts on diffusion weighted sequences of the brain, but did not affect other sequences (e.g. FLAIR and T2 weighted spin-echo images). CONCLUSION: The use of the MR conditional Evia PM in a MR environment under predefined conditions is feasible. No MR related SADEs nor clinically relevant changes in device functions occurred.

Prehospital treatment of patients with acute myocardial infarction with bivalirudin.

OBJECTIVES: Patients with acute myocardial infarction are at high risk of dying within the first hours after onset of coronary ischemia. Therefore, pharmacological intervention should be started in the prehospital setting. This study investigates the effect of the prehospital administration of bivalirudin on short-term morbidity and mortality compared to heparin plus abciximab in patients with ST-segment-elevation myocardial infarction (STEMI). METHODS: One hundred ninety-eight patients with STEMI treated with bivalirudin in the prehospital setting were prospectively collected. Coronary angiography was performed to identify the infarct-related artery. In case of a percutaneous coronary intervention, bivalirudin was given according to the guidelines. The historic control group consisted of 171 consecutive patients from the same myocardial infarction network treated with unfractioned heparin and abciximab administration before the admission to the emergency department of the percutaneous coronary intervention center. The primary outcome parameter was the incidence of major adverse cardiac events (recurrent myocardial infarction, stroke, death, target vessel revascularization for ischemia) within 30 days after the primary event. RESULTS: The overall rate of major adverse cardiac events was significantly lower in the bivalirudin group compared to the abciximab group (7.6% vs 14.6%; P = .04). The number of major bleedings was significantly higher in the abciximab group compared to the bivalirudin group (11.8% vs 3.8%; P = .03). CONCLUSIONS: The use of bivalirudin in the prehospital setting leads to a reduced rate of major cardiovascular events compared to a standard treatment with abciximab plus heparin. Bivalirudin is a reasonable choice of treatment in the prehospital setting for patients with STEMI.

Therapeutic hypothermia after cardiac arrest in Lower Austria--a cross-sectional survey.

This study was undertaken to evaluate the use of therapeutic hypothermia (TH) after cardiac arrest in Lower Austria. A questionnaire was sent to intensive care units (ICUs) in Lower Austria. Methods of inducing and maintaining hypothermia, the practise of rewarming, concomitant therapies and reasons not to cool were documented. Of the 23 ICUs 10 (43%) used TH. Nine (39%) cooled their patients to 32-34°C and one to 34-35°C. Duration of cooling was 24 h (n=8, 35%), 24-48 h (n=1) or 48 h (n=1). For induction of hypothermia, ICUs used cold infusions (n=5, 22%), surface (n=7, 30%) or endovascular cooling (n=6, 26%). The same methods were used during the maintenance period. Reasons not to cool were insufficient staff resources (n=4, 17%), technical complexity of cooling (n=4, 17%) and too little information (n=3, 13%). In conclusion, TH has been poorly implemented in Lower Austria. The reasons for not using hypothermia could possibly be dispelled by education.

Impact of dual chamber pacing on the incidence of atrial and ventricular tachyarrhythmias in recipients of implantable cardioverter defibrillators.

Recent observations suggest that frequent dual-chamber pacing in recipients of implantable cardioverter defibrillators (ICD) may adversely influence clinical outcomes. This prospective, multicenter study examined the relationship between the frequency of atrial (%AP) and ventricular pacing (%VP) and the incidence of atrial (AT) and/or ventricular tachyarrhythmias (VT) in a standard ICD population. A total of 141 consecutive patients with primary and secondary ICD indications were studied. Continuous arrhythmia detection with a dual-chamber ICD revealed paroxysmal AT in 60 (43%) and VT in 72 (51%) patients within 6 months of device implantation. Far-field oversensing of ventricular signals occurred in 13% of all "atrial tachy response" mode switches. Without adjustment for covariates, a higher %AP was associated with an increased incidence of AT (P < 0.05). However, this association remained only weakly significant after adjustment for covariates using a multivariate model. High New York heart failure functional classes correlated significantly with AT (P = 0.02) and VT (P = 0.007). Rate-modulated pacing, programmed in 1/3 of patients, correlated with occurrence of AT (P = 0.006), but not with occurrence of VT. With respect to dual-chamber pacing, a %AP >/= 48% combined with a %VP > 40% was associated with an increased probability for VT. In conclusion, AT and VT occurred frequently within 6 months after dual-chamber ICD implantation. High rates of DDD/R stimulation were associated with a trend toward higher incidence of AT, VT, or both.