Catheter ablation of concomitant atrial fibrillation improves survival of patients undergoing transcatheter edge-to-edge mitral valve repair.

Background: Atrial fibrillation (AF) is the most common concomitant disease in patients undergoing transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) and detrimentally affects their outcome. While there is increasing evidence for prognostic improvement and safety of catheter ablation (CA) of AF in the overall cohort of heart failure patients, corresponding data in TEER patients are lacking. Objectives: To investigate the impact of treatment regimens for concomitant AF on survival of TEER patients. Methods: In a multicenter observational cohort study consecutive patients successfully undergoing TEER were analyzed and survival of patients receiving CA of concomitant AF was compared with that of patients on pharmacological AF treatment and with that of patients without a history of AF, using propensity score matching (PSM). Results: A total of 821 patients were analyzed. Of these, 608 (74.1%) had concomitant AF, of whom 48 patients received CA. Patients with CA in AF showed significantly higher 3-year-survival after TEER compared to PSM-patients on pharmacological AF treatment (75.5% [36/48] vs. 49.4% [166/336], p = 0.009). The 3-year-survival after TEER of patients with concomitant AF treated with CA was not significantly different from PSM-patients without AF (75.5% [36/48] vs. 68.3% [98/144], p = 0.36). Conclusions: CA of AF is superior to pharmacotherapy as it significantly improves the survival of TEER patients in a PSM analysis. CA even offsets the prognostic disadvantage of coexisting AF in TEER patients. Given the growing evidence of prognostic benefits in the overall cohort of HF patients, our data point out the importance of treating concomitant AF and support CA as an essential part of a holistic management of TEER patients.

The Impact of Positive Inotropic Therapy on Hemodynamics and Organ Function in Acute Heart Failure: A Differentiated View.

BACKGROUND: Little is known about the impact of treatment with inotropic drugs on the interaction of hemodynamics, biomarkers, and end-organ function in patients with acute decompensated heart failure (HF) of different origins and heart rhythms. METHODS: Fifty patients with different causes of acute decompensated HF (dilated cardiomyopathy DCM, ischemic cardiomyopathy ICM, atrial fibrillation AF, sinus rhythm/pacemaker lead rhythm SR/PM) were treated with dobutamine or levosimendan. Non-invasive hemodynamics, biomarkers, and parameters of renal organ function were evaluated at hospital admission and after myocardial recompensation (day 5 to 7). RESULTS: Twenty-seven patients with ICM and twenty-three patients with DCM were included. Thirty-nine patients were treated with dobutamine and eleven with levosimendan. Sixteen were accompanied by persistent AF and thirty-four presented either with SR or PM. In the overall cohort, body weight and biomarkers (NT-proBNP/ST2) significantly decreased. GFR significantly increased during therapy with either dobutamine or levosimendan. However, hemodynamic parameters seem to be only improved in patients with DCM, in the levosimendan sub-group, and in patients with SR/PM. CONCLUSION: Patients with acute decompensated HF benefit from positive inotropic therapy during short-term follow-ups. In particular, patients with DCM, those after levosimendan therapy and those with SR/PM, seem to benefit most from inotropic therapy.

Antithrombotic Treatment and Its Association with Outcome in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients.

Transcatheter edge-to-edge mitral valve repair (TEER) has become established as a safe and efficacious therapy for severe mitral regurgitation (MR) in high-risk patients. Despite its widespread use, postprocedural antithrombotic therapy (ATT) still to date is based on local expertise rather than evidence. In a multicenter, observational cohort study, 646 consecutive patients undergoing TEER were enrolled; 609 patients were successfully treated and antithrombotic therapy analyzed; 449 patients (73.7%) were previously treated with oral anticoagulants (OAC) due to the high prevalence of atrial fibrillation (459/609, 75.4%). Postprocedural ATT in patients previously treated with OAC consisted of no additional, additional single (SAPT) or dual antiplatelet therapy (DAPT) in 146/449 (33.6%), 248/449 (55.2%) and 55/449 (12.2%), respectively. There were 234/449 (52.1%) patients treated with vitamin-k antagonists (VKA) and 215/449 (47.9%) with nonvitamin-k antagonist oral anticoagulants (NOAC). One hundred sixty patients (26.3%) had no prior indication for OAC and were predominantly treated with DAPT (132/160, 82.5%). Use of SAPT (17/160, 10.6%) and no APT (11/160, 6.9%) was marginal. No statistically significant differences in terms of in-hospital mortality or the rate of major adverse cardiac and cerebrovascular events (MACCE) between the different antithrombotic therapy regimens were observed. Multiple Cox regression analysis showed a statistically significant decreased risk for all-cause mortality after a median follow-up of 419 days for OAC monotherapy (HR 0.6, 95%-CI 0.5-0.9, p = 0.04). This study provides evidence for a more favorable long-term outcome of OAC monotherapy in patients with an indication for OAC and reiterates the urgent need for randomized controlled trials on the optimal antithrombotic treatment of TEER patients.

[What's new in pericardial disease?] / Was ist neu bei Perikard-Erkrankungen?

Pericardial disease represents a large diversity of inflammation related injury of the pericardium. Multifactorial causes may contribute to acute and recurrent pericarditis, pericardial effusion without major hemodynamic compromise, cardiac tamponade or constrictive pericarditis. Currently, inflammatory pericardial pathologies are observed in cases of SARS-CoV-2-infection or after vaccination. Beside established anti-inflammatory therapeutic strategies with NSAID, corticosteroids and colchicine, auto-inflammation and inflammasomes seam to offer more specific targets for advanced treatment options.

Impact of Rhythm vs. Rate Control in Atrial Fibrillation on the Long-Term Outcome of Patients Undergoing Transcatheter Edge-to-Edge Mitral Valve Repair.

Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR) undergoing transcatheter mitral valve repair (TMVR) and has been shown to significantly worsen their outcome. However, data on the impact of AF treatment strategy in this rapidly growing cohort of patients is unknown. In a multicenter, observational cohort study, 542 consecutive patients undergoing TMVR were enrolled, and subsequently, comprehensive survival analyses according to AF status and therapy were performed using propensity score matching and Cox regression. In the analyzed cohort, 373 (73.3%) of the TMVR patients had concomitant AF. Of these patients, 212 (59%) were on rate control therapy and 161 (41%) were on rhythm control therapy. At 3 years, significantly reduced cumulative survival was observed for patients on rhythm compared to patients on rate control (46.7% (75/161) vs. 56.5% (91/161), p = 0.032). Amiodarone was used to a substantial extent for rhythm control and found to be an independent mortality predictor (Hazard Ratio 1.5, 95%CI 1.1-2.1, p = 0.04). The adverse outcome of concomitant AF in TMVR patients was confirmed (AF: 47.3% (126/266) vs. non-AF: 58.3% (78/133), p = 0.047). Rhythm control achieved almost exclusively pharmacologically is associated with an adverse outcome compared to the rate control of AF in TMVR. This raises awareness of the importance of AF and its treatment, as this seems to be a promising key point for improving the prognosis of TMVR patients.

Comparison of Mechanical Support with Impella or Extracorporeal Life Support in Post-Cardiac Arrest Cardiogenic Shock: A Propensity Scoring Matching Analysis.

Our aim was to compare the outcomes of Impella with extracorporeal life support (ECLS) in patients with post-cardiac arrest cardiogenic shock (CS) complicating acute myocardial infarction (AMI). This was a retrospective study of patients resuscitated from out of hospital cardiac arrest (OHCA) with post-cardiac arrest CS following AMI (May 2015 to May 2020). Patients were supported either with Impella 2.5/CP or ECLS. Outcomes were compared using propensity score-matched analysis to account for differences in baseline characteristics between groups. 159 patients were included (Impella, n = 105; ECLS, n = 54). Hospital and 12-month survival rates were comparable in the Impella and the ECLS groups (p = 0.16 and p = 0.3, respectively). After adjustment for baseline differences, both groups demonstrated comparable hospital and 12-month survival (p = 0.36 and p = 0.64, respectively). Impella patients had a significantly greater left ventricle ejection-fraction (LVEF) improvement at 96 h (p < 0.01 vs. p = 0.44 in ECLS) and significantly fewer device-associated complications than ECLS patients (15.2% versus 35.2%, p < 0.01 for relevant access site bleeding, 7.6% versus 20.4%, p = 0.04 for limb ischemia needing intervention). In subgroup analyses, Impella was associated with better survival in patients with lower-risk features (lactate < 8.6 mmol/L, time from collapse to return of spontaneous circulation < 28 min, vasoactive score < 46 and Horowitz index > 182). In conclusion, the use of Impella 2.5/CP or ECLS in post-cardiac arrest CS after AMI was associated with comparable adjusted hospital and 12-month survival. Impella patients had a greater LVEF improvement than ECLS patients. Device-related access-site complications occurred more frequently in patients with ECLS than Impella support.

Left Ventricle Architecture and Valvular Integrity Following Microaxial Mechanical Support: A Two-Year Follow-Up Study.

Although the use of microaxilar mechanical circulatory support systems may improve the outcome of patients with cardiogenic shock (CS), little is known about its effect on the long-term structural integrity of left ventricular (LV) valves as well as on the development of LV-architecture. Therefore, we aimed to study the integrity of the LV valves and architecture and function after Impella support. Thus, 84 consecutive patients were monitored over two years having received ImpellaTM CP (n = 24) or 2.5 (n = 60) for refractory CS (n = 62) or for high-risk percutaneous coronary interventions (n = 22) followed by optimal medical treatment. Beside a significant increase in LV ejection fraction after two years (p ≤ 0.03 vs. pre-implantation), we observed a statistically significant decrease in LV dilation (p < 0.001) and severity of mitral valve regurgitation (p = 0.007) in the two-year follow-up period, suggesting an improved LV architecture. Neither the duration of support, nor the size of the Impella device or the indication for its use revealed any devastating impact on aortic or mitral valve integrity. These findings indicate that Impella device is a safe means of support of LV-function without detrimental long-term effects on the structural integrity of LV valves regardless of the size of the device or the indication of support.

Biventricular Unloading with Impella and Venoarterial Extracorporeal Membrane Oxygenation in Severe Refractory Cardiogenic Shock: Implications from the Combined Use of the Devices and Prognostic Risk Factors of Survival.

Since mechanical circulatory support (MCS) devices have become integral component in the therapy of refractory cardiogenic shock (RCS), we identified 67 patients in biventricular support with Impella and venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO) for RCS between February 2013 and December 2019 and evaluated the risk factors of mortality in this setting. Mean age was 61.07 ± 10.7 and 54 (80.6%) patients were male. Main cause of RCS was acute myocardial infarction (AMI) (74.6%), while 44 (65.7%) were resuscitated prior to admission. The mean Simplified Acute Physiology Score II (SAPS II) and Sequential Organ Failure Assessment Score (SOFA) score on admission was 73.54 ± 16.03 and 12.25 ± 2.71, respectively, corresponding to an expected mortality of higher than 80%. Vasopressor doses and lactate levels were significantly decreased within 72 h on biventricular support (p < 0.05 for both). Overall, 17 (25.4%) patients were discharged to cardiac rehabilitation and 5 patients (7.5%) were bridged successfully to ventricular assist device implantation, leading to a total of 32.8% survival on hospital discharge. The 6-month survival was 31.3%. Lactate > 6 mmol/L, vasoactive score > 100 and pH < 7.26 on initiation of biventricular support, as well as Charlson comorbity index > 3 and prior resuscitation were independent predictors of survival. In conclusion, biventricular support with Impella and VA-ECMO in patients with RCS is feasible and efficient leading to a better survival than predicted through traditional risk scores, mainly via significant hemodynamic improvement and reduction in lactate levels.

Early Impella Support in Postcardiac Arrest Cardiogenic Shock Complicating Acute Myocardial Infarction Improves Short- and Long-Term Survival.

OBJECTIVES: Early mechanical circulatory support with Impella may improve survival outcomes in the setting of postcardiac arrest cardiogenic shock after out-of-hospital cardiac arrest complicating acute myocardial infarction. However, the optimal timing to initiate mechanical circulatory support in this particular setting remains unclear. Therefore, we aimed to compare survival outcomes of patients supported with Impella 2.5 before percutaneous coronary intervention (pre-PCI) with those supported after percutaneous coronary intervention (post-PCI). DESIGN: Retrospective single-center study between September 2014 and December 2019 admitted to the Cardiac Arrest Center in Marburg, Germany. PATIENTS: Out of 2,105 patients resuscitated from out-of-hospital cardiac arrest due to acute myocardial infarction with postcardiac arrest cardiogenic shock between September 2014 and December 2019 and admitted to our regional cardiac arrest center, 81 consecutive patients receiving Impella 2.5 during admission coronary angiogram were identified. OUTCOMES/MEASUREMENTS: Survival outcomes were compared between those with Impella support pre-PCI to those with support post-PCI. MAIN RESULTS: A total of 81 consecutive patients with infarct-related postcardiac arrest shock supported with Impella 2.5 during admission coronary angiogram were included. All patients were in profound cardiogenic shock requiring catecholamines at admission. Overall survival to discharge and at 6 months was 40.7% and 38.3%, respectively. Patients in the pre-PCI group had a higher survival to discharge and at 6 months as compared to patients of the post-PCI group (54.3% vs 30.4%; p = 0.04 and 51.4% vs 28.2%; p = 0.04, respectively). Furthermore, the patients in the early support group demonstrated a greater functional recovery of the left ventricle and a better restoration of the end-organ function when Impella support was initiated prior to percutaneous coronary intervention. CONCLUSIONS: Our results suggest that the early initiation of mechanical circulatory support with Impella 2.5 prior to percutaneous coronary intervention is associated with improved hospital and 6-month survival in patients with postcardiac arrest cardiogenic shock complicating acute myocardial infarction.

Comparison of Mortality Risk Models in Patients with Postcardiac Arrest Cardiogenic Shock and Percutaneous Mechanical Circulatory Support.

BACKGROUND: Although scoring systems are widely used to predict outcomes in postcardiac arrest cardiogenic shock (CS) after out-of-hospital cardiac arrest (OHCA) complicating acute myocardial infarction (AMI), data concerning the accuracy of these scores to predict mortality of patients treated with Impella in this setting are lacking. Thus, we aimed to evaluate as well as to compare the prognostic accuracy of acute physiology and chronic health II (APACHE II), simplified acute physiology score II (SAPS II), sepsis-related organ failure assessment (SOFA), the intra-aortic balloon pump (IABP), CardShock, the prediction of cardiogenic shock outcome for AMI patients salvaged by VA-ECMO (ENCOURAGE), and the survival after venoarterial extracorporeal membrane oxygenation (SAVE) score in patients with OHCA refractory CS due to an AMI treated with Impella 2.5 or CP. METHODS: Retrospective study of 65 consecutive Impella 2.5 and 32 CP patients treated in our cardiac arrest center from September 2015 until June 2020. RESULTS: Overall survival to discharge was 44.3%. The expected mortality according to scores was SOFA 70%, SAPS II 90%, IABP shock 55%, CardShock 80%, APACHE II 85%, ENCOURAGE 50%, and SAVE score 70% in the 2.5 group; SOFA 70%, SAPS II 85%, IABP shock 55%, CardShock 80%, APACHE II 85%, ENCOURAGE 75%, and SAVE score 70% in the CP group. The ENCOURAGE score was the most effective predictive model of mortality outcome presenting a moderate area under the curve (AUC) of 0.79, followed by the CardShock, APACHE II, IABP, and SAPS score. These derived an AUC between 0.71 and 0.78. The SOFA and the SAVE scores failed to predict the outcome in this particular setting of refractory CS after OHCA due to an AMI. CONCLUSION: The available intensive care and newly developed CS scores offered only a moderate prognostic accuracy for outcomes in OHCA patients with refractory CS due to an AMI treated with Impella. A new score is needed in order to guide the therapy in these patients.

Comparison of mechanical circulatory support with venoarterial extracorporeal membrane oxygenation or Impella for patients with cardiogenic shock: a propensity-matched analysis.

BACKGROUND: Percutaneous mechanical circulatory devices are increasingly used in patients with cardiogenic shock (CS). As evidence from randomized studies comparing these devices are lacking, optimal choice of the device type is unclear. Here we aim to compare outcomes of patients with CS supported with either Impella or vaECMO. METHODS: Retrospective single-center analysis of patients with CS, from September 2014 to September 2019. Patients were assisted with either Impella 2.5/CP or vaECMO. Patients supported ultimately with both devices were analyzed according to the first device implanted. Primary outcomes were hospital and 6-month survival. Secondary endpoints were complications. Survival outcomes were compared using propensity-matched analysis to account for differences in baseline characteristics between both groups. RESULTS: A total of 423 patients were included (Impella, n = 300 and vaECMO, n = 123). Survival rates were similar in both groups (hospital survival: Impella 47.7% and vaECMO 37.3%, p = 0.07; 6-month survival Impella 45.7% and vaECMO 35.8%, p = 0.07). There was no significant difference in survival rates, even after adjustment for baseline differences (hospital survival: Impella 50.6% and vaECMO 38.6%, p = 0.16; 6-month survival Impella 45.8% and vaECMO 38.6%, p = 0.43). Access-site bleeding and leg ischemia occurred more frequently in patients with vaECMO (17% versus 7.3%, p = 0.004; 17% versus 7.7%, p = 0.008). CONCLUSIONS: In this retrospective analysis of patients with CS, treatment with Impella 2.5/CP or vaECMO was associated with similar hospital and 6-month survival rates. Device-related access-site vascular complications occurred more frequently in the vaECMO group. A randomized trial is warranted to examine the effects of these devices on outcomes and to determine the optimal device choice in patients with CS.

Analysis of Atrial Fibrillation Treatment Regimes in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients.

BACKGROUND: Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR). Recent studies show a deleterious outcome of patients with concomitant AF after transcatheter mitral valve repair (TMVR). This underlines the essential need for additional strategies that ameliorate the prognosis of these patients. Fundamental data on AF characteristics and treatment regimes in this special cohort of patients are lacking. METHODS: We retrospectively analyzed the data of 542 consecutive patients with severe MR undergoing TMVR in three tertiary heart centers with special focus on AF type and underlying treatment strategies. RESULTS: The prevalence of concomitant AF was 73.3%, and AF did not affect the procedural success or the incidence of major adverse cardiac and cerebrovascular events. The patients with AF were more frequently >75 years, had more tricuspid regurgitation, and less coronary artery disease than non-AF patients. The distribution of AF types was 32% paroxysmal AF, 27% persistent AF, and 41% permanent AF. Except for a higher degree in severe tricuspid regurgitation and a higher likelihood of male sex, no substantial differences were observed while comparing permanent and nonpermanent AF patients. The predominant treatment regime was rate control (57%), with only beta blockers (BB) in the majority of persistent and permanent AF patients, while additional digitalis or a pacemaker was used infrequently. Rhythm control was mainly achieved with BB alone in paroxysmal AF patients and with additional antiarrhythmic drugs in the majority of persistent AF patients. Interventional rhythm control therapy was performed in 2.5% and 30.9% of paroxysmal and persistent AF patients, respectively. The guideline-adherent use of oral anticoagulants was comparable and high in both groups (91.9% in nonpermanent vs. 90.1% in permanent AF). CONCLUSION: This is the first study to provide necessary information for the understanding of the current clinical practice in dealing with TMVR patients. Since evidence suggests that AF is not a benign concomitant disease, further investigations are needed to assess the prognostic impact of these different AF treatment strategies.

Effectiveness and Impact on Adherence of a New Fixed-Dose Combination of Ivabradine and Metoprolol in a Wide Range of Stable Angina Patients in Real-Life Practice.

INTRODUCTION: The antianginal effectiveness of ivabradine administration in addition to beta-blockers has been shown in patients with stable angina. The first fixed-dose combination (FDC) of ivabradine and metoprolol is now available and its evaluation in various stable angina patient populations relevant to clinical practice would be useful. METHODS: In this 4-month, prospective, multicenter, observational study, the effectiveness and tolerability of the metoprolol/ivabradine FDC was assessed in patient subgroups specified according to age, coronary artery disease (CAD) duration, Canadian Cardiovascular Society (CCS) class, co-morbidities, and previous myocardial infarction (MI) or revascularization. Heart rate (HR), angina attack frequency, short-acting nitrate (SAN) consumption, functional status, and medication adherence were documented at baseline and after 4 months of follow-up. RESULTS: A total of 747 stable angina patients were included and divided into subgroups. At 4 months, a significant decrease in HR, angina attack frequency, and SAN consumption per week was consistently observed across all patient subgroups. The proportion of CCS class I patients increased significantly from baseline to month 4. In all patient subgroups, at 4 months, a significant increase was observed in the proportion of patients with self-reported complete adherence. Complete adherence at the final visit was found to decrease with an increasing number of medications. Physicians evaluated the effectiveness and tolerability of the FDC as 'very good' and 'good' for more than 96% of patients in all analyzed patient subgroups. CONCLUSIONS: Treatment with metoprolol/ivabradine FDC significantly improved angina symptoms and adherence, with an excellent tolerability profile, in stable angina patient subgroups relevant to real-life clinical practice, regardless of age, CAD duration, CCS class, comorbidities, previous MI, or history of revascularization. TRIAL REGISTRATION: ISRCTN51906157. FUNDING: This study was sponsored by Servier Deutschland GmbH. Editorial assistance and the Rapid Service Fee were funded by Servier, France. Plain language summary available for this article.

Treatment of Stable Angina with a New Fixed-Dose Combination of Ivabradine and Metoprolol: Effectiveness and Tolerability in Routine Clinical Practice.

INTRODUCTION: In this prospective, multicenter, observational cohort study, the effectiveness and tolerability of the first fixed-dose combination (FDC) formulation of the selective heart rate reducing agent ivabradine and the beta-blocker metoprolol was evaluated in stable angina pectoris (AP) patients in a clinical practice setting. METHODS: Stable AP outpatients received a FDC of ivabradine and metoprolol (b.i.d.) for 4 months, in addition to cardiovascular standard therapy. Resting heart rate (HR), number of angina attacks, short-acting nitrate consumption, severity of symptoms (assessed by patient judgment and documented by CCS score) and tolerability were documented. Medication adherence was assessed by a modified four-item Morisky questionnaire. Descriptive statistics were performed on all data. RESULTS: A total of 747 stable AP patients (mean age, 66.4 years, 62% male, 50% and 31% with previous PCI and myocardial infarction, respectively) were included. Apart from ivabradine and beta-blockers as free combination, most frequently used concomitant standard medications at baseline were aspirin (68%), statins (71%), ACEI/AT1-blockers (76%), diuretics (35%), and calcium antagonists (15%). Highly prevalent comorbidities were hypertension (86%), hyperlipidemia (65%), and diabetes (35%). After 4 months, switch to treatment with the FDC was associated with a significant reduction in mean HR by 10 bpm. Proportion of patients with ≥ 1 angina attacks/week decreased from 38 to 7%. Patients in CCS class 1 increased (25 to 63%), while they decreased in CCS class 3 (19 to 5%). Medication adherence was also significantly improved (p < 0.001 for all changes from baseline). Mostly mild adverse events were documented in 5.4% of patients. CONCLUSIONS: In these stable AP patients in a real-life setting, treatment with a FDC of ivabradine and metoprolol was associated with reduced HR and angina symptoms, while exercise capacity (CCS score) was improved. These effects may be mainly mediated by the increased medication adherence of patients observed with use of the FDC formulation. FUNDING: Servier TRIAL REGISTRATION NUMBER: ISRCTN51906157.

Home monitoring after ambulatory implanted primary cardiac implantable electronic devices: The home ambulance pilot study.

BACKGROUND: The Home Monitoring (HM) system of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias or device system failures. The aim of this pilot study was to examine how the safety and efficacy of the HM system in patients after ambulatory implanted primary CIEDs compare to patients with a standard procedure and hospitalization. HYPOTHESIS: We hypothesized that HM and their modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs. METHODS: This retrospective analysis evaluates telemetric data obtained from 364 patients in an ambulatory single center over 6 years. Patients were assigned to an active group (n = 217), consisting of those who were discharged early on the day of implantation of the primary CIED, or to a control group (n = 147), consisting of those discharged and followed up with the HM system according to usual medical practices. RESULTS: The mean duration of hospitalization was 73.2% shorter in the active group than in the control group, corresponding to 20.5 ± 13 fewer hours (95% confidence interval [CI]: 6.3-29.5; P < 0.01) spent in the hospital (7.5 ± 1.5 vs 28 ± 4.5 h). This shorter mean hospital stay was attributable to a 78.8% shorter postoperative period in the active group. The proportion of patients with treatment-related adverse events was 11% (n = 23) in the active group and 17% (n = 25) in the control group (95% CI: 5.5-8.3; P = 0.061). This 6% absolute risk reduction (95% CI: 3.3-9.1; P = 0.789) confirmed the noninferiority of the ambulatory implanted CIED when compared with standard management of these patients. CONCLUSIONS: Early discharge with the HM system after ambulatory CIED implantation was safe and not inferior to the classic medical procedure. Thus, together with lower costs, HM and its modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs.

New Task Force Criteria Provide Evolution in Diagnosis of Arrhythmogenic Cardiomyopathy in Patients without Typical Progression of the Disease.

BACKGROUND The original Task Force Criteria from 1994 for the clinical diagnosis of ARVC were highly specific and based on structural, histological, EKG, and familial features of disease. However, recommendations for clinical diagnosis and management of ARVC are sparse and lacked sensitivity for early disease. CASE REPORT Ventricular electrical instability and sudden cardiac death are the hallmarks of ARVC, and are often present before structural abnormalities. In this case report, we describe a patient who had detectable electrical abnormalities and structural changes that remained unchanged for over 10 years. CONCLUSIONS The disease progression in this case was defined as the development of a new 2010 TFC, which was absent at enrolment in 1994 and in 2008.

A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.

AIMS: Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. METHODS AND RESULTS: This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%). CONCLUSIONS: The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

Cardiac troponin T and echocardiographic dimensions after repeated sprint vs. moderate intensity continuous exercise in healthy young males.

Regular physical exercise can positively influence cardiac function; however, investigations have shown an increase of myocardial damage biomarkers after acute prolonged endurance exercises. We investigated the effect of repeated sprint vs. moderate long duration exercise on markers of myocardial necrosis, as well as cardiac dimensions and functions. Thirteen healthy males performed two different running sessions (randomized, single blinded cross-over design): 60 minutes moderate intensity continuous training (MCT, at 70% of peak heart rate (HRpeak)) and two series of 12 × 30-second sprints with set recovery periods in-between (RST, at 90% HRpeak). Venous blood samples for cardiac troponin T (cTnT), creatine kinase (CK) and MB isoenzyme (CK-MB) were taken 1 and 4 hours after exercise sessions. After each session electrocardiographic (ECG) and transthoracic echocardiographic (TTE) data were recorded. Results showed that all variables - average heart rate, serum lactate concentration during RST, subjective exertion and cTnT after RST - were significantly higher compared to MCT. CK and CK-MB significantly increased regardless of exercise protocol, while ECG and TTE indicated normal cardiac function. Our results provide evidence that RST contributes significantly to cTnT and CK release. This biomarker increase seems to reflect a physiological rather than a pathological phenomenon in healthy, exercising subjects.

Predicting long-term outcomes of acute aortic dissection: a focus on gender.

Acute aortic disease ranks as the 19th leading cause of death with steadily increasing incidence. The prevalence of aneurysms varies depending on the localization along the aorta with a mortality of aortic rupture of around 80%. Traditionally, aortic disease affects men more frequently than women, however, with a varying gender ratio. Nevertheless, in the setting of acute aortic dissection, the International Registry of Acute Aortic Dissections identified significant gender-related differences in the management of both sexes with acute aortic conditions. Current data suggest that women are at an increased risk of both dying from aortic dissection and having aorta-related complications than men. This review aims to report on current evidence of gender impact on natural history, treatment and outcomes in patients with acute aortic dissection.

Early and late management of type B aortic dissection.

The management of type B aortic dissection is undergoing profound changes with timely TEVAR accepted as first-line strategy in the setting of complicated dissection; with recent technological advances and in experienced hands this intervention is considered safe and life-saving. With the ability to remodel the dissected aorta as a result of scaffolding even pre-emptive endovascular treatment is being considered and supported by long-term stability and often prevention of aneurysmal expansion. This insight and a growing number of silent risk conditions (resistant hypertension, partial false lumen thrombosis) may lower the threshold for TEVAR in asymptomatic patients in the subacute phase. In the chronic phase of a type B dissection patients are usually free of symptoms, however, with the expanding false lumen at risk of rupture. Advanced TEVAR options (including branches and fenestrations) are likely to be used more often than open surgical replacement of such aneurysmatic segment of the dissected aorta in that chronic phase. All dissection patients should be offered lifelong surveillance.