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Mitral valve transcatheter edge-to-edge repair (M-TEER) reduces secondary mitral regurgitation (MR) in heart failure and impacts survival in selected patients as demonstrated in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. However, long-term outcome data after M-TEER under real-world conditions are lacking. This study sought to assess long-term efficacy and survival after M-TEER in a large real-world registry. We analyzed patients with significant secondary MR undergoing M-TEER from the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry. Long-term MR reduction, functional outcomes, survival rate, and predictors for all-cause mortality were assessed. In this study, 1,628 patients undergoing M-TEER (mean age 73.8 years, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 6.9%, 86.6% NYHA functional class ≥III) with available long-term data were included. Five-year survival was 35.0%. Long-term MR reduction (MR grade ≤2+: baseline 4.1%, discharge 92.2%, 5-year follow-up 85.5%; P < 0.001) and functional improvement (NYHA ≤II: baseline 13.4%, 5-year follow-up 60.1%; P < 0.001) was observed. The degree of residual MR was associated with 5-year survival (residual MR grade ≤1+: 38.6%; 2+: 30.5%; ≥3+: 22.6%; P < 0.001). Independent predictors for 5-year all-cause mortality post–M-TEER included age, renal function, residual MR, NYHA functional class, left ventricular ejection-fraction, and COAPT trial eligibility (P < 0.01 for all). This extensive multicenter registry underscores the long-term efficacy of M-TEER in real-world clinical practice and identifies predictors for long-term survival. These findings contribute valuable insights for optimizing patient selection in routine clinical interventions. [Display omitted] [ABSTRACT FROM AUTHOR]

BACKGROUND Arrhythmia recurrence after pulmonary vein isolation (PVI) is common. We conducted a multicenter, randomized trial to determine the impact of increased physical activity on atrial fibrillation recurrence after PVI. METHODS: From 2018 to 2020, we randomly assigned 200 patients with atrial fibrillation to the ACTION or NO-ACTION group in 4 different centers in the local country of Brandenburg, Germany. Patients were eligible if they were scheduled to undergo PVI, aged ≥50 to ≤77 years, body mass index ≥23 to ≤35 kg/m², and accepted wearing an activity tracker allowing 24-hour activity monitoring via mobile app. Patients in the ACTION group were actively remote-controlled via transmitted activity data by a physiotherapist, and individual motivational interviewing call sessions were scheduled with each ACTION patient every 2 weeks. The primary end point was the composite of recurrence of any atrial arrhythmia >30 seconds, additional ablation procedure, cardioversion, and new onset of antiarrhythmic drugs earliest after 90 days after index PVI over 12 months. RESULTS Overall, the median age of patients was 66 (interquartile range, 61-71) years, 33.5% were women, and 52% had persistent atrial fibrillation. The number of steps per day increased in both groups of patients from baseline to 12 months (P<0.001). The absolute increase in steps per day did not differ between patients in the ACTION group with +3205 steps (597-4944) compared with those in the NO-ACTION group +2423 steps (17-4284), P=0.325. Unadjusted intention-to-treat analysis showed no difference in the primary composite end point in the ACTION group (27.3%) versus the NO-ACTION group (32.7%), P=0.405. CONCLUSIONS: Physical activity improved in patients after PVI. The present randomized controlled trial shows that activity tracker and motivational calls to increase physical activity versus activity tracker alone did not reduce the occurrence of the primary composite end point of atrial fibrillation recurrence or the absolute increase in steps per day. [ABSTRACT FROM AUTHOR]

Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients. The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort. Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular–to–pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMT tit) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years. Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMT tit showed a significantly higher long-term survival vs the 729 patients not on GDMT tit (61.8% vs 36.0%; P < 0.00001). Propensity score–matched analysis confirmed a significant association between GDMT tit and higher survival (61.0% vs 43.1%; P = 0.018). GDMT tit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMT tit vs those not on GDMT tit). Its association with better outcomes was confirmed among all subgroups analyzed. In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities. [Display omitted] [ABSTRACT FROM AUTHOR]

Acute decompensated heart failure (ADHF) is a global health problem and early detection of high-risk patients for effective treatment is important. Exhaled breath analysis and measurement of volatile organic compounds (VOCs) may be a fast and cost-effective non-invasive diagnostic and screening tool complementing measurement of cardiac biomarkers. Another technique to detect and characterize VOCs is the ion mobility spectrometry (IMS) not requiring vacuum or sample pretreatment. This prospective controlled proof-of-concept study prospectively enrolled adult patients with severe ADHF at the University Hospital Heart Centre Brandenburg. Severe ADHF was defined as patients presenting with symptomatic acute decompensation and NTproBNP >7000 pg/dL. Cardiac patients with NT-proBNP 220 pg/dL served as control. A gas chromatography ion mobility spectrometer (GC-IMS) of the type "MultiMarkerMonitor™" from GRAUPNER medical solutions GmbH was used. Measurement was performed at T0 (within 24 h of admission), T1 (after 3–5 days) and T2 (after 8–10 days). Forty patients were enrolled in the study, 20 patients with severe ADHF and 20 control patients. In patients with severe ADHF, three clusters with significantly altered maximum peak heights were detected compared to control. There was no change in the peak height of clusters 8, 9 and 206 at the time points T1 and T2 (all p > 0.50). Also, NT-proBNP was stable over time (p = 0.247). Sixteen control patients (16/20, 80 %) and four with severe ADHF (4/20, 20 %) presented without cluster deviation. Patients with deviation in at least two clusters had longer hospital stay, 11 days (5.0–15.0) compared to those without deviation, 4 days (2.0–9.5), p = 0.028. Longer-term follow-up studies are needed to assess the stability and clinical significance of the identified clusters by IMS and their diagnostic and prognostic relevance. [Display omitted] • Identification of VOC patterns differentiating between patients with and without ADHF • Promising utility of VOC analysis for the early detection of ADHF • Prolonged hospitalization in patients with cluster deviations observed [ABSTRACT FROM AUTHOR]

Guideline-directed medical therapy (GDMT) optimization is mandatory before transcatheter edge-to-edge mitral valve repair (M-TEER) in patients with secondary mitral regurgitation (SMR) and heart failure (HF) with reduced ejection fraction (HFrEF). However, the effect of M-TEER on GDMT is unknown. The authors sought to evaluate frequency, prognostic implications and predictors of GDMT uptitration after M-TEER in patients with SMR and HFrEF. This is a retrospective analysis of prospectively collected data from the EuroSMR Registry. The primary events were all-cause death and the composite of all-cause death or HF hospitalization. Among the 1,641 EuroSMR patients, 810 had full datasets regarding GDMT and were included in this study. GDMT uptitration occurred in 307 patients (38%) after M-TEER. Proportion of patients receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists was 78%, 89%, and 62% before M-TEER and 84%, 91%, and 66% 6 months after M-TEER (all P < 0.001). Patients with GDMT uptitration had a lower risk of all-cause death (adjusted HR: 0.62; 95% CI: 0.41-0.93; P = 0.020) and of all-cause death or HF hospitalization (adjusted HR: 0.54; 95% CI: 0.38-0.76; P < 0.001) compared with those without. Degree of MR reduction between baseline and 6-month follow-up was an independent predictor of GDMT uptitration after M-TEER (adjusted OR: 1.71; 95% CI: 1.08-2.71; P = 0.022). GDMT uptitration after M-TEER occurred in a considerable proportion of patients with SMR and HFrEF and is independently associated with lower rates for mortality and HF hospitalizations. A greater decrease in MR was associated with increased likelihood for GDMT uptitration. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Transvenous lead extraction (TLE) has evolved as one of the most crucial treatment options for patients with cardiac device-related systemic infection (CDRSI).Objective: The aim of this study was to characterize the procedural outcome and risk factors of patients with CDRSI undergoing TLE.Methods: A subgroup analysis of patients with CDRSI of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was performed. Predictors for complications, procedural failure, and all-cause mortality were evaluated.Results: A total of 722 patients (28.6%) in the GALLERY had "systemic infection" as extraction indication. Patients with CDRSI were older (70.1 ± 12.2 years vs 67.3 ± 14.3 years; P < .001) and had more comorbidities than patients with local infections or noninfectious extraction indications. There were no differences in complete procedural success (90.6% vs 91.7%; P = .328) or major complications (2.5% vs 1.9%; P = .416) but increased procedure-related (1.4% vs 0.3%; P = .003) and all-cause in-hospital mortality (11.1% vs 0.6%; P < .001) for patients with CDRSI. Multivariate analyses revealed lead age ≥10 years as a predictor for procedural complications (odds ratio [OR] 3.23; 95% confidence interval [CI] 1.58-6.60; P = .001). Lead age ≥10 years (OR 2.57; 95% CI 1.03-6.46; P = .04) was also a predictor for procedural failure. We identified left ventricular ejection fraction <30% (OR 1.70; 95% CI 1.00-2.99; P = .049), age ≥75 years (OR 2.1; 95% CI 1.27-3.48; P = .004), chronic kidney disease (OR 1.92; 95% CI 1.17-3.14; P = .01), and overall procedural complications (OR 5.15; 95% CI 2.44-10.84; P < .001) as predictors for all-cause mortality.Conclusion: Patients with CDRSI undergoing TLE demonstrate an increased rate of all-cause in-hospital, as well as procedure-related mortality, despite having comparable procedural success rates. Given these data, it seems paramount to develop preventive strategies to detect and treat CDRSI in its earliest stages. [ABSTRACT FROM AUTHOR]

Among patients with severe functional mitral regurgitation (FMR), atrial functional mitral regurgitation (aFMR) represents an underrecognized entity. Data regarding outcomes after mitral valve transcatheter edge-to-edge repair (M-TEER) in aFMR remain scarce. The objective of this study was to analyze the outcome of aFMR patients undergoing M-TEER. Using patients from the international EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry undergoing M-TEER for FMR, the authors analyzed baseline characteristics and 2-year outcomes in aFMR in comparison to non-aFMR and ventricular FMR. Additionally, the impact of right ventricular dysfunction (RVD) (defined as right ventricular to pulmonary artery uncoupling) on outcome after M-TEER was assessed. Among 1,608 FMR patients treated by M-TEER, 126 (7.8%) were categorized as aFMR. All 126 aFMR patients had preserved left ventricular function without regional wall motion abnormalities, left arterial dilatation and Carpentier leaflet motion type I. Procedural success (defined as mitral regurgitation ≤2+ at discharge) was 87.2% (P < 0.001) and New York Heart Association (NYHA) functional class significantly improved during follow-up (NYHA functional class III/IV: 86.5% at baseline to 36.6% at follow-up; P < 0.001). The estimated 2-year survival rate in aFMR patients was 70.4%. Two-year survival did not differ significantly between aFMR, non-aFMR, and ventricular FMR. Besides NYHA functional class IV, RVD was identified as a strong independent predictor for 2-year survival (HR: 2.82 [95% CI: 1.24-6.45]; P = 0.014). aFMR is a frequent cause of FMR and can be effectively treated with M-TEER to improve symptoms at follow-up. Advanced heart failure symptoms and RVD were identified as important risk factors for survival in aFMR patients. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Transvenous lead extraction (TLE) remains a high-risk procedure.Objective: The purpose of this study was to develop a machine learning (ML)-based risk stratification system to predict the risk of major adverse events (MAEs) after TLE. A MAE was defined as procedure-related major complication and procedure-related death.Methods: We designed and evaluated an ML-based risk stratification system trained using the European Lead Extraction ConTRolled (ELECTRa) registry to predict the risk of MAEs in 3555 patients undergoing TLE and tested this on an independent registry of 1171 patients. ML models were developed, including a self-normalizing neural network (SNN), stepwise logistic regression model ("stepwise model"), support vector machines, and random forest model. These were compared with the ELECTRa Registry Outcome Score (EROS) for MAEs.Results: There were 53 MAEs (1.7%) in the training cohort and 24 (2.4%) in the test cohort. Thirty-two clinically important features were used to train the models. ML techniques were similar to EROS by balanced accuracy (stepwise model: 0.74 vs EROS: 0.70) and superior by area under the curve (support vector machines: 0.764 vs EROS: 0.677). The SNN provided a finite risk for MAE and accurately identified MAE in 14 of 169 "high (>80%) risk" patients (8.3%) and no MAEs in all 198 "low (<20%) risk" patients (100%).Conclusion: ML models incrementally improved risk prediction for identifying those at risk of MAEs. The SNN has the additional advantage of providing a personalized finite risk assessment for patients. This may aid patient decision making and allow better preoperative risk assessment and resource allocation. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the impact of residual mitral regurgitation (resMR) on mortality with respect to left ventricular dilatation (LV-Dil) or right ventricular dysfunction (RV-Dys) in patients with secondary mitral regurgitation (SMR) who underwent mitral valve transcatheter edge-to-edge repair (TEER). The presence of LV-Dil and RV-Dys correlates with advanced stages of heart failure in SMR patients, which may impact the outcome after TEER. SMR patients in a European multicenter registry were evaluated. Investigated outcomes were 2-year all-cause mortality and improvement in New York Heart Association functional class with respect to MR reduction, LV-Dil (defined as LV end-diastolic volume ≥159 ml), and RV-Dys (defined as tricuspid annular plane systolic excursion-to-systolic pulmonary artery pressure ratio of <0.274 mm/mm Hg). Among 809 included patients, resMR ≤1+ was achieved in 546 (67%) patients. Overall estimated 2-year mortality rate was 32%. Post-procedural resMR was significantly associated with mortality (p = 0.031). Although the improvement in New York Heart Association functional class persisted regardless of either LV-Dil or RV-Dys, the beneficial treatment effect of resMR ≤1+ on 2-year mortality was observed only in patients without LV-Dil and RV-Dys (hazard ratio: 1.75; 95% confidence interval: 1.03 to 3.00). Achieving optimal MR reduction by TEER is associated with improved survival in SMR patients, especially if the progress in heart failure is not too advanced. In SMR patients with advanced stages of heart failure, as evidenced by LV-Dil or RV-Dys, the treatment effect of TEER on symptomatic improvement is maintained, but the survival benefit appears to be reduced. [Display omitted] [ABSTRACT FROM AUTHOR]

The authors sought to assess sex-based differences in characteristics and outcomes of patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for secondary mitral regurgitation (SMR). Subgroup analysis from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial indicated potential sex-related differences in outcomes after TMVR. The impact of sex on results after TMVR in a real-world setting is unknown. The authors assessed clinical outcomes and echocardiographic parameters in women and men undergoing TMVR for SMR between 2008 and 2018 who were included in the large, international, multicenter real-world EuroSMR registry (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation). A total of 1,233 patients, including 445 women (36%) and 788 men (64%), were analyzed. Although women were significantly older and had fewer comorbidities than men, TMVR was equally effective in women and men (mitral regurgitation [MR] grade ≤2+ at discharge: 93.2% vs. 94.6% for women vs. men; p = 0.35). All-cause mortality at 1 year (17.9% vs. 18.9%, adjusted hazard ratio: 0.806; p = 0.46) and at 2-year follow-up (26.5% vs. 26.4%, adjusted hazard ratio: 0.757; p = 0.26) were similar in women versus men after multivariate regression analysis. Durability of MR reduction, improvement in symptoms, quality of life, and functional capacity did also not differ during follow-up. Results from the EuroSMR registry confirmed effective and similar MR reduction with TMVR in women and men. There were no sex-related differences in clinical outcomes up to 2 years of follow-up. [Display omitted] [ABSTRACT FROM AUTHOR]

This study sought to assess the impact of right ventricular dysfunction (RVD) as defined by impaired right ventricular-to-pulmonary artery (RV-PA) coupling, on survival after edge-to-edge transcatheter mitral valve repair (TMVR) for severe secondary mitral regurgitation (SMR). Conflicting data exist regarding the benefit of TMVR in severe SMR. A possible explanation could be differences in RVD. Using data from the EuroSMR (European Registry on Outcomes in Secondary Mitral Regurgitation) registry, this study compared the characteristics and outcomes of SMR patients undergoing TMVR, according to their RV-PA coupling, assessed by tricuspid annular plane systolic excursion-to-systolic pulmonary artery pressure (TAPSE/sPAP) ratio. Overall, 817 patients with severe SMR and available RV-PA coupling assessment underwent TMVR in the participating centers. RVD was present in 211 patients (25.8% with a TAPSE/sPAP ratio <0.274 mm/mm Hg). Although all patients demonstrated significant improvement in their New York Heart Association (NYHA) functional class, there was a trend toward a lower rate of NYHA functional class I or II among patients with RVD (56.5% vs. 65.5%, respectively; p = 0.086) after TMVR. Survival rates at 1 and 2 years were lower among patients with RVD (70.2% vs. 84.0%, respectively; p < 0.001; and 53.4% vs. 73.1%, respectively; p < 0.001). On multivariate analysis, a reduced TAPSE/sPAP ratio was a strong predictor of mortality (odds ratio: 1.62; 95% confidence interval: 1.14 to 2.31; p = 0.007). RVD, as shown by impairment of RV-PA coupling, is a major predictor of adverse outcome in patients undergoing TMVR for severe SMR. The often neglected functional and anatomic RV parameters should be systematically assessed when planning TMVR procedures for patients with severe SMR. [Display omitted] [ABSTRACT FROM AUTHOR]

The purpose of this paper was to evaluate the impact of proportionality of secondary mitral regurgitation (SMR) in a large real-world registry of transcatheter edge-to-edge mitral valve repair (TMVr) Differences in the outcomes of recent randomized trials of TMVr for SMR may be explained by the proportionality of SMR severity to left ventricular (LV) volume. The ratio of pre-procedural effective regurgitant orifice area (EROA) to LV end-diastolic volume (LVEDV) was retrospectively assessed in patients undergoing TMVr for severe SMR between 2008 and 2019 from the EuroSMR registry. A recently proposed SMR proportionality scheme was adapted to stratify patients according to EROA/LVEDV ratio in 3 groups: MR-dominant (MD), MR-LV-co-dominant (MLCD), and LV-dominant (LD). All-cause mortality was assessed as a primary outcome, secondary heart failure (HF) outcomes included hospitalization for HF (HHF), New York Heart Association (NYHA) functional class, N-terminal pro–B-type natriuretic peptide (NT-proBNP), 6-min-walk distance, quality of life and MR grade. A total of 1,016 patients with an EROA/LVEDV ratio were followed for 22 months after TMVr. MR was reduced to grade ≤2+ in 92%, 96%, and 94% of patients (for MD, MLCD, and LD, respectively; p = 0.18). After adjustment for covariates including age, sex, diabetes, kidney function, body surface area, LV ejection fraction, and procedural MR reduction (grade ≤2+), adjusted rates of 2-year mortality in MD patients did not differ from those for MLCD patients (17% vs. 18%, respectively), whereas it was higher in LD patients (23%; p = 0.02 for comparison vs. MD+MLCD). The adjusted first HHF rate differed between groups (44% in MD, 56% in MLCD, 29% in LD; p = 0.01) as did the adjusted time for first death or HHF rate (66% in MD, 82% in MLCD, 68% in LD; p = 0.02). Improvement of NYHA functional class was seen in all groups (p < 0.001). Values for 6-min-walk distances, quality of life and NT-proBNP improved in most patients. MD and MLCD patients had a comparable, adjusted 2-year mortality rate after TMVr which was slightly better than that of LD patients. Patients treated with TMVr had symptomatic improvement regardless of EROA/LVEDV ratio. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Impedance-based remote monitoring (RM) failed to reduce clinical events in the OptiLink heart failure (HF) trial. However, rates of alert-driven interventions triggered by intrathoracic fluid index threshold crossings (FTC) were low indicating physicians' inappropriate reactions to alerts.Methods: We separated appropriate from inappropriate contacts to FTC transmissions in the OptiLink HF trial (Optimization of Heart Failure Management Using OptiVol™ Fluid Status Monitoring and CareLink™). Appropriate contacts had to meet the following criteria: (1) initial telephone contact within 2 working days after FTC transmission, (2) follow-up contacts according to study protocol, and (3) medical intervention initiated after FTC due to cardiac decompensation. We compared time to cardiovascular death or HF hospitalization between RM patients contacted appropriately or inappropriately and patients with usual care.Results: In the RM group, at least one FTC alert was transmitted in 356 patients (70.5%; n=505). Of note, only 55.5% (n=758) of all transmitted FTCs (n=1365) were followed by an appropriate contact. While 113 patients (31.7%; n=356) have been contacted appropriately after every FTC, in 243 patients (68.3%; n=356) at least one FTC was not responded by an appropriate contact. Compared with usual care, RM with appropriate contacts to FTC alerts independently reduced the risk of the primary end point (hazard ratio, 0.61 [95% CI, 0.39-0.95]; P=0.027).Conclusions: RM appropriate reactions to FTC alerts are associated with significantly improved clinical outcomes in patients with advanced HF and implantable cardioverter-defibrillators. [ABSTRACT FROM AUTHOR]

Background: Biventricular endocardial pacing (BiV ENDO) is a therapy for heart failure patients who cannot receive transvenous epicardial cardiac resynchronization therapy (CRT) or have not responded adequately to CRT. BiV ENDO CRT can be delivered by a new wireless LV ENDO pacing system (WiSE-CRT system; EBR Systems, Sunnyvale, CA), without the requirement for lifelong anticoagulation.Objective: The purpose of this study was to assess the safety and efficacy of the WiSE-CRT system during real-world clinical use in an international registry.Methods: Data were prospectively collected from 14 centers implanting the WiSE-CRT system as part of the WiCS-LV Post Market Surveillance Registry. (ClinicalTrials.gov Identifier: NCT02610673).Results: Ninety patients from 14 European centers underwent implantation with the WiSE-CRT system. Patients were predominantly male, age 68.2 ± 10.5 years, left ventricular ejection fraction 30.6% ± 8.9%, mean QRS duration 180.7 ± 27.0 ms, and 40% with ischemic etiology. Successful implantation and delivery of BiV ENDO pacing was achieved in 94.4% of patients. Acute (<24 hours), 1- to 30-day, and 1- to 6-month complications rates were 4.4%, 18.8%, and 6.7%, respectively. Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms.Conclusion: BiV ENDO pacing with the WiSE-CRT system seems to be technically feasible, with a high success rate. Three procedural deaths occurred during the study. Procedural complications mandate adequate operator training and implantation at centers with immediately available cardiothoracic and vascular surgical support. [ABSTRACT FROM AUTHOR]

• Post-procedural TR predicts long-term survival in PMVR patients. • TR improved in patients after PMVR. • Echocardiographic pulmonary pressure is decreased post PMVR. • TR is associated with more severe heart failure symptoms in PMVR patients. Functional tricuspid regurgitation (TR) is frequently present in patients with severe mitral regurgitation and is associated with worse outcome. While percutaneous mitral valve repair (PMVR) is on the increase, the role of TR in those patients is unclear. This study aimed to compare pre- and post-procedural TR and investigated the impact of post-procedural TR and major clinical risk factors on long-term survival in patients undergoing PMVR. In this retrospective observational cohort study, data from 213 consecutive patients at a tertiary care center undergoing PMVR from 2010 to 2016 were analyzed. Two different groups, dichotomized according to the degree of TR (none/mild and moderate/severe) were compared. Multivariable analyses were performed assessing predictors for long-term survival adjusting for major risk factors. Following PMVR TR was significantly reduced by at least 1 grade in 23.0% (p = 0.001), while echocardiographic pulmonary pressure was decreased (TR Vmax 3.21 ± 0.49 m/s vs. 2.98 ± 0.53 m/s; p = <0.001). Patients with moderate or severe TR presented with worse New York Heart Association functional class and elevated N-terminal pro B-type natriuretic peptide levels compared to patients with none or mild TR. Median survival time was 1458 days. Proportional hazards model, adjusted for major risk factors, revealed post-procedural TR grade (HR 2.055, CI 1.317–3.206, p = 0.02), severely impaired left ventricular function (HR 3.145, CI 1.199–8.250, p = 0.020), and chronic kidney disease [glomerular filtration rate (GFR) 30–60 ml/min HR 1.917, CI 1.109–3.314, p = 0.020; GFR < 30 ml/min HR 3.969, CI 1.981–7.951, p < 0.001] as independent predictors for long-term survival. Post-procedural moderate and severe TR predicts worsened long-term survival in patients undergoing PMVR and is associated with adverse clinical outcome. Whether outcome might be improved by interventional reduction of post-procedural TR has to be investigated in the future. [ABSTRACT FROM AUTHOR]

Background--The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS). Methods and Results--High-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.6 years; 74.3% women) were enrolled across 12 centers in Europe and Australia. The study's primary end point was all-cause mortality at 30 days. A total of 209 patients who received the Portico TAVI system were available for follow-up after the 30-day visit. Data collection included hemodynamic assessment by echocardiography with core laboratory evaluation and assessment of functional status. Valve Academic Research Consortium-defined adverse events were adjudicated by an independent Clinical Events Committee. TAVI using the Portico valve led to a significant and persistent improvement in aortic valve function at 1 year. More than mild paravalvular leak was present in 5.7% and 7.5% of patients at 30 days and 1 year, respectively. Kaplan-Meier estimates at 30 days and 1 year were 3.6% and 13.8% for all-cause mortality, 3.6% and 9.6% for cardiovascular mortality, and 3.2% and 5.8% for major (disabling) stroke. After 30 days and ≤1 year of follow-up, adverse events included stage 3 acute kidney injury (n=3), major vascular complications (n=5), and life-threatening/disabling bleeding (n=3). Overall permanent pacemaker rate was 14.7%. At 1 year, 74.8% improved ≥1 New York Heart Association class compared with baseline (P<0.0001). Conclusions--The Portico TAVI system is safe and effective at 1 year, yielding low mortality and stroke rates in high-risk patients with severe AS. [ABSTRACT FROM AUTHOR]

Background Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic stenosis and high surgical risk. Currently, various prosthesis types are available. Atrioventricular block (AVB) requiring pacemaker (PM) implantation is a typical complication after TAVI. This study investigated the recovery of AV node conduction and mid-term outcome of patients with or without PM implantation after TAVI according to prosthesis type. Methods From July 2008 to May 2015, 856 transcatheter heart valves were implanted at our center (age: 80.5 ± 6.1 years; logistic EuroSCORE: 15.4%). These patients were followed up regularly in our outpatient clinic. Results PM implantation was performed in 16.9% of patients due to severe conduction disturbances, mainly third-degree AVB. The need for PM implantation differed between the various prosthesis types: Medtronic CoreValve (Medtronic Inc., Minneapolis, MN, USA): 22.8% ( n = 272), Edwards Sapien XT (Edwards Lifesciences, Irvine, CA, USA): 13.0% ( n = 262), Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA): 16.2% ( n = 234), Direct Flow Medical (Direct Flow Medical, Santa Rosa, CA, USA): 7.3% ( n = 41), St. Jude Medical Portico (St. Jude Medical, St. Paul, MN, USA): 15.4% ( n = 26), Boston Scientific Lotus (Boston Scientific, Marlborough, MA, USA): 21.4% ( n = 14) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA): 14.3% ( n = 7). Kaplan–Meier analysis for all-cause mortality did not reveal any differences between the various prosthesis types. PM implantation rates declined over the years of experience in a stable intervention team; 45% of PM patients showed sufficient AV node conduction after PM reprogramming at our follow-up examination. Conclusions Mid-term all-cause survival after TAVI seems to be independent of prosthesis type and PM implantation after TAVI. Intrinsic AV node conduction recovers in a significant proportion of patients. Therefore, regular PM interrogations including reprogramming are required to avoid unnecessary permanent right ventricular stimulation. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system. Background The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances. Methods Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria. Results A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24). Conclusions Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients. [ABSTRACT FROM AUTHOR]

Objectives This single-center study was performed to analyze the effect of an increased transvalvular gradient after the MitraClip (MC) (Abbott Laboratories, Abbott Park, Illinois) procedure on patient outcome during follow-up. Background Percutaneous transcatheter repair of the mitral valve with the MC device has been established as a novel technique for patients with severe mitral regurgitation and high surgical risk. This study investigated the influence of an increased pressure gradient after MC implantation on the long-term outcome of patients. Methods A total of 268 patients were enrolled, who received MC implantation between April 2009 and July 2014 in our institution (75 ± 9 years of age, 68% men, weight 76 ± 15 kg, median N-terminal pro–B-type natriuretic peptide 3,696 [interquartile range: 1,989 to 7,711] pg/ml, left ventricular ejection fraction 39 ± 16%, log European System for Cardiac Operative Risk Evaluation score 20% [interquartile range: 12% to 33%]). Pressure in the left atrium and left ventricle were measured during the procedure using fluid-filled catheters. The pressure gradients over the mitral valve were determined simultaneously invasively and echocardiographically directly after MC deployment. A Kaplan-Meier analysis was performed and correlated with the pressure gradients. We used a combined primary endpoint: all-cause-mortality, left ventricular assist device, mitral valve replacement, and redo procedure. Results The Kaplan-Meier-analysis showed a significantly poorer long-term-outcome in the case of an invasively determined mitral valve pressure gradient (MVPG) in excess of 5 mm Hg at implantation for the combined endpoint (p = 0.001) and for all-cause mortality (p = 0.018). For the echocardiographically determined MVPG the cutoff value was 4.4 mm Hg. Propensity score matching was used to balance baseline differences between the groups. In a Cox model the increased residual MVPG >5 mm Hg was a significant outcome predictor in univariate and multivariate analysis (hazard ratio: 2.3; 95% confidence interval: 1.4 to 3.8; p = 0.002, multivariate after adjustment for N-terminal pro–B-type natriuretic peptide, age, and remaining mitral regurgitation). Conclusions It is recommended that the quality of the implantation result be analyzed carefully and repositioning of the MC be considered in the case of an elevated pressure gradient over the mitral valve. [ABSTRACT FROM AUTHOR]

Background MitraClip (MC; Abbott Vascular, Menlo Park, CA, USA) is a treatment option for mitral regurgitation. Renal dysfunction is closely associated with cardiovascular disease. However, the influence of renal function in MC remains not fully understood. In this study, we aimed to clarify the association between renal function and MC. Methods and results We examined 206 consecutive patients who underwent MC and divided patients into 3 groups according to estimated glomerular filtration rate (eGFR), normal eGFR (≥60 mL/min/1.73 m 2 ) ( n = 70), mild chronic kidney disease (CKD) (30–59 mL/min/1.73 m 2 ) ( n = 106), and severe CKD (<30 mL/min/1.73 m 2 ) ( n = 30). N-terminal pro-B type natriuretic peptide (NT-pro BNP) levels increased with decreasing eGFR. Kaplan–Meier curves revealed that the long-term survival rate significantly decreased with eGFR. After adjustment with the covariates, severe CKD was still associated with mortality. Improved renal function was observed in 30% and associated with baseline lower NT-pro BNP levels. Patients with improved renal function had higher chronic phase survival rate. Conclusion Renal dysfunction is common in MC patients and the survival rate decreased with eGFR in association with increased NT-pro BNP levels. MC may improve renal function in approximately 30% of MC patients. Improved renal function is associated with lower NT-pro BNP levels and results in satisfactory prognosis. These results implies a close association between renal function and MC treatment. [ABSTRACT FROM AUTHOR]

The purpose of this publication is to describe the intraoperative experience along with long-term safety and efficacy of the second-generation baroreflex activation therapy (BAT) system in patients with heart failure (HF) and reduced ejection fraction HF (HFrEF). In a randomized trial of New York Heart Association Class III HFrEF, 140 patients were assigned 1:1 to receive BAT plus medical therapy or medical therapy alone. Procedural information along with safety and efficacy data were collected and analyzed over 12 months. Within the cohort of 71 patients randomized to BAT, implant procedure time decreased with experience, from 106 ± 37 minutes on the first case to 83 ± 32 minutes on the third case. The rate of freedom from system- and procedure-related complications was 86% through 12 months, with the percentage of days alive without a complication related to system, procedure, or underlying cardiovascular condition identical to the control group. The complications that did occur were generally mild and short-lived. Overall, 12 months therapeutic benefit from BAT was consistent with previously reported efficacy through 6 months: there was a significant and sustained beneficial treatment effect on New York Heart Association functional Class, quality of life, 6-minute hall walk distance, plasma N-terminal pro-brain natriuretic peptide, and systolic blood pressure. This was true for the full trial cohort and a predefined subset not receiving cardiac resynchronization therapy. There is a rapid learning curve for the specialized procedures entailed in a BAT system implant. BAT system implantation is safe with the therapeutic benefits of BAT in patients with HFrEF being substantial and maintained for at least 1 year. [ABSTRACT FROM AUTHOR]

Background The aim of the study was to investigate mortality following transcatheter mitral valve repair with the MitraClip System (MC) (Abbott Vascular, Santa Clara, CA, USA) in patients with mitral regurgitation and moderate-to-severe symptomatic heart failure in comparison to mortality predicted by the Seattle Heart Failure Model (SHFM) and the heart failure calculator of the meta-analysis global group in chronic heart failure (MAGGIC). Methods and results This retrospective study included 194 consecutive patients, who received a MC implantation between 2009 and 2013 at our institution. The observed mortality was compared with that predicted by the SHFM and the MAGGIC after 1 year: 24% observed, 18% by SHFM ( p = 0.185) and 20.9% by MAGGIC ( p = 0.542). At 2 years: 32% observed vs. 33% by SHFM ( p = 0.919). The subgroup of patients with end-stage heart failure and N-terminal pro-B-type natriuretic peptide (NTproBNP) >10,000 pg/ml ( n = 41) had significantly worse mortality after 1 year (49%) than predicted by SHFM (24%, p = 0.034) and MAGGIC (24.8%, p = 0.041). Conclusion In the overall patient cohort defined by 3+ to 4+ mitral valve regurgitation with New York Heart Association III and IV symptomatic heart failure, mortality following MC is consistent with that predicted by SHFM and MAGGIC for patients that are not at high risk. However, the subset of patients with severe heart failure defined by NTproBNP >10,000 pg/ml had worse than predicted mortality and may not benefit from MC therapy, mainly due to a high 30-day mortality. [ABSTRACT FROM AUTHOR]

Background: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. Methods: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. Results: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P <0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P =0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. Conclusions: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria. [ABSTRACT FROM AUTHOR]

Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction.This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%.In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group. [ABSTRACT FROM AUTHOR]

The article assesses the efficacy of subcutaneous implantable cardioverter-defibrillator (S-ICD) in a clinical setting. It informs that ICD therapy is established as the best option to prevent sudden cardiac death due to ventricular tachyarrythmia. It concludes that ineffective shock delivery may occur in patients with S-ICD even after successful intraoperative testing. The article also suggests that multicenter trials are required with close monitoring of safety and efficacy end points.

Abstract: Background: Previous studies in patients and in dogs with experimentally induced heart failure (HF) showed that electrical signals applied to the failing myocardium during the absolute refractory period improved left ventricular (LV) function. We examined the effects these same cardiac contractility modulating (CCM) electrical signals on myocardial oxygen consumption (MVO2) in both patients and dogs with chronic HF. Methods and Results: Six dogs with microembolizations-induced HF and 9 HF patients underwent CCM leads and generator (OPTIMIZER II) implantation. After baseline measurements, CCM signals were delivered continuously for 2 hours in dogs and for 30 minutes in patients. MVO2 was measured before and after CCM therapy. In dogs, CCM therapy increased LV ejection fraction at 2 hours (26 ± 1 versus 31 ± 2 %, P = .001) without increasing MVO2 (257 ± 41 versus 180 ± 34 μmol/min). In patients, CCM therapy increased LV peak +dP/dt by 10.1 ± 1.5 %. As with dogs, the increase in LV function after 30 minutes of CCM therapy was not associated with increased MVO2 (13.6 ± 9.7 versus 12.5 ± 7.2 mL O2/min). Conclusions: The study results suggest that unlike cAMP-dependent positive inotropic drugs, the increase in LV function during CCM therapy is elicited without increasing MVO2. [Copyright &y& Elsevier]

In the article, the authors present the results of their study on the effects of commonly-worn face masks on physiological parameters like blood gases and the subjective perception of exertion under workload conditions. The face masks are used as protection against COVID-19. The study focused on surgical masks, cloth masks, and filtering facepiece 2 (FFP2) masks. Among the reported mask-specific discomfort are headache, dizziness, and dyspnoea.

Background: This study evaluates the acute and chronic resynchronizing effects of AV sequential left ventricular (LV) pacing on LV function in patients with impaired cardiac function and conduction disorders by 3-dimensional transesophageal echocardiography. Methods and Results: Twenty-nine patients with congestive heart failure, with LV ejection fraction (LVEF) ≤30%, QRS duration ≥120 milliseconds, and New York Heart Association Class II to IV, were implanted with a cardiac resynchronization device using an LV lead only, according to the invasively determined hemodynamic optimal pacing site and AV delay. Patients underwent 3-dimensional transesophageal echocardiography before randomization to treatment (baseline) and at 12-month follow-up (resynchronization–12 months). Three-dimensional volumes were acquired on resynchronization and during intermittent switch-off at intrinsic depolarization. The values of stroke volume were 43.2 ± 13.3 (intrinsic-baseline), 51.7 ± 17.4 (intrinsic–12 months), 57.2 ± 15.6 (resynchronization-baseline), and 64.6 ± 18.9 (resynchronization–12 months). Analysis of variance demonstrated a significant effect of resynchronization at different periods (P < .001) and a significant time effect (P < .05) for stroke volume. Similar results were observed with ejection fraction (LVEF). No effect was observed with LV end-diastolic volume, whereas a therapy effect with no time effect was observed with LV end-systolic volume. Conclusions: A significant acute increase of LV stroke volume and LVEF was found by resynchronization by LV pacing alone. A continuous improvement of LV stroke volume and LVEF occurred with time of follow-up (reverse remodeling). The initial therapeutic effect persisted during 12-month follow-up independently of time of follow-up and QRS width. No significant decrease of LV end-diastolic size during chronic resynchronization was detected in contrast to previous studies with resynchronization by biventricular pacing. [Copyright &y& Elsevier]

Objectives: We tested a simple noninvasive method for cardiac resynchronization therapy (CRT) optimization using standard finger photoplethysmography (FPPG).Background: CRT can increase left ventricular cardiac output in patients with heart failure and ventricular conduction delay. Optimal therapy delivery depends on an appropriate AV delay. Multiple invasive and noninvasive methods have been attempted to identify patients and the best AV delay for CRT, but all suffer from a combination of high patient risk, cost, complexity, and low reproducibility.Methods: FPPG and invasive aortic pressure data were simultaneously collected from 57 heart failure patients during intrinsic rhythm alternating with very brief periods of pacing at 4 to 5 AV delays. After correcting data for artifacts, the median percentage responses for each AV delay were classified as positive, negative, or neutral compared to baseline (Wilcoxon rank test).Results: FPPG correctly identified positive aortic pulse pressure responses with 71% sensitivity (95% CI: 60-80%) and 90% specificity (95% CI: 84-94%) and negative aortic pulse pressure responses with 57% sensitivity (95% CI: 44-69%) and 96% specificity (95% CI: 91-98%). The magnitude of FPPG changes were strongly correlated with positive aortic pulse pressure changes (R(2) = 0.73, P < .0001) but less well correlated with negative aortic pulse pressure changes (R(2) = 0.43, P < .0001). FPPG selected 78% of the patients having positive aortic pulse pressure changes to CRT and identified the AV delay giving maximum aortic pulse pressure change in all selected patients.Conclusions: FPPG can provide a simple noninvasive method for identifying significant changes in aortic pulse pressure with high specificity, including identifying patients in whom aortic pulse pressure increases with CRT and the AV delay giving the maximum aortic pulse pressure. [ABSTRACT FROM AUTHOR]