One-Year Outcomes According to Mitral Regurgitation Etiology Following Transcatheter Edge-to-Edge Repair With the PASCAL System: Results From a Multicenter Registry.

BACKGROUND: We previously reported procedural and 30-day outcomes of a German early multicenter experience with the PASCAL system for severe mitral regurgitation (MR). This study reports 1-year outcomes of mitral valve transcatheter edge-to-edge repair with the PASCAL system according to MR etiology in a large all-comer cohort. METHODS AND RESULTS: Clinical and echocardiographic outcomes up to 1-year were investigated according to MR etiology (degenerative [DMR], functional [FMR], or mixed [MMR]) in the first 282 patients with symptomatic MR 3+/4+ treated with the PASCAL implant at 9 centers in 2019. A total of 282 patients were included (33% DMR, 50% FMR, 17% MMR). At discharge, MR reduction to ≤1+/2+ was achieved in 58%/87% of DMR, in 75%/97% of FMR, and in 78%/98% of patients with MMR (P=0.004). MR reduction to ≤1+/2+ was sustained at 30 days (50%/83% DMR, 67%/97% FMR, 74%/100% MMR) and at 1 year (53%/78% DMR, 75%/97% FMR, 67%/91% MMR) with significant differences between etiologies. DMR patients with residual MR 3+/4+ at 1-year had at least complex valve morphology in 91.7%. Valve-related reintervention was performed in 7.4% DMR, 0.7% FMR, and 0.0% MMR (P=0.010). At 1-year, New York Heart Association Functional Class was significantly improved irrespective of MR etiology (P<0.001). CONCLUSIONS: In this large all-comer cohort, mitral valve transcatheter edge-to-edge repair with the PASCAL system was associated with an acute and sustained MR reduction at 1-year in all causes. However, in patients with DMR, MR reduction was less pronounced, reflecting the high incidence of complex or very complex anatomies being referred for mitral valve transcatheter edge-to-edge repair.

Carotid Stiffness After Transcatheter Aortic Valve Replacement.

The present study aimed to analyze common carotid artery strain properties in patients (n = 59) with severe aortic valve stenosis who underwent transcatheter aortic valve replacement (TAVR). Arterial compliance of the common carotid artery was assessed by ultrasound speckle-tracking before and after TAVR. For sub-analysis the study cohort was divided according to aortic valve area <.75 cm2 (n = 30) vs ≥.75 cm2 (n = 29). Comparison of pre- and post-procedural strain variables showed an improvement in median radial velocity (P < .0001), radial displacement (P = .007), circumferential strain (P = .004), radial strain rate (P = .023), and circumferential strain rate (P < .0001), while the increase of radial strain showed a trend (P = .082). Analysis of aortic valve area revealed an inverse correlation between aortic valve area and the differences (post-procedural-pre-procedural values) for radial strain rate, and circumferential strain. Moreover, sub-analysis revealed that the increase of carotid strain variables before and after TAVR were more pronounced in the sub-group of aortic valve area .75 vs ≥.75 cm2. TAVR led to a reduction of arterial wall stiffness of the common carotid artery assessed by ultrasound speckle-tracking. The decrease of arterial wall stiffness after TAVR was more pronounced in more severe aortic valve stenosis.

Clinical effects of cognitive behavioral therapy in heart failure patients: a meta-analysis of randomized controlled trials.

BACKGROUND: About 20-40% of people with Heart failure (HF) suffer from some depression, which is 4-5% greater than the overall population. This depression can lead to undesirable outcomes, including elevated mortality rate and frequent hospitalization. PURPOSE: The current study aims to evaluate the impact of cognitive behavioural therapy (CBT) on self-care and the symptoms of depression and anxiety in HF patients. METHODS: We searched PubMed, Web of Science (WOS), Scopus, and Cochrane Library till 15 October 2022. All relevant randomized controlled trials (RCTs) were included. The data were extracted and pooled using Review Manager software (RevMan 5.4). Continuous data were pooled as mean difference and 95% confidence interval (CI). RESULTS: Our search retrieved 1146 records, and 7 studies (611 patients) were finally included. We assessed the Beck Depression Inventory-II (BDI-II) as the primary outcome of the study. Hamilton Rating Scale for Depression (HRSD-17), Change in Beck Anxiety Inventory, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Self-Care of Heart Failure Index (SCHFI) were also assessed as secondary outcomes. With CBT, BDI-II showed a significant reduction after 4 to 6 months follow-up (MD = -4.87, 95% CI: [-8.06; -1.69], P = 0.003) as well as 8 to 9 months follow-up (MD = -5.71, 95% CI: [-8.95; -2.46], P = 0.0006). But no significant difference was shown with 3 months follow-up (M.D=-4.34; 95%CI: [-10.70; 2.03], P = 0.18). CONCLUSIONS: CBT has long-term (4-9 months) significant favorable outcomes decreasing anxiety and depression compared to non-CBT groups. No significant short-term (less than 3 months) impact on HF patients' self-care, depression, or anxiety were shown.

Prognostic Impact of the Get-with-the-Guidelines Heart-Failure Risk Score (GWTG-HF) after Transcatheter Aortic Valve Replacement in Patients with Low-Flow-Low-Gradient Aortic Valve Stenosis.

OBJECTIVES: This study examined the prognostic value of the get-with-the-guidelines heart-failure risk score (GWTG-HF) on mortality in patients with low-flow-low-gradient aortic valve stenosis (LFLG-AS) after transcatheter aortic valve implantation (TAVI). BACKGROUND: Data on feasibility of TAVI and mortality prediction in the LFLG-AS population are scarce. Clinical risk assessment in this particular population is difficult, and a score has not yet been established for this purpose. METHODS: A total of 212 heart failure (HF) patients with real LFLG-AS were enrolled. Patients were classified into low-risk (n = 108), intermediate-risk (n = 90) and high-risk (n = 14) groups calculated by the GWTG-HF score. Clinical outcomes of cardiovascular events according to Valve Academic Research Consortium (VARC-2) recommendations and composite endpoint of death and hospitalization for heart failure (HHF) were assessed at discharge and 1 year of follow-up. RESULTS: Baseline parameters of the groups showed a median age of 81.0 years [77.0; 84.0] (79.0 vs. 82.0 vs. 86.0, respectively p < 0.001), median EuroSCORE II of 6.6 [4.3; 10.7] (5.5 vs. 7.2 vs. 9.1, p = 0.004) and median indexed stroke volume of 26.7 mL/m2 [22.0; 31.0] (28.2 vs. 25.8 vs. 25.0, p = 0.004). The groups significantly differed at follow-up in terms of all-cause mortality (10.2 vs. 21.1 vs. 28.6%; p < 0.035). There was no difference in intrahospital event rate (VARC). Postprocedural mean gradients were lower in high-risk group (7.0 vs. 7.0 vs. 5.0 mmHg, p = 0.011). No differences in postprocedural aortic valve area (1.9 vs. 1.7 vs. 1.9 cm2, p = 0.518) or rate of device failure (5.6 vs. 6.8 vs. 7.7%, p = 0.731) could be observed. After adjustment for known predictors, the GWTG score (HR 1.07 [1.01-1.14], p = 0.030) as well as pacemaker implantation (HR 3.97 [1.34-11.75], p = 0.013) turned out to be possible predictors for mortality. An increase in stroke volume index (SVI) was, in contrast, protective (HR 0.90 [0.83-0.97]; p = 0.006). CONCLUSIONS: The GWTG score may predict mortality after TAVI in LFLG-AS HF patients. Interestingly, all groups showed similar intrahospital event and mortality rates, independent of calculated mortality risk. Low SVI and new conduction disturbances associated with PPI after THV implantation had negative impact on mid-term outcome in post-TAVI HF-patients.

Prevalence of sleep-disordered breathing in patients with mitral regurgitation and the effect of mitral valve repair.

PURPOSE: The relationship between chronic heart failure and sleep-disordered breathing (SDB) has been frequently described. However, little is known about the association of mitral regurgitation (MR) and SDB or the impact of transcatheter mitral valve repair (TMVR) on SDB. Our aims were first to determine the prevalence of SDB in patients with MR, and second to determine the effect of TMVR on SDB. METHODS: Patients with MR being evaluated for TMVR at the University Hospital Bonn underwent polygraphy (PG) to determine the prevalence of SDB. After TMVR, a subset of patients was followed up with transthoracic echocardiography (TTE) and PG to evaluate the effect of TMVR on SDB. RESULTS: In 53 patients, mean age was 76.0 ± 8.5 years and 62% were male. Patients predominantly had more than moderate mitral regurgitation (94%). SDB was highly prevalent (68%) with predominantly central sleep apnoea (CSA, 67%). After TMVR in 15 patients, the apnoea/hypopnoea index (AHI) and central apnoea index (AI) were significantly reduced among patients with SDB (AHI - 8.0/h, p = 0.021; central AI - 6.9/h, p = 0.046). The left atrial volume index (LAVI) at baseline was significantly higher in patients with CSA than in patients with obstructive sleep apnoea (OSA) and was significantly reduced after TMVR (63.5 ml/m2 ± 27.2 vs. 38.3 ml/m2 ± 13.0; - 18.4 ml/m2, p = 0.027). CONCLUSION: SDB, especially CSA, is highly prevalent in patients with mitral regurgitation. In the follow-up cohort TMVR led to a significant reduction of the AHI, predominantly of central events. The findings of the study suggest that TMVR may be a suitable therapy not only for MR but also for the accompanying CSA. LAVI may be a useful indicator for CSA in patients with MR.

Early Outcomes of 2 Mitral Valve Transcatheter Leaflet Approximation Devices: A Propensity Score-Matched Multicenter Comparison.

BACKGROUND: In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking. OBJECTIVES: The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems. METHODS: Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). RESULTS: Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562). CONCLUSIONS: In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome.

Deep sedation vs. general anesthesia for transcatheter tricuspid valve repair.

Background: Transcatheter tricuspid valve repair (TTVr) is routinely performed under general anesthesia (GA). This study aimed to investigate whether TTVr procedures can be performed effectively and safely without GA but using deep sedation (DS). Methods: We performed a retrospective analysis of 104 patients from three centers who underwent TTVr between 2020 and 2021. The primary performance endpoints were technical success and severity of TR assessed at the time of discharge. The safety outcome was a composite of in-hospital complications, including occurrence of death, conversion to surgery, major adverse cardiac and cerebrovascular events, major vascular complications, or occurrence of pneumonia. Results: Sixty-four procedures were performed in GA and 40 procedures were performed in DS. The groups did not differ in age, EuroScore II, TR severity, ventricular function, or hemodynamic parameters. Technical success was achieved in 92.5% of the patients in the DS group and in 93.6% of the patients in the GA group (p = 0.805). In none of the patients intraprocedural conversion from DS to GA was required. There was no difference in total duration of the procedure, and number of devices implanted. The degree of TR was ≤2+ in 77.5% of the patients in the DS group and in 74.2% of the patients in the GA group (p = 0.705). The composite safety endpoint did not differ between the groups (2.5 vs. 6.3%, p = 0.384). The total duration of hospital stay was shorter in patients who underwent TTVr in DS compared to those who underwent TTVr in GA (6 [5, 9] days vs. 8 [6, 11] days; p = 0.011). Conclusion: Performing TTVr in DS was effective with similar procedural results, and was safe with similar low complication rates compared to GA.

Acute Kidney Injury Following Tricuspid Transcatheter Edge-to-Edge Repair.

BACKGROUND: Little is known about the incidence and clinical relevance of postprocedural acute kidney injury (AKI) in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR). OBJECTIVES: The aim of this study was to investigate the prognostic impact of postprocedural AKI following TEER for TR. METHODS: Two hundred sixty-eight patients who underwent TEER for TR at 2 centers were retrospectively analyzed. Postprocedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days after the procedure compared with baseline. The association between AKI and the composite outcome, consisting of all-cause mortality and rehospitalization for heart failure within 1 year after the procedure, was determined. RESULTS: The mean age of the patients was 79.0 ± 6.8 years, and 43.3% were men. Postprocedural AKI occurred in 42 patients (15.7%). Age, male sex, an estimated glomerular filtration rate of <60 mL/min/1.73 m2, and absence of procedural success were associated with the occurrence of AKI. Patients with AKI had a higher incidence of in-hospital mortality than those without AKI (9.5% vs 0.9%; P = 0.006). Moreover, AKI was associated with the incidence of the composite outcome within 1 year after TEER for TR (adjusted HR: 2.39; 95% CI: 1.45-3.94; P = 0.001). CONCLUSIONS: Postprocedural AKI occurred in 15.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. These findings highlight the clinical impact of AKI following TEER for TR and should help in identifying patients at high risk for AKI.

3D-speckle-tracking echocardiography correlates with cardiovascular magnetic resonance imaging diagnosis of acute myocarditis - An observational study.

Background: The diagnostic importance of three-dimensional (3D) speckle-tracking strain-imaging echocardiography in patients with acute myocarditis remains unclear. The aim of this study was to test the diagnostic performance of 3D-speckle-tracking echocardiography compared to CMR (cardiovascular magnetic resonance imaging) for the diagnosis of acute myocarditis. Methods and results: 45 patients with clinically suspected myocarditis were enrolled in our study (29% female, mean age: 43.9 ± 16.3 years, peak troponin I level: 1.38 ± 3.51 ng/ml). 3D full-volume echocardiographic images were obtained and offline 2D as well as 3D speckle-tracking analysis of regional and global LV deformation was performed. All patients received CMR scans and myocarditis was diagnosed in 29 subjects based on original Lake-Louise criteria. The 16 patients, in whom myocarditis was excluded by CMR, served as controls. Regional changes in myocardial texture (diagnosed by CMR) were significantly associated with regional impairment of circumferential, longitudinal, and radial strain, as well as regional 3D displacement and total 3D strain. Interestingly, the 2D and 3D global longitudinal strain (GLS) showed higher diagnostic performance than well-known parameters associated with myocarditis, such as LVEF (as obtained by echocardiography and CMR) and LVEDV (as obtained by CMR). Conclusions: In this study, we examined the use of 3D-speckle-tracking echocardiography in patients with acute myocarditis. Global longitudinal strain was significantly impaired in patients with acute myocarditis and correlated with CMR findings. Therefore, 3D echocardiography could become a useful diagnostic tool in the primary diagnosis of myocarditis.

Guideline-directed medical therapy after transcatheter edge-to-edge mitral valve repair.

OBJECTIVE: A sizeable proportion of patients with secondary mitral regurgitation (SMR) do not receive guideline-directed medical therapy (GDMT) for heart failure (HF). We investigated the association between the use of GDMT and mortality in patients with SMR who underwent transcatheter edge-to-edge repair (TEER). METHODS: We retrospectively analysed patients with SMR and a left ventricular ejection fraction of <50% who underwent TEER at three centres. According to current HF guidelines, GDMT was defined as triple therapy consisting of beta-blockers, renin-angiotensin system (RAS) inhibitors and mineralocorticoid receptor antagonists (MRAs). Patients were divided into two groups: GDMT and non-GDMT groups. We calculated the propensity scores and carried out inverse probability of treatment weighting (IPTW) analyses to compare 2-year mortality between the two groups. RESULTS: Of 463 patients, 228 (49.2%) were treated with GDMT upon discharge. IPTW-adjusted Kaplan-Meier curve showed patients with GDMT had a lower incidence of mortality than those without GDMT (19.8% vs 31.1%, p=0.011). In IPTW-adjusted Cox proportional hazards analysis, GDMT was associated with a reduced risk of 2-year mortality (HR: 0.58; 95% CI: 0.35 to 0.95; p=0.030), which was consistent among clinical subgroups. Moreover, patients with GDMT had a higher rate of left ventricular reverse remodelling at 1 year after TEER than those without GDMT. CONCLUSION: GDMT, defined as triple therapy consisting of beta-blockers, RAS inhibitors and MRAs, was associated with a reduced risk of 2-year mortality after TEER for SMR. Optimisation of medical therapy is crucial to improve clinical outcomes in patients undergoing TEER for SMR.

Impact of right ventricular-pulmonary arterial coupling on clinical outcomes of tricuspid regurgitation.

BACKGROUND: In terms of pathophysiology, tricuspid regurgitation (TR) and right ventricular (RV) function are linked to each other. AIMS: This study sought to evaluate RV-pulmonary artery (PA) coupling and its impact on clinical outcomes of TR in patients undergoing mitral transcatheter edge-to-edge repair (TEER). METHODS: We calculated RV-PA coupling ratios in patients undergoing mitral TEER from August 2010 to March 2019 by dividing the tricuspid annular plane systolic excursion (TAPSE) by the echocardiographic estimated PA systolic pressure (PASP). TR was graded as none/trace, mild, moderate, or severe. The primary outcome was all-cause mortality or rehospitalisation within 12 months. RESULTS: Among 744 patients analysed, severe TR was documented in 22.3% of patients and the mean TAPSE/PASP was 0.43±0.25. Technical success of TEER was achieved in 97.2% of participants. Severe TR vs TR ≤moderate (adjusted HR 1.92, 95% CI: 1.39-2.66) and TAPSE/PASP (adjusted HR 0.45, 95% CI: 0.22-0.93) were associated with the outcome. Patients were divided according to the TAPSE/PASP tertile. Compared to patients with TR ≤moderate, patients with severe TR had a higher event rate (TAPSE/PASP <0.30: 32.9% vs 45.1%; 0.30≤ TAPSE/PASP <0.44: 27.8% vs 41.8%; TAPSE/PASP ≥0.44: 16.0% vs 40.4%), whereas the prognostic significance of TR was attenuated in patients with reduced TAPSE/PASP (i.e., RV-PA uncoupling; interaction term p=0.03). The trends were consistent in the multivariable regression models, spline curves, and sensitivity analysis using post-interventional parameters. CONCLUSIONS: RV-PA coupling affects the outcome correlation of TR in patients undergoing mitral TEER. The prognostic impact of TR is attenuated in patients with RV-PA uncoupling.

Recurrent Mitral Regurgitation After MitraClip: Predictive Factors, Morphology, and Clinical Implication.

BACKGROUND: Recurrent mitral regurgitation (MR) following MitraClip has not been thoroughly investigated. We aimed to examine the predictive factors, morphology, and long-term outcome of recurrent MR after MitraClip. METHODS: We assessed data from the Heart Failure Network Rhineland registry from August 2010 to October 2018. Competing risk analyses were performed using the Fine and Gray model to assess the risk of recurrent MR. RESULTS: Among 685 MitraClip patients with a reduction in MR to ≤2+, 61 patients developed recurrent MR within the first 12 months. Flail leaflet (hazard ratio, 3.68; P=0.002) and residual MR (MR grade 2+ versus ≤1+: hazard ratio, 2.56; P=0.03) were the predictors of recurrent MR in primary MR patients, while left atrial volume (per 10 mL increase: hazard ratio, 1.11; P<0.001) and residual MR (hazard ratio, 2.45; P=0.01) were independently associated with recurrent MR in secondary MR patients. In primary MR patients, loss of leaflet insertion or leaflet tear were the predominant morphologies with recurrent MR. In secondary MR patients, more than half of the patients with recurrent MR did not show any disorder of the clip or leaflets. Patients with recurrent MR were more likely to experience unplanned heart failure hospitalization or heart failure symptom with New York Heart Association scale III/IV (54.1% versus 37.8%; P=0.018) and undergo a repeat mitral valve intervention (9.8% versus 2.2%; P=0.005) during the follow-up. In the landmark survival analysis, patients with recurrent MR tended to have lower long-term survival (58.7% versus 83.9%; P=0.08) than patients without recurrent MR. CONCLUSIONS: Flail leaflet and residual MR were the predictors of recurrent MR in primary MR patients, while a larger left atrial volume and residual MR were associated with recurrent MR in secondary MR patients, which may be associated with long-term clinical outcomes of patients after MitraClip.

Leaflet-to-annulus index and residual tricuspid regurgitation following tricuspid transcatheter edge-to-edge repair.

BACKGROUND: A mismatch between tricuspid leaflet size and annular dilation is one of the morphological features tied to the development of tricuspid regurgitation (TR). AIMS: We assessed the association of the leaflet-to-annulus index (LAI) with residual TR after transcatheter edge-to-edge repair (TEER). METHODS: Consecutive patients who underwent TEER for TR were enrolled. Significant residual TR was defined as a post-procedural TR ≥3+, and patients were divided into two groups according to the amount of residual TR. The LAI was retrospectively calculated using procedural transoesophageal echocardiography and was defined as follows: (anterior leaflet length+septal leaflet length)/septolateral tricuspid annulus diameter. RESULTS: Of 140 patients, 43 patients had residual TR ≥3+ after TEER. The patients with residual TR ≥3+ had a lower LAI compared to those with residual TR <3+ (1.04±0.10 vs 1.13±0.09; p=0.001). In multivariable analysis, the LAI was associated with residual TR ≥3+ (odds ratio [OR] [per 0.1 increase]: 0.57; 95% confidence interval [95% CI]: 0.35-0.94; p=0.02), independent of baseline TR severity or coaptation gap size. Patients with residual TR ≥3+ had a higher incidence of the composite outcome, consisting of all-cause mortality and heart failure hospitalisation within one year after TEER (47.1% vs 26.6%, p=0.02). Residual TR ≥3+ was an independent predictor of the composite outcome within one year (hazard ratio: 2.04; 95% CI: 1.01-4.11; p=0.04). CONCLUSIONS: The leaflet-to-annulus mismatch (i.e., LAI) is associated with residual TR ≥3+ after TEER for TR. A detailed echocardiographic analysis of the tricuspid valve will be conducive to identifing suitable subjects for TEER.

Latest Advances in Transcatheter Aortic Valve Implantation (2022).

Since the last decade, transcatheter aortic valve implantation (TAVI) has become the treatment of choice in patients with symptomatic severe aortic stenosis (AS) who are ineligible or at higher risk for surgery. Due to the high safety profile of current device generation, TAVI has emerged as a qualified alternative to surgical aortic valve replacement (SAVR) in patients with classic aortic stenosis and intermediate surgical risk, severe bicuspid aortic valve stenosis, and isolated pure aortic regurgitation. Moderate aortic stenosis, with and without concomitant heart failure with reduced ejection fraction, are under investigation in randomized controlled clinical trials from which we will gain exciting insights on the best timing of TAVI to protect the left ventricle from further functional deterioration due to increasing AS. In these cases, a meticulous diagnostic approach including advanced imaging is becoming more and more important. Current evidence on antithrombotic strategies after TAVI is weak, contributing to poor levels of standardization and high variability in daily clinical practice. This review will provide a short overview of recent clinical trials including best timing for TAVI with moderate AS and antithrombotic strategies after TAVI with current and future TAVI generations.

A staging classification of right heart remodelling for patients undergoing transcatheter edge-to-edge mitral valve repair.

BACKGROUND: In patients with severe mitral regurgitation (MR) who are scheduled for transcatheter mitral valve repair (TMVR), risk stratification is predominantly based on surgical risk scores. AIMS: We sought to characterise and define stages of right heart remodelling in patients undergoing TMVR and evaluate the impact of this staging classification on survival. METHODS: According to echocardiographic parameters, 929 patients undergoing MitraClip treatment were classified into three stages: severe MR without right heart damage (stage 0), with moderate-to-severe tricuspid regurgitation (TR) (stage 1), with right ventricular dysfunction defined as a reduced fractional area change <35% and a tricuspid annular plane systolic excursion <17 mm, or with increased right atrial area >25 cm2 and/or indexed right ventricular volume >30 ml/m2 (stage 2). We compared clinical outcomes and performed a multivariate analysis to evaluate the predictive value of the extent of cardiac damage. RESULTS: Rates of one-year all-cause mortality increased with more advanced stages of right heart remodelling (stage 0: 8% vs stage 1: 9.7% vs stage 2: 18.1%; p<0.001). In the multivariate analysis, advanced cardiac damage was an independent predictor of one-year all-cause mortality (stage 2: p=0.007). CONCLUSIONS: A simple staging classification objectively characterises the extent of right heart remodelling caused by MR and allows risk prediction in patients undergoing a MitraClip procedure.

Early response of right-ventricular function to percutaneous mitral valve repair.

BACKGROUND: The change in right-ventricular function (RVF) after transcatheter mitral valve repair is still poorly understood. We assessed the early response of RVF to the MitraClip procedure and its clinical relevance. METHODS: We analyzed consecutive patients who underwent a MitraClip procedure to treat MR between August 2010 and March 2019 in the Heart Failure Network Rhineland registry. RVF was assessed before and after the procedure. Impaired RVF was defined as an RV fractional area change (RVFAC) < 35% or tricuspid annular plane systolic excursion (TAPSE) < 16 mm. RESULTS: 816 eligible patients (77 ± 9 years, 58.5% male) were included in the analysis. Baseline values of RVF were: RVFAC 38.6 (IQR 29.7-46.7) % and TAPSE 17.0 (IQR 14.0-21.0) mm. At a median time of 3 (IQR 2-5) days after the procedure, the RVF remained normal in 34% (n = 274), normalized in 17% (n = 140), deteriorated in 15% (n = 125), and was persistently impaired in 34% (n = 277) of patients. The RVF response was significantly associated with a composite outcome of all-cause mortality and hospitalization due to heart failure within a 2-year follow-up. Compared to stable/normal RVF, the adjusted hazard ratios for the outcome were 1.78 (95% CI 1.10-2.86) for normalized RVF, 1.89 (95% CI 1.34-3.15) for deteriorated RVF, and 2.25 (95% CI 1.47-3.44) for persistently impaired RVF. Changes in TAPSE and RVFAC as continuous variables were significantly correlated with the outcome. CONCLUSION: An early change in RVF following transcatheter mitral valve repair is predictive of mortality and hospitalization due to heart failure during follow-up. Early response of RVF after MitraClip and its clinical significance. An acute, early change in RVF can be observed following the MitraClip procedure, which is associated with the risk of mortality and hospitalization for HF.

Feasibility and Safety of an 8 F Angioseal® Vascular Closure Device for Closure of Large Bore Impella CP® Access.

PURPOSE: Percutaneous mechanical circulatory support (pMCS) with the Impella® device is routinely used in cardiogenic shock and high risk percutaneous coronary interventions (PCI). However, safety and feasibility to close the large bore access (LBA) post-hoc remain a challenge. MATERIALS AND METHODS: In patients with planned termination of Impella therapy, corresponding LBA closure was attempted using an undersized AngioSeal® device, which was deployed after insertion of a 0.035 in J-wire through the guidewire access port. Cross-over angiographic visualization before and after deployment as well as in-hospital follow up were performed to assess closure success and screening for short-term adverse events. RESULTS: We evaluated 17 patients (68 year old, IQR 58-76, 71% male) in whom 14 F LBA closure after pMCS using the Impella CP® was achieved with an undersized AngioSeal® device. Clinical indication for pMCS was cardiogenic shock in 94% and protected PCI in 6%. Impella CP® devices were withdrawn after a median of 4 days (IQR 3-6 days). Primary hemostasis was achieved in the majority of patients (14/17; 82%) while single cross-over balloon inflation led to hemostasis in the remaining patients. One patient suffered acute ischemia later in the course of the disease, but this was not directly related to the closure device. In this study, no major bleeding or other device-related adverse events were observed. CONCLUSION: The 8 F AngioSeal® vascular closure device has been safely used for removal of the Impella CP® microaxial pump in most cases of predominantly normal weight patients. This technique may be considered feasible for post-hoc LBA closure in the context of pMCS, especially when preclosure options are not suitable or unavailable.

Rationale and design of the EPCHF trial: the early palliative care in heart failure trial (EPCHF).

The progressive nature of heart failure (HF) coupled with high mortality and poor quality-of-life (QoL) mandates greater attention to palliative care (PC) as a routine component of HF management. Limited evidence exists from randomized controlled trials supporting the use of interdisciplinary palliative care in the progressive course of HF. The early palliative care in heart failure trial (EPCHF) is a prospective, controlled, nonblinded, multicenter study of an interdisciplinary palliative care intervention in 200 patients with symptomatic HF characterized by NYHA ≥ 2. The 12-month EPCHF intervention includes monthly consultations by a palliative care team focusing on physical and psychosocial symptom relief, attention to spiritual concerns and advance care planning. The primary endpoint is evaluated by health-related QoL questionnaires after 12 months of treatment. First the functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City cardiomyopathy questionnaire (KCCQ) measuring QoL living with heart failure will be determined. Secondary endpoints are changes in anxiety/depression (HADS), symptom burden score (MIDOS), spiritual well-being functional assessment of chronic illness therapy spiritual well-being scale (FACIT-Sp), medical resource and cost assessment. EPCHF will help evaluate the efficacy and cost-effectiveness of palliative care in symptomatic HF using a patient-centered outcome as well as clinical and economic endpoints. EPCHF is funded by the Bundesministerium für Bildung und Forschung (BMBF, 01GY17).