Prognostic Implications of Residual Tricuspid Regurgitation Grading After Transcatheter Tricuspid Valve Repair.

BACKGROUND: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern. OBJECTIVES: The authors sought to assess the impact of residual TR severity post-TTV repair on survival. METHODS: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe). RESULTS: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96). CONCLUSIONS: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention.

Residual tricuspid regurgitation after tricuspid transcatheter edge-to-edge repair: Insights into the EuroTR registry.

AIMS: Data on the prognostic impact of residual tricuspid regurgitation (TR) after tricuspid transcatheter edge-to-edge repair (T-TEER) are scarce. The aim of this analysis was to evaluate 2-year survival and symptomatic outcomes of patients in relation to residual TR after T-TEER. METHODS AND RESULTS: Using the large European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR registry) we investigated the impact of residual TR on 2-year all-cause mortality and New York Heart Association (NYHA) functional class at follow-up. The study further identified predictors for residual TR ≥3+ using a logistic regression model. The study included a total of 1286 T-TEER patients (mean age 78.0 ± 8.9 years, 53.6% female). TR was successfully reduced to ≤1+ in 42.4%, 2+ in 40.0% and 3+ in 14.9% of patients at discharge, while 2.8% remained with TR ≥4+ after the procedure. Residual TR ≥3+ was an independent multivariable predictor of 2-year all-cause mortality (hazard ratio 2.06, 95% confidence interval 1.30-3.26, p = 0.002). The prevalence of residual TR ≥3+ was four times higher in patients with higher baseline TR (vena contracta >11.1 mm) and more severe tricuspid valve tenting (tenting area >1.92 cm2). Of note, no survival difference was observed in patients with residual TR ≤1+ versus 2+ (76.2% vs. 73.1%, p = 0.461). The rate of NYHA functional class ≥III at follow-up was significantly higher in patients with residual TR ≥3+ (52.4% vs. 40.5%, p < 0.001). Of note, the degree of TR reduction significantly correlated with the extent of symptomatic improvement (p = 0.012). CONCLUSIONS: T-TEER effectively reduced TR severity in the majority of patients. While residual TR ≥3+ was associated with worse outcomes, no differences were observed for residual TR 1+ versus 2+. Symptomatic improvement correlated with the degree of TR reduction.

Paradox of disproportionate atrial functional mitral regurgitation and survival after transcatheter edge-to-edge repair.

AIMS: This study aims to assess the applicability of the mitral regurgitation (MR) proportionality concept in patients with atrial functional mitral regurgitation (aFMR) treated with transcatheter edge-to-edge repair (M-TEER). We hypothesized that patients with disproportionate MR (higher MR relative to left ventricular size) would exhibit different outcomes compared to those with proportionate MR, despite undergoing M-TEER. METHODS AND RESULTS: We retrospectively analysed 98 patients with aFMR from the EuroSMR registry who underwent M-TEER between 2008 and 2019. Patients met criteria for aFMR (normal indexed left ventricular end-diastolic volume [LVEDV], preserved left ventricular ejection fraction [LVEF] ≥ 50% without regional wall motion abnormalities, and structurally normal mitral valves). We excluded patients with missing effective regurgitant orifice area (EROA) or LVEDV data. The primary endpoint was 2-year mortality, with an EROA/LVEDV ratio employed to differentiate disproportionate from proportionate MR. Procedural success and baseline characteristics were analysed, and multivariate Cox proportional hazards models were used to identify mortality predictors. The mean patient age was 79 ± 7.3 years, with 68.8% female, and 79% had a history of atrial fibrillation. The mean EROA was 0.27 ± 0.14 cm2, and LVEDV was 95.6 ± 33.7 mL. Disproportionate MR was identified with an EROA/LVEDV ratio >0.339 cm2/100 mL. While procedural success was similar in both groups, disproportionate MR was associated with a numerically higher estimate of systolic pulmonary artery pressures (sPAP) and rates of NYHA ≥III and TR ≥ 3+. Disproportionate MR had a significant association with increased 2-year mortality (P < 0.001). The EROA/LVEDV ratio and tricuspid annular plane systolic excursion (TAPSE) were independent predictors of 2-year mortality (EROA/LVEDV: HR: 1.35, P = 0.010; TAPSE: HR: 0.85, P = 0.020). CONCLUSIONS: This analysis introduces the MR proportionality concept in aFMR patients and its potential prognostic value. Paradoxically, disproportionate MR in aFMR was linked to a 1.35-fold increase in 2-year mortality post-M-TEER, emphasizing the importance of accurate preprocedural FMR characterization. Our findings in patients with disproportionate MR indicate that a high degree of aFMR with high regurgitant volumes may lead to aggravated symptoms, which is a known contributor to increased mortality following M-TEER. These results underline the need for further research into the pathophysiology of aFMR to inform potential preventative and therapeutic strategies, ensuring optimal patient outcomes.

Comparison of Robotic Versus Conventional Open Thyroidectomy for Recurrent Laryngeal Nerve Safety: A Systematic Review and Meta-Analysis.

This review aims to investigate the safety of recurrent laryngeal nerve (RLN) by comparing robotic thyroidectomy (RT) versus open thyroidectomy (OT) in Western and Asian populations. Two main outcomes of this review were (1) the safety of RLN comparing the robotic and OT assessing transient and permanent laryngeal nerve (PLN) palsy as a postoperative complication in each surgical procedure and (2) the safety of RLN comparing the robotic and OT assessing transient and permanent laryngeal nerve (PLN) palsy as a postoperative complication between studies conducted in USA/Europe and Asia. We searched relevant literature in electronic databases such as PubMed, MEDLINE, Cochrane CENTRAL, ScienceDirect, and Cumulative Index to Nursing & Allied Health (CINAHL) up to September 2022. Further research was performed during January 2024 in the Scopus database. Two primary outcomes were set: transient RLN palsy and permanent RLN palsy, comparing RT and OT. In this review, 18 non-randomized studies were included. A statistically significant difference between robotic and conventional OT was not observed either in transient RLN or in permanent RLN palsy. The odds ratio (OR) for the overall comparison of transient RLN palsy was 1.18, and the 95% confidence interval (95% CI) was 0.80-1.74. The subgroup analysis for transient RLN palsy between USA/Europe studies was OR 1.28, and the 95% CI was 0.64-2.58. The subgroup analysis for transient RLN palsy between Asian studies was OR 1.14, and the 95% CI was 0.72-1.82. The OR for the overall comparison of permanent RLN palsy was OR 0.90, and the 95% CI was 0.38-2.15. The subgroup analysis for permanent RLN palsy between USA/Europe studies was OR 0.45, and the 95% CI was 0.07-2.97. The subgroup analysis for permanent RLN palsy between Asian studies was OR 1.13, and the 95% CI was 0.42-3.05. Heterogeneity I2 was 0% in all outcomes. The Mantel-Haenszel method fixed effect was used. First, RT and open conventional thyroidectomy have comparable safety for RLN, although the analysis showed no statistically significant results. Second, no statistically significant results were found for RLN safety in either USA/Europe or Asian studies. Considering that there is not a statistically significant difference between the two approaches for RLN safety, and due to the limited number of studies from Western countries, the results should be considered with caution. Important factors such as the patient's body characteristics, the existing thyroid pathology, and the surgical approach should be kept in mind. More comparable studies are needed on the Western population.

Role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair.

BACKGROUND: Severe tricuspid regurgitation (TR) is associated with chronic volume overload and right ventricular remodeling (RVR). Transcatheter tricuspid valve repair (TTVr) reduces TR and can improve quality of life (QoL), but the role of preprocedural RVR on TTVr outcomes remains unclear. AIMS: To investigate the role of RVR on outcomes after TTVr for severe TR. METHODS: Consecutive patients undergoing TTVr (61% edge-to-edge vs. 39% direct annuloplasty) for severe TR were retrospectively compared by preexisting RVR which was defined as dilation of RV mid-level diameter (> 35 mm) according to guidelines. QoL was evaluated using NYHA class, Minnesota Living with Heart Failure Questionnaire (MLHFQ), 36-Item Short Form Health Survey (SF-36), and 6-min walking distance (6MWD) 1-month after TTVr. Mid-term mortality and heart failure (HF) hospitalization were assessed through 1 year. RESULTS: RVR was present in 137 of 223 patients (61%). Symptoms and QoL improved equally in both groups: ≥ 1 NYHA class (57% vs. 65% of patients with vs. without RVR, respectively), 6MWD (36% vs. 34%), MLHFQ (81% vs. 69%), and SF-36 (68% vs. 65%) improvement. One-year mortality and HF hospitalization were significantly higher in patients with RVR (24% and 30%, respectively) than in patients without (8% and 13%, both p < 0.05). In multivariable analysis, RVR was independently associated with mortality (HR 2.3, 95%CI (1.0-5.0), p = 0.04) and the combined endpoint of mortality or rehospitalization (HR 2.0, 95%CI (1.1-3.8), p = 0.03). CONCLUSIONS: TTVr was associated with significant QoL improvement after 1 month, irrespective of RVR. Despite increased mortality and rehospitalization for heart failure, TTVr in the presence of RVR still provides substantial symptomatic benefit for patients with severe TR.

Frailty, periinterventional complications and outcome in patients undergoing percutaneous mitral and tricuspid valve repair.

BACKGROUND: Frailty is common in elderly and multimorbid patients and associated with increased vulnerability to stressors. METHODS: In a single centre study frailty according to Fried criteria was assessed in consecutive patients before transcatheter mitral and tricuspid valve repair. Postprocedural infections, blood transfusion and bleeding and renal failure were retrospectively assessed from records. Median follow-up time for survival was 560 days (IQR: 363 to 730 days). RESULTS: 90% of 626 patients underwent mitral valve repair, 5% tricuspid valve repair, and 5% simultaneous mitral and tricuspid valve repair. 47% were classified as frail. Frailty was associated with a significantly increased frequency of bleeding (16 vs 10%; p = 0.016), blood transfusions (9 vs 3%; p = < 0.001) and infections (18 vs 10%; p = 0.006), but not with acute kidney injury (20 vs 20%; p = 1.00). Bleeding and infections were associated with longer hospital stays, with a more pronounced effect in frail patients (interaction test p < 0.05, additional 3.2 and 4.1 days in frail patients, respectively). Adjustment for the occurrence of complications did not attenuate the increased risk of mortality associated with frailty (HR 2.24 [95% CI 1.62-3.10]; p < 0.001). CONCLUSIONS: Bleeding complications and infections were more frequent in frail patients undergoing transcatheter mitral and tricuspid valve repair and partly explained the longer hospital stay. Albeit some of the complications were associated with higher long-term mortality, this did not explain the strong association between frailty and mortality. Further research is warranted to explore interventions targeting periprocedural complications to improve outcomes in this vulnerable population.

Incidence and clinical impact of renal failure and bleeding following transcatheter tricuspid valve annuloplasty.

BACKGROUND: Bleeding is the most common complication after percutaneous leaflet-based tricuspid valve repair and associated with acute kidney injury (AKI) and adverse outcome. TTVA with the Cardioband system is a technically more complex procedure; however, frequency and prognostic impact of postinterventional bleeding and renal complications have not been thoroughly examined. AIMS: This study was performed to determine the incidence and clinical impact of bleeding complications (MVARC criteria) and acute kidney injury (KDIGO criteria) following transcatheter tricuspid valve annuloplasty (TTVA). METHODS: In a bi-center retrospective analysis of patients undergoing TTVA between 2018 and 2022, we examined frequency, predictors, and clinical impact of bleeding and renal failure. RESULTS: In 145 consecutive patients, the incidence of any MVARC bleeding was 20.7% (n = 30), whereas major MVARC bleeding occurred in 6.9% (n = 10). The incidence of AKI was 18.6% (n = 27). Risk factors for bleeding events included low baseline hemoglobin and elevated baseline creatinine levels. Risk factors for AKI included diabetes mellitus, arterial hypertension, high body mass index, and elevated baseline creatinine levels. Neither procedure duration nor amount of contrast media was associated with AKI or bleeding. Both bleeding and AKI led to a longer hospital stay. At 3 months, 10.0% (n = 3) of patients with bleeding and 7.8% (n = 9) of patients without bleeding complications died (p = 0.70). Additionally, mortality rate was 7.4% (n = 2) in patients with AKI compared to 8.5% (n = 10) without AKI (p = 0.83). CONCLUSION: While about a fifth of patients undergoing TTVA suffered from postinterventional AKI or bleeding, none of these complications was associated with higher mortality at short-term follow-up. One important risk factor for both complications was chronic renal dysfunction, indicating a high-risk patient population. The most frequent bleeding localizations were the femoral access site, pericardial hemorrhage, and the esophagus, which need explicit attention in periprocedural management.

Guideline-directed medical therapy assessment in heart failure patients undergoing percutaneous mitral valve repair.

AIMS: Achieving optimized guideline-directed medical therapy (GDMT) is recommended prior to transcatheter mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). We aimed to propose and validate an easy-to-use score for assessing the quality of GDMT in patients with heart failure with reduced ejection fraction (HFrEF) undergoing M-TEER. METHODS AND RESULTS: Among the 1641 EuroSMR patients enrolled in the EuroSMR Registry who underwent M-TEER, a total of 1072 patients [median age 74, interquartile range (IQR) 67-79 years, 29% female] had complete data on GDMT and a left ventricular ejection fraction ≤ 40% and were included in the current study. We proposed a GDMT score that considers the dosage levels of three medication classes (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists), with a maximum score of 12 points indicating optimal GDMT. The primary outcome was all-cause mortality. The median GDMT score was 4 points (IQR 3-6). All three domains of the scoring system were associated with all-cause mortality (P < 0.05 for all). The overall GDMT score was associated with all-cause mortality (hazard ratio 0.90, 95% confidence interval 0.86-0.95 for each 1-point increase in the GDMT score). This association remained significant after adjusting for renal function and co-morbidities. CONCLUSIONS: This study demonstrates the utility of a simple GDMT scoring system for assessing the adequacy of GDMT in HFrEF patients with relevant SMR undergoing M-TEER. The GDMT score has potential applications in guiding the design of future clinical trials and aiding clinical decision-making processes.

TRI-SCORE and benefit of intervention in patients with severe tricuspid regurgitation.

BACKGROUND AND AIMS: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE. METHODS: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years. RESULTS: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively). CONCLUSIONS: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category.

Comparison of transcatheter leaflet-approximation and direct annuloplasty in tricuspid regurgitation.

BACKGROUND: Transcatheter repair emerges as a treatment option in patients with tricuspid regurgitation (TR) and high surgical risk. AIMS: This study aimed to compare leaflet-based and annuloplasty-based transcatheter repair in patients with TR. METHODS: In a retrospective analysis consecutive patients undergoing either transcatheter edge-to-edge repair (TEER) or direct annuloplasty (AP) for relevant TR at 2 centers were compared with respect to baseline characteristics, procedural efficacy and safety (death, myocardial infarction, procedure or device-related cardiothoracic surgery, or stroke at 30 days). RESULTS: 161 patients (57% female, median age 79 [75-82] years) with comparable clinical baseline characteristics in the TEER (n = 87) and AP (n = 74) group were examined. Baseline TR grade was significantly less severe in the TEER compared to the AP group (torrential 9.2 vs. 31.1%, p = 0.001). Technical success and improvement of TR grades were not significantly different across groups. In analysis matched for baseline TR severity, reduction of TR grade to less than moderate was significantly more common in the AP group (47.8 vs. 26.1%, p = 0.031). Major or more severe bleeding occurred in 9.2% of TEER and 20.3% of AP patients (p = 0.049) without any fatal bleedings. Major adverse events (MAE) were similar across groups with four patients (4.7%) in the TEER group and five patients (6.9%) in the AP group (p = 0.733) and 6-month survival did not differ significantly. CONCLUSIONS: Differences observed between patients treated with TEER and AP provide first evidence for tailoring distinct transcatheter treatment techniques to individual patient characteristics.

Prognostic impact of cancer history in patients undergoing transcatheter mitral valve repair.

BACKGROUND: History of cancer is common in patients undergoing transcatheter mitral valve repair (TMVR). OBJECTIVES: Aim was to examine the impact of cancer history on outcomes after TMVR. METHODS: In patients of a monocentric prospective registry of TMVR history of cancer was retrospectively assessed from records. Associations with 6-week functional outcomes and clinical outcomes during a median follow-up period of 594 days were examined. RESULTS: Of 661 patients (mean age 79 years; age-range 37-101 years; 56.1% men), 21.6% had a history of cancer with active disease in 4.1%. Compared with non-cancer patients, cancer patients had a similar procedural success rate (reduction of mitral regurgitation to grade 2 or lower 91.6% vs. 88%; p = 0.517) and similar relevant improvement in 6-min walking distance, NYHA class, Minnesota Living with Heart Failure Questionnaire score and Short Form 36 scores. 1-year survival (83% vs. 82%; p = 0.813) and 1-year survival free of heart failure decompensation (75% vs. 76%; p = 0.871) were comparable between cancer and non-cancer patients. Patients with an active cancer disease showed significantly higher mortality compared with patients having a history of cancer (hazard ratio 2.05 [95% CI 1.11-3.82; p = 0.023]) but similar mortality at landmark analysis of 1 year. CONCLUSION: TMVR can be performed with equal efficacy in patients with and without cancer and symptomatic mitral regurgitation. Cancer patients show comparable clinical outcome and short-term functional improvement as non-cancer patients. However, longterm mortality was increased in patients with active cancer underlining the importance of patient selection within the heart-team evaluation.

Satisfaction of Patients with HIV/AIDS Infection from the Care Provided in the Special Infection Unit of University General Hospital of Alexandroupoli.

Background: C HIV/AIDS infection is characterized by a very low number of T lymphocytes (CD4), which makes sufferers vulnerable to various infections, and so they seek continuous care in Special Infections Units. Objective: The purpose of the survey is to investigate the factors that contribute to the satisfaction derived from the health services provided to people living with the human immunodeficiency virus; and they are monitored at the Special Infections Unit of the University General Hospital of Alexandroupoli. Methods: All patients who came to the Special Infections Unit of the University General Hospital of Alexandroupoli during the period June - July 2021 were asked to complete an anonymous questionnaire on satisfaction derived from the health services provided (E - PQ - SPCSS) and satisfaction derived from their work and quality of life (Occupational Stress Questionnaire, JCQ). The statistical package SPSS 19.0 was used for the statistical analysis of the data. With the help of the ANOVA statistical test, the differences between the variables were checked. P-Value in all audits was set at 0.05. Values showing equal to or less than 0.05 were considered statistically significant. Results: They were 85 patients who participated. Amongst them, they were mainly men (75.3%), the mean age was 35-50 years (50.6%), residents of Thrace (62.3%). 37.7% of the participants said they had some difficulty accessing SIU. Quality of life was positively correlated with education (p<0.001) where the higher reported level of education was, the higher satisfaction rates were. A positive correlation (p<0.001) was also observed amongst income rates where the higher incomes reported, the higher the satisfaction rates were. Lower incomes were significantly associated (p = 0.029) with mental disorders (anxiety, depression). Quality of life was positively associated with both satisfaction with medical as well as nursing care (p <0.008). The adequacy and clarity of the information the patients receive from SIU physicians during their visit shows a significant positive correlation (p<0.001). In addition, there is a significant correlation regarding the problems patients may have experienced in the last 6 months in terms of access to treatment (p<0.021). Conclusion: Participants showed high satisfaction rates from the medical and nursing care provided at the SIU of the PGNA. The opportunity of expression given to users - patients through satisfaction studies promotes and creates a climate of trust between them and the decision-making teams of health units.

Prevalence of anxiety and depression of health care workers during COVID-19 - a systematic review and meta-analysis.

Introduction: During the COVID-19 pandemic, the workload of healthcare workers managing the disease, increased significantly. The objective of this review is to determine the anxiety and depression prevalence among healthcare workers during the pandemic period. Methods: We searched systematically the literature in five electronic databases such as PubMed, CINAHL, ScienceDirect, MEDLINE, and Cochrane COVID-19 study register. The last online research was performed in May 2022. We included only cross-sectional studies and performed a meta-analysis of pooled prevalence. Publication bias was assessed with a funnel plot and Egger's and Begg's tests. A random effect was applied and heterogenicity I2 was calculated. Quality assessment of included studies was performed using the Joanna Briggs Institute tool. Results: In this review, we included 14 cross-sectional studies comprising 7780 healthcare workers. Participants were from the whole spectrum of healthcare workers. The pooled prevalence of depression was 33.8% (95% CI: 24.6 - 43.6), heterogenicity I2: 98.69%. The pooled prevalence of anxiety was 41.3% (95% CI: 30.2 - 52.9), heterogenicity I2: 99.01%. Conclusion: One-third of healthcare workers suffered from depression, and more than one-third suffered from anxiety during the COVID-19 pandemic. Increased measures of surveillance of mental health should have been taken, as well as the support of healthcare workers running a high risk of psychological distress during the COVID-19 pandemic.

Predicted impact of atrial flow regulator on survival in heart failure with reduced and preserved ejection fraction.

AIMS: We aim to assess the theoretical impact of the atrial flow regulator (AFR) on survival in heart failure. METHODS AND RESULTS: The prospective, multicentre, open-label, non-randomised PRELIEVE study (NCT03030274) assessed the safety and efficacy of the Occlutech AFR device in patients with symptomatic heart failure with reduced ejection fraction (HFrEF) (left ventricular ejection fraction (LVEF) ≥ 15% and <40%) or heart failure with preserved ejection fraction (HFpEF) (LVEF ≥40% and <70%) and elevated PCWP (≥15 mmHg at rest or ≥25 mmHg during exercise). In this analysis, after the first 60 patients completed 12 months of follow-up, the theoretical impact of AFR implantation on survival was assessed by comparing the observed mortality rate with the median predicted probability for one-year mortality. Each subject's risk of mortality was predicted from individual baseline data using the Meta-Analysis Global Group in Chronic HF (MAGGIC) prognostic model. A total of 87 patients (46% female, median age 69 years [IQR 62-74]) had undergone successful device implantation for the treatment of HFrEF (53%) and HFpEF (47%). Sixty patients had a complete 12 month follow-up. The median follow-up was 351 days (interquartile range [IQR] 202-370). Six (7%) patients died during follow-up (8.6 deaths per 100 patient-years; 95% confidence interval [CI] 2.7 to 15.5), all of which had HFrEF. The median predicted mortality rate for the overall study population was 12.2 deaths per 100 patient-years (95% CI 10.2 to 14.7). While the observed mortality rate (0 deaths per 100 patient-years) was significantly lower than the median predicted mortality rate (9.3 deaths per 100 patient-years; 95% CI 8.4 to 11.1) in patients with HFpEF (-9.3 deaths per 100 patient-years; 95% CI -11.1 to -8.4), there was no difference in patients with HFrEF (-3.6 deaths per 100 patient-years; 95% CI -9.5 to 3.0). Four deaths were HF-related deaths (5.7 HF-related deaths per 100 patient-years; 95% CI 1.4 to 11.9; 10.8 HF-related deaths per 100 patient-years; 95% CI 2.5 to 23.1 in the HFrEF subgroup). CONCLUSIONS: In patients with HFpEF, the mortality rate following AFR implantation was lower than the predicted mortality rate. Dedicated randomised, controlled trials are needed - and currently ongoing - to investigate whether the AFR improves mortality.

Disentangling Heart Failure and Physical Frailty: Prospective Study of Patients Undergoing Percutaneous Mitral Valve Repair.

BACKGROUND: Frailty and heart failure share pathophysiology and clinical characteristics. OBJECTIVES: The aim of this study was to analyze the contribution of heart failure to the physical frailty phenotype by examining patients with heart failure before and after percutaneous mitral valve repair (PMVR). METHODS: Frailty according to the Fried criteria (weight loss, weakness, exhaustion, slowness, and low activity) was assessed in consecutive patients before and 6 weeks after PMVR. RESULTS: A total of 118 of 258 patients (45.7%) (mean age: 78 ± 9 years, 42% female, 55% with secondary mitral regurgitation) were frail at baseline, which significantly decreased to 74 patients (28.7 %) at follow-up (P < 0.001). The frequency of frailty domains slowness, exhaustion, and inactivity significantly decreased, whereas weakness remained unchanged. Baseline frailty was significantly associated with comorbidities, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and functional capacity, whereas frailty after PMVR was not associated with NT-proBNP levels. Predictors of postprocedural reversibility of frailty were NYHA functional class 

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration.

BACKGROUND: 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. OBJECTIVES: The authors sought to evaluate frequency, prognostic implications and predictors of GDMT uptitration after M-TEER in patients with SMR and HFrEF. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Leaflet Morphology and its Implications for Direct Transcatheter Annuloplasty of Tricuspid Regurgitation.

BACKGROUND: Leaflet morphology has been associated with treatment success in edge-to-edge repair of tricuspid regurgitation (TR), but the impact on annuloplasty is unclear. OBJECTIVES: The authors sought to examine the association of leaflet morphology with efficacy and safety of direct annuloplasty in TR. METHODS: The authors analyzed patients who underwent catheter-based direct annuloplasty with the Cardioband at 3 centers. Leaflet morphology was assessed according to number and location of leaflets by echocardiography. Patients with simple morphology (2 or 3 leaflets) were compared with complex morphology (>3 leaflets). RESULTS: The study included 120 patients (median age 80 years) with ≥severe TR. A total of 48.3% of patients had a 3-leaflet morphology, 5% a 2-leaflet morphology, and 46.7% had >3 tricuspid leaflets. Baseline characteristics did not differ relevantly between groups except for a higher incidence of torrential TR grade (50 vs 26.6%) in complex morphologies. Postprocedural improvement of 1 (90.6% vs 92.9%) and 2 (71.9% vs 67.9%) TR grades was not significantly different between groups, but patients with complex morphology had more often residual TR ≥3 at discharge (48.2 vs 26.6%; P = 0.014). This difference did not remain significant (P = 0.112) after adjusting for baseline TR severity, coaptation gap, and nonanterior jet localization. Safety endpoints including complications of the right coronary artery, and technical success did not show significant differences. CONCLUSIONS: Efficacy and safety of transcatheter direct annuloplasty using Cardioband are not affected by leaflet morphology. Assessment of leaflet morphology should be part of procedural planning in patients with TR and might help to individually tailor repair techniques to patient anatomy.