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Bleeding events after arterial transcatheter procedures are associated with increased morbidity and mortality. The frequency and clinical implications of bleeding after mitral transcatheter edge-to-edge repair (M-TEER) have not been well-studied. The authors sought to explore the association of in-hospital bleeding events after M-TEER with patient outcomes. Patients undergoing M-TEER who were included in the TVT (Transcatheter Valve Therapy) Registry between 2013 and 2022 were included. Rates of the primary endpoint, the composite of death or hospital readmission at 30 days, were compared between patients who experienced in-hospital major or life-threatening bleeding vs those without bleeding. Secondary analyses examined the association between in-hospital bleeding and death or readmission at 1 year, as well as independent predictors of major in-hospital bleeding. Over the study period, in-hospital major bleeding occurred in 1,205 (2.3%) of 51,533 patients. Rates of bleeding decreased over time (from 7.1% in 2013 to 2.0% in 2021; P < 0.001). In-hospital bleeding was associated with increased rates of death or readmission at both 30 days (adjusted OR: 2.15 [95% CI: 1.81-2.54]; P < 0.0001) and 1 year (adjusted HR: 1.43 [95% CI: 1.27-1.60]; P < 0.0001). The strongest correlates of in-hospital bleeding included female sex, prior percutaneous coronary intervention, baseline hemoglobin, greater procedure acuity, and longer procedure duration. Bleeding after M-TEER is associated with increased risk of subsequent death and hospital readmission. Although reductions in bleeding complications over time are encouraging, continued efforts are needed to further mitigate hemorrhagic complications of M-TEER. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: The edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices—MitraClip, PASCAL, and TriClip—remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR. Methods: Five databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials. Results: The database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P < 0.01) [TriClip: (MD = -7.4; 95% CI: -9.24, -5.56), MitraClip: (MD = -4.04; 95% CI: -5.03, -3.05), and PASCAL: (MD = -6.56; 95% CI: -7.76, -5.35)]. The procedural success rates and incidence of single leaflet device attachment (SLDA) were similar across all devices. Furthermore, there were no significant differences in mortality, stroke rates, or major bleeding events among the three devices. Conclusion: The TriClip outperforms the MitraClip and PASCAL in reducing vena contracta width, indicating greater effectiveness for severe tricuspid regurgitation. All devices show similar safety profiles and procedural success rates. Further research is needed to confirm these results. [ABSTRACT FROM AUTHOR]

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Background: Transcatheter edge-to-edge repair (TEER) with MitraClip is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative risk. Pleth Variability Index (PVI) is a non-invasive, dynamic index based on analysis of the respiratory variations in the plethysmographic waveform recorded transcutaneously by the pulse oximeter. Objectives: The objective of the study was to evaluate if the hemodynamic effect of improved left-sided output after successful transcatheter mitral valve repair would lead to a significant change in PVI, and if it would correlate with the decrease in left atrial pressure (LAP). Design: Prospective, observational cohort study (ClinicalTrials.gov NCT03993938). Setting: Single academic hospital in Detroit, Michigan (USA), from October 2019 to February 2021. Participants: The authors included adult patients with severe mitral regurgitation who underwent successful MitraClip placement. Measurements and Main Results: Of 30 patients, all components of the LAP (a wave, v wave, and mean) decreased significantly after successful MitraClip placement (P <.01). The median (IQR) PVI increased from 21 (11-35) to 23 (13-38) after clip placement; however, this change was not statistically significant (P =.275). No significant correlation between change in PVI and change in LAP was observed (P =.235). Conclusions: In patients with severe mitral regurgitation, successful MitraClip resulted in a significant reduction in LAP without a significant change in PVI. A larger sample size may provide more insight on the utility of using PVI as an indicator of LAP change in patients with mitral regurgitation. [ABSTRACT FROM AUTHOR]

Abstract Background The edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices—MitraClip, PASCAL, and TriClip—remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR. Methods Five databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials. Results The database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P

Precise appreciation of the 3-dimensional relationship between the edge-to-edge clips and mitral valve apparatus remains clinically challenging. We demonstrate the images of clips observed in situ 4 years after implantation. Detailed observation from this case helps improve our understanding of 3-dimensional clinical cardiac anatomy related to transcatheter edge-to-edge mitral valve repair. (Level of Difficulty: Intermediate.).

Abstract Aims The long‐term cost‐effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long‐term cost‐effectiveness of MitraClip added to guideline‐directed medical therapy vs. guideline‐directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. Methods and results A two‐stage (decision + Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re‐hospitalization, and death and were calculated based on the 5 year follow‐up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country‐specific rates. The primary outcome was the lifetime incremental cost‐effectiveness ratio. The mean age of the base case in our model was 72.2 years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re‐hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality‐adjusted life‐year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost‐effectiveness ratios of ¥468 462, £28 910, €26 045, and $71 199 per quality‐adjusted life‐year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost‐effective in mainland China, the United Kingdom, Germany, and the United States at the country‐specific willingness‐to‐pay thresholds. Conclusions MitraClip + guideline‐directed medical therapy was cost‐effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system.

Aortic stenosis (AS) and mitral regurgitation (MR) result in different patterns of left ventricular remodeling and hypertrophy. We characterized left ventricular wall stress (LVWS) profiles in pressure and volume-overloaded systems, examined the relationship between baseline LVWS and cardiac remodeling, and assessed the acute effects of valve intervention on LVWS using invasive pressures combined with cardiac magnetic resonance (CMR) imaging measures of left ventricular volumes/mass. A total of 47 patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) and 15 patients with severe MR undergoing MitraClip (MC) underwent a 6-minute walk test (6MWT), transthoracic echocardiogram, and CMR before their procedures. Catheters in the left ventricle were used to record hemodynamic changes before and after valve/clip deployment. This was integrated with CMR data to calculate LVWS before and after intervention. The TAVR group demonstrated significant reductions in systolic LVWS post procedure (median 24.7 Pa [IQR: 14 Pa] pre vs median 17.3 Pa [IQR: 12 Pa] post; P < 0.001). The MC group demonstrated significant reductions in diastolic LVWS (median 6.4 Pa [IQR: 5 Pa] pre vs median 4.3 Pa [IQR: 4.1 Pa] post; P = 0.021) with no significant change in systolic LVWS (30.6 ±1.61 pre vs 33 ±2.47 Pa post; P = 0.16). There was an inverse correlation between baseline systolic LVWS and 6MWT in the TAVR group (r = −0.31; P = 0.04). TAVR results in significant reductions in systolic LVWS acutely. MC results in significant reductions in diastolic LVWS. Higher baseline systolic LVWS in TAVR is associated with shorter 6MWT suggesting that in AS, LVWS may be a useful marker of early decompensation. [ABSTRACT FROM AUTHOR]

Copyright of Revista Española de Cardiología (18855857) is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims Left ventricular global longitudinal strain (LVGLS) is a known outcome predictor in transcatheter edge-to-edge repair (TEER) for functional mitral regurgitation (MR). We aimed to assess its prognostic yield in the setting of TEER for chronic primary MR. Methods and results We conducted a single-centre, retrospective analysis of 323 consecutive patients undergoing isolated, first-time procedures. Stratified by baseline LVGLS quartiles (≤−19%, −18.9% to −16%, −15.9% to −12%, >−12%), the cohort was evaluated for the primary composite outcome of all-cause mortality or heart failure hospitalizations, as well as secondary endpoints consisting of mitral reinterventions and the persistence of significant residual MR and/or functional disability—all along the first year after intervention. Subjects with worse (i.e. less negative) LVGLS exhibited higher comorbidity, more advanced HF, and elevated procedural risk. Post-TEER, those belonging to the worst LVGLS quartile group sustained increased mortality (16.9% vs. 6.3%, Log-Rank P = 0.005, HR 1.75, 95% CI 1.08–4.74, P = 0.041) and, when affected by LV dysfunction/dilatation, more primary outcome events (21.1% vs. 11.5%, Log-Rank P = 0.037, HR 1.68, 95% CI 1.02–5.46, P = 0.047). No association was demonstrated between baseline LVGLS and other endpoints. Upon exploratory analysis, 1-month post-procedural LVGLS directly correlated with and was worse than its baseline counterpart by 1.6%, and a more impaired 1-month value—but not the presence/extent of deterioration—conferred heightened risk for the primary outcome. Conclusion TEER for chronic primary MR is feasible, safe, and efficacious irrespective of baseline LVGLS. Yet, worse baseline LVGLS forecasts a less favourable post-procedural course, presumably reflecting a higher-risk patient profile. [ABSTRACT FROM AUTHOR]

Aims: The long‐term cost‐effectiveness of MitraClip in heart failure patients with secondary mitral regurgitation is still unclear. This study aimed to evaluate the long‐term cost‐effectiveness of MitraClip added to guideline‐directed medical therapy vs. guideline‐directed medical therapy alone in heart failure patients with secondary mitral regurgitation from the perspective of the healthcare systems of mainland China, the United Kingdom, Germany, and the United States. Methods and results: A two‐stage (decision + Markov) model was built. Health utilities were defined by the New York Heart Association class, heart failure re‐hospitalization, and death and were calculated based on the 5 year follow‐up results of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation trial. Direct healthcare costs were derived from the nationally representative data. Future utilities and costs were discounted at country‐specific rates. The primary outcome was the lifetime incremental cost‐effectiveness ratio. The mean age of the base case in our model was 72.2 years. Over a lifetime horizon, treatment with MitraClip was associated with 829 fewer heart failure re‐hospitalizations per 1000 treated patients. The MitraClip treatment was associated with incremental quality‐adjusted life‐year gains of 0.71, 0.76, 0.78, and 0.78, as well as incremental cost‐effectiveness ratios of ¥468 462, £28 910, €26 045, and $71 199 per quality‐adjusted life‐year for a lifetime horizon in mainland China, the United Kingdom, Germany, and the United States, respectively. In probabilistic sensitivity analysis, 0.2%, 59.4%, 99.6%, and 84.7% of patients were cost‐effective in mainland China, the United Kingdom, Germany, and the United States at the country‐specific willingness‐to‐pay thresholds. Conclusions: MitraClip + guideline‐directed medical therapy was cost‐effective in heart failure patients with secondary mitral regurgitation in the United Kingdom, Germany, and the United States, but not in mainland China from the perspective of the national healthcare system. [ABSTRACT FROM AUTHOR]

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR. [ABSTRACT FROM AUTHOR]

Aim: The RESHAPE‐HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE‐HF2 trial compared to those enrolled in the COAPT and MITRA‐FR trials. Methods and results: The RESHAPE‐HF2 study is an investigator‐initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate‐to‐severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8–9.0) and median plasma N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) was 2745 (1407–5385) pg/ml. Most patients were prescribed beta‐blockers (96%), diuretics (96%), angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium–glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end‐diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA‐FR, those enrolled in RESHAPE‐HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT‐proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. Conclusion: Patients enrolled in RESHAPE‐HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate‐to‐severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA‐FR trials. The results of RESHAPE‐HF2 will provide crucial insights regarding broader application of the transcatheter edge‐to‐edge repair procedure in clinical practice. [ABSTRACT FROM AUTHOR]

BackgroundAtrioventricular valve regurgitation (AVVR) is present in up to 75% of Fontan patients, and it is associated with an increased risk of Fontan circulation failure, morbidity, and mortality. Traditional treatment options include surgical repair vs. surgical replacement. We present, to the best of our knowledge, one of the first cases of successful trans-catheter repair of severe common AVVR using the MitraClip device.Case summaryA 20-year-old male with a history of double-outlet right ventricle (DORV) with unbalanced common atrioventricular canal to the right ventricle, severely hypoplastic left ventricle, and total anomalous pulmonary venous return status post-Fontan procedure presented with progressively worsening dyspnoea on exertion. Transoesophageal echocardiogram demonstrated severe common AVVR. After discussion of the case during the adult congenital heart disease multidisciplinary conference, patient underwent successful placement of two MitraClip devices, reducing the regurgitation from torrential to moderate.DiscussionMitraClip therapy can be used to alleviate symptoms in patients deemed as high risk for surgery. However, careful attention must be paid to haemodynamics before and after clip placement, which may predict short-term clinical outcomes.

Background: There is conflicting evidence regarding the effect of residual transmitral mean pressure gradient (TMPG) after mitral transcatheter edge-to-edge repair (M-TEER). Different TMPG cutoffs have been employed in prior studies with varying results. Objectives: The purpose of this study was to examine the association between residual TMPG and M-TEER outcomes. Methods: Consecutive patients undergoing M-TEER at our institution between 2014 and 2022 were included and divided based on quartiles of predischarge TMPG. Outcomes were assessed using Kaplan-Meier analysis and Cox proportional hazard models. We performed subgroup analyses according to mitral regurgitation (MR) mechanism. The primary outcome was all-cause mortality or heart failure hospitalization. Results: We included 283 patients (age 76.7 ± 10.8 years, 42.8% women, 78.4% Caucasian, and baseline TMPG 2.4 ± 1.3 mm Hg). Higher baseline TMPG was a predictor of increased TMPG after M-TEER (coefficient 0.60 [95% CI: 0.40-0.70]; P

Study objective: Assessing if Transcatheter Edge to Edge Repair (TEER) with Mitraclip™ in patients with moderate to severe mitral regurgitation (MR) and cardiogenic shock (CS) improves outcomes compared to medical management alone. Design: A single-center, retrospective study was performed in an urban tertiary referral center. Setting: Rush University Medical Center, United States. Participants: Adult patients presenting with CS and moderate to severe MR between 2012 and 2021 were included. Interventions: Undergoing Mitral TEER with Mitraclip versus medical management alone. Main outcome measures: Major adverse cardiovascular events (MACE) defined as cardiovascular death, heart failure admission, stroke, and myocardial infarction assessed at 30 days, 6 months, and 1 year. The secondary outcome was a change in New York Heart Association (NYHA) classification at 30 days and 6 months. Results: There were 28 patients included in the medical management and 33 in the mitral valve TEER groups. There was a decreased MACE in the intervention group at 30 days (24.2 % vs. 46.4 %, p ≤0.001) and 6 months (27 % vs. 75 %, p = 0.002), though not at 1 year (29.4 % vs. 41.7 %, p = 0.42). At 30 days, more patients in the mitral valve TEER group improved to NYHA classes I/II compared to medical management alone (10 [35.7 %] vs. 16 [50 %], p = 0.043). There were no differences in NYHA classes I/II at 6 months (7 [43.7 %] vs. 13 [54.2 %], p = 0.63). Conclusion: Mitral valve TEER using the Mitraclip™ system improves mid-term cardiovascular compared to medical management alone in patients with CS but does not improve mortality.

The clinical benefits of transcatheter edge to edge mitral valve repair have been well established in patients with heart failure and severe mitral regurgitation (MR) who have prohibitive surgical risk. In March of 2019, the FDA approved the MitraClip for treatment of selected patients with HF and severe secondary MR. However, the relative outcomes of patients with HFrEF and HFpEF treated with MitraClip are largely unknown. We therefore sought to investigate the incidence and characteristics of in-hospital mortality in patients with HFpEF and HFrEF following MitraClip. The study sample analyzed was originated from the National Inpatient Sample (NIS) registry which includes data from hospitalized patients in the United States (US) between January 1, 2012 and December 31, 2020. Data were extracted from the entire NIS registry using ICD-9 codes. Patients with the primary or secondary diagnosis of MitraClip were identified. Hospitalizations for HFpEF and HFrEF were identified based on ICD-9-CM and ICD-10-CM codes. Demographics, conventional risk factors, and in-hospital outcomes were evaluated. 23,260 hospitalizations for MitraClip implantation between 2016 and 2020 were analyzed. The HFrEF group had higher absolute rates of complications as well as a higher observed in-hospital mortality (2.4 % vs 1.7 %; OR 0.75 95 % CI 0.44–1.26; p 0.28) which did not meet statistical significance. Absolute rates of acute myocardial infarction (AMI), acute kidney injury (AKI) and respiratory failure necessitating invasive mechanical ventilation were observed to be higher among HFrEF patients. Post-procedural shock was significantly more common in patients with HFrEF (9.0 % vs 2.8 %: OR 0.34 95 % CI 0.25–0.48 p < 0.001). Significantly longer hospitalizations were observed in the HFrEF cohort (5.3 ± 11.2 days vs 4.2 ± 7.3 days; p < 0.001) as well as a higher total hospitalization cost (61,723 ± 56,728 USD vs 57,278 ± 46,143). In the present study of US patients, those with HFrEF were observed to have statistically higher risk of in-hospital post-procedural shock and longer hospitalization length of stay when compared with patients with HFpEF who underwent MitraClip implantation. Additionally, patients with HFrEF undergoing MitraClip procedure were observed to have higher absolute rates of certain post-procedural complications, however these observations did not reach statistical significance. Understanding of the aforementioned differences after MitraClip implantation may be useful in-patient selection, prognostic guidance, and hypothesis generation to propel future large clinical studies. • Patients with HFrEF were associated with higher risk of in-hospital post-MitraClip shock and longer hospitalization length of stay when compared with patients with HFpEF. • Patients with HFrEF undergoing MitraClip procedure were observed to have higher absolute rates of certain post-procedural complications. • Understanding of the aforementioned differences after MitraClip implantation may be useful in-patient selection and prognostic guidance. [ABSTRACT FROM AUTHOR]

Background and Aims Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France. Methods Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes. Results A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563–0.832; P =.0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238–1.971; P =.0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835–1.118; P =.65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction. Conclusions Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER. [ABSTRACT FROM AUTHOR]

Copyright of Die Kardiologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Anaesthesiologie & Intensivmedizin is the property of DGAI e.V. - Deutsche Gesellschaft fur Anasthesiologie und Intensivmedizin e.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Over the last two decades, mitral transcatheter edge-to-edge repair (M-TEER) has become a safe and effective therapy for severe mitral regurgitation in patients deemed at high surgical risk. This review aims to encompass the most relevant and updated evidence in the field of M-TEER from its inception, focusing on clinical and anatomical features for proper patient and device selection. Growing operator experience and device iterations have resulted in improved clinical outcomes and an expansion of the therapy to patients with complex anatomies and clinical scenarios. Future investigations are warranted to determine the best management options and the most suitable device for every patient with MR. [ABSTRACT FROM AUTHOR]

Background: Mitral regurgitation (MR) is the most common valvular disease worldwide. MR has been managed surgically, with either a mitral valve replacement or repair. Percutaneous transcatheter mitral valve repair (TMVr) with MitraClip® insertion has gained wide popularity and success over medical and surgical therapy for MR. Some patients with acute MR or decompensated heart failure could benefit from urgent TMVr. This meta-analysis aims to compare clinical outcomes of urgent versus elective TMVr. Methods: We performed a study-level meta-analysis to compare the clinical outcomes of urgent versus elective TMVr using the MitraClip system. The primary endpoint outcome was all-cause mortality. Additional outcomes included procedural success, postoperative acute kidney injury (AKI), stroke, and length of in-hospital stay. Results: Overall, 30-day mortality was significantly higher in the urgent group (odds ratio [OR]: 2.74; 95% confidence interval [CI] [2.17, 3.48]; P < 0.00001; I2 =0%). However, subgroup analysis of matched cohorts showed no significant difference between both groups (OR: 1.80; 95% CI [0.94, 3.46]; P = 0.08; I2 =0%). One-year mortality was similar between both groups (and: 1.67; 95% CI [0.96, 2.90]; P = 0.07; I2 =0%). Procedural success was similar between both groups (89.4% vs. 89.8%; P = 0.43). Postoperative AKI was significantly higher in the urgent group (OR: 4.12; 95% CI [2.87, 5.91]; P < 0.00001; I2 =0%). Conclusion: Urgent TMVr should be indicated in select populations as it is considered therapeutic with acceptable outcomes therein.

[Display omitted] [ABSTRACT FROM AUTHOR]

In recent years, transcatheter edge-to-edge repair (TEER) has been widely adopted as an effective treatment for mitral regurgitation (MR). The aim of this study is to develop a personalized in silico model to predict the effect of edge-to-edge repair in advance to the procedure for each individual patient. For this purpose, we propose a combination of a valve deformation model for computing the mitral valve (MV) orifice area (MVOA) and a lumped parameter model for the hemodynamics, specifically mitral regurgitation volume (RVol). Although we cannot obtain detailed information on the three-dimensional flow field near the mitral valve, we can rapidly simulate the important medical parameters for the clinical decision support. In the present method, we construct the patient-specific pre-operative models by using the parameter optimization and then simulate the postoperative state by applying the additional clipping condition. The computed preclip MVOAs show good agreement with the clinical measurements, and the correlation coefficient takes 0.998. In addition, the MR grade in terms of RVol also has good correlation with the grade by ground truth MVOA. Finally, we try to investigate the applicability for the predicting the postclip state. The simulated valve shapes clearly show the well-known double orifice and the improvement of the MVOA, compared with the preclip state. Similarly, we confirmed the improved reverse flow and MR grade in terms of RVol. A total computational time is approximately 8h by using general-purpose PC. These results obviously indicate that the present in silico model has good capability for the assessment of edge-to-edge repair. [ABSTRACT FROM AUTHOR]

Background: Transcatheter edge-to-edge mitral valve repair (TEER) has emerged as a viable approach to addressing substantial secondary mitral regurgitation. In the contemporary landscape where ultimate heart failure-specific therapies, such as cardiac replacement modalities, are available, prognosticating a high-risk cohort susceptible to early cardiac mortality post-TEER is pivotal for formulating an effective therapeutic regimen. Methods: Our study encompassed individuals with secondary mitral regurgitation and chronic heart failure enlisted in the multi-center (Optimized CathEter vAlvular iNtervention (OCEAN)-Mitral registry. We conducted an assessment of baseline variables associated with cardiac death within one year following TEER. Results: Amongst the 1517 patients (median age: 78 years, 899 males), 101 experienced cardiac mortality during the 1-year observation period after undergoing TEER. Notably, a history of heart failure-related admissions within the preceding year, utilization of intravenous inotropes, and elevated plasma B-type natriuretic peptide levels emerged as independent prognosticators for the primary outcome (p < 0.05 for all). Subsequently, we devised a novel risk-scoring system encompassing these variables, which significantly stratified the cumulative incidence of the 1-year primary outcome (16%, 8%, and 4%, p < 0.001). Conclusions: Our study culminated in the development of a new risk-scoring system aimed at predicting 1-year cardiac mortality post-TEER. [ABSTRACT FROM AUTHOR]

Backgrounds: Ventricular functional mitral regurgitation (FMR) is a common morbidity in patients with heart failure (HF). In addition to guideline-directed medical therapy, mitral valve (MV) repair or replacement has become an option for such patients. However, the impact of different treatments on cardiac remodeling, function, and clinical outcomes remains unclear. Methods: We systematically searched PubMed, EMBASE, Medline, Clinical Trials.gov, and the Cochrane Central Register of Controlled Trials with search terms related to mitral regurgitation, mitral valve repair, surgical mitral valve replacement, mitral annuloplasty device, and MitraClip. The outcomes were left ventricular ejection fraction (LVEF), left ventricular (LV) remodeling, all-cause mortality, cardiovascular death, and HF hospitalization. Sensitivity analysis was performed by removing high-bias risk studies. The analysis was done by Review Manager 5.4 Analyzer and MedCalc Statistical Software version 19.2.6. Results: This meta-analysis included 10 studies with a total of 2533 patients (567 with transcatheter MitraClip, 823 with surgical MV repair, 651 with surgical MV replacement, and 492 with medical therapy). Our meta-analysis revealed that surgical MV repair had significant improvement in LVEF compared to the surgical MV replacement (mean differences (MD) 2.32, [95% CI 0.39, 4.25]), while transcatheter MitraClip treatment was associated with LVEF reduction (MD -4.82, [95% CI -7.29, -2.34]). In terms of LV remodeling, transcatheter MitraClip treatment was associated with improvement in left ventricular end-diastolic volume (MD -10.36, [95% CI -18.74, -1.99]). Furthermore, compared to surgical MV replacement, surgical MV repair was not associated with a reduction of all-cause mortality (risk ratio (RR) 0.83, [95% CI 0.61, 1.13]) and cardiovascular death (RR 0.95, [95% CI 0.56, 1.62]), while transcatheter MitraClip was associated with reduced risk of all-cause mortality (RR 0.87, [95% CI 0.78, 0.98]). Conclusions: Surgical MV repair was associated with significant improvement in LVEF but had no significant effect on all-cause mortality compared to surgical MV replacement. Transcatheter MitraClip was associated with better long-term survival than the non-MitraClip group, thus, transcatheter MitraClip could be considered an alternative treatment in patients with HF-complicated ventricular FMR. [ABSTRACT FROM AUTHOR]

Both the MitraClip and PASCAL systems offer transcatheter edge-to-edge repair (TEER) solutions for mitral regurgitation. Evidence indicates a lower technical success rate for TEER in complex degenerative mitral regurgitation (DMR) cases. We conducted a retrospective analysis of patients who underwent transcatheter edge-to-edge therapy for primary mitral regurgitation with advanced anatomy, defined as mitral regurgitation effective regurgitant orifice area (MR-EROA) ≥0.40 cm2 or large flail gap (≥5 mm) or width (≥7 mm) or Barlow's disease, that completed follow-up after 1 year. Our criteria were met by 27 patients treated with PASCAL and 18 with MitraClip. All patients exhibited a significant, equivalent short-term reduction in MR-EROA, mitral regurgitation vena contracta diameter (MR-VCD), regurgitant volume, and clinical status. At 1 year follow-up, reductions in MR-VCD, regurgitant volume, and MR-EROA remained significant for both groups without significant differences between groups. MR-Grade ≤ 1+ was achieved in 18 (66.7%) and 10 (55.6%) patients, respectively. At follow-up, no difference in hospitalization for cardiac decompensation was observed. Overall death was similar in both groups. Our study suggests that both the PASCAL and MitraClip systems significantly reduce mitral regurgitation even in advanced degenerative diseases. Within our limited data, we found no evidence of inferior performance of the PASCAL system. [ABSTRACT FROM AUTHOR]

Background: Mitral regurgitation (MR) is the most common valvular disease worldwide. MR has been managed surgically, with either a mitral valve replacement or repair. Percutaneous transcatheter mitral valve repair (TMVr) with MitraClip® insertion has gained wide popularity and success over medical and surgical therapy for MR. Some patients with acute MR or decompensated heart failure could benefit from urgent TMVr. This meta-analysis aims to compare clinical outcomes of urgent versus elective TMVr. Methods: We performed a study-level meta-analysis to compare the clinical outcomes of urgent versus elective TMVr using the MitraClip system. The primary endpoint outcome was all-cause mortality. Additional outcomes included procedural success, postoperative acute kidney injury (AKI), stroke, and length of in-hospital stay. Results: Overall, 30-day mortality was significantly higher in the urgent group (odds ratio [OR]: 2.74; 95% confidence interval [CI] [2.17, 3.48]; P < 0.00001; I2 =0%). However, subgroup analysis of matched cohorts showed no significant difference between both groups (OR: 1.80; 95% CI [0.94, 3.46]; P = 0.08; I2 =0%). One-year mortality was similar between both groups (and: 1.67; 95% CI [0.96, 2.90]; P = 0.07; I2 =0%). Procedural success was similar between both groups (89.4% vs. 89.8%; P = 0.43). Postoperative AKI was significantly higher in the urgent group (OR: 4.12; 95% CI [2.87, 5.91]; P < 0.00001; I2 =0%). Conclusion: Urgent TMVr should be indicated in select populations as it is considered therapeutic with acceptable outcomes therein. [ABSTRACT FROM AUTHOR]

Patients with dilated cardiomyopathy who have developed mitral valve regurgitation (MR) with reduced left ventricular ejection fraction and are too sick to undergo any surgical repair or replacement are being treated worldwide through catheter-based percutaneous intervention techniques to treat MR like MitraClip system®. There are very few case reports especially from India on anesthetic management during MitraClip device implantation and its specific considerations. We present a case of a 48-year-old male patient, diagnosed as post-myocarditis dilated cardiomyopathy with poor left ventricular ejection fraction (30–35%) and severe MR who underwent mitral clip implantation with fluoroscopy and transesophageal echocardiography guidance under general anesthesia. We hope that our experience will help and guide future such undertakings in our country. [ABSTRACT FROM AUTHOR]

Aims To explore the characteristics and outcomes of patients undergoing transcatheter edge-to-edge repair (TEER) for primary mitral regurgitation (MR) according to the presence of left ventricular ejection fraction (LVEF) reduction post-procedure. Methods and results We retrospectively analysed 317 individuals [median age 83 (interquartile range, 75–88) years, 197 (62.1%) males] treated with an isolated, first-time TEER that was concluded by a successful clip deployment. Stratified by LVEF change at 1-month compared with baseline, the cohort was evaluated for residual MR and heart failure (HF) indices up to 1-year, as well as all-cause mortality and HF hospitalizations at 2-years. Overall, 212 (66.9%) patients displayed LVEF reduction, which was mainly driven by lowered total stroke volume and diffuse hypocontractility. While post-procedural MR, transmitral mean pressure gradient, and functional status were comparable in the two study groups, patients with LVEF reduction exhibited a greater decline in filling pressures intra-procedurally; left ventricular mass index, pulmonary arterial systolic pressure, and serum natriuretic peptide level at 1-month; and walking limitation at 1-year. Also, by 2 years, they were less likely to die (13.3% vs. 5.7%, P = 0.019), be readmitted for HF (17.1% vs. 9.0%, P = 0.033), and experience either of the two (23.8% vs. 12.7%, P = 0.012). Lastly, LVEF reduction was the only 1-month echocardiographic parameter to independently confer an attenuated risk for the composite of deaths or HF hospitalizations (HR 0.28, 95% CI 0.10–0.78, P = 0.016). Conclusion LVEF reduction at 1-month post-TEER for primary MR is associated with better clinical outcomes, possibly reflecting a more pronounced unloading effect of the procedure. [ABSTRACT FROM AUTHOR]

The safety and feasibility are still not well known for exercise-induced mitral regurgitation (MR). This study is aimed to assess and compare the hemodynamic and symptomatic changes in patients with significant secondary MR during exercise stress echocardiography (ESE) before and after transcatheter edge-to-edge repair (TEER). The study included a total of 15 patients with secondary MR who underwent ESE before and after TEER using the MitraClip system (Abbott, Abbott Park, IL, USA). Echocardiographic data of ESE were collected both before the procedure and during the follow-up visit at 3 months. During the one-year postoperative observation period, the rate of readmission due to heart failure was 13% (n = 2), with no recorded fatalities. Although no significant differences of ESE data were observed in exercise-induced pulmonary hypertension or cardiac output before and after the repair, the severity of MR was significantly improved after the procedure, both at rest (2 [2–3] vs. 1 [1–2], p = 0.0125) and during ESE (3 [3–3] vs. 1 [1–1], p < 0.0001). Furthermore, the New York Heart Association Functional Classification was improved (3 [3–3] vs. 1 [1–1], p < 0.0001) after treatment. For a supplemental analysis, MR during ESE was significantly improved not only in cases with atrial secondary MR but also in ventricular secondary MR. Transcatheter edge-to-edge repair for exercise-induced MR resulted in a significant improvement in postoperative MR severity and subjective symptoms. These results are novel, as they have not been extensively reported previously, particularly among Japanese patients. [ABSTRACT FROM AUTHOR]

Little is known about mitral transcatheter edge-to-edge repair (TEER) in patients with mitral annular disjunction (MAD). The authors sought to explore TEER for degenerative mitral regurgitation (MR) according to MAD status. We retrospectively analyzed 271 consecutive patients (median age 82 [Q1-Q3: 75-88] years, 60.9% men) undergoing an isolated, first-ever TEER for whom there were viewable preprocedural echocardiograms. Stratified by MAD status at baseline, the cohort was evaluated for all-cause mortality, heart failure hospitalizations, and mitral reinterventions—the composite of which constituted the primary outcome—as well as functional capacity and residual MR, all along the first postprocedural year. Individuals with (n = 62, 22.9%) vs without MAD had more extensive prolapse and larger valve dimensions. Although the former's procedures were longer, utilizing more devices per case, technical success rate and residual MR were comparable. MAD presence was associated with higher mortality risk (HR: 2.64; 95% CI: 1.82-5.52; P = 0.014), and increased MAD length—with lower odds of functional class ≤II (OR: 0.65; 95% CI: 0.47-0.88; P = 0.006). Among 47 MAD patients with retrievable 1-month data, MAD regressed in 91.5% and by an overall 50% (Q1-Q3: 22%-100%) compared with baseline (P < 0.001). A greater MAD shortening conferred attenuated risk for the primary outcome. In our experience, TEER for degenerative MR accompanied by MAD was feasible and safe; however, its postprocedural course was somewhat less favorable. MAD shortening following TEER was observed in most patients and proved prognostically beneficial. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: mitral regurgitation (mr) is the most common valvular heart disease (vhd) in the elderly and tends to be more prevalent in women. while relevant sex differences in outcomes are evident in surgically treated collectives, there are very limited and conflicting sex-specific data for the growing cohort of patients undergoing transcatheter edge-to-edge repair (teer). Objective: to investigate whether sex impacts procedural safety and efficacy, and in-hospital- and long-term outcomes, after teer for mr. Methods: in a multicenter observational cohort study, patients who underwent teer were stratified by sex and relevant outcome measures, and analyzed using multivariable cox regression and propensity score matching (psm). Results: a total of 821 patients were analyzed, of whom 37.4% (307/821) were female. compared to male patients, females were significantly older (77 ± 8.5 vs. 80.4 ± 6.7 years, p = 0.03), and had less coronary artery disease (cad, 67.7% vs. 53.1%, p < 0.0001) and a higher proportion of preserved left ventricular function (lvef > 50%, 32.5% vs. 50.5%, p > 0.0001). safety and efficacy of the teer procedure and in-hospital mortality did not differ between the sexes. after psm, women showed significantly better survival 3 years after teer compared to men (60.7% vs. 54.2%, p = 0.04) and a lower risk of all-cause death according to multiple cox regression (hr 0.8, 95% ci 0.6–0.9, p = 0.02). after sex-specific stratification for concomitant atrial fibrillation (af), the most common comorbidity in the present collective, women with af experience significantly worse adjusted survival compared to women without af (53.9% vs. 75.1%, p = 0.042) three years after teer and lose the survival advantage over men. Conclusions: female patients are older and less comorbid than males undergoing TEER. The TEER procedure is equally safe and effective in both sexes. While in-hospital mortality did not differ, female patients experienced a significantly better adjusted long-term survival compared to male patients. Concomitant AF offsets the prognostic advantage of females over males and, in contrast to males, significantly impairs long-term survival in women undergoing TEER. Further research is warranted to elucidate underlying causes for the observed sex disparities and to develop sex-tailored treatment recommendations. [ABSTRACT FROM AUTHOR]

Background: Transcatheter edge-to-edge repair (TEER) of the mitral valve has emerged as an alternative treatment for mitral regurgitation (MR). However, the high radiation exposure during the process has been associated with multiple adverse effects for medical staff. In this study, we assessed the feasibility and safety of TEER performed solely under the echocardiographic (echo) guidance. Methods: Between April 2021 to August 2021, we retrospectively collected characteristics of 23 patients with MR who underwent TEER under echocardiographic guidance exclusively. Follow-up evaluations were performed at 1-, 3-months and 1-year post procedure. Results: All 23 patients (mean age, 66.1 ± 12.1 years; 65.2% males) successfully underwent echo-guided TEER, with 22 patients under transesophageal echo (TEE) guidance and 1 patient under transthoracic echo (TTE) guidance for severe esophageal stenosis. Of the patients, 60.9% received 1 implant and 39.1% received 2 implants. The median total procedural time was 130 (interquartile range, IQR: 90-150) min and the device procedure time was 73 (IQR: 58-100) min. The median length of stay was 6 (IQR: 5-9) days. At 3-months follow-up, 63.6% of patients had an MR =1+ and 90.9% had an MR =2+ (p < 0.001 vs. baseline). Improvement in functional status was observed, with 40.9% of patients classified as New York Heart Association (NYHA) functional class I and 45.5% as NYHA functional class II (p < 0.001 compared to baseline) at 3-months. At 1-year follow-up, 90.4% maintained MR reduction with MR =2+ (p < 0.001 vs. baseline). Single leaflet device attachment (SLDA) occurred in one patient (4.3%) 1-week post procedure. Conclusions: This retrospective, single-center, and pilot study demonstrates the feasibility, safety, and low complication rates of TEER guided solely by echocardiography. Our findings support the systematic use of echocardiography as the sole guidance modality for TEER, highlighting its potential as an alternative to fluoroscopy-guided procedures. Further multicenter and comparative studies are warranted to confirm these results and provide a more comprehensive evaluation of this approach. [ABSTRACT FROM AUTHOR]

Background and Objectives: Remimazolam is a new ultrashort-acting benzodiazepine anesthetic. Remimazolam appears to be useful in patients with severe valvular disease because of its minimal cardiovascular impact. In this retrospective case series study, we assessed the efficacy and safety of remimazolam for maintaining hemodynamic stability during anesthetic induction and maintenance. Cases: MitraClip was performed on 18 cases with severe mitral regurgitation with low left ventricular function who presented with heart failure, and remimazolam was administered for general anesthesia with induction (12 mg/kg/h) and maintenance (1 mg/kg/h). The impact of remimazolam on the hemodynamics at anesthetic induction and during anesthetic maintenance was investigated retrospectively using electronic medical records. Blood pressure decreased significantly during anesthetic induction with remimazolam (78.5 [72, 81.25] and 66.1 [62.2, 74.2], median [IQR], p = 0.0001), but only mildly, by about 10 mmHg. There was no significant change in the cardiac index (2.0 [1.8, 2.4] vs. 1.9 [1.8, 2.3], p = 0.57642) or pulse rate (73.5 ± 8.85 vs. 74.7 ± 11.7, mean ± SD, p = 0.0876) during anesthetic induction with remimazolam. All patients underwent MitraClip without major hemodynamic concerns, with no or small increases in inotropes. Conclusions: Remimazolam may be used safely in patients with severe mitral regurgitation and low left ventricular function presenting with heart failure. [ABSTRACT FROM AUTHOR]

Background Percutaneous alcohol septal ablation (ASA) is a non-surgical treatment for symptomatic hypertrophic obstructive cardiomyopathy. It has a potential risk for systolic anterior motion (SAM)–related mitral regurgitation (MR) deterioration, leading to acute congestive heart failure. In such clinical scenarios, additional surgical interventions for SAM-MR are risky. Case summary A 70-year-old man experienced acutely deteriorated heart failure caused by SAM-related MR following ASA, for which venous-arterial extracorporeal membrane oxygenation (ECMO) and a percutaneous left ventricular assist device (Impella CP, Abiomed, MA, USA) were required. Transoesophageal echocardiography showed that an interventricular septal oedematous protrusion led to a large coaptation gap of mitral leaflets with a pseudo-prolapse of the posterior mitral leaflet (PML). Because of his prohibitive surgical risks, we opted for transcatheter edge-to-edge mitral valve repair with MitraClip therapy. After removing the Impella device, an XT clip (Abbott Vascular, CA, USA) was located to cover the pseudo-prolapsed PML, resulting in optimal MR reduction with an acceptable mean transmitral valve-pressure gradient. Thereafter, his heart failure was well controlled, and venous-arterial ECMO was successfully removed on post-MitraClip Day 2. Discussion This case demonstrated that MitraClip therapy rescued the patient from a rare complication of severe acute heart failure with haemodynamic collapse caused by massive SAM-related MR following ASA. MitraClip therapy can be a feasible, less-invasive interventional therapy for SAM-related MR in cases with acceptable severity of iatrogenic mitral stenosis post-MitraClip implantation. [ABSTRACT FROM AUTHOR]

Background Amyloidosis is defined by abnormal protein folding and subsequent deposition in tissues. Cardiac involvement is usually related to misfolded monoclonal immunoglobulin light chains or misfolded transthyretin; however, apolipoprotein A-1–associated amyloidosis is a hereditary form of amyloidosis resulting from mutations in the AAPOA1 gene that can also result in cardiac amyloidosis. Although there have been advancements in noninvasive algorithms for the diagnosis of cardiac amyloidosis, endomyocardial biopsy (EMB) may still be warranted. All individuals undergoing EMB are susceptible to complications, including tricuspid valve injury resulting in severe tricuspid valve regurgitation. Case summary Our patient is a 70-year-old white man presented with symptoms of dyspnoea on exertion and decreased functional capacity, diagnosed previously with apolipoprotein A-I cardiac amyloidosis, confirmed by EMB. He developed progressive right-sided heart failure secondary to iatrogenic flail tricuspid leaflet related to the diagnostic EMB. He underwent a successful transcatheter tricuspid valve edge-to-edge repair with 4D intracardiac echocardiographic guidance. At the recent follow-up, the patient showed improved symptoms, with increased stamina, and transoesophageal echocardiography revealed a 65% ejection fraction and mild tricuspid regurgitation (TR). Discussion Tricuspid valve injury is one of the complications associated with EMB, which can result in severe TR. Transcatheter tricuspid valve edge-to-edge repair can be a useful option for patients considered too high risk for surgical intervention, such as those with advanced cardiac amyloidosis. [ABSTRACT FROM AUTHOR]

Aim. To study the changes of left ventricular (LV) contractile function in patients with severe mitral valve (MV) insufficiency with assessment of global longitudinal strain (GLS) indicators and LV myocardial function after the mitral transcatheter edge-to-edge repair (TEER) within 12-month follow-up.Material and methods. The study consisted of 43 patients with severe mitral regurgitation (MR) as follows: 23 patients with functional MR (FMR), 20 patients with degenerative MR (DMR). A comprehensive echocardiographic study, including speckle tracking echocardiography, was performed at baseline, 4-5 days, 6 and 12 months after TEER. Standard structural and functional indicators of the LV, LV GLS and myocardial performance parameters were assessed.Results. The early postoperative period (4-5 days) was characterized by a decrease in global constructive work (GCW) (FMR group — from 977 [684; 1253] to 857 [736; 1488] mm Hg%, (p=0,038); DMR group — from 1458 [1283; 1848] to 1350 [1010; 1488] mm Hg% (p=0,011)), an increase in global wasted work (GWW) (FMR group — from 177 [130; 280] to 336 [242; 388] mm Hg% (p=0,004); DMR group — from 128 [81; 172] to 216 [164; 279] mm Hg% (p=0,043)), which was accompanied by a decrease in myocardial efficiency (FMR group — from 81,5 [77; 87] to 76 [73; 79]%, (p=0,021); DMR group — from 90 [85; 93] to 82 [79; 85]% (p=0,018)). After 12-month follow-up, there was a significant increase in GCW relative to the initial values in both cohorts of patients as follows: FMR group — to 1128 [890; 1711] mm Hg% (p=0,048); DMR group — to 1818 [1478; 2034] mm Hg% (p

Background Minimally invasive mitral valve repair has a favorable risk–benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge‐to‐edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR). Methods and Results We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long‐term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%, P=0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%; P=0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no (P=0.558) patients. Clinical follow‐up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all P>0.05). Propensity score–adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 [95% CI, 0.09–0.81]; P=0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all P>0.05). Conclusions In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.

Background: CardioMEMS is a device suitable for telemedicine that is currently being evaluated by the Regional Health Technology Assessment (HTA) Committee of Tuscany. Two detailed HTA reports are available in the specialized literature, the results of which need to be transferred to our regional setting. These decisions in Tuscany are made by the so-called Centro Operativo HTA. Aim: To validate, with local cost-effectiveness data, the decision on CardioMEMS that will be made in the Tuscany region. Methods: Two detailed international HTA reports were rearranged and adapted to our regional setting to generate a simplified analysis that could form the basis of our decision. Two willingness-to-pay (WTP) thresholds of €20,000/quality-adjusted life year (QALY) and €50,000/QALY were considered. Results: Based on epidemiological and regulatory information, the target population in Tuscany for this device is 166 cases. The value-based price of CardioMEMS is estimated to be €4,332 and €16,662 at WTP thresholds of 20,000/QALY and 50,000/QALY, respectively. Its current price in Italy is €12,000. Conclusion: In our region, the introduction of CardioMEMS is likely to be gradual, around 50 patients/year (or €0.60 million/year at current price). This example highlights the need to adapt the information published in the international literature to the local context in which the approval decision is made. In this context, simplified analyses are easier to apply than complex Markov models.

Severe degenerative mitral regurgitation (DMR) is one cardiac manifestation of the multiorgan metabolic enzyme disorder Anderson-Fabry Disease (AFD). Although DMR is normally managed surgically, many patients with AFD are unsuitable for this. We present the first case of mitral transcatheter edge-to-edge repair in a patient with AFD.

Mitral valve regurgitation is a common heart valve disorder associated with significant morbidity and mortality. Transcatheter mitral valve repair using the MitraClip device has emerged as a safe and effective alternative for patients unsuitable for conventional surgery. However, the structural and hemodynamic implications of MitraClip implantation in the left ventricle have not been extensively explored. This study aimed to assess the structural and hemodynamic performance of the MitraClip device using a high-fidelity model of the human heart, specifically focusing on a healthy mitral valve geometry. The implantation of the MitraClip device was simulated using the finite element method for structural analysis and the lattice Boltzmann method for computational flow analysis. MitraClip implantation induced geometrical changes in the mitral valve, resulting in local maxima of principal stress in the valve leaflet regions constrained by the device. Hemodynamic assessment revealed slow-moving nested helical flow near the left ventricular wall and high flow velocities in the apex regions. Vorticity analysis indicated abnormal hemodynamic conditions induced by the double-orifice area configuration of the mitral valve after MitraClip implantation. By predicting possible adverse events and complications in a patient-specific manner, computational modeling supports evidence-based decision making and enhances the overall effectiveness and safety of transcatheter mitral valve repairs.

Abstract Aims We aimed to conduct a clinical process cost analysis to evaluate all upcoming costs of mitral valve transcatheter edge-to-edge repair (M-TEER) treatment using the MitraClip and the PASCAL repair system. Methods First, we prospectively enrolled 107 M-TEER patients treated with either the PASCAL or MitraClip system and compared all upcoming costs during the M-TEER procedure and the associated in-hospital stay. Second, we retrospectively analysed 716 M-TEER procedures with regard to the occurrence of complications and their associated costs. All materials used in the catheterization laboratory for the procedures were evaluated. The cost analysis considered various expenses, such as general in-hospital costs, device costs, catheter laboratory and material costs. Results In the prospective study, 51 patients were treated using the PASCAL system, and 56 were treated using the MitraClip system. The two groups had comparable baseline characteristics and comorbidities. The total in-hospital costs were 25 414 (Interquartile range (IQR) 24 631, 27 697) € in the PASCAL group and 25 633 (IQR 24 752, 28 256) € in the MitraClip group (p = 0.515). The major cost driver was initial material expenditure, mostly triggered by device costs, which were similar to the PASCAL and MitraClip systems. Overall intensive care unit and general ward costs did not differ between the PASCAL and MitraClip groups. In the retrospective analysis, M-TEER-related complications were rare but were associated with higher costs, mainly due to prolonged hospitalisation. Conclusion The major cost driver of M-TEER was the material expenditure, which was mostly triggered by high device costs. The costs of treating patients were similar for the PASCAL and MitraClip systems. M-TEER-related complications are associated with higher costs, mainly due to prolonged hospitalisation. This analysis provides valuable insights into reducing expenses by modifying the process of M-TEER.

The implantation of left ventricular assist devices (LVADs) has been increasing, with good long-term results, in parallel with a growing population with advanced heart failure (HF). However, in some European countries, LVADs are still underused, with one of the main issues being the patient's late referral. On the contrary, the use of transcatheter edge-to-edge mitral valve repair (TEER) has exponentially increased over the past decade, expanding its potential use even in patients on the heart transplantation waiting list. Even though the study populations of the main trials that investigated the prognostic impact of LVAD and TEER are different, in clinical practice a clear distinction might not be so clear. Therefore, patients with refractory HF symptoms and significant mitral regurgitation should be thoroughly evaluated through a multidisciplinary Heart Team meeting with both an advanced HF specialist and interventional cardiologist, to avoid futile procedures and to define the optimal timing for advanced HF therapies, when they are indicated. We analyzed the main available studies and registries on both TEERs and LVADs and we compared their populations and outcomes, to provide the current evidence on the use of LVAD and TEER in the HF population, especially in the light of the recently released 5-year follow-up results, giving some insights on the Italian situation, and finally to stress the importance of a solid HF network between hospitals, aiming for advanced HF patients’ timely referral for LVAD or heart transplants.