Global Longitudinal Strain Predicts Outcomes in Patients with Reduced Left Ventricular Function Undergoing Transcatheter Edge-to-Edge Mitral Repair.

BACKGROUND: The timing and selection of optimal candidates for mitral transcatheter edge-to-edge valve repair remains to be fully determined, especially in cases with severely depressed left ventricular ejection fraction (LVEF). The objective of this study is to evaluate the prognostic value of myocardial strain (LVGLS) in this setting. METHODS: Retrospectively, 172 consecutive patients with LVEF ≤40% and severe MR treated with MitraClip were included. Four groups were generated according to the LVEF (<30% or ≥30%) and median LVGLS. The primary end-point was cardiovascular mortality. RESULTS: Procedural success was high (96.5%) and complications were rare. At one-year follow-up, 82.5% of patients maintained MR grade ≤2, 79.2% were at a NYHA class ≤II and a reduction of 80% in heart failure admissions was observed in all groups. Interestingly, among patients with a more depressed LVEF, LVGLS was found to be an independent predictor for cardiovascular mortality (HR: 3.3; 95% CI: 1.1-10, p = 0.023). CONCLUSIONS: Mitral valve repair with MitraClip is safe and it improves the mid-term functional class of patients regardless of LVEF. LVGLS can help in the selection of optimal candidates and timing for this procedure, as well as in the recognition of those patients with worse prognoses.

Prognostic Impact of Nutritional Status After Transcatheter Edge-to-Edge Mitral Valve Repair: The MIVNUT Registry.

Background Malnutrition is associated with poor prognosis in several cardiovascular diseases. However, its prognostic impact in patients undergoing transcatheter edge-to-edge mitral valve repair (TEER) is not well known. This study sought to assess the prevalence, clinical associations, and prognostic consequences of malnutrition in patients undergoing TEER. Methods and Results A total of 892 patients undergoing TEER from the international MIVNUT (Mitral Valve Repair and Nutritional Status) registry were studied. Malnutrition status was assessed with the Controlling Nutritional Status score. The association of nutritional status with mortality was analyzed with multivariable Cox regression models, whereas the association with heart failure admission was assessed by Fine-Gray models, with death as a competing risk. According to the Controlling Nutritional Status score, 74.4% of patients with TEER had any degree of malnutrition at the time of TEER (75.1% in patients with body mass index <25 kg/m2, 72.1% in those with body mass index ≥25 kg/m2). However, only 20% had moderate-severe malnutrition. TEER was successful in most of patients (94.2%). During a median follow-up of 1.6 years (interquartile range, 0.6-3.0), 267 (29.9%) patients died and 256 patients (28.7%) were admitted for heart failure after TEER. Compared with normal nutritional status moderate-severe malnutrition resulted a strong predictor of mortality (adjusted hazard ratio [HR], 2.1 [95% CI, 1.1-2.4]; P<0.001) and heart failure admission (adjusted subdistribution HR, 1.6 [95% CI, 1.1-2.4]; P=0.015). Conclusions Malnutrition is common among patients submitted to TEER, and moderate-severe malnutrition is strongly associated with increased mortality and heart failure readmission. Assessment of nutritional status in these patients may help to improve risk stratification.

A Score to Assess Mortality After Percutaneous Mitral Valve Repair.

BACKGROUND: Risk stratification for transcatheter edge-to-edge mitral valve repair (TEER) is paramount in the decision-making process for treating severe mitral regurgitation (MR). OBJECTIVES: This study sought to create and validate a user-friendly score (MitraScore) to predict the risk of mortality in patients undergoing TEER. METHODS: The derivation cohort was based on a multicentric international registry that included 1,119 patients referred for TEER between 2012 and 2020. Score discrimination was assessed using Harrell's c-statistic, and the calibration was evaluated with the Gronnesby and Borgan goodness-of-fit test. An external validation was carried out in 725 patients from the GIOTTO registry. RESULTS: After multivariate analysis, we identified 8 independent predictors of mortality during the follow-up (2.1 ± 1.8 years): age ≥75 years, anemia, glomerular filtrate rate <60 mL/min/1.73 m2, left ventricular ejection fraction <40%, peripheral artery disease, chronic obstructive pulmonary disease, high diuretic dose, and no therapy with renin-angiotensin system inhibitors. The MitraScore was derived by assigning 1 point to each independent predictor. The c-statistic was 0.70. Per each point of the MitraScore, the relative risk of mortality increased by 55% (HR: 1.55; 95% CI: 1.44-1.67; P < 0.001). The discrimination and calibration for mortality prediction was better than those of EuroSCORE II (c-statistic 0.61) or Society of Thoracic Surgeons score (c-statistic 0.57). The MitraScore maintained adequate performance in the validation cohort (c-statistic 0.66). The score was also predictive for heart failure rehospitalization and was correlated with the probability of clinical improvement. CONCLUSIONS: The MitraScore is a simple prediction algorithm for the prediction of follow-up mortality in patients treated with TEER.

Clinical and echocardiographic outcomes of transcatheter mitral valve repair in atrial functional mitral regurgitation.

BACKGROUND: Isolated atrial fibrillation can cause mitral regurgitation (MR) in patients with normal left ventricular systolic function and no organic disease of the mitral valve. Little information is available regarding outcomes of Mitraclip in patients with atrial functional mitral regurgitation (AFMR). We aimed to evaluate 12-month clinical and echocardiographic outcomes of transcatheter mitral valve repair (TMVR) with MitraClip in patients with AFMR compared to those with ventricular functional or degenerative/mixed MR. METHODS: Registry-based analysis of all consecutive patients who underwent TMVR and were included in the Spanish Registry of Mitraclip. Changes in MR and NYHA functional class, and a combined endpoint including all-cause mortality and hospitalizations due to heart failure were the main outcomes. RESULTS: Overall, 1074 (69.1% male, 73.3 ± 10.2 years-old) patients were analyzed in this report. 48 patients (4.5%) presented AFMR. AFMR was significantly reduced after TMVR, with a procedural success rate of 91.7%, and this reduction persisted at 12-month (p < 0.001). Patients with AFMR showed a significant functional improvement at 6- and 12-month follow-up in our series (baseline: NYHA III 70.8% IV 18.8% vs. 1-year: NYHA III 21.7% IV 0%; p < 0.001). The probability of survival free of readmission for heart failure and all-cause mortality within the first year after TMVR was 74.9%. Procedural and clinical outcomes, as well as recurrent rates of MR were similar acutely and at 1-year compared to other etiologies. CONCLUSION: TMVR in patients with AFMR showed no significant differences compared to ventricular functional or degenerative/mixed MR regarding MR reduction or clinical outcomes.

Clinical Outcomes Following Urgent vs. Elective Percutaneous Mitral Valve Repair.

AIM: To examine procedural and clinical outcomes among patients undergoing percutaneous mitral valve repair (PMVR) within an admission for acute-decompensated heart failure (ADHF). METHODS AND RESULTS: Prospective registry of all consecutive patients with symptomatic mitral regurgitation (MR) grade 3+ or 4+ who underwent PMVR our centre and classified in 2 groups: elective group and urgent PMVR group (within the index admission for ADHF). Echocardiographic, procedural and clinical outcomes were compared between groups. 85 patients (median age 77.0 [67.8-83.4] years, 64.7% male) were treated within the recruitment period. Among them, 17 (20%) underwent urgent MitraClip®. Urgent PMVR were at a higher risk for conventional surgery (p = 0.002) and had worse estimated prognosis according to HF risk scores (p < 0.001). Overall technical success was 100%, without differences between groups. At 30 days, no differences were found in mortality, MR reduction and in NYHA functional improvement between groups. Cumulative estimated survival free from all-cause death was 92.9% (82.4% vs. 95.6%), 89.4% (82.4% vs. 91.1%), 76.3% (82.4 vs. 74.9%) at 6 months, 1-year and 2-years, respectively, with no significant differences between urgent or elective PMVR (p = 0.769). CONCLUSION: MitraClip® implantation can be considered as an urgent therapy during admission for ADHF.

Percutaneous treatment with Mitraclip for functional mitral regurgitation: medium-term follow up according to left ventricular function.

BACKGROUND: Functional mitral regurgitation (FMR) is a bad prognosis condition despite optimal medical treatment. Nowadays there is an open debate about the surgical versus percutaneous treatment. The main objective of this study is to evaluate the mid-term follow up clinical outcomes of patients with FMR treated with MitraClip® system, according to their left ventricular ejection fraction (LVEF). METHODS: Data was obtained from two experienced centers in transcatheter mitral valve repair (TMVR). All consecutive cases of severe FMR undergoing TMVR in both centers with the same inclusion criteria were included prospectively in this study and followed-up. Periodical follow-ups with clinical and echocardiographic evaluation were scheduled from the baseline procedure, at 3 months and then yearly. RESULTS: From October 2015 to October 2019, a total of 119 patients with FMR at 2 centers in Spain underwent TMVR with the MitraClip® procedure and were included in this study. The mean age was 73.8±8.9 years old and 32 patients (26.9%) were female. A 39.5% of cases [47] had a LVEF ≤30% (group 1) and 60.5% (72 cases) had a LVEF >30% (group 2). There was a similar distribution in cardiovascular risk factors, age and other diseases. All MitraClip® implantations were elective and procedural success was achieved in 110 patients (92.4%) with a similar distribution between the groups. There were no differences in procedural time and the number of implanted clips. The median follow-up was 22.6 months (IQR, 11.43-34.98 months). The primary combined endpoint occurred in the 41.6% of the global cohort, 57.5% in group 1 and 30.99% in group 2 (P=0.036). LVEF was associated to the main event in the multivariate analysis (HR 2.09, 95% CI: 1.12-3.89; P=0.02). CONCLUSIONS: The MitraClip edge-to-edge technique is a safe and effective procedure for the treatment of FMR. In this study, patients with LVEF >30% treated with Mitraclip presented better clinical cardiovascular outcomes than those with a LVEF ≤30%. Regardless clinical outcomes, at the end of the follow-up, there was a sustained reduction in MR grades and an important improvement in NYHA functional class.

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study.

BACKGROUND: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip® between two groups according to LVEF. METHODS: In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF. RESULTS: Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%, p = 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups. CONCLUSION: FMR patients with LVEF <30% treated with MitraClip® had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.

Surgical management of embolized Amplatzer septal occluder into the left ventricle tangled with the mitral valve.

Device embolization is a rare major complication of atrial septal defect percutaneous closures which requires surgical management if noninvasive retrieval fails. We report a symptomatic delayed embolization of an Amplatzer septal occluder device into the left ventricle outflow tract tangled with the mitral valve, complicated with ventricular arrhythmias and cardiac tamponade during percutaneous retrieval attempt. Emergent surgical treatment was performed, requiring a combined approach through the right atrium and the aorta for surgical removal.

Percutaneous Mitral Valve Repair Vs. Stand-Alone Medical Therapy in Patients with Functional Mitral Regurgitation and Heart Failure.

BACKGROUND: Functional mitral regurgitation (FMR) is a common finding among patients with heart failure (HF) and it is related to adverse events. Outcomes in patients undergoing transcatheter mitral valve repair (TMVR) are still a matter of debate. We performed a meta-analysis to assess mid- and long-term outcomes of patients with FMR treated with MitraClip® compared to medical management. METHODS: We conducted an electronic database search of all published data PubMed Central, Embase, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Google Scholar databases. The primary end-point was all-cause mortality. The secondary end-points were hospitalizations for HF, need for heart transplantation or left ventricular assist device, unplanned mitral valve surgery, myocardial infarction and stroke. RESULTS: Five studies (n = 1513 patients) were included in the analysis. The summary estimate including all the available studies showed a statistically significant reduction in all-cause mortality favoring MitraClip® (HR 0.56, CI 95% [0.38-0.84]) and HF hospitalizations (HR 0.65; CI 95% [0.46-0.92]). A significant reduction in the indication for advanced HF therapies (OR 0.48; CI 95% [0.25-0.90]) or the need for unplanned mitral valve surgery (OR 0.20; CI 95% [0.07-0.57]) was also found in the group of patients that underwent TMVR. No differences in the incidence of myocardial infarction or stroke were found between both groups of treatment. No publication bias was detected. CONCLUSION: TMVR with MitraClip® system was related to a significant reduction in all-cause mortality, hospitalizations for HF and the need for HF transplant, left ventricular assist device or unplanned surgery beyond 1-year follow up.

Beneficial effect of left atrial appendage closure during cardiac surgery: a meta-analysis of 280 585 patients.

In non-rheumatic atrial fibrillation (AF), left atrial appendage (LAA) is thought to be the source of embolism in 90% of the strokes. Thus, as recent clinical trials have shown the non-inferiority of percutaneous LAA closure (LAAc) in comparison to medical treatment, and despite a IIb recommendation in the latest guidelines for concomitant surgical LAAc, we sought to investigate the beneficial effect of LAAc in the surgical population. A meta-analysis model was performed comparing studies including any cardiac surgery with or without concomitant surgical LAAc reporting stoke/embolic events and/or mortality, from inception to January 2019. Twenty-two studies (280 585 patients) were included in the model. Stroke/embolic events both in the perioperative period [relative risk (RR) 0.66, 95% confidence interval (CI) 0.53-0.82; P = 0.0001] and during follow-up of >2 years (RR 0.67, 95% CI 0.51-0.89; P < 0.005) were significantly reduced in patients who underwent surgical LAAc (RR 0.71, 95% CI 0.58-0.87; P = 0.001). Regarding the rate of preoperative AF, LAAc showed protective effect against stroke/embolic events in studies with >70% preoperative AF (RR 0.64, 95% CI 0.53-0.77; P < 0.00001) but no benefit in the studies with <30% of preoperative AF (RR 0.77, 95% CI 0.46-1.28; P = 0.31). Postoperative mortality was also significantly lower in surgical patients with LAAc at the mid- and long-term follow-up. (RR 0.72, 95% CI 0.67-0.78; P < 0.00001; I2 = 0%). Based on these findings, concomitant surgical LAAc is associated with lower rates of embolic events and stroke in the postoperative period in patients with preoperative AF and also improves postoperative mortality in the mid- and long-term follow-up.

MitraClip improves cardiopulmonary exercise test in patients with systolic heart failure and functional mitral regurgitation.

AIMS: The aim of this study is to evaluate changes in cardiopulmonary exercise test (CPET) after percutaneous mitral valve repair (PMVR) with MitraClip in patients with heart failure with reduced ejection fraction who are potentially candidates for heart transplantation or destination left ventricular assist device. METHODS AND RESULTS: Prospective registry of all consecutive patients with heart failure with reduced ejection fraction and functional mitral regurgitation (MR) underwent elective PMVR between October 2015 and March 2018 in our institution. Patients with preserved or mid-range left ventricular ejection fraction (>40%), advanced age (>75 years old), or severe co-morbidities (end-stage organ damage) were not included. Treadmill exercise testing with respiratory gas exchange analysis was carried out in 11 patients (male, 72.7%; median age, 67 years old) within the month prior to the procedure and at 6 month follow-up. PMVR was successfully performed in all patients. At 6 month follow-up, PMVR was associated with an improvement in New York Heart Association functional class (P = 0.021) and a reduction in MR severity (P = 0.013) and N-terminal pro-brain natriuretic peptide levels (2805 [1878-5022] vs. 1485 [654-3032] pg/mL; P = 0.012). All patients completed pre-procedural and post-procedural CPET, and all the studies showed a respiratory exchange ratio ≥1 and were consistent with sufficient exercise effort. Compared with pre-procedural CPET, patients showed a significant increase in exercise time (295 [110-335] vs. 405 [261-540] s; P = 0.047), VO2 (9.8 [9.1-13.4] vs. 13.5 [12.1-16.8] mL/kg/min; P = 0.033), ventilatory anaerobic threshold (510 [430-950] vs. 850 [670-1070] mL/kg/min; P = 0.033), peak O2 pulse (7.2 [4.3-8.6] vs. 8.3 [6.2-11.8] mL/beat; P = 0.033), and workload (5 [3-6] vs. 6 [5-8] metabolic equivalents; P = 0.049). CONCLUSIONS: Percutaneous mitral valve repair with MitraClip was associated with an enhancement in cardiopulmonary performance in patients with systolic heart failure and secondary MR.

Internal Banding to Reduce Paravalvular Leaks for Open Transcatheter Valve Implantation.

Transcatheter valve implantation has become an alternative to open-heart conventional surgery in high-risk patients. We describe a new surgical technique that allows the implantation of a transcatheter valvular prosthesis through an open surgical approach to prevent the appearance of paravalvular leaks in patients with large native rings.

Transapical mitral valve-in-valve ring implantation with the Edwards Sapien 3 prosthesis.

We present the case of a high-risk patient with symptomatic severe mitral regurgitation following a surgical annuloplasty ring. An inverted aortic Edwards Sapien 3 bioprosthesis (Edwards Lifesciences, Irvine, CA) was successfully implanted through a transapical approach inside the previously implanted annuloplasty ring.

Emergent aortic surgery in octogenarians: is the advanced age a contraindication?

Surgery of both the ascending and descending aortic segments in the context of an acute aortic syndrome is one of the greatest challenges for the cardiac surgeon. In the case of surgery of the descending aorta, surgical risk increases due to the technical complexity, the required aggressive approach and because surgical indication is usually established as a result of complications and therefore involves, almost always, critically ill patients. The aging of the population is causing such surgery to be considered in an increasing number of octogenarians. The present review analyzes the available scientific evidence on the surgical indications and outcomes of these complex procedures in this population, particularly in the emergent scenario. Ascending and descending thoracic aortic diseases are reviewed separately, and the role of both the current risk scores and frailty assessments are comprehensively discussed.

Sutureless aortic bioprosthesis.

Aortic valve replacement (AVR) is the treatment of choice for aortic valve disease, with excellent results reported in the short- and long-term follow-up. Due to the increasing number of patient comorbidities and older age, various technical alternatives have been developed such as transcatheter aortic valve implantation and, more recently, sutureless valve bioprostheses. For patients with very high surgical risk, transcatheter implantation is becoming the top therapeutic option. However, the percutaneous technique still has major disadvantages including those related to implantation without excision of the diseased native valve without direct view of the annulus, which increases the probability of developing perivalvular leaks and a high percentage of atrioventricular block. Due to the need for aggressive crimping of pericardial layers, there is uncertainty about their long-term durability. A new technique for AVR using sutureless bioprosthesis has recently been developed. The main advantages of this technique are the excellent haemodynamic performance and fast deployment under direct view, thereby avoiding the knotting of surgical stitches, which is especially advantageous in more technically demanding procedures (e.g. minimally invasive surgery, calcified aortic root and reoperations). The good clinical results of these valves have been supported by scientific evidence, making it a feasible option for patients who are candidates for AVR using biologic prosthesis, especially for those with mid-high surgical risk for standard AVR and percutaneous transcatheter valve implantation. In this article, we review the latest evidence on these new prostheses, including their advantages and possible disadvantages.