Reduction Of Mitral Regurgitation Research Articles

Impact of Right Ventricular Function on Cardiopulmonary Exercise Capacity in Mitral Regurgitation Patients Undergoing Transcatheter Mitral Valve Intervention

Transcatheter mitral valve interventions (TMVI) has been proven to reduce symptom burden and improve outcome in patients with severe mitral regurgitation (MR). However, the impact of right ventricular function (RVF) on exercise capacity in MR patients is less well understood. Cardiopulmonary exercise testing (CPET) is the most comprehensive approach to assess maximum exercise capacity. Submaximal exercise capacity (SEC), assessed by constant work rate exercise time testing (CWRET), is presumed to be relevant in daily life activities, and gives a more differentiated physiological insight into the nature of exercise intolerance. Thus, 28 MR patients underwent CPET and CWRET (at 75% of maximum work rate in the initial incremental exercise test) prior to TMVI and 3-months post-procedurally. Patients´ mean age was 75.0±8.7 years and 32.1% were female. One patient presented with a MR reduction of less than 2 grades. RVF was at least moderately impaired in 25% of the patients. SEC of these patients was lower, but did not significantly differ (416.4s±359.6 vs. 296.1±216.5s; p=) from patients without RVF-deterioration. At follow up, the SEC improved significantly (from 337.4±262.2s to 517.4±393.5s; p=0.006). Maximum oxygen uptake (peakVO2) showed a positive trend, but no statistically significant difference (10.3±3.1ml/min/kg vs. 11.3±3.4ml/min/kg; p=0.06). RVF improved in 35.7% of the patients and these patients showed a significantly higher SEC increase (471.7±153.9s vs. 82.7±47.0s, p=0.003). SEC is significantly increased in MR patients undergoing TMVI, reflecting an improvement especially regarding daily life activities. This may be related to TMVI´s beneficial effect on right ventricular remodeling.

Thrombin generation, fibrin clot permeation and lysis in patients with severe mitral regurgitation undergoing transcatheter edge-to-edge mitral valve repair: mitral fibrin study

Abstract Background/Introduction The management of heart failure (HF), particularly in the context of reduced ejection fraction, is further complicated by an increased risk of thromboembolic events. Structural alterations of both left ventricle and mitral valve contribute to mitral regurgitation (MR). However, the body of evidence provides inconclusive insights into the relationship between MR and thromboembolic risk. Purpose This study aimed to investigate the impact of transcatheter edge-to-edge repair (TEER) on thrombin generation, clot permeation and clot lysis time in HF patients with severe MR eligible for mitral TEER. Methods A cohort of 31 HF patients with severe MR undergoing TEER underwent systematic evaluation at three time points. Coagulation parameters, including fibrinogen concentration, thrombin generation, fibrin clot permeability (Ks), and clot lysis time (CLT), were assessed. Comprehensive evaluations also covered echocardiographic, laboratory, and clinical parameters. Results TEER induced changes in fibrinogen levels (p=0.009, visit 3 vs. visit 2) and improved fibrin clot properties over a 50-day follow-up (Ks, p=0.005, visit 3 vs. visit 2). No significant differences were observed among time points in analyzed blood clot parameters. Linear regression, incorporating thrombin generation variables, Ks, and CLT for delta NT-proBNP, highlighted CLT as the sole predictor of NT-proBNP change between visit 2 and visit 1 (p=0.03; R2=0.18). Conclusions MR reduction through TEER led to transient alterations in fibrinogen concentration and improved fibrin clot characteristics. Additionally, baseline CLT emerged as a significant predictor of early NT-proBNP reduction, emphasizing its role as a key indicator of the hemodynamic response to TEER.

Vía transapical para reemplazo percutáneo de válvula mitral por valvulopatía: una experiencia ibérica

Introduction and objectives: Transcatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure.Methods: We conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year.Results: A total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively.Conclusions: Treatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

Outcomes of mitral transcatheter edge-to-edge repair in patients with mitral annular calcification: A meta-analysis

BackgroundThe impact of mitral annular calcification (MAC) on the clinical outcomes of patients undergoing mitral transcatheter edge-to-edge repair (MTEER) remains unclear. This meta-analysis aims to evaluate the clinical outcomes of MTEER among patients with moderate to severe MAC compared to those with mild or no MAC. MethodsWe systematically searched PubMed, EMBASE, and Cochrane CENTRAL databases through March 31st, 2024, comparing clinical outcomes of MTEER among patients with moderate/severe (MAC+) versus no/mild MAC (MAC-). We assessed pooled estimates for procedural success, all-cause mortality, residual mitral regurgitation (MR) ≤ moderate, and New York Heart Association (NYHA) class III/IV status at one year. ResultsAmong five studies (2533 patients; mean age 76.4 ± 10.9 years, 39.8 % women), MAC+ patients were predominantly women (55.7 % vs 37.5 %, p < 0.001), older (87.9 ± 11.1 vs. 75.9 ± 9.1 years; mean difference (MD) = 3.99, p = 0.011) and had higher STS scores (7.7 ± 6.7 % vs. 4.9 ± 4.6 %; MD = 1.34, p < 0.001). MAC+ patients had comparable procedural success rates, residual MR < moderate, and NYHA III/IV at 1 year. However, all-cause mortality at 1 year was higher for MAC+ patients (Relative Risk = 1.56, 95 % CI = 1.06–2.29). ConclusionsMTEER is a safe and feasible option for carefully selected patients with MAC and significant MR, offering durable MR reduction and functional status improvement. Significantly higher one-year mortality associated with MAC despite significant MR reduction suggests an increased risk unrelated to valvular dysfunction and highlights the need for further investigation into identifying patients who benefit the most from MTEER.

Outcomes of mitral transcatheter edge to edge repair with MitraClip™ – An Indian single center experience

ObjectiveTo evaluate the outcomes of transcatheter edge-to-edge repair (TEER) with MitraClip™ (Abbott Vascular) in symptomatic high surgical risk Indian patients with significant mitral regurgitation (MR). MethodsPatients with moderately severe or severe primary or secondary MR and deemed high surgical risk were treated with MitraClip™. The data were collected retrospectively from medical records. The primary outcome was technical success, and secondary outcomes were ≤2+ MR reduction and improvement in functional capacity at 30 days. ResultsBetween November 2018 and August 2023, 64 patients were treated with MitraClipTM. The mean age was 70.0 ± 12.1 years and 64 % were males. The mean EuroScore II and STS score predicted mortality for mitral valve repair were 5.8 ± 4.5 % and 4.0 ± 3.8 % respectively. MR etiology was primary in 56.3 %, secondary in 40.6 % and mixed in 3.1 %. The device was implanted successfully in all but one patient with technical success rate of 98.4 %. The average number of clips per patient was 1.5 ± 0.6 and 42.2 % patients received more than one clip. The mean mitral valve gradient was 3.5 ± 1.6 mmHg. The MR severity of ≤2+ was achieved in 91.8 % of the subjects and similar proportion were in New York Heart Association Functional Class I or II at 30 days. ConclusionIn high-risk Indian patients with symptomatic significant MR, TEER with MitraClip™ was achieved with a high technical success rate. It was associated with significant reduction in MR severity and improvement in functional capacity in >90 % of the subjects.

1-Year Outcomes of Fourth-Generation Mitral Transcatheter Edge-to-Edge Repair in Japan From the EXPAND G4 Study

BackgroundThe MitraClip (Abbott), a percutaneous edge-to-edge mitral valve (MV) repair device, is the only approved device in Japan for mitral transcatheter edge-to-edge repair (M-TEER) therapy to treat primary and secondary mitral regurgitation (MR). Outcomes of the fourth-generation M-TEER system, featuring independent grasping, improved clip deployment, and 4 clip sizes with wider and longer clip arms, have not been reported in Japan. ObjectivesThis study evaluates the 1-year safety and effectiveness of the fourth-generation M-TEER system in Japan to treat MR in a contemporary, real-world setting. MethodsEXPAND G4 is a prospective, single-arm, international, postmarket study. One-year outcomes from subjects treated in Japan include MR severity (assessed by an echocardiography core laboratory), all-cause mortality, heart failure hospitalization, NYHA functional class, and quality of life. ResultsA total of 95 subjects were treated with the fourth-generation M-TEER system at 7 centers in Japan. Subjects in Japan had a higher surgical risk with smaller cardiac dimensions and MV areas. A 100% implant rate was achieved with a large proportion of standard clips (NT/XT). At 1 year, there was significant and sustained MR reduction (99%, 77/78 MR ≤1+), with low MV mean gradients (2.9 ± 1.8 mm Hg) and improved functional capacity (96.2%, 75/78 NYHA functional class I/II). The 1-year rates of all-cause mortality and heart failure hospitalizations were 9.5% and 18.9%, respectively, with low major and device-related adverse event rates. ConclusionsThis first report of echocardiography core laboratory–assessed outcomes with the fourth-generation M-TEER system in Japan shows that excellent and durable technical and clinical outcomes can be achieved with M-TEER in Japan. (MitraClip EXPAND G4 Study; NCT04177394)

Effect of Preoperative Mitral Regurgitation on LVAD Outcomes in Patients with Elevated Pulmonary Vascular Resistance.

In patients with end-stage heart failure who undergo left ventricular assist device (LVAD) implantation, higher pulmonary vascular resistance (PVR) is associated with higher right heart failure rates and ineligibility for heart transplant. Concomitant mitral regurgitation (MR) could potentially worsen pulmonary hemodynamics and lead to worse outcomes; however, its effects in this patient population have not been specifically examined. Using an institutional database spanning November 2003 to August 2017, we retrospectively identified patients with elevated PVR who underwent LVAD implantation. Patients were stratified by concurrent MR: moderate/severe (PVR + MR) vs. mild/none (PVR - MR). Cumulative incidence functions and Fine-Gray competing risk regression were performed to assess the effect of MR on heart transplant rates and overall survival during index LVAD support. Of 644 LVAD recipients, 232 (171 HeartMate II, 59 HeartWare, 2 HeartMate III) had baseline PVR > 3 Woods units; of these, 124 (53%) were INTERMACS 1-2, and 133 (57%) had moderate/severe MR (≥ 3 +). Patients with PVR + MR had larger a baseline left ventricular end-diastolic diameter than patients with PVR - MR (87.9 ± 38.2 mm vs. 75.9 ± 38.0 mm; P = 0.02). Median clinical follow-up was 18.8 months (interquartile range: 4.7-36.4 months). Moderate/severe MR was associated with lower mortality rates during index LVAD support (adjusted hazard ratio 0.64, 95% CI 0.41-0.98; P = 0.045) and higher heart transplant rates (adjusted odds ratio 2.86, 95% CI 1.31-6.25; P = 0.009). No differences in stroke, gastrointestinal bleeding, or right heart failure rates were observed. Among LVAD recipients with elevated preoperative PVR, those with moderate/severe MR had better overall survival and higher transplant rates than those with mild/no MR. These hypothesis-generating findings could be explained by incremental LVAD benefits resulting from reduction of MR and better LV unloading in a subset of patients with larger ventricles at baseline. In patients with preoperative elevated PVR, MR severity may be a prognostic sign that can inform patient selection for end-stage heart failure therapy.

The impact of transcatheter aortic valve implantation (TAVI) on mitral regurgitation - a single center study.

The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.

Outcome of Transcatheter Aortic Valve Replacement for Pure Native Aortic Regurgitation in Patients with Pulmonary Hypertension.

In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a pivotal treatment for pure native aortic regurgitation (PNAR). Given patients with severe aortic regurgitation (AR) are prone to suffer from pulmonary hypertension (PH), understanding TAVR's efficacy in this context is crucial. This study aims to explore the short-term prognosis of TAVR in PNAR patients with concurrent PH. Patients with PNAR undergoing TAVR at Zhongshan Hospital, Affiliated with Fudan University, were enrolled between June 2018 to June 2023. They were categorized based on pulmonary artery systolic pressure (PASP) into groups with or without PH. The baseline characteristics, imaging records, and follow-up data were collected. Among the 103 patients recruited, 48 were afflicted with PH. In comparison to PNAR patients without PH, the PH group exhibited higher rates of renal dysfunction (10.4% vs. 0.0%, p = 0.014), increased Society of Thoracic Surgeons scores (6.4 1.9 vs. 4.7 1.6, p 0.001), and elevated Nterminal fragment of pro-brain natriuretic peptide (NT-proBNP). Transthoracic ultrasound examination revealed that patients with PH displayed lower left ventricular ejection fraction, larger left ventricle dimension, and more frequent moderate to severe tcuspid regurgitation (TR). Following TAVR, both groups experienced significant reductions in PASP, mitral regurgitation (MR) and TR. There were no significant differences in the incidence of postoperative adverse events in patients with or without PH. We found TAVR to be a safe and effective treatment for patients with PNAR and PH, reducing the degree of aortic regurgitation and PH without increasing the risk of postoperative adverse events.

Transapical transcatheter mitral valve replacement for mitral valve disease: an Iberian experience

Introduction and objectivesTranscatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure. MethodsWe conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year. ResultsA total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively. ConclusionsTreatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

Impact of heart failure severity on the mortality benefit of mitral transcatheter edge-to-edge valve repair.

To assess the interaction between heart failure (HF) severity and optimal reduction of secondary mitral regurgitation (SMR) on mortality in patients undergoing transcatheter edge-to-edge repair (M-TEER). Among 1656 patients included in the Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) 984 had SMR and complete data on advanced HF. Advanced HF was defined as NYHA class III or IV, left ventricular ejection fraction ≤ 30%, and > 1 HF hospitalization during the last 12months. Optimal M-TEER was defined as residual SMR ≤ 1 + at discharge. One hundred sixteen patients (11.8%) had advanced HF. Achievement of an optimal SMR reduction was similar in patients with and without advanced HF (65% and 60% respectively). Advanced HF was an independent predictor of 2-year all-cause death (adjusted HR 1.52, 95% CI 1.09-2.10). Optimal M-TEER, as compared to a no-optimal M-TEER, was associated with a reduced risk of death both in patients with advanced (HR 0.55, 95% CI 0.32-0.97; p = 0.039) and no-advanced HF (HR 0.59, 95% CI 0.46-0.78; p < 0.001; p = 0.778 for interaction). Advanced HF is associated with poor outcome in patients undergoing M-TEER. However, an optimal SMR reduction reduces the risk of 2-year mortality regardless of HFseverity.

Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison.

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.

Island Flap Rotation Technique as a Novel Repair Surgery Method for Severe Degenerative Mitral Valve Regurgitation

Background: The current study was done to assess the efficacy and safety of the island flap rotation technique as a novel method for severe mitral valve regurgitation. Methods: Twenty-three patients were selected to undergo mitral valve repair with the island flap rotational technique. It takes the principle of doing quadrangular resection of the P2 leaflet and flipping the dissected area so that the ruptured primary chordae are replaced with the secondary or tertiary chordae. Transesophageal echocardiography parameters were evaluated before surgery and 1 week after surgery, just prior to discharge. Results: The procedure was done successfully with 100% mitral regurgitation reduction to ≤1+ along with significantly reduced left ventricular end-diastolic diameter (p = 0.001) and left atrial dimension (p = 0.000). The left ventricular ejection fraction was significantly reduced after the procedure (p = 0.000). Older age significantly affects the presence of residual mitral regurgitation (p = 0.02). No thromboembolic adverse events and mortality were observed during the 3-month follow-up. Conclusions: The use of island flap rotation technique as a novel method for severe mitral regurgitation with P2 lesions has been proven to be effective and safe with preserving the valve tissue.

Ertugliflozin for Functional Mitral Regurgitation Associated With Heart Failure: EFFORT Trial.

The morbidity and mortality rates of patients with heart failure (HF) and functional mitral regurgitation (MR) remain substantial despite guideline-directed medical therapy for HF. We evaluated the efficacy of ertugliflozin for reduction of functional MR associated with HF with mild to moderately reduced ejection fraction. The EFFORT trial (Ertugliflozin for Functional Mitral Regurgitation) was a multicenter, double-blind, randomized trial to examine the hypothesis that the sodium-glucose cotransporter 2 inhibitor ertugliflozin is effective for improving MR in patients with HF with New York Heart Association functional class II or III, 35%≤ejection fraction<50%, and effective regurgitant orifice area of chronic functional MR >0.1 cm2 on baseline echocardiography. We randomly assigned 128 patients to receive either ertugliflozin or placebo in addition to guideline-directed medical therapy for HF. The primary end point was change in effective regurgitant orifice area of functional MR from baseline to the 12-month follow-up. Secondary end points included changes in regurgitant volume, left ventricular (LV) volume indices, left atrial volume index, LV global longitudinal strain, and NT-proBNP (N-terminal pro-B-type natriuretic peptide). The treatment groups were generally well-balanced with regard to baseline characteristics: mean age, 66±11 years; 61% men; 13% diabetes; 51% atrial fibrillation; 43% use of angiotensin receptor-neprilysin inhibitor; ejection fraction, 42±8%; and effective regurgitant orifice area, 0.20±0.12 cm2. The decrease in effective regurgitant orifice area was significantly greater in the ertugliflozin group than in the placebo group (-0.05±0.06 versus 0.03±0.12 cm2; P<0.001). Compared with placebo, ertugliflozin significantly reduced regurgitant volume by 11.2 mL (95% CI, -16.1 to -6.3; P=0.009), left atrial volume index by 6.0 mL/m2 (95% CI, -12.16 to 0.15; P=0.005), and LV global longitudinal strain by 1.44% (95% CI, -2.42% to -0.46%; P=0.004). There were no significant between-group differences regarding changes in LV volume indices, ejection fraction, or NT-proBNP levels. Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group (P=0.12). Among patients with functional MR associated with HF, ertugliflozin significantly improved LV global longitudinal strain and left atrial remodeling, and reduced functional MR. Sodium-glucose cotransporter 2 inhibitors may be considered for patients with functional MR. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04231331.

Left ventricule remodeling with improvement of mitral regurgitation after resynchronization therapy

Abstract Introduction Moderate or severe mitral regurgitation is common in patients with dilated cardiomyopathy who are candidates for resynchronization therapy (CRT). In many patients there is no improvement in mitral regurgitation (MR), and this factor may be associated with a lower response to CRT and worse prognosis. Purpose This study seeks to evaluate the association between MR reduction with left ventricular remodeling (LVR), left ventricular ejection fraction (LVEF) and mortality after CRT implantation. Methods This is a 4-year retrospective observational study. Patients who had CRT implantation according to the indications in the guidelines with moderate or severe MR were selected. A pre-implantation transthoracic echocardiogram and another at 12-month follow-up were performed. The LVEF, the left ventricle end-systolic volume (LVESV) and the severity of MR were evaluated, which was categorized into without, mild, moderate or severe, according to vena contracta and quantitative method of proximal isovelocity surface area. Patients with a reduction greater or equal to 15% in LVESV or an increase greater or equal to 5% in LVEF were considered responders to CRT. Results 86 patients had moderate or severe MR pre-CRT, with a mean age of 71.9±9.8 years and 62.2% were female. In 51.2% of the patients there was a reduction in the severity of the MR to without or mild. LVEF recovery was significantly greater in patients with MR reduction (13.1% vs 6.3%, p=0.01). Although not statistically significant, reverse remodeling was more frequent among patients with MR reduction (DLVESV 13.1% vs 6.3%, p=0.119) and mortality was also lower in patients with MR reduction (56% vs 44%, p=0.395). Conclusion Improvement in RM severity after CRT implantation appears to be associated with better response to this therapy and better prognosis at 1-year follow-up.

PERCUTANEOUS EDGE–TO–EDGE REPAIR OF MITRAL REGURGITATION IN CARDIAC AMYLOIDOSIS: DO IT BUT NOT TOO MUCH

Abstract We report the case of a 68 year old man with history of wild type TTR cardiac amyloidosis, treated with tafamidis since 1 year, symptomatic for advanced cardiac failure, already in optimal medical treatment, CRT–D, oral anticoagulation for permanent atrial fibrillation. The patient was hospitalised in our intensive care unit for refractory NYHA IV cardiac failure, anuria, very low ejection fraction combined with severe mitral regurgitation. He was treated with inotropes and diuretics then levosimendan however he remained in very critical state and we discussed the opportunity to reduce the mitral regurgitation by percutaneous edge to edge repair. In this setting of restrictive physiology literature is not unanimous and preload reduction secondary to mitral regurgitation treatment may sometimes be deleterious. We decided to offer our patient edge to edge repair by targeting a moderate reduction of mitral regurgitation and also considering some challenges linked to this pathology as atrial septal involvement with ovalis fossa relevant thickness. The procedure was successful with a reduction of mitral regurgitation grade from severe to mild–to moderate and this allowed the patient to re equilibrate his hemodynamic balance and he was able to be dismissed with a short term follow up program.

A RARE COMPLICATION OF MITRAL TEER PROCEDURE: CLIP LATE DETACHMENT AND EMBOLIZATION

Abstract Intraprocedural and late complications of MitraClip implantation have already been described. This report highlights the importance of conventional surgical options in the event of percutaneous treatment failure. An 85–year–old woman with a history of chronic anemia, and thalassemia Minor was referred to our clinic for severe mitral regurgitation (MR) due to a P2 flail with significant calcification of the posterior mitral annulus. During the Heart Team discussion, age and comorbidities led to consider the patient eligible for TEER with the MitraClip system (EuroSCORE II 9,34%; STS score 7,47%). TEER procedure was uneventful: one XTW was deployed at the level of the flail (A2–P2), a second XTW was then placed more lateral to treat a separate residual jet, and one NTW was finally placed between them. MR reduction was considered acceptable (moderate MR, mean grad 6 mmHg). After two months, symptoms worsened, and TTE showed severe MR (no device detachment) with increased sPAP and associated moderate TR. A couple of weeks later, the patient was hospitalized. Chest X–ray revealed clip embolization confirmed by coronary angiography that showed an XTW Clip embolized to the Right coronary sinus with partial occlusion of the ostium. Percutaneous clip retrieval is described in the literature, but the embolized device position and the presence of recurrent severe MR led us to prefer an urgent surgical intervention. Under CPB, the embolized XTW was easily retrieved through a small aortotomy; the intervention was completed by mitral valve replacement and tricuspid valve repair. The postoperative course was uneventful. Predischarge TTE showed normal mitral bioprosthesis function, mild AR, mild TR, and preserved LV function. DISCUSSION Clip embolization is a rare but potentially critical complication of TEER and can happen periprocedurally or on early follow–up. Single leaflet detachment is more common, but complete detachment and embolization can occur. Therapeutic options are represented by surgical or transcatheter approaches according to embolization sites and patient comorbidities. In our case, the risk of potential coronary obstruction or thrombosis and the concomitant need for MR treatment have led us to consider surgery as the first option. CONCLUSION TEER can be graved by acute or late complications. The best approach has to be tailored to each patient, and surgery can be an effective and safe option even for initially discarded high–risk patients.

SEVERE SYMPTOMATIC MITRAL REGURGITATION AFTER ANNULOPLASTY FAILURE: SUCCESSFUL TRANSCATHETER EDGE TO EDGE REPAIR

Abstract Surgical mitral valve repair is the most common, feasible and preferred procedure to treat primary and secondary mitral regurgitation (MR). However, 30% of patients suffer from residue severe regurgitation 10 years after surgical intervention, resulting in a considerable number of Redo procedures. In elderly and high–risk patients with major comorbidities medical treatment is the only and often insufficient option for symptoms’ relief. Percutaneous Transcatheter Edge to Edge repair technique (TEER) with MitraClip system is emerging as an off–label valid alternative to successfully treat severe mitral regurgitation after surgical valvuloplasty failure. Transesophageal echocardiography (TEE) is essential in diagnosis, planning, intraprocedural device placement, and follow up. In the peculiar setting of failed annuloplasty, with small residual valve area, the main risk is the creation of a gradient across the mitral valve. We present two cases of severe mitral regurgitation after surgical annuloplasty with ring placement, carefully evaluated for TEER and successfully treated with this procedure: 1) a 79–year–old man presented with exertional dyspnea and orthopnea in the setting of previous surgical mitral Annuloplasty (2003) with a 32–mm Carpentier Ring. Transesophageal echocardiography demonstrated severe mitral regurgitation due to P2 prolapse and central V–shaped cut of the valve, mean diastolic gradient 1.8 mmHg. 2) a 83 year–old woman presented with dyspnea (NYHA functional class III) and severe mitral regurgitation after previous Annuloplasty with a 34–mm Edwards Ring and placement of Goretex artificial Chordae (2016). TEE showed prolapse of P2 and P3 leaflets, mean diastolic gradient 2.17 mmHg, valvular area 3.5 cmq. Both patients underwent transfemoral and transseptal implantation of one MitraClip device (XTw and XT, respectively) under Transesophageal echocardiography guidance with successful reduction of mitral regurgitation to mild level and symptoms relief. In the first case post procedural mean diastolic gradient was 3.7 mmHg, in the second case it was 3.16 mmHg.

Impact of heart failure hospitalizations on clinical outcomes after mitral transcatheter edge-to-edge repair: Results from the EXPAND study.

This analysis aimed to compare the clinical outcomes associated with heart failure (HF) readmissions and to identify associations with HF hospitalizations (HFH) in patients treated with the MitraClip™ NTR/XTR System in the EXPAND study. The global, real-world EXPAND study enrolled 1041 patients with primary or secondary mitral regurgitation (MR) treated with the MitraClip NTR/XTR System. Echocardiograms were analysed by an independent echocardiographic core laboratory. The study population was stratified into HFH and No-HFH groups based on the occurrence of HFH 1 year post-index procedure. Clinical outcomes including MR severity, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and all-cause mortality were compared (HFH: n = 181; No-HFH: n = 860). Both groups achieved consistent 1-year MR reduction to ≤1+ (HFH vs. No-HFH: 87.3% vs. 89.5%, p = 0.6) and significant 1-year improvement in KCCQ scores (+16.5 vs. +22.3, p = 0.09) and NYHA functional class. However, more patients in the No-HFH group had 1-year NYHA class ≤II (HFH vs. No-HFH: 67.9% vs. 81.9%, p < 0.01). All-cause mortality at 1 year was 36.8% in the HFH group versus 10.4% in the No-HFH group (p < 0.001). The HFH rate decreased by 63% at 1 year post-M-TEER versus 1 year pre-treatment (relative risk 0.4, p < 0.001). Independent HFH associations were MR ≥2+ at discharge, HFH 1 year prior to treatment, baseline NYHA class ≥III, baseline tricuspid regurgitation ≥2+, and baseline left ventricular ejection fraction ≤40%. This study reports the impact of HFH on clinical outcomes post-treatment in the EXPAND study. Results demonstrate that the occurrence of HFH was associated with worse 1-year survival, and treatment with the MitraClip system substantially reduced HFH and improved patient symptoms and quality of life.

Impact of pulmonary hypertension on outcomes after TEER in patients suffering from mitral regurgitation.

Data on associations of invasively determined hemodynamic parameters with procedural success and outcomes in patients suffering from mitral regurgitation (MR) undergoing transcatheter edge-to-edge repair of the mitral valve (M-TEER) is limited. We enrolled 239 patients with symptomatic MR of grade 2 + , who received M-TEER. All patients underwent extensive pre-interventional invasive hemodynamic measurements via right heart catheterization (mean pulmonary arterial pressure (mPAP), systolic- (PAPsys) and diastolic pulmonary arterial pressure (PAPdia), pulmonary arterial wedge pressure (PAWP), a-wave, v-wave, pulmonary vascular resistance (PVR), transpulmonary pressure gradient (TPG), cardiac index (CI), stroke volume index (SVI)). mPAP and PAWP at baseline were neither associated with procedural success, immediate reduction of MR, nor residual MR after 6months of follow-up. The composite outcome (All-cause mortality (ACM) and/or heart failure induced rehospitalization (HFH)) and HFH differed significantly after M-TEER when stratified according to mPAP, PAWP, PAPdia, a-wave and v-wave. ACM was not associated with the afore mentioned parameters. Neither PVR, TPG, CI nor SVI were associated with the composite outcome and HFH, respectively. In multivariable analyses, PAWP was independently associated with the composite outcome and HFH. PVR and SVI were not associated with outcomes. PAWP at baseline was significantly and independently associated with HFH and might serve as a valuable parameter for identifying patients at high risk for HFH after M-TEER. ACM and procedural success were not affected by pulmonary arterial pressure before M-TEER. We suggest that the post-capillary component of PH serves as the driving force behind the risk of HFH.