Severe Symptomatic Mitral Regurgitation Research Articles

Gender and Sex Differences in the Management, Intervention, and Outcomes of Patients With Severe Primary Mitral Regurgitation.

Gender- and sex-based disparities in mitral valve disease exist; however the factors associated with these differences are unknown. Identifying these differences is essential in devising mitigating strategies. We evaluated gender and sex differences among patients with severe primary mitral regurgitation (MR) across treatment phases. We conducted a retrospective cohort study of patients with new diagnoses of severe primary MR between 2016 and 2020. We compared multidisciplinary evaluation incidence and 2-year survival between men and women. We analyzed a subgroup meeting class 1 indications for intervention, which includes severe symptomatic MR or severe asymptomatic MR with ejection fraction <60% or left ventricular end-systolic diameter >40 mm. Logistic regression models identified predictors associated with the likelihood of multidisciplinary evaluation. Among 330 patients meeting class 1 indications, women were older (79 versus 76 years, P=0.01) and had higher Society of Thoracic Surgeons risk scores for mitral valve repair than men (2.5% versus 1.4%, P=0.003). Women were less likely to undergo multidisciplinary evaluation (57% versus 84%, P<0.001) and intervention (47% versus 69%, P<0.001) than men. Median days to intervention for women and men were 77 and 43, respectively. Women had a higher 2-year mortality rate than men (31% versus 21%, P=0.035). On a multivariable model, female sex and older age were associated with lower odds of undergoing multidisciplinary evaluation (odds ratio, 0.26; P<0.001; odds ratio, 0.95; P<0.001, respectively). Women with severe primary MR with class 1 indication for intervention were less likely to undergo multidisciplinary evaluation and intervention and had a longer interval to intervention than men. Survival was comparable after accounting for age and comorbidity differences.

Transcatheter edge-to-edge mitral valve repair in patients with acute decompensated heart failure due to severe mitral regurgitation.

Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a therapy for severe symptomatic mitral regurgitation (MR) in stable patients, and it has recently emerged as a reasonable option for acutely ill patients. The aim of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure (ADHF) and severe MR that was deemed to play a major role in their deterioration. We included 31 patients who underwent emergent TEER for MR ≥ 3+ from 2012 to 2022 at Sheba Medical Center. Outcomes included procedural safety, procedural success, all-cause mortality, heart failure readmission, and functional improvement. Outcomes were evaluated at 3 months and at 1 year. Data were obtained retrospectively by chart review. Implantation of a TEER device was achieved in 97% of patients, and reduction in MR severity of at least two grades and final MR ≤ 2+ at discharge was achieved in 74%. No intra-procedural mortality or life-threatening complications were noted. Mortality at 30 days was 23%. No excess mortality occurred beyond 6 months, with a total mortality of 41%. At 1 year all survivors had MR ≤ 2+, all were free of heart failure hospitalizations, and 88% were at New York Heart Association class ≤ II. Mitral valve TEER for patients with ADHF and significant MR is safe, feasible, and achieves substantial reduction in MR severity. Despite high early mortality, procedural success is associated with good long-term clinical outcomes for patients surviving longer than 6 months.

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study

BackgroundA significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy. ObjectivesThe aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk. MethodsThis prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory. ResultsA total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg). ConclusionsThe 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363)

Redo transcatheter edge-to-edge mitral valve repair: a single centre experience

Abstract Introduction: Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a therapy for patients with severe symptomatic mitral regurgitation (MR) who are at high surgical risk. Failure to implant a TEER device and the occurrence of residual or recurrent MR ≥3+ are well documented but data regarding outcomes of redo-TEER following initial failure are sparse. Purpose To evaluate the safety and efficacy of redo-TEER following initial failed intervention. Methods We included 16 patients who underwent redo-TEER for symptomatic MR ≥3+ from July 2016 to December 2022. Acute results were assessed by echocardiography prior to discharge and safety was evaluated clinically, according to the occurrence of procedure-related adverse events. Mid- and long-term outcomes were evaluated at three months and one year respectively. Data were obtained retrospectively by chart review. Mortality data were drawn from the national death registry. Results Reasons for redo-TEER include device failure without detachment in nine (56%) patients, device failure due to single leaflet detachment in four (25%) patients and initial implantation failure in three (19%) patients. Median time from index procedure was 167 days (range: 19 – 1457 days). Technical (implantation of a TEER device) and procedural (MR ≤2+ at discharged) success were achieved in 94% and 87.5% of patients undergoing repeat intervention respectively. MR grade was reduced to 1+ in 71% of patients who had successful TEER. No intra-procedural mortality or life-threatening complications were noted. Mean post-TEER hospitalization length was 1.8 ± 1.3 days. No deaths were noted during the first year following redo-TEER. Echocardiography at three months and one year demonstrated MR ≤2+ for all patients in whom TEER was successful. At three months and one-year follow-up, respectively 67% and 50% of patients who underwent successful intervention were in New York Heart Association (NYHA) class I or II and only one had been hospitalized for heart failure. Conclusion Repeat mitral TEER following initial procedural failure is safe and has high acute and mid-term success rates. More research is needed to better characterise patients likely to benefit from repeated intervention.

Abstract 18591: Can the Clip Restore the Physiological Annular Morphology? Serial Quantitative 4d Echocardiographic Analysis

Background: We sought to seek an answer for the question whether the transcatheter mitral valve edge-to-edge repair (TEER) without annuloplasty can induce chronic positive remodeling of the annulus and restore the physiological saddle-shape morphology after the procedure. Methods: We serially analyzed the 3D echocardiographic images in 20 patients who were successfully treated with MitraClip for symptomatic severe mitral regurgitation (MR) (16 functional, and 8 degenerative). Four patients who had the recurrence of MR greater than moderate at chronic phase (3 functional, and 1 degenerative) were also evaluated. 4D-volumetric transesophageal (TEE) and transthoracic echocardiography (TTE) data were assessed offline by dedicated software at 1) before, 2) 5-day and 3) 1-year after the clipping procedure. Results: Annulus shortened in anterior-posterior (AP) direction in early after the TEER procedure (5-day), with keeping anterolateral-posteromedial (AL-PM) diameter and annulus circumference. Following the initial A-P reshape of the annulus, annular diameters reduced both in AP and ML directions with restoring physiological saddle shape (annulus height/AL-PM diameter) in one-year after the valve leaflet intervention (see figure). Conclusions: Fixing leaflet coaptation by successful TEER could induce chronic positive remodeling of the entire mitral annulus, with restoring its physiological saddle shape. Our results show that simple reduction in MR burden can cause the beneficial restoration of the valve apparatus morphology. Progressive negative annular remodeling was found in patients with recurrent MR.

Impact of Percutaneous Mitral Valve Repair on Left Atrial Strain and Atrial Fibrillation Progression.

Transcatheter edge-to-edge repair (TEER) currently represents a valuable therapeutic option for patients with severe mitral regurgitation (MR) considered at high surgical risk. Besides symptoms and left ventricular (LV) echocardiographic improvements upon TEER, it has been postulated that left atrial (LA) function plays a prognostic role. The aims of our study were to evaluate LA changes after TEER, measured by two-dimensional speckle-tracking echocardiography analysis (2D-STE), their association with atrial fibrillation (AF) occurrence, and relative arrhythmic burden. We considered in a single-center study 109 patients affected by symptomatic severe MR undergoing TEER from February 2015 to April 2022. By 2D-STE, LA reservoir (R_s), conduct (D_s), and contractile (C_s) strains were assessed along with four-chamber emptying fraction (LAEF-4CH) before, 1, 6, and 12 months following TEER. Statistical analysis for comparison among baseline, and follow-ups after TEER was carried out by ANOVA, MANOVA, and linear regression. Successful TEER significantly improved LV dimensions and LA performances, as indicated by all strain components, and LAEF-4CH after 1 year. Strikingly, a significant reduction in arrhythmic burden was observed, since only one case of subclinical AF detected by a previously implanted cardiac electronic device was found in the cohort of sinus rhythm patients (n = 48) undergone TEER; in addition, ventricular rate was reduced in the AF cohort (n = 61) compared to baseline, together with few episodes of nonsustained ventricular tachycardias (5/61, 8.2%) after MR improvement. Overall, TEER was associated with improved cardiac performance, LA function amelioration, and reduced arrhythmic burden.

Feasibility and safety of transseptal transcatheter mitral valve replacement for severe mitral regurgitation

A prospective, single-center, single-arm, and open-design study was performed to evaluate the feasibility and safety of transseptal transcatheter mitral valve replacement in the treatment of severe mitral regurgitation. Patients with symptomatic moderate-severe or severe mitral regurgitation at high-surgical risk and anatomically appropriate for the HighLife transseptal mitral valve replacement (TSMVR) system in West China Hospital, Sichuan University from December 2021 to August 2022 were enrolled. Four patients (1 male and 3 females) with severe mitral regurgitation were included, with a median age of 68.5 (64.0-77.0) years and a median Society of Thoracic Surgeons (STS) score of 8.1% (6.4%-8.9%). Technical success was achieved in all the patients. There was no residual mitral regurgitation, paravalvular leakage, or left ventricular outflow tract obstruction. Three major cardiovascular and cerebrovascular adverse events occurred within 30 days after the procedure, including ventricular tachycardia, iatrogenic atrial septal defect closure, and heart failure readmission. The current study preliminarily demonstrates that transcatheter mitral valve replacement using the HighLife system via the transseptal approach for severe mitral regurgitation is feasible and relatively safe.

Acute anatomic and hemodynamic impact of mitral TEER: G4 MitraClip vs. PASCAL

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transcatheter mitral edge-to-edge repair (TEER) represents a safe and effective alternative to surgery for high-risk patients suffering from symptomatic severe mitral regurgitation (MR). New devices and new device iterations are constantly developed and their impact on the mitral valve (MV) anatomy should be regularly evaluated to provide the best patient-tailored approach in the future. Purpose The purpose of this study was to compare the acute anatomic and hemodynamic effects of the worldwide most implanted commercially available TEER devices: the Abbott G4 MitraClip (MC) vs. the Edwards PASCAL. Methods Consecutive patients from our mitral registry treated by TEER were included. High quality volume datasets focused on the MV were acquired during each intervention. Mean transvalvular gradient (Gd) corrected for the heart rate (HR), 3D mitral valve area (MVA) and anteroposterior diameter (AP) of MV annulus were evaluated before and after the implantation of each device; remaining orifices created after implantation were measured independently and summed. Results Eighty patients were included in this analysis; the majority were treated with "bulky" first devices: PASCAL P10 (10mm wide) or MC NTW/XTW (6mm wide). Individuals treated with MC exhibited higher MVA before clipping, however there were no differences in the AP diameter of the annulus between both groups. The first device produced a significantly higher reduction of MVA in the MC group, while no difference in MVA reduction was seen after the second implant. The impact on the AP-diameter (i.e., the indirect annuloplasty) and on the transvalvular corrected Gd after one or two devices was not significantly different between groups despite the smaller native MVA in the PASCAL population. Conclusion The design differences between both devices with an active closure for MC and a passive one for PASCAL (possibly leading to a lower tension on the leaflets) could explain the lower impact of the latter on the MVA, despite the wider arms of the P10. A study including a higher number of patients is needed to confirm these findings, which may affect patient selection according to the native MVA and the treatment strategy.

Current status of transcatheter mitral valve replacement: systematic review and meta-analysis.

Mitral Regurgitation (MR) has a strong impact on quality of life and on mid-term survival. Transcatheter mitral valve replacement (TMVR) is rapidly expanding and a growing number of studies have been published recently. A systematic review of studies reporting on clinical data for patients with symptomatic severe MR undergoing TMVR was performed. Early- and mid-term outcomes (clinical and echocardiographic) were evaluated. Overall weighted means and rates were calculated. Risk ratios or mean differences were calculated for pre- and post-procedural comparisons. A total of 12 studies and 347 patients who underwent TMVR with devices clinically available or under clinical evaluation were included. Thirty-day mortality, stroke and major bleeding rates were 8.4%, 2.6%, and 15.6%, respectively. Pooled random-effects demonstrated a significant reduction of ≥ grade 3+ MR (RR: 0.05; 95% CI: 0.02-0.11; p < 0.001) and in the rates of patients in NYHA class 3-4 after the intervention (RR: 0.27; 95% CI: 0.22-0.34; p < 0.001). Additionally, the pooled fixed-effect mean difference for quality of life based on the KCCQ score yielded an improvement in 12.9 points (95% CI:7.4-18.4, p < 0.001), and exercise capacity improved by a pooled fixed-effect mean difference of 56.8 meters in the 6-minute walk test (95% CI 32.2-81.3, p < 0.001). Among 12 studies and 347 patients comprising the updated evidence with current TMVR systems there was a statistically significant reduction in ≥ grade 3+ MR and in the number of patients exhibiting poor functional class (NYHA 3 or 4) after the intervention. Overall rate of major bleeding was the main shortcoming of this technique.

MitraClip single-leaflet detachment and consequent migration in atrial functional mitral regurgitation.

An 84-year-old woman with symptomatic severe functional mitral regurgitation (MR) due to long standing atrial fibrillation underwent percutaneous edge-to-edge repair using the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) (see Supplementary data online, Video S1). Following deployment of an XTR clip in the A2-P2 segment, a second MitraClip XT device was deployed laterally to prevent recurrence of MR caused by stretching of left atrium and mitral leaflets. However, single leaflet detachment of the anterior leaflet occurred immediately (Panel A, Supplementary data online, Video S2). Since only mild MR was observed after the procedure, additional clipping was not performed, and her symptoms were relieved. However, at 2 weeks after discharge, she presented with right inguinal pain and aggravated dyspnea. The lateral clip was not observed on chest x-ray (Panels B and C). Computed tomography revealed the migrated MitraClip at the right common iliac artery bifurcation (yellow arrows in Panel D). Transesophageal echocardiogram showed recurrence of severe MR with newly developed small chordae rupture (Panel E, Supplementary data online, Video S3). The embolized MitraClip was successfully retrieved using 10- and 15-mm Amplatz GooseNeck® snares (Ev3, Plymouth, MN, USA) through a 16-French Check-Flo® Introducer sheath (Cook Medical, Bloomington, IN, USA) (Panels F, G, and H, Supplementary data online, Video S4), and another NTW clip was deployed. Post-procedure transesophageal echocardiogram confirmed residual mild to moderate MR (Panel I, Supplementary data online, Video S5). Images from this case show the complications of MitraClip single leaflet detachment and distal migration, and how this problem was solved.

Outcomes of transapical mitral valve repair with neochordae implantation.

Transapical off-pump beating-heart neochord implantation (NC) has shown encouraging early results in patients with degenerative mitral regurgitation. The aim of this study was to evaluate clinical and echocardiographic 5-year outcomes of patients who underwent NC. All patients who underwent NC at our institution from November 2013 to March 2016 were included. Indications were severe symptomatic degenerative mitral regurgitation due to leaflet prolapse/flail. Patients were classified as having favorable anatomy (FA) and unfavorable anatomy (UA) on the basis of the extent and severity of mitral valve disease. All patients underwent clinical and echocardiographic follow-up at 1, 3, 6, and 12months, and annually thereafter. Data were prospectively collected and retrospectively analyzed. Outcomes were on the basis of the Mitral Valve Academic Research Consortium guidelines. One hundred consecutive patients were included in the analysis (FA: 81%; UA: 19%). Median age was 66years (interquartile range, 58-76) and median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 1.4% (interquartile range, 0.7-2.3). Technical and procedural success were 98% and 94%, respectively. Thirty-day mortality was 2%. Device success was 94%, 92%, and 78%, at 30days, 1-year, and 5years, respectively. Patient success at 1year was 92%. Median follow-up was 5.1years. At 5years, overall survival was 83% with no difference between FA and UA patients. Cumulative incidence of severe mitral regurgitation recurrence at 5years was 14% (95% CI, 6.5%-22.8%) in FA patients and 63% (95% CI, 39.7%-86.2%) in UA patients, respectively (P<.001). Patients with FA compared with UAhad a lower incidence of reintervention (14.7% vs 43.4%; P<.001). Transapical off-pump beating heart NC might represent an acceptable option in patients with degenerative mitral valve disease and FA.

Thirty-day and one-year outcomes following transcatheter mitral valve edge-to-edge repair versus transapical mitral valve replacement in patients with left ventricular dysfunction

A comparison of 30-day and 1-year clinical outcomes in patients with pre-existing left ventricular (LV) dysfunction undergoing transcatheter mitral valve edge-to-edge repair (TEER) or transcatheter transapical mitral valve replacement (TMVR) has not previously been reported. We aimed to compare 30-day and 1-year rates of all-cause and cardiovascular mortality as well as rehospitalisation for heart failure (HFH). All patients with severe (≥3+) symptomatic mitral regurgitation (MR) and an LV ejection fraction ≤50% who underwent TEER or TMVR over a 5-year period were evaluated. Ninety-six patients (50 TEER, age 80±9 years, 70% secondary MR and 46 TMVR, age 72±9 years, 91% secondary MR) were studied. Baseline demographic and transthoracic echocardiogram characteristics were well-matched, with the exception of age (TEER 80±9 vs TMVR 72±9; p=0.01). Successful device implantation occurred in 96% of TEER patients and 97.8% of TMVR patients. Ninety-two percent of TEER patients had ≤2+MR predischarge, whilst no TMVR patient had ≥1+MR (p<0.01). No significant difference in the combined endpoint of 30-day all-cause mortality or HFH was observed (p>0.05). At 1 year, freedom from all-cause mortality and HFH was 79.2% across the entire study population but was significantly higher in patients undergoing TEER (TEER: n=45 [90%] hazard ratio 11.26, 95% confidence interval [CI]: 10.59-11.93 vs TMVR: n=39 [67.4%] 95% CI: 10.09-11.33;p=0.008). Despite comparable rates of successful device implantation, MR reduction, and 30-day all-cause mortality/HFH, TEER patients had lower all-cause mortality and HFH rates at 1 year.

Outcomes of Mitral Transcatheter Edge-to-Edge Repair in Patients With Rheumatic Heart Disease

Mitral transcatheter edge-to-edge repair (TEER) in patients with rheumatic heart disease (RHD) is challenging owing to leaflet thickening and calcification but is performed in select cases. Limited data exist on its outcomes. The aim of this analysis was to investigate the safety and efficacy of mitral TEER in patients with severe symptomatic rheumatic mitral regurgitation. We queried the Nationwide Readmissions Database for hospitalizations for mitral TEER between 2016 and 2018. Propensity score-weighted regression analysis was conducted to evaluate the association of RHD with in-hospital outcomes and 90-day readmissions after mitral TEER. A total of 18,240 procedures were included in the analysis, including 1,779 in patients with RHD. Mitral TEER in patients with RHD was associated with similar in-hospital mortality to that in patients without RHD (odds ratio [OR] 1.47, 95% confidence interval [CI] 0.94 to 2.30, p=0.089). However, RHD was associated with higher acute myocardial infarction (OR 1.65, 95% CI 1.07 to 2.56), acute kidney injury (OR 1.58, 95% CI 1.30 to 1.94), ventricular arrhythmia (OR 1.50, 95% CI 1.12 to 2.01), high-degree heart block (OR 1.67, 95% CI 1.25 to 2.23), and conversion to open surgical repair/replacement (OR 2.53, 95% CI 1.02 to 6.30). Mitral TEER in RHD was also associated with higher 90-day all-cause readmission (hazard ratio [HR] 1.19, 95% CI 1.04 to 1.47, p=0.012). In conclusion, mitral TEER in patients with RHD is associated with higher rates of hospital complications, crossover to surgery, and readmissions but could be performed selectively in patients at high surgical risk who have favorable anatomy.

Lithotripsy-Assisted Transcatheter Mitral Valve Replacement for Severe Mitral Annular and Valve Calcification.

Transcatheter mitral valve replacement (TMVR) is evolving; however, limitations include severe calcification of the mitral valve leaflets and mitral annular calcification (MAC), which may be associated with incomplete valve expansion. Shockwave intravascular lithotripsy (IVL)-assisted percutaneous mitral valvuloplasty to treat calcific mitral stenosis has been reported. We describe the first human use of IVL-assisted transseptal TMVR with the Intrepid valve to treat a severely calcified mitral valve in a patient with severe stenosis and regurgitation. An 83-year-old man with rheumatic heart disease and severe MAC (MAC score, 10; calcium volume score, 7756 cm3) presented with combined mitral stenosis and regurgitation (valve area, 1.5 cm2; 3+ mitral regurgitation [MR]) and medically refractory heart failure symptoms and was enrolled into the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial of Intrepid valve TMVR. Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two 8.0 × 60-mm M5+ balloons placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implant was provided by a Sentinel device and left subclavian balloon occlusion. Despite initial postimplant valve frame deformation and moderate central MR, postdilation achieved valve frame expansion and reduced MR. Echocardiography and computed tomography performed before hospital discharge and at 30 days show progressive valve frame expansion in the anteroposterior dimension, increased valve area, and resolution of MR. Intravascular lithotripsy of severe MAC before self-expanding TMVR may enhance annular compliance, mitigate fibroelastic recoil, and minimize TMVR valve frame deformation. Although promising, further study is required before IVL is considered a routine adjunct for TMVR in severe MAC.

680 SINGLE-CENTER EXPERIENCE IN TRANSCATHETER MITRAL VALVE REPLACEMENT WITH THE TENDYNE MITRAL VALVE SYSTEM

Abstract Background Transcatheter mitral valve replacement (TMVR) with the Tendyne System is a therapeutic option for selected patients with severe symptomatic mitral regurgitation (MR) not eligible for either surgical intervention or transcatheter repair. To date, only a few studies have evaluated the short-term and mid-term outcomes of these patients in a real-life scenario. Objectives To describe the baseline features, and the short- and mid-term outcomes of patients undergoing TMVR with the Tendyne System at our Center. Methods Consecutive patients undergoing TMVR with the Tendyne System at our Center from November 2018 and August 2022 were enrolled. The baseline features of the study cohort were collected during the index hospitalization and patients were followed-up for the endpoints of all-cause death, residual MR, and prothesis dysfunction. Results Twenty-two patients (aged 75±6 years, 36% men) with moderate-to-severe or severe MR undergoing TMVR with the Tendyne System were recruited. Many patients were highly symptomatic (45% New York Heart Association [NYHA] functional class III or IV) and the etiology of MR was secondary or mixed in 18 (82%) cases. Prostheses were successfully implanted in all patients, with no peri-procedural residual MR (only two patients had a mild paravalvular leak). One patient died of sepsis during the index hospitalization. Out of 19 patients evaluated at a 30-day follow-up, 18 (95%) had no residual MR, 16 (84%) had an improved functional status (of at least one NYHA grade). Mid-term (&amp;gt;6 months) follow-up was available for 15 patients, 4 of whom were dead (2 died of heart failure, one of sepsis, and one of intestinal ischemia). Among the 10 patients undergoing a mid-term follow-up echocardiography, 8 had no residual MR and 2 had only mild MR. Two valve-related adverse events (i.e., endocarditis) were registered during the follow-up. Conclusions TMVR with the Tendyne System appears to be a safe and promising technique for symptomatic patients affected by signficant MR and not suitable for other procedures. Since experience is still limited, more data including a longer follow-up is warranted to optimize patient selection and outcomes.

744 LEFT ATRIAL DISSECTION AFTER MITRACLIP IMPLANTATION: ECHOCARDIOGRAPHIC FEATURES

Abstract Introduction the MitraClip system (MC) is the leading transcatheter technique to treat mitral regurgitation (MR), presenting very low adverse event rates. Left atrial dissection (LAD) is defined as a gap from left atrial wall. Aim we report a case of LAD occurring after MC implantation, treated conservatively, focusing on suggestive echocardiographic features. Materials and methods transthoracic and transesophageal echocardiography with 3D reconstructions were performed. Results the patient was a 73-years-old woman with symptomatic severe MR due to flail leaflet, treated with MC. Seven days later, the echocardiography showed a large mass in the left atrium not visible previously, initially thought to be a thrombus. Further investigation using transoesophageal echocardiography showed a large formation, with uneven echogenicity, at the level of the left atrium without signs of obstructing mitral valve inflow. 3D-rendering was also performed, revealing an echolucent area between the endocardium and the left atrial free wall, presenting increase echogenicity portions, suggestive of being LAD with partial thrombosis inside. The patient was treated with unfractionated heparin and after six days the echocardiogram showed complete resolution of thrombotic elements, with residual double-track linear hyperechoic formation within the atrial posterior wall, identifying an anechoic space. Therefore, the echocardiographic features suggested the diagnosis of left atrial intramural hematoma, initially thrombosed, then dissolved. Conclusions LAD is a rare complication either of cardiosurgical and transcatheter procedures. Both operator awareness and imaging features are important for diagnosis. 3D rendering can be useful in the early differential diagnosis, facilitating an optimal management.

MitraClip: a review of its current status and future perspectives.

Mitral regurgitation (MR), among the most common valvular heart diseases, is closely associated with heart failure and worse clinical outcomes. Surgical repair or replacement as an intervention for MR is deemed too high risk in patients who are elderly or have multiple comorbidities; thus, nearly half of all patients with severe symptomatic MR are not referred for surgical therapy. MitraClip, a transcatheter mitral valve repair system for MR that mimics the Alfieri surgical edge-to-edge technique for mitral valve repair, was developed in the late 1990s. After clinical trials demonstrated its safety and efficacy, it received approval for clinical use, particularly for aging and inoperable or high-risk patients for heart surgery in Europe, the US, and Japan. Since the start of its clinical use, randomized clinical trials (RCTs) have optimized patient selection, and the latest generation MitraClip can increase procedural success, even in patients with challenging mitral valve anatomy. Therefore, here, we review evidence from clinical trials and RCTs and discuss optical patient selection and future perspectives for the MitraClip.

Transcatheter mitral valve repair is feasible and effective in oldest-old patients: results from real-world cohort.

To evaluate the safety and efficacy of transcatheter mitral valve repair (TMVR) using MitraClip® devices in oldest-old patients compared to younger patients. The study retrospectively included 340 consecutive patients who underwent TMVR. Patients were classified according to age into the oldest-old (age ≥ 85 years) patient group or the younger (age < 85 years) patient group. Immediate results of the procedure, intrahospital outcomes and one-year outcomes were compared. Oldest-old patients represented 15.9% (n = 54) of all patients. Procedure success was comparable for the oldest-old patient group and the younger patient group (92.6% vs. 95.8%, P = 0.30), and there was no difference in intrahospital mortality (9.2% vs. 4.2%, P = 0.12). At a one-year follow-up (interquartile range: 6-16 months), there was no significant difference in rehospitalization due to decompensated heart failure (25.5% vs. 34.3%, P = 0.24) or all-cause mortality (29.8% vs. 22.2%, P = 0.26) between the oldest-old patient group and the younger patient group. In patients with available echocardiographic follow-up, severity of residual mitral regurgitation was also comparable between the oldest-old patient group and the younger patient group. TMVR seems to be feasible and effective in oldest-old patients and should be considered for oldest-old patients presenting with symptomatic severe mitral regurgitation and high surgical risk.

Mitral valve: When conservative, when surgical, when interventional therapy?

The management of severe symptomatic mitral regurgitation is in contrast to the aortic-valve-intervention more challenging due to the complex mitral-valve anatomy. In primary mitral regurgitation surgical therapy is recommended, whereas there are various therapeutic options in secondary mitral regurgitation. Besides the established mitral-valve Transcatheter Edge-to-Edge-Repair (M-TEER) and the interventional annuloplasty - devices dynamic developments have recently been made in the field of Transcatheter Mitral Valve Replacement-therapy (TMVR). This article surveys the current recommendations and available therapeutic options in mitral regurgitation.

The road to a transcatheter edge-to-edge repair: patient experiences leading up to the procedure and in the early recovery period.

Mitral valve transcatheter edge-to-edge repair (TEER) is a minimally invasive treatment option for patients with severe symptomatic mitral regurgitation who are at increased risk for cardiac surgery and are receiving optimal medical therapy. Little is known about patients' perspectives on their journey of care, including their experiences leading up to treatment and their early recovery period. The aim of this study was to explore patients' experiences of their journey to TEER and their perspectives on early recovery. We conducted a qualitative study using interpretive description. A purposive sample of 12 patients from a purposive sample, 3-6 monthspost-TEER procedure, were recruited from a tertiary hospital. The median age of the patients was 79 years, with seven males and five females. Data collection included semi-structured interviews over the phone. Data analysis followed an iterative process and utilized thematic analysis. There were four central themes highlighting the experiences of the patients leading up to their procedure: (i) escalating challenges with everyday life; (ii) plummeting losses; (iii) choosing and readiness to proceed with TEER; and (iv) the long and uncertain waiting time. The theme-improved health status highlights the experiences of patients in their early recovery. Patients' experiences of waiting for TEER are complex and involve multifaceted challenges related to their worsening cardiac symptoms and navigating the healthcare system. Therefore, care pathways must be put in place to provide continuity of care and support.