Transcatheter Mitral Valve Repair Research Articles

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.

Early Outcomes of 2 Mitral Valve Transcatheter Leaflet Approximation Devices: A Propensity Score–Matched Multicenter Comparison

BackgroundIn addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking. ObjectivesThe aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems. MethodsProcedural and 30-day outcomes were investigated in a propensity score–matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). ResultsTechnical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562). ConclusionsIn this first large propensity score–matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome.

Abstract 13781: Same-Day Discharge After Transcatheter Mitral Valve Repair: Propensity Score-Matched Analysis From the Nationwide Readmissions Database 2014-2019

Introduction: Transcatheter mitral valve repair (TMVR) has evolved over the years, and early discharge strategies are being increasingly adopted. However, there is paucity of data on the outcomes and safety of same-day discharge (SDD) after TMVR. Methods: Data from the Nationwide Readmissions Database 2014 to 2019 were analyzed. International Classification of Diseases codes were used to identify adult patients admitted for elective TMVR. Patients who underwent uncomplicated TMVR were identified by excluding patients with periprocedural complications such as bleeding, vascular access site complications, pericardial complications, stroke, myocardial infarction, shock, or death before discharge. A 1:3 propensity score-matched analysis was performed to compare outcomes of patients undergoing SDD and different-day discharge (DDD). The primary outcome of interest was the 30-day unplanned readmission rate. Results: We identified 34,683 patients who received complication-free TMVR, of which 232 (0.67%) underwent SDD. There was a gradually rising trend of SDD after TMVR over the study period. The baseline characteristics of the unmatched and propensity-matched SDD and DDD groups are shown. Patients in SDD group did not have a significantly higher 30-day readmission rate (15.7% vs 14.8%, p = 0.82) compared to DDD group, but had significantly lower mean hospitalization costs ($33,060 vs $41,134, p &lt;0.001). Female gender, diabetes, chronic kidney or pulmonary disease, anemia, liver disease, cancer and atrial fibrillation were found to be independent predictors of 30-day readmissions after TMVR (shown in figure). Conclusions: Patients receiving a complication-free TMVR who were discharged on the same day as the procedure had a similar 30-day unplanned readmission rate compared with those that stayed in the hospital longer. Our findings suggest that same-day discharge after uncomplicated TMVR may be a safe and cost-effective strategy in selected patients.

Abstract 12188: Acute Bi-Ventricular Dysfunction and Cardiogenic Shock Following Transcatheter Mitral Valve Repair

Background: For patients with functional mitral regurgitation (MR) who remain symptomatic despite GDMT, transcatheter mitral valve repair (TMVR) is emerging as a less-invasive alternatives and can improve symptoms and longevity. We describe a rare case of cardiogenic shock following TMVR. Case: 63-year-old male with PMHx of CAD with prior CABG, severe MR with EF of 40% developed progressive dyspnea and evaluated for TMVR with a Mitraclip device. TEE pre-deployment confirmed moderate to severe MR (Figure 1). Right heart catheterization revealed preserved cardiac index. Intraoperative TEE after deployment showed improved MR. Post-procedure, he developed respiratory distress and progressive hypotension requiring vasopressors and inotropes. TTE showed mild MR with severely reduced biventricular function (EF 10%). Cardiac catheterization showed a severely reduced CO/CI 3.1/1.42. Mechanical circulatory support was initiated with Impella CP due to persistent cardiogenic shock. By POD 3, he was off all inotropes and MCS was discontinued. His EF recovered to 45% during a 3- month visit. Decision Making: Causes of cardiogenic shock post mitral valve procedure include cardiac tamponade, acute mitral stenosis, intrathoracic hemorrhage and afterload mismatch. Afterload mismatch is due to reduction in left ventricular stroke volume when preload is not compensated for an acute increase in afterload. It is a known complication after mitral valve surgery; however it is rarely seen post TMVR. This patient likely experienced afterload mismatch after his mitral clipping procedure as evidenced by the acute, transient decline in LVEF (55% to 10%). Conclusion: Afterload mismatch is a rare phenomenon that can cause cardiogenic shock post percutaneous mitral repair procedures. It must be rapidly addressed with inotropic and/or mechanical support to prevent permanent end organ dysfunction and circulatory collapse. Prompt treatment allows for excellent recovery.

Abstract 13731: 30-Days Readmission Rate, Mortality and Health Care Burden Among Patients Who Underwent Transcatheter Mitral Valve Repair With Co-Existing Atrial Fibrillation

Introduction: Transcatheter mitral valve repair (TMVR) is a minimally invasive technique for the treatment of selected patients with symptomatic chronic moderate to severe mitral regurgitation (MR). Depending on the severity &amp; chronicity of MR, there is left atrium remodeling in response to the volume overload, which contributes to the generation of atrial fibrillation (AF). Our study aimed to examine the 30-day readmission rates (30-DRr) among patients who underwent TMVR with co-existing AF in the United States. Methods: Using the 2017 National Readmission Database, we conducted a retrospective analysis of patient discharges with TMVR as a principal diagnosis and co-existing AF as a secondary diagnosis according to ICD-10 codes. Readmission was defined as the first admission to any hospital for any non-trauma diagnosis within 30 days of the index discharge. The primary outcome was 30-DRr, while secondary outcomes were readmission mortality rate, most common diagnoses for readmission, length of stay, hospitalization costs &amp; patient charge. Results: A total of 3,242 Index admission with TMVR and AF; mean age 79.2years, &amp; 53.3% male. In-hospital mortality rate was 2.46%, while all-cause readmission rate was 12%. Among this group of readmitted patients, the in-hospital mortality rate increased to 5.66% (aOR 2.38, adjusted p-value=0.009). The total hospital days associated with readmission were 2,244 days, with a total healthcare in-hospital economic burden of $6.24 million and total patient charge of 27 million. The most common diagnoses for readmission were hypertensive heart and chronic kidney disease with heart failure, hypertensive heart heart failure, Sepsis, AKI, Non-rheumatic MR &amp;, AF, respectively. Conclusions: We observed among patient who underwent TMVR with co-existing AF, 1 in 8 was readmitted within 30-days with subsequent readmission associated with an increase in mortality and prolonged LOS, thus contributing to a significant economic burden.

Abstract 12165: Transcatheter Mitral Valve Repair is Safe in Older Adults: Insight From the Nationwide Inpatient Sample Database

Introduction: Transcatheter mitral valve repair (TMVR) is an effective treatment for symptomatic mitral insufficiency, however in elderly patients is limited. We compared outcomes clinical outcomes, cost, and complications in adults aged ≥80 years old compared to &lt; 80 years old. Methods: We identified all cases of transcatheter mitral valve repair in patients admitted to hospitals in the United States (US) from 2016 to 2019 using the National Inpatient Sample. We compared outcomes between older adults and younger population using 79 years of age as the cutoff. Results: Out of 3130 patients who underwent TMVR , 33.42 % of patients were over the age ≥80 of years. Half of those patients were female (49.91%). Older patients ≥80 years of age were more likely to have congestive heart failure (79.36 versus 70.13, p&lt;.0001), dyslipidemia (57.64% versus 51.0%, p&lt;.0001), chronic kidney disease (34.66% versus 25.39%, p&lt;.0001), and coronary artery disease (58.51% versus 51.141%, p&lt;.0001). While patients younger than 80 years of age more frequently had diabetes mellitus(29.83% versus 19.92%, p&lt;.0001), hypertension (30.12% versus 21.30%, p&lt;.0001), and smoking(9.09% versus 0.72%, p&lt;.0001). Hospital mortality was lower in patients 80 years of age or older (2.56% versus 4.46%, p&lt;.0001). In addition, hospital length of stay and total charges were lower in the older group (4.93±6.62 days versus 10.85±13.61 days), and ( $222933 ±155969 versus $288776 ±314288, p &lt;.0001). However, multivariable analysis after adjusting for baseline comorbidities mentioned above did not show significant difference in mortality between the two groups (OR 0.792, CI 0.501-1.252). Conclusions: After adjustment for baseline characteristics, patients ≥80 years old and undergoing TMVR have similar in-hospital mortality to patients under age 80. Care for the ≥80 cohort was more costly. The present analysis suggests TMVR is safe in older adults.

Abstract 10388: Impact Of Right Ventricular Function On Cardiopulmonary Exercise Capacity In Mitral Regurgitation Patients Undergoing Transcatheter Mitral Valve Repair

Background/Objectives: To investigate the role of right ventricular (RV) function on exercise capacity in patients undergoing transcatheter mitral valve repair (TMVR) we aimed to perform cardiopulmonary exercise testing (CPET) and to show a correlation between an improved RV function and maximal and submaximal exercise capacity. Methods: Constant work rate exercise time testing (CWRET) reflects submaximal/endurance exercise capacity, which is more likely to be relevant for daily life activities, and gives a more differentiated physiologic insight into the nature of exercise intolerance. Thus, 28 Patients with mitral regurgitation (MR) and symptomatic heart failure (NYHA≥II) underwent CPET by assessment of maximal oxygen uptake (peak VO 2 ) and submaximal exercise capacity (at 75% of maximal achieved work rate in the initial incremental exercise test) accompanied by echocardiography prior to TMVR and 3 months post-procedure. Results: Mean age of the patients was 75.0±8.7 years and 32.1% of them were female. One patient presented a reduction of MR &lt;2 grades. RV function (assessed with fractional area change, tricuspid annular plane systolic excursion, longitudinal strain of the RV free wall and S`) was at least moderately impaired in 25% of the patients. The submaximal exercise capacity of these patients was impaired, but did not significantly differ (416.4±359.6sec vs. 296.1 ±216.5sec; p=0.152) compared to patients without a deteriorated RV function. Three months after intervention, exercise time at 75% of maximal achieved work rate significantly improved (from 337.4±262.2sec to 517.4±393. sec p=0.006), reflecting a gain in submaximal exercise tolerance. peak VO 2 showed a positive trend, but no statistically significant difference (10.3±3.1ml/min/kg vs. 11.3±3.4ml/min/kg; p=0.056). RV function (at least 2 of 4 parameters) improved in 35.7% and these patients showed a significantly higher submaximal exercise time increasement (471.7±153.9sec vs. 82.7±47.0sec, p=0.003). Discussion/Conclusions: TMVR may have a beneficial effect on RV remodeling. Furthermore, submaximal exercise capacity is significantly increased, reflecting an improvement especially regarding daily life activities in MR patients and impaired RV function.

Abstract 11879: Von Willebrand Factor Activity and Closure Time With Adenosine Diphosphate During Transcatheter Mitral Valve Repair

Introduction: Residual mitral regurgitation (MR) is associated with worse outcomes after transcatheter edge to edge mitral valve repair (TEER) but is difficult to assess by echocardiography. Shear-stress induced by MR leads to altered Von Willebrand factor activity (vWF:Act), also reflected by increased closure time with adenosine diphosphate (CT-ADP), representing potential ways to screen for residual MR. CT-ADP can be assessed easily during TEER and is known to normalize swiftly after the correction of turbulent flow. Hypothesis: The improvement of CT-ADP is quick enough to allow real-time procedural guidance. Methods: We enrolled 39 patients undergoing TEER. MR severity was assessed by echocardiography during the procedure, 24-hours and 1-month post-TEER. CT-ADP was measured before TEER, 8 minutes after each clip deployment, 1 hour and 24 hours after the procedure. CT-ADP values were related with vWF:Act and MR severity at each time point. Results: Of 39 patients after TEER, 6 (15%) and 8 (21%) patients had residual MR ≥ moderate at 24-hours and 1-month respectively. There was no significant change in CT-ADP values during the procedure. The decrease of CT-ADP was however significant 1-hour post-TEER with stable values at 24-hours (last clip deployment: 136 [110-193]; 1 hour: 99 [82-131] and 24 hours: 95 [82-121] seconds, p&lt;0.001). Concomitant increase in vWF:Act was observed after the procedure (baseline: 1.76 [1.29-2.05]; 1 hour: 1.84 [1.79-1.85] and 24 hours: 2.32 [1.84-2.5] IU/ml, p=0.002). Patients were stratified into 3 groups according to the residual MR grade at 1 month (≤ mild vs. moderate vs. &gt;moderate). CT-ADP was not different among the groups (p=0.74). However, the difference in CT-ADP (1 month vs baseline values) was associated with MR improvement at the same time points (r=0.50; p=0.007). Conclusions: Although CT-ADP decreases after TEER and correlates with vWF:Act and MR improvement at 1 month, this decrease is first observed 1 hour after the procedure and does not seem to be quick enough to provide real-time monitoring of MR severity during TEER.

Abstract 15900: Impact of Age on Readmission Following Mitraclip; National Readmission Database

Transcatheter mitral valve repair with the Mitraclip device has become a therapeutic option for patients with moderate to severe mitral regurgitation (MR) and high surgical risk. There are limited data evaluating Mitraclip outcomes in younger patients, although limited studies suggest decreased mortality in younger patients. As severe MR has increasing become recognized in younger patients, there is a need to investigate outcomes with Mitraclip in these subjects. Based on limited available data, our hypothesis was adverse clinical outcomes, including readmission, would be significantly lower among younger subjects following Mitraclip. The National Readmission Database (NRD) for 2018 and 2019 was queried to identify patients undergoing transcatheter mitral valve repair using ICD-10 procedure code ‘02UG3JZ’. Patients were stratified into 3 age groups: &lt; 65, 65-80, and &gt; 80 years of age (yoa) for comparison of readmission rates and risk factors. A total of 9742 who underwent Mitraclip were included in the study. The mean age of included subjects was 77 yoa, and 56 % were male. Approximately 16% had diabetes, 70% had hypertension, and 27% had chronic lung disease. Approximately 87% of subjects had Medicare coverage, while 3% had Medicaid, and 8% had private insurance. Approximately 90% of patients were cared for in 90% teaching hospitals. The overall rate of readmission following Mitraclip was 14%. While there was no difference in readmission by sex for subjects &lt; 65 or &gt; 80, there was a significant increase in readmission for women in comparison to men who were 65-80 yoa (15.8 vs. 12.4%, P &lt; 0.01). There was a significant decrease in rate of readmission for subjects &gt; 80% in 2019 in comparison to 2018 (13.1 vs. 15.5%, P = 0.03). There was significant increase in readmission to teaching hospitals in comparison to non-teaching hospitals for individuals &lt; 65 (15.0 vs. 9.8%, P &lt; 0.01). Rate of readmission was significantly higher for individuals &gt; 80 and 65-80 yoa with chronic lung disease (17.7 vs 13.1%, P &lt; 0.01). For all studied age groups, uncontrolled hypertension was associated with increased rate of readmission (P &lt;0.02). Our studies suggest overall similar outcomes for younger patients undergoing Mitraclip in comparison to other populations.

Assessment of the MitraClip Procedure: Reassessing the Goals

THE MITRACLIP (Abbott Laboratories) was first implanted in 2003, was approved in Europe in 2008, and approved by the US Food and Drug Administration in 2013. The MitraClip procedure has reduced hospitalization and mortality compared to medical therapy, with either improved or similar outcomes compared with isolated mitral valve surgery. 1 Shah MA Dalak FA Alsamadi F et al. Complications following percutaneous mitral valve edge-to-edge repair using MitraClip. J Am Coll Cardiol. 2021; 3: 370-376 Google Scholar , 2 Stone GW Lindenfeld JA Abraham WT et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018; 379: 2307-2318 Crossref PubMed Scopus (1514) Google Scholar , 3 Stone GW Adams DH Abraham WT et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 2: Endpoint definitions a consensus document from the mitral valve academic research consortium. J Am Coll Cardiol. 2015; 66: 308-321 Crossref PubMed Scopus (302) Google Scholar In the earlier and preliminary data, proponents of surgery highlighted less mitral regurgitation (MR) and fewer additional procedures after surgical correction of MR; however, the overall major cardiac adverse events were significantly lower (15% v 48%) for percutaneous procedures. 4 Feldman T Foster E Glower DD et al. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011; 364: 1395-1406 Crossref PubMed Scopus (1475) Google Scholar Since the initial experiences, all outcomes for MitraClip procedures have improved with greater experience. 5 Chhatriwalla AK Vemulapalli S Holmes DR et al. Institutional experience with transcatheter mitral valve repair and clinical outcomes. J Am Coll Cardiol. 2019; 12: 1342-1352 Crossref Scopus (100) Google Scholar Right Ventricular Failure in Emergent MitraClip Therapy—A Problem Worth InvestigatingJournal of Cardiothoracic and Vascular AnesthesiaPreviewThe MitraClip (Abbott, Santa Clara, CA) has emerged as a safe, effective, and durable treatment for hemodynamically significant mitral regurgitation (MR) refractory to maximally tolerable guideline-directed medical therapy in nonsurgical patients.1-9 Hemodynamically, the MitraClip reduces left ventricular volumes, unloads the left atrium and pulmonary circulation, reduces right ventricular afterload (as long as iatrogenic MitraClip-induced mitral stenosis does not develop), and facilitates biventricular reverse remodeling. Full-Text PDF Invited Commentary: “Assessment of the MitraClip procedure: Reassessing the goals”Journal of Cardiothoracic and Vascular AnesthesiaPreviewAsher and colleagues1 present two interesting cases that not only highlight the use of MitraClip in the urgent setting, but also how intraoperative case management can help facilitate procedural success. Mitral valve disease is one of the most common valvular disorders with an incidence anywhere from 10% to 24%, most commonly affecting people older than 75 years.2,3 Primary mitral regurgitation (MR) is due to a structural or degenerative abnormality while secondary MR is related to left ventricular (LV) or less commonly left atrial disease. Full-Text PDF

Right atrial structural remodeling predict worse outcomes in transcatheter mitral valve repair.

In the current study, we assess the predictive role of right and left atrial volume indices (RAVI and LAVI) as well as the ratio of RAVI/LAVI (RLR) on mortality following transcatheter mitral valve repair (TMVr). Transthoracic echocardiograms of 158 patients who underwent TMVr at a single academic medical center from 2011 to 2018 were reviewed retrospectively. RAVI and LAVI were calculated using Simpson's method. Patients were stratified based on etiology of mitral regurgitation (MR). Cox proportional-hazard regression was created utilizing MR type, STS-score, and RLR to assess the independent association of RLR with survival. Kaplan-Meier analysis was used to analyze the association between RAVI and LAVI with all-cause mortality. Hemodynamic values from preprocedural right heart catheterizationwere also compared between RLR groups. Among 123 patients included (median age 81.3 years; 52.5% female) there were 50 deaths during median follow-up of 3.0 years. Patients with a high RAVI and low LAVI had significantly higher all-cause mortality while patients with high LAVI and low RAVI had significantly improved all-cause mortality compared to other groups (p = 0.0032). RLR was significantly associated with mortality in patients with both functional and degenerative MR (p = 0.0038). Finally, Cox proportion-hazard modeling demonstrated that an elevated RLR above the median value was an independent predictor of all-cause mortality [HR = 2.304; 95%CI = 1.26-4.21, p = 0.006] when MR type and STS score were accounted for. Patients with a high RAVI and low LAVI had significantly increased mortality than other groups following TMVr suggesting RA remodeling may predict worse outcomes following the procedure. Concordantly, RLR was predictive of mortality independent of MR type and preprocedural STS-score. These indices may provide additional risk stratification in patients undergoing evaluation for TMVr.

Echocardiographic Predictors of Suboptimal Transcatheter Mitral Valve Repair in Patients With Secondary Mitral Regurgitation.

Residual mitral regurgitation (MR) following mitral valve transcatheter edge-to-edge repair (TEER) is associated with worse outcomes. This study sought to identify echocardiographic predictors of suboptimal residual MR after TEER in patients with secondary MR. In this retrospective single-center study, we identified all patients with secondary MR who underwent TEER between 2016 and 2021. Pre- and intraprocedural transesophageal echocardiographic images were reviewed. The primary outcome was suboptimal residual MR, defined as ≥2+ residual MR on postprocedural transesophageal echocardiography. The association of preprocedural echocardiographic parameters with the primary outcome was tested via logistic regression. Sixty-five patients (69 ± 15 years; 49% women) with secondary MR underwent TEER with MitraClip. All patients had moderate-severe or severe (3-4+) MR preoperatively, with an average left ventricular ejection fraction of 35% and New York Heart Association class III symptoms. Procedural success, defined as ≤2+ MR post-TEER, was achieved in 94%. A suboptimal residual MR was observed in 38%. Independent predictors of suboptimal residual MR included bicommissural MR (odds ratio [OR], 7.95; 95% CI, 1.50-42.3; P = .02), 2-dimensional anteroposterior diameter (OR, 6.46; 95% CI, 1.85-22.51 per cm; P < .01), and mitral valve area to left ventricular end-diastolic volume ratio (OR, 0.69; 95% CI, 0.50-0.93 per mm2/mL; P = .02). Certain echocardiographic features, including bicommissural MR, a larger annular diameter, and a smaller ratio of mitral valve area to left ventricular end-diastolic volume, are associated with suboptimal residual MR following TEER. These preprocedural measurements may optimize patient selection in those with secondary MR being considered for TEER.

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.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Guidance of Transcatheter Mitral and Tricuspid Valve Repair by Echocardiography.

Transcatheter valve therapies for mitral and tricuspid regurgitation are alternative methods to more invasive surgical treatment in candidates with high or prohibitive surgical risk. Echocardiography is the primary imaging modality for patient selection, pre-procedural planning, intra-procedural guidance, and post-procedural follow-up. This article outlines the applications of transcatheter valve repair therapy for mitral and tricuspid regurgitation based on the current cardiovascular guidelines and a growing body of evidence. In this review, we provide a stepwise approach echocardiography in the guidance of the MitraClip device as currently the only FDA-approved transcatheter edge-to-edge repair device.

Optimization of Preprocedural Full-cycle Computed Tomography in Patients Referred for Transcatheter Tricuspid Valve Repair: Test Bolus Versus Bolus Tracking.

Advancements in transcatheter mitral and tricuspid valve repair have resulted in growing demands in preprocedural computed tomography (CT) imaging. Due to the introduction of multidetector CT (MDCT), shorter acquisition times as well as high rates of heart failure and arrhythmias in this specific patient population, optimal synchronization between the passage of contrast agent and data acquisition is mandatory. There is no consensus on which acquisition technique should be used in this patient population. We aimed to optimize our preprocedural CT protocol comparing bolus tracking (BT) and test bolus (TB) techniques. We performed a retrospective analysis on 151 patients referred for full-cycle MDCT evaluation for transcatheter tricuspid valve repair comparing BT with TB (BT n=75 TB n=75). Contrast-to-noise ratios (CNR) were obtained. Demographic data, laboratory, electrocardiographic, and transthoracic echocardiography/transoesophageal echocardiography parameters were collected from electronic health records. Also, the volume of contrast agent and saline chaser and radiation dose length product and milliampere seconds were collected. BT and TB resulted in comparable CNR (BT: 0.47 [0.34 to 0.98]; TB: 0.51 [0.41 to 1.40]; P =0.1). BT was associated with a shorter scan duration (BT: 8.3min [4.1 to 24.4]; TB: 13.9min [6.2 to 41.4]; P <0.001), less radiation in terms of dose length product (BT: 1186±585; TB: 1383±679, P =0.04), and lower total volume administration (BT: 101mL [63 to 16]; TB: 114mL [71 to 154]; P <0.001). In patients with severely impaired ejection fraction (left ventricular ejection fraction [LVEF] ≤35%; n=65 [TB n=31; BT n=34]) using the TB technique yielded significantly better image quality in terms of CNR (TB=0.57 [0.41 to 1.07); BT=0.41 [0.34 to 0.65]; P =0.02). In patients with impaired LVEF (LVEF≤35%), the TB technique yielded significantly superior image quality and may be the preferred approach in this specific patient population. BT showed advantages in terms of shorter duration, less radiation, and lower contrast agent volume.

Right ventricular function and outcome in patients undergoing transcatheter mitral valve repair

Abstract Objectives This study sought to assess the impact of right ventricular dysfunction (RVD) on event-free survival after transcatheter mitral valve repair (TMVR) for severe mitral regurgitation. Background The prognostic value of left and RV global longitudinal strain (LV- and RV-GLS) on cardiovascular magnetic resonance feature tracking (CMR-FT) in patients undergoing TMVR is unknown. Methods Consecutive TMVR patients underwent pre-procedural and follow-up CMR-FT analysis. Kaplan-Meier estimates and multivariable Cox-regression analyses were performed, using a composite endpoint of heart failure hospitalization (HFH) and death. Results 62 patients (78.3±7.0y/o, 45% female, EuroSCORE-II: 9.6±7.1%) underwent CMR-FT prior to TMVR, 24% had concomitant tricuspid edge-to-edge repair (TTVR). On presentation, 23 (37%) patients suffered RVD, defined as RV-GLS &amp;gt;−20% on CMR-FT. RVD was associated with reduced LV and RV ejection fraction (LVEF: 39.2 vs. 48.7%, p=0.008, RVEF: 35.1 vs. 46.7%, p&amp;lt;0.001), as well as impaired LV-GLS (−14.0 vs. −19.5%, p=0.012). Eighteen events (12 deaths, 6 HFH) occurred during follow-up (11.4±9.1 months). On multivariable Cox-regression adjusted for baseline, procedural, imaging, and biomarker data, RV but not LV-GLS was significantly associated with outcome (adj.HR 2.50, 95% CI: 1.29–4.86, p=0.007 and 1.46, 95% CI: 0.50–4.28, p=0.491, respectively). Among various definitions of RVD on echocardiography and CMR, only RV-GLS on CMR-FT was significantly associated with outcome (RV-GLS &amp;gt;−20%: adj.HR 7.53, 95% CI: 2.07–27.42, p=0.002), but not RVEF on CMR or echo-indices of RV function (Central Illustration). Follow-up CMR-FT was performed in 21 (34%) patients and RV-GLS significantly improved after TMVR (−20.6 to −25.2%, p=0.016), irrespective of additional TTVR. Conclusions RV-GLS, as determined on CMR-FT, rather than LV-GLS or RVEF, is an independent predictor of outcome in patients undergoing TMVR. Funding Acknowledgement Type of funding sources: None.

Effect of frailty on in-hospital outcomes after transcatheter mitral valve repair

Abstract Background Mitral regurgitation (MR) is a common valvular disorder associated with significant morbidity and mortality. Transcatheter mitral valve repair (TMVr) is a minimally invasive procedure indicated for the treatment of selected patients with moderate-severe or severe primary MR. Despite a lack of a universal definition, frailty has been associated with poor post-procedural outcomes. Albeit several trials have examined individual prognostic factors in this population, there is a paucity of data regarding the effect of frailty on in-hospital outcomes after TMVr. Purpose To further elucidate the association of frailty with in-hospital outcomes in patients undergoing TMVr. Methods The national inpatient sample (NIS) database, which is part of the Healthcare Cost and Utilization Project (HCUP), was queried from 2016 to 2019 to identify all who underwent TMVr. International classification of diseases, tenth revision clinical modification (ICD-10-CM) codes were used to divide patients into frail and non-frail study groups. Frailty was defined using Johns Hopkins Adjusted Clinical Groups diagnosis cluster for frailty. Multivariate linear and logistic regression analysis was performed to compare in-hospital mortality, hospital length of stay, non-home discharge, and iatrogenic cardiac complications among Frail and Non-Frail groups. Results A total of 30,660 patients who underwent TMVr were identified. The mean age was 76±11.6 years. Of those, 2,950 (9.6%) were identified as frail. The overall in-hospital mortality rate for the entire study population was 1.89%. Compared to non-frail patients, those identified as frail had greater odds of in-hospital mortality (AOR= 2.13, 95% CI 1.29–3.51, p&amp;lt;0.001) and non-home discharge (AOR= 4.34, 95% CI 3.54–5.32, p&amp;lt;0.001). However, there was no statistically significant difference in hospital length of stay and rates of iatrogenic cardiac complications. Conclusions Frailty models continue to be underutilized as a prognostic tool in clinical practice. After following HCUP guidelines, our analysis found that frailty is independently associated with increased in-hospital mortality and non-home discharge in patients undergoing TMVr. Therefore, we recommend that further efforts in incorporating frailty models in the pre-procedural assessment of patients undergoing TMVr should be sought along with a standardized predictive model for defining frailty. Funding Acknowledgement Type of funding sources: None.

Transcatheter mitral-valve repair for functional mitral regurgitation data from the real-life in comparison with landmark randomized trials

Abstract Background Publication of COAPT and MITRA-FR trials on the use of transcatheter mitral-valve repair (TMVR) for functional mitral regurgitation (MR) in 2018, has raised many questions due to their divergent results despite having similar objectives. Purpose To investigate the characteristics and outcomes of patients from real-life data who underwent TMVR for functional MR, in comparison with the two landmark trials. Methods A meta-analysis was performed according to Cochrane Handbook for Systematic Reviews and the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. A comprehensive systematic literature search was conducted to identify observational studies that enrolled patients with functional MR, published in 2020 and 2021. No further restrictions were implemented. Independent reviewers performed study selection, data extraction, risk-of-bias and quality-of-evidence assessments. Variables of interest were related to patient demographics, medications, echocardiogram parameters, and outcomes. Patient variables from observational studies were compared with those reported in randomized trials, using a random-effects model for each variable. Mean difference (MD) and odds ratio (OR), with 95% confidence intervals (95% CI), were used to compare continuous and categorical data, respectively. Variables that were not reported in both COAPT and MITRA-FR trials were not presented. R software was used for non-comparative pooling of variables, and RevMan software was used for comparative meta-analysis. Results Thirty-two studies, enrolling 9497 patients, were included. Patients were found to be older in real-life than in landmark trials ([MD −2.73; 95% CI: −4.06, −1.40] for COAPT; [MD −4.33; 95% CI: −5.94, −2.72] for MITRA-FR), while more males were recruited in MITRA-FR trial (OR 1.71; 95% CI: 1.15–2.52). Moreover, patients in MITRA-FR trial were less likely to have atrial fibrillation or renal insufficiency. Patients from real-life were more likely to be more symptomatic (i.e., New York Heart Association (NYHA) class III/IV) and less likely to have implanted cardiac devices than those in randomized trials. MITRA-FR trial patients had better compliance with guideline-directed therapies for heart failure with reduced ejection fraction. Ejection fraction ranged from 31.3% to 33.9% between three study arms. More patients in randomized trials presented with moderate-to-severe MR (grade 3+), whereas severe MR (grade 4+) was more common among patients from real-life. Procedure success, defined as MR grade ≤2+, was more frequent in randomized trials, with better symptoms' relief in COAPT trial (NYHA class I/II). There was no difference in number of devices implanted between real-life and landmark trials data. [Tables 1 and 2] Conclusion Real-life data on TMVR in functional MR, as presented by low-quality and heterogenous observational studies, showed substantial differences from the results of the main randomized trials. Funding Acknowledgement Type of funding sources: None.

Impact of proportionate versus disproportionate mitral regurgitation on acute procedural changes and clinical outcomes following transcatheter mitral valve repair

Abstract Background Transcatheter mitral edge-to-edge repair (TEER) with MitraClip offers a less invasive alternative for patients with severe, symptomatic mitral regurgitation (MR) who are considered high risk for surgery. However, patient selection for TEER remains challenging given the variability in underlying MR pathology and current discordance among studies regarding predictors of procedural efficacy and clinical outcomes. Purpose This study aimed to assess acute procedural changes and long-term outcomes in patients who underwent TEER according to the proportionality of MR, defined as the ratio of the effective regurgitant orifice area (EROA) and left ventricular end-diastolic volume (LVEDV). Methods We analyzed patients who underwent TEER at our institution between 2014 and 2020 with available biplane left ventricular volume measurement. Relevant clinical comorbidities, demographics, and anthropometrics, along with pertinent pre- and post-procedural echocardiogram measurements, were obtained by review of the electronic medical record. The EROA to LVEDV index was calculated for all patients who were then stratified by quartiles. Patients with an EROA/LVEDV index in the lowest quartile were defined as having the most proportionate MR and those with an index in the highest quartile were defined as the most disproportionate MR. Baseline and post-TEER parameters were used to assess acute procedural and longitudinal outcomes. Results Baseline clinical and echocardiographic parameters of the 230 subjects according to quartile are shown in the table. Following TEER, there was a larger reduction in the left ventricular end-diastolic diameter and increased MR reduction with increasingly disproportionate MR (p=0.03 and p=0.05, respectively). The change in ejection fraction pre- versus post-TEER did not significantly differ across groups (p=0.64). Median follow up time was 1.7 (0.7–3.5) years; mortality occurred in 77 patients (33.5%) and heart failure hospitalizations occurred in 20 patients (8.7%) during follow up. No significant difference in all-cause mortality or post-procedural heart failure hospitalizations was identified across groups. Conclusions In our series, patients with proportionate MR were similarly symptomatic to those with disproportionate MR but had less severe MR with increased comorbidities. Post-TEER MR grade was similar between groups. Longer-term follow up in larger groups of patients is needed to determine the clinical implications. Funding Acknowledgement Type of funding sources: None.