Transcatheter Mitral Valve Research Articles

Mitral Regurgitation “Proportionality” in Functional Mitral Regurgitation and Outcomes After Mitral Valve Transcatheter Edge-to-Edge Repair: A Systematic Review and Meta-Analysis

BackgroundCertain patients with functional mitral regurgitation survive longer with fewer heart failure hospitalizations after undergoing transcatheter edge-to-edge repair (TEER); however, clinical markers identifying who will benefit have not been established. The ‘proportionality’ of mitral regurgitation (MR) severity compared to left ventricular size has been hypothesized to predict clinical outcome. MethodsWe sought to combine existing studies to compare outcomes between ‘proportionate’ MR and ‘disproportionate’ MR in patients undergoing TEER. PubMed and Medline were searched from January 2018 until May 2023. Data was extracted and synthesized by 2 independent authors using random effects models with risk ratios (RRs) for binary outcomes. The primary outcome was a combined endpoint of all-cause mortality or heart failure hospitalization (ACM/HFH). Other outcomes of interest included ACM and residual >2+ MR after TEER. ResultsSix trials with a total of 1594 patients (mean age 71 years, 66% male) were included, which assessed MR proportionality using either a ratio of estimated regurgitant orifice area to left ventricular end-diastolic volume (EROA:LVEDV) or regurgitant fraction. Seven hundred and five (mean age 70 years, 75% male) were classified as proportionate MR, and 889 (mean age 72 years, 60% male) had disproportionate MR. There was no significant association between MR proportionality (by EROA:LVEDV) and ACM (RR 0.79, 95% confidence interval [CI] 0.44-1.42). Proportionality did not significantly associate with ACM/HFH, though there were divergent effect signals when proportionality was measured by EROA:LVEDV (RR 0.80, 95% CI 0.45-1.44) or regurgitant fraction (RR 1.48, 95% CI 0.53-4.11). Disproportionate MR showed a greater association with residual MR > 2+ post-TEER that did not meet statistical significance (RR 1.86, 95% CI 0.77-4.49). ConclusionsIn patients undergoing TEER for functional mitral regurgitation, MR proportionality was not significantly associated with ACM/HFH, all-cause mortality, or residual MR.

Pulmonary Vein Flow Morphology After Transcatheter Mitral Valve Edge-to-Edge Repair as Predictor of Survival

Data on the prognostic factors after mitral valve (MV) transcatheter edge-to-edge repair (TEER;MV-TEER) are limited. Pulsed-wave Doppler interrogation of pulmonary vein flow (PVF) is a convenient method to assess the hemodynamic burden of residual mitral regurgitation (MR), which could be of utility as a predictor of outcomes. Patients that underwent MV-TEER between May 2014 and December 2021 at our institution were evaluated. Pulmonary vein flow patterns post-MV-TEER were reviewed on the procedural transesophageal echocardiogram and classified as normal (systolic dominant or codominant) or abnormal (systolic blunting or reversal). The PVF pattern was correlated with all-cause mortality at follow-up. Two-hundred sixty-five patients had diagnostic PVF post-MV-TEER, with 73 (27.5%) categorized as normal and 192 (72.5%) categorized as abnormal. Patients with abnormal PVF morphology were more likely to have atrial fibrillation (70% vs 42%, P<.001) and greater than moderate residual MR (16% vs 3%, P=.01) and had higher mean left atrial pressure (18.1±5.0 vs 15.9±4.2mm Hg, P=.002) and left atrial V wave (26.6±8.5 vs 21.4±7.3mm Hg, P<.001) postprocedure. In multivariable analysis, abnormal PVF morphology post-MV-TEER was independently associated with mortality at follow-up (hazard ratio= 1.70; 95% CI, 1.06-2.74; P=.03) after correction for end-stage renal disease, atrial fibrillation, and residual MR. Results were similar in subgroups of patients with moderate or less and those with mild or less residual MR. Pulmonary vein flow morphology is a simple and objective tool to assess MR severity immediately post-MV-TEER and offers important prognostic information to optimize procedural results. Additional studies are needed to determine whether patients with abnormal PVF pattern post-MV-TEER would benefit from more intensive goal-directed medical therapy postprocedure.

Artificial intelligence-derived risk score for mortality in secondary mitral regurgitation treated by transcatheter edge-to-edge repair: the EuroSMR risk score.

Risk stratification for mitral valve transcatheter edge-to-edge repair (M-TEER) is paramount in the decision-making process to appropriately select patients with severe secondary mitral regurgitation (SMR). This study sought to develop and validate an artificial intelligence-derived risk score (EuroSMR score) to predict 1-year outcomes (survival or survival + clinical improvement) in patients with SMR undergoing M-TEER. An artificial intelligence-derived risk score was developed from the EuroSMR cohort (4172 and 428 patients treated with M-TEER in the derivation and validation cohorts, respectively). The EuroSMR score was validated and compared with established risk models. The EuroSMR risk score, which is based on 18 clinical, echocardiographic, laboratory, and medication parameters, allowed for an improved discrimination of surviving and non-surviving patients (hazard ratio 4.3, 95% confidence interval 3.7-5.0; P < .001), and outperformed established risk scores in the validation cohort. Prediction for 1-year mortality (area under the curve: 0.789, 95% confidence interval 0.737-0.842) ranged from <5% to >70%, including the identification of an extreme-risk population (2.6% of the entire cohort), which had a very high probability for not surviving beyond 1 year (hazard ratio 6.5, 95% confidence interval 3.0-14; P < .001). The top 5% of patients with the highest EuroSMR risk scores showed event rates of 72.7% for mortality and 83.2% for mortality or lack of clinical improvement at 1-year follow-up. The EuroSMR risk score may allow for improved prognostication in heart failure patients with severe SMR, who are considered for a M-TEER procedure. The score is expected to facilitate the shared decision-making process with heart team members and patients.

Cardiac Structural and Functional Remodeling After Transcatheter Mitral Valve in Valve Implantation: Early Changes and Prognostic Significance

BackgroundTranscatheter mitral valve-in-valve (MViV) replacement has emerged as an alternative to redo mitral valve (MV) surgery for the management of failed bioprosthetic MVs. The degree of cardiac remodeling assessed by echocardiography has been shown to have prognostic implications in degenerative mitral regurgitation patients undergoing MV surgery. The impact of transcatheter MViV in patients with degenerative bioprosthetic MV failure on cardiac remodeling and its associated prognosis remains undescribed. ObjectivesThe aim of this study is to describe the early anatomic and functional changes of the left-sided chambers and right ventricle by echocardiography posttranscatheter MViV intervention and their impact on mortality outcomes. Additionally, we sought to analyze the outcome of heart failure in bioprosthetic MV failure patients undergoing transcatheter MViV replacement. MethodsWe analyzed consecutive patients undergoing MViV intervention for symptomatic bioprosthetic MV failure. Echocardiograms before intervention and within 100 days postintervention were analyzed. A chart review was performed to obtain baseline characteristics, follow-up visits, 30-day heart failure and 1-year all-cause mortality outcomes. ResultsA total of 62 patients (mean age 69 ± 13 years, 61% male) were included in the study. Most patients were undergoing MViV intervention for prosthetic mitral stenosis n = 48 (77.4%) and the rest for mitral regurgitation or mixed disease. Compared with baseline, significant reductions were observed in median left atrial volume (LAV; 103 [81–129] ml vs. 95.2 [74.5–117.5] ml, p < 0.01) and mean (SD) left atrial conduit strain (9.1% ± 5.2% vs. 10.8% ± 4.8%, p = 0.039) within 100 days postintervention. Early reduction in right ventricular free wall global longitudinal strain and fractional area change also occurred postintervention. No significant change in left ventricular chamber dimensions or ejection fraction was observed. During the 1-year follow up period, 5 (8%) patients died. While baseline LAV was not associated with 1-year all-cause mortality (OR 0.98 CI 0.95–1.01; p = 0.27), a change in LAV in the follow up period was associated with all-cause mortality at 1 year (OR 1.06 CI 1.01–1.12; p = 0.023). At 30 days postintervention, 65% of patients had an improvement in their New York Heart Association functional class. ConclusionIn this retrospective study of patients undergoing transcatheter MViV intervention for failed bioprosthetic MVs, early reverse remodeling of the left atrium occurs within 100 days postintervention and reduction in LAV is associated with reduced all-cause mortality at 1 year. In addition, there is significant improvement in heart failure symptoms at 30 days following intervention but further investigation into the longitudinal remodeling changes and long-term outcomes is needed.

Mitral Valve Transcatheter Edge-to-Edge Repair Volumes and Trends.

Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015. In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies.

Transcatheter Mitral Valve Edge-to-Edge Repair Following Papillary Muscle Rupture: Clinical Characteristics and Three-Year Outcomes

Transcatheter Mitral Valve Edge-to-Edge Repair Following Papillary Muscle Rupture: Clinical Characteristics and Three-Year Outcomes

Mitral valve transcatheter edge-to-edge repair with PASCAL vs MitraClip: A systematic review and meta-analysis.

Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited. We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems. Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments. Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.

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.

Changes in exercise stress echocardiographic parameters before and after transcatheter mitral valve edge-to-edge repair.

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

Abstract 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.

Abstract 16475: Mitral Valve Transcatheter Edge to Edge Repair: A Real-World Analysis of Racial Differences in Uptake and Outcomes

Introduction: Recently, percutaneous mitral valve transcatheter edge to edge repair (TEER) with the MitraClip system has grown as a treatment option for mitral regurgitation. However, data describing the real-world adoption of this technology are limited, especially regarding differences by race and ethnicity. Research Question: What have been the trends in usage of mitral valve TEER during its early uptake in the United States, and has there been equitable adoption across racial and ethnic groups? Methods: In a comparative study using the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking database from Jan 1,2017 to Dec 31, 2022, we describe temporal changes in mitral valve TEER use within the VA system, and differences in uptake by race/ethnicity (White non-Hispanic, Black non-Hispanic, Hispanic). We further describe 30-day and 1-year mortality following TEER by race/ethnicity. Results: The rate of mitral valve TEER use increased significantly overall (p=0.008), and across each race/ethnic group studied ( Figure 1 ). However, relative to White non-Hispanic patients, Black non-Hispanic and Hispanic patients were less likely to receive mitral valve TEER (adjusted OR 0.45 [95% CI 0.28-0.70] and adjusted OR 0.47 [95% CI 0.19 -0.98] respectively) ( Figure 2 ). The adjusted 30-day and 1-year mortalities following mitral valve TEER were similar between races/ethnicities. Conclusions: Although patients benefit similarly following mitral valve TEER, adoption among non-Hispanic Black and Hispanic patients trails non-Hispanic White patients. This highlights the importance of identifying and addressing barriers to adoption among underrepresented groups.

Mitral valve transcatheter edge-to-edge repair with PASCAL Vs MitraClip: A aystematic teview and meta-analysis.

Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited. We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems. Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments. Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.

Simplified ELASTA-CLIP Before Transapical Mitral Valve Replacement

Residual and recurrent mitral regurgitation after transcatheter edge-to-edge repair are therapeutically challenging. In the present case report, we describe a simplified, transapical electrosurgical laceration and stabilization of clip procedure that represents an alternative and direct approach for electrosurgical laceration of mitral valve leaflets enabling transcatheter mitral valve replacement for recurrent mitral regurgitation after mitral valve transcatheter edge-to-edge repair.

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients

BackgroundFavorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. ObjectivesThe authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. MethodsPatients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. ResultsNinety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). ConclusionsAt 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study

BackgroundThe fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated. ObjectivesThe aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system. MethodsEXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire). ResultsA total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed. ConclusionsM-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.

Mitral valve transcatheter edge-to-edge repair (M-TEER) in Germany : Treatment reality, potential needs, possible quality indicators and open questions

In 2020 in Germany, 21,753 patients were hospitalized with the main diagnosis of mitral valve regurgitation (MR), whereby 6050 isolated mitral valve (MV) operations, 4977 combined MV operations and 6011 transcatheter MV interventions were performed. In the last 10years there was anearly linear increase of MR-related hospitalizations and transcatheter MV interventions, whereas the numbers of isolated MV operations remained stable and the number of combined MV operations decreased. Due to demographic change and age distribution of MR patients, an increased need for minimally invasive transcatheter MV procedures can be expected in the future. In 2020 the 6011 transcatheter MV interventions were performed at approximately 180 centers in Germany. According to aretrospective analysis of diagnosis-related groups (DRG) hospital data up to 2017, two thirds of all 158 centers which provided transcatheter MV repair in Germany at that time carried out no more than 25procedures per year. Asignificant correlation between hospital intervention volume and intrahospital mortality has not yet been found for transcatheter MV repair; however, registry data from Germany, Italy and the USA consistently confirm that centers with a high intervention volume achieve a better reduction of mitral regurgitation, which could directly translate into long-term survival. Thresholds of 20 or 50procedures per year were suggested as predictive for abetter procedural result in terms of MR reduction. Such analyses should be implemented in considerations regarding the appropriate number of transcatheter MV centers for Germany.

TCT-14 Association Between Hospital Volume and 30-Day Readmissions Following Transcatheter Mitral Valve Edge-to-Edge Repair

TCT-14 Association Between Hospital Volume and 30-Day Readmissions Following Transcatheter Mitral Valve Edge-to-Edge Repair

Predictors of Improvement in Concomitant Tricuspid Regurgitation Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Improvement in concomitant tricuspid regurgitation (TR) after mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation (MR) occurs frequently; however factors determining the post-procedural course of TR are not well understood. We investigated the parameters associated with TR improvement after M-TEER. A total of 300 patients were consecutively included in this retrospective analysis. MR and TR severity as well as heart chamber metrics were assessed before the procedure and at follow-up. Device success was achieved in 97.3% of patients. TR decreased in 30.2% of patients. Patients with improved TR were more often female, had more severe TR at baseline, and their right heart dimensions at baseline trended to be smaller. Female sex (odds ratio (OR) 2.997), baseline MR-Grade (OR 3.181) and baseline TR-Grade (OR 2.653) independently predicted TR reduction. More pronounced right heart reverse remodeling was observed in patients with improved TR. TR regression independently predicted lower mortality (hazard ratio (HR) 0.333, 95% confidence interval 0.112-0.996, p = 0.049). A reduction in concomitant TR severity after M-TEER occurred mainly in females and in patients with high-grade TR and MR at baseline. TR regression is associated with better survival after M-TEER.

MitraCox Score Predicts In-Hospital Mortality in Patients Admitted for Transcatheter Edge-to-Edge Mitral Valve Repair

As mitral valve transcatheter edge-to-edge repair (M-TEER) is evolving as an effective treatment for high-risk surgical patients with mitral regurgitation, there is a pressing need for cardiologists to optimize resources through risk stratification of in-hospital mortality for this patient population. Although current risk-prediction models have been shown to predict adverse outcomes with reasonable accuracy, models trained using the US nationwide population are lacking. This study aimed to identify clinical, demographic, and procedural features that predict in-hospital mortality, and to derive and validate an in-hospital mortality risk-prediction tool in patients who have undergone M-TEER. A total of 9,373 admissions from the Nationwide Readmissions Database of patients who underwent M-TEER between 2015 and 2018 were used to develop and validate the model. We first performed least absolute shrinkage and selection operator (LASSO) regularization of Cox regression (Coxnet) that is 10-fold cross-validated. The non-zero coefficients were multiplied with the respective values of each observation of the predictors to build the scoring formula. Out of 9,373 admissions, 196 patients (2%) died in-hospital during index admission. In descending order, the top variables that were most predictive of in-hospital mortality were higher age, presence of fluid and electrolyte disturbance, and large metropolitan location of the hospital. The validation C-statistic of the MitraCox score was 0.82. Using X-tile software (Yale School of Medicine, New Haven, Connecticut), 2 cutoffs of the score were determined on the basis of in-hospital mortality and length of stay, and the survival of the population was classified into 3 risk groups: low, intermediate, and high. The scoring system deployed online as a web-based calculator can be accessed at https://kathavs.shinyapps.io/Mitracox_Kapadia/. In conclusion, MitraCox score is easy to calculate and predicts in-hospital mortality depending on length of stay in a dynamic manner.

Comparison of costs associated with transcatheter mitral valve repair: PASCAL vs MitraClip in a real-world setting

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