Showing papers on "MitraClip published in 2023"

Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study.

Abstract: The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter.The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system.EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality.1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies.The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811).

Transcatheter edge‐to‐edge repair for secondary mitral regurgitation with third‐generation devices in heart failure patients – results from the Global EXPAND Post‐Market study

Abstract: Mitral valve transcatheter edge‐to‐edge repair is a guideline‐recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis was to report contemporary real‐world outcomes in SMR patients treated with third‐generation MitraClip systems.

Significance of Spontaneous Echocardiographic Contrast in Transcatheter Edge-to-Edge Repair for Mitral Regurgitation

Abstract: Spontaneous echocardiographic contrast (SEC) in the left atrium can occur with transcatheter edge-to-edge repair (TEER), but the clinical significance is unknown.The authors examined the clinical association of the procedural appearance of SEC in 316 patients (median age, 82 years; interquartile range, 76-86 years; 43.4% women) undergoing TEER with the MitraClip for mitral regurgitation. Acute, 30-day, and 2-year clinical outcomes were analyzed.SEC was common, occurring following device implantation in 106 patients (34%). Although the occurrence of SEC was not related to clinical characteristics, such as atrial fibrillation, anticoagulant use, or left ventricular function, there was a strong relation to beneficial outcomes with TEER. The frequency of optimal reduction in mitral regurgitation was higher in patients who had SEC (99.1% vs 72.9%, P < .001). Survival was greater, with a 2-year estimate for freedom from all-cause mortality of 88.4% versus 71.5% (log-rank P = .004). Importantly, the higher survival observed in patients with SEC was present without increased rates of procedural complications or stroke and remained significant in multivariate analyses that adjusted for baseline clinical and echocardiographic variables (P = .01).The occurrence of SEC in patients with TEER is associated with beneficial acute and intermediate-term outcomes.

Anticoagulation therapy and clinical outcomes following transcatheter mitral valve repair for patients with mitral regurgitation: A meta‐analysis

Abstract: Transcatheter mitral valve repair (TMVR) using MitraClip (MC) is now an established technique in the interventional treatment of mitral regurgitation. Common complications after MC procedure are bleeding and ischemic events. However, 2017 ESC/EACTS and 2020 ACC/AHA did not give a clear antithrombotic protocol, the policy has been based on clinical experience. Here, we performed a meta‐analysis comparing outcomes with and without the addition of anticoagulants after TMVR. We searched the Cochrane Library, EMBASE, PubMed, and Web of Science from inception to October 6, 2022 to identify studies with or without the use of anticoagulants after TMVR. From each study, we extracted the number of people with bleeding, stroke, combined endpoints, and all‐cause death. Five observational cohort studies were included, enrolling a total of 1892 patients undergoing TMVR who were assigned to either the anticoagulation group (n = 1209) or the no‐anticoagulation group (n = 683). Pooled analysis showed a significantly lower stroke rate in the anticoagulated group (at least 4 weeks duration) compared with the non‐anticoagulated group (RR [95% CI] = 0.14 [0.0−0.77], p = 0.02), and similar rates of bleeding, combined endpoints, and all‐cause death in both groups (RR [95% CI] = 0.76 [0.48−1.22], p = 0.26), (RR [95% CI] = 0.52 [0.10−2.63], p = 0.43), and (RR [95% CI] = 0.89 [0.58−1.35], p = 0.58). We observed a reduced risk of stroke without elevated risk of bleeding, combined endpoints, or all‐cause death in patients using anticoagulants (at least 4 weeks duration) after TMVR compared to no anticoagulants.

Transcatheter Mitral Valve Repair for Degenerative Mitral Regurgitation.

Abstract: Importance There are limited data on the outcomes of transcatheter edge-to-edge mitral valve repair for degenerative mitral regurgitation (MR) in a real-world setting. Objective To evaluate the outcomes of transcatheter mitral valve repair for degenerative MR. Design, Setting, and Participants Cohort study of consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent nonemergent transcatheter mitral valve repair for degenerative MR in the US from 2014 through 2022. Exposure Transcatheter edge-to-edge mitral valve repair with the MitraClip device (Abbott). Main Outcomes and Measures The primary end point was MR success, defined as moderate or less residual MR and a mean mitral gradient of less than 10 mm Hg. Clinical outcomes were evaluated based on the degree of residual MR (mild or less MR or moderate MR) and mitral valve gradients (≤5 mm Hg or >5 to <10 mm Hg). Results A total of 19 088 patients with isolated moderate to severe or severe degenerative MR who underwent transcatheter mitral valve repair were analyzed (median age, 82 years; 48% women; median Society of Thoracic Surgeons predicted risk of mortality with surgical mitral valve repair, 4.6%). MR success was achieved in 88.9% of patients. At 30 days, the incidence of death was 2.7%; stroke, 1.2%; and mitral valve reintervention, 0.97%. MR success compared with an unsuccessful procedure was associated with significantly lower mortality (14.0% vs 26.7%; adjusted hazard ratio, 0.49; 95% CI, 0.42-0.56; P < .001) and heart failure readmission (8.4% vs 16.9%; adjusted hazard ratio, 0.47; 95% CI, 0.41-0.54; P < .001) at 1 year. Among patients with MR success, the lowest mortality was observed in patients who had both mild or less residual MR and mean mitral gradients of 5 mm Hg or less compared with those with an unsuccessful procedure (11.4% vs 26.7%; adjusted hazard ratio, 0.40; 95% CI, 0.34-0.47; P < .001). Conclusions and Relevance In this registry-based study of patients with degenerative MR undergoing transcatheter mitral valve repair, the procedure was safe and resulted in successful repair in 88.9% of patients. The lowest mortality was observed in patients with mild or less residual MR and low mitral gradients.

Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study.

Abstract: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) “unsuitability” have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach. The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study. EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory–assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days. Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events (<3%) and all-cause mortality (RoS 1.8%, RoIR 0%, MMR 1.5%, and TS 1.3%). Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device.

Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study

Abstract: Patients with severe mitral regurgitation (MR) and acute heart failure (HF) have refractory symptoms without adequate response to medical therapy. The objective of this analysis was to assess the impact of the MitraClip device in acutely ill HF patients, characterized by NYHA Class IV at baseline, in a real‐world, contemporary setting.

Impact of updated trial data on the cost-effectiveness of percutaneous mitral repair

Abstract: When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous mitral repair (PR) for secondary mitral regurgitation. We updated our previous three-state time-varying Markov model to assess the cost-effectiveness of PR + guideline directed medical treatment (GDMT) versus GDMT alone. Key clinical inputs (overall survival (OS) and heart failure hospitalisations (HFH)) were obtained using the 3-year trial findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) RCT. We calculated incremental cost-effectiveness ratios (ICER) and report how these differ between analyses based on early (2-year) and updated (3-year) evidence. Updated trial data showed an increase in mortality in the intervention arm between two and three years follow-up that was not seen in the control arm. Deterministic and multivariate cost-effectiveness modelling yielded incremental cost effectiveness ratios ICERs of €38,123 and €31,227 /QALY. Compared to our 2-year based estimate (€21,918 / QALY) these results imply an approximate 1.5-fold increase in ICER. The availability of updated survival analyses from the COAPT pivotal trial suggests previous estimates based on 2-year trial findings were over optimistic for the intervention.

Cerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy in the COAPT Trial.

Abstract: Little is known regarding the risk of cerebrovascular events (CVE) in patients with heart failure and severe secondary mitral regurgitation treated with transcatheter edge-to-edge repair (TEER).The study sought to examine the incidence, predictors, timing, and prognostic impact of CVE (stroke or transient ischemic attack) in the COAPT (Cardiovascular Outcomes Assessment of the Mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial.A total of 614 patients with heart failure and severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) vs GDMT alone.At 4-year follow-up, 50 CVEs occurred in 48 (7.8%) of the 614 total patients enrolled in the COAPT trial; Kaplan-Meier event rates were 12.3% in the TEER group and 10.2 in the GDMT alone group (P = 0.91). Within 30 days of randomization, CVE occurred in 2 (0.7%) patients randomized to TEER and 0% randomized to GDMT (P = 0.15). Baseline renal dysfunction and diabetes were independently associated with increased risk of CVE, while baseline anticoagulation was associated with a reduction of CVE. A significant interaction was present between treatment group and anticoagulation such that TEER compared with GDMT alone was associated with a reduced risk of CVE among patients with anticoagulation (adjusted HR: 0.24; 95% CI: 0.08-0.73) compared with an increased risk of CVE in patients without anticoagulation (adjusted HR: 2.27; 95% CI: 1.08-4.81; Pinteraction = 0.001). CVE was an independent predictor of death within 30 days after the event (HR: 14.37; 95% CI: 7.61, 27.14; P < 0.0001).In the COAPT trial, the 4-year rate of CVE was similar after TEER or GDMT alone. CVE was strongly associated with mortality. Whether anticoagulation is effective at reducing CVE risk after TEER warrants further study. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT); NCT01626079).

Intraprocedural Residual Mitral Regurgitation and Survival After Transcatheter Edge-to-Edge Repair: Prospective German Multicenter Registry (MITRA-PRO).

Abstract: Residual mitral regurgitation (MR) is thought to be an important predictor of long-term survival following transcatheter edge-to-edge repair (TEER). Intraprocedural MR assessment using transesophageal echocardiography could be limited by image quality, hemodynamics, and patient sedation. The MitraScore is a validated multimodal approach for intraprocedural MR assessment during TEER.This study aimed to assess the impact of residual MR using the MitraScore on 1-year mortality.Patients undergoing mitral TEER were eligible for inclusion in the prospective, multicenter MITRA-PRO registry (A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation). Patients with a MitraScore ≤3 were defined as patients with mild residual MR after mitral TEER, whereas a MitraScore ≥4 was considered as relevant residual MR. Mortality, rehospitalization, and major adverse events were assessed 1 year after TEER.A MitraScore ≤3 was found in 1,059 patients (71.0%), whereas 432 patients revealed a MitraScore ≥4 (29.0%). One-year mortality was significantly lower in patients with nonrelevant residual MR (MitraScore ≤3 14.6% vs MitraScore≥4 22.1%). An almost linear relationship between intraprocedural MitraScore after TEER and mortality was observed. The combined clinical endpoint of mortality and rehospitalization within the 1-year follow-up was also significantly lower in the MitraScore ≤3 group (31.5%) than in the MitraScore ≥4 group (40.8%). A subgroup analysis confirmed the predictive value of the MitraScore in patients with primary, secondary, or mixed MR etiologies.Residual MR assessed by intraprocedural MitraScore after TEER predicts 1-year mortality and rehospitalization. Therefore, the multimodal MitraScore improves MR assessment during mitral TEER and might improve patient survival.(A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation [MITRA-PRO]; DRKS00012288).

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4.

Abstract: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence. The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting. EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality. In EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 ± 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR ≤ 2+, and 91% achieved MR ≤ 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days. This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.

Ventricular Remodeling and Outcomes After Mitral Transcatheter Edge-to-Edge Repair in Heart Failure: The COAPT Trial.

Abstract: The relationship between left ventricular (LV) remodeling and clinical outcomes after treatment of severe mitral regurgitation (MR) in heart failure (HF) has not been examined.The aim of this study was to evaluate the association between LV reverse remodeling and subsequent outcomes and assess whether transcatheter edge-to-edge repair (TEER) and residual MR are associated with LV remodeling in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.Patients with HF and severe MR who remained symptomatic on guideline-directed medical therapy (GDMT) were randomized to TEER plus GDMT or GDMT alone. Baseline and 6-month core laboratory measurements of LV end-diastolic volume index and LV end-systolic volume index were examined. Change in LV volumes from baseline to 6 months and clinical outcomes from 6 months to 2 years were evaluated using multivariable regression.The analytical cohort comprised 348 patients (190 treated with TEER, 158 treated with GDMT alone). A decrease in LV end-diastolic volume index at 6 months was associated with reduced cardiovascular death between 6 months and 2 years (adjusted HR: 0.90 per 10 mL/m2 decrease; 95% CI: 0.81-1.00; P = 0.04), with consistent results in both treatment groups (Pinteraction = 0.26). Directionally similar but nonsignificant relationships were present for all-cause death and HF hospitalization and between reduced LV end-systolic volume index and all outcomes. Neither treatment group nor MR severity at 30 days was associated with LV remodeling at 6 or 12 months. The treatment benefits of TEER were not significant regardless of the degree of LV remodeling at 6 months.In patients with HF and severe MR, LV reverse remodeling at 6 months was associated with subsequently improved 2-year outcomes but was not affected by TEER or the extent of residual MR. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT]; NCT01626079).

The use of MitraClip for nonobstructive hypertrophic cardiomyopathy with mixed severe mitral valve regurgitation

Abstract: Reports on the treatment of nonobstructive hypertrophic cardiomyopathy (HCM) and severe mitral valve regurgitation (MR) with transcatheter edge‐to‐edge repair (TEER) are rare. Herein, we present the case of a 68‐year‐old Chinese man with nonobstructive HCM admitted to our hospital with dyspnoea [New York Heart Association (NYHA) functional Class IV]. Transthoracic echocardiography indicated severe MR in addition to asymmetric hypertrophy of the left ventricle. Despite administering maximal medical therapy for heart failure, the symptoms were not alleviated; because of the high risk of open surgery, TEER was performed for MR. After 4 months of follow‐up, the patient showed a significant improvement in symptoms. Herein, we also discuss and review the pathophysiology and treatment strategies for HCM patients with heart failure.

Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial

Abstract: Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.

Impact of Peripheral Artery Disease in Patients With Heart Failure Undergoing Transcatheter Mitral Valve Repair: The COAPT Trial

Abstract: Background Peripheral artery disease (PAD) and heart failure (HF) often coexist. Whether PAD influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF and severe secondary mitral regurgitation is unknown. The objectives are to assess the impact of PAD on outcomes of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone in patients with HF and secondary mitral regurgitation. Methods and Results The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) randomized patients with HF with ≥moderate-to-severe secondary mitral regurgitation to TMVr with MitraClip implant plus GDMT versus GDMT alone. We evaluated the relationship between PAD and 2-year outcomes in the COAPT trial and examined whether PAD modified the benefits of TMVr. Among 614 patients enrolled, 109 (17.8%) had PAD. By multivariable analysis, PAD was independently associated with 2-year mortality (adjusted hazard ratio [adjHR], 1.51 [95% CI, 1.07-2.15]) but not HF hospitalizations. Compared with GDMT alone, TMVr reduced the 2-year risk of death in patients without PAD (adjHR, 0.42 [95% CI, 0.30-0.60]) but not those with PAD (adjHR, 1.27 [95% CI, 0.72-2.27]; Pinteraction=0.001). In contrast, TMVr reduced HF hospitalizations consistently in patients with (adjHR, 0.65 [95% CI, 0.35-1.23]) and without (adjHR, 0.42 [95% CI, 0.31-0.57]) PAD (Pinteraction=0.22). Improvements in health status and exercise capacity at 2 years with TMVr compared with GDMT alone were similar in degree, irrespective of PAD status (Pinteraction=0.76 and 0.64, respectively). Conclusions In patients with HF and severe secondary mitral regurgitation, the reduced mortality with TMVr in the overall COAPT study population was not observed in the subgroup of patients with PAD. However, TMVr reduced HF hospitalizations and improved health status and exercise capacity consistently in patients with and without PAD. Registration Clinical Trial Name: Cardiovascular Outocmes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial); URL: https://www.clinicaltrials.gov/; Unique identifier: NCT01626079. https://clinicaltrials.gov/ct2/show/NCT01626079.

Contemporary Treatment and Outcomes of High Surgical Risk Mitral Regurgitation

Abstract: Before the development of transcatheter interventions, patients with mitral regurgitation (MR) and high surgical risk were often conservatively treated and subject to poor prognoses. We aimed to assess the therapeutic approaches and outcomes in the contemporary era. The study participants were consecutive high-risk MR patients from April 2019 to October 2021. Among the 305 patients analyzed, 274 (89.8%) underwent mitral valve interventions, whereas 31 (10.2%) received medical therapy alone. Of the interventions, transcatheter edge-to-edge mitral repair (TEER) was the most frequent (82.0% of overall), followed by transcatheter mitral valve replacement (TMVR) (4.6%). In patients treated with medical therapy alone, non-optimal morphologies for TEER and TMVR were shown in 87.1% and 65.0%, respectively. Patients undergoing mitral valve interventions experienced less frequent heart failure (HF) rehospitalization compared to those with medical therapy alone (18.2% vs. 42.0%, p < 0.01). Mitral valve intervention was associated with a lower risk of HF rehospitalization (HR 0.36 [0.18–0.74]) and an improved New York Heart Association class (p < 0.01). Most high-risk MR patients can be treated with mitral valve interventions. However, approximately 10% remained on medical therapy alone and were considered as unsuitable for current transcatheter technologies. Mitral valve intervention was associated with a lower risk of HF rehospitalization and improved functional status.

A focus on the percutaneous therapy of mitral and tricuspid regurgitation

Abstract: Abstract While mitral stenosis of rheumatic origin has been effectively treated percutaneously for more than 20 years, transcatheter treatment of mitral (MR) and tricuspid (TR) regurgitation appears as a contemporary unmet clinical need. The advent of new transcatheter therapies offers several treatment options for elderly and frail patients at high surgical risk. MitraClip is now consolidated as a therapy for functional MR in selected patients. Transcatheter mitral valve replacement is a promising alternative to transcatheter repair, for both functional and degenerative forms. However, further developments and new evidence are needed. Transcatheter treatment of the tricuspid valve has arrived late compared to similar technologies that have been developed for the aortic and mitral valve, and is currently in its infancy. This is likely due, in part, to the previously underreported impact of TR on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on annuloplasty and tricuspid valve replacement are limited and more evidence is needed. The future looks promising for transcatheter mitral and tricuspid valve therapies, although their place in clinical practice has yet to be clearly defined.

Cutting-Edge Trials in Structural Heart Disease at The Texas Heart Institute

Abstract: Mitral and tricuspid valvular disease have been managed surgically; however, multiple transcatheter technologies have diversified the therapeutic arsenal and expanded the number of patients eligible for treatment. These new technologies and active trials currently being performed at The Texas Heart Institute will be highlighted.Transcatheter edge-to-edge repair (TEER) with MitraClip (Abbott Structural Heart) plays an important role in the management of degenerative and functional mitral regurgitation (MR). Despite its success, the limitations of MitraClip include challenging anatomy that may not be amenable to TEER, the common need for multiple devices, risk of device-related mitral stenosis, and a not-trivial rate of residual MR.1 Delivered via a 22F sheath, the PASCAL device (Edwards Lifesciences) offers several improvements.2 Its 3-catheter system (including a guide, steerable, and implantation catheter) offers easy maneuverability in 3 independent planes. It has a spacer that fills the interleaflet area, helping reduce regurgitation. Additionally, its relatively larger “clasps” are designed to reduce leaflet stress by better distributing tension. Similar to the latest generation of MitraClip, PASCAL has independent gripper action.The CLASP IID and CLASP IIF trials randomized patients with degenerative and functional MR, respectively, to PASCAL vs MitraClip. The CLASP IID trial, which has completed enrollment, reported noninferiority of the PASCAL device with relation to procedural safety and effectiveness.3 It also showed durable reductions in MR to ≤1+ (87.2% at discharge and 83.7% at 6 months in the PASCAL arm; 88.5% at discharge and 71.2% at 6 months in the MitraClip arm). The CLASP IIF trial is currently enrolling.Compared with TEER, transcatheter mitral valve replacement (TMVR) theoretically offers treatment for complex mitral valvular anatomies, including mixed valvular disease and the potential for lower rates of residual regurgitation.4 The Intrepid valve (Medtronic) is a promising transcatheter device being studied in the APOLLO trial. Intrepid is designed as a double stent composed of a nitinol mesh, with an inner stent containing a bovine, trileaflet valve and a larger, outer stent that fixates onto the mitral annulus. It is available in 42- and 48-mm outer diameter sizes, with a 54-mm size currently in development.5 The APOLLO trial initially began as a randomized controlled trial comparing transapical TMVR to surgery, but because of developments in TEER technology, has evolved into a single-arm trial of patients who are not candidates for TEER or conventional mitral valve surgery. More recently, a 35F transfemoral delivery platform for the Intrepid system has been developed.One particularly important complication of TMVR is left ventricular outflow tract obstruction that is caused by displacement of the anterior mitral valve leaflet. Multiple efforts have been made to prevent this complication, including sophisticated computed tomography–based prediction of the neo–left ventricular outflow tract that help guide patient selection and the use of interventional techniques including leaflet laceration and alcohol septal ablation.6Early results of the Intrepid valve show excellent procedural success (96%) with mild or less MR in 100% of patients at a median 173-day follow-up.5 Whereas the early experience with transapical delivery of the Intrepid valve in a high-risk patient cohort was associated with high mortality (14% at 1 month),5 the development of a transfemoral delivery platform promises to reduce procedural morbidity and mortality.Often labeled the “forgotten valve,” tricuspid valvular regurgitation (TVR) is common and associated with substantial morbidity and mortality—as low as 34% survival at 5 years.7 However, late patient presentation, high comorbidity burden, and a high associated surgical mortality preclude many patients from receiving surgical treatment. Additionally, whether tricuspid valve intervention can improve patient outcomes is unclear because TVR is usually secondary to right ventricular dysfunction rather than being primary valvular disease. Therefore, it may often be a marker of severe disease rather than a pathophysiologic mediator.Nonetheless, transcatheter technologies are being studied for their potential to improve clinical outcomes of patients with severe TVR. The CLASP-TR trial, in which patients are being randomized to TEER with the PASCAL device vs medical therapy, should provide insight into the natural history of TVR and the utility of intervention.8 One of the major challenges is imaging. Owing to its more anterior position, clear transesophageal windows of the tricuspid valve are more difficult to obtain than are those with the mitral valve. Whereas the tricuspid valve has traditionally been viewed as trileaflet, tricuspid anatomy is actually quite diverse, often consisting of 4 or even 5 leaflets.9 New structural imaging guidelines aid in the evaluation of tricuspid valve disease and procedural guidance.10New transcatheter valve repair devices and transcatheter valve replacement technologies hold the promise of increasing the number of patients with structural heart disease who are eligible for transcatheter technologies and may permit more complete, durable responses to treatment; this will hopefully translate into better long-term patient outcomes.

Complications following transcatheter edge-to-edge mitral valve repair: Personal experience and review of the literature

Abstract: Mitral valve dysfunction affects around 2% of the population and its incidence is still increasing, making it the second most common valvular heart disease, after aortic stenosis. Depending on the etiology of the disease, it can be classified into primary or secondary mitral regurgitation. The first line of treatment is optimal medical therapy. If ineffective, mitral valve intervention can be considered. For patients disqualified from surgical treatment, transcatheter edge-to-edge repair with the use of MitraClip may be considered. Over 100,000 MitraClip procedures have been performed which makes this the most established transcatheter technique for the treatment of severe mitral regurgitation. The aim of this review is to discuss the technical details of the MitraClip procedure, clinical evidence regarding the efficacy of MitraClip, complications related to the clip implantation alongside with acute complications based on the currently available evidence and clinical experience.