Guideline-endorsed follow-up after percutaneous valve therapies-non-attendance of TAVI and MitraClip patients.

BACKGROUND: Percutaneous valve therapies (PVT) are performed on a large number of patients. With increasing procedural volume, the need for follow-up has also increased. Follow-up in the heart valve clinic is endorsed by recent guidelines but utilization is unknown, making resource allocation in the clinic difficult. Central follow-up in valve centers may not be feasible for all patients in the future. METHODS: In our center, follow-up for PVT patients is scheduled at 1 month and 12 months after the index procedure. Patients are reminded of their appointment by invitation letters or phone calls. We analyzed 150 consecutive patients who underwent transcutaneous aortic valve implantation (TAVI) and MitraClip implantation (n = 300) at our center. RESULTS: At 1 month, 72.7% of patients attended their follow-up, while at 12 months the rate dropped to 58%. Patients who underwent TAVI were older than the MitraClip patients (82.7 vs. 76.1 years) but had lower mean logEuroSCORE (22.6% vs. 25.9%). There was no significant difference in 1­year mortality between TAVI and MitraClip patients (20% vs. 17.3%). By contrast, the rate of missed follow-up visits was higher for TAVI compared to MitraClip patients (52% vs. 33.3%; p = 0.002). Female patients less frequently attended follow-up (p = 0.005), whereas age, EuroSCORE, NYHA class, ejection fraction, and health status (EQ-5DVAS) were not predictors of attendance in multivariable analysis. Although the result of the EQ-5D assessment was not associated with mortality or attendance, completing the questionnaire was associated with overall survival (p < 0.001). CONCLUSION: In our heart valve clinic, we observed a high percentage of missed follow-up appointments (42% at 12 months) despite a structured follow-up plan. Factors significantly associated with non-attendance in multivariable analysis were female gender and having a TAVI rather than MitraClip. Future follow-up concepts should take such findings into account, and decentralized approaches need to be explored.

Cerebral Embolic Protection: Is There a Benefit for Left Atrial and Mitral Valve Procedures?

PURPOSE OF REVIEW: This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. RECENT FINDINGS: Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

[Interventional treatment of heart failure : Stents and valves]. / Interventionelle Therapie der Herzinsuffizienz : Stents und Klappen.

The pharmacotherapy of heart failure has evolved in recent years and with the aid of new classes of drugs symptomatic and prognostic improvements can be achieved in patients with heart failure. Heart failure is particularly frequently associated with coronary artery disease or higher grade, often functional valve defects. In the context of the underlying disease, the operative risk is often increased, so that interventional treatment is preferred over surgical treatment options in interdisciplinary heart teams. Promising approaches with very different challenges are emerging for interventional myocardial revascularization and percutaneous correction of high-grade aortic valve stenosis or functional mitral or tricuspid valve regurgitation. It has consistently been shown that an elaborate diagnostic work-up and differentiated patient selection are decisive to achieve a prognostic or symptomatic benefit in these patients using interventional treatment. While awaiting further study data on this topic, the integration of a multidisciplinary heart team is essential to ensure a complementary and balanced therapeutic approach for patient-centered care in this complex patient population.

Long-Term Mortality after Transcatheter Edge-to-Edge Mitral Valve Repair Significantly Decreased over the Last Decade: Comparison between Initial and Current Experience from the MiTra Ulm Registry.

(1) Objective: We aimed to assess whether the candidate profile, the long-term outcomes and the predictors for long-term mortality after transcatheter edge-to-edge mitral valve repair (M-TEER) have changed over the last decade; (2) Methods: Long-term follow-up data (median time of 1202 days) including mortality, MACCE and functional status were available for 677 consecutive patients enrolled in the prospective MiTra Ulm registry from January 2010 to April 2019. The initial 340 patients treated in our institution before January 2016 were compared with the following 337 patients; (3) Results: Patients treated after 2016 showed significantly less ventricular dilatation (left ventricular end-systolic diameter of 43 ± 13 mm vs. 49 ± 16 mm, p < 0.007), lower systolic pulmonary pressures (50 ± 15 mmHg vs. 57 ± 21 mmHg, p = 0.01) and a lower prevalence of severe tricuspid regurgitation (27.2% vs. 47.3%, p < 0.001) at baseline than patients treated before 2016. Compared to the cohort treated before 2016, patients treated afterwards showed a significantly lower all-cause 3-year mortality (29.4% vs. 43.8%, p < 0.001) and lower MACCE (38.6% vs. 54.1%, p < 0.001), without differences for MR etiology. While severe tricuspid regurgitation and NYHA class IV remained independently associated with an increased long-term mortality over the last decade, severe left ventricular dilatation (hazard ratio, HR 2.12, p = 0.047) and severe pulmonary hypertension (HR 2.18, p = 0.047) were predictors of long-term mortality only in patients treated before 2016. (4) Conclusions: The M-TEER candidates are currently treated earlier in the course of disease and benefit significantly in terms of a better long-term survival than patients treated at the beginning of the M-TEER era.

Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year Outcomes From the MiCLASP Study.

BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. OBJECTIVES: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

Association of Baseline Tricuspid Regurgitation With Health Status and Clinical Outcomes After TAVR and Mitral TEER.

BACKGROUND: Tricuspid regurgitation (TR) is associated with worse clinical outcomes after transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (M-TEER), but little is known about its association with health status outcomes. OBJECTIVES: The aims of this study were to explore, using the Society of Thoracic Surgeons and American College of Cardiology TVT (Transcatheter Valve Therapy) Registry, the association between baseline TR and health status after TAVR and M-TEER and to determine if baseline TR was associated with clinical endpoints. METHODS: Health status was assessed using Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score in patients enrolled in the TVT Registry who underwent isolated TAVR or M-TEER between January 2019 and June 2021. The association among baseline TR and KCCQ-OS score, being alive and well, and clinical outcomes was examined. RESULTS: In total, 130,097 TAVR patients (13.1% with moderate TR, 2.3% with severe TR) and 19,593 M-TEER patients (33.2% with moderate TR, 14.7% with severe TR) were included. Mean KCCQ-OS scores were lower with severe vs moderate vs none to mild TR at baseline prior to TAVR (39.4 ± 24.2 vs 45.2 ± 24.7 vs 51.3 ± 25.3; P < 0.01) or M-TEER (38.1 ± 23.9 vs 41.9 ± 24.7 vs 45.4 ± 25.2; P < 0.01) and similarly at 30 days and 1 year. The odds of being alive and well at 1 year were lower with moderate or severe TR before TAVR (adjusted OR: 0.79 [95% CI: 0.74-0.85] and adjusted OR: 0.81 [95% CI: 0.70-0.94], respectively) and severe TR before M-TEER (adjusted OR: 0.53; 95% CI: 0.40-0.71). Furthermore, moderate or severe TR before TAVR was associated with higher 1-year mortality and readmission, whereas moderate or severe TR before M-TEER was associated with higher 1-year mortality. CONCLUSIONS: In a large cohort of U.S. patients who underwent TAVR or M-TEER, greater baseline TR was associated with worse health status and clinical outcomes. Understanding adverse outcomes of TR in patients with coexisting valvular abnormalities is important, especially with rapidly evolving transcatheter tricuspid valve interventions.

Ten Future Challenges in the Field of Transcatheter Mitral Valve Edge-to-Edge Repair.

Mitral valve transcatheter edge-to-edge repair (M-TEER) and replacement (TMVR) have evolved as guideline-recommended treatment approaches for mitral regurgitation (MR). Even though they are supported by a growing body of evidence from either randomized trials or large registries, there are still several unsolved challenges in the field of interventional MR treatment. In the present review, we discuss the ten most important open questions regarding M-TEER and TMVR.

Trends, Predictors, and Outcomes of Bleeding Complications After Mitral Transcatheter Edge-to-Edge Repair: TVT Registry Insights.

BACKGROUND: Bleeding events after arterial transcatheter procedures are associated with increased morbidity and mortality. The frequency and clinical implications of bleeding after mitral transcatheter edge-to-edge repair (M-TEER) have not been well-studied. OBJECTIVES: The authors sought to explore the association of in-hospital bleeding events after M-TEER with patient outcomes. METHODS: Patients undergoing M-TEER who were included in the TVT (Transcatheter Valve Therapy) Registry between 2013 and 2022 were included. Rates of the primary endpoint, the composite of death or hospital readmission at 30 days, were compared between patients who experienced in-hospital major or life-threatening bleeding vs those without bleeding. Secondary analyses examined the association between in-hospital bleeding and death or readmission at 1 year, as well as independent predictors of major in-hospital bleeding. RESULTS: Over the study period, in-hospital major bleeding occurred in 1,205 (2.3%) of 51,533 patients. Rates of bleeding decreased over time (from 7.1% in 2013 to 2.0% in 2021; P < 0.001). In-hospital bleeding was associated with increased rates of death or readmission at both 30 days (adjusted OR: 2.15 [95% CI: 1.81-2.54]; P < 0.0001) and 1 year (adjusted HR: 1.43 [95% CI: 1.27-1.60]; P < 0.0001). The strongest correlates of in-hospital bleeding included female sex, prior percutaneous coronary intervention, baseline hemoglobin, greater procedure acuity, and longer procedure duration. CONCLUSIONS: Bleeding after M-TEER is associated with increased risk of subsequent death and hospital readmission. Although reductions in bleeding complications over time are encouraging, continued efforts are needed to further mitigate hemorrhagic complications of M-TEER.

A Comparative Study of 1-Year Postprocedural Outcomes in Transcatheter Mitral Valve Repair in Advanced Primary Mitral Regurgitation: PASCAL vs. MitraClip.

Both the MitraClip and PASCAL systems offer transcatheter edge-to-edge repair (TEER) solutions for mitral regurgitation. Evidence indicates a lower technical success rate for TEER in complex degenerative mitral regurgitation (DMR) cases. We conducted a retrospective analysis of patients who underwent transcatheter edge-to-edge therapy for primary mitral regurgitation with advanced anatomy, defined as mitral regurgitation effective regurgitant orifice area (MR-EROA) ≥0.40 cm2 or large flail gap (≥5 mm) or width (≥7 mm) or Barlow's disease, that completed follow-up after 1 year. Our criteria were met by 27 patients treated with PASCAL and 18 with MitraClip. All patients exhibited a significant, equivalent short-term reduction in MR-EROA, mitral regurgitation vena contracta diameter (MR-VCD), regurgitant volume, and clinical status. At 1 year follow-up, reductions in MR-VCD, regurgitant volume, and MR-EROA remained significant for both groups without significant differences between groups. MR-Grade ≤ 1+ was achieved in 18 (66.7%) and 10 (55.6%) patients, respectively. At follow-up, no difference in hospitalization for cardiac decompensation was observed. Overall death was similar in both groups. Our study suggests that both the PASCAL and MitraClip systems significantly reduce mitral regurgitation even in advanced degenerative diseases. Within our limited data, we found no evidence of inferior performance of the PASCAL system.

Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.

BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.

Outcomes of COMBO therapy for severe mitral regurgitation compared with transcatheter edge-to-edge repair.

Background: There are different types of transcatheter mitral valve repair (TMVr) currently in clinical use, including leaflet approximation, annular cinching, and restoration of the chordal apparatus of the mitral valve (MV). While the concomitant combination (COMBO) therapy of mitral transcatheter edge-to-edge repair (M-TEER) with another TMVr concept has been proven feasible, potentially offering patient-tailored treatment for severe mitral regurgitation (MR), a comparison with M-TEER alone has not been made. Aims: To evaluate the procedural and clinical outcome of COMBO therapies compared with M-TEER alone. Methods: We included consecutive patients undergoing COMBO and M-TEER between March 2015 and April 2018 at our Heart Valve Center, while excluding patients presenting a case of redo or with previous MV surgery. Procedural outcomes and all-cause mortality were compared between COMBO therapy vs. M-TEER alone. Results: A total of 357 patients (mean age 78.9 ± 7.0 years, 53.2% male, M-TEER n = 322, COMBO n = 35; COMBO: MitraClip and the Carillon mitral contour system n = 26, MitraClip and Cardioband n = 5, and MitraClip and NeoChord n = 4) were analyzed. Patients with COMBO therapy had larger left chamber sizes, a lower left ventricular systolic ejection fraction (LVEF; COMBO: 37.4 ± 13.8%, M-TEER: 47.9 ± 14.3%, p < 0.001), and a more severe MR grade (p < 0.001). There were no significant differences in the prevalence of residual MR ≧2+. However, the need for re-intervention, always employing M-TEER, was more common in the COMBO group. During a mean 3.6-year long-term follow-up, there was no significant difference of all-cause mortality between both groups (Log rank p = 0.921). Conclusions: COMBO therapy may still be a beneficial therapy option for patients with severe MR who already have a more dilated left ventricle (LV), a more severe MR, and a more pronounced LV systolic dysfunction. The higher need for re-intervention in the COMBO group may signal more complex anatomies and possibly underlines the necessity of treating significant MR earlier. Future research is required to establish the COMBO approach as a toolbox-like treatment option, thus offering a patient-tailored approach depending on the individual anatomy and pathology.

Effectiveness of a new 3D printed simulator for mitral transcatheter edge-to-edge repair in enhancing the confidence and procedural skills of the operator.

BACKGROUND: . Mitral transcatheter edge-to-edge repair (m-TEER) is a minimally invasive procedure for treating mitral regurgitation (MR). m-TEER is a highly technical procedure, and a steep learning curve needs to be overcome for operators to ensure optimal patient outcomes and minimise procedural complications. Training via online simulation and observation of procedures is not sufficient to establish operator confidence; thus, advanced hands-on training modalities need to be explored and developed. METHODS: . In this study, a novel anatomical simulator for m-TEER training was evaluated in comparison to a standard model. The proposed simulator resembled the anatomical features of the right and left atrium, left ventricle and mitral valve apparatus. Participants in the questionnaire (n = 18) were recruited across 4 centres in London with (n = 8) and without (n = 10) prior experience in m-TEER. Participants were asked to simulate procedures on both an idealised, routinely used simulator and the newly proposed anatomical model. The questionnaire was designed to assess (i) participants' confidence before and after training and (ii) the realism of the model in the context of the m-TEER procedure. The results of the questionnaires were collected, and statistical analysis (t-test) was performed. RESULTS: . Both models were equally beneficial in increasing operator confidence before and after the simulation of the intervention (P = 0.43). However, increased confidence after training with the anatomical model was recorded (P = 0.02). Participants with prior experience with m-TEER therapy were significantly more confident about the procedure after training with the anatomical model than participants who had no prior experience (P = 0.002). On average, all participants thought that the anatomical model was effective as a training simulator (P = 0.013) and should be integrated into routine training (P = 0.015)). Participants with experience thought that the anatomical model was more effective at reproducing the m-TEER procedure than the idealised model (P = 0.03). CONCLUSIONS: . This study showed how a more realistic simulator can be used to improve the effectiveness of m-TEER procedural training. Such pilot results suggest planning future and large investigations to evaluate improvements in clinical practice.

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.

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.

Transcatheter edge-to-edge mitral valve repair in mitral regurgitation: current status and future prospects.

INTRODUCTION: Mitral regurgitation (MR) is associated with substantial morbidity and mortality. Within the past 15 years, mitral valve edge-to-edge repair (M-TEER) has developed from an experimental approach to a guideline-recommended, safe, and effective treatment option for patients with severe primary or secondary mitral regurgitation. AREAS COVERED: This review covered relevant publications of M-TEER and summarizes the development of M-TEER devices within the last 15 years. It outlines anatomical challenges which drove the evolution of M-TEER devices, provides an overview about the current state of clinical application and research, and offers an outlook into the future of transcatheter mitral valve treatment. EXPERT OPINION: The development and refinement of new M-TEER device generations offer the possibility to treat a wide range of mitral valve anatomies. Choosing the best device for the individual anatomic properties of the patients and considering comorbidities is the key to maximized MR reduction, minimalized complication rates, and thus optimized postinterventional prognosis. Independent from prognostic implications, quality of life has become an important patient-centered outcome that can be improved by M-TEER in virtually all patients treated.

One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.

BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. OBJECTIVES: The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. METHODS: Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. RESULTS: The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001). CONCLUSIONS: The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833).

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. OBJECTIVES: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial. METHODS: Patients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. RESULTS: A prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]). CONCLUSIONS: The CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.