MitraClip Research Articles

Transfemoral leadless pacemaker implantation after tricuspid valve surgery and intervention

Abstract Background and Purpose Pacemaker (PM) implantation after surgical or transcatheter tricuspid valve (TV) repair or replacement may be challenging. Transcatheter leadless pacemaker (LPM) implantation has become a routine procedure and is frequently adopted in patients without the need for an atrial lead, in cases with cardiac implantable device infection or in patients with marked comorbidities. The use of LPM in patients with previous TV repair or replacement has only been described in singular cases in literature. We present our single center experience of LPM implantation after TV repair. Methods Patients with a history of TV repair or replacement who underwent LPM in our institution between 01/2020 and 11/2023 were retrospectively analyzed. All patients underwent routine clinical follow-up investigations including LPM interrogation and transthoracic echocardiography to assess for TV status. For LPM implantation right anterior oblique (RAO) and left anterior oblique (LAO) caudal fluoroscopy projections were utilized to enable LPM device passage across the TV. Results The study population consisted of 10 patients (9 females, mean age 74.0±10.0 years). Two patients had a history of surgical TV annuloplasty repair and two patients a history of surgical valve replacement, four patients of transcatheter TV repair (one through the mitral clip), one patient of transcatheter valve-in-ring bio prosthesis implantation prosthesis after previous surgical ring deployment and one patient transcatheter TV replacement (Figure1). All patients suffered from permanent atrial fibrillation previous to implantation procedures. Three patients were on chronic hemodialysis therapy before LPM implantation. LPM systems were successfully implanted in all cases with a mean procedure time of 43.5±26.5 minutes and a mean fluoroscopy time of 5.9±5.5 minutes and a radiation dose of 1148,7±1424,9 cGy·cm2. For fluoroscopically guided TV crossing a mean LAO angle of 43.6±14.1° (range 22 to 53°) and caudal angle of 8.5±6.9° (range 0 to 20°) was utilized (Figure 2). The LPM device was positioned in the first positioning attempt in a right ventricular high septal localization in 8 cases. Mean pacing threshold was 0.36±0.07 V at 0.25 ms, with a mean sensing amplitude of 10.5±2.9 mV and a mean of 853±324 Ohms pacing impedance. No periprocedural complications occurred. Mean duration of follow-up was 8.1±9.2 months. There were no newly developed TV regurgitations noted. Pacing thresholds (0.37±0.1 V/0.25 ms), sensing amplitude (11.8±4.5 mV) as well as pacing impedances (865±365 Ohms) remained stable until the last follow-up investigation. Conclusion LPM implantation was feasible in patients with a history of TV repair or replacement. LPM implantation was safe and effective in various modalities of TV repair. LPM may be an alternative to conventional pacemaker implantations as well as surgical lead placement in selected patients.Figure 1.Figure 2.

ECHOCARDIOGRAPHIC PREDICTORS OF RESIDUAL MR ≥ 2+ AND CLINICAL OUTCOMES ONE YEAR AFTER MITRACLIP IMPLANTATION

Abstract Introduction The extent of residual mitral regurgitation (MR) (1+ vs ≥ 2+) has a notable impact on the outcome of MitraClip (MC) repair of significant functional MR. Aim The aim of the study was to analyze the one–year results in our series of patients with functional MR treated with MC. Materials and Methods Between 2020 and 2022, 58 consecutive patients underwent percutaneous mitral valve repair with MC technology. All patients had moderate–severe MR on a functional basis. Results At one year 10 patients died (mortality 17.2%). The remaining 48 patients had complete follow–up for up to one year and were included in the statistical analysis: The incidence of new hospitalizations was 8.3%; The incidence of grade 1+ and ≥ 2+ MR was 54.1% (26) and 45.9% (22), respectively; In patients with MR ≥ 2+ the clinical and instrumental outcomes were worse than in patients with MR 1+; Posterior leaflet height and extent of immediate postprocedural MR were independent predictors of MR ≥ 2+. In multivariable analysis, preprocedural posterior leaflet height (PLH) (OR 0.16, p = 0.02) and immediate postprocedural MR degree (IPOMR) (OR 12.4, p = 0.03) were predictive; preprocedural Ejection Fraction (EF) was almost significant (OR 0.87, p = 0.08) (Figure 1). Conclusions Percutaneous repair with MC of moderate/severe functional MR has favorable one–year outcomes in terms of mortality and rehospitalizations. The best results are obtained in cases with residual MR 1+. Echocardiographic parameters are independent predictors of residual MR ≥ 2+.

Mitral Valve Replacement for Failed Mitra Clip: A Case Report

Mitra Clip is an interventional procedure used in mitral regurgitation patients who are surgically inoperable or are at high surgical risk. However, there is a failure rate associated with this procedure and in some instances no surgical intervention can be offered due to the inoperability risk. We report a case of failed Mitra Clip in a patient that was originally considered to be high surgical risk due to frailty that later required a double valve surgery for failed Mitra Clip within 1 year of the procedure. Although her surgical risk was even higher at the time of surgery, the patient tolerated the surgical procedure well with no complication. This case highlights the importance of properly defining patients at high surgical risk at the first instance as subsequent surgery can be performed with excellent outcome.

Long-term outcomes and quality of life following implementation of dedicated mitral valve Heart Team decisions for patients with severe mitral valve regurgitation in tertiary cardiovascular care center.

This study was purposed to investigate which treatment strategy was associated with the most favourable prognosis for patients with severe mitral regurgitation (MR) following Heart Team (HT)-decisions implementation. In this retrospective study, long-term outcomes of patients with severe MR qualified after HT discussion to: optimal medical treatment (OMT) alone, OMT and MitraClip (MC) procedure or OMT and mitral valve replacement (MVR) were evaluated. The primary endpoint was defined as cardiovascular (CV) death and the secondary endpoints included all-cause mortality, myocardial infarctions (MI), strokes, hospitalizations for heart failure exacerbation and CV events during a mean (standard deviation [SD]) follow-up of 29 (15) months. From 2016 to 2019, 176 HT meetings were held and a total of 157 participants (mean age [SD] = 71.0 [9.2], 63.7% male) with severe MR and completely implemented HT decisions (OMT, MC or MVR for 53, 58 and 46 patients, respectively) were included into final analysis. Comparing OMT, MC and MVR groups statistically significant differences between the implemented procedures and occurrence of primary and secondary endpoints with the most frequent in OMT-group were observed (p < 0.05). However, for interventional strategy MC was non-inferior to MVR for all endpoints (p > 0.05). General health status assessed at the end of follow-up were significantly the lowest for MVR, then for MC and the highest for OMT-group (p < 0.01). In the present study it was demonstrated that after careful HT evaluation of patients with severe MR at high risk of surgery, percutaneous strategy (MC) can be considered as equivalent to surgical treatment (MVR) with non-inferior outcomes.

Abstract 18572: Mimickers of Chiari Network in the Left Atrium

Case: 84-year-old female with ischemic cardiomyopathy and severe secondary mitral regurgitation with restricted leaflet mobility due to chordae tethering and a large central regurgitant jet. She underwent trans-catheter edge to edge repair with Mitra Clip NTW. The clip was aligned in the 12 to 6 o'clock position in the middle of A2/P2 scallop and appropriate graft was obtained with good tissue bridging. The trans mitral gradient at the end of the procedure was 3 mmHg and final V-waves at 10 mmHg. After the guiding catheter was moved back to the right atrium, the transesophageal echocardiogram (TEE) showed the presence of an echo dense flickering, bubble-like mobile structure around the right upper pulmonary vein. The heart team agreed that it looked like an endothelial disruption induced by the guiding catheter. After careful consideration and using shared decision making, the patient was maintained on Eliquis for 6 months without evidence of thromboembolic phenomena. Repeat TEE showed a healed dissection flap and no echo dense structure seen previously. Discussion: Unlikely to be thrombus or air bubbles, this structure looked like what we would see in a Chiari network. Complications after Mitra Clip procedure have been well described and can be broadly divided into procedure related and device related. Endothelial disruption with the imaging characteristics shown in this case has not been described. There are no evidence-based guidelines on how to proceed with this type of complication. It is well known that endothelial damage increases the risk for thrombosis and embolic phenomena. Due to concerns of a stroke, the decision was made to start anticoagulation with the plan of redo TEE. This case demonstrates the importance of performing TEE after Mitra Clip procedure to look for lesions that would increase the risk of stroke. It also demonstrates that patients with endothelial disruption after Mitra clip may benefit from short term anticoagulation for stroke prevention.

Transapical electrosurgical laceration and stabilization of mitral clips followed by transcatheter mitral valve replacement—A one-stop shop

ObjectiveElectrosurgical laceration and stabilization of mitral clips (ELASTA-CLIP) is a bail-out technique to recreate a single-orifice mitral valve after transcatheter edge-to-edge repair (TEER) with subsequent transcatheter mitral valve replacement (TMVR). This technique is a novel option for patients with significant residual mitral regurgitation after TEER with high risk for conventional surgery. The original ELASTA CLIP procedure features a transseptal approach, whereas the TMVR with the Tendyne bioprosthesis has a transapical access. Hereby we tested the hypothesis that a modified transapical ELASTA CLIP technique can be safely applied transapically allowing a straightforward one-stop shop access strategy. MethodsWe developed the procedural steps in a porcine passive-beating heart model and applied the modified technique with subsequent TMVR in 2 consecutive patients with severe mitral regurgitation after previous TEER. Patients were followed up to 30 days. ResultsThe modified transapical ELASTA CLIP procedure was successful in both patients. The mean total procedure time was 118 minutes, and the mean fluoroscopy duration 22 minutes. At 30 days’ follow-up, both patients were alive without bleeding complications, reintervention, or prosthetic valve dysfunction. ConclusionsThe modified transapical ELASTA CLIP procedure is technically feasible and safe at 30 days. Procedure times are lower compared with previous reports of the original transseptal approach.

Novel Therapeutic Strategies in Heart Failure in Adult Congenital Heart Disease: of Medicines and Devices.

This paper reviews the latest literature on the growing field of heart failure in the adult congenital heart disease population. After highlighting the increasing prevalence and a few of the unique potential causes, including the concept of early senescence, this review begins with novel medical management strategies such as the angiotensin II receptor blocker and neprilysin inhibitors and sodium glucose cotransporter-2 inhibitors. Then, it addresses the latest applications of percutaneous techniques like implantable hemodynamic monitoring, transcatheter pulmonary and aortic valve replacement, and mitral clips. Cardiac resynchronization therapy and novel lymphatic system imaging and intervention are then described. Finally, the use of mechanical support devices, temporary and durable, is discussed as well as heart and combined heart and liver transplantation. There have been recent exciting advances in the strategies used to manage adult congenital heart disease patients with heart failure. As this population continues to grow, it is likely we will see further rapid evolution in this field.

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

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

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

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.

Machine learning used for simulation of MitraClip intervention: A proof-of-concept study.

Introduction: Severe mitral regurgitation (MR) is a mitral valve disease that can lead to lifethreatening complications. MitraClip (MC) therapy is a percutaneous solution for patients who cannot tolerate surgical solutions. In MC therapy, a clip is implanted in the heart to reduce MR. To achieve optimal MC therapy, the cardiologist needs to foresee the outcomes of different scenarios for MC implantation, including the location of the MC. Although finite element (FE) modeling can simulate the outcomes of different MC scenarios, it is not suitable for clinical usage because it requires several hours to complete. Methods: In this paper, we used machine learning (ML) to predict the outcomes of MC therapy in less than 1s. Two ML algorithms were used: XGBoost, which is a decision tree model, and a feed-forward deep learning (DL) model. The MC location, the geometrical attributes of the models and baseline stress and MR were the features of the ML models, and the predictions were performed for MR and maximum von Mises stress in the leaflets. The parameters of the ML models were determined to achieve the minimum errors obtained by applying the ML models on the validation set. Results: The results for the test set (not used during training) showed relative agreement between ML predictions and ground truth FE predictions. The accuracy of the XGBoost models were better than DL models. Mean absolute percentage error (MAPE) for the XGBoost predictions were 0.115 and 0.231, and the MAPE for DL predictions were 0.154 and 0.310, for MR and stress, respectively. Discussion: The ML models reduced the FE runtime from 6 hours (on average) to less than 1s. The accuracy of ML models can be increased by increasing the dataset size. The results of this study have important implications for improving the outcomes of MC therapy by providing information about the outcomes of MC implantation in real-time.

Comparison of Cardiovascular Procedure Rates in Patients With Supplementary vs Basic Insurance in Switzerland

Switzerland's mandatory health insurance provides universal coverage, but residents can opt for supplementary private insurance for nonessential, nonvital amenities. It is debated whether people with supplementary private insurance receive overtreatment due to financial incentives. To assess whether incidence rates of cardiovascular procedures in people with supplementary private insurance are higher than in those with basic insurance only. A population-based weighted cohort comparative effectiveness study, using administrative claims data from Switzerland assessing incidence rates (IRs), was conducted in adults undergoing a nonemergency cardiovascular inpatient procedure from January 1, 2012, to December 31, 2020. Analysis included primary or secondary discharge procedure codes for 1 of the following: percutaneous transluminal coronary angioplasty (PTCA), left atrial appendage (LAA) occlusion, patent foramen ovale (PFO) closure, transcatheter aortic valve replacement (TAVR), mitral valve clip implantation, cardiac pacemaker implantation, and atrial fibrillation/atrial flutter ablation. Supplementary private health insurance. Incidence rates of cardiovascular procedures between insurance groups calculated by negative binomial regression adjusted by inverse probability weights. Of 590 919 admissions (median age, 68 years; IQR, 57-77 years), 55.5% male, 15.7% non-Swiss nationality), 70.1% had basic insurance only. Independent of insurance status, IR for all cardiovascular procedures steadily increased over the study years. In general, people with supplementary private insurance received cardiovascular procedures more frequently (IR ratio [IRR], 1.11; 99% CI, 1.10-1.11) than people with basic insurance only. There was also an increase for every procedure: PTCA (IRR, 1.12; 99% CI, 1.12-1.13), LAA closure (IRR, 1.15; 99% CI, 1.13-1.16), mitral valve clip implantation (IRR, 1.08; 99% CI, 1.07-1.09), TAVR (IRR, 1.04; 99% CI, 1.03-1.06), PFO closure (IRR, 1.01; 99% CI, 1.00-1.02), pacemaker implantation (IRR, 1.08; 99% CI, 1.07-1.09), and atrial fibrillation/atrial flutter ablation (IRR, 1.12; 99% CI, 1.11-1.12). Sensitivity analyses, including side procedures, stratification by length of stay, and propensity score matching, suggested robustness of the results. This study found an association between supplementary private insurance and a higher likelihood of receiving nonemergency cardiovascular procedures. Whether this higher rate of procedures in people with supplementary private insurance is based on clinical reasoning or due to financial incentives warrants further exploration.

Impact of Gender on Outcomes of Transcatheter edge to edge mitral valve repair: A Meta-analysis.

Background: Gender disparities in outcomes after mitral valve surgery are well known. There are only few studies reporting the influence of gender on outcomes following transcatheter edge to edge repair (TEER) of the mitral valve using MitraClip (MC). In this meta-analysis, we describe outcomes by gender after mitral valve TEER. Methods: Studies reporting gender specific outcomes in patients treated with MC were reviewed from January 2010 to February 2022. Outcomes evaluated include all-cause mortality, New York Heart Association (NYHA) class, readmission for heart failure and residual mitral regurgitation (MR) at the longest follow up. Pooled odds ratio (OR) and 95% confidence interval (CI) were calculated using random effects models. Results: Seventeen studies with 33,747 patients (19,303 males and 14,444 females) were included. There was no difference in all-cause mortality (OR: 1.00, 95% CI: [0.90-1.12], p=0.93), residual MR (OR: 0.59, 95% CI: [0.34-1.02], p=0.06) or readmission for heart failure (OR: 1.04, 95% CI: [0.69-1.57], p=0.83). However, NYHA class III/IV was more frequent in female patients as compared to male patients at the end of follow up (OR: 0.62, 95% CI: [0.51-0.74], p&lt;0.00001). Conclusions: Our meta-analysis, the largest to date, suggests that female patients have worse NHYA functional class after TEER without any difference in all-cause mortality, readmissions for heart failure or residual MR when compared to male patients.

12 months outcomes of 12 young patients after mitral clip implantation

12 months outcomes of 12 young patients after mitral clip implantation

Two Cases of Surgical Correction of Recurrent Mitral Regurgitation due to Failed Catheter- Delivered Mitral Clip (MitraClip).

From April 2018 to February 2021, 150 patients underwent MitraClip implantation for severe functional mitral regurgitation (MR) at our hospital. Two of our patients, an 85-year-old man and an 84-year-old woman, developed a single leaflet device attachment in the acute phase after the implantation and had severe residual MR requiring surgical correction. The recurrent MR was first pointed out on day 5 and day 4, and the duration between MitraClip implantation and surgery was 13 and 55 days, respectively. Due to strong adhesions with the clips and severe valve damage after MitraClip implantation, both cases underwent mitral valve replacement with a good postoperative course. In patients with a high-risk baseline profile, surgical mitral valve replacement after failed MitraClip implantation should be considered at an optimal timing, and a detailed echocardiographic follow-up is required.

963 PRELIMINARY OBSERVANIONAL STUDY ON CARDIAC REMODELING IN PATIENTS UNDERGOING EDGE-TO-EDGE TRANS-CATHETER MITRAL VALVE REPAIR WITH MITRA CLIP DEVICE

Abstract Preliminary Observational Study on Cardiac Remodeling in Patients Undergoing Edge-to-Edge Trans-catheter Mitral Valve Repair with MitraClip Device Considering the current interest to the new trans-catheter mitral valve repair, it has been our aim to investigate the remodeling of left ventricular (LV), left atrium (LA) and right ventricular (RV) in a cohort of 24 patients with severe organic (13 cases) or functional (11 cases) mitral regurgitation (MR), on a 6 months follow-up. Their mean age was 78,54 ± 7,64 years, and STS score 4,69 ± 2,39 and EuroSCORE II of 5,10 ± 3,28%, and a corresponding ASA score of 3, due to age, co-morbidity and impaired cardiac function (NHIA III/IV). In our study we used advanced techniques of 3D- echocardiography, for the advantage of images independent from the cutting sections, probe angles, and operators skills: this method accuracy is comparable to that of cardiac magnetic resonance imaging. In detail, all enrolled patients underwent transthoracic 3D, spackle tracking imaging, to assess valve anatomy, and suitability for MitraClip treatment according to the EVEREST anatomic eligibility criteria. They were on optimized medications and, when necessary, previously treated with percutaneous angioplasty and stent implantation. Our results, in both functional and organic cases of MV regurgitation, can be summarized in a statically significant improvement of the NHYA class, reduction in the degree of MV and tricuspid valve insufficiency, decrease in LV end-diastolic diameter and diastolic volume, and mainly in a corrected direction of LV outflow towards the high pressure aortic system: so we explain the unchanged left ventricular ejection fraction. The LA remodeling was present with a significant reduction in LA volume only in patients without atrial fibrillation, while in its function there was a reduced peak strain. Regard the indicative parameters of afterload on the right heart chambers, the derived systolic pulmonary arterial pressure decreased, and in case of tricuspid regurgitation, a significant decrease in the maximal velocity of the blood flow was observed. There was also a statistically significant reduction in the right atrial area, and in RV size, both correlated with a reduced back flow in the RA. About the RV volumetric remodeling there was no statistically significant improvement in the end-diastolic RV volume, most probably of its better compliance towards a low pressure inflow. An improvement in RV systolic function parameters was obtained in terms of increased ejection fraction, decreased free wall strain, and decreased velocity at the tricuspid annular. In Conclusion, the clinical improvement observed after Mitral Clip repair consist in decreased overload to the left chambers, facilitating their reverse remodeling, and in the LV function. In perspective, we are planning to perform pre-operative models of MV repair, where we can calculate the reduced volume of regurgitated blood and the increase in the LVEF physiological outflow, in order to better tailor the indications to this procedure.

Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL: A Multicenter Propensity Score–Matched Comparison

BackgroundSince its introduction in 2003, Abbott’s MitraClip (MC) has become the most established catheter-based treatment for mitral regurgitation (MR). Recent approval of Edwards Lifescience’s PASCAL device has extended the field of TEER. ObjectivesThe aim of this retrospective multicenter study was to compare the PASCAL and MC regarding procedural results and short- and long-term outcomes after mitral valve transcatheter edge-to-edge repair (TEER). MethodsData from 3 high-volume centers were analyzed. The primary endpoint was residual MR at discharge. Secondary endpoints were technical success, MR reduction, and 30-day mortality. After 1 year, all-cause mortality and residual MR were reported. ResultsA total of 412 patients (216 MC, 196 PASCAL) treated between 2018 and 2020 were included. A total of 184 patients (92 in each treatment group) remained after propensity score matching. The rate of baseline MR ≥3 was 98.9% in both groups (P = 1.00). Both TEER systems achieved equally high technical success rates (97.8%; P = 1.00), resulting in residual MR ≤1 in 69.6% vs 77.1% of patients (P = 0.24) and MR reduction by ≥2 grades in 83.7% vs 92.4% of patients (P = 0.13) using the MC and PASCAL, respectively. Thirty-day mortality was 1.1% in both cohorts (P = 0.98), and 1-year follow-up showed similar MR reductions (residual MR ≤1, 78.0% with MC vs 82.3% with PASCAL; P = 0.70) and comparable all-cause mortality (14.1% with MC vs 6.5% with PASCAL; P = 0.14). In multivariate regression analysis, Society of Thoracic Surgeons score independently correlated with an optimal result (MR ≤1), while device choice did not show a significant impact. ConclusionsIn this retrospective multicenter study, the established MC and the novel PASCAL mitral valve TEER systems were safe and offered excellent performance with comparable short- and long-term outcomes.

Post-infarct mitral insufficiency: when to resort to reparative surgery, when to the mitral clip.

Severe mitral insufficiency is a feared complication that develops in 10-12% of patients with myocardial infarction and ST elevation. It results from the rupture of the papillary muscle or is secondary to an acute remodelling of the left ventricle in its entirety or of the infarcted region. The mortality of patients with acute clinical onset reaches 50%. The ideal treatment of acute mitral insufficiency is controversial and still a source of debate. Most of these patients are at high surgical risk or inoperable; therefore, they are treated conservatively and have a poor prognosis. In these candidates, percutaneous treatment of insufficiency with percutaneous edge to edge can be considered an alternative.

Abstract 11703: A Rare Case of Redo MitraClip Failure Requiring Salvage Mitral Valve Replacement

Presentation: A 74-year-old lady with history of hypertension, COPD, severe pulmonary hypertension, HFpEF, redo MitraClip placement for severe mitral regurgitation (MR) secondary to mitral valve (MV) prolapse presented with four months of progressive dyspnea and bilateral lower extremity swelling. Vitals were significant for hypotension and tachycardia. Examination revealed a holosystolic murmur at the apex, crackles in bibasilar lung fields, and 3+ bilateral pitting pedal edema. Work-up: TTE revealed EF of 65%, enlarged right ventricle, flattened interventricular septum, multiple mitral clips attached to the MV leaflets, and an eccentric MR jet. TEE revealed severe left atrial dilation, severe MR with eccentric and posteriorly directed regurgitant jet and mal-coaptation of MV leaflets with three MitraClips attached (Figure 1-3). Management: For recurrent severe mitral regurgitation resulting in decompensated heart failure, options included another redo MitraClip procedure versus surgical MV replacement. After extensive discussion with the multidisciplinary team and the patient, a decision was made to proceed with surgical MV replacement accepting a high operative risk with STS risk score of &gt;8%. Intraoperative findings revealed one inverted MitraClip with posterior leaflet detachment and two other clips that had densely scarred into the posterior leaflet leaving an unrecognizable MV (Figure 4). A 29 mm Epic Plus bioprosthetic MV was placed successfully. After a prolonged postoperative course, her clinical status improved. Conclusion: In patients who have failed the MitraClip procedure, significant destruction and fibrosis of the leaflets leaves surgical MV replacement being the only reasonable option. Surgical risk must be determined in conjunction with a multidisciplinary team as MV repair is performed at advanced centers in high-risk patients with good results. This can reduce the number of redo MitraClip and salvage MV surgery.

Utility and futility of MitraClip implantation in secondary mitral regurgitation in a real-world population: the role of 3D transthoracic echocardiography

Abstract Introduction Two recent prospective trials have been published, reporting opposite results on the efficacy and utility of the MitraClip (MC) procedure in patients with secondary mitral regurgitation (SMR). A ratio between the effective regurgitant orifice area (EROA) and left ventricular end-diastolic volume (LVEDV) ≥0.150 by two-dimensional (2D) transthoracic echocardiography (TTE) has been proposed to identify patients with disproportionate SMR, who would benefit from MC. Purpose To assess the prognostic role of clinical and echocardiographic parameters in a real-world population of SMR patients undergoing the MC procedure at our Institute. Methods Ninety-two patients underwent MC implantation. We retrospectively reviewed their clinical, and laboratory data, as well as 2D and three-dimensional (3D) TTE, and intraoperative transoesophageal echocardiography (Figure 1). The primary endpoint was a composite of cardiovascular death and/or hospitalisation for heart failure within 12-months follow-up. Results Thirty-one patients reached the endpoint (EP+), 61 did not (EP−). Demographics and anti-remodelling drugs were similar in EP+ and EP. Among comorbidities and laboratory data, EP+ significantly differed from EP− in smoking history, and extracardiac artery disease prevalence (65% vs. 39%, and 39% vs. 16%, respectively); EuroScoreII (12.2% vs. 5.2%); NYHA class ≥3 (94% vs. 69%); haemoglobin (12±2 vs. 13±2 g/dL), and brain natriuretic peptide levels (855 [426–1500] vs. 357 [170–902] pg/mL). At 2D TTE no significant difference emerged, including the SMR grade, except for the tricuspid annular plane systolic excursion (Figure 2). Biventricular 3D ejection fraction was significantly lower in EP+ vs. EP− (Figure 2). Residual intraoperative SMR grade after MC deployment was 1.9±0.6 in EP+ vs. 1.3±0.5 in EP− (p&amp;lt;0.001). Conclusion The proposed cut-off for EROA/LVEDV ratio may be suboptimal for predicting the MC utility in real-world populations. Rather, prognosis may be more influenced by the patient's pre-operative clinical status, right ventricular systolic function, 3D left ventricular ejection fraction, and by the success of the procedure. Funding Acknowledgement Type of funding sources: None.

COVID-19 RISK IN THE CARDIAC CATHETERIZATION LABORATORY

COVID-19 RISK IN THE CARDIAC CATHETERIZATION LABORATORY