MitraClip Repair Research Articles

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+.

Patient-Specific Quantitative In-Vivo Assessment of Human Mitral Valve Leaflet Strain Before and After MitraClip Repair.

Mitral regurgitation (MR) is a highly prevalent and deadly cardiac disease characterized by improper mitral valve (MV) leaflet coaptation. Among the plethora of available treatment strategies, the MitraClip is an especially safe option, but optimizing its long-term efficacy remains an urgent challenge. We applied our noninvasive image-based strain computation pipeline [1] to intraoperative transesophageal echocardiography datasets taken from ten patients undergoing MitraClip repair, spanning a range of MR etiologies and MitraClip configurations. We then analyzed MV leaflet strains before and after MitraClip implementation to develop a better understanding of (1) the pre-operative state of human regurgitant MV, and (2) the MitraClip's impact on the MV leaflet deformations. The MV pre-operative strain fields were highly variable, underscoring both the heterogeneity of the MR in the patient population and the need for patient-specific treatment approaches. Similarly, there were no consistent overall post-operative strain patterns, although the average A2 segment radial strain difference between pre- and post-operative states was consistently positive. In contrast, the post-operative strain fields were better correlated to their respective pre-operative strain fields than to the inter-patient post-operative strain fields. This quantitative result implies that the patient specific pre-operative state of the MV guides its post-operative deformation, which suggests that the post-operative state can be predicted using pre-operative data-derived modelling alone. The pre-operative MV leaflet strain patterns varied considerably across the range of MR disease states and after MitraClip repair. Despite large inter-patient heterogeneity, the post-operative deformation appears principally dictated by the pre-operative deformation state. This novel finding suggests that though the variation in MR functional state and MitraClip-induced deformation were substantial, the post-operative state can be predicted from the pre-operative data alone. This study suggests that, with use of larger patient cohort and corresponding long-term outcomes, quantitative predictive factors of MitraClip durability can be identified.

Early Effect of Transcatheter Mitral Valve Repair on Cardiac Sympathetic Nerve Activity

BackgroundCardiac sympathetic nerve activity (SNA) is overactivated in heart failure patients and associated with clinical outcomes. The aim of this study is to investigate the early effect of MitraClip repair on cardiac SNA. MethodsWe evaluated the change of cardiac SNA by 123I- meta-iodobenzylguanidine (MIBG) scintigraphy in patients who underwent MitraClip repair from March 2019 to June 2020 in our hospital. Patients without acute procedural success were excluded, including patients who died or underwent mitral valve surgery before discharge. MIBG scintigraphy was performed at baseline and 1 ​month after MitraClip repair. ResultsWe analyzed 48 patients (mean age 78.6 ± 10 years; 52.1% male; 37 secondary mitral regurgitation [SMR]/11 primary mitral regurgitation [PMR]). MR severity and New York Heart Association functional class significantly improved from baseline to 1 ​month after MitraClip repair (both p < 0.001). Overall, delay heart-mediastinum ratio (H/M) had no significant change, and washout rate (WR) showed a decreasing trend (delay H/M; pre 2.07 ± 0.46, post 2.05 ± 0.49, paired p = 0.348, WR; pre 36.1 ± 11.6%, post 33.6 ± 11.7%, paired p = 0.061). In PMR patients, WR was significantly decreased, however, delay H/M was not (delay H/M; pre 2.15 ± 0.50, post 2.10 ± 0.57, paired p = 0.019, WR; pre 34.6 ± 10.5%, post 26.7 ± 13.8%, paired p = 0.568). In contrast, in SMR patients, neither delay H/M nor WR were significantly changed (delay H/M; pre 2.05 ± 0.45, post 2.03 ± 0.47, paired p = 0.474, WR; pre 36.6 ± 11.9%, post 35.7 ± 10.4%, paired p = 0.523). ConclusionsOur study demonstrates that MitraClip repair could significantly decrease cardiac SNA of WR in PMR patients during 1-month follow-up, however, in SMR patients, the significant change of MIBG parameters was not observed.

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

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

Abstract 15014: Aberrant, Elevated Papillary Muscle and Left Ventricular Wall Forces Associated With Mitral Valve Prolapse Are Normalized by Surgical Neochordal Repair but Not by Transcatheter Edge-to-Edge Repair

Introduction: Recent studies have linked mitral valve prolapse (MVP) to localized myocardial fibrosis and ventricular arrhythmia, and early imaging work has shown altered ventricular motion with papillary muscle (PM) traction in MVP and MitraClip patients. We aimed to biomechanically compare MitraClip and neochordal repair for MVP on PM forces ex vivo . Methods: We developed a force transduction system to measure the forces exerted on the PMs throughout the cardiac cycle in a left heart simulator ( Fig A ) with consistent pressures. Using a randomized, paired procedure with porcine MVs (n=4), we measured the hemodynamics and forces for control, diseased (P2 prolapse via chordal rupture), MitraClip repair ( Fig B, C, D ) (single P2 clip), and neochordal repair (P2 primary neochord on each PM) conditions. Results: We found that MitraClip PM forces (7.19 ± 0.31 N) are higher by 9.34% compared with those of controls (6.58 ± 0.21 N, p&lt;0.001 ). This result is similar to MVP valves modeled by superior PM displacement, which showed 9.23% higher forces than those of controls (n=10, p&lt;0.001 ). Moreover, MitraClip repaired valves showed PM force increases of 6.4% compared with forces of neochordal repair (6.76 ± 0.22 N, p&lt;0.001 ), despite having similarly reduced regurgitation fractions (5.05% ± 1.98% vs. 4.25% ± 1.51%, respectively, p&gt;0.05 ) compared with those of the diseased state (16.96% ± 3.04%, p&lt;0.001 ) and controls (2.66% ± 0.87%). Additionally, neochordal repair valves had 2.79% higher forces compared to those of control valves ( p&lt;0.001 ). Conclusions: We discovered that MitraClip, while reducing regurgitation, does not restore aberrant forces on the PM induced in MVP to baseline or reduced levels, while neochordal repair does. Our work suggests that these elevated forces, associated with MVP and MitraClip, predisposes the MV to continued traction, which may present a long-term harm to patients by catalyzing localized fibrosis and ventricular arrhythmia.

Abstract 15237: Alterations in the Human Mitral Valve in-vivo Functional State in Mitraclip Repair

Introduction: The MitraClip for treatment of mitral regurgitation (MR) is a generally safe and effective procedure. However, recent clinical trials have reported contradictory outcomes, and long-term efficacy remains almost completely unknown. Therefore, there is an urgent need for quantitative, patient-specific treatment optimization grounded on a robust understanding of the functional consequences of the MitraClip repair procedure on each patient-specific mitral valve (MV). Methods: Real-time 3D echocardiography images of ten MR patients’ MVs were acquired during the MitraClip procedure. These images were analyzed using our validated noninvasive strain estimation method to compute the pre-operative leaflet strain fields in the circumferential and radial directions. For the post-operative analysis, 3D MitraClip models were implemented in the corresponding size and number in the simulation to directly grasp the MV leaflets at echo-dictated positions. Results: The MV pre-surgical states were highly variable in both geometry and deformation, underscoring the heterogeneity of the MR in the patient population. There were also no consistent post-surgical global or local strain patterns between MVs. However, the pre- and post-surgical strain fields in the same MV were significantly better correlated than random pre- and post-surgical pairs (p &lt; 0.005). This quantitative result implies that the post-surgical state for each patient can be predicted from available pre-surgical data-derived modelling. Conclusions: Due to the highly variable pre-surgical state of regurgitant MVs, a patient-specific approach to MitraClip repair is crucial to improving long-term patient outcomes. Moreover, these findings suggest that the post-surgical state can be correlated to, and therefore predicted from, the pre-surgical state, which would lay the foundation for quantitative surgical planning, tailored patient selection, and ultimately, a more durable repair.

Target-controlled infusion during MitraClip procedures in deep-sedation with spontaneous breathing.

Percutaneous mitral valve repair with the MitraClip system is an alternative procedure for high-risk patients not suitable for conventional surgery. The MitraClip can be safely performed under general anesthesia (GA) or deep sedation (DS) with spontaneous breathing using a combination of propofol and remifentanil. This study aimed to evaluate the benefits of target-controlled infusion (TCI) of remifentanil and administration of propofol during DS compared with manual administration of total intravenous anesthesia (TIVA) medication during GA in patients undergoing MitraClip. We assessed the impact of these procedures in terms of remifentanil dose, hemodynamic profile, adverse events, and days of hospital stay after the process. From March 2013 to June 2015 (mean age 73.5 ± 9,54), patients underwent transcatheter MitraClip repair, 27 received DS via TCI and 27 GA with TIVA. Acute procedural success was 100%. DS-TCI group, in addition to a significant reduction of remifentanil dose administrated (249 µg vs. 2865, p < 0.01), resulted in a decrease in vasopressor drugs requirement for hemodynamic adjustments (29.6% vs. 63%, p = 0.03) during the procedure and a reduction of hypotension (p = 0.08). The duration of postoperative hospitalization did not differ between the two groups (5.4 days vs. 5.8 days, p = 0.4). Administration of remifentanil by TCI for DS in spontaneously breathing patients offers stable anesthesia conditions, with a lower amount of drugs, higher hemodynamic stability, and decreased side effects.

Acute effect of edge-to-edge repair of mitral regurgitation on left heart mechanics and health status.

Examine the impact of acute changes in left heart strain and volumes with percutaneous edge-to-edge MitraClip repair on improvement in health status assessed using Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score. Changes in left atrial strain, left ventricular (LV) global longitudinal strain (LVGLS), LV end-systolic volume (LVESV), and end-diastolic volume (LVEDV) were evaluated in 50 patients undergoing MitraClip repair for symptomatic primary mitral regurgitation (PMR) and secondary mitral regurgitation (SMR) on transthoracic echocardiography before and 1 month after MitraClip. Multivariable regression was used to evaluate changes in left heart strain and volumes as predictors of change in KCCQ-12 scores, adjusting for baseline clinical and echocardiographic characteristics. Both PMR and SMR patients had significant increase in LVGLS and reduction in LVEDV and LVESV ( P < 0.05) after MitraClip, reduction trend in left atrial conduit strain (PMR P = 0.053; SMR P = 0.12) but no significant change in LV ejection fraction. KCCQ-12 score improved significantly in both PMR ( P < 0.001) and SMR cohorts ( P < 0.001). Higher delta KCCQ-12 tertiles were associated with greater reduction in LVEDV ( P = 0.022) after MitraClip. On multiple regression analysis, lower preprocedural Society of Thoracic Surgeons for Mitral Valve Replacement and KCCQ-12 score, and greater reduction in LVESV and left atrial strain conduit phase were associated with KCCQ-12 score improvement ( P < 0.001). There is a significant increase in LVGLS and reduction in LVEDV, LVESV and left atrial strain conduit after edge-to-edge MitraClip repair in both PMR and SMR. Lower preprocedural Society of Thoracic Surgeons for Mitral Valve Replacement and KCCQ-12 score, and greater reduction in LVESV and left atrial conduit strain were associated with KCCQ-12 score improvement after MitraClip. Further studies are warranted to understand the mechanism and significance of our findings.

Quantification of mitral regurgitation after transcatheter edge-to-edge repair: Comparison of echocardiography and patient-specific in silico models

BackgroundDoppler echocardiographic (echo) assessment of residual mitral regurgitation (MR) after transcatheter edge-to-edge repair (TEER) is challenging and often subjective. This study aimed to evaluate the accuracy and feasibility of standardized quantitative echo methods for assessment of MR severity after MitraClip repair by comparing measurements against a reference MR severity obtained from patient-specific in silico models. MethodsPost-procedure hemodynamics were simulated under five different MitraClip configurations in previously validated patient-specific in silico models for the treatment of functional MR. The residual regurgitant volume was calculated as in clinical practice using four quantitative virtual echo methods: pulsed Doppler, volumetric, proximal isovelocity surface area (PISA) and vena contracta area (VCA). Multiple permutations were performed for each method. Virtual echo MR results were evaluated against reference MR values directly extracted from the 5 patient-specific in silico models. ResultsThe echo methods with the greatest accuracy were the three-dimensional (3D) volumetric method (r = 0.957, bias −0.8 ± 1.2 ml, p = 0.01), the 3D VCA method wherein velocity time integrals were evaluated for each jet assessed (r = 0.919, bias −1.5 ± 1.7 ml, p = 0.03), and the 3D PISA method integrating surface areas throughout systole (r = 0.98, bias −2.0 ± 0.9 ml, p = 0.003). The pulsed Doppler and 2D volumetric methods had technical limitations that may result in a high underestimation or overestimation of the MR severity after TEER. In the case of multiple regurgitant jets, a more accurate MR assessment was obtained when all significant jets were evaluated. ConclusionsClinically, the 3D volumetric, 3D VCA and 3D PISA methods gave the most accurate MR quantification after TEER. Three-dimensional echo technologies harbor the potential of becoming the non-invasive imaging tool of choice for MR quantification after complex transcatheter mitral interventions.

Clinical Outcomes after Mitral Valve Surgery in Failed MitraClip Procedures.

We retrospectively evaluated in-hospital and overall outcome of patients who received mitral valve replacement (MVR) after failed MitraClip procedure. A total of 26 out of 740 patients received MVR after treatment with MitraClip between June 2010 and December 2020. We analyzed in-hospital mortality and overall mortality during the median follow-up period of 72 days after MVR. The median age in the entire cohort was 77.5 years. In-hospital mortality was 15.4% (n = 4) and the overall mortality during the follow-up period was 27% (n = 7). The median time between the MitraClip procedure and surgery was 34.5 days. The main reasons for surgery were mitral stenosis (23.1%), persistent prolapse of the mitral valve leaflets (42.3%), and persistent tethering of the mitral valve leaflets (34.6%). At the time of surgery all of the patients presented with New York Heart Association 3 and above. The underlying mitral valve pathology was mainly secondary 61.5% (n = 16). Median left ventricular end-diastolic diameter was 60 mm. Preoperative ejection fraction was 40% and above in 73% of the cohort. In addition to the mitral valve procedure, 57.7% of patients received either concomitant tricuspid annuloplasty, aortic valve surgery, ascending aortic replacement, or coronary artery bypass grafting. The need for MVR for failed MitraClip repair is low and the results are acceptable. However, remaining options for reconstruction are usually limited and MVR is often needed. Anticipating success or failure according to the underlying pathology more than according to concomitant risk factors should form the basis in decision making for the treatment modality of first choice.

Procedural, Short-Term, and Intermediate-Term Outcomes in Propensity-Matched Patients With Severe Mitral Valve Regurgitation Undergoing Urgent Versus Elective MitraClip Percutaneous Mitral Valve Repair

The study authors sought to compare outcomes in patients with severe mitral valve regurgitation (MR) undergoing urgent, as compared to elective, mitral valve repair employing MitraClip. They hypothesized that, compared to elective cases, MitraClip procedures performed for urgent indications would be associated with increased intraoperative and postoperative complications but have similar long-term outcomes. A retrospective chart review with 3:1 propensity score matching of elective-to-urgent cases. A single, large-volume tertiary care academic medical center. All consecutive patients with severe MR who underwent elective or urgent MitraClip procedures between December 15, 2015, and October 26, 2020. MR repair with MitraClip. As expected, patients in the urgent MitraClip group required a higher level of preprocedural care, and there were significant differences in baseline demographic and clinical variables as compared to the elective group. To reduce baseline characteristics heterogeneity, propensity matching was performed for age, left ventricular systolic dysfunction, congestive heart failure, chronic obstructive pulmonary disease, and smoking histories, using the nearest-neighbor matching with a caliper of 0.2 and with replacement. The final study cohort included 89 urgent and 252 matched elective cases, with a suitable alignment between the treatment groups. Propensity-matched urgent MitraClip patients experienced a longer hospital length of stay (p < 0.001), increased intensive care unit admissions (19% v 4%, p < 0.001) and mechanical ventilation (6.7% v 1.6%, p=0.023), postprocedural atrial fibrillation (11% v 4.4%, p=0.036), pericardial effusion (10% v 2.4%, p=0.005), and acute kidney injury (7.9% v 2%, p=0.016). Furthermore, patients in the urgent cohort incurred significantly higher 30-day cardiovascular mortality (6.7% v 2%, p=0.039), increased 30-day (16% v 5.6%, p=0.006), and 1-year (33% v 20%, p=0.021) readmission rates. However, there were no statistically significant differences in 30-day and 1-year overall and 1-year cardiovascular mortality. Urgent MitraClip repairs can be performed successfully, when needed, in critically ill patients with severe MR. Despite the procedural success, patients undergoing urgent MitraClip repair remain at high risk for adverse outcomes in the short- and intermediate-term and incur increased cardiovascular mortality and morbidity. Further efforts are required to develop strategies to optimize short and intermediate outcomes in this vulnerable group of patients.

Changes in the In-vivo Functional State of the Mitral Valve in MitraClip Repair

Objective: In this study, our focus is on the MitraClip procedure (Abbott Inc.), which is a minimally invasive surgical repair procedure to correct ischemic mitral valve regurgitation (IMR). While initial short-term outcomes have been encouraging, the long-term efficacy of this procedure, as well as patient-specific guidelines for optimization, remain unknown. The overall objective will be to develop a rapid and accurate simulation pipeline to predict and quantitatively assess the efficacy and longevity of the MitraClip procedure for individual patients using only pre-surgical and related population-based data. Methods: Clinical, real-time three-dimensional echocardiography (rt-3DE) images of patients’ mitral valves (MV) were segmented by a neural network (NN)-based approach to produce high-fidelity spline representations, which were integrated using isogeometric analysis into our custom finite element solver. This solver incorporated previous plasticity material models of the MV, in addition to measured changes in MV boundary conditions. We then simulated leaflet strains before and after the procedure and at three- and six-month follow up intervals, ultimately using only pre-surgical images. Results: Results to date to investigate the response of the MV to the MitraClip demonstrated an increase of radial strain and a decrease of circumferential strain in the posterior leaflets of the MV (Figure). Furthermore, stress concentrations were observed in both the circumferential and radial directions. Conclusions: The MitraClip clearly induced major alterations in MV leaflet strain and stress behaviors. This work confirms that such minimally invasive procedures dramatically alter the MV functional behaviors. This may lead to the underlying reasons long-term MV remodeling occurs in response to the observed stress concentrations, possibly leading to limited repair durability.

Risk Stratification of Percutaneous Edge-to-Edge Repair by MitraClip in Patients with Mitral Regurgitation.

Edge-to-edge repair using the MitraClip system is indicated in patients with severe mitral regurgitation (MR) who are at high risk for open-heart surgery due to comorbidity or reduced cardiac function. However, less is known about pre-procedural risk factors for mortality and morbidity following MitraClip implantation. Consecutive 25 patients with severe MR who underwent MitraClip therapy (mean age, 77 years old, 14 males) were included. Right heart catheterization and echocardiographic data before and after the procedure were collected and their prognostic impacts were investigated. Acute procedural success was 96%. At one week following MitraClip repair, left ventricular ejection fraction (LVEF) remained unchanged and left ventricular end-diastolic volume tended to be smaller. Cardiac index and mean pulmonary artery pressure (mPAP) were markedly improved following the procedure (P < 0.001 for both). In the multivariate analyses using baseline characteristics, both lower LVEF (hazard ratio 0.57, 95% confidence interval 0.30-0.89) and higher mPAP (hazard ratio 1.23, 95% confidence interval 1.06-1.56) were independently associated with post-procedural 1-year death or heart failure readmission (P < 0.05 for both). The lower LVEF and higher mPAP group had lower 1-year survival free from HF readmission compared with those without (16.7% versus 100%; P < 0.001). In conclusion, a combination of baseline mPAP and LVEF might be a useful tool in predicting post-MitraClip procedural clinical outcomes.

Abstract 16574: Short Term Outcomes With Mitraclip in Women Compared With Men: Evidence From a Meta-analysis

Introduction: MitraClip is now approved for severe functional mitral regurgitation in high-risk patients with contraindications to surgical mitral valve repair. Previous studies have shown conflicting results with respect to sex differences in outcomes with the MitraClip. This study sought to examine short-term outcomes with transcatheter mitraclip in women versus men. Hypothesis: Female patients will have higher all-cause mortality, major cardiovascular events, and complications than men following MitraClip. Methods: Electronic search was performed until April 2020 for studies reporting outcomes with MitraClip in women versus men. Random effects DerSimonian-Laird odds ratios were calculated. Outcomes included all-cause mortality and major cardiovascular events at short-term follow-up (in hospital or 30 days) as well as complications. Results: Six studies (4 MitraClip registries; 2344 patients; 925 women) were analyzed. Women were older but exhibited fewer comorbidities. At 30 days, men had more strokes (p &lt; 0.0347) and major vascular complications (p &lt; 0.042), without a difference in all-cause and cardiovascular mortality (OR 1.31, 0.67-2.57, p &lt;0.43) compared with men. There was no difference in pericardial effusion/cardiac tamponade (p &lt;0.311) or acute renal failure (p &lt;0.805). The female survival advantage remained consistent across multiple secondary analyses. The risk of stroke, moderate/severe aortic insufficiency, and all-cause mortality seemed to vary based on the type of valve used; however, without significant subgroup interactions. Conclusions: Despite conflicting data, women experience better short-term outcomes with the MitraClip repair.

TCT CONNECT-342 Outcomes of MitraClip Repair in Primary Mitral Regurgitation Patients With STS Repair Score of Less Than 6% and STS Replacement Score of Less Than 8%: Results From the Global EXPAND Study

TCT CONNECT-342 Outcomes of MitraClip Repair in Primary Mitral Regurgitation Patients With STS Repair Score of Less Than 6% and STS Replacement Score of Less Than 8%: Results From the Global EXPAND Study

Outcomes of MitraClip Placement in Patients With Liver Cirrhosis

IntroductionLiver cirrhosis is associated with increased morbidity and mortality. Many preoperative risk assessment tools do not take into account the presence or degree of liver cirrhosis prior to surgery. Over recent years, percutaneous mitral valve repair using MitraClip has emerged as an option for patients at high risk of surgical intervention. However, the safety, efficacy and outcomes of this procedure in patients with liver cirrhosis have not yet been evaluated. MethodsThis is a retrospective cohort study using the 2013–2017 National Inpatient Sample database of adults who were hospitalized for MitraClip repair of mitral valve. All patients were divided into patients with cirrhosis and those without cirrhosis. The primary outcome was all-cause mortality in patient with cirrhosis who underwent MitraClip. The secondary outcomes were to assess length of stay (LOS) and total hospital cost per year in cirrhotic patients compared to non-cirrhotic patients. ResultsIn-hospital mortality was higher in cirrhosis group compared to non-cirrhosis however not statistically significant (8.1% vs 3.2%, OR: 2.59 [95% CI: 0.47–14.28, p-value 0.27). Additionally, neither of the secondary outcomes, LOS and total cost, were found to be statistically significant. However, the incidence of cardiogenic shock was significantly higher in the cirrhosis group 13.3% versus 3.9% (p-value 0.032). ConclusionPatients with liver cirrhosis who underwent MitraClip repair of MV were at higher risk of developing cardiogenic shock, without any significant increase in in-hospital mortality, LOS or total cost. However, this study showed a trend toward higher rates of mortality, requirement of blood transfusion, mechanical ventilation, length of stay, and cost of care in cirrhosis patients.

BRADYCARDIA PACING-FACILITATED VENTRICULAR FIBRILLATION STORM: A RARE CASE REPORT

Short-long-short (SLS) sequences can initiate 30% of VT/VF. We report a rare case of VF storm in a patient with VDD pacing triggered by SLS. A 56-year-old man with non-ischemic cardiomyopathy (10%) due to severe mitral and aortic regurgitation underwent MitraClip repair. Due to sustained LV

128 Intravascular Haemolysis – A Rare Complication of the MitraClip

In high risk surgical candidates, percutaneous edge-to-edge repair using the MitraClip system is a well-established alternative to treat mitral regurgitation (MR), with over 80,000 cases performed since its conception. We report a case of transfusion-dependent intravascular haemolysis related to the MitraClip, a rare and seldomly reported complication. An 84-year-old lady with severe MR secondary to posterior leaflet prolapse on a background of hypertension, hypercholesterolaemia, osteoporosis and glaucoma underwent successful MitraClip repair with 2 clips deployed, resulting in MR reduction from severe to mild-to-moderate on echocardiogram. She was discharged home 48 hours later with no immediate complications. Macrocytic anaemia was noted at 1-month post procedure with replete iron, B12 and folate levels, and further assessment at 4-months revealed undetectable haptoglobin levels with positive urine haemosiderin. Immune-mediated haemolysis screens were negative. Peripheral blood film demonstrated polychromasia and target cells, with occasional bite cells and red cell fragments. Increased erythropoiesis was noted in a hypercellular bone marrow biopsy. The laboratory work-up and the temporal association of the intravascular haemolysis with MitraClip confirmed the diagnosis. The patient has been managed effectively with monthly red blood cell transfusions and folate supplementation. She declined further intervention for her mitral valve. To the best of the authors’ knowledge, this is only the second case of MitraClip-related intravascular haemolysis reported worldwide, and the first to require regular transfusions. Interestingly, red cell fragmentation was not prominent on blood film, in contrast to other presentations of mechanical haemolysis. This rare complication should be considered in persistently anaemic patients post-MitraClip.

P299 Acute effects of Levosimendan on myocardial function in patients with severe mitral regurgitation and left ventricular dysfunction undergoing MitraClip repair

Abstract Background MitraClip system has developed as a valid therapeutic option in patients affected by moderate to severe and severe mitral regurgitation, low left ventricular ejection fraction (LVEF) and high surgical risk. Often, after the procedure occurs afterload mismatch, an acute and transient worsening of LVEF. Inotropic drugs can improve hemodynamic values at the prize of severe side effects. Levosimendan increases myocardial contractility without an elevation of intracellular calcium concentration, tachyarrhythmia and cardiomyocytes necrosis. Purpose Aim of our study was to assess the acute Levosimendan effects on LVEF of patients who underwent MitraClip procedure Methods Among 160 patients who underwent MitraClip procedure in our institute, 99 patients, with LVEF ≤35%, were included in the study. Transthoracic echocardiogram was performed in all patients, at moment of hospital admission and at discharge; transesophageal echocardiogram was performed during the procedure. We recorded the LVEF by modified Simpson’s rule. Periprocedural hemodynamic parameters were also recorded. 59 patients received Levosimendan during and early after the procedure (L-group) and 40 patients did not (no-L-group). Levosimendan perfusion was started at 0.01 μg/kg/min 1 h before the procedure without a loading dose, and maintained for 12h, according to hemodynamics. Results In the overall population, patients suffered from a severe reduction of LVEF (29.5 ± 5.3%) and high systolic pulmonary arterial pressure (sPAP) (51 ± 14.2 mmHg), without significant difference between the two groups. Acute procedural success was achieved in 98% of the study population, with 2 procedural failures in no-L-group (p = 0.16). During the procedure we observed a significant improvement of LVEF compared to baseline values only in L-group (from 29.6 ± 5.7% to 32.1 ± 7.6%, p = 0.046); in no-L-group the LVEF improved from 29.4 ± 5% to 30.2 ± 4.9% (p = 0.47); at discharge the LVEF was 31.3 ± 4.9% and 30.8 ± 5.7%, in L-group and no-L-group, respectively (p = ns compared to baseline and procedure). At discharge the sPAP significantly reduced in the overall population to 46.3 ± 12.7 mmHg (p 0.015): from 50.8 ± 12.3 mmHg vs 48.7 ± 11.9 in L-group (p = 0.35); from 51.2 ± 16 to 44.3 ± 13.2 mmHg (p = 0.04) in no-L-group. In-hospital mortality was 1.7% in L-group (1 patient die) and 0% in no-L-group. No relevant arrhythmias were reported in any patient during the hospital recovery. Conclusion In MitraClip patients with severe reduction of LVEF, Levosimendan has proven to improve hemodynamic outcome, increasing myocardial contractility during and early after procedure.

Transcatheter MitraClip repair alters mitral annular geometry \u2013 device induced annular remodeling on three-dimensional echocardiography predicts therapeutic response

BackgroundEchocardiography (echo) is widely used to guide therapeutic decision-making for patients being considered for MitraClip. Relative utility of two- (2D) and three-dimensional (3D) echo predictors of MitraClip response, and impact of MitraClip on mitral annular geometry, are uncertain.MethodsThe study population comprised patients with advanced (> moderate) MR undergoing MitraClip. Mitral annular geometry was quantified on pre-procedural 2D transthoracic echocardiography (TTE) and intra-procedural 3D transesophageal echocardiography (TEE); 3D TEE was used to measure MitraClip induced changes in annular geometry. Optimal MitraClip response was defined as ≤mild MR on follow-up (mean 2.7 ± 2.5 months) post-procedure TTE.ResultsEighty patients with advanced MR underwent MitraClip; 41% had optimal response (≤mild MR). Responders had smaller pre-procedural global left ventricular (LV) end-diastolic size and mitral annular diameter on 2D TTE (both p ≤ 0.01), paralleling smaller annular area and circumference on 3D TEE (both p = 0.001). Mitral annular size yielded good diagnostic performance for optimal MitraClip response (AUC 0.72, p < 0.01). In multivariate analysis, sub-optimal MitraClip response was independently associated with larger pre-procedural mitral annular area on 3D TEE (OR 1.93 per cm2/m2 [CI 1.19–3.13], p = 0.007) and global LV end-diastolic volume on 2D TTE (OR 1.29 per 10 ml/m2 [CI 1.02–1.63], p = 0.03). Substitution of 2D TTE derived mitral annular diameter for 3D TEE data demonstrated a lesser association between pre-procedural annular size (OR 5.36 per cm/m2 [CI 0.95–30.19], p = 0.06) and sub-optimal MitraClip response. Matched pre- and post-procedural TEE analyses demonstrated MitraClip to acutely decrease mitral annular area and circumference (all p < 0.001) as well as mitral tenting height, area, and volume (all p < 0.05): Magnitude of MitraClip induced reductions in mitral annular circumference on intra-procedural 3D TEE was greater among patients with, compared to those without, sub-optimal MitraClip response (>mild MR) on followup TTE (p = 0.017); greater magnitude of device-induced annular reduction remained associated with sub-optimal MitraClip response even when normalized for pre-procedure annular circumference (p = 0.028).ConclusionsMitraClip alters mitral annular geometry as quantified by intra-procedural 3D TEE. Pre-procedural mitral annular dilation and magnitude of device-induced reduction in mitral annular size on 3D TEE are each associated with sub-optimal therapeutic response to MitraClip.