Significant Reduction In Mitral Regurgitation Research Articles

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

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

Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology

BackgroundMitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. MethodsThree consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. ResultsTechnical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. ConclusionsLonger-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. Short AbstractWe present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

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

BackgroundThe third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter. ObjectivesThe EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system. MethodsEXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality. Results1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies. ConclusionsThe study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811)

Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study

BackgroundAlthough transcatheter edge-to-edge repair (TEER) has been shown to improve clinical outcomes and improve quality of life in patients with symptomatic secondary mitral regurgitation (SMR) and left ventricular dysfunction, its effect in patients with atrial SMR (aSMR) has not been well described. ObjectivesThe aim of this study was to assess the safety, echocardiographic outcomes, and clinical effectiveness of TEER for aSMR. MethodsPatients with aSMR in the prospective, observational, multicenter EXPAND (A Contemporary, Prospective, Multi-Center Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study were identified by an echocardiography core laboratory. Follow-up occurred at discharge, 30 days, and 1 year. Key endpoints included mitral regurgitation (MR) severity, functional class, heart failure hospitalizations, mortality, and 30-day major adverse events. ResultsAmong 1,041 patients enrolled in EXPAND, 835 patients had evaluable echocardiograms at baseline. Of these, 53 patients had aSMR and 360 had ventricular SMR (vSMR). In the aSMR cohort, TEER resulted in a significant reduction in MR through 1 year (MR grade ≤2 in 100.0%), significantly increased 1-year Kansas City Cardiomyopathy Questionnaire score (+26.6 ± 30.5 points; P < 0.0001), and improved functional class from baseline, similar to the effects among patients with vSMR (MR grade ≤2 in 99.5% at 1 year, 1-year increase in Kansas City Cardiomyopathy Questionnaire score 21.23 ± 24.92 points). Major adverse events at 30 days and leaflet adverse events at 1 year were infrequent in both groups. ConclusionsIn a prospective, real-world, global registry, TEER for aSMR was associated with significant MR reduction and improvement in quality of life and functional class, similar to patients with vSMR. This suggests that TEER may provide clinical benefit in patients with atrial fibrillation with SMR in the setting of heart failure with preserved ejection fraction. (The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices; NCT03502811)

SOME INNOVATIVE TECHNOLOGIES FOR THE CORRECTION OF VALVULAR HEART DISEASES. REVIEW

Valve defects or congenital/acquired heart defects are damage to the valve and/or subvalvular structures, which leads to impaired hemodynamics and the development of heart failure. Asymptomatic valvular heart disease is present in 2.5% of the population; with age, this figure rises to 13%. In the absence of permanent treatment, lesions of the heart valves significantly reduce the quality and duration of life. The European Society of Cardiology (ESC) and the American Heart Association (AHA) regularly review the effectiveness of new surgical treatments and reflect their findings in international guidelines. Today, minimally invasive surgery is the most effective and safe way to treat patients with valvular heart disease. The article presents two new methods for the treatment of valvular heart disease. Transapical mitral valve repair on a beating heart with neochord implantation (TOP-MINI) is a new MVP option that has been approved for patients with severe mitral regurgitation due to prolapse of the leaflet (s) or chord (grades 2-4). The new procedure with the NeoChord DS1000 device results in a significant reduction in mitral regurgitation and in reverse remodeling of the left ventricle and left atrium after 6 months of follow-up. Also reviewed is Minimally Invasive Aortic Valve Replacement (MAVR), which has been shown to be beneficial in improving patient satisfaction by minimizing pain and earlier recovery. Sutureless valves are preferred over traditional aortic valve replacement (AVR) due to the reduced operation time and the need for blood transfusion. The Perceval valve (Sorin, Sallugia, Italy) is a self-expanding bovine pericardial prosthesis placed in a nitinol stent designed to facilitate aortic valve implantation. A systematic review and meta-analysis demonstrated that the early clinical and hemodynamic characteristics of the Perceval valve are satisfactory and comparable to those of conventional AVRs. This literature review was carried out in accordance with the PRISM statement. The databases searched in this review included Pubmed, Web of Science, Scopus and Cochrane databases for systematic reviews

Acute changes in mitral valve geometry after MitraClip procedure assessed by 3D transoesophageal echocardiography

Abstract Background MitraClip procedure is a treatment option in patients with symptomatic mitral regurgitation (MR) and prohibitive surgical risk. Echocardiographic evaluation of mitral valve (MV) is of paramount importance for the correct identification of patient eligibility and procedural success. Our aim is to assess the acute effect of device implantation on mitral annular geometric parameters still little explored with the use of three-dimensional (3D) transoesophageal echocardiography (TEE) and to investigate its relationship with residual MR at discharge. Methods 67 consecutive patients (mean age78.7±7.2 yrs, 41 males) undergoing percutaneous MV repair with MitraClip in our Centre were enrolled. Patients eligibility was evaluated according to the EVEREST criteria and current guidelines. Four groups were identified on the base of MR aetiology: 22 were degenerative (DMR), 19 ischemic functional (IFMR), 19 non-ischemic functional (NIFMR) and 7 atrial functional (AFMR). 3D TEE was performed before and immediately after clip deployment with MV anatomical quantification by PHILIPS® QLAB MVQ and GE® 4D-AUTO-MVQ software. Results Severe MR (4+) was found in 17 pts, and moderate-severe MR (3+) in 50 pts. Thirteen cases were unsuccessful because of unchanged or residual MR&amp;gt;2+. Immediately after device positioning, almost all the evaluated parameters showed a significant modification within each group with a reduction of anterior-posterior (AP-D) and bi-commissural (CC-D) MV diameters, MV annulus area and perimeter and an increase in tenting volume, tenting height and posterior mitral leaflet angle (PML α). Anterior mitral leaflet angle (AML α), sphericity index and aorto-mitral angle remained unchanged. We observed no significant difference in the sub-analysis between degenerative and all functional MR groups, although a different trend of parameters variation could be evidenced. Post-procedural tenting height with cut off of 5.5 mm was a predictor of procedural success (see fig.), while at univariate analysis basal AP-D in DMR group and sphericity index, PMLα and annulus height at baseline in the FMR group were all significantly correlated to the entity of MR reduction at discharge. Conclusions Percutaneous edge-to-edge repair with MitraClip acutely changes the MV annular geometry in degenerative and both ventricular and atrial functional MR, with a different trend within each group. Post-procedural tenting height correlates with significant MR reduction at discharge, a promising marker that could be used in clinical practice for identification of MitraClip procedure success. Funding Acknowledgement Type of funding source: None

Restrictive mitral annuloplasty with or without coronary artery bypass grafting in ischemic mitral regurgitation.

AimsIn patients with ischaemic mitral regurgitation (MR), the impact of mitral valve surgery with concomitant coronary artery bypass grafting (CABG) on post‐operative survival and left ventricular (LV) reverse remodelling remains unknown. Therefore, we investigated these outcomes following restrictive mitral annuloplasty (RMA) with and without CABG in those patients.Methods and resultsThis study included 309 patients with chronic MR and ischaemic cardiomyopathy for whom concomitant CABG was indicated (n = 225) or not indicated (n = 84) with RMA. The primary endpoint was all cause mortality during the follow‐up, and the secondary endpoint was defined as the composite of mortality and re‐admission for heart failure. Linear mixed model was used to analyse serial echocardiographic changes in LV function. To reduce the impact of treatment bias and potential confounding in the direct comparisons between patients who underwent RMA with and those who underwent it without CABG, we established weighted Cox proportional‐hazards regression models with inverse‐probability‐of‐treatment weighting. Pre‐operatively, there were no intergroup differences in age (RMA with CABG, 67 ± 9 vs. RMA without CABG, 68 ± 11, P = 0.409) and logistic EuroSCORE II (16 ± 14 vs. 15 ± 15%, P = 0.496). The 30‐day mortalities were 2.7% and 3.6%, respectively (P = 0.67). During follow‐up with a mean duration of 72 ± 37 months (range, 5.6–179), there were 157 deaths and 105 re‐admissions for heart failure. Overall 1‐year and 5‐year survival rates were 83 ± 2% and 58 ± 3%, respectively. Patients who did not receive CABG with RMA had a significantly lower 5‐year survival rate (45% vs. 63%, P = 0.049) and freedom from adverse events defined as mortality and/or admission for heart failure (19% vs. 43%, P < 0.001) than those who did. After adjustments for clinical covariates with inverse‐probability‐of‐treatment weighting, concomitant CABG was identified as an independent protective factor for adverse events (hazard ratio: 0.53; 95% confidence interval: 0.44–0.64; P < 0.001). Along with significant MR reduction, LV function parameters changed over time after surgery in both groups, with greater improvements in patients who underwent RMA with CABG (time effect, P < 0.001; and interaction effect, P = 0.002).ConclusionsRMA can be performed with an acceptable operative mortality, irrespective of indications for CABG. Patients with ischaemic MR for whom CABG is indicated with RMA are more likely to show better long‐term and event‐free survival and greater improvements in LV systolic function. The optimal revascularization strategy should be discussed with a heart team whenever indicated in patients with ischaemic MR; otherwise, they may miss the opportunity to benefit from concomitant CABG during subsequent RMA.

Mid-term effect of balloon aortic valvuloplasty on mitral regurgitation in aortic stenosis

BackgroundBalloon aortic valvuloplasty (BAV) offers an alternative to conventional aortic valve replacement in elderly and frail patients with severe aortic stenosis (AS) for whom there are no other effective options. We aimed to investigate the mid-term effect of BAV on mitral regurgitation (MR) in patients with severe AS.MethodsOur analysis was based on the data from 83 patients with severe AS (mean age, 86 ± 5 years; female, 68) treated using BAV. Echocardiography was performed before the procedure and at 1 and 3 months after. MR was quantified by measuring the MR jet area, with more-than-moderate MR being clinically significant.ResultsForty patients were classified in this group (MR group). Significant reduction of MR was observed in the MR group at 1 month and 3 months after procedure, with no improvement in patients in the non-MR group. At 3 months, 15 of the 40 patients in the MR group still had significant MR, with the change at 1 month in the left ventricular end-systolic dimension (OR: 1.36; 95% CI: 1.05–1.76; P = 0.022) and MR jet area (OR: 1.95; 95% CI: 1.16–3.29; P = 0.012) being predictive of persisting significant MR at 3 months after BAV. The prevalence of New York Heart Association functional class III or IV decreased at 1 and 3 months after BAV in both groups.ConclusionsBAV provides a useful therapeutic strategy for elderly patients with severe AS who are not candidates for surgical or transcatheter aortic valve replacement, especially in those with significant MR.

Direct Percutaneous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: When and How.

Mitral regurgitation (MR) is a frequent valvular disease among patients deemed too high risk for surgery. Echocardiography along with CT is the primary diagnostic tool for MR and offers a comprehensive 3D assessment in patient selection and screening for the optimal treatment method. The direct percutaneous mitral annuloplasty addresses the underlying mechanisms of functional MR with a less invasive, catheter-based approach. The here-described techniques proved a sufficient safety profile, delivered significant MR reduction in most of the cases, and were associated with a notable improvement of symptoms. Although long-term outcome assessment is needed to support these early reports, the percutaneous mitral annuloplasty is likely to set a new standard of treatment in the forthcoming future.

Evolution of mitral regurgitation in patients with heart failure referred to a tertiary heart failure clinic.

AbstractAimsSignificant mitral regurgitation (MR) is an important predictor for all‐cause mortality and heart failure (HF) hospitalizations independent of left ventricular ejection fraction (LVEF). The aims of this study were to investigate (i) in how many patients referred to a tertiary outpatient HF clinic HF therapy could be optimized, (ii) the effect of optimized treatment on MR severity, and (iii) whether a reduction in MR resulted in improvement of symptoms.Methods and resultsForty‐seven referred patients with therapy‐resistant symptomatic chronic HF with an LVEF &lt;40% and at least moderate MR were analysed on admission and after optimization of HF treatment after 6–18 months. The patients were classified as a volume responder when LV end‐systolic volume (LVESV) decreased ≥15%, as LVEF responder when LVEF increased by ≥5% points, as clinical responder when New York Heart Association (NYHA) class improved at least one category, and as MR responder when MR severity improved at least one category to maximally moderate. After 14 ± 4 months of treatment optimization, optimal doses of angiotensin‐converting enzyme inhibitors/angiotensin receptor blocker were seen in 18 (38%) patients compared with three (6%) at baseline (P &lt; 0.001), and optimal doses of beta‐blockers were seen in 14 (30%) patients compared with four (9%) at baseline (P &lt; 0.001). In total, 68% of the patients were clinical responders, 57% MR responders, 34% volumetric responders, and 49% LVEF responders. NYHA class improved from 2.9 ± 0.6 to 2.0 ± 0.9 (P &lt; 0.001), MR class from 5.2 ± 0.8 to 3.6 ± 1.5 (P &lt; 0.001), LVEF from 24% ± 9% to 31% ± 12% (P &lt; 0.01), and LVESV non‐significantly improved. The positive predictive value of MR response to NYHA response was 88%; the negative predictive value was 53%, agreement 69%, and kappa 0.39. The positive predictive value of LVEF response to NYHA response was 76%; the negative predictive value was 44%, agreement 60%, and kappa 0.21. The positive predictive value of LVESV volume response to NYHA response was 75%; the negative predictive value was 39%, agreement 51%, and kappa 0.12.ConclusionsAlthough this study was limited by a small number of patients, initiation and up‐titration of recommended HF therapy in patients referred to our tertiary HF outpatient clinic resulted in significant MR reduction in over half of the patients, emphasizing the importance of optimal medical treatment in these very sick cardiac patients with otherwise grave prognosis. MR reduction was best correlated to NYHA improvement.

Clinical role of transthoracic and transesophageal echocardiography in transapical mitral valve repair

Objective To evaluate the role of transthoracic echocardiography(TTE) and transesophageal echocardiography(TEE) in the process of transapical mitral valve repair using a novel edge-to-edge device(ValveClamp) and this device′s efficacy and safety in a preliminary clinical trial. Methods Six patients with moderate to severe or severe degenerative mitral regurgitation (DMR) confirmed by TTE and TEE were enrolled. TTE was performed pre and post procedure as well as 30 days post procedures.Related cardiac structure and hemodynamic parameters, including mitral regurgitation area(MRA-max), vena contracta width(VCW), mitral valve effective orifice area(MVEOA), left ventricular end diastolic diameter(LVEDD), left ventricular end systolic diameter(LVESD), left ventricular ejection fraction(LVEF), max and mean mitral valve pressure gradient(MVPG-max and MVPG-mean) were recorded and evaluated in a central core laboratory. Results All the procedures were successfully performed.MRA-max, VCW and MVEOA decreased significantly post procedures (all P 0.05). Meanwhile, MVPG-max and MVPG-mean slightly increased (all P 0.05). Conclusions Transapical mitral valve repair using ValveClamp can be performed safely and a significant reduction in mitral regurgitation can be achieved in patients with DMR. TEE and TTE facilitate the patient selection for ValveClamp procedures as well as perioperative navigation and assessment. Key words: Echocardiography, transthoracic; Echocardiography, transesophageal; Transcatheter mitral valve repair; Mitral regurgitation

FUNCTIONAL AND HEMODYNAMIC OUTCOME AT REST AND DURING EXERCISE AFTER A NOVEL TRANS ANNULAR MITRAL BRIDGE IMPLANTATION FOR FUNCTIONAL MITRAL REGURGITATION

Direct septal lateral diameter reduction (SLD) without circumferential cinching (in contrast to indirect SLD reduction by ring annuloplasty) by a curvilinear trans-annular mitral bridge has resulted in significant reduction of mitral regurgitation (MR) less than or equal to 1 at 2 year (yr) follow

Transcatheter Mitral Valve Therapy: Defining the Patient Who Will Benefit.

This report aims to define the clinical and anatomic variables key in determining patient suitability for transcatheter mitral valve therapies. Candidacy for transcatheter mitral valve repair requires weighing the clinical variables that may impact the ability to improve patient symptoms and prolong survival that include left ventricular ejection fraction, symptom severity, pulmonary hypertension, and magnitude of residual regurgitation or stenosis. Individualized selection of transcatheter repair or replacement based on patho-anatomy is being explored. The primary goal is achieving significant reduction in mitral regurgitation. Transcatheter mitral valve replacement requires rigorous anatomic screening using computed tomography and candidates should be able to take oral anticoagulation. Selection of patients for transcatheter mitral valve repair is complex and requires intimate knowledge of clinical variables and specific device limitations.

The mitral valve after 2 MitraClips deployed between A1 and P1 and A3 and P3 scallops resulting in a triple orifice mitral valve inflow and significant reduction of mitral regurgitation

The mitral valve after 2 MitraClips deployed between A1 and P1 and A3 and P3 scallops resulting in a triple orifice mitral valve inflow and significant reduction of mitral regurgitation

Current MitraClip experience, safety and feasibility in the Netherlands.

PurposeData on MitraClip procedural safety and efficacy in the Netherlands are scarce. We aim to provide an overview of the Dutch MitraClip experience.MethodsWe pooled anonymised demographic and procedural data of 1151 consecutive MitraClip patients, from 13 Dutch hospitals. Data was collected by product specialists in collaboration with local operators. Effect on mitral regurgitation was intra-procedurally assessed by transoesophageal echocardiography. Technical success and device success were defined according to modified definitions of the Mitral Valve Academic Research Consortium (MVARC).ResultsMedian age was 76 (interquartile range 69–82) years and 59% were males. Patients presented with ≥moderate mitral regurgitation and a predominance of functional mitral regurgitation (72%). Overall, 611 (53%) patients were treated with one Clip, 486 (42%) with ≥2 Clips and 54 (5%) received no Clip. The number of patients with ≥2 Clips increased from 22% in 2009 to 52% in 2016. Device success and technical success were 91 and 95%, respectively, and were consistent over the years. Significant reduction of mitral regurgitation by MitraClip was achieved in 94% of patients and was observed more often in patients with functional mitral regurgitation (95% vs. 91%, p = 0.025). Device time declined from 145 min in 2009 to 55 min in 2016.ConclusionMitraClip experience in the Netherlands is growing with excellent technical success and device success. Over the years, device time decreased and more patients were treated with ≥2 Clips.

MitraClip step by step; how to simplify the procedure.

The MitraClip system is a device for percutaneous edge-to-edge reconstruction of the mitral valve in patients with severe mitral regurgitation who are deemed at high risk for surgery. Studies have underlined the therapeutic benefit of the MitraClip system for patients at extreme and high risk for mitral valve surgery, suffering from either degenerative or functional mitral regurgitation. The MitraClip procedure shows low peri-procedural complication rates, and a significant reduction in mitral regurgitation, as well as an improvement in functional capacity and most importantly quality of life. It hereby widens the spectrum of mitral valve repair for the Heart Team. The current review underscores the efficacy of the procedure and describes the technique to simplify the procedure.

Transapical Coaptation Plate for Functional Mitral Regurgitation: An In Vitro Study.

A novel transapical coaptation plate (TCP) device was developed and anchored by sutures in the mitral valve to treat functional mitral regurgitation. The objective of this study was to test efficacy of the TCP in an in vitro model. Eight fresh porcine mitral valves were mounted in a left heart simulator to simulate functional mitral regurgitation by means of annular dilatation and asymmetrical or symmetrical papillary muscle (PM) displacement. Six polyurethane TCPs in thickness of 6.4(#1), 4.8(#2), 3.2(#3) mm and hardness of durometer 30 A (H) and 30 OO(S),were fabricated and labeled as H1, H2, H3 and S1, S2, S3, respectively. These TCPs were anchored by the sutures in the mitral annulus and left ventricle apex, and tested. Steady backward flow leakage in a hydrostatic condition and regurgitant volume in a pulsatile flow were measured before and after implantation of the TCPs. Mean regurgitant volume fractions in the asymmetric PM displacement were reduced significantly from 59.1 to 37.2% for H1, 43.2% for H2, 35.9% for S1 and 34.2% for S2 (p<0.021), after implantation of the TCPs. No significant reduction in mitral regurgitation was seen for H3 and S3 (p>0.067). Mitral regurgitation was mild in the symmetric PM displacement, and was not significantly reduced after implantation of the TCPs. In conclusion, the TCP anchored by the sutures in the mitral annulus and left ventricle apex functions successfully as a plug in the mitral valve leaflet gap. The TCP with thickness equal to or greater than 4.8mm is effective to reduce functional mitral regurgitation. The TCP hardness has no effect on difference in reduction of functional mitral regurgitation.

Three-Dimensional Transthoracic Echocardiography in the Comprehensive Evaluation of Right and Left Heart Chamber Remodeling Following Percutaneous Mitral Valve Repair

Percutaneous mitral valve repair (PMVR) is an alternative treatment in patients with significant mitral regurgitation (MR) who are denied surgery. Although in surgical patients, outcomes have been related both to acute hemodynamic favorable results and to positive cardiac remodeling in the midterm, in the case of PMVR the effect on cardiac chamber remodeling has never been extensively studied. The aims of this study were (1) to evaluate the short- and mid-term remodeling induced by PMVR on cardiac chamber volume using two- and three-dimensional (3D) transthoracic echocardiographic (TTE) imaging and (2) to assess changes in left ventricular (LV) shape on the basis of 3D TTE data. Patients undergoing PMVR were prospectively enrolled. Two-dimensional and 3D TTE data sets acquiredat baseline, and at 30days and 6months after PMVR were analyzed to assess LV and right ventricular (RV) volumes and ejection fraction and left atrial and right atrial volumes. Moreover, 3D endocardial surfaces were extracted to compute 3D shape indexes of LV sphericity and conicity at end-diastole and end-systole. Six of the 64 enrolled patients did not reach follow-up and were excluded. The analysis was feasible inall 58 patients considered (26 with functional MR and 32 [55%] with degenerative MR). PMVR resulted in significantreduction of MR and in favorable remodeling: (1) effective PMVR was mainly associated with decreased LV loading, (2) PMVR-related reverse remodeling was observed in patients with degenerative MR and those with functional MR at 30days and continued at 6-month follow-up, (3) favorable remodeling in LV shape from abnormally spherical to more normal conical took place in both groups after PMVR, and (4) RV volumes and systolic function were preserved after PMVR. A comprehensive two-dimensional and 3D TTE analysis allows investigation from a double perspective (volume and morphology) of the entity and modality of changes following PMVR. In high-risk patients undergoing PMVR, postprocedural heart remodeling involves all cardiac chambers, occurs in the short term, and further improves at midterm follow-up.

Transapical Beating-Heart Mitral Valve Repair With an Expanded Polytetrafluoroethylene Cordal Implantation Device: Initial Clinical Experience.

Degenerative mitral valve (MV) disease is a common cause of severe mitral regurgitation (MR) and accounts for the majority of MV operations. Conventional MV surgery requires cardiopulmonary bypass, aortic cross-clamping, cardioplegia, and a thoracotomy or sternotomy and, therefore, is associated with significant disability, risks, and unpredictable rates of MV repair. Transesophageal echocardiography-guided beating-heart MV repair with expanded polytetrafluoroethylene cordal insertion has the potential to significantly reduce surgical morbidity. We report the first-in-human clinical experience with a novel preformed expanded polytetrafluoroethylene knot implantation device (Harpoon TSD-5) designed to treat degenerative MR. Through a small left thoracotomy, the device was inserted into the heart and guided by transesophageal echocardiography to the ventricular surface of the prolapsed leaflet. Multiple expanded polytetrafluoroethylene cords were anchored in the leaflet and then adjusted to the correct length to restore MV leaflet coaptation and secured at the epicardium. Eleven patients with posterior leaflet prolapse and severe MR, with mean±SD age of 65±13 years and mean ejection fraction of 69±7%, were treated with 100% procedural success. Immediate postprocedural mean MR grade was trace. At 1 month, the mean MR grade was mild with significant decreases in end-diastolic volume (139 to 107 mL; P=0.03) and left atrial volume (118 to 85 mL; P=0.04). A novel device used for beating-heart image-guided MV repair demonstrates a significant reduction in MR with favorable left ventricular and left atrial reverse remodeling. This approach has the potential to decrease invasiveness and surgical morbidity. Further follow-up is necessary to assess long-term efficacy. URL: https://clinicaltrials.gov. Unique identifier: NCT02432196.

First Experience With Percutaneous Mitral Valve Plication as Primary Therapy for Symptomatic Obstructive Hypertrophic Cardiomyopathy

BackgroundFew therapeutic options exist for patients with severe heart failure due to obstructive hypertrophic cardiomyopathy (HCM) who are at unacceptable surgical risk. We hypothesized that percutaneous plication of the mitral valve could reduce left ventricular outflow tract (LVOT) obstruction and associated mitral regurgitation, thereby leading to amelioration of heart failure symptoms. ObjectivesThis study sought to evaluate the potential effectiveness of percutaneous mitral valve plication as a therapy for patients with symptomatic, obstructive HCM. MethodsSix patients (age 83 ± 8 years; 5 women), judged as not optimal candidates for septal myectomy, were referred for management of severe, drug-refractory heart failure symptoms due to obstructive HCM (New York Heart Association functional class III). Each underwent percutaneous mitral valve leaflet plication to reduce systolic anterior motion (SAM) and mitral regurgitation using the transcatheter mitral clip system. ResultsThe procedure was completed in 5 patients with placement of a single clip at the A2-P2 segments of the mitral valve. One other patient experienced cardiac tamponade, leading to termination of the procedure. Among the 5 treated patients, percutaneous plication with the eliminated SAM and consequently decreased the intraoperative LVOT gradient (91 ± 44 mm Hg to 12 ± 6 mm Hg; p = 0.007), left atrial pressure (29 ± 11 mm Hg to 20 ± 8 mm Hg; p = 0.06), and mitral regurgitation grade (3.0 ± 0 vs. 0.8 ± 0.4; p = 0.0002) associated with improved cardiac output (in n = 4; 3.0 ± 0.6 l/min to 4.3 ± 1.2 l/min; p = 0.03). Over follow-up of 15 ± 4 months, symptom improvement to New York Heart Association functional class I or II occurred in all patients. Follow-up echocardiography after 15 ± 4 months demonstrated continued absence of SAM and significant reduction in mitral regurgitation, although high systolic LVOT velocities (i.e., >4 m/s) were evident in 3 of the 5 treated patients. ConclusionsThis is a report of percutaneous mitral valve plication as a primary therapy in the management of severely symptomatic, obstructive HCM patients. This initial experience suggests that percutaneous mitral valve plication may be effective for symptom relief in such patients via reduction of SAM and mitral regurgitation. The significance of persistent elevations of LVOT velocities in some patients requires further study.