Annuloplasty System Research Articles

First-in-human experience with a novel transcatheter direct annuloplasty system for severe atrial functional mitral regurgitation.

First-in-human experience with a novel transcatheter direct annuloplasty system for severe atrial functional mitral regurgitation.

30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study

BackgroundSurgery for isolated functional tricuspid regurgitation (TR) poses a high risk. Several transcatheter approaches are being evaluated for the treatment of such patients. The K-Clip system is a percutaneous approach designed for functional TR; however, its utility remains unknown. ObjectivesThis study aimed to report the 30-day echocardiographic and clinical outcomes with the K-Clip system for severe TR, including changes in TR severity and NYHA functional class. MethodsTranscatheter tricuspid valve annuloplasty was performed in 39 patients with intermediate or high surgical risk who underwent the K-Clip system. The right internal jugular vein procedure was performed with annuloplasty guided by fluoroscopy and echocardiography. The primary outcomes were clinical success and all-cause mortality at the 30-day follow-up. ResultsThe K-Clip was successfully implanted in all cases, with 1 to 3 devices deployed. At the 30-day follow-up, none of the patients had died. TR severity was reduced by at least one grade in all patients. There were no severe procedural or 30-day adverse events, except for 1 new pacemaker implantation. The proportion of NYHA class III-IV patients decreased from 79.5% to 5.1%, and the ascites disappeared. The 6-minute walk distance increased by 78 m (P < 0.05), and the Kansas City Cardiomyopathy Questionnaire score improved by 11 points (P < 0.05). ConclusionsThe K-Clip device is practical, safe, and effective for patients with severe TR. A 30-day reduction in TR and enhanced cardiac function and quality of life were associated with transcatheter tricuspid annuloplasty using the K-Clip device, according to short-term follow-up studies. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System [TriStar]; NCT05173233)

Feasibility Study of a Novel Transcatheter Tricuspid Annuloplasty System in a Porcine Model

Gradually, more attention has been paid to tricuspid regurgitation. Formerly the "forgotten valvular heart disease," it has been recognized as having high incidence and adverse prognosis if untreated. However, isolated tricuspid valve surgery carries substantial risk and is thus not recommended. The K-Clip transcatheter tricuspid annuloplasty system has recently emerged as a minimally invasive therapeutic option that may help address these unmet clinical needs. The K-Clip technology simulates the Kay's procedure, which reduces the dimensions of the tricuspid annulus by folding and clamping the tricuspid annulus issue with a rigid clamping device. The feasibility of the K-Clip technology was investigated in this study, and annulus area reduction and declining tricuspid regurgitation grades were noted following the procedure. The findings of this study suggest that the K-Clip system may potentially be applicable as a novel transcatheter tricuspid annuloplasty device for the treatment of severe tricuspid in humans.

Computationally Assessed 3D Anatomical Proximities and Spatial Relationships Among the Tricuspid Valve Annulus, Right Coronary Artery, and Triangle of Koch: Implications for Transcatheter Tricuspid Annuloplasty Repair

BackgroundTranscatheter-based annuloplasty therapies for tricuspid regurgitation have demonstrated significant development over recent years. However, the tricuspid valve and neighboring vasculature and conductive tissue regions can present anatomical and device deployment challenges. This present study investigated the anatomical dimensions and spatial relationships of the cardiac structures essential to percutaneous annuloplasty procedures: the tricuspid annulus (TA), right coronary artery (RCA), and triangle of Koch border region. MethodsMeasurements were derived from computational three-dimensional reconstructions of static magnetic resonance imaging scans of perfusion-fixed human hearts (n = 82) with preserved right-sided heart anatomies. This specimen set included heart samples presenting with prediagnosed atrioventricular valvular regurgitation. ResultsOur anatomical assessments demonstrated that the TA to RCA proximities were intensified with the presence of atrioventricular valvular regurgitation, compared with healthy heart specimens. The minimal distances were frequently located between the lateral and posterior annular points. This annular region corresponds to the RCA distal segments and posterior descending branch origins. Greater portions and incidences of the RCA coursing parallel or inferior to the TA plane were recorded for these diseased hearts. Patient demographic variables (gender, age, and body mass index) were insignificant determinants of change for a majority of our results. ConclusionsThese three-dimensional reconstructions provide insights to guide the development and future iterations of transcatheter tricuspid valve annuloplasty systems with regards to device anchoring, annular geometry, tissue proximities, and implantation considerations.

Transcatheter Treatment of Secondary Tricuspid Regurgitation With Direct Annuloplasty: Results From a Multicenter Real-World Experience.

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Arrhythmic phenotypes in patients with left ventricular non-compaction cardiomyopathy

Abstract Background Identification of pts with left ventricular non-compaction cardiomyopathy (NCCM) at high risk of life-threatening arrhythmic events is focused on clinical and instrumental criteria. The genetic component is not taken into account when deciding on a strategy for preventive measures. Purpose To analyze life-threatening arrhythmic events in pts with the arrhythmic variant of NCCM and to identify genetic factors that may increase the risk of life-threatening arrhythmic events. Methods The study included 159 pts, among whom 58 had malignant ventricular arrhythmias (mean age 43.54±11.95 years, 34/24/58.6% male). The NCCM criteria were confirmed using Echocardiography and CMR. Mutation search was carried out by the next generation sequencing (NGS) in 21 pts with nonsustained ventricular tachycardia (NVT). Results During the follow-up period (median follow-up of 36 months), life-threatening arrhythmic events (documented sustained VT, SCD with successful resuscitation and CD implantation, SCD) were registered in 29 pts (50%), and 10 pts had CD implanted. As a result of sequencing, 23.8% (5 out of 21) of pts with NVT revealed rare genetic variants with uncertain clinical significance (VUS) in 3 genes encoding ion channel proteins: KCNQ1, KCNH2 (9.5%), RYR2 (9.5%). In 9 (42.9%) pts, 10 identified mutations were localized in the genes responsible for the synthesis of sarcomeric proteins: MYBPC3 (23.8%), MYH7 (23.8%). 12 genetic variants were found in overlapping phenotypes between NCCM, ARVC and DCM: PKP2, DSP, PLN, TRPM4 (14.3%), RBM20, LDB3 (9.5%), DPP6, DTNA, NEXN in 11 (52.4%) pts. In this group of pts, the most common (81.8% of cases) were life-threatening arrhythmic events that required surgical intervention: 6 pts were implanted with CD for primary prevention of SCD, two pts - CRT-D, two pts with systolic dysfunction were performed with OHT and one patient was implanted with the Accucinch transcatheter direct mitral valve annuloplasty system. In pts with mutations in sarcomeric protein genes, CD was implanted in 4.7% of cases, and in 14.3% of pts with mutations in ion channel genes (p&amp;lt;0.01). Conclusion The presence of mutations in genes that control the functioning of ion channels in complex overlapping genotypes is an additional risk factor for ventricular arrhythmias in patients with NCCM. Determining the genetic component opens up new opportunities for personalizing the risk stratification of pts with NCCM. Funding Acknowledgement Type of funding source: None

P341Life-threatening events in patients with non-compaction cardiomyopathy and mutations in ion channel genes

Abstract Purpose to analyze life-threatening events during follow-up in patients with non-compaction cardiomyopathy (NCCM) who have mutations in the genes responsible for the functioning of ion channels. Methods the study included 64 unrelated pts (aged 38.63 ± 14.72 years, 34/53.12% male, LVEF 43.02 ± 8.65%) with criteria of NCCM confirmed by imaging techniques (echocardiography (Jenni) and cardiovascular magnetic resonance (Petersen). Mutation search was carried out by the next generation sequencing (NGS). Pathogenic mutations or rare substitutions with possible clinical significance were found in 12 unrelated pts in the ion channel genes: KCNH2, KCNJ2, CACNA1C, RYR2, HCN4, TRPM4, PKP2, TRPM4. Mutations in other genes (PLN, DSP, NOTCH1, RBM20) were detected in 4 pts (1 pathogenic and 3 VUS). Results mutations in genes associated with long QT syndrome (LQTS) were found in 5 pts with NCCM: c.3107G &amp;gt; A (p.Gly1036Asp), с.2653С&amp;gt;T (p.Arg885Cys) in KCNH2 gene (16.7%); c.T28076 (p.F936C) in CaCNA1C gene (8.3%); c.1165G &amp;gt; C (p.Asp389Asn) in KCNJ2 gene (8.3%). There was no prolongation of the QTc interval &amp;gt; 480 msec on ECG; frequent episodes of nonsustained ventricular tachycardia (VT) were recorded on 24-hour ECG-monitoring. During the follow-up period (median follow-up of 2.4 years), two pts with mutations in KCNH2 genes with suddenly developed sustained VT were implanted with ICD. A 32-year-old patient with a mutation in CACNA1C gene and ST-elevation myocardial infarction of thromboembolic genesis underwent PCI. 58-year-old patient with widening of QRS &amp;gt; 130 msec and frequent paroxysms of nonsustained VT was implanted with CRT-D. An ICD was implanted in a 60-year-old patient with a mutation c.12665_12667del(p.4223del) in the RYR2 gene and suddenly developed a sustained VT. In the remaining two pts with RYR2 gene mutations c.12272C &amp;gt; T (p.Ala4091Val), c.12944G &amp;gt; A(p.Gly4315Glu), frequent episodes of nonsustained VT were recorded, which were corrected medically. Orthotopic heart transplantation and Accucinch transcatheter direct mitral valve annuloplasty system implantation were performed in two pts with ventricular tachyarrhythmias and severe systolic and diastolic dysfunction of the left ventricle with mutations c.3224T &amp;gt; C (p.Leu1075Pro), c.1459_1494del36 (p.Lys487_Leu498del) in the TRPM4 gene. In other pts with mutations in HCN4 (8.3%), DPP6 (8.3%), PKP2 (8.3%) genes ventricular tachyarrhythmias were treated with antiarrhythmic drugs. Conclusion the presence of mutations in the genes controlling the functioning of ion channels is an additional risk factor for adverse events in patients with NCCM.

Percutaneous Mitral Valve Repair: Multi-Modality Cardiac Imaging for Patient Selection and Intra-Procedural Guidance.

Percutaneous mitral valve repair is an important procedure for patients at high risk of surgical mitral valve repair. Multi-modality Cardiac Imaging plays a key role in these procedures. MitraClip is the first and most utilized percutaneous mitral repair device and experience is has grown to treat not only typical but atypical and complex lesions. Cardioband is an emerging percutaneous annuloplasty system with promising early results. This review will focus on the comprehensive multi-modality cardiac imaging for patient selection and intra-procedural guidance of the MitraClip and Cardioband systems.

The Cardioband annuloplasty system: is it ready for prime time?

The Cardioband annuloplasty system: is it ready for prime time?

Percutaneous tricuspid annuloplasty.

Severe tricuspid regurgitation (TR) is a common problem, affecting approximately 1.6 million Americans, with the majority (85%) of TR being functional in nature. When left untreated, TR is associated with progressive right-sided heart failure, with a poor prognosis entailing high morbidity and mortality. Surgical repair is still the gold standard for TR, but only a small proportion of patients undergo surgical repair leaving a high clinical demand for alternatives to conventional surgery. Percutaneous repair and replacement of cardiac valves have exponentially advanced in the past decade, including transcatheter tricuspid valve repair. There are still anatomical challenges that need to be addressed when performing a percutaneous transcatheter annuloplasty compared to a surgical annuloplasty, such as approach, access, landing zone, proximal structures and visibility. Current percutaneous annuloplasty systems either obtain a direct (Cardioband) or indirect (TriCinch and Trialign) annuloplasty. Both direct and indirect percutaneous annuloplasties are modeled after surgical experiences. This review will investigate novel direct and indirect transcatheter annuloplasty devices for repair of severe tricuspid regurgitation.

Percutaneous tricuspid valve replacement: orthotopic and heterotopic valves.

The tricuspid valve has long been described as the "forgotten valve", leaving tricuspid valve disease relatively neglected. However, the number of people in the United States affected by severe tricuspid regurgitation is growing. Isolated surgery for severe tricuspid regurgitation in the setting of right ventricular heart failure carries a high mortality risk, and therefore, attention to corrective therapies has increased. Because of the different etiologies for tricuspid regurgitation, multiple percutaneous transcatheter options for tricuspid valve repair for severe regurgitation are being studied and have been developed, including annuloplasty systems, leaflet and coaptation devices, vena caval (heterotopic) valve implantations, and tricuspid valve (orthotopic) replacement. In this paper, we review the heterotopic and orthotopic tricuspid valve transcatheter options for severe tricuspid regurgitation.

Geometric changes in the aortic valve annulus during the cardiac cycle: impact on aortic valve repair†

The growing experience in aortic valve (AV) repair showed that annular stabilization is a crucial component to achieve stable long-term results after AV repair. Dynamic changes in the AV annulus during the cardiac cycle may have an impact on annuloplasty design. We retrospectively analysed full cardiac cycle multislice computed tomography data from 58 consecutive patients (mean age 75.9 ± 6.5 years, 36% men) with normally functioning tricuspid AVs (normal AV subgroup). The following computed tomography parameters were measured during systole and diastole: maximum, minimum and mean AV annulus diameter, AV annular area and AV annular perimeter. The AV annular eccentricity index was calculated (%) [(max AV annulus × 100/min AV annulus) - 100] in systole and diastole. Subsequently, multislice computed tomography data from 20 patients with severe aortic regurgitation were analysed [aortic valve regurgitation (AR) subgroup]. In the normal AV subgroup, there was a significant decrease in the mean AV annulus diameter from systole to diastole (i.e. 24.6 ± 2.5 mm vs 23.9 ± 2.4 mm, respectively; P < 0.001), which occurred predominantly in the short annular axis (i.e. 21.2 ± 2.4 mm in systole vs 19.9 ± 2.3 mm in diastole; P < 0.001). The mean AV annular area decreased significantly in diastole (i.e. 467.5 ± 94.5 mm2 in systole vs 444.8 ± 86.1 mm2 in diastole; P = 0.012). The annular eccentricity index increased significantly in diastole (33.0 ± 12.2% in systole vs 41.4 ± 13.5% in diastole; P < 0.001). Furthermore, we found an inverse linear correlation between the mean AV annulus diameter and the annular eccentricity index (r = -0.40, P = 0.034). The diastolic annular eccentricity index was significantly reduced in the AR subgroup (i.e. 41.4 ± 13.5% in the normal AV subgroup vs 33.7 ± 14.8% in the AR cohort; P = 0.035). The normal AV annulus undergoes important geometric deformation during the cardiac cycle that is significantly reduced in diastole in the AR scenario. A novel AV annuloplasty system should ideally adapt for this marked diastolic annular eccentricity and thereby allow for dynamic aortic root changes during the cardiac cycle.

Transcatheter mitral valve repair and replacement; current therapies and general evaluation of new approaches

There have been a revolution in catheter based therapies for structural valvular heart diseases in last decade and many incredible improvements in the percutaneous treatment of mitral and aortic valve diseases. The use of transcatheter mitral valve repair has gained widespread acceptance in worldwide. More than 50.000 patients have been treated with percutaneous edge-to-edge repair system or annuloplasty systems. Although the most experience has been obtained with MitraClip®, using of percutaneous direct and indirect annuloplasty devices have been on the forefront in recent years. In addition, the percutaneous mitral valve replacement, like the transcathater aortic valve replacement (TAVI), will also be mentioned more in the near future.

Novel Direct Annuloplasty Fastener System for Minimally Invasive Mitral Valve Repair.

The development of less invasive approaches for mitral valve repair remains an important objective, particularly in patients with multiple comorbidities. We describe a novel method to affix a mitral valve annuloplasty ring in a minimally invasive manner. A delivery apparatus for an annuloplasty fastener system was designed. Two channels were created, one for advancing the annuloplasty ring, and another to accommodate the fastener applicator. Custom designed fasteners, either with a helical-shaped screw or a strap-shaped tack structure, were tested. Fasteners were primed within an application device and automatic alignment of fasteners was achieved to allow accurate firing of the fixators securing the ring. The delivery apparatus was constructed to be deployed within a 10mm trocar through a left atrial approach. Using a cadaveric swine heart model, access to the mitral valve from the left atrium was obtained with insertion of a trocar. The delivery apparatus was accurately directed to the mitral annulus under echocardiographic guidance. Fasteners were placed along the annular plane to secure the annuloplasty ring. Both fastener designs achieved considerable fixation force; the helical-shaped screw was found to have significantly greater fixation force compared to the strap-shaped tack design. The annuloplasty ring remained intact and did not experience any structural deformity during the fixation process. The use of a novel fastener system was successful in deploying and securing a mitral valve annuloplasty ring. These promising results may have further application for minimally invasive mitral valve repairs. Additional evaluation of this procedure with pre-clinical in vivo animal studies is necessary.

Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results

BackgroundThe SCOUT (Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional Tricuspid Regurgitation) trial is a prospective, single-arm, multicenter, early feasibility study of a novel transcatheter device to plicate the tricuspid annulus (TA) and reduce tricuspid regurgitation (TR). ObjectivesThis study tested the feasibility and safety of a novel transcatheter device and assessed its early performance and functional outcomes. MethodsBetween November 2015 and June 2016, 15 patients with New York Heart Association (NYHA) functional class ≥II and moderate or greater functional TR were enrolled. Primary performance and safety endpoint outcomes were technically successful at 30 days with no reintervention. Echocardiographic measurements (TA diameter, effective regurgitant orifice area [EROA], left ventricular stroke volume [LVSV]) and quality-of-life (QoL) measurements (NYHA functional class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and 6-min walk test [6MWT]) were performed at baseline and 30 days. ResultsAll patients (mean 73.2 ± 6.9 years of age, 87% female) underwent successful device implantation with no deaths, strokes, bleeding, tamponade, or valve reintervention. Technical success rate at 30 days was 80%, with 3 single-pledget annular detachments without reintervention. In the remaining 12 patients, there were significant reductions in TA (12.3 ± 3.1 cm2 to 11.3 ± 2.7 cm2, respectively; p = 0.019) and EROA (0.51 ± 0.18 cm2 vs. 0.32 ± 0.18 cm2, respectively; p = 0.020), with significant increase in LVSV (63.6 ± 17.9 ml vs. 71.5 ± 25.7 ml, respectively; p = 0.021). In the intention-to-treat cohort, there were significant improvements in NYHA functional class (≥1 class, p = 0.001), MLHFQ (47.4 ± 17.6 to 20.9 ± 14.8; p < 0.001), and 6MWT (245.2 ± 110.1 to 298.0 m ± 107.6 m; p = 0.008). ConclusionsThe 30-day results of the SCOUT trial confirmed the safety of the novel transcatheter device, which reduced TA and EROA, increased LVSV, and improved QoL. (Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign [SCOUT]; NCT02574650.)

TCT-41 Up to two years follow up results of mitral valve transcatheter annuloplasty system for mitral reconstruction multi-center trial

TCT-41 Up to two years follow up results of mitral valve transcatheter annuloplasty system for mitral reconstruction multi-center trial

Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System

BackgroundCurrent surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required. ObjectivesThis study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system. MethodsSeventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled. ResultsDevice success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (–0.31 ± 0.4 cm) and septal-lateral dimensions (–0.21 ± 0.3 cm), a decreased MV-tenting area (–0.57 ± 1.1 cm2) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (–0.20 ± 0.4 mm) and volume (–22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%. ConclusionsPercutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).

The Mitralign transcatheter direct mitral valve annuloplasty system.

The Mitralign transcatheter direct mitral valve annuloplasty system.

The Accucinch transcatheter direct mitral valve annuloplasty system.

The Accucinch transcatheter direct mitral valve annuloplasty system.

The Cardioband transcatheter direct mitral valve annuloplasty system.

The Cardioband transcatheter direct mitral valve annuloplasty system.