Mitral valvuloplasty using real-time three-dimensional transesophageal echocardiography.

OBJECTIVE: This study aimed to investigate the structure of the mitral valve in patients undergoing mitral valvuloplasty (MVP) using real-time three-dimensional transesophageal echocardiography (RT-3D-TEE). The main objective was to study the relationship between intraoperative annuloplasty ring size and mitral valve structure dimensions, with a focus on exploring the application value of RT-3D-TEE in MVP. METHODS: A total of 28 patients with degenerative mitral regurgitation (DMR), who underwent MVP between February and September 2022, as well as 12 normal control cases, were enrolled in this study. The MV annulus and leaflets were quantitatively analyzed using MVN software. RESULTS: The DMR group exhibited significantly greater dimensions in various parameters of the mitral valve, including the anterolateral-to-posteromedial diameter (DAlPm ), anterior-to-posterior diameter (DAP ), annulus height (HA ), three-dimensional annulus circumference (CA3D ), two-dimensional annulus area (AA2D ), anterior leaflet area (Aant ), posterior leaflet area (Apost ), anterior leaflet length (Lant ), posterior leaflet length (Lpost ), and tenting volume (Vtent ) compared to the control group. CONCLUSION: Real-time three-dimensional transesophageal echocardiography provides valuable insights into the morphological structure of the mitral valve and lesion location. It can aid in surgical decision-making, validate the success of MVP, and potentially reduce mortality and complications associated with mitral valve repair procedures.

Ex vivo biomechanical analysis of flexible versus rigid annuloplasty rings in mitral valves using a novel annular dilation system.

BACKGROUND: Mitral annuloplasty rings restore annular dimensions to increase leaflet coaptation, serving a fundamental component in mitral valve repair. However, biomechanical evaluations of annuloplasty rings are lacking. We aim to biomechanically analyze flexible and rigid annuloplasty rings using an ex vivo mitral annular dilation model. METHODS: Juvenile porcine mitral valves (n = 4) with intercommissural distance of 28 mm were dilated to intercommissural distances of 40 mm using a 3D-printed dilator and were sewn to an elastic mount. Fiber bragg grating sensors were anchored to native chordae to measure chordal forces. The valves were repaired using size 28 rigid and flexible annuloplasty rings in a random order. Hemodynamic data, echocardiography, and chordal force measurements were collected. RESULTS: Mitral annular dilation resulted in decreased leaflet coaptation height and increased mitral regurgitation fraction. Both the flexible and rigid annuloplasty rings effectively increased leaflet coaptation height compared to that post dilation. Rigid ring annuloplasty repair significantly decreased the mitral regurgitation fraction. Flexible annuloplasty ring repair reduced the chordal rate of change of force (7.1 ± 4.4 N/s versus 8.6 ± 5.9 N/s, p = 0.02) and peak force (0.6 ± 0.5 N versus 0.7 ± 0.6 N, p = 0.01) compared to that from post dilation. Rigid annuloplasty ring repair was associated with higher chordal rate of change of force (9.8 ± 5.8 N/s, p = 0.0001) and peak force (0.7 ± 0.5 N, p = 0.01) compared to that after flexible ring annuloplasty repair. CONCLUSIONS: Both rigid and flexible annuloplasty rings are effective in increasing mitral leaflet coaptation height. Although the rigid annuloplasty ring was associated with slightly higher chordal stress compared to that of the flexible annuloplasty ring, it was more effective in mitral regurgitation reduction. This study may help direct the design of an optimal annuloplasty ring to further improve patient outcomes.

Aortic Valve Repair Using HAART 300 Geometric Annuloplasty Ring: A Review and Echocardiographic Case Series.

Aortic valve repair (AVr) aims to preserve the native aortic leaflets and restore normal valve function. In doing so, AVr is a more technically challenging approach than traditional aortic valve replacement. Some of the complexity of repair techniques can be attributed to the unique structure of the functional aortic annulus (FAA), which, unlike the well-defined mitral annulus, is comprised of virtual and functional components. Though stabilizing the ventriculo-aortic junction (VAJ), a component of the FAA, is considered beneficial for patients with chronic aortic insufficiency (AI), the ideal AVr technique remains a subject of much debate. The existing AVr techniques do not completely stabilize the VAJ which may increase susceptibility to recurrent AI due to VAJ dilation. An emerging new technique showing promise for the treatment of both isolated and complex AI is AVr using HAART 300TM geometric annuloplasty ring (GAR). The GAR is implanted below the valve leaflets in the left ventricular outflow tract (LVOT), providing stability and creating a neo-annulus. As with other AVr subtypes, this procedure has a learning curve. There are unique surgical and echocardiographic aspects of AVr with GAR, including the appearance of the LVOT, the aortic valve leaflets, and their motion which cardiac anesthesiologists and echocardiographers must be familiar with. In this work, using an eight-patient echocardiographic case series, we provide an overview of this novel AVr technique, including some unique aspects of device sizing, patient selection, expected post-repair echocardiographic features, and a review of outcomes data.

Transcatheter tricuspid valve replacement in dehisced flexible ring.

Transcatheter tricuspid valve-in-surgical annuloplasty ring is an appealing concept in light of the high mortality associated with reoperation on the tricuspid valve. The clinical necessity of this procedure is derived from a considerable failure rate of tricuspid repairs over time. The presented case demonstrates that transcatheter valve-in-ring is a feasible option for patients with flexible tricuspid ring even in the context of significant ring dehiscence. Meticulous procedural planning, preemptively addressing a potential paravalvular leak, and clear understanding of the intricate three-dimensional anatomy are imperative for procedural success.

A modern approach to aortic valve insufficiency: Aortic root restoration via HAART 300 internal annuloplasty ring.

BACKGROUND AND AIM OF THE STUDY: HAART 300 is an internal geometric annuloplasty ring. The safety and efficacy of this novel device in aortic valve (AV) repair in a single referral center are reported. METHODS: Twenty patients with trileaflet AV insufficiency with ascending aorta and/or aortic root enlargement were included. Subannular implantation was performed to correct annular dilatation, whereas concomitant leaflet repair was performed whenever required. All but two patients also received ascending aorta replacement, whereas selective sinus replacement was performed in all but five patients. RESULTS: Follow-up was for a maximum of 3.8 years and a mean of 2.2 years. Mean age was 54.2 years old. Moderate to severe preoperative AV insufficiency was noted in 75% of patients, whereas 70% of them had an ascending aorta over 45 mm. One patient was lost from follow-up. Overall mortality as well as major complication rates were zero. Early postoperatively, no more than mild AV regurgitation was detected, whereas only one patient appeared with moderate AV regurgitation during our 2.2-year follow-up. New York Heart Association class was also significantly lower compared to preoperative values and valve gradients remained low at last follow-up. CONCLUSIONS: Geometric ring annuloplasty is a safe and effective valve sparing approach to deal with AV insufficiency contributing to overall root reconstruction. Short-term results are excellent rendering this easily reproducible and versatile method very attractive.

Mechanical properties of a new thermally deformable mitral valve annuloplasty ring and its effects on the mitral valve.

Ideally, an annuloplasty ring's shape should be changed intraoperatively if mitral valve repair is unsuccessful because of a short coaptation length or systolic anterior motion. Several post-implantation adjustable rings have been developed, but they are not freely deformable and are unsuitable for asymmetric repair of the valvular annulus. We developed a novel thermally deformable mitral annuloplasty ring to address these problems and assessed the ring's mechanical properties and its effect on the mitral valve anatomy. This ring was made of polycaprolactone. Tensile and bending tests were performed to evaluate the ring's mechanical properties. The ratio of the transverse and septal-lateral length was determined as 4:3. Using 10 pig hearts, we measured the post-deformation coaptation length and minimum distance from the coaptation to the ventricular septum, which is a factor of abnormal systolic anterior motion of the mitral valve. In the mechanical tests, the ring's yield point was greater than the deformation force of the annulus in humans. In pigs with deformation from "4:3" to "4:2", the coaptation length was significantly increased in each mitral valve part. In pigs with deformation from "4:3" to "4:4", the minimum distance from the coaptation to the ventricular septum was significantly increased. Asymmetrical ring deformation increased the coaptation length only at the deformed area. In conclusion, this new thermally deformable mitral annuloplasty ring could be "order-made" to effectively change the coaptation length in all parts of the mitral valve and the distance from the coaptation to septum post-deformation via intraoperative heating.

Biocompatibility and Systemic Safety of a Novel Implantable Annuloplasty Ring for the Treatment of Mitral Regurgitation in a Minipig Model.

Prosthetic annuloplasty rings are a common treatment modality for mitral regurgitation, and recently, percutaneous implantation techniques have gained popularity due to their favorable safety profile. Although in common use, biocompatibility of annuloplasty rings has been reported only sparsely in the literature, and none of these reports used the percutaneous technique of implantation. We report on the biocompatibility and the systemic safety of a novel transcatheter mitral valve annuloplasty ring (AMEND™) in 6 minipigs. This device is composed of a nitinol tube surrounded by a braided polyethylene terephthalate fabric tube. The device produced no adverse inflammatory response, showing gradual integration between the metal ring and the fabric by normal host fibrocellular response, leading to complete neoendocardium coverage. There was no evidence for adverse reactions, rejection, or intolerance in the valvular structure. In 2 animals, hemopericardium resulted from the implantation procedure, leading to right-sided cardiac insufficiency with pulmonary edema and liver congestion. The findings reported herein can serve as a case study for the expected healing pathology reactions after implantation of transcatheter mitral valve annuloplasty rings.

Three-dimensional dynamic morphology of the mitral valve in different forms of mitral valve prolapse - potential implications for annuloplasty ring selection.

BACKGROUND: Real-time three-dimensional transesophageal echocardiography has increased our understanding of the distinct pathomechanisms underlying functional, ischaemic or degenerative mitral regurgitation. However, potential differences in dynamic morphology between the subtypes of degenerative mitral prolapse have scarcely been investigated. METHODS: In order to compare the dynamic behavior of the different phenotypes of degenerative mitral valve prolapse, real-time three-dimensional transesophageal echocardiography recordings of 77 subjects, 27 with Barlow disease (BD), 32 with Fibroelastic deficiency (FED) and 18 normal controls (NC) were analysed. RESULTS: Geometric annular and valvular parameters of the myxomatous patients were significantly larger compared to controls (BD vs. FED vs. NC 3D annular area: 15 ± 2.8 vs. 13.3 ± 2.4 vs. 10.6 ± 2.3cm(2), all p < 0.01). Beside similar ellipticity, BD annuli were significantly flatter compared to FED. Myxomatous annuli appeared less dynamic than normals, with decreased overall 3D area change, however only the BD group differed from NC significantly (BD vs. FED vs. NC normalized 3D area change 4.40 vs. 6.81 vs. 9.69 %; BD vs. NC p = 0.000; FED vs. NC p = not significant, BD vs. FED p = 0.025). CONCLUSION: BD and FED differ not only in terms of valve morphology, but also annular dynamics. Both pathologies are characterized by annular dilatation. However, in BD the annulus is remarkably flattened and hypodynamic, whereas in FED its saddle-shape and contractile function is relatively preserved. These features might influence the choice of repair technique and the selection of annuloplasty ring.

Clinical and echocardiographic results of the MEMO 4D semi-rigid annuloplasty ring.

BACKGROUND: Mitral regurgitation is a frequent valvular disease, with an increasing prevalence. We analyzed the short-term outcomes of mitral valve repair procedures conducted in our clinic using a new semirigid annuloplasty ring featuring a gradual saddle shape design. METHODS: We retrospectively analyzed mitral valve repair surgeries performed at our Institution between December 2019 and November 2021 with the MEMO 4D semirigid annuloplasty ring. RESULTS: In total, 53 patients were included in the study. Mean patient age was 63.6 ± 11.7 years. Most patients presented with degenerative mitral valve regurgitation (N = 44; 83%). The grade of mitral regurgitation was equal or more than 3 + in 98.1% of the patients (N = 52). The most used ring size was size 34 mm (N = 30, 56.6%). There was no intraoperative or hospital mortality. No cases of stroke, bleeding, endocarditis or other major complications occurred. At discharge, most patients were in NYHA class I. Postoperative echocardiographic results showed no (90.6%) or 1+ (5.7%) mitral valve regurgitation. Only 1 patient (1.9%) presented with mitral valve regurgitation grade 2+. Mean postoperative transvalvular gradient was low (mean = 3.3 ± 1.2 mmHg). No cases of LVOT obstruction or systolic anterior motion occurred. CONCLUSIONS: Our series showed excellent mitral valve competency and very satisfactory early clinical outcomes. The transesophageal echocardiographic follow-up, despite obtained in a limited number of patients, further confirmed the effectiveness of findings of this preliminary experience.

Transjugular tricuspid valve-in-ring replacement using the novel system under three-dimensional printing guidance.

Recurrent tricuspid regurgitation after failed ring annuloplasty is associated with high mortality rates and unfavourable clinical outcomes. Transcatheter tricuspid valve-in-ring (TVIR) replacement offers an alternative to high-risk surgical reoperation, but challenges remain. We present a case of a 67-year-old male who underwent tricuspid annuloplasty 3 years ago and developed severe recurrent tricuspid regurgitation (regurgitation volume = 36 mL) 6 months ago. To avoid a high-risk thoracotomy, we finally performed TVIR replacement using the novel device, LuX-Valve Plus system, via the transjugular approach. Cardiovascular three-dimensional printing technology was utilized to investigate the distinct advantages offered by the new device in this specific intervention, as well as to simulate the procedure. Successful TVIR replacement resulted in significant symptomatic improvement. TVIR replacement with the LuX-Valve Plus system is feasible for failed annuloplasty ring cases. Patient-specific three-dimensional printed models enable personalized procedural planning, enhancing safety and precision.

A 3D-Printed Externally Adjustable Symmetrically Extensible (EASE) Aortic Annuloplasty Ring for Root Repair and Aortic Valve Regurgitation.

PURPOSE: The valve-sparing aortic root replacement (VSARR) procedure was developed to preserve the aortic valve apparatus to replace aneurysmal aortic roots with synthetic grafts and to eliminate associated aortic regurgitation (AR). However, residual post-repair AR is not uncommon and has been found to be associated with recurrent AR and future reoperation. METHODS: We designed and manufactured a 3D-printed, external adjustable symmetrically extensible (EASE) aortic annuloplasty ring that can symmetrically reduce the aortic annulus diameter via a radial constriction, compliant mechanism. An ex vivo porcine VSARR model with annular dilation and AR was developed (n = 4) and used for hemodynamic, echocardiography, and high-speed videography data collection. RESULTS: After ring annuloplasty repair using the EASE aortic ring, the regurgitant fraction decreased from 23.6 ± 6.9% from the VSARR model to 7.4 ± 5.6% (p = 0.05), which was similar to that measured from baseline with a regurgitant fraction of 10.2 ± 3.9% (p = 0.34). The leaflet coaptation height after annuloplasty repair also significantly increased from that measured in VSARR model (0.4 ± 0.1 cm) to 0.9 ± 0.1 cm (p = 0.0004), a level similar to that measured in baseline (1.1 ± 0.1 cm, p = 0.28). CONCLUSION: Using an ex vivo VSARR model, the EASE ring successfully reduced AR by reducing the annular diameter and improving leaflet coaptation. With its broad applicability and ease of use, this device has the potential to have a significant impact on patients suffering worldwide from AR due to root aneurysms.

The study of loading mode with in-vitro fatigue testing for mitral annuloplasty ring.

To maintain the physiological dynamics of the mitral annulus, mitral annuloplasty rings (MAR) must be flexible. Enhanced flexibility implies decreased resistance to fatigue and potential for fatigue fracture. This study established new methods to test the flexible fatigue life of MAR in-vitro using numerical analysis; the purpose is that the fatigue test could reflect the real stress distribution in-vivo. Based on the conventional test methods (C1, D1), this paper presents a novel test method (C2, D2). Four testing methods for open-end annuloplasty rings (C1, C2) and closed-end annuloplasty rings (D1, D2) were modelled and their stress distribution calculated by finite element analysis. The mean absolute error (Χ) and the Pearson correlation coefficient (Φ) were used to quantify the difference in stress distribution between the loading modes in-vivo and in-vitro. For closed-end annuloplasty rings, the novel test method (D2) is not obvious better than conventional test methods(D1) in duplicating the stress distribution (ΦD1 = 0.88 vs ΦD2 = 0.92). However, the maximum values of stress in the novel test method are closer to the maximum value of stress under in-vivo loading (ΧD1 = 5.2Mpa vs ΧD2 = 4.4Mpa). For open-end annuloplasty rings, the novel test method(C2) is obviously superior to the conventional test method(C1) in duplicating both the stress distribution and the stress peak values of the in-vivo loading (ΦC1 = 0.22 vs ΦC2 = 0.98; ΧC1 = 59.1Mpa vs ΧC2 = 11.0Mpa). The in-vitro loading methods described in this article more closely approximated in-vivo conditions compared to traditional methods. They are simpler to operate, more efficient and can help manufacturers expedite new product development, assist regulatory agencies with product quality oversight.

Entire Mitral Valve Reconstruction Using Porcine Extracellular Matrix: Adding a Ring Annuloplasty.

PURPOSE: This study investigated the implications of inserting a flexible annuloplasty ring after reconstructing the entire mitral valve in a porcine model using a previously investigated tube graft design made of 2-ply small intestinal submucosa extracellular matrix (CorMatrix®). METHODS: An acute model with eight 80-kg pigs, each acting as its own control, was used. The entire mitral valve was reconstructed with a 2-ply small intestinal submucosa extracellular matrix tube graft (CorMatrix®). Subsequently, a Simulus® flexible ring was inserted. The characterization was based on mitral annular geometry and valvular dynamics with sonomicrometry and echocardiography. RESULTS: After adding the ring annuloplasty, the in-plane annular dynamics were more constant throughout the cardiac cycle compared to the reconstruction alone. However, the commissure-commissure distance was statistically significantly decreased [35.0 ± 3.4 mm vs. 27.4 ± 1.9 mm, P < 0.001, diff = - 7.6 mm, 95% CI, - 9.8 to (-5.4) mm] after ring insertion, changing the physiological annular D-shape into a circular shape which created folds at the coaptation zone resulting in a central regurgitant jet on color Doppler. CONCLUSION: We successfully reconstructed the entire mitral valve using 2-ply small intestinal submucosal extracellular matrix (CorMatrix®) combined with a flexible annuloplasty. The annuloplasty reduced the unphysiological systolic widening previously found with this reconstructive technique. However, the Simulus flex ring changed the physiological annular D-shape into a circular shape and hindered a correct unfolding of the leaflets. Thus, we do not recommend a flexible ring in conjunction with this reconstructive technique; further investigations are needed to discover a more suitable remodelling annuloplasty.

Conformational changes during in vitro balloon fracture of internal aortic annuloplasty ring.

Objective: HAART 300 300 (BioStable Science and Engineering, Inc) aortic annuloplasty rings restore physiologic annular geometry during aortic valve repair. Transcatheter valve-in-ring implantation is appealing for recurrent valve dysfunction but may necessitate balloon fracture of downsized annuloplasty rings. We characterized the feasibility of ring fracture and changes in ring geometry preceding fracture. Methods: The 19-mm, 21-mm, and 23-mm HAART 300 annuloplasty rings were obtained, and 23-mm, 24-mm, 25-mm, and 26-mm valvuloplasty balloons were obtained. Under continuous fluoroscopy and video recording, a 23-mm balloon was inflated within a 19-mm ring at 1 atm/s until ring fracture or balloon failure occurred. If balloon failure occurred, experiments were sequentially repeated with 1-mm upsized balloons until ring fracture occurred or no larger-sized balloons were available. Results: Upon balloon inflation, all rings exhibited an irreversible conformational change from an elliptical, annular geometry to a circular shape with ring posts flaring outward. A 23-mm balloon burst at 21 atm without fracturing the 19-mm ring. The 24-mm balloon fractured the 19-mm ring at 15 atm. Likewise, a 24-mm balloon ruptured at 18 atm without fracturing the 21-mm annuloplasty ring. A 25-mm balloon fractured the 21-mm ring at 18 atm. Finally, a 26-mm balloon burst at 20 atm without fracturing a 23-mm annuloplasty ring, but it did elicit the confirmational changes described. All fractures occurred along the upslope of a ring post. The exposed metal frame was visible after the 21-mm ring fracture. Conclusions: Fracture of HAART 300 aortic annuloplasty rings is possible with an oversized, high-pressure balloon. However, the geometrical changes in the ring and subsequent rupture of its fabric covering may be obstacles to safe, in vivo ring fracture.

Suture tie-down forces and cyclic contractile forces after undersized tricuspid annuloplasty using a Tri-Ad Adams tricuspid annuloplasty ring in an ovine model.

OBJECTIVES: This study evaluated suture tie-down forces and cyclic contractile forces (CCFs) after undersized tricuspid annuloplasty using a hybrid band. METHODS: Downsized tricuspid annuloplasty was planned in adult male sheep using 8 force transducers attached from the septal to the anterior annular areas of the ring (segments 1 and 2, flexible septal; segments 3 and 4, semi-rigid posterior; segments 5 and 6, semi-rigid anterior; segments 7 and 8, flexible anterior). CCFs were analysed at 3 different levels of peak right ventricular pressure (RVP): 30, 50 and 70 mmHg. RESULTS: Eight 5-year-old male Corriedale sheep (average body weight = 66.8 kg) were used. The average suture tie-down force was 4.42 [standard deviation (SD): 2.32] N. When the forces were compared, it was lowest in the flexible anterior area and highest in the flexible septal area (P < 0.001). With the RVP of 30 mmHg, the average CCFs was lowest at segment 3 [0.07 (SD: 0.07) N] and highest at segment 7 [0.15 (SD: 0.08) N]. The CCFs were 0.12 (SD: 0.1) N, 0.09 (SD: 0.12) N, 0.14 (SD: 0.1) N and 0.13 (SD: 0.09) N in the flexible septal, semi-rigid posterior, semi-rigid anterior and flexible anterior parts, respectively (P = 0.208). As the peak RVP increased to 50 and 70 mmHg, the CCFs of each area increased significantly (P < 0.001). Despite this increase, the CCFs remained low (0.1 and 0.3 N), and differences in CCFs between segments and between annular areas showed similar patterns. CONCLUSIONS: The flexible end of the hybrid band reduces the CCFs and might prevent annular tears after ring tricuspid annuloplasty, and the risk of tear would be low even in the septal area.

Mid-term outcomes of aortic valve repair using an anatomically shaped internal annuloplasty ring.

OBJECTIVES: The Hemispherical Aortic Annuloplasty Reconstructive Technology (HAART) ring is a rigid, internal and geometric device. The objective of this article is to assess the mid-term outcomes of aortic valve repair (AVr) using this prosthesis. METHODS: A prospectively maintained database was used to obtain outcomes for adult patients undergoing AVr using the HAART ring between September 2017 and June 2023. All aortic patients at our institution undergo life-long surveillance with regular assessment and valve imaging. RESULTS: Seventy-one patients underwent AVr using the HAART device: 53 had a trileaflet valve and 18 a bicuspid valve. The median age was 54 years, and most were male (79%). Many required concomitant intervention: 46% had a root procedure and 77% an arch repair. There were no in-hospital deaths, and the median postoperative stay was 5 days. At a mean follow-up of 3.9 (±1.1) years, freedom from reoperation was 94%. Late imaging demonstrated: zero trace (25%), 1+ (54%), 2+ (15%) and 4+ (6%) aortic insufficiency (AI). Eleven patients have ≥moderate AI under surveillance, all of whom have a trileaflet valve (21% of trileaflet patients). Four patients required reoperation: 3 for ring dehiscence and 1 for endocarditis. CONCLUSIONS: Although early results using the HAART device are encouraging, mid-term results raise concern as 21% of trileaflet patients developed recurrent ≥moderate AI by 4 years post-repair. We experienced 3 incidences of ring dehiscence requiring reoperation. Based on this, we recommend caution using the sub-annular approach for stabilization in patients with trileaflet aortic valves. Long-term results are needed to assess outcomes against established techniques.

Transapical Mitral Valve-in-Ring Replacement Using the Innovative System under 3-Dimensional Printing Guidance.

BACKGROUND: Transcatheter mitral valve-in-ring replacement (TMViR) is an emerging alternative for patients with recurrent mitral regurgitation (MR) after a prior failed annuloplasty ring. However, intraoperative common issues and complications remain to be addressed. CASE SUMMARY: We describe the case of a 67-year-old male patient who underwent surgical mitral concomitant tricuspid annuloplasty repair 7 years ago who developed recurrent severe MR (New York Heart Association functional class IV). To avoid a high-risk surgical reoperation, we chose to perform a TMViR using an innovative dedicated device-the Mi-thos system-via a transapical approach. A patient-specific, 3-dimensional printed model was used to guide the procedure to avoid potential challenges. The procedure was performed successfully, and the patient exhibited symptomatic improvement. CONCLUSIONS: This case report highlights the first use of the innovative Mi-thos system in a TMViR procedure. The findings demonstrate the feasibility and safety of utilizing the Mi-thos system, guided by 3-dimensional printing technology, for patients who have experienced recurrent mitral regurgitation MR following a failed annuloplasty ring.

Long-term results of tricuspid valve repair using three-dimensional versus flexible rings in patients with functional tricuspid regurgitation.

OBJECTIVES: Significant functional tricuspid regurgitation (TR) should be corrected in patients undergoing surgery for left-sided valvular diseases. We hypothesized that ring type may affect outcomes in tricuspid annuloplasty. Herein, we report our experience with three-dimensional semi-rigid rings compared to open simple-band annuloplasty. METHODS: This is a retrospective study that included all patients who underwent tricuspid annuloplasty concomitant to left-sided valvular surgery. The study's main outcome measure was long-term recurrent TR probability. RESULTS: Of the 781 study patients, 611 (78%) underwent annuloplasty using flexible band and 170 (22%) underwent rigid ring implantation. Early mortality did not differ significantly between the rigid and flexible groups (4.4% vs 4.1%, P = 1.000). Long-term mortality was similar between the groups [hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.69-1.36, P = 0.847]. At a mean follow-up of 62 (50) months, freedom from TR grade 3+/4+ was 96.4% and 96.7% in the rigid and flexible groups, respectively (HR 1.41, 95% CI 0.55-3.61, P = 0.476). Furthermore, 2.4% of the rigid and 1.3% of the flexible groups required reoperation (HR 1.01, 95% CI 0.21-4.82, P = 0.988). Multivariable analysis demonstrated that rheumatic valve aetiology (HR 1.92, CI 1.04-2.98, P = 0.042) and mitral stenosis (HR 1.44, CI 1.01-2.2, P = 0.044) were predictors for recurrent TR (3+/4+). Ring type was not associated with recurrence (HR 0.86, 95% CI 0.3-2.47, P = 0.787). CONCLUSIONS: Open bands performed at least as well as three-dimensional rings. Our results suggest that late clinical results of tricuspid annuloplasty depend on left-sided pathology and patient factors and less on the type of ring used.

Safety and Effectiveness Outcomes of a Novel Automated Titanium Suture Fastener Device Applied for Heart Valve Surgery in an Ovine Model.

OBJECTIVE: This study was designed to evaluate the operability, effectiveness, and safety of the automated titanium suture fastener in a preclinical ovine model in comparison with manual tying in a mitral valve annuloplasty ring implantation surgery. METHODS: Eighteen adult Small-tailed Han sheep were prepared for the surgery of mitral valve annuloplasty ring implantation through lateral thoracotomy under cardiopulmonary bypass (CBP). A total of 12 stitches were performed to secure an annuloplasty ring, with 6 stitches done with the automated fastener and the other 6 by manual tying. The knotting time for the automated fastener or manual tying was recorded, respectively. The firmness of knots, mitral valve integrity, biocompatibility, thrombosis, local reactions, and other aspects were also compared at follow-up time (Days 30, 60, 90, and 180). RESULTS: Of the 18 sheep, 16 survived to the designated endpoints and were enrolled for further analysis. Compared with the control group, the knotting time was significantly reduced with the automated fastener (p < 0.01). All the annuloplasty rings were tightly secured by 6 fastener clips and 6 hand-made knots without any disengagement or displacement. All the mitral valves were intact without any defect, stenosis, prolapse, valve insufficiency, or perforation. Endothelialization was comparable between the two groups by Day 60. Small red thrombi formed at the thread end of the suture in both groups. No thrombus was found on the surface of the titanium clip. All the thrombi were within the acceptable range for the antithrombotic property. Thrombosis showed no significant difference by Day 60. No significant differences in the inflammatory response and pathological lesions were observed by Day 60. One case of diffuse renal infarction (area ratio = 20%) and 1 case of small focal renal infarction (area ratio < 5%) were caused by thromboembolism. CONCLUSIONS: The automated fastener significantly shortened the procedure time of tying knots for the implantation of the annuloplasty ring in the ovine model, with comparable safety and effectiveness as manual tying.