Mitral Valve Implantation Research Articles

TCT-940 A Comparative Study of TENDYNE and Traditional Transcatheter Mitral Valve Implantation on Reverse Remodeling and Outcome

TCT-940 A Comparative Study of TENDYNE and Traditional Transcatheter Mitral Valve Implantation on Reverse Remodeling and Outcome

Delayed Intervention’s Impact on Transcatheter Mitral Valve Implantation Strategy

Delayed Intervention’s Impact on Transcatheter Mitral Valve Implantation Strategy

Transcatheter Mitral Valve Implantation in a Failed Surgical Ring: Limitations of the Interventional Approach

Transcatheter Mitral Valve Implantation in a Failed Surgical Ring: Limitations of the Interventional Approach

Outcomes after transcatheter mitral valve implantation in valve-in-valve, valve-in-ring, and valve-in-mitral annular calcification.

We aimed to evaluate transcatheter mitral valve implantation (TMVI) using predominantly balloon-expandable transcatheter heart valves (THV) in patients with a landing zone for a percutaneously delivered prosthesis. Patients with a degenerated mitral valve bioprosthesis, annuloplasty ring, and mitral annulus calcification (MAC) considered at high surgical risk currently represent a treatment challenge. TMVI is an alternative treatment option. Retrospective analysis of patients with symptomatic degenerated mitral valve bioprosthesis, or annuloplasty ring, and MAC treated with TMVI between November 2011 and April 2021. Endpoints were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria and included device and procedure success at 30 days as well as mortality at 30 days and 1 year after the procedure. A total of 77 patients underwent TMVI (valve in valve [ViV = 56], valve in ring [ViR = 11], and valve in MAC [ViMAC = 10]). There was a trend toward higher technical success (all = 93.5%, ViV = 96.4%, ViR = 90.9%, ViMAC = 80%, p = 0.06) and lower 30-day (all = 11.7%, ViV = 10.7%, ViR = 9.1%, ViMAC = 20%, p = 0.49) and 1-year mortality (all = 26%, ViV = 23.2%, ViR = 27.3%, ViMAC= 40%, p = 0.36) after ViV and ViR compared to ViMAC. TMVI represents a reasonable treatment option in selected patients with MAC or who are poor candidates for redo mitral valve surgery. Technical success and survival up to 1 year were not significantly dependent on the subgroup in which TMVI was performed.

Case Series of First Microinvasive Fully Endoscopic Use of a New Mitral Prosthesis.

The use of bioprostheses is increasing in younger patients, but it is associated with the risk of later valve deterioration, especially in the mitral position. A new bioprosthesis for mitral valve replacement offers possible longer-term durability and improved hemodynamics. Objectives: Here, we report the implantation of the novel Edwards MITRIS RESILIA mitral valve (Edwards Lifesciences Inc., Irvine, CA, USA) through microinvasive fully endoscopic access as an innovative surgical approach based on a series of twelve patients. Methods: Contrast-based ECG gated CT was preoperatively performed in all patients to determine the intravascular calcifications and vascular parameters, as well as to assess noticeable problems during the operation. CT software for cardiac interventions (3Mensio Medical Imaging BV) was used to simulate surgical prostheses digitally inside the native annulus. With this, a digital LVOT and neo LVOT was created, and the difference between the valve prostheses was measured. Implantation of the MITRIS RESILIA valve was performed in 12 patients according to the instructions for use through microinvasive access in a fully endoscopic fashion using 3D visualization. Results: The mean patient age was 56.50 years, and 7/12 (58.33%) were redo procedures. All patients survived the first 30 days after the procedure, the mean aortic cross-clamp time was 40.17 ± 13.72 min. and mean postoperative transvalvular gradient was 4.45 ± 1.74 mmHg. The neo LVOT in the CT-based simulation was measured with an average area of 414.98 ± 88.69 mm2. The average difference between the LVOT and neo LVOT area was 65.35 ± 34.99 mm2. There was no case of paravalvular leakage or obstruction of the left ventricular outflow tract. Conclusions: The novel MITRIS RESILIA valve is a promising new bioprosthesis for mitral valve replacement that offers improved features as compared to other prostheses. The ease of implantation is increased by this prosthesis by the improved pliability of the sewing cuff and the inward folding of the struts, which was confirmed by short operative times in our series.

Chimney technique for recurrent mitral regurgitation posttransapical transcatheter aortic valve implantation and transcatheter edge-to-edge repair

Chimney technique for recurrent mitral regurgitation posttransapical transcatheter aortic valve implantation and transcatheter edge-to-edge repair

Ten-Year Experience with a Transapical Approach for Transcatheter Aortic and Mitral Valve Implantation.

The transfemoral approach represents the optimal access for TAVI due to its low invasiveness; however, up to 10-15% of TAVI candidates are considered unsuitable for femoral access because of significant peripheral vascular disease and need alternative access. This is a single-center retrospective observational study including all consecutive adult patients undergoing transcatheter procedures through a TA approach from March 2015 to April 2024. 213 patients underwent transcatheter aortic or mitral valve implantation through a TA approach and were enrolled in this study. The mean age of the patients was 79.5 ± 5.7 years, and 54% of the patients were males. The mean Euroscore II was 7.9 ± 6.4%. One-third of the patients had previous cardiac surgery. The overall mean survival time was 5.3 ± 0.3 years. Nine (4%) patients developed infective endocarditis (IE) during the follow-up. The transapical approach for transcatheter procedures is a safe and effective procedure for patients unsuitable for TF access with low periprocedural mortality and a low rate of post-procedural complications when performed by experienced surgeons and cardiologists.

Predictive nomogram for 28-day mortality risk in mitral valve disorder patients in the intensive care unit: A comprehensive assessment from the MIMIC-III database

BackgroundMitral valve disorder (MVD) stands as the most prevalent valvular heart disease. Presently, a comprehensive clinical index to predict mortality in MVD remains elusive. The aim of our study is to construct and assess a nomogram for predicting the 28-day mortality risk of MVD patients. MethodsPatients diagnosed with MVD were identified via ICD-9 code from the MIMIC-III database. Independent risk factors were identified utilizing the LASSO method and multivariate logistic regression to construct a nomogram model aimed at predicting the 28-day mortality risk. The nomogram's performance was assessed through various metrics including the area under the curve (AUC), calibration curves, Hosmer-Lemeshow test, integrated discriminant improvement (IDI), net reclassification improvement (NRI), and decision curve analysis (DCA). ResultsThe study encompassed a total of 2771 patients diagnosed with MVD. Logistic regression analysis identified several independent risk factors: age, anion gap, creatinine, glucose, blood urea nitrogen level (BUN), urine output, systolic blood pressure (SBP), respiratory rate, saturation of peripheral oxygen (SpO2), Glasgow Coma Scale score (GCS), and metastatic cancer. These factors were found to independently influence the 28-day mortality risk among patients with MVD. The calibration curve demonstrated adequate calibration of the nomogram. Furthermore, the nomogram exhibited favorable discrimination in both the training and validation cohorts. The calculations of IDI, NRI, and DCA analyses demonstrate that the nomogram model provides a greater net benefit compared to the Simplified Acute Physiology Score II (SAPSII), Acute Physiology Score III (APSIII), and Sequential Organ Failure Assessment (SOFA) scoring systems. ConclusionThis study successfully identified independent risk factors for 28-day mortality in patients with MVD. Additionally, a nomogram model was developed to predict mortality, offering potential assistance in enhancing the prognosis for MVD patients. It's helpful in persuading patients to receive early interventional catheterization treatment, for example, transcatheter mitral valve replacement (TMVR), transcatheter mitral valve implantation (TMVI).

Early outcomes of transapical mitral valve implantation versus surgical replacement in matched elderly patients at intermediate surgical risk.

Data comparing transcatheter mitral valve implantation (TMVI) with surgical mitral valve replacement (SMVR) are lacking. This study sought to compare the 30-day Valve Academic Research Consortium (VARC)-3 device success of TMVI with that of SMVR. Matching protocol combined exact matching (sex, atrial fibrillation, previous surgical aortic valve replacement [SAVR] or coronary artery bypass grafting [CABG]), coarsened exact matching (age) and propensity score matching (body mass index, mitral valve pathology and concomitant tricuspid regurgitation). A total of 40 Tendyne TMVI and 80 SMVR patients with similar baseline characteristics were analysed (TMVI vs SMVR): age (78 years [interquartile range [{IQR} 75; 80] vs 78 years [IQR 73; 80]; p=0.8), female (60% vs 60%; p=1.0), atrial fibrillation (67.5% vs 63.7%; p=0.8), previous SAVR (12.5% vs 10.0%; p=0.8), previous CABG (20.0% vs 16.2%; p=0.8), body mass index (25.54 kg/m² vs 25.24 kg/m²; p=0.7) and valve pathology (mitral regurgitation: 70.0% vs 73.8%, mitral stenosis: 7.5% vs 3.8%, and mixed disease: 22.5% vs 22.5%; p=0.6). Most baseline characteristics not included in the matching model were balanced among the TMVI/SMVR cohorts: European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (5.8% [IQR 2.9; 7.5] vs 4.2% [IQR 2.4; 6.8]; p=0.3) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score (5.2% [IQR 3.2; 8.6] vs 4.1% [IQR 3.3; 6.1]; p=0.076). Coronary artery disease (67.5% vs 32.5%; p<0.001) and previous percutaneous coronary intervention (47.5% vs 25.0%; p=0.023) differed among groups. Mitral VARC (MVARC) device success at 30 days was achieved in 82.5% of patients after TMVI and 57.5% of patients after SMVR (p=0.04). MVARC procedural success at 30 days was 75.0% after TMVI versus 52.5% after SMVR (p=0.07). Thirty-day mortality (2.5% vs 3.8%; p=0.47), technical success (97.5% vs 97.5%; p=1.0), major bleeding (17.5% vs 18.7%; p=0.087), stroke (5.0% vs 4.9%; p=1.0) and postoperative haemodialysis (7.5% vs 5.2%; p=0.4) were similar in both groups. Patients with intermediate surgical risk, according to STS-PROM and EuroSCORE II, demonstrated higher rates of MVARC device at 30 days after TMVI compared to 30 days after SMVR. Rates of survival and procedural success, neurological, renal and bleeding complications were similar. Transfusion count and length of stay were lower after TMVI. For elderly patients at intermediate risk, a TMVI eligibility assessment may be considered.

Kytococcus Schroeteri Prosthetic Valve Endocarditis Complicated by Aortic Pseudoaneurysm: A Rare Complication from A Rare Agent

Kytococcus schroeteri is a rarely described slow-growing gram-positive coccus, with recent association with Infective Endocarditis cases. A 29-year-old male with prior history of rheumatic valvular heart disease and HIV infection, previously submitted to two cardiac surgeries, the last one 12 years ago with mechanical mitral and aortic valve implantation plus tricuspid annuloplasty was evacuated from Cape Verde with congestive heart failure and no features of infection. The diagnostic workup revealed an aortic paravalvular leak and a large pseudoaneurysm as well as a severe tricuspid regurgitation. The patient underwent surgery with Bentall procedure and a mechanical tricuspid valve implantation. The microbiologic exam of the removed aortic valve using 16sRNA sequencing showed a Kytococcus schroeteri, revealing its association with a severe complicated case of prosthetic valve endocarditis

Emergent transcatheter mitral valve implantation: Early and mid-term outcomes

Emergent transcatheter mitral valve implantation: Early and mid-term outcomes

Comparison of direct oral anticoagulants and vitamin-K antagonists after transcatheter mitral valve implantation

Comparison of direct oral anticoagulants and vitamin-K antagonists after transcatheter mitral valve implantation

Comparison of direct oral anticoagulants and vitamin-k antagonists after transcatheter mitral valve implantation

Abstract Background No recommendation exists regarding antithrombotic treatment after transcatheter mitral valve implantation (TMVI). By analogy with surgical mitral bioprosthesis, vitamin-k antagonists (VKA) are mostly used after TMVI. Purpose To compare, in a prospective cohort of trans-septal TMVI using a prosthesis of the SAPIEN family, the bleeding and thrombotic risks according to the anticoagulant treatment by direct oral anticoagulants (DOAC) or VKA. Methods We included all consecutive patients undergoing trans-septal TMVI in our center from March 2011 to August 2022. Patients were followed up after the procedure at 1 month, 6 months and 1 year. The primary endpoint was the occurrence of bleeding under anticoagulant treatment. Patients were treated with VKA until October 2019 and with DOAC thereafter. Results A total of 145 patients were included. The mean age was 65.4 ± 18.6 years old and 96 patients (66.2%) were women. The mean EuroSCORE II was 10.3 ± 9,3 %. Regarding treatment, 24 patients were treated with DOAC and 121 patients with VKA. The occurrence of the primary endpoint was observed in 48 (40%) patients in the VKA group and 2 (8%) patients in the DOAC group (multivariate HR 0.21, 95%CI [0.05-0.97], p=0.047). In multivariate analysis, there were less vascular complications and stay duration was shorter in the DOAC group. There were no significant differences between groups regarding thromboembolic events, stroke, and death. Conclusion Treatment with DOAC after TMVI compared with VKA appears to decrease the risk of bleeding complications and to decrease the length of stay of patients without a significant increase in the risk of thromboembolic events.

Compact Design and Task Space Control of a Robotic Transcatheter Delivery System for Mitral Valve Implant.

Mitral regurgitation (MR) is one of the most common valvular abnormalities, and the gold-standard for treatment is surgical mitral valve repair/replacement. Most patients with severe MR are over the age of 75, which makes open-heart surgery challenging. Thus, minimally invasive surgeries using transcatheter approaches are gaining popularity. This paper proposes the next generation of a robotic transcatheter delivery system for the mitral valve implant that focuses on the design of the actuation system, modeling, and task space control. The proposed actuation system is compact while still enabling bidirectional torsion, bending, and prismatic joint motion. A pulley structure is employed to actuate the torsion and bending joints using only one motor per joint in conjunction with an antagonistic passive spring to reduce tendon slack. The robotic transcatheter is also optimized to increase its stability and reduce bending deflection. An inverse kinematics model (with an optimization algorithm), singularity analysis method, and joint hysteresis and compensation model are developed and verified. Finally, a task space controller is also proposed. Experiments, including trajectory tracking and demonstrations of the robot motion in an ex vivo porcine heart and a phantom heart through a tortuous path are presented.

Septal Bipolar Ablation to Prevent Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Implantation.

Septal Bipolar Ablation to Prevent Left Ventricular Outflow Tract Obstruction After Transcatheter Mitral Valve Implantation.

Double-layer horizontal cross sutures for intra-atrial mitral valve implantation: An effective surgical method for severe mitral annular calcification

ObjectiveSevere mitral annular calcification (MAC) can make prosthetic implantation extremely difficult. Although intra-atrial mitral valve prosthesis implantation without annular decalcification offers a simpler approach, it poses a potential rupture risk due to high left ventricular pressure. We developed a double-layer (DL) horizontal cross-suture technique, which ensures close proximity of the valve prosthesis to the calcified annulus and segregates the left atrial wall from the left ventricle. The aim of this study was to compare the outcomes of DL suture with conventional single-layer (SL) suture in patients with severe MAC. MethodsThis retrospective cohort study consecutively enrolled patients with severe MAC undergoing mitral valve replacement at Beijing Anzhen Hospital from May 2018 to December 2022. A detailed description of the DL suture method is described. Follow-up medical evaluations, including transthoracic echocardiography measurements, were obtained through outpatient chart reviews. ResultsThe study included 10 patients in the DL suture group and 20 in the SL suture group. All patients in the DL group and all but 3 in the SL group achieved technical success. Compared with the SL group, the DL suture technique was associated with lower rates of perivalvular leakage, stroke, new-onset atrial fibrillation, reoperation, and 30-day mortality. Follow-up was complete, with 1 late mortality in the DL group due to stroke and 4 cardiovascular deaths in the SL group. ConclusionsThe DL horizontal cross-suture technique offers a more effective and safer approach for intra-atrial mitral valve implantation in severe MAC cases than the conventional SL suture method.

Transapical transcatheter mitral valve implantation with J-valve in patients with degenerated mitral bioprostheses

BackgroundDue to the widespread application of bioprosthetic valve in the treatment of mitral valve disease in recent years, the incidence of valve failure has increased significantly, which is facing the need of reoperation. For high-risk patients, transcatheter mitral valve-in-valve placement is increasingly being used as an alternative to surgical reoperation.Case presentationHere we report the successful transapical transcatheter mitral valve-in-valve implantations of J-Valves in 3 patients with high risk of mitral bioprostheses failure. All patients were discharged successfully, and the follow-up results were good 30 days after operation without major complication.ConclusionsFor high-risk patients, transcatheter implantation of the J-valve is a feasible solution for the treatment of degenerated mitral bioprostheses.

Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI): Characteristics and early results from a nationwide registry.

Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI) is an emerging treatment alternative to reoperation in high-surgical risk patients with failed mitral bioprostheses. We aimed to describe the characteristics of ViV-TMVI and evaluate its 30-day outcomes in the Polish population. A nationwide registry was initiated to collect data on all patients with failed mitral bioprosthesis undergoing ViV-TMVI in Poland. This study presents the results of a 30-day clinical and echocardiographic follow-up. Overall, 27 ViV-TMVI procedures were performed in 8 centers up to May 2022 (85% from 2020 onwards). The mean (standard deviation [SD]) age was 73 (11.6) years with the median (interquartile range [IQR]) Society of Thoracic Surgeons score of 5.3% (4.3%-14.3%). Mean (SD) time between surgical implantation and ViV-TMVI was 8.2 (3.2) years. Failed Hancock II (29%) and Perimount Magna (22%) bioprostheses were most frequently treated. Mechanisms of failure were equally often pure mitral regurgitation or stenosis (both 37%) with mixed etiology in 26%. Balloon-expandable Sapien 3/Ultra valves were used in all but 1 patient. Technical success was 96.3% (1 patient required additional prosthesis). Mean (SD) transvalvular mitral gradient reached 6.7 (2.2) mm Hg and mitral valve area was 1.8 (0.4) cm2. None of the patients had moderate or severe mitral regurgitation with only 14.8% graded as mild. We achieved device success in 92.6% of patients (2 patients had mean gradient ≥10 mm Hg) and procedural success in 85.6%. There were no deaths, cerebrovascular events, or need for mitral valve surgery during the 30-day follow-up. In short-term follow-up, ViV-TMVI is a safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation. Longer observations on larger samples are warranted.

Anatomic suitability for transapical transcatheter mitral valve implantation using a tether-based device.

Transcatheter mitral valve implantation (TMVI) is a novel therapeutic option for treating symptomatic mitral valve disease. Evaluating patient anatomical suitability is a critical step in the TMVI screening process, but currently requires specialized software and computerized device models. This analysis sought to assess the effectiveness of simple and standardized multislice computed tomography (MSCT) anatomic measurements for their ability to discriminate between patients who passed anatomical screening for Tendyne™ TMVI. Subjects screened for the Tendyne Expanded Clinical Study from January 2016 through September 2019 were included. Core laboratory screening measurements included mitral annular (MA) dimensions at end-systole and end-diastole, simulated device implantation, and neo-left ventricular outflow tract (LVOT) area. Additionally, nine standard measurements of patient anatomy were assessed for their predictive value of patients passing the anatomic screening process. Out of 496 subjects screened for eligibility, 257 subjects met clinical eligibility criteria with MA dimensions within the manufacturer's suggested range: 153 (59.5%) underwent TMVI while 104 (40.5%) were excluded from the study for other anatomic reasons (76% due to risk of LVOT obstruction). CT-derived left ventricular end-systole diameter (LVESD) had the highest discriminatory power for predicting TMVI anatomical suitability (area under the curve of 0.908, p < 0.0001). The mitral inter-commissural (IC) dimension was best predictive of annular dimensions being within range, with dimensions <30 or >50 mm resulting in a negative predictive value of 94.4%. MSCT-derived mitral IC dimension and LVESD easily performed measures that are effective predictors of anatomical suitability or screen failure for this tether-based TMVI device.

Evaluation of the impact of transmitral mean gradient elevation after transcatheter mitral valve implantation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Transcatheter mitral valve implantation (TMVI) has emerged as an alternative to surgery in high risk patients with failing mitral bioprosthesis (valve-in-valve) or annuloplasties (valve-in-ring). The presence of an elevated mean gradient &amp;gt; 5mmHg after the procedure has been defined as an unsuccessful procedure but the impact and outcomes of an elevated mean gradient after TMVI have not been studied. Materials and methods 103 patients undergoing TMVI from 2010 to 2020 were included. Patients were classified in three groups according to mean gradient after the procedure: Group 1&amp;lt; 5mmHg, Group 2 between 5 and 10mmHg and Group 3 &amp;gt; 10mmHg. Results The median age was 71 (52.5–81.5) years. Indications for TMVI were bioprosthesis failure in 67 patients (65%) and ring annuloplasty failure in 36 patients (35%). 84 (81.6%) patients were in NYHA class III or IV. 42 patients were in group 1, 51 in group 2 and 10 in group 3, without any difference in baseline characteristics or procedural findings. At 30 days, the rates of all-cause mortality (respectively 2,6%, 0% and 0%, p = 0,66), rehospitalization for heart failure (respectively 8,4%, 7,7% and 8,4%, p = 0,89), paravalvular leak (10,3%, 27,7%, 22,2%, p = 0,33), LVOT obstruction (respectively 6,3%, 8,2% and 10%, p = 0,99) or valve thrombosis (respectively 7,7%, 4,3% and 0%) were similar in the three groups. At a median follow up of 2 years, 27 patients have died with a cumulative rate of all-cause mortality at 1 and 2 years of 21.5% and 38.1% respectively. The presence of an elevated mean gradient was not associated with increased risk of mortality (HR=1,11, (95% CI [0,93, 1,31]), p = 0,25) An improvement of NYHA class was observed in the three groups without any difference between the groups. Median systolic pulmonary arterial pressure significantly improved in group 1 (from 53mmHg (30–90) in baseline to 45mmHg (25–60), p = 0.005) and 2 (from 55mmHg (30–112) in baseline to 40mmHg (30–75), p = 0.004)) but not in group 3. Conclusion An elevated mean gradient post-TMVI had no impact on cardiovascular outcomes up to 2 years. Further studies with longer follow up are necessary.