Transcatheter Mitral Valve Implantation Research Articles

Transcatheter mitral valve implantation – a single centre experience

Transcatheter mitral valve implantation – a single centre experience

Multimodal imaging assessment of prosthetic mitral valve area after transcatheter mitral valve implantation: A three-dimensional echocardiographic and CT scan study

Multimodal imaging assessment of prosthetic mitral valve area after transcatheter mitral valve implantation: A three-dimensional echocardiographic and CT scan study

Incidence and prognostic impact of early major bleeding after transcatheter mitral valve implantation

Incidence and prognostic impact of early major bleeding after transcatheter mitral valve implantation

Outcomes after Transcatheter Mitral Valve Implantation: A Literature Review.

Mitral valve disease is the most common heart valve disease worldwide. Surgical mitral valve replacement or repair has been an established therapy in patients with severe mitral valve disease for many years. On the other hand, many patients with advanced mitral valve disease and severe comorbidities are treated conservatively and are excluded from the surgical procedure. Furthermore, in patients with severe comorbidities, transcatheter mitral valve repair by edge-to-edge technique with MitraClip or transcatheter mitral valve repair with a non-absorbable ring have been added as therapeutic options over the last few years. Alternative procedures for the treatment of patients with advanced prosthetic or native mitral valve diseases include transcatheter access for replacement or implantation of a new prosthetic valve in the diseased mitral valve. Promising results were published about short-term outcomes of patients who underwent the transcatheter mitral valve replacement. The current view and results of the transcatheter mitral valve implantation in patients with advanced native or prosthetic mitral valve disease are briefly discussed.

Abstract 12723: The Tendyne Valve: A Novel Approach to Mitral Valve Replacement

Clinical Presentation: 64-year-old female with history of CAD with STEMI s/p PCI of RCA, HFrEF (45%), afib, HTN, DM2, severe MR and moderate calcific MS presented with shortness of breath found to have recurrent CHF. She was not amenable to surgical valve replacement and standard transcatheter percutaneous options are limited given the significant MAC. Tendyne (Abbot) transcatheter mitral valve implantation (TMVI) is an experimental minimally invasive option to treat significant MR with challenging mitral anatomy. Patient underwent a minimal apical thoracotomy via TEE guidance, placement of delivery catheter and valve deployment followed by an apical tether to maintain adequate tension. Post-deployment, there was no significant MR, MS or LVOT obstruction. Imaging Findings: See Image. Discussion: TEE is critical from pre-procedure planning to device implant and post-procedural monitoring. Pre-procedural planning requires accurate understanding of the mitral valve anatomy. During the trans-apical thoracotomy, TEE is essential in confirming correct puncture site to ensure appropriate delivery catheter position. Once appropriately positioned, evaluation via color doppler nad 3D are necessary to evaluate device seating, residual regurgitation and LVOT obstruction. Once apical cap is tethered into apex, the valve is re-visualized on TEE to ensure appropriate valve tension prior to closure of thoracotomy. Conclusion: TENDYNE TMVI is a reasonable option to consider for patients with significant MR and challenging mitral anatomy and not an open surgical candidate. TEE imaging is critical to optimize valve implantation both pre-procedural and post-procedural.

Contemporary treatment of mitral valve disease with transcatheter mitral valve implantation

BackgroundTranscatheter mitral valve implantation (TMVI) with self-expanding (SAV) or balloon-expandable (BAV) valves are rising as promising treatment options for high-risk patients with symptomatic mitral valve (MVD) disease unsuitable for alternative treatment options.AimsThe aim of this study was to examine the clinical, procedural and outcome parameters of patients undergoing SAV or BAV for MVD.MethodsIn this observational and single-center case series, fifteen consecutive patients treated with the Tendyne Mitral Valve System (SAV) and thirty-one patients treated with SAPIEN prosthesis (BAV) were included.ResultsThe patients (aged 78 years [interquartile range (IQR): 65.5 to 83.1 years], 41% women, EuroSCORE II 10.3% [IQR: 5.5 to 17.0%] were similar regarding baseline characteristics, despite a higher rate of prior heart valve surgery and prevalence of MV stenosis in the SAV-group. At discharge, the SAV-group had a mean transvalvular gradient of 4.2 mmHg, whereas the BAV-group had a mean transvalvular gradient of 6.2 mmHg. None or trace paravalvular leakage (PVL) was assessed in 85% in SAV-group and 80% in the BAV-group. 320 day all-cause and cardiac mortality rates were comparable in both groups (SAV: 26.7% vs BAV: 20%, p = 0.60). Four deaths occurred early in the SAV-group until 32 days of follow-up.ConclusionsIn high-risk patients with MVD, TMVI presents a promising treatment option with encouraging mid-term outcomes and good valve durability. TMVI either with BAV or SAV may be developed to an established treatment option.Graphical abstract

Transcatheter mitral valve implantation versus conventional redo surgery for degenerated mitral valve prostheses and rings in a multicenter registry

ObjectivesDegeneration of mitral prostheses/rings may be treated by redo surgery, and, recently, by transcatheter valve-in-valve/ring implantation. This multicenter registry presents results of transcatheter valve-in-valve and repeat surgery for prostheses/rings degeneration. MethodsData provided by 10 German heart centers underwent propensity score-matched retrospective analysis. The primary endpoint was 30-day/midterm mortality. Perioperative outcome was assessed according to the Mitral Valve Academic Research Consortium criteria. Further, the influence of moderate or greater tricuspid regurgitation (TR) on 30-day/midterm mortality was analyzed. ResultsBetween 2014 and 2019, 273 patients (79 transcatheter mitral valve-in-valve [TM-ViV] and 194 redo mitral valve replacement [Re-MVR]) underwent repeat procedure for mitral prosthesis/ring degeneration. Propensity score matching distinguished 79 patient pairs. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II-predicted risk was 15.7 ± 13.7% in the TM-ViV group and 15.0% ± 12.7% in the Re-MVR group (P = .5336). TM-ViV patients were older (74.73 vs 72.2 years; P = .0030) and had higher incidence of atrial fibrillation (54 vs 40 patients; P = .0233). Severe TR incidence was similar (17.95% in TM-ViV vs 14.10%; P = .1741). Sixty-eight TM-ViV patients previously underwent mitral valve replacement, whereas 41 Re-MVR patients underwent valve repair (P < .0001). Stenosis was the leading degeneration mechanism in 42 TM-ViV versus 22 Re-MVR patients (P < .0005). The 30-day/midterm mortality did not differ between groups. Moderate or greater TR was a predictor of total (odds ratio [OR], 4.36; P = .0011), 30-day (OR, 3.76; P = .0180), and midterm mortality (OR, 4.30; P = .0378), irrespective of group. ConclusionsIn both groups, observed mortality was less than predicted. Redo surgery enabled treatment of concomitant conditions, such as atrial fibrillation or TR. TR was shown to be a predictor of total, 30-day, and midterm mortality in both groups.

Transcatheter mitral valve implantation in severely calcified rheumatic mitral stenosis without annular calcification.

Transcatheter mitral valve implantation in severely calcified rheumatic mitral stenosis without annular calcification.

Degenerative mitral valve stenosis diagnosis and management: literature review

Gustė Burneikaitė1 1Hospital of Vilnius University Santaros Clinics, Cardiology and Angiosurgery center, Lithuania Abstract Introduction. Mitral valve stenosis is fairly common valvular heart disease characterized by narrowing of the mitral valve orifice. The number of incidences of degenerative mitral valve stenosis are growing in developed countries. Accurate assessment and treatment of pathology is challenge in modern medicine due to changes in the structure of atrium and valve as well as other comorbidities in the aging population. Aim. To review information related to degenerative mitral valve stenosis especially its diagnosis and treatment options. Methods. The review of literature was conducted using medical database PubMed selecting publications investigating degenerative mitral valve stenosis and mitral annular calcification. Keywords were entered in the advanced search panel to gather data. After reviewing all the exclusion criteria, 42 scientific articles were included in this literature review. Review period is 2003 – 2022 with a few older publications. Results. Extensive mitral valve damage due to annular calcification is observed in degenerative mitral valve stenosis, which makes diagnosis and treatment particularly difficult. This pathology is most common in elderly patients with comorbidities, whose treatment options are limited. The potential for transcatheter mitral implantation can alleviate patient symptoms and improve prognosis, but this method is still not sufficiently analyzed. Conclusions. There are still no well-defined guidelines for diagnosis and treatment of degenerative mitral valve stenosis. The most promising diagnostic methods are 3D echocardiography and computed tomography of the heart, treatment – transcatheter mitral valve implantation. More detailed research is needed in this direction. Keywords: degenerative mitral valve stenosis, mitral annular calcification, diagnosis, management.

Technical challenges to a successful valve-in-valve Transcatheter Mitral Valve Implantation (TMVI)

Mitral valve disease is more common than Aortic valve stenosis in the developing world. Surgical approach has remained the gold standard in management of degenerative and failed bioprosthetic Mitral Valve Regurgitation (MR). However, with the success of Transcatheter Aortic Valve Implantations (TAVI), the percutaneous replacement of a diseased Mitral Valve (MV) is also becoming a viable option in select patients. One of the main challenges during TMVI is the location of transseptal puncture and manipulation of delivery catheter with highflexure capabilities to reach the mitral valve. These problems are only compounded when dealing with degenerated bioprosthetic mitral valves of various types. Here we present a case of valve-in-valve TMVI done, surmounting all technical challenges, resulting in excellent clinical outcome.

Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening.

Transcatheter mitral valve implantation (TMVI) represents a novel treatment alternative for patients with severe mitral regurgitation (MR) considered ineligible for standard therapies. Data on the management of patients after TMVI screening are scarce. We aimed to investigate outcomes of patients with severe MR undergoing TMVI evaluation treated with either TMVI, bailout-transcatheter edge-to-edge repair (bailout-TEER) or medical therapy (MT). Between May 2016 and February 2021, 121 patients with MR considered ineligible for standard therapy were screened for TMVI. Outcomes were assessed for the subgroups of patients treated with TMVI, bailout-TEER and MT. The primary composite endpoint was all-cause death or heart failure hospitalisation after one year. The subgroups of TMVI (N=38), bailout-TEER (N=28) and MT (N=44) differed significantly with regard to MR aetiology (secondary MR: TMVI 68.4%, bailout-TEER 39.3%, MT 38.6%, p=0.014) and left ventricular ejection fraction (TMVI 37.0% [31.4-51.2], bailout-TEER 48.0% [35.3-58.3], MT 54.5% [40.8-60.0], p<0.001). At discharge and after one year, MR was reduced to ≤mild residual MR in all patients undergoing TMVI, while ≥moderate residual MR was present in 25.9% and 20.0% of patients, respectively, after bailout-TEER, and in 100.0% of patients on MT at one year. The primary endpoint occurred in 72.2% of patients remaining on MT, in 51.6% of patients undergoing TMVI and in 40.2% of those receiving bailout-TEER. In MR patients considered ineligible for standard therapy, TMVI provided acceptable clinical outcomes and MR elimination in the majority of patients. In screen-failed patients, bailout-TEER represented a reasonable alternative while MT was associated with poor outcomes.

Concomitant use of Sapien 3 transcatheter valve for severe MAC with Intuity Elite rapid deployment valve for aortic stenosis

BackgroundConcomitant double valve pathology in the presence of severe MAC poses significant technical challenges when planning surgical intervention. With continued evolution of valve prosthesis, innovative techniques can be considered with the potential for additional therapeutic benefit.Case presentationWe present a novel technique of using a rapid deployment surgical aortic valve in combination with open surgical transcatheter mitral valve implantation (TMVI) for severe Mitral Annular Calcification (MAC). The Intuity Elite rapid deployment prosthesis (Edwards Lifesciences, Irvine, CA) was used concomitantly with the Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter prosthesis trans-atrially on cardiopulmonary bypass in a patient with critical aortic stenosis and moderate-severe mixed mitral valve disease in the setting of severe MAC (off-label use).ConclusionsWe demonstrate how both technologies can, not only be accommodated, but indeed complement each other achieving an excellent outcome in a high-risk patient.

Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry.

Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. From May 2014 to March 2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalization after 1year. Among 746 patients included (78.5 years, interquartile range [IQR] 72.0-83.0, EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with 10 different dedicated devices. At 1year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (n=517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. This registry included the largest number of patients treated with TMVI to date. TMVI with 10 dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes.

Embolisation of a prosthetic mitral valve fragment during valve-in-valve transcatheter mitral valve implantation.

Embolisation of a prosthetic mitral valve fragment during valve-in-valve transcatheter mitral valve implantation.

Transcatheter mitral valve implantation in the ongoing structural heart revolution.

Transcatheter mitral valve implantation (TMVI) has emerged as a less invasive approach potentially surmounting some of the current hurdles associated with transcatheter edge-to-edge repairand high-risk mitral valve surgery. In this review, we aimed to outline the main scenarios in the TMVI field, highlight current and upcoming devices, and describe challenges and clinical results. Finally, we briefly discuss the future perspectives for this emerging field and how TMVI might further advance the field of transcatheter treatments of mitral valve disease.

Feasibility evaluation of the transapical saddle-shaped valved stent for transcatheter mitral valve implantation.

Background and Aims of StudyTranscatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high‐risk mitral regurgitation. We aimed to investigate the feasibility of a novel self‐expanding valved stent for TMVI via apical access.MethodsWe designed a novel self‐expanding mitral valve stent system consisting of an atrial flange and saddle‐shaped ventricular body connected by two opposing anchors and two opposing extensions. During valve deployment, each anchor was controlled by a recurrent string. TMVI was performed in 10 pigs using the valve prosthesis through apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. Surviving pigs were killed 4 weeks later to confirm stent deployment.ResultsTen animals underwent TMVI using the novel mitral valve stent. Optimal valve deployment and accurate anatomical adjustments were obtained in nine animals. Implantation failed in one case, and the animal died 1 day later due to stent mismatch. After stent implantation, the hemodynamic parameters of the other animals were stable, and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract were 2.98 ± 0.91 mmHg and 3.42 ± 0.66 mmHg, respectively. Macroscopic evaluation confirmed the stable and secure positioning of the stents. No obvious valve displacement, embolism, or paravalvular leakage was observed 4 weeks postvalve implantation.ConclusionsThis study demonstrated that the novel mitral valve is technically feasible in animals. However, the long‐term feasibility and durability of this valved stent must be improved and verified.

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p=0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p=0.41). In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Challenges and Open Issues in Transcatheter Mitral Valve Implantation: Smooth Seas Do Not Make Skillful Sailors.

According to the European and American guidelines, surgery represents the treatment of choice for mitral valve (MV) disease. However, a number of patients are deemed unsuitable for surgery due to a prohibitive/high operative risk. In such cases, transcatheter therapies aiming at MV repair have been proven to be a valuable alternative and have been recently introduced in the latest American guidelines on valvular heart disease. Indeed, percutaneous repair techniques, particularly transcatheter edge-to-edge, have gained a broad experience and demonstrated to be safe and effective. However, given the complexity and heterogeneity of MV anatomy and pathology, transcatheter MV implantation (TMVI) has grown as a possible alternative to percutaneous MV repair. Current data about TMVI are still limited and come from different settings: valve-in-native MV, valve-in-valve (ViV), valve-in-ring (ViR), and valve-in-mitral annular calcification. Preliminary data are promising although several open issues still need to be addressed. This paper provides a comprehensive review of the available devices in the different clinical settings, to discuss potentialities, limitations, and future directions for TMVI.

Outcomes of patients with severe mitral regurgitation treated with transcatheter mitral valve implantation or medical therapy

Abstract Funding Acknowledgements Type of funding sources: None. Background Patients with severe mitral regurgitation (MR) unsuitable for standard therapy (i.e., open-heart surgery and transcatheter edge-to-edge repair [TEER]), often remain on medical therapy (MT) alone. Transcatheter mitral valve implantation (TMVI) may represent an alternative treatment option for these patients. Purpose We aimed to investigate differences in anatomical baseline characteristics and echocardiographic outcomes between MR patients unsuitable for standard therapy, that were either treated with TMVI or remained on MT. Methods Between 05/2016-02/2021, 121 high-risk patients with severe MR were evaluated for TMVI. Clinical, echocardiographic and functional outcomes between the subgroups of patients treated with TMVI and MT were compared. The primary combined endpoint was all-cause death or heart failure (HF) hospitalization at 1 year. Subgroup analyses were performed to define specific patient subsets favouring either TMVI or MT. Results At baseline, there were no differences between the TMVI group (n = 38) and the MT group (n = 44) regarding age (all TMVI vs. MT: 77.0 years [IQR 72.9, 80.1] vs. 79.0 [IQR 76.0, 81.7], p = 0.13), gender (42.1% female vs. 56.8% female, p = 0.27) and estimated surgical risk (EuroSCORE II 4.4% [IQR 2.8, 13.6] vs. 6.4 [IQR 3.4, 10.1], p = 0.72). Patients undergoing TMVI were more frequently treated for secondary MR (68.4%), while primary MR was the most prevalent MR etiology in patients remaining on medical therapy (50.0%). Left ventricular (LV) end-diastolic diameters (LVEDD) were larger and LV ejection fraction (LVEF) was lower in the TMVI group (LVEDD 58.0mm [IQR 51.4, 65.0], LVEF 37.0% [IQR 31.4, 51.2]) compared to the MT group (LVEDD 52.0mm [IQR 46.2, 58.8], LVEF 54.5% [IQR 40.8, 60.0]) (p = 0.02 for LVEDD, p &amp;lt; 0.001 for LVEF). MR was effectively reduced to ≤ mild MR in all patients undergoing TMVI. In the MT group, MR remained severe in 90% of patients after 1 year. The primary composite endpoint occurred numerically more often in the MT group (72.2%) compared to the TMVI group (51.6%, p = 0.061). Regarding the primary endpoint, the subgroups of patients with LVEF 30-49% (HR 0.28 [95%-CI 0.11-0.67], p = 0.004), effective regurgitant orifice area (EROA) &amp;lt;0.4 cm2 (HR 0.30 [95%-CI 0.13-0.71], p = 0.006), tricuspid annular plane systolic excursion (TAPSE) ≥17mm (HR 0.27 [95%-CI 0.11-0.67], p = 0.005) and New York Heart Association functional class III (HR 0.38 [95%-CI 0.18-0.81], p = 0.012) were more likely to benefit from TMVI compared to MT. Conclusions In patients with severe MR unsuitable for standard therapy, TMVI represents a reasonable therapeutic alternative yielding effective elimination of MR. While most patients eligible for TMVI suffer from secondary MR, the majority of patients remaining on MT has primary MR. The primary endpoint occurred numerically, yet not statistically, more often in patients on MT. Baseline echocardiography was able to identify subgroups of patients with beneficial outcome after TMVI.

Transcatheter Mitral Valve Implantation In Patients With Chronic Kidney Disease

There is a paucity of data regarding the outcomes of trans-septal transcatheter mitral valve implantation (TS-TMVI) in patients with chronic kidney disease (CKD). We queried the Nationwide Readmissions Database (2015 to 2018) for patients undergoing TS-TMVI. We identified patients with CKD (Stage III or higher). We conducted propensity score matching analysis to compare the outcomes in patients with CKD versus patients without CKD. The main outcomes were in-hospital mortality and 30-day nonelective readmissions. From 2015 to 2018, there were 2,017 admissions for patients receiving TS-TMVI, of whom 733 (36.34%) had CKD. In the CKD group, 76 (10.4%) required chronic dialysis. During the study years, the number of TS-TMVI procedures increased in patients with CKD (ptrend <0.001). Patients with CKD were older and less likely to be women. There was no difference in in-hospital mortality in those with versus without CKD in the matched cohorts (7.8% vs 7.3%; odds ratio 1.09; 95% confidence interval 0.64 to 1.80). Subgroup analysis showed no interaction between chronic dialysis status and in-hospital mortality after TS-TMVI. In the matched cohort, TS-TMVI in those with CKD was associated with higher rates of cardiogenic shock (12.3% vs 7.6%, p=0.03), acute kidney injury (35.7% vs 16.7%, p <0.001), hemodialysis (5.4% vs 1.5%, p=0.01) and longer median length of stay, (7 [12] vs 5 [8] days, p <0.001). Patients with CKD were more likely to have 30-day nonelective readmission (25.8% vs 16.5%, p=0.01), driven by more readmissions for bleeding/anemia. In conclusion, TS-TMVI in patients with CKD is associated with increased risk for cardiogenic shock, worsening renal function requiring hemodialysis, without increased risk of mortality when compared with patients without CKD. Also, there was a higher length of stay and 30-day readmission rate in patients with CKD versus patients without CKD.