scholarly journals Transcatheter mitral valve repair: an overview of current and future devices

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001564
Author(s):  
Ole De Backer ◽  
Ivan Wong ◽  
Maurizio Taramasso ◽  
Francesco Maisano ◽  
Olaf Franzen ◽  
...  

The field of transcatheter mitral valve repair (TMVr) for mitral regurgitation (MR) is rapidly evolving. Besides the well-established transcatheter mitral edge-to-edge repair approach, there is also growing evidence for therapeutic strategies targeting the mitral annulus and mitral valve chordae. A patient-tailored approach, careful patient selection and an experienced interventional team is crucial in order to optimise procedural and clinical outcomes. With further data from ongoing clinical trials to be expected, consensus in the Heart Team is needed to address these complexities and determine the most appropriate TMVr therapy, either single or combined, for patients with severe MR.

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Lowell Safren ◽  
Nayeem Nasher ◽  
Gemma Reddin ◽  
Brian Forrestal ◽  
Jaffar Khan ◽  
...  

Background: Despite an expanding armamentarium of devices, many patients with mitral regurgitation referred for transcatheter mitral valve repair or replacement are not eligible to participate in the clinical trials or receive a commercially available device. We sought to understand the reasons why patients were excluded from receiving therapy. Methods: We retrospectively analyzed the medical charts, and correspondence related to patients referred to our tertiary valve center for transcatheter mitral valve replacement (TMVR) or transcatheter mitral valve repair (TMVr) between June 2016 to September 2019. Patients were screened for eligibility by our structural Heart Team for either TMVR or TMVr. If TMVR or TMVr was not offered the reason for screen failure was recorded and categorized. Results: Over the 3-year period, 564 patients were referred for TMVR/TMVr. Of these, 15.9% were determined to be eligible for and underwent surgical repair or replacement. 440 patients (78.0%) were considered for TMVR/TMVr. 92 patients (16.3%) underwent TMVR/TMVr. The majority of patients (348/564, 61.7%) ultimately did not undergo intervention (Panel A). The reasons for exclusion were clinical in 78%, issues related to patient preference of care delivery in 49% of patients, anatomical in 37% and futility in 25% of patients (Panel B). Conclusions: The majority of patients with mitral regurgitation referred for transcatheter mitral therapy are excluded for a variety of reasons. Clinical trials testing new transcatheter mitral valve devices should be encouraged to follow patients who are excluded to better understand optimal timing of intervention, address challenging anatomies, and ultimately improve penetrance of these novel therapies.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
E Zweck ◽  
M Spieker ◽  
P Horn ◽  
C Iliadis ◽  
C Metze ◽  
...  

Abstract Background Transcatheter Mitral Valve Repair (TMVR) with MitraClip is an important treatment option for patients with severe mitral regurgitation. The lack of appropriate, validated and specific means to risk stratify TMVR patients complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice. Purpose We aimed to develop an optimized risk stratification model for TMVR patients using machine learning (ML). Methods We included a total of 1009 TMVR patients from three large university hospitals, of which one (n=317) served as an external validation cohort. The primary endpoint was all-cause 1-year mortality, which was known in 95% of patients. Model performance was assessed using receiver operating characteristics. In the derivation cohort, different ML algorithms, including random forest, logistic regression, support vectors machines, k nearest neighbors, multilayer perceptron, and extreme gradient boosting (XGBoost) were tested using 5-fold cross-validation in the derivation cohort. The final model (Transcatheter MITral Valve Repair MortALIty PredicTion SYstem; MITRALITY) was tested in the validation cohort with respect to existing clinical scores. Results XGBoost was selected as the final algorithm for the MITRALITY Score, using only six baseline clinical features for prediction (in order of predictive importance): blood urea nitrogen, hemoglobin, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY Score's area under the curve (AUC) was 0.783, outperforming existing scores which yielded AUCs of 0.721 and 0.657 at best. 1-year mortality in the MITRALITY Score quartiles across the total cohort was 0.8%, 1.3%, 10.5%, and 54.6%, respectively. Odds of mortality in MITRALITY Score quartile 4 as compared to quartile 1 were 143.02 [34.75; 588.57]. Survival analyses showed that the differences in outcomes between the MITRALITY Score quartiles remained even over a timeframe of 3 years post intervention (log rank: p<0.005). With each increase by 1% in the MITRALITY score, the respective proportional hazard ratio for 3-year survival was 1.06 [1.05, 1.07] (Cox regression, p<0.05). Conclusion The MITRALITY Score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR. These findings may potentially allow for more precise design of future clinical trials, may enable novel treatment strategies tailored to populations of specific risk and thereby serve future daily clinical practice. FUNDunding Acknowledgement Type of funding sources: None. Summary Figure


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Meijerink ◽  
I Wolsink ◽  
M Holierook ◽  
E V Chekanova ◽  
R N Planken ◽  
...  

Abstract Background Transcatheter mitral valve repair (TMVR) is increasingly used to treat mitral regurgitation (MR) in high risk patients. Optimal transseptal access and guiding catheter position are essential to perform adequate repair. Anatomy of the inter-atrial septum (IAS) and mitral annulus (MA) are often complex and difficult to determine from echocardiography. Purpose The aim of the current study was to evaluate whether pre-TMVR cardiac CT and 3D reconstruction of the IAS and MA could discriminate for complexity and hemodynamic effect of TMVR. Methods Patients planned for TMVR, underwent cardiac CT scan (if eligible). Post-processing software was used to segment and reconstruct the aortic root, IAS, fossa ovalis (FO) and MA, resulting in a 3D model. The following parameters were measured in each model: (1) IAS angle (°) (2) Posterior-FO angle (°) (3) FO-perpendicularity angle (°) (4) MA area (cm2). Patient specific anatomy was categorized in 4 groups as either (1) Posterior-perpendicular (PP) FO + limited IAS angle, (2) PP FO + wide IAS angle, (3) non-PP FO + limited IAS angle or (4) non-PP FO + wide IAS angle. PP FO was defined as posterior-FO angle >65° and FO-perpendicularity angle >135°. IAS angle was considered limited if <110°. Device implantation time (min) was used to assess complexity of the procedure and was compared between the different groups. MR reduction (grades), number of clips used and mitral valve (MV) gradient (mmHg) were compared for patients with MA area <14 cm2 vs. ≥14 cm2. Results 46 patients (mean age 75 years, 41% male) were included. Anatomy was classified (1) PP FO + limited IAS angle in 13, (2) PP FO + wide IAS angle in 13, (3) Non-PP FO + limited IAS angle in 8 and (4) Non-PP FO + wide IAS angle in 12. Median device implantation time was 20 min in group 1, compared to 39 min in group 2 (p=0.02), 33 min in group 3 (p=0.03) and 29 min in group 4 (p=0.08). In patients with MA area <14 cm2, MR reduction was greater (2.22 vs. 1.68, p=0.02), number of clips used was lower (1.44 vs. 1.79, p=0.05) and MV gradient was higher, though not significant (3.15 vs. 2.58, p=0.26) Conclusion The current study showed that TMVR seemed less complex in patients with an optimal anatomy. In patients with limited mitral annulus area a more favorable hemodynamic effect was achieved. Cardiac CT and 3D reconstruction could therefore be of strong aid for procedural planning of TMVR. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Abbott Vascular Anatomy and device implantation time Hemodynamic effect of annulus area


2021 ◽  
Vol 77 (18) ◽  
pp. 1756
Author(s):  
Michael Biersmith ◽  
Thura Harfi ◽  
David Orsinelli ◽  
Scott Lilly ◽  
Konstantinos Boudoulas

Author(s):  
Neal Duggal ◽  
Matthew Romano ◽  
Daniel Menees ◽  
Stanley J. Chetcuti ◽  
Steven F. Bolling ◽  
...  

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