scholarly journals New stent for transapical mitral valve replacement in acute swine experiment

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Yu Zou ◽  
Peng Teng ◽  
Liang Ma

Abstract Background Many patients with mitral regurgitation are denied open-heart surgery due to perceived high risk. Transcatheter mitral valve replacement is a therapeutic alternative for patients at high surgical risk. This study aimed to assess the feasibility of a new self-expanding valved stent for transcatheter mitral valve replacement via apex in an acute animal model. Methods Eight porcine experiments were performed in the acute study. A left thoracotomy was performed, and the new self-expanding transcatheter valved stent was deployed under fluoroscopic guidance in the native mitral annulus via apex. Hemodynamic data were recorded before and after implantation. Mitral annulus diameter and valve area were measured using echocardiography. Transvalvular and left ventricular outflow tract pressure gradients were measured using invasive methods. Results Seven animals underwent successful transapical mitral valve replacement; the implantation was unsuccessful in one animal. The mean procedure time, defined from placement to tightening of the purse-string suture, was 17.14 ± 7.86 min. Hemodynamic data before and after transapical mitral valve replacement showed no difference in statistical analysis. The mean diameter of the self-expanding device after implantation was 2.58 ± 1.04 cm; the mean functional area was 2.70 ± 0.26 cm2. Trace-to-mild central and paravalvular leaks were detected in 7 valves. The mean pressure gradient across the self-expanding device was 2.00 ± 0.82 mmHg; the corresponding gradient across the LVOT was 3.28 ± 1.11 mmHg. Postmortem evaluation confirmed precise device positioning in 7 animals with no signs of LVOT obstruction. Conclusion Transcatheter mitral replacement of the new valved stent was confirmed feasible in acute preclinical models. The new stent reveals optimal design parameters.

2020 ◽  
Author(s):  
Yu Zou ◽  
Peng Teng ◽  
Liang Ma

Abstract Background: Many patients with mitral regurgitation are denied open-heart surgery due to high risk. Transcatheter mitral valve replacement offers an alternative treatment. This study aimed to test the feasibility of a new self-expanding valved stent for transcatheter mitral valve replacement via apex in an acute animal model.Methods: Eight porcine experiments were performed in the acute study. A left thoracotomy was performed. The new self-expanding transcatheter valved stent was deployed under fluoroscopic guidance within the native mitral annulus via apex. Hemodynamic data, before and after implantation, were recorded. Mitral annulus diameter and valve area were measured using echocardiography. Transvalvular and left ventricular outflow tract pressure gradient were measured invasively. Results: Seven animals underwent successful transapical mitral valve replacement; the implantation was unsuccessful in one animal. The mean procedure time, defined from placing the purse-string to tightening the purse-string, was 17.14 ± 7.86 min. Hemodynamic data before and after transapical mitral valve replacement showed no difference in statistical analysis. The mean diameter and mean functional area of the self-expanding device after implantation were 2.58 ± 1.04 cm and 2.70 ± 0.26 cm2, respectively. Trace to mild central and paravalvular leak was detected in 7 valves. Mean pressure gradient across the self-expanding device was 2.00 ± 0.82 mm Hg; the corresponding gradients across the LVOT were 3.28± 1.11 mm Hg. Postmortem examinations confirmed precise device positioning in 7 animals with no signs of LVOT obstruction.Conclusion: Transcatheter mitral replacement of the new valved stent was confirmed feasible in acute preclinical models. The new stent reveals optimal design parameters.


PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0256569
Author(s):  
Alina Zubarevich ◽  
Marcin Szczechowicz ◽  
Arian Arjomandi Rad ◽  
Robert Vardanyan ◽  
Philipp Marx ◽  
...  

Background Transcatheter methods have been rapidly evolving to provide an alternative less invasive therapeutic option, mainly because redo patients often present with multiple comorbidities and high operative risk. We sought to evaluate and compare our experience with transapical transcatheter mitral valve replacement (TA-TMVR) to conventional redo mitral valve replacement in patients presenting with degenerated biological mitral valve prostheses or failed valve annuloplasty. Methods and material Between March 2012 and November 2020, 74 consecutive high-risk patients underwent surgical redo mitral valve replacement (n = 33) or TA-TMVR (n = 41) at our institution. All patients presented with a history of a surgical mitral valve procedure. All transcatheter procedures were performed using the SAPIEN XT/3™ prostheses. Data collection was prospectively according to MVARC criteria. Results The mean logistic EuroSCORE-II of the whole cohort was 19.9±16.7%, and the median STS-score was 11.1±12.5%. The mean age in the SMVR group was 63.7±12.8 years and in the TMVR group 73.6±9.7 years. Patients undergoing TA-TMVR presented with significantly higher risk scores. Echocardiography at follow up showed no obstruction of the left ventricular outflow tract, no paravalvular leakage and excellent transvalvular gradients in both groups (3.9±1.2 mmHg and 4.2±0.8 mmHg in the surgical and transcatheter arm respectively). There was no difference in postoperative major adverse events between the groups with no strokes in the whole cohort. Both methods showed similar survival rates at one year and a 30-day mortality of 15.2% and 9.8% in SAVR and TMVR group, respectively. Despite using contrast dye in the transcatheter group, the rate of postoperative acute kidney failure was similar between the groups. Conclusion Despite several contraindications for surgery, we showed the non-inferiority of TA-TMVR compared to conventional surgical redo procedures in high-risk patients. With its excellent hemodynamic and similar survival rate, TA-TMVR offers a feasible alternative to the conventional surgical redo procedure in selected patients.


2021 ◽  
Vol 14 (5) ◽  
pp. 541-550 ◽  
Author(s):  
John C. Lisko ◽  
Vasilis C. Babaliaros ◽  
Jaffar M. Khan ◽  
Norihiko Kamioka ◽  
Patrick T. Gleason ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Fukui ◽  
P Sorajja ◽  
M Goessl ◽  
R Bae ◽  
B Sun ◽  
...  

Abstract Background Data on changes in left atrial (LA) and left ventricular (LV) volumes after transcatheter mitral valve replacement (TMVR) are limited. Purpose This study sought to describe the anatomical and functional changes in left-sided cardiac chambers by computed tomography angiography (CTA) from baseline to 1-month after TMVR with Tendyne prosthesis. Methods We analyzed patients who underwent TMVR with Tendyne prosthesis (Abbott Structural, Menlo Park, CA) between 2015 and 2018. Changes in LV end-diastolic volume (LVEDV), ejection fraction (LVEF), mass (LV mass), LA volume and global longitudinal strain (GLS) were assessed at baseline and at 1-month after TMVR with CTA. Specific Tendyne implant characteristics were identified and correlated with remodeling changes. Results A total of 36 patients (mean age 73±8 years, 78% men, 86% secondary MR) were studied. There were significant decreases in LVEDV (268±68 vs. 240±66ml, p<0.001), LVEF (38±10 vs. 32±11%, p<0.001), LV mass (126±37 vs. 117±32g, p<0.001), LA volume (181±74 vs. 174±70 ml, p=0.027) and GLS (−12.6±5.1 vs. −9.5±4.0%, p<0.001) from baseline to 1-month follow-up. Favorable LVEDV reverse-remodeling occurred in the majority (30 of 36 patients, or 83%). Closer proximity of the Tendyne apical pad to the true apex was predictive of favorable remodeling (pad distance: 25.0±7.7 vs. 33.5±8.8mm, p=0.02 for those with and without favorable remodeling). Conclusions TMVR with Tendyne results in favorable left-sided chamber remodeling in the majority of patients treated, as detected on CTA at 1-month after implantation. CTA identifies the favorable post-TMVR changes, which could be related to specific characteristics of the device implantation. Funding Acknowledgement Type of funding source: None


Author(s):  
Abdallah El Sabbagh ◽  
Mohammed Al-Hijji ◽  
Dee Dee Wang ◽  
Mackram Eleid ◽  
Marina Urena ◽  
...  

Background: Several studies have evaluated preprocedural imaging predictors of left ventricular outflow tract obstruction (LVOTO) after transcatheter mitral valve replacement. The patient cohorts in these studies were heterogeneous and included patients with transcatheter mitral valve replacement in failed bioprostheses, annuloplasty rings, and severe mitral annular calcification (MAC). The goal of this study was to evaluate predictors of LVOTO specific to patients undergoing valve-in-MAC. Methods: This study included patients with severe MAC who underwent valve-in-MAC and had optimal quality preprocedural multidetector row computed tomography scans eligible for retrospective analysis. Baseline demographic, echocardiographic, and procedural data on these patients were collected. multidetector row computed tomography parameters were analyzed for association with LVOTO, defined as increase in mean LVOT gradient by ≥10 mm Hg with accompanying hemodynamic instability. Results: Seventy-one patients with optimal preprocedural computed tomography scans were included in this study (mean age, 72.5±13.5 years), 9 of which developed LVOTO (all female). Baseline mean LVOT area, neo-LVOT area (145.3 versus 270.9 mm 2 ; P =0.006), indexed neo-LVOT area (90.1 versus 157.4; P =0.05), and virtual transcatheter heart valve to septum distance (3.1 versus 6.9 mm; P =0.002) were lower in the LVOTO group. Expected % LVOT area reduction was higher in the latter group (58.3 versus 42.7%; P =0.008). In the univariable analysis, the baseline mean LVOT area, neo-LVOT area, indexed neo-LVOT area, and valve to septum distance were all significantly associated with LVOTO. Conclusions: The systolic mean LVOT area, neo-LVOT area, indexed neo-LVOT, expected percentage LVOT area reduction, and the valve to septum distance were associated with LVOTO after valve-in-MAC.


2020 ◽  
Vol 58 (3) ◽  
pp. 651-653 ◽  
Author(s):  
Daniel Grinberg ◽  
Matteo Pozzi ◽  
Chloé Bernard ◽  
Jean-Francois Obadia

Abstract We report a case of prosthesis dislodgement after transcatheter mitral valve replacement in an 85-year-old woman with chronic ischaemic heart failure. Two weeks after an initial successful implantation, she presented with a paravalvular leak associated with left ventricular outflow tract obstruction. Tether re-tensioning was performed and resolved the situation, but resulted in a deformation of the apical attachment zone into the left ventricle. Unfortunately, the patient finally expired from severe endocarditis. Proper anchoring is the main challenge for transcatheter mitral valve replacement techniques. Dislodgement of the prosthesis after transcatheter mitral valve replacement is an infrequent complication of the Tendyne® procedure. This case emphasizes the importance of assessing the quality of the myocardium at the implantation zone of the apical pad, and of prosthesis oversizing, especially if low-profile valves are chosen. .


Prosthesis ◽  
2020 ◽  
Vol 2 (1) ◽  
pp. 39-45
Author(s):  
Salvatore Pasta ◽  
Caterina Gandolfo

Obstruction of the left ventricular outflow tract (LVOT) is a common complication of transcatheter mitral valve replacement (TMVR). This procedure can determine an elongation of an LVOT (namely, the neo-LVOT), ultimately portending hemodynamic impairment and patient death. This study aimed to understand the biomechanical implications of LVOT obstruction in a patient who underwent TMVR using a transcatheter heart valve (THV) to repair a failed bioprosthetic heart valve. We first reconstructed the heart anatomy and the bioprosthetic heart valve to virtually implant a computer-aided-design (CAD) model of THV and evaluate the neo-LVOT area. A numerical simulation of THV deployment was then developed to assess the anchorage of the THV to the bioprosthetic heart valve as well as the resulting Von Mises stress at the mitral annulus and the contract pressure among implanted bioprostheses. Quantification of neo-LVOT and THV deployment may facilitate more accurate predictions of the LVOT obstruction in TMVR and help clinicians in the optimal choice of the THV size.


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