Transcatheter Mitral Valve Replacement: A Novel Anchor Technology

Yazhou Liu; Georg Lutter; Philipp Knueppel; Derk Frank; Lucian Lozonschi; Rouven Berndt; Tim Attmann; Thomas Puehler

doi:10.1055/s-0041-1722976

The Thoracic and Cardiovascular Surgeon, Table of Contents

Thorac Cardiovasc Surg 2022; 70(02): 126-132
DOI: 10.1055/s-0041-1722976

Original Basic Science

Transcatheter Mitral Valve Replacement: A Novel Anchor Technology

Yazhou Liu

¹Department of Experimental Cardiac Surgery and Heart Valve Replacement, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

²Department of Cardiothoracic Surgery, The First People's Hospital of Jingmen, Hubei Minzu University, Jingmen, Hubei, China

,

Georg Lutter

¹Department of Experimental Cardiac Surgery and Heart Valve Replacement, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

³Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

,

Philipp Knueppel

¹Department of Experimental Cardiac Surgery and Heart Valve Replacement, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

³Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

,

Derk Frank

⁴Department of Cardiology and Angiology, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

,

Lucian Lozonschi

⁵Department of Cardiothoracic Surgery, Tampa University, Tampa, Florida, United States

,

Rouven Berndt

¹Department of Experimental Cardiac Surgery and Heart Valve Replacement, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

³Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

,

Tim Attmann

¹Department of Experimental Cardiac Surgery and Heart Valve Replacement, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

³Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

,

Thomas Puehler

¹Department of Experimental Cardiac Surgery and Heart Valve Replacement, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

³Department of Cardiovascular Surgery, Christian-Albrechts-University of Kiel, School of Medicine, UKSH, Kiel, Germany

› Author Affiliations

Abstract

All articles of this category

Abstract

Background Mitral valved stents tend to migrate or to develop paravalvular leakage due to high–left ventricular pressure in this cavity. Thus, this study describes a newly developed mitral valved stent anchoring technology.

Methods Based on an existing mitral valved stent, four anchoring units with curved surgical needles were designed and fabricated using three-dimensional (3D) software and print technology. Mitral nitinol stents assembled with four anchoring units were successively fixed on 10 porcine annuli. Mechanical tests were performed with a tensile force test system and recorded the tension forces of the 10 nitinol stents on the annulus.

Results The average maximum force was 28.3 ± 5.21 N, the lowest was 21.7 N, and the highest was 38.6 N until the stent lost contact with the annulus; for the break force (zero movement of stent from annulus), the average value was 18.5 ± 6.7 N with a maximum value of 26.9 N and a minimum value of 6.07 N. It was additionally observed that the puncture needles of the anchoring units passed into the mitral annulus in all 10 hearts and further penetrated the myocardium in only one additional heart. The anchoring units enhanced the tightness of the mitral valved stent and did not destroy the circumflex coronary artery, coronary sinus, right atrium, aortic root, or the left ventricular outflow tract.

Conclusion The new anchoring units for mitral nitinol stents were produced with 3D software and printing technology; with this new type of anchoring technology, the mitral valved stent can be tightly fixed toward the mitral annulus.

Keywords

3D printing - anchoring method - mechanical testing - mitral valved stent - in vitro study - transcatheter mitral valve replacement - TMVR

Full Text

References

References
1 Goode D, Dhaliwal R, Mohammadi H. Transcatheter mitral valve replacement: state of the art. Cardiovasc Eng Technol 2020; 11 (03) 229-253
2 De Backer O, Piazza N, Banai S. et al. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv 2014; 7 (03) 400-409
3 Søndergaard L, De Backer O, Franzen OW. et al. First-in-human case of transfemoral cardiaq mitral valve implantation. Circ Cardiovasc Interv 2015; 8 (07) e002135
4 Cheung A, Webb J, Verheye S. et al. Short-term results of transapical transcatheter mitral valve implantation for mitral regurgitation. J Am Coll Cardiol 2014; 64 (17) 1814-1819
5 Bapat V, Buellesfeld L, Peterson MD. et al. Transcatheter mitral valve implantation (TMVI) using the Edwards FORTIS device. EuroIntervention 2104 10 (suppl U): U120-U128
6 Meredith I, Bapat V, Morriss J. et al. Intrepid transcatheter mitral valve replacement system: technical and product description. EuroIntervention 2016; 12 (Y): Y78-Y80
7 Navia JL, Baeza C, Maluenda G. et al. Transcatheter mitral valve replacement with the NaviGate stent in a preclinical model. EuroIntervention 2017; 13 (12) e1401-e1409
8 Regueiro A, Granada JF, Dagenais F. et al. Transcatheter mitral valve replacement: insights from early clinical experience and future challenges. J Am Coll Cardiol 2017; 69 (17) 2175-2192
9 Lange R, Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention 2016; 12 (Y): Y81-Y83
10 Moat N, Duncan A, Lindsay A. et al. Transcatheter mitral valve replacement for the treatment of mitral regurgitation: in-hospital outcomes of an apically tethered device. J Am Coll Cardiol 2015; 65 (21) 2352-2353
11 Nunes Ferreira-Neto A, Dagenais F, Bernier M. et al. Transcatheter mitral valve replacement with a new supra-annular valve: first-in-human experience with the altavalve system. JACC Cardiovasc Interv 2019; 12 (02) 208-209
12 Modine T, Vahl TP, Khalique OK. et al. First-in-human implant of the cephea transseptal mitral valve replacement system. Circ Cardiovasc Interv 2019; 12 (09) e008003
13 Loger K, Lutter G, Huenges K. et al. Transcatheter mitral valve implantation: supra-annular and subvalvular fixation techniques. Eur J Cardiothorac Surg 2018; 54 (06) 1013-1021
14 Hulman M, Bena M, Artemiou P. et al. Iterative learning of transcatheter mitral valve replacement in mitral valve annulus calcification: management and prevention of transcatheter mitral valve replacement dislocation. Ann Thorac Surg 2016; 102 (04) e287-e290
15 Blanke P, Naoum C, Webb J. et al. Multimodality imaging in the context of transcatheter mitral valve replacement: establishing consensus among modalities and disciplines. JACC Cardiovasc Imaging 2015; 8 (10) 1191-1208
16 Vukicevic M, Mosadegh B, Min JK, Little SH. Cardiac 3D printing and its future directions. JACC Cardiovasc Imaging 2017; 10 (02) 171-184
17 Loger K, Pokorny S, Schaller T. et al. Novel stent design for transcatheter mitral valve implantation. Interact Cardiovasc Thorac Surg 2018; 26 (02) 190-195
18 Kaklikkaya I, Yeginoglu G. Damage to coronary arteries during mitral valve surgery. Heart Surg Forum 2003; 6 (06) E138-E142
19 Kempfert J, Blumenstein J, Chu MW. et al. Minimally invasive off-pump valve-in-a-ring implantation: the atrial transcatheter approach for re-operative mitral valve replacement after failed repair. Eur J Cardiothorac Surg 2009; 35 (06) 965-969 , discussion 969
20 Robinson SS, Alaie S, Sidoti H. et al. Patient-specific design of a soft occluder for the left atrial appendage. Nat Biomed Eng 2018; 2 (01) 8-16
21 Pokorny S, Huenges K, Engel A. et al. In vivo quantification of the apical fixation forces of different mitral valved stent designs in the beating heart. Ann Biomed Eng 2015; 43 (05) 1201-1209
22 MacIver DH, Stephenson RS, Jensen B. et al. The end of the unique myocardial band: part I. Anatomical considerations. Eur J Cardiothorac Surg 2018; 53 (01) 112-119
23 Kocica MJ, Corno AF, Carreras-Costa F. et al. The helical ventricular myocardial band: global, three-dimensional, functional architecture of the ventricular myocardium. Eur J Cardiothorac Surg 2006; 29 (Suppl. 01) S21-S40
24 Maisano F, Vanermen H, Seeburger J. et al. Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience. Eur J Cardiothorac Surg 2012; 42 (03) 524-529
25 Rogers JH, Boyd WD, Smith TW, Bolling SF. Early experience with Millipede IRIS transcatheter mitral annuloplasty. Ann Cardiothorac Surg 2018; 7 (06) 780-786
26 Gooley RP, Meredith IT. The accucinch transcatheter direct mitral valve annuloplasty system. EuroIntervention 2015; 11 (suppl W): W60-W61