Emerging Trends in Heart Valve Engineering: Part II. Novel and Standard Technologies for Aortic Valve Replacement

The engineering of technologies for heart valve replacement (i.e., heart valve engineering) is an exciting and evolving field. Since the first valve replacement, technology has progressed by leaps and bounds. Innovations emerge frequently and supply patients and physicians with new, increasingly efficacious and less invasive treatment options. As much as any other field in medicine the treatment of heart valve disease has experienced a renaissance in the last 10 years. Here we review the currently available technologies and future options in the surgical and transcatheter treatment of aortic valve disease. Different valves from major manufacturers are described in details with their applications.

[1]  Ulrich Steinseifer,et al.  Transient, Three-Dimensional Flow Field Simulation through a Mechanical, Trileaflet Heart Valve Prosthesis , 2011, ASAIO journal.

[2]  D. Bach,et al.  Ten-year outcome after aortic valve replacement with the freestyle stentless bioprosthesis. , 2005, The Annals of thoracic surgery.

[3]  Marcio Forleo,et al.  Effect of Hypertension on the Closing Dynamics and Lagrangian Blood Damage Index Measure of the B-Datum Regurgitant Jet in a Bileaflet Mechanical Heart Valve , 2013, Annals of Biomedical Engineering.

[4]  Thomas Walther,et al.  Crimping may affect the durability of transcatheter valves: an experimental analysis. , 2011, The Annals of thoracic surgery.

[5]  Thierry Bové,et al.  Fifteen years' single-center experience with the ATS bileaflet valve. , 2009, The Journal of heart valve disease.

[6]  Tanya Shipkowitz,et al.  Evaluation technique for bileaflet mechanical valves. , 2002, The Journal of heart valve disease.

[7]  Alfonso Ielasi,et al.  Current and new-generation transcatheter aortic valve devices: an update on emerging technologies , 2013, Expert review of cardiovascular therapy.

[8]  Andreas Hoffmeier,et al.  Clinical and echocardiographic outcomes after implantation of the Trifecta aortic bioprosthesis: an initial single-centre experience. , 2013, Interactive cardiovascular and thoracic surgery.

[9]  Philippe Pibarot,et al.  Impact of Valve Prosthesis-Patient Mismatch on Short-Term Mortality After Aortic Valve Replacement , 2003, Circulation.

[10]  P. Pibarot,et al.  Prosthetic Heart Valves Selection of the Optimal Prosthesis and Long-Term Management , 2009 .

[11]  X. Jin,et al.  Performance of Edwards prima stentless aortic valve over eight years. , 2001, Seminars in thoracic and cardiovascular surgery.

[12]  Siamak Mohammadi,et al.  Bioprosthetic valve durability after stentless aortic valve replacement: the effect of implantation technique. , 2014, The Annals of thoracic surgery.

[13]  Antonio Colombo,et al.  Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. , 2014, Journal of the American College of Cardiology.

[14]  Craig A. Simmons,et al.  Emerging Trends in Heart Valve Engineering: Part III. Novel Technologies for Mitral Valve Repair and Replacement , 2015, Annals of Biomedical Engineering.

[15]  Susan Armstrong,et al.  Twenty-year results of the Hancock II bioprosthesis. , 2006, The Journal of heart valve disease.

[16]  Patrick Bruneval,et al.  Evidence of leaflet injury during percutaneous aortic valve deployment. , 2011, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[17]  Volkmar Falk,et al.  Intermediate follow-up results from the multicenter engager European pivotal trial. , 2013, The Annals of thoracic surgery.

[18]  Thierry Bové,et al.  Twenty-year single-center experience with the medtronic open pivot mechanical heart valve. , 2014, The Annals of thoracic surgery.

[19]  U Althaus,et al.  Early experience with the new Masters series of St. Jude Medical heart valve: in vivo hemodynamic and clinical results in patients with narrowed aortic annulus. , 1997, The Journal of heart valve disease.

[20]  Nicolo Piazza,et al.  Images in clinical medicines. Starr-Edwards heart valves. , 2008, The New England journal of medicine.

[21]  J Fisher,et al.  Comparative study of the hydrodynamic function of six size 19 mm bileaflet heart valves. , 1995, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[22]  Robert W Emery,et al.  Five-year follow up of the ATS mechanical heart valve. , 2004, The Journal of heart valve disease.

[23]  Christodoulos Stefanadis,et al.  CoreValve aortic bioprosthesis: repositioning techniques. , 2010, JACC. Cardiovascular interventions.

[24]  Neelakantan Saikrishnan,et al.  Micro Particle Image Velocimetry Measurements of Steady Diastolic Leakage Flow in the Hinge of a St. Jude Medical® Regent™ Mechanical Heart Valve , 2013, Annals of Biomedical Engineering.

[25]  Matthias Thielmann,et al.  First clinical experience and 1-year follow-up with the sutureless 3F-Enable aortic valve prosthesis. , 2008, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[26]  M. Fishbein,et al.  Tissue characterization and calcification potential of commercial bioprosthetic heart valves. , 2001, The Annals of thoracic surgery.

[27]  Bart Meuris,et al.  Antimineralization treatment and patient-prosthesis mismatch are major determinants of the onset and incidence of structural valve degeneration in bioprosthetic heart valves. , 2014, The Journal of thoracic and cardiovascular surgery.

[28]  Uberto Bortolotti,et al.  Single center experience with the Sorin Bicarbon prosthesis: a 17-year clinical follow-up. , 2014, The Journal of thoracic and cardiovascular surgery.

[29]  A. Cook,et al.  Permanent Pacemaker Insertion After CoreValve Transcatheter Aortic Valve Implantation: Incidence and Contributing Factors (the UK CoreValve Collaborative) , 2011, Circulation.

[30]  Friedrich-Christian Riess,et al.  Hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis up to ten years. , 2007, The Annals of thoracic surgery.

[31]  K. Riemslagh,et al.  A Three-dimensional Analysis of Flow in the Pivot Regions of an ATS Bileaflet Valve , 1999, The International journal of artificial organs.

[32]  Anja Mueller,et al.  Synthesis of a low thrombogenic heart valve coating with horseradish peroxidase , 2005 .

[33]  Robert W Emery,et al.  Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve. , 2002, The Annals of thoracic surgery.

[34]  J Goldstone,et al.  The development of the Starr-Edwards heart valve. , 1999, Texas Heart Institute journal.

[35]  Peter Kremer,et al.  Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years. , 2010, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[36]  Ofer Merin,et al.  Long-term results of aortic valve replacement with the St. Jude Toronto stentless porcine valve. , 2004, The Annals of thoracic surgery.

[37]  S. Bradley,et al.  Aortic Valve Insufficiency in the Teenager and Young Adult , 2013, World journal for pediatric & congenital heart surgery.

[38]  Denis Bouchard,et al.  Fifteen years of clinical and echocardiographic follow up with the carbomedics heart valve. , 2006, The Journal of heart valve disease.

[39]  Franz Schwarz,et al.  The Effect of Aortic Valve Replacement on Survival , 1982, Circulation.

[40]  Ravi Pillai,et al.  3f Prosthesis Aortic Cusp Replacement: Implantation Technique and Early Results , 2010, Asian cardiovascular & thoracic annals.

[41]  Hiroaki Harasaki,et al.  Blood compatibility of a newly developed trileaflet mechanical heart valve. , 2001 .

[42]  Erich Wintermantel,et al.  Impairment of pericardial leaflet structure from balloon-expanded valved stents. , 2012, The Journal of thoracic and cardiovascular surgery.

[43]  Cyrus K. Aidun,et al.  Numerical Investigation of the Effects of Channel Geometry on Platelet Activation and Blood Damage , 2011, Annals of Biomedical Engineering.

[44]  S. Pocock,et al.  Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. , 2010, The New England journal of medicine.

[45]  Bernard Chevalier,et al.  The Colibri heart valve: theory and practice in the achievement of a low-profile, pre-mounted, pre-packaged TAVI valve. , 2013, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[46]  Arash Kheradvar,et al.  The Effects of Positioning of Transcatheter Aortic Valves on Fluid Dynamics of the Aortic Root , 2014, ASAIO journal.

[47]  Gino Gerosa,et al.  Small aortic annulus: the hydrodynamic performances of 5 commercially available bileaflet mechanical valves. , 2004, The Journal of thoracic and cardiovascular surgery.

[48]  M. Borger,et al.  Carpentier-Edwards Perimount Magna valve versus Medtronic Hancock II: a matched hemodynamic comparison. , 2007, The Annals of thoracic surgery.

[49]  Fabio Miraldi,et al.  Sorin stentless pericardial valve versus Carpentier-Edwards Perimount pericardial bioprosthesis: Is it worthwhile to struggle? , 2007, International journal of cardiology.

[50]  Robert W Emery,et al.  Opposite trends in coronary artery and valve surgery in a large multisurgeon practice, 1979-1999. , 2004, The Annals of thoracic surgery.

[51]  Alec Vahanian,et al.  The Year in Cardiology 2013: valvular heart disease (focus on catheter-based interventions). , 2014, European heart journal.

[52]  L Goldman,et al.  The autopsy in clinical medicine. , 1989, Mayo Clinic proceedings.

[53]  Ulrich Steinseifer,et al.  In-vivo experience with the Triflo trileaflet mechanical heart valve. , 2006, The Journal of heart valve disease.

[54]  Shmuel Einav,et al.  Device Thrombogenicity Emulator (DTE)--design optimization methodology for cardiovascular devices: a study in two bileaflet MHV designs. , 2010, Journal of biomechanics.

[55]  Alain Cribier,et al.  Percutaneous transarterial aortic valve implantation: what do we know? , 2011, European heart journal.

[56]  Shmuel Einav,et al.  Design Optimization of a Mechanical Heart Valve for Reducing Valve Thrombogenicity—A Case Study with ATS Valve , 2010, ASAIO journal.

[57]  EuroPCR EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. , 2005 .

[58]  Patrick Bruneval,et al.  Traumatic leaflet injury during the use of percutaneous valves: a comparative study of balloon- and self-expandable valved stents. , 2013, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[59]  N H Hwang,et al.  Computational fluid dynamics study of a protruded-hinge bileaflet mechanical heart valve. , 2001, The Journal of heart valve disease.

[60]  Faisal H Cheema,et al.  Patents and heart valve surgery--I: mechanical valves. , 2013, Recent patents on cardiovascular drug discovery.

[61]  Stuart J Pocock,et al.  Transcatheter versus surgical aortic-valve replacement in high-risk patients. , 2011, The New England journal of medicine.

[62]  Arash Kheradvar,et al.  The effects of transcatheter valve crimping on pericardial leaflets. , 2014, The Annals of thoracic surgery.

[63]  Keith Myers,et al.  Tubular heart valves: a new tissue prosthesis design--preclinical evaluation of the 3F aortic bioprosthesis. , 2005, The Journal of thoracic and cardiovascular surgery.

[64]  Hélène A. Simon,et al.  FLUID MECHANICS OF ARTIFICIAL HEART VALVES , 2009, Clinical and experimental pharmacology & physiology.

[65]  P. Herijgers,et al.  Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. , 2001, The Annals of thoracic surgery.

[66]  Robert W Emery,et al.  The initial experience with the ATS Medical mechanical cardiac valve prosthesis. , 2003, The Annals of thoracic surgery.

[67]  Scott Lim,et al.  Two-year outcomes after transcatheter or surgical aortic-valve replacement. , 2012, The New England journal of medicine.

[68]  Arash Kheradvar,et al.  Echocardiographic particle image velocimetry: a novel technique for quantification of left ventricular blood vorticity pattern. , 2010, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[69]  Thomas Walther,et al.  Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes. , 2013, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[70]  L. Martinelli,et al.  CoreValve® transcatheter self-expandable aortic bioprosthesis , 2013, Expert review of medical devices.

[71]  Hélène A. Simon,et al.  A Numerical Investigation of Blood Damage in the Hinge Area of Aortic Bileaflet Mechanical Heart Valves During the Leakage Phase , 2012, Annals of Biomedical Engineering.

[72]  Adrian G Barnett,et al.  Long-term outcomes following Medtronic Open Pivot valved conduit. , 2014, The Journal of heart valve disease.

[73]  A. Matthews,et al.  The development of the Starr-Edwards heart valve. , 1998, Texas Heart Institute journal.

[74]  Samuel Z Goldhaber,et al.  "Bridging" and mechanical heart valves: perils, promises, and predictions. , 2006, Circulation.

[75]  Frederick J Schoen,et al.  Calcification of tissue heart valve substitutes: progress toward understanding and prevention. , 2005, The Annals of thoracic surgery.

[76]  Patrick Bruneval,et al.  Crimping and deployment of balloon-expandable valved stents are responsible for the increase in the hydraulic conductance of leaflets. , 2013, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[77]  A. Mirza,et al.  Perimount pericardial bioprosthesis for aortic calcified stenosis: 18-year experience with 1133 patients. , 2006, The Journal of heart valve disease.

[78]  W. Keeling,et al.  Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery , 2011 .

[79]  Lakshmi Prasad Dasi,et al.  Procoagulant Properties of Flow Fields in Stenotic and Expansive Orifices , 2007, Annals of Biomedical Engineering.

[80]  Wei Yin,et al.  A Biocompatible Flow Chamber to Study the Hemodynamic Performance of Prosthetic Heart Valves , 2012, ASAIO journal.

[81]  Roland Hetzer,et al.  Aortic valve replacement with the Mitroflow pericardial bioprosthesis: durability results up to 21 years. , 2008, The Journal of thoracic and cardiovascular surgery.

[82]  S. Rahimtoola,et al.  Choice of prosthetic heart valve in adults an update. , 2010, Journal of the American College of Cardiology.

[83]  I. Meredith,et al.  The next era of transcatheter aortic valve replacement: A case illustrating the benefit of a fully re‐positionable, re‐sheathable, and retrievable prosthesis , 2014, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[84]  Objectives Background Methods Results Conclusions , 2022 .

[85]  Arash Kheradvar,et al.  High-speed particle image velocimetry to assess cardiac fluid dynamics in vitro: From performance to validation , 2012 .

[86]  Guillermo Reyes,et al.  Results of aortic valve replacement with the supra-annular Sorin Bicarbon Overline prosthesis. , 2012, The Journal of heart valve disease.

[87]  Rune Haaverstad,et al.  The Scandinavian multicenter hemodynamic evaluation of the SJM Regent aortic valve , 2011, Journal of cardiothoracic surgery.

[88]  M. Bonacchi,et al.  Early and mid-term functional and hemodynamic evaluation of the St. Jude Medical Regent 17 mm aortic valve mechanical prosthesis. , 2014, The Journal of heart valve disease.

[89]  Fracp Robert Gooley Mbbs,et al.  The next era of transcatheter aortic valve replacement: A case illustrating the benefit of a fully re-positionable, re-sheathable, and retrievable prosthesis , 2013 .

[90]  Erwan Donal,et al.  Hemodynamic performance during exercise of the new St. Jude Trifecta aortic bioprosthesis: results from a French multicenter study. , 2014, Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography.

[91]  John Fisher,et al.  An Initial Parametric Study on Fluid Flow Through Bileaflet Mechanical Heart Valves Using Computational Fluid Dynamics , 1994 .

[92]  J. Chambers,et al.  Clinical event rates with the On-X bileaflet mechanical heart valve: a multicenter experience with follow-up to 12 years. , 2013, The Journal of thoracic and cardiovascular surgery.

[93]  Gino Gerosa,et al.  The fate of Hancock II porcine valve recipients 25 years after implant. , 2010, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[94]  Federico De Marco,et al.  Direct aortic transcatheter valve implantation via mini-thoracotomy using the Medtronic CoreValve. , 2013, Multimedia manual of cardiothoracic surgery : MMCTS.

[95]  J. Pepper,et al.  Hemodynamics and left ventricular mass regression following implantation of the Toronto SPV stentless porcine valve. , 1998, The American journal of cardiology.

[96]  Chad Hughes,et al.  Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. , 2014, The Journal of thoracic and cardiovascular surgery.

[97]  Axel Linke,et al.  Worldwide TAVI registries: what have we learned? , 2014, Clinical Research in Cardiology.

[98]  Thoralf M Sundt,et al.  2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. , 2014, Journal of the American College of Cardiology.

[99]  Gino Gerosa,et al.  Small aortic annulus: the hydrodynamic performances of 5 commercially available bileaflet mechanical valves. , 2004, The Journal of thoracic and cardiovascular surgery.

[100]  S. Baldus,et al.  JenaValve--transfemoral technology. , 2013, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[101]  B. Carabello,et al.  Aortic valve stenosis – Author's reply , 2009, The Lancet.