COMMENTARY For reprint orders, please contact: [email protected]
Transcatheter mitral valve therapies for mitral regurgitation: are we getting closer? “Despite significant advances in our understanding of the functional anatomy of the mitral valve and the pathophysiology of mitral regurgitation, restoring function either by repair or replacement remains a significant challenge…” Iwan B Harries1, Jan Kovac2 & Steve Ramcharitar*,1 Drawn by Da Vinci circa 1513 and later named by Vessalius on account of its resemblance to the episcopal miter, the mitral valve has captured the imagination of anatomists, surgeons and physicians for centuries. It is a highly complex structure, the competency and function of which relies on the harmonious action of its component parts. Perturbations of any of these parts, namely the annulus, leaflets, tendinous chords and papillary muscles, can compromise the function of not only the valve but the interdependent left ventricle. Furthermore, the mitral valve is afflicted by a wide spectrum of pathologies and the patient population is often comorbid and highly heterogeneous. Despite significant advances in our understanding of the functional anatomy of the mitral valve and the pathophysiology of mitral regurgitation (MR), restoring function either by repair or replacement remains a significant challenge to cardiothoracic surgeons and latterly, interventional cardiologists. Approaches to heart valve disease have progressed from open heart surgery to minimally invasive surgery and more recently to transcatheter therapies with the advent of transcatheter pulmonary and aortic valve replacement procedures in 2000 [1] and 2002 [2] , respectively. Whereas transcatheter aortic valve implantation (TAVI) has emerged as a recognized alternative to surgical aortic valve replacement (SAVR) in selected patients [3] , the more complex anatomical environment and heterogenous patient group encountered in mitral valve disease have proved significant
barriers to the development of transcatheter mitral valve repair and replacement therapies. Cardiothoracic surgeons favor mitral valve repair over replacement because of superior long-term outcomes [3] . Transcatheter mitral valve repair therapies have generally attempted to replicate established surgical repair techniques. MitraClip ® (Abbott Vascular, CA, USA), the most widely used transcatheter therapy for MR mimics the edge-to-edge leaflet repair pioneered by Alfieri et al. [4] by permanently opposing the center of the anterior and posterior leaflets, thus creating a double-orifice valve [5] . EVEREST II [6] reported that at 4-year follow-up, MitraClip was equivalent to conventional mitral valve surgery in terms of mortality (17.4 vs 17.8%; p = 0.914) and functional improvement (moderate/severe MR: 21.4 vs 24.7%; p = 0.745) although MitraClip patients more commonly required surgery to treat residual MR (24.8 vs 5.5%; p < 0.001), usually within the first year [6] . Furthermore, recently presented 5-year data suggest a sustained reduction in MR severity and sustained improvement in NYHA functional class independent of the etiology (functional or degenerative) [7] . Furthermore, few patients required mitral valve surgery beyond the 1-year primary end point. These data and other recent analysis [2] , help to support current societal guidelines (ESC/ EACTS), which recommend that the MitraClip may be considered in symptomatic patients with severe primary or secondary MR despite optimal medical therapy, who fulfil echo criteria
KEYWORDS
• MitraClip® Valve Technologies • mitral regurgitation • mitral valve • transcatheter valve
replacement
Wiltshire Cardiac Centre, Great Western Hospital, Swindon, UK Glenfield Hospital, Leicester, UK *Author for correspondence: [email protected] 1
part of
2
10.2217/FCA.14.60 © 2014 Future Medicine Ltd
Future Cardiol. (2014) 10(6), 687–691
ISSN 1479-6678
683
Commentary Harries, Kovac & Ramcharitar Table 1. Emerging transcatheter mitral valve repair therapies. Therapeutic target
Device
Description
Progress and ref.
Edge-to-edge repair Abbott (Abbott Vascular, CA, USA) Chordal repair NeoChord (NeoChord, Inc., MN, USA) Valtech (Valtech Cardio, Yehuda, Israel)
MitraClip®
US FDA approved
Annuloplasty (indirect)
CARILLON Mitral Contour System®
Transfemoral, trans-septal V-shaped clip for both degenerative and functional MR Transapical artificial chordae attaching leaflet to left ventricular apex. Performed off pump Trans-septal adjustable artificial chordae attaching leaflet to papillary muscle. Performed off pump Transjugular device implanted into coronary sinus for functional MR
Annuloplasty (direct)
Company
Cardiac (Dimensions Cardiac Dimensions, Inc., WA, USA) GDS (Guided Delivery Systems, CA, USA) Millipede (Millipede, LLC, MI, USA) Mitralign (Mitralign, Inc., MA, USA
NeoChord DS 1000™ V-Chordal™
MVRx – formerly Ample (MVRx, Inc., CA, USA)
ValCare (ValCare Medical, Herzlyia Pituach, Israel)
Valtech
Retrograde transventricular device for functional MR Millipede Ring Nitinol ring designed for mitral or tricuspid valve repair Mitralign Bident™ Transventricular dual tip catheter used to place 2–4 anchors through posterior mitral annulus that are plicated together PS3 System Transatrial shortening system using septal and lateral anchoring points that are tensioned together ValCare Mitral Percutaneous annuloplasty ring for both Valve Repair degenerative and functional MR System™ Cardioband-TA™ Transapical annuloplasty band
Valtech
Cardioband-TF™
Enhanced leaflet coaptation
Cardio-solutions Mitra-Spacer (Cardiosolutions, Inc., MA, Transapical™ USA) Transcardiac Therapeutics Mitraflex™ (Transcardiac Therapeutics, LLC, GA, USA)
Combination
GDS Accucinch®
Trans-septal annuloplasty band Transapical device designed to provide sealing surface for leaflets Transapical repair system anchoring leaflet tip to LV myocardium with artificial chordae. Edge-toedge repair can be performed simultaneously
of eligibility, are judged inoperable or at high surgical risk by a ‘heart team’ and have a life expectancy of greater than 1 year [3] . In addition to MitraClip, there are several other transcatheter mitral valve repair therapies currently in use and under development. Those that have progressed to the preclinical trial stage or beyond are listed according to their respective therapeutic targets in Table 1. Transcatheter repair therapies target specific MR aetiologies and, consequently, their use tends to be limited to selected patient populations who require multiparametric evaluation prior to intervention. Salerno et al. give a full description of this process in the current issue of this journal [9] . Partly as a result of this, the concept of transcatheter mitral valve replacement, which has the potential to address multiple etiologies using
684
Future Cardiol. (2014) 10(6)
[11]
CE mark gained [12] Preclinical trials underway [13] CE mark gained [14]
Preclinical trials underway [15] Preclinical trials underway [16] CE mark trial completed [17] First-in-man study underway [18] Preclinical trials underway [19] First-in-man study underway [13] CE mark trial underway [13] First-in-man study underway [20] Preclinical trials underway [21]
a single device, has gained credence. However, the complex functional anatomy of the mitral valve makes transcatheter valve implantation much more challenging than in the aortic position. The mitral annulus is large, asymmetrical, has eccentric geometry, is usually noncalcified and undergoes conformational changes during the cardiac cycle. Pressure gradients across the valve are high, meaning that leaks are poorly tolerated and there is a risk of obstructing the left ventricular outflow tract and deforming the aortic valve with the prosthesis. Furthermore, the replacement valve must accommodate and adapt to any left ventricular remodeling that may occur as a result of its implantation. All of which makes designing, implanting and anchoring a durable, functionally competent mitral valve prosthesis very difficult.
future science group
Transcatheter mitral valve therapies for mitral regurgitation: are we getting closer?
Commentary
Table 2. Emerging transcatheter mitral valve replacement therapies. Company
Device
Caisson (Caisson Caisson TMVR Interventional LLC., MN, USA) CardiAQ (CardiAQ Valve TMVI Technologies, Inc., CA, USA) CardiAQ™ TMVI (2nd generation)
Edwards (Edwards Lifesciences, CA, USA)
FORTIS™
HighLife (HighLife SAS, Paris, France) Medtronic (Medtronic Inc., MN, USA) MitrAssist (MitrAssist Ltd., Misgav, Israel) Neovasc (Neovasc Inc., Richmond, Canada)
HighLife Mitral Valve Replacement™ Medtronic TMVR
Tendyne (Tendyne Holdings, Inc., MN, USA) Valtech
Tendyne/Lutter TMVR
MitrAssist Tiara™
Cardiovalve
Encouragingly, proof of concept and feasibility has been reported using transcatheter
Description
Progress
Transfemoral trans-septal mitral valve replacement
Preclinical trials underway
Transfemoral trans-septal, self-anchoring mitral valve replacement Transapical mitral valve replacement. Anchored through leaflet engagement, chordal preservation and annular attachment Transapical mitral valve replacement using bovine pericardial tissue and cloth-covered self-expanding frame Transatrial mitral valve replacement
First-in-man June 2012 [22]
Self-expanding nitinol ring and a cylindrical, tri-leaflet pericardial valve Transventricular or transapical prosthesis positioned within native valve Transapical device with three bovine pericardial tissue leaflets mounted on self-expanding D-shaped metal alloy frame Transapical self-expanding bovine pericardial valvein-stent with atrial and ventricular fixation Transfemoral, trans-septal two-step mitral valve replacement system
Preclinical trials underway
First-in-man May 2014 [23]
First-in-man March 2014 [24]
Preclinical trials underway [25]
[26]
Preclinical trials underway [27]
First-in-man January 2014 [28]
First-in-man study underway [29]
Preclinical trials underway [13]
valves in patients with degenerative mitral bioprosthetic valves or prior annuloplasty (most
Figure 1. Edwards Fortis delivery system and valve. © EuroPCR.
future science group
www.futuremedicine.com
685
Commentary Harries, Kovac & Ramcharitar commonly using the Edwards Sapien valve; primarily designed for use in the aortic position [Edwards Lifesciences, Inc., CA, USA]). This is feasible because annuloplasty rings and bioprosthetic valves confer additional structural support to the transcatheter valve. However, treating native mitral valve disease has proved more challenging. Although the first implant (CardiAQ TMVI; Table 2) occurred in 2012 [10] , the procedure has been limited to small numbers of patients and performed mainly on compassionate grounds. Recently, three first-in-man cases using different devices were announced and experience with the Edwards Fortis valve was presented at EuroPCR (Figure 1) . There are several other devices under development and those that have progressed to the preclinical trial stage or beyond are listed in Table 2. Conclusion The field of transcatheter mitral valve therapy is still in its infancy. Despite this, transcatheter repair therapies have proved safe and efficacious, and in the case of the MitraClip, have emerged as a viable alternative to surgery in selected high-risk References 1
2
3
4
5
6
686
Bonhoeffer P, Boudjemline Y, Saliba Z et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 356(9239), 1403–1405 (2000). Cribier A, Eltchaninoff H, Bash A et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24), 3006–3008 (2002). Vahanian A, Alfieri O, Andreotti F et al. Joint task force on the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur. Heart J. 33(19), 2451–2496 (2012). Alfieri O, Maisano F, De Bonis M et al. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J. Thorac. Cardiovasc. Surg. 122(4), 674–681 (2001).
7
8
9
population groups. Transcatheter mitral valve replacement therapies are less advanced because of the challenge posed by the complex anatomy and function of the mitral valve but encouraging progress is now being made on several fronts. Progression from conventional surgery through minimally invasive surgery to transcatheter therapies can be viewed as a natural and inevitable procedural evolution. While we cannot currently claim that transcatheter therapies are as good as surgery (it may take years, even decades for this to be the case), the evidence suggests that we certainly are getting closer. Financial & competing interests disclosure The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
regurgitation. J. Am. Coll. Cardiol. 62(4), 317–328 (2013).
13 Valtech.
Kar S. The Everest II randomized controlled trial of percutaneous and surgical reduction of mitral regurgitation: five-year results stratified by degenerative and functional etiologies. Presented at: EuroPCR. Paris, France, 19–22 May 2014.
14 Cardiac Dimensions.
Franzen O, Baldus S, Rudolph V et al. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur. Heart J. 31(11), 1373–1381 (2010). Salerno G, Schmidt FP, Bigazzi MC et al. Preoperative evaluation before MitraClip®: present and future perspective. Future Cardiol. 10(6), 725–745 (2014).
10 Trahan R. CardiAQ™ Valve Technologies
reports cardiovascular medicine milestone: first-in-human nonsurgical percutaneous implantation of a bioprosthetic mitral heart valve. www.cardiaq.com
Feldman T, Young A. Percutaneous approaches to valve repair for mitral regurgitation. J. Am. Coll. Cardiol. 63(20), 2057–2068 (2014).
11 Abbott Vascular. MitraClip percutaneous
Mauri L, Foster E, Glower DD et al. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral
12 NeoChord. NeoChord DS1000.
mitral valve repair system. www.abbottvascular.com/int/MitraClip.html www.neochord.com
Future Cardiol. (2014) 10(6)
www.valtechcardio.com www.cardiacdimensions.com 15 Guided Delivery Systems. Closing in on
Heart Disease. www.gdsmed.com 16 Millipede Percutaneous Annuloplasty Ring.
Award Information. www.sbir.gov/sbirsearch/detail/16165 17 Mitralign. The Mitralign system for valve
repair. www.mitralign.com 18 PR Newswire. First Human Implants of
Ample Medical’s PS3 System. www.prnewswire.com 19 Valvecare Medical. Innovative Solutions for
Human Heart Valve Disease. www.valcaremedical.com 20 Cardiosolutions. The Mitra–Spacer.
www.cardiosolutionsinc.com 21 TransCardiac Therapeutics. Products.
www.transcardiac.com/products 22 CardiAQ Valve Technologies.
CardiAQ™ Valve Technologies reports cardiovascular medicine milestone: first-in-human nonsurgical percutaneous implantation of a bioprosthetic mitral heart
future science group
Transcatheter mitral valve therapies for mitral regurgitation: are we getting closer? valve. www.cardiaq.com 23 CRT Online. CardiAQ reports first
transapical implantation of its secondgeneration TMVI system. www.crtonline.org/pr.aspx?PAGE_ID=11314 24 Edwards Life sciences. Early patient cases
future science group
with fortis valve presented at EuroPCR 2014. www.edwards.com 25 HighLife SAS. Patent no. 20130116779 (2013). 26 Medtronic.
28 CNW. Neovasc Inc. announces successful
first human implant of Tiara™ transcatheter mitral valve. www.newswire.ca 29 Lutter G, Pokorny S, Frank D, Cremer J,
www.medtronic.com 27 Mitrassist: assisting the mitral valve.
www.mitrassist.com
Commentary
Lozonschi L. Transapical mitral valve implantation: the Lutter valve. Heart Lung Vessel. 5(4), 201–206 (2013).
www.futuremedicine.com
687
Transcatheter mitral valve therapies for mitral regurgitation: are we getting closer? “Despite significant advances in our understanding of the functional anatomy of the mitral valve and the pathophysiology of mitral regurgitation, restoring function either by repair or replacement remains a significant challenge…” Iwan B Harries1, Jan Kovac2 & Steve Ramcharitar*,1 Drawn by Da Vinci circa 1513 and later named by Vessalius on account of its resemblance to the episcopal miter, the mitral valve has captured the imagination of anatomists, surgeons and physicians for centuries. It is a highly complex structure, the competency and function of which relies on the harmonious action of its component parts. Perturbations of any of these parts, namely the annulus, leaflets, tendinous chords and papillary muscles, can compromise the function of not only the valve but the interdependent left ventricle. Furthermore, the mitral valve is afflicted by a wide spectrum of pathologies and the patient population is often comorbid and highly heterogeneous. Despite significant advances in our understanding of the functional anatomy of the mitral valve and the pathophysiology of mitral regurgitation (MR), restoring function either by repair or replacement remains a significant challenge to cardiothoracic surgeons and latterly, interventional cardiologists. Approaches to heart valve disease have progressed from open heart surgery to minimally invasive surgery and more recently to transcatheter therapies with the advent of transcatheter pulmonary and aortic valve replacement procedures in 2000 [1] and 2002 [2] , respectively. Whereas transcatheter aortic valve implantation (TAVI) has emerged as a recognized alternative to surgical aortic valve replacement (SAVR) in selected patients [3] , the more complex anatomical environment and heterogenous patient group encountered in mitral valve disease have proved significant
barriers to the development of transcatheter mitral valve repair and replacement therapies. Cardiothoracic surgeons favor mitral valve repair over replacement because of superior long-term outcomes [3] . Transcatheter mitral valve repair therapies have generally attempted to replicate established surgical repair techniques. MitraClip ® (Abbott Vascular, CA, USA), the most widely used transcatheter therapy for MR mimics the edge-to-edge leaflet repair pioneered by Alfieri et al. [4] by permanently opposing the center of the anterior and posterior leaflets, thus creating a double-orifice valve [5] . EVEREST II [6] reported that at 4-year follow-up, MitraClip was equivalent to conventional mitral valve surgery in terms of mortality (17.4 vs 17.8%; p = 0.914) and functional improvement (moderate/severe MR: 21.4 vs 24.7%; p = 0.745) although MitraClip patients more commonly required surgery to treat residual MR (24.8 vs 5.5%; p < 0.001), usually within the first year [6] . Furthermore, recently presented 5-year data suggest a sustained reduction in MR severity and sustained improvement in NYHA functional class independent of the etiology (functional or degenerative) [7] . Furthermore, few patients required mitral valve surgery beyond the 1-year primary end point. These data and other recent analysis [2] , help to support current societal guidelines (ESC/ EACTS), which recommend that the MitraClip may be considered in symptomatic patients with severe primary or secondary MR despite optimal medical therapy, who fulfil echo criteria
KEYWORDS
• MitraClip® Valve Technologies • mitral regurgitation • mitral valve • transcatheter valve
replacement
Wiltshire Cardiac Centre, Great Western Hospital, Swindon, UK Glenfield Hospital, Leicester, UK *Author for correspondence: [email protected] 1
part of
2
10.2217/FCA.14.60 © 2014 Future Medicine Ltd
Future Cardiol. (2014) 10(6), 687–691
ISSN 1479-6678
683
Commentary Harries, Kovac & Ramcharitar Table 1. Emerging transcatheter mitral valve repair therapies. Therapeutic target
Device
Description
Progress and ref.
Edge-to-edge repair Abbott (Abbott Vascular, CA, USA) Chordal repair NeoChord (NeoChord, Inc., MN, USA) Valtech (Valtech Cardio, Yehuda, Israel)
MitraClip®
US FDA approved
Annuloplasty (indirect)
CARILLON Mitral Contour System®
Transfemoral, trans-septal V-shaped clip for both degenerative and functional MR Transapical artificial chordae attaching leaflet to left ventricular apex. Performed off pump Trans-septal adjustable artificial chordae attaching leaflet to papillary muscle. Performed off pump Transjugular device implanted into coronary sinus for functional MR
Annuloplasty (direct)
Company
Cardiac (Dimensions Cardiac Dimensions, Inc., WA, USA) GDS (Guided Delivery Systems, CA, USA) Millipede (Millipede, LLC, MI, USA) Mitralign (Mitralign, Inc., MA, USA
NeoChord DS 1000™ V-Chordal™
MVRx – formerly Ample (MVRx, Inc., CA, USA)
ValCare (ValCare Medical, Herzlyia Pituach, Israel)
Valtech
Retrograde transventricular device for functional MR Millipede Ring Nitinol ring designed for mitral or tricuspid valve repair Mitralign Bident™ Transventricular dual tip catheter used to place 2–4 anchors through posterior mitral annulus that are plicated together PS3 System Transatrial shortening system using septal and lateral anchoring points that are tensioned together ValCare Mitral Percutaneous annuloplasty ring for both Valve Repair degenerative and functional MR System™ Cardioband-TA™ Transapical annuloplasty band
Valtech
Cardioband-TF™
Enhanced leaflet coaptation
Cardio-solutions Mitra-Spacer (Cardiosolutions, Inc., MA, Transapical™ USA) Transcardiac Therapeutics Mitraflex™ (Transcardiac Therapeutics, LLC, GA, USA)
Combination
GDS Accucinch®
Trans-septal annuloplasty band Transapical device designed to provide sealing surface for leaflets Transapical repair system anchoring leaflet tip to LV myocardium with artificial chordae. Edge-toedge repair can be performed simultaneously
of eligibility, are judged inoperable or at high surgical risk by a ‘heart team’ and have a life expectancy of greater than 1 year [3] . In addition to MitraClip, there are several other transcatheter mitral valve repair therapies currently in use and under development. Those that have progressed to the preclinical trial stage or beyond are listed according to their respective therapeutic targets in Table 1. Transcatheter repair therapies target specific MR aetiologies and, consequently, their use tends to be limited to selected patient populations who require multiparametric evaluation prior to intervention. Salerno et al. give a full description of this process in the current issue of this journal [9] . Partly as a result of this, the concept of transcatheter mitral valve replacement, which has the potential to address multiple etiologies using
684
Future Cardiol. (2014) 10(6)
[11]
CE mark gained [12] Preclinical trials underway [13] CE mark gained [14]
Preclinical trials underway [15] Preclinical trials underway [16] CE mark trial completed [17] First-in-man study underway [18] Preclinical trials underway [19] First-in-man study underway [13] CE mark trial underway [13] First-in-man study underway [20] Preclinical trials underway [21]
a single device, has gained credence. However, the complex functional anatomy of the mitral valve makes transcatheter valve implantation much more challenging than in the aortic position. The mitral annulus is large, asymmetrical, has eccentric geometry, is usually noncalcified and undergoes conformational changes during the cardiac cycle. Pressure gradients across the valve are high, meaning that leaks are poorly tolerated and there is a risk of obstructing the left ventricular outflow tract and deforming the aortic valve with the prosthesis. Furthermore, the replacement valve must accommodate and adapt to any left ventricular remodeling that may occur as a result of its implantation. All of which makes designing, implanting and anchoring a durable, functionally competent mitral valve prosthesis very difficult.
future science group
Transcatheter mitral valve therapies for mitral regurgitation: are we getting closer?
Commentary
Table 2. Emerging transcatheter mitral valve replacement therapies. Company
Device
Caisson (Caisson Caisson TMVR Interventional LLC., MN, USA) CardiAQ (CardiAQ Valve TMVI Technologies, Inc., CA, USA) CardiAQ™ TMVI (2nd generation)
Edwards (Edwards Lifesciences, CA, USA)
FORTIS™
HighLife (HighLife SAS, Paris, France) Medtronic (Medtronic Inc., MN, USA) MitrAssist (MitrAssist Ltd., Misgav, Israel) Neovasc (Neovasc Inc., Richmond, Canada)
HighLife Mitral Valve Replacement™ Medtronic TMVR
Tendyne (Tendyne Holdings, Inc., MN, USA) Valtech
Tendyne/Lutter TMVR
MitrAssist Tiara™
Cardiovalve
Encouragingly, proof of concept and feasibility has been reported using transcatheter
Description
Progress
Transfemoral trans-septal mitral valve replacement
Preclinical trials underway
Transfemoral trans-septal, self-anchoring mitral valve replacement Transapical mitral valve replacement. Anchored through leaflet engagement, chordal preservation and annular attachment Transapical mitral valve replacement using bovine pericardial tissue and cloth-covered self-expanding frame Transatrial mitral valve replacement
First-in-man June 2012 [22]
Self-expanding nitinol ring and a cylindrical, tri-leaflet pericardial valve Transventricular or transapical prosthesis positioned within native valve Transapical device with three bovine pericardial tissue leaflets mounted on self-expanding D-shaped metal alloy frame Transapical self-expanding bovine pericardial valvein-stent with atrial and ventricular fixation Transfemoral, trans-septal two-step mitral valve replacement system
Preclinical trials underway
First-in-man May 2014 [23]
First-in-man March 2014 [24]
Preclinical trials underway [25]
[26]
Preclinical trials underway [27]
First-in-man January 2014 [28]
First-in-man study underway [29]
Preclinical trials underway [13]
valves in patients with degenerative mitral bioprosthetic valves or prior annuloplasty (most
Figure 1. Edwards Fortis delivery system and valve. © EuroPCR.
future science group
www.futuremedicine.com
685
Commentary Harries, Kovac & Ramcharitar commonly using the Edwards Sapien valve; primarily designed for use in the aortic position [Edwards Lifesciences, Inc., CA, USA]). This is feasible because annuloplasty rings and bioprosthetic valves confer additional structural support to the transcatheter valve. However, treating native mitral valve disease has proved more challenging. Although the first implant (CardiAQ TMVI; Table 2) occurred in 2012 [10] , the procedure has been limited to small numbers of patients and performed mainly on compassionate grounds. Recently, three first-in-man cases using different devices were announced and experience with the Edwards Fortis valve was presented at EuroPCR (Figure 1) . There are several other devices under development and those that have progressed to the preclinical trial stage or beyond are listed in Table 2. Conclusion The field of transcatheter mitral valve therapy is still in its infancy. Despite this, transcatheter repair therapies have proved safe and efficacious, and in the case of the MitraClip, have emerged as a viable alternative to surgery in selected high-risk References 1
2
3
4
5
6
686
Bonhoeffer P, Boudjemline Y, Saliba Z et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 356(9239), 1403–1405 (2000). Cribier A, Eltchaninoff H, Bash A et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106(24), 3006–3008 (2002). Vahanian A, Alfieri O, Andreotti F et al. Joint task force on the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur. Heart J. 33(19), 2451–2496 (2012). Alfieri O, Maisano F, De Bonis M et al. The double-orifice technique in mitral valve repair: a simple solution for complex problems. J. Thorac. Cardiovasc. Surg. 122(4), 674–681 (2001).
7
8
9
population groups. Transcatheter mitral valve replacement therapies are less advanced because of the challenge posed by the complex anatomy and function of the mitral valve but encouraging progress is now being made on several fronts. Progression from conventional surgery through minimally invasive surgery to transcatheter therapies can be viewed as a natural and inevitable procedural evolution. While we cannot currently claim that transcatheter therapies are as good as surgery (it may take years, even decades for this to be the case), the evidence suggests that we certainly are getting closer. Financial & competing interests disclosure The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.
regurgitation. J. Am. Coll. Cardiol. 62(4), 317–328 (2013).
13 Valtech.
Kar S. The Everest II randomized controlled trial of percutaneous and surgical reduction of mitral regurgitation: five-year results stratified by degenerative and functional etiologies. Presented at: EuroPCR. Paris, France, 19–22 May 2014.
14 Cardiac Dimensions.
Franzen O, Baldus S, Rudolph V et al. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur. Heart J. 31(11), 1373–1381 (2010). Salerno G, Schmidt FP, Bigazzi MC et al. Preoperative evaluation before MitraClip®: present and future perspective. Future Cardiol. 10(6), 725–745 (2014).
10 Trahan R. CardiAQ™ Valve Technologies
reports cardiovascular medicine milestone: first-in-human nonsurgical percutaneous implantation of a bioprosthetic mitral heart valve. www.cardiaq.com
Feldman T, Young A. Percutaneous approaches to valve repair for mitral regurgitation. J. Am. Coll. Cardiol. 63(20), 2057–2068 (2014).
11 Abbott Vascular. MitraClip percutaneous
Mauri L, Foster E, Glower DD et al. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral
12 NeoChord. NeoChord DS1000.
mitral valve repair system. www.abbottvascular.com/int/MitraClip.html www.neochord.com
Future Cardiol. (2014) 10(6)
www.valtechcardio.com www.cardiacdimensions.com 15 Guided Delivery Systems. Closing in on
Heart Disease. www.gdsmed.com 16 Millipede Percutaneous Annuloplasty Ring.
Award Information. www.sbir.gov/sbirsearch/detail/16165 17 Mitralign. The Mitralign system for valve
repair. www.mitralign.com 18 PR Newswire. First Human Implants of
Ample Medical’s PS3 System. www.prnewswire.com 19 Valvecare Medical. Innovative Solutions for
Human Heart Valve Disease. www.valcaremedical.com 20 Cardiosolutions. The Mitra–Spacer.
www.cardiosolutionsinc.com 21 TransCardiac Therapeutics. Products.
www.transcardiac.com/products 22 CardiAQ Valve Technologies.
CardiAQ™ Valve Technologies reports cardiovascular medicine milestone: first-in-human nonsurgical percutaneous implantation of a bioprosthetic mitral heart
future science group
Transcatheter mitral valve therapies for mitral regurgitation: are we getting closer? valve. www.cardiaq.com 23 CRT Online. CardiAQ reports first
transapical implantation of its secondgeneration TMVI system. www.crtonline.org/pr.aspx?PAGE_ID=11314 24 Edwards Life sciences. Early patient cases
future science group
with fortis valve presented at EuroPCR 2014. www.edwards.com 25 HighLife SAS. Patent no. 20130116779 (2013). 26 Medtronic.
28 CNW. Neovasc Inc. announces successful
first human implant of Tiara™ transcatheter mitral valve. www.newswire.ca 29 Lutter G, Pokorny S, Frank D, Cremer J,
www.medtronic.com 27 Mitrassist: assisting the mitral valve.
www.mitrassist.com
Commentary
Lozonschi L. Transapical mitral valve implantation: the Lutter valve. Heart Lung Vessel. 5(4), 201–206 (2013).
www.futuremedicine.com
687
