Download Transcatheter Mitral Valve Replacement for Severe Mitral

Health Policy Advisory Committee on
Technology
Technology Brief
Transcatheter mitral valve replacement for severe mitral
regurgitation
December 2015
© State of Queensland (Queensland Department of Health) 2015
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DISCLAIMER: This Brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This Brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
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This Brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
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This brief was prepared by Dr Meegan Vandepeer from ASERNIP-S
Summary of findings
Transcatheter mitral valve replacement is a very new technology. Only three studies were
identified and described in this brief. Each study used a different valve and the maximum
number of patients was five. In each of the studies the patients selected were those
deemed not suitable for surgical valve replacement or percutaneous repair with a MitraClip.
All three studies demonstrated successful implantation of the device. Across all three
studies the longest follow-up of a surviving patient was 90 days. At least one of the authors
in each study was a consultant for the company that manufactured the valve. The studies
included in this brief were the first human trials describing this technology. Further studies
with larger patient numbers and longer follow-up periods are required to determine the
true safety and efficacy of these devices beyond implantation.
It is clear that there is strong interest in this technology given the number of devices that
are in various stages of development. Several clinical trials were identified that will
investigate the safety of these devices in larger series of patients. It has been reported that
progress with this technology will be significantly slower than that associated with the
development of transcatheter aortic valve replacement, primarily due to the complexity of
the mitral valve anatomy and its pathology.19
HealthPACT Advice
HealthPACT noted that this technology is in the early stages of development and is diffusing
into the health systems of Australia and New Zealand. None of the iterations of the device
are registered on the TGA; however it is currently being used under the TGA’s Special Access
Scheme. HealthPACT also noted that although only small numbers of patients have been
treated using this minimally invasive approach, the mortality rate in these patients is high.
HealthPACT recommends that use of this technology in the public health system should be
based on efficacy and cost-effectiveness, and as such larger clinical trials need to be
conducted, comparing transcatheter mitral valve replacement to conservative medical
management. HealthPACT does not support investment in this technology in clinical practice
at this time; however, it is recommended that the evidence be reviewed again in 24 months.
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
i
Technology, Company and Licensing
Register ID
WP225
Technology name
Transcatheter mitral valve replacement
Patient indication
Patients with severe mitral valve regurgitation requiring
mitral valve replacement but who are unable to have open
surgery or percutaneous repair
Description of the technology
Transcatheter mitral valve replacement is a minimally invasive surgical procedure that
replaces a patient’s damaged mitral valve with a bioprosthetic one. The bioprosthetic valve
is delivered into the heart using a catheter that has been crimped inside a covering sheatha.
When the valve is correctly positioned the sheath is pulled back and the valve is released.
The new bioprosthetic valve self-expands, pushing the old valve leaflets out of the way and
thereby taking over the job of regulating blood flow through the heart.1, 2
Compared with surgical valve replacement, which requires open heart surgery and full or
partial splitting of the breastbone (sternotomy or mini-sternotomy), the transcatheter
approach can be done through a small opening that leaves the breastbone intact. At present
there are several transcatheter mitral valves in various stages of development. They can be
delivered either via a transapical or transfemoral approach. With the transfemoral
approach, the catheter is passed through the femoral artery in the groin, avoiding the need
for a surgical incision in the chest. With the transapical approach, a small incision is made in
the chest and the catheter is passed into the heart through a large artery in the chest or
through the tip of the left ventricle.1 Both delivery techniques require the patient to
undergo general anaesthesia. The procedure is performed in a hybrid operating suite that
has both catheterisation and surgical capabilities. A team consisting of interventional
cardiologists, imaging specialists, heart surgeons and cardiac anaesthesiologists work
together using fluoroscopy and echocardiography to guide the new valve to the site of the
diseased valve.3 Patients stay in hospital for approximately 3 to 5 days after the procedure.1
The bioprosthetic valves are composed of three valve leaflets fashioned from animal heart
tissue that are mounted on a self-expanding nitinol frame or stent. The valves have an
anchoring mechanism, but they can be repositioned before final deployment. This
description is based on three transcatheter mitral valves that have peer-reviewed
publications describing their use, and as a result, form the basis of this technical brief: the
FORTIS and CardiAQ valves (Edwards Lifesciences Corporation, California, United States of
America [USA]) and the Tiara valve (Neovasc Inc., British Columbia, Canada). The Tiara valve
is shown in Figure 1.
a
An exception is the FORTIS mitral transcatheter valve which has a sheathless delivery system
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
1
Figure 1
The Tiara transcatheter mitral valve (with permission Neovasc Inc., British Columbia, Canada)
Company or developer
Several companies are developing transcatheter mitral valves (Table 1).
Reason for assessment
Transcatheter mitral valve replacement is a novel treatment for patients with severe mitral
valve regurgitation (MR) who are unable to undergo surgical replacement or repair.
Stage of development in Australia
Yet to emerge
Established
Experimental
Established but changed indication
or modification of technique
Should be taken out of use
Investigational
Nearly established
Licensing, reimbursement and other approval
There are no transcatheter mitral valves listed on the Australian Register of Therapeutic
Goods, and none have received United States Food and Drug Administration (FDA) approval
or a CE mark. Four transcatheter mitral valves have FDA investigational device exemptions:
the transfemoral and transapical transcatheter mitral valve implantation systems by
CardiAQ Valve Technologies Inc.b; the Tendyne Bioprosthetic Mitral Valve System by
Tendyne Holdings, Inc. (Minnesota, USA) and the Tiara valve by Neovasc Inc.4-6
b
CardiAQ Valve Technologies Inc. was acquired by Edwards Lifesciences Corporation in August 2015
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
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Table 1
Development status of transcatheter mitral valves as described by Levin and Thompson (2015)7
Device Name
Company
International Status
USA Status
Atlas™
St. George Medical, Florida,
USA
*
Applied for patent
Caisson TMVR
Caisson International,
Minnesota, USA
*
Preclinical assessment
underway
Cephea TMVR
Cephea, California, USA
*
In development
CardioValve
Valtech, Or Yehuda, Israel
Preclinical assessment
planned
*
Endovalve-transapical
Micro Interventional Devices,
Pennsylvania, USA
*
In development
FORTIS
Edwards Lifesciences,
California, USA
Clinical work suspended
USA feasibility study planned
HighLife Mitral Replacement
HighLife, California, USA
First human study underway
*
Inovare Mitral
Braile Biomedica, São José
do Rio Preto, Brazil
In development
*
Lutter Valve
Lutter†
Preclinical assessment
underway
*
MAESTRO
Mitralix, Jerusalem, Israel
In development
*
Medtronic TMVR
Medtronic Inc., Minneapolis,
USA
Preclinical assessment
underway
Preclinical assessment
underway
Mehr TMVR
Mehr Medical, Massachusetts,
USA
*
Applied for patent
MitraCath
Emory University, Georgia,
USA
*
In development
MitralHeal
MitralHeal, Tel Aviv, Israel
Preclinical assessment
underway
*
Mitraltech TMVR
Mitraltech, Or Yehuda, Israel
Applied for patent
*
MitrAssist Valve
MitrAssist Medical Ltd, Tel
Aviv, Israel
Preclinical assessment
underway
*
MITRICARES Device
MITRICARES, Paris, France
Applied for patent
*
Nakostech TMVR
Nakostech, Paris, France
*
Applied for patent
Navigate TMVR
Navigate Cardiac Structures
Inc., Ohio, USA
*
Preclinical assessment
underway
Saturn
HT Consultant†
Preclinical assessment
underway
*
SINOMED TMVR
SINOMED, Tianjin, China
Preclinical assessment
underway
*
Tiara
Neovasc Inc., British
Columbia, Canada
International feasibility study
underway
USA feasibility study underway
Tendyne TMVR
Tendyne Medical Inc.,
Maryland, USA
First human study underway
USA feasibility study underway
TMVI-TA
CardiAQ Valve Technologies
Inc., Massachusetts, USA‡
CE mark trial planned
IDE accepted for feasibility
study
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
3
TMVI-TF
CardiAQ Valve Technologies
Inc., Massachusetts, USA‡
First human study underway
IDE accepted for feasibility
study
TMVR
Twelve, California, USA
First human study underway
*
Tresillo
Transcatheter Technologies,
Regensburg, Germany
Preclinical assessment
planned
*
*no current activity
†location of company unable to be identified
‡CardiAQ Valve Technologies Inc. was acquired by Edwards Lifesciences Corporation in August 2015
IDE: investigational device exemption; TMVI-TA: transcatheter mitral valve implantation - transapical; TMVI-TF: transcatheter mitral valve implantation transfemoral; TMVR: transcatheter mitral valve replacement; USA: United States of America
Australian Therapeutic Goods Administration approval
Yes
ARTG number (s)
No
Not applicable
Technology type
Device
Technology use
Therapeutic
Patient Indication and Setting
Disease description and associated mortality and morbidity
The mitral valve, which is composed of two flaps of tissues called leaflets, lies between the
left ventricle and left atrium in the heart. It opens when blood flows from the left atrium
into the left ventricle and then closes to prevent the oxygenated blood that has just passed
into the left ventricle from flowing backwards. MR, also called mitral incompetence, occurs
when the heart’s mitral valve doesn’t close properly and blood leaks from the left ventricle
back into the left atrium. It is one of the most common forms of heart valve disorder in
Western countries.2, 8, 9
MR is classified as primary or secondary. Primary MR occurs when there is a problem with
the leaflets of the mitral valve. The most common causes of primary MR are:

mitral valve prolapse

rheumatic valve disease

endocarditis (inflammation of the heart tissue)

valve calcification

chord rupture (when the strings holding the valve in place snap)

ischaemic heart disease.10
Secondary MR, also known as functional MR, occurs when there is a problem with the
structures that hold the valve in place. The most common causes of secondary MR are heart
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
4
failure, coronary artery disease, complications due to a heart attack and hypertrophic
cardiomyopathy (a type of heart muscle disease).11
MR can be acute or chronic. Chronic MR comprises mild MR that progresses slowly over
many years. Patients may have no symptoms for decades and may be unaware that they
have the condition. When present, symptoms can include:

blood flowing turbulently through the heart (heart murmur)

shortness of breath (dyspnoea), especially with exertion

fatigue, especially during times of increased activity

heart palpitations

swollen feet or ankles.9
Acute MR, which is rarer, occurs suddenly and is a medical emergency. Patients with acute
severe MR can have the following symptoms: low blood pressure, shortness of breath,
dizziness and fainting.11
MR is also classified according to its severity (mild, moderate or severe). Mild MR may not
cause problems. Severe MR, in which approximately 50 per cent of the blood in the heart is
leaking backwards, can lead to heart failure, atrial fibrillation and pulmonary hypertension if
not treated.9, 11
Common diagnostic tests to diagnose MR include:

echocardiograms

electrocardiogram

chest x-rays

cardiac MRI

cardiac catheterisation

computed tomography angiogram

exercise tests or stress tests.9
Number of patients
MR is one of the most prevalent heart valve diseases in Western countries. It becomes more
common with age and affects almost 10 per cent of individuals over 75 years of age.8, 12 In
2012 to 2013 there were 2,975 hospitalisations in Australian public hospitals for MR.13 The
data did not report on the number of patients with severe MR or the number of patients
who were unable to undergo valve replacement using conventional surgical techniques.
No information was identified on the number of people with MR in New Zealand.
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
5
Speciality
Cardiology
Technology setting
Tertiary Setting
Impact
Alternative and/or complementary technology
Transcatheter mitral valve replacement using bioprosthetic mitral valves is a novel
technology for patients with severe MR who are in need of a new valve but are unable to
undergo open surgery or percutaneous repair.
Current technology
Fixing the valve through open heart surgery is the gold standard treatment for patients with
severe MR.12 However, around 49 per cent of patients with severe, symptomatic MR are
not referred for surgery because they are too ill or weak to withstand the stress of the
procedure. Patient characteristics associated with the decision not to operate include older
age, congestive heart failure and diabetes. Patients with a left ventricular ejection fraction
of less than 60 per cent and an MR grade of 3 out of 4 are also more frequently denied
surgery.14 Percutaneous mitral repair treatments are available, but these procedures are
only suitable for very specific forms of mitral valve disease and anatomic subsets. 2 As a
result, there is a subset of patients with severe MR for whom there is no treatment
currently available.
International utilisation
Country
Level of Use
Trials underway or
completed
Australia

Belgium

Canada

Denmark

France

Poland

The Netherlands

United Kingdom

United States of America

Limited use
Widely diffused
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
6
Diffusion of technology in Australia
The St Vincent’s Hospital in Sydney is participating in a clinical trial (NCT02321514) on the
Tendyne Bioprosthetic Mitral Valve System (Table 4). In addition, the Flinders Medical
Centre is in the process of obtaining ethics approval for a clinical trial on this mitral valve
system.
Cost infrastructure and economic consequences
The main cost of the procedure is the cost of the device. In a recent article on mitral valves
it was reported that an executive from Tendyne Holdings, Inc. stated the price of their mitral
valve will be equivalent to or greater than the current price for a prosthetic aortic valve,
which is approximately USD $30,000.5 The infrastructure requirements for this procedure
would be the same as those needed for a transcatheter aortic valve implantation (TAVI).
While TAVI procedures are performed in Australia, there is no diagnosis-related group (DRG)
listed for them.
Training would be required in order to perform transcatheter mitral valve replacement,
even for those who have performed TAVI procedures, due to the greater technical
challenges associated with the complex anatomy of the mitral compared with the aortic
valve.2, 7
Ethical, cultural, access or religious considerations
No ethical, cultural, access or religious considerations for transcather mitral valve
replacement were identified.
Evidence and Policy
Safety and effectiveness
Three prospective case series studies (level IV interventional evidence) were identified for
inclusion in this technology brief. The studies represent the first clinical evaluations of three
different transcatheter mitral valves. An overview of the studies is provided in Table 2.
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
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Table 2
Included study characteristics
Study/location
Inclusion criteria
Exclusion criteria
Length of follow-up,
number of patients
and losses to followup
Conflicts of interest
Bapat et al 201415
Patients with high surgical
risk and severe MR and
NYHA Class II symptoms or
greater who were considered
poor candidates for MitraClip
(Abbott Laboratories, Illinois,
USA) based on anatomical
findings. In addition, patients
were required to have a
native annular diameter
distance measuring between
30 and 44 mm, a posterior
leaflet length of >0.5 cm and
an anterior leaflet length <2.3
cm as assessed by
echocardiography
Able to have mitral
valve surgery or
percutaneous mitral
valve repair with
MitraClip.
Length: maximum of
76 days
n=5
Losses: 0
Five of the 16 authors are
consultants for Edwards
Lifesciences, the valve
manufacturer
Symptomatic severe MR and
class IV heart failure
Able to have mitral
valve surgery or
percutaneous mitral
valve repair with
MitraClip
Length: maximum of
90 days
One of the authors is a
consultant for the valve
manufacturer, CardiAQ
Valve Technologies Inc.
Level IV evidence
United Kingdom
Single centre case
series study
Sondergaard et al
201516
Level IV evidence
Denmark
Other exclusions
included patients
with leaflet prolapse
in the P2 segment,
mitral regurgitation
that is predominantly
commissural and a
small left ventricle
n=3
Losses: 0
Single centre case
series study
Chueng et al 201417
Level IV evidence
End-stage ischaemic
cardiomyopathy and severe
functional MR
Canada
Single centre case
series study
Able to have mitral
valve surgery or
percutaneous mitral
valve repair with
MitraClip
Length: maximum of
69 days
n=2
Losses: 0
One of the 8 authors is a
consultant for Neovasc
Inc. and another is the
medical director of
Neovasc Inc., the valve
manufacturer
MR: mitral regurgitation; NR: not reported; NYHA: New York Heart Association; NR: not reported; USA: United States of America
Bapat et al 201415
This study describes the first five patients treated with the FORTIS transcatheter mitral
valve. At least two of the patients were male and one was female. The sex of the other
patients was not reported, nor was the age of any of the patients. The device was inserted
via a transapical approach in high surgical risk patients with severe MR and New York Heart
Association (NYHA) class II symptoms or greater. Patients were assessed by a heart team
consisting of cardiothoracic surgeons and cardiologists who deemed that the risk with
conventional mitral valve surgery was too high. The longest reported follow-up time was 76
days post-implantation.
Effectiveness and safety
The device was successfully implanted in all five patients. In two patients there was no
evidence of residual MR and in another two there was minimal or trace MR after the
procedure. MR after implantation was not reported in the fifth patient, although it was
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
8
stated that the implantation was smooth and an excellent result was obtained. Three
patients survived beyond 30 days and two patients were alive at the time of reporting,
although the length of time between implementation and reporting was not provided.
Three of the five patients died. The first patient, who was discharged on day 15, was
readmitted on day 37 with signs of heart failure and died on day 76 post-implantation. The
30-day follow-up assessment of this patient revealed marginal improvement despite having
only minimal MR after the procedure. The second patient had a technically difficult
procedure because of an apical aneurysm that made it difficult to place the purse-string
access in a suitable position. The patient developed acute renal failure on day one and
required re-intubation for pulmonary oedema on day two. Despite aggressive treatment the
patient died on day four. Trans-oesophageal echocardiography revealed increasing MR and
some valve displacement. The third patient was discharged on day nine, but was readmitted
on day 15 with cardiac decompensation, abdominal pain and systemic inflammatory
response syndrome. Echocardiography demonstrated reduced leaflet mobility in two of the
three leaflets. Antibiotics and heparin were commenced but the patient died on day 15
post-implantation.
Both of the surviving patients were discharged on day six. It was reported that they
continued to slowly improve. The study did not state the length of the follow-up period for
the surviving patients.
Sondergaard et al 201516
A consecutive series of three patients with a Society of Thoracic Surgeons mortality score
greater than 22 per cent were selected for transcatheter mitral valve implantation with the
CardiAQ device. The patients ranged from 78 to 89 years in age; two were female and one
was male. The device was inserted via a transapical approach using fluoroscopy and transoesophageal guidance.
All patients had symptomatic severe MR and were deemed unsuitable for mitral valve
surgery or percutaneous mitral valve repair. Trans-oesophageal echocardiography and
cardiac multi-slice computed tomography were used to determine patient suitability.
Anatomical features taken into consideration were: mitral annulus diameter (<40 mm was
preferred to minimise the risk of paravalvular leak after implantation); the presence of a
very acute aorto-mitral angle, which would potentially increase the risk of left ventricle
outflow tract obstruction; and the presence of sub-valvular calcification.
Patient comorbidities included previous coronary artery bypass surgery (n=2), severe
pulmonary hypertension (n=1) and moderate to severe chronic renal failure (n=3). The
follow-up period varied between patients, with the longest being 90 days.
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
9
Effectiveness and safety
Accurate positioning and deployment of the CardiAQ transcatheter mitral valve was
achieved in all three patients. Two of the patients spent 14 days in hospital. The third
patient died in hospital on day nine post-procedure due to severe hospital-acquired
pneumonia. An autopsy revealed no prosthesis-related complications. Longer term followup results are described in Table 3.
Table 3
Follow-up of patients after transcatheter mitral valve replacement surgery 16
Variables
Patient 1 (day 90)
Patient 2 (day 60)
Patient 3 (day 8)
Residual MR
Trace
Trace
Trace
Valve function
Stable position, normal
function
Stable position, normal
function
Stable position, normal
function
Leaflet motion
Some restriction
Unrestricted
Unrestricted
Valve gradient
2 mm Hg
2 mm Hg
3 mm Hg
LVOT gradient
PG 8 mm Hg, MG 4 mm Hg
PG 10 mm Hg, MG 5 mm Hg
PG 10 mm Hg
LV function
Normal
40%
<20%
LV apical pseudoaneurysm
Not present
Not present
Not present
LV: left ventricle; LVOT: left ventricular outflow tract; MG: mean gradient; MR: mitral regurgitation; PG: peak gradient
Cheung et al 201417
This study described the first two cases of transcatheter mitral valve implantation for MR
using the Tiara device. The valve was implanted transapically in a woman aged 61 years and
a man aged 73 years. Both patients had severe functional MR, NYHA class IV heart failure
with depressed left ventricular ejection fraction (15% to 25%), pulmonary hypertension and
additional comorbidities. Both patients were assessed by a multidisciplinary heart team who
deemed that the risk with conventional mitral valve surgery was too high. Percutaneous
repair with a MitraClip was also ruled out for anatomical reasons. The maximum follow-up
period was two months following the implantation of the device.
Effectiveness and safety
Postoperatively, a left ventricular angiogram showed no significant MR and an invasive
pressure measurement confirmed an unobstructed left ventricular outflow tract in both
patients. Repeat transthoracic echocardiograms in both patients on day four, and at one
and two months post-implantation demonstrated normal valve function, with no evidence
of thrombus formation, paravalvular leakage or left ventricular outflow tract obstruction.
The 61-year-old patient was discharged five days after treatment and had significant
improvements after two months in brain natriuretic peptide levels, 6-minute walk test
results and NYHA functional class.
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
10
The 73-year-old patient experienced an episode of post-haemodialysis hypotension on
postoperative day 21, which required cardiopulmonary resuscitation and re-intubation. The
patient recovered and was discharged five weeks post-implantation. At 2 months the
patient had recurrent heart failure. A repeat transthoracic echocardiogram revealed poor
left ventricular function, although the valve prosthesis was functioning well and had
eliminated the MR. Despite this, the patient experienced cardiac failure and died on day 69
post-procedure.
Economic evaluation
No economic evaluation studies on transcatheter mitral valve implantation were identified.
Ongoing research
A total of five clinical trials on transcatheter mitral valves were identified from a search of
ClinicalTrials.gov and the Australian and New Zealand Clinical Trials Registry (Table 4). Four
of the trials were recruiting and one had not started recruiting; all were case series studies.
Other issues
At the time of writing this technical brief, Edwards Lifesciences had temporarily halted its
clinical trial of the FORTIS valve because of evidence of valve thrombosis.18 This valve was
used in one of the studies discussed in this brief.15
All three studies had one or more authors who were consultants to the company who
produced the valve used in the study.
It should be noted that there is interest in using transcatheter mitral valve replacement for
the treatment of other mitral valve disorders, such as mitral stenosis (clinical trial
NCT02370511).
Number of studies included
All evidence included for assessment in this technology brief has been assessed according to
the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the HealthPACT web site.
Total number of studies: 3
Total number of Level IV studies: 3
Search criteria to be used (MeSH terms)
(mitral regurgitation) AND ((transcatheter mitral valve implantation) OR transcatheter mitral
valve replacement)
Literature search date
27th July 2015
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
11
Table 4
Registered clinical trial characteristics
Study
Design
Location
Single or
multicentre
NCT02276547
Case series
United States of
America, Belgium,
Canada
Multicentre
NCT02428010
Case series
Poland
Single centre
NCT02478008
Case series
Denmark, France,
the Netherlands,
United Kingdom
Multicentre
NCT02515539
Case series
United States of
America
Multicentre
NCT02321514
Case series
United States of
America, Australia
Multicentre
Number of
patients
Intervention
30
Transcatheter mitral valve replacement (TMVR) with
the Tiara valve
Freedom from all-cause mortality and major adverse
events defined as disabling stroke, myocardial infarction,
renal failure requiring dialysis, life-threatening bleeding and
cardiac surgical or transcatheter reintervention
Recruiting
TMVR with the Twelve valve
Adverse events
Recruiting
10
Primary outcomes
Trial status
(Estimated completion
date)
(December 2015)
(September 2016)
60
TMVR with the CardiAQ valve (transapical approach)
Composite major adverse event rate
Recruiting
(December 2016)
20
30
TMVR with the CardiAQ valve (transfemoral and
transapical delivery systems)
Composite major adverse event rate
TMVR with the Tendyne Bioprosthetic Mitral Valve
System
Safety assessed by freedom from device or procedure
related adverse events
Transcatheter mitral valve replacement for severe mitral regurgitation: December 2015
Not yet recruiting
(July 2021)
Recruiting
(July 2016)
Performance assessed by freedom from device
malfunction
12
References
1.
American Heart Association (2014). What is TAVR? [Internet]. American Heart
Association. Available from:
http://www.heart.org/HEARTORG/Conditions/More/HeartValveProblemsandDisease/
What-is-TAVR_UCM_450827_Article.jsp [Accessed 24 August 2015].
2.
Preston-Maher, G. L., Torii, R.& Burriesci, G. (2015). 'A Technical Review of Minimally
Invasive Mitral Valve Replacements'. Cardiovascular engineering and technology, 6 (2),
174-84.
3.
Cleveland Clinic (2014). Heart Valve Disease - Percutaneous Interventions. [Internet].
Cleveland Clinic. Available from:
http://my.clevelandclinic.org/services/heart/disorders/valvetreatment/percutaneous
Valve [Accessed 24 August 2015].
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