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Percutaneous mitral valve leaflet repair for mitral regurgitation

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  NATIONAL INSTITUTE FOR HEALTH AND
        CLINICAL EXCELLENCE
     INTERVENTIONAL PROCEDURES PROGRAMME
  Interventional procedure overview of percutaneous
    mitral valve leaflet repair for mitral regurgitation
Mitral regurgitation occurs when the mitral valve does not close properly,
allowing blood to leak backwards. This can lead to shortness of breath and
the heart may be unable to pump enough blood to the rest of the body. During
percutaneous mitral valve leaflet repair, a catheter is inserted through the skin
via a large vein in the groin or neck and passed through to the heart. The two
leaflets of the mitral valve are partially clipped or sewn together to reduce the
amount of blood leaking backwards.

Introduction
The National Institute of Health and Clinical Excellence (NICE) has prepared
this overview to help members of the Interventional Procedures Advisory
Committee (IPAC) make recommendations about the safety and efficacy of an
interventional procedure. It is based on a rapid review of the medical literature
and specialist opinion. It should not be regarded as a definitive assessment of
the procedure.

Date prepared
This overview was prepared in October 2008.

Procedure name
• Percutaneous mitral valve leaflet repair


Specialty societies
• British Cardiovascular Intervention Society
• Society of Cardiothoracic Surgeons of Great Britain and Ireland




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Description

Indications and current treatment
Mitral regurgitation is characterised by backward flow of blood from the left
ventricle to the left atrium during systole. It may cause the left ventricle to
become enlarged and weakened because of the additional workload required
to maintain normal forward blood flow. Left untreated, moderate to severe
mitral regurgitation can cause congestive heart failure and eventually lead to
death.

Mitral regurgitation may be caused by a variety of mechanisms involving
abnormalities of the valve leaflets, the sub-valvar support apparatus, and the
mitral valve annulus. Most often it is caused by a combination of pathologies
resulting from degenerative leaflet disease, rheumatic disease and annular
dilation as a result of dilated or ischaemic cardiomyopathy.

Mild and moderate mitral regurgitation are often managed conservatively.
More severe mitral regurgitation may require surgical valve repair (for
example, through partial leaflet resection, annuloplasty, chordal repair or a
combination of these) or valve replacement, using either an open surgical or
thoracoscopic approach.

The severity of mitral regurgitation is graded using echocardiography on a
scale from 1 to 4: grade 1 is mild, grade 2 is moderate, grade 3 is moderate to
severe and grade 4 is severe.

What the procedure involves
The aim of percutaneous mitral valve leaflet repair is to create a double orifice
mitral valve during diastole and keep the leaflets more closely apposed during
systole, thereby reducing the amount of regurgitation.

With the patient under general anaesthesia, a catheter is advanced through
the femoral vein into the right atrium and then into the left atrium via a
transseptal puncture using fluoroscopy and transoesophageal guidance.
Subsequent technique details may vary according to the type of device used,
but all techniques involve partial clipping or suturing of the mitral leaflets to
each other at the point of origin of the regurgitant jet. Transoesophageal
echocardiography and/or fluoroscopy can be used to assess whether mitral
regurgitation has been adequately reduced and the clip or suture may be
repositioned as necessary.

List of studies included in the overview
This overview is based on 47 patients from one multicentre case series
(reported in four different publications) and an additional case report. All
studies reported outcomes after percutaneous mitral valve leaflet repair using
a clip device rather than with suturing.

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Efficacy
A case report of the first human case of percutaneous mitral valve leaflet
repair described a successful procedure in which mitral regurgitation was
reduced from grade 4 pre-operatively to grade 1 at 1- and 2-year follow-up.
The patient had exertional dyspnoea which resolved within 30 days of the
procedure and she remained asymptomatic at the 2-year follow-up1.

In a multicentre case series of 47 patients, the procedure was successful in 34
patients (72%). Procedural success was defined as clip placement with
reduction in mitral regurgitation to grade 2 or less as measured by core
laboratory echocardiographic assessments at hospital discharge. In 5 patients
the clip was not left in place because of insufficient reduction in mitral
regurgitation2.

Of the 27 patients who were involved in the phase I stage of the study, the
procedure was successful in 22 (81%) and these patients were discharged
from hospital with a clip in place. In 5 patients the procedure was
unsuccessful: in 3 patients the clip was not left in place; in 1 patient there was
partial clip detachment within 24 hours; and in 1 patient there was inadequate
mitral regurgitation reduction (although this was apparent during the
procedure, it was not possible to re-open and remove the clip because of
device malfunction, so it was left in place). All 5 patients who had
unsuccessful procedures had subsequent elective surgical mitral valve
repair3.

Of the 22 patients who had successful clip insertion, mitral regurgitation was
reduced to grade 2 or lower in 14 (64%) at 30-day follow-up (measured by
core laboratory echocardiographic assessments) and this improvement was
maintained in 13 patients at 6-month follow-up. At 30-day and 6-month follow-
up, mitral regurgitation of grade 3 or greater was measured in 6 (27%) and 4
(18%) patients, respectively. Two patients had mitral regurgitation recurrence
and another 2 patients had partial clip detachment at a 30-day follow-up
assessment3.

In the first 27 patients in the trial, mean mitral valve gradient increased from
1.79 mmHg at baseline to 3.31 mmHg immediately after clip deployment
(p = 0.004, n = 16) and 3.56 mmHg at 12-month follow-up (n = 13). Mitral
valve area (measured by planimetry) decreased from 6.49 cm2 at baseline to
4.46 cm2 after clip deployment (p < 0.001, n = 18) and 3.79 cm2 at 12-month
follow-up (n = 13)4.

In total (of the first 27 patients in the phase I study), 6 patients required
surgical revision after the procedure (mean 56 ± 55 days after percutaneous
mitral valve leaflet repair; range 1-133 days) for recurrent or persistent mitral
regurgitation because of malpositioning of the clip at the time of implantation
(n = 4) causing partial clip detachment in 3 patients, and insufficient mitral
regurgitation reduction at the time of implantation (n = 2)5.



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Safety
In the first 27 patients in the trial, 4 (15%) had a major adverse event within
30 days. Clip detachment from one of the two valve leaflets occurred in
3 patients (one was diagnosed during the 24-hour echocardiogram and two
were diagnosed at 30-day follow-up). One patient had a permanent
non-embolic stroke associated with postoperative hypotension. The only
in-hospital complication was that 1 patient needed a blood product transfusion
during the procedure3.

Among 19 patients who had 6-month follow-up transthoracic
echocardiograms, Doppler evidence of atrial septal shunting was present in
four, absent in seven, and indeterminate in eight3.

Literature review

Rapid review of literature
The medical literature was searched to identify studies and reviews relevant to
percutaneous mitral valve leaflet repair. Searches were conducted of the
following databases, covering the period from their commencement to
13/08/2008: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other
databases. Trial registries and the Internet were also searched. No language
restriction was applied to the searches (see appendix C for details of search
strategy).

The following selection criteria (table 1) were applied to the abstracts
identified by the literature search. Where selection criteria could not be
determined from the abstracts the full paper was retrieved.




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Table 1 Inclusion criteria for identification of relevant studies
Characteristic         Criteria
Publication type       Clinical studies were included. Emphasis was placed on
                       identifying good quality studies.
                       Abstracts were excluded where no clinical outcomes were
                       reported, or where the paper was a review, editorial, or a
                       laboratory or animal study.
                       Conference abstracts were also excluded because of the
                       difficulty of appraising study methodology, unless they reported
                       specific adverse events that were not available in the published
                       literature.
Patient                Patients with mitral regurgitation.
Intervention/test      Percutaneous mitral valve leaflet repair.
Outcome                Articles were retrieved if the abstract contained information
                       relevant to the safety and/or efficacy.
Language               Non-English-language articles were excluded unless they were
                       thought to add substantively to the English-language evidence
                       base.

Existing assessments of this procedure
There were no published assessments from other organisations identified at
the time of the literature search.

Related NICE guidance
Below is a list of NICE guidance related to this procedure. Appendix B gives
details of the recommendations made in each piece of guidance listed.

Interventional procedures

• Thoracoscopically assisted mitral valve surgery. NICE interventional
  procedures guidance 245 (2007). Available from www.nice.org.uk/IPG245




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       Table 2 Summary of key efficacy and safety findings on percutaneous mitral valve leaflet repair
Abbreviations used: EVEREST, Endovascular Valve Edge-to-Edge Repair Study; MR, mitral regurgitation; MV, mitral valve; NYHA, New York Heart Association
Study details                                  Key efficacy findings                                    Key safety findings              Comments
Silvestry (2007)2                                    Procedural success                                         Complications                   These patients were part of
                                                     •   72% (34/47) of patients had a successful procedure     2 patients had surgery before   EVEREST – a multicentre
                                                         (defined as placement of a clip with                   discharge: 1 for delivery       phase I safety and feasibility
Study type: multicentre case series (phase I                                                                                                    trial of the Mitraclip device.
trial)                                                   echocardiographic core laboratory reduction in MR      catheter malfunction and the
                                                         at discharge to at least grade 2+).                    other because of partial clip
Country: USA                                                                                                    detachment.
                                                     •   In 5 patients, the clip was not left in place due to                                   The stated study objective
Study period: not stated                                                                                                                        was to assess the impact of a
                                                         insufficient MR reduction (3 patients were enrolled
Study population: patients with moderate to              before placement of a second clip was allowed in                                       standardised
severe (grade 3) or severe (grade 4) MR                  the protocol). None of these 5 patients had major                                      echocardiographic protocol
Aetiology: degenerative disease of the MV                adverse events and all had elective surgery: 4 had                                     for the guidance of the
(87%), functional or ischaemic MR (13%)                  repair procedures and 1 had mitral valve                                               procedure (for example, on
                                                         replacement as intended.                                                               reducing procedure time).
n = 47
Mean age: 67 years (±12 years)
                                                                                                                                                Mitral regurgitation grading:
Sex: not stated
                                                                                                                                                grade 1: mild
Inclusion criteria:
                                                                                                                                                grade 2: moderate
•   Met American Heart Association criteria for                                                                                                 grade 3: moderate to severe
    MV repair.                                                                                                                                  grade 4: severe.
•   Transthoracic and transoesophageal
    echocardiograms showing at least three of
    the six American Society of
    Echocardiography criteria for moderate to
    severe or severe MR.

Technique: percutaneous MV leaflet repair using
the Mitraclip device (Evalve Inc., California).

Follow-up: 12 months

Conflict of interest: study was part funded by the
manufacturer




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Abbreviations used: EVEREST, Endovascular Valve Edge-to-Edge Repair Study; MR, mitral regurgitation; MV, mitral valve; NYHA, New York Heart Association
Study details                     Key efficacy findings                                                           Key safety findings                 Comments
Feldman (2005)3                          Technical success of procedure                                                            In-hospital complications            These patients
                                             • Successful clip implantation: 24/27 (89%):                                          • 1 patient required a blood         were part of
                                                                                                                                     product transfusion.               EVEREST – a
Study type: multicentre case                 - 22 patients were discharged from hospital with clips in place                                                            multicentre phase I
series (phase I trial)                       - 2 patients were discharged from hospital without a clip. In 1 patient, control      • There were no cases of             safety and
Country: USA                                 of MR was not adequate after implantation but the clip could not be                     mechanical ventilation             feasibility trial of the
                                             re-opened (device malfunction) so the clip was left in place. In the other              > 24 hours, new onset atrial       Mitraclip device.
Study period: not stated
                                             patient there was partial clip detachment detected at 24-hour follow-up (see            fibrillation, access site
Study population: patients with                                                                                                      complications requiring surgery,
                                             safety section). Both patients had subsequent elective surgical MV repair.
moderate-to-severe (grade 3) or                                                                                                      or renal failure or dialysis.      These patients are
severe (grade 4) MR                          • Unsuccessful clip implantation: 3/27 (11%):                                                                              likely to be the
Aetiology: degenerative disease of           - in all 3 patients, the clip and delivery system were uneventfully removed                                                same as those in
                                             during the procedure without major adverse events. Two patients had                   30-day major adverse events:         the study by
the MV (93%), functional or
                                             subsequent elective surgical MV repair and 1 patient had elective intended            4/27 (15%)                           Silvestry et al.
ischaemic MR (7%)
n = 27
                                             MV replacement.                                                                       • 1 patient had a permanent          (2007).
                                                                                                                                     stroke (non-embolic stroke
Mean age: 69 years (±13 years)                                                                                                       associated with post-procedure
                                         MR severity
Sex: 59% male                                                                                                                        hypotension).
                                         Of the 22 patients who were discharged with a clip in place, MR severity was
Comorbidities: history of congestive                                                                                               • 3 patients had clip detachment
                                         measured by core laboratory assessments.
heart failure (59%), NYHA class III                                                                                                  from one of the two valve
or IV (44%), atrial fibrillation (41%)                       Discharge       30 days            6 months                             leaflets. One was detected at
                                          Grade ≤ 2+         18/22 (82%)     14/22 (64%)        14/22 (64%)                          the 24-hour follow-up
Inclusion criteria:                                                     1
                                          Grade ≥ 3+         4/22 (18%)      6/22 (27%)         4/22 (18%)                           echocardiogram and the other
•   Symptomatic or if                     Not assessed       0               2                  4
                                                                                                 2
                                                                                                                                     two were detected at the 30-day
    asymptomatic:                        1
                                           These patients had MR grade 4+ at baseline and although they improved to grade 3+         follow-up echocardiogram.
•   Left ventricular ejection            at discharge, they did not improve to grade 2+ or less in the short term.
                                         2
                                           These patients required subsequent elective valve surgery.                              • There were no cases of
    fraction < 60% or                                                                                                                myocardial infarction, cardiac
•   Left ventricular end-systolic        30-day follow-up                                                                            tamponade or septicaemia.
    dimension > 45 mm
                                             • 2 patients had recurrence of MR at 30 days.
                                             • 2 patients had partial clip detachment.                                             6-month follow-up
Technique: percutaneous MV                                                                                                         Among 19 patients with 6 month
leaflet repair using the Mitraclip       6-month follow-up                                                                         follow-up transthoracic
device (Evalve Inc., California)                                                                                                   echocardiograms, Doppler
                                             • Of the patients having 6-month transthoracic echocardiograms (n = 19),
                                               evidence of atrial septal shunting was present in 4, absent in 7 and                evidence of atrial septal shunting
Follow-up: 6 months                            indeterminate in 8.                                                                 was present in four, absent in
                                             • 4 patients required elective valve surgery within 6 months.                         seven and indeterminate in eight.
Conflict of interest: none stated




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Abbreviations used: EVEREST, Endovascular Valve Edge-to-Edge Repair Study; MR, mitral regurgitation; MV, mitral valve; NYHA, New York Heart Association;
Study details                     Key efficacy findings                                                                       Key safety findings     Comments
Herrmann (2006)4                         In 3 patients, no clip was placed (no further information stated); 6 patients had their clips       No safety outcomes       These patients
                                         explanted by 6 months (range 1–133 days, none for mitral stenosis; no further information           were reported in this    were part of
                                         stated); 4 patients received two clips (‘in 1 patient the first clip was not optimally placed and   publication (see study   EVEREST – a
Study type: multicentre case             surgery was performed within 30 days’).                                                             by Feldman et al.        multicentre phase I
series (phase I trial)                                                                                                                       2005)                    safety and
Country: USA                                                                                                                                                          feasibility trial of
                                         Mitral valve area and gradient – before discharge from hospital                                                              the Mitraclip
Study period: not stated
                                         Haemodynamic outcomes were assessed immediately after the procedure and                                                      device.
Study population: patients with          echocardiographic outcomes were assessed on the day of hospital discharge (mean
moderate to severe (grade 3) or          1.8 days postoperatively).
severe (grade 4) MR                                                                                                                                                   These patients are
                                                                                      Preoperative    Postoperative p-value                                           the same as those
Aetiology: degenerative disease of
the MV (93%), functional or               Mean MV gradient by Doppler (mmHg)          1.79 ± 0.89     3.31 ± 2.09      0.004                                          included in the
ischaemic MR (7%)                         (n = 16)                                                                                                                    study by Feldman
                                          Mean MV gradient by haemodynamics           5.00 ± 3.38     3.5 ± 3.34       0.2                                            et al. (2005).
n = 27
                                          (mmHg) (n = 8)
Mean age: 69 years (±13 years)
                                          Peak MV gradient by Doppler (mmHg)          6.26 ± 2.79     7.09 ± 2.88      0.248
Sex: 59% male                             (n = 18)
Comorbidities: history of congestive      MV area by planimetry (cm2) (n = 18)        6.49 ± 1.61     4.46 ± 2.14      0.000036
heart failure (59%), NYHA class III
or IV (44%), atrial fibrillation (41%)    MV area by pressure half-time (cm2)         4.35 ± 0.98     3.01 ± 1.42      0.03781
                                          (n = 7)
Inclusion criteria:
                                          MV area by Gorlin formula (cm2) (n = 8)     2.78 ± 1.01     3.05 ± 0.90      0.6
•   Symptomatic or if
    asymptomatic:
•   Left ventricular ejection            Mitral valve area and gradient – at 12-month follow-up
    fraction < 60% or                                                                      Discharge             12 months        p-value
•   Left ventricular end-systolic         Mean MV gradient by Doppler (mmHg) (n = 13) 3.22 ± 2.17                3.56 ± 098       0.508
    dimension > 45 mm                     Peak MV gradient by Doppler (mmHg) (n = 12)      5.92 ± 2.53           9.90 ± 4.28      0.0076
                                          MV area by planimetry (cm2) (n = 13)             3.90 ± 1.90           3.79 ± 1.54      0.785
                                                                            2
Technique: percutaneous MV                MV area by pressure half-time (cm ) (n = 5)      4.60 ± 0.63           2.90 ± 0.91      0.02
leaflet repair using the Mitraclip
device (Evalve Inc., California)
                                         Other
                                         There was a significant reduction in MR in 14 patients, which lasted up to at least 1 year in
Follow-up: 12 months                     13 patients.
Conflict of interest: none stated




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Abbreviations used: EVEREST, Endovascular Valve Edge-to-Edge Repair Study; MR, mitral regurgitation; MV, mitral valve; NYHA, New York Heart Association
Study details                         Key efficacy findings    Key safety findings                                                           Comments
Dang (2005)5                                                     Complications                                                                      These patients were part of
                                                                 The 6 patients required subsequent surgical intervention (55.5 ± 55 days           EVEREST – a multicentre
                                                                 later, range 1–133 days) for recurrent or persistent MR.                           phase I safety and
Study type: case series                                                                                                                             feasibility trial of the
Country: USA                                                     • Four patients had malpositioning of the clip at the time of implantation (in     Mitraclip device.
                                                                   3 patients the clip partially detached from either the anterior or posterior
Study period: not stated
                                                                   leaflets).
Study population: patients from three                                                                                                               These patients are the
                                                                 • Two patients had insufficient MR reduction at the time of implantation (in
centres with MR after percutaneous clip                                                                                                             same as those included in
                                                                   1 patient the clip was placed suboptimally and could not be repositioned
deployment for MV repair and who later                                                                                                              the studies by Feldman et
                                                                   due to a malfunction of the delivery catheter).
required surgical intervention. The                                                                                                                 al. (2005) and Herrmann et
patients were part of a group of 27                                                                                                                 al. (2006).
patients enrolled in a phase I clinical                          Outcome of surgical revision
trial of the Mitraclip device.                                   In all patients, the clip was removed from the leaflets without difficulty. Five
n=6                                                              patients required MV repair and 1 patient underwent MV replacement.
                                                                 • Five patients recovered well without any complications and reported an
Technique: percutaneous edge-to-edge                               improvement in symptoms.
repair using the Mitraclip device (Evalve                        • One patient developed a right-sided ilio-femoral deep venous thrombosis
Inc., California)                                                  on the same side as the catheter insertion site 3 days after the surgical
                                                                   intervention and 4 days after the percutaneous procedure. The patient
Mean follow-up: 55 days                                            was maintained on anticoagulation therapy. The patient also developed a
                                                                   symptomatic pericardial effusion that required percutaneous
                                                                   pericardiocentesis.
Conflict of interest: six authors
disclosed a financial relationship with
the manufacturer                                                 Mean MR grade
                                                                 • Before percutaneous leaflet repair: 3.7 (±0.5).
                                                                 • Immediately after percutaneous leaflet repair: 1.8 (±1.0).
                                                                 • Before surgical revision: 3.2 (±0.8).
                                                                 • After surgical revision: 0.7 (±0.8).




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Abbreviations used: EVEREST, Endovascular Valve Edge-to-Edge Repair Study; MR, mitral regurgitation; NYHA, New York Heart Association
Study details                              Key efficacy findings                                                    Key safety findings   Comments
Condado (2006)1                               Echocardiography immediately after the procedure and 24 hours later      Complications
                                              showed the clip was well placed.                                         There were no
Study type: case series                       Exertional dyspnoea resolved within 30 days of the procedure and the     complications
                                              patient remained asymptomatic with mild MR 2 years after the procedure   reported.
Country: Venezuela                            (MR reduced from grade 4 preoperatively to grade 1 at 1- and 2-year
Study period: June 2003                       follow-up).
Study population: a 49-year old woman with
severe MR (grade 4) secondary to bi-leaflet
prolapse and anterior mitral leaflet flail
(presented with worsening exertional
dyspnoea)
n=1

Technique: percutaneous edge-to-edge
repair using the Mitraclip device (Evalve
Inc., California)

Follow-up: 2 years

Conflict of interest: two authors received
support from or had equity in the
manufacturer




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Validity and generalisability of the studies
• The overview is based on 48 patients in total, of whom 47 took part in a
  manufacturer-sponsored trial of a mitral valve clip device. There was no
  published evidence on the suturing technique for percutaneous mitral valve
  leaflet repair.

Specialist Advisers’ opinions
Specialist advice was sought from consultants who have been nominated or
ratified by their Specialist Society or Royal College. The advice received is their
individual opinion and does not represent the view of the society.

Michael O’Sullivan (British Cardiovascular Intervention Society), Francis Wells
(Society of Cardiothoracic Surgeons of Great Britain and Ireland).

• Both Specialist Advisers thought it was a novel procedure (or the first in a new
  class of procedures) and that the comparator would be open mitral valve
  repair.
• Both Advisers had never performed this procedure.
Safety
• Specialist Advisers thought that theoretical adverse events included: leaflet
  tearing, clip embolism, partial clip detachment, return of mitral regurgitation,
  complications from vascular access, cardiac tamponade from attempted trans-
  septal puncture and scar formation around the clip causing effective mitral
  stenosis and obstructing the mitral valve orifice.

Efficacy
• Specialist Advisers thought that key efficacy outcomes included: successful
   clip delivery, reduction of mitral regurgitation, durability, left ventricular
   dimensions and function, need for subsequent mitral valve surgery and quality
   of life.
• Specialist Advisers stated that there was uncertainty about the procedure’s
   efficacy in the short- and long-term. One Adviser stated that it should only be
   used in the context of clinical trials.

Issues for consideration by IPAC
• Long-term echocardiographic follow-up (longer than 1 year) is needed to
  assess residual mitral regurgitation.
• Is the current title appropriate? Consider ‘mitral valve leaflet apposition for
  mitral regurgitation’.




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References
1.     Condado JA, Acquatella H, Rodriguez L et al. (2006) Percutaneous edge-
       to-edge mitral valve repair: 2-year follow-up in the first human case.
       Catheterization and Cardiovascular Interventions 67: 323-325.

2.     Silvestry FE, Rodriguez LL, Herrmann HC et al. (2007) Echocardiographic
       guidance and assessment of percutaneous repair for mitral regurgitation
       with the Evalve MitraClip: lessons learned from EVEREST I. Journal of the
       American Society of Echocardiography 20: 1131-1140.

3.     Feldman T, Wasserman HS, Herrmann HC et al. (2005) Percutaneous
       mitral valve repair using the edge-to-edge technique: six-month results of
       the EVEREST Phase I Clinical Trial. Journal of the American College of
       Cardiology 46: 2134-2140.

4.     Herrmann HC, Rohatgi S, Wasserman HS et al. (2006) Mitral valve
       hemodynamic effects of percutaneous edge-to-edge repair with the
       MitraClip device for mitral regurgitation. Catheterization and
       Cardiovascular Interventions 68: 821-828.

5.     Dang NC, Aboodi MS, Sakaguchi T et al. (2005) Surgical revision after
       percutaneous mitral valve repair with a clip: initial multicenter experience.
       Annals of Thoracic Surgery 80: 2338-2342




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Appendix A: Additional papers on percutaneous mitral
valve leaflet repair
There were no additional papers identified.




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Appendix B: Related NICE guidance for percutaneous
mitral valve leaflet repair
Guidance           Recommendations
Interventional     Thoracoscopically assisted mitral valve surgery. NICE
procedures         interventional procedures guidance 245 (2007).

                   1.1. Evidence from large case series supports the safety and efficacy
                        of thoracoscopically assisted mitral valve surgery. Therefore,
                        clinicians wishing to use this procedure should do so with normal
                        arrangements for clinical governance and consent.
                   1.2. Thoracoscopically assisted mitral valve surgery is technically
                        demanding. Surgeons undertaking it should have special
                        expertise and specific training in thoracoscopic cardiac surgery,
                        and should perform their initial procedures with an experienced
                        mentor.




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Appendix C: Literature search for percutaneous mitral
valve leaflet repair

Database                                 Date searched   Version           No.
                                                         searched          retrieved
Cochrane Database of Systematic          08/08/2008      Issue 3, 2008     0
Reviews – CDSR (Cochrane
Library)
Database of Abstracts of Reviews of      08/08/2008      –                 0
Effects – DARE (CRD website)
HTA database (CRD website)               08/08/2008      –                 0
Cochrane Central Database of             08/08/2008      Issue 3, 2008     9
Controlled Trials – CENTRAL
(Cochrane Library)
MEDLINE (Ovid)                           07/08/2008      1950 to July      179
                                                         Week 5 2008
MEDLINE In-Process (Ovid)                07/08/2008                        15
EMBASE (Ovid)                            07/08/2008      1980 to Week      183
                                                         32 2008
CINAHL (NLH Search 2.0)                  08/08/2008      1981 to present   22
BLIC (Dialog DataStar)                   11/08/2008      –                 0
National Research Register (NRR)         11/08/2008      –                 0
Archive
UK Clinical Research Network             11/08/2008      –                 0
(UKCRN) Portfolio Database
Current Controlled Trials                11/08/2008      –                 2
metaRegister of Controlled Trials -
mRCT
Clinicaltrials.gov                       11/08/2008      –                 2


The following search strategy was used to identify papers in MEDLINE. A similar
strategy was used to identify papers in other databases.

1     Surgical Procedures, Minimally Invasive/
2     percutan$.tw.
3     endovascular$.tw.
4     or/1-3
5     Mitral Valve/
6     Heart Valves/
7     (mitral adj3 valve$).tw.
8     (heart adj3 valve$).tw.
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9     (bicuspid adj3 valve$).tw.
10    (cardiac adj3 valve$).tw.
11    or/5-10
12    (repair$ or reconstruc$ or clos$).tw.
13    11 and 12
14    Mitral Valve Insufficiency/
15    (Mitral adj3 insufficien$).tw.
16    (Mitral adj3 regurgitat$).tw.
17    (mitral adj3 incompet$).tw.
18    or/14-17
19    4 and 13 and 18
20    Mitraclip.tw.
21    19 or 20




IP overview: percutaneous mitral valve leaflet repair
                                        Page 16 of 16

				
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