Docstoc

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Document Sample
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE Powered By Docstoc
					                                                                                                         IP 392

    NATIONAL INSTITUTE FOR HEALTH AND
          CLINICAL EXCELLENCE
           INTERVENTIONAL PROCEDURES PROGRAMME

    Interventional procedure overview of percutaneous
     pulmonary valve implantation for right ventricular
                               outflow tract dysfunction

    Right Ventricular Outflow Tract (RVOT) dysfunction is the abnormal flow
    of blood between the heart and the lungs, often associated with a
    congenital abnormality. Percutaneous pulmonary valve implantation is an
    alternative to surgical valve repair or replacement. In this procedure, a
    catheter is inserted through the skin via a large vein in the groin and into
    the pulmonary artery. The replacement valve is implanted within a wire
    mesh, called a stent.


Introduction
This overview has been prepared to assist members of the Interventional
Procedures Advisory Committee (IPAC) in making 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 February 2007.

Procedure name
•    Percutaneous pulmonary valve implantation for right ventricular outflow
     tract dysfunction

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




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 1 of 17
                                                                                                         IP 392
Description

Indications
Right ventricular outflow tract dysfunction.

Right ventricular outflow tract dysfunction encompasses valve stenosis, valve
incompetence (also called insufficiency, or regurgitation) or combined (mixed)
lesions. The condition is usually associated with a congenital heart
abnormality, such as Tetralogy of Fallot. Right ventricular outflow tract
dysfunction is associated with symptoms and signs including haemodynamic
instability, cyanosis, shortness of breath and reduced exercise tolerance.
Depending on the chronicity and severity of the condition (and/or co-morbid
structural abnormalities of the heart), right ventricular outflow tract obstruction
may also cause right ventricular hypertrophy and varying degrees of heart
failure. Left untreated, clinically important right ventricular outflow tract
dysfunction is a life-limiting condition.

Pulmonary valve regurgitation

Pulmonary valve regurgitation allows blood to leak back into the right ventricle
and may result in haemodynamic instability

Outcome measures that are customarily used to characterise the severity of
the condition include:

     •    New York Heart Association heart failure classification (I−no limitation
          of physical activity to IV−inability to carry out any physical activity
          without physical discomfort).
     •    Right ventricular diameter (on echocardiography).
     •    Right ventricle to pulmonary artery pressure gradients.
     •    Regurgitation severity (based on echocardiographic criteria).
     •    Regurgitation fraction.


Current treatment and alternatives
Some patients with RVOT dysfunction may be treatable with balloon
valvuloplasty / dilation of the pulmonary valve −this option may be particularly
suitable for predominantly stenotic lesions. However, for some other patients
(e.g. those with severe stenotic lesions, or with predominantly incompetent
lesions, or failing previous valvuloplasty) open surgical removal, repair or
replacement of the valve is required.

Pulmonary valve surgery commonly involves insertion of a pulmonary conduit
(either with or without a valve) to re-establish blood flow into the pulmonary
artery. This is a relatively major cardiac surgery operation, requiring
cardiopulmonary bypass. Conduits may suffer from stenosis over time and
may also allow pulmonary regurgitation leading to (or exacerbating)
ventricular dysfunction.



IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 2 of 17
                                                                                                         IP 392


What the procedure involves
The aim of the procedure is to normalise the pulmonary valve function and to
improve circulation to the lungs at the same time easing the pressure on the
right ventricle.

Under general anaesthesia and without cardiopulmonary bypass,
percutaneous valve implantation consists of inserting a catheter system
inserted through a systemic vein (usually right femoral, but sometimes
arterial). Under angiographic guidance, using a guide wire, a stent mounted
biological valve (often a bovine jugular valve) is positioned into the diseased
valve or pulmonary conduit and deployed by balloon inflation. Sometimes a
plain stent is inserted first to provide a regular surface for the valve stent to
expand into. Repeat treatment with increasingly small diameter valve stents is
possible, and is usually necessary.


Efficacy
The Specialist Advisers considered the key efficacy outcomes of this
procedure to be implantation success, reduction in RVOT pressure gradient
(out to 5 years), freedom from regurgitation, improved right ventricular
function and volume, restenosis rate, freedom from re-intervention, improved
exercise tolerance / functional capacity, and improvement in symptoms.

Operative success
Across the case series and case reports, percutaneous pulmonary valve
implantation was successful in between 98% (58/59)1 and 100% of patients
(1/1,2 1/1,3 and 8/84).

Cardiac function
One case series of 59 patients reported a statistically significant decrease in
the mean pressure gradient across the RVOT immediately after the procedure
to 19.5 mmHg) compared with baseline (33.0 mmHg) (p < 0.001).1 A second
case series reported that the systolic pressure ratio between the right ventricle
and aorta decreased from 74% at baseline to 47% following the procedure
(p=NR), and the (right ventricular peak systolic pressure) decreased from 74
mmHg to 44 mmHg (measure of significance not stated for either
comparison)4.

One case series reported that pulmonary regurgitation had decreased
significantly after percutaneous pulmonary valve implantation. In 28 patients,
the regurgitation fraction decreased from 21% at baseline to 3% at 6 days’
follow-up (p < 0.001).1

Functional capacity
In one case series of 8 patients, 6 were evaluated to be in New York Heart
Association (NYHA) (heart failure) functional class I (no limitation on physical
activity) and 2 patients in class II (slight limitation) at 10 months follow up after
percutaneous pulmonary valve implantation4. A second case series of 59


IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 3 of 17
                                                                                                         IP 392
patients undergoing percutaneous pulmonary valve implantation reported that
median NYHA class improved significantly from class II at baseline to class I
at 10 months’ follow-up (p < 0.001).1

One case report of a 10-month-old patient treated with percutaneous
pulmonary valve implantation reported that, at 1 year after the procedure, the
patient’s weight had increased by 9 kg, there was no respiratory distress, and
the patient had not required hospitalisation.2 A second case report of a 16-
year-old patient found that shortness of breath had improved 1 month after
percutaneous pulmonary valve implantation.3

Safety
The Specialist Advisers stated the following important safety outcomes by
which to evaluate this procedure: survival, rates of surgical rescue, stent
fracture, device migration and early or late arrhythmias.

Severe bleeding and right haemothorax was reported in 1/59 patients (2%) in
one case series, and minor dissection of existing homograft was also reported
in 1 patient (2%).1

In one case series, the RVOT was completely obstructed by the delivery
system in 1/8 patients (13%), requiring immediate deployment of the valve in
a suboptimal position.4 In another case series, the distal tip of the valve-
delivery system detached in 2/59 patients (3%) during the percutaneous
pulmonary valve implantation.1

Across the two case series ‘in-stent’ stenosis occurred in 12% (7/59) of
patients1, and partial conduit obstruction occurred in 38% (3/8) of patients4 (10
months follow up for both). Stent migration occurred in between 0% (0/8)4 and
2% (1/59).1 Stent fracture occurred in between 12% (7/59)1 and 13% (1/8)4 of
patients, but without clinical sequelae.

Repeat valve insertion was necessary in 3/59 patients (5%) in one case
series, up to 10 months after the initial procedure.1

Literature review

Rapid review of literature
The medical literature was searched to identify studies and reviews relevant
to percutaneous pulmonary valve implantation for RVOT dysfunction.
Searches were conducted via the following databases, covering the period
from their commencement to 15 March 2007: 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 these criteria could not be
determined from the abstracts the full paper was retrieved.


IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 4 of 17
                                                                                                         IP 392


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 laboratory or animal study.
                             Conference abstracts were also excluded because of the difficulty of
                             appraising methodology.
 Patient                     Patients with right ventricular outflow tract dysfunction or obstruction
 Intervention/test           Percutaneous pulmonary valve implantation
 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.



List of studies included in the overview
This overview is based on two case series1,4 and two case reports.2,3

Other studies that were considered to be relevant to the procedure but were
not included in the main extraction table (Table 2) are listed in Appendix A.

Existing reviews on this procedure
No published systematic reviews with meta-analysis or evidence-based
guidelines were identified at the time of the literature search.

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

Interventional procedures
    • Balloon dilatation of pulmonary valve stenosis NICE Interventional
       Procedure Guidance 67 (June 2004). Available from
       http://guidance.nice.org.uk/IPG67.
    • Radiofrequency valvotomy for pulmonary atresia NICE Interventional
       Procedure Guidance 67 (June 2004). Available from
       http://guidance.nice.org.uk/IPG95.

Technology appraisals
None applicable

Clinical guidelines
None applicable

Public health
None applicable




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 5 of 17
                                                                                                                                                                     IP 392


Table 2 Summary of key efficacy and safety findings on percutaneous pulmonary valve implantation for right ventricular
outflow tract dysfunction
Abbreviations used: LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NYHA, New York Heart Association; PPVI percutaneous pulmonary valve
implantation, RVOT, right ventricular outflow tract
Study details                               Key efficacy findings                                 Key safety findings                      Comments




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction   Page 6 of 17
                                                                                                                                                                                    IP 392

Abbreviations used: LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NYHA, New York Heart Association; PPVI percutaneous pulmonary valve
implantation, RVOT, right ventricular outflow tract
Study details                               Key efficacy findings                                 Key safety findings                      Comments
Khambadkone S (2005)1                          Operative success                                          Complications                              Concomitant procedures were
                                               The pulmonary valve implantation procedure was             There were no deaths.                      undertaken in 5 patients.
Case series                                    completed successfully in 98% (58/59) of patients           Complication                  Rate
                                               (not defined)                                               Early                                     Retrospective case series
UK                                                                                                         All severe early              5% (3/59)
                                               The mean operative time was 102 minutes.                    complications                             Case accrual method not stated.
Study period: Jan 2000 to Sept 2004                                                                        Stent dislodgement over the 3% (2/59)
                                               Cardiac function                                            guide wire, requiring                     There was 100% follow-up for
n = 59                                         Outcomes evaluated immediately after procedure              surgical homograft                        the outcomes of mortality and
                                               Pressure gradient across the RVOT decreased                 implantation (requiring                   freedom from explanation.
Population: Age = 16 years, Male =             significantly from 33 ± 24.6 mmHg at baseline to            urgent surgery)
54%, weight = 56 kg.                           19.5 ± 15.3 mmHg after the procedure (p < 0.001).           Severe bleeding,              2% (1/59)   Operator experience not stated.
Aetiology: tetralogy of Fallot = 36,                                                                       hypotension and right
absent pulmonary valve syndrome = 3,           Right ventricular systolic pressure decreased               haemothorax in a patient                  Patients did no undergo
severe pulmonary stenosis = 20.                significantly from 34.4 ± 17.2 mmHg at baseline to          having PPVI after a                       cardiovascular MRI follow-up if
Homograft outflow tract material from          50.4 ± 14 mmHg after the procedure (p < 0.001).             dissected homograft during                there were no baseline data
previous surgery = 78%.                                                                                    balloon dilation (requiring               (referred from overseas) or if the
                                               Pulmonary artery diastolic pressure increased               urgent surgery)                           patient had a pacemaker,
Indications: Patients requiring re-            significantly from 9.9 ± 3.7 mmHg at baseline to            Minor dissection of           2% (1/59)   defibrillator or stent that made
intervention to the RVOT; > 5 years old        13.5 ± 5.3 mmHg after the procedure (p < 0.001)             homograft                                 imaging difficult.
and > 20 kg weight.                                                                                        Detachment of the distal tip 3% (2/59)
                                               Pulmonary regurgitation (evaluated by colour flow           of valve-delivery system                  NYHA functional class grades
Technique: Under general anaesthesia           Doppler echocardiography) was graded from 0                 Local bleeding                7% (4/59)   physical activity from I (no
access was obtained by the right               (absent) to 4 (severe). The regurgitation grade             Late                                      limitation on physical activity) to
femoral vein in most patients. A stent-        decreased from 2 (mild) or above in all patients at         ‘In-stent stenosis’         12% (7/59)    IV (inability to carry out any
mounted bovine jugular valve was               baseline to 2 (mild) or below in all patients at 24-hour    Repeat stent insertion        5% (3/59)   physical activity without physical
deployed in the RVOT and the position          follow-up (p < 0.001).                                      Stent embolisation to the     2% (1/59)   discomfort).
confirmed by angiography.                                                                                  right pulmonary artery
                                               In 28 patients there was a significant reduction in         (explanted and replaced                   Authors state that stent-mounted
Follow-up: 10 months                           pulmonary regurgitation fraction on cardiovascular          with a valved conduit)                    valve implantation deals
                                               MRI from 21 ± 13% at baseline to 3 ± 4% at 6 days’          Stent fracture (no clinical   12%         successfully with both the
Conflict of Interest: Authors supported        follow-up (p < 0.001). There was no significant             sequelae)                     (7/59)      stenosis and regurgitation
by government and charitable funding,          change in LVEF from baseline (63%) to 6 days’               RVOT pressure gradient        2% (1/59)   problems association with RVOT
or joint government and industry               follow-up (64%) (p < 0.45).                                 increased (treated by                     dysfunction.
funding. One author acts as consultant                                                                     repeat valve implantation)
to device manufacturer.                        Exercise capacity                                          Freedom from valve explantation was        Authors noted a learning curve
                                               Median NYHA functional class improved from II at           69.8% (95% CI 48.4 to 91.1%) at            associated with this procedure,
                                               baseline to I after the procedure (p < 0.001).             36 months’ follow-up (n = 5 patients       and that the patient cohort was
                                                                                                          were followed up to this time point)       heterogeneous.




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction             Page 7 of 17
                                                                                                                                                                                    IP 392

Abbreviations used: LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NYHA, New York Heart Association; PPVI percutaneous pulmonary valve
implantation, RVOT, right ventricular outflow tract
Study details                               Key efficacy findings                                 Key safety findings                      Comments
Bonhoeffer P (2002)4                           Operative success                                           Complications                              Group means have been
                                               Pulmonary valve implantation was completed                                                             calculated from individual patient
Case series                                    successfully in all 8 patients.                             Complication                   Rate        data presented.
                                                                                                           Complete obstruction of        13% (1/8)
UK and France                                  The mean fluoroscopy time was 52 minutes, and               the RVOT by the delivery                   Case accrual method not stated.
                                               operative time improved significantly after the first two   system, requiring rapid
Study period: Not stated                       procedures.                                                 deployment , which was                     No concomitant cardiac
                                                                                                           lower than intended                        procedures are described.
n = 8 (7 children and 1 adult)                 Doppler echocardiography at 10 months                       Insignificant paraprosthetic   25% (2/8)
                                               demonstrated a fully competent pulmonary valve.             regurgitation due to                       Authors state that the durability
Population: Age = 12 years (children),                                                                     suboptimal placement                       of the bovine valve has yet to be
38 years (adult), Male = NR, weight =          Cardiac function                                            Partial conduit obstruction    38% (3/8)   proven.
40 kg (children)                               Outcomes evaluated immediately after procedure              remaining
Aetiology: tetralogy of Fallot = 4, absent                                                                 Stent migration                0%          Unlikely to be the same patients
pulmonary valve syndrome = 1,                  Mean peak systolic pressure across the RVOT                 Stent fracture (no clinical    13% (1/8)   as reported in Khambadkone
pulmonary atresia with ventricular             decreased from 74 mmHg at baseline to 44 mmHg               sequelae)                                  (2005) on the basis of the
septal defect = 3. NYHA class II = 6,          after the procedure (p value not reported).                                                            publication date of this series.
class III = 2.
                                               Mean systolic pressure Ratio between the right
Indications: Symptomatic patients with         ventricle and aorta decreased from 74% at baseline
effort intolerance and breathlessness,         to 47% following the procedure, and right ventricular
requiring re-intervention to a previous        peak systolic pressure fell from 74mmHg to 44mmHg
pulmonary graft because of stenosis or         (p=NR).
insufficiency.
                                               Mean pulmonary artery diastolic pressure increased
Technique: Under general anaesthesia,          from 12 mmHg at baseline to 14 mmHg after the
access was obtained by the right               procedure (p value not reported).
femoral vein. A stent-mounted biological
valve was deployed in the RVOT and             Clinical function
the position confirmed by angiography.         All patients had subjective improvement in their
Patients were given heparin and                symptoms at 10 months’ follow-up.
antibiotics at the start of the procedure.
                                               Six patients were in NYHA class I at 10 months’
Follow-up: 10 months                           follow-up; two were in class II.

Conflict of Interest: not stated




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction              Page 8 of 17
                                                                                                                                                                             IP 392

Abbreviations used: LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NYHA, New York Heart Association; PPVI percutaneous pulmonary valve
implantation, RVOT, right ventricular outflow tract
Study details                               Key efficacy findings                                 Key safety findings                      Comments
Feinstein JA (2006)2                           Operative success                                         No safety outcomes are reported.   Operator experience not stated.
                                               The pulmonary valve implantation was completed
Case report                                    successfully.                                                                                It is not clear whether this was
                                                                                                                                            the first patient treated at this
USA                                            Cardiac function                                                                             institution.
                                               Echocardiography on the first postoperative day
Study period: not stated                       showed only mild pulmonary regurgitation.                                                    Patient had undergone
                                                                                                                                            significant cardiac surgery at
n=1                                            Right ventricular diameter decreased from 25 mm at                                           1 week of age.
                                               baseline to 19 mm 1 day after surgery.
Population: Age = 10 months; female;                                                                                                        Selection criteria were not
weight = 6.2 kg. Shone’s complex, free         Estimated right ventricular pressures were                                                   stated.
pulmonary regurgitation, severe right-         unchanged.
ventricular enlargement and moderate
hypertrophy, left-sided pulmonary              Clinical function
venous obstruction                             At 1 year’s follow-up, weight had increased by 9 kg.
                                               The child had not required hospitalisation during the
Indication: respiratory distress and           year, and was without respiratory distress.
repeated respiratory failure requiring
resuscitation

Technique: Under general anaesthesia,
access was gained via the right jugular
vein. A stent-mounted porcine valve
was deployed in the RVOT and the
position confirmed by angiography. The
patient was given heparin and
antibiotics at the start of the procedure.

Follow-up: 1 year

Conflict of interest: not stated




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 9 of 17
                                                                                                                                                                           IP 392

Abbreviations used: LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NYHA, New York Heart Association; PPVI percutaneous pulmonary valve
implantation, RVOT, right ventricular outflow tract
Study details                               Key efficacy findings                                 Key safety findings                      Comments
Garay F (2006)3                                Operative success                                         No safety outcomes are reported.   The procedure included
                                               The pulmonary valve implantation was completed                                               concomitant stenting of the
Case report                                    successfully.                                                                                pulmonary homograft to reduce
                                               Repeat angiography demonstrated good position and                                            stenosis.
USA                                            function of the valve and no regurgitation.
                                                                                                                                            Patient selection criteria are not
Study period: not stated                       Cardiac function                                                                             stated.
                                               Homodynamic measurement immediately following
n=1                                            the procedure revealing a 16 mmHg gradient across                                            Compassionate approval for use
                                               the RVOT, and a right ventricle to systemic pressure                                         of the valve obtained from the
Population: Age = 16 years; male               ration of 49%.                                                                               FDA; intended use is for aortic
Severe aortic valve stenosis; Ross                                                                                                          valve replacement.
operation performed at age 14 years            Clinical function
with 24 mm homograft from the right            The patient had less shortness of breath at 1-month’s                                        Authors state that placement of
ventricle to the pulmonary artery,             follow-up.                                                                                   the initial stent improved
replaced at a subsequent operation.                                                                                                         obstruction and acted as a
                                                                                                                                            scaffold for the stent valve
Indications: increasing symptoms of                                                                                                         deployment.
shortness of breath and fatigue;
echocardiogram demonstrated
obstruction to the homograft.

Technique: Under general anaesthesia
and continuous transoesophageal
echocardiographic monitoring, access
was obtained via the right femoral vein.
A stent-mounted equine valve
(Edwards–Cribier percutaneous heart
valve) was deployed.

Follow-up: 1 month

Conflict of Interest: Two authors have
financial or other interests in the
procedure.




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 10 of 17
                                                                                                         IP 392



Validity and generalisability of the studies
•    Two different stent-mounted valves systems were used in the studies
     reported in Table 2 and the technology may have developed over time.
•    Most patients received the valve via right femoral venous access, although
     the jugular vein was used for access in some patients.
•    No data are available to determine the long-term durability of the valve
     stent.

Specialist advisers’ opinions
Specialist advice was sought from consultants who have been nominated or
ratified by their Specialist Society or Royal College.

Mr D Barron, Mr M Haw, Prof S Qureshi, Mr N Wilson, Mr J Gibbs

•    The potential benefit of this procedure is to improve cardiac output
     dynamics, with less morbidity than is associated with open surgery
     involving cardiac bypass.
•    Three of the Specialist Advisers considered this procedure to be novel with
     unknown safety and efficacy profile; one thought it was the first in a new
     class of procedure; one was undecided about its current status.
•    Adverse events reported in the literature or known anecdotally include
     failed placement and migration of the valve stent, cardiac perforation and
     haemorrhage, para-prosthetic leak and haemolysis, iatrogenic pulmonary
     stenosis, valve damage during delivery (leading to pulmonary
     insufficiency), femoral vein injury, stent fracture, valve failure (with stenosis
     or regurgitation) and transient severe hypotension during valve placement.
•    Additional theoretical adverse events include death, compression of the
     coronary artery and endocarditis.
•    A number of specialist advisers noted that case selection was important,
     and that this should be undertaken by a multidisciplinary team.
•    The need for surgical rescue for failed procedures may diminish over time
     with increased experience but this is yet to be proven.
•    Four Specialist Advisers commented that the mid-to-long-term
     performance of the valve is of concern.
•    The data on reduction in RVOT pressure gradient were thought to be
     conflicting by one Specialist Adviser.
•    Limitations to the size of the valves currently available means that some
     patients may not be suitable for this procedure.
•    The procedure should only be undertaken by clinicians with experience in
     arterial stenting and device delivery and should be performed in tertiary
     care cardiac units with access to cardiac theatre. Early cases should be
     supervised by an experienced practitioner – this requirement may limit the
     speed of dissemination of this procedure.
•    One UK centre has a manufacturer-supported registry. Patient data should
     be submitted to the Department of Health UK Central Cardiac Audit
     Database (UKCCAD) database.


IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 11 of 17
                                                                                                         IP 392


•    The procedure is being rolled out through slow and controlled
     dissemination, and is being adopted by North American and European
     centres.
•    Deaths following the procedure to date have been in seriously ill patients
     for whom this technique was undertaken as a palliative procedure.

Issues for consideration by IPAC
•    The Melody™ Transcatheter Pulmonary Valve and Ensemble™
     Transcatheter Delivery System have received CE mark approval and are
     available for distribution in Europe. This system, or earlier developments of
     it, was used in the first three studies reported in table 2 . The Edwards–
     Cribier percutaneous heart valve used in the fourth case study does not
     have a CE mark.




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 12 of 17
                                                                                                         IP 392



References
1      Khambadkone S, Coats L, Taylor A et al. (2005) Percutaneous
       pulmonary valve implantation in humans: results in 59 consecutive
       patients. Circulation 112: 1189–1197.

2      Feinstein JA, Kim N, Mohan RV et al. (2006) Percutaneous pulmonary
       valve placement in a 10-month-old patient using a hand crafted stent-
       mounted porcine valve. Catheterization & Cardiovascular Interventions
       67: 644–649.

3       Garay F, Webb J and Hijazi ZM. (2006) Percutaneous replacement of
        pulmonary valve using the Edwards-Cribier percutaneous heart valve:
        first report in a human patient. Catheterization & Cardiovascular
        Interventions 67: 659–662.

4      Bonhoeffer P, Boudjemline Y, Qureshi SA et al. (2002) Percutaneous
       insertion of the pulmonary valve. Journal of the American College of
       Cardiology 39: 1664–1669.




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 13 of 17
                                                                                                         IP 392


Appendix A: Additional papers on percutaneous
pulmonary valve implantation for right ventricular
outflow tract dysfunction not included in summary
table 2
The following table outlines the studies that are considered potentially relevant
to the overview but were not included in the main data extraction table
(table 2). It is by no means an exhaustive list of potentially relevant studies.

Article title                                Number of           Direction of                 Reasons for
                                             patients/           conclusions                  non-inclusion in
                                             follow-up                                        table 2
                                             (FU)
Bonhoeffer P, Boudjemline Y,                 Case report         No complications to 1-       Same patient
Saliba Z et al (2000)                                            month FU; patient was        reported in
Percutaneous replacement of                  n=1                 in good physical             Bonhoeffer (2002)
pulmonary valve in a right-                                      condition.
                                             FU = 1 month
ventricle to pulmonary-artery
prosthetic conduit with valve
dysfunction. Lancet 356: 1403–
1405.
Coats L, Tsang V, Khambadkone                Case series         Procedure was                Same patients
S et al. (2005) The potential                                    completed successfully       reported in
impact of percutaneous                       n = 35              in 95% of attempts.          Khambadkone
pulmonary valve stent                                                                         (2005).
                                             FU = 4 months       Pressure gradient
implantation on right ventricular                                across the RVOT
outflow tract re-intervention.                                   decreased
European Journal of Cardio-                                      significantly.
Thoracic Surgery 27 (4): 536–
543.                                                             Operative
                                                                 complications occurred
                                                                 in 9% of patients.




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 14 of 17
                                                                                                         IP 392



Appendix B: Related published NICE guidance for
Percutaneous pulmonary valve implantation for right
ventricular outflow tract dysfunction

Guidance programme                            Recommendation
Interventional procedures                     IPG067 Balloon dilatation of pulmonary valve
                                              stenosis
                                               1.1 Current evidence on the safety and efficacy of
                                                   balloon dilatation of pulmonary valve stenosis
                                                   appears adequate to support the use of this
                                                   procedure, provided that the normal
                                                   arrangements are in place for consent, audit and
                                                   clinical governance.
                                               1.2 Balloon dilatation of pulmonary valve stenosis
                                                   should only be performed in a specialist unit
                                                   where paediatric cardiac surgery is available.
                                               1.3 The Department of Health runs the UK Central
                                                   Cardiac Audit Database (UKCCAD) and clinicians
                                                   are encouraged to enter all patients undergoing
                                                   paediatric cardiovascular interventions onto this
                                                   database

                                              IPG095 Radiofrequency valvotomy for pulmonary
                                              atresia

                                              1.1      Current evidence on the safety and efficacy of
                                                       radiofrequency valvotomy for pulmonary atresia
                                                       with intact interventricular septum is limited due to
                                                       the rarity of the condition, but appears adequate
                                                       to support the use of the procedure for the
                                                       treatment of seriously ill neonates, provided that
                                                       normal arrangements are in place for consent,
                                                       audit and clinical governance.
                                              1.2      Radiofrequency valvotomy for pulmonary atresia
                                                       with intact interventricular septum should be
                                                       performed in carefully selected patients in
                                                       specialist centres with paediatric cardiac surgery
                                                       facilities.
                                              1.3     The Department of Health runs the UK Central
                                                      Cardiac Audit Database (UKCCAD) and clinicians
                                                      are encouraged to enter all patients onto this
                                                      database.
Technology appraisals                         None applicable
Clinical guidelines                           None applicable
Public health                                 None applicable




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 15 of 17
                                                                                                         IP 392



Appendix C: Literature search for Percutaneous
pulmonary valve implantation for right ventricular
outflow tract dysfunction
IP: 392 Percutaneous pulmonary valve implantation

Database                                Date searched                           Version searched
Cochrane Library                        16/03/2007                              Issue 1, 2007

CRD databases (DARE                     16/03/2007                              Issue 1, 2007
& HTA)

Embase                                  15/03/2007                              1980 to 2007 Week 10

Medline                                 15/03/2007                              1950 to March Week 1
                                                                                2007
Premedline                              15/03/2007                              March 14, 2007

CINAHL                                  15/03/2007                              1982 to March Week 1
                                                                                2007
British Library Inside                  16/03/2007                                         -
Conferences
NRR                                     16/03/2007                              2007, Issue 1

Controlled Trials                       16/03/2007                                                -
Registry


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

1 Heart Valve Diseases/th [Therapy]                                                    510
2 Ventricular Dysfunction, Right/su [Surgery]                                          114
3 Ventricular Outflow Obstruction/su [Surgery]                                         603
4 Pulmonary Valve/su [Surgery]                                                         756
5 Pulmonary Valve Insufficiency/su [Surgery]                                           182
6 Heart Valve Diseases/th [Therapy]                                                    510
     (right adj3 ventricular adj3 outflow adj3
7                                                                                      6
     dysfunction).tw.
8 RVOT.tw.                                                                             364
     (right adj3 ventricular adj3 outflow adj3 tract adj3
9                                                                                      359
     obstruction).tw.



IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 16 of 17
                                                                                                         IP 392


10 RVOTO.tw.                                                                           40
11 (pulmonary adj3 valve adj3 stenosis).tw.                                            544
12 Pulmonary Valve Stenosis/                                                           4908
13 (valvular adj3 pulmonary adj3 stenosis).tw.                                         317
14 or/1-13                                                                             7472
15 percutaneous.tw.                                                                    56880
16 non-surgical.tw.                                                                    3928
17 15 or 16                                                                            60527
18 implant$.tw.                                                                        160964
19 replace$.tw.                                                                        179542
20 18 or 19                                                                            329491
21 ((pulmonary or cardiac) adj3 valve).tw.                                             4830
22 17 and 20 and 21                                                                    63
     (percutaneous adj3 pulmonary adj3 valve adj3
23                                                                                     10
     implantation).tw.
24 PPVI.tw.                                                                            3
25 (percutaneous adj3 valve adj3 replacement).tw.                                      61
26 PVR.tw.                                                                             2602
27 Heart Valve Prosthesis Implantation/                                                5063
28 (transcatheter adj3 valve adj3 replacement).tw.                                     6
29 Surgical Procedures, Minimally Invasive/                                            7530
     (transcatheter adj3 right adj3 ventricular adj3 outflow
30                                                           1
     adj3 tract adj3 intervention).tw.
     (pulmonary adj3 valve adj3 (replace$ or repair$ or
31                                                                                     354
     reconstruct$)).tw.
     (pulmonary adj3 balloon adj3 (valvuloplas$ or
32                                                                                     278
     dilat$)).tw.
33 (pulmonary adj3 stent adj3 implant$).tw.                                            19
34 or/22-33                                                                            15546
35 14 and 34                                                                           629
36 Animals/                                                                            4009294
37 Humans/                                                                             9613911
38 36 not (36 and 37)                                                                  3045532
39 35 not 38                                                                           592
40 limit 39 to (english language and yr="2000 - 2007")                                 274




IP Overview: Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction            Page 17 of 17