Primary Objective: 1. To evaluate if chest CT can be withheld in post-embolization patients without or with a minimal pulmonary right-to-left shunt, based on:a. The evaluation of the grade of pulmonary RLS on TTCE after PAVM embolization in patients…
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes include:
- the pulmonary RLS grade on TTCE: will be determined by the maximum number of
microbubbles in the left-sided heart chambers visualized in one frame: 1-30
microbubbles (grade 1), 30-100 microbubbles (grade 2), or >100 microbubbles
(grade 3).
- the change in echo density on TTCE: will be determined using ImageJ (National
Institutes of Health, Bethesda, MA, USA). Three images, two baseline
measurements and one frame with the maximum number of microbubbles in the left
ventricle, were selected and transported to ImageJ. The average of the two
baseline measurements will be calculated, as well as the absolute change in
echo density - with the LV baseline considered as darkest possible. A complete
white image has a value of 255. The corrected change in echo density will be
calculated by dividing the change in ED in the LV (maximum - baseline) by the
maximum change possible (255 - baseline).
- Presence of macroscopic PAVMs (yes/ no, number), type of PAVMs, presence of
reperfusion, recanalization or inadequate embolization, indication for
additional treatment on chest CT.
Secondary outcome
Clinical outcome measures, including: symptoms (dyspnoea, haemoptysis,
migraine), complications (cerebral infarction, cerebral abscess, transient
ischemic attack), and oxygen saturation - for the description of the study
population.
Background summary
A pulmonary arteriovenous malformation (PAVM) is a direct connection between
the pulmonary artery and -vein, creating a right-to-left shunt. Most PAVMs are
associated with hereditairy haemorrhagic telangiectasia, a rare genetic
vascular disease characterized by recurrent epistaxis, mucocutaneous
telangiectases, and visceral arteriovenous malformations. In PAVMs, by
bypassing the capillary network, emboli (with or without bacteria) may gain
access to the systemic circulation. Therefore, PAVMs are associated with an
increased risk of neurologic complications (brain abscess, TIA, stroke).
Treatment of PAVMs with embolization decreases the risk of these neurologic
complications.
Currently, the follow-up after embolization is consisting of a chest CT after
six months, followed by every 3-5 years. Altogether, leading to significant
exposure to ionizing radiation. Also, chest CT only provides information about
the anatomy. Previous research demonstrated a remaining RLS in 90% of the
patients- however not taken the RLS grade into account. In a treatment-naïve
population, a chest CT can be safely withheld in patients with only a minimal
RLS. Also, a small study including 30 patients suggests that is it to withhold
a chest CT in patients without or with a minimal RLS after embolotherapy.
However, since this is only a small study, further research is necessary.
In our clinical practice, the follow-up after embolization consists of both
TTCE and chest-CT in all patients: to provide both information about the size
of the shunt (physiology, with TTCE) as well as the anatomy (chest-CT).
Study objective
Primary Objective:
1. To evaluate if chest CT can be withheld in post-embolization patients
without or with a minimal pulmonary right-to-left shunt, based on:
a. The evaluation of the grade of pulmonary RLS on TTCE after PAVM embolization
in patients with an indication for retreatment based on chest CT (for a
re-treatable PAVM or new PAVM). (retrospective)
2. To evaluate if chest CT can be withheld in post-embolization patients with a
stable minimal or moderate right-to-left shunt, based on:
a. The evaluation of the pulmonary RLS grade on TTCE 6 months, 2-3 years and 5
years after embolization with the indication for re-treatment on chest CT.
(retrospective) A stable RLS is defined as remaining the same RLS-grade
category (absent, minimal (grade 1), moderate (grade 2)).
Secondary Objective(s):
3. To evaluate the correlation between change in echo density and the
indication for retreatment (retrospective) to evaluate the additional value of
the use of the change in ED in the number of needed chest-CTs.
4. To evaluate if TTCE directly after embolization can replace the follow-up 6
months after embolization by exploring the underlying biology of shunt
recurrence/ persistence after embolization, by
a. The evaluation of the grade of pulmonary RLS on TTCE directly after and 6
months after embolization. (prospective)
b. The evaluation of the change in ED on TTCE directly after and 6 months after
embolization. (prospective)
Study design
Retrospective part: in our current clinical practice, after the embolization,
follow-up consists of TTCE and chest-CT after 6 months, 3 years and
subsequently every 5 years. Data will be retrospectively collected from
included patients.
Prospective substudy: TTCE will be performed directly after embolization during
hospital admission.
Endpoints regarding the grade of the pulmonary RLS and change in ED will be
collected by reviewing the TTCEs. The chest-CTs will be reviewed by an
experienced interventional radiologists and evaluated for the presence of
reperfusion, recanalization, inadequate embolization, indication for additional
embolization. The chest CT before embolization and the images of the
embolization procedure and angiography directly after embolization will be
available as well, to optimize this evaluation. Endpoints regarding clinical
outcome measures (the presence of symptoms and occurrence of cerebral
complications) will be collected directly after embolization and at follow-up
visits - for description of the study population.
Study burden and risks
Inclusion in the retrospective observational study does not affect the patient,
not in a beneficial or negative way.
Participation in the prospective substudy includes an extra TTCE directly after
embolization, requiring an intravenous line and time. Placement may be
associated with some pain, and in some cases cause a hematoma. Also, in the
presence of large PAVMs - injection of the microbubbles may in rare cases cause
migraine. No benefits are present for participating patients.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Adult patients who underwent embolization for pulmonary arteriovenous
malformation and have a follow-up TTCE 6 months after embolization.
(restrospective part)
Adult patients with a treatable pulmonary arteriovenous malformation who will
undergo embolization at the St. Antonius Hospital. (prospective part)
Exclusion criteria
None
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80334.100.22 |