We plan to approach all EBVs candidates that have < 95% lobar fissure completion. Once
the patient agrees to participate and sign the consent, all the screening information
collected as part of the standard of care will be extracted retrospectively from the
medical records including appointment details, 6MWD, and PFTs results. In addition,
during the same visit, health-related quality of life will be measured using the Saint
George Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and dyspnea will
be assessed with the self-reported modified Medical Research Council dyspnea scale
(mMRC). After completing these questionnaires and indexes, subjects will be randomized by
an opaque envelope technique following a block 2-4 pattern to either Group 1 (Combined
robotic or VATS-fissure completion and BLVR with EBVs) or Group 2 (Medical management).
Both surgical stapling for fissure completion and EBVs implantation will be performed
during the same procedure and under general anesthesia in the operating room. Depending
on the duration of the surgical intervention, the endoscopic valve implantation might be
deferred and performed within 48 hours, based on the clinical judgment of the PI,
surgeon, and anesthesiologist present during the procedure.
Initial Bronchoscopic Evaluation Initial flexible bronchoscopy will be done by the
interventional pulmonologist who will perform the endoscopic valve placement as part of
the standard of care. The bronchoscope will be passed via the endotracheal tube and the
major airways will be examined. A bronchial wash will be performed with samples sent for
culture. If there are unexpected findings, such as a lesion suspicious for carcinoma or
secretions suggesting infection, then appropriate clinical samples will be obtained, and
the subject will be re-evaluated to determine if they are eligible to undergo the study
procedure later. If so, the procedure will be rescheduled. If not, the subject will be
withdrawn from the study and will be considered as an "Enrollment Failure" and recorded
as such for statistical analysis.
First Chartis Pulmonary System Evaluation of CV Following initial bronchoscopy,
evaluation of CV using the Chartis system (Pulmonx Inc., Redwood, CA, USA), will be
performed also as part of the standard of care of the patients. If there is no evidence
of CV between the target lobe and the adjacent one, the patient will be withdrawn from
the study and EBVs will be placed. On the other hand, if the ChartisTM evaluation is
positive for CV, the bronchoscope will be withdrawn, and the patient will undergo robotic
or VATS completion of the inter-lobar fissure adjacent to the previously selected target
lobe.
Robotic or VATS Inter-Lobar Fissure Completion Surgery will be performed with a robotic
or VATS approach under inhaled anesthetic agents by an experienced thoracic surgeon from
BIDMC. A double-lumen endotracheal tube will be inserted allowing one-lung ventilation
and the maximal collapse of the operative lung. The subject will be placed in lateral
decubitus with the operative side up. Through small incisions, the surgeon will create a
camera port through the intercostal space and then the anterior and posterior inferior
ports. Electrocautery will be used for dissection and exposure of the anterior aspect of
the hilum. Stapling will then be performed on the incomplete fissure adjacent to the
target lobe, using the Endo GIATM (CovidienTM, Mansfield, MA).
An attempt at conversion to a complete fissure will be made, though depending on the
anatomy, it may be possible that residual incomplete fissure of up to 5% may be
tolerated. Hemostasis will be evaluated. Sterile water will then be used to fill the
surgical area, followed by lung inflation and inspection to verify for air leaks at the
level of the stapling. If an air leak is detected, suturing, re-stapling, or applying
pleural sealants will be used to seal it. If the air leak persists at the site of
stapling despite these measures, the subject will still be allowed to proceed to EBVs
implantation. Once the fissure is surgically completed, a chest tube will be installed
and connected to a digital chest drainage system (ThopazTM Digital Chest Drainage System,
Medela Healthcare).
Second Chartis Pulmonary System Evaluation of CV The double-lumen endotracheal tube will
be removed, and a single-lumen tube (8.0 to 8.5 mm) inserted. The lung will be completely
re-inflated before this evaluation to return them to normal anatomy. Assessment of CV
with the ChartisTM system will be performed once again in the same inter-lobar fissure as
before following the previously described methods. If the result is negative for CV or
there is an improvement in the evaluation, then we will proceed with EBVs implantation.
EBVs Placement Bronchoscopic placement of EBVs will then be performed as part of the
standard of care of patients since they meet the previously mentioned inclusion criteria
and have no CV, same as patients with an initial negative ChartisTM evaluation. The
airway sizing system and a calibrated balloon will be used in the previous re-inflated
lung to determine the appropriate Zephyr® valves size to treat the target lobe airways.
The treatment algorithm is complete occlusion of one lobe by using valves to occlude all
segments of the lobe. Either upper or lower lobes may be targeted for treatment. The lobe
will have been selected by the CT core laboratory based on imaging with computed
tomography. However, the PI can choose the alternate eligible lobe if the airway in the
primary eligible lobe is overly challenging for valve implantation, such as difficulty
associated with the underlying airway anatomy.
A valve may be removed and replaced with a different size valve during the procedure and
a valve may also be removed and replaced to improve the location. However, a valve may
not be repositioned during the procedure. It is intended that the investigator occlude
all segments of the target lobe by placing valves into segmental or sub-segmental
airways. There is anatomic variability in the number and size of segments in a lobe, so
this protocol does not have a limit on the number of valves to be used. Subjects who do
not have any endobronchial valves placed at the end of the bronchoscopy procedure will be
withdrawn.
Follow-up Period After BLVR with EBVs, patients will be placed on a standardized
follow-up protocol used for individuals that underwent BLVR. All procedures and
appointments following EBV placement will be considered standard of care. Data from
follow-up appointments at 14 days and 3 months will be collected from the medical records
retrospectively including appointment details, complications, CT-scan results, 6MWD, and
PFTs results. TLVR will be assessed at 3 months using the CT scans performed on patients
as part of their standard of care. The only procedures that will be considered research
after the initial surgical intervention would be the measurement of health-related
quality of life with the SGRQ and CAT, and dyspnea assessment with the self-reported mMRC
at every follow-up appointment.
Crossover Group After the patient allocated to the medical management, the arm is
followed for 3 months, they will be offered the robotic or VATS fissure completion
procedure. It will be completely up to the candidates to undergo the intervention. If
they decide that they want to proceed with surgery, the previously described methods will
be used including the same surgical technique, same postoperative management, and same
follow-up timelines and datapoints.