A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation



Status:Terminated
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:February 2013
End Date:October 2015

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This is a randomized prospective study comparing outcomes of pulmonary vein isolation using
conventional and jet ventilation.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States today.
Its incidence increases with age, and the prevalence approaches 10% in patients over 80
years old. Atrial fibrillation increases the risk of strokes, and in some patients is
associated with worsened congestive heart failure and quality of life.

Catheter based radiofrequency ablation for atrial fibrillation is an evolving and promising
technology, and provides increased freedom from AF and improved quality of life compared
with pharmacologic therapy. The technique involves placing catheters through the femoral
veins into the heart, including the left atrium. Access to the left atrium is performed by
transseptal puncture. Ablation of atrial fibrillation is performed by delivery of
radiofrequency energy around the pulmonary veins in order to electrically dissociate them
from the atria. This is thought to eliminate common triggers for atrial fibrillation, and
therefore reduces the recurrence of AF in some patients.

The ablation procedure is done under general anesthesia and takes 4-8 hours. The first part
of the procedure involves creating a computer generated three dimensional model of the left
atrium. Once this model is created any patient movement will disrupt its accuracy and
interfere with the physician's ability to accurately locate the catheter within the atrium.

The success of AF ablation is dependent upon the creation of an accurate three dimensional
model, as well as physicians ability to perform durable lesions and achieve effective
isolation of the pulmonary veins. Among the barriers to technical success are the patient's
respiratory movement, which impairs catheter stability and the ability to maintain a stable
catheter position against the atrium of the heart during ablation. Thus, minimizing
respiratory movement during the procedure is critical to procedural outcome.

High frequency jet ventilation (HFJV) is a newer mode of ventilation that relies on very
small tidal volumes delivered at high frequency (approximately 80-120 breaths/minute).
Initially developed in the critical care setting, HFJV produces less respiratory motion due
the small tidal volumes delivered. HFJV has been used successfully in procedures requiring
increased stability of the field of interest, such as lithotripsy and percutaneous hepatic
and renal radiofrequency ablation as well as stereotactic high single-dose irradiation of
stage I non-small cell lung cancer and lung metastases. The initial report of the use of
HFJV in radiofrequency catheter ablation (RFCA) of atrial fibrillation was by Goode et al in
2006. In that retrospective analysis, the use of HFJV was associated with a decrease in the
number of ablation lesions, due to decreased number of attempts aborted by catheter
dislodgement, as well as decreased variation in the size of the left atrium (LA) due to
changes in pulmonary pressures associated with conventional ventilation. The incidence of
complications was not significantly different between the HFJV and conventionally ventilated
patients. More recently, Elkassabany et al. retrospectively reviewed their institutional
experience with Jet ventilation, and found that the procedure could be performed safely.

HFJV is increasingly used and may improve procedure efficacy and safety, and may be cost
effective. Data however are limited to small series and retrospective reviews. In order to
better compare the efficacy and safety of HFJV to conventional ventilation, the
investigators propose to conduct a prospective randomized study comparing the use of HJFV
and conventional ventilation in patients undergoing pulmonary vein isolation (PVI) at our
institution. Our hypothesis is that HFJV, by allowing greater catheter stability and more
accurate mapping of the left atrium will allow more effective radiofrequency lesion
creation, leading to a quicker procedure, requiring fewer lesions and less ablation and
fluoroscopy time with more effective isolation of the pulmonary veins with better short and
long term control of AF.

Inclusion Criteria:

- paroxysmal or persistent AF, first time PVI or left atrial procedure

Exclusion Criteria:

- repeat procedure

- any contraindications to receiving JET ventilation in the judgement of the treating
anesthesiologist
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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