Utilization of Confocal Microscopy During Cardiac Surgery

Phase 1

Completed

Interventions: Drug: Fluorescite
Device: Cellvizio 100 Series System with Confocal Miniprobes

Brief Summary: The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

Detailed Description: This is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System with Confocal Miniprobe) will be used to record images in several different locations of the heart. The image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. All subjects will be monitored while they are inpatient after surgery for any adverse events.

Recruitment & Eligibility

Inclusion Criteria

Males and females between 30 days and 21 years old
Undergoing elective surgery for closure of atrial septal defect
Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or an adult participant (age 18-21) may provide consent for him/herself

Exclusion Criteria

Prior history of adverse reaction to fluorescein sodium
Prior history of renal failure or abnormal renal function
Baseline PR interval > 220 msec or 98% for age
Baseline HR > 87% for age
Underlying genetic syndrome associated with progressive AV block of sinus node dysfunction (e.g. Holt-Oram or NKX2.5)

Arm && Interventions

Group	Intervention	Description
Imaging arm	Fluorescite	Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes
Imaging arm	Cellvizio 100 Series System with Confocal Miniprobes	Up to 5mL of 1:1000 dilute FLUORESCITE will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Adverse Events Possibly Related to Study Intervention	Surgery through discharge (approximately 5 days)	All adverse events will be collected and relatedness to study intervention will be determined.

Secondary Outcome Measures

Name	Time	Method
Percentage of Agreement in Classification of FCM Images	After all participants completed the study (range 2 months to 1 year post surgery)	A first reviewer selected 60 FCM images and classified them as reticulated, striated, or of poor quality (indistinguishable microstructure) with 20 images in each group. Quality of the files is measured by the ability of 8 blinded reviewers to classify the images accurately.
Number of Participants For Whom FCM Imaging During Cardiac Surgery Was Feasible	Surgery through discharge (approximately 5 days)	Evaluated by measuring increased time on bypass, rate of enrollment, and the ability to incorporate this imaging modality into standard OR procedures. The additional time on bypass and ability to incorporate the imaging into standard OR procedures was assessed for each subject. 3 additional minutes on bypass was determined as reasonable per the protocol. The ability to incorporate the imaging was considered successful when it did not interfere with the planned clinical procedure. The rate of enrollment was evaluated for the study as a whole.