The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.

Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Inclusion Criteria:

• Age 18 - 85 years male or female
• Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
• Acceptable surgical candidate, including use of general anesthesia
• Willing and able to provide written informed consent
• Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

• Cardiac valve surgical procedure via conventional full sternotomy
• Procedures that require a posterolateral thoracotomy
• Current pregnancy
• Current use of prescription opioids
• FEV1 < 40% predicted
• Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
• Documented psychiatric disease
• Documented chronic pain syndrome
• Documented history of substance abuse
• Patient currently enrolled in another research study that could directly affect results of either study
• Physical or mental condition that would interfere with patient's self-assessment of pain
• Disqualifying medical condition per investigator