Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial

Wei C Lau, Francis L Shannon, Steven F Bolling, Matthew A Romano, Marc P Sakwa, Andrea Trescot, Luoxi Shi, Robert L Johnson, Vaughn A Starnes, John F Grehan, Wei C Lau, Francis L Shannon, Steven F Bolling, Matthew A Romano, Marc P Sakwa, Andrea Trescot, Luoxi Shi, Robert L Johnson, Vaughn A Starnes, John F Grehan

Abstract

Introduction: Intercostal cryo nerve block has been shown to enhance pulmonary function recovery and pain management in post-thoracotomy procedures. However, its benefit have never been demonstrated in minimal invasive thoracotomy heart valve surgery (Mini-HVS). The purpose of the study was to determine whether intraoperative intercostal cryo nerve block in conjunction with standard of care (collectively referred to hereafter as CryoNB) provided superior analgesic efficacy in patients undergoing Mini-HVS compared to standard-of-care (SOC).

Methods: FROST was a prospective, 3:1 randomized (CryoNB vs. SOC), multicenter trial in patients undergoing Mini-HVS. The primary endpoint was the 48-h postoperative forced expiratory volume in 1 s (FEV1) result. Secondary endpoints were visual analog scale (VAS) scores for pain at the surgical site and general pain, intensive care unit and hospital length-of-stay, total opioid consumption, and allodynia at 6 months postoperatively.

Results: A total of 84 patients were randomized to the two arms of the trial CryoNB (n = 65) and SOC (n = 19). Baseline Society of Thoracic Surgeons Predictive Risk of Mortality (STS PROM) score, ejection fraction, and FEV1 were similar between cohorts. A higher 48-h postoperative FEV1 result was demonstrated in the CryoNB cohort versus the SOC cohort (1.20 ± 0.46 vs. 0.93 ± 0.43 L; P = 0.02, one-sided two-sample t test). Surgical site VAS scores were similar between the CryoNB and SOC cohorts at all postoperative timepoints evaluated, but VAS scores not related to the surgical site were lower in the SOC group at 72, 94, and 120 h postoperatively. The SOC cohort had a 13% higher opioid consumption than the CryoNB cohort. One of 64 CryoNB patients reported allodynia that did not require pain medication at 10 months.

Conclusions: The results of FROST demonstrated that intercostal CryoNB provided enhanced FEV1 score at 48 h postoperatively with optimized analgesic effectiveness versus SOC. Future larger prospective randomized trials are warranted to determine whether intercostal CryoNB has an opioid-sparing effect in patients undergoing Mini-HVS.

Trial registration: Clinicaltrials.gov identifier: NCT02922153.

Keywords: Analgesia; Cryo nerve block; CryoICE; Cryoanalgesia; Opioids; Pain management.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Description of cryoablation of intercostal nerve. a cryoICE probe bend. b External view of the position and application of the cryoICE probe. c Internal view of the position of cryoICE probe: ablation of the margin of the membranous section of the intercostal muscle, maintaining a distance of at least 2 cm from dorsal root ganglia, or 4 cm from the base of the probe, maintaining a still and gentle pressure for the duration of cryoablation. d One cryoablation at the intercostal level of the incision, then ablation two levels above and two levels below the incision site, avoiding going above the third and below the ninth intercostal space
Fig. 2
Fig. 2
Overall study and design workflow for the FROST trial
Fig. 3
Fig. 3
Summary statistics for FEV1 results by postoperative time (from 48 h through to 120 h) in the CryoNB and SOC cohorts. Results are from two sample t tests and are presented as the mean ± SD (N), where N = number of FEV1 samples collected for analysis. The asterisk indicates a significant difference between the CryoNB and SOC cohorts at the respective timepoint. CryoNB Intercostal cryo nerve block in conjunction with SOC, FEV1 Mean forced expiratory volume in 1 s, SOC standard of care

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