Novel vessel ligation device cuts blood loss, operative time during major head-neck surgery

The Thunderbeat, a novel energy-based sutureless vessel ligation device, can safely reduce blood loss and time under operation during neck dissection (ND), according to a recent study. The device also seems effective in total laryngectomy (TL) procedures.

“This is the first study to analyse the effect of the Thunderbeat device during major head and neck surgery, compared to standard electrocautery devices (SED) in a prospective, randomized double-arm trial,” the researchers said. “As there was no difference in postoperative complications for both procedures, the Thunderbeat can be regarded as a safe instrument for both TL and ND.”

The prospective, double-arm, randomized controlled trial compared TL and ND procedural outcomes to SED controls. Forty-two ND procedures (n=35 patients) were included in the analysis, with 23 performed with Thunderbeat and 19 with SEDs. Baseline demographic, tumour, comorbidity, and medication characteristics were comparable between arms. [Eur Arch Otorhinolaryngol 2021;doi:10.1007/s00405-021-06739-z]

Patients on Thunderbeat saw less than half the operative blood loss as their SED comparators (210±209 vs 431±409 mL; p=0.046). However, removal of an outlier attenuated this effect (210±209 vs 357±269 mL; p=0.078).

Nevertheless, operative time remained significantly shorter by close to an hour among Thunderbeat patients (101 vs 150 minutes; p=0.014). Complications also occurred more frequently among the SED controls, though the difference failed to reach statistical significance. Postoperative measures—length of hospital stay, drainage volume, and time between surgeries—did not differ between device arms.

For the TL analysis, 28 were eligible, of whom 15 were on Thunderbeat while 13 received SEDs. Both intervention groups had comparable baseline characteristics.

As opposed to ND, Thunderbeat yielded no statistical benefit on TL in terms of blood loss. Nevertheless, those on SEDs lost more than twice the blood volume of the Thunderbeat participants during the procedure (572±713 vs 214±203 mL; p=0.062). Removing an outlier from the analysis greatly lowered this difference (368±324 vs 214±203 mL; p=0.123).

Operative time was slightly longer among Thunderbeat participants, though the difference did not qualify for statistical significance (108 vs 91 minutes; p=0.512). Postoperative factors, as well as the complication rate, were also comparable between the Thunderbeat and SED arms.

“The differences within the TL part were likewise striking in term of blood loss and very likely statistically insignificant due to the small sample size,” the researchers pointed out. “As there was no difference in postoperative complications for both procedures, the Thunderbeat can be regarded as a safe instrument for both TL and ND.”

However, important limitations need to be considered. Notably, the loss of intraoperative data occurred in several instances, resulting in a relatively limited sample size. Other issues include the high degree of deviation among the datapoints and the unblinded nature of the study.

“This study demonstrates the safety of Thunderbeat compared to standard electrocautery devices in TL and ND,” the researchers said.

“Due to the limited sample size, the results need to be carefully interpreted and larger, randomized, powered studies are necessary to confirm the suggested trend for blood loss in TL and establish whether the TB could further diminish operative time in major head and neck surgery,” they added.