This study demonstrated that novel PES/PEC sensors exhibited a >90% reliable intraoperative PW detection rate amongst patients undergoing major abdominal, urological and cardiac surgery. A significant correlation between intraoperative SBP
IBP with both 1/PTT
PES and 1/PTT
PCS was also observed, while significant, albeit lower correlations were found for DBP
IBP and MAP
IBP, which is in line with previous studies[
17]. Additionally, an approximate 7% change in 1/PTT
PES and 1/PTT
PCS sensors could predict a 30% change in intraoperative SBP
IBP fluctuations. The only other comparable study of this nature found that a 15% change in PTT could predict a 30% change in SBP
IBP via PPG sensors[
17]. Thus, the results of this monocentric study promote the potential for beat-to-beat PTT tracking via PES/PCS as an innovative non-invasive sensor technology that may augment future intraoperative hemodynamic monitoring.
Prior PES/PEC research
A critical prerequisite to determine valid PTT is to detect and deliver a reliable PW morphology. Previous studies with piezo-based sensors have been able to detect reliable PW’s amongst healthy volunteers[
18,
19], volunteers with arrythmias[
20],and hypertensive volunteers[
13]. In a clinical setting, Clemente et al., also demonstrated a reliable beat-to-beat PW detection rate in a small cohort of ICU patients[
21]. All of these mentioned studies detected a reliable piezosensor based PW detection rate of >90%, which our study was also able to confirm. Not only did the PES/PCS system in our study detect a >90% PW
PES/PW
PCS rate, but was also able to achieve this in a rigorous perioperative environment from high-risk surgical patients, in which rapid changes in BP occur frequently.
Disrupting perioperative factors such as electro-cauterization, extreme BP fluctuations, positional changes, intraabdominal pressure, and changes in vascular tone due to bleeding, pain and vasoactive medications contribute to a challenging environment for testing novel non-invasive sensors. Despite this, a >90% PES
PW/PCS
PW validity was detected, compared to a 97% validity being determined for PW
IBP. This difference is most likely due to the above-mentioned factors, with electric cauterization being the primary cause for invalid PES
PW/PCS
PW. Despite these factors, the PES/PSC sensors were able to decipher a beat-to-beat PT for all valid PW’s, which has also been verified amongst ambulatory hypertensive patients[
22]. One other technical challenge of the PES/PCS sensors, is the correct amount of external pressure needed to obtain optimal PW measurement. The optimal contact pressure for piezosensors is in the range of 1.6–2 Newtons[
13], and too little, or too much application pressure can diminish the PW signal amplitude. The advantage of these sensors is the ability for the PCS portion to register the amount of pressure applied, thereby acting as a PW quality control mechanism, which was verified in this study. Future studies comparing PES/PCS with PPG based sensors to determine PW reliability, correlations, and predictive capabilities in the perioperative are needed to verify these findings.
PTT: correlation and predictive capabilities
While no study has examined correlations between piezo-sensor based PTT and IBP, as well the ability for piezo-based PTT to predict IBP fluctuations in the perioperative environment, there are a handful of comparable PPG studies of this nature. Two studies have provided evidence that piezo-sensor derived PTT shows a significant correlation and accuracy with PTT obtained from PPG devices[
10,
23]. Regarding correlations between non-invasively acquired PTT and BP, PTT demonstrates a good correlation with SBP, while correlations between MAP and DBP vary[
24,
25,
26]. One study demonstrated a significant correlation between PTT and SBP during the administration of vasoactive medications which is highly relevant for the perioperative environment, as vasoactive medications are frequently being administered to stabilize hemodynamic status[
27]. The only directly comparable study examining non-invasively acquired PTT amongst hypertensive kidney transplant patients in the perioperative setting, found a good correlation between PTT and SBP
IBP, while moderate correlations were found with MAP
IBP and DBP
IBP[
17]. The major differences to our study, is the technique used to measure PTT (PCS/PES vs PPG) and the time period of measurement (intraoperative vs induction). Kim et al., also found a greater level of correlation for SBP (R=>0.8), MAP (R=0.8), and DBP (R=0.6), which were higher than the correlations demonstrated by PES/PCS in this study. This is most likely due to the time frame that these correlations were recorded (induction period vs post-induction period), where disruptive intraoperative factors are minimal. Despite these differences, our study confirms this correlation trend.
Another clinical study tracking PTT during post spinal anesthesia demonstrated a good correlation between PTT with non-invasively acquired MAP, while no information was given about correlations between SBP and DBP[
28]. Retrospective analysis from >500 patients experiencing rapid declines in SBP in a non-perioperative setting showed a correlation between PTT with SBP of r=-0.91[
29]. The significant correlation between PTT and SBP were attributed to SBP being influenced by both cardiac activity and vascular tone[
27]. In that same study, the authors found no correlation between PTT and DBP and MAP. The reason for this being that both DBP and MAP are indicators of vascular stiffness, which diminishes the correlation with PTT. The reason why stronger correlations are found between PTT and SBP may be due to pressure and velocity factors, as well as the influence of the incoming pressure wave registered hemodynamic sensors. The systolic cycle involves the forward propulsion of blood (velocity) which exerts a pressure gradient (pressure), cumulating as a pressure wave, as opposed to DBP and MAP[
30]. Our study however found moderate correlations between PTT with MAP
IBP and DBP
IBP, which supports the findings of Kim et al., and refutes the findings of Payne et al,. These significant correlations could be due to the residual effects of the pulse reflection wave during DBP, thereby influencing MAP[
17].
Our patient cohort consisted of high-risk patients with co-morbidities, which could have impacted PTT measurements. The existence of cardiovascular co-morbidities may impact the relationship between PTT and systemic BP, as the structural changes to the myocardium and vascular architecture may alter PW propagation[
31]. Other clinical studies have found that the relationship between PTT and systemic BP is not affected amongst patients with hypertension[
17,
28]. Another study examining hemodialysis patients undergoing simulated fluid shifts via lower body negative pressure (LBNP), found that distally measured PTT showed a very good correlation during acute decreases in systemic BP[
32]. What is interesting in this study, is that despite the presence of high-risk patients with co-morbidities, significant correlations between PTT and IBP were found, suggesting that this type of hemodynamic monitoring is quite feasible, even amongst patients with existing cardiac dysfunction.
The ability for PTT to predict significant intraoperative BP fluctuations is a major advantage of this particular bio-signal. There exist a handful of clinical studies highlighting the potential for PTT to detect significant BP fluctuations. The most relevant study by Kim et al., found that a 15% change in 1/PTT could predict a 30% change in systolic blood pressure during anesthesia induction[
17]. During obstetric spinal anesthesia, beat-to-beat changes in PTT could detect significant blood pressure changes in normotensive and hypertensive women[
28,
33]. Our study supports these findings, albeit, a lower 1/PTT change (approximately 7%) could detect 30% changes in IBP, compared to 15%. This could be due to differences in sensor technology, and could suggest the piezo sensors may be more sensitive to subtle changes in peripheral vascular tone than PPG sensors. The 30% cut-off showed the highest sensitivity and specificity, while reducing this cut-off to 10–20% changes in SBP significantly reduced the sensitivity and specificity. Other studies have determined a PTT cut-off of 15% to detect a >30% change in IBP[
17], and a 20% change in intraoperative PTT could detect 10% changes in oscillometric MAP amongst women undergoing cesarean section[
33]. Significant fluctuation in intraoperative BP, particularly >30% decreases in SBP can lead to critical reductions in organ perfusion to myocardial tissue and renal tissue leading to organ damage[
34,
35], as well as increases in post-operative mortality[
36]and morbidity[
37]. Thus, a >30% change in BP seems to be a clinically relevant cut-off point. Prior findings have demonstrated that PTT shows a higher propensity over RR-Interval for predicting autonomic responses to nociceptive stimulation and fluctuations in anesthestic depth[
38]. PTT has also been shown to reliably indicate an effective axillary block via the loss of vasomotor tone. This was indicated by an increase in 12 ms 3 minutes after block with a sensitivity of 87% and specificity of 71%[
39]. The results of our study, suggest that smaller percentage changes in PTT can provide predictive information about BP fluctuations, however, the sensitivity is dependent upon the BP cut-off. Further studies are needed to determine ideal cut-off BP limits. The ability for PTT to serve as an early indicator of systemic blood pressure fluctuations has shown promise in theoretical models[
40], however there are only a handful of monocentric clinical trials that support this. Finally, all of the above mentioned studies utilized PTT recorded with PPG methods. While both deploy different modalities of PW recognition, both are comparable with each-other with regard to reliability. Thus, the results of this study highlight the ability for PTT via PES/PCS to detect significant SBP
IBP, DBP
IBP, and MAP
IBP correlations, as well as the ability for these sensors to track intraoperative BP fluctuations. Finally, both techniques show no difference with regards to measuring vascular tone.