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PleuraFlow Active Clearance Technology (ACT)
PleuraFlow®
Active Clearance
Technology®
ACT inserted between the chest
tube and the drainage canister.
Introduction
Chest tubes are utilized to clear blood from around the
heart and lungs after heart surgery. A recent prospective
observational study quantified that 36% of chest tubes
obstruct after heart surgery. Chest tube clogging can
contribute to Retained Blood Syndrome (RBS),
characterized by the need to re-explore for washout,
drain hemothorax or bloody pericardial and pleural
effusions. We hypothesized that preventing chest tube
occlusion may prevent RBS. To study this hypothesis
we initiated a continuous quality improvement process
to assess the incidence of RBS. Second, we developed
and implemented a universal protocol utilizing PleuraFlow
Active Clearance Technology (ACT), a new device that
periodically clears the internal lumen of chest tubes at
the bedside in the ICU.
Methods
A multidisciplinary team developed a simple protocol
to institute active clearance technology (ACT) to
preventatively clear chest tubes of clot in the first
24 hours after heart surgery. An extensive educational
in-service was performed before universal implementation
(Phase 1). We examined data from 1,849 patients
before (Phase 0) compared with data from 256 patients
collected prospectively after universal implementation
(Phase 2), and then the results of stopping the protocol
in 222 patients (Phase 3) to determine the impact of
ACT on outcomes. Statistics utilized included the 2
tests for non-continuous variables and Welch’s T-test
or Fisher’s Exact Test, for continuous variables.
Results
One fifth of the patients (360/1,849; 20%) had at least
one intervention for RBS at baseline (Phase 0)
Patient’s with RBS were more likely to suffer mortality
(11% vs. 5%, P < 0.0001). Patient’s with RBS were also
more likely to have higher mean 24 hour blood loss
(756.6 +/-759.9 mL vs. 480.7 +/- 357.89, P < 0.00001).
Patients with RBS were also more likely to have longer
lengths of hospital stay (15.59 +/-13.53 days vs. 13.41
+/-11.23 days, P < 0.005)
After the universal implementation of ACT in Phase 2,
the percent of patients with interventions for RBS was
reduced to 11%, representing a 42% reduction in RBS
in comparison with Phase 0 (P = 0.0022)
The cohort of Phase 2 ACT patients were also found to
have a significantly reduced incidence of postoperative
A Fib (POAF). (P=0.0033).
Patients treated with the ACT protocol in Phase 2
additionally had a statistically significant reduction
in total chest tube drainage (469.04 vs 534.12 mL,
P = 0.0067).
Once the ACT protocol was stopped and use of only
conventional chest tubes was resumed (Phase 3), the
RBS rate returned to baseline (18% in Phase 3 vs. 20%
in Phase 0, P = 0.54, compared to Phase 0) and there
was no longer a statistically significant decrease in
POAF (24% in Phase 3 vs. 29% in Phase 0, P = 0.1,
compared to Phase 0). (Figure 2)
Summary
We examined the frequency of Retained Blood Syndrome
and determined the impact of a preventative active
chest tube clearance protocol on these outcomes. At
baseline, 20% of patients were found to have RBS
complications that required re-interventions after
cardiac surgery, and 29% were found to have POAF.
This protocol significantly:
• Reduced the occurrence of RBS by 42%
• Reduced POAF by 30%
• Reduced total blood loss
• The complications of RBS and POAF returned to
baseline when the protocol was completed.
Conclusions
ACT reduced the need for interventions for RBS and
POAF. Our findings underscore the importance of chest
tube patency in the early hours after cardiac surgery.
References Shalli, S., Saeed, D., Fukamachi, K., Gillinov, A.M., Cohn, W.E., Perrault, L.P., and Boyle, E.M. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009; 24:503-509. Karimov, J.H., Gillinov, A. M., Schenck, L., Cook, M., Kosty Sweeney,
D., Boyle, E.M., Fukamachi, K. Incidence of chest tube clogging after cardiac surgery: A single-center prospective observational study. Eur J Cardiothorac Surg. 2013; 44:1029-1036. Shalli, S., Boyle, E.M., Saeed, D., Fukamachi, K., Cohn, W.E., and Gillinov, A.M. 2010. The active tube clearance system: a novel bedside chest-tube
clearance device. Innovations (Phila). 2010; 5:42-47. Perrault, L.P., Pellerin, M., Carrier, M., Cartier, R., Bouchard, D., Demers, P., and Boyle, E.M. The PleuraFlow Active Chest Tube Clearance System: Initial Clinical Experience in Adult Cardiac Surgery. Innovations (Phila). 2012; 7:354-358.
Presented at the 11th Annual
Cardiovascular-Thoracic (CVT) Critical Care Conference,
hosted by the Foundation for the Advancement
of Cardio-Thoracic Surgical Care (FACTS-Care)
October 10, 2014, Washington, DC, USA
Supported In part by a research grant from ClearFlow, Inc. Dr. Boyle is a Founder and Consultant
for ClearFlow, which manufactures PleuraFlow ACT.
Reduction in Re-Interventions for Retained Blood and Post Operative Atrial Fibrillation
with Active Clearance of Chest Drainage Catheters
J Sirch, MD1
, M Ledwon, MD1
, T Püski, MD1
, EM Boyle, MD2
, S Pfeiffer, MD1
, T Fischlein, MD1
1
Department of Cardiac Surgery, Cardiovascular Center, Paracelsus Medical University, Klinikum Nürnberg, Germany 2
St. Charles Medical Center, Bend, OR, United States of America
Phase 0 Phase 2
1,849 With regular drains 256 with PleuraFlow ACT
20% RBS (360 total) 11% RBS (29 total)
42% Reduction in RBS with
PleuraFlow ACT (P=0.0022)
Phase 0 Phase 2
1,849 With regular drains 256 with PleuraFlow ACT
29% POAF (543 total) 11% POAF (52 total)
30% Reduction in POAF with
PleuraFlow ACT (P=0.0033)
Pleural Interventions
(12.7%)
Pericardial Interventions
(1.9%)
Re-exploration
(3.6%)
Pneumothorax
(3.2%)
No RBC
80%

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Reduction in Reintervention for Retained Blood and Post Operative Atrial Fibrilation

  • 1. PleuraFlow Active Clearance Technology (ACT) PleuraFlow® Active Clearance Technology® ACT inserted between the chest tube and the drainage canister. Introduction Chest tubes are utilized to clear blood from around the heart and lungs after heart surgery. A recent prospective observational study quantified that 36% of chest tubes obstruct after heart surgery. Chest tube clogging can contribute to Retained Blood Syndrome (RBS), characterized by the need to re-explore for washout, drain hemothorax or bloody pericardial and pleural effusions. We hypothesized that preventing chest tube occlusion may prevent RBS. To study this hypothesis we initiated a continuous quality improvement process to assess the incidence of RBS. Second, we developed and implemented a universal protocol utilizing PleuraFlow Active Clearance Technology (ACT), a new device that periodically clears the internal lumen of chest tubes at the bedside in the ICU. Methods A multidisciplinary team developed a simple protocol to institute active clearance technology (ACT) to preventatively clear chest tubes of clot in the first 24 hours after heart surgery. An extensive educational in-service was performed before universal implementation (Phase 1). We examined data from 1,849 patients before (Phase 0) compared with data from 256 patients collected prospectively after universal implementation (Phase 2), and then the results of stopping the protocol in 222 patients (Phase 3) to determine the impact of ACT on outcomes. Statistics utilized included the 2 tests for non-continuous variables and Welch’s T-test or Fisher’s Exact Test, for continuous variables. Results One fifth of the patients (360/1,849; 20%) had at least one intervention for RBS at baseline (Phase 0) Patient’s with RBS were more likely to suffer mortality (11% vs. 5%, P < 0.0001). Patient’s with RBS were also more likely to have higher mean 24 hour blood loss (756.6 +/-759.9 mL vs. 480.7 +/- 357.89, P < 0.00001). Patients with RBS were also more likely to have longer lengths of hospital stay (15.59 +/-13.53 days vs. 13.41 +/-11.23 days, P < 0.005) After the universal implementation of ACT in Phase 2, the percent of patients with interventions for RBS was reduced to 11%, representing a 42% reduction in RBS in comparison with Phase 0 (P = 0.0022) The cohort of Phase 2 ACT patients were also found to have a significantly reduced incidence of postoperative A Fib (POAF). (P=0.0033). Patients treated with the ACT protocol in Phase 2 additionally had a statistically significant reduction in total chest tube drainage (469.04 vs 534.12 mL, P = 0.0067). Once the ACT protocol was stopped and use of only conventional chest tubes was resumed (Phase 3), the RBS rate returned to baseline (18% in Phase 3 vs. 20% in Phase 0, P = 0.54, compared to Phase 0) and there was no longer a statistically significant decrease in POAF (24% in Phase 3 vs. 29% in Phase 0, P = 0.1, compared to Phase 0). (Figure 2) Summary We examined the frequency of Retained Blood Syndrome and determined the impact of a preventative active chest tube clearance protocol on these outcomes. At baseline, 20% of patients were found to have RBS complications that required re-interventions after cardiac surgery, and 29% were found to have POAF. This protocol significantly: • Reduced the occurrence of RBS by 42% • Reduced POAF by 30% • Reduced total blood loss • The complications of RBS and POAF returned to baseline when the protocol was completed. Conclusions ACT reduced the need for interventions for RBS and POAF. Our findings underscore the importance of chest tube patency in the early hours after cardiac surgery. References Shalli, S., Saeed, D., Fukamachi, K., Gillinov, A.M., Cohn, W.E., Perrault, L.P., and Boyle, E.M. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009; 24:503-509. Karimov, J.H., Gillinov, A. M., Schenck, L., Cook, M., Kosty Sweeney, D., Boyle, E.M., Fukamachi, K. Incidence of chest tube clogging after cardiac surgery: A single-center prospective observational study. Eur J Cardiothorac Surg. 2013; 44:1029-1036. Shalli, S., Boyle, E.M., Saeed, D., Fukamachi, K., Cohn, W.E., and Gillinov, A.M. 2010. The active tube clearance system: a novel bedside chest-tube clearance device. Innovations (Phila). 2010; 5:42-47. Perrault, L.P., Pellerin, M., Carrier, M., Cartier, R., Bouchard, D., Demers, P., and Boyle, E.M. The PleuraFlow Active Chest Tube Clearance System: Initial Clinical Experience in Adult Cardiac Surgery. Innovations (Phila). 2012; 7:354-358. Presented at the 11th Annual Cardiovascular-Thoracic (CVT) Critical Care Conference, hosted by the Foundation for the Advancement of Cardio-Thoracic Surgical Care (FACTS-Care) October 10, 2014, Washington, DC, USA Supported In part by a research grant from ClearFlow, Inc. Dr. Boyle is a Founder and Consultant for ClearFlow, which manufactures PleuraFlow ACT. Reduction in Re-Interventions for Retained Blood and Post Operative Atrial Fibrillation with Active Clearance of Chest Drainage Catheters J Sirch, MD1 , M Ledwon, MD1 , T Püski, MD1 , EM Boyle, MD2 , S Pfeiffer, MD1 , T Fischlein, MD1 1 Department of Cardiac Surgery, Cardiovascular Center, Paracelsus Medical University, Klinikum Nürnberg, Germany 2 St. Charles Medical Center, Bend, OR, United States of America Phase 0 Phase 2 1,849 With regular drains 256 with PleuraFlow ACT 20% RBS (360 total) 11% RBS (29 total) 42% Reduction in RBS with PleuraFlow ACT (P=0.0022) Phase 0 Phase 2 1,849 With regular drains 256 with PleuraFlow ACT 29% POAF (543 total) 11% POAF (52 total) 30% Reduction in POAF with PleuraFlow ACT (P=0.0033) Pleural Interventions (12.7%) Pericardial Interventions (1.9%) Re-exploration (3.6%) Pneumothorax (3.2%) No RBC 80%