Randomized Trial of Miniaturized versus Standard Extracorporeal Circulation in Aortic Valve Surgery

Frank R. Halfwerk (Corresponding Author), Kees Knol, Silvia Mariani, Jan G. Grandjean, Gianclaudio Mecozzi

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)

Abstract

Background: Complications related to extracorporeal circulation remain serious. Although a minimal invasive extra corporeal circulation (MiECC) system was developed to cope with these complications, its effectivity on patient-related outcomes such as blood loss remain uncertain. Therefore, the aim of this study is to compare MiECC to an advanced standard system with respect to blood loss. Methods: A total of 128 adult patients undergoing elective isolated aortic valve replacement were enrolled in a randomized clinical trial. Patients who had undergone previous heart surgery and with preexisting kidney failure were excluded. The primary end point was postoperative blood loss after 12 hours and at drain removal. Secondary end points included intensive care and total length of stay and intubation time. At 1 hour and 12 hours after surgery, clinical laboratory data were determined. Early clinical outcomes and long-term survival were determined. Results: MiECC patients (n = 63) had a significant lower blood loss (230 mL, 95% confidence interval: 203 to 261 mL) than regular patients (n = 62) after 12 hours (288 mL, 95% confidence interval: 241 to 344 mL, p = 0.04). A preservation of hemoglobin levels 1 hour and 12 hours after surgery in the MiECC group were observed (p < 0.001). No difference was found in early clinical outcomes and long-term survival. Conclusions: This randomized controlled trial compares MiECC and an advanced system for aortic valve replacement with blood loss as primary end point. We conclude that using MiECC is clinically equal for short- and long-term follow-up regarding blood loss. Clinical trial registration: NTR3378.

Original languageEnglish
Pages (from-to)37-44
JournalAnnals of thoracic surgery
Volume108
Issue number1
Early online date13 Feb 2019
DOIs
Publication statusPublished - 1 Jul 2019

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Extracorporeal Circulation
Aortic Valve
Randomized Controlled Trials
Confidence Intervals
Postoperative Hemorrhage
Survival
Critical Care
Intubation
Thoracic Surgery
Renal Insufficiency
Length of Stay
Hemoglobins
Clinical Trials

Cite this

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title = "Randomized Trial of Miniaturized versus Standard Extracorporeal Circulation in Aortic Valve Surgery",
abstract = "Background: Complications related to extracorporeal circulation remain serious. Although a minimal invasive extra corporeal circulation (MiECC) system was developed to cope with these complications, its effectivity on patient-related outcomes such as blood loss remain uncertain. Therefore, the aim of this study is to compare MiECC to an advanced standard system with respect to blood loss. Methods: A total of 128 adult patients undergoing elective isolated aortic valve replacement were enrolled in a randomized clinical trial. Patients who had undergone previous heart surgery and with preexisting kidney failure were excluded. The primary end point was postoperative blood loss after 12 hours and at drain removal. Secondary end points included intensive care and total length of stay and intubation time. At 1 hour and 12 hours after surgery, clinical laboratory data were determined. Early clinical outcomes and long-term survival were determined. Results: MiECC patients (n = 63) had a significant lower blood loss (230 mL, 95{\%} confidence interval: 203 to 261 mL) than regular patients (n = 62) after 12 hours (288 mL, 95{\%} confidence interval: 241 to 344 mL, p = 0.04). A preservation of hemoglobin levels 1 hour and 12 hours after surgery in the MiECC group were observed (p < 0.001). No difference was found in early clinical outcomes and long-term survival. Conclusions: This randomized controlled trial compares MiECC and an advanced system for aortic valve replacement with blood loss as primary end point. We conclude that using MiECC is clinically equal for short- and long-term follow-up regarding blood loss. Clinical trial registration: NTR3378.",
author = "Halfwerk, {Frank R.} and Kees Knol and Silvia Mariani and Grandjean, {Jan G.} and Gianclaudio Mecozzi",
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Randomized Trial of Miniaturized versus Standard Extracorporeal Circulation in Aortic Valve Surgery. / Halfwerk, Frank R. (Corresponding Author); Knol, Kees; Mariani, Silvia; Grandjean, Jan G.; Mecozzi, Gianclaudio.

In: Annals of thoracic surgery, Vol. 108, No. 1, 01.07.2019, p. 37-44.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Randomized Trial of Miniaturized versus Standard Extracorporeal Circulation in Aortic Valve Surgery

AU - Halfwerk, Frank R.

AU - Knol, Kees

AU - Mariani, Silvia

AU - Grandjean, Jan G.

AU - Mecozzi, Gianclaudio

PY - 2019/7/1

Y1 - 2019/7/1

N2 - Background: Complications related to extracorporeal circulation remain serious. Although a minimal invasive extra corporeal circulation (MiECC) system was developed to cope with these complications, its effectivity on patient-related outcomes such as blood loss remain uncertain. Therefore, the aim of this study is to compare MiECC to an advanced standard system with respect to blood loss. Methods: A total of 128 adult patients undergoing elective isolated aortic valve replacement were enrolled in a randomized clinical trial. Patients who had undergone previous heart surgery and with preexisting kidney failure were excluded. The primary end point was postoperative blood loss after 12 hours and at drain removal. Secondary end points included intensive care and total length of stay and intubation time. At 1 hour and 12 hours after surgery, clinical laboratory data were determined. Early clinical outcomes and long-term survival were determined. Results: MiECC patients (n = 63) had a significant lower blood loss (230 mL, 95% confidence interval: 203 to 261 mL) than regular patients (n = 62) after 12 hours (288 mL, 95% confidence interval: 241 to 344 mL, p = 0.04). A preservation of hemoglobin levels 1 hour and 12 hours after surgery in the MiECC group were observed (p < 0.001). No difference was found in early clinical outcomes and long-term survival. Conclusions: This randomized controlled trial compares MiECC and an advanced system for aortic valve replacement with blood loss as primary end point. We conclude that using MiECC is clinically equal for short- and long-term follow-up regarding blood loss. Clinical trial registration: NTR3378.

AB - Background: Complications related to extracorporeal circulation remain serious. Although a minimal invasive extra corporeal circulation (MiECC) system was developed to cope with these complications, its effectivity on patient-related outcomes such as blood loss remain uncertain. Therefore, the aim of this study is to compare MiECC to an advanced standard system with respect to blood loss. Methods: A total of 128 adult patients undergoing elective isolated aortic valve replacement were enrolled in a randomized clinical trial. Patients who had undergone previous heart surgery and with preexisting kidney failure were excluded. The primary end point was postoperative blood loss after 12 hours and at drain removal. Secondary end points included intensive care and total length of stay and intubation time. At 1 hour and 12 hours after surgery, clinical laboratory data were determined. Early clinical outcomes and long-term survival were determined. Results: MiECC patients (n = 63) had a significant lower blood loss (230 mL, 95% confidence interval: 203 to 261 mL) than regular patients (n = 62) after 12 hours (288 mL, 95% confidence interval: 241 to 344 mL, p = 0.04). A preservation of hemoglobin levels 1 hour and 12 hours after surgery in the MiECC group were observed (p < 0.001). No difference was found in early clinical outcomes and long-term survival. Conclusions: This randomized controlled trial compares MiECC and an advanced system for aortic valve replacement with blood loss as primary end point. We conclude that using MiECC is clinically equal for short- and long-term follow-up regarding blood loss. Clinical trial registration: NTR3378.

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U2 - 10.1016/j.athoracsur.2019.01.019

DO - 10.1016/j.athoracsur.2019.01.019

M3 - Article

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SP - 37

EP - 44

JO - Annals of thoracic surgery

JF - Annals of thoracic surgery

SN - 0003-4975

IS - 1

ER -