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

    2 Citations (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

    Fingerprint

    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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    language = "English",
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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.

    UR - http://www.scopus.com/inward/record.url?scp=85066409197&partnerID=8YFLogxK

    U2 - 10.1016/j.athoracsur.2019.01.019

    DO - 10.1016/j.athoracsur.2019.01.019

    M3 - Article

    VL - 108

    SP - 37

    EP - 44

    JO - Annals of thoracic surgery

    JF - Annals of thoracic surgery

    SN - 0003-4975

    IS - 1

    ER -