TY - JOUR
T1 - Outcomes in Smaller Body Size Adults After HeartMate 3 Left Ventricular Assist Device Implantation
AU - Molina, Ezequiel J.
AU - Cowger, Jennifer
AU - Lee, Sangjin
AU - Horstmanshof, Douglas
AU - Cleveland, Joseph C.
AU - Goldstein, Daniel J.
AU - Mehra, Mandeep R.
AU - Uriel, Nir
AU - Salerno, Christopher T.
AU - Bourque, Kevin
AU - Chuang, Joyce
AU - Naka, Yoshifumi
N1 - Funding Information:
Ezequiel Molina has no conflicts to disclose. Jennifer Cowger: consultant/speaker for Abbott and Medtronic; on steering committee/study panels for Medtronic, Abbott, and Procyrion. Henry Ford: institutional funds from Abbott, Medtronic, and Procyrion. Sangjin Lee: consulting payments made to his institution from Medtronic. Douglas Horstmanshof: consultant and speaker’s bureau fees from Abbott. Joseph Cleveland: grant support from Abbott . Daniel Goldstein: educator and surgical proctor for Abbott. Mandeep Mehra: payments made to his institution from Abbott for consulting; consulting fees from Portola, Bayer, Triple Gene, and Baim Institute for Clinical Research; advisory board member for Medtronic, Janssen, NuPulseCV, Leviticus, FineHeart, and Mesoblast. Nir Uriel: grant support and consultant fees from Abbott and Medtronic. Christopher Salerno: consultant fees from Abbott and Medtronic. Kevin Bourque and Joyce Chuang: Abbott employees. Yoshifumi Naka: consultant fees from Abbott.
Funding Information:
The authors wish to acknowledge Gerald Heatley as a statistical contributor for this work. The authors have no funding sources to disclose. Ezequiel Molina has no conflicts to disclose. Jennifer Cowger: consultant/speaker for Abbott and Medtronic; on steering committee/study panels for Medtronic, Abbott, and Procyrion. Henry Ford: institutional funds from Abbott, Medtronic, and Procyrion. Sangjin Lee: consulting payments made to his institution from Medtronic. Douglas Horstmanshof: consultant and speaker's bureau fees from Abbott. Joseph Cleveland: grant support from Abbott. Daniel Goldstein: educator and surgical proctor for Abbott. Mandeep Mehra: payments made to his institution from Abbott for consulting; consulting fees from Portola, Bayer, Triple Gene, and Baim Institute for Clinical Research; advisory board member for Medtronic, Janssen, NuPulseCV, Leviticus, FineHeart, and Mesoblast. Nir Uriel: grant support and consultant fees from Abbott and Medtronic. Christopher Salerno: consultant fees from Abbott and Medtronic. Kevin Bourque and Joyce Chuang: Abbott employees. Yoshifumi Naka: consultant fees from Abbott.
Publisher Copyright:
© 2022 The Society of Thoracic Surgeons
PY - 2022/12
Y1 - 2022/12
N2 - Background: Outcomes in patients with smaller body size after HeartMate 3 left ventricular assist device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs larger body surface area (BSA) patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. Methods: The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA ≤1.70 m2 (small patients, n = 82) and BSA >1.70 m2 (large patients, n = 933). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or to remove a malfunctioning device. Adverse events were compared between groups. Results: Smaller patients were more frequently women (56.1% vs 17.7%; P <. 001) and had lower prevalence of diabetes (28.1% vs 43.9%; P =. 005) and hypertension (51.2% vs 71.9%; P <. 001), larger median indexed LVEDD (normalized by BSA, 40 vs 33 mm/m2; P <. 001), and lower median serum creatinine concentration (1.1 vs 1.3 mg/dL; P <. 001). The proportion of patients achieving the composite end point at 2 years was 77% in both groups (adjusted hazard ratio, 1.14; 95% CI, 0.68-1.91; P =. 62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs 14.9%; P =. 029) and cardiac arrhythmias (24.4% vs 35.3%; P =. 005), which were higher in the larger patients. Conclusions: Outcomes after HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable candidates for durable mechanical circulatory support.
AB - Background: Outcomes in patients with smaller body size after HeartMate 3 left ventricular assist device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs larger body surface area (BSA) patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. Methods: The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA ≤1.70 m2 (small patients, n = 82) and BSA >1.70 m2 (large patients, n = 933). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or to remove a malfunctioning device. Adverse events were compared between groups. Results: Smaller patients were more frequently women (56.1% vs 17.7%; P <. 001) and had lower prevalence of diabetes (28.1% vs 43.9%; P =. 005) and hypertension (51.2% vs 71.9%; P <. 001), larger median indexed LVEDD (normalized by BSA, 40 vs 33 mm/m2; P <. 001), and lower median serum creatinine concentration (1.1 vs 1.3 mg/dL; P <. 001). The proportion of patients achieving the composite end point at 2 years was 77% in both groups (adjusted hazard ratio, 1.14; 95% CI, 0.68-1.91; P =. 62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs 14.9%; P =. 029) and cardiac arrhythmias (24.4% vs 35.3%; P =. 005), which were higher in the larger patients. Conclusions: Outcomes after HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable candidates for durable mechanical circulatory support.
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U2 - 10.1016/j.athoracsur.2022.03.071
DO - 10.1016/j.athoracsur.2022.03.071
M3 - Article
C2 - 35452663
AN - SCOPUS:85129992700
SN - 0003-4975
VL - 114
SP - 2262
EP - 2269
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 6
ER -
