Expert Consensus on Clinical Application of Implantable Biventricular Assist Devices

Abstract

While biventricular assist devices (BiVADs) remain underutilized in Western countries for biventricular heart failure (BHF), their application is expanding in China. This consensus synthesizes international guidelines, medical evidence, and Chinese clinical expertise to establish standardized protocols for BiVAD management. Key recommendations include: (1) Preoperative right heart catheterization and echocardiography for central venous pressure (CVP): pulmonary capillary wedge pressure (PCWP) ratio and pulmonary artery pulsatility index (PAPi) assessment (Class I); (2) BiVAD indication in refractory BHF or high-risk right heart failure post-left ventricular assist device (LVAD) implantation (Class IIa); (3) Right atrial implantation as the preferred surgical approach (Class IIa); (4) Warfarin-based anticoagulation (INR 2.0–2.5) with aspirin, avoiding direct oral anticoagulants (DOACs) (Class III). The guidance addresses critical gaps in patient selection, pump speed titration, and complication management, positioning integrated BiVAD systems as a promising solution for complex BHF.

Keywords

Biventricular assist device / Mechanical circulatory support / Heart failure management / End-stage heart failure / Double heart failure

References

[1] Working Group on Heart Failure of National Center for Cardiovascular Quality Improvement. 2020 Clinical performance and quality measures for heart failure in China. Chin Circ J (Chinese). 2021;36(3):221–238.

[2] KhanMS, ShahidI, BennisA, et al.. Global epidemiology of heart failure. Nat Rev Cardiol., 2024, 21(10): 717-734.

[3] KapeliosCJ, LundLH, Wever-PinzonO, et al.. Right heart failure following left ventricular device implantation: natural history, risk factors, and outcomes: an analysis of the STS INTERMACS database. Circ Heart Fail., 2022, 156e008706.

[4] KurodaT, MiyagiC, FukamachiK, et al.. Biventricular assist devices and total artificial heart: Strategies and outcomes. Front Cardiovasc Med., 2023, 9. 972132

[5] RajapreyarI, SollimanO, BrailovskyY, et al.. Late right heart failure after left ventricular assist device implantation: contemporary insights and future perspectives. JACC Heart Failure., 2023, 11(8 Pt 1): 865-878.

[6] SolimanOII, AkinS, MuslemR, et al.. Derivation and validation of a novel right-sided heart failure model after implantation of continuous flow left ventricular assist devices: the EUROMACS (European Registry for Patients with Mechanical Circulatory Support) right-sided heart failure risk score. Circulation., 2018, 137(9): 891-906.

[7] ChungBB, GrinsteinJS, ImamuraT, et al.. Biventricular Pacing Versus Right Ventricular Pacing in Patients Supported With LVAD. JACC Clin Electrophysiol., 2021, 7(8): 1003-1009.

[8] AhmedMM, JacobsJP, MeeceLE, et al.. Timing and outcomes of concurrent and sequential biventricular assist device implantation: a Society of Thoracic Surgeons Intermacs analysis. Ann Thorac Surg., 2023, 116(2): 383-390.

[9] VarshneyAS, DeFilippisEM, CowgerJA, et al.. Trends and Outcomes of Left Ventricular Assist Device Therapy: JACC Focus Seminar. J Am Coll Cardiol., 2022, 79(11): 1092-1107.

[10] HahnRT, LerakisS, DelgadoV, et al.. Multimodality Imaging of Right Heart Function: JACC Scientific Statement. J Am Coll Cardiol., 2023, 81(19): 1954-1973.

[11] DavidsonLJ, TangGHL, HoEC, et al.. The Tricuspid Valve: A Review of Pathology, Imaging, and Current Treatment Options: A Scientific Statement From the American Heart Association. Circulation., 2024, 149(22): e1223-e1238.

[12] UtsunomiyaH, IzumiK, TsuchiyaA, et al.. Role of anatomical regurgitant orifice area and right ventricular contractile reserve in severe tricuspid regurgitation. Eur Heart J Cardiovasc Imaging., 2022, 23(7): 989-1000.

[13] AliHR, KiernanMS, ChoudharyG, et al.. Right ventricular failure post-implantation of left ventricular assist device: prevalence, pathophysiology, and predictors. ASAIO J., 2020, 66(6): 610-619.

[14] TurnerKR. Right ventricular failure after left ventricular assist device placement-the beginning of the end or just another challenge?. J Cardiothorac Vasc Anesth., 2019, 33(4): 1105-1121.

[15] LaRueSJ, RaymerDS, PierceBR, et al.. Clinical outcomes associated with INTERMACS-defined right heart failure after left ventricular assist device implantation. J Heart Lung Transplant., 2017, 36(4): 475-477.

[16] GrantCJr, RichardJB, FrakesM, et al.. ECMO and right ventricular failure: review of the literature. J Intensive Care Med., 2021, 36(3): 352-360.

[17] PaganiFD, SingletaryB, CantorR, et al.. The Society of Thoracic Surgeons National Intermacs Database Risk Model for durable left ventricular assist device implantation. Ann Thorac Surg, 2025, 119(4): 907-916.

[18] BriasoulisA, AdegbalaO, AkintoyeE, et al.. Temporal trends and outcomes of patients waiting on left ventricular assist devices and inotropes for heart transplantation. Clin Transplant., 2020, 346. e13857

[19] SaeedD, FeldmanD, BanayosyAE, et al.. The 2023 international society for heart and lung transplantation guidelines for mechanical circulatory support: a 10- year update. J Heart Lung Transplant., 2022, 42(7): e1-e222.

[20] VanderPluymCJ, CedarsA, EghtesadyP, et al.. Outcomes following implantation of mechanical circulatory support in adults with congenital heart disease: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). J Heart Lung Transplant., 2017, 37(1): 89-99.

[21] Kormos RobertL, Antonide ChristiaanF, Goldstein DanielJ, et al.. Updated definitions of adverse events for trials and registries of mechanical circulatory support: a consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant., 2020, 39(8): 735-750.

[22] AdamopoulosS, BoniosM, Ben GalT, et al.. Right heart failure with left ventricular assist devices: preoperative, perioperative and postoperative management strategies. A clinical consensus statement of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail., 2024, 26(11): 2304-2322.

[23] LaveeJ, MulzerJ, KrabatschT, et al.. An international multicenter experience of biventricular support with HeartMate 3 ventricular assist systems. J Heart Lung Transplant., 2018, 37(12): 1399-1402.

[24] ShehabS, MacdonaldPS, KeoghAM, et al.. Long- term biventricular HeartWare ventricular assist device support-case series of right atrial and right ventricular implantation outcomes. J Heart Lung Transplant., 2016, 35(4): 466-473.

[25] Pujol-LopezM, Jiménez-ArjonaR, GarreP, et al.. Conduction System Pacing vs Biventricular Pacing in Heart Failure and Wide QRS Patients: LEVEL-AT Trial. JACC Clin Electrophysiol., 2022, 8(11): 1431-1445.

[26] MaynesEJ, O'MalleyTJ, PatelP, et al.. Right atrial versus right ventricular HeartWare HVAD position in patients on biventricular HeartWare HVAD support: a systematic review. Artif Organs., 2020, 44(9): 926-934.

[27] SharafOM, BilgiliA, AhmedMM, et al.. Durable biventricular assist device support for 1212 days as a bridge to heart transplantation. J Surg Case Rep., 2023, 20237rjad372.

[28] ArabíaFA, MilanoCA, MahrC, et al.. Biventricular support with intracorporeal, continuous flow, centrifugal ventricular assist devices. Ann Thorac Surg., 2018, 105(2): 548-555.

[29] PotapovE, StarckC, FalkV, et al.. Mechanical circulatory support: technical tips for the implantation of a right ventricular assist device. JTCVS Open., 2021, 8: 37-40.

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