Twelfth Interagency Registry for Mechanically Assisted Circulatory Support Report: Readmissions After Left Ventricular Assist Device

Abstract

The twelfth annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 26 688 continuous-flow left ventricular assist device (LVAD) patients over the past decade (2011-2020). In 2020, we observed the largest drop in yearly LVAD implant volumes since the registry's inception, which reflects the effects of the COVID-19 pandemic on cardiac surgical volumes in the United States. The 2018 heart transplant allocation policy change in the United States continues to affect LVAD implantation volumes and device strategy, with 78.1% of patients now receiving LVAD implants as destination therapy. Despite an older and sicker patient cohort, survival in the recent era (2016-2020) at 1 and 2 years continues to improve at 82.8% and 74.1%. Patient adverse event profile has also improved in the recent era, with significant reductions in stroke, gastrointestinal bleeding, infection, and device malfunction/pump thrombosis. Finally, we review the burden of readmissions after LVAD implant and highlight an opportunity to improve patient outcomes by reducing this frequent and vexing problem.

Figure 1:

Consort Diagram with All Mechanical Circulatory Support Devices and Left Ventricular Assist Device Implants based on Flow-Type Over Time. A) Diagram depicts all durable mechanical circulatory support (MCS) devices entered into the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (STS Intermacs), January 1, 2011 to December 31, 2020. B) Annual yearly continuous-flow left ventricular assist device (CF-LVAD) implants by flow configuration.

Figure 1:

Consort Diagram with All Mechanical Circulatory Support Devices and Left Ventricular Assist Device Implants based on Flow-Type Over Time. A) Diagram depicts all durable mechanical circulatory support (MCS) devices entered into the Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (STS Intermacs), January 1, 2011 to December 31, 2020. B) Annual yearly continuous-flow left ventricular assist device (CF-LVAD) implants by flow configuration.

Figure 2:

Patient Profile and Device Strategy by Implant Year. A) Distribution of Intermacs Profiles by year of continuous-flow left ventricular assist device implantation. Profiles 5–7 account for <2% of implants and are excluded from the figure. B) The device strategy at time of continuous-flow left ventricular assist device implantation by year

Figure 2:

Patient Profile and Device Strategy by Implant Year. A) Distribution of Intermacs Profiles by year of continuous-flow left ventricular assist device implantation. Profiles 5–7 account for <2% of implants and are excluded from the figure. B) The device strategy at time of continuous-flow left ventricular assist device implantation by year

Figure 3:

Kaplan-Meier Survival Analysis for All Patients and by LVAD Era. A) Kaplan-Meier estimated survival after continuous-flow left ventricular assist device implantation for the past decade. Hazard rates are depicted by dashed red line. B) The estimated survival is compared between the previous era (2011–2015) and the current era (2016–2020). Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 3:

Kaplan-Meier Survival Analysis for All Patients and by LVAD Era. A) Kaplan-Meier estimated survival after continuous-flow left ventricular assist device implantation for the past decade. Hazard rates are depicted by dashed red line. B) The estimated survival is compared between the previous era (2011–2015) and the current era (2016–2020). Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 4:

Survival by Intermacs Profile and Device Implant Strategy. A) Kaplan-Meier estimated survival after continuous-flow left ventricular assist device implantation by Intermacs Profile and B) Device intent or strategy at time of implant. BTC, bridge to candidacy; BTT, bridge to transplant; DT, destination therapy. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support)

Figure 4:

Survival by Intermacs Profile and Device Implant Strategy. A) Kaplan-Meier estimated survival after continuous-flow left ventricular assist device implantation by Intermacs Profile and B) Device intent or strategy at time of implant. BTC, bridge to candidacy; BTT, bridge to transplant; DT, destination therapy. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support)

Figure 5:

Freedom from GI Bleeding, Device Malfunction, Stroke, and MCS Infection by Era. Freedom from adverse events as compared across eras (2011–2015 vs. 2016–2020): (A) GI bleeding, (B) Device Malfunction / Pump Thrombosis, (C) Stroke, (D) MCS Infection. GI, gastrointestinal; MCS, mechanical circulatory support. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 5:

Freedom from GI Bleeding, Device Malfunction, Stroke, and MCS Infection by Era. Freedom from adverse events as compared across eras (2011–2015 vs. 2016–2020): (A) GI bleeding, (B) Device Malfunction / Pump Thrombosis, (C) Stroke, (D) MCS Infection. GI, gastrointestinal; MCS, mechanical circulatory support. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 5:

Freedom from GI Bleeding, Device Malfunction, Stroke, and MCS Infection by Era. Freedom from adverse events as compared across eras (2011–2015 vs. 2016–2020): (A) GI bleeding, (B) Device Malfunction / Pump Thrombosis, (C) Stroke, (D) MCS Infection. GI, gastrointestinal; MCS, mechanical circulatory support. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 5:

Freedom from GI Bleeding, Device Malfunction, Stroke, and MCS Infection by Era. Freedom from adverse events as compared across eras (2011–2015 vs. 2016–2020): (A) GI bleeding, (B) Device Malfunction / Pump Thrombosis, (C) Stroke, (D) MCS Infection. GI, gastrointestinal; MCS, mechanical circulatory support. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 6:

Reasons for Readmission after LVAD and Patient Survival after Readmissions Occurring in the first 6-months. A) The major reasons for readmission after continuous-flow left ventricular assist device implantation. B) All continuous-flow left ventricular assist device patients who survived to 6-months (n=21,013) are stratified by the number of hospital readmissions occurring during the first 6-months after implant. Kaplan-Meier estimated survival is then provided based on number of readmissions during the initial 6-month period. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).

Figure 6:

Reasons for Readmission after LVAD and Patient Survival after Readmissions Occurring in the first 6-months. A) The major reasons for readmission after continuous-flow left ventricular assist device implantation. B) All continuous-flow left ventricular assist device patients who survived to 6-months (n=21,013) are stratified by the number of hospital readmissions occurring during the first 6-months after implant. Kaplan-Meier estimated survival is then provided based on number of readmissions during the initial 6-month period. Shaded areas indicate 70% confidence limits, p (log-rank) = <0.0001, Event: Death (censored at transplant or cessation of support).