Propensity Score-Matched Comparison of Right Ventricular Strain in Women and Men Before and After Left Ventricular Assist Device Implantation.

Objective: Adverse events following left ventricular assist device (LVAD) implantation are more common in women than in men, but the impact of gender differences on right ventricular (RV) failure is not well defined. Therefore, we calculated RV strain before and after LVAD implantation in matched groups of men and women to determine if gender differences in RV failure after LVAD might account for the gender differences in overall outcomes. Methods: RV free wall longitudinal strain (FWS) and fractional area change were calculated preoperatively and 3 months postoperatively using speckle-tracking echocardiography analysis. A total of 172 patients (86 women, 86 men) were then propensity score matched (1:1) for comparison. Results: Although women had higher preoperative CHA2DS2-VASc scores and more frequent moderate mitral regurgitation than men (P = 0.018), the preoperative hemodynamic parameters were similar. Preoperative RV-FWS was -6.7% in women and -6.0% in men (P = 0.65). Postoperatively, women had more progression to severe tricuspid regurgitation (TR) than men (15% vs 7%, P = 0.06). At 3 months the RV-FWS was -7.7% in women and -7.0% in men (P = 0.59). Postoperative TR was moderate-severe in 20% of women and in 9% of men (P = 0.001). Women had a higher incidence of venous thromboembolism, cardiac arrhythmias, and bleeding compared with men. Women also had higher mortality rates at discharge and 30 days after surgery, but the survival rates at 5 years were similar. Conclusions: RV strain measurements track standard hemodynamic and echocardiographic parameters and confirm that gender differences in outcomes following LVAD implantation are not related to gender differences in RV failure rates.

HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations.

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1-8).

HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations.

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices.

HVAD to HeartMate 3 Left Ventricular Assist Device Exchange: Best Practices Recommendations.

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices.