Novel percutaneous dual-lumen cannula-based right ventricular assist device provides effective support for refractory right ventricular failure after left ventricular assist device implantation

Abstract

OBJECTIVES Right heart failure after left ventricular assist device (LVAD) implantation is associated with significant morbidity and mortality. A new generation of percutaneous right ventricular assist devices (RVADs) may mitigate the need for invasive surgical RVAD implantation. The purpose of this study was to evaluate the safety and efficacy of the Protek Duo (TandemLife, Pittsburgh, PA, USA) RVAD in patients who developed severe acute right heart failure in the intensive care unit after LVAD implantation. METHODS This was a retrospective cohort study of 27 patients who received a Protek Duo after LVAD implantation from January 2016 to March 2019 at our centre. The primary outcome of interest was survival to hospital discharge. Secondary outcomes included procedural success, device-related complications and conversion to a surgical RVAD. RESULTS The median age of patients was 63 years (interquartile range 58–71), 78% were men and 78% were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2. Patients were on a median of 2 inotropes and 2 pressors prior to Protek Duo insertion. The device successfully implanted on the first attempt in all patients a median of 1 day (interquartile range 1–2) after LVAD implantation and the median duration of support was 11 days (interquartile range 7–16). Device weaning occurred in 86% of patients, with 15% in-hospital mortality. Major complications related to the device included new moderate-to-severe tricuspid regurgitation (36%), haemolysis (14%) and cannula migration (7%). Three patients (11%) required conversion to surgical RVAD. Overall survival to 1 year was 81%. CONCLUSIONS The use of the Protek Duo as a percutaneous RVAD is a safe and feasible treatment for patients who develop acute right heart failure after LVAD implantation.

Right heart failure considerations in pediatric ventricular assist devices

“…In carefully selected candidates, the Syncardia TM total artificial heart (TAH) is a sound option for biventricular failure. 25 The recent FDA approval of the 50 cc TAH provides an additional support option in pediatrics. 26 In summary, RHF after LVAD implantation remains a significant complication that limits the long-term mechanical circulatory support outcomes for end-stage heart failure in children.…”

“…The most commonly used devices for RV support include paracorporeal CF devices such as Centrimag, Pedimag and Rotaflow. Percutaneous devices such as the Impella RP and Protek Duo, 25 may also be good options for bigger patients, though these have size limitations limiting their use in smaller and younger children. Dependent on patient size; potential durable, longer‐term options include intrapericardial devices including Heartware TM HVAD TM and Heartmate 3 TM , and paracorporeal devices such as the Berlin Heart EXCOR ® , may be considered.…”

“…Dependent on patient size; potential durable, longer‐term options include intrapericardial devices including Heartware TM HVAD TM and Heartmate 3 TM , and paracorporeal devices such as the Berlin Heart EXCOR ® , may be considered. In carefully selected candidates, the Syncardia TM total artificial heart (TAH) is a sound option for biventricular failure 25 . The recent FDA approval of the 50 cc TAH provides an additional support option in pediatrics 26 …”

Commentary: Under pressure: Managing superior vena cava syndrome after right ventricular assist device cannulation

“…There is little published experience with the Protek Duo, and only 2 retrospective case series describe patients cannulated with the Protek Duo for right ventricular support, evaluating a total of 44 patients. 2 , 3 Although tricuspid regurgitation (36%), anticoagulation-related hemorrhage (29%), hemolysis (17%), and device migration (7%) are relatively common, SVC syndrome has not been described previously. However, this new report of the complication of SVC syndrome reveals little about the physiological mechanism for venous congestion.…”

Percutaneous right ventricular assist device, rapid employment in right ventricular failure during septic shock

“…Right Heart Failure with invasive ventricular device is associated with significant morbidity and mortality. A new generation of percutaneous right ventricular assist devices (RVADs) may mitigate the need for invasive surgical RVAD implantation [2]. The Protek Duo (TPD) temporary RVAD, capable of providing up to 4.5 L/min [3], is a dual-lumen cannula inserted via the right internal jugular vein, with its proximal inflow lumen positioned in the right atrium and distal lumen positioned in the main pulmonary artery [4].…”