Insertion, Maintenance, and Removal of the Percutaneous Dual Lumen Cannula Right Ventricular Assist Device

Summary

The present protocol provides a detailed description of a percutaneous dual lumen right ventricular assist device and illustrates step-by-step instructions on the safe implanting, managing, and removing the device. Guidance on its use and troubleshooting complications from one of the most significant single-center experiences is also included.

Abstract

Right ventricular (RV) shock, classically characterized by elevated central venous pressure (CVP) with normal to low pulmonary artery (PA) and pulmonary capillary wedge pressures (PCWP), remains a significant cause of morbidity and mortality worldwide if left untreated. Therapies for the treatment of RV shock range from medical management to durable or percutaneous mechanical circulatory support (MCS). A unique MCS device, a percutaneous right ventricular assist device (pRVAD), approved for use by the Food and Drug Administration (FDA) in 2014, works by temporarily off-loading the RV through a single, dual lumen catheter with extracorporeal mechanical support and is capable of shunting blood from the right atrium (RA) to the main PA. Although initially approved as venous-venous extracorporeal membrane oxygenation (VV-ECMO) device, this work will focus on the use of RV support, as ambulatory VV-ECMO strategies have been described previously. The catheter is most commonly inserted through the right internal jugular (IJ) vein into the PA and connected to an external pump, allowing flow up to 5 L/min. This device may be an attractive choice for the treatment of RV shock due to its percutaneous, minimally invasive insertion and removal and its ability to allow patient ambulation while the device is in place. This protocol discusses in detail the equipment, hemodynamic effects, indications, contraindications, complications, currently available research in the literature, and step-by-step instructions on how to implant, manage, and extract the device, along with the guidance on use and troubleshooting complications from one of the largest, single-center experiences with the device.

Introduction

Cardiogenic shock (CS) from right ventricular (RV) failure remains one of the most challenging cardiac pathologies to manage and portends high mortality and morbidity¹. There are three primary pathologic states which may result in RV failure: loss of myocardial contractility, volume overload, and pressure overload². After a heart transplant, loss of RV contractility can be secondary to myocardial ischemia, infarction, or inflammation caused by myocarditis or primary graft dysfunction³. RV volume overload may be secondary to right-sided valvular insufficiency, shunting, or inadequate....

Protocol

The present protocol is approved by the human research ethics committee of the University of Nebraska Medical Center. The protocol follows the guidelines of the human research ethics committee of the same university.

1. Insertion of the device

NOTE: This procedure needs to be ideally performed in a fluoroscopy suite to ensure accurate placement of the device.

1. Prepare the patient.
   NOTE: Any patient >18 years of age, male or fem.......

Discussion

RV shock portends exceptionally high mortality. It should be recognized early in the disease course and treated aggressively. The Protek Duo is a cutting-edge MCS for the treatment of RV shock that can be placed during any of the SCAI stages of shock. A few critical steps in the placement of the device include: obtaining access using the modified Seldinger technique²¹, sequential dilatation of the access site to appropriate size Fr sheath, floating a balloon-tipped catheter into the main PA, .......

Materials

Name	Company	Catalog Number	Comments
Amplatzer Super Stiff Wire 0.035' x 145 cm	Boston Scientific	M001465631	If not in stock, may use any stiff 0.035" wire.
Avalon Tracheal Dilator	Avalon Laboratories Inc., Rancho Dominguez, CA	12210	This comes in a set. The 30 Fr dilator is the only part used.
Full 29 Protek Duo Kit	LivaNova/ Tandem Life	5820-2916	Cannula, pump, holster, wrap
Full 31 Protek Duo	LivaNova/Tandem Life	5820-3118	Cannula, pump, holster, wrap
Hemochron Signature Elite ACT Testing Device and Supplies	Werfen North America	DCJACT-A and DCJACT-N
Lidocaine	Pharmaceutical	Pfizer
LifeSPARC Centrifugal Pump	LivaNova/ Tandem Life	5840-2417
Micropuncture needle	Cook Medical	G56202	5 Fr
Multi-Lumen Access Catheter	Arrow/Teleflex	AK-21242-CDC	9 Fr
Preparation solution	Pharmaceutical	NA	Chlorohexidine-based or iodine-based
Protek Duo Cannula 29Fr	LivaNova/ Tandem Life	5140-4629	Components: One 29 Fr ProtekDuo Veno-Venous Wire Reinforced Cannula with radiopaque tip markers, One 13 Fr Introducer
Protek Duo Cannula 31Fr	LivaNova/Tandem Life	5140-5131	- 31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer
Protek Duo Insertion Kit	LivaNova/ Tandem Life	5100-0014	Components: balloon tipped PA catheter, one 0.035 stiff guidewire
Protek Duo RD Cannula	LivaNova/Tandem Life	5820-3631	Cannula, introducer
Swan Ganz Catheter	Edwards Lifesciences	774F75 or 777F8
Ultrasound	Standard vascular ultrasound.	GE
Ultrasound probe cover over the ultrasound transducer	Standard probe cover to match vascular ultrasound transducer	GE
Voyager Vest Kit	LivaNova/Tandem Life	Contact LivaNova	Includes vest and wrap. Should not be used on patients with a known allergy to neoprene.