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Occlutech Atrial Flow Regulator to Treat Right Ventricular Failure in Severe Pulmonary Hypertension

Updated: May 7

Special Cases and Considerations, and the PROPHET-Trial

Ingram Schulze-Neick, MD; Anja Lehner, MD; André Jakob, MD; Lina Armbrust, MD; Robert Dalla Pozza, MD; Nikolaus A. Haas, MD

Abstract

The Balloon Atrial Septostomy (BAS) procedure is performed to relieve severe symptoms of right heart failure caused by end-stage pulmonary hypertension or other causes. We present a novel device, the Occlutech Atrial Flow Regulator (AFR), a purpose designed interventional device to stabilize the result of the BAS, controlling the shunt flow, and keeping the created atrial defect patent.



FIGURE 2 Details of the AFR device. 2a). The frontal view from the left atrial side shows the circular shape with the central fenestration of the device. 2b). The oblique view from the right-atrial side shows the connection hub to the delivery cable which is identical to the delivery set of the Occlutech Flex II® device family. Compare this view with Figure 8, see further below. 2c). The lateral view delineates the flat profile of the device, here a device with 2 mm thickness. 2d). After implantation into a standard atrial septum the fluoroscopy sows the flat profile of a device with a 5 mm thickness (marked “X1”) between the disks and 6 mm fenestration width.



Here we show, as an example, the results in three patients who have been treated with the BAS/AFR combination intervention on a compassionate basis. All AFR devices remained in situ and patent over the observation times of > 1 year. On one occasion, complete endothelialisation of the AFR device was confirmed when the patient received a heart transplantation.


These results are encouraging and might support the notion to offer the BAS, supported with the AFR device, more often and perhaps at an earlier time point within the algorithm for treatment of pulmonary hypertension.


Introduction

Pulmonary hypertension remains a devastating disease despite the advent of multiple new medications in inhaled, oral, and intravenous form. Clinically, most patients eventually suffer chronically from the sequelae of decompensated right heart failure, which also is the leading final cause of death.[1] In some patients, however, who have very reactive Pulmonary Vascular Disease, acute pulmonary hypertensive crisis following certain triggers such as aspiration, lung infection, or serious exercise, may lead to acute right heart failure and present as syncope with possible premature death, despite apparent otherwise, and at rest, good right heart function.[2] The pathophysiology of both forms - acute and chronic decompensated - include venous congestion and a lack of systemic forward flow due to impaired forward flow through the pulmonary capillaries.[3] Echocardiographically, this causes enlargement of the right ventricle, eventually also with the right atrial enlargement and with a bulging of the right atrial septum into the left atrium, while on the left, postcapillary side, an underfilled, and almost collapsed, left atrium and similarly underfilled and, therefore, banana-shaped left ventricle[4] cannot be missed.


To read the full article, please go to the December 2019 Issue of CCT.