A Novel Approach for Treating Benign Pleural Effusions - First in Human Application of a Diaphragmatic Pleuro-Peritoneal Valve

Sep 29, 2026

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A novel thoracoscopic treatment concept for persistent benign pleural effusion uses a diaphragmatic pleuro-peritoneal valve placed in the central tendon of the diaphragm. Off-label care was delivered to two patients under institutional oversight without general device approval. The early report evaluates safety, feasibility, and efficacy, describing alternatives such as talc pleurodesis and indwelling pleural catheters, and presenting valve insertion via biportal VATS with detailed perioperative outcomes.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages3

Reading Time8 min

AccessFree to download

Introduction

Background

Methods and Patients

Results and Follow-up

European Journal of Cardio-Thoracic Surgery 2026, 68(1), ezaf448 RAPID COMMUNICATIONS [https://doi.org/10.1093/ejcts/ezaf448](https://doi.org/10.1093/ejcts/ezaf448) Advance Access publication 23 December 2025 Cite this article as: Iskender I, Begic M, Prosch H, Aigner C. A Novel Approach for Treating Benign Pleural Effusions—First in Human Application of a Diaphragmatic Pleuro-Peritoneal Valve. Eur J Cardiothorac Surg 2026; doi:10.1093/ejcts/ezaf448. A Novel Approach for Treating Benign Pleural Effusions—First in Human Application of a Diaphragmatic Pleuro-Peritoneal Valve Ilker Iskender 1,2; Merjem Begic 1,2; Helmut Prosch 2,3; Clemens Aigner􀀃 ,1,2 1 Department of Thoracic Surgery, Medical University of Vienna, 1090 Vienna, Austria 2Comprehensive Center for Chest Diseases, Medical University of Vienna, 1090 Vienna, Austria 3 Division of General and Paediatric Radiology, Department of Biomedical Imaging and Image-guided Therapy, 1090 Vienna, Austria 􀀃 Corresponding author: Clemens Aigner, Department of Thoracic Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria (clemens. [aigner@meduniwien.ac.at](aigner@meduniwien.ac.at)) Received: October 28, 2025; Revised: November 27, 2025; Accepted: December 1, 2025 Keywords: chronic pleural effusion; diaphragm; pleuro-peritoneal valve; pleuro-peritoneal shunt. INTRODUCTION Herein, we present a novel treatment concept for persistent benign pleural effusion (BPE) using a pleuro-peritoneal valve inserted thoracoscopically into the central tendon of the diaphragm. Two patients were treated in an off-label individualised treatment attempt. This early report of a first-in-human application demonstrates the potential safety, feasibility, and efficacy of this device and treatment concept in patients with chronic BPE. BACKGROUND In case of BPE refractory to conservative treatment and requiring repeated punctures, symptom-oriented interventions are well established.1 Talc-pleurodesis is frequently used to obliterate the pleural space, however, talc may cause a restriction and is limited to unilateral situations in which the lung is fully expandable. A well-established alternative is the insertion of indwellingpleural-catheters (IPC). These catheters drain the pleural fluid externally and are feasible for bilateral use, including in patients with trapped lungs. Disadvantages are a reduced quality of life, risk for infection and metabolic or electrolyte disorders due to protein and electrolyte loss.2 Several other options, such aspleuro-peritoneal or pleuro-venous shunts, have been investigated using a device with manually operated pumps.3 These systems dependent on patient compliance and are prone to spontaneous closure, which ultimately led to market withdrawal. An internal pleuro-peritoneal drainage would be ideal due to the large peritoneal surface available for fluid resorption. However, because abdominal pressure is physiologically higher than pleural pressure, spontaneous drainage is limited.4 A oneway valve mechanism may overcome this challenge. METHODS AND PATIENTS Two patients with chronic symptomatic BPE were treated with a novel diaphragmatic pleuro-peritoneal valve (Medivio, Germany), as an off-label, individualized treatment-attempt under institutional oversight. No clinical approval for general use of the device exists. Written informed consent from both patients and local ethics-committee approval (2033/2025) was obtained. The first patient was a 33-year-old male with a history of mediastinal germ-cell-tumour resection including SVCreplacement with separate grafts to the brachiocephalic and innominate veins. Postoperatively, he initially developed a rightsided chylothorax followed by delayed thrombosis of the vascular grafts. Conservative management included anticoagulation, diuretics, a low-fat-diet, and repeated thoracentesis. Persistent serous bilateral BPE and exertional dyspnoea developed. Repeated bimonthly thora

FAQs

What is the novel treatment concept described for chronic benign pleural effusion?

A pleuro-peritoneal valve is inserted thoracoscopically into the central tendon of the diaphragm to enable internal drainage and resorption into the peritoneal space.

How were the two treated patients managed in this first-in-human report?

Two patients with chronic symptomatic benign pleural effusion received off-label individualized treatment under institutional oversight after obtaining informed consent and local ethics-committee approval.

Why was talc pleurodesis or an indwelling pleural catheter not selected for the first patient?

Talc pleurodesis was considered unsuitable due to bilateral effusions, and indwelling pleural catheter placement was declined because it limited quality of life and functional performance.

Sep 29, 2026

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