Acute right ventricular failure is a life-threatening condition with poor prognosis. It occurs as a result of right ventricular infarction, postcardiac transplantation, or postimplantation of a left ventricular assist device. Temporary mechanical right ventricular support could be a reasonable treatment option. Therefore, we developed a novel percutaneously implantable device.
The PERKAT device consists of a self-expandable chamber covered with multiple inflow valves carrying foils. A flexible outlet tube with a pigtail tip is attached to the distal end. PERKAT is designed for percutaneous implantation through the femoral vein (18 French sheath). The chamber is expanded in the inferior vena cava while the outlet tube bypasses the right heart and the pigtail tip is lying in the pulmonary trunk. An IABP balloon is inserted into the chamber and connected to an IABP console. Balloon deflation generates blood flow from the vena cava into the chamber through the foil valves. During inflation blood is pumped through the tube into the pulmonary arteries.
The novel percutaneously implantable right ventricular assist device offers emergency support of up to 3 l/min. Based on the successful
Int J Artif Organs 2015; 38(10): 537 - 541
Article Type: ORIGINAL RESEARCH ARTICLE
AuthorsDaniel Kretzschmar, Alexander Lauten, Markus W. Ferrari
- • Accepted on 18/09/2015
- • Available online on 27/10/2015
- • Published in print on 10/11/2015
This article is available as full text PDF.
Right ventricular failure (RVF) is a clinically unsolved problem. Neither inotropic drugs nor the use of intra-aortic balloon counter pulsation (IABP) are capable of reducing the extremely high rate of morbidity and mortality. RVF due to cardiogenic shock after right ventricular (RV) infarction is associated with a 1-month mortality rate of up to 50% (1). RVF occurs as a consequence of left-sided heart failure (2), after heart transplantation (3), during circulatory support with left ventricular assist systems (4), due to pulmonary hypertension (5, 6), after cardiothoracic surgery (7), or as a result of acute pulmonary hypertension, e.g., after pulmonary embolism (8).
Current therapeutic concepts of RVF treatment include inotropic support to improve RV contractility, volume infusion to maintain RV preload, and pulmonary vasodilatation to reduce RV afterload (9). In cases of profound RVF, refractory to medical treatment, surgical options such as heart transplantation, right ventricle exclusion strategies (10, 11), or implantation of RV assist devices may help to diminish the substantial mortality rate. Surgically implantable assist devices possess the risk of infection (12), thromboembolic events (13), hemolysis, and disseminated intravascular coagulation (14).
However, there is currently a lack of rapid, implantable, percutaneous options for mechanical circulatory support in patients with RVF. Recently, emergency devices such as the TandemHeart (Cardiac Assist, Pittsburgh, PA, USA) or the Impella RP (Abiomed Impella, Danvers, MA, USA) have been applied in first cases of acute mechanical support in the setting of RVF (15, 16). Nevertheless these systems have specific limitations.
Thus, we developed a pulsatile device for rapid percutaneous implantation specifically supporting the RV without the disadvantages of the continuous flow systems mentioned above. This novel device was named PERKAT (PERcutaneous KATheterpump).
Description of device and implantation procedure
The PERKAT device consists of a nitinol stent cage that is covered by flexible membranes containing numerous foil valves forming together the foil valve concept (
Longitudinal and cross section schematic drawing of PERKAT with inserted IABP balloon.
Unfolded device with standard IABP Balloon below.
Picture showing close-up view of the foil valves.
Cross-sectional scheme of PERKAT during IABP balloon deflation (left) and inflation (right).
The PERKAT device should be implanted using fluoroscopy guidance. The nitinol stent cage has to be placed in the inferior vena cava, while the flexible outlet tube bypasses the right atrium and ventricle and the pigtail tip is placed in the pulmonary trunk (
Positioning of PERKAT.
In vitro testing
The PERKAT device was placed in the lower reservoir with prespecified water levels simulating the preload of the inferior vena cava (
Experimental setup for
Summary of flow rates are listed in
|Inflation/Deflation rate (bpm)||Flow rate (l/min)|
|22 mmHg 40 mL Balloon||22 mmHg 30 mL Balloon||44 mmHg 40 mL Balloon||44 mmHg 30 mL Balloon|
|Flow rate dependency from inflation/deflation rate, pre-specified afterload, and balloon size.|
For the first time, we report the technical details of PERKAT, a novel catheter-based device for pulsatile mechanical RV support. Our initial,
PERKAT consists of a nitinol stent covered by special foils containing numerous valves. The novel foil valve concept of PERKAT and the interaction with the already established IABP balloon and conventional drive unit allows easy handling and rapid implantation. We do not expect any problems during implementation process in the clinical routine, since the IABP systems are well established in catheterization laboratories worldwide. Furthermore, percutaneous application of the circulatory support device without the need for open-heart surgery provides the opportunity for early intervention in the cascade of refractory right ventricular failure. Only a few other RV assist devices for percutaneous implantation have recently reported their first use in humans, such as the Impella RP (16) and the TANDEM Heart RV system (15). In contrast to these RV assist devices, the PERKAT system can be implanted through an 18-F sheath while the TANDEM Heart system requires two 21-F cannulas (17) and the Impella RP needs a 23-F access (18). The PERKAT system is completely percutaneously implantable using the femoral vein without the need for an additional arterial access. Since it only uses 1 femoral vein for implantation, the other groin can be used for catheterization, hemodynamic monitoring, or additional implantation of a left heart assist device like the Impella CP. The small diameter and use of a standard sheath allows rapid implantation of the PERKAT system. Thus, early reversal of acute RVF may help to prevent possible multiorgan failure due to venous overload. Percutaneous implantation reduces the risk of bleeding complications in comparison to surgically implantable devices (17). Assist devices based on a microaxial approach like the Impella RP may generate significant hemolysis (19). Kapur et al described elevated sodium levels and decreased hemoglobin and platelet counts after implantation of continuous flow devices (20). We plan to further evaluate this issue in animal experiments.
The data obtained in
We have described the development and design of a novel, percutaneously implantable, and rapidly deployable device for temporary right heart support with sufficient
- Kretzschmar, Daniel [PubMed] [Google Scholar] 1, * Corresponding Author (email@example.com)
- Lauten, Alexander [PubMed] [Google Scholar] 2
- Ferrari, Markus W. [PubMed] [Google Scholar] 3
Department of Internal Medicine I, Jena University Hospital, Friedrich-Schiller-University, Jena - Germany
Department of Cardiology, Charité – University Medicine Berlin, Berlin - Germany
HSK, Clinic of Internal Medicine I, Helios-Kliniken, Wiesbaden - Germany