Here we report on the first successful human use of the latest generation of the Reitan catheter pump (10F-RCP, Cardiobridge GmbH, Hechingen, Germany), which received CE mark in 2018. This novel percutaneous expandable pump intends to reduce cardiac afterload and to increase renal arterial perfusion in patients with cardiorenal syndrome.1,2
A 73 year old man was referred to our hospital for decompensated chronic heart failure (CHF) New York Heart Association (NYHA) class IV, after having experienced multiple hospital admissions for the same reason in the past. He had undergone coronary artery bypass grafting more than 20 years ago, repeated coronary intervention, ventricular tachycardia ablation, implantation of a cardiac resynchronization defibrillator, and suffered from cardiorenal syndrome.
Echocardiography revealed a dilated left ventricle (LV) with a reduced ejection fraction of 30% (see Video S1, Supplemental Digital Content 1, https://links.lww.com/ASAIO/A668), moderate aortic stenosis, and severe mitral and tricuspid regurgitation. Mean pulmonary arterial pressure was 37 mm Hg, capillary wedge pressure was 18 mm Hg, and cardiac index was 1.56 L/min/m2. Baseline estimated glomerular filtration rate (eGFR) was 38 ml/min/1.73 m2. The interdisciplinary heart team considered the patient eligible for left ventricular assist device (LVAD) implantation after appropriate cardiopulmonary recompensation and optimization of kidney function. Before the procedure, the patient signed informed consent for implantation of the novel 10F-RCP in the context of a clinical study.3
Implantation was conducted under minimal sedation (Figure 1). Hemodynamics were recorded with a left radial arterial line and a pulmonary artery catheter. A 10F 45 cm sheath was inserted through the right femoral artery, and aortography revealed a landing zone diameter at the proximal descending aorta of 24 mm (minimal study requirement: 21 mm). After adjusting the activated clotting time (ACT) to >300 s with unfractionated heparin and testing and priming of the pump (20% glucose solution with 10 IU/ml of heparin), the 10F-RCP was inserted. The pump head was forwarded to the landing zone (Figure 1), the protective cage was unfolded, and the pump was started (see Video S2, Supplemental Digital Content 1, https://links.lww.com/ASAIO/A669). For monitoring purposes, the patient was transferred to the intensive care unit (ICU), and anticoagulation was maintained at a target ACT of 160–180 s by continuous intravenous infusion of heparin. The patient remained in stable hemodynamic conditions throughout, without catecholamines.
RCP support was associated with an increase of diastolic and mean femoral arterial pressures (Figure 2), and urine output showed a progressive increase over time (Figure 2). Signs of bleeding, hemolysis, or ischemia were not observed. Pump speed was maintained at 11,000 revolutions per minute, and power consumption remained stable (Figure 2). Over time, pulmonary as well as radial arterial blood pressure increased. After 12 hours, purge pressures rised (Figure 2), which persisted despite adjusting pump speed. For safety reasons the pump was removed. Technical analysis by the manufacturer revealed that obstruction by microthrombi with or without microbubbles from degased glucose may have caused the observed purge pressure increase. Accordingly, the manufacturer has implemented measures to optimize purge algorithms for future applications. After pump removal, the femoral sheath was extracted at an ACT of <160 s, and the insertion site was compressed for hemostasis. On the same day, the patient was discharged from the ICU with relieved symptoms in CHF NYHA class III. Later on, the patient developed urinary tract infection, which was treated with antibiotics. Finally, the patient underwent successful LVAD implantation.
Cardiorenal syndrome is an important and independent driver of adverse outcome in patients with decompensated CHF.4–6 Importantly, recompensation by medical therapy is frequently complicated in patients with cardiorenal syndrome, mainly due to diuretic resistance and renal congestion and hypoperfusion. Mechanical circulatory support improves renal function and likely mitigates diuretic resistance in patients with severe cardiorenal syndrome,7,8 and thus represents a potentially powerful intervention for recompensation and preconditioning before cardiac surgery. In this context, the RCP is a novel temporary percutaneous circulatory support system for reducing cardiac afterload and increasing renal preload. The first device generation (14F-RCP) has been successfully tested in animal studies and a human pilot trial.1,9–12 The 10F-RCP is the latest version of the device. Compared with the 14F-RCP, the 10F-RCP has a smaller catheter. This intends to increase eligibility of patients with limited vascular access options, and to increase safety particularly in terms of access site complications and bleeding. In addition, the protective cage has been redesigned and is now fully made of nitinol. Moreover, the 10F-RCP has a modified purge system. Finally, all modifications have been introduced to increase safety, pump performance, and hemocompatibility.
Here, we report on the first-in-man successful use of the 10F-RCP device, which was associated with favorable effects in the context of cardiorenal syndrome. The device could be safely deployed with a fully percutaneous approach in a patient before LVAD implantation. RCP support can directly target hemodynamic drivers of cardiorenal syndrome, and has the advantage of extracardiac intravascular positioning. Further investigation is needed to evaluate safety and efficacy of this promising approach.
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