Permanent Implantable Cardiac Support Systems

Abstract

he prevalence of advanced heart failure will continue to increase due to demographic trends and better survival rates for persons with cardiac disease. In Germany, the number of hospital admissions for advanced heart failure continues to steadily increase, especially among people over 65 years of age. Nonetheless, there is a marked reduction in the rate of death due to advanced heart failure, from 63.7 per 100 000 inhabitants in 2006, to 42.8 in 2016. This is especially due to the improved treatment options (1, 2), for which permanent mechanical circulatory support also plays a role. Taking into account current guidelines, registries, and clinical studies, the following provides an overview of the current reality of care of permanent-use implantable mechanical circulatory support systems. Permanent implantable systems of mechanical circulatory support The development of mechanical circulatory support (MCS), from the first fully implantable artificial heart system up to advanced ventricular assist devices (VAD), addresses aspects such as pump size, biocompatibility, durability, effectiveness, and susceptibility to infection (3). Modern VADs generate continuous flow (CF) of blood, and patients who received an implant benefit from improved functional status and higher quality of life. One-year survival after left-ventricle assist device (LVAD) implantation improved to over 80% (68% to 81%), which is better compared to the early pulsatile systems (4, 5). Mortality with the current system is primarily due to treatment-related adverse events. Currently, centrifugal CF pumps for left ventricular support are the primary ones implanted. The first system of this type was the HeartWare ventricular assist device (HVAD). The more recent HeartMate 3 has a fully magnetically levitated vane rotor (6, 7). Biventricular MCS The paracorporeal EXCOR from Berlin Heart GmbH is the clinically most widely used and approved system for biventricular support. This extracorporeal displacement pump is approved for both left-, right-, and biventricular support. It is the only system available for pediatric use (8, 9). Clinically, two CF-LVAD systems have been implanted for biventricular support (10); however, these Summary Background: Nearly 1000 permanent ventricular assist devices (VADs) are implanted in patients with severe congestive heart failure in Germany each year. VADs are miniaturized centrifugal pumps that generate continuous blood flow; they are powered and controlled through a cable that passes through the skin. Paracorporeal systems are only rarely implanted, usually in children. Methods: In this selective review of the literature, including guidelines and registry data, we discuss the indications, therapeutic effects, and complications of permanently implantable cardiac support systems. Results: The optimal time for VAD implantation cannot be precisely defined. A comparative assessment of the various available systems is not possible, as no randomized trials have been performed on this topic. Registry data indicate that 69% to ...

Identification of characteristics, risk factors, and predictors of recurrent LVAD thrombosis: conditions in HeartWare devices

“…Long-term mechanical circulatory support with left-ventricular assist devices (LVAD) has increasingly become an established treatment option in advanced heart failure with improving outcomes during the past 2 decades [1,2]. In clinical routine, indication for LVAD implantation is provided by progressive heart failure (HF) often but not exclusively with severely impaired left-ventricular function in the context of exhausted medical therapy [1,2]. However, LVAD thrombus formation either in the inflow cannula, in the device body, or the outflow graft is one of the major complications that can lead to life-threatening low-flow or pump stop, implicating hemodynamic instability, hemolysis, renal or hepatic failure, or cerebral or peripheral thromboembolism [1][2][3].…”

Durable Continuous-Flow Mechanical Circulatory Support: State of the Art

“…This finding prompted the MCS scientific community to focus on the adoption of CF-VADs in the second half of the 1980s [8,9]. The advantages of CF-VADs over pulsatile and paracorporeal devices is that they are silent, miniaturized, and reduce trauma during surgery, allowing patients to gain a relatively unrestricted life [6][7][8][9][10][11][12]. The first human insertion of an implantable CF-VAD, the Mi-croMed DeBakey I, was performed in Berlin on November 11, 1998 in a patient with endstage heart failure (HF), who was supported for 47 days until his exitus [8,9].…”

“…Advanced medical therapy, last-generation pacemakers, and defibrillators have changed the clinical evolution of HF [9,11,12,[22][23][24]. However, 0.5-5% of patients are refractory to any optimized medical therapy and develop advanced HF.…”

“…Analyses from the United States of America (USA) suggest that 250,000-300,000 patients under the age of 75 years suffer from advanced systolic HF (defined as New York Heart Association (NYHA class IIIb-IV)) [1,3,22,23]. In Europe, 500,000 patients are likely to be suffering from HF [6,[9][10][11][12]24]. The prognosis for advanced HF is poor; the 1-year mortality rate is >25% for class III-IV outpatients and exceeds 50% for class IV patients.…”

Assist-Devices bei terminaler Herzinsuffizienz

“…Dies ist besonders hervorzuheben, da aktuelle Untersuchungen darauf hindeuten, dass derzeit zwischen einem Drittel und 50 % aller Patienten mit terminaler Herzinsuffizienz an einer ischämiebedingten Herzinsuffizienz leiden [3]. Dadurch nimmt seit Jahren die Zahl der Krankenhausaufnahmen aufgrund von Herzinsuffizienz in Deutschland zu [4]. Dies betrifft besonders Patienten im letzten Lebensviertel.…”