Johann Bauersachs

Aims: Mechanical Circulatory Support (MCS) remains limited in advanced heart failure due to blood-contact complications and the absence of biventricular support. We report the first prospective clinical trial of a novel soft-robotic, biventricular, pulsatile technology placed externally around the heart without blood contact, designed to deliver individualized cardiac assistance (reBEAT®, AdjuCor GmbH, Munich, Germany). Methods and Results: The system was temporarily applied in 10 end-stage heart failure patients immediately before elective LVAD implantation. Devices were custom-manufactured using preoperative CT scans to match individual cardiac anatomy. Safety, feasibility, and effects on haemodynamics were evaluated. Implantation was rapid (3±2 min), demonstrating procedural feasibility. We observed two procedure-related adverse events while no device- or procedure-related severe adverse events occurred. Absence of new ECG abnormalities, and no tissue injury confirmed safety. An iterative assessment on haemodynamics provided key insights into individualized cardio-circulatory support. While device presence reduced preload dependent haemodynamics in some patients, low average support pressures of 65–66 mmHg produced variable improvements towards baseline, predominantly on the pressure signal: mean arterial pressure (MAP; 67.5 ± 10.6 vs. 76.2 ± 11.7 mmHg, p<0.01), stroke work (SW; 347.8 ± 118.2 vs. 434.1 ± 131.0 mJ, p<0.01), and cardiac power output (CPO; 407.9 ± 108.2 vs. 503.7 ± 116.2 mW, p<0.01). Additionally, effects were observed on atrioventricular valve function and interventricular balance, which were not significant. Conclusion: This soft-robotic biventricular MCS platform provides short term evidence of a safe and feasible approach to pulsatile biventricular support without blood contact. Significant increases in MAP, CPO, and SW towards baseline indicate functional effects. Continuous device-driven workflow improvement is mandatory and further data are required to refine individualized optimization strategies. This technology may offer a novel biventricular assist modality. Its reduced complexity may enable broader adaption for both temporary and durable support. Avoiding blood contact and enabling balanced biventricular assistance will be central drivers of its continued clinical development.

Temporary mechanical circulatory support devices are increasingly used to stabilise haemodynamics in patients with compromised cardiac output. While devices vary regarding indications and haemodynamic effects, only left ventricular (LV) unloading by microaxial flow pumps in a specific subset of patients with acute ST-segment elevation myocardial infarction-associated cardiogenic shock (AMI-CS) has shown a reduction in mortality. This review elucidates on this evidence-based indication for LV unloading, namely patients with AMI-CS fulfilling the Danish-German (DanGer)-Shock trial’s inclusion and exclusion criteria. Furthermore, the review discusses cardiogenic shock scenarios encountered in everyday clinical practice beyond the trial population. It further extends beyond that, discussing clinical scenarios such as protected percutaneous coronary intervention including critical appraisal of recent trials, the negative results of unloading trials in AMI, as well as the settings of protected ventricular tachycardia ablation, LV unloading in veno-arterial extracorporeal membrane oxygenation (vaECMO) cases, escalated support with Impella 5.5 for postcardiotomy patients and as a bridge-to-decision or bridge-to-LV assist device (LVAD), and emerging indications such as protected cardiac as well as non-cardiac surgery.

Aims: Digitoxin reduced the composite of death or worsening heart failure in DIGIT-HF, but whether these benefits translate into economic value remains unknown. We assessed its cost-effectiveness as add-on therapy for heart failure with reduced ejection fraction (HFrEF) across all 27 European Union Member States (EU-27) and the United States (US). Methods: We developed a DIGIT-HF-informed, multi-jurisdictional three-state Markov cost-utility model projecting 10-year and lifetime outcomes. Clinical risks and intention-to-treat effects were held constant; hospitalization costs, EQ-5D-5L utilities, digitoxin costs, discounting, and willingness-to-pay (WTP) thresholds varied by jurisdiction. Uncertainty was assessed using 10 000 probabilistic simulations. Results: Across the EU-27, digitoxin was cost-effective at 10 years, with incremental costs of −€338 to +€25 per patient, incremental quality-adjusted life-years (QALYs) of 0.188–0.231, and a maximum incremental cost-effectiveness ratio (ICER) of €120/QALY. Over lifetime, corresponding ranges were −€79 to +€72, 0.373–0.453 QALYs, and a maximum ICER of €174/QALY. At €50 000/QALY, cost-effectiveness probability was 92%. Digitoxin was cost-saving in 24 of 27 Member States at 10 years and 10 of 27 over lifetime. In the USA, it was cost-saving (lifetime savings US$405 per patient; 0.43 QALYs; 93.4% probability of cost-effectiveness). Conclusion: Digitoxin generated clinically meaningful health benefits at negligible incremental cost and remained cost-effective across every evaluated EU-27 healthcare system and the USA. Economic value emerged earliest within the first decade and in higher-cost hospital systems, while lifetime analysis captured larger cumulative gains in quality-adjusted survival.

Zusammenfassung: Die arterielle Hypertonie zählt zu den häufigsten chronischen Erkrankungen und tritt häufig gemeinsam mit Diabetes mellitus und Herzinsuffizienz auf – eine Kombination mit deutlich erhöhtem kardiovaskulärem Risiko. Rund 70 % der Diabetiker haben auch eine Hypertonie. Hypertonie begünstigt sowohl die Herzinsuffizienz mit reduzierter (HFrEF) als auch die Herzinsuffizienz mit erhaltener (HFpEF) Ejektionsfraktion. Bei HFrEF sind Angiotensin-Rezeptor-Neprilysin-Inhibitoren/ACE-Inhibitoren/Angiotensin-II-Rezeptor-Blocker (ARNI/ACEi/ARB), Betablocker, SGLT2-Hemmer (SGLT2: Natrium-Glukose-Cotransporter 2) und Mineralokortikoidrezeptor-Antagonisten (MRA) Standard der Herzinsuffizienztherapie. Die Therapie sollte bei weiter bestehendem Bluthochdruck um einen langwirksamen Kalziumkanalblocker vom Dihydropyridin-Typ wie Amlodipin oder Felodipin ergänzt werden. Bei HFpEF sind SGLT2-Hemmer und Diuretika leitlinienempfohlen. Hier sollte bei arterieller Hypertonie die Therapie zunächst um einen ACE-Hemmer bzw. ARB ergänzt werden, auch ein MRA (bevorzugt Spironolacton) kann zur weiteren Blutdrucksenkung eingesetzt werden. Als zusätzliche Eskalationsstufe stehen auch hier langwirksame Kalziumkanalblocker zur Verfügung. Bei Diabetes und einer arteriellen Hypertonie sind SGLT2-Hemmer und ACE-Hemmer/ARB bevorzugt. Ergänzend kommen zur Blutdruckeinstellung Kalziumantagonisten, Diuretika und MRA zum Einsatz.