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. Author manuscript; available in PMC: 2025 Jan 1.
Published in final edited form as: Heart Fail Clin. 2023 Jul 4;20(1):61–69. doi: 10.1016/j.hfc.2023.05.003

Interatrial Shunt Devices

Husam M Salah a, Claudia Baratto b, Dmitry M Yaranov c, Karl-Philipp Rommel d,e, Satyanarayana Achanta f, Sergio Caravita b,g, Vinay Kumar Reddy Vasanthu f, Marat Fudim h,i,*
PMCID: PMC11232059  NIHMSID: NIHMS2006847  PMID: 37953022

INTRODUCTION

Despite several advances in drug therapies for heart failure (HF) over the past decade, HF remains one of the leading causes of hospitalizations with remarkedly reduced quality of life and excess morbidity and mortality worldwide.1,2 In addition, there remain limited pharmacologic options for patients with HF with preserved ejection fraction (HFpEF). Driven by these factors, device-based therapies have emerged as alternative approaches to target structural and biological HF-related abnormalities that may not be amenable to pharmacologic therapies.3,4

Elevated left atrial pressure (LAP) at rest and/or during exercise is one of the hallmarks of various phenotypes of HF and is associated with dyspnea, poor exercise capacity, and adverse outcomes (eg, increased mortality).5–8 Elevated LAP is also associated with adverse left atrial remodeling and dysfunction, pulmonary vascular disease (PVD), and right ventricular dysfunction in both HF with reduced ejection fraction (HFrEF) and HFpEF.8 The associated adverse left atrial remodeling actively contributes to the progression and clinical course of HF,9 and several classes of guideline-directed medical therapy indirectly exert their cardiovascular benefits by counteracting adverse left atrial remodeling.10–12 Based on these observations, it was postulated that a more direct approach to decompress the pressure-overloaded left atrium (eg, by creating an iatrogenic interatrial shunt) may be associated with improved HF-related outcomes. The concept of an iatrogenic interatrial shunt as a potential therapeutic pathway in patients with HF was further supported by the observation that the presence of concomitant mitral valve stenosis and atrial septal defect (ie, Lutembacher syndrome) is associated with less symptoms and better outcomes when compared with mitral valve stenosis alone.13,14 Further, surgical closure of atrial septal defects can lead to acute left HF due to an abrupt increase in LAP, necessitating partial reopening of the defect in some cases.15,16 Early attempts of using the concept of an iatrogenic interatrial shunt were conducted in patients with refractory acute HF under venoarterial extracorporeal membrane oxygenation (VA-ECMO). In such patients, left atrial decompression by creating a left-to-right atrial shunt was associated with improvement in LAP, left-to-right atrial pressure gradient, pulmonary edema, and overall clinical status.17–20 Subsequently, several device-based approaches were developed to create a permanent controlled left-to-right shunt for left atrial decompression in patients with HF. This review summarizes the current and future landscape of these devices. Conceptually, there are two types of device-based shunts1: Shunt is created, and a stent-like structure is left behind (implant-based approach) or2 shunt is created, and nothing is left behind (implant-free approach).

IMPLANT-BASED APPROACHES

InterAtrial Shunt Device

InterAtrial Shunt Device (IASD, Corvia Medical) is a device-based self-expanding metal stent with a double-disc shape and a central opening of 8 mm that is implanted across the interatrial septum.3 IASD system is delivered percutaneously via femoral venous access (16 Fr) followed by a standard trans-septal puncture of the interatrial septum and positioning of the device using an over-the-wire technique.21 IASD placement creates an anatomic communication between the left and right atria, which allows for a pressure-dependent left-to-right flow.21

The REDUCE LAP-HF was an open-label, single-arm, phase 1 study that included 68 symptomatic HF patients (despite medical therapy) with left ventricular ejection fraction (LVEF) greater than 40% and pulmonary capillary wedge pressure (PCWP) greater than 15 mm Hg at rest or greater than 25 mm Hg during exercise with the aim to assess the safety and performance of the IASD.21 The study demonstrated a good safety profile for IASD; no patient experienced periprocedural or major adverse cardiac or cerebrovascular events or needed surgical intervention for device-related complications at 6 months.21 At 6 months, 52% of the patients had a reduction in PCWP at rest, and 58% had a reduction in PCWP during exercise.21 In addition, mean exercise PCWP was significantly lower at 6 months compared with baseline despite increased mean exercise duration.21 Subsequently, the phase 2 REDUCE LAP-HF I study randomized 44 patients with LVEF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg to either IASD implantation or a sham procedure.22 Compared with sham control, IASD implantation resulted in a greater reduction in PCWP during exercise at 1 month (P = 5 .028) with no periprocedural or major adverse cardiac, cerebrovascular, or renal adverse events in the IASD group at 1-month follow-up (Fig. 1).22 Based on these results, the US Food and Drug Administration granted the IASD system a breakthrough device designation in 2019.3

Fig. 1.

Fig. 1.

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(A, B) Different views of the Interatrial Shunt Device (IASD) System. (C) The IASD system creates a pressure-dependent left-to-right atrial shunt that decompresses the pressure-overloaded left atrium. (D) Changes in pulmonary capillary wedge pressure (PCWP) during exercise hemodynamic testing at 1 month following IASD versus control. (Used with permission from Feldman T, Mauri L, Kahwash R, et al. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]). Circulation 2018;137:364–375.)

Following that, the phase 3 REDUCE LAP-HF II trial randomized 626 symptomatic HF patients with LVEF ≥40%, exercise PCWP ≥ 25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg to either IASD implantation or sham procedure.23 The primary endpoint was a hierarchical composite of cardiovascular mortality or nonfatal ischemic stroke at 12 months, total HF events at 24 months, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months.23 The study showed no difference between the two groups in the primary composite endpoint (win ratio 1.0 [95% CI 0.8–1.2]) or the individual components of the primary composite endpoint. There was also no difference in the composite safety endpoint between the two groups (P = .11).23 However, prespecified subgroup analyses of the REDUCE LAP-HF II trial demonstrated a differential effect of IASD on HF events based on pulmonary artery systolic pressure at 20 W exercise (pulmonary artery systolic pressure >70 mm Hg was associated with worse outcomes), right atrial volume index (a value > 29.7 mL/m2 was associated with worse outcomes), and sex (male sex was associated with worse outcomes).23 As IASD reduces PCWP by pressure-dependent redistributing of blood from the left to the right heart, an increase in pulmonary blood flow (up to 25%) is expected to occur.24 Although the increase in pulmonary blood flow is associated with favorable outcomes in the short term, a sustained increase in pulmonary blood flow (eg, with renal dialysis access) can be associated with the development of right HF.25 Driven by these observations, it is expected that creating an atrial shunt in patients with concurrent PVD and elevated LAP would be associated with worse outcomes. Although the REDUCE LAP-HF II trial excluded patients with severe PVD, which was defined as a resting pulmonary vascular resistance (PVR) of greater than 3.5 Wood units (WU); a growing body of evidence suggests that many patients display a more subtle form of PVD that is not identifiable on imaging or invasive testing at rest but becomes apparent during exercise (ie, latent PVD).26,27 Therefore, a differential effect of IASD on clinical outcomes based on the presence of latent PVD may exist.28 In a post hoc analysis of the REDUCE LAP-HF II trial, in which the primary outcome was analyzed based on the presence of latent PVD (defined as PVR ≥1.74 WU at peak exercise), IASD implantation was associated with a signal of better outcomes in patients without latent PVD (win ratio 1.31 [95% CI, 1.02, 1.68]) and with worse outcomes in those with latent PVD (win ratio 0.60 [95% CI, 0.42, 0.86]).28 It remains to be established whether latent PVD is a disease per se or a marker of right heart dysfunction, undermining the ability of these patients to cope with the increased right-sided cardiac flow: latent PVD patients were older, with more atrial fibrillation, more frequently had a pacemaker and presented with more dysfunctional right ventricles with lower cardiac output as well as with larger right atrial volumes than patients without latent PVD.

The RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure; NCT05425459) trial is a randomized, sham-controlled, double-blinded trial that aims to evaluate the efficacy and safety of IASD in patients with chronic symptomatic HF, LVEF ≥40%, and hemodynamic evidence of absence of latent PVD (peak exercise PVR < 1.75 WU).

V-Wave Interatrial Shunt

The V-Wave interatrial shunt is a percutaneously implanted (using transfemoral venous access), hourglass-shaped device. The initial design of the V-Wave consisted of an encapsulated nitinol frame that is implanted at the level of the interatrial septum and a trileaflet porcine pericardium tissue valve inside the frame to allow for a unidirectional left-to-right pressure-dependent flow (ie, when the pressure gradient between the left and right atria exceeds 5 mm Hg).

In a first-in-human experience in a 70-year-old patient with ischemic HF, New York Heart Association (NYHA) functional class III, LVEF of 35%, and PCWP of 19 mm Hg, V-Wave was implanted successfully with no complications.29 At 3 months follow-up, NYHA functional class improved to class II, and PCWP decreased to 8 mm Hg.29 There was also an improvement in KCCQ score and N-terminal (NT)-pro hormone brain natriuretic peptide (NT-proBNP).29 In a subsequent singlearm, open-label study of 38 patients (30 patients with HFrEF and 8 patients with HFpEF) with NYHA functional class III–IV despite medical therapy, implantation of the V-Wave system resulted in an improvement in NYHA functional class (60% of the patients improved to class I–II), quality of life in 73% of patients, and 6-min walk distance (mean increase 28 ± 83 m) at 12-month follow-up with a 2.6% rate of the major device- or procedure-related complications during that period.30 However, late valve-related pannus formation resulting in shunt narrowing/occlusion was observed in up to 50% of the patients at 12-month follow-up.31 Following this initial experience, a second-generation V-Wave system was developed with valve removal being the most important modification in this generation to improve late device patency (Fig. 2).31

Fig. 2.

Fig. 2.

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(A) Second-generation V-Wave device. (B) View of the valveless lumen of the second-generation V-Wave. (From Guimarães L, Bergeron S, Bernier M, et al. Interatrial shunt with the second-generation V-Wave system for patients with advanced chronic heart failure. EuroIntervention. 2020;15(16):1426–1428.)

The second-generation V-Wave was subsequently examined in 10 patients with HF and NYHA functional class III–IV despite medical therapy, 9 of whom underwent successful implantation of the device.31 Six patients (five with HFrEF and one with HFpEF) were alive and completed the planned 1-year follow-up. At the end of the follow-up period, there was an improvement in NYHA functional class (five patients improved to NYHA functional class I–II) and KCCQ score with a patent device in all patients.31 The RELIEVE-HF (REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure; NCT03499236) is an ongoing randomized, double-blind study that aims to enroll 605 patients with HF (regardless of LVEF) and NYHA functional class II–IV to examine the safety and efficacy of the second-generation of the V-Wave Interatrial Shunt System. Unlike the shunt size of IASD in the REDUCE LAP-HF II trial (ie, 8 mm), the shunt size of V-Wave in the RELIEVE-HF trial is smaller (ie, 5.1 mm), which may permit less blood flow from left-to-right atria and consequently limit the blood flow into the right ventricle and pulmonary vessels. The relatively less blood flow (compared with IASD) in the right ventricle and pulmonary vessels may subsequently attenuate the differential effect of the shunt based on the presence of latent PVD.

Occlutech Atrial Flow Regulator

The Occlutech atrial flow regulator (AFR) is a percutaneously implanted (using transfemoral venous access), double-disc device with self-expanding nitinol wire mesh that conforms completely to the right septum, creating an interatrial communication with a preselected fixed diameter.32 The AFR-PRELIEVE was a prospective, non-randomized, open-label pilot study that included patients with NYHA functional class III–IV and PCWP ≥15 mm Hg at rest or ≥25 mm Hg at exercise who underwent implantation of the AFR device.33 In the 3-month results of the AFR-PRELIEVE study with 36 patients (16 patients with HFrEF and 20 patients with HFpEF), the device remained patent in all patients and resulted in improvement in NYHA class, 6-minute walk distance, KCCQ, PCWP, and NT-proBNP.33 Subsequently, the 1-year results with 53 patients (24 patients with HFrEF and 29 patients with HFpEF) showed consistent results related to efficacy, safety, and device patency,34 and the 1-year follow-up data from 34 patients (24 patients with HFrEF and 10 patients with HFpEF) demonstrated an observed mortality (3.1/100 patient-years) that was better than the predicted mortality (13.4/100 patient-years) in these patients.35 The FROST-HF (Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study; NCT05136820) is an ongoing randomized, sham-controlled- double-blind trial that aims to enroll 698 patients with chronic symptomatic HF and NYHA functional class II–IV (regardless of LVEF) to examine the efficacy and safety of the AFR with two shunt sizes being examined (6 and 8 mm) and compared with sham.

Transcatheter Atrial Shunt System

The transcatheter atrial shunt system (Edwards Lifesciences) is a percutaneously implanted (using transjugular venous access) device that consists of a bare-nitinol implant edged by four arms (two arms sit on the left atrial wall, and the other two arms lie within the coronary sinus) with an internal shunting diameter of 7 mm.36 Transcatheter atrial shunt system allows for an atrial-to-coronary sinus shunting, so technically it is not an interatrial shunt.36 In a first-in-human study, 11 patients (7 with HFpEF and 4 with HFrEF) with symptomatic HF and NYHA functional class III or ambulatory class IV despite medical therapy underwent attempted implantation of the transcatheter atrial shunt system (Edwards Lifesciences). The procedure was successful in eight patients but unsuccessful in the other three patients due to the inability to track the guidewire in the coronary sinus in these patients.36 During a median follow-up of 201 days, there were no major periprocedural adverse events, and the patients with successful implantation experienced an improvement in NYHA functional class and PCWP with patent devices.36 The early feasibility ALt FLOW US study (NCT03523416) is an ongoing study that aims to evaluate the safety, device functionality, and effectiveness of the transcatheter atrial shunt system in 75 patients with symptomatic HF. Although an atrial-to-coronary sinus shunting system may minimize some of the risks associated with interatrial shunting (eg, right-to-left shunting, systemic embolization), its association with other risks (eg, right HF, the effects of volume overload on coronary sinus, and the associated hemodynamic and clinical consequences) remains unclear.

D-Shant Atrium Shunt Device

D-shant atrium shunt device (Wuhan Vickor Medical Technology Co, Ltd) is a percutaneously implanted double disc with a buckle-shaped, nickel-titanium, alloy mesh plug that is implanted in the atrial septum, creating a pressure-dependent left-to-right shunt.37 In a retrospective study including six patients with NYHA functional class II–IV HF, the D-shant atrium shunt device was associated with a significant reduction in left ventricular diameter and volume, functional mitral regurgitation, PCWP, and mean LAP (Fig. 3).37

Fig. 3.

Fig. 3.

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Clinical effects of implant-based interatrial shunt devices based on the currently available evidence (the level of evidence for the clinical effects of each device varies). 6MWD, 6-min walk distance; HFpEF, heart failure with preserved ejection fraction; HFrEF; heart failure with reduced ejection fraction; NYHA, New York Heart Association; PCWP, pulmonary capillary wedge pressure. (Created with BioRender.com.)

IMPLANT-FREE APPROACHES

Septal Cutting Balloon

The septal-cutting balloon approach is used to create a septal defect with pressure-dependent left-to-right atrial shunting.38 The use of this approach was documented in a case report of a 58-year-old female patient with refractory NYHA functional class III and severe postcapillary pulmonary hypertension (mean pulmonary arterial pressure: 49 mm Hg; PCWP: 29 mm Hg; right atrial pressure: 8 mm Hg) secondary to HFpEF.38 Under biplane transesophageal modality guidance, a transseptal puncture was performed in the midfossa ovalis using a radiofrequency transseptal needle. A cutting balloon was then positioned in the hole, inflated and deflated every 5 seconds, and rotated clockwise every 60 seconds. Following the procedure, pulmonary arterial pressure and PCWP improved significantly.38 NYHA functional class improved to class 2 within a month and remained the same at 6 months follow-up. The shunt remained patent and unidirectional during follow-ups.38

Alleviant System

The Alleviant System creates an implant-free interatrial shunt. Following transseptal puncture, the Alleviant System is used to excise a segment of the interatrial septum with a target shunt diameter of 7 mm via 0.5-second radiofrequency energy under fluoroscopic and echocardiographic guidance (Fig. 4).39 Preliminary results from HFpEF studies (ALLEVIATE-HF-1 and ALLEVIATE-HF-2) and a dedicated HFrEF study with a total of 30 patients showed successful procedures with no device-related adverse events in all patients.39 The Alleviant System decreased the mean peak exercise PCWP and increased the overall KCCQ score.39 At 6 months, shunt size remained stable, and there was a decrease in left atrial diameter in patients with HFpEF (−2.4 mm; P = .031).39 The pivotal ALLAY HF trial has been kicked off in 2023 with a trial population similar to RESPONDER HF (NCT NCT05685303).

Fig. 4.

Fig. 4.

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The atrial septostomy device (Alleviant). (A) Septal crossing and radiofrequency ablation of the septum. (B) Septal tissue removed via radiofrequency ablation. (Courtesy of Alleviant, Austin, TX, with permission.)

Atrial Septostomy Device (NoYA System)

Atrial septostomy device (NoYA system, NoYA MedTech, Hangzhou, China) is a percutaneous radiofrequency ablation-based interatrial shunting therapy that creates an artificial atrial septal defect with no implants.40 The system consists of a self-expanded flowerlike nitinol stent that is connected to a radiofrequency generator. After the completion of radiofrequency ablation, the device is completely removed, leaving nothing but the artificial atrial septal defect.40 The first-in-human RAISE trial included 10 patients with HFpEF who underwent interatrial shunting therapy.40 At 6 months of follow-up, no major safety events were observed, and continuous shunting was still observed in seven patients by the end of the follow-up period.40 NoYA system resulted in a significant improvement in the clinical status with the reduction in NT-proBNP, increase in 6-minute walk distance, and improvement in NYHA functional class.40 The NoYA RAISE Trial II (A Prospective, Multi-center and Objective Performance Criteria Study to Evaluate the Effectiveness and Safety of NoYA Radiofrequency Interatrial Shunt System for the Treatment of Chronic Heart Failure With Elevated Left Atrial Pressure; NCT05375110) is an ongoing, single-arm, open-label, prospective study that aims to enroll 120 patients with chronic symptomatic HF (NYHA functional class II–IV), elevated LAP, and LVEF ≥15% to examine the efficacy and safety of the NoYA Radiofrequency Interatrial Shunt System for the treatment of chronic HF with elevated LAP.

InterShunt PAS-C System

InterShunt percutaneous atrial shunt catheter (PAS-C) is another implant-free interatrial shunt system that is delivered percutaneously via transfemoral venous access and deployed in the left atrium following transseptal crossing under fluoroscopic and echocardiographic guidance.41,42 Following deployment in the left atrium, the InterShunt PAS-C system is used to capture, cut, and remove tissue from the interatrial septum based on prescribed surface area and shape.41 In preliminary results of a feasibility study including eight patients with HF and NYHA functional class II–IV, deployment of the InterShunt PAS-C system was successful in all patients with no device-related adverse events, and the left-to-right shunt remained patent at 1-month follow-up.41 In addition, the mean peak exercise PCWP decreased by 6 mm Hg and the mean NT-proBNP decreased by 405.6 pg/mL.41 The EASE HF (Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure; NCT05403372) study is still ongoing and aims to provide more information related to the safety and efficacy of the InterShunt PAS-C system.

SUMMARY AND FUTURE DIRECTIONS

Elevated LAP is a driving mechanism for several of the manifestations of HF and is associated with poor outcomes in both HFrEF and HFpEF. Several implant-based and non-implant-based device therapies were developed to create pressure-dependent, left-to-right atrial shunting systems to decompress the pressure-overloaded left atrium in HF (see Fig. 3). Although phase 1 and phase 2 studies of various atrial shunting systems have generally shown favorable safety profiles and encouraging signals of clinical benefits, the only phase 3 clinical trial (ie, REDUCE LAP-HF II) failed to show a reduction in HF events or health status improvement in the overall population of patients with LVEF of ≥40%. However, a post hoc analysis of the REDUCE LAP-HF II trial uncovered possible benefits in those without latent PVD and revealed a signal of harm in those with latent PVD, suggesting a differential effect of interatrial shunting on clinical outcomes based on the presence of latent PVD. This observation informs future and ongoing clinical trials in the field and underscores the importance of better phenotyping of HF to identify those who would benefit the most from device-based therapies and help exclude those who may experience harm.

KEY POINTS.

  • Elevated left atrial pressure during exercise is a hallmark of heart failure and is associated with adverse left atrial remodeling, impaired exercise tolerance, and poor long-term outcomes.

  • An iatrogenic, pressure-dependent, left-to-right atrial shunt has the potential to decompress the pressure-overloaded left atrium. This decompression may subsequently counteract adverse left atrial remodeling, improve exercise capacity, and decrease heart failure-related poor outcomes.

  • Several device-based interatrial shunt approaches have been developed and are currently in various stages of investigations in both heart failure with reduced ejection fraction and heart failure with preserved ejection fraction.

  • There is a pressing need for better phenotyping of heart failure to identify those who may benefit the most from interatrial shunt approaches.

OPEN QUESTIONS.

Future investigations will need to determine the following critical questions.

  • Identify the ideal patient population and confirm whether latent PVD is the key differentiator of response.

  • Resolve the apparent discrepancy between trial populations, which differ significantly in proposed key variables to predict benefit and risk from interatrial shunting, such as right ventricular dysfunction and PVD (aka RESPONDER HF/ALLAY HF vs RELEAVE HF).

  • Although a direct comparison of implant-based and implant-free shunt approaches is unlikely to happen, the critical review of benefits of each approach is needed. Considerations should include the evaluation of the limitations of an implant-based approach and potential limitations it provides to procedures requiring interatrial crossing (pulmonary vein isolation, atrial appendage closures, mitraclip, and so forth.). Additional considerations need to be given to the impact of implant-based approaches on the immobilization of the interatrial septum. Because the interatrial septum is contributing to the atrial reservoir function, implant-free approaches might have distinct benefit by avoiding a restriction of the septum.

  • The question of the correct size of the shunt remains unresolved. It is very likely that one size does not fit all, and future phenotyping approaches will have to match shunt size to HF physiology (and take the longitudinal nature of progressive right ventricular and left ventricular failure into consideration).

  • Although patency has so far not been an issue for the new-generation shunts (whether implant-based or implant-free), future long-term safety outcomes are needed, particularly for the implant-free devices given that there are less cases documented to date for those technologies.

CLINICS CARE POINTS.

  • Elevated left atrial pressure is a poor prognostic factor in patients with heart failure (HF).

  • Current evidence does not support the use of interatrial shunts to decompress the left atrium in patients with HF with reduced ejection fraction or HF with preserved ejection fraction (HFpEF). However, there is a signal of possible benefits of interatrial shunts in patients with HFpEF and hemodynamic evidence of the absence of latent pulmonary vascular disease (ie, peak exercise pulmonary vascular resistance < 1.75 WU).

DISCLOSURES

Dr M. Fudim was supported by the American Heart Association, United States (20IPA35310955), Doris Duke, United States, Bayer, United States, Bodyport, United States, and Verily. He receives consulting fees from Abbott, Ajax, Alio Health, Alleviant, Audicor, AxonTherapies, Bayer, Bodyguide, Bodyport, Boston Scientific, Broadview, Cadence, Cardionomics, Coridea, CVRx, Daxor, Deerfield Catalyst, Edwards LifeSciences, EKO, Feldschuh Foundation, Fire1, Galvani, Gradient, Hatteras, Impulse Dynamics, Intershunt, Medtronic, Merck, NIMedical, NovoNordisk, NucleusRx, NXT Biomedical, Pharmacosmos, PreHealth, ReCor, Shifamed, Splendo, Sumacor, SyMap, Verily, Vironix, Viscardia, and Zoll. Dr D.M. Yaranov is supported by research grant from Daxor and Nuwelis, United States. Dr K-P. Rommel is supported by a research grant from the Else-Kröner-Fresenius-Stiftung, United States, Bad Homburg, United States, Germany. Dr S. Achanta is supported by research grants from the NIEHS-NIH CounterACT program, United States (1R01-ES034387-01; 5R21-ES030331-02; 5R21-ES033020-02; 5U01-ES030672-03) and VisCardia, Inc. All other authors declare no disclosures.

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