Artificial trachea transplant: Tale of two stories.

South Korean-based team is first to successfully transplant 3D bioprinted artificial trachea. The success arises during scrutiny of artificial tracheal implants stemming from the denounced work of Dr. Paolo Macchiarini.

Bioartificial liver system approved for clinical trials in China.

Bioartificial organ systems are becoming more attractive options for end-stage organ disease. Currently, end-stage liver disease has several palliative options but relies on transplantation for curative management. A new bioartificial liver has been approved for clinical trials in China and helps support the failed liver via stem cells.

FDA on the verge of approving human clinical trial for artificial womb.

Premature delivery is responsible for immense mortality and morbidity, partially owing to insufficient development of organs. Current supportive measures, like mechanical ventilation, are necessary to sustain life but have deleterious effects on the underdeveloped organs. A more physiological environment-the artificial womb-has been developed and is on the verge of approval for human clinical trials.

Surgical and Transcatheter Mitral Valve Therapy: Medicare Utilization and Reimbursement.

BACKGROUND: We aimed to examine trends in the utilization and reimbursement of surgical and transcatheter mitral valve therapies and their changing relationship. METHODS: A query of administrative data on US Medicare beneficiaries undergoing mitral valve therapy was conducted from 2015 to 2020 using the Centers for Medicare and Medicaid Services Part B National Summary Data File. Inflation adjustment was to the 2020 Consumer Price Index. Trend analysis was quantified with growth rate and simple linear regression calculations. RESULTS: The annual number of all mitral valve procedures remained constant. Transcatheter mitral valve therapies increased by 313% with an increase of 1552 cases per year (P < .001), whereas surgical mitral valve therapies decreased by 31.4% with a decline of 1446 procedures per year (P = .004). As a proportion of all mitral valve therapies, surgical therapies decreased from 91.8% to 65.0%. Annual Medicare reimbursements for transcatheter and surgical mitral valve therapies mirrored the annual procedural trends. For transcatheter mitral valve therapies, per-case reimbursement decreased by 14.1% ($1283.18 to $1102.88), and for surgical mitral valve therapies, per-case reimbursement decreased by 3.8% ($1480.65 to $1424.57). CONCLUSIONS: Medicare utilization of mitral valve therapies has been stable in recent years, with growth of transcatheter volumes offset by a decrease in surgical volumes. This suggests that transcatheter therapy availability has not expanded the pool of patients with access to therapy. Nonetheless, case reimbursements decreased for both modalities.

Reliable long-term organ cryopreservation makes donor organ bank a feasible reality.

Long-term donor organ preservation has been sought after since the beginning of transplantation. Static cold storage is the gold standard for organ transport but is limited to short-term preservation because of the inability to maintain subfreezing temperatures without harmful ice cyrstal formation. Recent developments in cryopreservation via vitrification and nanowarming have demonstrated reliable storage and restoration of healthy donor organs without ice crystallization.

Two Decades of Declining Medicare Reimbursement in Cardiac Surgery.

BACKGROUND: Given the uncertainty of US health care finances, an understanding of reimbursement trends has become increasingly important in the field of cardiac surgery. We aimed to assess Medicare reimbursement trends for common cardiac surgical procedures from 2000 to 2022. METHODS: Reimbursement data were extracted from the Centers for Medicare and Medicaid Services Physician Fee Schedule Look-Up Tool during the study period for 6 common cardiac operations: aortic valve replacement, mitral valve repair and replacement, tricuspid valve replacement, Bentall procedure, and coronary artery bypass grafting. Reimbursement rates were adjusted for inflation to 2022 US dollars using the Consumer Price Index. Total percentage change and compound annual growth rate were calculated. A split-time analysis was performed to assess trends before and after 2015. Least squares and linear regressions were performed. The R2 value was calculated for each procedure, and slope was used to determine change in reimbursements over time. RESULTS: Inflation-adjusted reimbursement decreased by 34.1% during the study period. The overall compound annual growth rate was -1.8%. Reimbursement trends differed by procedure (P < .001), with all reimbursements trending down (R2 > 0.62), except for mitral valve replacement (P = .21) and tricuspid valve replacement (P = .43). Coronary artery bypass grafting decreased the most (-44.4%), followed by aortic valve replacement (-40.1%), mitral valve repair (-38.5%), mitral valve replacement (-29.8%), Bentall procedure (-28.5%), and tricuspid valve replacement (-25.3%). In split-time analysis, reimbursement rates did not significantly change from 2000 to 2015 (P = .24) but decreased significantly from 2016 to 2022 (P = .001). CONCLUSIONS: Medicare reimbursement significantly decreased for most cardiac surgical procedures. These trends justify further advocacy by The Society of Thoracic Surgeons to maintain access to quality cardiac surgical care.

The economics of artificial organs.

Spurred by devoted research and institutional financing, organ replacement therapies have progressed monumentally over the last century. Concomitantly, there has been an escalation in healthcare costs. In an aging society where organ replacement therapy utilization is expected to continue to rise, will society need to rethink the economics of end-stage organ dysfunction management?

New development in brain-computer interface platforms: 1-year results from the SWITCH trial.

Synchron publishes SWITCH trial results demonstrating the safety and efficacy of stentrode™ device. The stentrode™ is an endovascularly implanted brain-computer interface communication device capable of relaying neural activity from the motor cortex of paralyzed patients. The platform has been used to recover speech.

Regional pain relief with focused cooling of peripheral nerves.

Opioids are an effective remedy for pain control, but their detrimental side effects are prompting the development of less systemic and addictive options. A team from Pusan National University has developed an implant capable of precisely desensitizing peripheral nerves with temperature regulation. The device employs microfluidic technology.

Will electronic skins become a quintessential health tracker for everyday life?

Researchers from MIT have developed a chipless wireless electronic skin capable of detecting health information. They have improved upon the sensitivity, power efficiency, and long-term wearability of previous electronic skins. Continued development in this sector may soon make health tracking via electronic skin ubiquitous with the population.

Post-mortem cellular death may be salvageable with whole body perfusion.

A team of Yale researchers demonstrated cellular and metabolic recovery with whole body perfusion after prolonged warm ischemia. This study reveals an underappreciated potential of cellular recovery and may lead to the expansion of suitable warm ischemic times.

Comparative efficacy and mechanism of action of cardiac progenitor cells after cardiac injury.

Successful cell therapy requires cells to resist the hostile ischemic myocardium, be retained to continue secreting cardioprotective growth factors/exosomes, and resist immunological host responses. Clinically relevant stem/progenitor cells in a rodent model of acute myocardial infarction (MI) demonstrated that neonatal cardiac mesenchymal stromal cells (nMSCs) provide the most robust cardiac functional recovery. Transplanted nMSCs significantly increased the number of tissue reparative macrophages and regulatory T-cells and decreased monocyte-derived inflammatory macrophages and neutrophils in the host myocardium. mRNA microarray and single-cell analyses combined with targeted depletion studies established CD47 in nMSCs as a key molecule responsible for cell retention in the myocardium through an antiphagocytic mechanism regulated by miR34a-5p. Gain and loss-of-function studies demonstrated that miR34a-5p also regulated the production of exosomes and cardioprotective paracrine factors in the nMSC secretome. In conclusion, miR34a-5p and CD47 play an important role in determining the composition of nMSCs' secretome and immune evasion, respectively.

Individualized human physiology modeled in the first multi-organ chip of engineered human tissue.

A team of researchers succeeded in modeling complex human physiology using the first multi-organ chip of human tissue derived from induced pluripotent stem cells. The platform may help more accurately predict various disease and pharmacologic processes.

Cardiac Xenotransplantation: Progress in Preclinical Models and Prospects for Clinical Translation.

Survival of pig cardiac xenografts in a non-human primate (NHP) model has improved significantly over the last 4 years with the introduction of costimulation blockade based immunosuppression (IS) and genetically engineered (GE) pig donors. The longest survival of a cardiac xenograft in the heterotopic (HHTx) position was almost 3 years and only rejected when IS was stopped. Recent reports of cardiac xenograft survival in a life-sustaining orthotopic (OHTx) position for 6 months is a significant step forward. Despite these achievements, there are still several barriers to the clinical success of xenotransplantation (XTx). This includes the possible transmission of porcine pathogens with pig donors and continued xenograft growth after XTx. Both these concerns, and issues with additional incompatibilities, have been addressed recently with the genetic modification of pigs. This review discusses the spectrum of issues related to cardiac xenotransplantation, recent progress in preclinical models, and its feasibility for clinical translation.

Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome (CHILD Study).

Mortality in infants with hypoplastic left heart syndrome (HLHS) is strongly correlated with right ventricle (RV) dysfunction. Cell therapy has demonstrated potential improvements of RV dysfunction in animal models related to HLHS, and neonatal human derived c-kit+ cardiac-derived progenitor cells (CPCs) show superior efficacy when compared to adult human cardiac-derived CPCs (aCPCs). Neonatal CPCs (nCPCs) have yet to be investigated in humans. The CHILD trial (Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome) is a Phase I/II trial aimed at investigating intramyocardial administration of autologous nCPCs in HLHS infants by assessing the feasibility, safety, and potential efficacy of CPC therapy. Using an open-label, multicenter design, CHILD investigates nCPC safety and feasibility in the first enrollment group (Group A/Phase I). In the second enrollment group, CHILD uses a randomized, double-blinded, multicenter design (Group B/Phase II), to assess nCPC efficacy based on RV functional and structural characteristics. The study plans to enroll 32 patients across 4 institutions: Group A will enroll 10 patients, and Group B will enroll 22 patients. CHILD will provide important insights into the therapeutic potential of nCPCs in patients with HLHS.Clinical Trial Registration https://clinicaltrials.gov/ct2/home NCT03406884, First posted January 23, 2018.

First successful porcine to human heart transplantation performed in the United States.

In an 8-h operation, the cardiac surgery team at the University of Maryland Medical Center made history by performing the first porcine-to-human heart transplant without signs of early rejection. Xenotransplantation offers a potential solution to the thousands of patients worldwide who die annually while waiting for donor organs.

Competition brings out the best in people, and this year's KidneyX Summit did not disappoint.

Six teams receive large-sum awards in the first round of the Artificial Kidney competition to further develop concepts that significantly improve upon existing dialysis methods.