Kitahara H, Edelman JJ, Thourani VH

Kitahara H, Edelman JJ, Thourani VH

J. Thorac. Cardiovasc. Surg. 2019 Mar;

PMID: 31014663

Abstract

Indja B, Woldendorp K, Vallely MP, Grieve SM

J Am Heart Assoc 2019 05;8(9):e010920

PMID: 31017035

Abstract

Background Silent brain infarcts ( SBI ) are increasingly being recognized as an important complication of cardiac procedures as well as a potential surrogate marker for studies on brain injury. The extent of subclinical brain injury is poorly defined. Methods and Results We conducted a systematic review and meta-analysis utilizing studies of SBI s and focal neurologic deficits following cardiac procedures. Our final analysis included 42 studies with 49 separate intervention groups for a total of 2632 patients. The prevalence of SBI s following transcatheter aortic valve implantation was 0.71 (95% CI 0.64-0.77); following aortic valve replacement 0.44 (95% CI 0.31-0.57); in a mixed cardiothoracic surgery group 0.39 (95% CI 0.28-0.49); coronary artery bypass graft 0.25 (95% CI 0.15-0.35); percutaneous coronary intervention 0.14 (95% CI 0.10-0.19); and off-pump coronary artery bypass 0.14 (0.00-0.58). The risk ratio of focal neurologic deficits to SBI in aortic valve replacement was 0.22 (95% CI 0.15-0.32); in off-pump coronary artery bypass 0.21 (95% CI 0.02-2.04); with mixed cardiothoracic surgery 0.15 (95% CI 0.07-0.33); coronary artery bypass graft 0.10 (95% CI 0.05-0.18); transcatheter aortic valve implantation 0.10 (95% CI 0.07-0.14); and percutaneous coronary intervention 0.06 (95% CI 0.03-0.14). The mean number of SBI s per patient was significantly higher in the transcatheter aortic valve implantation group (4.58 ± 2.09) compared with both the aortic valve replacement group (2.16 ± 1.62, P=0.03) and the percutaneous coronary intervention group (1.88 ± 1.02, P=0.03). Conclusions SBI s are a very common complication following cardiac procedures, particularly those involving the aortic valve. The high frequency of SBI s compared with strokes highlights the importance of recording this surrogate measure in cardiac interventional studies. We suggest that further work is required to standardize reporting in order to facilitate the use of SBI s as a routine outcome measure.

Kitahara H, Edelman JJ, Thourani VH

J. Thorac. Cardiovasc. Surg. 2019 Apr;

PMID: 31101351

Abstract

Brown K, Solomon MJ, Young J, Seco M, Bannon PG

ANZ J Surg 2019 06;89(6):634-638

PMID: 30974516

Abstract

While the introduction of new surgical techniques can radically improve patient care, they may equally expose patients to unforeseen harms associated with untested procedures. The enthusiastic uptake of laparoscopic cholecystectomy in the early 1990s saw a dramatic increase in the rate of common bile duct injuries, and was described by Alfred Cuschieri as ‘the biggest unaudited free-for-all in the history of surgery’ due to ‘a lack of effective centralised control’. Whether a new surgical intervention is considered an acceptable ‘minor’ variation of an established procedure, or is sufficiently ‘novel’ to constitute experimentation on human subjects is often unclear. Furthermore, once a new technique is identified as experimental, there is no agreed protocol for safety evaluation in a first-in-human setting. In phase I (first-in-human) pharmacological trials only small, single arm cohorts of highly selected patients are enrolled in order to establish the safety profile of a new drug. This exposes only a small number of patients to the unknown or unforeseen risks that may be associated with a new agent, in a highly regulated and scientifically rigorous manner. There is no equivalent study design for the introduction of new and experimental surgical procedures. This article proposes a practical stepwise approach to the safe introduction of new surgical procedures that surgeons and surgical departments can adopt. It includes criteria for new surgical techniques which require formal prospective ethical evaluation, and a novel study design for conducting a safety evaluation at the ‘first in human’ stage.

Rogers T, Khan JM, Edelman JJ, Waksman R

Cardiovasc Revasc Med 2018 Dec;19(8):964-970

PMID: 30344056

Abstract

Medicare coverage for transcatheter aortic valve replacement (TAVR) in the United States (US) is governed by the 2012 National Coverage Determination (NCD 20.32), which enshrined minimum numbers of TAVR, surgical aortic valve replacement, and percutaneous coronary intervention that centers must perform to begin or maintain TAVR programs. In July 2018, the Centers for Medicare and Medicaid Services (CMS) convened a meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to review the evidence for setting minimum procedure volume requirements and to evaluate the impact of such requirements on access to care. In this paper, we summarize the MEDCAC panel deliberations, the evidence presented to the panel, and how the panel members voted. CMS is expected to publish a draft decision in March 2019 that may reshape the TAVR landscape in the US for years to come.

Woldendorp K, Selvaraj CN, Bannon PG, Dubenec S

J. Thorac. Cardiovasc. Surg. 2019 05;157(5):e223-e225

PMID: 30527780

Abstract

Tan RP, Chan AHP, Lennartsson K, Miravet MM, Lee BSL, Rnjak-Kovacina J, Clayton ZE, Cooke JP, Ng MKC, Patel S, Wise SG

Stem Cell Res Ther 2018 03;9(1):70

PMID: 29562916

Abstract

BACKGROUND: Induced pluripotent stem-cell derived endothelial cells (iPSC-ECs) can be generated from any somatic cell and their iPSC sources possess unlimited self-renewal. Previous demonstration of their proangiogenic activity makes them a promising cell type for treatment of ischemic injury. As with many other stem cell approaches, the low rate of in-vivo survival has been a major limitation to the efficacy of iPSC-ECs to date. In this study, we aimed to increase the in-vivo lifetime of iPSC-ECs by culturing them on electrospun polycaprolactone (PCL)/gelatin scaffolds, before quantifying the subsequent impact on their proangiogenic function.

METHODS: iPSC-ECs were isolated and stably transfected with a luciferase reporter to facilitate quantification of cell numbers and non-invasive imaging in-vivo PCL/gelatin scaffolds were engineered using electrospinning to obtain woven meshes of nanofibers. iPSC-ECs were cultured on scaffolds for 7 days. Subsequently, cell growth and function were assessed in vitro followed by implantation in a mouseback subcutaneous model for 7 days.

RESULTS: Using a matrix of conditions, we found that scaffold blends with ratios of PCL:gelatin of 70:30 (PG73) spun at high flow rates supported the greatest levels of iPSC-EC growth, retention of phenotype, and function in vitro. Implanting iPSC-ECs seeded on PG73 scaffolds in vivo improved their survival up to 3 days, compared to cells directly injected into control wounds, which were no longer observable within 1 h. Enhanced engraftment improved blood perfusion, observed through non-invasive laser Doppler imaging. Immunohistochemistry revealed a corresponding increase in host angiogenic mechanisms characterized by the enhanced recruitment of macrophages and the elevated expression of proangiogenic cytokines vascular endothelial growth factor and placental growth factor.

CONCLUSIONS: Knowledge of these mechanisms combined with a deeper understanding of the scaffold parameters influencing this function provides the groundwork for optimizing future iPSC-EC therapies utilizing engraftment platforms. The development of combined scaffold and iPSC-EC therapies could ultimately improve therapeutic angiogenesis and the treatment of ischemic injury.

Edelman JJ, Khan JM, Thourani VH

J. Thorac. Cardiovasc. Surg. 2018 Nov;

PMID: 30612753

Abstract

Zhao DF, Edelman JJ, Seco M, Bannon PG, Vallely MP

J. Am. Coll. Cardiol. 2018 Nov;72(21):2679-2680

PMID: 30466529

Abstract