Retrograde Coronary Venous Infusion as a Delivery Strategy in Regenerative Cardiac Therapy: an Overview of Preclinical and Clinical Data

Gathier, Wouter; Ginkel, Dirk Jan van; Naald, Mira van der; Slochteren, Frebus J. van; Doevendans, Pieter A.; Chamuleau, Steven A.J.

doi:10.1007/s12265-018-9785-1

Cited by 17 publications

(8 citation statements)

References 43 publications

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“…However, the available data on technical and safety aspects of RCVI are insufficient and incomplete. At present, there are not enough arguments to proceed with this technique in the clinical arena because well-designed confirmatory studies on retention rates and safety data are required to prove its value 12…”

Section: Introductionmentioning

confidence: 99%

Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

et al. 2019

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BackgroundCommonly used strategies for cell delivery to the heart are intramyocardial injection and intracoronary (IC) infusion, both having their advantages and disadvantages. Therefore, alternative strategies, such as retrograde coronary venous infusion (RCVI), are explored. The aim of this confirmatory study was to compare cardiac cell retention between RCVI and IC infusion. As a secondary end point, the procedural safety of RCVI is assessed.MethodsFour weeks after myocardial infarction, 12 pigs were randomised to receive mesenchymal stromal cells, labelled with Indium-111, via RCVI (n=6) or IC infusion (n=6). Four hours after cell administration, nuclear imaging was performed to determine the number of cells retained in the heart both in vivo and ex vivo. Procedure-related safety measures were reported.ResultsCardiac cell retention is significantly lower after RCVI compared with IC infusion (in vivo: RCVI: median 2.89% vs IC: median 13.74%, p=0.002, ex vivo: RCVI: median 2.55% vs IC: median 39.40%, p=0.002). RCVI led to development of pericardial fluid and haematomas on the frontal wall of the heart in three cases. Coronary venous dissection after RCVI was seen in three pigs, of which one also developed pericardial fluid and a haematoma. IC infusion led to no flow in one pig.ConclusionRCVI is significantly less efficient in delivering cells to the heart compared with IC infusion. RCVI led to more procedure-related safety issues than IC infusion, with multiple cases of venous dissection and development of haematomas and pericardial fluid collections.

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Section: Introductionmentioning

confidence: 99%

Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

et al. 2019

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“…In the metaanalysis by Gathier et al, only a transient increase in troponin-I levels was seen after retrograde stem cells infusion with resolution within 24 h. No arrhythmias were detected in this patients and there was no evidence of damage to the CS or increase of mortality rate releated to retrograde CS infusion [15].…”

Section: Discussionmentioning

confidence: 93%

“…for implanting the left ventricular pacing leads in resynchronisation therapy [10, 14] or for retrograde cardioplegia during cardiac surgery. This access is reported to be safe, with injury to the CS occurring in 0.06 to 0.6% of patients resulting in formation of hematoma on the atrioventricular groove, perforation of the CS wall, pericardial effusion, or laceration of the right ventricle [15].…”

Section: Discussionmentioning

confidence: 99%

Rationale and design of a prospective, randomised study of retrograde application of bone marrow aspirate concentrate (BMAC) through coronary sinus in patients with congestive heart failure of ischemic etiology (the RETRO study)

Pleva

Kukla

Vítková

et al. 2019

BMC Cardiovasc Disord

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BackgroundHeart failure (HF) is a major chronic illness and results in high morbidity and mortality. The most frequent cause of HF with reduced ejection fraction (HFREF) is coronary artery disease (CAD). Although revascularisation of ischemic myocardium lead to improvements in myocardial contractility and systolic function, it cannnot restore the viability of the already necrotic myocardium.Methods/designThe aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with HFREF of ischemic aetiology. The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 (Harvest Technologies, Plymouth, MA, USA). The study population will be a total of 40 patients with established CAD, systolic dysfunction with LV EF of ≤40% and HF in the NYHA class 3. Patients have been on standard HF therapy for 3 months and in a stabilised state for at least 1 month, before enrolling in the clinical study. Patients will be randomised 1:1 to either retrograde BMAC administration via coronary sinus or standard HF therapy. The primary end-points (left ventricular end-systolic and end-diastolic diameters [LVESd/EDd] and volumes [LVESV/EDV] and left ventricular ejection fraction [LV EF]) will be assessed by magnetic resonance imaging. The follow-up period will be 12 month.DiscussionThe application of bone marrow stem cells into affected areas of the myocardium seems to be a promising treatment of ischemic cardiomyopathy.The Harvest BMAC contains the entire population of nuclear cells from bone marrow aspirates together with platelets. The presence of both platelets and additional granulocytes can have a positive effect on the neovascularisation potential of the resulting concentrate. Our assumption is that retrograde administration on non-selected BMAC via coronary sinus, due to the content of platelets and growth factors, might improve left ventricular function and parameters compared to standard HF therapy. Furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.Trial registration(ClinicalTrials.gov; https://clinicaltrials.gov; NCT03372954).

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“…Besides CTA, coronary venous anatomy can also be visualised pre-procedurally in a subset of CRT candidates who are already scheduled for a routine coronary angiography using venous phase coronary angiography [ 8 ] Coronary venous anatomy visualisation may be useful in identifying those patients with suboptimal coronary venous anatomy and may potentially simplify the CRT implantation procedure, as it may reduce the need for extensive fluoroscopic coronary venous angiograms. In addition to CRT, evaluation of the coronary venous anatomy may also be relevant for other procedures, including radiofrequency ablation [ 9 ] or cell therapy [ 10 ].…”

Section: Discussionmentioning

confidence: 99%

Visualisation of coronary venous anatomy by computed tomography angiography prior to cardiac resynchronisation therapy implantation

et al. 2018

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BackgroundThe purpose of this study was to illustrate the additive value of computed tomography angiography (CTA) for visualisation of the coronary venous anatomy prior to cardiac resynchronisation therapy (CRT) implantation.MethodsEighteen patients planned for CRT implantation were prospectively included. A specific CTA protocol designed for visualisation of the coronary veins was carried out on a third-generation dual-source CT platform. Coronary veins were semi-automatically segmented to construct a 3D model. CTA-derived coronary venous anatomy was compared with intra-procedural fluoroscopic angiography (FA) in right and left anterior oblique views.ResultsCoronary venous CTA was successfully performed in all 18 patients. CRT implantation and FA were performed in 15 patients. A total of 62 veins were visualised; the number of veins per patient was 3.8 (range: 2–5). Eighty-five per cent (53/62) of the veins were visualised on both CTA and FA, while 10% (6/62) were visualised on CTA only, and 5% (3/62) on FA only. Twenty-two veins were present on the lateral or inferolateral wall; of these, 95% (21/22) were visualised by CTA. A left-sided implantation was performed in 13 patients, while a right-sided implantation was performed in the remaining 2 patients because of a persistent left-sided superior vena cava with no left innominate vein on CTA.ConclusionImaging of the coronary veins by CTA using a designated protocol is technically feasible and facilitates the CRT implantation approach, potentially improving the outcome.Electronic supplementary materialThe online version of this article (10.1007/s12471-018-1132-2) contains supplementary material, which is available to authorized users.

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Retrograde Coronary Venous Infusion as a Delivery Strategy in Regenerative Cardiac Therapy: an Overview of Preclinical and Clinical Data

Cited by 17 publications

References 43 publications

Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

Lower retention after retrograde coronary venous infusion compared with intracoronary infusion of mesenchymal stromal cells in the infarcted porcine myocardium

Rationale and design of a prospective, randomised study of retrograde application of bone marrow aspirate concentrate (BMAC) through coronary sinus in patients with congestive heart failure of ischemic etiology (the RETRO study)

Visualisation of coronary venous anatomy by computed tomography angiography prior to cardiac resynchronisation therapy implantation

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