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  1. Article ; Online: A novel technique for postclosure of large-bore sheaths using two Perclose devices.

    Choi, Charles H / Hall, James Kevin / Malaver, Diego / Applegate, Robert J / Zhao, David X M

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2020  Volume 97, Issue 5, Page(s) 905–909

    Abstract: Objectives: This study aimed to assess the feasibility, efficacy, and safety of a novel percutaneous postprocedure closure technique for large arterial sheath removal with the use of two Perclose ProGlide (Abbott Vascular Devices, Redwood City, CA) ... ...

    Abstract Objectives: This study aimed to assess the feasibility, efficacy, and safety of a novel percutaneous postprocedure closure technique for large arterial sheath removal with the use of two Perclose ProGlide (Abbott Vascular Devices, Redwood City, CA) devices.
    Background: Postprocedural closing of large-bore arteriotomies using the Perclose system can be difficult given the subsequent inability of the device to capture sufficient wall tissue.
    Methods: Our study was a single-center retrospective analysis of 22 consecutive patients who underwent large arteriotomy closure via the postclosure technique with a 12-16-Fr sheath. Efficacy endpoints included successful deployment of the system and hemostasis. Safety endpoints included the incidence of major or minor vascular complications as defined by the Vascular Academic Research Consortium-2 (VARC-2) definitions at 30-day follow-up.
    Results: The postclosure technique resulted in 100% technical success rate and no postprocedural bleeding or vascular complications.
    Conclusion: Postclosure technique is a safe, highly effective, and feasible percutaneous method to achieve large-bore arteriotomy hemostasis with low rates of major bleeding or vascular complications and favorable early outcome.
    MeSH term(s) Femoral Artery/diagnostic imaging ; Femoral Artery/surgery ; Hemorrhage/etiology ; Hemorrhage/prevention & control ; Hemostatic Techniques/adverse effects ; Humans ; Retrospective Studies ; Treatment Outcome ; Vascular Closure Devices ; Vascular Surgical Procedures
    Language English
    Publishing date 2020-10-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.29351
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Redo-aortic valve replacement in prior stentless prosthetic aortic valves: Transcatheter versus surgical approach.

    Choi, Charles H / Cao, Kevin / Malaver, Diego / Kincaid, Edward H / Lata, Adrian / Kon, Neal / Belford, P Matthew / Gandhi, Sanjay K / Applegate, Robert J / Zhao, David X M

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2021  Volume 99, Issue 1, Page(s) 181–192

    Abstract: Objectives: The objective was to compare outcomes of redo-aortic valve replacement (AVR) via surgical or transcatheter approach in prior surgical AVR with large percentage of prior stentless surgical AVR.: Background: With the introduction of ... ...

    Abstract Objectives: The objective was to compare outcomes of redo-aortic valve replacement (AVR) via surgical or transcatheter approach in prior surgical AVR with large percentage of prior stentless surgical AVR.
    Background: With the introduction of transcatheter aortic valve replacement (TAVR), patients with increased surgical risks now have an alternative to redo surgical AVR (SAVR), known as valve-in-valve (ViV) TAVR. Stentless prosthetic aortic valves present a more challenging implantation for ViV-TAVR given the lack of structural frame.
    Methods: We performed a retrospective study of 173 subjects who have undergone SAVR (N = 100) or ViV-TAVR (N = 73) in patients with prior surgical AVR at Wake Forest Baptist Medical Center from 2009 to 2019. Our study received the proper ethical oversight.
    Results: The average ages in redo-SAVR and ViV-TAVR groups were 58.03 ± 13.86 and 66.57 ± 13.44 years, respectively (p < 0.0001). The redo-SAVR had significantly lower STS (2.78 ± 2.09 and 4.68 ± 5.51, p < 0.01) and Euroscores (4.32 ± 2.98 and 7.51 ± 8.24, p < 0.05). The redo-SAVR group had higher percentage requiring mechanical support (8% vs. 0%, p < 0.05) and vasopressors (53% vs. 0%, p < 0.0001), longer length of stay (13.65 ± 11.23 vs. 5.68 ± 7.64 days, p < 0.0001), and inpatient mortality (16% vs. 2.78%, p < 0.005). At 30-day follow-up, redo-SAVR group had higher rates of acute kidney injury (10% vs. 0%, p < 0.01), however ViV-TAVR group had more new left bundle branch blocks (6.85% vs. 0%, p < 0.05). No significant differences regarding re-hospitalization rates, stroke, or death up to 1-year.
    Conclusion: Although the ViV-TAVR group had higher risk patients, there were significantly fewer procedural complications, shorter length of stay, and similar mortality outcomes up to 1-year follow-up.
    MeSH term(s) Adult ; Aged ; Aortic Valve/diagnostic imaging ; Aortic Valve/surgery ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/surgery ; Bioprosthesis ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation/adverse effects ; Humans ; Middle Aged ; Reoperation ; Retrospective Studies ; Risk Factors ; Transcatheter Aortic Valve Replacement/adverse effects ; Treatment Outcome
    Language English
    Publishing date 2021-08-17
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.29921
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  3. Article ; Online: A comparison of valve-in-valve transcatheter aortic valve replacement in failed stentless versus stented surgical bioprosthetic aortic valves.

    Choi, Charles H / Cheng, Vivian / Malaver, Diego / Kon, Neal / Kincaid, Edward H / Gandhi, Sanjay K / Applegate, Robert J / Zhao, David X M

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2018  Volume 93, Issue 6, Page(s) 1106–1115

    Abstract: Objectives: The objectives of this study were to compare short- and intermediate-term clinical outcomes, procedural complications, TAVR prosthesis hemodynamics, and paravalvular leak (PVL) in stentless and stented groups.: Background: Valve-in-valve ( ...

    Abstract Objectives: The objectives of this study were to compare short- and intermediate-term clinical outcomes, procedural complications, TAVR prosthesis hemodynamics, and paravalvular leak (PVL) in stentless and stented groups.
    Background: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) is an alternative to surgical redo for bioprosthetic valve failure. There have been limited data on ViV in stentless surgical valves.
    Methods: We retrospectively analyzed 40 patients who underwent ViV TAVR in prior surgical bioprosthetic valves at Wake Forest Baptist Medical Center from October 2014 to September 2017. Eighty percent (32/40) ViV TAVRs were in stentless, while 20% (8/40) were in stented bioprosthetic valves.
    Results: The primary mode of bioprosthetic valve failure for ViV implantation in the stentless group was aortic insufficiency (78%, 25/32), while in the stented group was aortic stenosis (75%, 6/8). The ViV procedure success was 96.9% (31/32) in stentless group and 100% in stented group (8/8). There were no significant differences in all-cause mortality at 30 days between stentless and stented groups (6.9%, 2/31 versus 0%, 0/8, P = 0.33) and at 1 year (0%, 0/25 versus 0%, 0/5). In the stentless group, 34.4% (11/32) required a second valve compared to the stented group of 0% (0/8). There was a significant difference in the mean aortic gradient at 30-day follow-up (12.33 ± 6.33 mmHg and 22.63 ± 8.45 mmHg in stentless and stented groups, P < 0.05) and at 6-month follow-up (9.75 ± 5.07 mmHg and 24.00 ± 11.28 mmHg, P < 0.05), respectively.
    Conclusions: ViV in the stentless bioprosthetic aortic valve has excellent procedural success and intermediate-term results. Our study shows promising data that may support the application of TAVR in stentless surgical aortic valve. However, further and larger studies need to further validate our single center's experience.
    MeSH term(s) Aged ; Aged, 80 and over ; Aortic Valve/diagnostic imaging ; Aortic Valve/physiopathology ; Aortic Valve/surgery ; Aortic Valve Insufficiency/diagnostic imaging ; Aortic Valve Insufficiency/mortality ; Aortic Valve Insufficiency/physiopathology ; Aortic Valve Insufficiency/surgery ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/mortality ; Aortic Valve Stenosis/physiopathology ; Aortic Valve Stenosis/surgery ; Bioprosthesis ; Female ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation/adverse effects ; Heart Valve Prosthesis Implantation/instrumentation ; Heart Valve Prosthesis Implantation/mortality ; Hemodynamics ; Humans ; Male ; Middle Aged ; Prosthesis Design ; Prosthesis Failure ; Recovery of Function ; Retrospective Studies ; Risk Factors ; Stents ; Time Factors ; Transcatheter Aortic Valve Replacement/adverse effects ; Transcatheter Aortic Valve Replacement/mortality ; Treatment Outcome
    Language English
    Publishing date 2018-12-27
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Observational Study
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.28039
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Comparison of paravalvular aortic leak characteristics in the Medtronic CoreValve versus Edwards Sapien Valve: Paravalvular aortic leak characteristics.

    Gilbert, Olivia N / Choi, Charles H / Franzil, Jodie L / Caughey, Melissa / Qureshi, Waqas / Stacey, R Brandon / Pu, Min / Applegate, Robert J / Gandhi, Sanjay K / Zhao, David X M

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

    2018  Volume 92, Issue 5, Page(s) 972–980

    Abstract: Objectives: Temporally quantify and localize paravalvular aortic leak (PVL) after transcatheter aortic valve replacement (TAVR) in the Medtronic CoreValve (MCV) versus the Edwards Sapien Valve (ESV).: Background: In order to increase the precision of ...

    Abstract Objectives: Temporally quantify and localize paravalvular aortic leak (PVL) after transcatheter aortic valve replacement (TAVR) in the Medtronic CoreValve (MCV) versus the Edwards Sapien Valve (ESV).
    Background: In order to increase the precision of THV selection and PVL intervention, an understanding of PVL characteristics is essential.
    Methods: The frequency, severity, and location of post-TAVR PVL were evaluated with transthoracic echocardiography pre-discharge, one month, and one-year post-procedure in 202 patients receiving a MCV (N = 120) or ESV (N = 81). This was done through application of a clock face to the short axis of the aortic valve in order to divide the area into three tertiles.
    Results: Pre-discharge differences between PVL frequency and severity in the MCV and ESV lost significance over time. Localizing these trends, MCV PVL frequency and severity significantly decreased in the first and third tertiles during most time periods while PVL in the second tertile of the MCV or in any of the tertiles of the ESV failed to improve. Presence of pre-discharge PVL was predictive of 30-day HF readmission and/or death (OR = 3.16, 95% CI: 0.99-10.12). Presence of pre-discharge and 30-day PVL was predictive of 1-year HF readmissions and/or death (OR = 2.12, 95% CI: 1.09-4.13 and OR = 1.99, 95% CI: 0.96-4.12).
    Conclusions: When comparing the MCV and ESV, not all locations of PVL improve equally over time, which has implications for heart failure readmissions. This could be used to influence valve selection and to identify cases in which earlier intervention on PVL may be appropriate.
    MeSH term(s) Aged ; Aged, 80 and over ; Aortic Valve/diagnostic imaging ; Aortic Valve/physiopathology ; Aortic Valve/surgery ; Aortic Valve Insufficiency/diagnostic imaging ; Aortic Valve Insufficiency/etiology ; Aortic Valve Insufficiency/physiopathology ; Bioprosthesis ; Female ; Heart Failure/etiology ; Heart Valve Prosthesis ; Humans ; Male ; Prosthesis Design ; Retrospective Studies ; Risk Factors ; Severity of Illness Index ; Time Factors ; Transcatheter Aortic Valve Replacement/adverse effects ; Transcatheter Aortic Valve Replacement/instrumentation ; Treatment Outcome
    Language English
    Publishing date 2018-05-04
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 1459995-8
    ISSN 1522-726X ; 1522-1946
    ISSN (online) 1522-726X
    ISSN 1522-1946
    DOI 10.1002/ccd.27643
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  5. Article ; Online: Treatment of unprotected left main coronary artery stenosis in a 5-year-old heart transplant patient using a sirolimus-eluting stent.

    Salloum, Joseph G / Dodd, Debra A / Slosky, David / Zhao, David X M

    The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation

    2007  Volume 26, Issue 10, Page(s) 1061–1064

    Abstract: Cardiac allograft vasculopathy is the most common cause of long-term graft failure in adult and pediatric heart transplant recipients. In the absence of a specific treatment for this condition, percutaneous revascularization has been the main palliative ... ...

    Abstract Cardiac allograft vasculopathy is the most common cause of long-term graft failure in adult and pediatric heart transplant recipients. In the absence of a specific treatment for this condition, percutaneous revascularization has been the main palliative treatment in the adult population. Revascularization of pediatric patients, however, is more problematic secondary to the lack of a large pool of outcome data and the encounter of special technical challenges. We present the case of a 5-year-old girl who presented with severe cardiac allograft vasculopathy of her left main coronary artery and was treated with sirolimus stent placement.
    MeSH term(s) Child, Preschool ; Coronary Angiography ; Coronary Stenosis/diagnostic imaging ; Coronary Stenosis/etiology ; Coronary Stenosis/therapy ; Drug Delivery Systems ; Female ; Heart Transplantation/adverse effects ; Humans ; Sirolimus/administration & dosage ; Stents ; Treatment Outcome
    Chemical Substances Sirolimus (W36ZG6FT64)
    Language English
    Publishing date 2007-10
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 1062522-7
    ISSN 1557-3117 ; 1053-2498
    ISSN (online) 1557-3117
    ISSN 1053-2498
    DOI 10.1016/j.healun.2007.07.020
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  6. Article ; Online: TIME Trial: Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis.

    Traverse, Jay H / Henry, Timothy D / Pepine, Carl J / Willerson, James T / Chugh, Atul / Yang, Phillip C / Zhao, David X M / Ellis, Stephen G / Forder, John R / Perin, Emerson C / Penn, Marc S / Hatzopoulos, Antonis K / Chambers, Jeffrey C / Baran, Kenneth W / Raveendran, Ganesh / Gee, Adrian P / Taylor, Doris A / Moyé, Lem / Ebert, Ray F /
    Simari, Robert D

    Circulation research

    2017  Volume 122, Issue 3, Page(s) 479–488

    Abstract: Rationale: The TIME trial (Timing in Myocardial Infarction Evaluation) was the first cell therapy trial sufficiently powered to determine if timing of cell delivery after ST-segment-elevation myocardial infarction affects recovery of left ventricular ( ... ...

    Abstract Rationale: The TIME trial (Timing in Myocardial Infarction Evaluation) was the first cell therapy trial sufficiently powered to determine if timing of cell delivery after ST-segment-elevation myocardial infarction affects recovery of left ventricular (LV) function.
    Objective: To report the 2-year clinical and cardiac magnetic resonance imaging results and their modification by microvascular obstruction.
    Methods and results: TIME was a randomized, double-blind, placebo-controlled trial comparing 150 million bone marrow mononuclear cells versus placebo in 120 patients with anterior ST-segment-elevation myocardial infarctions resulting in LV dysfunction. Primary end points included changes in global (LV ejection fraction) and regional (infarct and border zone) function. Secondary end points included changes in LV volumes, infarct size, and major adverse cardiac events. Here, we analyzed the continued trajectory of these measures out to 2 years and the influence of microvascular obstruction present at baseline on these long-term outcomes. At 2 years (n=85), LV ejection fraction was similar in the bone marrow mononuclear cells (48.7%) and placebo groups (51.6%) with no difference in regional LV function. Infarct size and LV mass decreased ≥30% in each group at 6 months and declined gradually to 2 years. LV volumes increased ≈10% at 6 months and remained stable to 2 years. Microvascular obstruction was present in 48 patients at baseline and was associated with significantly larger infarct size (56.5 versus 36.2 g), greater adverse LV remodeling, and marked reduction in LV ejection fraction recovery (0.2% versus 6.2%).
    Conclusions: In one of the longest serial cardiac magnetic resonance imaging analyses of patients with large anterior ST-segment-elevation myocardial infarctions, bone marrow mononuclear cells administration did not improve recovery of LV function over 2 years. Microvascular obstruction was associated with reduced recovery of LV function, greater adverse LV remodeling, and more device implantations. The use of cardiac magnetic resonance imaging leads to greater dropout of patients over time because of device implantation in patients with more severe LV dysfunction resulting in overestimation of clinical stability of the cohort.
    Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00684021.
    MeSH term(s) Adult ; Aged ; Bone Marrow Transplantation/methods ; Double-Blind Method ; Female ; Follow-Up Studies ; Heart Ventricles/pathology ; Humans ; Magnetic Resonance Imaging ; Male ; Microcirculation ; Middle Aged ; Organ Size ; ST Elevation Myocardial Infarction/complications ; ST Elevation Myocardial Infarction/pathology ; ST Elevation Myocardial Infarction/therapy ; Stroke Volume ; Time Factors ; Ventricular Dysfunction, Left/etiology ; Ventricular Dysfunction, Left/therapy
    Language English
    Publishing date 2017-12-05
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 80100-8
    ISSN 1524-4571 ; 0009-7330 ; 0931-6876
    ISSN (online) 1524-4571
    ISSN 0009-7330 ; 0931-6876
    DOI 10.1161/CIRCRESAHA.117.311466
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  7. Article ; Online: Bone marrow cell characteristics associated with patient profile and cardiac performance outcomes in the LateTIME-Cardiovascular Cell Therapy Research Network (CCTRN) trial.

    Bhatnagar, Aruni / Bolli, Roberto / Johnstone, Brian H / Traverse, Jay H / Henry, Timothy D / Pepine, Carl J / Willerson, James T / Perin, Emerson C / Ellis, Stephen G / Zhao, David X M / Yang, Phillip C / Cooke, John P / Schutt, Robert C / Trachtenberg, Barry H / Orozco, Aaron / Resende, Micheline / Ebert, Ray F / Sayre, Shelly L / Simari, Robert D /
    Moyé, Lem / Cogle, Christopher R / Taylor, Doris A

    American heart journal

    2016  Volume 179, Page(s) 142–150

    Abstract: Background: Although several preclinical studies have shown that bone marrow cell (BMC) transplantation promotes cardiac recovery after myocardial infarction, clinical trials with unfractionated bone marrow have shown variable improvements in cardiac ... ...

    Abstract Background: Although several preclinical studies have shown that bone marrow cell (BMC) transplantation promotes cardiac recovery after myocardial infarction, clinical trials with unfractionated bone marrow have shown variable improvements in cardiac function.
    Methods: To determine whether in a population of post-myocardial infarction patients, functional recovery after BM transplant is associated with specific BMC subpopulation, we examined the association between BMCs with left ventricular (LV) function in the LateTIME-CCTRN trial.
    Results: In this population, we found that older individuals had higher numbers of BM CD133(+) and CD3(+) cells. Bone marrow from individuals with high body mass index had lower CD45(dim)/CD11b(dim) levels, whereas those with hypertension and higher C-reactive protein levels had higher numbers of CD133(+) cells. Smoking was associated with higher levels of CD133(+)/CD34(+)/VEGFR2(+) cells and lower levels of CD3(+) cells. Adjusted multivariate analysis indicated that CD11b(dim) cells were negatively associated with changes in LV ejection fraction and wall motion in both the infarct and border zones. Change in LV ejection fraction was positively associated with CD133(+), CD34(+), and CD45(+)/CXCR4(dim) cells as well as faster BMC growth rates in endothelial colony forming assays.
    Conclusions: In the LateTIME population, BM composition varied with patient characteristics and treatment. Irrespective of cell therapy, recovery of LV function was greater in patients with greater BM abundance of CD133(+) and CD34(+) cells and worse in those with higher levels of CD11b(dim) cells. Bone marrow phenotype might predict clinical response before BMC therapy and administration of selected BM constituents could potentially improve outcomes of other future clinical trials.
    MeSH term(s) AC133 Antigen/metabolism ; Adult ; Aged ; Antigens, CD34/metabolism ; Body Mass Index ; Bone Marrow Cells/metabolism ; Bone Marrow Transplantation ; C-Reactive Protein/metabolism ; CD11b Antigen/metabolism ; Cohort Studies ; Female ; Humans ; Hypertension/metabolism ; Leukocyte Common Antigens/metabolism ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Myocardial Infarction/diagnostic imaging ; Myocardial Infarction/metabolism ; Myocardial Infarction/physiopathology ; Myocardial Infarction/therapy ; Obesity/metabolism ; Prospective Studies ; Receptors, CXCR4/metabolism ; Recovery of Function ; Smoking/metabolism ; Ventricular Dysfunction, Left/diagnostic imaging ; Ventricular Dysfunction, Left/metabolism ; Ventricular Dysfunction, Left/physiopathology ; Ventricular Dysfunction, Left/therapy ; Ventricular Function, Left
    Chemical Substances AC133 Antigen ; Antigens, CD34 ; CD11b Antigen ; CXCR4 protein, human ; ITGAM protein, human ; PROM1 protein, human ; Receptors, CXCR4 ; C-Reactive Protein (9007-41-4) ; Leukocyte Common Antigens (EC 3.1.3.48) ; PTPRC protein, human (EC 3.1.3.48)
    Language English
    Publishing date 2016-07-06
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 80026-0
    ISSN 1097-6744 ; 0002-8703
    ISSN (online) 1097-6744
    ISSN 0002-8703
    DOI 10.1016/j.ahj.2016.06.018
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  8. Article ; Online: Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN).

    Simari, Robert D / Moyé, Lemuel A / Skarlatos, Sonia I / Ellis, Stephen G / Zhao, David X M / Willerson, James T / Henry, Timothy D / Pepine, Carl J

    Journal of cardiovascular translational research

    2009  Volume 3, Issue 1, Page(s) 30–36

    Abstract: The emerging sciences of stem cell biology and cellular plasticity have led to the development of cell-based therapies for advanced human disease. Pre-clinical studies which defined the potential of bone marrow-derived mononuclear cells to repair damaged ...

    Abstract The emerging sciences of stem cell biology and cellular plasticity have led to the development of cell-based therapies for advanced human disease. Pre-clinical studies which defined the potential of bone marrow-derived mononuclear cells to repair damaged and dysfunctional myocardium led to the rapid advancement of these strategies to the clinic. Such rapid advancement has led to controversy regarding the appropriate conduct of such studies. In the United States, the National Heart, Lung, and Blood Institute established the Cardiovascular Cell Therapy Research Network (CCTRN) to facilitate the early translation of clinical trials of cell therapy for left ventricular dysfunction. The premise upon which the CCTRN was established was that multiple clinical trial sites would interact effectively with a Data Coordinating Center to perform early phase 1 and 2 clinical trials within a highly coordinated network structure. In order to develop this network, the unmet needs of the community needed to be defined, the clinical trials identified, and the structure to perform the studies needed to be established. This manuscript highlights the challenges in the development of the CCTRN and the approaches faced to define a network to perform clinical trials in human cell therapy of cardiovascular disease.
    MeSH term(s) Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Cooperative Behavior ; Evidence-Based Medicine ; Humans ; Interinstitutional Relations ; Multicenter Studies as Topic ; National Heart, Lung, and Blood Institute (U.S.)/organization & administration ; Organizational Objectives ; Practice Guidelines as Topic ; Program Development ; Recovery of Function ; Research Design ; Stem Cell Transplantation ; Translational Medical Research/organization & administration ; Treatment Outcome ; United States ; Ventricular Dysfunction, Left/physiopathology ; Ventricular Dysfunction, Left/surgery ; Ventricular Function, Left
    Language English
    Publishing date 2009-03-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2422411-X
    ISSN 1937-5395 ; 1937-5387
    ISSN (online) 1937-5395
    ISSN 1937-5387
    DOI 10.1007/s12265-009-9160-3
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  9. Article ; Online: Bone marrow characteristics associated with changes in infarct size after STEMI: a biorepository evaluation from the CCTRN TIME trial.

    Schutt, Robert C / Trachtenberg, Barry H / Cooke, John P / Traverse, Jay H / Henry, Timothy D / Pepine, Carl J / Willerson, James T / Perin, Emerson C / Ellis, Stephen G / Zhao, David X M / Bhatnagar, Aruni / Johnstone, Brian H / Lai, Dejian / Resende, Micheline / Ebert, Ray F / Wu, Joseph C / Sayre, Shelly L / Orozco, Aaron / Zierold, Claudia /
    Simari, Robert D / Moyé, Lem / Cogle, Christopher R / Taylor, Doris A

    Circulation research

    2014  Volume 116, Issue 1, Page(s) 99–107

    Abstract: Rationale: Despite significant interest in bone marrow mononuclear cell (BMC) therapy for ischemic heart disease, current techniques have resulted in only modest benefits. However, selected patients have shown improvements after autologous BMC therapy, ... ...

    Abstract Rationale: Despite significant interest in bone marrow mononuclear cell (BMC) therapy for ischemic heart disease, current techniques have resulted in only modest benefits. However, selected patients have shown improvements after autologous BMC therapy, but the contributing factors are unclear.
    Objective: The purpose of this study was to identify BMC characteristics associated with a reduction in infarct size after ST-segment-elevation-myocardial infarction.
    Methods and results: This prospective study comprised patients consecutively enrolled in the CCTRN TIME (Cardiovascular Cell Therapy Research Network Timing in Myocardial Infarction Evaluation) trial who agreed to have their BMCs stored and analyzed at the CCTRN Biorepository. Change in infarct size between baseline (3 days after percutaneous coronary intervention) and 6-month follow-up was measured by cardiac MRI. Infarct-size measurements and BMC phenotype and function data were obtained for 101 patients (mean age, 56.5 years; mean screening ejection fraction, 37%; mean baseline cardiac MRI ejection fraction, 45%). At 6 months, 75 patients (74.3%) showed a reduction in infarct size (mean change, -21.0±17.6%). Multiple regression analysis indicated that infarct size reduction was greater in patients who had a larger percentage of CD31(+) BMCs (P=0.046) and in those with faster BMC growth rates in colony-forming unit Hill and endothelial-colony forming cell functional assays (P=0.033 and P=0.032, respectively).
    Conclusions: This study identified BMC characteristics associated with a better clinical outcome in patients with segment-elevation-myocardial infarction and highlighted the importance of endothelial precursor activity in regenerating infarcted myocardium. Furthermore, it suggests that for these patients with segment-elevation-myocardial infarction, myocardial repair was more dependent on baseline BMC characteristics than on whether the patient underwent intracoronary BMC transplantation.
    Clinical trial registration information url: http://www.clinicaltrials.gov. Unique identifier: NCT00684021.
    MeSH term(s) Adult ; Aged ; Bone Marrow Cells/physiology ; Bone Marrow Transplantation/methods ; Cohort Studies ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Myocardial Infarction/diagnosis ; Myocardial Infarction/therapy ; Prospective Studies
    Language English
    Publishing date 2014-11-18
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 80100-8
    ISSN 1524-4571 ; 0009-7330 ; 0931-6876
    ISSN (online) 1524-4571
    ISSN 0009-7330 ; 0931-6876
    DOI 10.1161/CIRCRESAHA.116.304710
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Identification of Bone Marrow Cell Subpopulations Associated With Improved Functional Outcomes in Patients With Chronic Left Ventricular Dysfunction: An Embedded Cohort Evaluation of the FOCUS-CCTRN Trial.

    Taylor, Doris A / Perin, Emerson C / Willerson, James T / Zierold, Claudia / Resende, Micheline / Carlson, Marjorie / Nestor, Belinda / Wise, Elizabeth / Orozco, Aaron / Pepine, Carl J / Henry, Timothy D / Ellis, Stephen G / Zhao, David X M / Traverse, Jay H / Cooke, John P / Schutt, Robert C / Bhatnagar, Aruni / Grant, Maria B / Lai, Dejian /
    Johnstone, Brian H / Sayre, Shelly L / Moyé, Lem / Ebert, Ray F / Bolli, Roberto / Simari, Robert D / Cogle, Christopher R

    Cell transplantation

    2015  Volume 25, Issue 9, Page(s) 1675–1687

    Abstract: In the current study, we sought to identify bone marrow-derived mononuclear cell (BM-MNC) subpopulations associated with a combined improvement in left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and maximal oxygen ...

    Abstract In the current study, we sought to identify bone marrow-derived mononuclear cell (BM-MNC) subpopulations associated with a combined improvement in left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and maximal oxygen consumption (VO
    MeSH term(s) Bone Marrow Transplantation ; Cell- and Tissue-Based Therapy ; Clinical Trials as Topic ; Female ; Heart Failure/physiopathology ; Heart Failure/therapy ; Humans ; Immunophenotyping ; Male ; Middle Aged ; Myocardial Ischemia/physiopathology ; Myocardial Ischemia/therapy ; Prospective Studies ; Stem Cells/cytology ; Stroke Volume/physiology ; Ventricular Dysfunction, Left/physiopathology ; Ventricular Dysfunction, Left/therapy ; Ventricular Function, Left/physiology
    Language English
    Publishing date 2015-11-19
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1135816-6
    ISSN 1555-3892 ; 0963-6897
    ISSN (online) 1555-3892
    ISSN 0963-6897
    DOI 10.3727/096368915X689901
    Database MEDical Literature Analysis and Retrieval System OnLINE

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