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Vasoplegia in Orthotopic Heart Transplant Patients

Posted in Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, International Global Work in Pharmaceutical, Medical Devices R&D and Inventions, Nitric Oxide in Health and Disease, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Systemic Inflammatory Response Related Disorders, Technology Transfer: Biotech and Pharmaceutical, tagged BMI, cardiothoracic surgery, Cheyne-Stokes Respiration, Conditions and Diseases, Heart Failure, Heart Lung Transplant, Larry H. Bernstein, mechanical support, surgery, thyroid disease, vasoplegia on June 30, 2013| Leave a Comment »

Pre-operative Risk Factors and Clinical Outcomes Associated with Vasoplegia in Recipients of Orthotopic Heart Transplantation in the Contemporary Era.

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Patarroyo M, Simbaqueba C, Shrestha K, Starling RC, Smedira N, Tang WH, Taylor DO.

J Heart Lung Transplant. 2012 Mar;31(3):282-7. http://dx.doi.org/10.1016/j.healun.2011.10.010 Epub 2011 Nov

BACKGROUND: Patients who underwent orthotopic heart transplant (OHT) can develop vasoplegia, which is

associated with high mortality and morbidity.

Herein we examine the per-operative risk in OHT recipients at Cleveland Clinic. Vasoplegic syndrome is

low systemic vascular resistance ( SVR index <1,600 dyn∙seg/cm5/m2 ) and
high cardiac output ( cardiac index >2.5 l/min/m2 )
within the first 4 postoperative hours.

VPS occurs more frequently after on pump CABG surgery versus off pump CABG surgery.

Methylene blue and vasoplegia: who, when, and how?

Stawicki SP, Sims C, Sarani B, Grossman MD, Gracias VH.

Department of Surgery, Division of Surgical Critical Care, University of Pennsylvania School of Medicine

Mini Rev Med Chem. 2008 May;8(5):472-90. http://www.ncbi.nlm.nih.gov/pubmed/18473936

Vasoplegia or vasoplegic syndrome (VS) is thought to be due to

dysregulation of endothelial homeostasis and subsequent endothelial dysfunction
secondary to direct and indirect effects of multiple inflammatory mediators.

Vasoplegia has been observed in all age groups and in various clinical settings, such as anaphylaxis (including protamine reaction), sepsis, hemorrhagic shock, hemodialysis, and cardiac surgery. Among mechanisms thought to be contributory to VS, the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) pathway appears to play a prominent role.

Methylene blue (MB),

an inhibitor of nitric oxide synthase (NOS) and guanylate cyclase (GC),

has been found to improve

the refractory hypotension associated with endothelial dysfunction of VS.

METHODS: We reviewed peri-operative data from 311 consecutive adult patients who underwent OHT between January 2003 and June 2008.

Vasoplegia was defined as

persistent low systemic vascular resistance,
despite multiple intravenous pressor drugs at high dose,
between 6 and 48 hours after surgery.

RESULTS: In our cohort of 311 patients, 35 (11%) patients developed vasoplegia syndrome; these patients were more likely to be UNOS Status 1A, with

a higher body surface area (1.8 ± 0.25 vs 1.63 ± 0.36, p = 0.0007),
greater history of thyroid disease (38.2% vs 18.5%, p = 0.0075) and
a higher rate of previous cardiothoracic surgery (79% vs 48%, p = 0.0006).

Pre-operatively,

they were more frequently treated with aspirin (73% vs 48%, p = 0.005) and
mechanical assist devices (ventricular assist devices [VADs]: 45% vs 17%, p < 0.0001;
total artificial hearts: 8.6% vs 0%, p < 0.0001), and
less treated with milrinone (14.7% vs 45.8%, p = 0.0005).

Bypass time (118 ± 37 vs 142 ± 39 minutes, p = 0.0002) and

donor heart ischemic time (191 ± 46 vs 219 ± 51 minutes, p = 0.002) were longer, with

higher mortality (3.2% vs 17.1%, p = 0.0003) and morbidity in the first 30 days after transplant.

In the multivariate analysis, history of thyroid disease (odds ratio [OR] = 2.7, 95% CI 1.0 to 7.0, p = 0.04) and VAD prior to transplant (OR = 2.8, 95% CI 1.07 to 7.4, p = 0.03)

were independent risk factors for development of vasoplegia syndrome.

CONCLUSIONS:

High body mass index,
long cardiopulmonary bypass time,
prior cardiothoracic surgery,
mechanical support,
use of aspirin, and
thyroid disease

are risk factors associated with development of vasoplegia syndrome.

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First drug to improve heart failure mortality in over a decade – HealthCanal.com (pharmaceuticalintelligence.com)
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Other related articles fpublished on thie Open Access Online Sceintific Journal include the following:

Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure (larryhbern)

http://pharmaceuticalintelligence.com/2013/06/20/phrenic-nerve-stimulation-in-patients-with-cheyne-stokes-respiration-and-congestive-heart-failure/
First drug to improve heart failure mortality in over a decade – HealthCanal.com (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/06/03/first-drug-to-improve-heart-failure-mortality-in-over-a-decade-healthcanal-com/
Meta-analysis: Heart Failure Worsens Short-term Prognosis of NSTE-ACS Patients – TCTMD
(Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/06/06/meta-analysis-heart-failure-worsens-short-term-prognosis-of-nste-acs-patients-tctmd/

Scientists prevent heart failure in mice (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/05/29/scientists-prevent-heart-failure-in-mice/
Economic Toll of Heart Failure in the US: Forecasting the Impact of Heart Failure in the United States – A Policy Statement From the American Heart Association (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/04/25/economic-toll-of-heart-failure-in-the-us-forecasting-the-impact-of-heart-failure-in-the-united-states-a-policy-statement-from-the-american-heart-association/
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http://pharmaceuticalintelligence.com/2013/05/16/stenosis-ischemia-and-heart-failure/
Congestive Heart Failure & Personalized Medicine: Two-gene Test predicts response to Beta Blocker Bucindolol (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2012/10/17/chronic-heart-failure-personalized-medicine-two-gene-test-predicts-response-to-beta-blocker-bucindolol/

Gene Therapy Into Healthy Heart Muscle: Reprogramming Scar Tissue In Damaged Hearts
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http://pharmaceuticalintelligence.com/2013/01/09/gene-therapy-into-healthy-heart-muscle-reprogramming-scar-tissue-in-damaged-hearts/

Heart Renewal by pre-existing Cardiomyocytes: Source of New Heart Cell Growth Discovered
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http://pharmaceuticalintelligence.com/2012/12/23/heart-renewal-by-pre-existing-cardiomyocytes-source-of-new-heart-cell-growth-discovered/

Heart Remodeling by Design – Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony (Aviva lev-Ari)

http://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-symphony/

Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty (larryhbern)
http://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/
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http://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-of-intractable-cardiogenic-shock/
Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD) (larryhbern)
http://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/
Clinical Indications for Use of Inhaled Nitric Oxide (iNO) in the Adult Patient Market: Clinical Outcomes after Use, Therapy Demand and Cost of Care (Aviva Lev-Ari)
http://pharmaceuticalintelligence.com/2013/06/03/clinical-indications-for-use-of-inhaled-nitric-oxide-ino-in-the-adult-patient-market-clinical-outcomes-after-use-therapy-demand-and-cost-of-care/

Space-filling model of the cyclic guanosine monophosphate molecule, also known as cGMP, a nucleotide. This image shows the anionic (negatively charged) form. Colour code (click to show) : Black: Carbon, C : White: Hydrogen, H : Red: Oxygen, O : Blue: Nitrogen, N : Orange: Phosphorus, P (Photo credit: Wikipedia)

Ball-and-stick model of the cyclic guanosine monophosphate molecule, also known as cGMP, a nucleotide. This image shows the anionic (negatively charged) form. Colour code (click to show) : Black: Carbon, C : White: Hydrogen, H : Red: Oxygen, O : Blue: Nitrogen, N : Orange: Phosphorus, P (Photo credit: Wikipedia)