BME 301 - Rice University

BME 301 - Rice University

BME 301 Lecture Nineteen Progression of Heart Disease High Blood Pressure High Cholesterol Levels Atherosclerosis Ischemia Heart Failure Heart Attack Review of Last Time What is heart failure?

Occurs when left or right ventricle loses the ability to keep up with amount of blood flow http://www.kumc.edu/kumcpeds/cardiology/ movies/sssmovies/dilcardiomyopsss.html How do we treat heart failure? Heart transplant LVAD Rejection, inadequate supply of donor hearts Can delay progression of heart failure Artificial heart

Artificial Heart - History First artificial heart implanted in 1969 No more human trials until the 1980s History of Artificial Heart http://images.usatoday.com/news/_photos/2001-11-30- http://www.cnn.com/ 2001/HEALTH/ conditions/07/03/ artificial.heart/ June 2001

August 2001 http://discover.npr.org/ features/feature.jhtml? wfId=1123833 http://discover.npr.org/ features/feature.jhtml? wfId=1127758 November 2001 http://discover.npr.org/ features/feature.jhtml? wfId=1133260 heartguy.jpg

History of Artificial Heart 1958: http:// www.access excellence.o rg/WN/ graphics/ Designed by Drs. Willem Kolff and Tetsuzo Akutsu Polyvinyl chloride device Sustained a dog for 90 minutes 1965:

Dr. Willem Kolff Silicone rubber heart Tested in a calf http:// www.abiomed.co m/images/ History of Artificial Heart 1969: http:// www.abiome d.com/ images/ Dr. Domingo Liotta

First to be implanted in human as bridge to transplant Patient survived for 3 days with artificial heart and 36 hours more with transplanted heart 1982: Drs. Willem Kolff, Donald Olsen, and Robert Jarvik, Jarvik-7 First to be implanted in a human as destination therapy http://www.ps-lk3.de/images/ABIOCOR.JPG http://static.howstuffworks.com/gif/artificial-heart-abiocordiagram.gif AbioCor Artificial Heart

http:// www.heartpioneers .com/ newsimages.html# Cost: $70-100k http://www.cardiocaribe.com/newsite/images/articulos/feb02/ abiocor_hand.jpg Surgical Procedure

Surgeons implant energy-transfer coil in the abdomen The chest is opened and patient is placed on a heartlung machine Surgeons remove the right and left ventricles of native heart. This part of the surgery takes two to three hours Atrial cuffs are sewn to native heart's right and left atria A plastic model is placed in the chest to determine the proper placement and fit of the heart in the patient Grafts are cut to an appropriate length and sewn to the aorta and pulmonary artery The AbioCor is placed in the chest. Surgeons use "quick connects" -- sort of like little snaps -- to connect heart to the pulmonary artery, aorta and left and right atria. All of the air in the device is removed The patient is taken off the heart-lung machine http://www.heartpioneers.com/images/news/ implant_thumb.jpg http://www.louisville.edu/hsc/medmag/ss01/ images/abio-prep.gif http://www.pbs.org/wgbh/nova/eheart/transplantwave.html Clinical Trial of AbioCor

Goals of Initial Clinical Trial Determine whether AbioCor can extend life with acceptable quality for patients with less than 30 days to live and no other therapeutic alternative To learn what we need to know to deliver the next generation of AbioCor, to treat a broader patient population for longer life and improving quality of life. Clinical Trial of AbioCor Patient Inclusion Criteria (highlights)

Bi-ventricular heart failure Greater than eighteen years old High likelihood of dying within the next thirty days Unresponsive to maximum existing therapies Ineligible for cardiac transplantation Successful AbioFit analysis Patient Exclusion Criteria (highlights) Heart failure with significant potential for reversibility Life expectancy >30 days Serious non-cardiac disease

Pregnancy Psychiatric illness (including drug or alcohol abuse) Inadequate social support system Clinical Trial of AbioCor Clinical Trial Endpoints All-cause mortality through sixty days Quality of Life measurements Repeat QOL assessments at 30-day intervals until death Number of patients Initial authorization for five (5) implants

Expands to fifteen (15) patients in increments of five (5) if 60-day experience is satisfactory to FDA Consent Form http://www.abiomed.com/ Fabiocor.html Planning a Clinical Trial Two arms: Outcome:

Treatment group Control group Primary outcome Secondary outcomes Sample size: Want to ensure that any differences between treatment and control group are real Must consider $$ available Example Planning a Clinical Trial New drug eluting stent Treatment group:

Control group: Primary Outcome: Secondary Outcomes: Sample Size Calculation There will be some statistical uncertainty associated with the measured restenosis rate Goal:

Uncertainty << Difference in primary outcome between control & treatment group Choose our sample size so that this is true Types of Errors in Clinical Trial Type I Error: Type II Error: We mistakenly conclude that there is a difference between the two groups, when in reality there is no difference

We mistakenly conclude that there is not a difference between the two, when in reality there is a difference Choose our sample size: Acceptable likelihood of Type I or II error Enough $$ to carry out the trial Types of Errors in Clinical Trial Type I Error: We mistakenly conclude that there IS a

difference between the two groups p-value probability of making a Type I error Usually set p = 1% - 5% Type II Error: We mistakenly conclude that there IS NOT a difference between the two Beta probability of making a Type II error Power = 1 beta = 1 probability of making a Type II error Usually set beta = 10 - 20%

How do we calculate n? Select primary outcome Estimate expected rate of primary outcome in: Set acceptable levels of Type I and II error Treatment group Control group Choose p-value Choose beta Use sample size calculator

WA10 http://www.bme.utexas.edu/faculty/richardskortum/BME301/students/calendardoc.htm Drug Eluting Stent Sample Size Treatment group: Control group: 1 year restenosis rate Expected Outcomes:

Get angioplasty Primary Outcome: Receive stent Stent: 10% Angioplasty: 45% Error rates: p = .01 Beta = 0.2

55 patients required Assignments Due Next Time HW8, Part Two Presentations: April 8th E-mail from Mark Carlson with details Exam Two:

April 13th Will cover Vaccines Cancer Detection Practice Exam is posted TA review session -

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