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The Hearts Have It
Emily E. Hass, M.D.
University of Colorado Denver
777 Bannock St
Denver, CO 80204
(303) 436-5498
[email protected]
Kevin J. Kuhn
Wheeler Trigg O’Donnell LLP
370 Seventeenth St, Ste 4500
Denver, CO 80202-5647
(303) 244-1841
[email protected]
Emily E. Hass, MD, is the Director, Cardiac Cath Lab/Interventional Cardiology
at Denver Health Medical Center and an Assistant Professor at the University
of Colorado. A former Duke internal medicine professor, Dr. Hass performs
interventional cardiology procedures and diagnostic studies. She is a graduate of
Penn State University and the Pennsylvania State College of Medicine.
Kevin J. Kuhn is a partner at Wheeler Trigg O’Donnell LLP in Denver, Colorado.
He has 34 years of experience defending health care providers and institutions,
including cardiologists and cardiothoracic surgeons. He has tried 80 jury trials and
is a Fellow in the American College of Trial Lawyers.
The Hearts Have It
Table of Contents
I.Introduction....................................................................................................................................................5
II.Presentation....................................................................................................................................................5
A. Guidelines for Cardiac Care....................................................................................................................5
B. Heart Anatomy Refresher.......................................................................................................................5
C. Fun Heart Facts.......................................................................................................................................8
D. Normal Heart Function—and the Abnormal Caveats..........................................................................8
E. Tests to Measure Heart Functions..........................................................................................................9
F. Indications for Cardiac Catheterizations.............................................................................................10
G. Risks of Cardiac Catheterization..........................................................................................................11
H. Significant, Insignificant and Borderline Coronary Stenoses Found on Cardiac Catheterization.......11
I. Possible Treatments of Verified Significant Coronary Stenoses Depending on
Clinical Symptoms.................................................................................................................................12
J. Indications for Revascularization (A Stent/PCI or CABG).................................................................12
K. If Revascularization Is Appropriate, Who Should Get a CABG and Who Should Get Stents?.........13
L. Percutaneous Revascularization Tools.................................................................................................13
M. Additional Common Percutaneous Heart Interventions....................................................................14
N. Medico Legal Issues in Heart Cases.....................................................................................................14
1. Medico Legal Issues in Myocardial Infarctions (commonly known as a heart attack).............14
2. Medico Legal Issues in Atrial Fibrillation....................................................................................16
3. Medico Legal Issues in Infective Endocarditis.............................................................................17
O. Medical Malpractice Claims “Converted” to Business Torts..............................................................18
1. Unfair Trade Practices Acts...........................................................................................................18
2. Advertising Claims.........................................................................................................................19
3. Fraud Claims..................................................................................................................................19
4. Other Legal Issues..........................................................................................................................20
III. Helpful Resources.........................................................................................................................................20
The Hearts Have It ■ Hass and Kuhn ■ 3
The Hearts Have It
I.Introduction
Dr. Hass will provide an overview of “the heart” from a medical perspective, with an emphasis on
techniques and procedures that are used for diagnosis and therapy of various heart disease processes that may
be encountered in the medico-legal setting. Mr. Kuhn will provide an overview of medical malpractice and
other legal issues that relate to matters of the heart.
II.Presentation
A. Guidelines for Cardiac Care
Guidelines for cardiac care are generally determined from study-driven evidence. Guidelines are
published by the American College of Cardiology (ACC), American Heart Association (AHA) and Society for
Coronary Angiography and Intervention (SCAI). Surgical guidelines are published through The Society of
Thoracic Surgeons (STS) and the American Association of Thoracic Surgery (AATS).
Each such set of guidelines are intended to assist physicians, but are not intended to substitute
for independent judgment given the particular circumstances of the patient. The guidelines include such a
caveat:
The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define
practices that meet the needs of most patients in most circumstances. The ultimate judgment
regarding care of a particular patient must be made by the healthcare provider and patient in
light of all the circumstances presented by that patient. As a result, situations may arise for
which deviations from these guidelines may be appropriate.
Levine, et al., 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention at e48.
B. Heart Anatomy Refresher
1.Definition (From Taber’s Cyclopedic Medical Dictionary). “A hollow, muscular organ, the pump of
the circulatory system.”
2.The heart has 4 chambers: 2 atria (“upper” chambers) and 2 ventricles (“lower” chambers).
A wall (atrial septum) divides the right atrium from the left, and a wall (ventricular septum)
divides the right and left ventricle from each other.
3.Left side of the heart: the circuit for the blood begins here. The left side and arteries transport
blood from the heart to the body. Oxygen rich blood from the lungs fills the left atrium, which
dumps into the main pumping chamber of the heart, the left ventricle. The left ventricle squeezes
to pump oxygen-rich blood out into the system via the aorta, the largest artery in the body.
Branches of arteries from the aorta supply all of the oxygenated blood to the body.
The Hearts Have It ■ Hass and Kuhn ■ 5
Diagram Source: Wikipedia.
4.Right side of the heart: the circuit for the blood is completed here, bringing blood from the body
back to the heart. As blood comes back from the body, oxygen is used by the organs and muscles. Branches of veins transport oxygen-poor blood into the largest veins in the body, the inferior and superior vena cava bring the oxygen-poor blood back to the right atrium of the heart
which dumps into the right ventricle. The right ventricle pumps blood to the lungs via the pulmonary artery to become oxygenated. The pulmonary veins then dump oxygen-rich blood to the
left atrium and the cycle begins again.
BRIEFLY: arteries carry oxygen-rich blood, veins carry oxygen-poor blood. The exception to
this is the pulmonary system: the pulmonary artery carries oxygen-poor blood and the pulmonary veins carry oxygen-rich blood.
5. The heart has four valves:
1. Mitral valve: between the left atrium and left ventricle.
2. Aortic valve: valve through which left ventricular blood is ejected into the arterial circulation via the aorta.
3. Tricuspid valve: between the right atrium and right ventricle.
4. Pulmonic valve: valve through which the right ventricular blood is ejected to the pulmonary artery (lungs) to pick up oxygen.
6.Coronary arteries: There are two main coronary systems of the heart, one that comes off the left
side of the aorta (the left coronary system), and one that comes off the right (the right coronary
system). The arteries typically lie on the surface of the heart muscle, supplying blood to this
muscle as it contracts.
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Diagram source: Wikipedia.
a.
Left coronary system: supplies the left main artery, which divides into two arteries, the left
anterior descending artery and the left circumflex.
● Left anterior descending (LAD) supplies branches called diagonals; the LAD and its
branches supply the anterior and anterolateral (the front and the front-side) heart
muscle
● Left circumflex (LCX) supplies branches called obtuse marginal: the LCX and its
branches supply the lateral and inferolateral (side and bottom-side) heart muscle.
20% of the time, the LCX also supplies a posterior descending artery (PDA)
b.
Right coronary system: supplies one artery, the right coronary artery (RCA). The RCA supplies branches called marginal branches and posterolateral branches. 80% of the time, the
RCA also supplies the posterior descending artery (PDA). The RCA and its branches supply
the right ventricle muscle, the inferolateral (bottom-side), posterior and inferior (back and
bottom) of the left ventricle heart muscle.
● Dominance: a coronary vessel system is termed either right or left dominant, determined by which system supplies the back and bottom of the heart via the PDA. 70%
of the time, the PDA arises from the right system, 20% of the time from the left system, and 10% of the time from both (termed co-dominant)
c.
Coronary veins: the heart has one main vein which takes blood back from the heart muscle, called the coronary sinus.
d.
Electrical System of the Heart: transmits signals to the heart muscle to control its pumping.
● Sinoatrial node (SA node)—a bundle of cells located in the upper right atrium; electrical signal is initiated here
● Atrioventricular node (AV node)—a bundle of cells located in the floor of the right
atrium that receives electrical signal and delivers it to the ventricles where pathways
carry signal throughout the muscle to tell it to contract
The Hearts Have It ■ Hass and Kuhn ■ 7
C. Fun Heart Facts
● Every day you are alive, your heart creates enough energy to power a truck for 20 miles of driving. For your whole lifetime, that would be enough to drive that truck to the moon and back.
● During a normal life span, the heart will pump about 1.5 million barrels of blood – enough to fill
about 200 train tank cars.
● Your heart pumps blood to almost all of your cells, quite a feat considering there are about 75
trillion of them. Only our corneas receive no blood supply.
● Of the days of the year, Christmas Day sees the most heart attacks, followed by December 26th,
followed by New Year.
● The time when the most heart attacks occur? Monday morning.
● The first cardiac catheterization was performed in 1929, with the doctor, a German surgeon by
the name Werner Forssmann, putting the catheter in his own arm vein, and examining his own
heart.
● The first successful heart transplant was performed in 1967 by Dr. Christian Barnard of South
Africa. The recipient only lived 18 days. It was a huge medical breakthrough.
● Laughter has terrific benefits for your heart. Laughter can actually send 20% more blood flowing
through your entire body, relaxing the walls of your vessels.
● People can actually die from a broken heart. After suffering a terrible loss or traumatic event, the
body releases stress hormones into your bloodstream that can temporarily mimic the symptoms
of a heart attack, even causing heart failure.
D. Normal Heart Function—and the Abnormal Caveats
1.Ejection fraction (EF): a measurement of percentage of blood that is ejected from the left ventricle with each squeeze of the ventricle. A normal heart at rest ejects 55-75% of the blood in the
ventricle (EF=55-75%).
a. If the ventricle is weakened, this will produce a decreased EF, termed systolic dysfunction. There are grades of dysfunction: mild—EF 45-54%, moderate—EF 30-44%, severe—
EF<30%.
2.Diastolic heart function: diastole is the relaxation of the ventricle after it squeezes. Normal diastolic function allows the ventricle to fill with blood.
a. If the heart does not relax well, it becomes “stiff,” making it difficult for the ventricle to fill
with blood without backing up into the pulmonary circulation. This is called diastolic dysfunction.
3.Heart valve function: Normal heart valve function allows blood to go forward from the atria to
the ventricles (tricuspid and mitral valves) and from the ventricles to the arteries (pulmonic and
aortic valves). There should be no impediment to forward flow and should not leak backward.
a. Heart valves may become “stiff,” inhibiting forward flow (valve stenosis) or may become
leaky, causing backward flow (valve regurgitation). Both can be present simultaneously.
4.Coronary blood flow: In normal coronary artery flow, there is adequate perfusion of the heart
muscle at both rest and during exercise.
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a. Abnormal coronary blood flow (most often caused by a partial or complete blockage of an
artery) can lead to decreased blood flow to the heart muscle. When the heart muscle does
not get enough oxygen/blood either at rest or with exercise, it produces heart muscle pain
(angina). If the heart muscle is deprived of blood flow/oxygen for too long, it may cause
portions of the heart muscle to die (heart attack).
5Heart rate and rhythm: Normal heart rhythm is called sinus rhythm, an electrical signal that is
generated in the sinus node and is transmitted to the ventricles without disturbance, causing the
atria to contract, followed by the ventricles. A normal resting heart rate is between 55 and 90
beats per minute. A high level of fitness may lead to a lower resting heart rate.
a. Abnormal rhythms are called arrhythmias, and may arise from either the atria or ventricles. Abnormal heart rates are usually the result of a malfunction of the electrical system,
causing bradycardia (slow) or tachycardia (fast).
E. Tests to Measure Heart Functions
1.Echocardiogram: an ultrasound of the heart performed with probe on top of the chest (termed a
transthoracic echo or TTE). Echo is best used to evaluate chamber sizes and motion, systolic and
diastolic function and heart valve function. If more detailed pictures of certain heart structures
are needed, it may require inserting a special probe down the esophagus, termed a transesophogeal echo (TEE).
2.Electrocardiogram (ECG): a painless tracing of the heartbeat produced by placing multiple electrodes on the skin of the chest. ECG has two primary uses:
a. Determine if the electrical system of the heart is functioning properly
b. Determine if there are deviations in the electrical signal that may indicate decreased perfusion of the heart muscle, most commonly depression or elevation in a certain portion of the
tracing called the ST segment
3.Myocardial stress testing: a test that evaluates how well the heart muscle is perfused by blood,
first at rest and then during actual or simulated exercise. There are multiple stress testing modalities.
a. Methods—means to determine normal or abnormal blood flow to heart muscle:
● Using ECG by itself or in combination with
i. echocardiography or
ii. nuclear perfusion imaging—computer scan generated following injection of a radioactive tracer that is taken up in the heart muscle
b. Stressors—agents that put stress on the heart:
● Exercise—the encouraged method unless the patient cannot perform exercise; if a patient
cannot exercise, then medicines are used which stress the heart (trying to simulate what
occurs during exercise)
● Vasodilating agents—medicines which increase blood flow in arteries that do not have
blockages/disease. Examples are adenosine, regadenoson and persantine
● Inotropic/chronotropic agents—medicine which increases the work of the heart by raising
heart rate and producing more squeeze. Dobutamine is the common agent used
The Hearts Have It ■ Hass and Kuhn ■ 9
4.Cardiac catheterization: a procedure to determine patency of coronary blood vessels. This is performed by inserting a 1.5-2mm tube (catheter) into an artery that leads to the aorta. The catheter is advanced to the aortic root where the coronary arteries originate. Contrast dye is injected
into the coronary arteries and x-ray images are obtained that may identify partial or complete
blockage/lesion. If a partial blockage needs further characterization, adjunctive procedures may
be used during the catheterization:
a.
Intravascular Ultrasound (IVUS)—a small ultrasound camera is advanced down the coronary artery producing images that may help quantify the extent of blockage, characterize a
blockage (such as calcium, blood clot or plaque), or visualize a tear in an artery (dissection)
b.
Optical Coherence Tomography (OCT)—similar to IVUS, but with laser technology
c.
Fractional Flow Reserve (FFR)—a wire that measures pressure is advanced past a partial
blockage to determine if the lesion is flow-limiting and to assist in decisions about revascularization. Pressure measurements are obtained at rest and again after administration of a
vasodilating agent (adenosine). The pressure measurement past the blockage is divided by
pressure measurement before the blockage. If this ratio is ≤ 0.80, the lesion is considered to
be flow-limiting
5.Holter monitor and loop recorders: portable monitors which record electrical activity of the
heart over a period time. Usually used to detect arrhythmia, bradycardia or tachycardia when
it is present only intermittently. Holter monitors are detachable. Loop recorders are generally
inserted under the skin and are reserved for longer-term recording.
6.Cardiac-specific laboratory blood tests:
a. B-type natriuretic peptide (BNP) or NT-proBNP-substances that are produced in the heart
and released when the heart is stretched and working hard to pump blood—generally elevated in heart failure; kidney dysfunction also creates an elevated level. Normal levels ≤
100 pg/ml.
b. Cardiac troponin I and troponin T—a heart-specific protein that is released into the blood
when heart cells die. Level begins to rise 2-4 hours after the onset of symptoms of heart
attack, peak at 18-36 hours and slowly decline over 10-14 days. Note that in renal failure,
troponin levels may be persistently slightly elevated. Generally, the higher the troponin, the
more damage. Normal level is ≤ 0.04 ng/ml.
c. CK-MB—a blood test that is somewhat heart specific which rises with heart damage. With
more specific testing available (troponin), it is no longer recommended to test CK-MB for
cardiac injury.
F. Indications for Cardiac Catheterizations
In 2012, SCAI updated guidelines for appropriateness to perform cardiac catheterization. (http://content.onlinejacc.org/cgi/content/full/j.jacc.2012.03.003v1).
1. Catheterization is considered appropriate in the following patients:
a. Without prior stress testing but who report symptoms and have a high pre-test probability
(>90%) or high likelihood of coronary disease in the physician’s judgment—this includes
patients with cardiac arrest or malignant ventricular heart rhythm
b. Definite or suspected coronary disease
10 ■ Medical Liability and Health Care Law ■ March 2016
c. With typical symptoms and intermediate or high risk findings on prior diagnostic testing
(usually stress testing)
d. Those undergoing transplant or heart valve surgeries
2. The panel noted situations which should NOT prompt direct cardiac catheterization. Among
others, this would include diagnostic work ups for:
a. Asymptomatic patients at low risk for coronary disease or without symptoms suggestive of
the same
b. As part of a preoperative work up for non-cardiac surgery in patients with good functional
or exercise capacity or
c. Those undergoing low-risk surgeries
G. Risks of Cardiac Catheterization
(Grossman et al, Cardiac Catheterization, Angiography and Intervention, Baltimore 1996, p. 17)
1. Vascular access risks
a. Bleeding—usually from access site (femoral > radial), with a 1-2% risk of significant bleeding
● Advanced age, being female, very thin or obese, reduced kidney function, reduced clotting
ability or blood thinners all escalate this risk
b. Dissection (tearing) of vessel at access site, perforation, creation of fistula (abnormal communication between an artery and vein), pseudoaneurysm (contained bleeding into the
vessel wall), thrombus (blood clot) formation, all <1%
2. Stroke risk 0.07%—higher if crossing the aortic valve
3. Heart attack risk 0.17%
4. Coronary perforation or dissection risk less than 0.5%, but increases to approximately 1% if
intervention performed
5. Arrhythmia, infection, allergy all <1% combined
6. Kidney damage from contrast dye (contrast induced nephropathy or CIN)—risk depends on
multiple factors, primarily baseline kidney function. If normal, risk is less, but also depends on
weight, age, sex, cardiac function and amount of dye used during the procedure
a. Risk calculators can be used to determine risk of CIN
H. Significant, Insignificant and Borderline Coronary Stenoses Found on
Cardiac Catheterization
(Catherterization and Cardiovasc Int 83:509-518; 2014)
1. Significant coronary stenosis:
a. Left main stenosis ≥ 50% diameter narrowing in the worst view by visual assessment on
angiography
b. Non-left main stenosis > 70% diameter narrowing in worst view by visual assessment on
angiography
2. Insignificant coronary stenoses: Any coronary < 50% diameter narrowing in worst view by visual
assessment on angiography
The Hearts Have It ■ Hass and Kuhn ■ 11
3. Borderline coronary stenoses: Non-left main coronary stenosis 50-69% diameter narrowing by
visual assessment
4. If visual determination by angiography is unclear or the stenosis is borderline, further assessment for significance is warranted by:
a. FFR –described above; a finding of ≤ 0.80 is considered flow limiting and should be considered significant
b. IVUS—described above; IVUS imaging indicating a left main luminal area of <6.0 sq mm
is considered significant; a non-left main vessel area of >4.0 sq mm is considered non-significant but significance of smaller areas has not been validated and probably requires FFR
testing
c. OCT—described above; is not useful in evaluation of left main
I. Possible Treatments of Verified Significant Coronary Stenoses Depending
on Clinical Symptoms
1. Do nothing
2. Treat with medications only—anti-anginal agents, aspirin, statins
3. Proceed with revascularization as appropriate to the clinical scenario
a. Percutaneous intervention (PCI/stent)
b. Coronary artery bypass grafting (CABG)
J. Indications for Revascularization (A Stent/PCI or CABG)
In 2012, SCAI updated guidelines for appropriateness to perform coronary revascularization. (JACC
Vol 59; No. 9,2012: 857-81)
1. Appropriateness was graded on a score of 1-9 which was derived from extensive literature review
and synthesis of evidence by a technical panel. Generally, higher scores indicated patients who
were at higher risk or more symptomatic and therefore derived more benefit with revascularization.
2. Factors that most heavily influenced scores indicating appropriate revascularization:
a. Acute coronary syndromes—Non ST elevation MI (NSTEMI) and ST elevation MI
(STEMI)
b. The presence of symptoms (angina or its equivalent), especially with low level activity or at
rest
c. The presence of significant left main or proximal LAD disease or the presence of significant
disease in all 3 major vessels
d. High risk noninvasive study (annual cardiac mortality >3%)
3. Factors which most heavily influenced scores indicating inappropriate revascularization:
a. Lack of symptoms
b. A low-risk non-invasive study (annual cardiac mortality <1%)
4.Scores:
a. Scores 7-9: Appropriate—revascularization likely to improve health outcomes or survival
12 ■ Medical Liability and Health Care Law ■ March 2016
b. Scores 4-6: Uncertain—likelihood that revascularization would improve health outcomes
or survival was considered uncertain. Note that “uncertain” should not be viewed as
excluding PCI for such patients
● “Uncertain” generally meant one of 2 scenarios:
i. There was insufficient clinical information in the scenario
ii. There was not a substantial literature base upon which to make a firm recommendation
c. Scores 1-3: Inappropriate—revascularization unlikely to improve health outcomes or survival
d. Health outcomes: symptoms, functional status, quality of life
5. Assumptions that affect appropriateness:
a. PCI or CABG is performed with established standards of care
b. PCI and CABG operators have appropriate clinical training and experience and outcomes
by quality assurance monitoring
● It is recommended that PCI operators perform a minimum of 50 PCIs (11 of which should
be for acute myocardial infarction/ST elevation MI) per year to maintain competency but
should not be denied privileges or excluded from performing interventions based solely on
procedural volume (JACC;62(4):357-396)
c. Note unusual circumstances exist affecting ability to revascularize such as inability to comply with necessary medications, do not resuscitate status, patient unwilling to consider
revascularization, technically not feasible, comorbidities likely to markedly increase the
procedural risk
K. If Revascularization Is Appropriate, Who Should Get a CABG and Who
Should Get Stents?
1. In general, CABG is considered appropriate with:
a. Isolated left main stenosis
b. Left main stenosis and additional CAD (low or high burden)
c. Two-vessel CAD if one of the lesions is proximal LAD
d. Three vessel CAD
2. PCI under the same scenarios above is considered inappropriate only when there is left main stenosis with an additional high CAD burden. All other scenarios are deemed PCI appropriate or
uncertain.
L. Percutaneous Revascularization Tools
1. Balloon angioplasty—A balloon is positioned in a coronary vessel across a stenosis and inflated,
pushing the blockage aside prior to placement of a stent
2. Coronary stents:
a. Bare metal—a nitinol metal cage placed across a stenosis which acts like a piece of scaffolding to hold the vessel open
The Hearts Have It ■ Hass and Kuhn ■ 13
b. Drug-eluting stents—same concept as bare metal, but coated with a drug designed to prevent new growth or blockage over time within the stent after it is placed (termed in-stent
restenosis or ISR)
3. Rotablator—a small drill used in a coronary artery to reduce a stenosis that primarily calcium
4. Thrombectomy devices—used to manually or mechanically remove blood clots from coronary
arteries
5. Ventricular assist devices:
a. Intraaortic balloon pump—a long flimsy balloon that is placed in the aorta used to take
pressure off of the heart and improve coronary blood flow. Used when the left heart is
weak.
b. Impella—a mechanical tube placed in the left ventricle which helps to deliver blood to the
aorta when the left ventricle is failing.
6. Temporary pacemakers—small electrode placed through the vein into the right ventricle to help
the heart beat properly when the electrical system of the heart fails
7. Vascular access closure devices—devices designed to close the hole in the accessed artery (usually femoral artery) at the completion of the procedure after removal of the access tube (sheath).
These can be suture-based (Perclose), or collagen-plugs (Angioseal), among others.
M. Additional Common Percutaneous Heart Interventions
1. ASD closure—a small plug is used to close a hole between the atria
2. Mitral balloon valvuloplasty—a balloon is placed across the mitral valve to open a stenosed
valve—most often caused by rheumatic heart disease earlier in life
3. Mitraclip—one or more small clips are placed on the mitral valve leaflets to help reduce severe
leaking (regurgitation) of the valve
4. Transaortic valve replacement (TAVR)—placement of a new aortic valve in patients with severe
aortic valve stenosis, approved for high risk surgical patients. In testing to be approved for moderate-risk surgical patients
a. Procedure often requires a multidisciplinary team approach which includes interventional
cardiology, cardiac surgery, anesthesiology and noninvasive cardiology (for imaging), and
takes place in a hybrid suite (room that can be used for both percutaneous intervention
and surgery)
N. Medico Legal Issues in Heart Cases
1.Medico Legal Issues in Myocardial Infarctions (commonly known as a
heart attack)
According to recent statistics from the American Heart Association, about 735,000 people in the U.S.
have heart attacks each year. Of those, about 120,000 die. Delays in treatment and misdiagnoses are common
causes of death that may lead to medical malpractice actions.
Certain factors that are commonly associated with delays in treatment, include: (1) Diabetes mellitus,
(2) Female gender, (3) Older age, especially over 70 years of age, and (4) Black or Hispanic race. Dan J. Tennenhouse, Heart Attack, 2 Attorneys Medical Deskbook §24:3.20.
14 ■ Medical Liability and Health Care Law ■ March 2016
Statistically, women have a much worse prognosis than men following a heart attack, due in part to
longer delays seeking health care by women after a heart attack. Women’s symptoms tend to not fit the classic patterns for heart attacks in men (women often do not experience chest pain), and, as a result, physicians
often fail to consider heart attack in women and delay the diagnosis. Id.
Comparative negligence of the plaintiff/patient: Many heart attack victims wait two or more hours
after their symptoms begin before seeking medical help. A recent study concluded that many may ignore
potentially life-saving warning signs as long as days or even weeks before they collapse. Delays in treatment
increase the risk of complications and death. Often when the patient finally seeks help, it is too late.
Differential diagnosis: A big challenge for emergency physicians is to determine whether patients
with chest pain actually have a myocardial infarction. The failure to diagnose an impending heart attack can
be a frequent claim against emergency medicine providers, as well as internists, cardiologists, and other physicians who understandably may not recognize vague, confounding symptoms as signs of a heart attack. See,
e.g., Keogan v. Holy Family Hosp., 622 P.2d 1246, 1261 (Wash. 1980) (Hicks, J. concurring in part, dissenting in
part) (“At trial in this case, one doctor testified that 200 different things might cause chest pain, only three of
which related to the heart.”).
The failure to diagnose a heart attack may account for as many as one-fifth of all claims paid for medical malpractice claims against emergency rooms. Patrick A. Malone, Failure to Diagnose Impending Heart
Attack, 1 Am. Jur. Proof of Facts 3d 691 (Originally published in 1988).
The patient’s description of present pain and past medical history may be helpful tools in recognizing
impending heart attack. Id.
Proximate Cause NOT Established As a Matter of Law: Draeger v. United States, No. SA-13-CA-1131,
2015 WL 5725677, at *2-*5 (W.D. Tex. Sept. 29, 2015) – The Western District of Texas found that Plaintiffs did
not meet their burden for establishing that the decedent’s regular treating physician was the proximate cause
of death from myocardial infarction for failing to order a stress test or echocardiogram. While his blood pressure readings taken at the clinic indicated fairly severe hypertension, his at home readings were not elevated.
The doctor concluded that the explanation for this contradiction lay in the phenomenon known as “White
Coat Hypertension,” meaning that an individual becomes so nervous upon visiting a doctor’s office or clinic
that it causes his blood pressure reading to be abnormally high. Evidence in the patient’s medical records
supported this conclusion, including a note from another doctor that he had White Coat Hypertension and
that he “felt nervous” on every visit to the clinic. Although the patient was in the “at risk” category (he was
a male over 70-years-old and had been diagnosed with peripheral arterial disease), the doctor did not refer
him to Cardiology for the purpose of administering a stress test or an echocardiagram, because the patient
was asymptomatic. Plaintiffs contended that the failure of the physicians to order these tests was negligent.
The court concluded that the evidence shows the decedent was asymptomatic up until the day of his heart
attack. He was physically active, he never complained of chest pains, shortness of breath, or easy fatigue. The
high blood pressure readings on his clinic visits were explained by White Coat Hypertension. Therefore, the
Plaintiffs did not establish proximate cause.
Specialty Consultation NOT Required: Guerri v. Fiengo, 49 A.3d 243, 245-48 (Conn. App. Ct. 2012)
– The decedent was suffering from chest pains and numbness in his left arm and went to the emergency
room. Pursuant to established procedures, a triage nurse performed an electrocardiogram, which indicated
an “abnormal result.” The physician working in the emergency room reviewed the results of the electrocardiogram and examined the decedent. The physician subsequently diagnosed the decedent with atypical chest wall
pain and discharged him. Later that evening, the defendant on-call cardiologist received and reviewed a copy
of the decedent’s electrocardiogram. The defendant concluded that no critical values were present and took no
The Hearts Have It ■ Hass and Kuhn ■ 15
further action. Three days later, the decedent died of a myocardial infarction. Plaintiffs claimed that the defendant failed to contact the decedent’s treating physician. Expert testimony provided that the over-reading cardiologist only has a duty to contact the treating physician when a critical value is present. The court found that
this testimony did not support a standard of care that would have required the defendant to contact the treating physician despite the absence of a critical value.
Administrative “Error” in Communicating Test Results – Violation of Standard of Care: Aubert v.
United States, No. CIV.A. 09-3566, 2011 WL 1558787, at *2-*8, *16-*17 (E.D. La. Apr. 21, 2011) – The court
found that an internist/primary care physician violated the applicable standard of care when she failed to
order diagnostic testing with the requisite amount of urgency. When the doctor first examined the decedent on January 3, 2008, she ordered an echocardiogram (ECG) and increased the dosage of his medication
because his LDL cholesterol was “abnormally high.” The doctor also conducted electrocardiogram (EKG),
which showed “P mitrale,” but no EKG changes and normal sinus rhythm. Based on her findings, she planned
to schedule an echocardiogram (ECG) with Doppler and a Pulmonary Function Test (PFT) and have the
patient return after the results of ECG and PFT were processed. The ECG (Echo /w doppler) was not performed until almost a month later on February 1, 2011 and the results were “ABNORMAL.” When the patient
returned for the results of the tests on February 11, 2011, he complained of even more frequent chest pains—
i .e., “chest pain on and off at least 20 times in 1 month....”, his LDL cholesterol levels had increased , and he
reported spikes in blood pressure with chest pain and shortness of breath on minor exertion. The doctor noted
“atypical” chest pain most likely due to reflux, but also “multiple risk factors” for coronary artery disease and
that she would order a thallium stress test. The patient was not instructed to return to the clinic or to report to
the hospital if chest pain continued, but simply to return after the stress test, which was delayed until March
11, 2008. The doctor did not enter the stress test into the system until two days later and did not indicate any
urgency whatsoever or follow up to determine why the stress test was taking so long to schedule. Due to some
bureaucratic hiccups, the order to an outside cardiology clinic was not placed until February 27, 2008. By
March 5, 2008, his stress test was scheduled for March 11, 2008. The stress test revealed abnormalities in that
there was a decrease flow in the inferior and lateral apex of the heart. When the results came back, they were
not reviewed before the nurse left for vacation on March 17, 2008. The nurse faxed the results to the clinic on
March 25, 2008. After failing to respond to two calls from the patient’s wife, the doctor finally called on March
25, 2008 to remind the patient about an upcoming appointment. His then-widow informed her that he had
passed away on March 15.
2.Medico Legal Issues in Atrial Fibrillation
Atrial fibrillation is an irregular and often rapid heart rate that can increase risk of stroke, heart failure and other heart-related complications.
Atrial fibrillation is an abnormality of the electrical system of the heart. During atrial fibrillation, the
heart’s two upper chambers (the atria) beat chaotically and irregularly — out of coordination with the two
lower chambers (the ventricles) of the heart. Atrial fibrillation occurs when this electrical impulse no longer
travels in the normal manner.
An estimated 2.7–6.1 million people in the United States have atrial fibrillation. With the aging of
population, this number is expected to increase. Approximately 2% of people younger than age 65 have atrial
fibrillation, while about 9% of people aged 65 years or older have atrial fibrillation. Symptoms may include
heart palpitations, shortness of breath and weakness.
Anti-coagulant therapy is a treatment for atrial fibrillation and may reduce the risk of stroke. However, anti-coagulants may cause increased risk of serious bleeding.
16 ■ Medical Liability and Health Care Law ■ March 2016
Doctors Met Appropriate Standard of Care When Prescribing Anti-Coagulant: Moats v. United States,
No. 3:06CV120, 2008 WL 8872727, at *9 (N.D. W. Va. Mar. 19, 2008) aff ’d, 340 F. App’x 862 (4th Cir. 2009)
and aff ’d, 340 F. App’x 862 (4th Cir. 2009) – Doctor’s prescription of a particular anti-coagulant (which was a
newer drug) was well-supported within the medical community. Plaintiff suffered a retroperitoneal hematoma
(swelling of clotted blood), which is a relatively rare complication of anticoagulation. However, a patient with
atrial fibrillation and additional risk factors of diabetes mellitus, obesity, and enlarged left atrium (all of which
plaintiff had) was in much greater risk of suffering a stroke. Therefore, treatment of the newer anti-coagulant
drug was appropriate given the risks.
Surgery is possible to treat atrial fibrillation, though it is not necessary in most patients. The “MAZE”
surgery consists of creating a number of incisions in the atrium that are then sewn together again. The atrium
can then hold and squeeze blood, but the electrical impulse cannot cross the incisions. The surgery gets its
name because it looks like a maze – there is only one path that the electrical impulse can take from the sinoatrial note to the atrioventrical node.
Diagram Source: http://www.sts.org/patient-information/arrhythmia-surgery/atrial-fibrillation-surgery
Doctor Met Standard of Care Where Patient Died from Known Complications of Surgery: Gabriel v.
Ohio State Univ. Med. Ctr., No. 14AP-870, 2015 WL 3963953(Ohio Ct. App. June 30, 2015) – The Ohio Court of
Appeals upheld the trial court’s finding that the doctor met the appropriate standard of care when performing
the “MAZE” surgery to correct the patient’s chronic atrial fibrillation. The patient died from complications of
the surgery, specifically, she developed a fistula between her left atrium and esophagus. The court concluded
that, even though the patient died as a result of the surgery, the doctor met the standard of care. The development of a fistula between the atrium and esophagus is a recognized complication of the surgery, and the doctor advised the patient of the risks.
3.Medico Legal Issues in Infective Endocarditis
Infective endocarditis (IE) is an infection caused by bacteria that enter the bloodstream and settle in
the heart lining, a heart valve or a blood vessel.
It is uncommon, but people with some heart conditions have a greater risk of developing it. In the
United States, there are up to 34,000 hospital discharges related to IE each year.
Surgical and dental procedures on certain at-risk patients increase the risk of developing IE.
The American Heart Association recommends that antibiotics be administered prior to dental procedures for patients with the highest risk of IE, including patients with a prosthetic heart valve, a history of
endocarditis, a heart transplant with abnormal heart valve function, or certain congenital heart defects.
The Hearts Have It ■ Hass and Kuhn ■ 17
Dentist’s Alleged Failure to Obtain Medical History was Not Proximate Cause of IE: Renfroe v.
Arrington, 519 S.E.2d 3 (1999) – Patient developed infective endocarditis two months after dentist performed
a cleaning, filled teeth, extracted two teeth, and fitted the patient with dentures. When filling out her patient
information form, she checked “no” on certain risk factors, including heart disease, anemia, and blood disorder. The patient testified that she was unsure what “anemia” meant. However, the dentist testified that he
would not have altered her treatment if he had known she had anemia. The court concluded that, even if the
dentist failed to take a proper medical history by failing to question patient about each response on the form
and failing to note on the form that her responses were incorrect, the patient did not show how this failure
proximately caused her injuries. At the time of treatment, the patient was unaware that she suffered from any
diseases on the form that could have placed her at risk for contracting IE.
IE may cause blocked blood vessels and reduce the blood flow to other tissues or organs, which can
lead to further complications.
$17 Million Settlement for Failure to Diagnose Infective Endocarditis – In 2014, a case reportedly settled for $17 million where plaintiff – a 13-year-old boy – suffered loss of blood to the brain, which caused left
side paralysis, blindness in left eye, and speech and cognitive deficits. The plaintiff alleged that the emergency
medicine physician failed to recognize the significance of his medical history; he had every major risk factor for
the development of infective endocarditis (congenital heart defect, surgical repairs, conduit, two stents, and prior
episode of infective endocarditis). The physician failed to order a consult from the pediatric cardiology team
which had cared for him at this hospital since birth, failed to order an admission, and failed to order urine and
blood cultures. The child was discharged without an evaluation of the potential for infective endocarditis. Medical Liability, Emergency Medicine, 34 No. 4 Verdicts, Settlements & Tactics art. 8 (April 2014).
$10 Million Settlement for Failure to Diagnose Infective Endocarditis – In 2008, a case reportedly
settled for $10.2 million where a 34-year-old corporate vice-president who earned $188,000 per year was left
with expressive language and cognitive deficits, and only limited use of his right hand and arm and a pronounced limp when walking. Plaintiff alleged that his condition of infective endocarditis was not diagnosed
by his primary care doctor or the emergency room physicians. Plaintiff ’s symptoms included murmur, fever,
and anemia. Medical Liability, Emergency Medicine/Primary Care, 28 No. 12 Verdicts, Settlements & Tactics art. 7 (Dec. 2008).
O. Medical Malpractice Claims “Converted” to Business Torts
1.Unfair Trade Practices Acts
Traditionally, physicians were exempt from unfair trade practice laws based on the view that professional services are necessary to the community and not devoted to enhancing profit. This has changed in
recent decades given the growing recognition of the business dimension of a professional practice. Lori J.
Parker, Proof of a Claim Involving Alleged Violation of State Consumer Protection or Similar Statute Against
Physician or Attorney, 79 Am. Jur. Proof of Facts 3d 199 (Originally published in 2004).
Medical malpractice claims cannot be “recast” as unfair trade practices claims. See, e.g., Sherwood
v. Danbury Hosp., 746 A.2d 730, 741 (Conn. 2000) (decision to transfuse patient with blood that had not
been tested for the presence of HIV when tested blood was available was professional judgment, not a business decision). Courts determine the underlying nature of the claim, regardless of what label is used. See, e.g.,
Lucas v. Awaad, 830 N.W.2d 141, 150 (Mich. Ct. App. 2013). Courts may examine:
(1) whether the claim pertains to an action that occurred within the course of a professional relationship; and
18 ■ Medical Liability and Health Care Law ■ March 2016
(2) whether the claim raises questions of medical judgment beyond the realm of common knowledge
and experience.
If both these questions are answered in the affirmative, the action is subject to the procedural
and substantive requirements that govern medical malpractice actions.
Id. (citation omitted).
Typically, billing and other commercial and entrepreneurial aspects of a medical practice are not
exempt from consumer protection laws. See, e.g, Scull v. Groover, Christie & Merritt, P.C., 76 A.3d 1186, 1196
(Md. 2013) (collecting cases).
2. Advertising Claims
Physicians are allowed to advertise. Following a lawsuit by the Federal Trade Commission, the AMA
is no longer permitted to restrict, regulate, or interfere with the advertisement of physician services. Am. Med.
Ass’n v. F.T.C., 638 F.2d 443, 445-46 (2d Cir. 1980).
Some courts treat physician advertising claims as entrepreneurial and subject to unfair trade practices claims. See, e.g., Wright v. Jeckle, 16 P.3d 1268, 1269 (Wash. Ct. App. 2001) (doctor’s advertising and
marketing diet drugs implicated the entrepreneurial aspects of medicine and were subject to a consumer
protection act cause of action). Others have found that advertising falls within the realm of professional, not
entrepreneurial, services. Vincent v. Essent Healthcare of Connecticut, Inc., 368 F. Supp. 2d 181, 185 (D. Conn.
2005) (allegation that hospital misrepresented its ability to provide timely emergency cesarean sections was
properly brought as a medical negligence claim, not an unfair trade practices claim).
3. Fraud Claims
Examples of Fraud Claims may include:
● False and intentionally misleading statements to patients.
● Submitting false bills or claims for service.
● Falsifying medical records or reports.
● Lying about credentials or qualifications.
● Unnecessary medical treatment or drug prescription.
A Kentucky hospital entered into a $41 million settlement of false claims related to 2006 and 2011
angioplasties and implanting stents in patients who did not need them. (http://www.justice.gov/usao-edky/
pr/ashland-hospital-pay-nearly-41-million-us-government-part-landmark-settlement). The individual doctor responsible was indicted in September 2015 on one count of fraud and 26 counts of putting false information in patients’ records to justify unneeded heart surgeries. (http://www.kentucky.com/news/hot-topics/
article42612162.html).
A Midwestern cardiologist allegedly overbilled Medicare $7.2 million for stents and catheterizations: “Dr. ______ was convicted of one count of health care fraud, 13 counts of making false statements and
one count of engaging in monetary transactions in property derived from criminal activity.” (https://www.fbi.
gov/cleveland/press-releases/2015/westlake-cardiologist-convicted-of-overbilling-medicare-and-others-of7.2-million-for-unnecessary-procedures).
Federal investigators (as well as news organizations) have begun to analyze data to evaluate doctors’
practice patterns and determine when cardiac procedures are being used unnecessarily. (http://www.usnews.
com/news/articles/2015/02/11/are-doctors-exposing-heart-patients-to-unnecessary-cardiac-procedures).
The Hearts Have It ■ Hass and Kuhn ■ 19
4.Other Legal Issues
a.Anti-Kickback Statutes
The Anti-Kickback Statute, 42 U.S.C. §1320a-7b(b), is a criminal law that prohibits the knowing and
willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients).
Last July, a Chicago doctor was convicted of accepting $2,000 monthly kickbacks from a hospital in
exchange for sending patients to the struggling facility. (http://www.chicagotribune.com/news/local/breaking/
ct-sacred-heart-hospital-kickback-met-20150702-story.html).
b.Stark Law
The Stark law, 42 U.S.C. 1395nn, prohibits physician referrals of designated health services for Medicare and Medicaid patients if the physician (or an immediate family member) has a financial relationship with
that entity.
Exemptions from the Stark law include: services provided personally by a member of the referring
physician’s group, in-office ancillary services provided by the referring physician or by a member of the physician’s group, and services located within the same building in which the referring physician generally practices.
The Stark law is a strict liability statute. Penalties for physicians who violate the Stark law include
fines as well as exclusion from participation in the Federal health care programs.
c.Affordable Care Act
California passed a law expanding the facilities that could perform catheterizations in anticipation of
a boom with more insured patients. 22 CCR §70438.2.
III. Helpful Resources
Grossman et al, Cardiac Catheterization, Angiography and Intervention, Baltimore 1996.
Hillis, et al., 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery.
Levine, et al., 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention.
Lotfi et al., Expert consensus statement on the use of fractional flow reserve, intravascular ultrasound,
and optical coherence tomography: a consensus statement of the society of cardiovascular angiography and interventions, Catheter Cardiovasc Interv. 2014; 83:509–518.
Patel, et al., ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/ SCMR/STS 2012 Appropriate Use Criteria for Diagnostic Catheterization.
Patel, et al., ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update.
Patrick A. Malone, Failure to Diagnose Impending Heart Attack, 1 Am. Jur. Proof of Facts 3d 691
(originally published 1988).
Lori J. Parker, Proof of a Claim Involving Alleged Violation of State Consumer Protection or Similar
Statute Against Physician or Attorney, 79 Am. Jur. Proof of Facts 3d 199 (Originally published in 2004).
Dan J. Tennenhouse, Heart Attack, 2 Attorneys Medical Deskbook §24:3.20.
20 ■ Medical Liability and Health Care Law ■ March 2016