Arrhythmia -- 3/23/15, 3 pg.   http://healthfully.org/rc/id13.html

Pharma:  A thought experiment:  Think like a pharma CEO (a marketing expert who maximizes profits).  It starts with FDA approval based on a phase-III trial in a select population whom would show some short-term benefit (compared to a sugar pill). You then expand usage on the basis of testing with junk marketing science called “phase IV studies” and publish them. No FDA approval is needed if your company doesn’t advertise the new usage.  You give required continuing education class taught by “friendly” key opinion leaders who “inform” doctors—so too can your sales reps.   You schmooze with “donations” politicians, regulators, health care administrators, physicians, and the medical organization that establish treatment protocols.  Advertising blitz exaggerates disease risks, hypes benefits, and hides side effects.  Pharma views clinical trials as an investment to which they can--other than falsifying data--message the evidence and conditions of the trial to produce favorable results, which is the business norm.  One study found 32% positive bias.  See Inferior Treatments, Side Effects, Marketing Science & video for an “ad nausea” account of pharma.    

A basic problem with treating an irregular heart beat with drugs is that they are not a magic bullet that just works upon the cardiac nerves.  They affect neurotransmitters; thus upset cognitive and bodily functions.  Moreover, they don’t stop arrhythmia (just modest reduction short term) and can cause pro-arrhythmia (section below).   A second basic problem is they have at best minimal effect upon the endpoint death. Cochrane Review found a failure to show benefits as to number of deaths, heart failure, and embolism (endpoints).  “In adults > 90% of sudden cardiac deaths are due to heart disease.  Advanced coronary arteriosclerosis is found in at least 2 or 3 major coronary vessels in at least 75% of cases.”[1]  These drugs do not treat cardiovascular disease (CVD).  For these 2 reasons drugs make little difference in death rate.  

“Cardiac dysrhythmia (also known as arrhythmia or irregular heartbeat) is any of a large and heterogeneous group of conditions in which there is abnormal electrical [nerve] activity in the heart.  The heartbeat may be too fast or too slow, and may be regular or irregular. A heart beat that is too fast is called tachycardia and a heart beat that is too slow is called bradycardia.  Arrhythmia may be classified by rate (normal sinus rhythm, tachycardia, bradycardia) or mechanism (automaticity, reentry, junctional, fibrillation).  Although many arrhythmias are not life-threatening, some can cause cardiac arrest.^{[B: 1]}  Arrhythmias can occur in the upper chambers of the heart, (atria), or in the lower chambers of the heart, (ventricles). Arrhythmias may occur at any age. Some are barely perceptible, whereas others can be more dramatic and can even lead to sudden cardiac death^[1].  In fact, most people will on occasion feel their heart skip a beat or give an occasional extra strong beat; neither of these is usually a cause for alarm” Wiki.  Drugs used to treat this phenomena pass the lowest standard for approval based on a short-term (surrogate outcome), and if honestly evaluated (not based on pharma’s tobacco science) would very possible for all the drugs turn out to promote, rather than prevent death (see pro-arrhythmia below).   As Sir Ian Chalmers noted “anti-arrhythmic drugs were more likely to be lethal than helpful” BMJ 2015. As Ben Goldacre (Bad Pharma, p 11) states, “over 100,000 people in their graves prematurely.” 

“Sudden cardiac death, which is a natural death from cardiac causes, heralded by abrupt loss of consciousness within one hour of the onset of acute symptoms…. commonly caused … coronary artery atheroma.   A significant number of cases also have an identifiable thrombus (clot) in a major coronary artery which causes transmural occlusion of that vessel.  Death in these cases is thought to result from a period of transient or prolonged ischaemia [lack of blood supply] in the myocardium [muscle of the heart wall] which induces an arrhythmia [a conduction disturbance], usually a ventricular arrhythmia, which progresses to ventricular fibrillation.  The second leading cause is left ventricular hypertrophy which is associated with cardiac arrhythmias.  The mechanism of death in the majority of patients dying of sudden cardiac death is ventricular fibrillation; as a consequence, there may be no prodromal symptoms associated with the death. Patients may be going about their daily business and suddenly collapse, without any typical features of myocardial infarction (heart attack) like chest pain or shortness of breath. There are a number of cases in which patients feel the effect of myocardial ischaemia. Myocardial ischaemia is associated with referred pain, classically to the front of the chest, the left arm and the jaw. Patients may feel generally unwell, with nausea, dizziness, and vomiting. These symptoms may precede the death for any length of time between a few minutes and several hours.” Wiki.  

“Proarrhythmia is a new or more frequent occurrence of pre-existing arrhythmias, paradoxically precipitated by anti-arrhythmic therapy, which means it is a side effect associated with the administration of some existing anti-arrhythmic drugs, as well as drugs for other indications.  In other words, it is a tendency of anti-arrhythmic drugs to facilitate emergence of new arrhythmias” Wiki.  The 12-year CAST trial ending in 1998 reversed the practice of giving a standard treatment antiarrhythmic drugs during and following AMI (aute myocardial infarction)—or should have.  Compared to the placebo group at 10 months, there were 3.5 times more deaths.  A CAST II had similar dismal results.  Estimates for this practice placed the deaths in excess of 100,000 (Goldacre, supra. p 134).  In addition Neurological drugs & polypharmacy and other drugs which weakens muscles very likely will cause pro-arrhythmia and thus deaths.    

Electrocardiography (ECG or EKG from Greek: kardia, meaning heart) is a transthoracic (across the thorax or chest) interpretation of the electrical activity of the heart over a period of time, as detected by electrodes attached to the surface of the skin and recorded by a device external to the body.^[1] The recording produced by this noninvasive  procedure is termed an electrocardiogram (also ECG or EKG).An ECG is a way to measure and diagnose abnormal rhythms of the heart, and helps to diagnose properly^[2] particularly abnormal rhythms caused by damage to the conductive tissue that carries electrical signals, or abnormal rhythms caused by electrolyte imbalances.^[3] In a myocardial infarction (MI), the ECG can identify if the heart muscle has been damaged in specific areas, though not all areas of the heart are covered.^[4] The ECG cannot reliably measure the pumping ability of the heart, for which ultrasound-based (echocardiography) or nuclear medicine tests are used. It is possible for a human or other animal to be in cardiac arrest, but still have a normal ECG signal (a condition known as pulseless electrical activity). An ECG is used to measure the rate and regularity of heartbeats, as well as the size and position of the chambers, the presence of any damage to the heart, and the effects of drugs or devices used to regulate the heart, such as a pacemaker.  Ten electrodes are used for a 12-lead ECG. The electrodes usually consist of a conducting gel, embedded in the middle of a self-adhesive pad onto which cables clip. Sometimes the gel also forms the adhesive.

Management:  The method of cardiac rhythm management depends on whether or not the affected person is stable or unstable. Treatments may include physical maneuvers, medications, electricity conversion, or electro or cryocautery.

Physical maneuvers: A number of physical acts can increase parasympathetic nervous supply to the heart, resulting in blocking of electrical conduction through the AV node. This can slow down or stop a number of arrhythmias that originate above or at the AV node (see main article: supraventricular tachycardias). Parasympathetic nervous supply to the heart is via the vagus nerve, and these maneuvers are collectively known as vagal maneuvers.

Anti-arrhythmic drugs:  There are many classes of antiarrhythmic medications, with different mechanisms of action and many different individual drugs within these classes. Although the goal of drug therapy is to prevent arrhythmia, “nearly every antiarrhythmic drug has the potential to act as a pro-arrhythmic” Wiki.  Though the doctors believe they are life savers, the CAST trial (supra) showed they have the opposite outcome.  Avoid for they are not magic bullets affecting just the heart. 

Electrical:  Dysrhythmias may also be treated electrically, by applying a shock across the heart — either externally to the chest wall, or internally to the heart via implanted electrodes.  Electrical treatment of dysrhythmia also includes cardiac pacing. Temporary pacing may be necessary for reversible causes of very slow heartbeats, or bradycardia, (for example, from drug overdose or myocardial infarction). A permanent pacemakermay be placed in situations where the bradycardia is not expected to recover.

Cardioversion is either achieved pharmacologically or via the application of a shock synchronised to the underlying heartbeat. It is used for treatment of supraventricular tachycardias. In elective cardioversion, the recipient is usually sedated or lightly anesthetized.

Defibrillation differs in that the shock is not synchronised. It is needed for the chaotic rhythm of ventricular fibrillation and is also used for pulseless ventricular tachycardia. Often, more electricity is required for defibrillation than for cardioversion. In most defibrillation, the recipient has lost consciousness so there is no need for sedation.  Defibrillation or cardioversion may be accomplished by an  implantable cardioverter-defibrillator (ICD).

Electrical cautery:  “Some cardiologists further sub-specialise into electrophysiology. In specialised catheter laboratories, they use fine probes inserted through the blood vessels to map electrical activity from within the heart. This allows abnormal areas of conduction to be located very accurately, and subsequently destroyed with heat, cold, electrical or laser probes.  This may be completely curative for some forms of arrhythmia, but for others, the success rate remains disappointing. AV nodal reentrant tachycardia is often curable. Atrial fibrillation can also be treated with this technique (e.g. pulmonary vein isolation), but the results are less reliable” Wiki. 

On the avoid list of American Geriatrics Society, Beers list for seniors are Anti-arrhythmic drugs (Class la, lc, iii) Amiodarone, Dofetilide, Dronedarone, Flecainide, Ibutilide, Procainamide, Propafenone, Quinidine, Sotatol.  Amiodarone is associated with multiple toxicities; Disopyramide induces heart failure.  Arrhythmia is a disease of mostly seniors and in the majority of patients following an MI.   The need for intervention is exaggerated, and drugs are not the long-term magic bullet.    Data supports in matched studies pacemaker & quality of life (for failure types). 

Anticoagulants:  arrhythmia is used to push anticoagulants based on marketing studies.  MCID = Minimal Clinically Important Difference.   “We were able to determine the MCID of warfarin therapy for the prevention of stroke from the perspective of patients with non-valvular atrial fibrillation. Their MCIDs were much smaller than those that have been implied by some experts and clinicians” journal.   This is true for all anticoagulants.  The sales ploy is to exaggerate the risk and benefits, and to hide the side effects.  Cochrane confirmed no advantage above aspirin for Warfarin or Plavix. The only worth-while preventative treatment is aspirin, made worth-while by its many benefits. Low dose aspirin is ineffective long-term because of the tolerance effect.  A study over 2 years showed that 8% of were to   

CONCLUSIONS:  arrhythmia involves the greatest degree of complexity: in treatments tailored to conditions & in diagnosis relying upon technologies.  Diagnostic sophistication is a sales made obscure by lack of clinical trial that provide answers, and made all the worse by deliberate journal bias.  Looking in from the outside, it would be inappropriate to judge physical interventions listed above, though given the record of corporate medicine caution is wise; e.g., catheter ablation has critics, drugs critics and so on.  Long-term drug treatment is highly suspect because there aren’t drugs that single out heart muscle or nerve impulses to the heart.  Long-term distorting of the carefully balanced bodily systems often has consequences that outweigh benefits. Such drugs are not muscle tonics, nor magic bullets like penicillin is for certain bacterial infections or morphine for acute pain. “Treatment strategies designed solely to suppress these arrhythmias should no longer be followed” JAMA.  Recommendations: 1) avoid drugs for arrhythmia (they are not magic bullets) including during an emergency with the exception of morphine, lidocaine, and epinephrine.  2) Avoid anticoagulants except for aspirin taken in sufficiently high dose (325, or 325 mg with meals to also prevent atherogenesis) to prevent thrombi (clots), & for its many other benefits.  Low dose is a pharma ploy, for long term, tolerance stops its antiplatelet effect—pharma studies on aspirin are short-term and don’t test for tolerance.  3) Go to a teaching hospital. 4) Ask “What would you do if you were in my shoes,” and “how significantly does quality-clinical trials support this choice.”  Most doctors believe in what they practice because they have been taught by pharma and their opinion leaders.  Most doctors are mechanics not scientists; they follow treatment protocols set up by pharma.  Major physical interventions are oversold (electrical cautery, vaga maneuvers, etc.).  You came in for their help, and their income depends on their “helping” you; thus doing something doesn’t equal doing good.  For a heart health learn about diet and prevention of atherosclerosis.  With healthy lifestyle, the body has heals itself.    

The ad post hoc fallacy (after this because of that) proves naught.   My father in the pre big-Pharma era lived 23 years after his first major heart attack in 1953.  He had another major one in 1955 and 2 minor ones several years later.  He died in 1976 of a stroke.   Dwight Eisenhower had a major heart attack in 1955.   Both were heavy cigarette smokers who quit after their first heart attack.   Subsequently Eisenhower had 6 more heart attacks and died of congestive heart failure in 1969, 14 years after the first one.  The body does a better job at healing then pharma when it comes to the heart.  As said before doing something doesn’t fix the damage caused by atherosclerosis.  Too often what pharma offers doesn’t have the sought after risk reduction endpoint. Income is dependent upon chronic illness.  Best course is to prevent atherosclerosis, the underlying cause for CVD, and thus hypertension MI, and arrhythmia.