This section discusses common cardiac procedures that may be unnecessary or result in overtreatment of the patient. The improper use of a cardiac procedure risks complications in otherwise stable patients.
Some cardiac procedures have been found to be in the top ten unnecessary or overused medical procedures, according to a 2016 Journal of the American Medical Association report. See: Cardiovascular Business, JAMA: Cardiac procedures among the 10 most unnecessary, overused treatments of 2016 (Anicka Slachta; Oct 10, 2017).
Commentators have noted that “some doctors may be putting patients at risk - and reaping the benefits in Medicare payments.” See: U.S. News & World Report, Are Doctors Exposing Heart Patients to Unnecessary Cardiac Procedures? (Steve Sternberg and Geoff Dougherty; Feb. 11, 2015). This article found that angioplasties and related procedures, including implanting stents, are some of the most common and controversial, but that the number of unnecessary catheterizations has been reduced after reduction efforts were made. See also “Angioplasty” and “Stenting” discussed below in this part.
In one recent situation, a South Miami Hospital agreed to pay the federal government approximately $12 million to settle allegations that it violated the False Claims Act by submitting false claims for medically unnecessary cardiac procedures. See: Cardiovascular Business, Hospital agrees to $12 million settlement for alleged unnecessary cardiac procedures (Tim Casey; Dec 09, 2016). And, 82 lawsuits, which alleged unnecessary cardiac procedures, were settled. See: Cardiovascular Business, Plaintiffs settle 82 lawsuits with cardiologist, hospitals for alleged unnecessary cardiac procedures (Tim Casey, Mar 09, 2017).
For an overview of the cardiovascular system see: Attorneys Medical Atlas, Chapter 4. Cardiovascular System.
For general information on the cardiovascular system see: Attorneys Medical Advisor §§5:1 to 5:14.
For images see: Attorneys Medical Atlas, Figure 26:5:8 Mediastinum & heart; balloon angioplasty; cut-away view; treatment and Attorneys Medical Atlas, Figure 26:5:9 Mediastinum & heart; bypass graft; cut-away view; treatment.
Coronary angioplasty, also known as percutaneous coronary intervention, is used to open clogged heart arteries usually resulting from atherosclerosis, a heart disease. Angioplasty is used to improve the symptoms of blocked arteries, such as chest pain and shortness of breath. This procedure may be used during a heart attack to open a blocked artery and reduce the amount of damage to the heart. See: Mayo Clinic, Coronary angioplasty and stents.
The angioplasty procedure involves temporarily inserting and inflating a small balloon into the artery at the clog to widen the artery. Usually, a stent in placed in the artery during the angioplasty. See: Mayo Clinic, Coronary angioplasty and stents.
See also “Stenting” discussed below in this part.
There are three pieces of equipment used during the angioplasty: a balloon catheter, coronary guide wires, and a “guide” catheter. See: Attorneys Medical Advisor § 27:47.
Counterindications for angioplasty occur in patients in which the main artery that brings blood to the left side of the heart is narrow, for patient’s with a heart muscle, if the patient has multiple diseased blood vessels, or if the patient has diabetes and multiple blockages. In these instances, coronary artery bypass surgery may be an option, and may be the better procedure than angioplasty. See: Mayo Clinic, Coronary angioplasty and stents. See also, “Bypass and Grafting” discussed below in this part.
The risks of the angioplasty procedure include:
- Blood clotting
- Re-narrowing of the artery, called restenosis
- Also possible: heart attack, damage to the artery, kidney damage, stroke, and abnormal heart rhythms
See: Mayo Clinic, Coronary angioplasty and stents.
On March 6, 2017, the FDA alerted the public about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use as the FDA has approved balloon angioplasty for use only in arteries only, not in the venous system. See: the FDA Safety Alert and the FDA Medical Devices Safety Alert.
A stent is a small wire mesh tube that allows the artery to open and supports the opening, and decreases the chance of the artery narrowing again. Some stents are coated with medication to aid keeping the artery open (drug-eluting stents), while other stents are not (bare-metal stents). See: Mayo Clinic, Coronary angioplasty and stents. For an image of a coronary artery stent see: Mayo Clinic, coronary artery stent.
Stent devices are tubular inserts of various designs. They are made of mesh that can be expanded to line the artery after the stent is threaded to the area. See: Attorneys Medical Advisor § 27:47.
After a stent placement, the patient often is prescribed medications, such as aspirin or clopidogrel (Plavix), to reduce the occurrence of blood clots forming on the stent. See: Mayo Clinic, Coronary angioplasty and stents.
Some patients diagnosed with heart disease, and treated with angioplasty and a stent, actually may have gave coronary artery spasm, a condition not requiring stenting. Researchers found that providing nitroglycerin prior to placing a stent resolved the artery blockages, indicating the true diagnosis was coronary artery spasm. See: Science Daily, A simple fix to avoid unnecessary coronary stents is overlooked by cardiologists and current cardiovascular guidelines (March 20, 2017).
When a restriction of heart blood flow is suspected, the coronary angiogram general procedures known as heart, or cardiac, catheterizations, which are used to diagnose and treat heart conditions. An angiogram is the most common type of cardiac catheterization procedure. The procedure consists of injection of a dye into the blood vessels of the heart. The x-ray machine takes a quick series of images (angiograms) of the blood vessels. If necessary, the doctor can perform an angioplasty to open clogged heart arteries during the coronary angiogram. See: Mayo Clinic, Coronary angiogram. See also “Catheterization” below in this part.
Because angiography is used to identify constricted or blocked arteries, it is a prelude to procedures to correcting a blockage problem using coronary bypass or angioplasty. See: Attorneys Medical Advisor §§17:116.
An angiogram can provide the following information:
- Shows how many of the coronary arteries are blocked or narrowed by fatty plaques (atherosclerosis)
- Pinpoints where blockages are located in the blood vessels
- Shows how much blood flow is blocked through the blood vessels
- Checks the results of a previous coronary bypass surgery
- Checks the blood flow through the heart and blood vessels
See: Mayo Clinic, Coronary angiogram.
Angiograms usually are performed only after an electrocardiogram, an echocardiogram, or a stress test as these are less invasive. See: Mayo Clinic, Coronary angiogram.
There are some risks associated with angiograms, such as radiation exposure from the x-rays. However, major complications are rare. See: Mayo Clinic, Coronary angiogram.
Cardiac catheterization is used to diagnose and treat cardiovascular conditions. For this procedure, a long thin tube called a catheter is inserted in an artery or vein in the groin, neck, or arm, and is threaded through the blood vessels to the heart. This allows diagnosis of a heart disease. Heart disease treatments, such as coronary angioplasty, are completed using cardiac catheterization. See: Mayo Clinic, Cardiac catheterization.
There are several types of catheters used in the procedure, which includes the use of guidewires, needles, and attachments to allow placement and to obtain the necessary diagnostic information. See: Attorneys Medical Advisor §§23:42, 85:34.
For a listing of normal cardiac catheterization values (pressures in mm Hg) see: Attorneys Medical Deskbook §17:5.
Cardiac catheterization is used as part of other procedures to treat heart disease, including:
- Angioplasty with or without stent placement
- Closure of holes in the heart and fixing other congenital defects
- Repair or replacement of heart valves
- Balloon valvuloplasty (to open narrowed heart valves)
- Heart arrhythmia treatment (ablation)
- Closing off part of the heart to prevent blood clots
- Alcohol septal ablation (to treat abnormally thickened heart muscle)
See: Mayo Clinic, Cardiac catheterization.
Contraindications for cardiac catheterization include patients with hypertension or who have had a recent heart attack. See: Attorneys Medical Advisor §23:43.
There is a low risk of complications with cardiac catheterization. See: Mayo Clinic, Cardiac catheterization. However, the degree of risk is affected by various patient characteristics, including age. See: Attorneys Medical Advisor §23:45.
Cardiac catheters have been the subject of several recent recalls. See: Attorneys Medical Advisor §23:45.
Bypass and Grafting
Coronary bypass surgery diverts the flow of blood around a section of a blocked or partially blocked artery in the heart. This type of surgery improves blood flow to the heart muscle by creating a new pathway to the heart. The physician takes a healthy blood vessel from the patient’s leg, arm, or chest and connects it to the other arteries in the heart so that blood bypasses the diseased or blocked artery. See: Mayo Clinic, Coronary bypass surgery.
Suitability of a patient as a candidate for coronary artery bypass grafting usually is considered by a team of cardiologists and cardiac surgeons who view coronary angiograms to visualize circulation in the coronary vessels in order to indicate where bypasses may be suitable and beneficial. See: Attorneys Medical Advisor § 27:48.
Coronary bypass surgery may be performed when a patient:
- Has severe chest pain caused by narrowing of several of the arteries that supply the heart muscle, leaving the muscle short of blood during even light exercise or at rest and when angioplasty and stenting are not recommended
- Has more than one diseased coronary artery and the heart's main pumping chamber (the left ventricle) is not functioning as it should
- Has a left main coronary artery, the artery supplying most of the blood to the left ventricle, that is severely narrowed or blocked
- Has an artery blockage for which angioplasty is not appropriate, a previous angioplasty or stent placement has not been successful, or the patient had a stent placement, but the artery has narrowed again (restenosis)
- Has an emergency situations, such as a heart attack, if the patient is not responding to other treatment
See: Mayo Clinic, Coronary bypass surgery.
During the procedure itself, it has been said that “a challenging problem is to make the grafts the proper length. Too much length allows the graft to kink; too taut a graft may pull loose.” See: Attorneys Medical Advisor § 27:49.
There may be complications that result from bypass surgery. Because this is an open-heart surgery, complications of coronary bypass surgery include:
- Heart rhythm irregularities (arrhythmias)
- Infections of the chest wound
- Memory loss or troubles with thinking clearly, which often improve within six to twelve months
- Kidney problems
- Heart attack, if a blood clot breaks loose soon after surgery
See: Mayo Clinic, Coronary bypass surgery.
It has been noted that heart attack (myocardial infarction) is the primary intraoperative complication of this type of surgery. See: Attorneys Medical Advisor § 27:50.
Prognosis and Ability to Work
The ability to work with after a coronary procedure varies significantly depending on the procedure and the characteristics of the affected person.
Regarding angioplasting and stenting, the Mayo Clinic notes that if the patient had a non-emergency procedure, the patient probably will remain hospitalized one day while the heart is monitored and medications are adjusted. Generally, the patient should be able to return to work or a normal routine the week after the angioplasty. If the patient needed angioplasty and stenting during a heart attack, the hospital stay and recovery period will likely be longer. See: Mayo Clinic, Coronary angioplasty and stents.
Regarding cardiac catheterization, recovery time is said to be quick with the patient being able to go home the same day. A patient may need to stay overnight or longer if the patient has an additional procedure, such as an angioplasty and stent placement. See: Mayo Clinic, Cardiac catheterization.
Regarding coronary bypass surgery, noting, from this group of papers at an international symposium, such general factors, which affect a return to work, are the medical treatment, psychosocial and behavioral aspects, economic considerations, cardiac rehabilitation, and comparisons of valve surgical procedures and coronary angioplasty. See: Mayo Clinic Proceedings, Return to Work After Coronary Artery Bypass Surgery (Gerald T. Gau, M.D.; September 1986).
Also, according to the Mayo Clinic, because coronary bypass surgery is a major operation, the patient can expect to spend a day or two in the intensive care unit and, barring complications, the patient likely will be discharged from the hospital within a week. However, even after the patient has been released, there may be some difficulty performing everyday tasks or walking. See: Mayo Clinic, Coronary bypass surgery. The patient’s prognosis may include a decrease in pain and a reduction in sudden death after coronary bypass. See: Attorneys Medical Advisor § 27:50.