Angioplasty Surgery

Angioplasty surgery is a procedure to open narrowed or blocked blood vessels that supply blood to the heart. These blood vessels are called the coronary arteries.

A coronary artery stent is a small, metal mesh tube that expands inside a coronary artery. A stent is often placed during or immediately after angioplasty. It helps prevent the artery from closing up again. A drug-eluting stent has medicine embedded in it that helps prevent the artery from closing in the long term.

Description

Before the angioplasty procedure begins, you will receive some pain medicine. You may also be given medicine that relaxes you, and blood-thinning medicines to prevent a blood clot from forming.

You will lie on a padded table. Your doctor will insert a flexible tube (catheter) into an artery. Sometimes the catheter will be placed in your arm or wrist, or in your upper leg (groin) area. You will be awake during the procedure.

The doctor will use live x-ray pictures to carefully guide the catheter up into your heart and arteries. Liquid contrast (sometimes called "dye," will be injected into your body to highlight blood flow through the arteries. This helps the doctor see any blockages in the blood vessels that lead to your heart.

A guide wire is moved into and across the blockage. A balloon catheter is pushed over the guide wire and into the blockage. The balloon on the end is blown up (inflated). This opens the blocked vessel and restores proper blood flow to the heart.

A wire mesh tube (stent) may then be placed in this blocked area. The stent is inserted along with the balloon catheter. It expands when the balloon is inflated. The stent is left there to help keep the artery open.

The stent may be coated with a drug (called a drug-eluting stent). This type of stent may lower the chance of the artery closing back up in the future. Currently, drug-eluting stents are used in certain situations.

Reasons the Procedure is Performed

Arteries can become narrowed or blocked by deposits called plaque. Plaque is made up of fat and cholesterol that builds up on the inside of artery walls. This condition is called hardening of the arteries (atherosclerosis). Angioplasty may be used to treat: - Blockage in a coronary artery during or after a heart attack
- Blockage or narrowing of one or more coronary arteries that may lead to poor heart function (heart failure)
- Narrowings that reduce blood flow and cause persistent chest pain (angina) that medicines do not control
- Not every blockage can be treated with angioplasty. Some people who have several blockages or blockages in certain locations may need coronary bypass surgery.

Surgery Risks

Angioplasty is generally safe, but ask your doctor about the possible complications. Risks of angioplasty and stent placement are: - Allergic reaction to the drug used in a drug-eluting stent, the stent material (very rare), or the x-ray dye
- Bleeding or clotting in the area where the catheter was inserted
- Blood Clot
- Clogging of the inside of the stent (in-stent restenosis). This can be life-threatening.
- Damage to a heart valve or blood vessel
- Heart attack
- Kidney failure (higher risk in people who already have kidney problems)
- Irregular heartbeat (arrhythmias)
- Stroke (this is rare)

Before the Procedure

Angioplasty is often performed when you go to the hospital or emergency room for chest pain, or after a heart attack. If you are admitted to the hospital for angioplasty: - Tell your health care provider what drugs you are taking, even drugs or herbs you bought without a prescription. - You will most often be asked not to drink or eat anything for 6 to 8 hours before the test. - Take the drugs your provider told you to take with a small sip of water. - Tell your provider if you are allergic to seafood, you have had a bad reaction to contrast material or iodine in the past, you are taking Viagra, or you are or might be pregnant. - After the Procedure - The average hospital stay is 2 days or less. Some people may not even have to stay overnight in the hospital.
In general, people who have angioplasty are able to walk around within a few hours after the procedure depending on how the procedure went and where the catheter was placed. Complete recovery takes a week or less. You will be given information on care after your surgery.
(Prognosis)

For most people, angioplasty greatly improves blood flow through the coronary artery and the heart. It may help you avoid the need for coronary artery bypass surgery (CABG).

Angioplasty does not cure the cause of the blockage in your arteries. Your arteries may become narrow again.

Follow your heart-healthy diet, exercise, stop smoking (if you smoke), and reduce stress to lower your chances of having another blocked artery. Your healthcare provider may prescribe medicine to help lower your cholesterol or control your blood pressure. Taking these steps can help reduce your chances of complications from atherosclerosis.

Stenosis of the intracranial arteries accounts for about 8 to 10% of all ischemic strokes in the United States (Thijs et al., 2000). Of the 900,000 strokes or transient ischemic attacks (TIAs), about 70,000 to 90,000 are caused by intracranial arterial stenosis (Chimowitz et al., 2005). The major intracranial arteries include the anterior and middle cerebral arteries, the basilar artery and the intracranial segments of the vertebral artery. In previous instances (CAG#00085N), CMS has considered treatment of the internal carotid arteries grouped together with the intracranial arteries. In this analysis, CMS is evaluating stenting of the intracranial arteries separately since the treatment (angioplasty and stenting) of intracranial arterial stenosis is more technically difficult and has more inherent risks compared to carotid artery stenting.

Medical therapy with antithrombotic agents such as aspirin and warfarin to reduce ischemic events has been the standard treatment for intracranial arterial stenosis. The recently completed Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial concluded that “aspirin should be used in preference to warfarin” (Chimowitz et al., 2005). The WASID trial was a well designed and conducted randomized trial and provided evidence of the outcomes of these patients on medical therapy. Even with aspirin therapy, the investigators reported a 15% probability of ischemic stroke, brain hemorrhage, or death from vascular causes other than stroke during 1 year of follow-up (Chimowitz et al., 2005). With the high risk of subsequent events, other approaches to patients with symptomatic intracranial arterial stenosis have been considered and studied. However, there have been no published trials on other medications or procedures compared to standard medical therapy.

In recent years, intracranial angioplasty with and without stent placement has been used in patients with significant intracranial arterial stenosis who either continue to have symptoms of a TIA or develop a stroke while on treatment with antithrombotic medications. A variety of stents have been placed in the intracranial arteries outside of their FDA-approved indication for use in other vessels of the body such as the coronary arteries. In 2005, the Boston Scientific Corporation received FDA approval of a Humanitarian Device Exemption (HDE1) application for the Wingspan Stent System with Gateway PTA Balloon Catheter (FDA- Boston Scientific Reconsideration Request Letter). The Wingspan Stent System is the first system specifically indicated for intracranial angioplasty and stenting.

On February 9, 2006, CMS accepted a formal request for a national coverage analysis for intracranial angioplasty and stenting with the Wingspan Stent System with Gateway PTA Balloon Catheter. Previously, CMS had issued national noncoverage determinations for “performance of PTA to treat obstructive lesions of the vertebral and cerebral arteries” because “the safety and efficacy of these procedures are not established” (Medicare NCD Manual Section 20.7). The request recommended the following language to replace the current noncoverage language:

Effective xxxxx, Medicare covers PTA and stenting of cerebral arteries when performed in vessels with greater than or equal to 50% stenosis for patients who are refractory to medical therapy, concurrent with use of a device approved for marketing by the FDA (subject to any requirements established by the applicable FDA approval or clearance process) for this specific indication.

The requestor did not request that CMS consider the coverage of PTA without stenting. Therefore, CMS will only review the evidence for the use of intracranial stenting in association with PTA and not the use of PTA alone. The public is welcome to request a reconsideration of the use of PTA alone if sufficient evidence exists to support that request. In addition, CMS will review the use of all stents, not only the Wingspan stent, since other stents, mainly balloon expandable coronary ones, have been studied and used off FDA label for the treatment of symptomatic intracranial arterial stenosis.

History of Medicare Coverage

History of Medicare Coverage of Percutaneous Transluminal Angioplasty

Over the past six years, Medicare has expanded coverage for PTA, specifically of the carotid artery, but intracranial stenting has been nationally noncovered throughout this period. Medicare first covered PTA of the carotid artery concurrent with stent placement in accordance with the FDA approved protocols governing Category B IDE clinical trials and later in FDA required post-approval studies (Medicare NCD Manual 20.7).

Current Medicare Coverage of Percutaneous Transluminal Angioplasty

Effective March 17, 2005, Medicare expanded coverage of PTA of the carotid artery when performed on patients who are at high risk for carotid endarterectomy (CEA) and also have symptomatic carotid artery stenosis = 70% only when performed in a CMS-approved facility for carotid artery stenting with FDA-approved carotid artery stenting systems and embolic protection devices.

PTA to treat obstructive lesions of the vertebral and cerebral arteries remained noncovered with the release of this NCD on March 17, 2005. Because of the existing noncoverage policy for PTA of the vertebral and cerebral arteries, the angioplasty would not be covered by Medicare for beneficiaries participating in FDA designated investigational device exemption (IDE) clinical trials.

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