Percutaneous coronary intervention ( PCI) is a minimally invasive non-surgical procedure used to treat stenosis of the coronary artery of the heart found in coronary artery disease. The procedure is used to place and deploy , a permanent wire-meshed tube, to open narrowed coronary arteries. PCI is considered 'non-surgical' as it uses a small hole in a peripheral artery (leg/arm) to gain access to the arterial system; an equivalent surgical procedure would involve the opening of the chest wall to gain access to the heart area. The term 'coronary angioplasty with stent' is synonymous with PCI. The procedure visualises the blood vessels via Fluoroscopy imaging and . PCI is performed by an interventional cardiologists in a catheterization laboratory setting.
Patients who undergo PCI broadly fall into two patient groups. Those who are suffering from a heart attack and are in a critical care emergency room setting and patients who are clinically at a high risk of suffering a heart attack at some future point. PCI is an alternative to the invasive surgery coronary artery bypass grafting (CABG, often referred to as "bypass surgery"), which bypasses narrowed arteries by grafting vessels from other locations in the body. Coronary angioplasty was first introduced in 1977 by Andreas Gruentzig in Switzerland.
Medical uses
The use of PCI in addition to antianginal in stable angina may reduce the number of patients with angina attacks for up to 3 years following the therapy, but does not reduce the risk of death, future myocardial infarction or need for other interventions.
Adverse events
For most patients who are not receiving primary PCI (not having PCI to treat a heart attack) the patient is usually awake during PCI, and chest discomfort may be experienced during the procedure. Bleeding from the insertion point in the groin (femoral artery) or wrist (radial artery) is common, in part due to the use of antiplatelet drugs. Some bruising is common, but occasionally a hematoma may form. This may delay hospital discharge as flow from the artery into the hematoma may continue (pseudoaneurysm) which requires surgical repair. Infection at the skin puncture site is rare and dissection (tearing) in the interior wall of an arterial blood vessel is uncommon. Allergic reaction to the contrast dye used is possible, but has been reduced with the newer agents. Deterioration of kidney function can occur in patients with pre-existing kidney disease, but kidney failure requiring dialysis is rare. Vascular access complications are less common and less serious when the procedure is performed via the radial artery.
The most serious risks are death, stroke, ventricular fibrillation (non-sustained ventricular tachycardia is common), myocardial infarction (heart attack, MI), and aortic dissection. A heart attack during or shortly after the procedure occurs in 0.3% of cases; this may require emergency coronary artery bypass surgery. Heart muscle injury characterized by elevated levels of CK-MB, troponin I, and troponin T may occur in up to 30% of all PCI procedures. Elevated enzymes have been associated with later clinical outcomes such as higher risk of death, subsequent MI, and need for repeat revascularization procedures. Angioplasty carried out shortly after an MI has a risk of causing a stroke, but this is less than the risk of a stroke following thrombolytic drug therapy.
As with any procedure involving the heart, complications can sometimes, though rarely, cause death. The mortality rate during angioplasty is 1.2%. Sometimes chest pain can occur during angioplasty because the balloon briefly blocks off the blood supply to the heart. The risk of complications is higher in:
- People aged 65 and older
- People who have kidney disease or diabetes
- Women
- People who have poor pumping function in their hearts
- People who have extensive heart disease and blockages
Procedure
- Implantation of Coronary stent
- Arterial blockage debulking: removal or reshaping of plaque
- Rotational, orbital, and/or laser atherectomy (cutting plaque out)
- Brachytherapy (use of radioactive source to inhibit restenosis)
- Coronary intravascular lithotripsy (IVL), or using sonic waves to break up calcified plaques
PCI consists of preparation of the skin area to be accessed (groin or arm), by shaving and swabbing the area with a bacteriostatic agent, usually a chlorhexidine based product. An introducer needle is inserted into the target artery. Once the access is gained, a "sheath introducer" is inserted to keep the artery open. This procedure is termed percutaneous access. As of 2023, catheter systems used in PCI procedures are often fully integrated medical devices. They are usually referred to as "over the wire" or OTW catheters. Typically having two lumen paths (a cavity within any tubular structure), the larger one for the navigating highly flexible guidewire and the smaller one for inflating and deflating the balloon or balloon/catheter assembly. The guidewire lumen extends the total length of the catheter. A balloon-stent is often part of the assembled device, other features may also be part of the medical device design depending on the nature of the procedure.
The interventional cardiologist uses the entry point created during the percutaneous access step, to introduce the catheter system and guides it to the occluded area of the coronary artery being treated, using fluoroscopy and radiopaque dyes as an imaging tool. The device and its balloon/stent components can be inflated to open the Stenosis diseased artery area. When a stent is used, the stent tube mesh is initially collapsed onto the balloon component of the catheter. In this collapsed state, it is small enough to be passed though relatively narrow peripheral arteries and then inflated by the underlying balloon and pressed firmly against the diseased coronary artery wall. It is expanded by pressure introduced by injecting physiological saline into the device through the lumen of the still attached catheter. Inflation time and pressure used are recorded during this placement procedure. After the balloon inflation/deflation or the deposition of the stent, the placement device/deflated balloon are removed leaving the stent in place.
The interventional cardiologist decides how to treat the blockage in the best way during the PCI/stent placement, based on real-time data. The cardiologist uses imaging data provided by both intravascular ultrasound (IVUS), and Fluoroscopy imaging (combined with a radiopaque dye) during the procedure. The information obtained from these two sources enables the cardiologist to track the path of the catheter-device as it moves through the arterial vessels. This information also helps determine both the location and physical characteristics of plaque(s) causing narrowing in the arteries. Data from these two techniques is used to correctly position the stent and to obtain detailed information relating to the coronary arterial anatomy. This anatomy varies greatly among individuals, having this information becomes crucial for effective treatment. The obtained data is recorded on video and is of value in cases when future treatment is needed.
Types of stent
DES stents have been shown to help prevent restenosis of the artery through mechanisms that rely upon the suppression of tissue growth at the stent site and local modulation of the body's inflammatory and immune responses. The first two drug-eluting stents to be utilized were the paclitaxel-eluting stent and the sirolimus-eluting stent, both of which have received approval from the U.S. Food and Drug Administration. Most current FDA-approved drug-eluting stents use sirolimus (also known as rapamycin), everolimus and zotarolimus. Biolimus A9-eluting stents, which utilize biodegradable polymers, are approved outside the U.S.
Newer-generation PCI technologies aim to reduce the risk of late stent thrombosis or other long-term adverse events. Some DES products market a biodegradable polymer coating with the belief that the permanent polymer coatings of DES contribute to long-term inflammation. Other strategies: A more recent study proposes that in the case of population with diabetes mellitus—a population particularly at risk—a treatment with paclitaxel-eluting balloon followed by BMS may reduce the incidence of coronary restenosis or myocardial infarction compared with BMS administered alone.
After placement of a stent or scaffold, the patient needs to take two antiplatelet medications (aspirin and one of a few other options) for several months to help prevent blood clots. The length of time a patient needs to be on dual antiplatelet therapy is individualized based risks of ischemic events and bleeding risk.
Thrombus aspiration
Complex lesions
Recovery and rehabilitation
If a stent has been placed as part of the PCI procedure, the patient will be given a 'medical device card' (US) with information about the implanted stent such as a medical device serial number, this is important as it informs clinicians performing future potential medical procedures, this is also the case with arterial closure systems which are also medical devices.
There is usually significant soreness at the point of entry into the arterial system, and fairly large (significant bruising) are very common, this soreness usually improves after a week or so. Patients are generally advised to 'take it easy' for a week or two and are instructed to be cautious not to lift any substantial weight, this is primarily to ensure the access site heals. Follow up appointments within a week or two of the procedure with a cardiologist or primary care provider/GP are a standard global practice.
It is a standard practice to have further follow-up examinations every three to six months for the first year, though these practices do vary by region and practitioners. Further diagnostic coronary angiography is not routinely indicated after coronary stent implantation. If progression of heart disease is suspected, a stress test will be performed; patients who develop symptoms or show evidence of ischemia in a stress test may undergo diagnostic cardiac re-catheterization.
Physical examinations play an important role after PCI-stenting procedures. Those patients at high risk of suffering from complications and those with more complexed coronary issues, angiography may be indicated regardless of the findings of non-invasive stress tests.
Cardiac rehabilitation activities are dependent on many factors, but largely are connected to the degree of heart muscle damage prior to the PCI/DES procedure. Many patients who undergo this procedure have not had a heart attack, and may have no notable damage to their hearts. Others may have had a serious heart attack and the amount of damage to their heart's ability to supply the body with oxygenated blood might be impaired. Rehabilitation activities are prescribed to fit each individuals needs.
Usage
Comparison to CABG
History
Research
Controversy
/ref> 85% of patients in the medical therapy arm elected to have PCI at the end of the trial.
The 2019 ISCHEMIA trial has confirmed that invasive procedures (PCI or CABG) do not reduce death or heart attacks compared to medical therapy alone for stable angina. Patients with angina experienced improved quality of life with PCI compared to medical therapy.
External links
- Q&A: Primary angioplasty, 18 Oct 2008
- Percutaneous Coronary Intervention - Patient UK
- Percutaneous Coronary Intervention - Medscape
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