Management of Patients with CAD receiving Invasive Interventions PCI

Prepared by: Ahmad Khalil Al-Sadi (RN, MSN, CNS)

More than 1 million PCI procedures were performed worldwide in 2000, and more than 62,000 in the UK in 2004. In 2000, more than 500,000 percutaneous coronary interventions (PCIs) were performed in the United States. By 2004, the number exceeded 650,000 in the United States with rapid growth in other developed countries. Worldwide, the number of PCIs continues to increase annually. More than 1 million PCI procedures were performed worldwide in 2000, and more than 62,000 in the UK in 2004.

The term is used to describe various procedures that can be used to mechanically improve myocardial perfusion without resorting to surgery.

WHAT IS PCI Percutaneous Coronary Intervention

1) PTCA 2) Stent implantation 3) Atherectomy

Angioplasty

Angioplasty is the mechanical alteration of a narrowed or totally obstructed vascular lumen, generally caused by atheroma (the lesion of atherosclerosis). The term derives from the roots "Angio" or vessel and "plasticos" fit for molding. The term has come to include all manner of vascular interventions typically performed in a minimally invasive or percutaneous method.

Percutaneous Transluminal Coronary Angioplasty [PTCA]

A long catheter is passed from femoral artery up to the openings of the coronary arteries. Using radioopaque dye and fluoroscopy, areas of stenosis can be identified. A deflated balloon is passed over a guidewire to a site of stenosis, where the balloon is inflated.

GOALS OF PTCA

Improve blood flow to myocardium-cracking

the atheroma

Several inflations & balloon sizes may be required to achieve desired goal, usually defined as less <20% residual stenosis
Performed under local anesthesia Provides alternative to surgery Eliminates recovery from thoracotomy surgery Pt is ambulatory within 24hrs 1-3 Days vs 5-7 post CABG

Advantages of PTCA

PTCA: Outcome
Cannot always successfully perform procedure Diffuse disease Total occlusion Calcified disease Restenosis Occurs in 25-54% of patients Usually occurs within 6 months

Mechanism of angioplasty

The enlargement of the vessel lumen through a mechanism of atheromatous plaque compression. Most of improvement in luminal diameter following balloon angioplasty results from stretching of the vessel wall and partial disruption of not only the intimal plaque but also the media and adventitia, resulting in enlargement of the lumen and the outer diameter of the vessel. Axial redistribution of plaque material also contributes to improvements in lumen diameter. Atherectomy devices and, subsequently, intracoronary stents were developed, in part, to decrease the early and late loss in luminal diameter observed with conventional balloon angioplasty.

Indications

Acute coronary syndromes PCI for ST-elevation myocardial infarction (STEMI) is more efficacious and safer than thrombolysis. In non-ST-elevation myocardial infarction (NSTEMI) and unstable angina, a strategy of early mechanical revascularization reduces later coronary events and mortality. Stable angina PCI should be considered in patients with angina despite medical therapy (or in those in whom medication is poorly tolerated because of side-effects) or high-risk features on non-invasive testing.

Angiographic indications and contraindications to PTCA

Indications: Hemodynamically significant lesion in a vessel serving viable myocardium (vessel diameter >1.5 mm)

Pts with lesions >70% stenosis placing large areas of heart

At risk for ischemia.

Relative contraindications
Left main stenosis or left main equivalent stenosis (Coronary artery bypass graft [CABG] surgery is still the preferred treatment for left main stenosis. However, this area is rapidly evolving toward safe and feasible PCI options.) Chronic total occlusion (CTO) with the following:

No proximal stump visible Extensive bridging collaterals present

Diffusely diseased small-caliber artery or vein graft Other coronary anatomy not amenable to percutaneous intervention

Once positioned, the balloon is inflated for about 10 to 30 seconds (occluding coronary flow). The balloon is then deflated and withdrawn from the coronary circulation into the guiding catheter. Injection of contrast into the coronary artery during cine acquisition enables assessment of the result.

Stents

Small stainless steel scaffold supports artery and enables blood flow. Delivered over balloon catheter. Half of PTCA procedures now include stenting.

Metallic stents Tiny, cylindrical, expandable tubes of metallic mesh, to overcome the restenosis of balloon angioplasty. Stainless steel or nitinol. Drug-eluting stents Metallic stents coated with pure drug or polymer matrix containing drug. Complications: Thrombosis (antiplatelet agents are required) Restenosis (cell proliferation should be suppressed)

CURRENT INTERVENTIONAL CARDIAC PROCEDURES

Intracoronary Stents

Used to prop or support the arterial wall. Used to keep vessels open. Anticoagulant & antiplatelet meds given to reduce risk for thrombus formation at site

an intracoronary stent (a cylindrical steel mesh) is then deployed. Inflation pressures used for stent deployment are usually higher (1220 atmospheres). After about 1530 seconds, the balloon is deflated and withdrawn into the guiding catheter, leaving the stent mesh pressed firmly against the walls of the coronary artery. Advances in stent design are such that it is now often possible to position a stent across a tight stenosis without pre-dilating the lesion (so-called primary stent implantation).

Broad indications for Stent implantation

Acute or threatened artery closure following balloon angioplasty, resulted in decreased the need for emergency surgery. Elective stent implantation for optimizing the initial and longer-term revascularization result.

Comparing Stents with Balloon Angioplasty

Reduced adverse cardiac events with stents by about 30 % in the 6 mos following the procedure. Decrease risk and need for repeat revascularization of about 50%. Stents decrease restenosis by providing the largest intimal angiographic gain and by preventing early recoil and late vessel constriction. Higher procedural success rate, long term patency, and improved in-hospital clinical outcome with stenting vein grafts.

Problems with Stenting

Neointimal hyperplasia Healing process Cellular proliferation Thrombosis Blood clotting Response to foreign body Restenosis Re-narrowing of the vessel

Drug-eluting stent

multiple types of DESs are available, with the 2 most commonly used in the United States being the sirolimus (Cypher) stent (SES) and the paclitaxel (Taxus) stent (PES). These stents comprise a metal stent with a polymer that elutes a drug that reduces neointimal hyperplasia. Newer stent platforms are evolving with more uniform drug delivery systems and with the ability for some stents to store different drugs for local intracoronary delivery. SES and PES have both been extensively tested in a wide spectrum of coronary lesions, all of which have demonstrated significant reductions in restenosis and target lesion revascularization (TLR) rates when compared with bare metal stents.

RAVEL: 1-Year survival free of MI or repeat revascularization

Controlled release of cell growth inhibitors from stents has shown promise in preventing restenosis. Most experience has accrued with sirolimus. The Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Nova Native Coronary Artery Lesions (RAVEL) evaluated a stent coated with a 5-mm thick layer of a sirolimuspolymer matrix. The stent releases active drug over a period of 30 days following placement.

1-year data in 238 patients with stable/unstable angina or silent ischemia, a single primary target lesion in a native coronary vessel of 2.5 to 3.5 mm in diameter, stenosis of 51% to 99% of luminal diameter, and a TIMI flow rate >1. Study subjects were randomized to receive the sirolimus-eluting stent or an uncoated stent. The estimate of survival free from MI and repeat revascularization. The difference between the two groups was entirely due to greater need for repeat revascularization in the uncoated-stent group ( 22.8%) versus the sirolimus-eluting stent group (0%). None of the sirolimus-eluting stent group had acute, subacute, or late thrombosis, which suggested to the RAVEL investigators that re-endothelialization had occurred.

TAXUS I: Results at 6 and 12 months

Encouraging preliminary results on preventing restenosis have been reported with a paclitaxel-eluting stent in the TAXUS I trial. To evaluate a stent coated with a paclitaxel-polymer matrix that releases active drug over 10 days, the study enrolled 61 patients with lesions of 50% to 99% luminal diameter in a native coronary vessel of 3.0 mm to 3.5 mm in diameter. Subjects were randomized to the paclitaxel-eluting stent or an uncoated stent.

TAXUS I: Results at 6 and 12 months

As shown, at 6 months there was a significant improvement in the paclitaxel eluting stent compared with the uncoated stent with regard to diameter stenosis within the stented area, with no differences at the proximal and distal edges. At 12 months, the rate of target-lesion PCI was 10% in the control group and 0% in the paclitaxel-eluting stent group.

Comparison of Therapy
Hospital Stay:
CABG 4-7 days

Angioplasty 1-2 days Stent 1-2 days

Restenosis:
CABG 5-6%, usually after 5 years Angioplasty 25-45%, usually within 6 months Stent 15-20%, usually within 6 months

Comparison of Therapy
Cost CABG $35,000 Angioplasty $17,000 Stent $19,000 Cost-effectiveness Additive procedures: Within 5 years, 20-40% of patients have second PTCA, 25% have CABG Additive costs: 0 years: per patient costs of PTCA 30-50% those of CABG 1 year: 50-60% 3 years: 60-80% >3 years: >80%

PCI COMPLICATIONS

Allergic reactions to contrast dye and contrast nephropathy

Allergic reactions related to iodine-based contrast agents for angiographic imaging are classified as minor (hives, rash), moderate (urticaria, bronchoconstriction), or severe (anaphylactoid reaction [as opposed to anaphylactic reaction] with hemodynamic collapse). In patients with a history of contrast reaction, the risk for repeated anaphylactoid reaction is generally reported to range from 17% to 35%. Previous adverse reactions to shellfish or seafood in general are believed to be associated with future anaphylactoid reaction to iodine-based contrast.

Most recent studies have defined contrast nephropathy as an increase in serum creatinine concentration of 25% or an absolute increase of 44 mol/L (0.5 mg/dL). Contrast nephropathy usually first manifests as an elevation in creatinine concentration 24 to 48 hours after the procedure that peaks 3 to 5 days after the procedure. Patient-related factors associated with an increased risk for contrast nephropathy include diabetes; preexisting renal insufficiency; and, possibly, reduced intravascular volume status.

In-stent restenosis (ISR)

Pooled data from six trials indicate that the rate of instent restenosis steadily increases over the first year, regardless of how restenosis is defined. At 12 months, 12% of patients require target lesion revascularization, almost double the rate at 6 months. At 12 months, 15.8% of patients have target vessel failure. These findings underscore the importance of at least 12-month follow-up when assessing strategies for reducing in-stent restenosis.

Restenosis is the process by which a treated arterial narrowing recurs over time. The restenosis process is now believed to occur because of negative arterial remodeling (arterial constriction) and intimal hyperplasia, combined with other complex processes. Factors associated with an increased risk for restenosis include diabetes; unstable or severe angina at the time of PCI; lesions in the left anterior descending artery or in a saphenous vein graft; total length of the lesion treated; chronically occluded arteries; previously treated lesions; and factors related to technical aspects of the procedure itself, most notably minimum luminal diameter immediately afterward. The restenotic process occurs over the first 1 to 6 to 8 months after PCI.

The presenting symptom for most patients with restenosis is exertional angina (25% to 85%); fewer patients (11% to 41%) present with unstable angina, and presentation with acute MI is rare (1% to 6%). Stents have been demonstrated to decrease restenosis rates in saphenous vein bypass grafts, in chronically occluded arteries, and in patients treated with primary angioplasty for acute MI. Drug-eluting stents dramatically reduces the rates of restenosis compared with bare-metal stents.

Stent Thrombosis

A catastrophic complication, associated with 30-day mortality rates in recent series of 20.8% to 26%. Most frequently occurs in the first days to weeks after stent implantation. Patients usually present with severe chest pain and often present with ST-segment elevation. Patients treated with bare-metal (non drug-eluting) stents should receive 4 weeks of clopidogrel in addition to aspirin to prevent stent thrombosis. Because of concern that late stent thrombosis may develop in patients who are treated with drug-eluting stents, most recent trials have extended clopidogrel treatment to 3 to 6 months after PCI, in addition to aspirin therapy.

Stent infection

Foreign body implantation predisposes to the development of infections by damaging or invading epithelial or mucosal barriers, by supporting growth of micro-organisms and by impairing host defense mechanisms. Manifested within the first four weeks after stent implantation with fever being the clinical hallmark, chest pain, and positive blood cultures. Stent infection should be suspected and blood cultures should be withdrawn in all patients presenting with fever within the first weeks after coronary stent implantation even in the absence of chest pain, ECG abnormalities or elevation of cardiac enzymes.

verification of the local infection by cardiac imaging modalities, including transthoracic and transoesophageal echocardiography, coronary angiography, computed tomography, and magnetic resonance imaging. Compliance with current standards for the prevention of infections during cardiac catheterisation are measures to prevent infection include the removal of hair from the puncture site, application of antiseptic to the skin, and the use of sterile drapes. Operators should perform appropriate hand washing, wear a sterile gown and sterile gloves and a generally sterile environment should be maintained during the procedure. Rapid institution of antibiotic treatment represents the mainstay of therapy, and surgical drainage of the infective focus including stent removal may be necessary.

Abrupt vessel closure

May occur in as many as 5% of balloon angioplasty cases and typically develops when compression of the true lumen by a large dissection flap occurs, thrombus formation, superimposed coronary vasospasm, or a combination of these processes. The presence of large coronary dissections immediately after balloon angioplasty is associated with a 5-fold increase in the risk of abrupt closure. The use of intracoronary stents and new antiplatelet drugs has decreased the incidence of abrupt closure significantly (to <1%).

Factors predictive of abrupt vessel closure

Preprocedure: Clinical factors: Female gender, Unstable angina, Insulindependent diabetes mellitus, Inadequate antiplatelet therapy. Angiographic factors: Intracoronary thrombus, >90% stenosis, Stenosis length 2 or more luminal diameters, Stenosis at branch point, Stenosis on bend ( 45). Right coronary artery stenosis. Postprocedure: Intimal dissection >10 mm Residual stenosis >50% Transient in-lab closure Residual transstenotic gradient 20 mm Hg

Myocardial Infarction

can occur during PCI because of coronary dissection, abrupt vessel closure, thrombotic occlusion of the epicardial vessel, distal embolization of thrombus or atheromatous material to the microcirculation, side branch occlusion, coronary spasm, or a combination of events. The incidence of MI, defined primarily as CK-MB concentrations elevated to more than two to three times the upper limit of normal, generally ranges between 5% and 30%. Serial CK and CK-MB measurements (6 to 8 and 16 to 24 hours after the procedure) should be obtained in patients with suspected ischemia during PCI.

Emergency Coronary Bypass Surgery and Death

Recent data demonstrate that the need for emergency CABG has decreased since the introduction of coronary stents and that CABG rates are currently less than 1%. Death is similarly rare, most recent registries and clinical trials report mortality rates of less than 1%. Factors associated with increased mortality rates during PCI include advanced age, female sex, diabetes, previous MI, multivessel disease, left main or equivalent coronary disease, a large area of myocardium at risk, preexisting left ventricular function, and preexisting renal insufficiency.

Factors associated with increased mortality for angioplasty

Clinical Factors: Female gender, Age >65 years, Unstable angina, Congestive heart failure, Chronic renal failure. Angiographic Factors: Left main coronary disease, Three-vessel disease, Left ventricular ejection fraction < 0.30. Risk index: Myocardial jeopardy score, Proximal right coronary stenosis, Collaterals originate from dilated vessel.

Vascular Complications

overt bleeding with a decrease in hemoglobin level of at least 30 to 50 g/L (3 to 5 g/dL), need for blood transfusion, or retroperitoneal bleeding. In current clinical practice, as evidenced by results of recent interventional trials, rates of major bleeding complications are low (0.7% to 1.7%). Insertion of vascular sheaths may produce groin or retroperitoneal hematomas. Groin hematomas may present with localized pain, lowerextremity edema due to femoral vein compression, or neurologic symptoms due to compression of the femoral nerve, palpation of localized swelling or tenderness in the area, or loss of sensory or motor function.

Retroperitoneal hematoma should be suspected in patients with unexplained hypotension and/or a marked decrease in hematocrit, may experience flank, abdominal, or back pain. Most retroperitoneal hematomas can be treated conservatively with discontinuation or reversal of anticoagulation and antiplatelet therapy and with blood transfusions alone when necessary; only 16% of patients require surgery. Indications for surgical intervention include persistent hypotension, decreasing hematocrit despite transfusion, or femoral neuropathy (due to nerve compression).

A femoral pseudoaneurysm is a communication between the femoral artery and the overlying fibromuscular tissue, resulting in a bloodfilled cavity. The reported incidence ranges from 0.5% to 6.3%. Groin tenderness, a palpable pulsatile mass, and/or new bruit in the groin area should prompt examination by Doppler flow imaging. Can be treated with ultrasound-guided compression, ultrasound-guided thrombin injection, or surgical repair.

Arterial pseudoaneurysm

An arteriovenous (AV) fistula can result from sheath mediated communication between the femoral artery and femoral vein, may be suggested by the presence of a systolic and diastolic bruit and confirmed by Doppler ultrasonography. Reported incidence ranges from 0.2% to 2.1%. Can be treated with conservative therapy (careful observation) in most patients or with ultrasoundguided compression, surgical repair, or percutaneous implantation of covered stents if necessary.

Characteristics of type A, B, and C lesions

Type A lesions (minimally complex) : Discrete (length <10 mm) Concentric Readily accessible Nonangulated segment (<45) Smooth contour Little or no calcification Less than totally occlusive Not ostial in location No major side branch involvement. Absence of thrombus Type B lesions (moderately complex)*: Tubular (length 1020 mm) Eccentric Moderate tortuosity of proximal segment. Moderately angulated segment (>45, <90). Irregular contour Moderate or heavy calcification Total occlusions <3 mo old Ostial in location Bifurcation lesions requiring double guide wires Some thrombus present

Type C lesions (severely complex): Diffuse (length >2 cm) Excessive tortuosity of proximal segment. Extremely angulated segments >90 Total occlusions >3 mo old and/or bridging collaterals. Inability to protect major side branches Degenerated vein grafts with friable lesions Although the risk of abrupt vessel closure may be moderately high with Type B lesions, the likelihood of a major complication may be low in certain instances such as in the dilation of total occlusions <3 mo old or when abundant collateral channels supply the distal vessel

OTHER INTERVENTIONAL CARDIAC PROCEDURES

Although coronary stents are the mainstay for treatment for obstructive coronary artery disease, several adjunctive devices and techniques are available for coronary intervention

Laser Angioplasty
Uses pulsed laser energy to vaporize plaque & reopen blocked arteries

Directional coronary atherectomy

Used to debulk coronary plaques. A steel fenestrated cage housing a cup-shaped blade is positioned against the coronary lesion by a lowpressure positioning balloon, allowing any protruding plaque to be removed. Atherectomy is typically followed by balloon dilation and stenting. Major complication rates associated with directional atherectomy are low and similar to conventional balloon angioplasty. Other complications (eg, distal embolization of plaque, transient sidebranch occlusion, coronary vasospasm, the no reflow phenomenon, nonQ-wave MI) are greater with DCA than with balloon angioplasty. Because of the increased complication rates and the greater technical demands of DCA compared with balloon angioplasty or stenting, the use of DCAs has greatly decreased in recent years.

Directional coronary atherectomy has been shown to improve acute angiographic results and facilitate both balloon angioplasty and coronary stenting in select lesions. It has not been shown to reduce the need for repeat target lesion revascularization, a clinical measure of restenosis. Its greatest value is for use in lesions in which the physical removal of plaque at ostial or bifurcation lesions will allow successful balloon angioplasty and coronary stenting.

Rotational atherectomy catheter (Rotablator)

Is a device designed for the removal of plaque from coronary arteries. This device, which has a diamondstudded burr at its tip, rotates at about 160,000 rpm and is particularly well suited for ablation of calcific or fibrotic plaque material . Relies on plaque abrasion and pulverization. Rotational atherectomy is successful in 92-97% of these cases, with a low incidence of major complications. It causes dislodgement of particles into the microcirculation, which occasionally may lead to infarction and no reflow. Currently, the use of rotational atherectomy is largely confined to fibrotic or heavily calcified lesions that can be wired but not crossed by a balloon catheter.

Used to facilitate stent delivery in complex lesions, especially when balloon angioplasty alone has failed. plays an important role in the treatment of ostial and bifurcation lesions. The Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study showed rotational atherectomy was associated with a higher short-term success rate than balloon angioplasty (90% vs 80%), but major ischemic complications and repeat revascularization were higher 6 months after treatment (46% vs 37%).

RHEOLYTIC THROMBECTOMY

Rheolytic thrombectomy has become a useful tool for the removal of coronary thrombi before coronary stenting. The rheolytic thrombectomy catheter works by forcing saline out of the distal tip of the catheter at high flow rates into a proximal lumen of the catheter. The high saline flow rates allow for suction of thrombus into the proximal lumen by the Venturi effect . Although rheolytic thrombectomy has not been shown to reduce restenosis, it is extremely effective in clearing thrombus and facilitating balloon angioplasty or coronary stenting . It is of particular value in the treatment of acute myocardial infarction, sub-acute stent thrombosis, and lesions in degenerated saphenous vein grafts.

DISTAL PROTECTION DEVICES

Used to prevent embolization of particulate matter during percutaneous coronary intervention. It is approved for percutaneous coronary intervention on saphenous vein grafts, occludes the vein graft with a balloon during intervention and allows for removal of particulate matter from the graft by means of an aspiration catheter, resulted in 53% fewer periprocedural ischemic complications than during vein graft intervention without distal protection.

Nursing Care of the Client having a Coronary Angiogram/or PTCA

PREPROCEDURE CARE

Informed consent, Check for Allergies Hold Aspirin, Anti-platelet drugs & any other anti-coagulants NPO 4- 8 hrs prior Give all meds-especially cardiac meds with sips of H20 Baseline Head-Toe Assessment, including peripheral pulses Pt Instruction: They will be awake during procedure, takes 1-2hrs. May experience a momentary sensation of warmth [hot flash] & metallic taste when dye injected.

POSTPROCEDURE CARE

VS Q15x1; q30x1,q2 BR, HOB 20-30O Check pressure drsg. Over arterial site Immobilize extremity. Inc. fluid intake, unless contraindicated Assess for CP & Dysrhythmias

Discharge Instructions

Medications: new drug and potential side effect. Activity: bath/shower. Not lifting anything over 5kg Not driving themselves home Return to work & resume sexual activity. Things to watch: Groin site re-bleed Signs of infection over the site Chest pain.

Patient basic needs

Alteration in comfort Actual/potential alteration in hemodynamic status. Anxiety and lack of knowledge.