How to Avoid Potential Complications from PCI

avoid PCI complicationsPercutaneous coronary intervention—or PCI—and Protected PCI™ are nonsurgical procedures for people with blocked coronary arteries. The purpose of both procedures is to open up narrowed arteries and improve blood flow to the heart. PCI is recommended for people who otherwise have a healthy heart.

Protected PCI is recommended for patients with stable blood flow and a combination of severe coronary artery disease, a low ejection fraction, and other conditions such as diabetes, heart failure, advanced age, peripheral vascular disease, complex lesions, history of angina, or prior surgeries. Protected PCI is a PCI procedure performed with extra support from a heart pump. The heart pump such as Impella 2.5® helps maintain heart function, blood pressure, and blood flow, while the blockages in one or more arteries are repaired.

The arteries are successfully opened up in most people. The removal of plaque from blood vessels can cause blood clots to form. To prevent blood clots from forming, people are given aspirin or other anti-clotting medication, called blood thinners. The names of some of these anti-clotting medications are clopidogrel bisulphate (Plavix)1, warfarin (Coumadin), heparin (Clexane, Lovenox, Arixtra), argatroban (Argatroban), lepirudin (Refludan), bivalirudin (Angiomax, Angiox) and dabigatran (Pradaxa).

To prevent blood clots, make sure you take your medication regularly. Do not stop taking your medication without consulting your cardiologist.

Tips to Avoid Complications and Recover Faster:

Ask your cardiologist to discuss lifestyle changes, and answer any questions you have regarding your medications or your heart disease, recovery from PCI or Protected PCI.

Next Steps:

1 The chemical name of each drug appears first, and the brand name is in parentheses.

PROTECTED PCI™ – INDICATION & SAFETY INFO.

Indication for Use

The Impella 2.5™ System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Contraindications

In connection with the above indication, the Impella 2.5™ is contraindicated for use with patients experiencing any of the following conditions:

  • Mural thrombus in the left ventricle
  • Presence of a mechanical aortic valve or heart constrictive device
  • Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less)
  • Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2)
  • Severe peripheral arterial disease precluding placement of the Impella 2.5™ System

Potential Adverse Events

Additionally, potential for the following risks has been found to exist with use of the Impella 2.5 in the above indication: Acute renal dysfunction; Aortic insufficiency; Aortic valve injury; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cardiopulmonary resuscitation; Cerebral vascular accident/Stroke; Death; Device malfunction; Failure to achieve angiographic success; Hemolysis; Hepatic failure; Insertion site infection; Limb ischemia; Myocardial infarction; Need for cardiac, thoracic or abdominal operation; Perforation; Renal failure; Repeat revascularization; Respiratory dysfunction; Sepsis; Severe hypotension; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack; Vascular injury; Ventricular arrhythmia, fibrillation or tachycardia.