James “Craig” Carroll, a Site Manager for Gray Construction, has been a heart patient since early adulthood. He received his first stent at the young age of 27 years.

For the past four years, Craig has been in and out of the hospital for heart procedures and has received a total of 11 stents. Last year, Craig was told he was not a candidate for open heart surgery due to his diabetes and narrowed blood vessels. Craig’s physicians told him his heart condition was severe and he was a high risk for complex coronary artery bypass surgery. The surgeons were afraid he would not survive open heart surgery.

A few months after receiving this news, Craig was on a business trip to Houston when he began experiencing  chest pain.  Craig immediately went to the emergency room at Clear Lake Regional Medical Center in Webster, Texas.   Dr. Rakesh Shah, an interventional cardiologist, discovered a severe blockage in Craig’s main coronary artery.  Dr. Shah performed a Protected percutaneous coronary artery (PCI) by inserting the Impella 2.5 heart pump to temporarily support Craig’s heart while placinga stent to open Craig’s blocked coronary artery.

Craig recovered well from the Protected PCI procedure and returned to Clear Lake Regional Medical Center about a month later for a follow-up procedure. Since then, Craig has regained his strength and has returned to his normal daily routine.

Recently, the hospital held a celebration for Craig, gathering Craig and his family, as well as the interventional cardiologists, staff, and local Emergency Medical Services (EMS) professionals —all of which worked together to help Craig. The Celebration of Life event was Clear Lake Regional Medical Center’s kickoff for American Heart Month–a national effort to raise awareness of heart disease and stroke. He wanted to thank everyone for saving his life.

Listen to Craig’s story below:

Next Steps:

1. See how the Impella 2.5 heart pump works
2. Read more about Clear Lake Regional Medical Center’s Celebration of Life event
3. Learn more about Protected PCI
4. Learn more about complex heart disease
5. Read about PCI and Protected PCI procedures

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.