Comorbidities, Complexity Need Not Keep Patients From Getting Needed PCI. ACC 2016
Focusing on reducing inappropriate use of interventional procedures may be doing a disservice to patients who may be helped by revascularization, according to a presentation at the American College of Cardiology 2016 Scientific Session.
”Lost in this overemphasis of reducing inappropriate cases also is this issue of patients who ought to come to the cath lab never making it there at all,” said Ajay J. Kirtane, MD, SM, of NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City.
Dr. Kirtane outlined the premise for CHIP (Complete Revascularization for Higher-Risk Indicated Patients), noting that some patients may be undertreated based on their risk due to comorbidities or the complexity of their anatomy.
“I’m not talking about PCI versus medical therapy,” said Dr. Kirtane. “I’m talking about revascularization versus no revascularization. In these cohorts, PCI may have a role, particularly for those who are not surgical candidates.”
Patients may, legitimately, wonder why, if their symptoms are real, they are denied treatment simply because an interventionalist isn’t trained or comfortable with advanced PCI techniques. “The indications for the case do not change just because the lesion is ‘harder to treat,’” said Dr. Kirtane. The risk/benefit equation can be modified with training and the use of advanced devices.
“If the patient is going to merit revascularization, you need to figure out how to do it safely and effectively using the appropriate devices and equipment so that patient can reap the benefit of what we have to offer.”
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
IMPELLA® LEFT-SIDE DEVICES INDICATION & SAFETY INFORMATION
The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems 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.
The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
Important Risk Information for Impella devices
The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are 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 System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*
* This condition is a contraindication for the cardiogenic shock indication only.
POTENTIAL ADVERSE EVENTS
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.
The Impella Connect® transfers the video image of the screen on the Automated Impella® Controller to an authorized remote user. The transmitted image can be viewed by authorized remote users. The users can include the hospital’s clinicians, Abiomed local support staff, and Customer Support Center (CSC) team members.
Impella Connect Precautions
- Impella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella® Controller.
- During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.
- The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.
- During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella® Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.
- The Impella Connect is not designed for use during transport.
- Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.
- Portable and mobile RF communications equipment can affect medical electrical equipment.
Right-Side Support – Indication & Safety Info.
INDICATIONS FOR USE
The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Important Risk Information for Impella RP
The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.
POTENTIAL ADVERSE EVENTS
The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.
General Indication and Safety Information
To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/