Trends in Cardiovascular Care: Data from the NCDR® Registries
In an effort to improve care quality for patients receiving cardiovascular-related therapies and procedures, the American College of Cardiology (ACC) developed the National Cardiovascular Data Registries (NCDR®) in 1998. The NCDR® measures compliance to performance metrics and aims to provide evidence-based performance feedback for centers wishing to discover opportunities for improving their quality of care.
A report published in the Journal of American College of Cardiology sought to evaluate the NCDR® to determine the current outlook of cardiovascular care in the United States, especially as it relates to percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG).1
The NCDR® registries analyzed in this review include:
- Implantable Cardioverter Defibrillator (ICD)®
- Acute Coronary Treatment and Intervention Outcomes Network
- (ACTION)®–Get with the Guidelines (GWTG)™
- Improving Pediatric and Adult Congenital Treatment (IMPACT)®
Currently, over 2000 hospitals and healthcare facilities participate in the NCDR® reporting process and are used as an accurate representation of patient care across the nation.
This registry examines the characteristics and outcomes of patients who have received a cardiovascular procedure, like PCI or CABG, in a Cath lab. Included in this program were 667,424 patients who received PCI in 2014, many of whom had a coronary event prior to the procedure. Median time to primary PCI in non-transferred patients was around 59 minutes. Only 32.3% of patients who were transferred received PCI within a 90-minute window of presentation.
Around 98.3% of patients with an acute coronary syndrome (ACS) had the appropriate indications for PCI. In 2014, mechanical ventricular support was used for 2.4% of PCI cases (Figure 1), 1.7% of which was attributed to the intra-aortic balloon pump (IABP). The Impella was initiated prior to PCI in 77.6% of cases, whereas IABP was used in 36.7% of cases.
Unadjusted rates of postprocedural stroke, acute kidney injury, and vascular access site injury was 0.2%, 2.6%, and 1.3%, respectively.
Sponsored by both the ACCF and the American Heart Association, this program examines the treatment outcomes of acute myocardial infarction (AMI) patients with both ST segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI). The majority of patients included in the 2014 registry analysis had NSTEMI (61.0%) vs STEMI (39.0%). In regard to patient characteristics, many had a present diagnosis of diabetes mellitus (34.8%), and a smaller subset had a history of MI (24.8%), stroke (7.7%), and heart failure (12.8%). Rates of cardiogenic shock, death, heart failure, and reinfarction occurred more frequently in patients with STEMI than NSTEMI, according to the available data on in-hospital events.
Participation in and routine evaluation of the NCDR® programs plays a pivotal role in the evolution of cardiovascular care. Subsequently, any knowledge and/or advancement garnered from these data may translate into improved outcomes for patients undergoing interventional cardiovascular procedures. Additional involvement in the program may enable improved comprehension of cardiovascular disease and its treatment. Thus, hospitals and care centers are encouraged to participate in these programs to ensure further understanding of common cardiovascular therapies as well as the relationship between therapies and patient characteristics, geographic data, and level of care.
- Masoudi FA, Ponirakis A, de Lemos JA, et al. Trends in U.S. Cardiovascular Care: 2016 Report from 4 ACC National Cardiovascular Data Registries. J Am Coll Cardiol. 2016.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
The Impella 2.5® and Impella CP® 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 and Impella CP 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 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 and Impella CP, and ≤ 6 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.
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.
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.
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/