The Impact of Public Reporting for Cardiogenic Shock
- An investigative study sought to examine the effect of excluding cardiogenic shock from public reporting and its impact on referring patients for guideline-directed care.
- There was a 19% increase in the use of PCI for cardiogenic shock patients in New York after the exclusion of cardiogenic shock from public reporting.
In New York state, public reporting of mortality following PCI and coronary artery bypass grafting (CABG) has been in effect since the late 1980s and early 1990s.2 This publicly available data has significantly affected interventionalists’ decisions on whether to perform PCI. In fact, close to 80% of cardiologists interviewed by the University of Rochester said public reporting impacted their choice of revascularization procedure. Subsequently, patients in New York state are often less likely to undergo CABG and PCI compared with other states.
Can Excluding Cardiogenic Shock from Public Reporting Increase Surgical Referrals?
An investigative study published in JAMA Cardiology sought to examine the effect of excluding cardiogenic shock from public reporting and its impact on referring patients for guideline-directed care (PCI, CABG, or cardiac catheterization).3
This analysis included patients with cardiogenic shock complicating acute MI between 2002 and 2011 across four states: California, Michigan, New Jersey, and New York. The primary outcome was the amount of patients undergoing PCI prior to and following the exclusion of cardiogenic shock from publicly available outcomes data. The proportion of patients who underwent the following interventions were also included:
- Invasive Management
- Cardiac catheterization
According to the findings, there was a 19% increase in the use of PCI for cardiogenic shock patients in New York after the exclusion of cardiogenic shock from public reporting. Similar increases were found with the use of invasive management and revascularization (18% and 23%, respectively) for New York patients; however, there was no significant increase in CABG following exclusion of cardiogenic shock from public reporting.
This study found that when cardiogenic shock was excluded from publicly available cardiovascular data, more patients underwent invasive treatment for cardiogenic shock complicating MI.
- Santora M. Cardiologists Say Rankings Affect Surgical Decisions. New York Times. January 11, 2005. http://query.nytimes.com/gst/fullpage.html?res=9F00E0DA1F39F932A25752C0A9639C8B63. Accessed December 6, 2016.
- Hannan EL, Cozzens K, King SB, Walford G, Shah NR. The New York State cardiac registries: history, contributions, limitations, and lessons for future efforts to assess and publicly report healthcare outcomes. J Am Coll Cardiol. 2012;59(25):2309-2316.
- Bangalore S, Guo Y, Xu J, et al. Rates of Invasive Management of Cardiogenic Shock in New York Before and After Exclusion From Public Reporting. JAMA Cardiol. 2016;1(6):640-647.
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.
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.
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/