Appropriate Use Guidance for IMPELLA

I. Appropriate Use Guidance

（1）Indication Criteria (Targeted Diseases and Conditions)

As per the “Indications and Usage” section of its approval document, this circulatory assist pump catheter is indicated for use during drug-resistant acute heart failure such as cardiogenic shock. Cardiogenic shock accompanied by prolonged circulatory failure, which is mainly due to medically-resistant acute left ventricular heart failure, and conditions in which hemodynamic supporting by existing circulatory assist devices, such as IABP or PCPS, is expected to be insufficient. Cardiogenic shock is described separately in the Detailed Guidance section.

However, careful attention should be given to indications, and exclusion of IMPELLA use should also be taken into consideration in cases where Return of Spontaneous Circulation (ROSC) cannot be expected, cases in which hypoxic encephalopathy is strongly suspected and expected outcome is extremely poor.

Existing circulatory assist devices should be selected in each of the disease states by referring to the following device functionalities.

IABP

• Used in severe heart failure without cardiogenic shock where improvement in hemodynamics and coronary blood flow can be expected, by providing auxiliary pressures support (Including the purpose to increase coronary blood flow during peri- PCI period).
• In severe heart failure with cardiogenic shock, auxiliary pressure support is not sufficient to support the systemic blood flow, therefore, transition to another therapy or device should be considered.

PCPS

• Used to assist the systemic blood flow for severe heart failure with cardiogenic shock, in whom cardiopulmonary arrest or multi-organ failure is predicted.
• There is very little cardiac unloading effect, in addition, there is possibility to rather increase left heart afterload. Since direct improvement in cardiac function cannot be expected, early transition to VAD is required when weaning is not possible.

Circulatory assist pump catheters

• Blood flow assisting device having equivalent function to circulatory assist device (VAD), which is placed inside the left ventricle to directly pump blood out from the left ventricle and ejecting to the entire body through the ascending aorta.
• Improvement in cardiac function can be expected through cardiac unloading and improvement in myocardial circulation; due to its catheter-based VAD design, quick and less invasive insertion is possible in treatment of shock.
• Since the device is a temporary support system, transitioning to a mid to long term VAD system should be considered when weaning is not possible.
• May not be used as a supported-PCI device only.

（2）Facilities Requirements

1. Qualified Cardiovascular Center by the Japanese Board of Cardiovascular Surgery. (qualification is to be reconsidered if a new Specialty System is implemented.)
2. Registered as an extracorporeal VAD treatment site, or qualified site for implantable VAD treatment, or close in collaboration with above sites.
3. There are qualified extracorporeal circulation technicians with sufficient knowledge of circulatory support.
4. There is ICU or CCU with staff members who are fully knowledgeable of circulatory support.
5. Prior to the device use, all physicians and staff must become thoroughly proficient in the procedure, by receiving the training program provided by the manufacturer.
6. Must participate in the Registry program which is conducted by the Committee established by the Related Society Council.
7. Detailed conditions for Facility qualification and staff requirements will be determined by the Committee established by the Related Society Council. After the Facility is certified, all cases will be reviewed by the Committee established by the Related Society Council, to determine safety and efficacy of the device use. The Detailed Guidance will be revised by the Council, as cases accumulate and verification becomes possible.
8. This guidance is effective as of July 4th 2017.

II. Detailed Guidance

（1）Definitions of Cardiogenic Shock

The Definition conforms with those established for the Cardiogenic Shock Registry by the Japanese Circulation Society, including any definition added in the future.

Definition: Patient in a shock state due to in- or out-of-hospital onset of cardiac disease at the initial emergency treatment (before or during the initial treatment, which meet 1 or more of the following major and minor criteria). In case of out-of-hospital cardiac arrest, the patient is eligible if the shock state is continuing after spontaneous heart beat returns.

• Major Criteria:
  • Systolic blood pressure <100 mmHg and heart rate <60 or ≥100 beats/min
  • More than 30 mmHg drop in systemic blood pressure from the usual values
• Minor Criteria:
  • Determined by the initially treating physician as peripheral circulatory failure, based on the presence of cold sweat, skin pallor, cyanosis, capillary refill time ≥2 seconds, or consciousness disturbance (JCS-2 or above), etc.

（2）Facility Qualification Criteria

1. The Facility must have emergency/intensive care facilities with sufficient experience in cardiogenic shock treatment.
2. Must have qualified cardiology specialist and cardiovascular surgery specialist (in case of a pediatric hospital, a pediatric cardiology specialist). In addition, a Heart Team consisting of intensivist, certified interventional cardiologist, etc. is in place for the circulatory assist therapy.
3. There are 3 or more certified extracorporeal circulation technicians or certified artificial organ management technicians.
4. Number of annual cardiovascular surgery is 100 or more (in case of a pediatric hospital, must include 50 or more cardiac surgery cases of patients under 18 years old.)
5. More than 30 IABP cases and more than 20 PCPS/ECMO cases in the last 3 years.
6. More than 300 PCI cases in the last 3 years.

In the case no intensivists are already included in the heart team, the facility should hire or train intensivists to add to the team afterwards.
The device use in pediatric hospital is limited to use in “pediatric patients with low body weight”, according to “The pediatric Ventricular Assist Device guideline and appropriate use guidance”. Number of IABP and PCI cases are not required in qualifying these hospitals. Requirement for total ECMO cases will be defined as “number of mechanical circulatory support (ventricular assist device/ECMO) in under 11-year-old is more than 3 cases in the last 5 years.”

（3）Facility requirement, criteria and recommendations for device use

1. Staff members in each of the departments involved must receive the introductory training.
2. The device is supplied to only those Facilities which will participate in the circulatory assist pump catheter all-patient registration (the Registry, including PMS).
3. Considering proper usage and patient safety, a facility’s first three cases with this device should be considered for patients expected to have hemodynamic deterioration within a few hours (may not be used as a supported-PCI device only).

（4）Role of the Ventricular Assist Device Treatment Related Societies Council

1. Management of the Registry
2. Certify and review the Facilities for device use
3. Monitor and make recommendations for the Appropriate Use Guidance
4. Provide continued education (such as seminars)
5. The above roles are delegated to the IMPELLA Committee with the approval of the Ventricular Assist Device Treatment Related Societies Council.

（5）Amendment of the Indication, Facility and Management Criterion by the IMPELLA Committee

1. The Registry results will be verified, and eligibility criteria including inclusion/exclusion criteria, indication, Facility requirements, and method of management will be revised as necessary.
2. In case of significant delays in patient registration or data entry, there will be corrective action such as suspension of the Facility qualification, until improvement is confirmed.
3. Geographic factors will be taken into consideration as the Facility qualification process is promoted, based on the speed of the therapy penetration.
4. The Guidance details, such as Facility criteria and management method will be reviewed/updated in approximately 3 years, based on any constraints related to Facility training and support structure, as well as evaluation of clinical results.
5. Procedure for renewal of the Facility certification will be determined separately.
6. The Detailed Guideline is effective as of 4 July 2017.