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  • Measure Summary
  • NQMC:010880
  • Dec 2015

Implantable cardioverter-defibrillator (ICD): risk-standardized rate of procedural complications following the first time implantation of an ICD.

Heart Rhythm Society (HRS). HRS-3 implantable cardioverter-defibrillator (ICD) complications rate. Washington (DC): Heart Rhythm Society (HRS); 2015 Dec 18. 12 p.

This is the current release of the measure.

This measure updates a previous version: Heart Rhythm Society. Performance measure technical specifications. Washington (DC): Heart Rhythm Society; 2014 Sep. 5 p.

Primary Measure Domain

Clinical Quality Measures: Outcome

Secondary Measure Domain

Does not apply to this measure

Description

This measure is used to assess the physician-specific risk-standardized rate of procedural complications following the first time implantation of an implantable cardioverter-defibrillator (ICD).

This measure is to be reported a minimum of once per reporting period for patients with a first time implantation of an ICD during the reporting period. This measure may be reported by clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.

There are two reporting criteria for this measure:

  1. Patients with first time implants with one or more complications or mortality within 30 days
  2. Patients with first time implants with one or more complications within 90 days

Rationale

The proposed measure of implantable cardioverter-defibrillator (ICD) complications has the potential to significantly improve the quality of care delivered to patients with advanced heart disease. The model used for risk adjustment meets recognized standards for outcomes measurement and was developed with extensive input from stakeholders with a broad range of expertise and perspectives. The study sample is appropriately defined, consisting of an ICD population that has distinct outcomes that will allow for valid comparisons of physician quality. The definition of the complications, the complication-specific period of assessment, and the risk-adjustment variables all have strong face validity, which may facilitate physician acceptance. The developer excluded covariates that it would not want to adjust for in a quality measure.

In summary, the developer presents an ICD complications measure that is suitable for public reporting. The proposed measure capitalizes on the National Cardiovascular Data Registry (NCDR) ICD Registry data already collected as part of an ongoing collaboration between Centers for Medicare & Medicaid Services (CMS) and NCDR. Accordingly, the incremental burden of data collection on physicians would be minimal and the proposed measure could be implemented by using the direct patient identifiers already being collected by CMS.

ICD implantation is an expensive procedure performed on patients with advanced cardiovascular disease and, often, significant comorbidities. Despite improvements in technology and increasing experience with device implantation, the procedure carries a significant risk of complications (Hammill & Curtis, 2008).

  • Roughly 150,000 ICDs are implanted each year and approximately two thirds of implantations are performed on Medicare patients.
  • Direct total medical cost per device (Sanders, Hlatky, & Owens, 2005) is $68,000 to $100,000. The total national costs range from $10 to $15 billion, of which $7 to $10 billion represents fee-for-service (FFS) Medicare.
  • Complications are expensive and, in one study (Reynolds et al., 2006), associated with increased length of stay (1 to 10 days) and costs $5,000 to 20,000 (mean $7,251), adding roughly $80 million in Medicare costs.
  • Reported complication rates following ICD implantation vary from 4% to 30%, depending largely on how complications are defined and the period of assessment. In the NCDR ICD Registry, the incidence of in-hospital complications is approximately 4%. However, complications such as device infection, malfunction, or cardiac tamponade are not fully captured by the registry since they may only become evident following hospital discharge.
  • Al-Khatib et al. (2008) analyzed administrative claims data and found overall rates of complication within 90 days of ICD implantation ranged from 18.8% in 2002 to 14.2% in 2005 (Al-Khatib et al., 2005).

The developer analyzed Medicare FFS administrative claims to assess complications rates following ICD implantation. From 2006 through 2009, a total of 105,575 implants performed by 3,488 physicians met inclusion/exclusion criteria and were included in the analysis. The number of eligible implants increased over time from 22,931 in 2006 to 28,383. The overall complication rate decreased modestly over this time period, from 8.60% to 7.55%. The rate of mechanical complications requiring system revision had the largest decrease over time (0.78%), but similar relative declines were seen across all complications. As expected, the characteristics of patients with and without adverse events differed significantly. Most notably, patients receiving a cardiac resynchronization therapy (CRT-D) device had a significantly higher complication rate than patients receiving a single and dual chamber device (8.09%, 6.30%, and 5.33% respectively). These results demonstrate an opportunity to improve physician-level performance.

Evidence for Rationale

Al-Khatib SM, Greiner MA, Peterson ED, Hernandez AF, Schulman KA, Curtis LH. Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002-2005. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):240-9. PubMed External Web Site Policy

Al-Khatib SM, Lucas FL, Jollis JG, Malenka DJ, Wennberg DE. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol. 2005 Oct 18;46(8):1536-40. PubMed External Web Site Policy

Hammill SC, Curtis J. Publicly reporting implantable cardioverter defibrillator outcomes: grading the report card. Circ Arrhythm Electrophysiol. 2008 Oct;1(4):235-7. PubMed External Web Site Policy

Heart Rhythm Society (HRS). HRS-3 implantable cardioverter-defibrillator (ICD) complications rate. Washington (DC): Heart Rhythm Society (HRS); 2015 Dec 18. 12 p.

Reynolds MR, Cohen DJ, Kugelmass AD, Brown PP, Becker ER, Culler SD, Simon AW. Complications among Medicare beneficiaries, receiving implantable cardioverter-defibrillators. J Am Coll Cardiol. 2006 Jun 20;47(12):2493-7. PubMed External Web Site Policy

Sanders GD, Hlatky MA, Owens DK. Cost-effectiveness of implantable cardioverter-defibrillators. N Engl J Med. 2005 Oct 6;353(14):1471-80. PubMed External Web Site Policy

Primary Health Components

Implantable cardioverter-defibrillator (ICD) implantation; procedural complications; mortality

Denominator Description

Patients with a first time implantation of an implantable cardioverter-defibrillator (ICD) (see the related "Denominator Inclusions/Exclusions" field)

Numerator Description

Reporting Criteria 1: Number of patients with one or more of the specified complications or mortality within 30 days (depending on the complication) following implantable cardioverter-defibrillator (ICD) implantation

Reporting Criteria 2: Number of patients with one or more of the specified complications within 90 days (depending on the complication) following ICD implantation

See the related "Numerator Inclusions/Exclusions" field.

Type of Evidence Supporting the Criterion of Quality for the Measure

  • A formal consensus procedure, involving experts in relevant clinical, methodological, public health and organizational sciences
  • One or more research studies published in a National Library of Medicine (NLM) indexed, peer-reviewed journal

Additional Information Supporting Need for the Measure

Unspecified

Extent of Measure Testing

In March 2010, the Heart Rhythm Society's (HRS) Quality Improvement Subcommittee conducted a strategic planning meeting to identify recommendations on how the Society could best prepare for the increased focus of performance measurement by the United States (U.S.) government and others. The topics discussed included performance measurement in general, as well as public reporting and value-based purchasing, specifically. Through the work of the Measure Development Task Force during Cycle 1 of the initiative, two physician-level measures were fully-specified and tested: HRS-3: Implantable Cardioverter-Defibrillator (ICD) Complications Rate and HRS-4: In-Person Evaluation Following Implantation of a Cardiovascular Implantable Electronic Device (CIED). The measures were developed with the intent to submit them to the National Quality Forum (NQF) for endorsement consideration when a relevant call for measures is issued. Pilot testing is a prerequisite for NQF.

Evidence for Extent of Measure Testing

Heart Rhythm Society (HRS). Performance measure development initiative quality improvement pilot implementation plan. Washington (DC): Heart Rhythm Society (HRS); 9 p.

State of Use

Current routine use

Current Use

Internal quality improvement

Pay-for-reporting

Public reporting

Measurement Setting

Hospital Inpatient

Hospital Outpatient

Professionals Involved in Delivery of Health Services

Physicians

Least Aggregated Level of Services Delivery Addressed

Individual Clinicians or Public Health Professionals

Statement of Acceptable Minimum Sample Size

Does not apply to this measure

Target Population Age

Age greater than or equal to 65 years

Target Population Gender

Either male or female

National Quality Strategy Aim

Better Care

National Quality Strategy Priority

Making Care Safer
Prevention and Treatment of Leading Causes of Mortality

IOM Care Need

Living with Illness

IOM Domain

Effectiveness

Safety

Case Finding Period

  • Reporting Criteria 1: January 1 through November 30
  • Reporting Criteria 2: January 1 through September 30

Denominator Sampling Frame

Patients associated with provider

Denominator (Index) Event or Characteristic

Encounter

Institutionalization

Patient/Individual (Consumer) Characteristic

Therapeutic Intervention

Denominator Time Window

Does not apply to this measure

Denominator Inclusions/Exclusions

Inclusions
Patients with a first time implantation of an implantable cardioverter-defibrillator (ICD)

  • Reporting Criteria 1: Include patients with procedures that are performed greater than or equal to 31 days prior to the end of the reporting period.
  • Reporting Criteria 2: Include patients with procedures that are performed greater than or equal to 91 days prior to the end of the reporting period.

Denominator Criteria (Eligible Cases):

Patient aged greater than or equal to 65 years on date of encounter

AND

Implantation of ICD (refer to the original measure documentation for International Classification of Diseases, Tenth Revision, Procedure Coding System [ICD-10-PCS] codes)

AND/OR

Patient encounter during reporting period (refer to the original measure documentation for Current Procedural Terminology [CPT] codes)

AND NOT

ICD-10-PCS codes: 0JPT0PZ, 0JPT3PZ

Note: Include only patients that have had first time implantation through November 30 for evaluation of complications for 30 days and September 30 for evaluation of complications for 90 days post procedure within the reporting period. This will allow the evaluation of ICD implant complications within the reporting year.

Exclusions
None

Exclusions/Exceptions

None

Numerator Inclusions/Exclusions

Inclusions
Reporting Criteria 1: Number of patients with one or more of the following complications or mortality within 30 days (depending on the complication) following implantable cardioverter-defibrillator (ICD) implantation

Complications measured for 30 days:

  1. Death
  2. Pneumothorax or hemothorax plus a chest tube
  3. Hematoma plus a blood transfusion or evacuation
  4. Cardiac tamponade or pericardiocentesis

Reporting Criteria 2: Number of patients with one or more of the following complications within 90 days (depending on the complication) following ICD implantation

Complications measured for 90 days:

  1. Mechanical complications requiring a system revision
  2. Device related infection
  3. Additional ICD implantation

Note:

  • The eligible professional should submit data on both Reporting Criteria 1 and 2 for a patient that meets the denominator.
  • Refer to the original measure documentation for administrative codes.

Exclusions
None

Numerator Search Strategy

Fixed time period or point in time

Data Source

Administrative clinical data

Registry data

Type of Health State

Adverse Health State

Instruments Used and/or Associated with the Measure

  • 2016 Registry Individual Measure Flow: PQRS #348 HRS-3: Implantable Cardioverter-Defibrillator (ICD) Complications Rate–Reporting Criteria One
  • 2016 Registry Individual Measure Flow: PQRS #348 HRS-3: Implantable Cardioverter-Defibrillator (ICD) Complications Rate–Reporting Criteria Two

Measure Specifies Disaggregation

Measure is disaggregated into categories based on different definitions of the denominator and/or numerator

Basis for Disaggregation

There are two reporting criteria for this measure:

Reporting Criteria 1: Patients with first time implants with one or more complications or mortality within 30 days.

  • Denominator: Patients with a first time implantation of an implantable cardioverter-defibrillator (ICD)
  • Numerator: Number of patients with one or more of the following complications or mortality within 30 days (depending on the complication) following ICD implantation

Reporting Criteria 2: Patients with first time implants with one or more complications within 90 days.

  • Denominator: Patients with a first time implantation of an ICD
  • Numerator: Number of patients with one or more of the following complications within 90 days (depending on the complication) following ICD implantation

Scoring

Rate/Proportion

Interpretation of Score

Desired value is a lower score

Allowance for Patient or Population Factors

Risk adjustment devised specifically for this measure/condition

Description of Allowance for Patient or Population Factors

Hierarchical Logistic Regression
The specification is designed to align with the National Quality Forum (NQF)-endorsed Hospital Risk-Standardized Complication Rate following Implantation of Implantable Cardioverter-Defibrillator performance measure (NQF #0694).

The variables apply to both the 30 and 90 day outcomes, but how the variables are to be utilized within the performance calculation is part of a risk model developed by Yale.

    Standard of Comparison

    External comparison at a point in, or interval of, time

    External comparison of time trends

    Internal time comparison

    Original Title

    HRS-3: implantable cardioverter-defibrillator (ICD) complications rate.

    Submitter

    Heart Rhythm Society - Disease Specific Society

    Developer

    Heart Rhythm Society - Disease Specific Society

    Funding Source(s)

    Unspecified

    Composition of the Group that Developed the Measure

    The Heart Rhythm Society Performance Measures Development Task Force consists of thought leaders in atrial fibrillation ablation, device implantation, cardiovascular health policy, performance measures development, patient safety, clinical outcomes, and population science. The roster can be provided upon request at policy@hrsonline.org.

    Financial Disclosures/Other Potential Conflicts of Interest

    Conflicts, if any, are disclosed in accordance with the Heart Rhythm Society conflict of interest disclosure policy.

    Measure Initiative(s)

    Physician Quality Reporting System

    Adaptation

    This measure was not adapted from another source.

    Date of Most Current Version in NQMC

    2015 Dec

    Measure Maintenance

    Unspecified

    Date of Next Anticipated Revision

    Unspecified

    Measure Status

    This is the current release of the measure.

    This measure updates a previous version: Heart Rhythm Society. Performance measure technical specifications. Washington (DC): Heart Rhythm Society; 2014 Sep. 5 p.

    Source(s)

    Heart Rhythm Society (HRS). HRS-3 implantable cardioverter-defibrillator (ICD) complications rate. Washington (DC): Heart Rhythm Society (HRS); 2015 Dec 18. 12 p.

    Measure Availability

    Source not available electronically.

    For more information, contact the Heart Rhythm Society (HRS) at 1325 G Street, NW, Suite 400, Washington, DC 20005; Phone: 202-464-3400; Fax: 202-464-3401; E-mail: info@HRSonline.org; Web site: www.hrsonline.org External Web Site Policy.

    NQMC Status

    This NQMC summary was completed by ECRI Institute on January 26, 2015. The information was verified by the measure developer on February 23, 2015.

    This NQMC summary was updated by ECRI Institute on June 28, 2016. The information was verified by the measure developer on July 7, 2016.

    Copyright Statement

    This NQMC summary is based on the original measure, which is subject to the measure developer's copyright restrictions.

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