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									Combined Heart Failure Device Diagnostics
    Identify Patients at Higher Risk of
Subsequent Heart Failure Hospitalizations:
   Results from PARTNERS HF Study

                 David J. Whellan, MD FACC
               Associate Professor of Medicine
Director, Jefferson Coordinating Center for Clinical Research
                  Jefferson Medical College

               on behalf of the PARTNERS HF Study Investigators




Whellan et al. JACC Vol. 55, No. 17, April 27, 2010:1803–10
                  Disclosure

I will not discuss off label use or investigational use
  in my presentation.
I have financial relationships to disclose:
Employee of: Thomas Jefferson University
Consultant for: Medtronic
Stockholder in: NA
Research support from: Medtronic
Honoraria from: Medtronic
                                                   Background

• Despite medical interventions, there remains
  a high rate of HF hospitalizations in the CRT-D
  patient population.

• Identifying at risk patients is a challenge

• Recent publications have shown a single parameter
  HF diagnostic identifies high risk patients                     1,2




  1. Small et al. J Card Fail. November 2009; 15(9):813.
  2. Perego et al. Interv Card Electrophysiol 2008, 23:235-242.
                  Hypothesis


Routine evaluation of combined diagnostics
recorded by implantable devices can identify HF
patients at risk for subsequent heart failure
hospitalizations.
       Combined Diagnostic Algorithm
• Based on 8 Diagnostic
  trends which are            OptiVol

  recorded daily

• Individual algorithms for
                              VT/VF
  each trend have been        therapy
  used to flag significant
                              AF burden
  observations from the
  trends in Medtronic         Rate during
                              AF
  ICDs/CRTs
                              %CRT

                              HR

                              Activity

                              HRV
                      Study Design
• Prospective observational study

• Subjects with CRT ICDs

• 12-month follow-up, scheduled visits every 3
  months

• Clinical and device data collected at all visits

• Limitations:
   Clinicians had access to the diagnostics

   Review and/or interventions based on trends were not
    required and alerts were not utilized
    Methods – Categorization of Events

• All CV and HF-related events were collected
• Events and deaths were classified and
  adjudicated by an independent committee


• Primary endpoint was the number of HF
  hospitalizations with pulmonary congestion
                  Combined Algorithm
Positive Combined Algorithm = any 2 criteria +

    Parameter              Criterion

    Fluid Index            ≥60 ohm/days
    AT/AF Duration         ≥6 hours & not persistent AT/AF
    V. rate during AT/AF   AT/AF ≥24 hrs & V. ≥ 90 bpm
    Patient Activity       Avg. <1 hr over 1 week
    Night Heart Rate       ≥85 bpm for 7 consecutive days
    HRV                    <60 ms for 7 consecutive days
    CRT % Pacing           < 90% for 5 of 7 days
    Shock(s)               1 or more shocks


          OR Fluid Index ≥100
                Combined Algorithm

• Algorithm criteria were tested on an independent data set
  from a registry (819 patients) to determine optimal # of
  criteria met to trigger combined algorithm

          # Criteria Evaluations
              1         43%      too high
              2         14%      optimal
              3          3%      too few

• Combined algorithm also used prior finding that a high
  (≥100) fluid index alone has higher specificity
                  Monthly Evaluation Model

      Start*          30                  60                90    ...Repeat until
                                                                  End of Follow-up
       Diagnostic Risk     HF Event
       Assessment 1        Assessment 1
                 Evaluation 1

                         Diagnostic Risk     HF Event
                         Assessment 2        Assessment 2
                                   Evaluation 2


                                             Diagnostic Risk   HF Event
                                             Assessment 3      Assessment 3
                                                       Evaluation 3
        * Day 0 = later of consent date or
                  60 days post-implant

• Repeated using Quarterly (90 days) and Semi-monthly (15 days) evaluations
                  Statistical Methods
• Cox proportional hazards model to adjust for
  pre-defined clinical variables including:
    Age
    Gender
    Heart Failure Etiology
    NYHA Class*
    Diabetes
    HF Medication Regimen (Diuretics, ACE/ARB, B-Blocker)*
   * Most recent prior to evaluation


• Sub-group analysis for subjects with and without a
  HF event.
     Results: Cohort and Event Rates

• 694 patients in this analysis cohort who had
  impedance monitoring and >2 months of FU

• 60 patients (8.5%) had 78 monthly evaluation
  periods with at least one HF hosp. (pulmonary)

• Low event rate: 1.4% (78/5693) of monthly
  evaluations had HF hosp. (pulmonary)
Baseline Characteristics (N = 694)
 Age                    68 yrs
 Female                 33%
 African American       11%
 NYHA (Class III)       95%
 History of AF          26%
 Ischemic HF            62%
 Diabetic               40%
 Diuretics              83%
 ACE Inhibitor or ARB   81%
 Beta Blockers          89%
       Combined Diagnostics Triggered
   1324 monthly evaluations with combined algorithm triggered
        ≥ 2 Diagnostic Criteria Met            OptiVol Fluid Index ≥100 ohm days Met


                                  43%      29%     28%        % of triggered evaluations




               75%                  67%
% of                                         62%
evaluations    60%

when ≥2        45%
                                                               43%

Diagnostic     30%   21%
Criteria Met                                          14%
                                                                      18%
               15%           7%
(N = 960)                                                                    5%
               0%
                     AF    AF+RVR OptiVol     Low     Night    Low    Low ICD Shock(s)
                                    Index ≥60 Activity HR      HRV    Pacing%
    Kaplan-Meier HF Hospitalization Curves
Evaluations with Heart Failure

                                 6%          P < 0.0001
Hospitalization (Pulmonary)

                                             Hazard Ratio = 5.5 (95% CI: 3.4 – 8.8)
                                 5%

                                 4%                                           + Diagnostic

                                 3%

                                 2%

                                 1%                                           - Diagnostic

                                  0
                                      0               10                 20                30
                                                 Days After Diagnostic Evaluation
                                          Risk of a HF hosp. for pts with
                                          + Diagnostic was 5.5 x risk of pts w/ - Diagnostic
                Multivariable Analysis
                                                                                P-Value
                                     1
Age                                                                             0.90
                               0.7
Gender                                                                          0.15
                                     1
Heart Failure Etiology                                                          0.91
                                         1.4
NYHA Class*                                                                     0.18
                                          1.6
Diabetes (@baseline)                                                            0.06
                                          1.6
Diuretics*                                                                      0.35
                               0.7
ACE/ARB*                                                                        0.7
                                0.9
Beta-Blockers*                                                                  0.90
                                                              4.8
+ Combined Diagnostic                                                           <0.0001

* Before evaluation date   0         1          2     3   4     5   6   7   8
                                                    Hazard Ratio
      Patients w/ + combined diagnostic were 4.8 times
      more likely to have a HF hospitalization with
      pulmonary congestion independent of other clinical variables.
           Subgroup by HF Event
                        0.9

                                    5.4
                                          P = 0.85
                        0.9
Subjects with
                                        5.4
Pulm HF Hosp.      -1    1      3   5         7      9



                   -1    1      3   5         7      9

                        0.9

                   P < 0.0001           5.4

Subjects without
Pulm. HF Hosp.
                   -1    1      3   5         7      9
    Effect of Evaluation Frequency

 Evaluation Frequency
                                             6.9
 15 Days (Semi-Monthly)
                                       5.5
 30 Days (Monthly)
                                 3.1
 90 Days (Quarterly)

                        -1   1   3     5      7    9   11
                             Hazard Ratio



• More frequent evaluations enhance risk stratification.
• Monthly evaluations provide reasonable balance of
  risk stratification benefit and clinician effort.
                 Conclusion
• Patients with a + combined diagnostic were
  5.5x more likely to have a HF hospitalization
  with pulmonary congestion before the next
  evaluation

• The combined algorithm is an independent
  predictor of HF hospitalization in patients
  without a HF hospitalization, while it provides
  limited information in patients who have
  experienced a HF hospitalization.
            Clinical Implications

• Monthly evaluation of combined
  diagnostics can identify patients at a
  higher risk of a HF hospitalization within
  the next month.

• Intervening by either modification of
  medications (i.e. diuretic dosing) or
  increase surveillance (i.e. clinic visit) may
  reduce clinical events
                                     HF Hosp. w/Pulm. Cong.
          30 Day Evaluation window
Case                 AF+
Study 1




                        Fluid +
Case Study 2                        HF Hospitalization with
                                    Pulmonary Congestion

               Evaluation Window


                                     OptiVol Index+




                        Activity+


                         HRV+

								
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