here - Heart Failure Society of America

Faculty
James L. Januzzi, Jr., MD, FACC, FESC
Hutter Family Professor of Medicine
Harvard Medical School
Roman DeSanctis Endowed Clinical Scholar
Massachusetts General Hospital
Faculty, Harvard Clinical Research Institute
Boston, MA
Ileana L. Piña, MD, MPH
Professor of Medicine & Epidemiology and
Population Health
Albert Einstein College of Medicine
Associate Chief for Academic Affairs
Division of Cardiology
Staff Heart Failure/Transplant
Montefiore Medical Center
Bronx, NY
Barry H. Greenberg, MD
Distinguished Professor of Medicine
Director, Advanced Heart Failure
Treatment Program
University of California San Diego
Medical Center
La Jolla, CA
Disclosures
FACULTY DISCLOSURES
James L. Januzzi, Jr., MD, has disclosed the following relevant
financial relationships:
Served as an advisor or consultant for: Amgen Inc.; Critical Diagnostics; and
Novartis Pharmaceuticals Corporation.
Received speaker honoraria for: Critical Diagnostics; Roche; and Sphingotec
GmbH.
Received grants for clinical research from: Prevencio, Inc.; Roche; Siemens
AG; and Thermo Fisher Scientific Inc.
Barry H. Greenberg, MD, has disclosed no relevant financial
relationships.
Ileana L. Piña, MD, MPH, has disclosed no relevant financial
relationships.
This activity has been independently reviewed for balance.
Learning Objectives
§  Discuss the epidemiology, pathophysiology, and
diagnosis of chronic heart failure and how
management goals for chronic heart failure differs
from acute heart failure
§  Review the data on the current and emerging
therapeutics for the management of chronic heart
failure
§  Apply evidence based strategies to optimize
pharmacological treatment, overcome barriers to
care, and improve outcomes in patients with chronic
heart failure
Program
7:15 am Program Overview 7:20 am Heart Failure Hospitalization: The Epidemiology,
Pathophysiology, and Diagnosis of Chronic
Heart Failure vs. Acute Heart Failure 7:30 am Current and Emerging Therapeutics for the
Management of Chronic Heart Failure 7: 45 am Optimizing Treatment Plans, Overcoming
Barriers to Care, and Improving Patients
Outcomes in Chronic Heart Failure 8:00 am Panel Discussion 8:15 am Adjourn Presentation Download
Instructions to access the presentations online can
be found on page 5 in the program handout:
Slide Download Instructions:
Speaker slides can be accessed via the HFSA website:
•  Go to www.hfsa.org and click on the picture of the 19th Annual
Scientific Meeting on the right
•  Under the Annual Meeting 2015 blue menu on the right, click on
2015 Satellite Symposia
•  Scroll down to Monday, September 28th to Improving Patient
Outcomes and Reducing Re-Admission Rates in Chronic Heart
Failure to download the slides.
Questions
If you have a question, please write it on a
question card and the onsite staff will bring it up to
the panel for review/discussion at the end of the
session.
Question
Submit a question for the faculty on this card. Please print clearly.
Accreditation and Certificate Instructions
ACCREDITATION STATEMENT:
PHYSICIANS:
The Heart Failure Society of America is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide continuing medical education for
physicians.
The Heart Failure Society of America designates this live activity for a maximum of 1.0
AMA PRA Category 1 Credit™. Physicians should claim credit commensurate with the
extent of their participation in the activity.
NURSES:
This program has been approved by the American Association of Critical Care Nurses
(AACN) for 1.00 Contact Hour. Synergy CERP Category A, File Number 00019413.
HOW TO CLAIM CREDIT
CE certificates will be available on-site in the registration area. The expo card
included with the name badge is required to sign in and print certificates.
Certificates will also be available online following the meeting.
Support Acknowledgment
This activity is supported by educational funding
provided by Amgen.
Pre Activity Polling
Heart Failure Hospitalization:
The Epidemiology,
Pathophysiology, and
Diagnosis of Chronic Heart
Failure vs. Acute Heart Failure
James L. Januzzi, Jr., MD, FACC, FESC
Hutter Family Professor of Medicine
Harvard Medical School
Roman DeSanctis Endowed Clinical Scholar
Massachusetts General Hospital
Faculty, Harvard Clinical Research Institute
Boston, MA
Topics
§  The problem of decompensated heart failure
§  Characterizing the patient with decompensated
heart failure
§  Predicting risk in decompensated heart failure
Topics
§  The problem of decompensated heart failure
§  Characterizing the patient with decompensated
heart failure
§  Predicting risk in decompensated heart failure
Age-adjusted hospitalization rates for heart
failure
Fang J, et al. J Am Coll Cardiol. 2008;52:428-434.
Improvement in Heart Failure
Assessment and Management is Needed
§  Direct and indirect cost estimates for HF up to
$56 billion USD annually
§  Average HF Admission costs between $7,000 $13,000 USD/admission
§  Re-hospitalization rate: 50% within 6 months
§  ACA has made HF readmission a major focus for
improvement
Berkowitz R, et al. Lippincotts Case Manag. 2005 Nov-Dec;10(6 Suppl):S1-15.
Schlendorf KH, Kasper EK. Curr Treat Options Cardiovasc Med. 2011 Dec;13(6):475-88.
Topics
§  The problem of decompensated heart failure
§  Characterizing the patient with decompensated
heart failure
§  Predicting risk in decompensated heart failure
The Most Common Cause of Acute Heart
Failure is Decompensation of Chronic Heart
Failure
LVEF > 40%
Low LVEF
Prior HF
De novo HF
ADHERE Registry
200,000 patient hospitalizations for HF
2001-2005
Causes of Hospital Readmission for
Heart Failure
Diet Noncompliance
24%
16%
Inappropriate Rx
Rx Noncompliance
24%
19%
Failure to Seek
Care
17%
Other
Ashton CM, et al. Ann Intern Med. 1995 Mar 15;122(6):415-421.
Distribution of LVEF in Patients Hospitalized
With a Primary Discharge Diagnosis of HF
Documented LVEF Measured
Prior to or During Hospitalization
5,000
4,183
4,000
3,814
Patients (n)
3,506
3,193
2,924 2,947
3,000
2,345
2,812 2,806
2,331
1,833
2,000
1,270
1,137
1,000
553
274
0
100
44
05
610
1115
16- 21- 26- 31- 36- 41- 46- 51- 56- 61- 66- 71- 7620 25 30 35 40 45 50 55 60 65 70 75 80
32
10
1
81- 86- 91- 9685 90 95 100
Left Ventricular Ejection Fraction (%)
Stough W, et al. J Am Coll Cardiol. 2006;47:47A. Poster presented at ACC 2006.
Major Comorbidities in Patients
Hospitalized with AHF: OPTIMIZE-HF
42
45
40
Patients (%)
32
31
35
28
30
25
20
15
20
18
14
11
10
5
15
6
3
3
0
Fonarow GC, et al. JAMA. 2007;297:61-70.
Topics
§  The problem of decompensated heart failure
§  Characterizing the patient with decompensated
heart failure
§  Predicting risk in decompensated heart failure
Natural History of Chronic and Acute
Heart Failure
Normal heart
Chronic heart failure
5 million in the US
10 million in Europe
Heart Viability
Initial
myocardial
injury
Death
Cost of final 2 yrs of life:
$156K
75% for hospitalizations
during last 6 months
First ADHF episode:
Pulmonary edema
ER admission
Later ADHF episodes:
Rescue therapy
ICU admission
Initial phase
Last year
Gheorghiade M. Am J Cardiol. 2005;96(suppl 6A):1-4G.
Repeat Hospitalizations Predict Mortality
Kaplan–Meier Cumulative Mortality
All-Cause Mortality After Each Subsequent Hospitalization for HF
1.0
0.8
Heart Failure
1st admission (n = 14,374)
2nd admission (n = 3358)
3rd admission (n = 1123)
4th admission (n = 417)
0.6
0.4
1st hospitalization:
30-day mortality = 12%
1-year mortality = 34%
0.2
0.0
0.0
0.5
1.0
1.5
2.0
Time Since Admission
Reproduced with permission from Setoguchi S, et al. Am Heart J. 2007;154:260-266.
Vicious Cycle of Congestion in AHF
Myocardial ischemia Worsening HF Myocardial oxygen demand Elevated LVEDP Increased wall stress Increased func@onal MR Variables that May Predict
Increased Mortality in HF
Age
Diabetes
HBG < 12
NYHA Class IV / Pres
Atrial fibrillation
Duration of
symptoms
Heart rate
Peripheral Edema
Hemoglobin
Primary Insurance
QRS duration >120ms
Dyspnea type
HF: Baseline NYHA
class
BUN / Creatinine ratio
Ever smoked
HF: pre-hospital
CAD
Fatigue
Hyperlipidemia
BNP
Blood urea nitrogen
(BUN)
Dyspnea category
CAD: Prior myocardial First diastolic BP
infarction (MI)
First height
CAD: Prior
First systolic BP
re-vascularization
First weight
Cardiac enzymes
Congest /1st x-ray
Creatinine
Gender
Hypertension
Qualitative LVEF
Race / ethnicity
Rales
Sodium
Hypertensive-SBP
>140
Stroke / TIA
Ischemic Etiology
Tachycardia >100
UNC HF score
Time in care
LOS-inpatient
Fonarow GC et al. JAMA 2005; 293:572-580.
Risk associated with higher heart rates in
chronic HF
Patients with CV death/HF hospitalization (%)
40
≥ 75 bpm
30
70 to <75 bpm
65 to <70 bpm
60 to <65 bpm
20
<60 bpm
10
0
0 Day 28
6
12
18
24
Time (months)
Böhm M, et al. Clin Res Cardiol. 2013;102(1):11-22.
In Hospital Mortality
In-Hospital Mortality Risk by Initial BNP
Levels Reduced vs. Preserved Systolic
Function HF
7
LVEF < 0.40
LVEF > 0.40
P<0.0001
P<0.0001
6.4
6
2
2.7
3.8
4
3
5
4
5
5
2.8
3
2.8
2
1.4
1.5
1
1
0
Q1
(<622)
Q2
(622-1210)
Q3
(1210-2310)
Q4
(>2310)
0
Q1
(<336)
Q2
(336-630)
Q3
(630-1230)
Q4
(>1230)
48,629 (63%) out of 77,467 pt episodes had BNP assessment at initial evaluation
ADHERE Q2 2003 to Q4 2004
Fonarow GC et al. J Am Coll Cardiol 2007; 49(19):1943-1950.
Relationships between Discharge BNP
and Outcomes are Curvilinear
Hazard Ratio (vs. BNP = 100)
3.5
•  An unchanged or rising
BNP/NT-proBNP by
hospital discharge is an
independent predictor of
short-term death/repeat
hospitalization
3.0
2.5
2.0
•  A reduction of 30% or
more of either biomarker
is desirable prior to
discharge
1.5
1.0
0
1000
2000
3000
4000
Discharge BNP
Kociol RD, et al. Circ Heart Fail. 2011; 4: 628-636.
Risk-Treatment Mismatch in HF
Patients (%)
At Hospital Discharge
90 Day Follow-Up
90
80
70
60
50
40
30
20
10
0
ACEI
ACEI or
ARB
βBlocker
Low Risk
ACEI
Average Risk
ACEI or
ARB
βBlocker
1 Year Follow-Up
1 Year
Mortality Rate
High Risk
Use rates in absence of contraindications. For all drug classes, P<.001 for trend.
Lee, D. JAMA. 2005;294:1240-1247.
ADHERE: Change in Weight
During Hospitalization
Evidence of Incomplete Relief From Congestion
33%
Enrolled Discharges (%)
35
30
24%
20% of ADHF patients
discharged with weight
gain or no change in weight
25
20
13%
15
10
7%
15%
6%
3%
5
2%
0
<-20
-20 to -15
All Enrolled (n=105,388)
-15 to -10
-10 to -5
-5 to 0
0 to 5
5 to 10
>10
Change in Weight (lbs)
Note: For the chart, n represents the number of patients who have both baseline and discharge weight,
and the percentage is calculated based on the total patients in the corresponding population. Patients
without baseline or discharge weight are omitted from the histogram calculations.
Yancy CW, et al. Curr Heart Fail Rep. 2004;1(3):121-128.
Thank you
Current and Emerging
Therapeutics for the
Management of Chronic
Heart Failure
Barry Greenberg, M.D.
Distinguished Professor of Medicine
Director, Advanced Heart Failure
Treatment Program
University of California, San Diego
Current and Emerging Therapeutics for the
Management of Chronic Heart Failure
§  Overview of current therapy
§  New therapies
–  Ivrabradine
–  Sacubitril/losartan
–  Agents to lower serum potassium (e.g. potassium
binders)
Pharmacologic Treatment for Stage C
HFrEF
HFrEF Stage C
NYHA Class I – IV
Treatment:
Class I, LOE A
ACEI or ARB AND
Beta Blocker
For all volume overload,
NYHA class II-IV patients
For persistently symptomatic
African Americans,
NYHA class III-IV
For NYHA class II-IV patients.
Provided estimated creatinine
>30 mL/min and K+ <5.0 mEq/dL
Add
Add
Add
Class I, LOE C
Loop Diuretics
Class I, LOE A
Hydral-Nitrates
Class I, LOE A
Aldosterone
Antagonist
Yancy CM, et al. Circulation. 2013;128:e240–319.
Ivrabradine
§  Acts by dose-dependent
§ 
§ 
specific inhibition of If
funny channels that are
highly expressed in the SA
node.
Delayed diastolic
depolarization results in
HR reduction.
In CAD patients with
HR>70 bpm, ivrabradine
reduced coronary events
by 22%, MI by 36% and
revascularization by 30%*.
Fox K, et al. Lancet. 2008 Sep 6;372(9641):807-16.
Ivrabradine and Outcomes in Chronic HF:
The SHIFT Study
§  Double blind, placebo controlled RCT in
symptomatic HF patients in NSR with HR >70
beats/min and EF <0.35.
§  Pts were hospitalized within past year and on
stable Rx including a beta blocker, if tolerated.
§  Randomized to ivrabadine 7.5 mg bid or
placebo.
§  Primary EP was CV death or HF hospitalization.
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
Background Rx in SHIFT
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
Changes in HR Over Time in SHIFT
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
Ivrabradine Effects on Combined CV
Mortality and HF Hospitalization
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
Ivrabadine Reduced Mortality in SHIFT
Heart failure mortality
All cause mortality
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
Adverse Events in SHIFT
Patients with an adverse event
Patients with an adverse event
leading to drug withdrawal
Ivabradine
group
(n=3232)
Placebo group
(n=3260)
p value
Ivabradine
group
(n=3232)
Placebo group
(n=3260)
p value
All
2439 (75%)
2423 (74%)
0·303
467 (14%)
416 (13%)
0·051
Heart failure
804 (25%)
937 (29%)
0·0005
70 (2%)
82 (3%)
0·367
Symptomatic
bradycardia
150 (5%)
32 (1%)
<0·0001
20 (1%)
5 (<1%)
0·002
Asymptomatic
bradycardia
184 (6%)
48 (1%)
<0·0001
28 (1%)
5 (<1%)
<0·0001
251 (8%)
0·012
135 (4%)
113 (3%)
0·137
Atrial fibrillation 306 (9%)
Phosphenes*
89 (3%)
17 (1%)
<0·0001
7 (<1%)
3 (<1%)
0·224
Blurred vision
17 (1%)
7 (<1%)
0·042
1 (<1%)
1 (<1%)
1·000
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
SHIFT: Subgroup Analysis
Swedberg K, et al. Lancet. 2010 Sep 11;376(9744):875-85.
Biological Actions of Combined Angiotensin
Receptor Blockade and Neprilysin Inhibition
§  AT1 receptor blockade
reduces Ang mediated:
- vascular tone ( afterload),
salt and water retention
( preload)
- hypertrophy and fibrosis
- CNS stimulation (less
catecholamine release)
- aldosterone release
§  Neprilysin inhibition
blocks the breakdown of
a variety of vasoactive
and other peptides
including natriuretic
peptides (e.g. ANP, BNP,
CNP) and bradykinin
resulting in:
- vasodilation
- natriuresis
- anti-growth effects in the
heart
PARADIGM-HF Study
LCZ696 (Sacubitril/valsartan) in HFrEF Patients
§  Phase III RCT evaluating the efficacy and safety profile of
§ 
§ 
LCZ696 vs enalapril in 8,436 patients with NYHA Class II-IV
symptoms, EF <35% and elevated BNP level.
Primary endpoint - LCZ696 is superior to enalapril in
delaying time to composite of CV mortality and HF
hospitalization.
PARADIGM-HF was prematurely stopped by the DMC due to
evidence that patients receiving LCZ696 lived longer without
being hospitalized for heart failure than those who received
standard care with ACE-inhibitor enalapril.
PARADIGM-HF: Outcomes
McMurray JJ, et al. N Engl J Med. 2014 Sep 11;371(11):993-1004.
Adverse Events during Randomized Treatment
McMurray JJ, et al. N Engl J Med. 2014 Sep 11;371(11):993-1004.
Hyperkalemia in Heart Failure:
Magnitude of the Problem and
Emerging Therapy
Pharmacologic Treatment for Stage C
HFrEF
HFrEF Stage C
NYHA Class I – IV
Treatment:
Class I, LOE A
ACEI or ARB AND
Beta Blocker
For all volume overload,
NYHA class II-IV patients
For persistently symptomatic
African Americans,
NYHA class III-IV
For NYHA class II-IV patients.
Provided estimated creatinine
>30 mL/min and K+ <5.0 mEq/dL
Add
Add
Add
Class I, LOE C
Loop Diuretics
Class I, LOE A
Hydral-Nitrates
Class I, LOE A
Aldosterone
Antagonist
Yancy CM, et al. Circulation. 2013;128:e240–319.
Hyperkalemia in Heart Failure
§  Guidelines state to limit RAAS inhibitor use in HF
patients exhibiting hyperkalemia
§  Current RAAS inhibitor prescribing labels restrict
use in patients with potassium levels >5.0 mEq/L
§  Novel HF therapies (e.g. LCZ696) exclude
hyperkalemic patients from their clinical trials
§  Even with precaution, HF patients on emerging
therapies will struggle with potassium elevating
side effects
Hyperkalemia in PARADIGM-HF
LCZ696
(N = 4187) Event Elevated serum
potassium Enalapril
(N = 4212) P Value no (%)
5.5 mmol/liter 674 (16.1) 727 (17.3) 0.15 > 6.0 mmol/liter 181 (4.3) 236 (5.6) 0.007 Patients Excluded Due to Elevated K+ Levels During Run-in Period Veils
Number of Patients with Elevated K+ Due to Treatment
McMurray JJ, et al. N Engl J Med. 2014 Sep 11;371(11):993-1004.
The Addition of MRA to RAS Therapy Increases
the Risk for Hyperkalemia (≥6.0) in CHF Patients
Hyperkalemia with spironolactone in
Real-world vs Clinical-trial HF patients
Clinical trials
14
Real-world
12
% of Patients
12
10
8
6
6
4
2
0
2.5
2
RALES 1
EMPHASIS 2
Shah 2005 3
N=822
N=1,336
N=840
1. 
2. 
3. 
4. 
Bozkurt 2003
4
N=104
Pitt B, Zannad F, Remme WJ, et al. N Engl J Med. 1999;341(10):709-717.
Zannad F. N Engl J Med. 2011;364:11-21.
Shah KB, et al. J Am Coll Cardiol. 2005;46(5):845-849.
Bozkurt B, et al. J Am Coll Cardiol. 2003;41(2):211-214.
Hyperkalemia and the RALES Study
Spironolactone
prescription rate
(per 1000 patients)
§  Publication of RALES sparked an increase in prescriptions for spironolactone
§  Also a parallel increase in hospital admissions and death from hyperkalemia
160
140
120
100
80
60
40
20
0
Online release
of RALES
Rate of admission
for hyperkalemia
(per 1000 patients)
1994
1996
12
10
8
6
4
2
0
1998
1999
Study year
2000
2001
2000
2001
Online release
of RALES
1994
1996
1998
1999
Study year
Adapted from: Juurlink DN, et al. N Engl J Med. 2004;351:543-551.
Patiromer For Oral Suspension: An
Investigational New Drug Not Approved by the
Food and Drug Administration
Patiromer
Electron Microscopy Image
Free-flowing powder of small,
spherical beads (~100 µm)1
Active moiety, patiromer,
is nonabsorbed1,2
Calcium (rather than sodium)
is exchanged for potassium1,2
Site of action is the
gastrointestinal tract, mainly in the
lumen of the colon where1
-  K+ is the most abundant cation
-  Residence time of the polymer
is the longest
1. Bushinsky DA, et al. Poster presented at: ASN Kidney Week 2014; Philadelphia, PA;
November 11-16, 2014; Poster SA-PO153.
2. Weir MR, et al. N Engl J Med. 2015;372(3):211-221.
Mean Serum K+ (mEq/L)
Phase 3 Part A: Primary and Secondary
Efficacy Endpoints
Secondary Efficacy Endpoint:
76% of subjects had serum K+ in the
target range (3.8 to <5.1 mEq/L) at
week 4
Baseline
Weir MR, et al. N Engl J Med. 2015;372(3):211-221.
Phase 3 : Adverse Event Profile
Adverse Events During the Initial Treatment
Phase and Through the Safety Follow-up Period
for That Phase*
Events are listed if they
occurred in at least 3% of the 243 patients overall
Adverse Events During the Randomized
Withdrawal Phase and Through the Safety
Follow-up Period for That Phase*
Adverse events are listed if they occurred in at least
4% of patients in the patiromer group
* The safety follow-up period was 1 to 2 weeks after discontinuation of the study drug.
‡ None of the serious adverse events were considered related to the study drug by the investigators.
Weir MR, et al. N Engl J Med. 2015;372(3):211-221.
Phase 3 Part B: Exploratory Endpoints
Proportion of Subjects (%)
P<0.001*
P<0.001*
94%
100%
80%
60%
62%
44%
40%
20%
0%
Placebo
Patiromer
16%
Requiring any adjustment of
RAASi (ie, down-titration or
discontinuation) or patiromer
dose increase due to
hyperkalemia at any time during
Part B
Receiving any dose
of a RAASi at the
end of Part B
Weir MR, et al. N Engl J Med. 2015;372(3):211-221.
ZS-9 is a Novel First-in-Class Inorganic
Crystalline Compound Designed Specifically
to Trap K+
Adapted from: Stavros F, et al. PLoS One. 2014;9(12):e114686.
Dose-Dependent Serum K+ Reduction Over 48
Hours in HF Patients on RAASi
Source: El-Shahawy M, et al. Oral Presentation During a Late-Breaking Clinical Trial Session at the Heart Failure Society of America
(HFSA) 18th Annual Scientific Meeting, Sep 15, 2014,
Once Daily ZS-9 10g Maintained Normal Range of
Mean Serum K+ Levels Compared With Placebo:
HF Patients on RAASi
Source: El-Shahawy M, et al. Oral Presentation During a Late-Breaking Clinical Trial Session at the Heart Failure Society of America
(HFSA) 18th Annual Scientific Meeting, Sep 15, 2014,
Impact of New and Emerging Therapies on
HF Management
§  Add ivrabadine to regimen of patients whose
HR >70 despite maximal tolerated beta
blocker dose.
§  Sacubitril/valsartan is indicated to replace an
ACEI or ARB to reduce the risk of CV death
and HF hospitalization in symptomatic HFrEF
patients.
§  New potassium binding agents are highly
effective in reducing K+ and should help
increase the safety of RAAS inhibitors,
particularly in high risk patients.
Thank you
Optimizing Treatment Plans
Overcoming Barriers to Care
Improving Patients Outcomes
in Chronic Heart Failure
Ileana L. Piña, MD, MPH
Professor of Medicine & Epidemiology and
Population Health
Albert Einstein College of Medicine
Associate Chief for Academic Affairs
Division of Cardiology
Staff Heart Failure/Transplant
Montefiore Medical Center
Bronx, NY
Continuity of HF Care
Reliable Care: Not Missing the Steps
Black
hole*
#1
Hospital
ED
• Diagnosis
• Admit
• CCU?
• Acute Rx
• Evaluation
CCU
Telemetry
• IV Meds
• Oral Meds
• LV function
• Echo and/or
Cath?
• Other
Evaluation
• Tx to Floor
DC
• Oral Meds
• Other Rx?
• Other
eval
• Pt Ed
• F/U
• Disease
Manage
Prehospital?
Black
hole*
#2
Early
Post DC
Outpatient
• Right
meds?
• Titration
• Pt
Education
Disease
Manage
• Continuity
Device?
• On right
meds?
• On right
dose?
• Volume
status
• Re-assess EF
• Device?
• Self Manage?
• Other Issues?
* Who is responsible????
Fonarow GC, et al. Rev Cardiovasc Med. 2006;7:S3-11.
Optimizing Treatment Plans
§ 
§ 
Plans-venue
–  Pre hospital
–  In hospital
–  At transition #1
–  At transition #2 (may be different from #1)
Include
–  Diet
•  What to eat
•  What to avoid
–  Is hyperkalemia present or potentially present?
–  Medical Therapy
•  Why, how
•  Up-titration schedule
•  Flexible diuretic regimen
–  Activity
•  Actual advice with specifics– Exercise Rx
Low Na + and now low K+ diet
Compliance is Difficult
1.  Foods rich in potassium content are pervasive and all
encompassing.
2.  Consequently, strictly adhering to a low sodium and
potassium diet affects quality of life.
There needs to be a link!
Transitions of care beyond the front door:
Wishful thinking!
Transitions of care beyond the front door:
Reality
There needs to be a link!
Navigating the In-patient Landscape
From acute to
chronic: A
transition
ignored
Patel SR, Piña IL.
Am J Cardiol.
2014 Dec 15;114(12):1923-9
73
How to best transition care beyond the front
door?
§  Personal physician visits to home
§  Visiting nurses trained in HF care
§  Phone monitoring by a nurse/team
§  Early/frequent visits to HF team
§  Home monitoring (scale, phone systems,
devices, internet based reporting)
§  Let the patient decide when to call
Shouldn’t it work?
§  Is it a monitor or the system its deployed in?
§  Who monitors the monitor?
§  Who responds to monitoring signals and how?
§  Do those that monitor and assess have authority
to change therapy?
Hospital Variation in Early Follow-up After
Heart Failure Hospitalization
Median
Follow-up
Visit within
7 days =
37.5%
225 Hospitals
32
Hernandez et al. JAMA. 2010;303:1716-1722.
H2H Core Concepts
§ 
§ 
§ 
Post-discharge medication management. Patients
must not only have access to the proper medications,
they need to be properly educated on how to use
them.
Early follow-up. Discharged patients should have a
follow-up visit scheduled within a week of discharge,
as well as the means of getting to that appointment.
Symptom management. Patients must recognize the
signs and symptoms that require medical attention, as
well as the appropriate person to contact if those signs/
symptoms appear.
Hernandez et al. JAMA. 2010;303:1716-1722.
7-10 day visit: Why may it not work
(38% of pts at discharge are NOT being
given a post discharge appt.
§  What processes occur?
§  Information obtained/acted upon
§  Changing course of therapy
§  Uptitration of evidence based care
§  Patient education---who delivers?
Understanding health care
as a system
How we improve
what we make
What society
needs
How we create,
make health care
186/month Nov ICD 428- 1 hospital
HOME
EMS
SNF
CC
U
ED
97
%
MD office
HOME
Patien
t Flow
B
r
o
w
n
b
a
g
c
li
n
i
c
Step
dow
n
Direct
Admit
WARD
Walk in
Clinic
Patient
Interaction:
RN
MD
PT Rehab
Nutrition
Psych
Pharmacy
Card
(33)
Surgery
(6)
IM
(45)
IM
PA
(37)
Familiy
Med
(5)
CMO
Provider
s
Hospitalist
s (50)
SNF
30-40%
Long Term
Geriatrics
(9)
Follow up : 7-10 Day
Brown Bag clinic
Med Rec.
Brown Bag Clinic
A Montefiore initiative for
HF patients to improve
transitions of care postdischarge
SERIOUS Model for
Medication Reconciliation
Solicit (from patient)
- Medications and allergies from patient at each encounter, including all medications and herbal supplements
- Obtain information from other pharmacies if needed
Examine
- At each inpatient and outpatient encounter
- Look for discrepancies in doses, frequencies between list and reported regimen
Reconcile
- Compare home list and list in medical record, make changes to make them match as appropriate
- Reconcile with interactions and allergies and take appropriate actions
Inform
- Educate patients and caregivers about indications and adverse effects of medications
Optimize
- Optimize medication doses to target guidelines or to improve symptoms
- Reduce medications if appropriate to address polypharmacy or improve adherence
Update
- Update list with appropriate changes
Share
- With patient/caregiver when leaving and all other providers
Hoover D. IHI Quality Improvement Forum 2008. [Abstract]
Work Flow
§  Staffed by clinical hospital pharmacists
§  Clinical pharmacists as “preceptors”
§  Nurse practitioner/Fellow/attending available
§  Symptom evaluation (vitals, questionnaire, KCCQ)
§  Review pre-discharge BNP, serum Cr, electrolytes;
•  If none, order
–  Extensive pt education
§  Focus on medications
•  Education, drug interaction self-management tools, pill
box fills, discard duplicates
§ 
One half day per week
Identify the problem
OTC/Herbs Active Rx
Expired/duplicates
“Under the counter”- “my husbands NTG for CP”
Eliminate poly-pharmacy
Duplicates/Expired/No longer
needed
Reasons for processes in Brown Bag
§  KCCQ
§  Pro-BNP
§  Medication Reconciliation
–  Patient education
–  Reinforcement
–  Cognitive difficulties
§  Next appointment made
Typical List of Meds: BB Clinic
Average # meds
At discharge = 15
Brown Bag Clinic: Better Adherence
Methods
Overcoming Barriers to Care
§  Lack of input by Cardiologists/HF specialists in
hospital care: Hospitalists teams with PA
§  Clinical inertia or “I already do the right thing for
patients. Do not need any other guidance”
§  Lack of leadership at the hospital administration
level.
§  Familiarity with team care
§  Discomfort of physicians in ACEI use in patients
with abnormal renal function: “I have already
tried this. He/she doesn’t tolerate it.”
Overcoming Barriers to Care
§  59% of pts scheduled do not come to clinic
§  Main reason: transportation
§  Discomfort of physicians at changing or uptitrating medications: “MY patient”. “I want to
do this myself”.
§  Experience with diuretic flexible regimen—
new to providers
§  Optimal timing for next visit
§  Should a BB clinic count as a provider clinic?
Improving Patients Outcomes:
Possible or
Brown Bag Clinic: HFPeF & HFReF
AGE M/F AA HISPANIC EF % Systolic BP Diastolic BP HR Serum Cr BB Clinic n=112 65 + 11 61/51 55 39 30 + 12 125 + 21 72 + 15 81 + 14 1.57 + 1.08 Pro-BNP admission Pro-BNP close to d/c 8,944 + 12,062 8,905 + 14,641 Controls= No shows to BB clinic
Controls n=88 65 + 13 42/46 38 + 15 121 + 21 71 + 12 77 + 12 1.62 + 0.88 13,616 +
22,921 7,964 + 6,156 Brown Bag Clinic Meds
Carvedilol
(mg)
Enalapril
(mg)
Valsartan (mg)
Spironolactone
(mg)
HFReF N=96 EF 27 + 7% Baseline BB clinic mean
Std n 24.33 18.33 153.33 39.58 19.45 93.00 14.03 60.00 87.69 6.00 49.17 12.00 End of BB
mean std n 28.78 19.84 95.00 18.49 14.57 76.00 173.33 71.80 6.00 33.75 38.75 20.00 3mos
mean std n 31.85 20.23 93.00 20.46 14.51 71.00 224.00 78.38 5.00 32.07 36.46 23.00 Clinical Summary
Overall Summary
Social Limitation
Quality of Life
Self-Efficacy
Total Symptom
Score
Symptom Burden
Symptom
Frequency
Symptom Stability
Physical Limitation
KCCQ at Brown Bag
mean 50.83 66.81 58.45 63.29 60.87 70.39 46.73 47.07 51.38 55.85 STD 27.87 28.00 29.92 29.58 28.46 26.76 26.05 29.68 21.85 22.39 Physical Limitation
Brown Bag Clinic: The KCCQ
Symptom Stability
Symptom Frequency
Symptom Burden
Total Symptom Score
Self-Efficacy
Quality of Life
Social Limitation
Overall Summary
Clinical Summary
30 Day Readmissions
BB: 8 readmits <=30 days ---8.3%
4 for HF (50%)
Controls: 16 readmits <=30 days—24.4%
There need to be more links!
§ 
Partnering with community physicians or physician groups to reduce
readmission
§ 
Partnering with local hospitals to reduce readmissions
§ 
Having nurses responsible for medication reconciliation
§ 
arranging follow-up appointments before discharge
§ 
Having a process in place to send all discharge paper or electronic
summaries directly to the patient’s primary physician
§ 
Assigning staff to follow up on test results that return after the patient is
discharged
Bradley EH, et al. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):444-450.
Number of Strategies
Bradley EH, et al. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):444-450.
Post Activity Polling
QUESTIONS
AND
ANSWERS