FileNewTemplate · 6/27/2016 4 Mechanical Circulatory Support • MCS is beneficial in carefully...

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Advanced Heart Failure: Weeding Through Issues & Candidacy

AAHFN Annual Meeting, June 24, 2016

Kismet Rasmusson, DNP, FNP-BC, FAHA, CHFN

Nicole Fenwick, MSW, LCSW

We will not discuss off label use or investigation use in our

presentation

We have no financial relationships to disclose

Disclosure

1. Describe the guidelines for patients with Stage D HF who may be candidates for advanced therapies (Heart transplant, MCS, hospice).

2. Learn about the comprehensive work up for Stage D candidacy: the medical, psychosocial and financial aspects.

3. The learner will see how real life cases were applied to patients with both financial and psychosocial challenges to candidacy and how these were overcome.

Objectives

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*2013 ACCF/AHA Guidelines for the Management of Heart Failure Bozkurt et al. Circulation

2013;128:e240-327.

The Course of Heart FailureThe trajectory

Larry A. Allen et al. Circulation. 2012;125:1928-1952

Definition of Advanced HF

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Identifying Advanced HF

Advanced Heart Failure: Recognition & Treatment

roughly 10% of patients with heart failure (HF) end up with advanced disease with a trajectory that increases the risk of death

Cardiac Transplant

• Evaluation for transplant is indicated in carefully

selected patients with stage D HF, despite GDMT,

device and surgical management.

Class I, LOC C

Bozkurt et al. Circulation 2013;128:e240-327.

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Mechanical Circulatory Support

• MCS is beneficial in carefully selected patients with Stage D HF in whom

definitive management with transplant or recovery is anticipated or

planned.

• Nondurable MCS (temporary support) is reasonable as “bridge to recovery”

or “bridge to decision” for carefully selected patients with HFrEF with

acute, profound hemodynamic compromise.

• Durable MCS is reasonable to prolong survival in carefully selected

individuals with Stage D HFrEF

Class Iia, LOE B

Bozkurt et al. Circulation 2013;128:e240-327.

Transplant vs. LVAD?

Donor shortage, LVAD

complications

Improved LVAD outcomes,

accessibility, size, technology

Strategy for Stage D HF- screen for transplant 1st, then consider Destination Therapy – this is under debate

Colvin. JACC 2015;65:2542-55.

1. Describe the guidelines for patients with Stage D HF who may be candidates for advanced therapies (Heart transplant, MCS, hospice).

2. Learn about the comprehensive work up for Stage D candidacy: the medical, psychosocial and financial aspects.

3. The learner will see how real life cases were applied to patients with both financial and psychosocial challenges to candidacy and how these were overcome.

Objectives

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Guidelines from the International Society of Heart & Lung

Transplantation

Feldman, D., et al., The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant, 2013. 32(2): p. 157-87.

Merhra et al., The 2016 International Society for Heart and Lung Transplantation Listing criteria for heart transplantation. J Heart Lung Transplant, 2016. 35(1).

Determining Candidacy for Advanced HF Therapies

Medical assessment

Financial assessment

Psychosocial assessment

Heart Transplant Indications

• Cardiogenic shock requiring either continuous inotropic MCS

• Persistent NYHA class IV symptoms refractory to maximal medical therapy

• (left ventricular ejection fraction <20 percent; peak Vo2 <12 mL/kg/min).

• Intractable or severe anginal symptoms in patients with coronary artery disease not amenable to percutaneous or surgical revascularization or severe transplant coronary artery disease.

• Intractable life-threatening arrhythmias unresponsive to medical therapy, catheter ablation, surgery, and/or ICD

• Congenital heart disease NYHA class III to IV HF not amenable to palliative or corrective surgery.

• Patients with complex intracardiac abnormalities and significant pulmonary vascular obstructive disease may require heart/lung transplantation

• Other considerations:

• Severe Hypertrophic or restrictive cardiomyopathies

• Cardiac tumors

• cardiac amyloidosis

• arrhythmogenic right ventricular dysplasia (ARVD)

UpToDate, accessed June 2016

Medical assessment

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LVAD as Destination Therapy

• Indications

• NYHA class IV end-stage ventricular heart failure (HF)

• Not candidates for heart transplant and, meet all of the following:

• Failed optimal medical management (BB, ACE inhibitors for at least 45 of the last 60 days, or IABP dependent for 7 days, or inotrope dependent for 14 days;

• Have an LV ejection fraction (LVEF) <25%; and

• Have demonstrated functional limitation with a peak oxygen consumption of ≤14 ml/kg/min unless balloon pump or inotrope dependent or physically unable to perform the test.

Centers for Medicare & Medicaid Services

Medical assessment

Pre-Transplant EvaluationMedical Candidacy- assessing prognosis

UptoDate, accessed June 2016

Medical assessment

Pre-Transplant Evaluation

• Oxygen consumption; VO2 max

• <14 ml/kg/min (BB intolerant), < 12 if on BB

• If < 50 years of age, consider VO2 max < 50% predicted for age

• If ambiguity in results- consider using HF Survival Score

• Right heart catheterization

• Vasodilator challenge for PAS > 50 mm Hg and

• either Trans Pulmonic Gradient > 15

• Or Pulmonary Vascular Resistance > 3 Wood units

• If unable to improve hemodynamics with vasoactive agents, inotropes & diuretics- then consider IABP, or VAD

Medical Candidacy- assessing prognosis

Mehra et al. 2016 ISHLT Listing Criteria for Heart Transplant: 10 year update. ISHLT. Jan 2016:35(1).

Medical assessment

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Pre-Transplant Candidacy

• Non-reversible PAH

• Other considerations:

• Age > 70: careful selection

• Obesity: worse outcomes for BMI > 35 kg/m2

• Cancer: if treatable, cured or in remission with oncology assessment of low recurrence rate

• Diabetes: consider unless uncontrolled (HgbA1c > 7.5%), and/or with significant end-organ damage

• Renal dysfunction: consider unless reversible with improved CO

• Cerebral and PAD: consider unless significant symptomatic

Comorbidities and Considerations for Listing

Ask- is this patient an MCS- Bridge to Candidate?

Medical assessment

Other MCS Candidacy Considerations

• MCS candidates need heart transplant candidacy

addressed

• Assess INTERMACS profile- risk stratify

• Consider temporary MCS

• Assess for hematologic disorders

• Perform nutritional assessment

• Assess infection risk

Medical assessment

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Pre-Transplant/VAD Candidacy

• Assess for use: smoking- Illicit drug use- ETOH abuse

• Palliative care consultation - Include goals, symptom

management, EOL preferences

• Assess frailty and cognitive status

• Infectious, hematologic issues

• Surgical approach

Other considerations

Medical assessment

Transplant Patient Selection Procedure

1. Multidisciplinary team review

• Patient consent

• Medical/ surgical, financial, psychosocial, dietician, pharmacist evals

2. Prepare for presentation to present to committee

• HF cardiologist & nurse coordinator prepare worksheet

3. Present patient’s case to committee- group decision

4. Notify patient of committee decision to list, or not

5. List patient with UNOS if approved for transplant

Medical assessment

Similar multidisciplinary review for potential MCS

Complexity of Challenges

Stress

Financial

Physical

Emotional

Support

Addiction/substance use/abuse

Assessing patients and caregivers

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The Role of a Financial Coordinator

• A mechanism must be in place to provide financial aid or

support for those who have limitation to medical

coverage.

• UNOS suggests that all transplant program have dedicated

staff to for financial assessments and clarifying insurance

issues

Financial Assessment


Expenses of Advanced Therapies

• Evaluation process Surgery and ICU care contribute to the majority of the expense

• Surgeon, anesthesia, operating room expenses

• Ongoing follow up care, labs testing and other procedures (heart biopsies- HTx, for example)

• Physical, cardiac, and/or occupational rehabilitation

• Readmissions

• Medications

• For transplant patients:

• Cost of transplanted organ and its recovery (HTx specific)

• Ongoing immunosuppressant therapy

• For MCS candidates:

• Device costs and equipment, driveline supplies

• For patients who live distant to the transplant/VAD center: travel, hotel/lodging, food

• Transportation to and from the medical center – during the evaluation and post-care

• Lost earnings for either the patient or their family member, as income earner

• Insurance premiums, deductibles and co-pays


Heart Transplant Charges

• Estimated billed charges for HTx totals just under $1 million dollars in 2011. Th charge summary is accounted for by:

• 30- day pre-transplant care: $47,200

• Organ procurement: $80,000

• Hospital transplant admissions: $634,300

• Physician during transplant: $67,700

• 180 days of post-transplant care: $137,800

• Medication costs (immunosuppressants and other medications): $30,000

(Hanson SG, B.T. 2011 U.S. organ and tissue transplant cost estimates. )


VADs cost ~$150,000 for implantation and the first year of care

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30-day Estimated Retail Drug Costs

Calcineurin Inhibitor

$300-500

Antiproliferatives

$180-2800

Steroids

$15

Prophylaxis

Other meds for comorbidities

$-$$$$

Post Transplant



• The most common funding sources are:

• Private Insurance – either through an employer or a personal policy

• Extending Insurance Coverage through COBRA

• Medicare Coverage

• Medicaid Coverage

• Fundraising Campaigns

• Family support

Financial Assessment


80% of hospital cost is covered by insurance

Financial Coordinator Steps

• Does the patient have insurance?

• Gather insurance information, make copies of cards

• Call company to verify eligibility and benefits, obtain authorizations

• Document benefits

• Schedule meeting with patient to review benefits, discuss ability to

pay for all phases

• Patient undergoes work up - team determination of candidacy

• Patient listed with UNOS

• Periodically re-verify insurance coverage

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Financial Coordinator Worksheet Financial assessment

Sign Here Please…

Social Worker Requirement

The Joint Commission

CMS


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LCSW Role & Check List

Introduce LCSW role to patient

Gather basic demographic information from patient, establish rapport

Discuss upcoming psychosocial assessment and what it entails, explain 3 main area to patient, mental health, support system and compliance

Involve patient in setting up date/time and who they would like to include during assessment (if possible)

Review patient’s medical history/chart that is available

Conduct thorough assessment

Discuss any “red flags” regarding mental health, compliance, or support system with patient and/or family

Assist patient with problem solving “red flags” in the above areas: possible options include: counseling, substance abuse programs, family meetings and/or behavior contracts.

Discuss clinical assessment with Heart Failure team

Write up full report for medical chart with level of recommendation: weak, adequate, good, strong

Present patient’s psychosocial assessment at MCS meeting and community transplant meeting

Continue discussion if necessary to address concerns regarding patient’s psychosocial assessment



• Ability to give informed consent

• Ability to adhere with instructions

• Screen for cognitive dysfunction

• Assessment of financial, social, emotional support

systems at home or in community

• Include caregiver burden

• Assess substance use/abuse

• Tobacco use

• Substance abuse (includes ETOH abuse)

Psychosocial Assessment


The Psychosocial Assessment: Having Honest Discussions

• History of handling previous stressful events

• Current status

• Potential future issues:

• financial issues,

• psychosocial issues,

• mental health of patient and mental health of their

support network

• Need for ongoing surveillance

With the patient/caregivers


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Questions to Consider

• Is there family/personal history of mental health issues/mental illness? (use terms: depression/anxiety)• If yes, what is your understanding of these issues?

• How do you currently handle stress?

• Have you suffered previous traumas? • If yes, how did you “get through”?

• Does your culture/religion play a role in your health care?• if yes, how?

Mental Health



• Who is your primary support person?

• What is their availability?

• Who is your back up primary person? (primary becomes

unavailable)

• What is your history and relationship with this support system?

• Do your designated caregivers have health or mental health issues?

• Who else makes up your support team? (extended family, friends,

religious affiliations/colleagues)

Social Support


Complexity of AdherencePsychosocial assessment

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• Do you currently manage your own medication?

• Do you have history of addiction?(tobacco, ETOH, drugs,

gambling)

• If yes, how was it treated?

• If applicable: Can you identify certain triggers that affect your

behavior?

• What do you do for self care?

• Will your current support system help you to maintain

adherence?

Adherence


Having Honest Discussions

• Forum for communication- weekly meeting

• Communicate clearly any concerns that may affect patient’s self care or their adherence

• Educate team as needed on barriers/stressors that are specific to patient

• Provide monitoring plan

• Documentation needed by providers

With the team


HF “Group”

• Combination of education and support: team/community member discussing specific topic/ central theme for open discussion

• Provides peer interaction for those in similar situations

• Discussion of similar challenges: financial, emotional, physical

• Celebrate anniversaries, goals achieved, progress made

• Gentle moderation of discussion

Support Group for Patients/Caregivers


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Social Work Support

Before Hospital & After

Screen for:• Psychological risks• Cognitive dysfunction• Family, social and emotional

support• Adherence• History of addiction-

abstinence plan/rehab, plan for long-term monitoring

• Well being/availability of caregiver

• Use discharge checklist for transition plans• Complete training with patient/caregiver (transplant or

MCS ed)• Assess barriers for medical appointments• Provide routine outpatient support• Discuss any financial concerns that would affect medical

care: Rx, child care, disability• Monitor for psychiatric issues• Encourage patient to attend support group and/or seek

outpatient counseling if needed• After MCS:

• Ensure electricity, emergency electricity plans• Ensure home safety- fall prevention• Primary caregiver must display competency with

MCS- problem solving• routinely assess neurocognitive function (3, 6, 12, 18

months after implant)

The Continuum of Advanced Therapies


Case Studies

• PMH:

• Long history of high level Adderall use. Back fracture when working as EMT 10 years ago -struggled with weaning off opiates. Depression.

• IDC- became advanced, he was waiting to start a new job with benefits.

• Financial Hx: Admitted for advanced heart failure-uninsured and did not qualify for Medicaid due to his assets.

• Social Hx: Volatile relationship with his ex wife and limited extended family support locally.

• Mental health: on Effexor, states mood controlled. He struggled with stopping Adderall completely.

• What would you do?

GM- 46 yo RN, divorced male, 3 children ages 4, 10, 14

Case Study

• PMH: IDC, end-stage

• Financial Hx: uninsured when he was admitted to the hospital and declined quickly. Had been trying to work but had been unable to due to physical limitations.

• Social Hx:

• had been living with his mother, He was somewhat estranged from his 7 brothers and sisters, although they all lived locally.

• history of drinking and smoking marijuana, which his wife also reported had led to the strain on their marriage.

• mother is also a recovering alcoholic and on the liver waiting list. Daniel’s father had died suddenly from heart disease most likely and this caused him high anxiety.

• What do you do?

DM, 42 yo Mexican American, father of 2, separated from wife

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Case Study

• PMH: transported to our hospital from out of state due to advanced HF-

due to excessive substance abuse. Presented emotionally depressed and

guilt-ridden; accepted his role in his current situation.

• Financial Hx: family coverage through spouse’s employment

• Social Hx:

• Addiction: He vowed to stay clean and fight for himself and his family.

• Jake’s wife agreed to fight with him, however she had to stay at home

to continue to work to retain their insurance.

• What do you do?

JM- 35 yo Caucasian, married, father of 4 (1, 3, 5, 7 yrs)

Case Studies

• PMH: Came to our team with advanced IDC, admitted, declined quickly

• Financial Hx: insurance coverage through spouse’s employment

• Social Hx:

• He was primary caregiver for young children while his wife worked His

brother and niece agreed to be his caregiver while his wife worked and

then retracted their offer due to change in employment.

• Culturally: he asked to discharge home for time to discuss MCS this with

his family, however he was too medically fragile. HF team asked another

Samoan patient to visit - this helped immensely.

• What do you do?

TT: 35 yo Samoan male, married, father of 3

Patient Quotes

“While I was waiting for my new heart it was exciting and

nervous at the same time. The waiting period for waiting

for a heart wasn't really that bad. I had one time they told

me that I might get a heart. I was excited about it but not

scared. When they told me it wasn't a perfect match I

wasn't really upset . I just knew I trusted the Dr. that they

would know want they are doing. I basically lived my life

one day at a time. Not knowing when I would get a new

heart.” –M

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Patient Quotes

“The L-VAD and Heart Transplant Team along with family assured me everything would be ok. They were a great support to me. Its important to have a good support team with you at all times. It was important to involve myself in as many activities as possible to keep me from getting depressed. Even though things were going great a form of depression was always there. It would come for me when I would realize the things I could not do. Then I had to tell myself to be grateful for the things I still can do. “ -R

Patient Quotes

“Waiting on the Transplant list generates a fair amount of

anxiety. I managed my feelings by keep a positive attitude

and believing it would all work out. Trusting that I had

made the right choice for me and my family.” -J

Patient Quotes

“I am a very optimistic person so the process for me wasn't that bad, but I had some down time. whenever I was down I told myself come on you got this. I would go for a lot of walks and hikes. I really enjoy the outdoors that was my main coping strategy. My cheer squad of a family and my loving husband they were there when I needed a shoulder to cry on and they also told me you are the bravest person ever. In the end I think they were the ones that was the bravest warrior.” - A

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• HF guidelines assist with determining which patients

are candidates for advanced therapies

• The advanced therapies work up includes medical,

financial, and psychosocial assessments

• Having team members to assist with complex financial

and psychosocial issues is imperative to optimizing

outcomes

Summary

Thank You!

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