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Resolute PAS CONDITION: Coronary artery disease PI: YaleWang, MD CONTACT INFO: Rose Peterson | [email protected] | 612-863-6051 DESCRIPTION: A study to assess the continued safety and efficacy of the Resolute Onyx stent for the treatment of lesions in coronary arteries amenable to treatment with the Resolute Onyx 2.0 mm – 5.0 mm stent. The purpose of the study is to observe the continued performance of the Resolute Onyx Zotarolimus-Eluting Stent System in a real-world population. CRITERIA LIST/ QUALIFICATIONS: Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non- ST elevation and ST-elevation myocardial infarction Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer’s Instructions for Use, and the Declaration of Helsinki. Key exclusion criteria: unprotected left main disease; subjects with planned PCI of three vessel disease SPONSOR: Medtronic Page 1 of 15

103017 Zakaib N Equals One Musings on an Anecdotal …...Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes

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Page 1: 103017 Zakaib N Equals One Musings on an Anecdotal …...Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes

Resolute PAS• CONDITION: Coronary artery disease

• PI: YaleWang, MD

• CONTACT INFO: Rose Peterson | [email protected] | 612-863-6051

• DESCRIPTION: A study to assess the continued safety and efficacy of the Resolute Onyx stent for the treatment of lesions incoronary arteries amenable to treatment with the Resolute Onyx 2.0 mm – 5.0 mm stent. The purpose of the study is to observethe continued performance of the Resolute Onyx Zotarolimus-Eluting Stent System in a real-world population.

• CRITERIA LIST/ QUALIFICATIONS:Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarctionSubject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer’s Instructions for Use, and the Declaration of Helsinki.Key exclusion criteria: unprotected left main disease; subjects with planned PCI of three vessel disease

• SPONSOR: Medtronic

Page 1 of 15

Page 2: 103017 Zakaib N Equals One Musings on an Anecdotal …...Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes

C A R D I O L O G Y G R A N D R O U N D S Title: N = 1: Musings on an Anecdotal Experience

Speaker: John S. Zakaib, MD Staff Electrophysiologist Minneapolis Heart Institute® at Abbott Northwestern Hospital

Date: Monday, October 30, 2017 Time: 7:00 – 8:00 AM

Location: ANW Education Building, Watson Room

OBJECTIVES At the completion of this activity, the participants should be able to: 1. Understand the implications of applying data about populations to individual patients. 2. Acknowledge the emotional impact of illness and intervention. 3. Evaluate approaches to care based upon a patient’s point of view.

ACCREDITATION Physician Allina Health is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Nurse This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.

DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) Dr. Zakaib has disclosed that he does not have any conflicts of interest in making this presentation. Planning Committee Dr. Alex Campbell, Dr. Kevin Harris, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Dr. Scott Sharkey, and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. David Hurrell declares the following relationship –Boston Scientific: Chair, Clinical Events Committee. Dr. Mario Goessl declares the following relationships-Atricure: Consultant; Edwards Lifesciences: Grant/Research support.

We gratefully acknowledge the following organizations for their financial contributions for this activity: Janssen Pharmaceutical Companies of

Johnson & Johnson Novartis

PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE

Signature: __________________________________________________________________________ My signature verifies that I have attended the above stated number of hours of the CME activity.

Allina Health - Learning & Development - 2925 Chicago Ave - MR 10701 - Minneapolis MN 55407

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MHIF CV Grand Rounds – Oct. 30, 2017

N=1Musings on an Anecdotal Experience

John S. Zakaib, MDMinneapolis Heart Institute

October 30, 2017

How it works:• Medical Knowledge

– what we know or think we know

– what we haven’t realized is wrong yet

– we drown in it in Medical School

• Medical Training– what we do

– how and why we do what we do

– we glean it in Training Programs

• Medical Judgement– how we know whether to intervene

– how we decide what to offer

– we develop it in Practice

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MHIF CV Grand Rounds – Oct. 30, 2017

Good Judgement comes fromExperience

ExperienceComes from Bad Judgement

Note to self…

Anecdotes in Medicine

• We gain our experience of the practice of medicine in increments of “one patient at a time”

• Each individual interaction hones our acumen and tempers our exuberance for offering therapy a little bit

• Anecdotes are the universal unit of tangential knowledge

• Anecdotes provide focus – they are relevant and entertaining but not central to our understanding

• Evidence comes from average outcomes in large groups

• Care is what providers offer individual patients

• Anecdotes come from real human interactions

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MHIF CV Grand Rounds – Oct. 30, 2017

Why am I here?

• Dr. Sharkey asked me to be here at 6:30am

• There is no place I would rather be?

• You gotta be someplace

• I am the New Guy

• I survived

Life Stories• St. Christopher’s School, Richmond 1975-1988• The University of Virginia 1988-1992• The Medical College of Virginia 1995-2003• Chief Resident, 2002-2003• The Cleveland Clinic Foundation 2003-2008• Chief Fellow, CCF, 2004-2008

• I had no inkling that I wouldn’t continue to achieve at a high level and have a long and predictably successful life and career

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MHIF CV Grand Rounds – Oct. 30, 2017

If you write your life story in advance…

use a pencil.

Note to self…

An Anecdote

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MHIF CV Grand Rounds – Oct. 30, 2017

The Odessey of cardiac testing

• EKG - Normal

• Transthoracic Echocardiogram- ???

• Cardiac CT scan - ?Fluid in Transverse Sinus?

• Cardiac MRI scan – Solid Tumor

• Cardiac PET/CT scan - Low grade Malignancy?

• Cardiac Catheterization• feeder vessels LMT

• contrast in the core of the tumor

As is common in anecdotes,the pictures show the pathology,

but they don’t tell the whole story

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MHIF CV Grand Rounds – Oct. 30, 2017

Angiography

The Odessey: Cardiac testing

• EKG - Normal• Transthoracic Echocardiogram- ???• Cardiac CT scan - ?Fluid in Transverse Sinus?• Cardiac MRI scan – Solid Tumor• Cardiac PET/CT scan - Low grade Malignancy?• Cardiac Catheterization

• feeder vessels from the LMT • contrast in the core of the tumor

• Pulmonary Angiogram – No PA feeders• Transesophageal Echocardiogram

Page 8 of 15

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MHIF CV Grand Rounds – Oct. 30, 2017

Note to self…

If you are planning to gag someone with a TEE probe, put holes in their femoral artery

and vein AFTER, not BEFORE…

The Stages (of Grief)On Death and Dying, Elizabeth Kubler-Ross, 1969

• Denial – A defense against the reality

• Anger – Why is this happening to me?

• Bargaining – Dialogue with a higher power or an internal monologue? “If only…”

• Depression – Presumption of the worst

• Acceptance – The peace of inevitability

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MHIF CV Grand Rounds – Oct. 30, 2017

The Stages (of Grief)On Death and Dying, Elizabeth Kubler-Ross, 1969

• Denial – A defense against the reality

• Anger – Why is this happening to me?

• Bargaining – Dialogue with a higher power or an internal monologue?

• Depression – Presumption of the worst

• Acceptance – The peace of inevitability

• Robert Kastenbaum, MD, editor of International Journal of Aging and Human Development:– There is no empirical evidence for the existence of stages of grief

– There is no evidence that people progress through these stages

October 19th, 2004

• Awaken and shower with surgical scrub

• 1mg Ativan just to get out of the house

• Pre-Op unit 7AM

• To OR 8AM

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MHIF CV Grand Rounds – Oct. 30, 2017

Hopeful in the pre-operative suite

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MHIF CV Grand Rounds – Oct. 30, 2017

October 19th, 2004

• Awaken and shower with surgical scrub

• 1mg Ativan (just to get out of the house)

• Pre-Op unit 7AM

• To OR 8AM…

• Extubated in the OR around noon

• “It was benign…”

• 4PM visitors in ICU, Chest tube drainage clear

• 8PM hypotension, IV Fluids, pressors

October 20th, 2004

• Midnight: refractory hypotension and tachycardia (6L IVF, 3 pressors infusing)

• Profound fatigue, lethargy, burning pain

• Echo reveals RV beating empty

• Chest tube suddenly drains thousands of mL blood

• Rapid Transfusion, Transition to OR, Sense of Futility

• 23rd Psalm

• The mask…

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MHIF CV Grand Rounds – Oct. 30, 2017

Recovery• ICU care

• Tubes and drains

• Dyspnea

• Pain

• Solitude

• Loneliness

• Fear

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MHIF CV Grand Rounds – Oct. 30, 2017

Recovery• Walking, Breathing

• Coughing, Sitting up

• Hurting

• Anger

• Anguish

• Exhaustion

• Insomnia

• Hope

The emotional response to illness

• A pervasive change in outlook

• Evolution of emotions and feelings

• Lots of questioning and revisiting of events

• Recovery… Now what?

• Starting anew – how life changes

• Life is precious… and fragile…

• Amazingly, newfound insight and renewal leads to a quest for normalcy and the ease of the mundane tasks of life

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MHIF CV Grand Rounds – Oct. 30, 2017

Aftermath…

• Scars fade but they are never gone

• The pane between sympathy and empathy is thin

• The best intentioned intervention is fraught with risk of mayhem

• I strive to do my best for each person each day

• I hope to try again tomorrow

• Life stories are retrospective case reports where N=1, but their anecdotal lessons guide us – we should share them!

Aftermath…

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