One Heart Magazine, 2013

ONE HEART MAGAZINE Global Cardiovascular Alliance

COMPASSIONATE CARDIOLOGY LEADERS IN PHILANTHROPY One Hear t Global Cardiovascular Alliance

2013

THE FIRST ROUND WAS TOUGH ENOUGH.

I’D RATHER NOT GO A SECOND ROUND.

Proven market experience Effient is included in the Guidelines for UA/NSTEMI and STEMI patients undergoing PCI

1

2013 ACCF*/AHA† STEMI Guideline2,3 2012 ACCF/AHA Guideline Update for UA/NSTEMI4,5 2011 ACCF/AHA/SCAI‡ Guideline for PCI6,7

For more information, call your Effient representative or visit EffientHCP.com today.

Effient® (prasugrel) is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: [1] patients with unstable angina (UA) or non–STelevation myocardial infarction (NSTEMI); [2] patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. The loading dose (LD) of Effient is 60 mg and the maintenance dose (MD) is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product

WARNING: BLEEDING RISK Effient® (prasugrel) can cause significant, sometimes fatal, bleeding.

Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.

In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered.

Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.

Additional risk factors for bleeding include: body weight <60 kg propensity to bleed concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs]) Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.

If possible, manage bleeding without discontinuing Effient.

Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.

WARNINGS AND PRECAUTIONS Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines

ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Brief Summary of Prescribing Information, including Boxed Warning regarding bleeding risk, on subsequent pages. *American College of Cardiology Foundation. †American Heart Association. ‡Society for Cardiovascular Angiography and Interventions.

References: 1. Data on file: #EFF20130124a: DSI/Lilly. 2. O’Gara PT, Kushner FG, Ascheim DD, et al. Circulation. 2013;127:e362-e425. 3. O’Gara PT, Kushner FG, Ascheim DD, et al. J Am Coll Cardiol. 2013;61:e78-e140. 4. Jneid H, Anderson JL, Wright RS, et al. Circulation. 2012;126:875-910. 5. Jneid H, Anderson JL, Wright RS, et al.

J Am Coll Cardiol. 2012;60:653-689. 6. Levine GN, Bates ER, Blankenship JC, et al. Circulation. 2011;124:e574-e651. 7. Levine GN, Bates ER, Blankenship JC, et al. J Am Coll Cardiol. 2011;58:e44-e122.

Effient and the Effient logo are registered trademarks of Eli Lilly and Company.

Copyright © 2013 Daiichi Sankyo, Inc. and Lilly USA, LLC. All Rights Reserved.

PG84132. PGHCPISI03Oct2011. Printed in USA. May 2013.

®

BRIEF SUMMARY: Please see Full Prescribing Information for additional information about Effient.

WARNING: BLEEDING RISK Effient can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 and 5.2) and Adverse Reactions (6.1)].

Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications (4.1 and 4.2)].

In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in highrisk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered [see Use in Specific Populations (8.5)].

Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.

Additional risk factors for bleeding include: • body weight <60 kg • propensity to bleed • concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]) Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.

If possible, manage bleeding without discontinuing Effient.

Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events [see Warnings and Precautions (5.3)].

1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome: Effient® is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: • Patients with unstable angina (UA) or non–ST-elevation myocardial infarction (NSTEMI).

• Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. Effient has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)].

It is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation. In the clinical trial that established the efficacy of Effient, Effient and the control drug were not administered to UA/NSTEMI patients until coronary anatomy was established. For the small fraction of patients that required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial [see Warnings and Precautions (5.2)]. Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for CABG is considered unlikely. The advantages of earlier treatment with Effient must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG. 2 DOSAGE AND ADMINISTRATION Initiate Effient treatment as a single 60-mg oral loading dose and then continue at 10 mg orally once daily. Patients taking Effient should also take aspirin (75 mg to 325 mg) daily [see Drug Interactions (7) and Clinical Pharmacology (12.3)]. Effient may be administered with or without food [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

Dosing in Low Weight Patients: Compared to patients weighing ≥60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients <60 kg. The effectiveness and safety of the 5 mg dose have not been prospectively studied.

4 CONTRAINDICATIONS 4.1 Active Bleeding: Effient is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

4.2 Prior Transient Ischemic Attack or Stroke: Effient is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel),

patients with a history of TIA or ischemic stroke (>3 months prior to enrollment) had a higher rate of stroke on Effient (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with Effient and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from TRITONTIMI 38. Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (14)].

4.3 Hypersensitivity: Effient is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS 5.1 General Risk of Bleeding: Thienopyridines, including Effient, increase the risk of bleeding. With the dosing regimens used in TRITONTIMI 38, TIMI (Thrombolysis in Myocardial Infarction) Major (clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL, or intracranial hemorrhage) and TIMI Minor (overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL) bleeding events were more common on Effient than on clopidogrel [see Adverse Reactions (6.1)].

The bleeding risk is highest initially, as shown in Figure 1 (events through 450 days; inset shows events through 7 days).

Figure 1: Non-CABG-Related TIMI Major or Minor Bleeding Events.

Non-CABG-Related TIMI Major or Minor Bleeding Events (%)

Effient® (prasugrel) tablets Brief Summary of Prescribing Information

Effient

5 4

Clopidogrel 3

3 2

2

1

1

0 0

0

Number at risk: Effient 6741 Clopidogrel 6716

90

6042 6023

0

1

2

3

4

5

6

7

180

270

360

450

5707 5764

4813 4883

4078 4138

2747 2792

Days from Randomization

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures even if the patient does not have overt signs of bleeding.

Do not use Effient in patients with active bleeding, prior TIA or stroke [see Contraindications (4.1 and 4.2)].

Other risk factors for bleeding are: • Age ≥75 years. Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients ≥75 years of age, use of Effient is generally not recommended in these patients, except in high-risk situations (patients with diabetes or history of myocardial infarction) where its effect appears to be greater and its use may be considered [see Adverse Reactions (6.1), Use in Specific Populations (8.5), Clinical Pharmacology (12.3), and Clinical Trials (14)].

• CABG or other surgical procedure [see Warnings and Precautions (5.2)].

• Body weight <60 kg. Consider a lower (5 mg) maintenance dose [see Dosage and Administration (2), Adverse Reactions (6.1), Use in Specific Populations (8.6)].

• Propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate to severe renal impairment) [see Adverse Reactions (6.1) and Use in Specific Populations (8.7 and 8.8)].

• Medications that increase the risk of bleeding (e.g., oral anticoagulants, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs], and fibrinolytic agents). Aspirin and heparin were commonly used in TRITON-TIMI 38 [see Drug Interactions (7), Clinical Studies (14)].

Thienopyridines inhibit platelet aggregation for the lifetime of the platelet (7-10 days), so withholding a dose will not be useful in managing a bleeding event or the risk of bleeding associated with an invasive procedure. Because the half-life of prasugrel’s active metabolite is short relative to the lifetime of the platelet, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding: The risk of bleeding is increased in patients receiving Effient who undergo CABG. If possible, Effient should be discontinued at least 7 days prior to CABG. Of the 437 patients who underwent CABG during TRITON-TIMI 38, the rates of CABG-related TIMI Major or Minor bleeding were 14.1% in the Effient group and 4.5% in the clopidogrel group [see Adverse Reactions (6.1)]. The higher risk for bleeding events in patients treated with Effient persisted up to 7 days from the most recent dose of study drug. For patients receiving a thienopyridine within 3 days prior to CABG, the frequencies of TIMI Major or Minor bleeding were 26.7% (12 of 45

patients) in the Effient group, compared with 5.0% (3 of 60 patients) in the clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the clopidogrel group.

Do not start Effient in patients likely to undergo urgent CABG. CABGrelated bleeding may be treated with transfusion of blood products, including packed red blood cells and platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

5.3 Discontinuation of Effient: Discontinue thienopyridines, including Effient, for active bleeding, elective surgery, stroke, or TIA. The optimal duration of thienopyridine therapy is unknown. In patients who are managed with PCI and stent placement, premature discontinuation of any antiplatelet medication, including thienopyridines, conveys an increased risk of stent thrombosis, myocardial infarction, and death.

Patients who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events. Lapses in therapy should be avoided, and if thienopyridines must be temporarily discontinued because of an adverse event(s), they should be restarted as soon as possible [see Contraindications (4.1 and 4.2) and Warnings and Precautions (5.1)].

5.4 Thrombotic Thrombocytopenic Purpura: Thrombotic thrombocytopenic purpura (TTP) has been reported with the use of Effient. TTP can occur after a brief exposure (< 2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment, including plasmapheresis (plasma exchange). TTP is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragment red blood cells] seen on peripheral smear), neurological findings, renal dysfunction, and fever [see Adverse Reactions (6.2)].

5.5 Hypersensitivity Including Angioedema: Hypersensitivity including angioedema has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines [see Contraindications (4.3), Adverse Reactions (6.2)].

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience: The following serious adverse reactions are also discussed elsewhere in the labeling: • Bleeding [see Boxed Warning and Warnings and Precautions (5.1, 5.2)] • Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.4)] Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with Effient (60-mg loading dose and 10 mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year). The population treated with Effient was 27 to 96 years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive aspirin. The dose of clopidogrel in this study was a 300-mg loading dose and 75 mg once daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared with the rates observed in other clinical trials of another drug and may not reflect the rates observed in practice.

Drug Discontinuation: The rate of study drug discontinuation because of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient and 1.4% for clopidogrel).

Bleeding: Bleeding Unrelated to CABG Surgery - In TRITON-TIMI 38, overall rates of TIMI Major or Minor bleeding adverse reactions unrelated to coronary artery bypass graft surgery (CABG) were significantly higher on Effient than on clopidogrel, as shown in Table 1.

Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38) Effient (%) Clopidogrel (%) (N=6741) (N=6716) TIMI Major or Minor bleeding 4.5 3.4 2.2 1.7 TIMI Major bleedingb Life-threatening 1.3 0.8 Fatal 0.3 0.1 Symptomatic intracranial 0.3 0.3 hemorrhage (ICH) Requiring inotropes 0.3 0.1 Requiring surgical 0.3 0.3 intervention Requiring transfusion 0.7 0.5 (≥4 units) 2.4 1.9 TIMI Minor bleedingb

p-value p=0.002 p=0.029 p=0.015

p=0.022

Patients may be counted in more than one row. b See 5.1 for definition.

Figure 1 demonstrates non-CABG related TIMI Major or Minor bleeding. a

The bleeding rate is highest initially, as shown in Figure 1 (inset: Days 0 to 7) [see Warnings and Precautions (5.1)].

Bleeding rates in patients with the risk factors of age ≥75 years and weight <60 kg are shown in Table 2.

Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38) Major/Minor Fatal Effient Clopidogrel Effient Clopidogrel (%) (%) (%) (%) Weight <60 kg (N=308 Effient, N=356 clopidogrel) Weight ≥60 kg (N=6373 Effient, N=6299 clopidogrel) Age <75 years (N=5850 Effient, N=5822 clopidogrel) Age ≥75 years (N=891 Effient, N=894 clopidogrel)

10.1

6.5

0.0

0.3

4.2

3.3

0.3

0.1

3.8

2.9

0.2

0.1

9.0

6.9

1.0

0.1

Bleeding Related to CABG - In TRITON-TIMI 38, 437 patients who received a thienopyridine underwent CABG during the course of the study. The rate of CABG-related TIMI Major or Minor bleeding was 14.1% for the Effient group and 4.5% in the clopidogrel group (Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient persisted up to 7 days from the most recent dose of study drug.

Table 3: CABG-Related Bleedinga (TRITON-TIMI 38) TIMI Major or Minor bleeding TIMI Major bleeding Fatal Reoperation Transfusion of ≥5 units Intracranial hemorrhage TIMI Minor bleeding

Effient (%) Clopidogrel (%) (N=213) (N=224) 14.1 4.5 11.3 3.6 0.9 0 3.8 0.5 6.6 2.2 0 0 2.8 0.9

a Patients may be counted in more than one row.

Bleeding Reported as Adverse Reactions - Hemorrhagic events reported as adverse reactions in TRITON-TIMI 38 were, for Effient and clopidogrel, respectively: epistaxis (6.2%, 3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous hematoma (0.5%, 0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).

Malignancies: During TRITON-TIMI 38, newly diagnosed malignancies were reported in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The sites contributing to the differences were primarily colon and lung. It is unclear if these observations are causallyrelated or are random occurrences.

Other Adverse Events: In TRITON-TIMI 38, common and other important non-hemorrhagic adverse events were, for Effient and clopidogrel, respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic reactions (0.36%, 0.36%), and angioedema (0.06%, 0.04%). Table 4 summarizes the adverse events reported by at least 2.5% of patients.

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group

Effient (%) Clopidogrel (%) (N=6741) (N=6716) Hypertension 7.5 7.1 Hypercholesterolemia/Hyperlipidemia 7.0 7.4 Headache 5.5 5.3 Back pain 5.0 4.5 Dyspnea 4.9 4.5 Nausea 4.6 4.3 Dizziness 4.1 4.6 Cough 3.9 4.1 Hypotension 3.9 3.8 Fatigue 3.7 4.8 Non-cardiac chest pain 3.1 3.5 Atrial fibrillation 2.9 3.1 Bradycardia 2.9 2.4 2.8 3.5 Leukopenia (<4 x 109 WBC/L) Rash 2.8 2.4 Pyrexia 2.7 2.2 Peripheral edema 2.7 3.0 Pain in extremity 2.6 2.6 Diarrhea 2.3 2.6

6.2 Postmarketing Experience: The following adverse reactions have been identified during post approval use of Effient. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders — Thrombocytopenia, Thrombotic thrombocytopenic purpura (TTP) [see Warnings and Precautions (5.4) and Patient Counseling Information (17.3)] Immune system disorders — Hypersensitivity reactions including anaphylaxis [see Contraindications (4.3)] 7 DRUG INTERACTIONS 7.1 Warfarin: Coadministration of Effient and warfarin increases the risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

7.2 Non-Steroidal Anti-Inflammatory Drugs: Coadministration of Effient and NSAIDs (used chronically) may increase the risk of bleeding [see Warnings and Precautions (5.1)].

7.3 Other Concomitant Medications: Effient can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see Clinical Pharmacology (12.3)].

Effient can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers [see Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy: Pregnancy Category B - There are no adequate and well-controlled studies of Effient use in pregnant women. Reproductive and developmental toxicology studies in rats and rabbits at doses of up to 30 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite) revealed no evidence of fetal harm; however, animal studies are not always predictive of a human response. Effient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

In embryo fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in pup body weight was observed; but, there were no structural malformations in either species. In prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure [see Nonclinical Toxicology (13.1)].

8.3 Nursing Mothers: It is not known whether Effient is excreted in human milk; however, metabolites of Effient were found in rat milk.

Because many drugs are excreted in human milk, prasugrel should be used during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.

8.4 Pediatric Use: Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology (12.3)].

8.5 Geriatric Use: In TRITON-TIMI 38, 38.5% of patients were ≥65 years of age and 13.2% were ≥75 years of age. The risk of bleeding increased with advancing age in both treatment groups, although the relative risk of bleeding (Effient compared with clopidogrel) was similar across age groups.

Patients ≥75 years of age who received Effient had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). In patients ≥75 years of age, symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received Effient and in 3 patients (0.3%) who received clopidogrel. Because of the risk of bleeding, and because effectiveness is uncertain in patients ≥75 years of age [see Clinical Studies (14)], use of Effient is generally not recommended in these patients, except in high-risk situations (diabetes and past history of myocardial infarction) where its effect appears to be greater and its use may be considered [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

8.6 Low Body Weight: In TRITON-TIMI 38, 4.6% of patients treated with Effient had body weight <60 kg. Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see Dosage and Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].

Consider lowering the maintenance dose to 5 mg in patients <60 kg.

The effectiveness and safety of the 5 mg dose have not been prospectively studied.

8.7 Renal Impairment: No dosage adjustment is necessary for patients with renal impairment. There is limited experience in patients with end-stage renal disease, but such patients are generally at higher risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

8.8 Hepatic Impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B). The pharmacokinetics and pharmacodynamics of prasugrel in

patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

8.9 Metabolic Status: In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, there was no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, or CYP3A5 on the pharmacokinetics of prasugrel’s active metabolite or its inhibition of platelet aggregation.

10 OVERDOSAGE 10.1 Signs and Symptoms: Platelet inhibition by prasugrel is rapid and irreversible, lasting for the life of the platelet, and is unlikely to be increased in the event of an overdose. In rats, lethality was observed after administration of 2000 mg/kg. Symptoms of acute toxicity in dogs included emesis, increased serum alkaline phosphatase, and hepatocellular atrophy. Symptoms of acute toxicity in rats included mydriasis, irregular respiration, decreased locomotor activity, ptosis, staggering gait, and lacrimation.

10.2 Recommendations about Specific Treatment: Platelet transfusion may restore clotting ability. The prasugrel active metabolite is not likely to be removed by dialysis.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis - No compound-related tumors were observed in a 2-year rat study with prasugrel at oral doses up to 100 mg/kg/day (>100 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite). There was an increased incidence of tumors (hepatocellular adenomas) in mice exposed for 2 years to high doses (>250 times the human metabolite exposure).

Mutagenesis - Prasugrel was not genotoxic in two in vitro tests (Ames bacterial gene mutation test, clastogenicity assay in Chinese hamster fibroblasts) and in one in vivo test (micronucleus test by intraperitoneal route in mice).

Impairment of Fertility - Prasugrel had no effect on fertility of male and female rats at oral doses up to 300 mg/kg/day (80 times the human major metabolite exposure at daily dose of 10 mg prasugrel).

17 PATIENT COUNSELING INFORMATION See Medication Guide 17.1 Benefits and Risks • Summarize the effectiveness features and potential side effects of Effient.

• Tell patients to take Effient exactly as prescribed.

• Remind patients not to discontinue Effient without first discussing it with the physician who prescribed Effient.

• Recommend that patients read the Medication Guide.

17.2 Bleeding: Inform patients that they: • will bruise and bleed more easily.

• will take longer than usual to stop bleeding.

• should report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine.

17.3 Other Signs and Symptoms Requiring Medical Attention • Inform patients that TTP is a rare but serious condition that has been reported with Effient.

• Instruct patients to get prompt medical attention if they experience any of the following symptoms that cannot otherwise be explained: fever, weakness, extreme skin paleness, purple skin patches, yellowing of the skin or eyes, or neurological changes.

• Inform patients that they may have hypersensitivity reactions including rash, angioedema, anaphylaxis, or other manifestations.

Patients who have had hypersensitivity reactions to other thienopyridines may have hypersensitivity reactions to Effient.

17.4 Invasive Procedures: Instruct patients to: • inform physicians and dentists that they are taking Effient before any invasive procedure is scheduled.

• tell the doctor performing the invasive procedure to talk to the prescribing health care professional before stopping Effient.

17.5 Concomitant Medications: Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g., warfarin and NSAIDs).

Literature Revised: December 21, 2012 Effient® is a registered trademark of Eli Lilly and Company.

Manufactured by Eli Lilly and Company, Indianapolis, IN 46285 Marketed by Daiichi Sankyo, Inc. and Lilly USA, LLC Copyright © 2009, 2011, 2012 Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

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1 Hanna H et al. J Clin Oncol. 2004;22(15):3163-3171. 2 Leon C et al. Intensive Care Med. 2004;30(10):1891-1899. 3 Zabramski JM et al. J Neurosurg. 2003;98(4):725-730. 4 Chatzinikolaou I et al. Am J Med. 2003;115(5):352-357. 5 Raad I et al. Ann Intern Med.1997;128(4):267-274. 6 Gould PA et al. J Am Med Assoc. 2006;295(2):1907-1911. 7 Bloom H et al. Pacing Clin Electrophysiol. 2011;34(2):133-142. 8 Kolek MJ et al. Pacing Clin Electrophysiol.2013;36(3):354-361. 9 Henrickson, Citadel & Centurion study. Presented at the Late Breaking Clinical Trials session at the European Heart Rhythm Association (EHRA), EUROPACE 2013. 10 Mittal et al. 2013 HRS Scientific Session, PO 05-43, NY/NJ Valley Health System. 11 Inpatient Prospective Payment System (IPPS) Final Rule, FY13. 12 Data on file, 092713-1.

Cardiovascular Credentialing International

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• Certified Cardiographic Technician (CCT) • Certified Rhythm Analysis Technician (CRAT) • Registered Congenital Cardiac Sonographer (RCCS) • Registered Cardiac Electrophysiology Specialist (RCES)

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Credentials administered by CCI are accredited by the American National Standards Institute (ANSI) based on the ISO/IEC 17024 Accreditation Standard.

TABLE OF CONTENTS

18

His Legacy Lives On

By Harry G. Mond, M.D. and Benedict S. Maniscalco, M.D.

34

HBI of Guatemala Expands

By Laura Maniscalco DeLise and Michael Maniscalco

26

Interview with

Dr. Joseph Messer Working for the Global Cardiovascular Good

44

Macapasos de Vida Para Ti HBI of El Salvador By Francisco Rivera

www.heartbeatsaveslives.org

ONE HEART MAGAZINE

9

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TABLE OF CONTENTS

49

HBI of Trinidad and Tobago

By Farouk Khan Hosein

54

An Army in Waiting

By Sandra Kreul, ARNP

Global Health Care: Issues & Strategies

58

By David R. Holmes, Jr., M.D.

38

Arrhythmia Alliance’s Heart

48

By Steve Hayes

International Children’s Heart Foundation By Holly Whitfield

www.heartbeatsaveslives.org

64

Persistence Yields Dynamic Results

52

Echo Standardization Around the Globe

62

Protecting Doctors

By Ivan Berkowitz

ONE HEART MAGAZINE

11

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ONE HEART MAGAZINE Global Cardiovascular Alliance

ONE HEART MAGAZINE Global Cardiovascular Alliance

2013

Corporate Headquarters 4302 Henderson Blvd., Ste 102 Tampa, Florida 33629, USA Tel. (813) 259-1213

COMPASSIONATE CARDIOLOGY LEADERS IN PHILANTHROPY One Hear t Global Cardiovascular Alliance

Chairman Heartbeat International Foundation Dr. Benedict S. Maniscalco Executive Vice President Heartbeat International Foundation Laura Maniscalco DeLise

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Vice President of Business Development Johnathan Hartmand Accounting Leanne Ragano Kim Ribinski Advertising Associates Jason Easton Penn Mills Gage Pierce Creative Director Bryan Clapper Editorial Director Kevin Anderson Sales Support Staff Michelle Santiago Alfredo Escandion Special Thanks American Heart Association Million Hearts Initiative American College of Cardiology Biotronik World Heart Federation World Health Organization Heart Rhythm Society Atrial Fibrillation Association

Publisher Adam Longaker The Custom Publishing Company Ed Suyak ESS Media Group Inc.

Contributing Writers Harry G. Mond, MD Benedict S. Maniscalco, MD Joseph V. Messer, MD Federico Alfaro, MD David R. Holmes, Jr., MD Sandra Kreul, ARNP Michael Maniscalco Farouk Khan Hosein Steve Hayes Ivan Berkowitz Holly Whitfield Francisco Rivera Non-Profit Liaison Laura Maniscalco DeLise Heartbeat International Support Staff Georgina Cronin Christine Conley Michael Maniscalco Production Associate Michael Johns Legal Counsel Albert Salem, Esquire ŠCopyright 2013 Heartbeat International Foundation. All rights reserved. Reproduction of editorial content in whole or in part without written permission is prohibited.

Heartbeat International Foundation does not assume responsibility for the advertisements, nor any representation made therein, nor the quality or deliverability of the products themselves.

Reproduction of articles and photographs, in whole or in part, contained herein is prohibited without expressed written consent of the publisher, with the exception of reprinting for news media use. Printed in the United States of America.

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THEIR LEGACIES LIVE ON Welcome

Philanthropy: the concern and promotion of the welfare of another human being

Like most people, I long considered philanthropy the sole domain of either the very wealthy or the well-endowed foundations (created by the very wealthy)! This misconception has been corrected as I adopted the broader definition of philanthropy offered in the title line. I now realize that in every walk of life, vocation, and human interaction, we find philanthropists in our midst.

Contributions of time, talent, and treasury are the tools of the philanthropist!

By using their tools, indirectly or directly, to improve the condition of their fellowman, individuals, organizations, and professionals may all be involved in philanthropy. In this issue of One Heart, we feature both individuals and organizations that are committed to such philanthropic activities and learn why and how they have chosen to apply the tools of philanthropy.

ONE HEART MAGAZINE Global Cardiovascular Alliance

2013

COMPASSIONATE CARDIOLOGY LEADERS IN PHILANTHROPY One Hear t Global Cardiovascular Alliance

ABOUT DR. BENEDICT S. MANISCALCO Dr. Benedict S. Maniscalco, chairman and CEO of Heartbeat International, has been a private practitioner specializing in cardiovascular diseases since 1976. In addition to his work in preventive and consultative cardiology, he serves as medical advisor to multiple companies involved in medically related business. Well regarded as an innovator and educator in cardiovascular medicine, Dr. Maniscalco has been engaged with the American College of Cardiology at the local, state, and national levels, serving in leadership roles that have directly influenced healthcare practices

HEARTBEAT INTERNATIONAL FOUNDATION, soon to be 30 years old, was founded on this principle of philanthropy and has long espoused the notion that “the service we give to our fellow man is the rent we pay to live on this earth”.

and policy.

Please join with us to read about some of these efforts and marvel at the level of human concern shown by all!

in Atlanta and did his junior and senior

After graduating from the Duke University School of Medicine, Dr. Maniscalco interned at Grady Memorial Hospital residencies at Emory University and its affiliated hospitals, and followed that with a

Sincerely,

fellowship in cardiovascular diseases from 1973–1975. He served on the faculty at the University of South Florida School

Benedict S. Maniscalco, M.D. CEO and Chairman, Heartbeat International Foundation

SAVING HEARTS IN NEED, ONE PACEMAKER AT A TIME. www.heartbeatsaveslives.org

of Medicine before leaving to found the St. Joseph’s Heart Institution in Tampa, Florida. He is a member of the American Medical Association, American Heart Association and a Fellow of the American Heart Association, the American College of Cardiology, the American College of Physicians, the American College of Chest Physicians, and the Society for Cardiac Angioplasty.

ONE HEART MAGAZINE

15

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The HeartCheck PEN is an everyday personal solution to a need for early diagnosis of lifethreatening arrhythmias TM

The HeartCheckTM PEN handheld ECG device represents a state-of-the-art addition to a physician’s diagnostic armamentarium. As an FDA cleared consumer product, the HeartCheckTM PEN can also empower anyone experiencing symptoms such as palpitations, dyspnea, syncope or presyncope to record their cardiac rhythm and document whether their symptoms are associated with the occurrence of arrhythmias such as atrial fibrillation (AF), supraventricular or ventricular tachycardia, bradycardia or even a heart block.

detection of QT interval prolongation, a risk factor for sudden cardiac death. Common cardiac and non-cardiac drugs may prolong QT interval, such as antibiotics or anti-depressants. Use of the HeartCheckTM ECG devices for AF screening/ detection as a stroke prevention measure has also been a focus of activity within public screening initiatives as well as clinical research projects.

The HeartCheckTM PEN is a personalize solution to the need for early diagnosis of potentially lifethreatening arrhythmias, captured at the time individuals are experiencing symptoms but do not have access to the care they may need.

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SMART Monitoring reports are interpreted by a licensed physician and these can then be shared with the individual’s own physician for follow up.

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and save $25 The HeartCheck™ PEN can be unlocked to view ECG waveforms by CardioComm Solutions, Inc. under the direction of a physician. Self Measurement is not the same as medical diagnosis. Please consult your doctor.

HIS LEGACY LIVES ON

By Harry G. Mond, OAM, MD, FACC, FHRS, CCDS and Benedict S. Maniscalco MD, FACC, FACCP, FAHA

O

n the 26th December 2008, Dr. Henry D. McIntosh MD, MACC passed away in Lakeland Florida following a long illness. A distinguished and much beloved physician and administrator, Dr. McIntosh served on numerous cardiology committees and boards, including the Presidency of the American College of Cardiology in 1974-5.

A humble man and forever a humanitarian and champion of the poor, Dr. McIntosh is best known internationally as founder of Heartbeat International, a charitable 501(c) (3) organization. Heartbeat International, through its strategic alliances with Rotary International and other civic organizations, pacemaker manufacturers and an army of medical and non-medical volunteers is responsible for providing cardiac implantable electronic devices for indigent and needy patients in 25 countries over four continents. His creed “the service we give to our fellow man, is the rent we pay for the right to live” is a testimony to his lifetime service in helping the poor.

HISTORY The genesis of Heartbeat International occurred over 30-years ago in Guatemala, Central America, when a local 18

physician, Dr. Federico Alfaro was referred a profoundly symptomatic 19-year old with complete heart block. The family was unable to afford the cost of a potentially “curative” pacemaker and all Dr. Alfaro could do was watch the boy die.

He vowed that in the future, his countrymen would not die because they could not afford a pacemaker.

With the help of the local Rotary group, Dr. Alfaro organized the first “Pacemaker Bank” in 1977. A board of directors of nonmedical Rotarians, a medical director and cooperating cardiologists and surgeons were responsible for organizing and operating the bank. Initially refurbished pacemakers were used, the recipients were indigent, and the implants performed free of charge. Pacemakers donated to the Guatemala Bank were not limited to their own populace, but also distributed in Nicaragua, Costa Rica, El Salvador,

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Honduras and the Dominican Republic.

In 1983, while visiting Dr. Alfaro, his former student, Dr. McIntosh learned of the program and was so impressed with the beneficial and humanitarian potential that he felt obligated to help in developing a similar international program. On October 18, 1984, Heartbeat International was born at the Watson Clinic in Lakeland, Florida where Dr. McIntosh was a staff member. This was a cooperative effort of the Watson Clinic, Rotary International of Evanston, Illinois, representatives of the United States pacemaker industry and consultative support of the American College of Cardiology.

Intermedics (Boston Scientific, St Paul, MN) donated 486 new pulse generators together with some leads and Rotary International provided a grant of $US250,000 for the purchase of extra pacing leads.

By 1986, 16 Pacemaker Banks had been established in the Americas and Asia. The same year Heartbeat International, was awarded a US Presidential Citation for its international humanitarian work. By 1991, the number of pacemaker banks had expanded to 25 centers worldwide. During this period, Dr. McIntosh retired from the Watson Clinic and established Heartbeat International at the St. Joseph’s Heart Institute in Tampa, Florida upon the invitation of Dr. Benedict S. Maniscalco, a former student of Dr. McIntosh.

By the early 1990’s, with the ever increasing demand for more pacemakers, industry donations failed to supply sufficient implantable devices. Pacemaker pulse generators which exceeded “use before dates” were distributed from the Mount Alvernia Convent in Montego Bay, Jamaica, and the Board of Directors discussed the concept of collecting used devices and refurbishing them for use outside the United States. However, the regulatory obstacles were overwhelming.

Thankfully, soon after, inventory donations once again

www.heartbeatsaveslives.org

IN 1983, WHILE VISITING DR. ALFARO, HIS FORMER STUDENT (IN GUATEMALA), DR. MCINTOSH LEARNED OF THE PROGRAM AND WAS SO IMPRESSED THAT HE FELT OBLIGATED TO HELP IN DEVELOPING A SIMILAR INTERNATIONAL PROGRAM.

increased to workable levels and the concept of refurbishment was not implemented.

1993 was an active and productive year for Heartbeat International. The organization’s co-mission to educate and train implanting physicians was generously supported by Medtronic and St. Jude; and the Arnold Zohn Pacemaker Bank in Chengdu, China was opened as a training center; at two days of age, Jose Alirio Perez of Medellin, Colombia, became the youngest recipient to receive a donated pacemaker; and Heartbeat International was accepted as a member of the Independent Charities of America. In August 1995 Heartbeat International earned its 501(C)(3) tax exempt status from the Internal Revenue Service.

ONE HEART MAGAZINE

19

In 1999, Heartbeat International became the first recipient of the North American Society of Pacing and Electrophysiology (Heart Rhythm Society, Washington DC) benevolent fund. The organization celebrated its 5,000th pacemaker implant and new Pacemaker Banks were established in the Eastern European block. After many years as its founding champion, Dr. Henry McIntosh retired and Dr. Maniscalco took on the leadership role as Chairman and Chief Executive Officer and continues to serve in this capacity.

Although Heartbeat International is accountable for the correct selection of medically and financially appropriate recipients, the actual work is done locally under the auspices of the Board of Directors for each Pacemaker Bank (now called There can only be one objective for Heartbeat International; to save a Heart Center). Once a device is implanted, the appropriate and improve the quality of life of those who cannot afford to do so paper work and follow-up themselves, thus making “poor” hearts beat better. reports are sent to Heartbeat International and entered into a numbers of indigent patients actually requiring implantable data base. In this way every patient and the implanted device devices. A conservative estimate of need may exceed one are tracked. Recalls and other issues can be easily addressed. million per annum world-wide.

Recognizing the need to provide greater economies of The program is dependent on the continued generosity scale, ensure leadership succession, create local stakeholder of the pacemaker manufacturers, volunteers from the private participation and governance and deal with legislative and and professional sectors, and donors from all sectors of the governmental issues, management began a restructuring of economies within the United States and in the countries the Pacemaker Banks (Heart Centers) in the early 2000’s. With served by Heartbeat International. this came a stricter compliance program and the concept of The visionary and philanthropic work of Dr. Henry one Heart Center per country with multiple implantation D. McIntosh has served as an inspiration to generations of centers. physicians, and all people throughout the world who believe Over a time span of nearly 30 years, Heartbeat in the dignity and right to a productive life for all and who International has been responsible for the implantation and serve their fellowman with humility and joy. follow-up of cardiac implantable electronic devices in nearly Heartbeat International shall never forget Dr. McIntosh!

11,000 indigent recipients in predominantly developing In his honor and in his memory, the Henry D. McIntosh countries. The organization employs few staff and its success Fellowship was established and recognizes all who wish to is dependent on the members of Rotary International, the help Heartbeat International continue his work and to carry incredible generosity of the implantable device manufactures out his mission to provide “Pacemakers as Peacemakers”. and the dedicated physicians and hospital personnel in the When we watch a child or adult with a potentially fatal countries of operation. cardiac arrhythmia receive an implantable device and return to a fully functional and productive life, the joy is immeasurable.

FUTURE ENDEAVORS Heartbeat International has only begun to fulfil the mission There can be only one objective for Heartbeat and welcomes all who may help in the work that Dr. McIntosh International; to save and improve the quality of life of those has started and we must sustain. Join us in this campaign and who cannot afford to do so themselves, thus making “poor” become a Henry D. McIntosh Fellow. hearts beat better. Although remarkable, the saving of nearly Remember “the service we give to our fellow man, is the rent 11,000 lives is but the tip of an iceberg in regard to the we pay for the right to live”. Let us not fail him.

20

ONE HEART MAGAZINE www.heartbeatsaveslives.org

His legacy lives on…

ABOUT HEARTBEAT INTERNATIONAL

Heartbeat International Foundation, Inc. (HBI) saves lives globally by providing cardiovascular implantable devices and treatment to the needy people of the world. With the help of generous device manufacturers, compassionate physicians, and kind supporters like you, Heartbeat International provides the pacing device, implantation, and follow-up care for the device at no cost to our indigent patients. Since our founding in 1984, our Pacemaker Program has saved more than 11,000 lives.

THE HENRY D. MCINTOSH FELLOWSHIP

Formed to honor and recognize the Founding Chairman of Heartbeat International, the Henry D. McIntosh Fellowship is comprised of supporters who recognize and share in the founding vision of Heartbeat International and want to ensure the success of our global mission through a donation of $1,000 or more.

WILL YOU JOIN US IN BUILDING A LEGACY? YES…I WANT TO SAVE LIVES:

Henry D. McIntosh Fellowship: $1,000

PLEASE MAIL YOUR CHECK TO:

Heartbeat International Foundation, Inc. 4302 Henderson Blvd., Suite 102 Tampa, FL 33629

Henry D. McIntosh Fellowship A talented physician, humble man, and compassionate humanitarian, Dr. Henry D. McIntosh left behind a legacy.

As the Founding Chairman of Heartbeat International, Dr. McIntosh believed, “The service we give to our fellow man is the rent we pay for the right to live.”

Prefer to Donate Online?

Please visit our website and submit the secure online donation form. www.HeartbeatSavesLives.org “Henry was my teacher, partner and friend. I shall always honor him for his humility, benevolence and philanthropy. He was a great and noble man!”

Dr. Benedict S. Maniscalco, Chairman and CEO

FEDERAL TAX IDENTIFICATION NUMBER EIN 26-0330887. FLORIDA STATE REGISTRATION NUMBER CH26760. A COPY OF THE OFFICIAL REGISTRATION AND FINANCIAL INFORMATION MAY BE OBTAINED FROM THE DIVISION OF CONSUMER SERVICES BY CALLING, TOLL FREE, 800-435-7352 WITHIN THE STATE. REGISTRATION DOES NOT IMPLY ENDORSEMENT, APPROVAL OR RECOMMENDATION BY THE STATE.

We carry on his vision, saving hearts in need, one pacemaker at a time.

Join the Fellowship.

Honor his legacy.

One Heart. One World. www.HeartbeatSavesLives.org

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The Panama resort features 109 rooms and nine suites on four floors along with four meeting rooms with 3,918 square feet of flexible space, a number of onsite restaurants and bars, full-service spa, 18-hole golf course, state-of-the-art fitness center and outdoor pool and whirlpool.

Tamarindo features international cuisine with a focus on locally sourced ingredients and is open for breakfast, lunch and dinner. While Prime 19 focuses on serving juicy steaks for lunch and dinner in a relaxed atmo-

sphere, Tai Kai offers Japanese plates in a casual dinner setting. El Faro reaches out to guests in the pool and beach areas with lunch and dinner options.

Solera Pool Bar features a swim-up wet bar serving the most thirst-quenching concoctions around, and Bar-alago provides a variety of top-shelf liquors and a wide assortment of wines.

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Down duvets and Egyptian cotton linens on one king or two double beds ensure a sound nightâ&#x20AC;&#x2122;s sleep, while marble bathrooms with soaking tubs, premium bath products, plush bathrobes and terry slippers pamper all guests. High-speed Internet access, 42-inch LCD TVs, iPod docking stations, in-room coffeemakers and irons and ironing boards are among high-end luxuries travelers can expect from the JW Marriott.

DR. JOSEPH MESSER BRIDGING TIME, TALENT AND PHILANTHROPY FOR

GLOBAL CARDIOVASCULAR GOOD

D

r. Joseph V. Messer is Professor of Medicine at Rush Medical College, Senior Attending Physician and former Director of the Section of Cardiology at Rush University Medical Center in Chicago, Illinois. He now practices cardiology at NorthShore University HealthSystem where he is Consulting Staff and Senior Clinician Educator, Pritzker School of Medicine.

Dr. Messer graduated from Harvard College, scl, and Harvard Medical School with residency and cardiology fellowship at Boston City and Peter Bent Brigham Hospitals. He served in the Air Force as Assistant Chief of the Acceleration Section and Officer-in-Charge of the Aerospace Physiology Cardiopulmonary Measurement Unit at Wright-Patterson Air Force Base. He returned to Boston in 1963 as a Fellow in Biochemistry at Brandeis University and as a Chief of the Cardiovascular Unit at the Boston City Hospital with faculty appointments at Brandeis, Tufts, Boston University and Harvard. In 1973 Dr. Messer was appointed Director, Section of Cardiology and Professor of Medicine at Rush Presbyterian St. Luke’s Medical Center and Director of Illinois’ Interinstitutional Cardiovascular Center, a research and demonstration program comprised of the cardiology faculties of the state’s several medical schools, the Chicago Boards of Health and Education, the Chicago Fire Department and administered by the Chicago Heart Association.

Dr. Messer has participated in the local and national activities of several organizations including service as Illinois Governor of the American College of Cardiology, President of the American Heart Association of Metropolitan Chicago, and Chairman of the Chicago Cardiology Group. He co-chairs the Illinois Medicare Carrier Advisory Committee. Nationally, he has served the American College of Cardiology as Chairman of the Board of Governors, Chair of its Task Force on Managed Health Care, the Coding and Nomenclature Committee, Guideline Writing Groups, and the Task Force on Performance Measures. He chaired the College’s Cardiology Carrier Advisory Committee, and served as a member of the College’s Budget, Finance and Investment and Audit Committees. He has served on the College’s Technical Panels for Appropriateness Criteria for Nuclear Imaging, Computed Cardiac Tomography and Cardiac Magnetic Resonance 26

Imaging, Echocardiography, Heart Failure Imaging, and Ischemic Heart Disease. He represents the College on the Physicians’ Consortium for Performance Improvement of the American Medical Association. He is currently active in the College’s Patient Centered Care Committee. He has served as a member of the National Quality Forum’s Ambulatory Care Heart Disease Technical Panel, its Cardiovascular Consensus Standards Maintenance Committee, and as a consultant to the Accreditation Council for Graduate Medical Education.

In June, 2010 he completed service on the AMA’s CPT Editorial Panel. In 2001 Dr. Messer was made a Master of the American College of Cardiology and received the College’s Distinguished Fellowship Award in 2008. In 2011 he received the Claypoole Award of the American College of Physicians.

Dr. Messer is a Fellow of the American College of Physicians, the American College of Chest Physicians, The Society for Cardiac Angiography and Interventions, The American Heart Association, and the Institute of Medicine of Chicago. Other society memberships include the Association of University Cardiologists, American Physiological Society, American Federation for Clinical Research and the Central Society for Clinical Research. Since 2005 he has served on the Board of Trustees of Chicago’s Weiss Memorial Hospital, a University of Chicago affiliate.

He has served as Associate Editor of Chest, Editor for Cardiology of the World Book Rush Presbyterian St. Luke’s Medical Center Encyclopedia, a member of the Editorial Boards of the Journal of the American College of Cardiology, the College’s Extended Learning Program (ACCEL), Catheterization and Cardiovascular Diagnosis, and the American Heart Hospital Journal.

ONE HEART MAGAZINE: Dr. Messer, could you please tell us a little bit about your professional background?

DR. MESSER: Following my residency and cardiology

ONE HEART MAGAZINE www.heartbeatsaveslives.org

www.heartbeatsaveslives.org

ONE HEART MAGAZINE

27

fellowship at the Peter Bent Brigham Hospital in Boston, I was appointed Officer-in-Charge of the Cardiopulmonary Measurements Unit in the USAF Aerospace Medical Research Laboratories at Wright-Patterson Air Force Base. Returning to Boston I directed the Circulation Laboratory at the Boston City Hospital and later became Chairman of the Cardiovascular Unit. In 1973, I was appointed Professor of Medicine and Director of Cardiology at Rush University Medical Center in Chicago. After 26 years in academic positions I entered private practice as President of Medical Cardiology Associates, Chairman of the Board and Medical Director of Chicago Cardiovascular Associates, S.C. and Medical Director of VIVRA Heart Services of Chicago.

Recently I joined the Consulting Staff of NorthShore University HealthSystem and was appointed Senior Clinical Educator at the University of Chicago Pritzker School of Medicine.

ONE HEART MAGAZINE: What led you to become a cardiologist?

DR. MESSER: It’s my recollection that what led me into cardiology was a very interesting question from a gentleman who had become a mentor of mine at the Peter Bent Brigham Hospital in Boston where I did my residency and cardiology fellowship. He asked me that very question— what was I going to do with my career? He had been Dean 28

at the Harvard Medical School and a wonderful gentleman. It got me thinking. I was pretty much unfocused at that time, other than internal medicine. I decided what I really wanted to do was to measure things and to see what could be done with the results of measurement. When I came to that initial step, he suggested I talk with a particular gentleman who was measuring things, and he turned out to be a very well- known cardiologist. His name was Richard Gorlin. He developed the formula to calculate the area of valves inside the heart. That’s how I started with measurements and being able to do something with the data. I suspect that if I had a second choice career-wise, it would be as an architect.

It’s interesting that my daughter is an architect. I think it kind of fits. I’m interested in spatial relations and the relationship of things. Cardiology fits beautifully into that particular interest set.

ONE HEART MAGAZINE: How has The American College of Cardiology influenced your work?

DR. MESSER: I think that the ACC opened my eyes to a whole new arena of health care. Pathways to leadership are fairly well structured within the American College of Cardiology. There are various opportunities that interested cardiologists can take if they wish. That was a wonderful learning experience. The other things that were attractive to me within the College were the profound interest in the

ONE HEART MAGAZINE www.heartbeatsaveslives.org

quality of cardiovascular care and the development of what we call guidelines, which are recommendations to physicians and cardiologists of how to deal with certain kinds of problems. They’re not standards of care but rather guidelines based on the best evidence that’s available at the time.

A writing group will work together to answer a particular question that needs clarification. That process was very appealing to me.

After guidelines, another activity that I admired within the College was performance measurement. Performance is related to guidelines, and the College was one of the first to develop a performance measurement taskforce.

As Chairman of the College’s Board of Governors, I was an advocate for performance measurement and became the College’s representative to the American Medical Association’s Physicians Consortium for Performance Improvement. This group has generated more performance measurement systems for cardiovascular care than any other group in the world. It has done so by bringing together experts from a variety of disciplines to develop performance measures. Currently that is my primary interest through the College. It has been a wonderful experience.

ONE HEART MAGAZINE: How else have you been involved with the ACC? You served on several of the boards, haven’t you?

DR. MESSER: Let me give you examples of what I was talking about concerning the step-wise path to leadership development. The College developed Chapters, on a stateby-state basis, many years ago. Back in the late 1980s, I

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became involved with the Chapter in Illinois. One thing led to another and I was elected by the cardiologists of Illinois to be the governor for the College in Illinois and president of the Chapter. That put me on the Board of Governors of the American College of Cardiology. There is one representative from each state and also some from abroad.

The representatives, in turn, elect the Chairman of the Board of Governors. I had the honor and privilege to serve in that capacity. That brings you in contact with other people who are just outstanding in their leadership and thinking abilities, and it’s fascinating to watch people solve problems in so many different ways. In addition I have served on many Committees, of which the Executive Committee and the Budget and Finance Committee have been the most instructive. . That has been the general structure of my involvement with the College. I still serve on a few of the Committees, including the Partners In Quality Committee, and enjoy reviewing manuscripts submitted to the College’s outstanding journals.

ONE HEART MAGAZINE: Other than Heartbeat International and the Global Cardiovascular Alliance, what other non-profits do you support and or work with?

DR. MESSER: I continue in my family’s tradition of supporting community programs with special emphasis on student education, facilities for individuals having special needs, and senior assisted living facilities. As President of the Messer Family Foundation, I oversee support for college scholarships, the Kiwanis Educational Foundation which my father established, Alzheimer garden construction for senior citizens, and similar institutional capital projects. I view

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my recent participation in Heartbeat International as an opportunity to assist in the expansion of these interests to the much broader community of those in need of improved health care.

I’m also particularly interested in Cardiovascular Credentialing International that I think dovetails very well with the Global Cardiovascular Alliance and Heartbeat. . Many years ago, I was asked by the American College of Chest Physicians to be their representative on the board of CCI. I am sure that you know that they support groups of exam writers that are experts in the technology and teaching of echocardiography, electrocardiography, cardiac catheterization interventional work, and electrophysiology, among others fields. They write the exams, which the professional technologists in these fields take in order to achieve their credentialing as qualified experts in, for example, the technological work in echocardiography, which is probably one of the largest of the specialties. After I served as a representative of the American College of Chest Physicians, I continued to serve as the representative of the American College of Cardiology. This is an organization the American College of Cardiology should support. It is the only credentialing organization for technologists that is specifically limited to cardiovascular work. It’s a very symbiotic relationship. It has been wonderful to work with the people who are assuring the quality of the technology professionals upon which we depend. By “we” I mean the cardiologists who every day depend upon the quality of the studies that we interpret and which inform our

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medical decisions. It seemed to me that the three, Heartbeat International, the Global Cardiovascular Alliance and Cardiovascular Credentialing International, which oversees the credentialing process in a variety of international locations, ought to get together and work on a broader agenda of improving healthcare throughout the world.

ONE HEART MAGAZINE: Were you attracted to Heartbeat through the connection with CCI and how you saw there can be a synergistic type of relationship between the two of them?

DR. MESSER: Actually, it wasn’t through CCI that I became interested in Heartbeat. It was because I have known Dr. Maniscalco for many years. We had worked together within the College. He played the key role in establishing the Florida Chapter of American College of Cardiology. He came to Illinois and helped us develop our Chapter. Over the years we have talked a lot about the general issues related to health care. He explained his vision as a possible next step in expanding the outreach of Heartbeat International. I had been aware of Heartbeat for years under Dr. Henry Macintosh’s leadership, and knew of the work the organization had done. I was impressed with Dr. Maniscalco’s vision and agreed to serve on Heartbeat’s Board. After I came on the Board of Heartbeat International I felt there was a very interesting opportunity for a relationship between CCI and Heartbeat.. So I simply helped introduce people to each other.

ONE HEART MAGAZINE: In closing, is there anything else that you would like to say?

DR. MESSER: I will say that I am very concerned about what is happening with health care currently in the United States. Though the focus of our discussion has been more the international and global, I think what happens in the United States to health care is often echoed internationally in many ways. My primary concern is what is happening to the definitions of value, quality and performance. There is a well-known equation of health care economics that I don’t think one can refute. That is that quality multiplied by access equals cost. If quality goes up, costs are going to go up, unless these are quality issues involving greater efficiency or the reduction of unnecessary procedures and costs. When access goes up, costs will go up. In our current environment, it’s my impression that the primary concern of planners and health care policy formulators is on the cost part of that equation. I’m very concerned about maintaining the traditional definitions of value and quality, because in a highly political environment that is primarily driven by cost reduction and increased access, value and quality are vulnerable and can often suffer. I think it is very hard to keep these elements straight. Unfortunately, when changes occur as they sometimes do in American systems, it is virtually impossible to reverse such steps. I hope that we will have more concern about the protection of quality, and the definition of value, in addition to our justified concern about cost.

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Beautifully positioned on a two-mile stretch of talcum-powder beach - considered by many as the finest in the Caribbean - The Meridian Club is an environmentally-sensitive private island resort ideally suited for those seeking an unspoiled, upscale but unpretentious retreat. With no automobiles, televisions, radios or telephones, guests unwind and enjoy the island’s natural beauty.

Soothing trade winds ensure comfortable temperatures and low humidity while surrounding waters teem with marine life. Underwater visibility often exceeds 100 feet and there are miles of coral gardens within a five minute boat ride. Ashore, Pine Cay remains a pristine natural haven with vast open space and seven freshwater ponds, a perfect habitat for the abundant local fauna and flora.

Aside from the obvious – bask in the sun on a deserted beach – guests can enjoy a variety of activities such as snorkeling, kayaking, paddle boarding, biking, playing basketball or tennis, and the most popular … taking golf carts out to explore the island.

Culinary Adventures Mornings begin with freshly brewed coffee, fresh-baked pastries and breakfast on a private screened porch, with the option to join other guests at outdoor tables on the pool terrace. In the afternoon visitors have the option of a tasty buffet lunch, often off the grill, or a more adventurous picnic lunch (prepared upon request.)

The club offers only the freshest seafood - locally caught ocean fish, lobster and conch prepared in various styles. There are other options, such as steak, chops, rack of lamb, duck and Cornish hen, and the award-winning chef prepares vegetarian meals upon request. With an new pastry chef this season, the club is excited to continue the tradition of fine desserts, beautifully presented with coffee or cordials.

Spa Offerings The Sand Dollar Spa, staffed by a Balinese masseuse, offers specialty spa techniques, including massage, hot stone treatment, manicures, pedicures, and facials. Balinese massage is a highly evolved, distinctive form employing a combination of gentle stretches, deep tissue kneading, acupressure and aromatherapy oils to stimulate the flow of blood, oxygen and “qi” (energy) around your body, bringing relaxation and a sense of wellness. An ancient technique, related to the Ayurveda, the Indian holistic medical system, this type of massage is known to help with a wide range of ailments, including migraine, muscle and joint pain, sleep disorder, anxiety and depression, as well as allergies and breathing problems such as asthma which often are worsened by stress. The use of oils is calming and sensual and leaves guests feeling tranquil and serene.

Fishing With great fishing only 20 minutes off shore and a boat ride that in itself is an memorable excursion, many who visit Pine Cay come for the fishing or include fishing in their visit to the island. From deep sea fishing to fishing in the flats, there is always something interesting for any level fisherman. Some take their catch back to our chef and have it prepared for the next meal, while others enjoy “catch and release” for the sport of it. Whatever your pleasure, if you plan to fish during your Caribbean vacation, many say Pine Cay is the best option.

For more information, call The Meridian Club at 866.746.3229 or visit www.meridianclub.com.

HBI OF GUATE EXPANDS TO SERVE

34 ONE HEART MAGAZINE www.heartbeatsaveslives.org

EMALA

MORE IN NEED

By Laura Maniscalco DeLise and Michael Maniscalco

O

ne idea emerged in Guatemala and went around the world…

In 1978 Dr. Federico Alfaro proposed an idea- create a Pacemaker Bank which would hold pacing devices to be used for those who had the medical need, but not the financial resources to utilize this life saving technology. This idea came about after Dr. Alfaro had finished his cardiovascular medical training at Baylor University School of Medicine in the United States and returned home to find that neither the national hospitals in Guatemala, nor the family’s of numerous potential patients had the financial resources to provide or utilize such a life saving device.

Many Guatemalans faced death or a severely comprised quality of life due to the lack of a pacemaker. In its first five years, Dr. Alfaro’s initiative was able to help 83 local Guatemalan patients and some Central American patients as well. Now, after nearly 30 years, and an international journey, Heartbeat International has helped over 1,300 Guatemalans and over 12,000 others around the world. …what started as a national initiative soon became a world organization, Heartbeat International. www.heartbeatsaveslives.org

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36 ONE HEART MAGAZINE www.heartbeatsaveslives.org

THIS NEW PARTNERSHIP DEMONSTRATES THE CONCEPT THAT TWO INDEPENDENT ORGANIZTIONS CAN OFTEN REACH FURTHER WHEN THEY WORK TOGETHER TOWARDS THE SAME END GOAL, IN THIS CASE, TREATING AND PREVENTING CARDIOVASCULAR DISEASE AMONG INDIGENT POPULATIONS AND SAVING LIVES. Heartbeat International of Guatemala is led by Heartbeat International founding Chairman, Dr. Federico Alfaro.

After 30 years of saving lives, Heartbeat International of Guatemala has reached a milestone agreement with UNICAR, Unidad de Cirugia Cardiovascular de Guatemala, furthering the ability of Heartbeat International of Guatemala to serve Guatemala’s needy population. UNICAR will serve as an additional Implant Center of Heartbeat International of Guatemala.

UNICAR, the national cardiovascular facility of Dr. Federico Alfaro Guatemala, was formed in an effort to solve the ever growing and increasing cardiovascular disease epidemic in Guatemala and to establish a world class medical facility to assist in the treatment, education and prevention of cardiovascular diseases in Guatemala. UNICAR focuses exclusively on providing cardiovascular healthcare services to both the children and adults of Guatemala.

Thanks to the tireless efforts and leadership of those such as Dr. Franics Robiscek, Dr. Rail Cruz Molina and Dr. Ismael Guzman Rodriguez, UNICAR was formalized in 1982 through a government agreement allowing UNICAR to function as semiautonomous facility in the medical treatment of cardiovascular diseases. With UNICAR’s autonomy came a more efficient, organized and successful cardiovascular program for Guatemala. Like Heartbeat International, UNICAR has a rich history of providing lifesaving cardiovascular services to underserved populations in Guatemala.

Over the last 12 years, more than 20,000 patients have received cardiovascular treatment at UNICAR. One of www.heartbeatsaveslives.org

UNICAR’s guiding principles is that the health and recovery of their patients leads to a better quality of life and their reintegration into the social and economic fabric of their community. Heartbeat International and the One Heart Global Cardiovascular Alliance share the conviction that access to quality healthcare is critical to the economic and emotional well being of families, communities and entire countries.

On July 26, Heartbeat International of Guatemala and UNICAR held a ceremony to formally establish a new Heartbeat International Implant Center that will operate at UNICAR’s facility in Guatemala City. This new partnership demonstrates the concept that two independent organizations can often reach further when they work together towards the same end goal, in this case, treating and preventing cardiovascular disease among indigent populations and saving lives. This partnership is an outstanding example of how governmental agencies, charitable organizations and other concerned groups can come together to seek a common objective.

Upon establishment of the partnership, Heartbeat International Foundation (U.S.) dispatched a shipment of implantable cardiovascular devices, which had generously been donated by BIOTRONIK. Many of these devices have already been provided to waiting indigent patients. Many more will be served in the months and years ahead.

Chairman of Heartbeat International Foundation states that “the addition of UNICAR as a strategic partner of Heartbeat International Foundation opens the door wide to a multiplicity of potential projects to serve the needy in the country of Guatemala. This, of course, is in perfect alignment with the ‘spiritual’ founder of Heartbeat International, Dr. Federico Alfaro, who’s vision to serve his fellow countrymen has now become a permanent reality both in Guatemala and around the world.”

We are indeed proud, as well as pleased, to welcome UNICAR to the official Heartbeat International family.

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38 ONE HEART MAGAZINE www.heartbeatsaveslives.org

The Heart Behind the

Arrhythmia Alliance

By Steve Hayes

T

he story of Arrhythmia Alliance founder, Trudie Lobban, is one which highlights more than most how a personal experience can be transformed into a force for change.

What started as a patient support group run from Trudie’s kitchen table in a tiny, rural, English village has evolved into an international charity at the forefront of the fight to raise awareness of arrhythmias.

In two decades of campaigning one challenge has remained: engaging people.

Arrhythmia Alliance’s latest campaign, Hearts & Goals, has seen it use football as a platform to do this with great success.

Here Trudie Lobban tells One Heart about the success of Hearts & Goals and reveals the personal and professional challenges she has overcome to establish the charity as a leading voice.

F

ootball has helped to make the last year one of the most successful in Arrhythmia Alliance’s history. Hearts & Goals, rooted within the sport, has proved a hugely effective means of spreading one of the charity’s long held lifesaving messages about the importance of having public-access AEDs (automated external defibrillators) in communities.

Since its launch at the start of the 2012/13 English football season, Hearts & Goals has developed into a thriving and dynamic campaign, with the central aim of tackling sudden cardiac arrest. Pivotal to its success has been a partnership between the charity and former England footballer, Fabrice Muamba, whose collapse on a UK football pitch, in March 2012, and subsequent recovery hit headlines around the world.

The shock and subsequent outpouring of goodwill across the footballing world towards Fabrice Muamba after his sudden cardiac arrest during a televised FA Cup match has been transformed with great effect via the campaign into engagement.

With Fabrice as ambassador, Hearts & Goals has thrust the issue onto the agenda with the result that Arrhythmia Alliance has been able to work with thousands of clubs and communities, place more than 150 public-access AEDs (automated external defibrillators) and train thousands of www.heartbeatsaveslives.org

people in lifesaving skills.

“There is no doubt football has proven a fantastic way for us to reach out to communities and spread this crucial message further,” explains Trudie.

“What happened to Fabrice was felt throughout the footballing world and it really opened people’s eyes to sudden cardiac arrest.

“Here was a young man at the peak of physical fitness who collapsed without warning.

“It was a high profile example of not only how sudden cardiac arrest can strike anyone at any time, but also of how important early CPR and the use of an AED is when someone collapses with sudden cardiac arrest.

“When we launched the campaign with Fabrice the response was just incredible and it has gone from strength to strength.”

Underpinning the campaign is the principle that all communities should have AEDs, or more accurately, that they should be ‘as common as fire extinguishers’, in Trudie’s own words.

“There are communities who are leading the way globally in terms of public-access AEDs and the results are clear to see.

“Some communities in Norway and the US, for example, ONE HEART MAGAZINE

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Trudie with Fabrice Muamba at the launch of the UK’s biggest 10k Run, for which Hearts & Goals was the official charity campaign.

have sudden cardiac arrest survival rates which dwarf the average. It is always because they have defibrillators in communities and they teach children from a young age the importance of early intervention with CPR and an AED. We need to make sure this is the same in communities around the world.”

In keeping with the charity’s continual growth, ambitious plans to spread the campaign internationally and engage with the global football community are already underway.

For Trudie, Hearts & Goals is the latest in a series of success stories and a continuation of the charity’s efforts to find fresh ways of engaging people on the issue of arrhythmias.

Whether within the public, medical profession or policy making arena, the story of Trudie Lobban and Arrhythmia Alliance is one of getting arrhythmias onto the agenda and keeping them there.

It is now 20 years since Trudie’s daughter Francesca suddenly and inexplicably began blacking out and collapsing at just ten months old. Little could she have known this was to be the beginning of a remarkable journey.

Terrified at what was happening to Francesca, Trudie visited countless medical professionals desperately trying to 40

find an answer.

Then finally, aged three, after seeing a consultant neurologist Francesca was diagnosed with Reflex Anoxic Seizures (RAS) – which causes the heart to stop for short periods.

“It was a real awakening for me,” said Trudie. “I had absolutely no medical knowledge at that time.

“Knowing Francesca’s heart was actually stopping, and sometimes for nearly 40 seconds, was terrifying but at least we had an answer and we knew we could deal with it.”

So grateful for the help of consultant Prof John Stephenson for his diagnosis, Trudie set up a small support group for other affected parents. And in 1993, the first of Trudie’s charities, STARS (Syncope Trust And Reflex anoxic Seizures), was born.

“I could never have believed where it would lead and just how quickly it would take off,” Trudie recalls.

“When I started out my aim was simply to help as many people as possible by ensuring they or their loved one gained access to the advice, diagnosis and treatment they needed. I did not want anyone to have to go through what my family and many others had.

“It took off in a way I could never have imagined. As we came into contact with more and more people and my

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own knowledge began to grow it became apparent I had only scratched the surface of a much wider issue and that understanding and awareness of heart rhythm disorders lagged way behind at every level. I just knew I had to do something.

“At first I was working out of my kitchen and dining room and then we moved to my garage and then finally into our first offices.

“We were taking so many calls from people affected and not just parents with children with the condition but people suffering with a host of heart rhythm disorders.”

From these humble beginnings the achievements flowed – the first patient conference, the formation of a committee containing medical professionals looking into the spectrum of arrhythmias and a host of successful campaigns were launched within the first few years.

What had started as an effort to prevent others having to

Trudie and Tony Blair, former British Prime Minister.

suffer the fear and uncertainty she had, had touched upon a huge lack of awareness about arrhythmias among not only the public but also the medical profession.

“I started to realise we were on to something very significant. People were increasingly calling us about a broad spectrum of heart rhythm disorders.

“Common strands were emerging with each enquiry, whether it was about AF, syncope, tachycardia or any heart rhythm problem. People were confused and scared about what was happening to them or their loved one and many of them hadn’t been able to find or access the information, diagnosis or treatment that they should be getting.”

To reflect the ever-increasing scope of the charity’s work Arrhythmia Alliance was established in 2004 and launched at Parliament in the UK to raise awareness and highlight the deficiencies in the treatment and care for people with arrhythmias.

The biggest breakthrough would come just one year later.

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“We became aware the National Service Framework for Coronary Heart Disease, which guides National Health Service policies in the UK, only mentioned the word arrhythmia once; despite evidence which showed the huge prevalence of the disorders in society.

“We began efforts to get a new chapter written specifically on arrhythmias. The then Prime Minister, Tony Blair, was diagnosed with atrial flutter around the same time and we started a focussed letter campaign from our members. Within months it had been agreed a new chapter documenting arrhythmias would be adopted. We had finally managed to get arrhythmias onto the policy agenda.”

It was a significant shift and one which has resulted in Arrhythmia Alliance growing from strength-to-strength to become a coalition which now includes thousands of patients, doctors, nurses, cardiologists and carers all united with the same goal of giving heart rhythm patients access to early diagnosis, appropriate treatment, support and improved quality of life.

In two decades Trudie has transformed the small patient group she had originally conceived into a global charity leading the fight to improve the diagnosis and treatment for arrhythmias, now established in more than 40 countries and continuing to expand.

The fact heart rhythm disorders had been so neglected is staggering when one is furnished with any one of the burgeoning number of statistics surrounding the disorders.

“The lack of awareness and action by governments is extraordinary when you consider the devastating impact arrhythmias have in society. It is a constant struggle to get those who can do something to make a change to recognise this,” continues Trudie.

“We have found the same story over and over.

Communities across the world face exactly the same problem that we unearthed in the UK: arrhythmias are not prioritised enough in health policy and as a consequence there is a systematic lack of knowledge, awareness, diagnosis, care and treatment.

“What we have is a situation where worldwide there are millions of people affected by heart rhythm disorders but many of them are not even aware of what an arrhythmia is despite the potentially devastating consequences it could have on their life.

“Just as worrying is the fact many people who do have a diagnosis are still not receiving the treatment they should be getting. Many people with AF are not receiving appropriate anticoagulation; many who have suffered a sudden cardiac arrest are not receiving an ICD and so on. We absolutely must address this situation.”

This is an account backed up by the charity’s rapid growth and expansion overseas. It is now established across Europe, the Americas, Asia and Africa and recently launched in Australia, always working in partnership with healthcare professionals, patients and governments to improve the picture for arrhythmia patients.

As an increasingly significant number of enquiries to the charity were about the most common arrhythmia, atrial fibrillation, a sister charity, the AF Association, was established in 2007 to allow a more focussed effort on this disorder.

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Trudie with STARS patron, Sir Roger Moore and his wife Kristina Tholstrup.

The Alliance, the AF Association and STARS have published and translated into many different languages, a wealth of accredited publications on heart rhythm disorders which are used by medical professionals across the globe and given to their patients. They have also launched a number of high profile campaigns to fulfil the twin aims of raising awareness and working for practical change.

Successful patient-focused campaigns have included Know Your Pulse, a simple, yet effective campaign encouraging people to be aware that checking their pulse regularly can be the easiest way of detecting an arrhythmia.

While campaigns like Wholehearted, to address the inequality of ICD (implantable cardioverter defibrillator) implantation rates, are focused on educating healthcare professionals and changing policy to ensure practical benefits for patients and health services.

The charity’s continued focus on sudden cardiac arrest, which causes hundreds of thousands of deaths worldwide every year, brings out an unmistakable passion in Trudie one borne out of her own personal tragedy.

In 2008, by a cruel twist of fate, her husband Charles, who had been at Trudie’s side from the beginning and was instrumental in the success of the Arrhythmia Alliance, died from a sudden cardiac arrest aged 58.

“When people ask what motivates me, or how I do it, www.heartbeatsaveslives.org

my answer is quite simple really. I knew I had to carry on after that and it did really strengthen my resolve – it made me more determined than ever.

“This is something which has deeply affected my own life and I know the devastating effects only too well.”

Trudie, who was awarded an MBE from the Queen in 2009 to recognise her work, is now established as a world expert and patient representative – continuing to push for greater awareness, working with patients and medical professionals and influencing policy. A number of her papers have been published in high profile medical journals.

“The real tragedy here is arrhythmias are nearly always treatable so a huge proportion of the tens of thousands of deaths every year are avoidable,” Trudie continues.

“I’m very proud we have been able to get arrhythmias onto the agenda but there is so much work still to be done.

“Awareness of arrhythmias in both the public and the medical profession still lags way behind relative to other illnesses. Only when this is addressed can more lives be saved.

“I want the work of the charity to go on long after me and continue to make our aims reality.”

It is an inspirational vision from a woman absolutely committed to a cause so very close to her own heart.

Visit www.aa-international.org for more information.

ONE HEART MAGAZINE

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HEARTBEAT INTERNATIONAL OF EL SALVADOR:

“MARCAPASOS DE VIDA PARA TI” 44

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eartbeat International of El Salvador is the newest member of the Heartbeat International family. Founded in March of 2013, HBI of El Salvador is managed by members of the Santa Tecla Rotary Club in San Salvador and medical doctors practicing at Hospital Rosales, the largest public hospital in El Salvador.

Hospital Rosales assists patients from 12 years of age onwards and provides an extensive range of specialized medical services, including, of course, cardiology services. The Cardiology Department receives patients nearly every day from each of El Salvador’s 14 Departments.

Many of these patients suffer from cardiovascular diseases that require permanent pacemakers as part of their treatment. Therefore, these electronic devices are vital for patients to recover their health and go back to their daily activities.

Hospital Rosales does not have the budget to purchase the pacemakers.

There are some patients who, with the help of their family or altruistic people in the community, are able to secure devices on their own, Many others, however, lack the financial resources to acquire these devices and, as a consequence, either die or are Patient after being operated by Dr. Solomon Flores who is part of the Board of Heartbeat forced to remain in uncertain health International of El Salvador. conditions.

Fortunately, the Cardiology Hospital Rosales and the commitment of members of the Department’s staff is well qualified to Santa Tecla Rotary Club, Heartbeat International’s mission implant these devices. In fact, these procedures have been has arrived in El Salvador. This has meant, in just our first performed at Hospital Rosales for the past twenty years at few months of operations, that 14 qualified patients, who an average (and increasing) rate of 126 per year.

Furthermore, social workers at Hospital Rosales are well- would have otherwise gone without, have received the devices they so desperately needed. These 14 patients qualified to assess the economic status of patients waiting continue to receive periodic check-ups through the hospital’s for a pacemaker so that we can be sure devices are reserved outpatient services department. for those truly in need.

Thanks to the dedication and skill of the team at

www.heartbeatsaveslives.org

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PATIENT TESTIMONIALS Name: Berta Gonzalez Age: 83 years Right: Mrs. Berta González and one of her relatives explaining her changes after the surgery.

This pacemaker recipient is a person of limited economic resources whose family fled to the United States during the civil war in El Salvador. Because of this, she has no one to take care of her. She is diabetic and has lost some sight. She also no longer coordinates speaking and cannot communicate without somebody’s help.

Name: Daniel Ramos Age: 19 years Young Daniel Ramos explaining that he has used a pacemaker since he was a child.

This young man has a congenital problem that has forced him to use a pacemaker since the age of 3. His family comes from a low income neighborhood and could not afford the cost of the equipment. After having experienced the benefits of one of these devices, his main aim is to study medicine and become a cardiologist specifically to give back to society. He thanks Heartbeat and “Marcapasos de vida para ti” for having selected him as a recipient of one of the donated pacemakers and for giving him another chance to live.

Name: Elia Magaña Age: 87 years Mrs. Elia Magaña comes from a poor family who could not afford a pacemaker for her.

Mrs. Magaña suffered from constant dizziness and fainting and once even had a bruise on her face produced by a fainting spell.

She visited several doctors, but none provided her an accurate diagnosis of her condition, until she reached the Rosales Hospital.

After a 20 day hospital stay, her blood pressure was stabilized enough to undergo a pacemaker procedure.

Her relatives are economically disadvantaged and were looking for somebody to lend them money to buy a pacemaker, but they could not get anybody to help them. Finally they became aware of the tangible hope that was being given out at the Hospital Rosales by Heartbeat.

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PEDIATRIC TEAMS SAVE LIVES IN IRAQ, ECUADOR, MACEDONIA AND UKRAINE

By Holly Whitfield

Reprinted with permission from the July 2013 edition of Good Health Memphis published by Commercial Appeal

In just the last few weeks, four pediatric surgery teams have been busy saving children’s lives in four different nations: Iraq, Ecuador, the Republic of Macedonia, and Ukraine. These teams are made up mostly of volunteers-nurses, surgeons, and others who donate their time and expertise to join one or more of the 30-40 missions that the International Children’s Heart Foundation (ICHF) takes on each year.

According to the ICHF website, “the U.S. and other developed countries have hundreds of medical centers with trained specialists to care for children with heart disease. For children born in developing nations, this is not the case.” To correct the most common birth defect, heart disease, usually just one surgery is required, but sometimes follow-up procedures are necessary. Thirtyfive percent of children born with these kinds of heart problems require surgery within the first month of their 48

lives in order to survive.

Dr. William Novick of Memphis always had a passion for pediatric cardiac surgery, but it wasn’t until a solo mission to Colombia in 1991 that he had a realization.

“I couldn’t wear all the hats; I just couldn’t do it alone.

To maximize the impact, I needed a team,” he says. The first group of volunteers traveled to Croatia in 1993. “The difference in how those children did, and how many kids we were able to help as compared to my previous solo trips was so significant,” Dr. Novick recalls. “I decided, ‘this is how we should do it.’” Since then, the ICHF has operated on 6,000 children in 31 countries on every continent except Australia and Antarctica.

Most importantly, part of the ICHF’s mission is to improve the overall state of international children’s health.

Foreign pediatric health care providers receive training from experienced ICHF physicians, who have developed best practices and insights into the care of children in locations where resources are limited. “We train physicians in the countries we visit,” says Dr. Novick. “We want them to sustain care for the children long after we leave.”

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HEARTBEAT INTERNATIONAL OF TRINIDAD & TOBAGO:

SERVING AS THE GLOBAL MODEL OF HEARTBEAT INTERNATIONAL HEART CENTERS

By Farouk Khan Hosein

H

eartbeat International of Trinidad and Tobago (HBITT) is the local Heart Centre (HC) in the Republic of Trinidad and Tobago, formerly known as the Rotary Club of St. Augustine Pacemaker Bank Club of which started in 1985 under the kind auspices and guidance of the HBI Worldwide (HBIWW). During the last 28 years the organization evolved and went through two significant changes. Under the aforementioned name 294 devices were donated to September 2006. In October of 2006 the HC was reorganized and operated under the name Rotary Clubs (T&T) PMB of HBI and donated 126 devices up to April of 2009. There was further reorganization in May of 2009 when the HC was renamed Heartbeat International of Trinidad and Tobago (HBITT).

The catalyst of this reorganization was the HBI Worldwide restructuring process of heart centers around the globe to acquire pledges and commitments of compliance and ensure that all satellite operations of Heartbeat International aligned strategically to the organization’s vision, mission and objectives. The birth of the new HC that is now HBITT brought about a re-evaluation of the process and procedures for the donations of devices and the reporting on the devices that were donated, and the reporting on patients that benefited from this charitable and humanitarian venture.

There was also a change in the business model and organizational structure of the HC, whereby instead of the HC being solely managed by a Rotary Club a new formula of management, took effect. This formula was evolutionary in its own regard, in view of the fact that it sought to open www.heartbeatsaveslives.org

the membership of the HC and get the involvement of other local agencies and organizations in the management of the HC. Today HBITT boasts of having involvement from Rotary Clubs, Lion’s Clubs and ACI (a private cardiac hospital), and also Cardiologists, Engineers and Consultants as members of the organization, it also had John’s Hopkins Cardiology as an advisor to the Board in the past. The HBITT’s business model, part of which includes the device donation process and the patient care process (HBITT Patient Flow Chart) has been adopted by HBIWW as the platform that all HCs should adopt with regards to the donation and patient care delivery form a HC perspective.

There are several aspects to the business model which in itself is at an evolving state. The patient flow process has 7 stages and 5 sub-stages. Stage 1 is the patient referral; stage 2 administrative evaluation ; stage 3 medical evaluation ; ONE HEART MAGAZINE 49

stage 4 the Implant scheduling; stage 5 implant procedure; stage 6 Implant reporting; stage 7 patient follow up. The device donation process runs parallel to the patient flow process and has 7 stages as well. Stage 1 request device and accessories from HBI;stage 2 assign device to patient (based on prescription and medical evaluation);stage 3 pair device with accessories; stage 4 deliver device to the Cath Lab for implant; stage 5 receive patient/device implant report; stage 6 proof read report for accuracy; stage 7 forward report to HBI. At stage 5 in the patient flow process is where stage 5 of the device donation process merges. Through its full time staff HBITT has been able to manage this process along with other aspects of the operations of the heart centre.

However the donation of a device and coordination of the implant for the patient is not where the process stops.

HBITT has to provide ancillary patient care during and after this process, for e.g when administratively evaluating patients, a patient is not only assessed and reviewed. Every patient is mandated to list a representative (friend or family member to accompany the patient or be used as a person of contact). The patient and the representative would be given a scheduled appointment together with at least 4 other patients and receive a group orientation on HBI/HBITT, the process and procedure, why they were referred, what is CAD, what is a device, use by date (UBD), the need for follow ups after the procedure and general patient education on a healthy lifestyle and consultation with their cardiologist.

The patient at this review is given education brochures and also encouraged to make donations or get their friends and families involved in donating to the HBITT cause. HBITT also encourages patients and their relatives to sign up as volunteers to the organization.

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HBITT would also have to get involved with assisting patients administratively, all the patients will fall under the category of indigent however not all our patients are mature and retired. Many patients that are working either in blue collar jobs or on contract, or individuals trying to make ends meet on a daily basis to assist in the basic physiological needs for themselves and their families. They sometimes cannot take time off from their jobs for fear of termination, therefore HBITT would have to issue letters on behalf of the patients to their employers or sometimes even schools, citing their diagnosis and the patientâ&#x20AC;&#x2122;s pending implant date to assist the patient in getting the time off they need to get treated.

In addition to the patient, HBITTâ&#x20AC;&#x2122;s office liaises with all the other stakeholders that are involved in the process in some way such as the hospitals, the social workers, the referring doctors and the health ministry to ensure that the patients acquire the best possible treatment and have a pleasant experience and a smooth transition from being confirmed for eligibility for a device to having a device implanted and moving to the follow up stage.

Since itâ&#x20AC;&#x2122;s restructuring in May 2009 and with the support of staff and volunteer implanters, general volunteer s, HBITT has donated and implanted a total of 400 devices. That added to the 420 devices that were donated and implanted prior would put the Trinidad and Tobago HC at a total of 820 devices donated and implanted over the last 28 years.

Gratitude for which is expressed and reflected in letters such as Mr. Razack Ali husband of Mrs. Evelyn Ali who received her humanitarian donation and implant of a dual chamber pacemaker on 2nd August 2011.

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Currently Recruiting Participants with a History of

Heart Attack, Stroke, or Peripheral Artery Disease

Now recruiting for a Phase 3 clinical trial for individuals with clinically evident cardiovascular disease. The study sponsor is conducting a clinical research study evaluating the effect of AMG 145, an investigational medication, on individuals’ risk for cardiovascular events. We are seeking your help to identify patients who may be eligible to participate.

Key eligibility criteria include: • Between 40 and 85 years of age • History of myocardial infarction, stroke, or peripheral artery disease The primary hypothesis of this study is that additional LDL-C lowering with the investigational medication decreases the risk of cardiovascular death, myocardial infarction, stroke, coronary revascularization and hospitalization for unstable angina.

If you have any patients who may qualify please visit our website at:

www.CVDstudy.com

ADVANCING ECHO STANDARDIZATION AROUND THE WORLD T he American Society of Echocardiography (ASE), the largest international non-profit organization for cardiovascular ultrasound imaging, started the ASE Education and Research Foundation in 2003 to support its philanthropic initiatives.

Strengthened by donations from individuals, corporate partners and other non-profit organizations, ASE Foundation enables the organization to increase its global outreach in the field of echocardiography. With an acknowledgment that worldwide patient care is varied, ASE Foundation aims for the global standardization of cardiovascular ultrasound patient care by providing education through ASE’s guideline documents, supporting international research exchanges, and taking echo training to parts of the world where that training will make a difference. The results of these efforts have been impressive.

• ASE guideline documents and posters have been translated by international physician volunteers in four different languages and disseminated free of charge worldwide.

• Travel grants have been targeted to international physicians enabling them to travel to U.S.-based conferences to present their work and obtain access to innovative education.

• ASE Foundation volunteers conducted humanitarian missions in 2012 and 2013, using telemedicine to train local physicians and providing direct care to the underserved in rural parts of the world.

Contributions to the ASE Foundation support research, scholarships and travel grants, guideline-based projects and humanitarian missions advancing the field of cardiovascular ultrasound.

To leave a lasting impact on echocardiography and cardiovascular health worldwide, contribute to the 2013 Annual Appeal by visiting www.asefoundation. org/donate. For more information about ASE, go to www.asecho.org.

Building off the success of the first humanitarian event, ASE volunteers returned to the same rural location in India in December 2012, this time with an added element that was deficient in the January event – the training of Indian physicians. ASE volunteers took on the role of teachers, working side by side with 17 Indian physicians, while U.S. based sonographers conversed with Indian physicians through a virtual training lab.

ASE Foundation, with the help of its donor base, plans to expand its educational outreach through future missions and guideline dissemination, continuing to drive uniformity in cardiac ultrasound imaging. As explained by Thomas Ryan, MD, FASE, Chair of the ASE Foundation, standardizing echo practice is necessary for improved patient care. “Echocardiography, due to its portability, safety and its value in the diagnosis of most heart and circulation conditions, is already used throughout the world. This necessitates a global voice for cardiac ultrasound to speak the same language everywhere. With the growth of telemedicine it will be increasingly necessary and useful to have standardization across international borders. ASE Foundation plays a crucial role in standardizing the practice of echocardiography, which makes a tangible difference in patient care throughout the world.”

Making an Impact ASE Foundation has worked hard to support global efforts – most recently in India and Vietnam - that create a ripple effect from the organization’s presence, empowering physicians and healthcare providers to continue enhancing patient care after ASE has left the host country. In January 2012, the ASE Foundation’s first humanitarian project elevated cardiac ultrasound to a new level, moving care out of the lab and employing handheld devices to reach a rurally-based population of patients. Over two days, volunteers broke a world record for the image acquisition of 1,000+ patients, many of whom had never seen a doctor. The images were uploaded to a cloud-picture archiving and communication program, which allowed 75 physicians around the world to be part of the image consultation. Follow-up care was arranged for those in need and lives were improved as a result of the project.

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AN ARMY IN WAITING

By Sandra Kreul, ARNP, MSN, CLS, FAHA, FNLA, FPCNA

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orldwide, non-communicable diseases (NCDs) are estimated to account for 35 million deaths and are the leading cause of mortality and morbidity in the majority of low and middle income countries (LMICs). NCDs include diabetes, cancer, cardiovascular disease and asthma. In LMICs millions of people over the age of 60 die each year because of poor living habits which include unhealthy diets, excessive alcohol consumption, physical inactivity and nicotine addiction. A significant contributing factor is that affordable medications and health care are not accessible and/or affordable to the general population.

Sandra Kreul

In the next 10 years, the NCD burden will increase by 17% globally, 27% in regions of Africa, but the highest increase will occur in the Western Pacific and certain regions of Southeast Asia. The societal, governmental, and economic burden of NCDs in these countries is staggering to contemplate and enormously difficult to combat. Without a global plan of attack in the prevention of NCDs they will become the leading cause of disability by 2030. 1 Developed countries such as those of Europe and the United States have successfully turned the tide in their battle against NCDs. A very significant factor in this accomplishment was the use of advanced registered nurse practitioners (ARNPs) in the evaluation and care of patients and in particular as health educators. This strategy is one to be emulated and implemented in the developing world in order to confront successfully the scourge of NCDs.1

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The NCDs: Defined Diabetes is a group of metabolic diseases characterized by high blood glucose levels resulting from defects in the pancreas. The result of these defects is that the body either does not produce enough insulin or its cells do not respond to the insulin produced.2 As of 2010, diabetes affected 285 million people globally and is the most common NCD. Without an aggressive prevention and treatment program that number will increase to 552 million by 2030.1 If diabetes is ONE HEART MAGAZINE 55

not treated properly, patients will develop serious health complications, including diabetic ketoacidosis, hyperosmolar coma, cardiovascular disease, chronic renal failure, and diabetic retinopathy. In some low-income countries, life expectancy of children with diabetes is less than one year.

The majority of diabetic complications can be prevented through patient education emphasizing the relationship between diabetes and obesity and how exercise and appropriate medications can treat the disease. Such a program will only be effective if population screening, evaluation, and therapy are implemented and supported by the governments of LMICs. Yet, although diabetes accounts for approximately 60% of deaths in these countries, its identification, treatment and prevention are not developmental priorities.

Indeed, only 0.9% of the $22 billion in international aid is allocated for health in developing countries.

Moreover, the World Health Organization (WHO) has 2,500 people on staff; yet only one person is dedicated to diabetes. Confounding the problem, diabetic medications do not reach the patients who need them most, because many countries still apply tariffs and taxes on essential medicines, which limit their affordability and access.3 Cancer is a group of diseases involving uncontrolled cell growth. The cause of cancer is diverse, complex and not fully understood. It is, however, a major burden for the worldâ&#x20AC;&#x2122;s poor. It accounts for more deaths than tuberculosis, AIDS, and malaria combined.3 It is estimated that 70% of cancer patients are in LMICs and claim 5.3 million lives annually. Many things are known to increase the risk of developing cancer, including tobacco use, poor nutrition, certain infections, radiation exposure, physical inactivity, obesity, and pollutants.

Cardiovascular disease (CVD) refers to any disease that affects the cardiovascular system. The primary causes of cardiovascular disease are atherosclerosis and hypertension. CVD is the leading cause of death worldwide;17 million people die annually, with over 80% occurring in LMICs. By 2030, it is estimated that nearly 23.6 million people will die from CVD.3 The contributing factors of CVD include unhealthy diet, tobacco use, inactivity, obesity, hypertension and diabetes.

Asthma is a chronic inflammatory disease of the airways, producing a wide variety of symptoms. Asthma affects 300 million people worldwide and has many precipitating causes both genetic and environmental.

Asthma is often exacerbated by triggers which often include smoke, air pollution, non-selective beta blockers and sulfite containing foods. Asthma causes moderate to severe disability in 19.4 million people globally (16 million in LMICs).

Reflecting on the NCDs, we can see the commonality of risk factors that are interrelated and present in all of the NCDs. The Nurse as Healthcare Educator and Provider Considering the magnitude of the worldwide problem of NCDs, there needs to be a multidisciplinary approach to the solution, an approach which dovetails nicely with the 56

skillset of nurses. Physicians are trained to focus on and manage chronic diseases. In contrast, nurses are trained to think more holistically about the patient who has the disease and even consider his or her family. Nurses can extend the health plan into many rural areas in which there are no physicians and do an excellent job in controlling blood pressure, glucose and lipids.

Dating all the way back to the 16th century, nurses have had a role in restoring the sick back to health. Over the last hundreds of years, the role of nursing has changed from just book learning to a combination of medical training and clinical experience. The biggest shift occurred in the 1850â&#x20AC;&#x2122;s when the American Methodists, the largest Protestant denomination, engaged in large scale missionary activity in Asia and elsewhere in the world.

Around the world, the scope of nursing practice is very diverse as well as its educational requirements. In the periphery of the Israeli community, nurses practice in roles similar to the Advanced Nurse Practitioner (APN). Their practice, however, is very structured and they work under delineated and prescribed medical protocols. Israel has four universities which offer a masterâ&#x20AC;&#x2122;s degree in nursing but only one teaches both theoretical and clinical APN skills in the same program. In Botswana, they have advanced diploma programs that have evolved from one year to 18 months and is now approved for only 4 semesters.

In addition, health care protocols are just as diverse throughout the world. For example, in Thailand, there are 3 levels of primary care. The first is a community medical center responsible for 15,000-20,000 people. These facilities are only staffed by one MD, one dentist, one

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pharmacist, 3 nurses, and 6 other health care professionals.

The second level of care in Thailand is a community health center responsible for 5,000-10,000 people. The third is a health post-district taking care of less than 5,000 people.

Both the community health center and the health postdistrict do not have an MD, dentist, or pharmacist. To address the need, many schools of nursing established 4 months of post basic nursing to prepare general nurses to work in the community as primary care providers.

All countries have nurses but not all countries have ANPs. In some countries, registered nurses train for 2 years and become community health nurse practitioners.

The focus of the curriculum is on personal health habits, stressors, genetics, and health risk factors to further the goals of appropriate health promotion, prevention of illness, and early detection of disease.

In January 2005, the International Nurse Practitioner / Advanced Practice Nursing Network (ICN) provided a draft of the scope of practice, standards and competencies of the Advanced Practice Nurse. This document was intended to be used as a guideline for nations and organizations planning to implement APN in their country. By increasing the accessibility of ANP in the developing countries, they were able to better engage in risk stratification and to implement a formal educational program addressing NCDs. For every NCD identified, there is an educational component which needs to be implemented countrywide.

If this risk stratification/educational program is developed under the supervision of a medical doctor, then nurses and ANP’s can take it to the people on a wide scale basis.

In order to make a significant impact on NCDs, this grand www.heartbeatsaveslives.org

scale risk stratification program will need the worldwide cooperation of all governments and health organizations.

The long term effects of NCDs and the ongoing societal risk of exposure necessitate a holistic approach for the prevention, diagnosis, treatment, and care services of all ages. Every country needs to have a full range of prevention programs, including diagnostic tools to identify disease, palliative and rehabilitative care, and treatment tools available to all ages of the population. It is critical that the entire population be risk stratified and then placed in an appropriate algorithm of care.

Children and adolescents learn health behaviors from those around them. The behaviors underlying many NCDs – poor eating habits, tobacco use, alcohol abuse and a sedentary lifestyle – begin to form in childhood, accelerate in adolescence and reach a crescendo in working-aged individuals. Unfortunately, even in countries where NCD intervention programs exist, children, adolescents, and many adults are not reaping the benefit of the programs.

Therefore, there needs to be put into place an aggressive prevention, education, and treatment program globally through the NCD Alliance.

The educational requirements to become an advanced practice nurse are rigorous and include advanced coursework and clinical rotations. In the United States, an APN must receive a master’s degree. The curriculum includes and is not limited to epidemiology, physical assessment, health promotion, pathophysiology, differential diagnosis, pharmacology, laboratory and radiography diagnostics, statistics and research methods, health policy, acute and chronic disease management, role development and leadership, and culture. This level of education prepares the APN to function independently with a high level of expertise.

Nurses and APNs play a critical and strategic role in the NCD Alliance. Nurses and APNs are efficient and cost effective. When compared to the amount of time and cost it takes to educate physicians, nurses can become APNs and already be working in a third of that time. Because they are trained to think holistically, APNs are a critical component to the approach of NCDs. In each country, they can provide the necessary direction to make a significant contribution to the global target.

Currently, all countries have nurses but not all countries have nurse practitioners. And in those countries that do have APNs, the educational requirements are very diverse. In order to truly affect the NCDs, there needs to be standardized education for APNs. Every country needs to establish a college curriculum which prepares all the nurses with the same level of expertise. These colleges need to be funded by the government of each country, making sure that it is affordable for nurses to attend. Then we will have huge numbers of health professionals participating in the war on NCDs. RESOURCES

1. http://www.ncdalliance.org/globalepidemic 2. http://www.diabetes.org/diabetes-basics/?loc=GlobalNavDB 3. http://ncdalliance.org/sites/default/files/rfiles/The%20MDGs%20 and%20NCDs_0.pdf

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GLOBAL HEALTH CARE ISSUES AND STRATEGIES

By David R. Holmes, Jr., M.D. President, American College of Cardiology

T

he pace of change in healthcare worldwide is accelerating. This is the result of multiple factors, many of which have a dramatic impact on cardiovascular health and disease.

The most recent data from the World Health Organization (WHO) indicates that more people die every year from cardiovascular disease (CVD) than from any other cause. The data from 2008 indicated that there were 17.3 million deaths mainly from either coronary heart disease or stroke. By 2030, this number has been projected to increase to 23.3 million, with cardiovascular disease continuing to be the leading cause of death.

Although there has been focus on earlier detection of disease and optimizing strategies for improving access to care, risk factors continue to worsen.

In the United States, obesity has become an epidemic and now Dr. David R. Holmes, Jr. affects approximately 30% of all adults and an alarming number of children. Hypertension and hyperlipidemia still remain sub-optimally controlled for the population at large. Similarly, as obesity rates increase, the incidence of type 2 diabetes rises in parallel. An important development has been increased initiatives to strictly legislate, either locally or statewide, tobacco use in the www.heartbeatsaveslives.org

American public sphere, including work places, restaurants and bars. These initiatives have proven to be very successful in reducing cardiovascular mortality, both myocardial infarction as well as sudden cardiac death. In some publications, despite an increase in obesity and diabetes mellitus, the implementation of smoke-free regulations has resulted in approximately a 50% reduction in the combination of myocardial infarction and sudden cardiac death. Such successful outcomes have been seen in multiple communities across the United States.

Global increases in cardiovascular disease are very concerning. According to WHO statistics, over 80% of the worldâ&#x20AC;&#x2122;s deaths from CVD occur in low and middle income countries. The specific relative incidence of stroke versus coronary artery disease varies from country to country.

There are a number of reasons for this preponderance of CVD in these low and middle income countries. Some of the preventive strategies found to be effective in more developed countries include healthy diet, avoidance of tobacco, regular physical activity, access to preventive care medical personnel, both primary and secondary, after a clinical event, and treatment of hypertension, diabetes and obesity. Since poorer countries do not have the resources to implement these strategies, the global locus of CVD has shifted from developing countries to lower and middle income countries.

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cannot be emphasized enough. The former is implicated in the development of both stroke as well as coronary artery disease. Screening, ongoing surveillance, and patient compliance to treatment regimens varies widely. There has been enthusiasm for the development of a “poly pill” which combines several different drugs, including antiplatelet agents, to simultaneously treat hypertension and hyperlipidemia. These so-called “poly pills” may help substantially if they can be implemented economically.

Strategies to control tobacco use have been difficult to implement. Global use of at least one form of tobacco is extremely high. Even in developed countries and in low risk groups such as young women, its use has been associated with a substantial decrease in survival. This risk likely increases proportionately in lower and middle income countries. The use of individual counseling has not proved to be an effective strategy to reduce tobacco use.

What appears to be more effective is combining individual counseling with both the political commitment of local and national authorities and efficient governance mechanisms and investment strategies. This approach appears to offer the optimal chance of reducing the widespread after-effects of this self-inflicted illness.

GIVEN THAT CVD MAY OCCUR DURING SOME OF THE MOST PRODUCTIVE YEARS OF LIFE, THEY HAVE A SUBSTANTIAL IMPACT ON ECONOMICS. SOME ESTIMATES INDICATE THAT CVD AND DIABETES MAY REDUCE GDP

BY UP TO ALMOST 7 PERCENT IN SOME LOW AND MIDDLE INCOME COUNTRIES WHICH ARE DEVELOPING RAPIDLY.

Other risk factors for CVD include advanced age, inherited disposition, gender, psychological factors, poverty and low educational standing. Some of these are obviously not modifiable, but the latter three can be altered with the long term commitment of national authorities to employ efficient government programs.

The global economic effects of CVD are staggering.

They have been evaluated in a variety of ways. Medical professionals use the rubric of disability adjusted life years (DALYS) to indicate the number of healthy years lost to CVD. Given that CVD may occur during some of the most productive years of life, the disease can have a substantial impact on economics. In certain low and middle income countries which are developing rapidly, some estimates indicate that CVD and diabetes may reduce GDP by up to almost 7%. The global costs of these diseases has been 60

estimated to be approximately 860 billion U.S. dollars.

The American College of Cardiology, in collaboration with the American Heart Association, European Society of Cardiology, the European Heart Network and the World Heart Federation, has described their global goal to be to “save preventable death from cardiovascular disease (heart disease and stroke)”. This goal originated from a high level meeting at the United Nations on non-communicable diseases held in September 2011. They advocated a global target of reducing premature non-communicable disease mortality by 25% by the year 2025. At that time, the attenders identified four specific measures and timelines to address these issues. The concept of “best buys” received considerable attention, because all countries can implement low cost strategies, irrespective of socio-economic status.

Several of these strategies were the focus of substantial debate. The first four targets included 1. Physical activity with a proposed 10% relative reduction in insufficient physical activity; 2. A 25% relative reduction in raised blood pressure; 3. Relative reduction in the mean population intake of salt with an aim of achieving a recommended level of <5g/d (2,000 mg of sodium); 4. A 30% relative reduction in tobacco use. A number of other targets were also discussed, each of which has the potential to improve global health.

These included such items as saturated fat intake, obesity, excessive use of alcohol, hyperlipidemia, and drug therapy.

The latter might include a “poly pill” and basic technologies to treat major non-communicable diseases. The participants recommended the first four for all signatory United Nation member states.

Global CVD represents a major health hazard that impacts not only individuals and micro family units but also local and national societies and the world as a whole.

Much has been learned about approaches to address these hazards, but optimal strategies will depend on 1. Recognition of their importance, 2. Development of programs which can be implemented widely, 3. Formation of partnerships between health care systems and local and national governments, as well as industry, 4. Identification of specific strategies and metrics to monitor effectiveness and 5. Flexibility and creativity to continually reinvent these processes. Professional organizations such as the American College of Cardiology that work in concert with other organizations have the opportunity to raise awareness of the issues and help design policies aimed at reducing this major health hazard.

RESOURCES

1.

Smith SC, Collins A, Ferrari R et al: Our Time: A Call to Save Preventable Death from Cardiovascular Disease (Heart Disease and Stroke).

Circulation 126:2769-2775, 2012 2. Cardiovascular Diseases (CVDs). World Health Organization. www. who.int/mediacentre/factsheets/fs317/en/index.html 3. Zoghbi WA, Holmes DR: Improving Cardiovascular Health: A Balance Between Discovery and Delivery. JAMA 309:1117-8, 2013 4. Global Status Report on Noncommunicable Diseases 2010. Geneva, World Health Organization, 2011 5. Global Atlas on Cardiovascular Disease Prevention and Control. Eds S. Mendis, P. Puska and B. Norrving. Published by the World Health Organization in collaboration with the World Heart Federation and the World Stroke Organization, 2011

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MEDICAL MALPRACTICE COMPANY WITH HBI TIES SUCCEEDS

N

estled in a small office behind St. Joseph’s Women’s Hospital, Lancet Indemnity Risk Retention Group protects more than 3,500 healthcare providers across the country.

If you didn’t know where you were heading, you’d be lost among the many doctor offices and never know there is a bustling organization fighting to protect the rights of physicians. There isn’t a glamorous office or flashy sign, but quietly this company that started with just five policyholders in 2008 is now a $25,000,000 company operating across the country.

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The road to success hasn’t been easy, the journey started when five practicing Tampa Physicians (Benedict S. Maniscalco, M.D., F.A.C.C., Alan J. Iezzi, M.D., William L. Luria, M.D., Dennis S. Agliano, M.D. F.A.C.S. and Charles E. Cernuda, M.D., F.A.C.P., F.C.C. P.) joined together to form a risk retention group to insure themselves. The Chairman of the company, Dr. Benedict S. Maniscalco, quickly brought the idea to his brother, Anthony Maniscalco, who had 17 years previous experience working with Physicians at his medical billing and Collections Company. Anthony formed a team of professionals from around the area and the company wrote its first policy.

Like many companies in 2008 this group wasn’t immune to problems. Business relationships that seemed so promising quickly ended and the company that was barely a year old was reorganizing and changing its name. Anthony, the Chief Operating Officer hired an industry veteran with decades of experience in J. Dennis Watts to be the Director of Underwriting.

In the summer of 2008 the company previously known as Shoreline Physicians changed its name and Lancet Indemnity was born.

The company’s gross written premium has increased every year since 2008 and has become one of the largest Risk Retention Groups providing coverage in Florida. “In 2008, we wrote 10 policies, Lancet will issue more than 2,000 policies insuring more than 4,000 physicians by the end of 2013” said Anthony.

“We continue to employee and hire experienced professionals that allow our company to continue on the path we are on.”

In 2012, Lancet received its first Financial Stability Rating® of A, Exception, from Demotech, Inc. an organization that specializes in rating insurance carriers and Risk Retention Groups. This was the first such rating that the company had received and solidified that it is on the right path. It lead to more physicians joining the organization and more insurance professionals applying for appointments with the carrier.

The company’s policies are sold through a network of independent insurance brokers from across the country. Each broker specializes in Medical Malpractice which helps to make sure that each physician knows the coverage they’re purchasing. “It is important to acknowledge our brokers because they are the ones that have helped us to grow at such a rapid pace” said Maniscalco.

The main priority for Lancet is “protecting our doctor’s best interest” explained Maniscalco. “We recently took our first case to trial and were awarded a defense verdict, it was in Hernando County and we couldn’t be more proud. That is what our company was created for, protecting doctors and we will do that for every one of our policyholders.”

Lancet insures all medical specialties and groups of varying sizes. The company currently writes policies in 14 states but Florida is where more that 55% of the policies are written. Lancet insures many of Tampa www.heartbeatsaveslives.org

LOOKING TO THE NEXT FEW YEARS, MANISCALCO SAYS THE LANCET BOARD AIMS TO CONTINUE STEADY GROWTH OF BETWEEN 20 AND 25% A YEAR TO A LEVEL OF SOME $20 MILLION IN GROSS WRITTEN PREMIUMS. THE BOARD IS COMMITTED TO PLOWING PROFITS INTO SURPLUS TO STRENGTHEN THE CAPITAL BASE AS THE COMPANY GROWS.

Bay’s physicians and hopes to continue growing in the area. Looking to the next few years, Maniscalco says the Lancet Board aims to continue steady growth of between 20 and 25% a year to a level of some $20 million in gross written premiums. The Board is committed to plowing profits into surplus to strengthen the capital base as the company grows.

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VISION FUELED BY PERSISTENCE YIELDS DYNAMIC RESULTS

By Ivan Berkowitz

I

n 1978, a small group of friends recognized that Myles Robinson’s sudden, untimely death left not only a massive hole in his family but also in his business community where he had achieved incredible success despite virtual anonymity.

Led by the indefatigable Harold Buchwald, the group expanded to include Victor Krepart, the President of Myles’ Metropolitan Properties; John Rae, Met’s CFO; Jack Levit, President of Lakeview Properties (a partner in a number of Myles’ ventures); Al Fraser, President of Furnasman Heating (which Al was proud of having installed his products in all of the thousands of homes Myles’ companies had built); Bernie Wolfe (a friend and consultant to Myles, especially for Myles’ expansive projects in Transcona); and Ivan Berkowitz (a friend whose cousin Connie Heft, Myles’ wife, had died six years earlier, leaving Myles to care for their four young children).

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Myles Robinson

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The initial vision was to raise some funds, beginning with a community dinner at which many business leaders associated with Myles, as well as many small building tradesmen whom Al Fraser gathered, agreed to significant donations. Family and friends also contributed. Fueled by the 18-20% interest rates of the 1980’s, the MYLES ROBINSON MEMORIAL HEART FUND grew to over half a million dollars.

After many meetings, the seven founders became the directors of the Fund and visualized how best to create a program of which Myles would have been proud. An agreement was reached to pursue three visions: 1. to encourage the pursuit of knowledge, in order to improve heart health 2. to mentor the work of a young person (a lifelong dream of Myles) 3. to nurture a “scholar” to continue to work in Manitoba Accepting the suggestion of the Dean of Medicine, Dr. Arnold Naimark, the directors were enthused to select Dr. Luis Oppenheimer as the first MYLES ROBINSON MEMORIAL HEART SCHOLAR. Dr. Oppenheimer has often said that such support encouraged him to stay in Manitoba.

His research and growth as a leader in our medical community brought such great delight to the trustees that his appointment was extended for 12 years.

In 2001, Ivan Berkowitz introduced Dr. Naranjan Dhalla to the group, and they agreed to become a significant sponsor for Dhalla’s World Congress, an event which brought nearly 2,000 cardiologists, scientists and cardiac surgeons to Winnipeg from 72 countries. Two years later, when Dr. Dhalla was shattered by the death of his son Sam, the Fund made a donation in Sam’s name to the organization which Dr. Dhalla had founded. Additionally, they encouraged him to locate the global headquarters of the International Academy of Cardiovascular Sciences (IACS) to Winnipeg. Founding President Howard Morgan stated his vision: “The challenge for the Academy and its members is to adopt a mind-set, which continuously raises the question of how new and existing knowledge can be translated into prevention, improved diagnosis and therapy of cardiovascular disease.

This approach offers the hope of a continued reduction in morbidity and mortality due to cardiovascular diseases.”

Mr. Buchwald was especially enraptured by the initiative’s potential to transform Winnipeg into an important world centre for heart health. For this reason, he made numerous efforts to assist, including a proposal that the Fund support the work of Dr. Dhalla’s Institute of Cardiovascular Sciences at the St. Boniface Research Centre.

They funded Dr. Oppenheimer’s successors as the Robinson Scholars, first Dr. Anton Lucas and then Dr. Ian Dixon for six years. In 2006, Mr. Berkowitz organized the Global Conference on Heart Health & Disease in collaboration with Dr. Alan Menkis and the WRHA Cardiac Sciences Program.

In celebration of Dr. Dhalla’s 70th birthday the directors again recognized his contribution not only to science but also, as Mr. Buchwald was always cognizant, to the raised profile of Winnipeg as an important place to live and work.

In 2006, plans were being made for the IACS to honour www.heartbeatsaveslives.org

the 100th birthday of Houston physician Michael DeBakey, who has been recognized as the “founder of cardiac surgery.” In addition, discussions began between Dr. Dhalla and Mr. Buchwald to explore how the Fund and the Academy might work more closely to improve heart health right here in Manitoba. Sadly, “Bucky” died on April 17th and Dr. DeBakey’s death on July 11th meant that he missed his 100th birthday by two months.

Accepting the subsequent proposal by Dr. Dhalla, the Myles Robinson Memorial Heart Fund Directors agreed to support the work of the IACS initiatives to promote prevention and early detection of heart disease in Manitoba.

The directors made an effort to acknowledge this support in all of the IACS print and online materials. More importantly, to honour the vision and persistence of Harold Buchwald, the keynote address in the Symposium on the Future of Heart Health was changed to “Celebrate the Life of Dr. Michael DeBakey.” IACS also named it the Harold Buchwald Memorial Lecture. Most appropriately, the lecture

L - R Back – John Rae, Chuck LaFleche; Front – Jack Levit; Ivan Berkowitz; Luis Oppenheimer

was given by one of Canada’s leading cardiologists, Dr. Eldon Smith from Calgary. He delivered a progress report on his two years as chair of the committee responsible for creating Canadian Heart Health Strategy. While the strategy has not brought the Canada-wide results the committee envisioned, Manitoba Health has translated many of the recommendations into practice.

On September 25, 2009, the second Harold Buchwald Memorial Public Lecture on Heart Health was delivered at a luncheon by Dr. Jay Cohn from Minneapolis, one the world’s premier cardiologists. Since becoming head of the Rasmussen Centre at the University of Minnesota, Dr. Cohn’s work has shifted significantly to focus on prevention and early detection of cardiovascular disease. His dynamic talk was titled “A STRATEGY FOR EVERYONE TO LIVE PAST 100!” Utilizing new technology, the talk was recorded and available online, allowing over 2,500 listeners to benefit from Dr. Cohn’s expertise. Ivan Berkowitz was inspired by the outpouring of interest from Manitobans in the highlight of Dr. Cohn’s talk – his research at the Rasmussen Center ONE HEART MAGAZINE

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for Cardiovascular Disease Prevention. Mr. Berkowitz has conducted investigations in collaboration with Dr. Todd Duhamel, who holds a joint appointment with the Institute of Cardiovascular Sciences at the St. Boniface Hospital and the Faculty of Kinesiology and Recreation Management at the University of Manitoba. Funding for a plan for “Early Detection of Cardiovascular Diseases to Improve the Health of Manitobans” has been committed by the St. Boniface Hospital Research Foundation. Moreover, Dr. Cohn’s prevention initiative will shortly become a reality in Manitoba.

The third annual Harold Buchwald Memorial Public Lecture on Heart Health was delivered at a luncheon on Sept.

8, 2011 by Dr. Sharon Mulvagh, an exceptional cardiologist who directs the Women’s Heart Clinic at the Mayo Clinic in Rochester, MN. Her topic was “A STRATEGY TO AVOID HEART DISEASE”. At St. Boniface Hospital, her experience aroused interest and support to improve prevention and

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treatment of women’s heart diseases Over 300 Winnipeggers from all parts of the community attended the IACS luncheon on Sept. 20, 2012. The 4th speaker in tribute to Harold Buchwald was Dr. Piero Anversa, a physician from Harvard and the 2012 recipient of an IACS Medal of Merit for his outstanding achievements in cardiovascular education and research. He has been conducting ground-breaking research which promises to discover how an ill patient’s own stem cells can be used to prolong their lives.

Indeed, bringing such imaginative thinking to Manitoba represents the future vision of the Academy. Such events enable the medical community to become more informed about innovative developments around the world, to analyze possible applications locally, and how to work with the local medical community to lower the incidence of cardiovascular disease, reduce morbidity and allow Manitobans to live longer, healthier lives. The vision of Harold Buchwald and his

ONE HEART MAGAZINE www.heartbeatsaveslives.org

colleagues who created the MYLES ROBINSON MEMORIAL HEART FUND has facilitated the persistence on long term results that will be of immense benefit.

The number of directors are now reduced by the deaths of Al Fraser, Vic Krepart and Harold Buchwald and the retirement of Bernie Wolfe (now an advisor), leaving only Jack Levit, John Ray, and Ivan Berkowitz and Luis Oppenheimer. The remaining directors have considered options to assure that the goals of the Fund will continue to be realized. In collaboration with Charles LaFleche, President and CEO of St. Boniface Hospital & Research Foundation, Ivan Berkowitz followed the direction of the board and created a proposal which was unanimously accepted on December 20, 2012.

The Myles Robinson Fund has transferred $500,000 to the St. Boniface Hospital Foundation (STBHF). The agreement reads as follows: • The STBHF is committed to grow the Myles Robinson Memorial Heart Fund to $1 million by attracting $500,000 in matching funds. These funds will be raised in the context of a $25 million Research Capital Campaign STBHF is currently launching • The STBHF, in collaboration with directors of the Fund will create a committee that will meet at least once per year to determine the use of the interest revenue for the upcoming year. These committee members will include but are not limited to: o All current directors of the Myles Robinson Memorial Heart Fund o The President & CEO of the St-Boniface Hospital Foundation o A representative from the Manitoba cardiology community

• The aforementioned committee will: o maximize the effectiveness of the spending of the earnings and, possibly, the capital of the Fund. o respect the specific interests of the current directors, including but not limited to: • The International Academy of Cardiovascular Sciences • Dr. Todd Duhamel’s project based on IACS Fellow Dr. Jay Cohn’s Rasmussen Center for Cardiovascular Disease Prevention - “Early detection of cardiovascular disease and testing of a targeted healthy living intervention to restore cardiovascular health” • The Manitoba Heart Health Think Tank to which IACS appointed 18 professional and community leaders to an Advisory Board which met initially on Nov. 13, 2012. The mandate includes how IACS might encourage Manitobans to be more engaged in their own prevention, both primary and secondary, of cardiovascular diseases. The most significant contribution to heart health in Manitoba will be to improve communication between general practitioners, related health professionals, prevention programs and the general public.

The Think Tank should encourage employers to support their staff to investigate their heart health and develop programs to avoid the major corporate and community expense of heart diseases, morbidity and mortality.

On Oct. 3, 2013, the first project of the Think Tank, supported by the Myles Robinson Fund and the St. Boniface Hospital Foundation, will be the 5th Harold Buchwald Memorial Heart Health Lecture by Dr. Salim Yusuf, PresidentElect of the World Heart Federation and an IACS Fellow, who will speak on “MOST PREMATURE HEART DISEASE IS PREVENTABLE”. Tickets are available through the IACS website: www.heartacademy.org

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of, a physician (or properly licensed practitioner).

Indications for Use

Contraindications

ICDs: The Ilesto Family of Implantable Cardioverter Defibrillators (ICDs) is intended to provide ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.

Ilesto ICDs and CRT-Ds The Ilesto ICDs and CRT-Ds are contraindicated for use in patients with the following conditions:

The VR-T DX ICDs are part of a system that includes both a BIOTRONIK DX ICD lead and an Ilesto DX ICD device.

CRT-Ds: The Ilesto CRT-Ds are indicated for use in patients with all of the following conditions: • • • •

Indicated for ICD therapy Receiving optimized and stable Congestive Heart Failure (CHF) drug therapy Symptomatic CHF (NYHA Class III/IV and LVEF ≤ 35%) Intraventricular conduction delay (QRS duration ≥ 130 ms)

Linoxsmart S DX ICD Leads: The Linoxsmart S DX steroid-eluting, single-coil ICD lead system is intended for use in the right ventricle of patients for whom implantable cardioverter defibrillators are indicated. The Linoxsmart S DX ICD lead is indicated for use only as a system that includes both the Linoxsmart S DX ICD lead and a BIOTRONIK DX ICD.

© by BIOTRONIK SE & Co. KG All rights reserved.

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• Patients whose ventricular tachyarrhythmias may have transient or reversible causes such as: • Acute myocardial infarction • Digitalis intoxication • Drowning • Electrocution • Electrolyte imbalance • Hypoxia • Sepsis • Patients with incessant VF/VT • Patients whose only disorder is bradyarrhythmias or atrial arrhythmias Linoxsmart S DX ICD Leads: Do not use the Linoxsmart Lead System in patients with severe tricuspid valve disease or patients who have a mechanical tricuspid valve implanted.

The Linoxsmart steroid-eluting leads with active fixation are additionally contraindicated for patients who cannot tolerate a single systemic dose of up to 1.3 mg of dexamethasone acetate (DXA).

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin • Germany Tel (+49 30) 6 89 05 -600 Fax (+49 30) 6 85 28 04 www.biotronik.com

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego Oregon 97035-5369 • USA Tel (+1 5 03) 6 35 35 94 Fax (+1 5 03) 6 35 99 36

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Next Generation

BIOTRONIK DX System A New Paradigm in ICD Therapy

Dual-chamber diagnostics with a single lead Dual-chamber diagnostics

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