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©2012 MFMER | 3136985-1 Electronic Nicotine Delivery Systems (ENDS) Jon O. Ebbert, MD, FASAM Professor of Medicine Mayo Clinic Rochester, MN Email: [email protected]

Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

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Page 1: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-1

Electronic Nicotine Delivery Systems(ENDS)

Jon O. Ebbert, MD, FASAMProfessor of MedicineMayo ClinicRochester, MNEmail: [email protected]

Page 2: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-2

Goals & Objectives

• Understand the mechanics of ENDS

• Summarize the data regarding ENDS & nicotine delivery

• Define the known health risks of ENDS

• Know the rates of ENDS use of among adolescents

• Recall what summary reports expert recommendations exist on ENDS

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DisclosuresRelevant Financial Relationship(s)Name Nature of Relationship Company NameJon Ebbert, M.D. Consultant Nesmah

Stock Shareholder (self-managed) Al Kaif

Off Label/Investigational UsageNone

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©2012 MFMER | 3136985-4

“Vaping” - Technically Aerosolization

Page 5: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

NiCadNiMh

Li-polyLiMn

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©2012 MFMER | 3136985-6

ENDS Evolution

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©2012 MFMER | 3136985-7

Page 8: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-8

Vape Pens

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©2012 MFMER | 3136985-9

Mod Systems

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©2012 MFMER | 3136985-10

Pod Systems

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©2012 MFMER | 3136985-11

Pod Systems

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©2012 MFMER | 3136985-12

Pod System - Juul

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Vaping “Archetypes”

©2012 MFMER | 3136985-13

Sub-Ohm Vapingwith

Mod Systems

“Low-profile” Vapingwith

Pod Systems

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©2012 MFMER | 3136985-14

Aerosolization With Heat: “It’s All About The Coil”1. Kanthal (chromium-iron-

aluminum)2. Nichrome (nickel-chrome)3. Stainless steel4. Nickel5. Titanium

Pod Systems

ModSystems

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©2012 MFMER | 3136985-15

Mod SystemCoils

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©2012 MFMER | 3136985-16

Pod System Coil

Page 17: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Coil Mechanics Drive Aerosol Production

©2012 MFMER | 3136985-17

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©2012 MFMER | 3136985-18

E-Juice or E-Liquid (7,700

Flavors*)

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©2012 MFMER | 3136985-19

Page 20: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

E-liquid Flavorings

©2012 MFMER | 3136985-20

Stratton KR, Kwan LY, Eaton DL, National Academies of Sciences Engineering and Medicine (U.S.). Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018.

Page 21: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-21

Solvent Carrier: Vegetable Glycerin (“VG”)

• Glycerol from vegetables

• Sweetener - 60% as sweet as sucrose

• Food preservative

• Gel capsule component

• Personal care products to make them “smooth”

Page 22: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-22

Solvent Carrier: Propylene glycol (“PG”)

• Pharmaceutical solvent

• Food additive

• Additive in moisturizer, cosmetics toothpaste, hand sanitizer

• Non-toxic antifreeze (toxic = ethylene glycol)

• Asthma inhaler & nebulizer component

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©2012 MFMER | 3136985-23

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©2012 MFMER | 3136985-24

Fearon IM, et al. Regul Toxicol Pharmacol. 2018;100:25-34.

Nicotine Delivery By Device Type

Page 25: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

What is a “Nicotine Salt”?

©2012 MFMER | 3136985-25

Free Base:

• Harsher taste• Limits

concentration delivered

Salt:

• Smoother taste• Higher

concentration delivered

Add:Benzoic acidSalicylic acid

Malic acid

Make:Nicotine benzoateNicotine salicylate

Nicotine malate

Lower pH

Page 26: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Nicotine Salt Delivers More Nicotine

• Requires a higher temperature to properly vaporize (Pod system)

• Relative nicotine content• E-liquids (non salts)

• 0, 3, 6, 12, and 18 mg/mL• Juul

• 5% nicotine by weight (59 mg/mL)• 3% nicotine by weight (35 mg/mL)

©2012 MFMER | 3136985-26

Page 27: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-27

Page 28: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Mean blood serum nicotine levels for cigarette and ENDDs users

Yingst JM, Foulds J, Veldheer S, Hrabovsky S, Trushin N, et al. (2019) Nicotine absorption during electronic cigarette use among regular users. PLOS ONE 14(7): e0220300. https://doi.org/10.1371/journal.pone.0220300

Page 29: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Nicotine Salt Delivery in Pod Systems

©2012 MFMER | 3136985-29

Goniewicz ML, et al. Tob Control. 2018.

“Median urinary cotinine concentration measured in participants who used pods was 244.8 ng/mL (IQR 8.4–1255.8), higher than 155.2 ng/mL (IQR: 68.8–579.2) in 55 adolescents (ages 13–19 years) who regularly smoked conventional tobacco cigarettes.”

Page 30: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Health Effects of

ENDS

©2012 MFMER | 3136985-30

Page 31: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

TSNAs Levels in 105 ENDS Replacement Liquids

Kim , et al. Journal of Chromatography A Volume 1291 2013 48 – 55.

Page 32: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

ENDS Fluid & Cytotoxicity• Embryonic and adult cells & refill fluids

• Cytotoxicity varied among fluids and was correlated with the number and concentration of chemicals used to flavor fluids

• Cytotoxicity was not due to nicotine

©2012 MFMER | 3136985-32

Bahl V, et al. Reprod Toxicol. 2012 Dec;34(4):529-37.

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©2012 MFMER | 3136985-33

Carbonyl Compounds Created By Oxidation of E-Juice From Contact with the Heated Nichrome Wire (>350ºC)

Bekki K, et al. Int J Environ Res Public Health. 2014 Oct 28;11(11):11192-200.

**Aerosolization - Up to 18 additional compounds

Page 34: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Carbonyl Compounds in Ecig Vapor by Voltage & Heat

Kosmider L, et a. Nicotine Tob Res. 2014;16(10):1319-1326.

Flora JW, et al. J Chromatogr Sci. 2017;55(2):142-148.

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©2012 MFMER | 3136985-35

Williams M, Bozhilov KN, Talbot P. Analysis of the elements and metals in multiple generations of electronic cigarette atomizers. Environmental research. 2019;175:156-166.

Page 36: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Carbonyl Production Associated with Coil Metal & Coil Age

©2012 MFMER | 3136985-36

Saliba NA, etl al . J

Anal Appl Pyrolysis.

2018;134:520-525.

Formaldehyde (FA), acetaldehyde (AA), acetone (Acet), acrolein (Acr), propionaldehyde (PA), butyraldehyde (BA), glyoxal (GA), and methylglyoxal (MGA)

Page 37: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Heating & Reactive Oxidative Species

©2012 MFMER | 3136985-37

Son Y, Mishin V, Laskin JD, et al. Hydroxyl Radicals in E-cigarette Vapor and E-vapor Oxidative Potentials under Different Vaping Patterns. Chem Res Toxicol. 2019.

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©2012 MFMER | 3136985-38

ENDS: Health Effects• 30 healthy smokers (Athens, Greece)

• Minimum of 5 pack-years • Aged 19-56 years • 14 male

• Ecigarettes for 5 minutes• Ecigarettes associated with a significant

increase in airway resistance

Vardavas CI, et al. Chest. 2011 Dec 22. PubMed PMID: 22194587.

Page 39: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

ENDS & Lipoid Pneumonia• Ecigarettes x 7 months • SOB, fevers, cough• Chest CT showed opacities

consistent with lipoid pneumonia. • Macrophages in bronchoalveolar

lavage fluid were loaded with lipid. • Patient stopped Ecigarettes • Hypothesized condition may have

been caused by inhaling Ecigarette aerosol.

©2012 MFMER | 3136985-39McCauley L, et al. Chest. 2012 Apr;141(4):1110-3.

Page 40: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Lithium Battery Explosions “Thermal Runaway”

©2012 MFMER | 3136985-40

Shastry S, Langdorf MI. West J Emerg Med. 2016 Mar;17(2):177-80. PubMed PMID:

26973744.

Brownson EG, et al. . N Engl J Med. 2016 Oct 6;375(14):1400-1402. PubMed PMID: 27705271.

Injury types:• Flame• Chemical• Blast

Page 41: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

ENDS & Health RiskConclusion 7-2. There is substantial evidence that components of e-cigarette aerosols can promote formation of reactive oxygen species/oxidative stress. Although this supports the biological plausibility of tissue injury and disease from long-term exposure to e-cigarette aerosols, generation of reactive oxygen species and oxidative stress induction is generally lower from e-cigarettes than from combustible tobacco cigarette smoke.

Conclusion 10-4. There is substantial evidence that some chemicals present in e-cigarette aerosols (e.g., formaldehyde, acrolein) are capable of causing DNA damage and mutagenesis. This supports the biological plausibility that long-term exposure to e-cigarette aerosols could increase risk of cancer and adverse reproductive outcomes.

©2012 MFMER | 3136985-41

Page 42: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

ENDS Prevalence & Impact

©2012 MFMER | 3136985-42

Page 43: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Conceptual Framework for Transition from ENDS Use Initiation and Progression

©2012 MFMER | 3136985-43

National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press.

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©2012 MFMER | 3136985-44

Gentzke AS, Creamer M, Cullen KA, et al. Vital Signs: Tobacco Product Use Among Middle and High School Students — United States, 2011–2018. MMWR Morb Mortal Wkly Rep

2019;68:157–164.

Estimated percentage of high school students who currently use any tobacco product,* any combustible tobacco product,† ≥2 tobacco product types,§ and selected

tobacco products — National Youth Tobacco Survey, 2011–2018¶,**,††

**Juul released June, 2015

Page 45: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-45

Gentzke AS, Creamer M, Cullen KA, et al. Vital Signs: Tobacco Product Use Among Middle and High School Students — United States, 2011–2018. MMWR Morb Mortal Wkly Rep

2019;68:157–164.

Estimated percentage of middle school students who currently use any tobacco product,* any combustible tobacco product,† ≥2 tobacco product types,§ and selected

tobacco products — National Youth Tobacco Survey, 2011–2018¶,**,†

**Juul released June, 2015

Page 46: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-46

SOURCE: Tobacco Product Use Among Middle and High School Students — United States, 2011-2018. Morbidity and Mortality Weekly Report (MMWR), February 2019.

Tobacco product use among high school students—2018

Page 47: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Cigarette Smoking Initiation Among Adolescents & Young Adults

©2012 MFMER | 3136985-47

Soneji S, et al. JAMA Pediatr. 2017 Aug 1;171(8):788-797. PubMed PMID: 28654986.

Page 48: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

ENDS and Conventional Cigarette Use

Substantial evidence: good-quality observational studies or controlled trials with few or no credible opposing findings.

• Conclusion 16-1. There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.

©2012 MFMER | 3136985-48

Page 49: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Reasons for ENDS Use Among Adolescents: Characteristics of 12th Graders With a History of Vaping • Monitoring the Future (MTF)

study: annual cross-sectional surveys of nationally representative samples of 12th grade students in public and private schools across the contiguous United States

• Completed 2015 and 2016 surveys

©2012 MFMER | 3136985-49

Evans-Polce RJ, et al. J Adolesc Health. 2017 Dec 20. PubMed PMID: 29273302.

Page 50: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Summary Reports & Expert Recommendations

©2012 MFMER | 3136985-50

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©2012 MFMER | 3136985-51

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©2012 MFMER | 3136985-52

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©2012 MFMER | 3136985-53

Page 54: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

Expert Panel Conclusions & Recommendations

• American Cancer Society• “…switching to the exclusive use of e-cigarettes is preferable

to continuing to smoke combustible products.”• American Heart Association

• “If a patient has failed initial treatment, has been intolerant to or refuses to use conventional smoking cessation medication, and wishes to use e-cigarettes to aid quitting, it is reasonable to support the attempt.”

• American Lung Association• “If smokers are ready to quit smoking for good, they should call

1-800-QUITNOW or talk with their doctor about finding the best way to quit using proven methods and FDA-approved treatments and counseling.”

©2012 MFMER | 3136985-54

Page 55: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

“Smokers who have tried other methods of quitting without success could be encouraged to try e-cigarettes (EC) to stop smoking and stop smoking services should

support smokers using EC to quit by offering them behavioral support.” – Public Health England

©2012 MFMER | 3136985-55

Published August 2015

Page 56: Electronic Nicotine Delivery Systems (ENDS) · 2019-10-09 · Conceptual Framework for Transition from ENDS Use Initiation and Progression ©2012 MFMER | 3136985-43 National Academies

©2012 MFMER | 3136985-56

Goals & Objectives

• Understand the mechanics of ENDS

• Summarize the data regarding ENDS & nicotine delivery

• Define the known health risks of ENDS

• Know the rates of ENDS use of among adolescents

• Recall what summary reports expert recommendations exist on ENDS