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MHIF Research Highlights: NOVEMBER 2018

presentations or posters featuring MHIF research

FEATURED MHIF STUDIES Open for Enrollment and Referrals!

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AHA Highlights

DISSEMINATING RESEARCHMHIF will be well-represented at AHA 2018

Shout out to Dr. Michael Miedema for his

commitment to publishing MHIF research with

7 presentations or posters at AHA!

272018 Heartbeat Gala, October 14AND THE AWARD GOES TO…• Dr. William Katsiyiannis for

receiving the Robert G. Hauser Leadership Award

• Dr. Jay Traverse for receiving the Ray Bentdahl Distinguished Service Award

39

MHIF CV Grand Rounds – Nov. 5, 2018

Statin Eligibility and Prevalence of Statin Prescriptions According to the 2013 ACC/AHA Guidelines In a Large Multi-Center Healthcare system

Joe Jensen MDMHI Grand Rounds5 November 2018


ASCVD

LDL >190

Diabetes

10 year risk >7.5%

Our Investigation

● Cross Sectional Analysis with EHR data from Allina

● Years 2013 and 2017

● All patients aged 40-79 with outpatient clinic visits


Prevalence of any statin prescription per eligibility category


Prevalence of high potency statin prescription per eligibility category


What does other data say?

Wait, but why?

RemindersEducational

Outreach VisitsAudit and

Feedback Provider Incentives


Wait, but why?

13 Models from:1. Medicine2. Rural Sociology3. Psychology4. Human Factors

and Systems Engineering

5. Organization Management

6. Marketing7. Health Education

Wait, but why?


It’s Complicated


Percutaneous Coronary Intervention for Chronic Total Occlusions:Insights from the PROGRESS CTO (PROspective Global REgiStry for

the Study of Chronic Total Occlusion Intervention) Multicenter International Registry.

Peter Tajti MD

Minneapolis Heart Institute, Abbott Northwestern Hospital, MN, USA

University of Szeged, Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, Hungary

AHA 2018

1. Application of the Hybrid Approach to Percutaneous Coronary Interventions for

Chronic Total Occlusions: Update from the PROGRESS CTO International

Registry

2. Contemporary Outcomes of the Retrograde Approach to Chronic Total Occlusion

Interventions: Insights from the PROGRESS CTO International Registry.


41 Sites – Study PI: E. S. Brilakis – National coordinator: B.V. Rangan – Database manager: P. Tajti/I. Xenogiannis

Funding: Abbott Northwestern Hospital Foundation

Appleton Cardiology, WIK. Alaswad

Mid America Heart Institute, MO J.A. Grantham

Dallas VAMC, TXS. Abdullah, H. Khalili

Minneapolis VAMC, MNS. Garcia

Providence Health Center, TXC. Shoultz

PeaceHealth St. Joseph Medical Center, WA W. Lombardi

Henry Ford, MI K. Alaswad

CAVHS, ARB. Uretsky

Medical Center of the Rockies, COA. Doing, P. Dattilo

Baylor Dallas, TXJ. Choi

Tulane, LAN. Abi-Rafeh, O. Mogabgab

Piedmont Heart Institute, GAD. Kandzari

UT Southwestern, TXS. Banerjee

Northwestern Cardiovascular Institute, ILM. Ricciardi

Minneapolis Heart Institute, MN N. Burke, E.S. Brilakis

Baylor Plano, TXE. HolperS. Potluri

Banner Samaritan Medical Center, AZ A. Pershad

Memorial Hospital, FLL. Van-Thomas Crisco

Tristar Centennial, TNB. Jefferson, T. Patel

Emory Hospital, GAW. Jaber, H. Samady

UPMC, PAC. Toma, A.J. Conrad Smith Trinity Medical, NY

H. Meltser

Carolina East HC, NC D. Jessup, M. Groove, Alex R. Kirby

Maimonides MC, NYB.A. Malik

CWRU, OHM. Costa, H. Bezerra, P. Poommipanit, F. Forouzandeh

Columbia University, NYD. Karmpaliotis, J. Moses, N. Lembo, A.J. Kirtane, R. Hatem, M. Parikh, Z. Ali

San Diego VAMC and UCSD, CAE. Mahmud, M. Patel

Torrance Medical Center, CAM.R. Wyman

Massachusetts General Hospital, MAF. Jaffer

Beth Israel Deaconess MC, MAR.W. Yeh

PROspective Global REgiStry for the Study of CTO interventionswww.progresscto.org

NCT02061436

International sites:

•Meshalkin Novosibirsk Research Institute, Russia, O. Krestyaninov, D. Khelimskii

•Korgialeneio-Benakeio Hellenic Red Cross Hospital, Greece,M. Koutouzis, Y. Tsiafoutis

•Henry Dunant Heart Hospital, Greece,V.Tzifos, A. Kolyviras, D. Damaskos

•St. Boniface General Hospital, CanadaB. Elbarouni, K. Atwal, M. Love, X. Patel

•St. George Hospital University Medical Center, LebanonA. Maalouf, F. A. Jaoudeh, G. Maalouf, K. Jbara, N. A. Rafeh

Cleveland Clinic, OH J. Khatri

WellStar Health System, GAA. Sheikh

The Christ Hospital, OH R. Riley, J. Kong, J. Reginelli

Kettering Health Network, OH N. Redd

Hybrid algorithm

Brilakis et al. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79.


Application of the Hybrid Approach for CTO PCI

1. Appleton Cardiology, WI

2. Baylor Heart and Vascular Hospital, TX

3. Beth Israel Deaconess Medical Center, MA

4. Columbia University, NY

5. Central Arkansas VAMC, AR

6. Dallas VAMC/UTSW, TX

7. Emory University, GA

8. Henry Ford Hospital, MI

9. Korgialeneio-Benakeio Hellenic Red Cross General Hospital of Athens, Athens, Greece

10. Massachusetts General Hospital, MA

11. Medical Center of the Rockies, CO

12. Minneapolis VAMC, MN

13. Minneapolis Heart Institute, MN

14. Meshalkin Novosibirsk Research Institute, Novosibirsk, Russia

15. PeaceHealth St. Joseph MC, WA

16. Piedmont Heart Institute, GA

17. San Diego VAMC and UCSD, CA

18. St Luke’s Mid America Heart Institute, MO

19. The Heart Hospital Baylor Plano, TX

20. Torrance Medical Center, CA

21. UPMC Medical Center, PA

5/2012 to 5/201821 centers, 3,571 lesions in 3503 patients

87%

13%

Technical success Technical failure

Baseline patient demographics

Clinical characteristics

Technical success (n=3043)

Technical failure (n=460)

p value

Age (years) * 64.3 ± 10.2 65.6 ± 9.6 0.012

Male gender 84.% 89% 0.022

Diabetes 43% 39% 0.179

Dyslipidemia 90% 91% 0.795

Hypertension 89% 93% 0.017

Family history of CAD 34% 33% 0.847

CCS Angina Classification 0.387

• Class ≤1 89% 91%

• Class 2≤ 11% 9%

* mean ± SD; † median (IQR)


Baseline patient demographics

Clinical characteristics



p value

Prior MI 46% 53% 0.009

Heart failure 30% 36% 0.012

Prior PCI 64% 69% 0.037

Prior CABG 31% 39% <0.001

Baseline creatinine (mg/dL) † 1.0 (0.9, 1.2) 1.1 (0.9, 1.3) 0.112

Prior CVD 11% 13% 0.388

Prior PAD 14% 17% 0.156

Left ventricular EF (%) † 55 (43, 60) 50 (40, 60) 0.064


Angiographic characteristics



p value

Target vessel

0.089

• RCA 55% 59%

• LAD 25% 19%

• LCX 19% 21%

• Other 1% 1%

CTO length (mm)* 32.5 ± 23.4 37.3 ± 23.8 <0.001

Proximal cap ambiguity 32% 55% <0.001

Blunt stump/no stump 49% 73% <0.001

Baseline angiographic characteristics






p value

Interventional collaterals 59% 47% <0.001

Moderate/severe calcification 51% 65% <0.001

Moderate/severe tortuosity 34% 44% <0.001

Previously failed CTO PCI 20% 26% 0.003

J-CTO score * 2.3 ± 1.3 3.1 ± 1.1 <0.001

PROGRESS-CTO score * 1.2 ± 1.0 1.7 ± 1.0 <0.001

PROGRESS-CTO complication score * 2.9 ± 1.9 3.4 ± 2.0 <0.001



Technical characteristics


Procedural outcomes Technical success Technical failure p value

Dual injection 69% 74% 0.081

Balloon uncrossable lesions 10% 28% <0.001

Balloon undilatable lesions 10% 18% 0.030

Procedure time (min) † 121 (80, 184) 140 (85, 224) <0.001

Contrast volume (mL) † 260 (200, 350) 300 (220, 400) <0.001

Fluoroscopy time (min) † 45.0 (27.3, 73.7) 66.0 (39.0, 93.6) <0.001

Patient AK dose (Gray) † 2.8 (1.6, 4.5) 3.9 (2.4, 6.0) <0.001

Baseline technical and procedural characteristics


Overall technical characteristics

ADR: antegrade dissection and re-entry; AWE: antegrade wire escalation.

89%

72%

51%

33%

18% 18%

5%

14%

20%

23%

21%17%

3%

9%

19%

30%

41%44%

0%

20%

40%

60%

80%

100%

J-CTOScore 0

J-CTOScore 1

J-CTOScore 2

J-CTOScore 3

J-CTOScore 4

J-CTOScore 5

59%

44% 42% 40%46%

16%

17% 18% 26%

25%

21%

27%24% 16% 5%

0%

20%

40%

60%

80%

100%

PROGRESSCTO Score 0

PROGRESSCTO Score 1

PROGRESSCTO Score 2

PROGRESSCTO Score 3

PROGRESSCTO Score 4


Overall procedural complications

ADR: antegrade dissection and re-entry; AWE: antegrade wire escalation;CABG, coronary artery bypass graft; MACE major adverse cardiac event; MI,myocardial infarction; PCI, percutaneous coronary intervention

In-hospital MACE Death Acute MI Stroke Re-PCI Re-CABG Pericardiocentesis Perforation

ADR 2.7% 0.8% 1.1% 0.3% 0.5% 0.0% 0.8% 5.2%AWE 0.9% 0.3% 0.0% 0.1% 0.1% 0.1% 0.4% 1.2%Retrograde 5.5% 1.5% 2.2% 0.6% 0.6% 0.1% 1.2% 7.5%

0.0%

2.0%

4.0%

6.0%

8.0%

p<0.001

p<0.001

p<0.001

p=0.006

p=0.111 p=0.105 p=0.681

p=0.052

Overall procedural complications

J-CTO Score 0 J-CTO Score 1 J-CTO Score 2 J-CTO Score 3 J-CTO Score 4 J-CTO Score 5Retrograde 0.0% 0.9% 1.1% 1.3% 3.6% 5.0%ADR 0.4% 0.2% 0.4% 1.0% 0.5% 0.8%AWE 0.8% 0.2% 0.8% 1.0% 0.5% 0.0%

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

AWE ADR Retrograde

ADR: antegrade dissection and re-entry; AWE: antegrade wire escalation;CABG, coronary artery bypass graft; MACE major adverse cardiac event; MI,myocardial infarction; PCI, percutaneous coronary intervention

p<0.001

p=0.032

p=0.075

p=0.072

p=0.230

p=0.040


The Retrograde Approach to Chronic Total Occlusion Interventions

5/2012 to 5/201821 centers, 1,350 lesions in 1,344 patients

38%

62%

Retrograde Antegrade only


Retrograde(n=1350)

Antegrade-only (n=2221)

p value

Target vessel

<0.001

• RCA 68% 48%

• LAD 16% 29%

• LCX 15% 22%

• Other 1% 1%

CTO length (mm)* 42.3 ± 27.2 28.0 ± 19.3 <0.001

Proximal cap ambiguity 54% 25% <0.001

Blunt stump/no stump 73% 42% <0.001





Retrograde(n=1350)


p value

Distal cap at bifurcation 47% 25% <0.001

Adequate distal landing zone 54% 76% <0.001

J-CTO score * 3.1 ± 1.1 2.0 ± 1.3 <0.001

PROGRESS-CTO score * 1.3 ± 1.0 1.3 ± 1.1 0.088

PROGRESS-CTO complication score * 4.0 ± 1.7 2.4 ± 1.8 <0.001




Retrograde(n=1350)


p value

Interventional collaterals 79% 45% <0.001

Collateral filling <0.001

• Contralateral 66% 41%

• Ipsilateral 12% 26%

• Contralateral & ipsilateral 21% 31%

• None 1% 3%

Werner collateral classification<0.001

• CC 0 11% 30%

• CC 1 60% 50%

• CC 2 29% 21%

Collateral assessment

Werner classification:CC0 – no continuous connectionCC1 – threadlike continuous connectionCC2 – side‐branch size continuous connection


Procedural outcomesRetrograde

(n=1350)Antegrade-only (n=2221) p value

Procedure time (min) † 189 (137, 244) 94 (62, 132) <0.001

Contrast volume (mL) † 300 (220, 400) 240 (180, 310) <0.001

Fluoroscopy time (min) † 78.7 (57.0, 103.0) 32.8 (21.0, 48.2) <0.001

Patient AK dose (Gray) † 3.7 (2.2, 5.5) 2.2 (1.2, 3.6) <0.001

Baseline technical and procedural characteristics


Application of the retrograde approach per J-CTO score

Antegrade-only: antegrade dissection and re-entry [ADR] & antegrade wire escalation [AWE]

96%86%

70%

51%

35%25%

4%14%

30%

49%

65%75%

0%

20%

40%

60%

80%

100%

J-CTO 0 J-CTO 1 J-CTO 2 J-CTO 3 J-CTO 4 J-CTO 5

Antegrade-only Retrgorade


Technical characteristics of the retrograde approach

64%

34%

14%

2%

0%

10%

20%

30%

40%

50%

60%

70%

Septal Epicardial SVG LIMA

Collateral channels used

32%

4%6% 6%

3%

58%

8%

0%

10%

20%

30%

40%

50%

60%

70%

True-to-truecrossing

Kissing wire Marker wire Knuckle wire CART rCART Guideextension

rCART

Crossing techniques used

CART, controlled antegrade and retrograde subintimal tracking and re-entry;LIMA, left internal mammary artery; rCART, reverse controlled antegrade andretrograde subintimal tracking and re-entry; SVG, saphenous vein graft

In-hospitalMACE

Vascular accesscomplication

Equipment lossDonor arterycomplication

BleedingAortocoronary

dissectionCIN

Retrograde 5.65% 2.01% 0.37% 1.79% 1.79% 0.15% 0.45%Antegrade-only 1.11% 1.02% 0.14% 0.60% 0.69% 0.09% 0.23%

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

Retrograde Antegrade-only

p<0.001

p<0.001p=0.003

p=0.632p=0.353p=0.273

p=0.015

Procedural complications for the retrograde approach

CIN, contrast induced nephropathy; MACE major adverse cardiac event.


Conclusions

1. Technical success can be achieved in almost 9 out of 10 patients undergoing

CTO PCI

2. Change in crossing strategy can facilitate successful CTO lesion crossing

3. Overall in-hospital complications occur in 3%; the retrograde approach is

associated with higher risk

Thank you for your attention!

Email: [email protected]

Phone: 612-295-5371


Impact of Concomitant Treatment of Non-Chronic Total

Occlusion Lesions at the Time of Chronic Total Occlusion

Intervention: Insights from the PROGRESS-CTO registry

Iosif Xenogiannis, MD

Minneapolis Heart Institute, Abbott Northwestern HospitalMinneapolis Heart Institute Foundation

I, Iosif Xenogiannis DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Disclosure Statement of Financial Interest


Simultaneous CTO and non-CTO PCI

• 13-52% of patients with CAD have at least one CTO.

• CTO PCI may require high radiation and contrast dose – whetherPCI of non-CTO lesions should be performed at the same timeremains controversial.

• Study question: Compare outcomes of simultaneous CTO andnon-CTO PCI vs CTO PCI only, in a large multicentercontemporary registry.

CTO PCI: success and complications

First Author Study Period

Centers Cases Techni-cal

Success

Proce-dural

Success

Overall MACE

Death Acute MI Stroke TVR Tampo-nade

Tajti 2012–2017

20 3,055 87% 85% 3.0% 0.3% 0.7% 0.1% 0.2% 0.5%

Habara 2012–2013

56 3,229 — 88% 0.5% 0.2% 0.1% 0.1% — 0.3%

Wilson 2012–2014

7 1,156 90% — 1.6% 0.0% 0.8% 0.4% 0.0% 0.7%

Maeremans 2014–2015

17 1,253 89% 86% 2.6% 0.2% 0.2% 2.2% 0.1% 1.3%

Sapontis 2013–2017

12 1,000 86% 85% 7.0% 0.9% 2.6% 0.0% 0.1% —∗


Definitions CTO: Coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow of at least 3

months duration.

Technical success: Achievement of <30% residual diameter stenosis within the treated segment and

restoration of TIMI grade 3 antegrade flow.

Procedural success: Achievement of technical success without any in-hospital major adverse cardiac

events (MACE).

In-hospital MACE: Death, myocardial infarction, recurrent symptoms requiring urgent repeat target

vessel revascularization with PCI or coronary artery bypass graft surgery (CABG), tamponade requiring

either pericardiocentesis or surgery, and stroke

Funding: Abbott Northwestern Hospital Foundation

Appleton Cardiology, WIK. Alaswad

Mid America Heart Institute, MO J.A. Grantham

Dallas VAMC, TXS. Abdullah, H. Khalili

Minneapolis VAMC, MNS. Garcia

Providence Health Center, TXC. Shoultz

PeaceHealth St. Joseph Medical Center, WA W. Lombardi

Henry Ford, MI K. Alaswad

CAVHS, ARB. Uretsky

Baylor Dallas, TXJ. Choi

Medical Center of the Rockies, COA. Doing, P. Dattilo

Tulane, LAN. Abi-Rafeh, O. Mogabgab

Piedmont Heart Institute, GAD. Kandzari

UT Southwestern, TXS. Banerjee

Northwestern Cardiovascular Institute, ILM. Ricciardi

Minneapolis Heart Institute, MN N. Burke, E.S. Brilakis

Baylor Plano, TXE. HolperS. Potluri

Banner Samaritan Medical Center, AZ A. Pershad

Memorial Hospital, FLL. Van-Thomas Crisco

Tristar Centennial, TNB. Jefferson, T. Patel

Emory Hospital, GAW. Jaber, H. Samady

UPMC, PAC. Toma, A.J. Conrad Smith

Trinity Medical, NYH. Meltser

Carolina East HC, NC D. Jessup, M. Groove, Alex R. Kirby

Maimonides MC, NYB.A. Malik

CWRU, OHM. Costa, H. Bezerra, P. Poommipanit, F. Forouzandeh

Columbia University, NYD. Karmpaliotis, J. Moses, N. Lembo, A.J. Kirtane, R. Hatem, M. Parikh, Z. Ali

San Diego VAMC and UCSD, CAE. Mahmud, M. Patel

Torrance Medical Center, CAM.R. Wyman

Massachusetts General Hospital, MAF. Jaffer

Beth Israel Deaconess MC, MAR.W. Yeh

Cleveland Clinic, OH J. Khatri

Houston Methodist, TXA. Shah, J. Parker

WellStar Health System, GAA. Sheikh

Oklahoma City VAMC, OKC. Adams, F. Latif

International sites:

Meshalkin Novosibirsk Research Institute, Russian FederationO. Krestyaninov, D. Khelimskii

Kogialeneio-Benakeio Hellenic Red Cross, GreeceM. Koutouzis, Y. Tsiafoutis

Henry Dunant Heart Hospital, GreeceV. Tzifos, A. Kolyviras, D. Damaskos

St. Boniface General Hospital, CanadaB. Elbarouni, K Atwal, M. Love, X. Patel

St. George Hospital University Medical Center, LebanonA. Maalouf, F. A., Jaoudeh, G. Maalouf, K. Jbara, N.A. Rafeh

The Christ Hospital, OH R. Riley, J. Kong, J. Reginelli

Kettering Health Network, OH N. Redd

NCT02061436

41 Sites – Study PI: E. S. Brilakis – National Coordinator: B.V. Rangan – Database Manager: P. Tajti, I. Xenogiannis


Study Population

Between January 2012 and April 2018, 3,598 CTO PCIs in 3,534 patients were performed at 21 centers.

CTO PCI CTO plus non‐CTO pci

2,784 (87.4%)

814 (22.6%)

Clinical CharacteristicsClinical characteristics Overall (n=3534) CTO + non-CTO PCI

(n=814)Only CTO PCI

(n=2720)p-value

Age (years) 64.50±10.14 65.22±10.17 64.27±10.12 0.0289

Male gender (%) 84.92 83.20 85.47 0.1331BMI (kg/m2) 30.70±6.22 30.41±6.19 30.80±6.22 0.1637

Smoking (current) (%) 26.79 23.08 27.97 0.0093Diabetes (%) 42.09 44.22 41.42 0.1810

Dyslipidemia (%) 90.23 91.97 89.67 0.0672Hypertension (%) 89.89 88.32 90.38 0.1049

Prior MI (%) 47.32 46.77 47.49 0.7356Heart failure (%) 30.83 33.10 30.11 0.1280

Left ventricular EF (%) 50.14±12.98 49.16±13.83 50.42±12.72 0.0453

CAD presentation <0.0001ACS 25.00 31.73 22.81Stable angina 64.67 58.77 66.59

No symptoms, no angina 7.57 7.31 7.65Symptoms unlikely to be ischemic 2.76 2.19 2.95

Ad hoc PCI 13.30 18.99 11.38 <0.0001


Angiographic Findings-Target Vessels

Angiographic Findings - Dedicated CTO Scores

Angiographic characteristics Overall (n=3598) CTO + non CTO (n=814) CTO (n=2784) p-value

CTO length (mm) 29 (15, 40) 25 (15, 40) 30 (17, 40) <0.0001

Vessel diameter (mm) 3 (2.5, 3 ) 2.8 (2.5, 3) 3 (2.5, 3) <0.0001

Proximal cap ambiguity (%) 35.17 34.61 35.35 0.7350

Moderate/severe calcification (%) 52.68 56.32 51.67 0.0279

Moderate/severe tortuosity (%) 34.99 36.86 34.47 0.2364

Interventional collaterals (%) 57.44 55.10 58.18 0.1801

J-CTO score 2.41±1.31 2.33±1.25 2.44±1.33 0.0469

PROGRESS-CTO score 1.44 ± 0.98 1.52±0.99 1.42±0.97 0.0276

PROGRESS-CTO complications score 2.38 ± 1.70 2.42 ± 1.70 2.36 ± 1.70 0.3856


Technical Characteristics

Final crossing strategy Overall (3598) (n=3598)

CTO + non-CTO(n=814)

CTO (n=2784)

P-value

= 0.048

AWE (%) 45.84 50.06 44.58

ADR (%) 17.81 17.06 18.03

Retrograde (%) 23.19 20.89 23.87

None (%) 13.17 11.99 13.51

Crossing strategies used Overall 3598(n=3598)

CTO + non-CTO(n=814)

CTO (n=2784)

P-value

AWE (%) 82.38 85.87 81.36 0.0029

ADR (%) 30.13 25.55 31.47 0.0012

Retrograde (%) 37.38 35.38 35.38 0.1798

Procedural Results

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Technical success Procedural success MACE

88% 86%

3.4%

87% 85%

2.7%

Technical and procedural success, MACE

non‐CTO + CTO PCI (n=814) exclusively CTO PCI (n=2720)


Procedural Results

0

50

100

150

200

250

300

350

Contrast Volume (ml)

non‐CTO + CTO Exclusively CTO

300 (220, 380)

0

1

2

3

4

Patient AK Dose (Gray)


250 (180, 350)

p<0.001

p<0.001

3.00 (1.91, 4,81)2.76 (1.50, 4.59)

0

20

40

60

80

100

120

140

160

Procedural time (minutes)


131 (88, 201)

117 (75, 179)

p<0.001

Limitations

Observational retrospective study with no long-term-follow up

No core lab analysis

Procedures were performed in dedicated, high volume CTO

centers by experienced operators, limiting the extrapolation to

less experienced operators and lower volume centers.


Conclusions

Non-CTO PCI in addition to CTO PCI and can be effectively and safely performed during the same procedure.

Procedure time, contrast volume and patient AK radiation dose are higher when

apart from a CTO PCI, a non-CTO is attempted.

Close monitoring of contrast volume and AK radiation dose particularly important

during CTO and non-CTO PCI.


CD34+ Cell Therapy Significantly Reduces Adverse Cardiac Events and Healthcare Expenditures in Patients with Refractory Angina

Grace L. Johnson BA1, Timothy D. Henry MD1,2, Thomas J. Povsic MD

PhD3, Doug W. Losordo MD4, Larissa I. Stanberry PhD1, Jay H.

Traverse MD1,5

1Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN; 2Cedars Sinai Medical Center, Los Angeles, CA; 3Duke University School of Medicine, Durham, NC; 4Caladrius Biosciences, Rye Brook, NY; 5University of Minnesota School of Medicine, Minneapolis, MN

Background

• Many patients with refractory angina have limited treatment options.

• CD34+ stem cell therapy may benefit these patients:• Improved exercise time

• Increased from 77 seconds at 3 months to 99 seconds at 12 months (vs. 31 seconds at 3 months to 50 seconds at 12 months for placebo, p<0.05)

• Decreased angina frequency• 10-20% reduction (p>0.05)

• Decreased mortality• 12.1% reduction (vs. 2.5% for placebo, p<0.05)


Auto-CD34+ cellsPlacebo


Research Questions

• Do subjects experience fewer cardiac events in the 12 months following CD34+ cell injection than in the 12 months prior to injection?

• Is CD34+ cell therapy associated with a cost savings in the first year after treatment?

Methods

• Retrospective chart review of 58 subjects at Abbott Northwestern Hospital enrolled in one of three CD34+ trials sponsored by Baxter Healthcare.

• Health expenditures were determined from average patient costs at Abbott Northwestern Hospital.


All Cardiac Events: Treatment (n=39)

Events 12 months pre‐injection Events 12 months post‐injection

ER – CP 7 4

Admit – CP 7 5

Angiogram 19 6

CP – PCI 15 4

NSTEMI – PCI 6 0

CABG 2 1

CVA/TIA 0 2

CHF 0 0

Other CV 2 2

Total 58 24

Average (p<0.0002) 1.49 0.62

All Cardiac Events: Placebo (n=19)

Events 12 months pre‐injection Events 12 months post‐injection

ER – CP 1 1

Admit – CP 4 5

Angiogram 10 0

CP – PCI 4 2

NSTEMI – PCI 0 0

CABG 0 0

CVA/TIA 1 1

CHF 2 0

Other CV 4 1

Total 26 10

Average (p=0.0018) 1.37 0.53


Major Cardiac Events

Treatment (n=39) Placebo (n=19)

Events 12 months pre‐injection

Events 12 months post‐injection

Events 12 months pre‐injection

Events 12 months post‐injection

CABG 2 1 0 0

CP – PCI 15 4 4 2

NSTEMI – PCI 6 0 0 0

Total 23 5 4 2

Average 0.59 0.13 0.21 0.11

p=0.0028 p>0.05

0

2

4

6

8

10

12

14

16

CABG CP - PCI NSTEMI - PCI

Num

ber

of E

vent

s

Major adverse cardiac events experienced 12 months pre- and post-injection of CD34+ stem cells.

Pre-injection Post-injection


Cost Savings

Treatment (n=39) Placebo (n=19)

Variable cost/stay

($)

Events 12 months before injection

Events 12 months after

injection

Cost before injection

($)

Cost after

injection ($)

Events 12 months before injection

Events 12 months after

injection

Cost before injection

($)

Costafter

injection ($)

CABG 37,229 2 1 74,458 37,229 0 0 0 0

CP – PCI 13,737 15 4 206,055 54,948 4 2 54,948 27,474

NSTEMI –PCI

13,737 6 0 82,422 0 0 0 0 0

Total 23 5 362,935 92,177 4 2 54,948 27,474

Average 0.59 0.13 9,306 2,363 0.21 0.11 2,892 1,446

Conclusions

• CD34+ stem cell therapy:• May result in fewer hospital admissions for cardiac events.• Is associated with significant savings in healthcare expenditures.

• Next steps:• Replication with larger data pool.• Analysis of cost savings for all cardiac events.• Application to other hospitals.


Timothy D Henry, Douglas W Losordo, Jay H Traverse, Richard A Schatz, E Marc Jolicoeur, Gary L Schaer, Robert Clare, Karen Chiswell, Christopher J White, F David Fortuin, Dean J Kereiakes, Andreas M Zeiher, Warren Sherman, Andrea S Hunt, Thomas J Povsic; Autologous CD34+ cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials, European Heart Journal, Volume 39, Issue 23, 14 June 2018, Pages 2208–2216, https://doi.org/10.1093/eurheartj/ehx764

Thank YouRoss GarberichTimothy Henry, MDMiranda KunzDoug Losordo, MDJolene MakoweskyBetsy NicholsThomas Povsic, MD, PhD

Larissa StanberryKatelyn StoreyJay Traverse, MD

And everyone else at MHIF for supporting our research.

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