1. Opportunities for Intervention
Emerging Indications for Endovascular Treatment:
Erectile Dysfunction
David E. Kandzari, MD, FACC, FSCAI
Director, Interventional Cardiology,
Piedmont Heart Institute
Chief Scientific Officer,
Piedmont Healthcare
Atlanta, Georgia

2. Disclosure
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below
Affiliation/Financial Relationship Company
Grant/Research Support Abbott Vascular, Cordis Corporation, Medtronic CardioVascular
Consulting Fees/Honoraria Abbott Vascular, Cordis Corporation, Medtronic CardioVascular, Micell Technologies, Terumo Medical
Major Stock Shareholder/Equity None
Royalty Income None
Ownership/Founder None
Intellectual Property Rights None
Other Financial Benefit None

3. Erectile Dysfunction and Vascular Risk Frequency and Implications
ED independently predicts cardiovascular disease1
~40% increased risk
Development of ED predates the onset of symptomatic cardiovascular atherosclerotic disease by 3-5 years2
ED predictive of
All cause mortality3
Cardiovascular death/MI/stroke/heart failure3
At least as predictive as smoking history or family history for premature CAD4
Up to 70% of men with CAD have ED5
Association with CAD6
More likely to be sexually inactive (31% vs 0)
Greater ED prevalence among sexually active (86% vs 73%)
1Araujo et al. JACC 2010; 2Thompson et al. JAMA 2005; 3Bohm et al. Circulation 2010; 4Chiurlia et al. JACC 2005; 5Rogers et al PANPI TCT2009; 6Justo et al. Int Impotence Res 2010 3

4. Erectile Dysfunction 80% of ED has a vasculogenic etiology1
ED is associated with substantially reduced quality of life for both the patient and partner2
Treatments directed toward underlying pathophysiology are limited, particularly for advanced disease
Treatment Severity
PDE 5i
Oral Therapy
IC Penile Injection
Intra-urethral Suppository
Vacuum Pump
Penile Prosthesis
Sildenafil (Viagra, Pfizer)
Vardenafil (Levitra, Bayer)
Tadalafil (Cialis, Lilly)
1Lue. NEJM 2000; Goldstein et al. 2J Sex Med 2005 4

5. Erectile Dysfunction and Vascular Risk Frequency and Implications
“Up to 2.5 million men in Western Europe are exposed to illicit sildenafil…”
“Among men with ED purchasing non-prescription ED drugs, 67% do so over the Internet and the proportion of these counterfeit drugs are estimated 44% to 90%.”
“Inconsistent doses of active pharmaceutical ingredient range from 0 to >200% of labelled dose, contaminants including talcum powder, commercial paint and printer ink...” 5

6. Erectile Dysfunction and Vascular Etiology Non-Invasive Assessment
Erectile Function Domain Scores
Sexual Encounter Profile (SEP)
International Index of Erectile Function (IIEF) 6

7. Erectile Dysfunction and Vascular Etiology Non-Invasive Assessment
Erectile Function Domain Scores
Sexual Encounter Profile (SEP)
International Index of Erectile Function (IIEF)
Intracavernosal Injection and Duplex Ultrasound
Gray scale studies assess:
Corporal Fibrosis
Grade 1-3
Caversnosal Atherosclerosis
Grade 1-3 7

8. Erectile Dysfunction and Vascular Etiology Non-Invasive Assessment
Erectile Function Domain Scores
Sexual Encounter Profile (SEP)
International Index of Erectile Function (IIEF)
Intracavernosal Injection and Duplex Ultrasound
Gray scale studies assess coporal fibrosis and cavernosal atherosclerosis
Peak systolic flow velocities to assess cavernosal artery insufficiency
End diastolic velocities to assess corporal veno-occlusive capacity 8

9. Erectile Dysfunction and Vascular Etiology Duplex Ultrasound
“Normal Inflow, No Leak”
“Abnormal Inflow, Leak”
Left Cavernosal PSV 31.9 cm/s EDV 0 cm/s
Right Cavernosal
PSV 15.9 cm/s EDV 7.5 cm/s 9

10. Feasibility of Percutaneous Revascularization with DES for Erectile Dysfunction
Cavernosal arteries fed by the internal pudendal artery (IPA)
IPA caliber mm
Non-tortuous, relatively easy access
ZEN: FIM trial for PDE-5 inhibitor resistant patients
Angiogram of IPA
Stenoses

11. Erectile Dysfunction and Vascular Etiology Angiography
38 RCTs
18,000 pts

12. Erectile Dysfunction and Vascular Etiology Angiography
38 RCTs
18,000 pts

13. Selective Left Internal Pudendal Angiography
38 RCTs
18,000 pts

14. Pudendal Angiography, IVUS and OCT Insights From Imaging
38 RCTs
18,000 pts

15. Pudendal Angiography, IVUS and OCT Insights From Imaging
38 RCTs
18,000 pts

16. Selective Right Internal Pudendal Angiography (Normal)
Case 1: 43yo with Cholesterol, Smoker, HTN, Family History for Early CAD
Selective Right Internal Pudendal Angiography (Normal)
38 RCTs
18,000 pts

17. Case 1
Left Internal Pudendal Artery Stenosis
38 RCTs
18,000 pts

18. Case 1 Pre-Dilation and Stent Deployment Stent Deployment
38 RCTs
18,000 pts
Stent Deployment
2.5X30 mm DES
Pre-Dilation

19. Case 1
Final Result
38 RCTs
18,000 pts

20. Case 1
Final Result: No Distortion with Hip Flexion
38 RCTs
18,000 pts

21. 65yo with HTN, Cholesterol
Selective Right IPA Angiogram
38 RCTs
18,000 pts

22. Case 2
Predilation and Stent Delivery
2.75X30 mm DES

23. Case 2
Left IPA Non-Selective Angiogram
38 RCTs
18,000 pts

24. Case 2
Left IPA: Final Result
38 RCTs
18,000 pts

25. Case 2 Objective Assessment: 30 Day Ultrasound Pre-procedure
Post-procedure
Left CA: PSV 10.4 cm/sec; EDV 3.0 cm/sec; RI 3.5
Left CA: PSV 31.9 cm/sec; EDV 0 cm/sec; RI 31.9

26. Lessons Learned in Early Experience with PPI
PercutaneousPudendal Intervention
38 RCTs
18,000 pts
PPI is feasible and may be achieved with existing catheter-based technologies and technique
Enrollment screening presents unique challenges and opportunities for patient and health care provider education
Despite rigorous run-in screening for apparently eligible patients, not all patients may be appropriate, highlighting opportunities for enhanced noninvasive assessment
Early experience with ZEN introduces potential to inform ED physiology, predictors of outcome and risk stratification
With appropriate patient selection, PPI is associated with promising early clinical success