- Email: [email protected]
Pudendal artery stenting for complex erectile dysfunction in males
JICC-277; No. of Pages 6 journal of indian college of cardiology xxx (2015) xxx–xxx
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.elsevier.com/locate/jicc
Short Communication
Pudendal artery stenting for complex erectile dysfunction in males N.N. Khanna a,*, Suparna Rao b a
Sr. Consultant, Interventional Cardiology & Vascular Interventions, Advisor – Apollo Group of Hospitals, Coordinator – Vascular Services, Indraprastha Apollo Hospitals, New Delhi, India b Registrar, Cardiology, Indraprastha Apollo Hospitals, New Delhi, India
article info Article history: Received 2 September 2015 Accepted 3 October 2015 Available online xxx
1.
Introduction
Erectile dysfunction (ED) is defined as recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.1 More than 150 million men worldwide have ED and 52% men in United States between the age of 40–70 years report some degree of ED.2,3. It is something, the treatment of which has been shifting from psychologists to urologists and now, probably cardiologists, some of whom have transformed themselves into vascular interventionists. With the discontinuation of the ZEN trial, our centre is one of the very few centres in the world where pudendal artery stenting for male erectile dysfunction is regularly being practiced. We report our experience and the procedural details in treating patients of complex ED. 50% of the men have suboptimal response to PDE-5 inhibitor therapy and tend to subsequently go for more intrusive therapies (penile injection of vasodilators, vacuum pump or implants).4 ED and coronary artery disease (CAD) have common risk factors, such as diabetes, hypertension, dyslipidemia, use of
tobacco and insulin resistance.5–7 It is a known fact that ED predates manifest CAD by 5 years, and 50–70% of the patients of manifest CAD would have varying degrees of ED.8–11 Endothelial dysfunction, abnormal vasomotion, and atherosclerosis are the factors contributing to ED. Many patients of ED, especially complex ED, have atherosclerotic blockages in the inflow of penile arteries, i.e., anterior division of internal iliac or the internal pudendal artery (IPA). Middle age to elderly patients have atherosclerotic obstructive lesions in iliac, internal pudendal and cavernosal arteries. Restoring arterial inflow in patients with penile arterial insufficiency can improve erectile function. This has been known from surgical revascularisation, which has been used successfully in younger men with blunt perineal trauma or pelvic fractures.12
2.
Anatomy and physiology
The IPA is a branch of anterior division of internal iliac artery, and is the longest inflow segment. The distal IPA
* Corresponding author. Tel.: +91 9810494072. E-mail address: [email protected] (N.N. Khanna). http://dx.doi.org/10.1016/j.jicc.2015.10.007 1561-8811/# 2016 Published by Elsevier B.V. on behalf of Indian College of Cardiology.
Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
2
journal of indian college of cardiology xxx (2015) xxx–xxx
Fig. 1 – Anatomical consideration.
divides into dorsal penile artery, cavernosal and urethral arteries (Fig. 1). It is very important to know the exact anatomy of the IPA for interventional treatment, as it has many variations. The corpora cavernosa muscle of the penis are smooth musculature that encircle vascular sinusoids, which normally in a flaccid state are collapsed having very minimal blood needed for nutrition. The penile veins present at the outer aspect of tunica albuginea normally drain out this blood. During erection, endothelium of these sinuses releases nitric oxide (NO) into the smooth muscles of corpora cavernosa. This results in relaxation of the muscle leading to increase blood flow into the sinuses, which leads to cavernosal expansion against the tunica. The drainage veins are then constricted against high pressure from the wall of tunica, and this results in rapid and rigid erection (Fig. 2).
3.
Diagnosis
Diagnosis of a blockage in IPA is suspected clinically after excluding psychological, endocrinological and urological factors, and confirmed by properly done penile Doppler studies and selective pudendal artery angiographies.
3.1.
Penile Doppler study
Penile Doppler study is a safe technique, accurate and most cost effective technique for diagnosing erectile dysfunction. Some of the techniques used in the past were highly invasive and not suitable for routine clinical use. Penile Doppler is a pre-requisite before selecting patients for selective angiography. It is done after inducing erection by
Fig. 2 – Cavernosal changes during erection process. In flaccid state cavernosal sinusoids are collapsed while in arousal state these are filled with blood resulting in swollen cavernosa that blocks the draining veins and causes rigid hard erection. Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6 journal of indian college of cardiology xxx (2015) xxx–xxx
3
Fig. 3 – (a) Ultrasonic image of penis (transverse view) with probe placed ventrally; depicting two cavernosa with cavernosal arteries and deep dorsal arteries. Shadow of corpus spongiosum can be appreciated. (b) The pictorial diagram of ultrasonic image.
intracavernosal injection of papaverine at an insonation angle >608. Peak systolic velocity at the cavernosal arteries <25 cm/s is highly suggestive of IPA stenosis. The end diastolic velocity of >5 cm/s signifies venous leak and excludes patients for IPA stenting (Figs. 3 and 4).
3.2.
with venous leak in 95% of patients, and RImore than 0.9 is consistent with a normal response to the cavernosal stimulant in approximately 90% of patients.
4.
Angiography
Penile Doppler patterns (Table 1)
An end diastolic ante grade velocity (EDV) of less than 5 cm/s is considered normal, whereas a value of above 10 cm/s is considered abnormal; however, this is interpreted in conjunction with resistive index (RI). This index semi-quantifies the vascular resistance and is computed as: PSVEDV RI ¼ PSV The maximum value for RI is 1.0 and if this index is below 0.75, it implies failure of veno-occlusive mechanism. At 20 min post-pharmaco stimulation, RI less than 0.75 is associated
Angiography is done by selective cannulation of internal iliac artery and anteroposterior, oblique and caudal views are used to profile the IPA in its entire length (Fig. 5). A pharmacologically induced partial erection by intracavernosal injection of vasodilator is recommended.
4.1.
Pudendal artery stenting
Internal pudendal artery stenting (IPAS) works only in highly selected patients of complex ED. It is not recommended for routine treatment of erectile dysfunction. We have one of the largest experiences in the world of IPAS for treating complex ED. For a successful treatment of complex ED by IPAS, we have to be very selective in choosing the patients and have to be very methodical in terms of the technique, reporting of data, and follow-up of these patients.
4.2.
Our protocol
Patients were enrolled as referrals from urologists, endocrinologists, general physicians and self-referrals. The key inclusion criteria were:
Fig. 4 – Penile Doppler.
1. Men >20 years of age. 2. Suboptimal response to PDE-5 inhibitor therapy for more than 1 month. 3. No obvious psychological, urological or endocrinological problems. 4. Penile cavernosal arterial peak velocity <25 cm/s after intracavernosal injection of papaverine. 5. Cavernosal artery diameter at midshaft more than 0.3 mm. 6. Focal angiographic stenosis of one or both IPA.
Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
4
journal of indian college of cardiology xxx (2015) xxx–xxx
Table 1 – Penile Doppler patterns. Physiological stages Latent
Doppler pattern Rapid increase in systolic and diastolic velocities Slow or no increase in systolic velocity. Decrease in diastolic velocity End diastolic velocity is zero Decrease in systolic velocity with reversal of diastolic velocity Decreased systolic velocity with reappearance of diastolic velocities
Tumensence Full erection Rigid erection Detumensence
7. Angiographic IPA diameter of ≥2.25 mm, <4.0 mm and length ≤25 mm. Exclusion criteria: 1. Any non-vascular cause of ED, e.g., hypogonadism, diabetes mellitus, prostatectomy, pelvic radiation or trauma, Peyronie's disease and psychogenic factors. 2. Life expectancy <12 months. 3. Severe cardiovascular disease such as myocardial infarction, cerebrovascular accident and life-threatening ventricular arrhythmias. 4. Bleeding diathesis. 5. Renal failure. 6. Penile veno-occlusive disease (venous leak).
4.3.
Procedure
Selective angiography was done by femoral route to profile both pudendal arteries in its entire length. Unilateral stenosis
Fig. 5 – Angiogram showing IPA stenosis.
>70%, bilateral stenosis >50% or 100% stenosis of one IPA and >50% stenosis of the other IPA were used as criteria for treatment. Mother and child approach was used in all cases. 0.01400 guidewire was used to cross the lesion. Predilatation was usually avoided. Stenting was done with Zotarolimus DES – Cobalt chromium alloy platform coated with Biolinx biocompatible polymer coated with Zotarolimus at a concretion of 1.6 mg/mm3 (in our initial cases, DEB was used).
Fig. 6 – Angiograms showing (a) pudendal artery stenosis, (b) stenting and (c) final result. Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
5
journal of indian college of cardiology xxx (2015) xxx–xxx
Procedures were performed under DSA (Fig. 6). All patients were on dual antiplatelets for one year.
4.4.
Follow-up
Patients were followed up until one year. Following parameters were observed: Procedure-related safety endpoints – Death – perineal, scrotal, penile gangrene, improvement in IIEF-6 (International Index of Erectile Function-6) score by ≥4 points at 3 months, and penile velocities on penile Doppler at 3 months, 6 months and 12 months (Fig. 7).
5.
Personal experience N: 32 Mean age: 58.2 7.2 years CAD: 20/32
Improvement in >4 points in the IIEF-6 score 3 months: 22/32 (68%) 6 months: 24/32 (75%) 12 months: 25/32 (78%)
Death: 0 Perineal, penile gangrene: 0 Tech success: 32/32
Penile velocity Baseline: 16 cm/s 3 months: 44 cm/s 6 months: 50 cm/s 12 months: 58 cm/s
Results
We screened 138 patients and included 32 patients in our experience for revascularisation of IPA stenosis. We used Drug Eluting Balloon (DEB) in 11, and Drug Eluting Stents in 21 patients, and had a clinical success in 31/32 patients. Our personal experience is summarised in Table 2.
6.
Table 2 – Personal experience of 32 cases.
Discussion
In carefully selected patients of complex ED (with limited response to pharmacological therapy), IPA stenting is feasible and associated with subjective and objective improvement in erectile functions. There have been case reports in mid 80s about percutaneous transluminal angioplasty of erectile related arteries in young and middle aged men with ED.13–18 Recently, PANPI (Pelvic Angiography in Nonresponders to PDE-5 Inhibitors) study described angiographic characteristics of pelvic arteries in patients of complex ED, who underwent coronary angiography for suspected CAD.19
The ZEN trial was the first-in-man investigation to assess safety and feasibility of stenting atherosclerotic IPA lesions in highly selective subjects. It revealed safety and feasibility of IPA stenting in patients with penile arterial insufficiency but suggested that there was a significant learning curve for the procedure and it was difficult to identify responders to IPAS. Other observation in ZEN trial was that many patients were excluded because of diffuse or insufficient angiographic disease or venous leak. The data of the trial was not sufficient to warrant widespread adoption of this technique. There was 34% binary restenosis at 6 months as compared to 9.2% in coronary lesions in the Resolute US trial.20 Another important observation was that despite binary restenosis, there was persistent improvement in erectile functions after IPA stenting. This may reflect interim distal vascular remodelling during the period of increased penile flow (before restenosis). An interesting phenomenon observed during ZEN trial was that 5 out of 30 subjects had stents put in non-IPA vessels because of marked variation in anatomy of IPA.
Fig. 7 – Follow-up penile Doppler. Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
6
journal of indian college of cardiology xxx (2015) xxx–xxx
7.
Conclusion 8.
Angioplasty of focal stenosis of IPA by DEB or DES appears to be a very promising therapy for male erectile dysfunction. It is safe, feasible and leads to sustained improvement of male erectile dysfunction. Larger studies are required to be able to accept it as an acceptable therapy to treat male ED. Maybe in future, interventional cardiologists, or more precisely, vascular interventionists will be dealing with and treating patients of complex ED.
Conflicts of interest
9.
10.
11.
The authors have none to declare.
12.
references
13.
14. 1. NIH Consensus Conference. Impotence. JAMA. 1993;270: 83–90. 2. Willke RJ, Yen W, Parkerson GR, Linet OI, Erder MH, Glick HA. Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa. Int J Impot Res. 1998;10:239–246. 3. Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54–61. 4. Campbell HE. Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005;11:151–171. 5. El-Sakka AI, Morsy AM, Fagih BI, Nassar AH. Coronary artery risk factors in patients with erectile dysfunction. J Urol. 2004;172:251–254. 6. Gazzaruso C, Giordanetti S, De AE. Relationship between erectile dysfunction and silent myocardial ischemia in apparently uncomplicated type 2 diabetic patients. Circulation. 2004;110:22–26. 7. Rosen MP, Greenfield AJ, Walker TG. Cigarette smoking: an independent risk factor for atherosclerosis in the
15.
16.
17.
18.
19.
20.
hypogastric cavernous arterial bed of men with arteriogenic impotence. J Urol. 1991;145:759–763. Chiurlia E, D'Amico R, Ratti C, Granata AR, Romagnoli R, Modena MG. Subclinical coronary artery atherosclerosis in patients with erectile dysfunction. J Am Coll Cardiol. 2005;46:1503–1506. Dong JY, Zhang YH, Qin LQ. Erectile dysfunction and risk of cardiovascular disease: meta-analysis of prospective cohort studies. J Am Coll Cardiol. 2011;58:1378–1385. Montorsi F, Briganti A, Salonia A. Erectile dysfunction prevalence, time of onset and association with risk factors in 300 consecutive patients with acute chest pain and angiographically documented coronary artery disease. Eur Urol. 2003;44:360–364. Thompson IM, Tangen CM, Goodman PJ, Probstfield JL, Moinpour CM, Coltman CA. Erectile dysfunction and subsequent cardiovascular disease. JAMA. 2005;294:2996–3002. Hatzichristou D, Goldstein I. Penile microvascular arterial bypass: indications and surgical considerations. Surg Annu. 1993;25:207–229. Angelini P, Fighali S. Early experience with balloon angioplasty of internal iliac arteries for vasculogenic impotence. Cathet Cardiovasc Diagn. 1987;13:107–110. Becker GJ, Rowe DM, Holden RW, Dalsing MC, Bendick PJ. Percutaneous transluminal angioplasty for vasculogenic impotence. Indiana Med. 1986;79:256–262. Castaneda-Zuniga WR, Smith A, Kaye K. Transluminal angioplasty for treatment of vasculogenic impotence. AJR Am J Roentgenol. 1982;139:371–373. Goldwasser B, Carson CC, Braun SD, McCann RL. Impotence due to the pelvic steal syndrome: treatment by iliac transluminal angioplasty. J Urol. 1985;133:860–861. Valji K, Bookstein JJ. Transluminal angioplasty in the treatment of arteriogenic impotence. Cardiovasc Intervent Radiol. 1988;11:245–252. van Unnik JG, Marsman JW. Impotence due to the external iliac steal syndrome treated by percutaneous transluminal angioplasty. J Urol. 1984;131:544–545. Rogers JH, Karimi H, Kao J. Internal pudendal artery stenoses and erectile dysfunction: correlation with angiographic coronary artery disease. Catheter Cardiovasc Interv. 2010;76: 882–887. Yeung AC, Leon MB, Jain A. Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial. J Am Coll Cardiol. 2011;57:1778–1783.
Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.elsevier.com/locate/jicc
Short Communication
Pudendal artery stenting for complex erectile dysfunction in males N.N. Khanna a,*, Suparna Rao b a
Sr. Consultant, Interventional Cardiology & Vascular Interventions, Advisor – Apollo Group of Hospitals, Coordinator – Vascular Services, Indraprastha Apollo Hospitals, New Delhi, India b Registrar, Cardiology, Indraprastha Apollo Hospitals, New Delhi, India
article info Article history: Received 2 September 2015 Accepted 3 October 2015 Available online xxx
1.
Introduction
Erectile dysfunction (ED) is defined as recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.1 More than 150 million men worldwide have ED and 52% men in United States between the age of 40–70 years report some degree of ED.2,3. It is something, the treatment of which has been shifting from psychologists to urologists and now, probably cardiologists, some of whom have transformed themselves into vascular interventionists. With the discontinuation of the ZEN trial, our centre is one of the very few centres in the world where pudendal artery stenting for male erectile dysfunction is regularly being practiced. We report our experience and the procedural details in treating patients of complex ED. 50% of the men have suboptimal response to PDE-5 inhibitor therapy and tend to subsequently go for more intrusive therapies (penile injection of vasodilators, vacuum pump or implants).4 ED and coronary artery disease (CAD) have common risk factors, such as diabetes, hypertension, dyslipidemia, use of
tobacco and insulin resistance.5–7 It is a known fact that ED predates manifest CAD by 5 years, and 50–70% of the patients of manifest CAD would have varying degrees of ED.8–11 Endothelial dysfunction, abnormal vasomotion, and atherosclerosis are the factors contributing to ED. Many patients of ED, especially complex ED, have atherosclerotic blockages in the inflow of penile arteries, i.e., anterior division of internal iliac or the internal pudendal artery (IPA). Middle age to elderly patients have atherosclerotic obstructive lesions in iliac, internal pudendal and cavernosal arteries. Restoring arterial inflow in patients with penile arterial insufficiency can improve erectile function. This has been known from surgical revascularisation, which has been used successfully in younger men with blunt perineal trauma or pelvic fractures.12
2.
Anatomy and physiology
The IPA is a branch of anterior division of internal iliac artery, and is the longest inflow segment. The distal IPA
* Corresponding author. Tel.: +91 9810494072. E-mail address: [email protected] (N.N. Khanna). http://dx.doi.org/10.1016/j.jicc.2015.10.007 1561-8811/# 2016 Published by Elsevier B.V. on behalf of Indian College of Cardiology.
Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
2
journal of indian college of cardiology xxx (2015) xxx–xxx
Fig. 1 – Anatomical consideration.
divides into dorsal penile artery, cavernosal and urethral arteries (Fig. 1). It is very important to know the exact anatomy of the IPA for interventional treatment, as it has many variations. The corpora cavernosa muscle of the penis are smooth musculature that encircle vascular sinusoids, which normally in a flaccid state are collapsed having very minimal blood needed for nutrition. The penile veins present at the outer aspect of tunica albuginea normally drain out this blood. During erection, endothelium of these sinuses releases nitric oxide (NO) into the smooth muscles of corpora cavernosa. This results in relaxation of the muscle leading to increase blood flow into the sinuses, which leads to cavernosal expansion against the tunica. The drainage veins are then constricted against high pressure from the wall of tunica, and this results in rapid and rigid erection (Fig. 2).
3.
Diagnosis
Diagnosis of a blockage in IPA is suspected clinically after excluding psychological, endocrinological and urological factors, and confirmed by properly done penile Doppler studies and selective pudendal artery angiographies.
3.1.
Penile Doppler study
Penile Doppler study is a safe technique, accurate and most cost effective technique for diagnosing erectile dysfunction. Some of the techniques used in the past were highly invasive and not suitable for routine clinical use. Penile Doppler is a pre-requisite before selecting patients for selective angiography. It is done after inducing erection by
Fig. 2 – Cavernosal changes during erection process. In flaccid state cavernosal sinusoids are collapsed while in arousal state these are filled with blood resulting in swollen cavernosa that blocks the draining veins and causes rigid hard erection. Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6 journal of indian college of cardiology xxx (2015) xxx–xxx
3
Fig. 3 – (a) Ultrasonic image of penis (transverse view) with probe placed ventrally; depicting two cavernosa with cavernosal arteries and deep dorsal arteries. Shadow of corpus spongiosum can be appreciated. (b) The pictorial diagram of ultrasonic image.
intracavernosal injection of papaverine at an insonation angle >608. Peak systolic velocity at the cavernosal arteries <25 cm/s is highly suggestive of IPA stenosis. The end diastolic velocity of >5 cm/s signifies venous leak and excludes patients for IPA stenting (Figs. 3 and 4).
3.2.
with venous leak in 95% of patients, and RImore than 0.9 is consistent with a normal response to the cavernosal stimulant in approximately 90% of patients.
4.
Angiography
Penile Doppler patterns (Table 1)
An end diastolic ante grade velocity (EDV) of less than 5 cm/s is considered normal, whereas a value of above 10 cm/s is considered abnormal; however, this is interpreted in conjunction with resistive index (RI). This index semi-quantifies the vascular resistance and is computed as: PSVEDV RI ¼ PSV The maximum value for RI is 1.0 and if this index is below 0.75, it implies failure of veno-occlusive mechanism. At 20 min post-pharmaco stimulation, RI less than 0.75 is associated
Angiography is done by selective cannulation of internal iliac artery and anteroposterior, oblique and caudal views are used to profile the IPA in its entire length (Fig. 5). A pharmacologically induced partial erection by intracavernosal injection of vasodilator is recommended.
4.1.
Pudendal artery stenting
Internal pudendal artery stenting (IPAS) works only in highly selected patients of complex ED. It is not recommended for routine treatment of erectile dysfunction. We have one of the largest experiences in the world of IPAS for treating complex ED. For a successful treatment of complex ED by IPAS, we have to be very selective in choosing the patients and have to be very methodical in terms of the technique, reporting of data, and follow-up of these patients.
4.2.
Our protocol
Patients were enrolled as referrals from urologists, endocrinologists, general physicians and self-referrals. The key inclusion criteria were:
Fig. 4 – Penile Doppler.
1. Men >20 years of age. 2. Suboptimal response to PDE-5 inhibitor therapy for more than 1 month. 3. No obvious psychological, urological or endocrinological problems. 4. Penile cavernosal arterial peak velocity <25 cm/s after intracavernosal injection of papaverine. 5. Cavernosal artery diameter at midshaft more than 0.3 mm. 6. Focal angiographic stenosis of one or both IPA.
Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
4
journal of indian college of cardiology xxx (2015) xxx–xxx
Table 1 – Penile Doppler patterns. Physiological stages Latent
Doppler pattern Rapid increase in systolic and diastolic velocities Slow or no increase in systolic velocity. Decrease in diastolic velocity End diastolic velocity is zero Decrease in systolic velocity with reversal of diastolic velocity Decreased systolic velocity with reappearance of diastolic velocities
Tumensence Full erection Rigid erection Detumensence
7. Angiographic IPA diameter of ≥2.25 mm, <4.0 mm and length ≤25 mm. Exclusion criteria: 1. Any non-vascular cause of ED, e.g., hypogonadism, diabetes mellitus, prostatectomy, pelvic radiation or trauma, Peyronie's disease and psychogenic factors. 2. Life expectancy <12 months. 3. Severe cardiovascular disease such as myocardial infarction, cerebrovascular accident and life-threatening ventricular arrhythmias. 4. Bleeding diathesis. 5. Renal failure. 6. Penile veno-occlusive disease (venous leak).
4.3.
Procedure
Selective angiography was done by femoral route to profile both pudendal arteries in its entire length. Unilateral stenosis
Fig. 5 – Angiogram showing IPA stenosis.
>70%, bilateral stenosis >50% or 100% stenosis of one IPA and >50% stenosis of the other IPA were used as criteria for treatment. Mother and child approach was used in all cases. 0.01400 guidewire was used to cross the lesion. Predilatation was usually avoided. Stenting was done with Zotarolimus DES – Cobalt chromium alloy platform coated with Biolinx biocompatible polymer coated with Zotarolimus at a concretion of 1.6 mg/mm3 (in our initial cases, DEB was used).
Fig. 6 – Angiograms showing (a) pudendal artery stenosis, (b) stenting and (c) final result. Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
5
journal of indian college of cardiology xxx (2015) xxx–xxx
Procedures were performed under DSA (Fig. 6). All patients were on dual antiplatelets for one year.
4.4.
Follow-up
Patients were followed up until one year. Following parameters were observed: Procedure-related safety endpoints – Death – perineal, scrotal, penile gangrene, improvement in IIEF-6 (International Index of Erectile Function-6) score by ≥4 points at 3 months, and penile velocities on penile Doppler at 3 months, 6 months and 12 months (Fig. 7).
5.
Personal experience N: 32 Mean age: 58.2 7.2 years CAD: 20/32
Improvement in >4 points in the IIEF-6 score 3 months: 22/32 (68%) 6 months: 24/32 (75%) 12 months: 25/32 (78%)
Death: 0 Perineal, penile gangrene: 0 Tech success: 32/32
Penile velocity Baseline: 16 cm/s 3 months: 44 cm/s 6 months: 50 cm/s 12 months: 58 cm/s
Results
We screened 138 patients and included 32 patients in our experience for revascularisation of IPA stenosis. We used Drug Eluting Balloon (DEB) in 11, and Drug Eluting Stents in 21 patients, and had a clinical success in 31/32 patients. Our personal experience is summarised in Table 2.
6.
Table 2 – Personal experience of 32 cases.
Discussion
In carefully selected patients of complex ED (with limited response to pharmacological therapy), IPA stenting is feasible and associated with subjective and objective improvement in erectile functions. There have been case reports in mid 80s about percutaneous transluminal angioplasty of erectile related arteries in young and middle aged men with ED.13–18 Recently, PANPI (Pelvic Angiography in Nonresponders to PDE-5 Inhibitors) study described angiographic characteristics of pelvic arteries in patients of complex ED, who underwent coronary angiography for suspected CAD.19
The ZEN trial was the first-in-man investigation to assess safety and feasibility of stenting atherosclerotic IPA lesions in highly selective subjects. It revealed safety and feasibility of IPA stenting in patients with penile arterial insufficiency but suggested that there was a significant learning curve for the procedure and it was difficult to identify responders to IPAS. Other observation in ZEN trial was that many patients were excluded because of diffuse or insufficient angiographic disease or venous leak. The data of the trial was not sufficient to warrant widespread adoption of this technique. There was 34% binary restenosis at 6 months as compared to 9.2% in coronary lesions in the Resolute US trial.20 Another important observation was that despite binary restenosis, there was persistent improvement in erectile functions after IPA stenting. This may reflect interim distal vascular remodelling during the period of increased penile flow (before restenosis). An interesting phenomenon observed during ZEN trial was that 5 out of 30 subjects had stents put in non-IPA vessels because of marked variation in anatomy of IPA.
Fig. 7 – Follow-up penile Doppler. Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007
JICC-277; No. of Pages 6
6
journal of indian college of cardiology xxx (2015) xxx–xxx
7.
Conclusion 8.
Angioplasty of focal stenosis of IPA by DEB or DES appears to be a very promising therapy for male erectile dysfunction. It is safe, feasible and leads to sustained improvement of male erectile dysfunction. Larger studies are required to be able to accept it as an acceptable therapy to treat male ED. Maybe in future, interventional cardiologists, or more precisely, vascular interventionists will be dealing with and treating patients of complex ED.
Conflicts of interest
9.
10.
11.
The authors have none to declare.
12.
references
13.
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Please cite this article in press as: Khanna NN, Rao S. Pudendal artery stenting for Q1complex erectile dysfunction in males, J Indian Coll Cardiol. (2016), http://dx.doi.org/10.1016/j.jicc.2015.10.007