- Email: [email protected]
Pudendal artery stenting for male erectile dysfunction
Accepted Manuscript Title: Pudendal Artery Stenting For Male Erectile Dysfunction Author: N.N. Khanna Suparna Rao PII: DOI: Reference:
S1561-8811(17)30110-4 http://dx.doi.org/doi:10.1016/j.jicc.2017.06.012 JICC 420
To appear in: Received date: Accepted date:
26-5-2017 10-6-2017
Please cite this article as: N.N. KhannaSuparna Rao Pudendal Artery Stenting For Male Erectile Dysfunction (2017), http://dx.doi.org/10.1016/j.jicc.2017.06.012 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
PUDENDAL ARTERY STENTING FOR MALE ERECTILE DYSFUNCTION Dr. (Prof.) N. N. Khanna MD, DM, FRCP (London), FRCP (Edin.), FRCP (Glasg.), FACC, FESC, FSCAI, FCCP, FAPSIC, FIMSA, FEISI, FICC, FIAMS, FCSI, FICP
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Chairman – National Interventional Council, CSI Chairman – Asia Pacific Vascular Society Sr. Consultant Interventional Cardiology Sr. Consultant Vascular Interventions Coordinator - Vascular Services Advisor - Apollo Group of Hospitals Indraprastha Apollo Hospitals New Delhi
Abstract:
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Address for Correspondence: L-117, Sarita Vihar, New Delhi Contact: 011-29871899, +91 9810494072 E-mail: [email protected]
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Dr Suparna Rao MBBS, MRCP (UK) Associate Consultant Indraprastha Apollo Hospitals, New Delhi
Ac ce p
Erectile Dysfunction (ED) is an important and growing health problem. Erectile Dysfunction (ED) is the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse and this is a very important and growing underreported health issue in India as well as abroad. It is estimated that more than 200 million men (between the age of 40 – 70 years) suffer from ED. Out of the many etiologies, 80% of cases are of vasculogenic origin. In patients who fail PDE–5 inhibitors therapy (Complex ED), vasculogenic causes should be strongly suspected. We present our series of 32 cases of complex ED who underwent pudendal artery stenting. Introduction:
Erectile Dysfunction (ED) is the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse and this is a very important and growing underreported health issue in India as well as abroad. It is estimated that after the age of 40 years, more than 50% of the men would have different degrees of erectile dysfunction. The etiology really is vasculogenic, but the most important etiology is venous leak and in 20% of the patients there is an arterial inflow problem, which can start right
Page 1 of 5
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from the aortic bifurcation to internal iliac artery or internal pudendal artery (IPA). Other causes could be trauma, post-surgical, chronic hormonal diseases, medication, and psychological1,2 (Fig. 1). These causes have to be excluded before we start suspecting inflow problem of pudendal artery circulation. The evolution has started from PDE-5 Inhibitor oral therapy which is useful in only about 50% of the patients. The patients who fail Viagra or PDE-5 inhibitors are known as patients of complex erectile dysfunction. Pudendal artery stenting is only indicated in the patients of Complex ED.
Fig. 1: Causes of Erectile Dysfunction
Method:
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One of the permanent solutions is to identify an inflow problem in the internal pudendal artery or in the internal iliac artery, and if it is there, to treat in on the table.
Ac ce p
The workup is done by excluding the endocrinal, urological and psychological causes and then subjecting these patients to a penile Doppler study. Before doing an angiogram or a duplex scan, full dilatation of this vessel needs to be achieved. This is done by intracavernosal injection of papaverine or some other vasodilating agents. If after intracavernosal injection of papaverine, the peak penile velocity does not increase beyond 25 cm/sec, an inflow problem in internal pudendal artery should be suspected, and these are the patients who undergo selective angiography. It is very important to know the path of the internal pudendal artery, which has a lot of anatomical variations. This is one of the longest arteries in the body and it is usually in a constricted state. This was our first patient, a 55 year old gentleman who actually had a complex ED also had coronary artery disease which usually co-exists in many of these patients3,4 (Fig. 2).
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Fig. 2: Pudendal Angiogram showing Pudendal A stenosis, stenting and final result.
Ac ce p
Results:
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The wire is negotiated across the lesion and this is done from a contralateral approach by the help of a mother and child technique. A Whisper wire is passed across the stenosis in the internal pudendal artery and after the balloon dilation, good result is achieved. If recoil is present, it is followed by another balloon or a stent. 32 consecutive worked up patients of complex ED with pudendal artery stenosis underwent pudendal artery angioplasty (with DEB or DES).
The procedure was successful in all patients. There were no death, perineal or penile gangrene. (Fig. 3) The mean penile velocity increased from base line of 16cm/sec to 44, 50, 58cm/sec at 3, 6, 12 months respectively. Improvement of > 4 points in International Index of Erectile Functions (IIEF -6) score at 3, 6 and 12 months were 68 %, 75 % and 78 % respectively. (Fig. 4)
Page 3 of 5
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Fig. 3: Personal Experience
Fig. 4: Follow up visits
Discussion: 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 IPA stenting.5
Page 4 of 5
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. Conclusion:
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Angioplasty of focal stenosis of internal pudendal artery by DEB or DES appears to be a very promising therapy for male erectile dysfunction.6,7 It is safe, feasible and leads to sustained improvement of male erectile dysfunction. However, still many cases are ineligible for pudendal artery stenting or have multifactorial etiologies for ED (non responders). Some of them have good post procedure erections but suffer from premature ejaculation. Larger studies are required to be able to accept it as an acceptable therapy to treat male ED.8
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Bibliography:
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1. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54-61. 2. Campbell HE; Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005;11:151-71. 3. El-Sakka AI, Morsy AM, Fagih BI, Nassar AH. Coronary artery risk factors in patients with erectile dysfunction. J Urol. 2004;172:251-4. 4. Rogers JH, Karimi H, Kao J. Internal pudendal artery stenoses and erectile dysfunction: correlation with angiographic coronary artery disease. Catheter Cardiovasc Interv. 2010;76:882-7. 5. Rogers JH, Goldstein I, Kandzari DE, Köhler TS, Stinis CT, et al. Zotarolimuseluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors. J Am Coll Cardiol. 2012;60:2618–27. 6. Valji K, Bookstein JJ. Transluminal angioplasty in the treatment of arteriogenic impotence. Cardiovasc Intervent Radiol. 1988;11:245-52. 7. van Unnik JG, Marsman JW. Impotence due to the external iliac steal syndrome treated by percutaneous transluminal angioplasty. J Urol. 1984;131:544-5. 8. Castaneda-Zuniga WR, Smith A, Kaye K, Transluminal angioplasty for treatment of vasculogenic impotence. AJR Am J Roentgenol. 1982;139:37173.
Page 5 of 5
S1561-8811(17)30110-4 http://dx.doi.org/doi:10.1016/j.jicc.2017.06.012 JICC 420
To appear in: Received date: Accepted date:
26-5-2017 10-6-2017
Please cite this article as: N.N. KhannaSuparna Rao Pudendal Artery Stenting For Male Erectile Dysfunction (2017), http://dx.doi.org/10.1016/j.jicc.2017.06.012 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
PUDENDAL ARTERY STENTING FOR MALE ERECTILE DYSFUNCTION Dr. (Prof.) N. N. Khanna MD, DM, FRCP (London), FRCP (Edin.), FRCP (Glasg.), FACC, FESC, FSCAI, FCCP, FAPSIC, FIMSA, FEISI, FICC, FIAMS, FCSI, FICP
cr
ip t
Chairman – National Interventional Council, CSI Chairman – Asia Pacific Vascular Society Sr. Consultant Interventional Cardiology Sr. Consultant Vascular Interventions Coordinator - Vascular Services Advisor - Apollo Group of Hospitals Indraprastha Apollo Hospitals New Delhi
Abstract:
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d
M
Address for Correspondence: L-117, Sarita Vihar, New Delhi Contact: 011-29871899, +91 9810494072 E-mail: [email protected]
an
us
Dr Suparna Rao MBBS, MRCP (UK) Associate Consultant Indraprastha Apollo Hospitals, New Delhi
Ac ce p
Erectile Dysfunction (ED) is an important and growing health problem. Erectile Dysfunction (ED) is the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse and this is a very important and growing underreported health issue in India as well as abroad. It is estimated that more than 200 million men (between the age of 40 – 70 years) suffer from ED. Out of the many etiologies, 80% of cases are of vasculogenic origin. In patients who fail PDE–5 inhibitors therapy (Complex ED), vasculogenic causes should be strongly suspected. We present our series of 32 cases of complex ED who underwent pudendal artery stenting. Introduction:
Erectile Dysfunction (ED) is the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse and this is a very important and growing underreported health issue in India as well as abroad. It is estimated that after the age of 40 years, more than 50% of the men would have different degrees of erectile dysfunction. The etiology really is vasculogenic, but the most important etiology is venous leak and in 20% of the patients there is an arterial inflow problem, which can start right
Page 1 of 5
M
an
us
cr
ip t
from the aortic bifurcation to internal iliac artery or internal pudendal artery (IPA). Other causes could be trauma, post-surgical, chronic hormonal diseases, medication, and psychological1,2 (Fig. 1). These causes have to be excluded before we start suspecting inflow problem of pudendal artery circulation. The evolution has started from PDE-5 Inhibitor oral therapy which is useful in only about 50% of the patients. The patients who fail Viagra or PDE-5 inhibitors are known as patients of complex erectile dysfunction. Pudendal artery stenting is only indicated in the patients of Complex ED.
Fig. 1: Causes of Erectile Dysfunction
Method:
te
d
One of the permanent solutions is to identify an inflow problem in the internal pudendal artery or in the internal iliac artery, and if it is there, to treat in on the table.
Ac ce p
The workup is done by excluding the endocrinal, urological and psychological causes and then subjecting these patients to a penile Doppler study. Before doing an angiogram or a duplex scan, full dilatation of this vessel needs to be achieved. This is done by intracavernosal injection of papaverine or some other vasodilating agents. If after intracavernosal injection of papaverine, the peak penile velocity does not increase beyond 25 cm/sec, an inflow problem in internal pudendal artery should be suspected, and these are the patients who undergo selective angiography. It is very important to know the path of the internal pudendal artery, which has a lot of anatomical variations. This is one of the longest arteries in the body and it is usually in a constricted state. This was our first patient, a 55 year old gentleman who actually had a complex ED also had coronary artery disease which usually co-exists in many of these patients3,4 (Fig. 2).
Page 2 of 5
ip t cr us
an
Fig. 2: Pudendal Angiogram showing Pudendal A stenosis, stenting and final result.
Ac ce p
Results:
te
d
M
The wire is negotiated across the lesion and this is done from a contralateral approach by the help of a mother and child technique. A Whisper wire is passed across the stenosis in the internal pudendal artery and after the balloon dilation, good result is achieved. If recoil is present, it is followed by another balloon or a stent. 32 consecutive worked up patients of complex ED with pudendal artery stenosis underwent pudendal artery angioplasty (with DEB or DES).
The procedure was successful in all patients. There were no death, perineal or penile gangrene. (Fig. 3) The mean penile velocity increased from base line of 16cm/sec to 44, 50, 58cm/sec at 3, 6, 12 months respectively. Improvement of > 4 points in International Index of Erectile Functions (IIEF -6) score at 3, 6 and 12 months were 68 %, 75 % and 78 % respectively. (Fig. 4)
Page 3 of 5
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Ac ce p
te
d
M
Fig. 3: Personal Experience
Fig. 4: Follow up visits
Discussion: 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 IPA stenting.5
Page 4 of 5
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. Conclusion:
us
cr
ip t
Angioplasty of focal stenosis of internal pudendal artery by DEB or DES appears to be a very promising therapy for male erectile dysfunction.6,7 It is safe, feasible and leads to sustained improvement of male erectile dysfunction. However, still many cases are ineligible for pudendal artery stenting or have multifactorial etiologies for ED (non responders). Some of them have good post procedure erections but suffer from premature ejaculation. Larger studies are required to be able to accept it as an acceptable therapy to treat male ED.8
an
Bibliography:
Ac ce p
te
d
M
1. Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54-61. 2. Campbell HE; Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005;11:151-71. 3. El-Sakka AI, Morsy AM, Fagih BI, Nassar AH. Coronary artery risk factors in patients with erectile dysfunction. J Urol. 2004;172:251-4. 4. Rogers JH, Karimi H, Kao J. Internal pudendal artery stenoses and erectile dysfunction: correlation with angiographic coronary artery disease. Catheter Cardiovasc Interv. 2010;76:882-7. 5. Rogers JH, Goldstein I, Kandzari DE, Köhler TS, Stinis CT, et al. Zotarolimuseluting peripheral stents for the treatment of erectile dysfunction in subjects with suboptimal response to phosphodiesterase-5 inhibitors. J Am Coll Cardiol. 2012;60:2618–27. 6. Valji K, Bookstein JJ. Transluminal angioplasty in the treatment of arteriogenic impotence. Cardiovasc Intervent Radiol. 1988;11:245-52. 7. van Unnik JG, Marsman JW. Impotence due to the external iliac steal syndrome treated by percutaneous transluminal angioplasty. J Urol. 1984;131:544-5. 8. Castaneda-Zuniga WR, Smith A, Kaye K, Transluminal angioplasty for treatment of vasculogenic impotence. AJR Am J Roentgenol. 1982;139:37173.
Page 5 of 5