LONG-TERM FOLLOWUP AND SELECTION CRITERIA FOR PENILE REVASCULARIZATION IN ERECTILE FAILURE

v01.160,1680-1684,November 1998

0022-5347/98/1605-1680$03.00/0 THE JOURNAL OF UROLQCY

Printed in U.S.A.

Copyright 0 1998 by AMERICAN UROLQCICAL ASSocUTlON, INC.

LONG-TERM FOLLOWI.JP AND SELECTION CRITERIA FOR PENILE REVASCULARIZATION IN ERECTILE FAILURE MARTINA MANNING, KLAUS-PETER m E M A ” , JEROEN R. SCHEEPE, PETER BRAUN, ANDREAS KRAUTSCHICK AND PETER ALKEN From the Department of Urology, Klinikum Mannheim of the University of Heidelberg, Mannheim, Germany

ABSTRACT

Purpose: We report the long-term results of penile revascularization surgery for erectile failure and suggest possible selection criteria for this controversial surgical procedure. Materials and Methods: In 7 years 62 impotent men who did not respond to pharmacotherapy underwent microsurgical penile revascularization and completed long-term followup evaluation in 41 months (range 18 to greater than 62) consisting of a detailed questionnaire, duplex sonography and optional pharmacotherapy or angiography. The Virag procedure was chosen for the first 7 patients, the original Hauri technique for the next 13 and the modified Mannheim triple anastomosis for 42. Results: Of all patients 34% achieved spontaneous and another 20%pharmacologicallyinduced erections. Success in diabetics and older patients was lower (43% for diabetics, 39% for those older than 50 years at surgery), while it was high in men with less than 2 risk factors (58%)as well as in younger patients (69% for those up to 50 years old). Shunt patency was 92%. Complications such as glans hyperemia developed in 13% of patients, shunt thrombosis in 8% and inguinal hernias in 6.5%. Conclusions: Patient selection is vital for the successful outcome of penile revascularization surgery. We adhere to strict selection criteria, such as patient age maximum of 50 years, less than 2 risk factors, no recent diabetes and termination of nicotine abuse. Penile revascularization surgery is highly indicated in this group of patients, especially since it is the only causal therapy for erectile failure. KEYWORDS:impotence; anastomosis, surgical; penile erection

The organic origin of erectile dysfunction is estimated at 50 to 80%. Therapeutic options are mainly intracavernous injections of vasoactive agents, for example prostaglandin E l , papaverine/phentolamine or triple drug, as well as intraurethral administration of prostaglandin E l . About 80% of the patients respond to intracavernous injection therapy but the dropout rate is high, ranging from 91 to 76%.2 A solution must be found for those remaining men who do not benefit from pharmacotherapy, particularly nonresponders to intracavernous injection. Venous ligation, penile revascularization and implantation of penile prosthesis are treatment options for such patients, although each has its disadvantages. Venous ligation has poor long-term results of only 25 to 40% after 2 years.3 Implantation of a penile prosthesis means destruction of the cavernous tissue. Goldstein et a1 reported survival rates of 85% after 36 months for the Mentor Alpha I* prosthesis.4 According to recent reports by Daitch et a1 long-term survival of the AMSt prosthesis is only 40% after 10 years.5 The only causal therapeutic option is penile revascularization. Various surgical techniques have been developed that can be divided into the 3 groups of venous arterialization,6.7 arteriovenous shuntin@ and arterioarterial shunting.9-12 The fact that the functional mechanisms of these penile revascularization techniques remain unknown is problematic. Moreover, the long-term outcome has not been as good as expected.

We determine the overall long-term success of penile revascularization. We also examine whether success is dependent on risk factors relating to erectile dysfunction (diabetes, general arteriosclerosis, coronary heart disease, hyperlipidemia, arterial hypertension), patient age at the time of surgery or the surgical technique (Virag procedure, Hauri original triple anastomosis, modified triple anastomosisl3). Finally, we attempted to define the selection criteria for revascularization surgery. MATERIAL AND METHODS

Between 1989 and 1996, 62 patients with a n average age 48 years (range 19 to 70) underwent penile revascularization surgery at our department. None of the patients responded to papaverindphentolamine or prostaglandin E l despite maximum dosages (4.5 mgJ1.5 mg. papaverine/phentolamine or 40 pg. prostaglandin El). Before surgery all 62 patients underwent a complete and extensive impotence evaluation on a n inpatient basis consisting of medical and sexual history by standardized questionnaire (all potential risk factors for erectile dysfunction were examined), blood analysis (hormones, including testosterone, prolactin, follicle-stimulating hormone, luteinizing hormone, thyroid hormones, blood lipids, blood glucose, normal blood count), psychiatric examination by a consultant psychiatrist, pharmacoduplex sonography of penile arteries, pharmacotherapy with up to 4.5 mg./ Accepted for publication May 15, 1998. 1.5 mg. papaverindphentolamine and up to 40 ~*g.prostaglandin Santa Barbara, California. E l , neurological examination (in select cases corpus caver*f American Mentor edical ‘ Systems, Inc., Minnetonka, Minnesota. Editor’s Note: This article is the third of 5 published in this nosum electromyography was performed), pharmacocavernissue for which category 1 CME credits can be earned. In- osography/pharmacocavernosometry and pharmacoarteriogstructions for obtaining credits are given with the questions raphy of the penis. on pages 1846 and 1847. Surgical procedures included the Virag technique in the 1680

LONG-TERM FOLLOWUP RESULTS OF PENILE REVASCULARIZATION

first 7 patients, the original Hauri procedure, consisting of a triple anastomosis between the dorsal penile vein and dorsal penile artery (side-to-side) with the inferior epigastric artery (end-to-side) in the next 13 (fig. 1) and the majority of patients (42) underwent a modified version of the original Hauri technique in which the dorsal penile artery is cut completely and 3 separate end-to-side anastomoses are constructed (fig. 2). Postoperative patient care included a strict anticoagulation strategy. For the first 24 hours after surgery 25,000 units heparin were administered intravenously beginning the last hour of surgery. Thereafter, 7,500 units heparin were administered subcutaneously 3 times a day for 7 days followed by cumarin for 6 months and 100 mg. acetylsalicylic acid daily for 1and a half years. Spontaneous erections were classified as complete success. Nonresponders to pharmacotherapy showing a response after surgery were classified as having a partial success. Followup was subdivided into phases 1 and 2. Phase 1 included mean followup of 29 months at which physical examination, duplex sonography, quality of life questionnaire and optional pharmacotherapy or angiography were done. At phase 2 patients answered a second questionnaire, neither physical examination nor duplex sonography was considered necessary, and followup averaged 41 months with a minimum of 18 months and a maximum of 6 years (table 1). RESULTS

Patient population and diagnostic evaluation. Mean patient age at surgery was 48 years (range 19 to 70) and 31 patients were 50 years old or younger, 26 between 51 and 60, and 5 older than 60. Diagnostic evaluation revealed that no patient responded to intracavernous injection of papaverinel phentolamine (maximum 4.5 mg./1.5 mg.) or prostaglandin E l (maximum 40 pg.). The majority of patients (84%) had combined arteriogenic and cavernovenuos pathology, while 21% had neurogenic and 13% psychogenic pathology (table 2). Table 3 and figure 3 show the distribution of the main risk factors, which were diabetes, nicotine abuse, alcoholism, obesity, hyperlipidemia, coronary heart disease and arterial hypertension. Of the patients 21% had no risk factor, 40% had 1,21% had 2, 15% had 3 and 3% had 4. Erectile dysfunction was a primary problem in 13% of the patients (8). Mean duration of impotence in the remaining 54 patients was 2.7 years. Of the men 29% had complete loss of erectile capability, 37% weak penile rigidity combined with premature detumescence, 21% premature detumescence only and 14% only weak rigidity. Surgical success. Spontaneous erections were classified as

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complete success, and former nonresponders to pharmacotherapy showing a response after surgery were classified as having partial success or failure if they were unable t o achieve spontaneous or pharmacotherapy induced erections during phase 2 followup. The overall success rate at last followup evaluation or questionnaire was 54%, with 34% of the patients experiencing spontaneous erections and 20% (former pharmacotherapy nonresponders) having pharmacologically induced erections. Long-term failure occurred in 46% of the men. With respect t o risk factors, overall success was lower (43%)in patients with diabetes (success in 6 of 14 diabetics). Male patients with 2 or more risk factors, including patient age older than 50 years at surgery (39%), had lower success rates (48%). In contrast, surgery was highly successful in patients with less than 2 risk factors (58%),including patient age to 50 years (68%)(fig. 4). A strong correlation between success and elapsed time from surgery was noted. Of the 62 patients 53 reported erections (51 spontaneous, 2 pharmacologically induced) during the first 6 months after surgery. However, this rate progressively declined with time until after more than 30 months 54% remained successful (34% spontaneous, 20% pharmacologically induced). One patient ceased followup between 18 and 24 months after surgery, 1 between 24 and 30 months and 1after 30 months. A progressive deterioration of success rates was not only found during elapsed time from surgery, but was also related t o increasing patient age (fig. 5). Comparison of successful surgical techniques demonstrated a clear advantage of the modified triple anastomosis (fig. 6). Shunt patency was verified by duplex sonography a t phase 1followup in 12 of 62 patients (19%) 6 t o 12 months after surgery, in 15 (24%) aRer 12 to 18 months, in 5 (8%) after 18 to 24 months, in 11(18%) after 24 to 30 months and in 19 (31%) after 30 months or later. The patency rate was 92% (57 of 62 patients). Complications. Complications included shunt thrombosis in 8%of the patients (5), inguinal hernia followed by surgical intervention in 6% (4) and glans hyperemia in 13% (8, table 4). Of the 8 patients with glans hypervascularization 4 requested surgical intervention. Distal venous ligation alone was successful in 2 patients but the epigastric penile shunt was ligated in the remaining 2. Extensive widening in the diameter of the epigastric artery was the cause of glans hyperemia in 1 patient. Penile prosthesis implantation was performed in 7 of the 27 failures (26%). Evaluation of the modified triple anastomosis. After a learning curve with the Virag and Hauri methods, the mod-

dorsal penile vein

dorsal penile artery inferior epigastric

FIG. 1. Original Hauri procedure

LONG-TERM FOLLOWUP RESULTS OF PENILE REVASCULARIZATION

1682

dorsal penile vein

/

dorsal penile artery (proximal part)

inferior epigastric dorsal penile artery (distal part)

FIG.2. Modified triple anastomosis according to Lobelenz et all3

TABLE1. Patient distribution in phases 1 and 2 of followup No. Pts.

Last Objective Postop. Evaluation (mos.)

(%)

Phase 1:: 6-12 12 (19) 12-18 15 (24) la24 (8) 5 2P30 11 (18) 30 or more 19 (31) Phase 2:t la24 1 1.6 2 3.2 24-30 30 or more 59 95.2 * Including duplex sonography and physical examination. t Questionnaire only.

FIG. 3. Risk factors in patient population

TABLE2. Origin of erectile dysfunction in accordance with the diaznostic evaluation of all 62 patients No. Pts. 56 57 13 8

Arteriogenic components Venogenic components Additional neurogenic components Additional psychogenic components

Risk Factor

(%)

(90) (92) (21) (13)

TABLE3. Risk factors No. Pts.

Diabetes Nicotine abuse Alcoholism Obesity Hyperlipidemia Coronary heart disease Arterial~hypertension Some patients had several risk factors.

14 32 8 8 15 2 7

ified triple anastomosis was finally chosen as the surgical technique. Therefore, an additional separate evaluation was performed in the 42 patients undergoing this procedure. The overall long-term success rate was 57%, whereas erection in the first 6 months after surgery was reported by 93% of the patients. At last followup only 31% still experienced spontaneous erections and 26% had pharmacologically induced erections (table 5). Of the 8 diabetics treated with the modified triple anastomosis 4 (50%)continued to have spontaneous erections at long-term followup. Success was higher in patients with less than 2 risk factors (15 of 25, 60%) compared to those with 2 or more risk factors (9 of 17, 53%). Better results were noted in patients younger than 50 years a t surgery (15 of 18,83%)than in older men (9 of 24. 37.5%).

Of 42 patients 2 had shunt thrombosis (5%),6 glans hypervascularization and 3 inguinal hernia. DISCUSSION

Of our patients undergoing penile revascularization surgery 54%had long-term benefit, with 34% achieving spontaneous erections more than 30 months after surgery and 20% had pharmacologically induced erections. Comparison of the diverging success rates reported in the literature for the various surgical revascularization procedures is difficult as standardized followup criteria are still lacking, and preoperative diagnosis and patient selection are inadequate. Sharaby et a1 recently reported on the Virag I procedure and anastomosis between inferior epigastric artery to dorsal artery and deep dorsal vein with complete success in 40% and improvement of erectile capability in 32% of the patients with a mean age of 46 years and a mean followup of 35 months.14 Their overall success rate of 72% is superior to our 54% rate. In 1994 Lizza and Zorgniotti published followup data of various revascularization techniques for 1 to 5 years after surgery.15 Success was 53% in year 1, 41% in year 2, 54% in year 3,56%in year 4 and 40% in year 5 compared to our 74%total success rate after year 1,61%after year 2 and 54% after more than 30 months. Our statistics demonstrate a continuous progressive decline in success (spontaneous and pharmacologically induced erections) during elapsed time from surgery. Table 6 gives a comparison between our success rate statistics and those reported in the literature for a specified followup.14-17 The first encouraging success rates of penile revascularization were 76.6%complete cure,lo 80%18 and even 89%.19 Later publications reporting results from diverging followup or patient population did not reflect this high success. The lack of standardization and definition for both methods makes precise comparison of the published statistics

1683

LONG-TERM FOLLOWUP RESULTS OF PENILE REVASCULARIZATION

FIG. 4. A, age dependent long-term success (complete and partial success), including phase 2 followup. B , success rates depending on risk factors, including phase 2 followup. TABLE4. Complications afier penile revascularization surgery No.Pts.

Ii-+x of patients

Shunt thrombosis Inguinal hernia (followed by surgery) Glans hyperemia requiring intervention Glans hyperemia not requiring intervention

TABLE5. Results

of

5 4 4 4

(C)

(8) (6.5) (6.5) (6.5)

modifid triple anastomosis only No. Pts~TotalNo.

I

I

Long-term success: Overall Diabetics Less than 2 risk fadors 2 or more risk factors 50 or less yrs. old More than 50 yrs. old Complications: Shunt thrombosis Glans hypervascularization Inguinal hernia

28/42 U8

15/25 9/17 15/18 9/24 2/42 6/42 3/42

FIG. 5. Differentiated long-term success rates of complete period, including phase 2 followup. TABLE6 . ComDarison of success rates No. Pts.lTotal No. (%)

FIG. 6. Success rates according to surgical technique

impossible. There is also still no clear definition of the SUCcessful outcome of revascularization surgery. Our patient population was divided into 3 groups. A clear distinction must be made between cure rate (defined as complete SUCcess), improvement of erection (partial success) and complete failure. A decline in success during the elapsed time from surgery has been demonstrated by different authors, which confirms that length of followup is one of the most important factors for correct determination of success. In accordance with our experience followup of at least 2 years is obligatory. Moreover, erectile capability can be subjectively and objectively assessed. Subjective success is often reported in questionnaires completed by the patient. The importance of this

Followup (mas.)

Present Series

Michal et Lizza and Lizza and Sharaby all6 Zorgni~tti'~ Zorgniotti" et all4

6 12 18 24 30 Greater Than 30

53/62(85) 10/18 (56) 46/62(74) 40162 (65) 37/61(61) 38/60 (54) 31/59(54) -

3/4(75)

-

-

-

19/36(53) No exact data 13/32(41) No exact data (40-56) (40-32)

self-assessment should not be underestimated as the patient must be personally satisfied with the outcome of penile revascularization surgery, which is subjectively difficult to assess. Assessing objective success is also not easy. Although duplex sonography documents shunt patency, this is not necessarily the same as successful erection. Our statistics reveal a shunt patency was confirmed in 57 of our 62 patients (92%) but only 54% reported successful erections, which indicates that at least 1 additional factor contributes to a successful outcome. Although the exact mechanism of the erectile effect of penile revascularization has not yet been demonstrated, improvement in intracavernous pressure seems to have a major role. Cavernous smooth muscle fibrosis might inhibit this specific mechanism and, therefore, surgical success. The onset of smooth muscle fibrosis is especially feared by patients with diabetes or severe and long-standing arteriosclerosis. This particular patient group demonstrated poor results in our study (43% overall success for diabetics). As a result of our findings it was possible to select suitable patients for positive prediction of penile revascularization.

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LONG-TERM FOLLOWUP RESULTS OF PENILE REVASCULARIZATION

Surgery i s highly indicated i n pharmacotherapy nonresponders younger t h a n 50 years at time of surgery with less t h a n 2 risk factors and no diabetes. No smoking is compulsory. Others have defined similar selection criteria. For example, Z u m K et a1 included pharmacotherapy nonresponders and patients younger than 55 years but excluded men with confirmed cavernous insufficiency or stenosis of the internal pudendal artery i n the first and second segments.*O The indication of pelvic trauma for penile revascularization is controversial. Several authors describe men with such a medical history as ideal candidates,** while others exclude these cases from surgery due t o t h e possible influence of severe neurogenic aspects on impotence.22 Therefore, no clear statement can be made in regard to this particular patient group. CONCLUSIONS

The overall success rate of penile revascularization was good at 54% (348 spontaneous erections, 20% pharmacologically induced erections). However, it was lower i n diabetics (43%) and older patients (42% older t h a n 50 years at surgery). In contrast, success was high in men with 2 or less risk factors and i n younger patients (54% overall success r a t e for patients with up to 2 risk factors, 65% for patients younger t h a n 50 years). Patient selection is vital for the successful outcome of penile revascularization surgery. We strictly adhere to selection criteria of age younger t h a n 50 years, a maximum of 2 risk factors, no recent diabetes and termination of nicotine abuse. Penile revascularization surgery i s highly indicated in this group of patients, particularly since i t is the only causal therapy for erectile failure. REFERENCES

1. Ulshofer, B., Kuhl, H., Rohrmoser, K. and Elsebach, K.: Phar-

makotherapie der Erektionsstorungen nach Operationen im kleinen Becken. Urol., suppl., 2 9 1990. 2. Irwin, M. B. and Kata. E. J.: High attrition rate with intracavernous injection of prostaglandin E l for impotency. Urology, 4 3 84, 1994. 3. Wespes, E., de Goes. P., Sattar, A. A. and Schulman, C.: Objective criteria in the long-term evaluation of penile venous surgery. J. Urol., 152: 888, 1994. 4. Goldstein. I., Newman, L., Baum, N., Brooks, M., Chaikin, L., Goldberg, K., McBride, A. and Krane, R.: Safety and efficacy outcome of Mentor Alpha 1 inflatable penile prosthesis implantation for impotence treatment. J. Urol., 157: 833, 1997. 5. Daitch, J. A., Angermeier, K. W., Lakin, M. M., Ingleright, B. J. and Montague, D. K.: Long-term mechanical reliability of A M S 700 series inflatable penile prosthesis: comparison of CWCXM and Ultrex cylinders. J . Urol., 158 1400, 1997.

H.and Legman, M.: Vasculo. genic impotence: a review of 92 cases with 54 surgical operations. Vasc. Surg., 15 9, 1981. 7. Virag, R.: Surgical treatment of impotence: indications and late results on 300 cases. Presented a t the Fifth Conference on Vasculogenic Impotence and Corpus Cavernosum Revascularization. Second World Meeting on Impotence. International Society for Impotence Research, Prague, 1986. 8. Hauri, D.: Therapiemoglichkeiten bei der vaskular bedingten erektilen Impotenz. Akt. Urol., 1 5 350, 1984. 9. Michal, V., Kramar, R., Pospichal, J. and Hejhal, L.: Arterial epigastricocavervenous anastomosis for the treatment of sexual impotence. World J. Surg., 1: 515, 1977. 10. Crespo, E. L., Bove, D. and Farrell, C.: Microvascular surgery technique and follow-up. Vasc. Surg., 21: 277, 1987. 11. Konnak, J. W. and Ohl, D. A.: Microsurgical penile revascularization using the central corporeal penile artery. J. Urol., 142: 305, 1989. 12. Austoni, E., Colombo, F. and Mantovani, F.: Arteriogenic impotence: long-term follow-up in 68 patients treated by end-to-end epigastro-dorsal ortho and antiflow double anastomosis. In: Urology. Edited by L. Giuliani and P. Puppo. Bologna, Italy: Monduzzi Editore, p. 805, 1992. 13. Ubelenz, M., Junemann, K. P., Kohrmann, K. U., Seeman, O., Rassweiler, J., Tschada, R. and Alken, P.: Revascularization in nonresponders to intracavernous injections using a modified microsurgical technique. Eur. Urol., 21: 120, 1992. 14. Sharaby, J. S., Benet, A. E. and Melman, A,: Revascularization: a 5-year followup study. J . Urol., part 2, 1 5 3 369A, abstract 562, 1995. 15. Lizza, E. F. and Zorgniotti, A. W.: Experience with the long-term effect of microsurgical penile revascularization. Int. J. Impotence Res., 6 145, 1994. 16. Michal, V., Kramar, R., Pospichal, J., Simana, J., Blazkova, J., Lachman, M. and Hejhal, L.: Vascular surgery in the treatment of impotence; its present possibilities and prospects. Czech. Med., 3: 213, 1980. 17. Lizza, E. and Zorgniotti, A,: Penile revascularization for impotence: comparison of the V5 and the Furlow operations. J . Urol., part 2, 139 298A, abstract 544, 1988. 18. Goldstein, I.: Arterial revascularization procedures. Sem. Urol., 4 252, 1986. 19. Hauri, D.: Diagnosis and treatment of arteriogenic impotence. Presented a t the 21st Congress of the International Society of Urology. International Society of Urology, Buenos Aires, 1988. 20. Zumbe, J., Grozinger, K. and von Pokrzywnitzki, W.: Selektionskriterien zur penilen Revaskularisation bei arteriell bedingter erektiler Dysfunktion. Akt. Urol., 2 6 114, 1995. 21. Sharaby, J . S., Benet, A. E. and Melman, A.: Penile revascularization. Urol. Clin. N. Amer., 22: 821, 1995. 22. Hatzichristou, D. and Goldstein, I.: Penile microvascular arterial bypass surgery: indications and surgical considerations. Surg. Ann., 25: 207, 1993. 6. Virag, R., Zwang, G., Dermange,