Vascular Hemodynamic Effects of Penille Revascularization Surgery and the Role of Resisti̇ve Index in Follow-up

doi:10.21203/rs.3.rs-4843046/v1

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Vascular Hemodynamic Effects of Penille Revascularization Surgery and the Role of Resisti̇ve Index in Follow-up

https://doi.org/10.21203/rs.3.rs-4843046/v1

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published 20 Dec, 2024

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Purpose

The aim of this study is to measure the effects of penile revascularization on penile vascular hemodynamics and to determine the importance of resistive index in postoperative patient follow-up.

Methods

In this study A total of 35 patients were opereted. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery separately. During this evaluation, peak systolic velocity, end diastolic velocity, and resistive index were measured. The International Index of Erectile Function questionnaire was applied in the preoperative period and at the 3rd postoperative month.

Results

The average preoperative resistive index values of the operated cases were determined as 0.74 ± 0.07/0.73 ± 0.09 cm/s for the right cavernosal artery and left cavernosal artery, respectively. The same values were found as 0.95 ± 0.09/0.96 ± 0.06 cm/s at the last postoperative control. The average International Index of Erectile Function − 5, 15 scores were determined as 8.52 ± 4.83, 19.4 ± 8.54, respectively, in the preoperative period, and 15.26 ± 4.50, and 35.76 ± 13.65, respectively, at the last postoperative follow-up.

Conclusion

This study showed that the resistive index can be used in the diagnosis of vascular originated erectile dysfunction and in the postoperative follow-up of the patients.

Trial registration number and date of registration:

NCT06350019 / 04/03/2024 (retrospectively registered)

Erectile dysfunction

Penile revascularization

Penile color doppler ultrasonography

Resistive index

Erectile dysfunction (ED) can be defined as the inability to achieve and/or maintain an erection for satisfactory sexual performance[1]. It has been reported that erectile dysfunction is of organic origin in more than 70% of cases without endocrine or neurological disorders and is caused by hemodynamic factors, arterial or venous insufficiency[2]. Penile color doppler ultrasonography (PCDU), used to evaluate penile vascular structures, is a widely used noninvasive radiological evaluation method. Peak systolic velocity (PSV), end diastolic velocity (EDV) and resistive index (RI) used in PCDU to evaluate erectile dysfunction are parameters with predictive value[3]. RI, which was developed to show the pattern change and measure the resistance to flow in PCDU, is a parameter that provides important information in revealing the resistance to vascular flow and evaluating organ perfusion and is used in the examination of small vessels. It is predicted that this parameter can be used together with the erection rigidity value to distinguish arterial and venous insufficiency in the first evaluation of erectile dysfunction patients[4]. In this study, PCDU was performed on patients who underwent penile revascularization, and PSV, EDV, and RI measurements were used together with the International Index of Erectile Function (IIEF) [5] inquiry questionnaire before and after surgery, and their importance in interpreting penile vascular hemodynamic changes was evaluated. Whether the anastomosis area was open or not was confirmed by computurized tomography angiography(CTA) with intravenous contrast in the 3rd postoperative month.

Local ethics committee approval was obtained for the planned study (Ankara Yildirim Beyazıt University Record Number and Date : 26379996/91 – 18.06.2014). All patients were informed about interventional and surgical procedures for diagnosis and treatment, and their informed consent was obtained. A total of 35 cases who underwent penile revascularization surgery with the diagnosis of vascular erectile dysfunction in our clinic were included in this study. Detailed anamnesis of the cases was taken, including age, duration of ED, comorbidities that may cause ED, previous trauma, medical or surgical history and lifestyle. After the physical examination, IIEF-5/15 questionnaires were filled out. In order to exclude hypogonadism, follicle stimulating hormone (FSH), luteinizing hormone (LH), total testosterone and prolactin levels were measured in the preoperative period. PCDU, corpus cavernosum electromyography (CC-EMG) and cavernosometry tests were applied to all patients in the preoperative period. Cases that did not benefit from phosphodiesterase 5 inhibitors (PDE-5I) and intracavernosal alprostadil injection used in the preoperative period were included in the study. Cases with a history of urogenital, rectal and similar operations that may affect erectile functions, cases with penile pathologies such as Peyronie's disease, and cases with ED of neurogenic and psychogenic origin were excluded from this study. After the 3rd postoperative month, patients were interviewed face to face. During these follow up, the patients were re-evaluated with the IIEF-5/15 questionnaires, and PCDU and CTA was performed.

PCDU technique: The PCDU was performed in a quiet and comfortable room for the patients' comfort. For the diagnosis of arterial insufficiency or veno-occlusive disease, PCDU(B-K Medical, Herlev, Denmark) was performed with the patient lying in the supine position. First, gray scale imaging of the flaccid penile shaft in transverse and sagittal planes was performed to exclude intracavernosal fibrosis and calcifications. Then, 60 mg papaverine hydrochloride(Papaverine HCl®, Galen Medical Industry, Turkey) was injected laterally into any of the corpus cavernosum with a 22 Gauge needle. 20 minutes after papaverine hydrochloride injection, PCDU was performed with an 8 MHz linear probe at an angle of approximately 45 degrees. PSV, EDV, RI values of both cavernosal arteries and anastomosis region were calculated. Measurements were repeated at 5-minute intervals and continued for 30 minutes. Cases with PSV<25 cm/s were interpreted as arterial insufficiency, and cases with PSV>25 cm/s, EDV >5 cm/s and RI<0.85 were interpreted as veno-occlusive disease. RI was calculated with the formula[RI=(PSV-EDV)/PSV] [6]. Patients were warned about the risk of priapism after papaverine hydrochloride injection and were asked to immediately consult the clinic if the erection persisted after four hours(Figure 1).

CC-EMG technique: Penile cavernous electrical activity (CEA) was recorded using a high-speed electromyography module equipped with a computer(Medical Measurement Systems, Enschede, the Netherlands). The sampling frequency was 200 Hz, and a band-pass ﬁlter with a cut-off frequency of 0.1–20 Hz was used. During the CC-EMG recordings, monopolar needle electrode was used to measure the cavernous electrical activity. A grounding electrode was placed to the patient's foot to avoid electrical activity simultaneously originating from non-penile areas. It appears as a single line in the EMG recording. CC-EMG recordings were started after the patients rested for 10 minutes in a quiet and dim room. CEA potentials were recorded for 10 minutes. Later the CEA potentials of the penile cavernous nerves was assessed by detecting the peak-to-peak amplitudes. Ten minutes later, papaverine hydrochloride(60 mg) was injected into a single cavernous body for avoiding the pattern of discoordination, which manifested by an increase or no difference in the CEA recording following the injection and suggested the neurogenic ED. Patients with a discoordination pattern were not included in the study. The relaxation degree(RD) was calculated using the formula: RD=Pre-injection CEA–Post-injection CEA/Preinjection CEA×100, as previously described[7]. Patients having less than 50% relaxation degrees were excluded from the study.

Cavernosometry technique: After CC-EMG recordings were made, cavernosometry was conducted with the same device. In the presence of the following criteria, a diagnosis of caverno-occlusive dysfunction was made.

1. Requires a maintenance flow rate greater than 5 ml/min after revealed an intracavernous pressure of 150 mmHg with the artificial erection test.

2. The intracavernous pressure decreased by a minimum of 45 mmHg within 30 s following the termination of infusion.

Surgical technique: The operations, were conducted using the Furlow-Fisher procedur, of the Virag–V technique [8]. Unlike the Furlow– Fisher procedure, the circumﬂex collaterals were preserved, and the deep dorsal venous valves were not disrupted by a stripper. After the inferior epigastric artery (IEA) was brought to the penile root through the subcutaneous tunnel, an end-to-side anastomosis was performed with the proximal part of the deep dorsal vein. 7-0 polypropylene suture were used according to a standard microsurgical procedure. After the anastomosis, the deep dorsal vein was ligated proximal to the arteriovenous anastomosis. The procedure was performed under optical magnification (x2.5) to prevent neurovascular bundle damage. In the postoperative period, intravenous heparin (5000 IU/day) was prescribed for 3 days, 75 mg/day dipyridamole and 300 mg/day acetylsalicylic acid daily for three months. He was warned not to have sexual intercourse for 2 months after the operation.

CTA technique: In the third postoperative month, patients underwent CTA. 60 mg papaverine HCl was administered to the subjects 10 minutes before the shooting. A 22-gauge branule was placed in the basilic or cephalic vein of the patient's forearm. Then, the patient was placed supine on the imaging stretcher and the area to be imaged was determined. Then, using an automatic injector pump, iodinated contrast material(Iopromide, Ultravist®, Schering, Germany) was given to the patient intravenously at a dose of 2 mg/kg and at a flow rate of 3 ml/s. Then, arterial phase pelvic CTA with 2 mm slice thickness was performed with a 64-detector, multi detector CT machine(Aquilion 64, Toshiba®, Tokyo, Japan). After CTA examination, sagittal and coronal reformatted images(slice thickness: 1 mm) were obtained. CT images were evaluated by an experienced radiologist.

Analysis of outcome and statistics

At least five points of increase in the IIEF-5 score during the latest patient visit in the postoperative period compared with the preoperative period was regarded as improvement(surgical success). Other results were regarded as failure. All the statistical analyses were performed using SPSS for Windows software (version 21.0, SPSS Inc, Chicago, Illonois, USA). Continuous data were expressed as mean ± standard deviation (SD). Student's t test was used to compare means, and the Chi-square Fischer test was used to compare categorical variations. Categorical data were expressed as value and percentage. P< 0.05 was considered statistically significant.

At the time of surgery, the mean age of the patients was 47,17 ± 13,26(23–69) years. The mean duration of erectile dysfunction was 32,08 ± 2,13(29–48) month. Of the remaining patients, 18(51.4%) were diagnosed with caverno-occlusive disease; 10(28.5%) with arteriogenic insufficiency and 7(20.0%) with both caverno-occlusive and arterial pathology. Diabetes mellitus was detected in 9 patients, smoking history in 16 patients, hyperlipidemia in 6 patients, and hypertension in 11 patients. Average BMI was determined as 26.60 ± 2.04(22–30). The mean (SD) total IIEF-15 score was 19,4 ± 8,54 before surgery(P < 0.001). In the postoperative third month, IIEF-15 score was found to be 35,76 ± 13,65. The mean IIEF-5 score was 8,52 ± 4,83 before surgery, and it was 15,26 ± 4,50 at the end of the follow-up(P < 0.001). The mean right cavernosal artery (RCA) RI was 0,74 ± 0,08 before surgery(P < 0.001). In the postoperative third month, RCA RI was found to be 0,93 ± 0,07(P < 0.001). The mean left cavernosal artery (LCA) RI was 0,77 ± 0,09 before surgery(P < 0.001). In the postoperative third month, LCA RI was found to be 0,94 ± 0,08(P < 0.001). Postoperative RI of the anastomosis area is 0.93 ± 0.09(Table 1). For the total IIEF-15, IIEF-5, RCA RI and LCA RI there were significant increases after surgery. A significant increase in cavernosal artery RI, correlated with IIEF, was detected in 71.4% of the operated cases.

Table 1

Changes in RI, IIEF-5 and IIEF-15 scores in the preoperative and postoperative periods.
	Preoperative	Postoperative 3rd month	P
Right cavernosal artery RI	0,74 ± 0,08	0,93 ± 0,07	< 0,001
Left cavernosal artery RI	0,77 ± 0,09	0,94 ± 0,08	< 0,001
Anastomosis region RI	-	0,93 ± 0,09	< 0,001
IIEF-5	8,52 ± 4,83	15,26 ± 4,50	< 0,001
IIEF-15	19,4 ± 8,54	35,76 ± 13,65	< 0,001

Erectile function is a complex neuropsychological and hormone-mediated vascular mechanism associated with central and peripheral sensory stimuli [9]. Organic erectile dysfunction, which includes non-psychogenic conditions, can result from vascular, neurogenic, endocrinological and pharmacological problems [10]. The cause of ED of vascular origin may be arterial insufficiency, venous insufficiency, or mixed insufficiency with both [11]. There are hemodynamic findings showing that erectile dysfunction is significantly linked to arterial and veno-occlusive vascular diseases [12, 13].

As recommended by the Process of Care Consensus Panel, penile vascular surgeries were considered as the third-line treatment after the failure of intracavernosal injections [14]. Surgical techniques for revascularization operations can be summarized as end-to-end anastomosis of the IEA to the dorsal artery in various modifications, anastomosis of the IEA to the deep dorsal vein at the base of the penis with a few modifications, direct anastomosis to cavernosal bodies or cavernosal artery and triple anastomoses between the dorsal penile vein and dorsal penile artery (side to side) with the IEA (end to side) [15].

PCDU is a non-invasive and dynamic method and is one of the leading tests to be performed in the evaluation of erectile dysfunction. PCDU reveals the penile corporal vascular anatomy in detail, providing ease of examination of the arterial and venous components simultaneously. Color imaging of blood flow enables perfect doppler angle adjustment and more accurate measurement of systolic and diastolic velocities [16]. In PCDU, arterial insufficiency and veno-occlusive dysfunction can be diagnosed. Although flow rate measurement can be performed in the first minutes following intracavernosal vasoactive drug injection, it can be waited up to 30 minutes to eliminate anxiety during measurement. Some indexes have been developed to show pattern change and measure flow resistance in PCDU [17, 18]. These indexes are based on PSV, EDV and the average velocity value obtained during a cycle. The advantage of these indexes is that they do not require angular correction and it is not necessary to know the vessel dimensions. This is very important in examining small or moving vessels. These indexes provide very important information in revealing the resistance to vascular flow and evaluating organ perfusion [19].

In PCDU, EDV and resistive index are used in the evaluation of venous compression. Quam et al stated that if the EDV is above 5 cm/s, venous leakage can be mentioned [20]. In general, PSV reflects penile cavernosal artery blood flow function and EDV reflects venous function [21]. RI reflects the vascular resistance of the vessels and the general condition of the corpus cavernosum, which depends on various factors including the peripheral pressure of the vessels, blood supply to the corpus cavernosum, blood backflow and blood circulation [22]. RI measurement is a sensitive method in distinguishing abnormal waveforms. Because the denominator is never zero. Xu-Jun Xuan and colleagues found a significant positive correlation between RI and penile rigidity in their study and reported that RI is the most valuable hemodynamic parameter to evaluate penile rigidity. It is emphasized that using RI to quantitatively diagnose ED may increase the consistency and accuracy of the ED grading diagnostic concept [23].

In PCDU studies, PSV values below 25 cm/s were defined as arterial insufficiency. Veno-occlusive dysfunction is defined as PSV being over 25 cm/s, EDV being over 5 cm/s, and RI being less than 0.85 [24, 25]. Despite reports that RI is a marker of VOD, Valji K and colleagues reported that RI may also be affected in case of arterial insufficiency [26]. Factors that constrict the penile arterial system due to organic or neuropsychogenic reasons will increase the resistance to blood flow. Therefore, it has been reported that when PSV is < 25 cm/s, the increase in RI may be caused by arterial insufficiency or VOD. In these cases, penile cavernometry is used as the gold standard in the diagnosis of VOD [27].

In order for the expected benefit from penile revascularization to occur in the postoperative period, the anastomosis must function properly. Obliteration or thrombotic occlusion of the anastomosis will reduce the effect of the surgery. In cases where anastomotic patency in PCDU cannot be evaluated, patency can be confirmed by performing a CTA. In our study, RI values in preoperative PCDU were found to be 0.74 ± 0.08/0.77 ± 0.09 (< 0.85) for the RCA and LCA, respectively. The same values were found to be 0.93 ± 0.07/0.94 ± 0.08 (RI > 0.85) in cases with an intact anastomosis in the postoperative period. This change in RI can provide information about both the increase in resistance to flow, that is, the prevention of venous leakage, and the increase in cavernous tissue perfusion. It is predicted that RI can be used together with the erection rigidity value in the first evaluation of patients with erectile dysfunction, in the distinction of arterial and venous insufficiency, and in the postoperative evaluation. As a result, PCDU may better reveal the structural and functional changes of the vascular tissue in the corpus cavernosum in patients with ED. The fact that RI increased in correlation with IIEF scores in patients with subjective clinical improvement has been shown that the resistive index is a costefective, noninvasive and objective method that can be used effectively in patient follow-up in the postoperative period. Administration of contrast material and radiation exposure during CTA imaging may be seen as a disadvantage. However, CTA can be performed in selected cases where the anastomosis cannot be evaluated with PCDU. We also believe that the use of RI will reduce the need for more invasive examinations such as cavernosometry.

Penile revascularization surgery may be recommended to patients with ED who cannot benefit from oral PDE-5I and intracavernous injections before more invasive procedures such as penile prosthesis implantation. Our study showed that penile revascularization positively affects penile hemodynamics in ED with vascular origin. RI measured in PCDU is an cost effective, fast, easily available and noninvasive parameter that can be used both in the diagnosis of ED and to measure the postoperative success and effectiveness of penile revascularization surgery. If anastomotic patency cannot be fully evaluated in postoperative PCDU, CTA can be performed. CTA applied to selected cases, together with the PCDU and IIEF questionnaire, makes significant contributions to the management of ED after penile revascularization.

Funding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Competing interests: The authors have no relevant financial or non-financial interests to disclose.

Author contributions: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by FA and ÖK. The first draft of the manuscript was written by FA and ÖK and all authors commented on previous versions of the manuscript. Critical revision of manuscript were performed by FA and ÖK. All authors read and approved the final manuscript.

Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Ankara Yıldırım Beyazıt University Faculty of Medicine.

Ankara Yildirim Beyazıt University Record Number and Date : 26379996/91 – 18.06.2014

ClinicalTrials.gov Identifier: NCT06350019

Consent to participate: Informed consent was obtained from all individual participants included in the study.

Consent to publish: The authors affirm that human research participants provided informed consent for publication of the images in Figures

Acknowledgements: None

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No competing interests reported.

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You are reading this latest preprint version

Vascular Hemodynamic Effects of Penille Revascularization Surgery and the Role of Resisti̇ve Index in Follow-up

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Abstract

Purpose

Methods

Results

Conclusion

Trial registration number and date of registration:

Figures

INTRODUCTION

MATERIAL AND METHODS

RESULTS

DISCUSSION

CONCLUSION

Declarations

References

Additional Declarations

Status:

Journal Publication

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