Men with erectile dysfunction (ED) should be screened for cardiovascular risk factors - Cost-benefit considerations in Swiss men.

Background: Current evidence indicates that erectile dysfunction (ED) is an independent risk factor for future cardiovascular events. This study aimed to estimate the cost-effectiveness of screening and subsequent preventive treatment for cardiovascular risk factors among men newly diagnosed with ED from the Swiss healthcare system perspective. Methods: Based on known data on ED and cardiovascular disease (CVD) prevalence and incidence costs and effects of a screening intervention for cardiovascular risk including corresponding cardiovascular prevention in men with ED were calculated for the Swiss population over a period of 10 years. Results: Screening and cardiovascular prevention over a period of 10 years in Swiss men with ED of all seriousness degrees, moderate and severe ED only, or severe ED only can probably avoid 41,564, 35,627, or 21,206 acute CVD events, respectively. Number needed to screen (NNS) to prevent one acute CVD event is 30, 23, and 10, respectively. Costs for the screening intervention are expected to be covered at the seventh, the fifth, and the first year, respectively. Conclusion: Screening and intervention for cardiovascular risk factors in men suffering from ED is a cost-effective tool not only to strengthen prevention and early detection of cardiovascular diseases but also to avoid future cardiovascular events.

Endovenous Thermal Ablation for Treatment of Symptomatic Saphenous Veins-Does the Body Weight Matter?

OBJECTIVE: This study aimed to examine whether body weight may affect the effectiveness and safety of endovenous thermal ablation (ETA) for the treatment of symptomatic varicose veins. METHODS: This retrospective single-center cohort study analyzed the outcomes and patient demographic data with a focus on the body weight of all patients who had ETA of symptomatic varicose veins between September 2017 and October 2020. RESULTS: A total of 1178 treated truncal veins from 636 patients were analyzed. The mean ± standard deviation body mass index (BMI) was 25.5 ± 4.9. In 2.3% of cases, the patients were underweight (BMI < 18.5), 31.0% were overweight (BMI > 25), and 16.6% were obese (BMI > 30). Complete truncal occlusion was observed 1 year post intervention in 97.6-100% and patients were satisfied or very satisfied in 96.2-100% across BMI groups. Pain was low but significantly higher in the patients with obesity 6 weeks post intervention (visual analog scale 0.84 ± 1.49) and a higher infection rate was observed in the patients with obesity (n = 4/132; 3.0%). No significant association was observed between BMI and bleeding or thromboembolic events. CONCLUSIONS: Patients with obesity experienced prolonged pain and more infections after ETA, but ETA for varicose vein treatment remains effective and safe, independent of the patient's BMI.

Safety and efficacy of endovenous thermal ablation for treatment of symptomatic varicose veins during summertime.

Background: Traditionally, varicose vein treatment is predominately performed during the colder seasons. However, data whether higher outdoor temperatures affect the outcome and/or complication rate of endovenous thermal ablation (ETA) for treatment of symptomatic varicose veins are missing. Patients and methods: In this observational study, the medical records of all patients who had ETA of the great saphenous vein (GSV), accessory saphenous vein (ASV), or small saphenous vein (SSV) between September 2017 and October 2020 were reviewed. Results: In total 846 ETA interventions in 679 patients with 1239 treated truncal veins and an average length of 69 cm phlebectomy were included. The highest temperature recorded on and within the first 14 days after treatment was on average 19.0°C (SD±7.2°C) with a minimum and maximum of -1°C and 35.9°C. Interventions were categorized according to the recorded temperature (<25°C n=584; 25-29.9°C n=191; and ≥30°C n=71). The occlusion rates were excellent (99-100%) across groups. Despite a significantly higher proportion of patients with obesity, personal history of superficial vein thrombosis and length of phlebectomies in the high temperature groups, no significant difference regarding days of work loss, patients' satisfaction or complications including bleeding or thromboembolic events was observed. Infections were rare (0.8%), but more frequently observed in the 25-29.9°C group (2.6%; p=0.058). No infection was observed in the ≥30°C group and pain 6 weeks after the intervention was even lower (VAS 0.5±1.0 and 0.5±1.2 vs. 0.0±0.1, p=0.008). Conclusions: Given the minimal invasive nature of ETA, our results can reassure clinicians and patients that ETA varicose vein treatment is possible and safe throughout the year, even on hot summer days. A non-significant trend to more infections was observed but was not associated with other adverse outcomes such as prolonged analgetics intake or inability to work.

Long-Term Outcomes of Drug-Eluting Stent Implantation for Patients With Atherosclerotic Erectile Dysfunction not Responding to PDE-5-Inhibitors.

PURPOSE: Endovascular therapy of erection-related arteries was shown to be a promising treatment option for patients with severe erectile dysfunction. Purpose of this study was to assess the longer-term safety and clinical success rate of endovascular revascularization of erection-related arteries with the Angiolite BTK stent in patients with arteriogenic erectile dysfunction. MATERIALS AND METHODS: A total of 147 consecutive men (63.5±9.3 years) with erectile dysfunction due to 345 atherosclerotic lesions underwent endovascular revascularization. Patients received an International Index of Erectile Function (IIEF)-15 questionnaire at 30.3±7.2 months (follow-up [FU] period no less than 18 months) after stenting. An improvement by 4 points in the erectile function domain consisting of 6 questions (IIEF-6) was defined as minimal clinically important difference (MCID). RESULTS: Technical success was achieved in 99% of lesions. One major adverse event occurred after endovascular revascularization. Sixty-eight (46%) patients completed their latest FU at least 18 months following the last intervention. Minimal clinically important difference was achieved in 54% (37/68) of patients. CONCLUSIONS: In patients with arteriogenic erectile dysfunction not responding to phosphodiesterase-5-inhibitors (PDE-5-Is), endovascular therapy with a novel thin-strut sirolimus-eluting stent is a safe and effective treatment option during short- and longer-term FU. CLINICAL IMPACT: Patients with severe erectile dysfunction profit greatly from endovascular therapy of erection-related arteries. Stable clinical outcomes are seen beyond a 1-year timeframe. It is proven that, the drug-eluting stent therapy for atherosclerotic ED in patients who have not responded to PDE-5-I therapy is safe and effective during longer-term follow-up.

Role of Lp(a) in patients with erectile dysfunction undergoing angioplasty for symptomatic pelvic artery disease.

Background: Atherosclerotic disease of erection-related arteries is a major reason for erectile dysfunction (ED). Lp(a) has been implied in the pathophysiology of atherosclerosis in the coronary and lower limb arteries. Here, we investigated if Lp(a) plays a specific role in ED due with symptomatic pelvic artery atherosclerosis. Patients and methods: Out of 276 consecutive patients treated for ED with angioplasties on proximal (69%) and distal (31%, distal to Alcock channel) erection-related arteries, 236 patients (age: 62±10 years) of which Lp(a) values were available were retrospectively analyzed. Results: The baseline International Index of Erectile Function-15 (IIEF-15) score was 29±15 and significantly increased to 43±20 (increase: 14±21) after treatment at average follow up of 286±201 days. In 25%, Lp(a) values were elevated to more than 30 mg/dL. Hypercholesterolemia, coronary, lower extremity peripheral, and polyvascular disease were more common in patients with Lp(a) ≥60 mg/dl. Anatomic arterial lesion distribution (proximal/distal), improvement in IIEF-15 and clinically driven re-intervention rate (overall 7%) did not differ between patients with <30, 30-59, and ≥60 mg/dL Lp(a). Conclusions: While angioplasty is an effective therapy for ED of arterial origin in patients with obstruction of erection-related arteries, Lp(a) does not seem to play a major role for clinical outcomes in these patients.

Combining Proximal Foam Sclerotherapy and Distal Endovenous Laser Ablation for Recurrent Varicose Vein Treatment.

BACKGROUND: Recurrent varicose veins with neovascularization are a common clinical problem. Although endovenous laser ablation (EVLA) has become the standard treatment modality to treat truncal veins, additional sclerotherapy is required to treat newly formed tortuous veins. A novel laser fiber with an injection channel (nLF) allows for such simultaneous proximal sclerotherapy and offers a potentially more effective treatment option. OBJECTIVE: The aim of this study was to present our experience using the nLF for combined EVLA and sclerotherapy treatment of symptomatic recurrent varicose veins. MATERIALS AND METHODS: A retrospective single-center cohort study analyzed the outcomes of all patients with symptomatic recurrent varicose veins, treated with an nLF between September 2020 and August 2022. RESULTS: In total, 28 combined EVLA/sclerotherapy procedures performed with the nLF in 26 patients were analyzed. In all cases, neovascularizations were treated by sclerotherapy through the nLF catheter, followed by laser ablation of the remaining truncal veins. All follow-up ultrasound examinations showed persistent complete occlusion of the treated truncal veins and neovascularizations. No clinically relevant complications were observed. CONCLUSION: Combining proximal foam sclerotherapy and distal EVLA using an nLF for the treatment of symptomatic recurrent varicose veins is safe and effective.

Frequency and anatomic distribution of arterial obstructions in patients with vasculogenic erectile dysfunction not responding to intracavernous prostaglandin.

Background: The extent of arterial disease in patients with erectile dysfunction (ED) non-responsive to intracavernosal injection of Alprostadil is of importance for therapeutic options. However, published evidence, in particular angiographically validated is scarce. Here we investigated arterial lesion patterns in this specific patient cohort by selective angiography. Patients and methods: A cohort of 239 patients received a clinical and duplex-sonographic workup for ED of suspected vascular origin. Duplex ultrasound of the cavernosal arteries was performed after intracavernosal injection of 10 µg Alprostadil. Consequently, standardized workup included grading of the erectile and determination of peak systolic velocity (PSV) and end-diastolic velocity (EDV) in both cavernosal arteries. PSV-values below 30 cm/sec indicated reduced arterial flow, whereas EDV-values above 15 cm/sec indicated a venous leak of the pudendal veins. All patients with suspected arterial ED based on duplex sonography underwent contrast-enhanced computed tomography. Endovascular therapy was carried out in ED patients not responsive or with significant side effects to PDE-5-inhibitors or Alprostadil by selective angiographic depiction of erection-related arteries. Results: 54 patients with a mean age of 61.2 (±9.8) years underwent angioplasty of erectionr elated arteries. Out of these 48/54 (89%) patients presented with an erection considered insufficient for penetration (E0-E3) subsequent to intracavernous application of 10 µg Alprostadil. 14/48 (29%) patients had bilateral arterial obstructions and 34/48 (71%) had unilateral disease. Commonly affected was the internal pudendal artery (n = 31, 65%), followed closely by the common penile artery (n = 30, 64%). The least affected arteries were the dorsal penile (n = 6, 13%), hypogastric (n = 4, 8%), common iliac (n = 4, 8%), cavernosal (n = 4, 8%), and inferior gluteal (n = 1, 2%) arteries. Conclusions: Arterial obstructions amenable to endovascular revascularization are frequent in patients non-responsive to intracavernosal prostaglandin administration. Therapeutic strategies in ED patients non-responsive to conservative measures should therefore consider endovascular treatment opportunities.

Endovascular Therapy for Arteriogenic Erectile Dysfunction With a Novel Sirolimus-Eluting Stent.

BACKGROUND: Arteriogenic erectile dysfunction is a common disease oftentimes not satisfactory treatable with medical therapy. AIM: To assess the safety and clinical success rate of endovascular revascularization of erection-related arteries with the angiolite BTK stent in patients with arteriogenic erectile dysfunction. METHODS: A total of 100 consecutive men (61.8 ± 10 years) with atherosclerotic lesions in erection-related arteries agreed to participate and were included into a single-center all-comers registry. Endovascular therapy with angiolite BTK drug-eluting stents was performed on a total of 211 lesions. Patients received a baseline International Index of Erectile Function (IIEF)-15 questionnaire at first presentation and 3 and 12 months after stenting. An improvement by 4 points in the erectile function domain consisting of 6 questions (IIEF-6) was defined as minimal clinically important difference. A total of 24 patients with 52 stented arterial lesions underwent angiographic follow-up of the initially treated arterial side during secondary revascularization of the contralateral side (angiographic sub-study). OUTCOME: Clinical improvement of erections in 100 patients undergoing endovascular revascularization of erection-related arteries. RESULTS: No major adverse events occurred during endovascular revascularization or within 30 days thereafter. Technical success was achieved in all lesions and procedural success in all patients. At 1 year, 55 of 97 patients (56.7%) improved by at least 4 points in IIEF-6 score and thus achieved a clinically relevant improvement of erectile function.In the angiographic sub-study, arterial patency and binary restenosis were observed in 46 of 52 (88.5%) and in 8 of 52 (15.4%), respectively, after a mean follow-up of 9.6 ± 5.8 months. CLINICAL IMPLICATIONS: In patients with arteriogenic erectile dysfunction, endovascular therapy with a novel thin-strut sirolimus eluting stent is a safe and feasible treatment option. STRENGTHS & LIMITATIONS: This real-world arterial revascularization registry included patients with a multitude of risk factors for ED, thereby representing the heterogeneity in patients in the clinical practice, which is one of its strengths but also one of its weaknesses. Another strength was the focus being laid on analyzing outcomes of patients with arteriogenic ED using only a single endovascular device. Further studies are warranted to better define subgroups of patients with impaired clinical outcomes. CONCLUSION: Within the present all-comers registry, endovascular therapy of erectile dysfunction with the angiolite BTK stent was shown to be a safe and feasible treatment option resulting in clinical improvement rates comparable to earlier clinical trials although also showing that further research is warranted to define patient subgroups with particular benefits of endovascular therapy. Schönhofen J, Räber L, Knöchel J, et al. Endovascular Therapy for Arteriogenic Erectile Dysfunction With a Novel Sirolimus-Eluting Stent. J Sex Med 2021;18:315-326.

Thromboprophylaxis practice after outpatient endovenous thermal ablation.

OBJECTIVE: The use of endovenous thermal ablation (ETA) for the treatment of truncal varicose veins has been increasing worldwide; however, uncertainty remains regarding the need for thromboprophylaxis and follow-up of patients undergoing this minimally invasive procedure. A nationwide survey of among physicians performing ETA was conducted to assess the thromboprophylaxis practice and follow-up protocols after ETA in Switzerland. METHODS: A questionnaire was sent to all ETA-certified physicians (n = 193) in Switzerland. The survey covered procedure type, thromboprophylaxis (including pharmacologic and compression therapy), duplex ultrasound follow-up examinations, and the management of endovenous heat-induced thrombosis (EHIT). RESULTS: Overall, 121 responses were received, for a response rate of 62.7%. Of the 121 respondents, 71 were vascular medicine specialists (58.7%) and 46 were general or vascular surgeons (38.0%), representing the two largest groups of specialists, followed by 2 dermatologists (1.7%) and 2 interventional radiologists (1.7%). Pharmacologic thromboprophylaxis after ETA was always used by 86 physicians (71.1%), nearly always by 8 (6.6%), frequently used by 5 (4.1%), rarely used by 21 (17.4%), and never by 1 physician (0.8%). A direct oral anticoagulant drug was the preferred type of thromboprophylaxis used by 92 physicians (77.3%). The first dose of thromboprophylaxis was mostly administered immediately after intervention by 53 physicians (53.7%). The duration of postablation thromboprophylaxis ranged from 1 to 21 days, with 7 to 10 days used by 57 physicians. Compression therapy was used by all physicians, with large variation in duration ranging from 1 to 42 days after a single ETA session and after ETA with concomitant phlebectomy. Postablation duplex ultrasonography was performed routinely by 120 respondents (99.2%), and 84 respondents (69.4%) performed two to three duplex ultrasound scans. Management of EHIT depended on the EHIT class and differed widely among the physicians. CONCLUSIONS: Our nationwide survey on thromboprophylaxis practices after ETA of truncal varicose veins in Switzerland showed that most physicians use pharmacologic thromboprophylaxis, with a direct oral anticoagulant drug the preferred agent. However, the timing of the first dose and the duration of thromboprophylaxis varied widely among the respondents, reflecting the uncertainty in this domain owing to the absence of high-quality evidence-based guidelines.

Feasibility and safety of flush endovenous laser ablation of the great saphenous vein up to the saphenofemoral junction.

OBJECTIVE: The optimal ablation distance from the catheter tip to the common femoral vein during endovenous laser ablation (EVLA) of the great saphenous vein (GSV) is a matter of debate. In this study, we evaluated the feasibility and safety of flush ablation (fEVLA) of the GSV. METHODS: This single-center, retrospective analysis of prospectively collected data included all consecutive fEVLA interventions of the GSV between September 2017 and October 2018. Interventions were performed with a 1470-nm radially emitting fiber. Primary end points were technical feasibility of fEVLA and endovenous heat-induced thrombosis (EHIT) class 2 to class 4. Secondary end points were procedure-related complications; anatomic success at week 6; and flush occlusion at day 1, day 10, and week 6. RESULTS: A total of 135 consecutive intended fEVLA procedures were performed in 113 patients (86 female, 27 male). The average body mass index was 24.9 ± 4.3 kg/m2. The Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) clinical class for these patients was C2 in 78 (57.8%), C3 in 48 (35.6%), C4 in 8 (5.9%), and C5 in 1 (0.7%). The GSV diameter at the saphenofemoral junction was 9.4 ± 2.7 mm with a maximum of 16 mm. In 126 cases (93.3%), concomitant treatment of tributaries with phlebectomy or foam sclerotherapy was performed. In 127 cases (94.1%), fEVLA was technically feasible; in 8 cases (5.9%), appropriate catheter tip placement was not possible. In these cases, "standard" GSV ablation 10 to 20 mm distal to the saphenofemoral junction was performed. In the remaining 127 cases, one (0.8%) EHIT class 2 and one (0.8%) EHIT class 3 developed at day 10. After a 2- to 3-week course of anticoagulation with rivaroxaban, these EHIT cases resolved without sequelae. Furthermore, one (0.8%) superficial vein thrombosis and one (0.8%) calf vein thrombosis at the site of phlebectomy were observed. No local groin complication occurred. Flush occlusion was observed in 94.5%, 95.3%, and 88.2% of the cases at day 1, day 10, and week 6, respectively. Multivariate regression analysis revealed no significant association between flush ablation at day 1 and age, body mass index, CEAP class, fiber type, maximum vein diameter, or applied joules per centimeter. CONCLUSIONS: The results of this study suggest that fEVLA of the GSV using a radial emitting laser is feasible and seems to be safe.

Bedside hand vein inspection for noninvasive central venous pressure assessment.

Rapid estimates of the central venous pressure (CVP) can be helpful to administer early fluid therapy or to manage cardiac preload in intensive care units, operating rooms or emergency rooms in order to start and monitor an adequate medical therapy. Invasive CVP measurements have inherent and non-negligible complication rates as well as great expenditures. Several noninvasive methods of CVP measurements, like ultrasound-guided techniques, are available, but require trained skills and special equipment which might not be at hand in all situations. Our purpose was to evaluate the feasibility and accuracy of CVP estimates assessed upon the height of hand veins collapse (HVC) using invasively measured CVP as the gold standard. The HVC was determined by slowly lifting the patient's hand while watching the dorsal hand veins to collapse. The vertical distance from the dorsal hand to a transducer air zero port was noted and converted to mmHg. The observer was blinded to the simultaneously measured CVP values, which were categorized as low (<7 mmHg), normal (7-12 mmHg) and high (>12 mmHg). Measurements were performed in 82 patients who had a median [IQR] age of 67 [60;74]. Median CVP was 12 [8;15] mmHg and the median absolute difference between the measured HVC and CVP was 4 [2;7] mmHg. The Spearman correlation coefficient between CVP and HVC was 0.55, 95%-CI [0.35;0.69]. Overall CVP categorization was correct in 45% of the cases. HVC had a sensitivity of 92% for a low CVP with a negative predictive value of 98%. A high HVC had a sensitivity of 29% but a high specificity of 94% for a high CVP. The overall performance of observing the hand vein collapse to estimate CVP was only moderate in the intensive care setting. However, the median difference to the CVP was low and HVC identifies a low CVP with a high sensitivity and excellent negative predictive value.

Duration of pharmacological thromboprophylaxis after outpatient endovenous laser ablation: a propensity score-matched analysis.

AIM OF THE STUDY: The objective of this study was to identify the optimal duration of pharmacological thromboprophylaxis after outpatient endovenous laser ablation (EVLA). METHODS: In this multicentre retrospective study in a university hospital, regional hospital and private practices, we collected the demographic, procedural and outcome data of all consecutive patients with varicose veins class C2 to C6 undergoing outpatient EVLA of truncal and accessory veins between February 2009 and December 2015. The cumulative primary efficacy endpoint consisted of endovenous heat-induced thrombosis (EHIT) class 2–4, deep vein thrombosis (DVT) and pulmonary embolism (PE) diagnosed with duplex ultrasound or computed tomography angiography after 1 and 4 weeks of follow-up. Cumulative secondary endpoints were complete ablation of the treated veins and major bleeding, skin burns and infection. RESULTS: A total of 864 patients were treated with EVLA as an outpatient procedure. Of those, 35 patients were omitted because of therapeutic anticoagulation or dual antiplatelet therapy. Another 36 cases were excluded as the patients received pharmacological thromboprophylaxis for 5 days. A total of 793 were included in the final analysis. Of those, 225 patients (28.4%) received fondaparinux 2.5 mg s.c. for 3 days, 166 patients (20.9%) received rivaroxaban 10 mg p.o. for 3 days and 402 patients (50.7%) received rivaroxaban 10 mg for 10 days. The incidence of EHIT class 2–4 was 0.8% (n = 6) in total, 1.3% (n = 6) in group 1 (treated for 3 days) and 0.3% (n = 1) in group 2 (treated for 10 days) (odds ratio [OR] 0.19, confidence interval [CI] 0.02–1.66, p = 0.133). The cumulative primary composite endpoint at 4-week follow-up was 1.1% (n = 9) and was 2.1% (n = 8) in group 1 and 0.3% (n = 1) in group 2 (OR 0.0.12, CI 0.01–0.96, p = 0.046). Propensity score-matched analysis revealed no significant difference in the composite primary endpoint (CI −0.074 to 0.26). Complete occlusion rate was 99.2% in group 1 and 98.8% in group 2 (OR 0.61, CI 0.15–2.59, p = 0.506). No PE or major bleeding events occurred in either group. Propensity score-matched analysis showed no significant difference in the secondary endpoints. CONCLUSION: Using propensity score-matched analysis we showed that pharmacological thromboprophylaxis after EVLA seems to be equally effective with 3 days or 10 days of treatment with a similar success rate and safety profile. Undoubtedly, a large randomised control trial, ideally including a group without pharmacological thromboprophylaxis, is needed to draw more definitive conclusions on the optimal duration of pharmacological post-EVLA thromboprophylaxis.

Endovascular Therapy for Erectile Dysfunction-Who Benefits Most? Insights From a Single-Center Experience.

PURPOSE: To report the 1-year outcomes of a single-center, all-comers registry aimed to assess effectiveness and safety of endovascular revascularization for atherosclerotic erectile dysfunction (ED) in an unselected patient cohort. MATERIALS AND METHODS: Between April 2016 and October 2017, 50 consecutive patients (mean age 59.6±10.3 years) underwent endovascular revascularization for ED owing to >50% stenosis in 82 erection-related arteries. Patients were treated by means of standard balloon angioplasty (16%), drug-coated balloon angioplasty (27%), or drug-eluting stent (55%) implantation. The primary feasibility outcome measure was the incidence of a minimum clinically relevant improvement of ≥4 in the 6-question International Index of Erectile Function Questionnaire (IIEF-6) score at 12 months. Clinical effectiveness was improvement in erectile function as quantified in the mean difference (MD) of the IIEF-15 score at 3 and 12 months as well as the mean changes in IIEF-15 questions 3 and 4. RESULTS: Procedure success was achieved in 49 (98%) of 50 patients. At 12 months, 30 (65%) of 46 patients achieved a minimum clinically relevant improvement in the IIEF-6 score. The overall IIEF-15 score, as well as scores for questions 3 and 4, improved in 32 (65%) of 49 patients, 28 (57%) of 49 patients, and 29 (60%) of 48 patients, respectively. Change in the overall IIEF-15 score at 12 months was consistent among subgroups, except for elderly patients [MD -5.0 (95% CI -9.7 to -0.2), p=0.041] and those with hypertension [MD -11.0 (95% CI -20.5 to -1.5), p=0.025], who showed less improvement. CONCLUSION: Endovascular revascularization was safe and efficacious in the majority of ED patients through 1 year.

Early Recoil After Balloon Angioplasty of Erection-Related Arteries in Patients With Arteriogenic Erectile Dysfunction.

PURPOSE: To evaluate the incidence of elastic recoil in patients presenting with erectile dysfunction (ED) undergoing endovascular revascularization of the pudendal or penile arteries. METHODS: A consecutive series of 21 ED patients (mean age 58.3±9.3 years) undergoing minimally invasive revascularization of 31 arteries was analyzed. ED lesions included the pudendal arteries (n=27) and the penile artery (n=4). Mean lesion length was 20.6±13.9 mm. Minimal lumen diameter (MLD) measurements were assessed at baseline, immediately after balloon angioplasty, and 10 minutes thereafter. Early recoil was defined as an MLD reduction >10%. Elastic recoil with >10% lumen compromise was treated with drug-coated balloons, while severe elastic recoil (>30%) required drug-eluting stents (DES). The International Index of Erectile Function (IIEF-15) score was obtained prior to and 3 months after the procedure to obtain information on functional outcomes subsequent to angioplasty. RESULTS: Mean MLD at baseline was 0.9±0.6 mm, which improved to 2.0±0.9 mm immediately after balloon dilation. At 10 minutes after dilation, the MLD was 1.7±1.0 mm. Elastic recoil was observed in all 31 lesions and resulted in a mean lumen compromise of 21.2%. Severe (>30%) recoil was observed in 14 arteries, which underwent DES therapy. The IIEF-15 score improved from 31.3±11.2 at baseline to 49.8±16.8 (p<0.001) at the 3-month follow-up. CONCLUSION: Endovascular revascularization constitutes a safe and feasible treatment modality to restore erectile function in patients with arteriogenic ED and ineffective conservative management. Early elastic recoil is very frequent subsequent to balloon dilation of small-caliber erection-related arteries. Thus, mechanical scaffolding with DES is required in a high subset of ED patients to provide favorable early angiographic and clinical results.

Endovascular revascularization of below-the-knee arteries: prospective short-term angiographic and clinical follow-up.

PURPOSE: To evaluate arterial lesion characteristics and their impact on angiographic and clinical outcomes after endovascular below-the-knee (BTK) revascularization. MATERIALS AND METHODS: Between April 2008 and June 2009, 33 patients (mean age 74.9 years) with 34 limbs and 50 arterial segments (mean lesion length 59.3 mm) undergoing endovascular BTK revascularization agreed to undergo prospective clinical and intraarterial angiographic 6-month follow-up evaluation. Clinical indication for BTK revascularization was critical limb ischemia (CLI) in 18 patients and delayed wound healing without hemodynamic evidence of CLI and intermittent claudication (IC) in 15 patients. RESULTS: Binary restenosis was observed in 40% of treated segments at 6 months. Primary sustained clinical improvement was 82.4% and 55.9% at 3 months and 6 months. Lesion length was independently associated with binary restenosis (hazard ratio [HR] 1.013, 95% confidence interval [CI] 1.000-1.016, P = .05) and lower rates of primary sustained clinical improvement (HR 1.024, 95% CI 1.006-1.042, P = .008). CONCLUSIONS: Endovascular BTK revascularization yields clinical and angiographic benefits both for patients with IC and for patients with CLI. Although arterial lesion length adversely affects angiographic and clinical outcomes after endovascular revascularization, limb salvage rates were substantially higher compared with the comparatively low patency rates after BTK angioplasty.

Endovascular treatment of common femoral artery obstructions.

OBJECTIVE: To evaluate the clinical efficacy of endovascular therapy of symptomatic obstructions of the common femoral artery (CFA). METHODS: Consecutive series of patients undergoing endovascular therapy of chronic CFA obstructions between 1995 and 2009 and who were followed systematically within a prospectively maintained database. Clinical assessment was based on current guidelines including ankle-brachial index (ABI) and was performed at baseline and the day of discharge and then repeated at 3, 6, and 12 months and annually thereafter. Technical success of intervention was defined as a final residual diameter stenosis of <30%. Sustained clinical improvement was defined as a sustained upward shift of at least one category on the Rutherford classification compared with baseline without the need for repeated target lesion revascularization (TLR) or amputation in surviving patients. Limb salvage was defined as absence of a major (ie, above the ankle) amputation. Survival analysis was performed using the Kaplan-Meier method. RESULTS: Ninety-eight patients (38 women, mean age 72 ± 11 years) presented with 104 ischemic limbs, 20 of which (19%) were classified as having critical limb ischemia (CLI). Technical success rate was 98%. Stents were placed in eight CLI patients (40%) and in 20 claudicants (24%). Mean ABI improved from 0.28 to 0.54 (P < .001) in CLI patients and from 0.61 to 0.85 (P < .001) in claudicants. Mean follow-up was 16 months. Primary sustained clinical improvement rates at 3, 6, 12, and 24 months were 55%, 55%, 40%, and 0% in CLI patients and 81%, 75%, 68%, and 52% in claudicants, respectively. Limb salvage rates at 24 months were 94% in CLI patients and 100% in claudicants. After adjustment for confounding factors, presence of ischemic ulcers (hazard ratio [HR], 4.7; 95% confidence interval [CI], 1.49-14.85; P = .009), obstruction of the femoropopliteal arterial tract (HR, 3.9; 95% CI, 1.66-9.16; P = .002) and diabetes mellitus (HR, 2.3; 95% CI, 1.02-5.28; P = .045) were independently associated with lower rates of sustained clinical improvement. CONCLUSIONS: Endovascular therapy of CFA obstruction is associated with high rates of sustained clinical success in claudicants with patent femoropopliteal outflow. Presence of ischemic skin ulcers and diabetes mellitus, however, are associated with impaired efficacy of endovascular CFA treatment.

MR angiography of infrapopliteal arteries in patients with peripheral arterial occlusive disease by using Gadofosveset at 3.0 T: diagnostic accuracy compared with selective DSA.

PURPOSE: To prospectively compare the diagnostic accuracy of steady-state, high-spatial-resolution magnetic resonance (MR) angiography of the lower leg, performed with a blood pool contrast agent, with selective digital subtraction angiography (DSA) as the reference standard in patients with symptomatic peripheral arterial disease. MATERIALS AND METHODS: Local ethics committee approval and written informed consent were obtained. In a nonrandomized trial, selective DSA and MR angiography were performed at 3.0 T with a blood pool contrast agent on 22 calves in 20 patients (mean age, 69.4 years +/- 11.3 [standard deviation]), 16 men (mean age, 67.8 years +/- 12.4) and four women (mean age, 75.6 years +/- 3.6 years), to evaluate 352 arterial segments. DSA and MR angiography were performed within 24 hours of each other and directly compared by three experienced, blinded radiologists by using high-spatial-resolution steady-state MR angiograms. Consensus reading for both DSA and MR angiography served as the reference standard. RESULTS: MR angiography was successful and occurred without serious adverse events in all patients. Seven significantly stenosed and 40 occluded segments were rated equally in both modalities. In three cases, the tibial arteries were shown to be occluded or significantly stenosed at DSA but appeared normal or significantly stenosed at MR angiography. The respective average segment sensitivity, specificity, and accuracy were 98.3% (59 of 60), 98% (113.7 of 116), and 98.1% (172.7 of 176) for DSA and 100% (60 of 60), 100% (116 of 116), and 100% (176 of 176) for MR angiography. Steady-state MR angiography was especially useful for the distal peroneal artery and the proximal anterior tibial artery. CONCLUSION: MR angiography performed with blood pool agents has an accuracy comparable with that of selective DSA in the lower leg but with less risk involved. Steady-state imaging performed with blood pool agents facilitates evaluation of MR angiography of infrapopliteal arteries.

Bailout revascularization of chronic femoral artery occlusions with the new outback catheter following failed conventional endovascular intervention.

PURPOSE: To report the application of a true lumen re-entry device in the bailout treatment of chronic total occlusions (CTO) of the superficial femoral artery (SFA) after failed angioplasty. METHODS: Nineteen patients (12 men; mean age 81 years, range 61-97) with 20 SFA CTOs and Rutherford category 2 to 5 ischemia were prospectively evaluated. All CTOs had unsuccessful recanalization using conventional techniques and were subsequently treated with the Outback LTD catheter. Follow-up at 3, 6, and 12 months included ankle/toe pressure measurement and pulse volume recordings. Endpoints were revascularization rate, target lesion revascularization, and limb salvage. RESULTS: Revascularization was achieved in 95% of the cases. There were 2 (10%) periprocedural complications unrelated to the re-entry device, which were resolved by endovascular or surgical treatment. The target lesion revascularization rate was 10%, with the 2 events occurring at 3 and 6 months, respectively, in patients with Rutherford category 4-5 ischemia. There was one below-the-knee amputation in the patient with failed revascularization. CONCLUSION: The acute failure of endovascular treatment of SFA CTOs is most often due to an inability to re-enter the true lumen after the occlusion is crossed in a subintimal plane. Bailout revascularization with the Outback LTD catheter is highly successful and shows a low device-related complication rate. This needle- and fluoroscopic-based re-entry device increases the endovascular success rate and is therefore expanding the minimally invasive treatment options for surgically unfit patients.

Integrity of venoarteriolar reflex determines level of microvascular skin flow enhancement with intermittent pneumatic compression.

OBJECTIVE: To investigate whether intermittent pneumatic compression (IPC) augments skin blood flow through transient suspension of local vasoregulation, the veno-arteriolar response (VAR), in healthy controls and in patients with peripheral arterial disease (PAD). METHODS: Nineteen healthy limbs and twenty-two limbs with PAD were examined. To assess VAR, skin blood flow (SBF) was measured using laser Doppler fluxmetry in the horizontal and sitting positions and was defined as percentage change with postural alteration [(horizontal SBF--sitting SBF)/horizontal SBF x 100]. On IPC application to the foot, the calf, or both, SBF was measured with laser Doppler fluxmetry, the probe being attached to the pulp of the big toe. RESULTS: Baseline VAR was higher in the controls 63.8 +/- 6.4% than in patients with PAD (31.7 +/- 13.4%, P = .0162). In both groups SBF was significantly higher with IPC than at rest (P < .0001). A higher percentage increase with IPC was demonstrated in the controls (242 +/- 85% to 788 +/- 318%) than in subjects with PAD, for each one of the three different IPC modes investigated (98 +/- 33% to 275 +/- 72%) with IPC was demonstrated. The SBF enhancement with IPC correlated with VAR for all three compression modes (r = 0.58, P = .002 for calf compression, r = 0.65, P < .0001 for foot compression alone, and r = 0.64, P = .0002 for combined foot and calf compression). CONCLUSION: The integrity of the veno-arteriolar response correlates with the level of skin blood flow augmentation generated with intermittent pneumatic compression, indicating that this may be associated with a transient suspension of the autoregulatory vasoconstriction both in healthy controls and in patients with PAD.

Influence of pulmonary status and diabetes mellitus on aortic neck dilatation following endovascular repair of abdominal aortic aneurysms: a EUROSTAR report.

PURPOSE: To elucidate the association of impaired pulmonary status (IPS) and diabetes mellitus (DM) with clinical outcome and the incidences of aortic neck dilatation and type I endoleak after elective endovascular infrarenal aortic aneurysm repair (EVAR). METHODS: In 164 European institutions participating in the EUROSTAR registry, 6383 patients (5985 men; mean age 72.4+/-7.6 years) underwent EVAR. Patients were divided into patients without versus with IPS or with/without DM. Clinical assessment and contrast-enhanced computed tomography (CT) were performed at 1, 3, 6, 12, 18, and 24 months and annually thereafter. Cumulative endpoint analysis comprised death, aortic rupture, type I endoleak, endovascular reintervention, and surgical conversion. RESULTS: Prevalence of IPS was 2733/6383 (43%) and prevalence of DM was 810/6383 (13%). Mean follow-up was 21.1+/-18.4 months. Thirty-day mortality, AAA rupture, and conversion rates did not differ between patients with versus without IPS and between patients with versus without DM. All-cause and AAA-related mortality, respectively, were significantly higher in patients with IPS compared to patients with normal pulmonary status (31.0% versus 19.0%, p<0.0001 and 6.8% versus 3.3%, p = 0.0057) throughout follow-up. In multivariate analysis adjusted for smoking, age, gender, comorbidities, fitness for open repair, co-existing common iliac aneurysm, neck and aneurysm size, arterial angulations, aneurysm classification, endograft oversizing >or=15%, and type of stent-graft, the presence of IPS was not associated with significantly higher rates of aortic neck dilatation (30.6% versus 38.0%, p>0.05) and did not influence cumulative rates of type I endoleak, endovascular reintervention, or conversion to open surgery (p>0.05). Similarly, the presence of DM did not influence the above-mentioned study endpoints. CONCLUSION: In contrast to observations regarding the natural course of AAAs, impaired pulmonary status does not negatively influence aortic neck dilatation, while the presence of diabetes does not protect from these dismal events after EVAR.