Antiplatelet therapy guided by CYP2C19 point-of-care pharmacogenetics plus multidimensional treatment decisions.

Aim: Implementation of CYP2C19 point-of-care (POC) pharmacogenetic (PGx) testing with personalized treatment recommendations. Methods: POC CYP2C19 genotyping plus expert evaluation of risk factors for ischemic and bleeding events. Results: 167 patients underwent PGx testing, 54 (32.3%) were CYP2C19 loss of function carriers, and POC versus standard PGx analysis results for *2 and *3 variants matched in 100%. Antiplatelet therapy was adjusted in 44 patients (26.3%), but always required consideration of patient-specific factors. Conclusion: CYP2C19 POC-PGx is reliable and offers clinically relevant advantages for immediate evidence-based adaptations of antiplatelet therapy, whereas in less acute cases conventional PGx testing can also have advantages. Antiplatelet therapy has become more complex, and implementation of PGx-based personalized antiplatelet therapy requires complementary expert knowledge.

Venous thrombosis following endovenous laser ablation with and without thromboprophylaxis.

OBJECTIVE: Venous thromboembolism (VTE) occurs infrequently after endovenous laser ablation (EVLA). The purpose of this study was to assess the incidence of VTE after EVLA with and without pharmacologic prophylaxis. METHODS: From October 2019 to March 2020, a series of consecutive patients from the prospectively maintained VEINOVA (vein occlusion with various techniques) registry was retrospectively analyzed. All the patients underwent EVLA with and without postoperative thromboprophylaxis. A 1470-nm laser wavelength with a radial fiber was used for EVLA. Concomitant phlebectomy or sclerotherapy of insufficient tributaries was allowed. Perivenous tumescence was applied with 1% Rapidocaine (lidocaine hydrochloride monohydrate; Sintetica SA). Ablation of varicose veins was performed by continuously drawing back the laser fiber at a power of 10 W, aiming for a linear endovenous energy delivery of 60 to 90 J/cm. Compression stockings were applied postoperatively, and the patients were advised to wear them for 1 week. Duplex ultrasound was performed at the 1- and 4-week follow-up visits to determine the occlusion rate and the occurrence of EHIT and VTE. RESULTS: Overall, 249 patients were identified from the registry. Of the 249 patients, 26 were omitted because of treatment of recurrent varicose veins. Finally, 223 consecutive patients with 223 legs and 227 saphenous veins (159 great saphenous veins, 49 small saphenous veins, and 19 anterior accessory saphenous veins) were included in the final analysis. Their mean age was 58.1 ± 13.8 years, and 167 patients (73.1%) were women. The clinical CEAP (clinical, etiology, anatomy, pathophysiology) classification was C2 for 11 legs (4.9%), C3 for 123 legs (55.2%), C4a or C4b for 86 legs (38.6%), and C5 to C6 for 3 legs (1.4%). Thromboprophylaxis was given to 132 patients (59.2%) for 3 days (rivaroxaban 10 mg once daily to 130 patients [98.5%] and low-molecular-weight heparin to 2 patients [1.5%]). No thromboprophylaxis was administered to 91 patients (40.8%) after EVLA. The average treatment length was 34.2 ± 19.3 cm and the average diameter was 5.0 ± 1.3 mm. At 1 week of follow-up, no thrombotic event had occurred in either group. At 4 weeks of follow-up, one case of EHIT class 2 (1.1%) and one case of pulmonary embolism (1.1%) had occurred in the group without thromboprophylaxis. In the thromboprophylaxis group, one deep vein thrombosis (0.8%) event had occurred (adjusted P = .135). At 1 and 4 weeks of follow-up, the treated varicose veins remained occluded in both groups. CONCLUSIONS: Endovenous ablation of truncal varicose veins appears to be safe with a low thrombotic event rate with or without pharmacologic thromboprophylaxis. However, more data are needed before a final recommendation regarding the best thromboprophylaxis treatment option can be given.

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.

Erectile dysfunction: role of computed tomography cavernosography in the diagnosis and treatment planning of venous leak.

BACKGROUND: Venous leak appears to be the most common cause of vasculogenic erectile dysfunction (ED), which can be treated with venous embolization. Traditionally, conventional cavernosography was used for the diagnosis and treatment planning of venous leak. Recently, computed tomography (CT) cavernosography was introduced as a novel cross-sectional imaging method proposed to be advantageous over conventional cavernosography. We created a novel management algorithm for diagnosing venous leak including CT cavernosography as an imaging modality. In order to provide a broader basis for our management algorithm, a systematic literature review was conducted. MAIN BODY: In this article we systematically review relevant literature on using CT cavernosography for the diagnosis and treatment planning in ED patients with venous leak following the PRISMA selection process. Nine full-text articles were included in the review and assigned a level of evidence grade (all grade II). Two studies (2/9) compared the results of conventional cavernosography with those of CT cavernosography which was superior for site-specific venous leak identification (19.4% vs. 100%, respectively). CT cavernosography is a more detailed imaging method that is faster to perform, exposes the patient to less radiation, and requires less contrast material. In one study (1/9), CT cavernosography was used for diagnostic purposes only. Eight studies (8/9) cover both, diagnostic imaging and treatment planning including embolization (1/9) and sclerotherapy (2/9) of venous leak in patients with venogenic ED. Three studies (3/9) describe anatomical venous leak classifications that were established based on CT cavernosography findings for accurate mapping of superficial and/or deep venous leak and identification of mixed or more complex forms of venous leak present in up to 84% of patients. In addition to treatment planning, one study (1/9) used CT cavernosography also for follow-up imaging post treatment. CONCLUSION: CT cavernosography is superior to conventional cavernosography for diagnosis and treatment planning in patients with ED caused by venous leak (grade II levels of evidence). Consequently, CT cavernosography should be included in management algorithms for ED patients with suspected venous leak.

Safety, feasibility, and early efficacy of the water-specific 1940-nm laser wavelength for ablation of saphenous incompetence.

Objective: The aim of the present study was to evaluate the safety, feasibility, and early efficacy of saphenous vein ablation using a water-specific 1940-nm diode laser wavelength using low linear endovenous energy density. Methods: We retrospectively analyzed a series of patients who had undergone endovenous laser ablation (EVLA) between July 2020 and October 2021 from the multicenter, prospectively maintained VEINOVA (vein occlusion with various techniques) registry. EVLA was performed using a water-specific 1940-nm radial laser fiber. In the same session, all insufficient tributaries were treated by phlebectomy or sclerotherapy. Tumescent anesthesia was injected into the perivenous space. The vein diameter, energy delivered, and linear endovenous density were reviewed at baseline. The incidence of venous thromboembolism, endovenous heat-induced thrombosis (EHIT), burns, phlebitis, paresthesia, and occlusion were reviewed at 2 days and 6 weeks of follow-up. We used descriptive statistics to describe the results. Results: Overall, 229 patients were identified. Of the 229 patients, 34 were excluded because of treatment of recurrent varicose veins at a previously operated site (residual or neovascularization). Finally, 108 patients with varicose veins and 87 with recurrent varicose veins (new varicose veins in an untreated area) due to disease progression were included in the present analysis. A total of 256 native saphenous veins (163 great saphenous veins, 53 small saphenous veins, and 40 accessory saphenous veins) in 224 legs had undergone EVLA. The mean patient age was 58.3 ± 16.5 years. Of the 195 patients, 134 (68.7%) were women and 61 (31.3%) were men. Nearly one half of the patients had a history of saphenous vein surgery (44.6%). The CEAP (clinical, etiology, anatomy, pathophysiology) class was C2 in 31 legs (13.8%), C3 in 108 (48.2%), C4a to C4c in 72 (32.1%), and C5 or C6 in 13 legs (5.8%). The treatment length was 34.8 ± 18.3 cm. The mean diameter was 5.0 ± 1.2 mm. The average linear endovenous density was 34.8 ± 9.2 J/cm. Concomitant miniphlebectomy was performed in 163 patients (83.6%) and concomitant sclerotherapy in 35 patients (18%). At 2 days and 6 weeks of follow-up, the occlusion rate of the treated truncal veins was 99.6% and 99.6%, respectively, with only one truncal vein (0.4%) with partial recanalization at 2 days and 6 weeks of follow-up. No cases of proximal deep vein thrombosis, pulmonary embolism, or EHIT had occurred at follow-up. Only one patient (0.5%) had developed calf deep vein thrombosis at 6 weeks of follow-up. The incidence of postoperative ecchymosis was rare (1.5%) and had resolved at 6 weeks of follow-up. Conclusions: EVLA of incompetent saphenous veins using the water-specific 1940-nm diode laser wavelength is feasible and appears to be safe and efficient with a high occlusion rate, minimal side effects, and a zero rate of EHIT.

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.

Venogenic erectile dysfunction: diagnosis on computed tomography cavernosography and endovascular treatment using an anterograde access via deep dorsal penile vein.

BACKGROUND: The underlying etiologies of erectile dysfunction may be manifold. Among them, vasculogenic etiologies are of increasing relevance and are not strictly limited to the elderly population. According to recent study, venogenic erectile dysfunction appears to be even more relevant than arteriogenic erectile dysfunction. Venogenic erectile dysfunction due to venous leakage causes insufficient penile blood retention. Proper diagnosis of venous leakage should include both color Doppler flow analysis and computed tomography cavernosography for adequate patient selection and treatment planning. Besides surgical ligation of penile draining veins, endovascular treatment methods may demonstrate more promising results. Especially endovascular embolization of venous leakage using an anterograde access via deep dorsal penile veins appears to be more beneficial for patients' clinical outcome and awareness of this technique should be raised among endovascular interventionalists. CASE PRESENTATION: A 47-year-old man was diagnosed with venogenic erectile dysfunction due to venous leakage on color Doppler flow analysis and computed tomography cavernosography. He did not respond to PDE-5-inhibitors. This patient demonstrated major venous leakage of paired deep dorsal penile veins via periprostatic veins and internal pudendal veins draining into both iliohypogastric veins. This patient's venous leak was treated with endovascular embolization using an anterograde access via deep dorsal penile veins. CONCLUSION: This patient's erectile dysfunction due to venous leakage, based on findings in color Doppler flow analysis and computed tomography cavernosography, was embolized using an anterograde access via deep dorsal penile veins as a minimally-invasive endovascular treatment option.

Towards a better understanding of the posttreatment hemodynamic behaviors in femoropopliteal arteries through personalized computational models based on OCT images.

The hemodynamic behavior following endovascular treatment of patients with peripheral arterial disease plays a significant role on the occurrence of restenosis in femoro-popliteal (FP) arteries. The atheroprone flow conditions that are generally accepted to promote restenosis can be calculated by computational fluid dynamics (CFD) analyses, and these results can be used to assess individualized treatment outcomes. However, the impact of endovascular therapy on the flow behaviors of FP arteries are still poorly understood, as the imaging modalities used in existing numerical works (X-ray angiography, computed tomography angiography) are unable to accurately represent the post-treatment arterial geometry due to their low resolutions. Therefore, this study proposes a new algorithm that combines intra-arterial lumen geometry obtained from high-resolution optical coherence tomography (OCT) images with centerlines generated from X-ray images to reconstruct the FP artery with an in-plane resolution of 10 µm. This superior accuracy allows modeling characteristic geometrical structures, such as angioplasty-induced arterial dissections, that are too small to be reconstructed with other imaging modalities. The framework is applied on the clinical data of patients treated either with only-percutaneous transluminal angioplasty (PTA) (n = 4) or PTA followed by stenting (n = 4). Based on the generated models, PTA was found to cause numerous arterial dissections, covering approximately 10% of the total surface area of the lumen, whereas no dissections were identified in the stented arteries. CFD simulations were performed to investigate the hemodynamic conditions before and after treatment. Regardless of the treatment method, the areas affected by low time-averaged wall shear stress (< 0.5 Pa) were significantly higher (p < 0.05) following endovascular therapy (pre-PTA: 0.95 ± 0.59 cm2; post-PTA: 2.10 ± 1.09cm2; post-stent: 3.10 ± 0.98 cm2). There were no statistical differences between the PTA and the stent groups. However, within the PTA group, adverse hemodynamics were mainly concentrated at regions created by arterial dissections, which may negatively impact the outcomes of a leave-nothing-behind strategy. These observations show that OCT-based numerical models have great potential to guide clinicians regarding the optimal treatment approach.

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.

Endovascular therapy for erectile dysfunction: current knowledge and future perspectives.

Erectile dysfunction (ED) is defined as the inability to attain or maintain penile erection sufficient for successful sexual intercourse. ED carries a notable influence on quality of life, with significant implications for family and social relationships. Because atherosclerosis of penile arteries represents one of the most frequent causes of ED, patients presenting with it should always be investigated for potential coexistent coronary or peripheral disease. Up to 75% of patients with ED have a stenosis of the iliac-pudendal-penile arteries, supplying perfusion of the male genital organ. Recently the potential treatment of this pathological condition by percutaneous approaches has emerged with good angiographic results and with a significant improvement in symptoms and quality of life. This review will focus on the normal anatomy and physiology of erection, the pathophysiology of ED, the relation between ED and cardiovascular diseases and, lastly, on new treatment modalities aimed at restoration of normal erectile function.

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.

Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial.

Purpose: To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). Materials and Methods: An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.6 years; 26 men) or uncoated balloon (n=41; mean age 67.6±10.2 years; 26 men) angioplasty (ClinicalTrials.gov identifier NCT01594684). Additionally, the protocol provided for an observational arm composed of patients from either randomized arm who experienced recurrent ISR ≥30 days after the index treatment. Redo treatment consisted of 2 DCBs sequentially inflated at the same location (double dose therapy). The majority of patients (66, 78%) had Rutherford category 3 ischemia. The mean lesion length was 140 mm; a third (27, 31%) were total occlusions. The primary endpoint was angiographic late lumen loss (LLL) at 6 months evaluated by an independent core laboratory. Results: Twenty-two patients (7 DCB +15 uncoated) were treated for recurrence with fully overlapping double DCB angioplasty. Six-month LLL was lower after DCB (0.34±1.12 mm) treatment than after angioplasty with an uncoated balloon (1.58±1.10 mm, p<0.001). At the 12-month follow-up, target lesion revascularization (TLR) was performed in 18 (49%) of 37 patients in the uncoated group, 6 (14%) of 43 patients in the single-dose DCB group (p=0.001), and no patients from the recurrent ISR group. At ~2 years after treatment, a remarkable number (14/27, 52%) of TLRs were recorded in the single-dose DCB group. Conclusion: Treatment with DCBs resulted in significantly less 6-month LLL and fewer TLRs up to 24 months than treatment with uncoated balloons. The double dose for treating recurrent ISR did not cause recognizable adverse events or require TLR up to 24 months.

Incidental findings during computed tomographic angiography diagnostic work-up in patients with arteriogenic erectile dysfunction.

AIM: To analyse the incidental findings during computed tomographic angiography (CTA) diagnostic work-up in patients with arteriogenic erectile dysfunction (ED). PATIENTS AND METHODS: The medical records of all patients with suspected arteriogenic ED were entered into a database. Risk factors and underlying comorbidities were also collected. Pathological CTA findings were extracted from the CT readings and entered into the database. Incidental findings on CTA were classified as those requiring immediate medical treatment, requiring deferred medical treatment or of no clinical importance. RESULTS: A total of 200 patients underwent CTA for suspected arteriogenic ED. Mean patient age was 59.6 ± 11.7 years. Of these, 181 patients (90.5%) had obstructions of erection-related arteries. In 168 patients (84.0%), CTA showed multiple incidental pathological findings. Eighty-five of 200 patients (42.5%) exhibited incidental findings requiring immediate further medical workup and/or treatment: coronary artery calcification was diagnosed in 75/200 (37.5%), aorto-iliac aneurysms in 8/200 (4%) of patients and incidentally detected embolism in 1/200 patient. Pancreatic and liver tumours were less frequent (incidence 1.5% and 1%, respectively). Incidental findings requiring deferred medical workup and/or treatment were detected in 175/200 patients (87.5%). The findings with the highest prevalence were liver steatosis followed by colon diverticulosis and prostate hyperplasia. Findings of little to no clinical importance were reported in 117 (58.5%) patients. These included uncomplicated renal cysts, spinal degeneration and renal vascular anomalies. Almost every second patient presenting with ED had an incidental finding which required immediate treatment. CONCLUSIONS: Incidental findings not directly related to ED were common among patients undergoing CTA scans for suspected arterial obstructions. Coronary artery calcification was the leading finding requiring further medical workup and/or treatment. Thus, the benefit of CTA investigations extends beyond the anatomic description of arterial obstructions of erection-related arteries.

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.

Prediction of restenosis based on hemodynamical markers in revascularized femoro-popliteal arteries during leg flexion.

Endovascular therapy in patients suffering from peripheral arterial disease shows high rates of restenosis. The poor clinical outcomes are commonly explained by the demanding mechanical environment due to leg movements, but the mechanisms responsible for restenosis remain unknown. In this study, we hypothesized that restenosis following revascularization is associated with hemodynamical markers derived from blood flow during leg flexion. Therefore, we performed personalized computational fluid dynamics (CFD) analyses of 20 patients, who underwent routine endovascular femoro-popliteal interventions. The CFD analyses were conducted using 3D models of the arterial geometry in straight and flexed positions, which were reconstructed from 2D angiographic images. Based on restenosis rates reported at 6-month follow-up, logistic regression analyses were performed to predict restenosis from hemodynamical parameters. Results showed that severe arterial deformations, such as kinking, induced by leg flexion in stented arteries led to adverse hemodynamic conditions that may trigger restenosis. A logistic regression analysis based solely on hemodynamical markers had an accuracy of 75%, which showed that flow parameters are sufficient to predict restenosis (p = 0.031). However, better predictions were achieved by adding the treatment method in the model. This suggests that a more accurate image acquisition technique is required to capture the localized modifications of blood flow following intervention, especially around the stented artery. This approach, based on the immediate postoperative configuration of the artery, has the potential to identify patients at increased risk of restenosis. Based on this information, clinicians could take preventive measures and more closely follow these patients to avoid complications.

Safety and efficacy of outpatient endovenous laser ablation in patients 75 years and older: a propensity score-matched analysis.

AIMS OF THE STUDY: The purpose of this study was to evaluate the safety and efficacy of endovenous laser ablation (EVLA) in patients 75 years and older in an outpatient setting. METHODS: In this multicentre retrospective study, we collected the demographic, procedural and outcome data of all consecutive patients with varicose veins class C2 to C6 undergoing EVLA of truncal and accessory saphenous veins. The primary efficacy endpoint was complete ablation of the treated veins diagnosed with duplex ultrasound at 4-week follow up. The primary safety endpoint was endothermal heat-induced thrombosis (EHIT) and deep vein thrombosis (DVT) at 4-week follow up as diagnosed by duplex ultrasound. A secondary endpoint was minor or major bleeding. RESULTS: Between February 2009 and December 2015, a total of 829 patients were treated with EVLA of the truncal and accessory saphenous veins. Among them, 747 were <75 years old (group 1) and 82 were ≥75 years old (group 2). The primary efficacy outcome was reached in 739 patients (98.9%) in group 1 and in 80 patients (97.6%) in group 2 (odd ratio [OR] 0.43, confidence interval [CI] 0.09–2.07; p = 0.295). The number of patients with EHIT type 2 and DVT were 4 (0.5%) and 2 (0.3%), respectively, in group 1, and 2 (2.4%) and 1 (1.2%), respectively, in group 2 (OR 4.64, CI 0.83–25.75; p = 0.079 and OR 4.59, CI 0.41–51.27; p = 0.215, respectively). Minor bleeding events occurred in 36 patients (4.8%) in group 1 and 7 patients (8.9%) in group 2 (OR 1.84, CI 0.79-4.29; p = 0.155). No major bleeding occurred in either group. Propensity score-matched analysis revealed no significant difference in efficacy and safety outcomes. CONCLUSION: EVLA performed as an outpatient procedure seems to be effective and safe in the elderly population as compared to the younger age group.