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.

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.

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.

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.

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.

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.

First-in-Man Experience with a Novel Catheter-Based Renal Denervation System of Ultrasonic Ablation in Patients with Resistant Hypertension.

PURPOSE: To report results of renal denervation (RDN) with the first catheter-based, non-balloon occlusion ultrasonic system in patients with resistant hypertension. MATERIALS AND METHODS: In a multicenter, single-arm trial, 39 patients with resistant hypertension (defined as uncontrolled hypertension while taking ≥ 3 antihypertensive medications) were treated. The cohort consisted of 4 groups: severe resistant hypertension (office systolic blood pressure [OSBP] ≥ 160 mm Hg) treated with a unidirectional catheter (group 1; n = 14); severe resistant hypertension treated with a multidirectional catheter (group 2; n = 18); moderate resistant hypertension (OSBP 140-159 mm Hg) treated with a multidirectional catheter (group 3; n = 5); and recurrent severe resistant hypertension, after an initial response to RF RDN (group 4; n = 2). Blood pressure monitoring was performed for 6 months. RESULTS: Severe adverse events were not noted immediately after the procedure or during follow-up. Treatment time was longer with unidirectional than with multidirectional catheters (36.7 min ± 9.6 vs 11.9 min ± 5.8; P < .001). Mean reductions in office blood pressure (systolic/diastolic) at 1, 3, and 6 months were -26.1/-9.6 mm Hg, -28.0/-9.9 mm Hg, and -30.6/-14.1 mm Hg (P < .01 for all). Per-group analysis showed significant OSBP reduction for groups 1 and 2. Patients with isolated systolic hypertension had a significantly smaller reduction in OSBP after 6 months compared with patients with combined systolic/diastolic hypertension (-16.2 mm Hg ± 18.5 vs -9.9 mm Hg ± 33.4; P < .005). CONCLUSIONS: Use of the RDN system was feasible and safe in this phase I study. Significant blood pressure reductions were observed over 6 months, although less in patients with isolated systolic hypertension.

In Vivo Quantification of the Deformations of the Femoropopliteal Segment: Percutaneous Transluminal Angioplasty vs Nitinol Stent Placement.

PURPOSE: To quantify the deformations of the femoropopliteal (FP) segment in patients undergoing endovascular revascularization and to compare the posttreatment deformations caused by primary nitinol stent implantation to those produced by percutaneous transluminal angioplasty (PTA). METHODS: Thirty-five patients (mean age 69±10 years; 20 men) scheduled for endovascular therapy were recruited for the study. During endovascular interventions, angiographic images were acquired with the legs straight and with a hip/knee flexion of 20°/70°. Image acquisition was performed before PTA for all patients, after PTA in 17 patients receiving this treatment only, and after primary stent implantation in the remaining 18 patients. A semiautomatic approach was used to reconstruct the 3-dimensional patient-specific artery models from 2-dimensional radiographs. Axial shortening and curvature changes in the arteries in vivo were calculated for the calcified, dilated, and stented regions, as well as the regions that were distal and proximal to the diseased and treated segments. RESULTS: Leg flexion resulted in shortening of the artery in all investigated FP segments. The dilated arteries exhibited greater shortening compared with their stented counterparts (post-PTA 7.6%±4.9%, poststent 3.2%±2.9%; p=0.004). Leg flexion also led to an increase in the curvatures of all the sections of the FP segment. While stented arteries had significantly higher curvature values than PTA within the regions proximal to the treated sections, the choice of the treatment method did not affect the curvature of the other segments. Despite this, 40% of the stented arteries exhibited kinking during leg flexion. CONCLUSION: The choice of the treatment method affects the postinterventional axial deformations of the FP segment but does not influence the curvature behavior. While PTA results in a more flexible artery, stents restrict the arteries' shortening capabilities. Depending on the anatomical position of the stents, this axial stiffening of the arteries may lead to chronic kinking, which may cause occlusions and, consequently, affect the long-term success of the procedure.

Effect of Stent Implantation on the Deformations of the Superficial Femoral Artery and Popliteal Artery: In Vivo Three-Dimensional Deformational Analysis from Two-Dimensional Radiographs.

The objective of this work was to develop a system for three-dimensional (3D) reconstruction of the femoropopliteal artery from two angiographic views and to quantify the in vivo 3D deformations in 18 patients before balloon angioplasty and after primary stent implantation. The procedure had an insignificant effect on the bending behavior of the artery, as the average mean curvature change within the lesion remained constant before (0.04 cm-1 ± 0.03) and after stent implantation (0.03 cm-1 ± 0.04). A significant effect of stent implantation was measured in terms of a decrease in arterial shortening during leg flexion.

Use of a stent graft in tumor erosion of the common femoral artery with life-threatening bleeding.

We report a case of a 56-year-old male patient with a life-threatening left common femoral artery bleeding due to tumor erosion. The patient had a history of advanced high-grade pleomorphic leiomyosarcoma of the left groin with pulmonary metastasis. Clinical examination revealed a massive tumor bulking at the left groin with necrosis and phleb- and lymphedema. Given the circumstances, open surgery was not possible. Thus, it was decided to treat the patient with an endovascular procedure. The postprocedural course was uneventful, the patient received blood product and was hemodynamically stable. He was discharged at day six with ambulatory follow-up. Endovascular therapy using stent grafts to exclude a life-threatening bleeding is a valuable alternative treatment option in oncologic patients with limited life expectancy, which are unsuitable for surgery.

Erectile dysfunction - overview from a cardiovascular perspective.

Erectile dysfunction (ED) is an evolving health problem with growing incidence in the ageing male population with potentially predictive value for cardiovascular and other chronic diseases. ED shares the common cardiovascular risk factors. The aetiology of ED is numerous including neurogenic, psychogenic, arteriogenic, and venogenic reasons. The origin of arteriogenic ED is frequently atherosclerosis. Patients not adequately responding to conservative measures including oral medication are often referred to further vascular diagnostics and therapy. At present, the refinements in endovascular therapy allow for minimal-invasive revascularization of erection-related arteries. The role of endovascular therapy in the complex framework of the multifactorial causes of ED requires further scientific scrutiny.

Lesion Pattern in Patients With Erectile Dysfunction of Suspected Arterial Origin: An Angiographic Study.

PURPOSE: To determine the specific lesion pattern of supplying arteries in patients with cardiovascular risk factors suffering from treatment-refractory erectile dysfunction (ED). METHODS: From May 2012 to August 2013, 26 men (median age 55 years) poorly responsive to phosphodiesterase-5 inhibitor therapy were evaluated for a possible vascular cause for their ED. The men were examined with penile duplex sonography and digital subtraction angiography (DSA). Arterial lesions in the common and internal iliac arteries and the internal pudendal arteries considered amenable to endovascular therapy were treated with angioplasty ± stents. Retrospectively, 2 blinded investigators independently evaluated the DSA images and categorized the vascular patterns of the erection-related arteries as normal, macroangiopathy (occlusive lesions of the internal pudendal arteries), or microangiopathy (smaller caliber arteries distal to the internal pudendal circulation with no distal arterial reconstitution). RESULTS: Seventeen macroangiopathic lesions were successfully treated by angioplasty in 11 patients. The treated arterial lesions were mainly located in the internal (n=10) and common iliac arteries (n=2), whereas the internal pudendal artery were involved in 5 cases. Microangiopathic lesions lacking distal reconstitution were present in 7 patients, and the remaining 8 patients had normal vessels supplying the penis. Patients with macroangiopathy undergoing angioplasty had a higher prevalence of peripheral artery disease (63.6% vs 6.7%, p=0.003). CONCLUSION: In this preliminary series of ED patients with cardiovascular risk factors and pathologic duplex sonographic flow parameters, roughly 40% exhibited arterial lesions amenable to endovascular revascularization. In the patients with macroangiopathy, vessels upstream of the internal pudendal artery were most commonly affected. More studies are warranted to define the role of endovascular procedures in this ED subpopulation.

Endothelial progenitor cells as a biological marker of peripheral artery disease.

The role of endothelial progenitor cells (EPCs) in peripheral artery disease (PAD) remains unclear. We hypothesized that EPC mobilization and function play a central role in the development of endothelial dysfunction and directly influence the degree of atherosclerotic burden in peripheral artery vessels. The number of circulating EPCs, defined as CD34(+)/KDR(+) cells, were assessed by flow cytometry in 91 subjects classified according to a predefined sample size of 31 non-diabetic PAD patients, 30 diabetic PAD patients, and 30 healthy volunteers. Both PAD groups had undergone endovascular treatment in the past. As a functional parameter, EPC colony-forming units were determined ex vivo. Apart from a broad laboratory analysis, a series of clinical measures using the ankle-brachial index (ABI), flow-mediated dilatation (FMD) and carotid intima-media thickness (cIMT) were investigated. A significant reduction of EPC counts and proliferation indices in both PAD groups compared to healthy subjects were observed. Low EPC number and pathological findings in the clinical assessment were strongly correlated to the group allocation. Multivariate statistical analysis revealed these findings to be independent predictors of disease appearance. Linear regression analysis showed the ABI to be a predictor of circulating EPC number (p=0.02). Moreover, the functionality of EPCs was correlated by linear regression (p=0.017) to cIMT. The influence of diabetes mellitus on EPCs in our study has to be considered marginal in already disease-affected patients. This study demonstrated that EPCs could predict the prevalence and severity of symptomatic PAD, with ABI as the determinant of the state of EPC populations in disease-affected groups.

Fixed low-dose ultrasound-assisted catheter-directed thrombolysis for intermediate and high-risk pulmonary embolism.

AIMS: No standardized local thrombolysis regimen exists for the treatment of pulmonary embolism (PE). We retrospectively investigated efficacy and safety of fixed low-dose ultrasound-assisted catheter-directed thrombolysis (USAT) for intermediate- and high-risk PE. METHODS AND RESULTS: Fifty-two patients (65 ± 14 years) of whom 14 had high-risk PE (troponin positive in all) and 38 intermediate-risk PE (troponin positive in 91%) were treated with intravenous unfractionated heparin and USAT using 10 mg of recombinant tissue plasminogen activator per device over the course of 15 h. Bilateral USAT was performed in 83% of patients. During 3-month follow-up, two [3.8%; 95% confidence interval (CI) 0.5-13%] patients died (one from cardiogenic shock and one from recurrent PE). Major non-fatal bleeding occurred in two (3.8%; 95% CI, 0.5-13%) patients: one intrathoracic bleeding after cardiopulmonary resuscitation requiring transfusion, one intrapulmonary bleeding requiring lobectomy. Mean pulmonary artery pressure decreased from 37 ± 9 mmHg at baseline to 25 ± 8 mmHg at 15 h (P < 0.001) and cardiac index increased from 2.0 ± 0.7 to 2.7 ± 0.9 L/min/m(2) (P < 0.001). Echocardiographic right-to-left ventricular end-diastolic dimension ratio decreased from 1.42 ± 0.21 at baseline to 1.06 ± 0.23 at 24 h (n = 21; P < 0.001). The greatest haemodynamic benefit from USAT was found in patients with high-risk PE and in those with symptom duration < 14 days. CONCLUSION: A standardized catheter intervention approach using fixed low-dose USAT for the treatment of intermediate- and high-risk PE was associated with rapid improvement in haemodynamic parameters and low rates of bleeding complications and mortality.

Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia.

PURPOSE: To assess the extent of early recoil in patients with critical limb ischemia (CLI) undergoing conventional tibial balloon angioplasty. METHODS: Our hypothesis was that early recoil, defined as lumen compromise >10%, is frequent and accounts for considerable luminal narrowing after tibial angioplasty, promoting restenosis. To test this theory, 30 consecutive CLI patients (18 men; mean age 76.2±12.1 years) were angiographically evaluated immediately after tibial balloon angioplasty and 15 minutes later. Half the patients were diabetics. Target lesions included anterior and posterior tibial arteries and the peroneal artery with / without the tibioperoneal trunk. Mean tibial lesion length was 83.8 mm. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after tibial balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). RESULTS: Elastic recoil was observed in 29 (97%) patients with a mean luminal compromise of 29% according to MLD measurements (MLDbaseline 0.23 mm, MLD postdilation 2.0 mm, and MLD15min 1.47 mm). CONCLUSION: Early recoil is frequently observed in CLI patients undergoing tibial angioplasty and may significantly contribute to restenosis. These findings support the role of dedicated mechanical scaffolding approaches for the prevention of restenosis in tibial arteries.

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.

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.