Sex disparities in popliteal artery aneurysms.

OBJECTIVE: Only 5% of patients with popliteal artery aneurysms (PAAs) are female. Evidence on PAA treatment and outcomes in women is therefore scarce. The POPART Registry provides one of Europe's largest data collections regarding PAA treatment. Data on clinical presentation, aneurysm morphology, and perioperative outcomes after open surgical PAA repair in women will be presented. METHODS: POPART is a multicenter, noninterventional registry for open and endovascular PAA repair, with 42 participating centers in Germany and Luxembourg. All patients aged >18 years who have been treated for PAA since 2010 are eligible for study inclusion. Data collection is based on an online electronic case report form. RESULTS: Of the 1236 PAAs, 58 (4.8%) were in women. There were no significant differences in age or cardiopulmonary comorbidities. However, female patients had a lower prevalence of contralateral PAAs and abdominal aortic aneurysms (P < .05). PAAs in women were more likely to be symptomatic before surgery (65.5% vs 49.4%; P = .017), with 19% of women presenting with acute limb ischemia (vs 11%; P = .067). Women had smaller aneurysm diameters than men (22.5 mm vs 27 mm; P = .004) and became symptomatic at smaller diameters (20 mm vs 26 mm; P = .002). Only 8.6% of women and 11.6% of men underwent endovascular aneurysm repair (P > .05); therefore, the perioperative outcome analysis focused on open surgical repair. In total, 23.5% of women and 16.9% of men developed perioperative complications (P > .05). There were no differences in major cardiovascular events (P > .05), but women showed a higher incidence of impaired wound healing (15.7% vs 7.2%; P = .05) and major amputation (5.9% vs 1.1%; P = .027). Female sex was significantly associated with the need for nonvascular reinterventions within 30 days after surgery (odds ratio: 2.48, 95% confidence interval: 1.26-4.88), whereas no significant differences in the odds for vascular reinterventions were observed (odds ratio: 1.98, 95% confidence interval: 0.68-5.77). In the multiple logistic regression model, female sex, symptomatic PAAs, poor quality of outflow vessels, and graft material other than vein graft were independently associated with perioperative reinterventions. CONCLUSIONS: Women have smaller PAAs, are more likely to be symptomatic before treatment, and are more often affected by nonvascular reinterventions in the perioperative course. As our understanding of aneurysmatic diseases in women continues to expand, sex-specific treatment strategies and screening options for women in well-selected cohorts with modified screening protocols should be continuously re-evaluated.

Diagnosis and treatment of venous leg ulcers: S2k Guideline of the German Society of Phlebology and Lymphology (DGPL) e.V.

This S2k guideline on venous leg ulcers was created on the initiative and under the leadership of the German Society of Phlebology and Lymphology (DGPL). The guideline group also consisted of representatives from the German Society for Phlebology and Lymphology, German Dermatological Society, German Society for General Medicine, German Society for Angiology, German Society for Vascular Surgery and Vascular Medicine, German Society for Surgery, German Society for Dermatosurgery, German Society for Wound Healing and Wound Treatment, Professional Association of Phlebologists and Lymphologists and Initiative Chronische Wunden. The aim of this guideline is to combine the different approaches and levels of knowledge of the respective professional groups on the basis of consensus, so that a basic concept for the best possible treatment of patients with venous leg ulcers can be provided. A total of 70 specific recommendations were formulated and agreed upon, divided into the subject areas of diagnostics, therapy, prevention of recurrences, and everyday challenges. The guideline thus reflects the current state of scientific knowledge and is intended to be widely used as the best available document for the treatment of patients with venous leg ulcers in everyday clinical practice.

Safety and efficacy of endovenous laser ablation (EVLA) using 1940 nm and radial emitting fiber: 3-year results of a prospective, non-randomized study and comparison with 1470 nm.

OBJECTIVES: To evaluate the safety, efficacy and ≥36 months outcomes of endovenous laser ablation (EVLA) by means of 1940 nm laser with radial fiber for the treatment of truncal vein insufficiency and compare the results to a historical cohort, obtained via reviewing the literature. METHODS: This prospective, non-randomized, single-center clinical study included 139 consecutive patients with 177 incompetent great saphenous (GSV, n = 135) and short saphenous veins (SSV, n = 42). The maximum laser power (Pmax. 10 W) and pullback velocity were adjusted individually (Vmax = 1 mm/s). The laser fiber was placed at the junction to the deep vein under duplex monitoring. Simultaneous phlebectomies were performed on all the patients. Regular follow up with clinical and duplex ultrasound examination (DUS) were carried out postoperatively at 1 month (1 M), 6 months (6 M), 12 months (12 M), 24 months (24 M), 36 months, and after that (≥36 M). The results were compared with three cohorts (total 616 EVLA procedures with 1470 nm laser and radial fiber) from literature (criteria: >100 procedures, follow-up of ≥2 years). RESULTS: The follow-up rate was 100%, 91%, 73%, 48%, and 23% of the truncal veins at 1, 6, 12, 24, and ≥36 M, respectively. In comparison to the literature using 1470, a lower average linear endovenous energy density (LEED) (53 vs. 77-82 J/cm) resulted in 100% (6 M) and 96.5% (24 M) occlusion rates, reduced local ecchymosis (2.2% vs. 3.2%-18.7%) and reduced average postoperative pain levels (1.3 vs. 2.18). Regarding adverse events, induration (1.1% vs. 1.8%), skin burns (0% vs. 0.45%), endovenous heat-induced thrombus propagation (EHIT) in the deep veins (2.3% vs. 1.8%) and laser-induced persistent paresthesia (2.2% vs. 0.5%-2.9%) were comparable. Recanalizations observed in this study (GSV 0, SSV 3) were asymptomatic and required no treatment. At ≥36 M reflux in the accessory veins was observed in 5% versus 10.5% of patients. Reintervention was required in none (0% vs. 21%). At >36 M, short average stump lengths of 1 cm (GSV) and 0.3 cm (SSV) were observed. CONCLUSION: EVLA with 1940 nm laser with radial emitting fiber is as safe and effective as 1470 nm laser for the treatment of truncal vein insufficiency. Lower postoperative pain, low analgesic requirements, short convalescence add to patients' comfort. EVLA with 1940 nm laser-guided by intraoperative DUS permits reproducible placement of the radial fiber at the saphenofemoral and saphenopopliteal junction, enabling further studies to assess the effect of shorter stump length on patterns and frequency of recurrence without increased risk of EHIT.

Endovenous laser ablation using laser systems emitting at wavelengths > 1900 nm: a systematic review.

The aim of this systematic review was to summarize the currently available literature reporting clinical application of endovenous laser ablation (EVLA) by means of laser systems emitting at wavelengths > 1900 nm, pertaining dosimetry, intraoperative parameters, postoperative outcomes, and efficacy based on occlusion rates, recanalization, and postoperative complications. A literature search was conducted in PubMed, Cochrane Library, Embase, OVID, and Web of Science for publications since the year 2000 until December 2021. Case series, prospective trials, retrospective studies, and randomized controlled trials describing the application of a 1920/1940-nm wavelength laser for EVLA in humans with a minimum of one postoperative follow-up visit were included in the study. Four case series and one randomized controlled trial with a total of 509 EVLA procedures (396 great saphenous veins and 113 small saphenous veins) were identified, meeting the inclusion criteria. The studies were heterogenous in their documentation, EVLA, and duplex ultrasound protocol and result reporting. Overall, the applied average cumulative LEED values ranged from 17.8 to 53 J/cm. Complications observed were pigmentation (0-9.75%), paresthesia (2.5-7.3%), thrombophlebitis (0-5%), EHIT Class 2 (2.26-2.4%), and EHIT Class 1 (1.2-2.4%). Four cases of recanalizations were observed in one study cohort within the first month after treatment. Follow-up at 12 months was available for 3 studies (procedures n = 218) with recanalizations in 8 limbs. Follow-up at 24-36 months was available for 2 studies (procedures n = 126) showing recanalizations in 5 limbs. Recanalizations were asymptomatic and incidental findings on follow-up duplex ultrasound. Pooled occlusion rates were 99.2% at 1 M, 96.3% at 12 M, and 96% at 24 M. Overall, patients undergoing EVLA with long wavelength laser systems > 1900 nm show high occlusion rates, significant improvement in VCSS, low postoperative complication rate, low pain levels, low analgesic requirement, and early convalescence. Apart from persistent paresthesia, all the complications regressed spontaneously within 6 months. EVLA by means of 1920/1940 nm shows promising clinical results with high efficacy and low complication rates. Heterogeneity still exists regarding ideal protocol for duplex ultrasound examination and documentation of anatomical parameters (e.g., vein diameter, ideal stump length and status of accessory veins) and light dosimetry for EVLA.

Real-time Volumetric Assessment of the Human Carotid Artery: Handheld Multispectral Optoacoustic Tomography.

Background Multispectral optical imaging has the capability of resolving hemoglobin, lipid, and water. Volumetric multispectral optoacoustic tomography (MSOT) is a hybrid imaging technique that provides a unique combination of functional and molecular contrast with real-time handheld imaging. Purpose To investigate whether volumetric MSOT can provide real-time assessment of the anatomic and functional status of the human carotid artery bifurcation noninvasively. Materials and Methods Imaging of healthy volunteers (n = 16) was performed with a custom-designed handheld volumetric MSOT scanner capable of high-spatial-resolution (approximately 200 µm) and real-time (10 volumes/sec) three-dimensional imaging, while further providing spectroscopic capacity through fast tuning of the excitation light wavelength. For comparison and anatomic cross-validation, volunteers were also scanned with clinical B-mode US. Results Volumetric MSOT achieved real-time imaging and characterization of the entire carotid bifurcation area across three dimensions simultaneously captured in a single volumetric image frame. Analysis of the acquired data further showed that a higher contrast-to-noise ratio can be achieved for wavelengths corresponding to a high optical absorption of oxygenated hemoglobin. Conclusion The human carotid artery was visualized by using handheld volumetric multispectral optoacoustic tomography. This imaging approach is less prone to motion artifacts than are the conventional clinical imaging methods, holding promise for providing additional image-based biomarkers for noninvasive label-free assessment of carotid artery disease. © RSNA, 2019 Online supplemental material is available for this article. See also the editorial by Mezrich in this issue.

Prospects of Endovenous Laser Ablation (EVLA) Standardization-Mid-Term Results of a Four-Zone Dosimetry Guiding Tool for 1940 nm Laser.

BACKGROUND: Heterogeneity regarding dosimetry and reporting of endovenous laser ablation (EVLA) mandates the development of a standardized protocol. This study presents the mid-term results of EVLA with 1940 nm-laser and radial-fibre, supported by a four-zone dosimetry tool. MATERIALS AND METHODS: Four anatomical dosimetry zones for great saphenous veins (GSV) and two for small saphenous veins (SSV) were defined with set power levels. Zone-1G (4 W) extended from the inguinal ligament to the apex of femoral triangle, Zone-2G (4 W) from the apex of femoral triangle to the upper border of patella. Zone-3G (3 W) from the patella to the tibial tuberosity. Zone-4G (2 W) extended from the tibial tuberosity to the ankle. Zone-1S from the sapheno-popliteal junction to the tibial tuberosity. Zone-2S from the tibial tuberosity to the ankle. Power was increased by 1 W for veins >10 mm and decreased by 1 W when fibre sticking was encountered. Pullback-velocity was max. 1 mm/s. RESULTS: A total of 152 consecutive patients (185 procedures) were recruited. Mean follow-up time was 11.9 months. Mean linear endovenous energy density for GSV was Zone-1G:42 J/cm, Zone-2G:33 J/cm, Zone-3G:27 J/cm, Zone-4G:22 J/cm, Zone-1S:34 J/cm, Zone-2S:27 J/cm. Occlusion rates were 98.9% (1-month) and 93.7% (12-months). Complications at 1 M were low, namely laser-induced paraesthesia (LIP) 2.2% and endovenous heat-induced thrombosis (EHIT) 1.6%. Persistent LIP (12 M) was observed in 0.5%. CONCLUSION: The proposed four-zone guiding tool is a step towards standardizing dosimetry and documentation for EVLA with 1940 nm. This strategy shows good mid-term results with minimal complications. Long-term follow-up and application in further centres are necessary to prove its reproducibility. Such a guiding tool could improve the ability to analyse, compare and review different EVLA wavelengths and fibre types.

Impact of laparoscopic and conventional surgery on Kupffer cells, tumor-associated CD44 expression, and intrahepatic tumor spread.

BACKGROUND: The oncologic feasibility of laparoscopic surgery for the cure of colorectal cancer is under debate. The effect of laparoscopic colorectal cancer resection on hepatic tumor spread has not yet been clarified. HYPOTHESIS: Laparoscopic surgery affects cell-mediated immune response and hepatic tumor spread dependent on intraperitoneal insufflation. METHODS: Thirty WAG/Rij rats were randomized into 3 operative groups: carbon dioxide (CO( 2)) laparoscopy (n = 10), "gasless" laparoscopy (n = 10), and laparotomy (n = 10). To induce liver metastases, 50 000 CC531 colon carcinoma cells were injected into the portal vein during either laparoscopy or laparotomy. Twenty-eight days after injection, specimens were explanted, sectioned, and examined immunohistochemically for CC531 tumor cells (monoclonal antibody CC52), CD44v5, v6 (monoclonal antibody OX49), and Kupffer cells (monoclonal antibody HIS36). For quantification, a morphometric analysis system was applied. Data were analyzed using the Kruskal-Wallis, Dunn, and Holm tests. RESULTS: No statistically significant differences in hepatic tumor growth were found between CO(2) laparoscopy and laparotomy (P =.37). However, compared with CO(2) laparoscopy and laparotomy, a significant decrease in intrahepatic tumor growth was found after gasless laparoscopy (P =.02). Kupffer cells had significantly decreased after CO(2) laparoscopy and laparotomy compared with after gasless laparoscopy (P<.001 and P =.002, respectively). CD44v5, v6 expression was significantly increased after CO(2) laparoscopy and laparotomy compared with after gasless laparoscopy (P =.002 and P =.05, respectively). CONCLUSIONS: Hepatic resistance to tumor growth is best preserved by gasless laparoscopy as opposed to CO(2) laparoscopy or laparotomy. The amount of intra-abdominal pressure with circulatory changes rather than the used gas may explain this finding. On the other hand, conventional laparoscopy vs laparotomy did not preserve hepatic immune function.

The ox-foot-model for investigating endoluminal thermal treatment modalities of varicosis vein diseases.

The introduction of technical surgical innovations in clinical medicine is preceded by preclinical evaluation of prototypes. Surgical aspects such as energy dependent tissue response and tissue sealing to reduce bleeding are usually investigated in animal experiments. Extra-corporal organ models can provide the required experimental information without harming animals and thus reduce or even replace in vivo experiments. Here we describe the ex vivo ox-foot-model, which can be used for surgical investigations and for training purposes. In the ox-foot-model the vein remains in its anatomical bed under reproducible experimental conditions, i.e., blood perfusion, blood pressure, and temperature. Innovative endoluminal surgical procedures using laser light and radio frequency for varicosis treatment were tested. Treatment parameters were investigated systematically in a large number of samples. A standardized preclinical testing procedure could be established and optimized on the basis of acute macroscopic and histological findings. Further, optical coherence tomography could be evaluated as a time-saving diagnostic tool. The ox-foot-model is suitable for training surgical techniques relevant for the treatment of varicosis veins. It is a cost-effective alternative to conventional in vivo experiments, providing standardized experimental conditions and reproducible experimental results while respecting the Principles of Humane Experimental Techniques: Reduction, Refinement, and Replacement of animal experiments.

Endovenous laser therapy--application studies and latest investigations.

Endovenous laser therapy (ELT) was introduced in clinical practice as a therapy for incompetent veins about ten years ago. One characteristic of ELT is the broad spectrum of different treatment protocols by means of a variety of laser systems as well as manifold application forms and dosimetry concepts are under investigations. Clinical results with effective, relatively pain-free occlusion of incompetent varicosis veins have been observed, as well as undesired side effects such as ecchymosis, phlebitis and recanalization. In recent years systematic experimental investigations and the analysis of clinical results have increased the understanding of the interrelation between the clinical and physical aspects, followed to a continuous optimization of ELT. The use of IR wavelengths and radial irradiation concepts, together with continuous moving of the optical fiber seem to reduce possible side effects. This way ELT treatment becomes a more standardized effective method for the treatment of varicose veins. In future controlled randomized studies are required to compare optimized ELT treatment with other endoluminal modalities as well as conventional surgery.

Evaluation of endovenous radiofrequency ablation and laser therapy with endoluminal optical coherence tomography in an ex vivo model.

BACKGROUND: This study evaluated the ability of endovascular optical coherence tomography (eOCT) to detect qualitative tissue alteration and quantitative changes of vein wall thickness and vein lumen diameter comparing endovenous radiofrequency ablation (RFA) and endovenous laser therapy (ELT) in an established ex vivo model. METHODS: Endoluminal eOCT was performed by means of a new prototype rotating system (System M1, LightLab Imaging Inc, Boston, Mass) with automatic pullback of 1 mm/s. In the course of an eOCT examination of a 50-mm vein segment, 264 electronic cross section images with a spatial resolution of 15 to 20 mum are acquired. The eOCT scans were performed before and after treatment of each of 13 treated vein segments and of six control vein segments. Thirteen subcutaneous cow foot veins were reperfused in situ, and the defined 50-mm vein segments in the study were treated with RFA (n = 2) and ELT (n = 11). RFA followed the clinical VNUS-Closure protocol (VNUS Medical Technologies, San Jose, Calif) using a 6F 60-mm Closure-Plus catheter. ELT was performed using light of lambda = 980 nm with a laser power of 3 (n = 2), 5 (n = 2), and 7 W (n = 4) with a paced pullback protocol with laser irradiation for 1.5 seconds every 3 mm, resulting in linear endovenous energy densities (LEED) of 15, 25, and 35 J/cm. Using 11 W (n = 3) with a continuous pullback protocol at 3 mm/s resulted in a LEED of 36.5 J/cm. Ten histologic cross sections of each treated and control vein segment were correlated with the corresponding eOCT cross sections to evaluate qualitative representation of vein wall layers and tissue alterations such as ablation and vein wall perforation. In addition, 26 eOCT cross sections of every treated vein segment before and after treatment and every control vein segment were analyzed to calculate quantitative changes in media thickness and vein lumen diameter. RESULTS: In all specimens, qualitative analysis with eOCT demonstrated a clear match with histologic cross sections. A symmetrical, complete, circular disintegration of intima and media structures, without any transmural tissue defects, was shown after RFA. Pronounced semicircular tissue ablations (3 to 14 per 50 mm) and complete vessel wall perforations (0 to 16 per 50 mm) were detected after ELT. The quantitative analysis demonstrated a significant (P < .0001) increase in intima-media thickness after RFA (37.8% to 66.7%) and ELT (11.1% to 45.7%). A significant (P < .0001) reduction of vessel lumen diameter (36.3% to 42.2%) was found after RFA. Owing to the limited number of treated vein segments and inhomogeneous baseline vein lumen diameters, no linear correlation between laser energy level and effects on tissue such as ablation/perforation, media thickening, or vein lumen diameter could be identified. CONCLUSIONS: In our ex vivo cow foot model, eOCT is able to reproduce normal vein wall structures and endovenous acute thermal alterations, such as tissue ablation and vessel wall perforations. Endovenous eOCT images can also be analyzed quantitatively to measure media thickness or vein lumen diameter. Endovascular OCT could become a valuable alternative tool for morphologic investigation of tissue alterations after endovenous thermal procedures.

Endovascular optical coherence tomography ex vivo: venous wall anatomy and tissue alterations after endovenous therapy.

Endovascular optical coherence tomography (OCT) is a new imaging modality providing histology-like information of the venous wall. Radiofrequency ablation (RFA) and laser therapy (ELT) are accepted alternatives to surgery. This study evaluated OCT for qualitative assessment of venous wall anatomy and tissue alterations after RFA and ELT in bovine venous specimens. One hundred and thirty-four venous segments were obtained from ten ex-vivo bovine hind limbs. OCT signal characteristics for different wall layers were assessed in 180/216 (83%) quadrants from 54 normal venous cross-sections. Kappa statistics (kappa) were used to calculate intra- and inter-observer agreement. Qualitative changes after RFA (VNUS-Closure) and ELT (diode laser 980 nm, energy densities 15 Joules (J)/cm, 25 J/cm, 35 J/cm) were described in 80 venous cross-sections. Normal veins were characterized by a three-layered appearance. After RFA, loss of three-layered appearance and wall thickening at OCT corresponded with circular destruction of tissue structures at histology. Wall defects after ELT ranged from non-transmural punctiform damage to complete perforation, depending on the energy density applied. Intra- and inter-observer agreement for reading OCT images was very high (0.90 and 0.88, respectively). OCT allows for reproducible evaluation of normal venous wall and alterations after endovenous therapy. OCT could prove to be valuable for optimizing endovenous therapy in vivo.

Primary incisional hernia repair with or without polypropylene mesh: a report on 384 patients with 5-year follow-up.

BACKGROUND AND AIM: Several studies have claimed that mesh repair of incisional hernia lowers recurrence rates when compared to suture repair. We investigated the relative effectiveness of mesh and suture repair in a large homogeneous cohort of patients with primary incisional hernia. PATIENTS AND METHODS: In a retrospective single-centre cohort study, a total of 446 consecutive patients were identified, of whom 86% could be followed up. Mean length of follow-up was 5 years. In 79 patients (22%), we implanted a mesh, usually polypropylene (Prolene). RESULTS: Compared to suture repair, mesh repair prolonged operating time by over 30 min and caused seroma in 12.7% of the patients (p<0.001). Only 4 of the 79 patients with mesh repair developed recurrence, compared to 55 of the 305 patients with suture repair (5 vs 18%, p=0.02 by log-rank test). In multivariate Cox regression, recurrence rates were fourfold higher after suture than after mesh repair (p=0.02). Interestingly, old age was associated with a decreased susceptibility for recurrence (p=0.01). CONCLUSION: Our data confirms the long-term effectiveness of mesh repair under routine conditions. Suture repair should be restricted to small hernias in patients free of known risk factors.

Endovascular aneurysm repair: Treatment of choice for abdominal aortic aneurysm coincident with horseshoe kidney? Three case reports and review of literature.

There is still controversy as to which surgical method is the most suitable for repair of abdominal aortic aneurysm with concomitant horseshoe kidney (AAA-HSK). We report three cases of AAA-HSK treated with endovascular aneurysm repair. In one of these patients we sacrificed the accessory renal artery by applying coils before the operation. Renal infarction, hypertension, or elevated serum creatinine level was not observed in any of our patients. If the blood supply to the kidneys is taken into consideration, endovascular aneurysm repair is our preferred surgical method for repair of AAA-HSK when anatomic conditions are suitable for stent-graft application and kidney function is normal.

Are postoperative complaints and complications influenced by different techniques in fashioning and fixing the mesh in transperitoneal laparoscopic hernioplasty? Results of a prospective randomized trial.

It is unknown at present what the best method is among mesh implantation, central incision, reconstructing the deep inguinal ring, or a non-incised mesh implant in laparoscopic hernia surgery. Further, it is unproven to what extent a circular enclosure of the cremasteric structures by an incised mesh implant could cause postoperative complications and complaints. To evaluate the possible effects of different configurations and fixation techniques of mesh implants in transperitoneal repair of inguinal hernias, a randomized trial (phase IIIa study) was conducted to compare incised versus non-incised mesh and clip fixation versus suturing the mesh. A total of 360 male patients with unilateral primary hernias were randomized to 3 groups. Postoperative complaints were documented by means of a visual analog scale. These values showed no significant differences between study arms. At the first postoperative control, on day 3, patients after repair of Nyhus type II hernias had significantly fewer complaints than those after Nyhus type IIIa and IIIb repair. To gain additional facts, a duplex flow examination of testicular vessels was performed pre- and postoperatively. Testicular perfusion was not influenced by mesh configurations in the trial. There were no statistical differences in postoperative complications and recurrence rates between groups. In conclusion no influence on postoperative complaints and complications could be demonstrated by different mesh fashioning and fixation alternatives studied in this trial.