Background: The BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™.
Methods and design: This is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months.
Discussion: The BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD.
Trial registration: #DRKS00029947 (who.int). PROTOCOL APPROVAL ID: #22-0047(Ethics Committee at Ludwig-Maximilians-University Munich).
The technique and outcomes of pulmonary artery pseudoaneurysm (PAP) embolization was retrospectively evaluated in 13 patients undergoing 14 PAP embolizations between January 2014 and September 2023. The etiology of the PAP was iatrogenic (4/13), tumor (3/13), chronic lung (2/13), idiopathic (2/13) and mycotic (2/13). Clinical presentation was massive hemorrhage (6/13), incidental (4/13), and non-massive hemoptysis (3/13). The average PAP size was 13.5 mm. Coil embolization of the PAP sac was performed in all but two extenuating cases (11/13). Follow-up of 12 patients over an average 5.3-months showed persistent occlusion in all cases. There were no major adverse events attributed to the embolization. Five out of ten patients with procedures performed at least one year before this study were noted to be deceased after an average seven-month time. PAPs of various etiologies may be safely and effectively treated by occluding the aneurysm inflow, outflow, and sac.
Background: Although the candy-plug technique has been reported to be useful for the treatment of post-dissection aortic aneurysm, the stent graft needs be to customized to accommodate the size of vascular occluders.
Case presentation: We present a case of a persistent false lumen successfully treated with endovascular stent-graft and atrial septal defect occluder in a patient with Stanford Type B dissection. A covered stent graft was implanted into the false cavity through a distal rupture, and an atrial septal defect occluder was inserted into the covered stent to seal of the false cavity. Decreased aneurysmal diameter and false lumen thrombosis were noted by CT scan at 6-month follow-up.
Conclusions: Our case showed that combined use of a stent graft and atrial septal defect occluder is safe, technically feasible and effective in sealing of the false lumen in post-dissection aortic aneurysm patients with previously failed false lumen thrombosis.
Radial arterial lines are inserted in critically ill patients admitted to hospital intensive care units for continuous monitoring of their blood pressure. On removal the line can rarely become transected, potentially leading to thrombosis of the radial artery. Retrieval of the broken fragment can be achieved by open surgery, however other retrieval methods using ultrasound-guidance have been performed as they are considered safer and less invasive. We describe our technique of ultrasound-guided percutaneous retrieval of a broken non-radioopaque radial line in one patient, which involved the use of a microsnare. Under local anaesthesia and ultrasound guidance, a 6 Fr 5.5 cm short brite tip sheath was introduced into the radial artery, followed by a microsnare which was used to capture the arterial line, track the line back into the sheath and remove it uneventfully. The use of a microsnare under ultrasound-guidance is only one method to retrieve transected radial lines, with other interventional methods described in the literature. It enables a minimally invasive and safer approach to this potentially critical challenge and can help affected patients avoid open surgery to achieve the same management outcome.
A 66-year-old female presented in the emergency department with Blue-Toe-Syndrome (BTS) and signs of osteitis of her left big toe. Imaging workup of the peripheral vasculature showed no findings. Upon invasive angiography, severe focal stenosis of the dorsalis pedis artery (DPA) could be seen at the talonavicular joint. Complete regression of the stenosis was inducible by dorsal extension in the ankle joint. Further imaging revealed an underlying subluxation of the talonavicular joint as cause of the arterial compression. Entrapment of the DPA is a rare condition and most often described in relation to connective tissue bands or variant muscular tendons (McCabe et al. 70:213-8, 2021; Weichman et al. 24:113, 2010; Smith et al.58:212-4, 2013; Griffin et al. 20:325-8; 2012). In the presented case, bony compression of the PDA due to cranial subluxation of the talus was seen as the cause of BTS and osteitis of the phalanx of the first toe.
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.
Background: Endobronchial forceps are commonly used for complex IVC filter removal and after initial attempts at IVC filter retrieval with a snare have failed. Currently, there are no clear guidelines to help distinguish cases where primary removal should be attempted with standard snare technique or whether attempts at removal should directly be started with forceps. This study is aimed to identify clinical and imaging predictors of snare failure which necessitate conversion to endobronchial forceps.
Methods: Retrospective analysis of 543 patients who underwent IVC filter retrievals were performed at three large quaternary care centers from Jan 2015 to Jan 2022. Patient demographics and IVC filter characteristics on cross-sectional images (degree of tilt, hook embedment, and strut penetration, etc.) were reviewed. Binary multivariate logistic regression was used to identify predictors of IVC filter retrieval where snare retrieval would fail.
Results: Thirty seven percent of the patients (n = 203) necessitated utilization of endobronchial forceps. IVC filter hook embedment (OR:4.55; 95%CI: 1.74-11.87; p = 0.002) and strut penetration (OR: 56.46; 95% CI 20.2-157.7; p = 0.001) were predictors of snare failure. In contrast, total dwell time, BMI, and degree of filter tilt were not associated with snare failure. Intraprocedural conversion from snare to endobronchial forceps was significantly associated with increased contrast volume, radiation dose, and total procedure times (p < 0.05).
Conclusion: IVC filter hook embedment and strut penetration were predictors of snare retrieval failure. Intraprocedural conversion from snare to endobronchial forceps increased contrast volume, radiation dose, and total procedure time. When either hook embedment or strut penetration is present on pre-procedural cross-sectional images, IVC filter retrieval should be initiated using endobronchial forceps.
Level of evidence: Level 3, large multicenter retrospective cohort.
Background: This study evaluated nontarget embolization (NTE) during prostatic artery embolization (PAE) with ethylene vinyl alcohol copolymer (EVOH).
Results: Ten consecutive patients treated by PAE with EVOH for the presence of disabling benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS) between June 22 and January 2023 were included in this prospective study. The inclusion criteria were as follows: LUTS attributed to BPH, LUTS duration ≥ 6 months, failure to respond to standard pharmacotherapy, IPSS > 18 or QoL score > 2, and prostate volume > 40 mL. Embolization was performed under general anaesthesia. According to established techniques, a microcatheter was positioned bilaterally within the feeding arteries, and EVOH was injected slowly under X-ray control. Unenhanced pelvic computed tomography scans were carried out before and after embolization to assess the NTE. The safety of the prostatic embolization procedure with EVOH was assessed by collecting adverse effects over 3 months of evaluation that included the International Prostate Symptom Score (IPSS) and quality of life (QoL) score.-up evaluations, occurring at 3, 6, and 12months, included International Prostate Symptom Score. Bilateral PAE was technically successful in 9 patients, and unilateral injection was performed in one patient. The postoperative scanner showed a distribution of the embolization material in the two lobes of the prostate in all patients. The procedure time varied from 120 to 150 (mean: 132) minutes. Eight out of 10 patients developed pollakiuria within 24 h; none of the patients had postoperative pain. Two patients required catheterization for postoperative urinary retention. Catheters were removed successfully at the end of the first day for one of these patients and on the tenth day for the other. At the 3-month follow-up, patients showed significant improvement in the International Prostate Symptom Score (n = 10; mean = -11,5; P < 0.01) and quality of life score (n = 10; mean = -3,40; P < 0.01). Only one patient presented one asymptomatic muscular NTE.
Conclusions: PAE with EVOH is safe, effective, and associated with few NTEs and no postoperative pain. Prospective comparative studies with longer follow-ups are warranted.
Trial registration: IDRCB, 2021-AO29-56-35. Registered 27 May 2022, http://clinicaltrials.gov/study/NCT05395299?cond=embolization&term&rank=1 .
Background: Compared to conventional open surgery, minimally invasive catheter-based procedures have less post procedural complications. Transcatheter aortic valve implantation (TAVI) and endovascular aneurysm repair (EVAR) require large bore arterial access. Optimal site management of large bore arterial access is pivotal to reduce the hospital-acquired complications associated with large bore arterial access. We wanted to compare surgical cutdown versus percutaneous closure devices in site management of large bore arterial access.
Methods: Participants planned for TAVI or EVAR with large bore arterial access more than 10 French were included, while participants with history of bypass surgery, malignancies, thrombophilia, or sepsis were excluded. A consecutive sample of 100 participants (mean age 74.66 ± 2.65 years, 61% males) was selected, underwent TAVI or EVAR with surgical cutdown (group 1) versus TAVI or EVAR with Proglide™ percutaneous closure device (group 2).
Results: The incidence rate of hematoma was significantly lower in group 2 versus group 1 (p = 0.014), the mean procedure time (minutes) and the median hospital stay (days) were significantly higher in group 1 versus group 2 (t(98) = - 2.631, p = 0.01, and U = 2.403, p = 0.018, respectively), and the c-reactive protein pre-procedure and the c-reactive protein post-procedure were significantly lower in group 2 versus group 1 (U = -2.969, p = 0.003, and U = -2.674, p = 0.007, respectively).
Conclusions: Our study showed a lower incidence rate of large bore arterial access complications as hematoma, a shorter procedure time, and a shorter hospital stay with percutaneous closure devices compared to surgical cutdown.