Sheath Size Research Articles

Use of a mechanical crimper for mounting covered stents in aortic coarctation

BackgroundDespite the continued evolution in use of covered stents in congenital cardiology, no standard technique is available for crimping stents onto balloons. ObjectivesWe aimed to describe the use of a mechanical crimper to mount covered stents and its effects on stent integrity, uniformity, and sheath size for intervention. MethodsSingle-center retrospective review of patients with coarctation of the aorta (CoA) and variants of arch obstruction undergoing stent angioplasty with covered stents between January 2019 and December 2022. Sheath size used for intervention was recorded and compared to the manufacturers' IFU. A bench testing model was then performed to confirm the decrease in sheath size by mechanically crimping six covered stents. Percent reduction in size after crimping, stent uniformity, and PTFE integrity after balloon inflation were recorded. ResultsTwenty-five events were identified for review. Median age at procedure was 18 years, and the most common diagnosis was isolated CoA (80 %). 76 % (n = 19) of stents were mechanically crimped, and 24 % (n = 6) were manually crimped. The median sheath size for mechanically crimped stents was −2 Fr compared with a median of 0 Fr for manually crimped stents (p = 0.007). Bench testing revealed a median 12.8 % reduction in stent diameter after mechanical crimping. All mechanically crimped stents were successfully introduced through sheaths 2 Fr smaller than the IFU. ConclusionThe use of mechanical crimpers for mounting covered endovascular stents allows the delivery of these devices through smaller profile sheaths, facilitating intervention in smaller patients and reducing the risk of vascular access related injuries without affecting stent performance.

The influence of needleless connectors and inserted catheters on flow rates through vascular introducer sheaths.

SummaryA vascular introducer sheath is often used for rapid volume replacement. However, common manipulations such as the addition of needleless connectors to infusion ports and the insertion of catheters or other devices through the introducer sheath may impede flow. In this study we utilised a rapid infuser to deliver room-temperature normal saline through two introducer sheath configurations with and without the addition of needleless connectors and the placement of catheters through the introducer sheaths. The maximal flow rate delivered by the rapid infuser was 1000 mL/min, which was observed with both introducer sheath sizes tested without additional resistive elements. However, with the addition of a needleless connector, flow rates through the introducer sheaths were substantially lower (64 (standard deviation (SD) 6) mL/min and 61 (SD 7) mL/min for the 8.5 Fr and 9 Fr introducers, respectively). Flow rates were also reduced when catheters were placed within the sheaths (298 (SD 9) mL/min with the 7 Fr catheter and 74 (SD 9) mL/min with the 8 Fr catheter placed in an 8.5 Fr sheath; 649 (SD 6) mL/min with the 7 Fr catheter and 356 (SD 14) mL/min with the 8 Fr catheter placed in the 9 Fr sheath). These findings indicated that both needleless connectors and the placement of catheters through vascular introducer sheaths substantially reduced potential flow rates. Even 'large' vascular introducer sheaths capable of delivering high flow rates could be rendered minimally effective for rapid fluid administration when used in this way. Clinicians should consider these impediments to flow when rapid fluid administration is required, and obtain alternative vascular access if necessary.

The Effect of Laser Settings and Ureteral Access Sheath Size on Intrapelvic Temperature during Holmium Laser Lithotripsy

Introduction: Thermal damage to the kidney during holmium laser lithotripsy is a serious complication, which cannot always be prevented considering the diversity of conditions in the kidney and the lack of technical capability to measure intrarenal temperature in real-time. The aim of this study was to analyze the impact of different power settings of the holmium laser and the flow rate of irrigation fluid conditioned by the size of the sheath on the fluid temperature in a model of the pelvicalyceal system during lithotripsy. Materials and Methods: A lithotripsy of artificial stones was performed in a 3D-printed model of the renal pelvicalyceal system with a volume of 20.5 mL. A gravity-driven fluid flow was applied (p = 60 cm H2O). A 9.2Fr ureteroscope was introduced into the model through a ureteral access sheath of either 10/12Fr or 12/14Fr. Lithotripsy power ranged from 12 to 25 W. Temperature was measured using thermography. Results: For the 10/12Fr ureteral access sheath, the fluid flow rate was 2.7 mL/min, with the maximum temperature reached within 20 min ranging from 45 to 50 °C. For the 12/14Fr ureteral access sheath, the fluid flow rate was 9.8 mL/min, with the achieved temperature ranging from 35 to 45 °C. Laser power influenced the rate of temperature increase and the maximum temperature reached. During the first 5 min, the rate of temperature increase was solely dependent on laser power, not on the flow rate. Temperatures of 40 °C were only not exceeded with high flow rates (12/14Fr sheath) and power below 20 W. Conclusions: In a short period, the rate of temperature increase depends solely on laser power, not on the irrigation flow rate. During prolonged lithotripsy, the maximum temperature value depends on both parameters.

Effect of nephrostomy sheath size on renal pelvic pressure during endoscopic combined intrarenal surgery: artificial kidney model study

BackgroundThis study aimed to evaluate the intrarenal pelvic pressure in endoscopic combined intrarenal surgery using an artificial kidney model.MethodsAn artificial kidney model was created using the Urovac evacuator™. Four sizes of nephrostomy sheaths (MIP-L: 25/26 Fr, MIP-M: 16.5/17.5 Fr, MIP-S: 11/12 Fr, MIP-XS: 8.5/9.5 Fr) and two sizes of ureteral access sheaths (12/14 Fr and 10/12 Fr) were installed into the model. For each combination of nephrostomy and ureteral access sheath, renal pelvic pressure was measured with and without insertion of the retrograde flexible ureteroscope. Irrigation from the nephroscope was adjusted to 40–160 mmHg using an automatic irrigation device, and the irrigation of the ureteroscope was by spontaneous dripping at 80 cmH2O. Conditions were measured six times, and the renal pelvic pressure was compared in different conditions.ResultsWithout ureteroscope insertion through the ureteral access sheath, the renal pelvic pressure never exceeded 30 mmHg. Meanwhile, when the ureteroscope was inserted, the renal pelvic pressure increased as the nephrostomy sheath and ureteral access sheath became narrower and as the irrigation pressure increased. Intrarenal pelvic pressure exceeded 30 mmHg when the irrigation pressure was increased in 12/14 Fr ureteral access sheath when MIP-XS was used, and in 10/12 Fr ureteral access sheath when MIP-XS and MIP-S were used.ConclusionsThe use of a thin nephrostomy sheath in endoscopic combined intrarenal surgery can lead to increased intrarenal pelvic pressure. Although our results are from an artificial kidney model, special care is suggested to be required when using a retrograde flexible ureteroscope simultaneously in treatment of patients.

Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement

BackgroundHemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. MethodsData were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone (“legacy strategy”) and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. ResultsA total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. ConclusionsA contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

The scaling relationships between leaf sheath size and leaf lamina size in six bamboo species

ABSTRACT The scaling relationship between functional traits of leaf sheath and leaf lamina in bamboo is of significant importance in regulating bamboo growth, yet related studies are lacking. In this study, we collected a total of 2006 leaves from six bamboo species (including Pleioblastus argenteostriatus, Pleioblastus chino var. hisauchii, Pleioblastus fortunei, Pleioblastus kongosanensis f. aureostriatus, Pleioblastus maculatus, and Pleioblastus viridistriatus) growing in Nanjing, China, and measured leaf sheath length (SL), leaf sheath fresh mass (SFM), leaf lamina length (LL), leaf lamina area (LA), and leaf lamina fresh mass (LFM). We used reduced major axis regression protocols to fit the scaling relationships between various measures of leaf lamina and leaf sheath. For each individual species and the pooled data of six species, allometric relationships were found in lamina (LFM vs. LA) and sheath (SFM vs. SL), respectively. We also found robust allometric relationships between leaf sheath and leaf lamina (LA vs. SL and LFM vs. SL). These results revealed the strong coupling among leaf traits in terms of morphology and mass, providing insights into the understanding of the physiological process of bamboo growth.

Safety of multi-access site venous closure following catheter ablation of atrial fibrillation and flutter

BackgroundFollowing catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications.MethodsThirty-six subjects (63 ± 10.7 years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30 days. Subjects were evaluated for clinically apparent vascular complications.ResultsMean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30 days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site.ConclusionsThis study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.Graphical abstract

A single center study of the efficacy and safety of Pro-Glide used for closure in thoracic endovascular aortic repair in patients with previous groin intervention.

This study aimed to evaluate the efficacy and safety of Pro-Glide, a suture-mediated vascular closure device, regarding technical success and complications in patients who had undergone aortic intervention and had previous groin intervention (PGI). One hundred and thirty-five patients who underwent percutaneous thoracic endovascular aortic repair via the femoral artery and were closed with the Pro-Glide device were analyzed retrospectively. PGI was defined as a history of open surgical access to the femoral artery or wide sheath (>18 F) placement due to endovascular or valvular intervention. The patients were divided into two groups 38 cases with PGI and 97 cases without PGI. The overall success rate of closure of the femoral artery with Pro-Glide was not statistically significant between the two groups (93.8% vs 92.1%, p = .711). Sheath sizes were compared between the groups and PGI (+) group had significantly higher sheath sizes compared to PGI (-) group (24.3 ± 1.1 F vs 23.8 ± 1.0 F, p = .011). Three patients in the PGI (+) group and six patients in the PGI (-) group experienced technical failure of the percutaneous femoral approach. Femoral complications were seen after the procedures in four patients in the PGI (+) group and four in the PGI (-) group. The PGI (+) group had a higher complication rate when compared to the PGI (-) group; however, this was not statistically significant (p = .181). The present study was conducted on a significantly larger sample compared to previous studies and the findings suggest that the Pro-Glide vascular closure device is a safe option for patients with a history of PGI and may not be considered as a contraindication.

Initial experience of thrombectomy using vascular snare with multiple loops for chronic organized thrombi in patients with thrombosed native hemodialysis fistulas.

Thrombi in native hemodialysis access frequently exhibit chronic organized feature because they have formed over a long period. Removal of these is quite difficult owing to relatively large volume, resilient feature, limitations of the introducer sheath size, etc. In this study, we report our experience using a vascular snare for the removal of these thrombi in native arteriovenous fistula (AVF). The medical records of patients who underwent recanalization for thrombosed AVFs from January 2019 to August 2023 were reviewed. During the study period, a total of 29 native fistulas (19 brachiocephalic, nine radiocephalic, and one radiobasilic) in 25 patients were treated using a vascular snare with multiple loops (19 men and six women). Characteristics of the AVFs, endovascular procedures, technical and clinical results, and complications were evaluated. Anatomic and clinical success rates were 96.6% and 100%, respectively. Total thrombosis was observed in 21 (72.4%) fistulas. Aneurysmal changes were found in 22 (75.9%) fistulas. The mean fistula age at the time of the procedure was 60.9 months (standard deviation, 52.2). Thrombectomy was initiated using a vascular snare in 14 fistulas. In 15 fistulas for which the procedures were initiated using a rotational percutaneous thrombectomy device (PTD), a vascular snare was subsequently used because recanalization failed or was insufficient due to chronic organizing thrombi. Additional aspiration and balloon angioplasty were performed in 27 (93.1%) and 28 (96.6%), respectively. Pharmacological thrombolysis was performed in one fistula for long segmental thrombosis combined with arterial thrombosis. The mean procedure time, excluding thrombolysis, was 91.9 min (standard deviation, 55.5). No complications related to the use of the vascular snare was observed. The use of a vascular snare with multiple loops was safe and highly effective for the removal of chronic organized thrombi in the recanalization of thrombosed AVFs.

Effects of Sandbag-Free Follow-up After Manual Compression in Patients Who Underwent Transfemoral Access for Percutaneous Intervention.

Femoral access site complications (ASC) are frequent yet significant conditions associated with percutaneous intervention procedures that affect patient-physician comfort. In this study, we compared ASC rates between patients who received compression with a sandbag, the standard practice in many clinics, and patients monitored solely with bedrest without sandbag compression. This study included patients undergoing any transfemoral percutaneous intervention (mostly coronary interventions) between April 2019 and May 2023 at our clinic. Patients were classified into two groups: those monitored without a sandbag (n = 160) and those with a sandbag (n = 158). ASC rates (ecchymosis, pseudoaneurysm, hematoma, bleeding) were compared between the two groups. No differences were observed between the two groups in gender, age, sheath size, and bed rest times. Complications were observed in 16.9% (n = 27) of patients without sandbags and 25.3% (n = 40) of patients with sandbags. The most common complication was ecchymosis, seen in 10.6% (n = 17) of the no-sandbag group and 13.9% (n = 22) of the sandbag group. Following manual compression after femoral sheath removal, patients receiving bedrest without sandbag use are less likely to develop ASC. Additionally, dismissing sandbag use leads to a significant increase in patient comfort.

Feasibility of a modified hybrid glubran-supported single-proglide technique for access closure during endovascular aneurysm repair.

This study aimed to evaluate the feasibility of a hybrid Glubran-supported single-Proglide technique for large bore femoral access closure during percutaneous access endovascular aneurysm repair (EVAR). A retrospective cohort study was performed for all percutaneous EVARs at our center from January 2023 to June 2023. All patients received the hybrid Glubran-supported single-Proglide technique involving a mixture of surgical glue and Lipiodol injection after single suture placement for femoral access closure. Technical success was defined as achieving complete hemostasis without a bailout strategy. Vascular complications and bleeding were defined by Valve Academic Research Consortium-3 (VARC-3) criteria. Vascular access changes and 30-day mortality were recorded. The technique success rate for the entire study population was 100% (55 femoral access in 37 patients; median age: 72; 78% males). The mean sheath size was 20.4 ± 2.3F. The mean manual compression time was 3.5 ± 1.4 min, the mean hemostasis time was 9.0 ± 2.5 min, and the mean procedural time was 103.9 ± 34.7 min. One patient (1.6%) developed an access site infection and recovered conservatively. No VARC-3 vascular complications and access changes were observed. No 30-day mortality happened. The hybrid Glubran-supported single-Proglide technique is feasible for large bore access closure during EVAR and may be a viable alternative; however, larger prospective studies are required to confirm its efficacy.

Predicting pressure gradient using artificial intelligence for transcatheter aortic valve replacement

ObjectiveAfter transcatheter aortic valve replacement, the mean transvalvular pressure gradient indicates the effectiveness of the therapy. The objective is to develop artificial intelligence to predict the post–transcatheter aortic valve replacement aortic valve pressure gradient and aortic valve area from preprocedural echocardiography and computed tomography data. MethodsA retrospective study was conducted on patients who underwent transcatheter aortic valve replacement due to aortic valve stenosis. A total of 1091 patients were analyzed for pressure gradient predictions (mean age 76.8 ± 9.2 years, 57.8% male), and 1063 patients were analyzed for aortic valve area predictions (mean age 76.7 ± 9.3 years, 57.2% male). An artificial intelligence learning model was trained (training: n = 663 patients, validation: n = 206 patients) and tested (testing: n = 222 patients) to predict pressure gradient, and a separate artificial intelligence learning model was trained (training: n = 640 patients, validation: n = 218 patients) and tested (testing: n = 205 patients) for predicting aortic valve area. ResultsThe mean absolute error for pressure gradient and aortic valve area predictions was 3.0 mm Hg and 0.45 cm2, respectively. Valve sheath size, body surface area, and age were determined to be the top 3 predictors for pressure gradient, and valve sheath size, left ventricular ejection fraction, and aortic annulus mean diameter were identified to be the top 3 predictors of post–transcatheter aortic valve replacement aortic valve area. A training dataset size of more than 500 patients demonstrated good robustness of the artificial intelligence models for pressure gradient and aortic valve area. ConclusionsThe artificial intelligence–based algorithm has demonstrated potential in predicting post–transcatheter aortic valve replacement transvalvular pressure gradient predictions for patients with aortic valve stenosis. Further studies are necessary to differentiate pressure gradient between valve types.

The Intrapelvic Pressure during Retrograde Intrarenal Surgery in the Setting of Ureteral Access Sheath Size: Experimental Study on 3D Printed Model

Introduction: There is no standardised, universal method to assess physical conditions such as pressure in the pelvicalyceal system in real time during RIRS (retrograde intrarenal surgery). Therefore, the problem of increased pressure in the upper urinary tract during the procedure is underestimated. Moreover, it can potentially cause micro-damage and longer postoperative recovery. The aim of this study was to evaluate intrapelvic pressure (IPP) during RIRS procedures. Materials and Methods: The 3D printed models of the pelvicalyceal system were printed based on a CT scan of the real patient. They were used to perform 50 RIRS procedures with laser lithotripsy of artificially synthesised kidney stones with two different sizes of ureteral access sheath-UAS (10/12Fr vs. 12/14Fr) together with different energy settings generated by the holmium:YAG laser. IPP monitoring during RIRS was performed with the use of the PressureWire X Guidewire compatible with the CoroFlow system. Results and Conclusions: The results showed that a high IPP of up to 400 cmH2O would be achieved using a 10/12Fr UAS, while the use of a 12/14Fr UAS would significantly reduce the peak pressure to approximately 100 cmH2O; hence, the size of the UAS is a pivotal factor of the IPP generated during the procedure.

The number of screwing attempt and predictors for the success of left bundle branch area pacing : A multicenter experience with standard stylet-driven pacing leads

Abstract Objectives Although Left Bundle Branch Area Pacing (LBBAP) is emerging conduction system pacing modality, it is unclear which parameters are predictive of procedural success and how many screwing attempts are acceptable. This retrospective observational study sought to assess predictors of successful LBBAP, left bundle branch (LBB) capture, and factors associated with the number of screwing attempts. Methods We performed a multicenter retrospective analysis of 120 patients who underwent LBBAP with stylet driven lead. We analyzed factors affecting the number of screwing attempts and procedural success. Procedural, 12-lead ECG, echocardiographic parameters and clinical variables were used in multivariate analyses. Results LBBAP success rate was 95.8% (115/120), and LBB capture success rate was 86.1% (99/115). Few screwing attempts was associated with procedural success (2.1 ± 1.2, 2.7 ± 1.2, and 3.5 ± 1.3 in LBBAP with LBB capture, LBBAP without LBB capture and failed LBBAP group, respectively) (p for trends=0.03). 4 or more screwing attempt was independently associated with higher complication rate compared to fewer screwing attempt (n≤3) (p&amp;lt;0.05). The larger RA size (B = 1.901, 95% confidence interval [CI] 1.07 - 2.73, p &amp;lt;0.001), smaller RV size (B = -0.995, 95% CI -1.88 - -0.31, p = 0.007), and intraventricular conduction delay (IVCD) at pre-implant ECG were independently associated with more screwing attempts. Larger RA size (4th quartile) was associated with larger final sheath size and frequent sheath size change to larger sheath when compared to others. Conclusions More screwing attempts was associated with failed LBBAP procedure and failed LBB capture, and 4 or more screw attempts was associated with higher complication rate. Larger the RA size, smaller the RV size, and IVCD in pre-implant ECG are predictive of more screwing attempt.

Abstract 12712: Safety of Latex Containing Swan-Ganz Catheters in Patients With Cutaneous Hypersensitivity to Latex

Introduction: Hypersensitivity to latex is common. Balloon-tipped right heart catheters are typically made from latex. Latex-free catheters while available have limitations including the need for large sized vascular sheaths. It is unknown if latex balloon catheters can be safely used in patients who have cutaneous reactions to latex. Goals: The goal of this study was to assess the safety of using latex-containing catheters for right heart catheterization (RHC) in patients with a prior history of cutaneous allergy to latex. Methods: Electronic medical records and cardiac catheterization procedure database identified 127 consecutive patients with a history of cutaneous hypersensitivity (rash, urticaria) to latex who underwent RHC with balloon-tipped catheters. Patients with known anaphylaxis to latex were excluded. The primary outcome was the occurrence of periprocedural hypersensitivity reactions. Outcomes of patients with latex-containing catheters (LC Group, n=99) were compared to patients with latex-free catheters (LF Group, n=28). Results: The study population consisted of 28 men and 99 women, aged 65 + 14 years. Indications for RHC were heart failure in 48 (38%), pulmonary hypertension in 25 (20%), cardiomyopathy in 19 (15%), valvular heart disease in 19 (15%), unexplained dyspnea in 13 (10%), and heart transplant in 2 (2%). LC and LF patients had comparable demographics, cardiac risk factors, and indications for RHC. In-body catheter exposure times in the LC and LF groups were 8.6 + 5.0 and 9.7 + 6.1 minutes, respectively (p=ns). Venous sheath sizes were smaller in the LC group; sheaths &lt; 5 Fr were used in 52/99 (53%) of the LC group vs. 0/28 in the LF group (p&lt;0.001). Antecubital vein access was used in 42/99 (42%) of the LC group but in none of the LF group (p&lt;0.001). There were no procedural hypersensitivity reactions in either the LC or LF groups. Repeat procedures were common; in total, 149 RHC were performed using latex catheters with no reactions. Conclusions: In patients with a history of non-anaphylactic cutaneous hypersensitivity to latex, the use of latex balloon-tipped catheters was not associated with allergic reactions. Latex catheters offer technical advantages including smaller sized vascular sheaths and more options for venous access.

Single femoral artery access is safe and feasible during transcatheter aortic valve replacement: a propensity score matched analysis.

Transcatheter aortic valve replacement (TAVR) potentially may be significantly simplified by using the single artery access (SA) technique, which does not require a secondary artery access. Nevertheless, the safety and efficacy of this technique remains unclear. Our goal was to determine if single artery access TAVR (without upgrading the sheath size) is a feasible, minimally invasive procedure. Patients with symptomatic severe aortic stenosis who underwent TAVR via the femoral artery were consecutively enrolled in this study. Eligible individuals were divided into 2 groups: the SA group and the dual artery access (DA) group. The primary end point was device success (defined by the valve academic research consortium 3, VARC 3). A 6-month follow-up and propensity score matching analyses were performed. After propensity score matching analysis, a total of 130 patients were included: 65 in the SA group and 65 in the DA group. The SA procedure achieved similar device success (95.4% vs. 87.7%; P = 0.115) compared with the DA procedure. The SA procedure shortened the operating time (102 min vs. 125 min; P = 0.001) but did not increase the x-ray time or dose. Both a 20 Fr and a 22 Fr sheath (without upgrading the sheath size) could be used for the SA procedure. There was no major vascular complication occurred in both groups. The incidence of minor main vascular and access complications in the SA group was comparable to those of the DA procedure (0.0% vs. 3.1%; P = 0.156). The SA access procedure is a promising minimally invasive TAVR technique with a low incidence of vascular complications and a high incidence of device success. It is safe and possibly applicable in all TAVR procedures.

Clinical outcomes of MANTA closure device in percutaneous endovascular aortic aneurysm repair

ObjectiveThe MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR). MethodsAll data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up. ResultsIn total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m2. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events. ConclusionsThis single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.

A Comparative Analysis of the Early and Late Complication Rates and the Effect of Calcification on the Efficacy of MANTA and ProGlide Vascular Closure Devices.

Introduction The Perclose ProGlide and, more recently, MANTA Large-Bore Closure Device are commonly used vascular closure devices (VCDs) for managing large-bore vascular access haemostasis. The extent of calcification in the common femoral artery (CFA) plays a crucial role in choosing between these devices. ProGlide may face challenges with anterior calcification, while MANTA may have issues with posterior calcification. Our study compared their effectiveness, adjunct usage, calcification impactand early/late complications. Methods A retrospective analysis of procedures involving large-bore CFA access from 2017 to 2022 was conducted. Closure was grouped according to VCD as Group A (ProGlide) and Group B (MANTA). Calcification was designated as anterior and posterior and combined on pre-operative computed tomography angiography along 10 mm segments with 0.625 mm slice thickness. The success of haemostasis was graded as Grade 1 (haemostasis without adjuncts), Grade 2 (haemostasis with adjuncts) and Grade 3 (failed haemostasis needing rescue); Grades 1 and 2 were pooled as successful haemostasis. Statistical analysis was undertaken in Minitab 21 for Windows, particularly analysing calcification and its impact on the success of haemostasis. Results We evaluated 370 large-bore CFA accesses, distributed across two groups: Group A(64.9%, n=243)and Group B(35.1%, n=127), for a total of 205 endovascular procedures (93.1% (191) EVAR and 5.3% (11) TEVAR). The mean age was 74.9±8 years, predominantly males(88.2%, n=181). The average body mass index (BMI) was 28±5.8, with 20.9% (43) individuals having diabetes and 18.5% (37) current smokers. The mean sheath size OD was 16±2.5, with 4.5% (11) re-do groins in Group A and 6.2% (8) in Group B. Successful haemostasis was achieved in 91.8% (n=223) in Group A(44.8%, n=109 Grade 2)and 90.5% (n=115) in Group B(21%, n=27 Grade 2). Rescue operations were needed in 8.2% (20) in Group A and 9.1% (12) in Group B. Pseudoaneurysms developed more commonly in Grade 2 haemostasis with 9.9% (11) in Group A and 1.6% (2) in Group B(p=0.3). Anterior calcification was observed in 14.8% (36) in Group A and 18.8% (24) in Group B. In comparison, posterior calcification was present in 62.5% (152) in Group A and 66.9% (85) in Group B. Notably, calcification did not significantly impact haemostasis (p=0.79). Additional VCD deployment was necessary due to device failure in 4.5% (11) cases in Group A and 1.5% (2) cases in Group B. Conclusion The overall success rate was comparable between the two groups. However, Group A required more adjuncts to achieve successful haemostasis. The site of calcification did not impact the efficacy ofclosure devices.Pseudoaneurysm formation was more frequent when adjuncts were needed.

Computed tomography defined femoral artery plaque composition predicts vascular complications during transcatheter aortic valve implantation.

Vascular and bleeding complications after transcatheter aortic valve implantation (TAVI) are common and lead to increased morbidity and mortality. Analysis of plaque at the arterial access site may improve prediction of complications. We investigated the association between demographic and procedural risk factors for Valve Academic Research Consortium (VARC-3) vascular complications in patients undergoing transfemoral TAVI with use of a vascular closure device (ProGlide® or MANTA®) in this retrospective cohort study. The ability of pre-procedure femoral CT angiography to predict complications was investigated including a novel method of quantifying plaque composition of the common femoral artery using plaque maps created with patient specific X-ray attenuation cut-offs. 23 vascular complications occurred in the 299 patients in the study group (7.7%). There were no demographic risk factors associated with vascular complications and no statistical difference between use of closure device (ProGlide® vs MANTA®) and vascular complications. Vascular complications after TAVI were associated with sheath size (OR 1.36, 95% CI 1.08-1.76, P 0.01) and strongly associated with CT-derived necrotic core volume in the common femoral artery of the procedural side (OR 17.49, 95% CI 1.21-226.60, P 0.03). Plaque map analysis of the common femoral artery by CT angiography reveals patients with greater necrotic core are at increased risk of VARC-3 vascular complications. The novel measurement of necrotic core volume in the common femoral artery on the procedural side by CT analysis was associated with post-TAVI vascular complications, which can be used to highlight increased risk.

Transradial or Transulnar Long Sheath Access to the Brachial Artery Allows for Neuroendovascular Procedures in Patients with Radial or Ulnar Artery Occlusion

Transradial access is an important tool for many neuroendovascular procedures. Occlusion of the radial or ulnar artery is not uncommon after transradial or transulnar access and can present a challenge for patients requiring repeat angiography. Between March 2022 and June 2023, patients undergoing transradial or transulnar angiography who were found to have a radial artery occlusion or ulnar artery occlusion were identified. Repeat catheterization of the occluded artery was attempted using a 21-gauge single wall puncture needle and a 0.021-inch wire to traverse the occlusion and insert a 23-cm sheath into the brachial artery. A total of 25 patients undergoing 26 angiograms during the study period were found to have a radial artery occlusion or ulnar artery occlusion. Successful repeat catheterization of the occluded artery was achieved in 21 of 26 cases (80.7%). Outer diameter sheath size ranged from 5 Fr (0.0655 inch) to 8 Fr (0.1048 inch). No access complications were encountered. Number of prior angiograms, time since prior angiogram, and prior angiogram procedure time were associated with lower likelihood of successful access. Transradial or transulnar neuroangiography through an occluded radial or ulnar artery is safe and feasible by traversing the occlusion into the brachial artery with a 23-cm sheath. Repeat catheterization is most successful in patients with an arterial occlusion <6 months old. This technique is important in patients who have limited options for arterial access, avoiding access site complications inherent in transfemoral access, and in patients who specifically require radial or ulnar artery access.