ProGlide Group Research Articles

Evaluation of Pain Following the Use of Different Single-file Glide Path Systems: A Randomized Clinical Trial

IntroductionThis study aimed to evaluate postoperative pain intensity following glide-path preparation using the ProGlider (PG) and WaveOne Gold Glider (WOGG) systems in asymptomatic teeth with necrotic pulp and periapical lesions. MethodsIn this randomized clinical trial (ClinicalTrials.gov ID: NCT05955742) maxillary and mandibular molars with asymptomatic apical periodontitis of 78 patients (age, 18–65 years) were included. The patients were randomly divided into 3 groups: control (n = 26), PG (n = 26), and WOGG (n = 26). All the systems were used according to the manufacturer's instructions, and all the root canal treatments were completed by a single operator within 2 sessions. Postoperative pain was assessed using a numerical rating scale at 6, 12, 18, 24, 48, and 72 hours. Analgesics administered and abscess formation were also recorded. Statistical analyses were performed using the Mann–Whitney U, Bonferroni Dunn, Friedman, Chi-square, and Fisher exact tests. ResultsThe postoperative pain at 12 and 18 hours was lower in the WOGG group than in the other groups (P < .05). The postoperative pain scores at 6 and 24 hours were higher among women than among men (P < .05). The highest postoperative pain scores were observed at 6 hours (P < .05). ConclusionsThe WOGG glide-path file system was associated with less postoperative pain than the other systems. Abscess formation and analgesic use were higher in the PG group than in the other groups. Postoperative pain was greater in women than in men.

Vascular complications of ProGlide versus Prostar in transcatheter aortic valve replacement (TAVR) procedures: meta-analysis.

The aim of this study was to compare the vascular complications of ProGlide and Prostar in percutaneous transfemoral transcatheter aortic valve replacement. Electronic databases were searched in July 2022 for studies that compared the vascular complications of ProGlide and Prostar for percutaneous closure in transcatheter aortic valve replacement. The primary outcome was major vascular complications and the secondary outcomes were minor vascular complications, types of access-site vascular complications, device failure, and additional intervention. Estimates of relative effects were pooled to generate ORs and their 95 per cent c.i. using a random-effects model. The risk of bias in non-randomized comparative studies was assessed using the Risk Of Bias In Non-randomized Studies - of Interventions ('ROBINS-I') tool. Nine studies were identified and a total of 7529 patients were included. Among them, 4144 patients received ProGlide and 3385 received Prostar. The pooled data showed that the risk of major vascular complications was significantly lower with ProGlide versus Prostar (OR 0.50, 95 per cent c.i. 0.32 to 0.78). Regarding the types of vascular complications, vascular trauma was the most common complication and the risk was similar between groups (OR 1.02, 95 per cent c.i. 0.55 to 1.91). ProGlide had a lower risk of bleeding complications (OR 0.46, 95 per cent c.i. 0.22 to 0.94), but a higher risk of ischaemia complications (OR 1.90, 95 per cent c.i. 1.10 to 3.27). The risk of device failure was lower in the ProGlide group (OR 0.45, 95 per cent c.i. 0.21 to 0.95). Both groups had a similar risk of having additional interventions for vascular complications (OR 1.02, 95 per cent c.i. 0.75 to 1.39). The use of ProGlide was associated with a lower risk of additional surgical treatments (OR 0.52, 95 per cent c.i. 0.34 to 0.80), but a higher risk of endovascular treatments (OR 2.69, 95 per cent c.i. 1.29 to 5.63). In percutaneous transfemoral transcatheter aortic valve replacement procedures, ProGlide has superior safety and efficacy when compared with Prostar; it is associated with fewer major vascular complications and device failures. The vascular complications of ProGlide are more likely to be dealt with using endovascular treatments than surgical treatments.

Feasibility and clinical benefits of the double-ProGlide technique for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants.

To access the efficacy and safety of the double-ProGlide technique for the femoral vein access-site closure in cryoballoon ablation with uninterrupted oral anticoagulants (OAC), and its impact on the electrophysiology laboratory time as well as hospital stay after the procedure in this observational study. Patients with atrial fibrillation undergoing cryoballoon ablation with uninterrupted OAC at Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China from May 2019 to May 2021 were enrolled in this study. From October 2020, double-ProGlide technique was consistently used for hemostasis (ProGlide group), and before that conventional manual compression was utilized (manual compression group). The occurrence of vascular and groin complications was accessed during the hospital stay and until the three-month follow-up. A total of 140 participants (69.30% of male, mean age: 59.21 ± 10.29 years) were evaluated, 70 participants being in each group. Immediate hemostasis was achieved in all the patients with ProGlide closure. No major vascular complications were found in the ProGlide group while two major vascular complications were occurred in the manual compression group. The incidence of any groin complication was obviously higher in subjects with manual compression than patients with ProGlide devices (15.71% vs. 2.86%, P = 0.009). In addition, compared with the manual compression group, the ProGlide group was associated with significantly shorter total time in the electrophysiology laboratory [112.0 (93.3-128.8) min vs. 123.5 (107.3-158.3) min, P = 0.006], time from sheath removal until venous site hemostasis [3.8 (3.4-4.2) min vs. 8.0 (7.6-8.5) min, P < 0.001], bed rest time [8.0 (7.6-8.0) h vs. 14.1 (12.0-17.6) h, P < 0.001] and hospital stay after the procedure [13.8 (12.5-17.8) h vs. 38.0 (21.5-41.0) h, P < 0.001]. Utilization of the double-ProGlide technique for hemostasis after cryoballoon ablation with uninterrupted OAC is feasible and safe, which has the clinical benefit in reducing the total electrophysiology laboratory time and the hospital stay length after the procedure.

Effect of different glide path establishing systems on apically extruded debris in curved root canals – An in vitro study

ABSTRACT Aim: The aim of this study was to evaluate the effect of different glide path establishing systems when used along with WaveOne Gold (WOG) single-file reciprocating system and ProTaper Gold (PTG) rotary multifile system on apically extruded debris in curved root canals. Methods: Eighty extracted mandibular molar teeth with curved mesial roots were selected for this study. Specimens were randomly divided into eight experimental groups according to the root canal preparation (n = 10): Group 1 (WOG + H and K-file), Group 2 (WOG+ G-Files),Group 3 (WOG+ One G), Group 4 (WOG + ProGlider), Group 5 (PTG + Hand K-file), Group 6 (PTG+ G-Files), Group7 (PTG+ One G), and Group 8 (PTG + ProGlider). Roots were attached to preweighed Eppendorf tubes. All instruments were used according to the manufacturers’ instructions. During root canal preparation, 8 mL of distilled water was used for each specimen. Apically extruded debris was collected in Eppendorf tubes. After the completion of root canal preparation, Eppendorf tubes were removed from the specimens and stored in an incubator at 70°C for 5 days. Eppendorf tubes were weighed after evaporation to calculate the amount of extruded debris. The data were subjected to statistical analysis using one-way analysis of variance and post hoc Tukey’s test at a significance level of P &lt; 0.05. Results: A statistically significant difference was observed between the ProGlider and K-file groups. The ProGlider group was associated with significantly less debris extrusion than the K-file group for both the shaping systems used: WOG (P = 0.048) and PTG (P = 0.044). There was no statistically significant difference between NiTi rotary glide path files: ProGlider, G-Files, and One G files. All experimental groups caused apical debris extrusion. Conclusion: Among all mechanical glide path files tested, ProGlider showed the least debris extrusion which was significantly less than K-file. Glide path preparation using NiTi rotary files in combination with rotary shaping files (PTG) was associated with less apical debris extrusion than the rotary glide path files used along with reciprocating file (WOG).

Comparative analysis of torsional and cyclic fatigue resistance of ProGlider, WaveOne Gold Glider, and TruNatomy Glider in simulated curved canal.

This study aimed to compare the torsional and cyclic fatigue resistance of ProGlider (PG), WaveOne Gold Glider (WGG), and TruNatomy Glider (TNG). A total of 15 instruments of each glide path system (n = 15) were used for each test. A custom-made device simulating an angle of 90° and a radius of 5 millimeters was used to assess cyclic fatigue resistance, with calculation of number of cycles to failure. Torsional fatigue resistance was assessed by maximum torque and angle of rotation. Fractured instruments were examined by scanning electron microscopy (SEM). Data were analyzed with Shapiro-Wilk and Kruskal-Wallis tests, and the significance level was set at 5%. The WGG group showed greater cyclic fatigue resistance than the PG and TNG groups (p < 0.05). In the torsional fatigue test, the TNG group showed a higher angle of rotation, followed by the PG and WGG groups (p < 0.05). The TNG group was superior to the PG group in torsional resistance (p < 0.05). SEM analysis revealed ductile morphology, typical of the 2 fracture modes: cyclic fatigue and torsional fatigue. Reciprocating WGG instruments showed greater cyclic fatigue resistance, while TNG instruments were better in torsional fatigue resistance. The significance of these findings lies in the identification of the instruments' clinical applicability to guide the choice of the most appropriate instrument and enable the clinician to provide a more predictable glide path preparation.

Comparison of complication and success rates of perclose proglide device with surgical cut down in patients undergoing TAVI and TEVAR/EVAR Procedures

Background: The Common Femoral Artery (CFA) is the most frequently used peripheral artery for Trans-catheter aortic valve implantation (TAVI) and Endovascular Aortic Repair (EVAR)/ Thoracic Endovascular Aortic Repair (TEVAR) procedures. CFA access hemostasis could be obtained by manual compression, surgical cut-down, or using arteriotomy closure devices, including ProGlide. Method: During a retrospective cohort study we compared ProGlide with surgical cut-down hemostasis in 225 patients who underwent TAVI or EVAR/TEVAR, including 290 access sites, during a 10 years period in terms of access site complications, procedure length and post-procedural hospitalization duration. Results: The success rate of hemostasis was 100% in the PP device group and 98.3% in the SCD group. The mean Procedure length was significantly shorter in ProGlide device hemostasis and the mean post-procedural hospitalization length had a non-significant difference between the two groups. Access site complications occurred in 21.1% of the ProGlide group and 26% of the SCD group. Conclusion: Perclose ProGlide device is safe and effective for access site closure in procedures that need large sheaths and it is non-inferior to standard surgical cut-down. Training, experience and careful application of the device have significant importance in ensuring successful hemostasis.

Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation.

Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited. We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI. We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria. Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08). A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

Comparison of MANTA vs ProGlide Vascular Closure Device and 30-Day Outcomes in Transfemoral Transcatheter Aortic Valve Implantation.

Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have an increased mortality risk, and vascular closure device (VCD) use is mandatory. The percutaneous MANTA VCD (Teleflex) is a novel collagen-based technology for closure of large-bore arteriotomies. We compared the MANTA VCD with the suture-based ProGlide VCD (Abbott Vascular). A retrospective review was performed on all consecutive patients who underwent transfemoral TAVI in our center from January 1, 2015, to February 28, 2021, and 30-day outcomes were recorded. Major adverse cardiovascular events (MACE) were cardiac death, disabling stroke, and/or major VCs. Access site-related VCs were VCs related to the access site vessel from which the transcatheter valve was introduced and advanced. The MANTA VCD was used in 99 patients and the ProGlide in 224. There was 4.0% MACE in the MANTA group and 4.9% in the ProGlide group (P = .999). Overall VCs were 10.1% vs 7.6%, major VCs were 3.0% vs 2.2%, and minor VCs 7.1% vs 5.4%(P = .753). Access site-related VCs were 5.1% vs 5.8% in the (P = .999), and periprocedural vascular surgical intervention was needed in 6.1% of the MANTA group vs 2.2% of the ProGlide group (P = .099). There was no significant difference in MACE, mortality, cardiovascular mortality, VCs, access site-related VCs, periprocedural vascular surgical interventions, bleeding, or transfusion rate between the 2 groups. The MANTA VCD group had more periprocedural vascular surgical interventions which did not reach statistical significance.

Comparing the outcomes of bedside percutaneous VA-ECMO decannulation by ProGlide and Manta in a high-ECMO-volume center in Hong Kong.

The use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) decannulation with different percutaneous closure devices has been increasing. At our center, ProGlide devices have been used since November 2018, and Manta devices became an alternative since March 2020. This study aimed to compare the success and complication rates and the clinical outcomes of ProGlide and Manta devices for VA-ECMO decannulation after arteriotomy wound closure. We retrospectively reviewed the results of bedside VA-ECMO decannulation between November 2018 and June 2021. Patients with VA-ECMO who could be bridged to recovery were recruited and divided into the ProGlide or Manta group based on the closure device used. Procedure time, amount of blood loss, amount of blood products transfused, and use of vasoactive medications during the procedure were documented. Clinical examination and Doppler ultrasound were performed to detect any complications. After the closure technique, ProGlide was used in 44 patients and Manta was used in 13. There was no significant difference in the success rate between the ProGlide and Manta groups (86.4% vs. 100%). Amount of blood loss was greater in the ProGlide group than in the Manta group (290 [100-400] ml vs. 50 [50-100] ml), and more patients in the ProGlide group required an increased dose of inotropes during the procedure (59.1% vs. 15.4%), but the transfusion requirement was similar between the two groups. The success rate of hemostasis using arteriotomy wound closure during VA-ECMO decannulation was similar between the two devices.

Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique.

Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.

Sheath Size Up and Down With Single Proglide – A Technique for Achieving Hemostasis With Use of Large Size Delivery System During Endovascular Graft Placement

A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device (ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach. We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months. We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34% patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (P-0.005) CONCLUSION: In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice.

A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization

The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin. Between December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95%CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95%CI: 1.93 to 6.15; p = 0.0016). In patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success. Step trial was registered on http://ClinicalTrials.gov (NCT03192033).

Comparison between Surgical Access and Percutaneous Closure Device in 787 Patients Undergoing Transcatheter Aortic Valve Replacement

Background: The vascular access in transcatheter aortic valve replacement (TAVR) was initially dominated by a surgical approach. Meanwhile, percutaneous closure systems became a well-established alternative. The aim of this study was to compare the clinical outcome between the two approaches. Methods: In this retrospective study, we observed 787 patients undergoing a TAVR-Procedure between 2013 and 2019. Of those, 338 patients were treated with surgical access and 449 with the Perclose ProGlide™-System (Abbott, Chicago, IL, USA). According to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium (VARC) criteria, the primary combined endpoints were defined. Results: Overall hospital mortality was 2.8% with no significant difference between surgical (3.8%) and percutaneous (2.2%) access (p = 0.182). Major vascular complications or bleeding defined as the primary combined endpoint was not significantly different in either group (Surgical group 5.3%, ProGlide group 5.1%, p = 0.899). In the ProGlide group, women with pre-existing peripheral artery disease (PAD) were significantly more often affected by a vascular complication (p = 0.001 for female sex and p = 0.03 for PAD). Conclusions: We were able to show that the use of both accesses is safe. However, the surgical access route should also be considered in case of peripheral artery disease.

Large Bore Vascular Access Closure Device Strategies

ABSTRACT Background: The optimal strategy for large bore vascular closure following TAVR is a matter of contention as major bleeding and vascular complications remain a challenge. We compared three strategies for post-TAVR vascular closure in terms of safety and efficacy: a dual ProGlide-based strategy, a hybrid strategy of ProGlide and Angio-Seal, and a MANTA strategy. Methods: Patients were enrolled in one of the three strategies: two ProGlides, a single ProGlide with an 8 F Angio-Seal, or a single 18 F MANTA. Results: In total, 172 patients were enrolled in this study: 86 in the MANTA group, 40 in the ProGlide/Angio-Seal group, 46 in the dual ProGlide group. Hemostasis was achieved in 95% of patients. MANTA was associated with vessel occlusion in 2% of cases. The dual ProGlide group required an extra device to achieve hemostasis in 35% of cases. Conclusion: The three strategies of MANTA, dual ProGlides, or ProGlide/Angio-Seal are all effective, but there are important differences between them which mandate careful consideration by operators. Abbreviations: TAVR: Transcatheter Aortic Valve Replacement; VCD: Vascular Closure Device; CT: Computed Tomography; DSA: Digital Subtraction Angiography

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

A comparative assessment of apical debris extrusion by various glide path establishing endodontic instruments: An in vitro study

Introduction: A reproducible glide path provides guidance to fulfil the mechanical objective of cleaning and shaping root canals with minimal procedural errors. Debris expelled during this procedure contributes to inter-appointment flare-up. The objective of this in vitro study was to estimate and compare the quantity of debris extruded by; hand, rotary and reciprocating glide path preparation instruments. Materials and Methods: Seventy-five human single rooted, matured mandibular incisors with single canal and comparable lengths were randomly allocated into three groups (n = 25): group A – Stainless steel (SS) K-file (No 15), Group B – ProGlider, and Group C –WaveOne Gold Glider. Customized apparatus using Meyers and Montgomery method was utilized to accumulate the debris expelled apically in the Eppendorf tubes weighed priorly in digital analytical balance of 10−6 g accuracy. All groups were instrumented as per the manufacturer's guidelines. After instrumentation, teeth were detached from the Eppendorf tubes and tubes incubated at 70°C for 5 days to vaporize the irrigating solution. The tubes with dry debris were later weighed in the same weighing balance. The collected information was analyzed by one-way ANOVA and Tukeys honest significant difference post hoc test at significance level (P Results: The ProGlider group expressed statistically significant result with least quantity of extruded debris in the comparison to other groups (P Conclusion: Glide path preparations with rotary ProGlider resulted in the minimal extrusion of debris in comparison to the reciprocating WaveOne Gold Glider and the manual stainless-steel K-files.

Safety and effectiveness of single ProGlide vascular access in patients undergoing endovascular aneurysm repair

ObjectiveThe objective of this study was to evaluate the safety and effectiveness of single ProGlide use per bilateral access site for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms. MethodsA retrospective cohort study was performed for all elective percutaneous EVARs from November 2015 to December 2017 at the QEII Health Sciences Centre (Halifax, Nova Scotia, Canada). Exposure of interest was number of ProGlides used per access site, dichotomized into bilateral single ProGlide closure vs nonsingle ProGlide closure on at least one femoral arteriotomy. Outcomes included Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC) criteria. Groups were compared with Fisher exact test, analysis of variance, or Wilcoxon rank sum, as appropriate. Logistic regression was used to compare the effect of single ProGlide use on VARC-2 and BARC criteria. ResultsA total of 131 cases were included, of which 116 had bilateral single ProGlide use for access closure. Baseline characteristics including comorbidities and smoking status were compared between groups. Groups were similar for all characteristics except smoking status, with an increased proportion of former smokers in the nonsingle ProGlide group. There were 119 (90.8%) patients who had single ProGlide use on the right femoral artery and 121 (92.4%) on the left; 16 (12.2%) patients had ProGlide deployment issues. Median maximal right and left femoral sheath diameters were 16F (interquartile range [IQR], 16F-18F) and 14F (IQR, 14F-16F), respectively. Median length of stay was 1 day (IQR, 1-1 day). VARC-2 criteria occurred in 8 of 131 (6.11%) patients, 6 of 116 (5.17%) with bilateral single ProGlides and 2 of 15 (13.3%) with nonsingle ProGlides. BARC criteria occurred in 6 of 131 (4.58%) patients, 5 of 116 (4.31%) with bilateral single ProGlides and 1 of 15 (6.67%) with nonsingle ProGlides. Single ProGlide use was not associated with a difference in VARC-2 (odds ratio, 0.35; 95% confidence interval, 0.64-1.94) or BARC (odds ratio, 0.63; 95% confidence interval, 0.07-6.79) criteria. No patients developed pseudoaneurysms or required repeated intervention for bleeding. ConclusionsSingle ProGlide use per vascular access site in patients undergoing EVAR is a safe and effective method for access closure with sheath diameters up to and including 16F.

Safety and Effectiveness of Single Proglide Vascular Access in Patients Undergoing Endovascular Aneurysm Repair

To evaluate the safety and effectiveness of single Proglide use per access site for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). A retrospective cohort study was performed for all elective percutaneous EVARs from November 2015 to December 2017 at the QEII Health Sciences Centre, Nova Scotia. Exposure of interest was number of Proglides used per access site. Outcomes of interest included Vascular Access Site and Access Related Complications 2 (VARC-2) and Bleeding Academic Research Consortium (BARC) criteria. Groups were compared with Fisher exact test, analysis of variance, or Wilcoxon rank-sum tests, as appropriate. Logistic regression was used to compare the effect of single Proglide use on VARC-2 and BARC. A total of 131 cases were included, of which 116 had bilateral single Proglide for access closure. Patient demographic and operative data are presented in Tables I and II, respectively. Groups were similar for all characteristics except smoking status, with an increased proportion of former smokers in the nonsingle Proglide group. There were 119 patients (90.8%) who had single Proglide use on the right femoral artery and 121 (92.4%) on the left. Sixteen patients had Proglide deployment issues (12.2%). VARC2 occurred in 8 of 131 patients (6.11%)—6 of 116 (5.17%) with bilateral single Proglides and 2 of 15 (13.3%) with at least two Proglides on one access site. BARC occurred in 6 of 131 patients (4.58%)—5 of 116 (4.31%) with bilateral single Proglides and 1 of 15 (6.67%) with at least two Proglides on one access site. Single Proglide use was not associated with a difference in VARC-2 (odds ratio, 0.35; 95% confidence interval, 0.64-1.94) or BARC (odds ratio, 0.63; 95% confidence interval, 0.07-6.79). No patients developed pseudoaneurysms or required repeat intervention for bleeding. The median length of stay was 1 day. Single Proglide use per vascular access site in patients undergoing EVAR is a safe and effective method for access closure.Table IBaseline characteristics and comorbiditiesEntire cohort (N = 131)Single Proglide (n = 116)Nonsingle Proglide (n = 15)P valueNo. or median% or IQRNo. or median% or IQRNo. or median% or IQRAge7368-796674-796872-75.318Male sex10680.99380.21386.7.735American Society of Anesthesiologists class.161 22836.42332.9571.4 34558.44361.4228.6 445.1945.7100.0Body mass index2426.9-30.226.924.0-30.225.124.7-28.4.504Comorbidities Coronary artery disease4937.44437.9433.3.785 Hypertension10983.29884.51173.3.280 Chronic kidney disease1612.21512.916.67.693 Pulmonary vascular diseaseDyslipidemiaDiabetes mellitus6448.95648.315100.788IQR, Interquartile range. Open table in a new tab Table IIOperative dataEntire Cohort (n = 131)Single Proglide (n = 116)Nonsingle Proglide (n = 15)P valueNo., median or mean%, IQR or SDNo., median or mean%, IQR OR SDNo., median or mean%, IQR or SDAnesthesia.270 Local10680.99682.71066.7 General2317.61815.5533.3 Local to general21.521.7200.0Surgery length (n = 99)10539.51064195.822.9.375Heparin (n = 114)581418825798192459331579.7950Protamine (n = 108)33.814.233.714.6359.12.7883Sheath size Right1616-181616-181616-18.203 Left1414-161414-161414-14.536IQR, Interquartile range.P values are from Fisher exact test, analysis of variance, or Wilcoxon rank-sum test as appropriate. Open table in a new tab

A Stopped Pilot Study of the ProGlide Closure Device After Transbrachial Endovascular Interventions

Purpose: To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials and Methods: From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications. Results: Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions: surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped. Conclusion: Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.

Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide

BackgroundDespite decreasing sheath diameter, access site bleeding and vascular complications are still a major concern in transfemoral aortic valve implantation (TAVI), and may increase morbidity and even increase mortality. The aim was to compare safety of arterial closure in transfemoral TAVI with two different principles, pre-suture with ProGlide and collagen plug closure with Manta.ResultsSeventy-six patients treated with ProGlide and 75 with Manta were analysed. The endpoints were 1: access site vascular complications and 2: non-planned vascular or endovascular surgery at the puncture site. Complications occurred in 2 (2.7%) ProGlide and in 8 (10.7%) Manta cases, p = 0.047. During the learning phase there were no significant differences. In the established phase there was one event (2%) in the ProGlide group, compared to 6 endpoints (12.0%), p = 0.047, in the Manta group.Unplanned surgery or intervention was seen in two (2.7%) ProGlide and in 7 (9.3%) Manta patients, p = ns. There were no significant differences during the learning phase. In established use, endpoints occurred more frequently in patients treated with the Manta device (12%), than in patients treated with the ProGlide (2%), p = 0.047.ConclusionThe ProGlide presuture closure device was associated with significantly lower rates of vascular complications and lower rates of surgery and interventions compared to the collagen plug Manta system.Trial registrationThe data were collected from Internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål.