Objective: To compare the safety and effectiveness of the 'pre-close' technique for percutaneous femoral artery (FA) access and closure (PEVAR) to Surgical Cutdown (SEVAR).
| PEVAR Perclose N=50 |
SEVAR N=50 |
Difference 95% CI13 |
p-value13 | |
|---|---|---|---|---|
| Major Complications [95% CI]17 |
6% (3/50) [1.3%, 16.5%] |
10% (5/50) [3.3%, 21.8%] |
-4.0% [-, 4.9%] |
0.0048 |
| PEVAR Perclose N=50 |
SEVAR N=50 |
p-value13 | |
|---|---|---|---|
| Minor Ipsilateral Access Site Vascular Complications at 30 Days [95% CI]17 | 4% (2/50) [0.5%, 13.7%] |
8% (4/50) [2.2%, 19.2%] |
0.677714 |
11. By two-sample t-test.
12. PEVAR-Perclose analyzed independently from Prostar™ XL.
13. One-sided p-value and 95% confidence interval for non-inferiority test by using asymptotic test statistics with non-inferiority margin of 10%.
14. No statistically significant difference.
15. By Fisher's exact test.
16. Major Complications: access site vascular injury requiring repair; new onset lower extremity ischemia requiring surgical or percutaneous intervention; Access site-related bleeding requiring transfusion; access site-related infection requiring IV antibiotic or prolonged hospitalization; access site-related nerve injury that is permanent or requires surgery.
17. By Clopper-Pearson exact confidence interval.
18. Minor Complications: pseudoaneurysm or AV fistula; hematoma ≥ 6 cm; post-discharge bleeding requiring > 30 minutes to re-achieve hemostasis; lower extremity arterial emboli or stenosis attributed to access site; deep vein thrombosis; access site-related vascular laceration; transient access site-related nerve injury; access site wound dehiscence; access site-related lymphocele; localized access site infection treated with IM or PO antibiotic.
Source: Nelson, Peter R. et al. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). Journal of Vascular Surgery. (2014): 1181-1193.
A prospective analysis was performed to evaluate the safety and effectiveness of the Perclose in closing large-sized venous access sites through a retrospective data collection. The prospective analysis included subjects in whom Perclose was used as the primary method for large-bore venous access site closure during the TMVr index procedure with a 24F vascular sheath.
Low major complications at 30 days
19. EVEREST II/REALISM Continued Access Registry Study.
Source: The Use of the Perclose ProGlide™ Suture Mediated Closure (SMC) Device for Venous Access-Site Closure up to 24F Sheaths. Kar, Saibal; Hermiller, James; et al. CRT 2018.
The Perclose vs. Surgical Cutdown retrospective study is designed to compare clinical outcomes and complication rates among patients undergoing closure of large-bore arterial access using Perclose versus Surgical Cutdown (Cutdown) in a real-world setting.
The use of Perclose for repair of large-bore arterial access is associated with significantly lower blood transfusions, infections, mortality, and length of stay compared to Surgical Cutdown.
| Cutdown | Perclose | |
|---|---|---|
| # of Patients | 757 | 757 |
| Anticoagulants◊ | 17.8% | 44.9% |
◊p<0.05
Patients may have had multiple procedures during index admission
Less likely to have an infection
Shorter hospital stay
Less likely to die within 30 days post-procedure
Less likely to require a blood transfusion
Source: Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
Objective: The aim of this publication was to report outcomes of endovascular aneurysm repair with percutaneous femoral access (PEVAR) using Prostar™ XL and Perclose closure systems, from the multi-center Italian Percutaneous EVAR (IPER) registry.
20. Technical success was defined as the ability to obtain a successful percutaneous vascular access and closure without serious complications.
21. Major access-related complications included all the complications requiring an early surgical conversion due to bleeding, pseudoaneurysm, CFA stenosis/occlusion, and were considered a technical failure of system closure.
22. Minor access-related complications were related to the presence of minimal bleeding at the access site not requiring surgical conversion.
Source: Pratesi, G., et al. "Italian Percutaneous EVAR (IPER) Registry: outcomes of 2,381 percutaneous femoral access sites' closure for aortic stent-graft." The Journal of Cardiovascular Surgery 56.6 (2015): 889-898.
Objective: Assessment of efficacy, complication, and potential risk factors for Perclose
23. Device failure defined as failure to achieve hemostasis at the access site, leading to alternative treatment other than manual compression.
Source: Saadi, Eduardo Keller, et al. "Totally Percutaneous Access Using Perclose ProGlide™ for Endovascular Treatment of Aortic Diseases." Brazilian Journal of Cardiovascular Surgery 32.1 (2017): 43-48.
Objective: Evaluate the outcomes and predictive factors for additional Perclose deployment
24. Learning curve shown to be most pronounced over first 18 months. Bechara C.F. et al.: Predicting the learning curve and failures of total percutaneous endovascular aortic aneurysm repair. J Vasc Surg 2013; 57: pp. 72-76.
25. Primary technical success rate defined as the ability to achieve hemostasis without additional ProGlide™ device deployment or surgical repair.
26. Secondary technical success rate defined as the ability to achieve hemostasis after deployment of one or two ProGlide™ devices without surgical repair.
Source: Lin, Shen-Yen, et al. "Predictive Factors for Additional Perclose Deployment in Percutaneous Endovascular Aortic Repair." Journal of Vascular and Interventional Radiology 28.4 (2017): 570-575.
Objective: To evaluate the safety and effectiveness of the “pre-close” technique for PEVAR compared to surgical cutdown (SEVAR)
| Perclose PEVAR | SEVAR | p-value | |
|---|---|---|---|
| Major Complications | 6% (3/50) | 10% (5/50) | 0.0048 |
| Procedure Time | 106.5 ± 44.9 min | 141.1 ± 73.4 | 0.0056 |
| Time to Hemostasis | 9.8 ± 17.0 | 22.7 ± 22.9 | 0.00233 |
27. Procedural technical success defined as successful vascular access and closure per randomized assignment, and successful endograft delivery, deployment, and catheter removal, without serious complication or need for vascular exposure in the percutaneous group.
Source: Nelson, Peter R., et al. "A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial)." Journal of Vascular Surgery 59.5 (2014): 1181-1193.
Objective: Demonstrate clinical and cost benefits when utilizing a Fast-Track EVAR protocol with the Ovation stent graft system
| Fast Track | Standard EVAR*** | Fast-Track Savings | |
|---|---|---|---|
| Anesthesia | Local/Regional $300 |
General $500 |
$200 |
| Access | Bilateral PEVAR $1,200 |
Cutdown† $300 |
($900) |
| ICU | 0% $0 |
1.4 Days, 51% $15,300 |
$15,300 |
| Non-ICU | 1.2 Days $6,700 |
2.3 Days $12,900 |
$6,200 |
| 30D Reintervention | 0% $0 |
$29.4K, 1.1% $300 |
$300 |
| Total | $8,200 | $29,300 | $21,100 |
**Standard EVAR Control group: Benchmarked 8,306 patients treated with standard, elective infrarenal EVAR at an alliance of ~3,750 U.S. Premier hospital facilities, based on Inpatient Discharge between 2012-2015.
***Standard EVAR: Average costs per patient, extracted costs for access, anesthesia, ICU, and hospital stay to calculate costs associated with Fast-Track.
†Assumes 30% applicability based on anatomic criteria, with 23% bilateral PEVAR and 7.0% unilateral PEVAR (Manunga et al., J Vasc Surg. 2013).
Source: Kracjcer, Z. Fast-Track Endovascular Aortic Repair: Final Results from the Prospective LIFE registry. VIVA 2016.
28. Technical Success (Successful Bilateral PEVAR)
Source: Kracjcer, Z. Fast-Track Endovascular Aortic Repair: Final Results from the Prospective LIFE registry. VIVA 2016.
Objective: To evaluate the efficacy of Perclose
Source: Barbash, Israel M., et al. "Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation." European Heart Journal 36.47 (2015): 3370-3379.
Objective: Evaluate the safety and efficacy of Perclose
29. Device failure defined as failure to achieve hemostasis at the access site leading to alternative treatment other than manual compression. 4.6% (n=16) needed stenting for device failure.
Source: Seeger, Julia, et al. “Impact of suture mediated femoral access site closure with the Prostar XL compared to the Perclose system on outcome in transfemoral aortic valve implantation.” International Journal of Cardiology 223 (2016): 564-567.
Objective: Assessment of efficacy, complication, and potential risk factors for Perclose
30. Device failure defined as failure to achieve hemostasis at the access site, leading to alternative treatment other than manual compression.
Source: Saadi, Eduardo Keller, et al. "Totally Percutaneous Access Using Perclose ProGlide™ for Endovascular Treatment of Aortic Diseases." Brazilian Journal of Cardiovascular Surgery 32.1 (2017): 43-48.
Safety and performance of Perclose ProGlide™ vascular closure device in managing large-hole venous access site
Objective: The primary objective of this study was to evaluate the safety and performance of ProGlide™ in the closure of the venous access site in subjects treated with a large-caliber femoral vein sheath (24F).
Time management, patient and staff flow, hospital costs, and throughput can all impact overall hospital efficiency. Access site management, early ambulation and discharge with Perclose ProGlide™ Suture-Mediated Closure System can help reduce patient length of stay, optimize nursing time, improve patient flow, and drive overall hospital efficiency.
MAT-2103420 v1.0
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