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CARDIOVASCULAR
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Clinical Trials

PEVAR Clinical Trial

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).

Key Findings

  • Mean procedure time was reduced in PEVAR patients by 34 minutes (106.5 ± 44.9 minutes PEVAR vs. 141.1 ± 73.4 minutes SEVAR, p=.0056)11
  • Mean time to hemostasis was reduced following PEVAR by 13 minutes (9.8 ± 17.0 minutes PEVAR vs. 22.7 ± 22.9 minutes SEVAR, p=.0023)11

 

PEVAR Clinical Trial Design

Primary Endpoint Achieved

Major16 Ipsilateral Vascular Access
Complications at 30 Days
  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
Composite of Minor18 Ipsilateral Vascular Access
Complications at 30 Days
  PEVAR Perclose
N=50
SEVAR
N=50
p-value13
Minor Ipsilateral Access Site Vascular Compliations 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.

Clinical Evidence on Closure of Large-Bore Venous Access

Perclose Cohort in the REALISM19 Clinical Trial

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.

Key Findings

  • Major complication was low at 1.9%
  • Freedom from major femoral vein access site-related complications was 98.1% at 30 days
  • Perclose is safe and effective in the closure of venous access-site with up to 24F sheath
Pie chart showing low major complications at 30 days

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 Realism Clinical Trial: Perclose Cohort Brochure

Real-World Evidence on Repair of Large-Bore Arterial Access

Perclose vs. Surgical Cutdown

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.

Key Findings

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.

 

Patient Baseline

  Cutdown Perclose
# of Patients 757 757
Anticoagulants 17.8% 44.9%

p<0.05

Patient procedures graph

Patients may have had multiple procedures during index admission

Perclose Patients

41 percent of perclose patients

Less likely to have an infection

43 percent of Perclose patients

Shorter hospital stay

70 percent of Perclose patients

Less likely to die within 30 days post-procedure

80 percent of Perclose patients

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.

  • Perclose vs. Surgical Cutdown Brochure

PEVAR Publications

Italian Percutaneous EVAR (IPER) Registry

Outcomes of 2,381 percutaneous femoral access sites’ closure for aortic stent-graft

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.

Method

  • Prospective
    – 7 centers
    – Operators with at least 50 closure device deployments
  • January 2010 – December 2014
    – Use of Perclose began in 2013
  • 2,381 femoral access sites
    – 514 Perclose closes
    – 1,867 Prostar closes
  • > 18F sheath size: 26.5%

Perclose-Only Result

  • 97.5% (501/514) technical success rate20

Total Results including Prostar

  • 3.2% (76/2,381) major complications21 requiring surgical cutdown
  • 1.1% (27/2,381) minor complication22
  • 0.25% (6/2,381) puncture site complication observed during one-month follow-up

Key Takeaways

  1. High device success (Perclose 97.5%) even with demanding cases due to the presence of obesity (24.7%), femoral artery calcification (53%), and iliac tortuosity (22.6%)
  2. First and largest prospective study carried out on a cohort of unselected patients undergoing PEVAR with different endografts in well-trained centers by highly experienced operators
  3. Femoral calcification was the only independent predictor of technical failure

 

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.

Perclose in PEVAR and TAVI – Brazil Study

Objective: Assessment of efficacy, complication, and potential risk factors for Perclose

Method

  • 123 Patients
    – 47.6% TAVI – 33.5% EVAR
    – 13.7% TEVAR, 3.2% TAAA
  • 242 vascular access sites
  • Single-center retrospective study
  • ≥ 18F sheath size: 54.3%
  • Single operator with 50 small-hole closure experience
    (no prior large-hole experience)
  • Angiotomography instead of ultrasound used for puncture

Perclose Result

  • 98.37% (121/123) patient technical success rate23
  • 1.62% acute major complication rate
    – Failures had > 2/3 CFA calcification
  • 0.81% (1/123) minor complication observed at 30-day follow-up
  • Operator encountered an initial learning curve with the 3 complications occurring during the first 35 cases

Key Takeaways

  1. Experience with Perclose for small-hole closure helps with large-hole closure success
  2. Pre-operative imaging on the puncture site to assess calcification important for device success

 

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.

Perclose in PEVAR – Taiwan Study

Objective: Evaluate the outcomes and predictive factors for additional Perclose deployment

Method

  • 268 patients, 418 vascular access sites
  • 9 operators
    – 3 were within the learning curve for Perclose24
  • Factors measured
    – Depth
    – Sheath size
    – CFA diameter
    – Any CFA calcification
    • Anterior wall
    • Lateral wall
    • Medial wall
    • Posterior wall

Perclose Result

  • 87.6% (366/418) Primary technical success25 with two Perclose
  • 99% secondary technical success26 with additional Perclose device
    – 38 required one additional device and 10 required two additional devices
  • Only anterior CFA wall calcification was a significant predictor for additional Perclose deployment

Key Takeaways

  1. It is important to perform a femoral angiogram to evaluate the severity and location of calcification at the puncture site
  2. Even with additional device deployment, high success rate was able to be achieved even in the presence of anterior wall calcification (17% of total access sites)

 

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.

Perclose PEVAR Trial

Objective: To evaluate the safety and effectiveness of the “pre-close” technique for PEVAR compared to surgical cutdown (SEVAR)

Method

  • Prospective, randomized, 20 U.S. centers
  • Perclose N=50, SEVAR N=50, Prostar N=51
  • Primary endpoint: Procedural technical success27 and major complications at 30 days
  • Noninferiority trial design

Result

  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

Key Takeaways

  1. It is important to perform a femoral angiogram to evaluate the severity and location of calcification at the puncture site
  2. Even with additional device deployment, high success rate was able to be achieved even in the presence of anterior wall calcification (17% of total access sites)

 

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.

Perclose LIFE Registry

Objective: Demonstrate clinical and cost benefits when utilizing a Fast-Track EVAR protocol with the Ovation stent graft system

Method

  • Prospective multi-center registry
  • 250 patients, 35 U.S. centers
  • 14F Ovation Abdominal Stent Graft
  • Fast-Track EVAR Protocol
    – Percutaneous access
    – No general anesthesia
    – No ICU admission
    – Next-day discharge

Perclose Result

  • 97.6% Perclose technical success28 rate (244/250)
  • No device-related or procedure-related major adverse events
  • Cost analysis shows Fast-Track EVAR is less costly than standard EVAR

Cost Analysis

  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.

 

Key Takeaways

  1. Fast-Track is less costly than standard EVAR with hospital and ICU stay as the main cost drivers
  2. Patient selection is critical to success as femoral arteries should be free of heavy calcification or extreme tortuosity to facilitate bilateral percutaneous access

 

28. Technical Success (Successful Bilateral PEVAR)

Source: Kracjcer, Z. Fast-Track Endovascular Aortic Repair: Final Results from the Prospective LIFE registry. VIVA 2016.

TAVI Publications

Perclose in TAVI – CONTROL Study

Objective: To evaluate the efficacy of Perclose

Method

  • Retrospective study
  • 9 centers in Europe, North America, and the Middle East
  • 472 Perclose compared to 472 Prostar deployment
  • TAVI devices used: Sapien (51.1%) and CoreValve (43.2%)
  • 18.3 ± 1.7F mean sheath size

 

Key Takeaways

  1. Low major vascular complication rate in TAVI procedures – 1.9%
  2. Major complication rate decreased significantly after first 20 procedures, showing a learning curve effect

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.

Perclose-Only Result

  • 1.9% (9/472) major complications
  • 18% (85/472) minor complications
  • There was a significant decrease in major vascular complications after the first 20 cases, showing a learning curve effect

Chart showing decrease in major vascular complications after the first 20 cases

Perclose in TAVI – Germany Study

Objective: Evaluate the safety and efficacy of Perclose

Method

  • Prospective single-center study
  • 348 Perclose patients compared to 237 Prostar patients
  • TAVI devices used
    – Sapien 3
    – Lotus
    – CoreValve
  • Sheath size 23.7F ± 1.5F

Perclose-Only Result

  • 95.4% (332/348) technical success rate29
  • 2.3% (8/348) major vascular complications
  • 5.7% (20/472) minor vascular complications

Key Takeaways

  1. High technical success rate
  2. Low major vascular complication in TAVI procedures

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.

Perclose in PEVAR and TAVI – Brazil Study

Objective: Assessment of efficacy, complication, and potential risk factors for Perclose

Method

  • 123 Patients
    – 47.6% TAVI
    – 33.5% EVAR
    – 13.7% TEVAR, 3.2% TAAA
  • 242 vascular access sites
  • Single-center retrospective study
  • ≥ 18F sheath size: 54.3%
  • Single operator with 50 small-hole closure experience (no prior large-hole experience)
  • Angiotomography instead of ultrasound used for puncture

Perclose-Only Result

  • 98.37% (121/123) patient technical success rate30
  • 1.62% acute major complication rate
    – Failures had > 2/3 CFA calcification
  • 0.81% (1/123) minor complication observed at 30-day follow-up
  • Operator encountered an initial learning curve with the 3 complications occurring during the first 35 cases

Key Takeaways

  1. Experience with Perclose for small-hole closure helps with large-hole closure success
  2. Pre-operative imaging on the puncture site to assess calcification important for device success

 

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.

TMVr Publications

Prospective Analysis for Large-Bore Venous Access

The Use of the Perclose ProGlide™ Suture-Mediated Closure (SMC) Device for Venous Access Site

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).

Early Ambulation and Discharge

AF Ablation

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.

Early Ambulation and Same-Day Discharge for Atrial Fibrillation Ablation Cases

Dr. Sumit Verma from Baptist Heart and Vascular Institute discusses how the facility implemented same-day discharge for atrial fibrillation ablation cases and how the strategy has the potential to reduce complications, decrease resource utilization, and allow cost savings, while improving patient satisfaction.

References

*As compared to Angio-Seal, ExoSeal, FemoSeal, InClosure, MANTA, Mynx, PerQseal, Vascade, Velox CD, X-Seal. Data on file at Abbott.

  1. Primary intention healing occurs where vessel wall edges are brought together, adjacent to each other. This can be achieved with suture, stitches, staples and clips.
  2. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
  3. For venous sheath sizes greater than 8F, at least one device and the pre-close technique are required.
  4. Max. OD 26F/0.340 inches/8.62 mm; Max. OD 29F/0.378 inches/9.59 mm. Tests performed by and data on file at Abbott.
  5. Time to hemostasis, ambulation and discharge applies to the arterial access.
  6. Bhatt, Deepak L. et al. Successful “Pre-Closure” of 7Fr and 8Fr Femoral Arteriotomies With a 6Fr Suture-Based Device (The Multicenter Interventional Closer Registry). American Journal of Cardiology Vol 89. March 2002.
  7. Mercandetti, Michael. Wound Healing and Repair. Medscape. WebMD, 02 April 2019. Web. January 15, 2020.
  8. Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
  9. 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.
  10. Applies to arterial access.

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