Scientific news VenaSeal – neue wissenschaftliche Arbeiten über den Venenkleber VenaSeal

 

 

We want to report about scientific news  VenaSeal.   Wir möchten aktuelle wissenschaftliche Arbeiten über die VenaSeal – Therapie vorstellen. Sie dokumentieren eindrucksvoll unsere eigenen klinischen Erfahrungen nach 57 Monaten Arbeit mit dem VenaSeal-Sytem

 

Unser Statement 

Alle Arbeiten bestätigen unsere eigenen  5  – jährigen Erfahrungen mit der VenaSeal – Therapie an inzwischen 1436 Venen bei 814 Patienten: die Methode ist zur Behandlung der Stamm-und Akzessoriavaricosis sehr gut geeignet, ist sicher und effektiv. Das Tragen von Kompressionsstrümpfen ist nicht notwendig, auch die Behandlung stark erweiterter Stammkrampfadern ist effektiv möglich. Die Arbeitsunfähigkeit beträgt nur einen Tag, die Rekonvaleszenzphase ist im Vergleich zu anderen Verfahren sehr kurz. Der Quality of Life – Index  (QOL) ist, verglichen mit anderen  alternativen Therapieverfahren günstiger.

 

http://evtoday.com/2017/04/three-year-veclose-data-and-1-year-waves-data-presented-for-medtronics-venaseal-closure-system

Three-Year VeClose Data and 1-Year WAVES Data Presented for Medtronic’s VenaSeal Closure System

April 25, 2017—Medtronic announced 3-year outcomes from the VeClose United States pivotal clinical trial and 1-year data from the WAVES study, which were presented by Kathleen Gibson, MD, at the 2017 Charing Cross Symposium in London, United Kingdom. The company stated that the new data demonstrate the clinical and quality-of-life benefits of the VenaSeal closure system (Medtronic) in treating patients with venous reflux disease.

Medtronic stated that the VenaSeal closure system is a nontumescent, nonthermal, nonsclerosant procedure that uses a medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux.

The VeClose United States pivotal clinical trial is a prospective randomized controlled trial comparing the safety and effectiveness of the VenaSeal closure system to the ClosureFast endovenous radiofrequency ablation system (Medtronic) in a noninferiority design. The trial enrolled 242 patients with symptomatic refluxing GSVs, of which 222 were randomized 1:1 to receive treatment with VenaSeal or ClosureFast.

At 3 years, complete closure of the GSV was achieved in 94.4% of patients treated with VenaSeal compared to 91.9% of patients treated with ClosureFast, showing both the continued long-term, noninferior outcomes (P = .005) and the durability of the treatment.

Additionally, patient improvement was rated on three assessments: Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire, and EQ-5D. In all three assessments, patients treated with either VenaSeal or ClosureFast showed statistically significant improvement from baseline.

In the company’s press release, Dr. Gibson commented, „The 3-year outcomes for this randomized trial reinforce the consistent clinical performance of VenaSeal and ClosureFast. These long-term VenaSeal data along with postmarket WAVES study results continue to build on the prior findings for this innovative treatment option for venous reflux disease, demonstrating safety, effectiveness, and quality of life.“

In a separate session at Charing Cross, Dr. Gibson presented the 1-year data from the independent, physician-initiated WAVES study that examined quality-of-life, safety, and effectiveness outcomes with the VenaSeal closure system. The single-center study enrolled 50 patients in a real-world assessment of the treatment of one or more incompetent truncal veins in a single setting without mandatory postoperative compression stockings.

Medtronic summarized the key findings from the WAVES study. The 1-year GSV closure rate for VenaSeal was 100%. In comparison, the GSV closure rate for VenaSeal in VeClose, which required postoperative compression stockings, was 96.8%. Further, the mean vessel diameter in WAVES was larger than in VeClose. The mean time for patients to return to work was 0.2 days ± 1.1 days. The mean time for returning to normal activities, including a patient’s exercise routine, was 2.4 days ± 4.1 days, reported the company.

 

J Vast Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8

Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins.

Kolluri R1, Gibson K2, Cher D3, Madsen M4, Weiss R5, Morrison N6.

Abstract
OBJECTIVE:
Cyanoacrylate closure (CAC) was shown in the recently published VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) randomized clinical study to be an effective and noninferior option (in terms of both safety and effectiveness) to radiofrequency ablation (RFA) in the treatment of incompetent great saphenous veins. The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups.

Methods

The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician’s familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study’s primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events.

RESULTS:

Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P < .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%. Reported intraprocedural pain ratings were similar between the roll-in and randomized groups. Other clinical assessments, including quality of life improvement and adverse events, were similar between the roll-in and randomized groups. Increasing procedure number did not affect clinical outcomes.

CONCLUSIONS:

The results from the VeClose study roll-in group demonstrate that despite the physician’s lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period.

 

J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.

VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins.

 Abstract

OBJECTIVE:

Endovenous cyanoacrylate closure (CAC) is a new U.S. Food and Drug Administration-approved therapy for treatment of clinically symptomatic venous reflux in saphenous veins. The device is indicated for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV). Early results from a randomized trial of CAC have been reported previously. Herein we report 1-year outcomes.

METHODS:

There were 222 subjects with symptomatic GSV incompetence randomly assigned to receive either CAC (n = 108) or radiofrequency ablation (RFA; n = 114). After the month 3 visit, subjects could receive adjunctive therapies aimed at treating visible varicosities and incompetent tributaries. Vein closure was assessed at day 3 and months 1, 3, 6, and 12 using duplex ultrasound. Additional study visit assessments included the Venous Clinical Severity Score; Clinical, Etiology, Anatomy, and Pathophysiology classification; EuroQol-5 Dimension; and Aberdeen Varicose Vein Questionnaire. Both time to closure and time to first reopening of the target vein were evaluated using survival curve analysis. Adverse events were evaluated at each visit.

RESULTS:

Of 222 enrolled and randomized subjects, a 12-month follow-up was obtained for 192 (95 CAC and 97 RFA; total follow-up rate, 192/222 [86.5%]). By month 1, 100% of CAC subjects and 87% of RFA subjects demonstrated complete occlusion of the target vein. By month 12, the complete occlusion rate was nearly identical in both groups (97.2% in the CAC group and 97.0% in the RFA group). Twelve-month freedom from recanalization was similar in the CAC and RFA groups, although there was a trend toward greater freedom from recanalization in the CAC group (P = .08). Symptoms and quality of life improved equally in both groups. Most adverse events were mild to moderate and not related to the device or procedure.

CONCLUSIONS:

In patients with incompetent GSVs, treatment with both CAC and RFA results in high occlusion rates. Time to complete occlusion was faster with CAC, and freedom from reopening was higher after CAC. Quality of life scores improved equally with both therapies.

 

Phlebology. 2017 Mar;32(2):99-106. doi: 10.1177/0268355516638200. Epub 2016 Jul 9.

Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome.

Chan YC1, Law Y1, Cheung GC1, Ting AC1, Cheng SW1.

Abstract
Introduction This is a single-center clinical study for the evaluation of safety, efficacy, and performance of endovenous cyanoacrylate (Sapheon Venaseal Closure System, now Medtronic Medical) for the treatment of great saphenous vein (GSV) reflux.

Methods

Primary outcome measures included the GSV obliteration, with clinical recurrence on follow up as detected by serial clinical and duplex examinations of patients at 1 week, 1 month, 6 months, and 1 year. Venous clinical severity score (VCSS), Aberdeen varicose vein questionnaire (AVVQ), Short Form Health Survey 36 Item (SF-36) questionnaires were used at clinical follow up. Diameter of the GSV, treatment length of the GSV, and pretreatment clinical severity of the varicose vein were analyzed to predict recanalization using Cox regression analysis.

Results

Fifty-seven legs in 29 patients with primary varicose veins were included. One week follow-up duplex showed successful obliteration of the GSV in all except one of the legs. Two legs had minimal extension of thrombus to deep vein. None of the patients had deep venous thrombosis. All the patients were discharged the same day of operation. Median time to return to work was 1 day (range 1-16 days). Our VCSS, AVVQ, and the SF-36 physical and mental scores changed from a mean of 6.91, 23.66, 44.24, 54.26 at baseline to 2.43, 6.10, 43.85, 52.50 at 1 month post operation, respectively. Kaplan-Meier analysis showed that the GSV closure rates were 98.2%, 94.3%, 89.7%, and 78.5% at post-op 1 week, 1 month, 6 months, and 1 year, respectively. With median follow-up period of 9 months (range 1-13 months), no clinical recurrence of varicosity was observed. Mean GSV diameter ≥8 mm was a significant predictor for recanalization (hazard ratio 6.92, 95%CI 1.34-35.67, p = 0.021).

Conclusion

This study showed that the use of endovenous cyanoacrylate in the treatment of the GSV reflux was safe. All patients had symptomatic improvement as shown by the VCSS and AVVQ.

 

J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.

Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose).   Morrison N1, Gibson K2, McEnroe S3, Goldman M4, King T5, Weiss R6, Cher D7, Jones A8

Abstract
Whereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs.

RESULTS:
All subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study’s noninferiority hypothesis (all P < .01); some of these analyses supported a trend toward superiority (P = .07 in the predictive model). Pain experienced during the procedure was mild and similar between treatment groups (2.2 and 2.4 for CAE and RFA, respectively, on a 10-point scale; P = .11). At day 3, less ecchymosis in the treated region was present after CAE compared with RFA (P < .01). Other adverse events occurred at a similar rate between groups and were generally mild and well tolerated.

CONCLUSIONS:
CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month 3 after the procedure. Both treatment methods showed good safety profiles. CAE does not require tumescent anesthesia and is associated with less postprocedure ecchymosis.

 

Phlebology. 2016 Apr 6. pii: 0268355516638200. [Epub ahead of print]

Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome.
Chan YC1, Law Y2, Cheung GC2, Ting AC2, Chen

Introduction

This is a single-center clinical study for the evaluation of safety, efficacy, and performance of endovenous cyanoacrylate (Sapheon Venaseal Closure System, now Medtronic Medical) for the treatment of great saphenous vein (GSV) reflux.

RESULTS:
Fifty-seven legs in 29 patients with primary varicose veins were included. One week follow-up duplex showed successful obliteration of the GSV in all except one of the legs. Two legs had minimal extension of thrombus to deep vein. None of the patients had deep venous thrombosis. All the patients were discharged the same day of operation. Median time to return to work was 1 day (range 1-16 days). Our VCSS, AVVQ, and the SF-36 physical and mental scores changed from a mean of 6.91, 23.66, 44.24, 54.26 at baseline to 2.43, 6.10, 43.85, 52.50 at 1 month post operation, respectively. Kaplan-Meier analysis showed that the GSV closure rates were 98.2%, 94.3%, 89.7%, and 78.5% at post-op 1 week, 1 month, 6 months, and 1 year, respectively. With median follow-up period of 9 months (range 1-13 months), no clinical recurrence of varicosity was observed. Mean GSV diameter ≥8 mm was a significant predictor for recanalization (hazard ratio 6.92, 95%CI 1.34-35.67, p = 0.021).

CONCLUSION:
This study showed that the use of endovenous cyanoacrylate in the treatment of the GSV reflux was safe. All patients had symptomatic improvement as shown by the VCSS and AVVQ.

 

Vascular. 2016 May 20. pii: 1708538116651014. [Epub ahead of print]

Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study).
Gibson K1, Ferris B2.

Introduction

Cyanoacrylate closure of the great saphenous vein with the VenaSeal™ Closure System is a relatively new modality. Studies have been limited to moderate-sized great saphenous veins and some have mandated postoperative compression stockings. We report the results of a prospective study of cyanoacrylate closure for the treatment of great saphenous vein, small saphenous veins, and/or accessory saphenous veins up to 20 mm in diameter.

Methods:

Fifty subjects with symptomatic great saphenous vein, small saphenous veins, and/or accessory saphenous veins incompetence were each treated at a single session. Compression stockings were not used post-procedure. Subjects returned to clinic at week 1 and again at one month. Post-procedure evaluations were performed at seven days and one month and included numerical pain rating score, revised venous clinical severity score, the Aberdeen Varicose Vein Questionnaire score, and time to return to work and normal activities. Duplex ultrasound was performed at each visit.

CONCLUSIONS:

Cyanoacrylate closure is safe and effective for the treatment of one or more incompetent saphenous or accessory saphenous veins. Closure rates were high even in the absence of the use of compression stockings or side branch treatment. Time back to work or normal activities was short and improvements in venous severity scores and QOL were significant, comparing favorably with alternative treatment methods.

 

 

 

 

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