fibrin glue vasectomy reversal®. who am i? why am i here?

Fibrin Glue Vasectomy Reversal®

Who am I?Why am I

here?

•Urethroplasties/GU Reconstruction

•Male and Female Slings/AUS

•Neuromodulation

•Urodynamics

?

1: Fibrin glue assisted 3-suture vasovasostomy.J Urol. 2005 Oct;174(4 Pt 1):1360-3; discussion 1363. 2: Evaluation of a fibrin sealant free of bovine-derived components in an experimental vas anastomosis study. Urol Int. 2000;65(4):196-9. 3: Vasal reanastomosis using fibrin glue combined with sutures: which combination of sutures in a delayed protocol? Experimental study in rats. Eur Urol. 1998;33(3):318-22. 4: Fibrin-glue assisted vasoepididymostomy: a comparison to standard end-to-side microsurgical vasoepididymostomy in the rat model. J Urol. 1997 Oct;158(4):1602-5. 5: Delayed vasovasostomy: experimental study using fibrin glue. Eur Urol. 1997;31(2):182-6. 6: Delayed vasal reanastomosis in rats: comparison of a microsurgical technique and a fibrin-glued procedure.Br J Urol. 1996 Aug;78(2):271-4. 7:A randomised trial of fibrin sealant in peripheral vascular surgery. Vox Sang. 1996;70(4):210-2. 8:Fibrin glue and conventional sutured vasal anastomosis in the rat. J Surg Res. 1995 Nov;59(5):601-5. 9:Microscopic vasovasostomy: current practice and future trends. Microsurgery. 1995;16(5):325-32. Review. No abstract10:Fibrin-glue vasovasostomy as an alternative to the conventional two-layer suture techniqu? Investig Urol (Berl). 1994;5:253-11: Comparison of vasovasostomy techniques in rats utilizing conventional microsurgical suture, carbon dioxide laser, and fibrin tissue adhesives. Urology. 1993 May;41(5):479-83. 12:Vasovasostomy in rabbits using fibrin adhesive prepared from a single human source.J Urol. 1993 Jan;149(1):183-5. 13: Fibrin glue vasal anastomosis compared to conventional sutured vasovasostomy in the rat. J Urol. 1991 Jun;145(6):1288-91. 14: Comparison of microsurgical vasovasostomy techniques in the rat. Eur Urol. 1990;17(3):241-2.

Division of UrologyContact Information

Erin T. Bird, M.D.Associate Professor of Urology

Scott & White Hospital, Texas A&M Health Science Center College of MedicineTemple, TX 76508

Phone: 254-724-1773E-mail: abanderson@swmail.sw.org

Fibrin Glue Vasectomy Reversal® Patient GuideHow much will the vasectomy reversal cost?

Is there a money back guarantee?Why is the vasectomy reversal price at Scott & White so inexpensive?

How is the Scott & White procedure different?What is fibrin glue? Is it safe?How long is the procedure?

What is a VE (vasoepididymostomy)?How is success measured? What type of follow-up is expected?

What can be expected following surgery?Appointments Scheduling

Surgery DatePayment

•9-year period 1,469, 5 institutions•sperm were present in the semen in 865 of 1,012 men (86%) •pregnancy occurred in 421 of 810 couples (52%) •less than 3 years patency was 97% and pregnancy 76%, 3 to 8 years 88% and 53%, 9 to 14 years 79% and 44% and 15 years or more 71% and 30%. •The patency and pregnancy rates were no better after 2-layer microsurgical vasovasostomy than after modified 1-layer microsurgical procedures and they were statistically the same for all patients regardless of the surgeon. •When sperm were absent from the intraoperative vas fluid bilaterally and the patient underwent bilateral vasovasostomy rather than vasoepididymostomy, patency occurred in 50 of 83 patients (60%) and pregnancy in 20 of 65 couples (31%). •presence or absence of a sperm granuloma at the vasectomy site affected results.

Results of 1,469 microsurgical vasectomy reversals by the Vasovasostomy Study Group. J Urol. 1991 Mar;145(3):505-11.

Belker

8897

8271

85% Patency

40+% Pregancy

85% Pat.

40+% Preg.

• video

Use Exactly…And the VV market

Competition/Free Market Healthcare

• Google Search

• Yahoo Search

Web Site Development

• Scott and White Link

Hits and Clicks

• Yahoo – March 2006– 17K “impressions”– 196 clicks– $130

• Google – March 2006– 4500 “impressions– 124 clicks– $165

2-6 vas reversals/month

Cost Breakdown – $4,500

• Surgeon 1,500

• Anesthesia 500

• Clinic 1,300

• Supplies/Overhead 1,200

Patients by Region – Year One

Temple Experience

2004 2005 2006

PDF

Validation of a Vasoepididymostomy Predictor Model: Is Vasoepididymostomy Truly Predictable Preoperatively?

Parviz K Kavoussi MD, Erin T Bird MD

Introduction• 50% divorce rate in United States

• 500,000 men undergo vasectomies annually

• 2-6% of men will desire reversal at some point

• Range in microsurgical training for reversals (V-V vs V-E)

Sheynkin YR, Hendin BN, Schlegel PN, Goldstein M:  Microsurgical repair of iatrogenic injury to the vas deferens.   J Urol  1998; 159:139-141.

Model Constructed to Predict Need for V-V vs V-E• Model based on:

– Age

– Time period since vasectomy

• Model validated in a 7 institution study

• Purpose: Allow referral to urologists trained and comfortable performing V-E’s

Parekattil SJ, Kuang W, Agarwal A, Thomas AJ. Model to predict if a vasoepididymostomy will be required for vasectomy reversal. J Urol. 2005 May;173(5):1681-4.

Parekattil SJ, Kuang W, Kolettis PN, Pasqualotto FF, Teloken P, Teloken C, Nangia AK, Daitch JA, Niederberger C, Thomas AJ Jr. Multi-institutional validation of vasectomy reversal predictor. J Urol. 2006 Jan;175(1):247-9

r

Methods

• IRB approval obtained

• 115 consecutive patients who underwent reversals included

• No exclusion criteria

• All underwent reversal by fibrin glue technique

Methods

• Predictor model applied to all patients

• Predicted outcomes analyzed with respect to outcomes with consideration to actual procedures performed

• Maximum follow up 30 months

• Median follow up 16 months

Results

• Out of 115 patients, 40 would have been predicted to require V-E on 1 or both sides, but actually underwent bilateral V-V

• Follow up data was available in 62% of these patients

• 88% of these were patent and 52% achieved pregnancies thus far

Predicted V-V, had V-VNumber of patients Number successfully

patentNumber achieved pregnancy

70 (42 had f/u data) 41 (98%) 15 (36%)

Predicted V-E, but had V-VNumber of patients Number successfully

patentNumber achieved pregnancy

40 (25 had f/u data) 22 (88%) 13 (52%)

The assessed pre-operative nomogram to identify patients who might benefit from a

V-E vs those who will simply need a V-V is not a reliable predictor in our patient

population seeking a more affordable fibrin glue vasectomy reversal option

Conclusions

• Results of fibrin glue vasectomy reversal are comparable to published series

• Limited marketing resources are required

• Dealing with failures and fertility couples in general….

• Future Directions