John H. Crabtree, MD Visiting Clinical Faculty Harbor – UCLA Medical Center Torrance, California, USA April 6 - 7, 2017 Effective Use of Laparoscopy for Peritoneal Dialysis Access Catheter Implantation Approaches

 Open Surgical Dissection

 Percutaneous Puncture

‒ Seldinger Technique W/WO Image Guidance ‒ Y-TEC® Approach (Laparoscopic Assisted) ‒ Surgical Laparoscopy No single PD catheter implantation approach has been shown to produce superior outcomes RCTs Comparing Laparoscopic PD Catheter Insertion to Other Methods

Subject Number Author (Year) (L:Other) Flow Function Wright et al. (1999) 21:24 L = O Tsimoyiannis et al. 19:25 L > O (2000) Jwo et al. (2010) 37:40 L = O Voss et al. (2012) 56:57 L = P

L = Laparoscopic, O = Open dissection, P = Percutaneous image guided Wright et al. Perit Dial Int 1999; 19:372-5 Tsimoyiannis et al. Surg Laparosc Endosc Tech 2000; 10:218-21 Jwo et al. J Surg Res 2010; 159:489-96 Voss et al. Nephrol Dial Transplant 2012; 27:4196-204 RCTs Comparing Basic Laparoscopic PD Catheter Insertion to Other Methods Meta-Analysis: Flow Dysfunction Meta-Analyses Examining Laparoscopic vs Open PD Catheter Insertion Catheter Function and Author (Year) Studies Survival Xie et al. (2012) RCTs + Cohort L = O Studies Hagen et al. RCTs + Cohort L > O (2013) Studies Qiao et al. (2016) RCTs + Cohort L > O Studies Problems: • Errors in event counts • Mixture of intensity of interventions in laparoscopic groups Xie et al. BMC Nephrology 2012, 13:69 Hagen et al. PLoS ONE 2013; 8(2): e56351. doi:10.1371/journal.pone.0056351 Qiao et al. Renal Failure 2016; DOI: 10.3109/0886022X.2015.1077313 RCTs & Cohort Studies Comparing Basic Laparoscopic PD Catheter Insertion to Other Methods Meta-Analysis: Flow Dysfunction

Gajjar: Laparosc vs Blind Percutan; Voss & Maher: Laparosc vs Fluoro Percutan; All others: Laparosc vs Open RCTs & Cohort Studies Comparing Advanced Laparoscopic PD Catheter Insertion to Open Dissection Meta-Analysis: Flow Dysfunction

R = rectus sheath tunneling O = omentopexy A = adhesiolysis L = loop suture anchor S = suture anchor to pelvis RCT and Cohort Study Citations for Basic Laparoscopy vs Other Meta-Analysis: 1. Draganic et al. Aust NZ J Surg 1998; 68:735-9 2. Wright et al. Perit Dial Int 1999; 19:372–5 3. Tsimoyiannis et al. Surg Laparosc Endosc Tech 2000; 10:218-21 4. Ogunc G. Surg Today 2001; 31:942-4 5. Batey et al. J Endourol 2002;16:681-4 6. Crabtree et al. Am Surg 2005; 71:135-43 7. Soontrapornchai et al. Surg Endosc 2005; 19:137-9 8. Gajjar et al. Am J Surg 2007; 194:872-6 9. Lund et al. Int Urol Nephrol 2007;39:625-8 10. Jwo et al. J Surg Res 2010; 159:489-496 11. Li et al. Surg Laparosc Endosc Tech 2011; 21:106-10 12. Voss D, et al. Nephrol Dial Transplant 2012; 27:4196-4204 13. Maher et al. J Vasc Interv Radiol 2014; 25:895-903 14. Krezalek et al. Surgery 2016; 160:924-35

Catheter Implantation Approaches in the U.S.*  Open Surgical Dissection (18.5%)

 Percutaneous Puncture

‒ Seldinger Technique W/WO Fluoroscopy (28.6%) ‒ Y-TEC® Approach (Laparoscopic Assisted) (0.3%) ‒ Surgical Laparoscopy (52.6%)

∗ Estimates from 2014 Medicare Physician/Supplier Procedure Summary Master File based upon reported medical specialties and CPT codes 49418, 49421 and 49324. Physician/Supplier Procedure Summary Master File, 2014, Baltimore, MD: Centers for Medicare & Medicaid Services, Department of Health & Human Services. The Proportion of Catheters Placed Laparoscopically in the U.S. Continues to Increase* All Other 49324 Laparoscopy 80%

70%

60%

50% 53% 50% 52% 40% 45% 47% 39% Percent 30% 33% 20% 26%

10%

0% 2007 2008 2009 2010 2011 2012 2013 2014

∗ Distribution of 2007-1014 CMS Part B Claims for CPT 49324 (Laparoscopy) and all other methods (Open and Percutaneous Needle-Guidewire W/WO Fluoroscopy), 2007- 2014 Medicare Physician/Supplier Procedure Summary Master File Physician/Supplier Procedure Summary Master File, 2007-2014, Baltimore, MD: Centers for Medicare & Medicaid Services, Department of Health & Human Services.

Adjunctive Procedures to Laparoscopic Implantation • Rectus sheath tunneling to promote pelvic orientation of catheter tip and prevent catheter tip migration. • Selective prophylactic omentopexy (omental tacking procedure) to prevent catheter obstruction. • Selective adhesiolysis to enable implantation and eliminate compartmentalization of peritoneal cavity. • Resection of redundant epiploic appendices, epiploectomy, to prevent catheter obstruction. • Tacking up of redundant colon, colopexy, to prevent catheter obstruction. • Diagnosis and treatment of previously unsuspected hernias. Laparoscopically Guided Rectus Sheath Tunneling of Catheter

Laparoscopic Port Tunneling Process Rectus Sheath Tunneling Catheter Over Stylet is Advanced Through Port Catheter Insertion Port and Stylet are Withdrawn Deep Cuff Position and Fascial Purse String Suture Greater Omentum Fat laden sheet of peritoneum that hangs down from the greater curvature of the stomach and covers the colon and small intestines.

Omental Apron Redundant Omentum

Omental Wrap Selective Prophylactic Omentopexy

Omentum is displaced into upper abdomen and fixed to the abdominal wall with 0-polygalactic or polypropylene suture using Endo Close needle or Carter Thomason needle.

Endo Close Needle Omentopexy Adhesiolysis for Compartmentalization

Dialysis Poor Drainage Catheter Here of Dialysate Here Adhesiolysis with Ultrasonic Shears Epiploic Appendices

Obstruction Normal Redundant Epiploic appendices are fat-filled tabs or pendants of peritoneum that project from the serous coat of the colon. Epiploectomy Redundant Sigmoid Colon Can be a Cause of Catheter Flow Dysfunction

Redundant sigmoid colon can fill the pelvic inlet and obstruct catheter flow. Colopexy of Sigmoid Colon

Epiploicae of redundant colon sutured to lateral abdominal wall (colopexy) . Laparoscopy Permits Diagnosis of Unsuspected Hernias

Patent Processus Vaginalis (Male) Umbilical Hernia

Patent Processus Vaginalis (Female) Spigelian Hernia Laparoscopy Enables Access in Patients that You Might Not Consider for PD Can these patients do PD?

What Method Would You Use to Insert a Peritoneal Dialysis Catheter ?

Urostomy Colostomy Laparoscopy Not Only Enables Access but Minimizes the Magnitude of Surgical Trauma

What is the Best Way to Provide Peritoneal Access for this Patient? Presternal Catheter

BMI = 58.9 Cohort Studies Comparing Advanced and Basic Laparoscopic PD Catheter Insertion Meta-Analysis: Flow Dysfunction Catheter Survival: Probability of Remaining Free of Mechanical Flow Obstruction

log-rank p < 0.0001

Crabtree et al. Am Surg 2005; 71:135-43 Catheter Survival: Probability of Remaining Free of Mechanical Flow Obstruction

log-rank p = 0.09

Krezalek et al. Surgery 2016; 160:924-35 2-Year Catheter Survival Free of Catheter Flow Dysfunction Meta-Analysis: 2-Year Catheter Survival

Crabtree et al. Am Surg 2005; 71:135-43 Krezalek et al. Surgery 2016; 160:924-35 Surgical Laparoscopy is More Expensive than Other Catheter Implantation Methods

Procedure Cost of Radiologic and Open Catheter Placement as a Fraction of Laparoscopic Insertion Costs* Convention Laparoscopi Radiologic al Open c Fractional 0.5 0.8 1.0 Cost

* Modified from: Crabtree, et al. Adv Perit Dial 2001; 17:88-92. Crabtree, Perit Dial Int 2009; 29:394-406. Jwo et al. J Surg Res 2010; 159:489-496. Voss, et al. Nephrol Dial Transplant 2012; 27:4196-4204 Davis et al. J Surg Res 2014; 187:182-8 Cost Per Patient Per Year by Dialysis Modality in Canada Difference in Annual Cost Per Patient Per Year Between HD and PD: $15,000-$51,000 CA$

Klarenbach, et al. Nat Rev Nephrol 2014; 10:644–52 Operating Room Access Issues May Delay Laparoscopic Catheter Implantation

Surgical Barriers for Timely Intervention: • Less than enthusiastic interest in PD access procedures due to deficient training • Lack of understanding of importance of appropriate prioritization of cases • Worn-down over constant struggle for operating room time • Incentive and motivation affected by poor remuneration for catheter procedures www.pdusurgeons.com Skill Stations (Surgical Laboratory)

www.pdusurgeons.com Advantages of Laparoscopy for PD Access Summary:  Laparoscopic adjunctive procedures produces better catheter survival free of flow dysfunction

 Enables a larger candidate pool of patients for PD  Prior abdominal surgery, especially the multiply operated abdomen  Previous peritoneal catheter loss from peritonitis  Obesity

 Allows co-interventions (in addition to adjunctive procedures)  Cholecystectomy  Hernia repair

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