Prospective, monocentric observational study on the clinical use and patient satisfaction of an implantable venous access Port.

Abstract

Purpose: Long-term totally implantable venous access ports (TIVAP) are essential for administering chemotherapy and parenteral nutrition in cancer patients. This study aimed to evaluate patient satisfaction and postoperative complications, compared to existing literature, emphasizing patient-reported outcomes (PRO) as a critical factor in treatment decisions.

Methods: A prospective, monocentric observational study included 149 patients requiring TIVAP between April 13 and August 17, 2022. Patient satisfaction was assessed using a questionnaire covering four domains: overall satisfaction, willingness to choose the port again, cosmetic result, and pain experience. A meta-analysis of seven studies (1,035 patients) was performed to establish baseline data. The study assumed a non-inferiority margin of 12 points on a 0-100 scale (lower scores indicating better outcomes). Follow-ups were carried out at four weeks and six months.

Results: Of the 149 patients (mean age 58.8 years, 96% with oncological diseases), 117 (78.5%) TIVAPs were implanted via the cut-down technique, primarily using the cephalic vein (84.6%). Out of 1,240 documented catheter accesses, 91.4% were complication-free. Satisfaction scores demonstrated non-inferiority across all domains compared to literature: overall satisfaction (18.5 vs. 35.6; p < 0.001), willingness to choose the port again (15.8 vs. 29.4; p < 0.001), cosmetic result (38.0 vs. 39.9; p = 0.003), and pain experience (17.1 vs. 31.5; p < 0.001).

Conclusion: The study demonstrated adequate patient satisfaction and non-inferiority of the investigated TIVAP system compared to other systems, though no superiority was found in cosmetic outcomes.