Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review

Joao G Porto; Maria Camila Suarez Arbelaez; Ruben Blachman-Braun; Ansh Bhatia; Shivank Bhatia; Ramgopal Satyanarayana; Robert Marcovich; Hemendra N Shah

doi:10.1007/s00345-023-04440-w

Complications associated with minimally invasive surgical therapies (MIST) for surgical management of benign prostatic hyperplasia: a Manufacturer and User Facility Device Experience (MAUDE) database review

World J Urol. 2023 Jul;41(7):1975-1982. doi: 10.1007/s00345-023-04440-w. Epub 2023 May 24.

Authors

Joao G Porto¹, Maria Camila Suarez Arbelaez¹, Ruben Blachman-Braun¹, Ansh Bhatia², Shivank Bhatia³, Ramgopal Satyanarayana¹, Robert Marcovich¹, Hemendra N Shah⁴

Affiliations

¹ Desai Sethi Urology Institute, University of Miami, Miller School of Medicine, Coral Gables, USA.
² Seth GS Medical College and KEM Hospital, Mumbai, India.
³ Department of Interventional Radiology, University of Miami, Miller School of Medicine, Coral Gables, USA.
⁴ Desai Sethi Urology Institute, University of Miami, Miller School of Medicine, Coral Gables, USA. hns35@miami.edu.

PMID: 37222779
DOI: 10.1007/s00345-023-04440-w

Abstract

Purpose: MAUDE database houses medical device reports of suspected device-related complications received by Food and Drug Administration. In the present study we aim to evaluate the MAUDE database for reported complications of MIST procedures.

Methods: The database was queried using keywords: rezum, urolift, prostate embolization (PAE), transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), prostate stent and Temporarily Implanted Nitinol Device (iTIND) on 10/1/22 to extract information regarding device problems and procedure-related complications. Gupta classification system was used to stratify complications. Statistical analysis was performed to compare frequency of complications among MIST procedures.

Results: We found a total of 692 reports (Rezum-358, urolift-226, PAE-53, TUNA-31, TUMT-19, prostatic stent-4, and iTIND-1). Most complications related to device or users were minor (level 1 and 2) and there was no significant difference among various MIST procedures. The screen/system error was responsible for 93% and 83% aborted cases in Rezum and TUNA, respectively, and PAE showed 40% of device component detachment/fracture. Overall Urolift and TUMT were associated with statistically significant higher incidence of major (level 3 and 4) complications (23% and 21%, respectively) as compared with Rezum (7%). Most major complications needing hospitalization after Urolift included hematoma and hematuria with clots and those after Rezum included urinary tract infection and sepsis. Thirteen deaths were reported, mostly due to cardiovascular events, which were classified as not associated with the proposed treatment.

Conclusion: MIST for BPH can occasionally cause significant morbidity. Our data should assist urologists and patients in shared decision-making process.

Keywords: Benign prostatic hyperplasia; Complications; Enlarged prostate; Minimally invasive surgical therapy; Rezum; Urolift.

Publication types

Review

MeSH terms

Humans
Lower Urinary Tract Symptoms* / etiology
Male
Minimally Invasive Surgical Procedures / adverse effects
Prostate
Prostatectomy / methods
Prostatic Hyperplasia* / complications
Transurethral Resection of Prostate* / adverse effects
Treatment Outcome