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Late-Breaking: Preoperative frailty in older women undergoing prolapse surgery: 36 to 60 month outcomes

Wednesday, October 4, 2023

5:10 PM – 5:20 PM US PST

Location: Oregon Ballroom

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Presenting Author(s)

Elisabeth Erekson, MD MPH

Chair
Maine Medical Center
Portland, Maine, United States

PDF

Co-Author(s)

Shawn Menefee, MD

Division Director
Kaiser Permanente
San Diego, California, United States
RW

Ryan Whitworth, PhD

Research Statistician
RTI International
Houston, Texas, United States
SG

Selen Gizlice, BSPH

Statistician
RTI International
Research Triangle Park, North Carolina, United States
HZ

Halina Zyczynski, MD (she/her/hers)

Professor
University of Pittsburgh, Magee-Womens Research Institute
Pittsburgh, Pennsylvania, United States
David D. Rahn, MD

Professor of Ob/Gyn
University of Texas Southwestern Medical Center
Dallas, Texas, United States
CA

Cindy Amundsen, MD

Professor of Obstetrics and Gynecology, Professor of Urology
Duke University
Vivian Sung, MD MPH (she/her/hers)

Professor
Women and Infants Hospital/Alpert Medical School of Brown University,
Providence, Rhode Island, United States
LA

Lily Arya, MD MS

Professor of Obstetrics and Gynecology
University of Pennsylvania
Philadelphia, Pennsylvania, United States
CF

Cecile A. Ferrando, MD, MPH

Physician
Cleveland Clinic
Cleveland, Ohio, United States
DM

Donna Mazloomdoost, MD (she/her/hers)

Medical Officer and Project Scientist/Director
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Bethesda, Maryland, United States
ST

Sonia M. Thomas, DrPH

Senior Research Statistician
RTI
Research Triangle Park, North Carolina, United States
Holly E. Richter, PhD, MD

Professor of Obstetrics and Gynecology, Urology and Geriatrics
University of Alabama at Birmingham
Birmingham, Alabama, United States

Disclosure(s):

Elisabeth Erekson, MD MPH: No financial relationships to disclose

Shawn Menefee, MD: Neuspera: Research Funding (Ongoing)

Ryan Whitworth, PhD: No financial relationships to disclose

Selen Gizlice, BSPH: No financial relationships to disclose

Halina Zyczynski, MD: Amara Therapeutics: Advisory Board (Ongoing)

David D. Rahn, MD: No financial relationships to disclose

Cindy Amundsen, MD: BlueWind Medical: Clinical Trial Investigator (Ongoing), Consultant/Advisory Board (Ongoing)

Vivian Sung, MD MPH: No financial relationships to disclose

Lily Arya, MD MS: Urovant sciences: consultant (Ongoing), Consultant/Advisory Board (Ongoing)

Cecile A. Ferrando, MD, MPH: Collamedix: Advisory Board (Ongoing)

Donna Mazloomdoost, MD: No financial relationships to disclose

Sonia M. Thomas, DrPH: No financial relationships to disclose

Holly E. Richter, PhD, MD: Allergan: Clinical Trial Investigator (Terminated, January 28, 2022); BlueWind Medical: DSMB Member (Ongoing); Coloplast: Consultant/Advisory Board (Ongoing); COSM: Consultant/Advisory Board (Ongoing); EBT Medical: Clinical Trial Investigator (Terminated, December 31, 2022); Laborie: Consultant/Advisory Board (Ongoing); Neomedic: Consultant/Advisory Board (Ongoing); Palette Life Science: Consultant/Advisory Board (Ongoing); Reia LLC: Clinical Trial Investigator (Ongoing); Renovia: Clinical Trial Investigator (Ongoing)

Objectives: To determine the impact of preoperative frailty on 36 to 60 month outcomes in older women undergoing apical prolapse surgery.

Methods: Participants ≥ 65 years were enrolled in a randomized surgical trial of post-hysterectomy apical prolapse procedures (native tissue, vaginal mesh or sacrocolpopexy) and completed preoperative assessments of frailty and mobility using Robinson Frailty index, a 7-point scale covering cognition (Mini-cog), Katz activities of daily living (ADLs), functional comorbidities, history of falls, albumin, hematocrit, and Timed Up and Go (TUG) test. Frailty scores ≤1 were considered non-frail; ≥2 considered pre-frail/frail. Compromised mobility was defined as TUG≥15sec, use of assistive device or observed gait difficulties. Participants were assessed twice a year until a minimum of 36 months and a maximum of 60 months. The primary outcome was time to composite treatment failure (prolapse retreatment, prolapse beyond the hymen, or prolapse symptoms) evaluated with an interval-censored proportional hazards survival model. Secondary study outcomes included patient-reported outcomes at 36 months, assessed via mixed linear models. Geriatric-specific outcomes included 30-day post-op complications, need for increased social support assessed 6-weeks post-op, falls, new admission to skilled nursing facilities (SNF), all-cause hospital admissions and mortality throughout the follow-up period.

Results: Of 145 predominantly white (88%) participants, mean age was 72.0(±5.2) years, 33% (n=48) were frail and 46% (n=67) demonstrated compromised mobility.

Time to treatment failure (Figure) for participants with frailty was significantly shorter compared to non-frail with an adjusted hazard ratio [AHR], 2.06 [95%CI 1.19, 3.57, p=0.001]. Time to treatment failure for compromised mobility was AHR 1.75[95%CI 1.02, 3.00, p=0.043]. There was no difference in treatment failure by age≥65 vs < 65 AHR 1.10[95%CI 0.77, 1.58, p=0.612]. At 36 months, all treatment arms showed sustained improvement over baseline in patient-reported outcomes.

Twenty percent of participants experienced a moderate/severe postoperative complication not attributable to intraoperative event. Compared with non-frail subjects, frail subjects experienced no difference in moderate/severe postoperative complications, discharge to SNF, falls, or 30-day readmission (Table). Frail subjects living alone before surgery were more likely to live with support (family or in assisted living) immediately after surgery (19% vs. 6%, p=0.04). Compared with mobile subjects, subjects with compromised mobility had fewer moderate/severe postoperative complications (7% vs 32%, p< 0.001).

Frail participants were similar with non-frail for geriatric outcomes at 36 to 60 months for falls (51% vs 38%, p=0.11), all-cause hospital admissions (21% vs 22%, p=0.95) and mortality (2% vs 2%).

Conclusions: Despite measurable frailty or compromised mobility, many older women undergo prolapse surgery with few complications; however, enhanced social support in the first six weeks after surgery may be necessary. Treatment failure was higher for women with frailty with no difference in < 65 vs ≥65 years suggesting frailty as a unique modifier of surgical treatment outcome.