PMID- 37302473
OWN - NLM
STAT- MEDLINE
DCOM- 20231023
LR  - 20231027
IS  - 1535-7732 (Electronic)
IS  - 1051-0443 (Linking)
VI  - 34
IP  - 10
DP  - 2023 Oct
TI  - Objective Performance Goals Based on a Systematic Review and Meta-Analysis of 
      Clinical Outcomes for Bare-Metal Stents and Percutaneous Transluminal Angioplasty 
      for Hemodialysis-Related Central Venous Obstruction.
PG  - 1664-1673.e3
LID - S1051-0443(23)00413-X [pii]
LID - 10.1016/j.jvir.2023.05.036 [doi]
AB  - PURPOSE: To use safety and efficacy outcomes following treatment with 
      percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic 
      central venous obstruction in hemodialysis-dependent patients to establish 
      objective performance goals (OPGs). METHODS: A systematic literature review and 
      meta-analysis were conducted for articles published between January 1, 2000, and 
      August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 
      months, and safety outcomes included adverse events (AEs) categorized as access 
      loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the 
      upper and lower bounds of the 95% confidence intervals for primary patency and 
      SAE rates. RESULTS: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, 
      n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary 
      patency rates for PTA were 50.9% and 36.7%, respectively. Based on these 
      findings, the proposed 6- and 12-month primary patency OPGs identifying 
      superiority against PTA were 66.5% and 52.6%, respectively, and those for 
      noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- 
      and 12-month primary patency rates were 69.7% and 47.9%, respectively. The 
      proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% 
      and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, 
      respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, 
      respectively. Proposed safety OPGs for noninferiority versus superiority for PTA 
      and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively. 
      CONCLUSION: The OPGs derived from real-world studies of PTA and stent placement 
      may serve as a benchmark for future interventions indicated for this patient 
      population.
CI  - Copyright (c) 2023 SIR. Published by Elsevier Inc. All rights reserved.
FAU - Razavi, Mahmood K
AU  - Razavi MK
AD  - St. Joseph Heart and Vascular Center, Orange, California. Electronic address: 
      mrazavi@pacbell.net.
FAU - Rajan, Dheeraj K
AU  - Rajan DK
AD  - University Medical Imaging Toronto/University of Toronto, Toronto, Ontario, 
      Canada.
FAU - Nordhausen, Craig T
AU  - Nordhausen CT
AD  - Merit Medical Systems, Inc., South Jordan, Utah.
FAU - Bounsanga, Jerry
AU  - Bounsanga J
AD  - Merit Medical Systems, Inc., South Jordan, Utah.
FAU - Holden, Andrew
AU  - Holden A
AD  - Auckland City Hospital, Auckland, New Zealand.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20230609
PL  - United States
TA  - J Vasc Interv Radiol
JT  - Journal of vascular and interventional radiology : JVIR
JID - 9203369
SB  - IM
CIN - J Vasc Interv Radiol. 2023 Oct;34(10):1674-1675. PMID: 37302470
MH  - Humans
MH  - Goals
MH  - *Angioplasty, Balloon/adverse effects
MH  - Vascular Patency
MH  - Angioplasty
MH  - *Vascular Diseases/therapy
MH  - Stents
MH  - Renal Dialysis
MH  - Treatment Outcome
EDAT- 2023/06/12 00:42
MHDA- 2023/10/23 00:44
CRDT- 2023/06/11 19:13
PHST- 2022/12/28 00:00 [received]
PHST- 2023/04/24 00:00 [revised]
PHST- 2023/05/06 00:00 [accepted]
PHST- 2023/10/23 00:44 [medline]
PHST- 2023/06/12 00:42 [pubmed]
PHST- 2023/06/11 19:13 [entrez]
AID - S1051-0443(23)00413-X [pii]
AID - 10.1016/j.jvir.2023.05.036 [doi]
PST - ppublish
SO  - J Vasc Interv Radiol. 2023 Oct;34(10):1664-1673.e3. doi: 
      10.1016/j.jvir.2023.05.036. Epub 2023 Jun 9.