PMID- 29746546
OWN - NLM
STAT- MEDLINE
DCOM- 20180801
LR  - 20220330
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 5
DP  - 2018
TI  - Transcatheter aortic valve implantation for aortic stenosis in high surgical risk 
      patients: A systematic review and meta-analysis.
PG  - e0196877
LID - 10.1371/journal.pone.0196877 [doi]
LID - e0196877
AB  - BACKGROUND: Symptomatic aortic stenosis has a poor prognosis. Many patients are 
      considered inoperable or at high surgical risk for surgical aortic valve 
      replacement (SAVR), reflecting their age, comorbidities and frailty. The clinical 
      effectiveness and safety of TAVI have not been reviewed systematically for these 
      high levels of surgical risk. This systematic review compares mortality and other 
      important clinical outcomes up to 5 years post treatment following TAVI or other 
      treatment in these risk groups. METHODS: A systematic review protocol was 
      registered on the PROSPERO database (CRD42016048396). The Cochrane Library, 
      Centre for Reviews and Dissemination Databases, MEDLINE, EMBASE, and ZETOC were 
      searched from January 2002 to August 2016. Clinical trials or matched studies 
      comparing TAVI with other treatments for AS in patients surgically inoperable or 
      operable at a high risk were included. Data extraction and quality assessment 
      were conducted by two reviewers. Data were pooled using random-effects 
      meta-analysis. The main outcomes were all-cause mortality, efficacy and major 
      complications. RESULTS: Three good quality randomised controlled trials (RCTs) 
      were included. Patients' mean age ranged from 83-85 years, around half were 
      female and New York Heart Association (NYHA) functional class III or IV ranged 
      from 83.8% to 94.2% with frequent comorbidities. In 358 surgically inoperable 
      patients from one RCT, TAVI was superior to medical therapy for all-cause 
      mortality at 1 year (hazard ratio (HR) 0.58, 95% confidence interval (CI) 
      0.36-0.92), 2 years (HR 0.50, 95% CI 0.39-0.65), 3 years (HR 0.53, 95% CI 0.41to 
      0.68) and 5 years (HR 0.50, 95% CI 0.39-0.65), and NYHA class III or IV at 2 
      years (TAVI 16.8% (16/95), medical therapy 57.5% (23/40), p<0.001), quality of 
      life and re-hospitalisation. TAVI had higher risks of major bleeding up to 1 
      year, of stroke up to 3 years (at one year 11.2% versus 5.5%, p = .06; HR at 2 
      years 2.79, 95% CI 1.25-6.22; HR at 3 years 2.81; 95% CI 1.26-6.26) and of major 
      vascular complication at 3 years (HR 8.27, 95% CI 2.92-23.44). Using the GRADE 
      tool, this evidence was considered to be of moderate quality. In a meta-analysis 
      including 1,494 high risk surgically operable patients from two non-inferiority 
      RCTs TAVI showed no significant differences from SAVR in all-cause mortality at 
      two years (HR 1.03, 95% CI 0.82-1.29) and up to 5 years (HR 0.83, 95% CI 
      0.83-1.12). There were no statistically significant differences in major vascular 
      complications and myocardial infarction at any time point, discrepant results for 
      major bleeding on variable definitions and no differences in stroke rate at any 
      time point. Using the GRADE tool, this evidence was considered of low quality. 
      CONCLUSIONS: Symptomatic aortic stenosis can be lethal without intervention but 
      surgical resection is contraindicated for some patients and high risk for others. 
      We found that all-cause mortality up to 5 years of follow-up did not differ 
      significantly between TAVI and SAVR in patients surgically operable at a high 
      risk, but favoured TAVI over medical therapy in patients surgically inoperable. 
      TAVI is a viable life-extending treatment option in these surgical high risk 
      groups.
FAU - Liu, Zulian
AU  - Liu Z
AD  - Nuffield Department of Population Health, University of Oxford, Oxford, United 
      Kingdom.
FAU - Kidney, Elaine
AU  - Kidney E
AD  - Institute of Applied Health Research, University of Birmingham, Birmingham, 
      United Kingdom.
FAU - Bem, Danai
AU  - Bem D
AD  - Institute of Applied Health Research, University of Birmingham, Birmingham, 
      United Kingdom.
FAU - Bramley, George
AU  - Bramley G
AD  - Institute of Applied Health Research, University of Birmingham, Birmingham, 
      United Kingdom.
FAU - Bayliss, Susan
AU  - Bayliss S
AUID- ORCID: 0000-0003-3025-9323
AD  - Institute of Applied Health Research, University of Birmingham, Birmingham, 
      United Kingdom.
FAU - de Belder, Mark A
AU  - de Belder MA
AUID- ORCID: 0000-0003-2690-8319
AD  - The James Cook University Hospital, Middlesbrough, United Kingdom.
FAU - Cummins, Carole
AU  - Cummins C
AUID- ORCID: 0000-0001-5464-1944
AD  - Institute of Applied Health Research, University of Birmingham, Birmingham, 
      United Kingdom.
FAU - Duarte, Rui
AU  - Duarte R
AUID- ORCID: 0000-0001-6485-7415
AD  - Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, 
      United Kingdom.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20180510
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Aged, 80 and over
MH  - Aortic Valve Stenosis/*mortality/*surgery
MH  - Female
MH  - Humans
MH  - MEDLINE
MH  - Male
MH  - Risk Factors
MH  - *Transcatheter Aortic Valve Replacement
PMC - PMC5944928
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2018/05/11 06:00
MHDA- 2018/08/02 06:00
PMCR- 2018/05/10
CRDT- 2018/05/11 06:00
PHST- 2017/10/03 00:00 [received]
PHST- 2018/04/21 00:00 [accepted]
PHST- 2018/05/11 06:00 [entrez]
PHST- 2018/05/11 06:00 [pubmed]
PHST- 2018/08/02 06:00 [medline]
PHST- 2018/05/10 00:00 [pmc-release]
AID - PONE-D-17-44187 [pii]
AID - 10.1371/journal.pone.0196877 [doi]
PST - epublish
SO  - PLoS One. 2018 May 10;13(5):e0196877. doi: 10.1371/journal.pone.0196877. 
      eCollection 2018.