PMID- 29195573
DCOM- 20171226
LR  - 20171226
IS  - 1532-9488 (Electronic)
IS  - 1043-0679 (Linking)
VI  - 29
IP  - 3
DP  - 2017 Autumn
TI  - Complications After Self-expanding Transcatheter or Surgical Aortic Valve
PG  - 321-330
LID - S1043-0679(17)30165-X [pii]
LID - 10.1053/j.semtcvs.2017.06.001 [doi]
AB  - Procedural complications following transcatheter aortic valve replacement (TAVR) 
      or surgical aortic valve replacement (SAVR) are usually reported as retrospective
      analyses. We report the first comparison of complications following SAVR or
      self-expanding TAVR from a prospectively randomized study of high-risk SAVR
      patients. Three hundred ninety-five TAVR and 402 SAVR patients were prospectively
      enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical 
      bioprosthetic valve. The rates of major procedural and vascular complications
      occurring (periprocedurally (0-3 days) and early (4-30 days)) were compared for
      TAVR vs SAVR patients. All-cause mortality, stroke, myocardial infarction, and
      major infection were similar in both periods post procedure. Within 0-3 days, the
      major vascular complication rate was significantly higher with TAVR (P = 0.003). 
      Life-threatening or disabling bleeding (P < 0.001), encephalopathy (P = 0.02),
      atrial fibrillation (P < 0.001), and acute kidney injury (P < 0.001) were
      significantly higher with SAVR. Non-iliofemoral TAVR approaches had a higher
      incidence of major or life-threatening or disabling bleeding at 0-3days (P <
      0.05). Procedural complications unique to TAVR included coronary occlusion 0.5%
      (2) and TAVR pop outs 2.8% (11) with no valve embolizations. Pop outs were
      similar between iliofemoral 2.8% (9/324) and non-iliofemoral approaches 3.0%
      (2/66). Procedural complications unique to SAVR included aortic dissection 0.8%
      (3/357) and injury to other heart structures 2.0% (7/357). The procedural
      complication profiles of TAVR and SAVR are unique. Intraoperative deaths were
      seen in TAVR only. Mortality at 3 and 30 days was similar. The higher incidence
      of some complications likely reflects the greater invasiveness of SAVR in this
      aged high-risk population.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Conte, John V
AU  - Conte JV
AD  - Departments of Surgery and Medicine, Johns Hopkins University, Baltimore,
      Maryland. Electronic address:
FAU - Hermiller, James Jr
AU  - Hermiller J Jr
AD  - St. Vincent's Heart Center of Indiana, Indianapolis, Indiana.
FAU - Resar, Jon R
AU  - Resar JR
AD  - Departments of Surgery and Medicine, Johns Hopkins University, Baltimore,
FAU - Deeb, G Michael
AU  - Deeb GM
AD  - Department of Surgery, University of Michigan, Ann Arbor, Michigan.
FAU - Gleason, Thomas G
AU  - Gleason TG
AD  - Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh,
FAU - Adams, David H
AU  - Adams DH
AD  - Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New
FAU - Popma, Jeffrey J
AU  - Popma JJ
AD  - Department of Medicine, Beth Israel Deaconess Medical Center, Boston,
FAU - Yakubov, Steven J
AU  - Yakubov SJ
AD  - Riverside Methodist Hospital, Columbus, Ohio.
FAU - Watson, Daniel
AU  - Watson D
AD  - Riverside Methodist Hospital, Columbus, Ohio.
FAU - Guo, Jia
AU  - Guo J
AD  - Medtronic, Minneapolis, Minnesota.
FAU - Zorn, George L 3rd
AU  - Zorn GL 3rd
AD  - Cardiovascular Research Institute, University of Kansas Hospital, Kansas City,
FAU - Reardon, Michael J
AU  - Reardon MJ
AD  - Department of Surgery, Houston Methodist DeBakey Heart and Vascular Center,
      Houston, Texas.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170619
PL  - United States
TA  - Semin Thorac Cardiovasc Surg
JT  - Seminars in thoracic and cardiovascular surgery
JID - 8917640
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve/diagnostic imaging/physiopathology/*surgery
MH  - Aortic Valve Stenosis/diagnostic imaging/mortality/physiopathology/*surgery
MH  - *Bioprosthesis
MH  - Female
MH  - *Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation/*adverse effects/*instrumentation/mortality
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Postoperative Complications/diagnosis/*etiology/mortality
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Transcatheter Aortic Valve Replacement/*adverse
MH  - Treatment Outcome
MH  - United States
OT  - acute kidney injury
OT  - bleeding
OT  - complications
EDAT- 2017/12/03 06:00
MHDA- 2017/12/27 06:00
CRDT- 2017/12/03 06:00
PHST- 2017/06/01 00:00 [accepted]
PHST- 2017/12/03 06:00 [entrez]
PHST- 2017/12/03 06:00 [pubmed]
PHST- 2017/12/27 06:00 [medline]
AID - S1043-0679(17)30165-X [pii]
AID - 10.1053/j.semtcvs.2017.06.001 [doi]
PST - ppublish
SO  - Semin Thorac Cardiovasc Surg. 2017 Autumn;29(3):321-330. doi:
      10.1053/j.semtcvs.2017.06.001. Epub 2017 Jun 19.