Comparing Quality Of Life And Postoperative Pain After Limited Access And Conventional Aortic Valve Replacement: A Randomized Clinical Trial
Idserd D.G. Klop1, Geoffrey T. Kloppenburg1, Bart P. van Putte1, Mirjam A. Sprangers2, Pythia T. Nieuwkerk2, Patrick Klein1
1St. Antonius Hospital, Nieuwegein, Netherlands, 2Amsterdam UMC, Amsterdam, Netherlands
BACKGROUND:Limited access aortic valve replacement (LA-AVR) yields excellent results as an alternative to conventional surgical aortic valve replacement by full median sternotomy (C-AVR). However, robust data on quality of life (QoL) improvements and the differences in postoperative QoL and pain compared to C-AVR are lacking. We report the one-year results of the LImited access Aortic valve Replacement (LIAR) Trial.
METHODS:The LIAR-Trial is an investigator initiated, Dutch government
sponsored randomized controlled trial comparing postoperative QoL and pain in patients between LA-AVR through partial upper hemisternotomy (UHS) and
AVR for symptomatic severe aortic valve stenosis. All patients were intended to
have their native aortic valve replaced by a rapid deployment stented bioprosthesis (RDSBP). Primary outcome was Cardiac Related QoL, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at one, three, six and twelve months postoperatively. Secondary outcomes included generic QoL, postoperative pain, analgesic use and postoperative complications.
RESULTS:A total of 161 patients were randomized. Per protocol analysis
demonstrated significant differences in the primary outcome measures:
estimated mean differences of both the Physical Limitations domain (2.22
points;95%CI, 0.96 - 3.28;p=0.01) and the Total Symptom Score of the KCCQ
(3.31 points;95%CI, 0.30 - 6.31;p=0.031) demonstrated significantly increase
improvement after LA-AVR compared to C-AVR. Regarding the secondary
outcome measures: LA-AVR was associated with a significant increased
improvement in the Overall Summary Score and Social Limitation of the KCCQ,
Mental Health SF 36 and reduced postoperative pain. Operative times were
significantly longer in the LA-AVR group. No significant differences were found
regarding 30-day complication-rate.
CONCLUSIONS:LA-AVR trough UHS with the use of a RDSBP is associated with an increased improvement in cardiac related QoL and reduced postoperative pain compared to C-AVR.