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. 2020 May;28(5):240-248.
doi: 10.1007/s12471-020-01374-5.

Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial

J Vendrik  1 , W Vlastra  2 , M S van Mourik  2 , R Delewi  2 , M A Beijk  2 , J Lemkes  3 , J J Wykrzykowska  2 , R J de Winter  2 , J S Henriques  2 , J J Piek  2 , M M Vis  2 , K T Koch  2 , J Baan Jr  2
Affiliations

Early mobilisation after transfemoral transcatheter aortic valve implantation: results of the MobiTAVI trial

J Vendrik et al. Neth Heart J. 2020 May.

Abstract

Background: Immobilisation of patients after transfemoral transcatheter aortic valve implantation (TF-TAVI) is the standard of care, mostly to prevent vascular complications. However, immobilisation may increase post-operative complications such as delirium and infections. In this trial, we determine whether it is feasible and safe to implement early ambulation after TF-TAVI.

Methods: We prospectively included TF-TAVI patients from 2016 to 2018. Patients were assessed for eligibility using our strict safety protocol and were allocated (based on the time at which the procedure ended) to the EARLY or REGULAR group.

Results: A total of 150 patients (49%) were deemed eligible for early mobilisation, of which 73 were allocated to the EARLY group and 77 to the REGULAR group. The overall population had a mean age of 80 years, 48% were male with a Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of 3.8 ± 1.8. Time to mobilisation was 4 h 49 min ± 31 min in the EARLY group versus 20 h 7 min ± 3 h 6 min in the REGULAR group (p < 0.0001). There were no differences regarding the primary endpoint. No major vascular complications occurred and a similar incidence of minor vascular complications was seen in both groups (4/73 [5.5%] vs 6/77 [7.8%], p = 0.570). The incidence of the combined secondary endpoint was lower in the EARLY group (p = 0.034), with a numerically lower incidence for all individual outcomes (delirium, infections, pain and unplanned urinary catheter use).

Conclusion: Early mobilisation (ambulation 4-6 h post-procedure) of TF-TAVI patients is feasible and safe. Early ambulation decreases the combined incidence of delirium, infections, pain and unplanned urinary catheter use, and its adoption into contemporary TAVI practice may therefore be beneficial.

Keywords: Ambulation; Early mobilisation; Percutaneous valve; Safety protocol; Transfemoral transcatheter aortic valve implantation; Vascular complications.

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Conflict of interest statement

J. Baan Jr. receives an unrestricted research grant from Edwards Lifesciences. J. Vendrik, W. Vlastra, M.S. van Mourik, R. Delewi, M.A. Beijk, J. Lemkes, J.J. Wykrzykowska, R.J. de Winter, J.S. Henriques, J.J. Piek, M.M. Vis and K.T. Koch declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of study patient selection. (T1 pre-TAVI, T2 during procedure, T3 4 h after the procedure, AVR aortic valve replacement, PM pacemaker, TAVI transcatheter aortic valve implantation. aOperator recommended not including the patient in the early ambulation group. bTwo eligible patients were not willing to ambulate early)
Fig. 2
Fig. 2
Primary and secondary endpoint: in-hospital outcomes for EARLY versus REGULAR group. (aPresence of pain the next morning is defined as a Numerical Rating Scale/Visual Analogue Scale score >3 during the start of the day shift. bCombined secondary endpoint: incidence of pain, infection, delirium and unplanned urinary catheter use (some patients had >1 endpoint))
See this image and copyright information in PMC

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