Key result
Omitting predilation in balloon-expandable TAVI is linked to ~57% lower 30-day mortality and shorter procedures.
Why the study?
The effect of omitting predilation on feasibility, procedural results, and safety in balloon-expandable TAVI was not well established.
Does the omission of predilation improve procedural outcomes and safety in patients undergoing balloon-expandable TAVI?
Cohort (n=680)
No
Does the omission of predilation improve procedural outcomes and safety in patients undergoing balloon-expandable TAVI?
Omitting predilation in balloon-expandable TAVI is feasible and associated with shorter procedure times, less contrast use, and lower 30-day mortality compared to routine predilation.
Answers are grounded in this paper and cite their sources.
May favor omitting predilation in balloon-expandable TAVI; leaves open confirmation in randomized trials.
AIMS: We aimed to evaluate the effect of omitting predilation on feasibility, procedural results and safety in balloon-expandable TAVI. METHODS AND RESULTS: We performed an analysis of all 680 patients scheduled for a balloon-expandable TAVI prosthesis between January 2011 and August 2016. Patients treated with or without predilation were compared. Procedure times decreased from 85.6±42.9 to 56.7±26.1 minutes (p<0.001), fluoroscopy times from 9.5±5.7 to 6.2±3.9 minutes (p<0.001) and contrast volume from 131.9±60.8 to 85.4±37.4 ml (p<0.001) without predilation. Intraprocedural CPR was significantly more frequent in the predilation group (5.3% vs. 1.4%, p=0.01). Stroke rate was low at 1.5% and with no detectable difference. Applying VARC-2 definitions, the combined endpoints device success (88.3% vs. 92.4%, p=0.07) and clinical efficacy (88.7% vs. 92.4%, p=0.11) were comparable with or without prior valvuloplasty, while early safety was less frequent with predilation (85.2% vs. 90.2%, p=0.04). At 30 days, all-cause mortality and cardiovascular mortality were 6.8% with predilation vs. 2.9% without predilation (p=0.03) and 5.3% vs. 1.4% (p=0.01). CONCLUSIONS: TAVI without prior valvuloplasty is feasible without apparent adverse impact in patients receiving a balloon-expandable TAVI prosthesis. The omission of predilation is associated with shorter procedure time, less radiation exposure and lower rates of intraprocedural resuscitation.
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Hamm et al. (2017) conducted a cohort in Scheduled for balloon-expandable TAVI (n=680). Omission of predilation vs. TAVI with predilation (prior valvuloplasty) was evaluated on 30-day all-cause mortality (p=0.03). Omission of predilation during balloon-expandable TAVI was associated with lower 30-day all-cause mortality and shorter procedure times compared to prior valvuloplasty.
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