Elsevier

The American Journal of Cardiology

Volume 139, 15 January 2021, Pages 71-78
The American Journal of Cardiology

Evaluation of a Low-Dose Radiation Protocol During Transcatheter Aortic Valve Implantation

https://doi.org/10.1016/j.amjcard.2020.10.035Get rights and content

We aimed to evaluate the efficacy and safety of a low-dose imaging protocol to reduce intraprocedural radiation during transcatheter aortic valve implantation (TAVI). Observational analysis: 802 transfemoral TAVI patients receiving balloon-expandable devices ≥23 mm at a high-volume centre. After propensity score matching, a standard-dose group (SD, n = 333) treated between January 2014 and February 2016 was compared with a low-dose group (LD, n = 333) treated between August 2017 and March 2019 after departmental uptake of a low-dose imaging protocol (reduced field size, high table height, use of “fluoro save,” 3.75 frames/second acquisition, increased filtering). Primary end point was dose-area product (DAP). Secondary safety end points were VARC-2 device success and a composite of in-hospital complications. The LD protocol was associated with lower DAP (4.64 [2.93, 8.42] vs 22.73 [12.31, 34.58] Gy⋅cm2, p <0.001) and fluoroscopy time (10.4 [8.1, 13.9] vs 11.5 [9.1, 15.3] minutes, p = 0.001). Contrast use was higher in the LD group (LD 110 [94, 130] vs SD 100 [80, 135] milliliters, p = 0.042). Device success (LD 88.3% vs SD 91.3%, p = 0.25), and the composite end point (LD 8.1% vs SD 11.4%, p = 0.19) were similar. In multivariate analysis, the low-dose protocol was associated with a 19.8 Gy⋅cm2 reduction in procedural DAP (p <0.001). In conclusion, compared with standard imaging, a low-dose protocol for TAVI significantly reduced radiation dose without compromising outcomes.

Section snippets

Methods

This observational intention-to-treat analysis included patients who underwent transfemoral TAVI using the Sapien 3 (Edwards Lifesciences, Irvine, CA) balloon-expandable transcatheter heart valve (THV) at the Clinic for Heart and Circulatory Disorders, at the high-volume German Heart Centre in Munich, Germany. All patients receiving ≥23 mm balloon-expandable Sapien 3 THVs were eligible for inclusion. A reference group of consecutive patients treated between January 2014 and February 2016 using

Results

After exclusions, 802/819 (97.9%) patients were evaluated; comparative analysis was performed on propensity score matched pairs (Figure 2). The median age of the unmatched population was 80 (77, 84) years, 40.9% female, median weight 75 kg (67, 86), median BMI 26.1 kg/m2(23.7, 29.4), with a median logistic EuroSCORE of 13.48% (7.96 to 22.76).

Baseline characteristics for the overall patient cohort, the 2 unmatched imaging protocol subgroups (SD, n = 449; LD, n = 353), and the propensity matched

Discussion

Patient radiation dose from high-dose procedures such as structural heart interventions will vary depending on case complexity,19 operator experience,20,21 imaging device settings,22,23 and age of the imaging system.1,24 This study aimed to determine the impact of a low-dose imaging protocol developed for TAVI on procedural DAP in a large cohort of patients. The primary finding is that, compared with a SD protocol, use of the LD protocol resulted in a large reduction in median DAP, in a

Author Contribution

Jonathan M. Michel: Conceptualization, Methodology, Data Curation, Investigation, Formal Analysis, Writing – Original Draft, Writing - Review & Editing

Desard Hashorva: Investigation

Angela Kretschmer: Methodology, Investigation, Writing - Review & Editing

Hector A. Alvarez- Covarrubias: Methodology, Data Curation, Investigation, Writing - Review & Editing

N. Patrick Mayr: Writing - Review & Editing

Costanza Pellegrini: Investigation, Software, Writing - Review & Editing

Tobias Rheude: Investigation,

Disclosures

This study was performed without external or industry funding. Dr. Michel has received honoraria from Edwards Lifesciences. Dr. Kasel is a consultant and proctor for Edwards Lifesciences. Dr. Frangieh is a consultant and proctor for Edwards Lifesciences. The remaining authors report no disclosures.

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