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Published on: February 18, 2020
Imaging Comparisons Between Bifurcation Stenting Procedures Performed in Human Patients and Those Within Reanimated
Francesco Bianchini1, Enrico Romagnoli1, Cristina Aurigemma1
1Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Background:
Reanimated swine hearts have been used for over a decade to study bifurcation percutaneous coronary intervention, on the assumption that their results resemble those in patients, which has rarely been tested directly.
Objectives:
The objective of the study was to test how closely provisional bifurcation procedures performed in reanimated swine hearts agree with the human stent-geometry result of a given technique.
Methods:
We pooled individual-case data from 2 randomized (1:1) trials sharing 1 protocol, comparing proximal optimization technique (POT)/kissing/POT and POT/side/POT (PSP) in 30 percutaneous coronary interventions in 17 reanimated swine hearts and 60 patients. Stent geometry was assessed across ten endpoints in 4 subsegments by human-optical coherence tomography (OCT), swine-OCT, and micro-computed tomography (CT) of the explanted swine stents.
Results:
Swine-OCT agreed with micro-CT at the distal main vessel (concordance correlation coefficient 0.83). The technique effect agreed in direction at 8 of 10 endpoints; the descriptive calibration slope was 1.04 (indistinguishable from unity), although the case-level bootstrap was imprecise (slope 0.88; 95% CI: 0.47-1.54). Distal main-vessel expansion was lowest with PSP (mean 91% vs 98% in swine; 84% vs 99% in patients); major malappositions were rare after POT/kissing/POT but affected about half of PSP cases in both species. OCT matched micro-CT for expansion but not eccentricity; underexpansions extended farther along the larger human vessel.
Conclusions:
A reanimated swine-heart model showed close concordance with the human geometric result of bifurcation techniques, matching the direction at 8 of 10 endpoints and, approximately, the magnitude. This is descriptive concordance, not proven predictive equivalence, and supports the model as a preclinical screening tool pending prospective validation.
