Predicting the risk of iliofemoral vascular complication in complex transfemoral-TAVR using new generation transcatheter devices

Ofir Koren; Vivek Patel; Yuval Tamir; Keita Koseki; Danon Kaewkes; Troy Sanders; Robert Naami; Edmund Naami; Daniel Eugene Cheng; Sharon Shalom Natanzon; Alon Shechter; Jeffrey Gornbein; Tarun Chakravarty; Mamoo Nakamura; Wen Cheng; Hasan Jilaihawi; Raj R Makkar

doi:10.3389/fcvm.2023.1167212

Predicting the risk of iliofemoral vascular complication in complex transfemoral-TAVR using new generation transcatheter devices

Front Cardiovasc Med. 2023 Jul 6:10:1167212. doi: 10.3389/fcvm.2023.1167212. eCollection 2023.

Authors

Ofir Koren^{1

2}, Vivek Patel¹, Yuval Tamir³, Keita Koseki^{1

4}, Danon Kaewkes⁵, Troy Sanders⁶, Robert Naami⁷, Edmund Naami⁸, Daniel Eugene Cheng¹, Sharon Shalom Natanzon¹, Alon Shechter^{1

9

10}, Jeffrey Gornbein⁶, Tarun Chakravarty¹, Mamoo Nakamura¹, Wen Cheng¹, Hasan Jilaihawi¹, Raj R Makkar¹

Affiliations

¹ Cedars-Sinai Medical Center, Smidt Heart Institute, Los Angeles, California.
² Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel.
³ Weizmann Institute of Science, Rehovot, Israel.
⁴ Department of Cardiology, The University of Tokyo Hospital, Tokyo, Japan.
⁵ Queen Sirikit Heart Center of the Northeast, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
⁶ David Geffen School of Medicine, University of California (UCLA), Los Angeles, California.
⁷ Internal Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve, University School of Medicine, Cleveland, United States.
⁸ School of Medicine, University of Illinois, Chicago, IL, United States.
⁹ Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
¹⁰ Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.

Abstract

Objective: Design a predictive risk model for minimizing iliofemoral vascular complications (IVC) in a contemporary era of transfemoral-transcatheter aortic valve replacement (TF-TAVR).

Background: IVC remains a common complication of TF-TAVR despite the technological improvement in the new-generation transcatheter systems (NGTS) and enclosed poor outcomes and quality of life. Currently, there is no accepted tool to assess the IVC risk for calcified and tortuous vessels.

Methods: We reconstructed CT images of 516 propensity-matched TF-TAVR patients using the NGTS to design a predictive anatomical model for IVC and validated it on a new cohort of 609 patients. Age, sex, peripheral artery disease, valve size, and type were used to balance the matched cohort.

Results: IVC occurred in 214 (7.2%) patients. Sheath size (p = 0.02), the sum of angles (SOA) (p < .0001), number of curves (NOC) (p < .0001), minimal lumen diameter (MLD) (p < .001), and sheath-to-femoral artery diameter ratio (SFAR) (p = 0.012) were significant predictors for IVC. An indexed risk score (CSI) consisting of multiplying the SOA and NOC divided by the MLD showed 84.3% sensitivity and 96.8% specificity, when set to >100, in predicting IVC (C-stat 0.936, 95% CI 0.911-0.959, p < 0.001). Adding SFAR > 1.00 in a tree model increased the overall accuracy to 97.7%. In the validation cohort, the model predicted 89.5% of the IVC cases with an overall 89.5% sensitivity, 98.9% specificity, and 94.2% accuracy (C-stat 0.842, 95% CI 0.904-0.980, p < .0001).

Conclusion: Our CT-based validated-model is the most accurate and easy-to-use tool assessing IVC risk and should be used for calcified and tortuous vessels in preprocedural planning.

Keywords: TAVR; aortic stenosis; calcification; crossability; iliofemoral vascular complications; risk model; tortuosity; validation & verification component.