Elsevier

Annals of Vascular Surgery

Volume 46, January 2018, Pages 208-217
Annals of Vascular Surgery

Clinical Research
A Novel Iliac Morphology Score Predicts Procedural Mortality and Major Vascular Complications in Transfemoral Aortic Valve Replacement

Presented at the 44th Annual Meeting of the Society for Clinical Vascular Surgery, March 12–16, 2016.
https://doi.org/10.1016/j.avsg.2017.06.137Get rights and content

Background

Vascular complications remain a significant technical challenge for transfemoral TAVR (transcatheter aortic valve replacement). The goal of this study is to develop a preoperative tool for prediction of major vascular complications of TAVR.

Methods

A retrospective review was performed of all patients who underwent transfemoral TAVR at a tertiary medical center from 2011 to 2015. Iliofemoral arterial measurements were obtained with computed tomography angiography three-dimensional reconstruction images and an Iliac Morphology Score (IMS) was created from these measurements. Vascular complications were defined by Valve Academic Research Consortium (VARC-2) criteria. Statistical analyses were performed utilizing chi-squared test, Student’s t-test, and binomial regression.

Results

We analyzed the data of 198 transfemoral TAVR patients. VARC-2 vascular complications were seen in 25 patients (13%). Major and minor vascular complication rates in the entire cohort were 4% (n = 7) and 9% (n = 18), respectively. Thirty-one patients (15.6%) required vascular surgery consultation. A total of 24 patients (12%) required surgical or percutaneous vascular interventions. Univariate analysis identified gender, iliac diameter, iliac calcification, and access type (open versus percutaneous) as predictors of major complications. The IMS was composed of ipsilateral minimum iliac diameter and iliac calcifications based on area under the receiver operator curve (AUROC) analysis (P < 0.05, AUROC = 0.82). Arterial size and calcification were classified with a value of 0–3 based on severity. Multivariate analysis identified gender and IMS as independent predictors of major complications. The mean IMS for the cohort was 3.4 (range 0–6). Patients were divided into high (IMS ≥ 5, n = 55) and low risk (IMS<5, n = 143) groups based on the inflection point for specificity (73%) and sensitivity (83%). The high-risk group had smaller iliac diameters, areas, luminal volumes, and a higher rate of major vascular complications (9% vs. 1%, P = 0.001). The 30-day mortality rate in the high score group was 9% and 1.4% in low score group (P = 0.02, AUROC = 0.72).

Conclusions

An IMS composed of ipsilateral minimum iliac diameter plus iliac calcification is an excellent predictor of major vascular complications and mortality. Alternative access in patients with high IMS may reduce major vascular complications and 30-day mortality.

Introduction

Dr. Alain Cribier performed the first transcatheter aortic valve replacement (TAVR) in 2002; since then more than 50,000 TAVR procedures have been performed worldwide.1 TAVR is an established alternative to open heart procedures for treatment of severe aortic valve stenosis. TAVR is performed in high-risk patients who typically have multiple comorbidities and therefore at very high risk for access-related vascular injuries.2 Vascular complications have been shown to increase morbidity and mortality in this high-risk population. As such, TAVR candidates should be carefully screened to reduce their complication rate during surgery.

Vascular access site complications remain the most common complication of TAVR. Review of the literature reveals a high degree of variability in reported complication rates, ranging from 13% to 28%.3 This variability in outcomes is likely created by inconsistencies in early reporting standards and by the introduction of newer technology in recent years. To address inconsistencies, the Valve Academic Research Consortium (VARC-2) released a set of reporting standards to be adopted for all future TAVR data.4

Independent predictors of access site vascular complications in TAVR have been identified. No study until now has presented a scoring system for the relevant predictive anatomic and patient factors. Predictive models and anatomic scoring systems have been created and validated for both EVAR5, 6 and TEVAR7 procedures. With this study, an anatomic grading scale was created to provide reliable and reproducible risk stratification of patients based on anatomy relevant to transfemoral TAVR. The scoring system was applied and correlated with major vascular complications and mortality.

Section snippets

Iliac Morphology Score Model

The Iliac Morphology Score (IMS) was created from the evaluation of computed tomography angiography (CTA) images. All measurements were taken on centerline after appropriate three-dimensional (3D) reconstruction. The IMS was developed based on key anatomical measurements recommended by literature review, multivariable statistical analysis of the cohort, and the VARC-2.

The IMS model (Table I) comprises iliac artery calcification and iliac artery minimum diameter. Each attribute is graded on a

Patient Demographics

Between February 2011 and July 2015, a total of 344 patients underwent TAVR; of those, 280 had transfemoral access. The study cohort includes only patients treated through transfemoral access that had adequate and available preoperative CTA imaging (n = 198). The cohort comprises 51% men and 49% women with a mean age of 81 years and a body mass index (BMI) of 29. The majority of patients were Caucasian (82%). Patient demographics are presented in Table IV.

Procedural Characteristics

Procedural characteristics are

Discussion

Data from the landmark PARTNER trial supports the use of TAVR as an alternative to standard therapy in patients unable to withstand open surgery. Transfemoral aortic valve repair was shown to have equal long-term outcomes when compared with surgical valve replacement.10 Three-year follow-up data suggest that TAVR patients have fewer hospitalizations and a higher functional status.11 Vascular complication rates present a key difference between traditional open surgical approaches and

Conclusion

Increased center experience and reduced valve delivery profiles have improved outcomes for TAVR, but vascular access complications remain a frequent occurrence.

An IMS composed of ipsilateral minimum iliac diameter plus iliac calcification is an excellent predictor of major vascular complications and 30-day mortality. Early vascular consultation and evaluation of the vasculature with alternative access in high IMS patients may reduce major vascular complications and 30-day mortality.

Cited by (13)

  • Incidence, predictors, impact, and treatment of vascular complications after transcatheter aortic valve implantation in a modern prospective cohort under real conditions

    2020, Journal of Vascular Surgery
    Citation Excerpt :

    We identified four factors of all VCs in the multivariate analysis: IMS, SIFAR, moderate-severe iliofemoral calcification, and moderate-severe iliofemoral tortuosity. Concerning IMS, Blakeslee-Carter et al13 reported that an IMS ≥5 had the best discriminatory power for predicting VCs (sensitivity, 54%; specificity, 90%). However, our results were less convincing (area under the receiver operating characteristic curve, 0.58 [95% CI, 0.40-0.76] vs 0.82 [95% CI, 0.65-0.98]).

  • Impact of Gender on Transcatheter Aortic Valve Implantation Outcomes

    2020, American Journal of Cardiology
    Citation Excerpt :

    Women in our cohort had higher rates of peri-procedural major bleeding. Previous reports have demonstrated conflicting results, with some studies demonstrating similar rates of bleeding between men and women18 and other reports agrees with ours.11,17,19 In our cohort, bleeding was due to access site vascular complications in 46% in women and in 50% in men.

  • Trends in vascular complications and associated treatment strategies following transfemoral transcatheter aortic valve replacement

    2020, Journal of Vascular Surgery
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    Later experience from the PARTNER nonrandomized continued access registry showed notable improvements, with major bleeding occurring in 6.2% to 8.6% and major VCs in 6.2% to 9.7% of patients.13 Improved results have also been documented in recent single-center series across multiple continents, citing rates of major VC of 4.0% to 7.1% and minor VC of 9.0% to 29.3%.14-16 The incidence of iliofemoral access complications in our series is also consistent with similar reports among patients undergoing endovascular repair of the abdominal and thoracic aorta.17-19

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Disclosures: Blakeslee-Carter, Dexter, Ahanchi, Steerman, Larion, and Cain have no conflicts of interest to disclose. Mahoney is on the speaker’s bureau and is a consultant for Medtronic Inc., Edwards LifeSciences, and Boston Scientific; Panneton is on the speaker’s bureau, is a consultant, is on the scientific advisory board of Medtronic Inc., and is a consultant for Volcano.

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