Abstract

Objective: Vascular Complications (VCs) are independent predictors of mortality after Transcatheter Aortic Valve Implantation with Transfemoral Access (TF-TAVI) and remain an unsolved problem regardless of the Percutaneous (PC) or Surgical Cut-down (SC) access for patients with severe Aortic Valve Stenosis (AVS). The debate about the short- and long-term results, safety, risks of procedural complications and the complementary roles of SC and PC approaches is still open. We aim to show VCs in our series of patients submitted to TF-TAVI using a surgical-cutdown.

Methodsː Retrospective analysis of consecutive patients with symptomatic severe AVS receiving TF-TAVI. The accesses were studied by computed tomography and Echo Color Doppler. The STS score was <4 in 172 (66.4%), 4-8 in 72 (27.8%) and >8 in 15 (5.8%) patients. The outcomes were the incidence of VCs. SC procedures were applied by Edwards SAPIENTM 3 (Edwards Lifesciences, Irvine, CA, USA) BE device.                                               

Resultsː We enrolled 259 patients, 244 (94.2%) underwent TF-TAVI with the SC approach. The mean patients’ age was 82 ± 2 (range: 58-99). Female patients were 160/259 (62%) and male 99/259 (38%). The mean fluoroscopic time was 22 minutes. The 30-day mortality rate was 0.77% (two deaths). Intraoperative VCs were 6 (2.3%) and 1 (0.4%) at 1-year follow-up. The ICU stay was one day, the median post-operative hospitalization was two days.

Conclusionː This study contributes to the debate about the advantages of the SC approach compared to PC according to the patients’ profile with AVS and proposes multicenter prospective trials, especially for a future TAVI use in young and low-risk patients.

Keywords: Vascular Complications; Transcatheter Aortic Valve Implantation; Percutaneous Transfemoral Aortic Valve Replacement; Surgical Cut-Down Transfemoral Aortic Valve Replacement; Aortic Valve Stenosis

Introduction

Transcatheter Aortic Valve Implantation (TAVI) for patients with Aortic Valve Stenosis (AVS) is preferably performed by Trans-Femoral Access (TF-TAVI) and the approaches of TF-TAVI are Percutaneous (PC) or Surgical Cut-down (SC) [1,2]. The TF-TAVI procedure is widespread, but may bear specific complications. In particular, the Vascular Complications (VCs) of TF-TAVI, such as annular rupture, vessel dissection or major bleeding, classified by the Valve Academic Research Consortium-2 (VARC-2) are deemed independent predictors of mortality after TAVI [3-5]. Early complications of TF-TAVI at the peripheral vasculature can arise in the presence of small vessels, calcification at the puncture site, tortuosity of high vessels, inadequate ratio total tortuosity/arterial diameter and concomitant peripheral vascular disease [6-8]. Despite the advancing technology and the heart teams’ experience in recent years, the reduction of VCs after TF-TAVI has not decreased regardless of the access methods [9]. Therefore, the TF-TAVI-related VCs remain an unsolved problem, even though downsized over time [10,11].

The current evidence about the comparisons between SC and PC approaches for TAVI is based on meta-analyses of different study types (randomized or non-randomized trials, retrospective reports). Observational studies and unmatched cohorts often miss clinical information and different follow-up times [2]. Moreover, the SC and PC approaches also differ from access routes or transcatheter valve systems.

The objective of this retrospective study is to contribute to the current debate about the short- and long-term effectiveness, safety, risks of procedural complications and complementary roles of SC and PC approaches of TF-TAVI according to the characteristics and predictive factors of the patients with AVS.

Material and Methods

We report the retrospective analysis of 259 consecutive patients with AVS who received TAVI for aortic valve replacement between 2016 and 2019. Data was collected in accordance with the Declaration of Helsinki. Ethic Committee is not mandatory due to the retrospective nature of this study, according to Italian law. An informed consent was not obtained due to the retrospective nature of the study.

A TF access for TAVI was performed in 244/259 (94.2%) of patients. TF access site was not suitable for 15/259 (5.8%) patients due to artery diameter, tortuosity and calcifications.

We included patients with symptomatic severe AVS, classified according to New York Heart Association (NYHA) and life expectancy greater than two years. All the cases not suitable for the transfemoral approach were excluded from this study.

The preoperative characteristics of the patients enrolled in the present study are displayed in Table 1. Our patients were at a different level of risk according to the STS (Society of Thoracic Surgeons) score; most of them, 172/259 (66.5%) were at low-risk (STS score <4), while 72/259 (27.8%) at intermediate-risk (STS score 4-8) and 15/259 (5.8%) at high-risk (STS score >8).

TF is the first access choice for TAVI. When the diameter of common femoral and iliac artery is more than 5 mm, we selected valve sizing 23 and 26. If the diameter is 5.5 mm, the TF access was suitable for valve sizing 29, unless there were circumferential calcifications and/or excessive tortuosity. The 1-year follow-up was performed by transthoracic echocardiography.

The outcomes of the study were defined as the incidence of VCs. The bleeding during the surgical procedures was defined according to VARC-2 and Bleeding Academic Research Consortium (BARC) criteria [3].

The SC procedures were applied for all the patients by Edwards SAPIENTM 3 (Edwards Lifesciences, Irvine, CA, USA) BE device. This device is a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, with a skirt made of polyethylene terephthalate.

Surgical procedures were conducted under trans-esophageal echographic guidance. We systematically studied the accesses by imaging with both Computed Tomography Angiography (CTA) and Echo Color Doppler.  The hemostasis technique was always performed by a polypropylene purse-string and additional suture if needed. The vessels were not less than 5 mm. Methods and criteria of assessment were obtained by CT scan planning.

In the follow-up, we collected data of VCs and other post-procedural complications at 30 days and one year after TF-TAVI intervention for all 259 patients. We conducted the follow-up by Echo Color Doppler and clinical examination. Continuous and categorical variables were reported as numbers and percentages, means, medians and ranges.

Ethical Statement

The project did not meet the definition of human subject research under the purview of the IRB according to federal regulations and therefore was exempt.

Results

In this study, we enrolled and followed up 259 patients. All the patients underwent TAVI with the SC approach and a TF access was performed for most patients (244/259, 94.2%).   The baseline demographic and clinical preoperative characteristics of the 259 participants are described in Table 1. The mean age of the patients was 83 ± 3.2 (range: 58-99), the median age was 86 years and 160/259 patients (62%) were female.

The Edward SAPIENTM 3 valve measures that we used were 20 mm for 4 (1.5%), 23 mm for 106 (41%), 26 mm for 88 (34%) and 29 mm for 61 (23.5%) patients. Two-hundred and forty-six (95%) patients underwent general anesthesia, while the remaining 13 (5%) local anesthesia.

The mean fluoroscopic time was 22 minutes. During the present study, the procedures concomitant to TAVI were Percutaneous Coronary Intervention (PCI) for one patient and Superior Mesenteric Artery (SMA) stenting for another patient.

Table 2 and Table 3 summarizes the pre-operative and post-operative echocardiographic parameters. Intra-hospital, 30-days and 1-year follow-up data about the procedural outcomes are reported in Table 4.

Table 5 shows the data about major bleedings, while Table 6 displays the data regarding ilio-femoral artery and access site complications.