Table 1: Demographic and clinical baseline characteristics of the patients who received TF-TAVI.

Table 2: Pre-operative echographic parameters.

Table 3: Post-operative echographic parameters.

Table 4: Intra-hospital, 30-day and 1-year results

Table 5: Major bleeding complications.

Table 6: Ileo-femoral artery and access site complications.

Discussion

Most of the patients of our study with severe AVS who underwent TF-TAVI with SC approach were deemed at high-risk based on baseline characteristics, such as a mean age (83 years), STS score <4 in 66.4%, EuroSCORE II value (3.93), III and IV NYHA in 61%. The results showed a mortality rate and an incidence of intra-hospital and VCs values remarkably lower than those found in the studies on patients with comparable baseline characteristics. The 30-day mortality rate was 0.77% (two deaths) and there were a total of 6 intraoperative VCs (2.3%) and one 1-year follow-up VC (0.4%). The two intra-hospital deaths were due to aortic dissection (1 patient) and annular rupture (1 patient). The reduced number of major and minor VCs and vascular and access site complications in 2 (0.77%) patients were observed only in the operative time and access site complications were found in 7 (2.7%) patients at 30-day. Most intrahospital complications were atrial fibrillation in 18 (7%) patients. Regarding the patients’ access site complications, the three patients with hematoma required hospitalization.

The absence of dialysis requirement and the mean value of post-operative creatinine suggested the renal safety of our SC approach. Moreover, our patients remained in ICU stay for one day and the median post-operative hospitalization time was two days. The follow-up (1-year) data achieved for all the patients strengthened the safety findings of this study.

The limitations of the present study are mainly due to the retrospective nature of the data capture. However, most of the data related to SC and PC approaches of TF-TAVI currently reported in the literature is retrospective and this reduces the possibility of direct comparisons.

It is known that the VCs and risk of serious bleeding events after TAVI are associated with morbidity and mortality rates [12,13]. A retrospective chart review of 388 consecutive patients who most underwent TF-TAVI of Raju, et al., reported a high incidence of VCs defined by VARC-2 guidelines [8]. Of the 68 (28.7%) VCs, only 7 (3.38%) were major, 42 (17.9%) were post-operative and the remaining 26 (11.4%) occurred in the perioperative phase. Perioperative VCs significantly correlated with short-term (30-day) mortality rate that involved 6 (2.5%) patients. The majority of the VCs were dissections and hematomas. Of the 26 (10.9%) intra-operative VCs, 4 (1.6%) were classified as major and 22 (9.3%) as minor; of the post-operative 42 (17.2%) VCs, 3 (1.3%) were minor. In 10 (4.2%) cases, VCs required correction procedures, most (90%) received surgical correction and the remaining were corrected by endovascular techniques. However, this study did not report the precise numbers of patients per each approach, thus hindering a comparison. The authors underscored the importance of the involvement of cardio surgeons in the multidisciplinary team to optimize the patients’ selection and reduce the incidence of major VCs [8].

The evidence based on Randomized Clinical Trials (RCT) comparing PC and SC strategies is limited to the small trial of Holper, et al., performed at a TAVI-experienced center on 30 consecutive patients, who most were at high risk [14]. This trial has highlighted no significant differences in safety and efficacy between PC and SC approaches. Major and minor VCs as the primary endpoint was 25% in the PC group versus 29% in the SC group. Female gender and pre-operative femoral arterial velocity were identified as significant predictors of complications [14]. In the Optimized CathEter vAlvur iNtervention (OCEAN)-TAVI registry study, PC and SC methods were compared in a non-randomized trial on 332 propensity-matched patients and evaluated under the VARC-2 criteria [15]. In this study, the PC approach provided fewer VCs, bleeding and acute kidney injuries than the SC approach. Real-world evidence about the differences between PC and SC approaches encompasses national registries, retrospective reports and single or multi-center observational prospective studies. Several meta-analyses have been contributing to the literature synthesis over time. The Spanish TAVI registry reported different VCs patterns in 3,046 patients who received PC- or SC-TAVI; higher rates of minor VCs but lower rates of major VCs in the PC group of patients compared to the SC group at 30-day and 323-day [16].

The vascular access site complications observed in 162/1680 patients of the Polish registry were significantly higher in the PC than the SC group performed in the groin with exposure of the artery and manual suture after the procedure [17]. Data of the Brazilian national registry showed similar 1-year safety and effectiveness data of PC and SC approaches in two comparable groups of patients who underwent TF-TAVI with different procedural profiles [18]. A multicenter registry was used by Kochman, et al., to retrospectively compare PC and SC in 683 high-risk patients with major and minor VCs incidence as primary endpoints [19]. The Heart Team (general cardiologist, interventional cardiologist, cardiac surgeon) qualified the patients for TAVI based on clinical symptoms, echocardiography findings and multi-slice CT imaging and chose the approaches. The baseline characteristics revealed a significantly higher risk of the patient who underwent the SC approach. There was no significant difference between the two groups regarding the VARC-2 major VCs and type of bleedings, but minor VCs were significantly higher in the PC group. The procedure duration, the volume of contrast media and the length of hospital stay were superior in the PC than in the SC group [18].

The performance of the SC approach resulted significantly superior to the PC method in 667 consecutive patients regarding mean procedure time (P<0.001), with lower access, bleeding complications and hospital mortality rates [20]. A retrospective analysis compared the outcomes of SC or PC access complications in TF-TAVI 334 patients >75-year-old at high surgical risk or with contraindications for conventional surgery [21]. The SC group showed a significantly shorter mean time of procedure (69 ± 19 min) than PC group (91 ± 22 min; P<0.01); significantly less VARC-2 access complications (n=11/135; 8.1%) (n=41/190; 20.6%; P = 0.04); and less frequent VARC-2 bleeding complications (18.1% vs 4.4%; P=0.029). Moreover, the hospital mortality with the SC approach was less than PC (1.5 vs 3.5%, P = n.s.). The authors underscored the SC hallmarks as more advantageous, in particular, for patients with calcified vessels, such as controlled and safe access to the puncture site. This SC feature has an adjunctive benefit of the direct vision that can ease the repair in the presence of vessel injury. There was no significant difference in major complications in the hospital stay duration. The authors evaluated the PC and SC as complementary approaches instead of superior or inferior one another. Furthermore, they suggested tailoring the two strategies as per the patients’ characteristics through multidisciplinary TAVI teamwork to achieve the best outcomes [21].

A retrospective cohort analysis compared the PC and SC approaches for TF-TAVI according to the VCs at 30 days and late vascular adverse events at 12 months of 146 patients with severe AVS at high risk for surgery [22]. Compared with SC, the PC approach showed a shorter hospital length of stay but required a significantly more endovascular balloon assist (P < 0.001) and covered stents (P < 0.05) [22]. The meta-analysis of Ando, et al., of eight observational studies and one RCT (2513 patients with PC and 1767 with SC), did not show any relevant difference of major and minor VCs, bleeding complications, need for surgical intervention for VCs and peri-operative all-cause mortality [23].

In a recent meta-analysis of 13 trials with a total of 5,859 patients (PC in 3447 patients; SC in 2412 patients), 2 the two approaches have led to similar major VCs and bleeding risk, perioperative mortality, urgent surgical repair, stroke, myocardial infarction and renal failure. Compared with SC, PC was linked to a shorter hospital stay (9.1 ± 8.5 versus 9.6±9.5 days; mean difference of 1.07-day, 95% CI=-2.0 to -0.15, P=0.02) and less blood transfusion (18.5% versus 25.7%; OR=0.61, 95% CI=0.43-0.86, P=0.005), but showed a higher risk of minor VCs (11.9% versus 6.9%; OR=1.67, 95% CI= 1.04-2,67, P=0.03) [2].

Conclusion

In the literature, VCs are not always univocally defined and the technological evolution occurred over time may account for the varied outcomes and limit the possible comparisons. Therefore, comparative studies, systematic reviews and meta-analyses about PC and SC strategies have not yet reached definitive conclusions on their safety and effectiveness, highlighting the importance of accurate patient selection and center TAVI’s experience. The strengths of our observational study are the careful preoperative planning, echo-guided mini-access, purse-string in a non-calcific point, preparation of a small clamping zone, access vascular skills and immediate management of any bleeding. The results of the present study can be generalized based on the criteria of patients’ selection and assessment and the experience of the Heart team. This real-world study meant contributing to the debate about the advantages of the SC approach compared to PC of TF-TAVI for patients with severe AVS. A multicenter randomized trial, especially for a future use of TAVI in young and low-risk patients, may provide data to optimize the results concerning vascular access complications according to the patients’ profile. In addition, future prospective studies can provide further evidence to optimize the patients’ selection and matching with the SC and PC approaches.

Conflict of Interests

The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.

Acknowledgement

The authors acknowledge Rossella Ferrari for editing the manuscript and providing editorial assistance.

Financial Disclosure

No funding was not involved in the manuscript writing, editing, approval or decision to publish.

Authors Contribution

All authors contributed equally for the preparation of this paper.

Data Availability

All authors had access to the data and a role in writing the manuscript. All data generated or analyzed in this study are included in this article. Access to data is possible with permission from the responsible author.

Consent for Publication

Informed consent was obtained from the patient for publication of this case report and is stated in the manuscript.

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