426 Percutaneous or surgical access for transfemoral transcatheter aortic valve implantation: a propensity matched analysis of a multicentre registry

Aims The transfemoral (TF) approach appeared to be the safest and the broadest used approach in TAVI, characterized by a lower rate of periprocedural bleedings and vascular complications and is currently recommended by the guidelines as a first line approach when feasible. If in the early experience TF access was achieved using a surgical cutdown approach, through the last years, there has been increasing evidence of the safety and efficacy of a fully percutaneous approach over a surgical access, albeit available evidences are controverting and mostly including first generation prostheses and high risk patients. The aim of the study is to compare percutaneous and surgical access in a large, real-word, multicentre of TF TAVI. Methods and results Consecutive patients undergoing successful TF TAVI were prospectively enrolled in local clinical registries of five high volume centres in Italy: IRCCS Ospedale Policlinico San Martino (Genoa), IRCCS Policlinico San Donato (Milan), Città Della Salute e della Scienza, (Turin), Ospedale Niguarda Ca’ Granda (Milan), Magna Graecia University, (Catanzaro), between January 2014 to December 2019. Univariate and multivariate analysis using IPTW were performed. A total of 1946 TF TAVI patients (female 42.8%) were prospectively included. Patients underwent surgical access had a significantly higher surgical risk (STS score of 8.9 vs. 6.4, P < 0.001, and EuroSCORE of 15.1 vs. 8.7, P < 0.001, respectively). Overall survival was comparable between the two groups (HR: 1.14, 95% CI: 0.76–1.71). Patients who underwent surgical access experienced more VARC-2 major and VARC-2 minor vascular complications (13% vs. 7%, P = 0.003 and 11% vs. 6.1%, P = 0.007, respectively) and more VARC-2 major/life threatening and minor bleeding (27.4% vs. 17.8, P = 0.001, and 9.6% vs. 2.1%, P < 0.001, respectively). After IPTW adjustment, surgical access was associated with an increased risk of major vascular complications (HR: 3.32, 95% CI: 1.84–5.97), minor bleeding (HR: 4.24, 95% CI: 1.16–15.54) and stage 2–3 AKI (HR: 2.60, 95% CI: 1.07–6.33). Conclusions The performance of the percutaneous transfemoral TAVI approach was safe and feasible and resulted in fewer major vascular complications, bleedings and AKI than the surgical femoral isolation. Procedural time and hospital length were also lower in the percutaneous group. Routine application of the percutaneous approach might reduce acute complications in patients undergoing transfemoral TAVI and reduce procedural time and hospital length.

Interventional Treatment of Access Site Complications During Transfemoral TAVI: A Single Center Experience

Introduction: Transcatheter aortic valve implantation (TAVI) has rapidly developed over the last decade and is nowadays the treatment of choice in the elderly patients irrespective of surgical risk. The outcome of these patients is mainly determined not only by the interventional procedure itself, but also by its complications.Material and Methods: We analyzed the outcome and procedural events of transfemoral TAVI procedures performed per year at our institution. The mean age of these patients is 79.2 years and 49% are female. All the patients underwent duplex ultrasonography of the iliac arteries and inguinal vessels before the procedure and CT of the aorta and iliac arteries.Results: Transfemoral access route is associated with a number of challenges and complications, especially in the patients suffering from peripheral artery disease (PAD). The rate of vascular complications at our center was 2.76% (19/689). Typical vascular complications (VC) include bleeding and pseudoaneurysms at the puncture site, acute or subacute occlusion of the access vessel, and dissection or perforation of the iliac vessels. In addition, there is the need for primary PTA of the access pathway in the presence of additional PAD of the common femoral artery (CFA) and iliac vessels. Balloon angioplasty, implantation of covered and uncovered stents, lithoplasty, and ultrasound-guided thrombin injection are available to treat the described issues.Conclusion: Interventional therapy of access vessels can preoperatively enable the transfemoral approach and successfully treat post-operative VC in most of the cases. Training the heart team to address these issues is a key focus, and an interventional vascular specialist should be part of this team.

Transcatheter Aortic Valve Implantation: All Transfemoral? Update on Peripheral Vascular Access and Closure

Transfemoral access remains the most widely used peripheral vascular approach for transcatheter aortic valve implantation (TAVI). Despite technical improvement and reduction in delivery sheath diameters of all TAVI platforms, 10–20% of patients remain not eligible to transfemoral TAVI due to peripheral artery disease. In this review, we aim at presenting an update of recent data concerning transfemoral access and percutaneous closure devices. Moreover, we will review peripheral non-transfemoral alternative as well as caval-aortic accesses and discuss the important features to assess with pre-procedural imaging modalities before TAVI.

Intravascular Lithotripsy-Assisted Transfemoral TAVI: The Copenhagen Experience and Literature Review

Transcatheter aortic valve implantation (TAVI) is currently an established therapy for elderly patients with symptomatic severe aortic valve stenosis across all surgical risk categories. Access is an important aspect when planning for and performing TAVI. The superiority of a transfemoral (TF) approach compared to a transthoracic (transapical, direct aortic) approach has been demonstrated in several studies. Recently, the introduction of intravascular lithotripsy (IVL) has made it possible to treat patients with calcified iliofemoral disease by TF approach. This article aimed to provide a comprehensive overview on the following aspects: (1) preprocedural planning for IVL-assisted TF-TAVI; (2) procedural aspects in IVL-assisted TF-TAVI; (3) outcomes of IVL-assisted TF-TAVI in an experienced TAVI center; and (4) literature review and discussion of this new emerging approach.

Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort

Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.

Coagulation derangement and risk factors for valve thrombosis following transcatheter aortic valve implantation

AimsDurability of transcatheter aortic valve implantation (TAVI) is key to its expansion. We sought to identify incidence of valve thrombosis and predictors of valve thrombosis in our single centre with associated coagulation testing pre-TAVI and post-TAVI.Methods and resultsThis single-centre observational study comprised patients undergoing transfemoral TAVI discussed in the Heart Team meeting . Patients were followed up with echocardiography at 120 days to identify incidence of elevated transvalvular gradient and multivariable analysis was performed to identify factors associated with an increased odds of developing valve thrombosis. In addition, 11 patients underwent baseline, day 1 and day 120 post-TAVI coagulation testing. Between August 2017 and August 2019, 437 consecutive patients underwent transfemoral TAVI. Of these patients, 207/437 (47.4%) had 3-month follow-up echo data available and were analysed. Of these patients, 26/207 (12.6%) had elevated transvalvular gradients. These patients tended to be younger (80±14 vs 83±6 years; p=0.047) with a lower ejection fraction (49±13 vs 54%±11%; p=0.021), with a greater proportion of the population experiencing atrial fibrillation (14/21, 54% vs 68/181, 38%; p=0.067). Following multivariable analysis, there remained a trend towards higher eccentricity index associated with elevated gradients. Baseline (pre-TAVI) elevation of thrombin antithrombin levels (56±63; reference range 1.0–4.1 ng/L) and PF 1+2 (791±632; reference range 69–229 ng/mL) normalised at 120 days post-TAVIConclusionThis study demonstrated that in the cohort of patients undergoing transfemoral TAVI in our centre: younger age, poor ejection fraction, atrial fibrillation and increased baseline eccentricity of the aortic valve annulus were present to a greater extent in patients exhibiting elevated transvalvular gradients at 3-month follow-up. Further work is required to delineate the extent of coagulation derangement and confirm predictors of thrombosis.

Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

Funding Acknowledgements Type of funding sources: None. Background Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, Leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left sided femoral venous approach may benecessary. We hypothesized that a left sided femoral venous approach is as safe and effective as compared to a right sided approach. Objective We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach as compared to the conventional right sided approach. Methods and Results: In this retrospective single-center analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases as compared to 8% in the remaining population (p = 0.003). Final leadless pacemaker position within the right ventricle was mid-septal in 82% (102/125) for right femoral access vs 72% (13/18) for left femoral access (p = 0.16). In the remaining cases (28 %, 5/18), the device was placed infero-septal following a left femoral venous access, as compared to 14% (18/125) for a right sided approach (p = 0.19). No repositioning was needed in 68% (85/125) using a right femoral access vs 72% (13/ 18) patients with a left femoral access (p = 0.84). Conclusions A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left- vs. right femoral venous access was a previous transfemoral TAVI procedure.

Left femoral venous access for leadless pacemaker implantation: patient characteristics and outcomes

Aims Leadless pacing has become an alternative approach for patients requiring a single-chamber pacemaker. Conventionally, leadless Micra Transcatheter Pacing System (TPS) pacemakers are implanted via a right femoral venous access. However, due to various reasons, a left-sided femoral venous approach may be necessary. We hypothesized that a left-sided femoral venous approach is as safe and effective when compared with a right-sided approach. We assessed indications, procedural characteristics, safety and mid-term outcomes of Micra TPS implantation via a left femoral venous approach when compared with the conventional right-sided approach. Methods and results In this retrospective single-centre analysis, 143 consecutive patients undergoing Micra TPS implantation were included. 87% (125/143) underwent Micra TPS implantation via a right, and 13% (18/143) via a left femoral venous access. The mean age at implantation was 79.8 ± 7.5 years. Acute procedural success, mean procedure and fluoroscopy times as well as device parameters at implantation and follow-up (mean 15 ± 11.5 months) were similar between the two groups. Five major complications (3.5%) were encountered, all using a right-sided approach. After a transfemoral TAVI procedure, left femoral venous access was used in 42% of cases when compared with 8% in the remaining population (P = 0.003). Conclusions A left femoral venous access for Micra TPS implantation is safe and effective with an excellent implantation success rate similar to a conventional right femoral venous access without longer implantation and fluoroscopy times. The most frequent reason for choosing left vs. right femoral venous access was a previous transfemoral TAVI procedure.

Thirty-day incidence of stroke after transfemoral transcatheter aortic valve implantation: meta-analysis and mixt-treatment comparison of self-expandable versus balloon-expandable valve prostheses

Aims Stroke is a major complication after transcatheter aortic valve implantation (TAVI). Although multifactorial, it remains unknown whether the valve deployment system itself has an impact on the incidence of early stroke. We performed a meta- and network analysis to investigate the 30-day stroke incidence of self-expandable (SEV) and balloon-expandable (BEV) valves after transfemoral TAVI. Methods and results Overall, 2723 articles were searched directly comparing the performance of SEV and BEV after transfemoral TAVI, from which 9 were included (3086 patients). Random effects models were used for meta- and network meta-analysis based on a frequentist framework. Thirty-day incidence of stroke was 1.8% in SEV and 3.1% in BEV (risk ratio of 0.62, 95% confidence interval (CI) 0.49–0.80, p = 0.004). Treatment ranking based on network analysis (P-score) revealed CoreValve with the best performance for 30-day stroke incidence (75.2%), whereas SAPIEN had the worst (19.0%). However, network analysis showed no inferiority of SAPIEN compared with CoreValve (odds ratio 2.24, 95% CI 0.70–7.2). Conclusion Our analysis indicates higher 30-day stroke incidence after transfemoral TAVI with BEV compared to SEV. We could not find evidence for superiority of a specific valve system. More randomized controlled trials with head-to-head comparison of SEV and BEV are needed to address this open question. Graphic abstract