Clinical
Procedural and thirty-day outcomes following transfemoral implantation of the fully repositionable and retrievable Lotus valve without routine pre-dilatation in a consecutive patient cohort: a single-center experience

https://doi.org/10.1016/j.carrev.2017.10.017Get rights and content

Highlights

  • 146 consecutive patients underwent transfemoral TAVI with the Lotus system.

  • 145 (99.3%) of procedures were successful.

  • None or mild residual aortic regurgitation was achieved in 98.6% of patients.

  • Over time, there was a reduction in major vascular complications (14.3% vs. 2.2%, p = 0.03).

  • The use of the Lotus valve without routine pre-dilatation is safe and efficacious

Abstract

Background / Purpose

The Lotus valve (Boston Scientific, Natick, MA, USA) is a contemporary transcatheter aortic valve implantation (TAVI) device that is fully repositionable and retrievable to aid implantation and optimise procedural results. The ability to implant the device without routine pre-dilatation is another possible advantage reducing associated risks and procedure times. The aim of this study is to report procedural and 30-day outcomes following TAVI in a consecutive patient group presenting with severe symptomatic aortic stenosis with the Lotus valve system without routine pre-dilatation.

Methods / Materials

146 consecutive patients that underwent TAVI at the John Radcliffe Hospital, Oxford between January 2015 – December 2016 were retrospectively analysed.

Results

The mean age was 81.1 ± 7.4 years and the mean logistic EuroSCORE was 14.6 ± 10. 134 (91.8%) of patients were treated under conscious sedation. 144 (98.6%) of procedures were successful. Two patients (1.4%) died during the follow-up period. None or mild residual aortic regurgitation was achieved in 98.6% of patients. The mean and peak transvalvular gradients were 8.6 ± 3.6mmHg and 16.6 ± 6.6mmHg respectively. Eight patients (5.5%) suffered a stroke. Over time, there was a reduction in major vascular complications (14.3% vs. 2.2%, p = 0.03) and a trend toward shorter procedure times (97.6 ± 44.3 vs. 86.8 ± 31.4 minutes, p = 0.14) and the administration of less contrast (104.4 ± 45.2 vs. 91.7 ± 37.6 millilitres, p = 0.16). The overall new pacemaker implantation rate was 36.3%.

Conclusions

The use of the Lotus valve as a ‘workhorse’ device without routine pre-dilatation is safe and efficacious and is associated with a very low incidence of residual aortic regurgitation and acceptable transvalvular haemodynamics.

Introduction

Transcatheter aortic valve implantation (TAVI) is now the accepted treatment option for patients deemed to be inoperable or of high surgical risk presenting with severe symptomatic aortic stenosis [1], [2], [3]. A number of randomised trials have demonstrated efficacy and mortality benefit over medical therapy [4] and conventional surgery in high-risk patients [5]. With increasing institutional and operator experience combined with technological advancements, there has been an interest in the applicability of TAVI in the management of intermediate [6], [7] and even low risk [8] patients. Additionally, in a bid to further simplify the procedure, there has been a decreasing trend in the proportion of patients undergoing pre-dilatation prior to valve implantation [9]. This approach is potentially also associated with benefits of shorter procedure times, reduced radiation and contrast use and the avoidance of balloon aortic valvuloplasty (BAV) related complications (e.g. cerebrovascular events, conduction disturbances, severe aortic regurgitation) [10], [11].

First generation devices however were limited by vascular complications, paravalvular leak, stroke, renal impairment and the requirement of permanent pacemaker implantation [12]. Newer generation devices have therefore been developed with improvements in both the delivery systems and prostheses to overcome these and is particularly important when considering the treatment of lower-risk, younger patients. The Lotus valve (Boston Scientific, Natick, MA, USA) is a second-generation device that is fully repositionable and retrievable with an adaptive seal to reduce the occurrence of paravalvular leak. The use of this valve has been demonstrated to be safe and efficacious in the setting of clinical trials [13], [14], single- [15] and multi-centre [16], [17] registries. However, these were all limited to specific pre-selected groups that were also predominantly treated with pre-dilatation prior to valve implantation that may not be representative of an ‘all-comer’ contemporary patient cohort treated with present day techniques.

We here describe our experiences of implantation of the Lotus device as a ‘workhorse’ device in an unselected consecutive patient cohort without routine pre-dilatation.

Section snippets

Study population

All patients that underwent transfemoral TAVI for native severe symptomatic aortic stenosis at the John Radcliffe Hospital, Oxford, United Kingdom between January 2015 (first Lotus valve (Boston Scientific, Natick, MA) implant) and December 2016 were prospectively collected and retrospectively analysed. All first time transfemoral TAVI patients were treated with the Lotus device during this period (with no other device used). Patients that underwent valve-in-valve TAVI, intervention for aortic

Patient population

146 consecutive patients were treated within the study period and were included in the final analysis. Baseline demographics of the study population are summarised in Table 1. The mean age was 81.1 ± 7.4 years and 47.3% of patients were male. Seventeen patients (11.6%) presented with concomitant pulmonary hypertension and 23 patients (15.8%) had a history of previous sternotomy. Twenty patients (13.7%) had severely impaired resting left ventricular systolic function. The mean logistic EuroSCORE

Discussion

The principal findings of this study are: (1) the Lotus valve can be used safely and is efficacious in a consecutive patient ‘all-comer’ group as a ‘work-horse’ device; (2) the absence of routine pre-dilatation prior to Lotus valve implantation is associated with acceptable transvalvular haemodynamics and; (3) very low rates of (greater than mild) residual paravalvular leak; (4) permanent pacemaker implantation rates remain high although the significance of this remains uncertain.

This is the

Conclusion

The Lotus valve can be used safely and is efficacious in the management of an unselected consecutive patient cohort presenting with severe symptomatic aortic stenosis without mandatory pre-dilatation and is associated with a very low incidence of residual aortic regurgitation and acceptable transvalvular haemodynamics.

Acknowledgements

None

References (27)

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Disclosure Statement: All authors confirm that there are no conflicts of interest with regards to the contents of this work.

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