Cath Lab Digest

Abstract

We report on our center’s clinical experience which supports the view that the new TIF Pinnacle sheath offers superior performance and enhanced safety. The complication rate was essentially nil and the use of closure devices was obviated altogether. However, these conclusions should be tempered by the limited nature of the study, mainly, the absence of a control patient subset, the potential built-in bias related to case selection and observation of outcomes, and its small size.

VASCULAR DISEASE MANAGEMENT 2010;7:E168–E170

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Introduction

Vascular access techniques and strategies are the acknowledged foundations for all catheter-based percutaneous cardiovascular procedures. It is within this context that puncture closure technologies have evolved. Their development and refinement have consumed a great deal of effort and investment over the past several years.^1,2 Intriguingly, only little if any attention has been focused on the factors surrounding the creation of the vessel puncture in the first place, and the design and construct of the all-important introducer sheath. It could be reasonably theorized that minimizing vessel damage through the creation of a smooth, optimal entry would lead to fewer complications. And it would likely facilitate the technical performance of the necessary procedural steps and result in enhanced comfort to the patient. Moreover, an emphasis on “less damage going in” (as opposed to “damage control after the fact”) would be obviously attractive and lead to increased safety and potential cost savings.

The purpose of this short paper is to report the results of a single-center clinical study on the use of a newly designed introducer sheath on patients undergoing peripheral vascular intervention. The new Pinnacle TIF (Total Integrated Fit) Tip™ introducer sheath, which is now commercially available, was designed by Terumo Interventional Systems (Somerset, New Jersey) in the effort to optimize critical characteristics that may prove effective to create a smoother entry across the various tissue layers and into the target vessel. It was postulated that such a device would result in less damage to the vessel wall and, consequently, a lower risk of complications. It could also obviate (or minimize) the need for closure. The development of a new and refined sheath manufacturing technology was a prerequisite to achieve critical features such as a super-fine tapered edge and super-smooth transitions at the dilator-to-sheath and guidewire-to-dilator junctions (Figures 1 and 2). The tips of the sheath and dilator are perfectly rounded. When put all together, these features combine to produce excellent performance as evidenced on bench testing where the TIF sheath was shown to require 24% less penetration force (than standard introducers), and to flex beyond 45 degrees without kinking or collapsing.³

Methods

This was a prospective, nonrandomized, single-institution clinical study performed during a recent 12-month time period. The data were collected and recorded prospectively by a certified research coordinator and audited by an independent auditor at the end of the study. The endpoints of the study included any access-site complication at hospital discharge and within 30 days, any evidence of blood loss, and the incidence of readmission and reintervention. Multiple variables were recorded such as previous use of the same access site, sheath size, target vessel and the like. Completion of a matrix of subjective TIF sheath performance characteristics was also an important aspect of the follow-up (Table 1). In each case, the operator was asked to provide subjective assessment of the TIF sheath related to 10 performance characteristics that had to be graded on a scale of 1 through 5, with 1 representing “failure to achieve access” and 5 reflecting “excellent performance”. The following performance characteristics were included in the matrix: durability (the sheath’s ability to support all necessary device and catheter exchanges); fish-mouthing (the oval-deformation of the sheath tip as a result of penetration resistance or transition mismatch); kinking (any buckling or bending during introduction); peeling (accordioning or “bunching’ of the sheath on the dilator); stiffness; trackability; visualization; resistance (the force required to insert and advance the sheath); penetration force (the subjective assessment of required pressure); and tactile feel.

The Scar Score⁴ was also used to help categorize anticipated difficulties with sheath insertion and to provide another metric to judge its performance.