Safety and Performance of the Terumo Pinnacle TIF Tip Sheath

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(8):E168–E170

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.

Results

A total of 128 patients underwent percutaneous peripheral (non-cardiac) diagnostic and/or therapeutic arterial procedures with use of the new Terumo Pinnacle TIF introducer sheath during the study time period. They underwent a combined total of 169 sheath insertions: a 5 Fr sheath was used in 130 instances; a 6 Fr sheath in 38; and a 7 Fr sheath in 1 instance. Three patients had left brachial artery access; the right and/or left femoral artery was punctured in all others. It is noteworthy that 76 patients 76/128 (59.4%) underwent a previous vascular procedure performed through the same access site. In all cases, access involved initial needle puncture using a micro-puncture technique with placement of a 0.018 inch wire, followed by a small skin nick (made with a #11 blade) prior to the introduction of a short sleeve catheter for subsequent exchange for a standard floppy-tip 0.035 inch guidewire that supported advancement of the TIF sheath into the accessed artery. Systemic heparin was administered routinely in all procedures, and every patient was premedicated with aspirin and clopidogrel. After completion, the sheath was removed in the recovery room as soon as the activated clotting time (ACT) could be documented to be ≤ 180 seconds. Hemostasis was achieved by external manual compression held for 20 minutes. Closure devices were not used at all in this group of patients. Post procedure, all patients were prescribed aspirin indefinitely and clopidogrel was administered for 30 days or longer. None of the patients had an access-related complication of any kind, and no patient required prolonged hospitalization or a procedure to correct an access problem. In 1 patient, there was excessive bleeding around the sheath (5 Fr) that had been placed through a heavily scarred groin into a very small femoral artery. The sheath was removed immediately to allow for more effective external compression to achieve hemostasis. No further issues or problems ensued, and the patient was brought back to the hospital 1 month later for a repeat procedure (which was successfully completed). Performance of the Terumo Pinnacle TIF sheath was judged subjectively (by the operator) using the performance matrix (Table 1). Such evaluation resulted in a 99.9% favorable response to the defined performance standards. Scar Score percentages were as follows: 151 sheath insertions (93%) fell into the mild category, 6 insertions (4%) fell into the moderate category, and 2 insertions (1%) were in the severe category. There was no categorization provided for 3 insertions. Patients were followed for 30 days to assess the possible delayed occurrence of access-related complications; none were noted. And no patient required readmission or reintervention for treatment of an access- or sheath-related complication.

Discussion

Optimal strategies for management of the vascular access entry site have come into sharper focus over the last two decades. These strategies have evolved due to a better understanding of the pivotal role of vascular access in cardiac and vascular interventions, and the observation that access-related complications represent the most significant potential risk to patients undergoing catheter-based procedures.⁵ In the beginning, it was a rather simple — and genial — technique (developed by Seldinger in 1952) that provided the critical foundation for everything we do today.⁶ And it is not surprising that — essentially — the entire focus in those early days was on the ability to gain percutaneous entry into the vascular system effectively and relatively safely. It took many years and an enormous cumulative international experience for the focus to shift gradually from entry strategies to puncture-site management, prompted mainly by a growing awareness of access-related problems and complications. Patient comfort issues and procedure throughput and efficiencies have also exerted a powerful influence. Vascular closure thus emerged, and has continued to evolve. A number of devices and technologies have been developed over the past several years, some more effective than others. They all seem to offer something good, including, of course, the ability to close off the entry site after introducer sheath removal, preventing hemorrhage and — presumably — avoiding many of the adverse complications of manual compression. Unfortunately, they have also created a “brand-new disease” of their own, as use or implantation of such devices can cause unique and potentially serious — even fatal — complications.⁷ Infections rank highest on this list, followed by arterial occlusion and thromboembolic complications, among others. Such downsides, together with economic costs, have dimmed the initial excitement and sense of promise felt by many when the new closure technologies were first proposed more than 10 years ago. Given such considerations, it is comforting to acknowledge that recent efforts by various authors and experts in the field have smartly refocused our attention on what should have been first and foremost all along: the “how and where” of percutaneous arterial access. The crucial importance of where has been addressed, as the wisdom of image guidance (fluoroscopy and/or ultrasound) to ascertain entry into the infrainguinal common femoral artery is no longer a matter of dispute.⁸ However, little, if any, attention has been paid to the “how and with what equipment”. It would seem intuitive that, in addition to size (outer diameter or profile), the smooth and atraumatic nature of the puncture and sheath insertion would be conducive to enhanced safety and optimal outcomes. In this context, “puncture” can be defined as the creation of a path that goes from the epidermal layer of the skin (at the chosen entry site) to the vascular lumen of the target vessel; generally, the common femoral artery in the groin. Needling and initial arterial entry are, of course, important, and there is little doubt today that a micropuncture 21 gauge needle/0.018 inch guidewire set offers the best there is in this regard. Insertion of an introducer sheath is the next step, common to all diagnostic and therapeutic procedures. The importance of the design and construct of the sheath itself has somehow been lost — until now. In particular, the super-smooth transitions at the dilator-to-sheath and wire-to-dilator interfaces, as well as the perfect roundness of the sheath and dilator combine to produce a highly atraumatic access device that can literally “sail” through the tissue layers with ease and causing little, if any, trauma — even when going through thick scar tissue produced by previous catheterization procedures or surgery (Figures 1 and 2). It is with the latter situations, in particular, where conventional access sheaths tend to fail or result in excessive trauma and tissue damage.

Conclusion

In conclusion, the clinical procedural experience herein reported supports the view that the new TIF Pinnacle sheath offers superior performance and safety. The complication rate was essentially nil, and use of closure devices was obviated altogether. But 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.

References

1. Dangas G, Mehran R, Kokolis S, et al. Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 2001;38:638–641.

2. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the suture to ambulate and discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864–869.

3. Data from bench testing performed internally by Terumo Interventional Systems.

4. Allie DE, Hebert CJ, Walker CM, et al. Manual compression may not be benign. Endovasc Today 2003;2:42–46.

5. Shammas NW, Lemke JH, Dippel EJ, et al. In-hospital complications of peripheral vascular interventions using unfractionated heparin as the primary anticoagulant. J Invasive Cardiol 2003:15;242–246.

6. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography. Acta Radiol 1953;39:366–376.

7. Allie DE, Hebert CJ, Patlola RR, et al. Optimizing vascular access management. Cath Lab Digest 2009;17:1–10.

8. Turi ZG. Overview of vascular closure. Endovasc Today 2009(Feb):24–32.

From the Department of Vascular Surgery and Endovascular Intervention, Union Memorial Hospital-MedStar Health, Baltimore, Maryland. Disclosure: FJC is a consultant to Terumo Interventional Systems. Manuscript submitted April 30, 2010; provisional acceptance given June 4; final version accepted June 4, 2010. Address for correspondence: Frank J Criado, MD, 3333 N. Calvert St., Suite 570, Baltimore, MD 21218. frank.criado@medstar.net