Initial Report of a New Suture Cerclage Tape for Sternal Closure
Paul L. DiGiorgi, MD, FACS
Cardiothoracic Surgeon
Shipley Cardiothoracic Center
Lea Health
Acknowledgements: We acknowledge Ms. Nalani Yeager, RN for her
assistance in data collection and analysis.
Funding statement: no funding was provided to our institution to perform
this study.
Dr. DiGiorgi is a consultant for Arthrex, Inc.
This study has not been presented elsewhere.
Contact information for corresponding author:
Paul DiGiorgi MD, FACS
Shipley Cardiothoracic Center
9981 South HealthPark Drive, suite 156
Fort Myers, FL 33908
(239) 343-6341
pdigiorgi@earthlink.net
Abstract
PURPOSE: We sought to evaluate a new, flexible suture cerclage tape for
sternal closure after cardiac surgery.
DESCRIPTION: Fiber Tape (Arthrex, Naples, FL, USA) suture cerclage has
been successfully utilized in the stabilization of long bone fractures
for several years. To date, it has not been reported in sternal closure.
For sternal closure, it is placed similarly to wire cerclage. Uniquely,
it allows a measurable amount of tension to be applied to the sternum
and it is at least twice as strong as stainless steel wire. We
hypothesized this flexible tape would provide short term safety and
efficacy, as measured by incidence of deep sternal wound infection.
EVALUATION: We performed a retrospective, single center analysis of
adult patients undergoing sternotomy closure with FT. The observed
incidence of deep sternal wound infection (DSWI) was compared to the
expected incidence calculated through the Society of Thoracic Surgery
(STS) risk calculator. A total of 45 patients were closed with FT. No
patients suffered DSWI. Thirty of the 45 patients had STS risk
calculations. For these 30 patients, the expected rate of DSWI was
0.2%.
CONCLUSIONS: Despite study limitations, FT appears to be a safe method
for sternal closure.
TECHNOLOGY
Stainless steel wire cerclage (SSC) is the most common method of closing
the sternum in adult cardiac surgery. Despite relatively low cost and
familiarity, stainless wire closure remains vulnerable to fracturing,
uneven force application, boney pull through, and sharp edges that can
lead to glove perforation with wound contamination and injury to staff.
These limitations are associated with excessive boney movement,
increased postoperative pain, nonunion, reoperation, and potentially
life threatening deep sternal wound infection the latter two effect
thousands of patients each year in the United States alone[1]. Given
these potential limitations, boney reconstruction throughout the body
has generally progressed beyond stainless steel wires.
Attempts at improving on SSC have been made over time. Other devices to
close the sternum with improved outcomes have been developed[2-8].
Unfortunately, each has suffered from cost limitations, complexity,
study selection bias, and/or ineffectiveness. Additionally, clinical
outcomes did not necessarily reflect contemporary experience and
possibly introduce new complications[9]. As a result, SSC remains
the most common method to close the sternum despite its limitations.
More recently, a flexible suture cerclage tape (Fiber Tape, Arthrex,
Inc., Naples, FL, USA) has been successfully utilized in the
stabilization of bone fractures [10]. Fiber Tape (FT) is flexible
avoiding potential glove penetration of wire ends and easier to work
with compared to much stiffer stainless steel wire. FT is significantly
stronger than stainless steel wire as well (2-4x, internal report). It
is placed similarly to SSC with standard interrupted or figure-of-eight
suturing techniques simplifying closure compared to plates. Unlike other
devices, it allows a measurable amount of tension to be applied using a
tensioner thereby allowing optimal tension to be applied to the sternum.
We hypothesized FT would provide short term safety and efficacy similar
to SSC in adult cardiac surgery patients.
TECHNIQUE
FT closure is performed in a similar manner to SSC. The manubrium is
closed with two interrupted tapes. Then, figure of eight tape placement
is performed around the sternal body in separate interspaces (Figure 1).
The tape ends are then brought through a preformed loop and hand
tightened down closing the sternum loosely. A tensioner is then placed
on each tape and gradually tensioned (Figure 2) to 60-80 newtons. Once
adequate tension across all tapes is achieved (Figure 3), the tape ends
are then cut (Figure 4).
CLINICAL EXPERIENCE
We performed a retrospective, single center trial for adult patients
undergoing sternotomy closure after cardiac surgery. We measured
clinical outcomes of our initial cohort of adult cardiac surgical
patients closed with FT cerclage at HealthPark Medical Center (Fort
Myers, FL, USA) between March 2019 and September 2019. Patients’
outcomes were quantified and compared to expected results based on
national data calculated through the Society of Thoracic Surgery (STS)
risk calculator. Patient preoperative characteristics are summarized in
Table 1. There were 45 patients with an average age of 70 years old.
Operative date are summarized in Table 2. Relevant postoperative
outcomes are summarized in Table 3. The observed incidence of deep
sternal wound infection (DSWI) was compared to the expected incidence
calculated through the Society of Thoracic Surgery (STS) risk
calculator. A total of 45 patients were closed with FT. No patients
suffered DSWI. Thirty of the 45 patients had STS risk calculations. For
these 30 patients, the expected rate of DSWI was 0.2%. No patients
underwent reoperation for any reason. The STS expected incidence of
reoperation was 3.2%. After a short learning curve we found that FT
closure was faster than a typical SSC closure as well.
COMMENT
Sternal closure continues to be performed most commonly with SSC despite
mulitple attempts at creating improved methods and materials. More
recently, FT has been shown to be an effective material for boney
reconstruction [10]. It is significantly stronger than stainless
steel and handles much more easily being a braided material. Because it
is placed in a similar manner to SSC the learning curve is steep.
Additionally, as a cerclage closure, it allows circumferenctial closure
of the bone. Our initial experience was positive: we found no early
failures, it was faster after a few cases, allowed exact tension to be
applied to the bone, and there were no deep (or superficial) sternal
wound infections found. There are several limitations to our study
however. This is an initial cohort study and not randomized. With only
45 patients it is likely underpowered to definitively know its effect on
deep sternal wound infection rates. Other criteria for efficacy should
also be evaluated and were not in the scope of this reoprt. These
include pain and healing assessments as well as cost effectiveness.
These will be part of a more comprehensive, randomzied trial.
Acknowledgements
Acknowledgements: We acknowledge Ms. Nalani Yeager, RN for her
assistance in data collection and analysis.
Disclosures
Dr. DiGiorgi receives consultant fee from Arthrex, Inc.
FIGURE 1.