T-SPeC Brochure - Swan Valley Medical

The Catheterization Paradigm
Disruptive technology that is challenging the
“Standards of Practice” for bladder management…
T-SPeC® has two models based on patient size.
The T7 model will accommodate patient abdomen
thickness up to 7 cm, the T14 model up to 14 cm —
addressing the obese and morbidly obese patient.
…enabling transition from other cystostomy
options and from transurethral catheterization.
Suprapubic cystostomy (SPC) is a
common method for treating acute or
chronic urinary retention and urinary
incontinence as an alternative to
transurethral catheterization.
to long-term indwelling and clean
intermittent urethral catheterization.
In addition, SPC eliminates potential
injury to urethra and bladder sphincter
from catheterization.
SPC is frequently used to provide
drainage during and following
common surgical procedures due to
Post-Op Urinary Retention (POUR).
Despite clinical advantages and
patient preference, SPC has not
been widely used for transurethral
catheterization. This is largely due
to high rates of bowel injury and
mortality associated with blind
percutaneous “trocar punch”
cystostomy and open cystostomy the current “standards of practice”
for placing suprapubic catheters.
Over twenty years of clinical studies
have proven that patients with SPC
have lower rates of urinary tract
infection,1, 2 lower pain and improved
quality of life 3, 4 when compared
2
Current “Standards of Practice” — Procedure Risks & Complications:
BOWEL INJURY
INADVERTENT PUNCTURE
LARGE INCISION
Percutaneous Trocar Punch
Percutaneous Trocar Punch
Open Cystostomy
THE INABILITY TO PRECISELY LOCATE THE PUBIC BONE
LOSS OF NEEDLE/TROCAR DEPTH CONTROL LEADING TO
OPEN CYSTOSTOMY IS HIGHLY INVASIVE, REQUIRING A
AND CONTROL THE CORRECT ANGLE OF NEEDLE/TROCAR
INJURY AT BASE OF BLADDER, COLON AND ADJACENT
LARGE INCISION, LONG PROCEDURE AND EXTENDED
CONTRIBUTE TO INACCURATE PLACEMENT, PUNCTURE OF
PELVIC ORGANS.
INPATIENT RECOVERY TIME.
PERITONEAL CAVITY AND/OR SMALL BOWEL.
7
Indicates optimal catheter placement in the bladder dome.
Clinical Procedure Outcomes
Documented Percutaneous Trocar
Punch SPC Complication Rates:
Ahluwalia 5
Percutaneous Trocar Punch
Open Cystostomy
T-SPeC®
Minimally Invasive
15 Minute Procedure*
Small Catheter Size
(unreliable drainage)
Unpredictable Surgical Tract
High Complication Rate - 45.5% 5
High Mortality - 4.4% 10
Highly Invasive
1-2 Hour Procedure Time
Long Recovery Post-Op Hospitalization
Large Open Incision
High Complication Rate - 30.3% 32
High Mortality - 1.83% 32
Minimally Invasive
5 Minute Procedure
Large-bore 18 Fr. Catheter
(reliable drainage)
Small Surgical Tract (5mm)
Low Complication Rate - 3.5% 6
No Mortality - 0% 6
* 30+ minutes when placed by interventional radiologist.
BAUS Suprapubic Catheter Guidelines 7, 8
The British Association of Urological Surgeons (BAUS) has created SPC practice guidelines based on a 2010 audit
directed by the National Patient Safety Agency. The audit was initiated due to the number of adverse events and
studies confirming high morbidity and mortality rates relating to percutaneous trocar puncture techniques. As a result,
the guidelines recommend
ultrasonography by individuals who have received specific training and are experienced with
SwanValleyMedical.com
the SPC procedure. The full BAUS report can be reviewed on-line at: swanvalleymedical.com/clinical/baus.
Cases
219
Intra-operative complication/difficulties
Anaesthetic-related complications
1.8%
Bowel injury/perforation
2.3%
Malpositioning/expulsion
2.7%
30 Day post-operative complications
UTI
9.1%
Septicaemia secondary to UTI
4.6%
SPC exit site infection
10%
Exit site bleeding
1.8%
Catheter blockage
13.2%
TOTAL
45.5%*
Mortality (U.S. Data)
4.4% 10
*Complications directly related to SPC procedure and not associated
with the concurrent surgical procedure.
3
Misplaced Trust: Transurethral “Foley” Catheter
It’s time to change the approach, not just the catheter.
86.6% CAUTI Reduction:
Prospective randomized controlled trial of urethral versus
suprapubic catheterization.
“We propose that, when catheterization is required during
a general surgical procedure, the suprapubic route is to be
preferred.”
Sethia, Selkon, Berry, Turner, Kettlewell, Gough. Prospective randomized controlled
trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5.
Suprapubic catheterization can effectively
reduce transurethral Catheter Associated Urinary
Tract Infections (CAUTI) by as much as 86.6% 15, 33
77.8% CAUTI Reduction:
Suprapubic or urethral catheter: what is the optimal method
of bladder drainage after radical hysterectomy?
“...suprapubic catheterization is associated with a lower rate of
UTI and an earlier trial of voiding...”
80% of HAI are UTI 28
•
32% of all HAI are due to CAUTI (Transurethral Catheterization) 28
•
9,000 deaths are attributed to CAUTI each year 28 ($1.8 billion*)
•
$45 billion is spent annually in treatment of HAI 29
•
400% increase in multi-drug resistance to E. coli bacteria, a leading cause of UTI 11
•
Affordable Care Act (ACA) Penalties for CAUTI events due to transurethral catheters
•
ACA nonpayment for treatment cost of transurethral catheter related HA-CAUTI events 25
•
SPC is not included in ACA CAUTI Score/Penalties
73% CAUTI Reduction:
Suprapubic Percutaneous Cystostomy versus Urethral
Catheterisation in Abdominal Surgery: A Prospective
Randomised Controlled Study.
*U.S. Data
Urethral Catheter
Infection Rate
Up to 87% Higher 15, 33
Suprapubic Catheter
Lower 26, 27, 31, 33
Urethral Trauma - False Passage/Perforation 18
N/A
Urethral Lesions/Strictures (scarring)
N/A
20
Return to Normal Voiding
22
Voiding Trials - Early Discharge
21
Requires Office Visit for Catheter Change
Risk of Bladder Cancer
Nursing Costs
9
30
14, 24
Re-catheterization Rate
17
Residual Urine 19, 24
Economics - Cost of Catheterization 12, 13, 15
Quality of Life - Patient Preferred
“It allows prompt re-establishment of normal micturition,
is better tolerated by the patients and has a lower risk of
complications.”
25
25, 30
Complication/Issue
Erosion of Urethra 21
4
Wells, Steed, Capstick, Schepanksy, Hiltz, Faught. Suprapubic or urethral catheter:
what is the optimal method of bladder drainage after radical hysterectomy? J Obstet
Gynaecol Can. 2008;30(11):1034-8.
•
N/A
Slow
Rapid
Yes
No
No
Yes
Higher
Lower
Higher
Lower
Higher
Lower
Higher
Higher
“Hurts like hell.”
Lower
16
Lower
89% patient preferred 5
Botsios, Demetriades, Goulimaris, Kanellos, Dadoukis. 4th Surgical Department,
Aristotelian University of Thessaloniki, G. Papanicolaou General Hospital,
Thessaloniki, Greece, Dig Surg 1997;14:404–408 (DOI:10.1159/000172583)
65% CAUTI Reduction:
Suprapubic Bladder Drainage in General Surgery.
“The results reported favor suprapubic over urethral catheterization in that urinary tract infections are reduced. 35% incidence
of bacteriuria (100% for urethral catheters inserted an equal
length of time).”
Peloso, Wilkinson, Floyd. Arch Surg. 1973;106(4):568-572.
The T-SPeC® (Transurethral Suprapubic endo-Cystostomy)
Clinical advantages of precise inside-to-out technology
T-SPeC® versus
percutaneous
trocar punch.
Mortality rate:
0% vs. 4.4%
6
10
Complication rate:
3.5% vs. 45.5%
6
The T-SPeC® works amazingly well and was
5
simple to use. I found the T-SPeC® created a faster,
easier, and safer tract for suprapubic cystostomy
catheter placement. It required less anesthesia when
compared to other cystostomy kits I have used for
more than 10 years. I had a lot of optimism for the
T-SPeC® device when I first heard about an ‘insideto-out’ cystostomy kit — T-SPeC® exceeded my
expectations. The device will play an important role
in my practice to allow a safe and minimally invasive
procedure to place a suprapubic catheter in my
patients with urinary retention and incontinence. The
current cystostomy kits use an ‘outside-to-in’ technique
that does not always allow accurate placement of the
catheter and has been shown to cause rare but serious
complications such as small bowel perforation that can
result in sepsis and even death. The T-SPeC® utilizes
the safer and innovative passageway, ‘inside-to-out’
T-SPeC® Bladder Management Applications:
technique, allowing reliable catheter placement and
(Incontinence & Retention)
equally important — virtually eliminates the
risk of small bowel injury.
DR. BRIAN FLYNN
DIRECTOR OF FEMALE PELVIC MEDICINE AND
RECONSTRUCTIVE SURGERY
ASSOCIATE PROFESSOR OF UROLOGY
UNIVERSITY OF COLORADO HEALTH SCIENCE CENTER
Neurologic Diseases/Patient Conditions
Post Operative Urinary Retention (POUR)
• Alzheimer’s Disease
• Cerebral Palsy
• Encephalitis
• End-stage Bladder
• Multiple Sclerosis
• Obesity
• Parkinson’s Disease
• Spinal Cord Injury
• Stroke
• Bladder Cancer
SwanValleyMedical.com
For more information on T-SPeC®, visit: www.swanvalleymedical.com.
• Bladder Stones
• Brachytherapy
• Colorectal Surgery
• Female Surgery (Prolapse, Sling)
• General Surgery
• Hifu
• Prostate Surgery
• Urethroplasty
5
Simple
and Fast
T-SPeC®
Technique
1
3
2
4
5 mm incision
5 minute procedure
Procedure
Steps
6
1. Insert T-SPeC® Sound
The stainless steel T-SPeC®
sound with embedded
blade is inserted into the
urethra and advanced into
the bladder. The urethane
tip of the sound facilitates
smooth insertion. The pubic
bone is detected against
the inside bend of the
T-SPeC® sound.
2.Attach and Adjust
Positioning Arm
The T-SPeC® is equipped
with a positioning arm
and blade capture
mechanism in alignment
with the distal tip of
the instrument sound.
These features reliably
control the location of the
surgical tract.
3.Advance Blade
4.Remove Blade
The blade is advanced
by sliding the rear handle
forward. The smooth
action of the cutting
mechanism ensures a
precise surgical tract,
created from the bladder
dome to the skin surface.
The blade and capture
mechanism are removed
with a simple twisting
motion, leaving only
the catheter bayonet
connection and coil above
the skin surface.
5
7
Published Clinical Study
Prospective study of the
Transurethral Suprapubic
endo-Cystostomy (T-SPEC®):
an ‘inside-out’ approach to
suprapubic catheter insertion.
Int’l Urology Nephrology
Feb. 20156
Cases
114
Intra-operative
complication/difficulties
6
8
Anaestheticrelated
complications
0%
Bowel injury/
perforation
0%
Malpositioning/
expulsion
0%
30 Day post-operative
complications
5.Connect Catheter
The catheter is attached
to the bayonet connector
with a simple clockwise
twisting motion.
SwanValleyMedical.com
6.Remove
Positioning Arm
7.Remove T-SPeC®
and Cut Catheter
8.Position Catheter
and Inflate Balloon
The positioning arm is
removed by opening
the latch and lifting the
assembly from the handle.
The T-SPeC® is withdrawn
from the patient and the
catheter is cut in the
designated area between
the drainage holes and
the sound tip. The open
end allows for use of a
guidewire during Councill
catheter replacement.
Precise surgical tract
creation ensures optimal
placement of the catheter
balloon at the bladder
dome. The 18 Fr. silicone
suprapubic catheter is
now properly positioned
and procedure is complete.
UTI
0.9%
Septicaemia
secondary to
UTI
0.9%
SPC exit site
infection
0%
Exit Site
bleeding
0%
Catheter
blockage
1.8%
TOTAL
3.5%*
Mortality
0%
*Complications directly related to SPC
procedure and not associated with
the concurrent surgical procedure.
7
Founded in 2006, with
headquarters in Bigfork,
Montana, manufacturing
in Denver, Colorado, Swan
Valley Medical specializes
in developing innovative,
single-use instruments for
endourologic surgery.
Caution: Federal law
(USA) restricts this
device to sale by or
on the order of a
physician.
Caution: Refer to
package insert
provided with the
product for complete
Instructions for Use,
Contraindications,
Warnings and
Precautions prior to
using this product.
1
De Ruz, Leoni, Cabrera. Epidemiology and
risk factors for urinary tract infection in
patients with spinal cord injury. Journal of
Urology. 2000; 164:1285-1289
2 Mitsui, Minami, Furuno, Morita, Koyanagi. Is
suprapubic cystostomy an optimal urinary
management in high quadriplegics?. A
comparative study of suprapubic cystostomy
and clean intermittent catheterization. Eur
Urol. 2000;38 (4): 434-8.
3 Ichsan, Hunt. Suprapubic Catheters: a
comparison of suprapubic versus urethral
catheters in the treatment of acute urinary
retention. ANZ Journal of Surgery. 1986; 57
(1): 33-36
4 McPhail, Abu-Hilal, Johnson. A meta-analysis
comparing suprapubic and transurethral
catheterization for bladder drainage after
abdominal surgery. Br J Surg. 2006 Sep;93
(9): 1038-44.
5 Ahluwalia, e. a. The surgical risk of suprapubic
catheter insertion and long-term sequelae.
The Royal College of Surgeons of England –
Urology. 2006; (88): 210-213.
6 Flynn, Larke, Knoll, Anderson, Siomos,
Windsperger. Prospective study of the
Transurethral Suprapubic endo-Cystostomy
(T-SPEC®): an ‘inside-out’ approach to
suprapubic catheter insertion. Int Urol
Nephrol, DOI 10.1007/s11255-014-0884-x.
November 2014.
7 UK National Patient Safety Agency.
(2009). Minimizing risks of suprapubic
catheter insertion. Rapid Response Report
NPSA/2009/RRR005 .
8 British Association of Urological Surgeons’,
BJU International, 107 , 7 7 – 8 5, 2010
9 West, Cummings, Longo, Virgo, Johnson and
Parra. Role of chronic catheterization in the
development of bladder cancer in patients
with spinal cord injury. Urology. 53 (2): 292-7
(1999).
10 US Dept of Health and Human Services,
Agency for Healthcare Research and
Quality (AHRQ). National and Regional
Estimates on Hospital Use from the HCUP
Nationwide Inpatient Sample (NIS). www.
Hcupnet.ahrq.gov
Emergo Europe
EU Authorized
Representative
Molenstraat 15, 2513 BH
The Haag, The Netherlands
Manufacturer:
Swan Valley Medical, Incorporated
4246 Carson Street, Suite 102, Denver CO 80239 US
The T-SPeC Surgical System is a patented medical device. U.S. and International Patents Pending.
©2016 Swan Valley Medical, Incorporated. All Rights Reserved. Printed in the USA.
®
11 Centers for Disease Control and Prevention,
U.S. Dept. of Health and Human Services.,
ANTIBIOTIC RESISTANCE THREATS in the
United States. http://www.cdc.gov/narms/
12 R3 Report, Requirement, Rationale, Reference
A complimentary publication of The Joint
Commission Issue 2, September 28, 2011
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economics of health care quality and
medical errors. J Health Care Finance. 2012
Fall;39(1):39-50.
14 Healthcare Infection Control Practices
Advisory Committee (HICPAC). Guideline for
Prevention of Catheter-associated Urinary
Tract Infections, 2009. http://www.cdc.gov/
hicpac/cauti/005_background.html
22 Kasturi, Cassiere, Bentley-Taylor, Woodman,
Hale. Use of suprapubic tube to assess
voiding function after synthetic midurethral
slings. Female Pelvic Med Reconstr Surg. 2012
May-Jun;18(3):179-82.
23 Bergman, Matthews, Ballard, Roy. Suprapubic
versus transurethral bladder drainage after
surgery for stress urinary incontinence.
Obstetrics & Gynecology 1987;69:546-549.
24 Wilde, McDonald, Brasch, McMahon,
Fairbanks, Shah, Tang, Scheid. Long-term
urinary catheter users self-care practices and
problems. J Clin Nurs. 2013 Feb;22(3-4):35667. doi: 10.1111/jocn.12042.
25 Center for Medicare & Medicaid Services.
CMS final rule (#8)
15 Sethia KK, Selkon JB, Berry AR, Turner CM,
Kettlewell MG, Gough MH. Prospective
randomized controlled trial of urethral versus
suprapubic catheterization. Br J Surg. 1987
Jul;74(7):624-5.
26 Wells, Steed, Capstick, Schepanksy, Hiltz,
Faught. Suprapubic or urethral catheter:
what is the optimal method of bladder
drainage after radical hysterectomy? J Obstet
Gynaecol Can. 2008;30(11):1034-8.
16 Saint, Lipsky, Baker, McDonald, Ossenkop.
Urinary catheters: What type do men
and their nurses prefer? J Am Geriatr Soc
1999;47:1453-1457.
27 Peloso, Wilkinson, Floyd. Suprapubic Bladder
Drainage in General Surgery. Arch Surg.
1973;106(4):568-572.
17 Niel-Weise, van der Broek. Urinary catheter
policies for short term bladder drainage
in adults. Cochrane Database Syst Rev
2005;3:CD004203.
18 Catheterisation. Indwelling catheters in
adults: urethral and suprapubic. Agency for
Healthcare Research and Quality. http://www.
guideline.gov/content.aspx?id=36631
19 Selius, Subedi. Urinary Retention in
Adults: Diagnosis and Initial Management.
Northeastern Ohio Universities College
of Medicine, St. Elizabeth Health Center,
Youngstown, Ohio
20 Horgan, Prasad, Waldron, O’Sullivan. Acute
urinary retention. Comparison of suprapubic
and urethral catheterization. Br J Urol
1992;70:149-151.
21 Vaidyanathan, Soni, Hughes, Singh, Oo,
Severe ventral erosion of penis caused by
indwelling urethral catheter and inflation of
Foley balloon in urethra-need to create list of
“never events in spinal cord injury” in order to
prevent these complications from happening
in paraplegic and tetraplegic patients. Adv
Urol. 2010:461539. doi: 10.1155/2010/461539.
Epub 2010 Jun 27.
28 National Healthcare Safety Network (NHSN)
Catheter-associated Urinary Tract Infection
(CAUTI) Outcome Measure. Centers for
Disease Control and Prevention
29 Kennedy, Greene, Saint. Estimating Hospital
Costs of Catheter-Associated Urinary Tract
Infection, J Hosp Med. 2013 Sep; 8(9):
519–522.
30 Peasah, McKay, Harman, Al-Amin, Cook.
MMRR Medicare Non-Payment of HospitalAcquired Infections: Infection Rates Three
Years Post Implementation. 2013: Volume 3,
Number 3.
31 Harrison, Lawrence, Morley, et al. British
Association of Urological Surgeons’
suprapubic catheter practice guidelines. BJU
Int. 2011;107:77–85.
32 Healey, Shackford, Osler, Rogers, Burns.
Complications in Surgical Patients. Arch Surg.
Vol 137, May 2002.
33 Clinical document files: http://www.
swanvalleymedical.com/references/clinicalpapers
www.swanvalleymedical.com
Ordering Information:
1 (855) 792-7926 (USA)
+1 (303) 371-0431 (International)
7000444_6
Clinical References