2
Innovations in Minimally Invasive GI Surgery
C. Daniel Smith, MD
Florida Gastroenterologic SocietyAnnual Meeting
September 25, 2010Lake Buena Vista, Florida
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Innovations in Minimally Invasive GI Surgery
• Natural Orifice Translumenal Endoscopic Surgery (NOTES)
• Single Incision Laparoscopic Surgery (SILS)
• Minimally Invasive Esophagectomy
• Antireflux Surgery
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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NOTES
• Natural
• Orifice
• Translumenal
• Endoscopic
• Surgery
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Laparoscopic Surgery
Advanced Imaging & Guidance
Interventional Endoscopy
NOTES
NOTES
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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NOTES
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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NOTES - U.S. Adoption
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Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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NOTES Surgery - Elsewhere
Dr. Christine Ren, an associate professor of surgery at New York University’s school of medicine, called the vaginal procedure “repulsive” and said: “As a woman I find it very invasive, physically and emotionally. To me it’s quite distasteful. You will really have to prove to me that there is a benefit.”
NOTES - U.S. Adoption
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010 11
NOTES - Future ?
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010 9
New Treatment Success – Key Elements
Clinical Results
Ease of Use
Patient Demand
Cost
Reimbursement
Other Rx Options
WIDELY ADOPTED
Lap Chole
-
-
+++++
-
+/-
-
YES
Lap Nissen
+++
+/-
+++
+/-
+
+++++
NO
Carotid Stenting
++
-
++++++
-
+/-
-
YES
Lap Colectomy
+++
-
+++
+
++
+
NO
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010 10
Clinical Results
Ease of Use
Patient Demand
Cost
Reimbursement
Other Rx Options
WIDELY ADOPTED
Lap Chole
-
-
+++++
-
+/-
-
YES
Lap Nissen
+++
+/-
+++
+/-
+
+++++
NO
Lap Colectomy
+++-
+++
+/-
++
+/-
NO
NOTES
- - -
++
- - -
+++++
NO
New Treatment Success – Key Elements
Lap Colectomy
+++-
+++
+/-
++
+/-
NO
Sunday, November 25, 12
12
Which would you rather have:
A lap chole by a skilled surgeon
OR
A transgastric/vaginal cholecystectomy
Innovations in MIS. FGS Annual Meeting. September 24-26, 2010
NOTES - Future ?
Sunday, November 25, 12
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Closing Comments
MIS vs. NOTES. SAGES Best of NOTES April 10, 2008
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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NOTES – Impact?
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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NOTES – Impact?
Single Incision Laparoscopic Surgery
Natural Orifice Surgery
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Single Incision Laparoscopic Surgery
• Less pain
• Faster recovery
• Earlier return to work
• Superior cosmesis
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Single Incision Laparoscopic Surgery
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Single Incision Laparoscopic Surgery
“The Next Lap Chole”
Over 100,000 hits with Google Search
Laparocopic colectomy - 58,000 hits
Natural Orifice Surgery
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Single Incision Laparoscopic Surgery
Laparoscopic surgery performed through a single incision: a systematic review of the literature. JACS, Jan 2011, In Press
2007-2010
219 publications4,585 operations
Procedure No. Publications
Cholecystectomy 52
Nephrectomy 34
Appendectomy 28
GYN 19
Colectomy 15
Inguinal Hernia 11
6 institutions - 57 cits1 institution - 26 cits
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
14
Single Incision Laparoscopic Surgery
Laparoscopic surgery performed through a single incision: a systematic review of the literature. JACS, Jan 2011, In Press
2007-2010
219 publications4,585 operations
OUTCOMES
48% perioperative outcomes only
12% compared outcomes to another technique
1 PRCT - Lap chole v. Single incision chole
Improved pain scores
Longer OR time
6 institutions - 57 cits1 institution - 26 cits
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010 10
Clinical Results
Ease of Use
Patient Demand
Cost
Reimbursement
Other Rx Options
WIDELY ADOPTED
Lap Chole
-
-
+++++
-
+/-
-
YES
Lap Nissen
+++
+/-
+++
+/-
+
+++++
NO
Lap Colectomy
+++-
+++
+/-
++
+/-
NO
SILS
--
++
-
+/-+++++
NO
New Treatment Success – Key Elements
Lap Colectomy
+++-
+++
+/-
++
+/-
NO
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
14
Single Incision Lap Surgery – Impact?
Single Incision Laparoscopic Surgery
“The Next Lap Chole”
????
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Single Incision Lap Surgery – Impact?
Single Incision Laparoscopic Surgery
Two Field MIE
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Esophagectomy Outcomes
Transthoracic Transhiatal
Operative mortality (%) 4 2
Blood loss 1402 847
LOS 19 15
Respiratory complications (%) 57 27
Cardiac complications (%) 26 16
Anastomotic leak (%) 15 14
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Minimally Invasive Esophagectomy (MIE)
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Minimally Invasive Esophagectomy (MIE)
2-Field Technique
No. patients 8 (3 low risk, 5 high risk)EBL (cc) 63 (25-400)Operative time (min) 292 (194-375)Lymph nodes harvested 23 (13-29)LOS in ICU (days) 1 (1-5)LOS overall (days) 7 (5-16)Use of chest tubes 0Reoperation 0Mortality 0
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Two-Field MIE - Impact?
Two Field MIE
No. patients 8 (3 low risk, 5 high risk)EBL (cc) 63 (25-400)Operative time (min) 292 (194-375)Lymph nodes harvested 23 (13-29)LOS in ICU (days) 1 (1-5)LOS overall (days) 7 (5-16)Use of chest tubes 0Reoperation 0Mortality 0
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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GERD
• Most common GI condition
• $ 10 billion healthcare expenditure
• Mechanical defect in valve
• Surgery effective treatment
• Nissen (3600) fundoplication is gold standard
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Antireflux Surgery - Failure
No. patients
Mortality (%)
Conversion (%)
Intraoperative comp (%)
Early postop comp (%)
Late postop comp (%)
Reoperation (%)
Symptom free 12 months (%)
Continued medical Rx (%)
Satisfied with results (%)
300
0.4
1.3
8
17 (transient)
4
-
93
3
97
1127
0.2
0.7
4
30 (transient)
5
3.5
92
11
95
1690
0.1
0.4
4
35 (transient)
5
2.8
90
18
94
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
4
Antireflux Surgery - Failure
No. patients
Follow-up (yrs)
Reoperation
Failure** Reoperation, patient dissatisfaction,
severe GERD symptoms
166
11±1.2
26 (16%)
43 (26%)
Surg Endosc (2007) 21:1978–1984 When Fundoplications Fails: Redo? Ann Surg (2005) 241: 861-871
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
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Antireflux Surgery – New Device
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
5
Antireflux Surgery – New Device
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
0
12.5
25.0
37.5
50.0
Pre-Implant 3 months 12 month 24 months
Tota
l GER
D H
RQ
L S
core
Baseline
Follow-up
Antireflux Surgery – New Device
0
25
50
75
100
3 months 12 months 24 months
Per
cen
t of
Pat
ien
ts Normalized (Total pH < 5.3)
! Pilot Trial • 44 patients, 4-centers, US and Europe
• Published J of Gastro 2008• To be published Annals of Surgery, November 2010
! Over 160 pts. implanted to date under clinical protocol
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
Antireflux Surgery – New Device
! FDA Pivotal Trial
• 100 pt, 15-center, USA and Europe• Jan 09 – Sept 09 (data pending completion of follow-up Sept 10)
University of Southern California
Policlinico San Donat
Academic Medical Center, Amsterdam
Abbott Northwestern
University of California San Diego
University of Rochester Medical Center
Legacy Health, Portland
Mayo Clinic - Jacksonville
Ohio State University
University of Washington
University of Pittsburgh Medical Center
Knox Community, Ohio
Washington University
Phoebe Putney Medical Center
Gunderson Lutheran, Wisconsin
Sunday, November 25, 12
Innovations in MIS. FGS Annual Meeting. Lake Buena Vista. Sept 25, 2010
5
Antireflux Surgery – New Device - Impact?
0
25
50
75
100
3 months 12 months 24 months
Per
cen
t of
Pat
ien
ts
Normalized (Total pH < 5.3)
Sunday, November 25, 12
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Innovations in Minimally Invasive Surgery
C. Daniel Smith, MD
Sunday, November 25, 12
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