Surgery Grand rounds Presentation at Rush University Medical Center on March 20, 2013. Presentation highlights clinical use of Prone Thoracoscopy, Fluorescence Angiography, Transcervical Videoscopic Esophageal Dissection (TVED) and Linx.

1. Conflict of Interest / Disclosure
• Paid Consultant to Torax - Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
1

2. Innovations in Foregut Surgery
Surgery Grand Rounds
Rush University Medical Center
March 20, 2013
Chicago, Illinois
C. Daniel Smith, MD, FACS
2

3. My Cases for The Past Two
Weeks?
Surgery Grand Rounds
Rush University Medical Center
March 20, 2013
Chicago, Illinois
C. Daniel Smith, MD, FACS
3

4. March 4 - March 15 - Personal Case List
Week of March 4
Monday Tuesday Wednesday Thursday Friday
• O Umbilical Hernia • L Hiatal Hernia/Nissen
• L Nissen • L Hiatal
• L Redo Hiatal Hernia/Nissen/PEG
Hernia/Nissen/PEG • L Nissen
• 2-Field MIE • L Hiatal Hernia/Nissen
Week of March 11
Monday Tuesday Wednesday Thursday Friday
• LES Augmentation • LES Augmentation
• L Esophageal • L Hiatal Hernia/Nissen
Diverticulectomy • Stage II 3-Field MIE
• L Heller/Toupet
• L Ventral Hernia
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

5. March 4 - March 15 - Personal Case List
Week of March 4
Monday Tuesday Wednesday Thursday Friday
• O Umbilical Hernia
Esophageal • L Hiatal Hernia/Nissen
Diverticulectomy
• L Nissen • L Hiatal
• L Redo Hiatal Hernia/Nissen/PEG
Hernia/Nissen/PEG • L Nissen
• 2-Field MIE • L Hiatal Hernia/Nissen
Stage II 3-Field MIE
Week of March 11
2-Field MIE
Monday Tuesday Wednesday Thursday Friday
• LES Augmentation • LES Augmentation
• L Esophageal • L Hiatal Hernia/Nissen
LES Augmentation • Stage II 3-Field MIE
Diverticulectomy
• L Heller/Toupet
• L Ventral Hernia
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

6. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

7. Innovations in Foregut Surgery That I Use
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

8. Prone Thoracoscopy
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

9. Prone Thoracoscopy
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

10. Prone Thoracoscopy - Advantages
• Gravity facilitated dissection & exposure
Blood and lung fall away from operative field
• Ergonomically better angles for surgeon
Stand only on one side of patient
• Fewer trocars / retractor sites
Three trocar technique
• No need for a skilled assistant
Camera driver only role for assistant
• Dissecting too deep less concern
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

11. Case 1
• 53 yo female
• History of Barrett’s
• Recently developed dysphagia and was
found to have esophageal
adenocarcinoma (T3N0Mo)
• Underwent neoadjuvant therapy, restaged
as T1NoMo
• Now undergoing esophagectomy
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

12. • Go to next slide for Prone MIE Video
12

13. Prone Thoracoscopy
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

14. MIE Open Difference [Open-MIE]
Outcome P-value
(N=56) (N=41) (95% CI)
Cardiac complications 18 (32%) 17 (41%) 9% (-10%, 29%) 0.40
Pulmonary complications 19 (34%) 18 (44%) 10% (-10%, 30%) 0.40
Pulmonary intervention 17 (30%) 14 (34%) 4% (-15%, 23%) 0.83
Pulmonary embolism or deep vein thrombosis 4 (7%) 1 (2%) -5% (-13%, 4%) 0.39
Leak 6 (11%) 4 (10%) -1% (-13%, 11%) 1.00
Leak intervention 3 (5%) 0 (0%) -5% (-11%, 1%) 0.26
Renal complications 2 (4%) 2 (5%) 1% (-7%, 9%) 1.00
Wound infection 3 (5%) 4 (10%) 4% (-6%, 15%) 0.45
Pharmacologic interventions* 22 (39%) 21 (51%) 12% (-8%, 32%) 0.30
Delayed gastric emptying 1 (2%) 1 (2%) 1% (-5%, 7%) 1.00
Voice hoarseness/laryngeal injury 5 (9%) 3 (7%) -2% (-13%, 9%) 1.00
In-hospital mortality 2 (4%) 2 (5%) 1% (-7%, 9%) 1.00
Discharged on total parental nutrition 2 (4%) 1 (2%) -1% (-8%, 6%) 1.00
Discharged on tube feeding 2 (4%) 10 (24%) 21% (7%, 35%) 0.004
Clavien classification (Grade III or higher) 19 (34%) 17 (41%) 8% (-12%, 27%) 0.53
30-day mortality** 2 (4%) 3 (7%) 4% (-6%, 13%) 0.65
90-day follow-up
Dilatations for stricture 5 (9%) 5 (12%) 3% (-9%, 16%) 0.74
- P-values result from Fisher’s exact test. *Pharmacologic intervention includes total parental nutrition, tube feeding, and blood transfusion.
**30-day mortality includes those patients who died in the hospital.

15. MIE Open Difference [Open-MIE]
Outcome P-value
(N=56) (N=41) (95% CI)
Cardiac complications 18 (32%) 17 (41%) 9% (-10%, 29%) 0.40
Pulmonary complications 19 (34%) 18 (44%) 10% (-10%, 30%) 0.40
Pulmonary intervention 17 (30%) 14 (34%) 4% (-15%, 23%) 0.83
Pulmonary embolism or deep vein thrombosis 4 (7%) 1 (2%) -5% (-13%, 4%) 0.39
Leak 6 (11%) 4 (10%) -1% (-13%, 11%) 1.00
Leak intervention 3 (5%) 0 (0%) -5% (-11%, 1%) 0.26
Renal complications 2 (4%) 2 (5%) 1% (-7%, 9%) 1.00
Wound infection 3 (5%) 4 (10%) 4% (-6%, 15%) 0.45
Pharmacologic interventions* 22 (39%) 21 (51%) 12% (-8%, 32%) 0.30
Delayed gastric emptying 1 (2%) 1 (2%) 1% (-5%, 7%) 1.00
Voice hoarseness/laryngeal injury 5 (9%) 3 (7%) -2% (-13%, 9%) 1.00
In-hospital mortality 2 (4%) 2 (5%) 1% (-7%, 9%) 1.00
Discharged on total parental nutrition 2 (4%) 1 (2%) -1% (-8%, 6%) 1.00
Discharged on tube feeding 2 (4%) 10 (24%) 21% (7%, 35%) 0.004
Clavien classification (Grade III or higher) 19 (34%) 17 (41%) 8% (-12%, 27%) 0.53
30-day mortality** 2 (4%) 3 (7%) 4% (-6%, 13%) 0.65
90-day follow-up
Dilatations for stricture 5 (9%) 5 (12%) 3% (-9%, 16%) 0.74
- P-values result from Fisher’s exact test. *Pharmacologic intervention includes total parental nutrition, tube feeding, and blood transfusion.
**30-day mortality includes those patients who died in the hospital.

16. Case 2
• 72 yo male
• Known about problem
for 10 years
• Worsening cough
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

17. • Go to next slide for Prone
Diverticulectomy Video
17

18. Case 2 - Postop
• Barium swallow POD 1
• Tolerated liquids
• Discharged POD 2
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

19. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

20. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

21. Fluorescence Angiography
• Indocyanine Green (ICG) Fluorescence
• Assess quality of tissue perfusions and
blood flow
• Capture images of fluorescence
• Real time quantitative analysis of
perfusion
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

22. Fluorescence Angiography - Spy Elite
• 2 cc if ICG
intravenous followed
by 10 cc NaCl flush
• Fluorescence video of
tissue captured
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

23. Fluorescence Angiography
• Use in breast reconstruction and tissue
flap surgery
• Preliminary use in GI surgery to assess
anastomoses and bowel perfusion
• Described in esophagectomy to assess
gastric conduit
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

24. Two Stage 3-Field MIE
• Complications related to gastric conduit
ischemia remain significant morbidity/mortality
• In small studies, ischemic preconditioning may
improve conduit perfusion
• Clinical effectiveness difficult to prove - large
sample size to show lower leak rate
• Fluorescence angiography may provide real-
time quantitative assessment of perfusion
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

25. Two Stage 3-Field MIE
Stage I
• Diagnostic laparoscopy, ligation left gastric
and short gastric artery, J-tube placement
2-3 weeks tube feeds - Impact
Stage II
• 3-field MIE
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

26. Case 1 (again)
• 53 yo female
• History of Barrett’s
• Recently developed dysphagia and was
found to have esophageal
adenocarcinoma (T3N0Mo)
• Underwent neoadjuvant therapy, Stage II
restaged as T1NoMo
• Now undergoing esophagectomy
• Next slide for video or SPY Setup
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

27. Fluorescence Angiography
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

28. Fluorescence Angiography - ACS Forum 2013
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

29. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

30. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

31. 2-Field MIE (TVED)
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

32. Case 3
• 74 yo male
• 15 year history of Barrett’s
• Sep 2012 EGD with biopsy - HGD and
single flat area of adenoCa
• Oct 2012 underwent EMR with RFA
• Focus of adeno with deep margin positive
T1bN0Mo
• Next slide for 2-Field MIE Video
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

33. Case 3 - Pathology (T1bN1M0)
A: EsophagusTUMOR SIZE: Greatest dimension: at least 0.6 cm HISTOLOGIC TYPE:
Adenocarcinoma HISTOLOGIC GRADE: G2: Moderately differentiated G3: Poorly differentiated
MICROSCOPIC TUMOR EXTENSION: Tumor invades submucosa PROXIMAL MARGIN: Uninvolved
by invasive carcinoma DISTAL MARGIN: Uninvolved by invasive carcinoma or dysplasia
TREATMENT EFFECT: Marked response Moderate response PERINEURAL INVASION: Not
identified PRIMARY TUMOR (pT): pT1b: Tumor invades submucosa REGIONAL LYMPH NODES
(pN): pN1: Regional lymph node metastasis involving 1 to 2 nodes NUMBER OF LYMPH NODE(S)
INVOLVED: 1 NUMBER OF LYMPH NODE(S) EXAMINED: 26 ADDITIONAL PATHOLOGIC
FINDINGS: Intestinal metaplasia (Barrett's esophagus)
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

34. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

35. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

36. Fundoplication
• Use of fundoplication for GERD has peaked,
use slowly declining
• GIs have largely stopped referring patients except
for desperate or complicated cases
• Most cases are done for complicated conditions
(redo, large hiatal hernia, Barretts, severe
refractory GERD
• PPIs remain treatment of choice for all but the
most severe cases of GERD
5

37. Fundoplication – Why Not?
• Technical failures – inconsistent and
questionable outcomes
• Lack of standardized approach/technique
• Inconsistent use – patients still have fundoplication
performed without objective confirmation of GERD
• Patients are afraid of the operation – troubling side-
effects of gas bloat and excess flatus or perception
that failure rate is 50%
• Competing treatments – primarily PPIs, some
endolumenal approaches
6

38. Case 4
• 33 yo male, attorney
• Heartburn for past 18 years controlled
with daily PPI
• Recently with breakthrough symptoms
and now on twice-daily PPI - HB
symptoms better
• Sleeps with HOB elevated and frequently
wakes up regurgitating
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

39. Case 4 (cont.)
• EGD - no esophagitis, irregular SCJ (no
Barrett’s), no hiatal hernia
• Bravo pH - pH in distal esophagus < 4 5% of
time day one, 11% day 2
• BaSw - normal
• Motility study - LESP 12mmHg, mild
disordered peristalsis (80%), body pressure
45mmHg
• Concerned about long-term effects of PPIs
and side effects of fundoplication
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

40. Linx
FDA Approved March 2012 - PMA
8

41. Linx - Animations
• Go to next 2 slides for Linx Animations
10

42. Linx – Barium Swallow
Next slide for Video Esophagram
11

43. Linx - Postop Capsule
LINX Bead Fibrous
Capsule
In-tact
Muscular
Layer
Mucosa
Next slide for Explant Video
13

44. Linx – Procedure
12

45. Linx - Clinical Studies
14

46. Linx - Pivotal Study Results
n engl j med 368;8 nejm.org february 21, 2013
14

47. Linx - Patient Satisfaction
n engl j med 368;8 nejm.org february 21, 2013
14

48. Linx - Symptom Response
n engl j med 368;8 nejm.org february 21, 2013
14

49. Linx - Symptom Response
n engl j med 368;8 nejm.org february 21, 2013
14

50. Linx - Esophageal Acid Exposure
n=100
P<0.001
n=96
n engl j med 368;8 nejm.org february 21, 2013
15

51. Linx - Gas Bloat
P<0.001
n=100
n=90 n=84
n=95
n engl j med 368;8 nejm.org february 21, 2013
22

52. Linx - Clinical Summary
Baseline Post-LINX
% of Pts Characteristic % of Pts
3 Years
100% Daily PPI dependence 8%
70% Reflux affecting their sleep on a daily basis 2%
Reflux affecting their food tolerances on a daily
76% basis 2%
Moderate or severe regurgitation including
57% aspirations 1%
55% Severe heartburn affecting their daily life 1%
Experiencing extra esophageal symptoms in
51% addition to heartburn and/or regurgitation 12%
40% Esophagitis 11%

53. Innovations in Foregut Surgery - My Practice
Esophageal Prone Thoracoscopy
Diverticulectomy
Fluorescence
Stage II 3-Field MIE
Angiography
2-Field MIE 2-Field MIE (TVED)
LES Augmentation Linx
Rush University Medical Center Surgery Grand Rounds:
Innovations in Foregut Surgery, March 20, 2013
3

54. Innovations in My Foregut Practice
Surgery Grand Rounds
Rush University Medical Center
March 20, 2013
Chicago, Illinois
C. Daniel Smith, MD, FACS
54