View Dylewski`s Presentaion - the Association of Physician

Advanced Robotic Technology vs. VATS
for Pulmonary Resection
“A Time For Choosing”
Mark R. Dylewski, M.D.
Chief of General Thoracic Surgery
Medical Director of Thoracic Robotic Surgery
Baptist Health of South Florida
“Art of Persuasion”

Techniques
–
–
–
–
Cover-up
Denial
Misdirection
Conviction
Disclosures
 Clinical
educator
– Intuitive Surgical
– Ethicon
– Bard Medical
Introduction

Standard of Care for early-stage NSCLC
– Thoracotomy
– Anatomical lobectomy
– Systematic lymphadenectomy

Traditional approach
– Rib spreading thoracotomy
– Most common
– VATS Lobes for clinically operable disease
» STS database- 35% VATS lobes
» Medicare / other databases 5-7%
GOPALDAS ET AL. VATS VERSUS OPEN THORACOTOMY LOBECTOMY Ann Thorac Surg 2010;89:1563–70
VATS Lobectomy For EarlyStage I Disease

Advantages of VATS
– Length of Stay 4.4 vs 11 days (Mckenna, 1999)
– Reduced complication rates
– Reduced post-op pain - equivalent at 2 wks (Nomori, 2000)
– Improved post-op PFT’s over thoracotomy (Kaseda, 2000)
– Improved compliance with adjuvant therapy (Patterson, 2007)
– Cosmetically appealing
– Reduced costs (Swanson, 2011)
– Improved Quality of life Outcomes (CALGB 39802)
Incidence of NSCLC by Stage
al Cancer
P-Stage Percentage %
No. Patients
Clinically operable
I
II
IIIA
IIIB
IV
10%
20%
15%
15%
40%
22,500
45,000
33,750
33,750
90,000
New Cancer cases annually 225,000
Deaths 159,000
Rate of Complications
VATS vs. Open for Stage I NSCLC
5-Year Survival for Stage I Lung Cancer by
VATS



Randomized Trials
VATS vs. Open Lobectomy
Lobectomy using video-assisted thoracic surgery vs.
muscle-sparing thoracotomy. A randomized trial (Kirby, 1995)
– No significant difference other than less pain for VATS in first 2weeks
Do we still need a randomized prospective trial comparing
VATS to open lobecyomy? (A.F. Verhagen)
– Conclusion:
» Evidence is based on comparative non-randomized cohort and patient control
studies, resulting in imbalanced patient groups
» To recommend VATS lobectomy as a standard of care, randomized controlled
trials are necessary both with regards to functional and oncologic outcome
Treatment of early stage lung cancer by VATS vs. Open
lobectomy (SCOPE) (Radboud Univ,2013)
Skepticism
 Lack
of adoption of VATS
(Mack, 1997)
– Multi-factorial
»Limited instrumentation
»Operative times
»Insufficient training and experience
»Oncological control
Adequacy of mediastinal lymph node dissection
 Treatment of more advanced disease

Assessment of
Oncological Equivalence in
VATS Lobectomy
Assessment of Oncological
Equivalence
Systematic review VATS vs. Open Lobectomy
– Comparative , non-randomized cohort studies
– Studies included a predominance of stage IA tumors
<2 cm
– Stage I accounts for 10-15% of all Dx lung cancers
– Associated with improved survival - selection bias
– Supports the use of VATS in limited populations of
patients
Whitson ,2008)
MLND versus MLNS
Remains controversial in operable lung cancer
MLND is advocated by many in all operable lung cancer (Naruke, 1981)
Some advocate MLNS in order to reduce morbidity and mortality (ALCSG)
MLND - no increased morbidity / mortality vs. sampling (ACSOG Z0030, 2006)
– Some have try to argue that any MLND may be unnecessary
Preponderance of evidence demonstrates that MLND offers:
– Better local control with prognostic benefits in patients with N2 disease (Hata, 1990)
– More likely to identify occult metastases thus improves staging
Adjuvant Therapy
– MLND improves survival in stage II and IIIA NSCLC (ECOG, Keller, 2000)
» MLND associated with improved survival in right-side NSCLC.
– MLND associated with improved survival in limited N2 disease (Izbicki, 1998)
– Randomized controlled trials show adjunctive chemotherapy associated
with significant survival advantage and DFS (Scagliotti, 2003 and Hotta, 2004)
Assessment of Oncological Equivalence
ACSOG Z0030 (Darling Et al, J. Thorac Cardiovasc Surg, 2011)
–
–
–
–
Randomized trial MLND vs. MLNS in pts w/ N0 or N1 Dz
Inclusion criteria – Required a negative FS of 4 MLN stations
Demonstrated 5-yr dz-free survival similar between groups
Trend toward improved 5-yr survival in MLND group (8.5 vs. 8.1)
Limitations
»
»
»
»
»
»
»
Not real world practice of most surgeons
Taking more nodes in P-N0/N1 patients proved to be unnecessary
Occult N2 nodes found in only 21 (4%) patients – selection bias
Limited to early stage disease w/o N1/N2 disease
No adjuvant chemotherapy in N1/N2 disease- influenced survival
Only 7% patients received a VATS lobectomy
Limited validity in patients with the potential for higher stage disease
“IT IS ALL ABOUT THE
LYMPH NODES”
Lymph Node Evaluation by Open or
Video-Assisted Approaches in 11,500
Anatomic Lung Cancer Resections
STS database
2001 and 2010 clinically staged primary lung cancer
– T1N0M0
– T2N0M0
Open:
n = 7,137
VATS: n = 4,394
Lymph Node Evaluation by Open or
Video-Assisted Approaches in 11,500
Anatomic Lung Cancer Resections
Boffa et al. (Ann Thorac Surg 2012;94:347–53)
Lymph Node Evaluation by Open or
Video-Assisted Approaches in 11,500
Anatomic Lung Cancer Resections

“Conclusions.
During
lobectomy
or
segmentectomy for clinical N0 lung cancer,
mediastinal nodal evaluation by VATS and
thoracotomy
results
in
equivalent
upstaging. In contrast, lower rates of N1
upstaging in the VATS group may indicate
variability in the completeness of the
peribronchial and hilar lymph node
evaluation.
Boffa et al. (Ann Thorac Surg 2012;94:347–53)
Lymph Node Evaluation Achieved by Open
Lobectomy Compared with Thoracoscopic
Lobectomy for N0 Cancer
Merritt RE, Hoang CD, Ann Thor Surg, 2013
Table 6 Percentage of Lymph Node Upstaging
VATS Lobectomy (n-60)
Open Lobectomy (N-69)
Nodal Upstaging
Overall Number
N1
N2
No. (%)
6 (10)
No. (%)
17 (24.6)
pValue
0.05
5 (8.3)
15 (1.8)
12 (17.4)
5 (7.2)
0.2
0.3
Percentage of upstaging from N0 to N1 or N2: 24.6% open vs 10% VATS (p-0.05)
Conclusion
In an environment in which VATS
lobectomies are being preformed on a
infrequent basis and likely achieving less
complete lymph node evaluation than would
have been completed by thoracotomy, it is
imperative that VATS lobectomies be
preformed primarily in clinical stage N0
patient with minimal chance of harboring
occult N1 or N2 disease
Complete Thoracic Mediastinal
Lymphadenectomy Leads to a Higher Rate of
Pathologically Proven N2 Disease in Patients with
NSCLC (Cerfolio, Ann Thorac Surg. 2012)

Conclusion:
When complete MLND is performed during
pulmonary resection in patients with clinically
negative N2 nodes (surgical staging), without
intraoperative FS of N2/N1, more patients are
diagnosed with N2 disease and considered for
adjuvant chemotherapy
PORT BASED ROBOTIC
LOBECTOMY WITH LYMPH
NODE DISSECTION
2
C
3
A
Robot Lobectomy (CRPL3)
Zero Degree
scope
ACCESS PORT
Spacing btwn ports 5-6 in
Radical Lymph Node Dissection
Subcarinal
Paratracheal / Pretracheal
Para-Diaphragmatic Specimen Removal and
Repair of Diaphragm
11th rib
10th rib
10th Rib
Diaphragm
Diaphragm
11th rib
Complete Port Access RoboticAssisted Lobectomy
ROBOTIC LOBECTOMY
PERIOPERATIVE OUTCOMES
Perioperative Results of Robotic Lung :
Lobectomy: Summary of the Literature
Takagi, et al. Surg Endosc June 2012
Perioperative Results of Robotic Lung
Lobectomy: Summary of the Literature
Takagi, et al. Surg Endosc June 2012
Pulmonary Resection Using a Total Endoscopic
Robotic Video-Assisted Approach
Dylewski, et al. Semin Thoracic Surg 23:36-42
Pulmonary Resection Using a Total Endoscopic
Robotic Video-Assisted Approach
Dylewski, et al. Semin Thoracic Surg 23:36-42
Pulmonary Resection Using a Total Endoscopic
Robotic Video-Assisted Approach
Overall complication rate 26%
Major complication rate – 8%
60-day Mortality 1.5%
Dylewski, et al. Semin Thoracic Surg 23:36-42
Initial Consecutive Experience of Completely
Portal Robotic Pulmonary Resection with 4-Arms
(Cerfolio, J. of Thorac and Cardiovasc, 2011)

Compared pulmonary resection performed CPRL4 vs. Rib sparing thoracotomy
– No. N2 MLN’s removed: 12 vs. 11
– No. N1 MLN’s removed: 5 vs. 4





Blood loss 30cc vs. 90cc
Mortality 0% vs. 3% (p=0.11)
Morbidity 28 vs. 120 (p<0.05)
Pain Score 2.5 vs. 4.4
Chest tube duration 1.5d vs. 3.0d (p<0.001)
ROBOTIC LOBECTOMY
ONCOLOGIC OUTCOMES
Robotic Lobectomy for Non-Small Cell Lung
Cancer: Long-term Oncologic Results




2002 – 2010
3 institutions
325 patients
underwent robotic
lobectomy
CALGB consensus
technique
Park et al. (J Thorac Cardiovasc Surg 2012;143:383-9)
Robotic Lobectomy for Non-Small Cell Lung
Cancer: Long-Term Oncologic Results

“Conclusions: Robotic lobectomy for earlystage NSCLC can be performed with low
morbidity and mortality. Long-term stagespecific survival is acceptable and consistent
with prior results for VATS and thoracotomy.”
Park et al. (J Thorac Cardiovasc Surg 2012;143:383-9)
Open, Video-Assisted Thoracic Surgery, and Robotic
Lobectomy: Review of a National Database
Hypothesis: Robotic thoracic surgery is harmful
• State Inpatient Databases
• Arizona; California; Florida; New York; New
Jersey; Maryland; Massachusetts; and Washington
•
•
Represents approximately 33% of the US population
Trends in utilization of the robot over a 3-year
period
• Comparison of in-hospital mortality and morbidity
between the 3 approaches
•
KENT ET AL. OPEN, VATS, AND ROBOTIC LOBECTOMY USING SID. Ann Thorac Surg 2013
Propensity Matching
Age
•
Chronic pulmonary disease
Gender
•
Peripheral vascular disease
Coronary artery disease
•
chronic renal insufficiency or
Failure
•
Race
•
Hospital setting
Congestive heart failure
Hypertension
Diabetes
Open, Video-Assisted Thoracic Surgery, and
Robotic Lobectomy: Review of a National
Database
Outcomes
Open
VATS
Robotic
n
1233
1233
411
Mortality
2.0%
1.1%
0.2% (p<0.001)
LOS (mean)
8.2
6.3
5.9 (p=0.003)
Prolonged LOS
9.6%
6.9%
4.4% (p=0.089)
Any complications
54.1%
45.3%
43.8% (p=0.74)
Bleeding
complication
1.9%
1.3%
1.7% (p=0.385)
KENT ET AL. OPEN, VATS, AND ROBOTIC LOBECTOMY USING SID. Ann Thorac Surg 2013
What is Robotic Surgery?
Why use it?
Future of Robotic Technology
Quadrocopter Pole Acrobatics
ETH Zurch’s Institute for Dynamic Systems and Control (Dario Brescianini)
Missing Link
Real-Time Imaging
Value of Robotic-Assisted Lobectomy Over
Conventional VATS Lobectomy
Models conventional open surgical techniques
– Teachable to larger caliber of surgeon’s
mproved accuracy of dissection
– Allows precise isolation of vascular structure
» Reduces traction injury - “Arterial Avulsion”
» Limiting blood loss
» Reduces post-op bleeding and transfusion rate (0.8%)
– Meticulous dissection
» Reduces Iatrogenic trauma limiting air leaks (5.1%)
– Minimal lung retraction
» Limited manipulation of tumor mass (No touch technique)
» Reduces likelihood of tumor translocation / capsule disruption
» May attribute to low rates of SVT (2.2%)
Value of Robotic-Assisted Lobectomy Over
Conventional VATS Lobectomy
Complete dissection of lymph node stations
–
Minimal capsular disruption
No need for access incision
–
–
–
–
–
Performed through 4 ports often positioned along a single rib space
No need for extension of thoracic incisions to remove lobe
Reduced pain and neuralgia
Reduces morbidity and mortality
Reduces Port site recurrences (McKenna 2006 – 0.6%)
Wider utilization
No need to preselect patients for MIS approach
– Safe and effective for locally advanced disease
– Large tumor size
–
Therapy for Complex Pulmonary
Resection and Locally Advanced
Disease
Lobectomy for Treatment of
Locally Advanced NSCLC
Population with high morbidity and mortality profile
Majority of cases performed through thoracotomy
Technical difficulties
– Hilar or mediastinal nodal dissection N1/N2
– Large central tumors
– Proximity and adherence to pulmonary vessels
– Induction therapy induced fibrosis


Stage IIIA NSCLC: Morbidity and Mortality of
Three Distinct Multimodality Regimens
Seder, CW, Allen, MS Ann Thorac Surg, 2013
Mayo Clinic Experience
–
–
–
–
–
144 Pts receiving three distinct Multimodality treatment regimens
Platinum-based chemotherapy
Trimodality with 45Gy XRT plus surgery
Trimodality with 60Gy XRT plus surgery
Definitive chemo/XRT (60Gy) w/o surgery
Morbidity and Mortality
– D-CRT: were 74% and 2.3%
– Trimodality with surgery: 48% and 1.8%
» No significant difference based on dose between the two surgical
groups

Stage IIIA NSCLC: Morbidity and Mortality of
Three Distinct Multimodality Regimens
Seder, CW, Allen, MS Ann Thorac Surg, 2013
Surgical Complications total
–
–
–
–
–
–
–
Atrial Fibrillation
Transfusion
Bronchoscopy for mucous plug
Pneumonia
Acute Renal Failure
Readmission for effusion
Mortality
48%
19%
11%
11%
15%
7%
7%
2%
VATS Lobectomy for Treatment
of Locally Advanced NSCLC
Thoracoscopic Lobectomy: A safe and Effective Strategy for
Patients Receiving Induction Therapy for NSCLC

Petersen, Ann Thorac Surg, 2006
97 Consecutive patients with NSCLC who
received induction therapy
– All patients received induction chemotherapy
– 74 patients received induction radiotherapy
– 85 patients resected via thoracotomy
» 78% in thoracotomy group received radiotherapy
– 12 patient resected with VATS
» 67% in VATS group received radiotherapy
» 1 Patient required conversion
Thoracoscopic Lobectomy: A safe and Effective Strategy for
Patients Receiving Induction Therapy for NSCLC




Petersen, Ann Thorac Surg, 2006
Safe and feasible
All patients had complete resection
1 (8%) patient converted
VATS group
– Shorter median hospital stay
– Decreased chest tube duration
– No significant differences
»
»
»
»
Mortality
Hemorrhage
Pneumonia
Respiratory failure
– Findings consistent with safety and efficacy of VATS lobectomy
in surgery alone patients
Robotic-Assisted Lung Resection
Advanced Stage Disease
71 cases underwent robotic-assisted lung
resection from January 2007 – May 2012
Stage II (T3,N0) and IIIA NSCLC
28 female / 43 males
15 patients Stage IIIA NSCLC received
neoadjuvant chemo/XRT (w/ 6000 rads)
Ages range from 33 – 92 years of age
Median age of 68 years
Median Tumor size 3 cm (0.7-11.0 cm )
Robotic-Video-Assisted Thoracoscopic
Anatomical Lung Resection (RVATLR)
Median length of stay (days)
3 (range 1-44)
 Traditional Open lobectomy (2003-06): LOS 6 days
Median length of ICU stay (days)
Median blood loss (cc)
Median chest tube duration (days)
Median operative time (min)
 Average operative time all patients
Total OR time (min)
Median lymph node stations
0 (range 0-15)
100 (range 25-500)
2 (range 1-15)
121 (range 30-280)
97 min
222 (range 83-370)
6 (range 4-8)
Complications (30-day)
Hospital Death
1.4%
Reop Bleeding
1.4%
nversion/difficulty
Pneumonectomy
1.4%
1.4%
2.8%
onversion bleeding
Sleeve Lobectomy
1.4%
Bilobectomy
enectomy/bleeding
1.4%
1.4%
Air leak > 6 days
Lobectomy
4.2%
ural Thrombus/PE
1.4 %
Effusion
9.8%
Arrhythmia
Overall
Morbidity
5.6%
Post-op bleeding
Major Morbidity
n = 3 (4%)
1.4%
RLN
1.4%
Pneumonia
5.6 %
nd infection/fistula
n=71
1.4%
0
2
4
6
8
EBR- enbloc resection
Locally Advanced Right Upper
Lobe NSCLC
Locally Advanced Right Upper
Lobe NSCLC
Treatment protocol
75-y/o male
January 2011 diagnosed
with T3N2Mx Stage IIIA
adenocarcinoma
Neoadjuvant Chemotherapy
and full dose (6000 rads)
radiotherapy
No post-operative
chemotherapy
Recent restaging CT/PET
scan shows single stable
Restaging Ct/PET scan
T4 Left Upper Lobe Tumor
47 year-old Female
 Presented with:

– Hoarseness
– Paralyzed Left hemi-diaphragm
CT/PET confirms a large LUL involving the
Innominate Vein
 Mediastinoscopy was negative
 Pre-operative Chemoradiotherapy

Case 7
Left Upper Lobe Anterior T4 Tumor
COSTS
Two Retrospective studies VATS vs. Open
– VATS cost less ($2000) (Burfeind, 2010)
– Open ($21,016) vs. VATS ($20,316) (Swanson, 2012)
– Causative factors
»
»
»
»
Reduced pre-op workup
Reduced Intensity of care
Reduced length of hospital stay
Reduced adverse events
Open vs. VATS vs. Robotic
– Robotic lobectomy less costly than open lobectomy by $4000 (Park, 2008)
– Defining cost of Care for Lobe / Segment (Swedish - Deen, S.A, 2014)
» No significant cost difference btwn VATS vs. Open (greater by $1207)
» Robotic cases cost $3182 more than VATS (p<0.001)
Financial Data for Lobectomy
2005 - 2010
End use of VATS
Direct Cost/Case for Lobectomy
VATS (FY05) vs. CPRL 3 (FY10)
Cases Numbers
VATS – 31
CPRL 3- 67
Video-Assisted Thoracoscopic Lobectomy Is Less Costly and Morbid Than
Open Lobectomy: A Retrospective Multiinstitutional Database Analysis
Swanson SJ, Meyers BF, Et al, Annals of Thorac Surgery 2012; 93: 1027-32
Premier perspective database (Third Quarter 2007 through 2008)
– National database from (2007 through 2008)
– Open vs. VATS lobectomy
» Total cost (Indirect and Direct costs)

No standard method of Procedure costing
» Open lobectomy was associated with



Longer average length of hospital stay (Open 7.83 vs. VATS 6.15)
Shorter surgery times (Open 3.75 vs. VATS 4.09)
Higher total costs (Open $21,016 vs. VATS $20,316)
– Initial Cost of Capital equipment not included in analysis
– Total patients: 3,961 (Open 2,907 ( 74%) / VATS 1,054 (26%)
» No information provided regarding stage of disease
Your Guide to Costing Methods and
Terminology
Robert M. Dowless, Nursing Management, April 2007
Procedure Costing
– Ratio of Cost-to-Charges (RCC)
» Major limitations

Assumes cost of each procedure is related to charge of the procedure
in exactly the same proportion (i.e: CXR on floor vs. ICU patients)
– Relative Value Unit (RVU)
» Most prevalent and accurate
» Allocates cost to individual procedures based on resources used
– Activity-based Costing (ABC)
» Measures the actual resource used or consumed by procedure
» Allocates cost based on factors such as number and duration of
activities required to provided the procedure
Comparative Financial Analysis of
Robotic versus VATS Lobectomy
28,174
28,046
Dir. Cap
cost/case
Supply cost
RVU
RCC
Dir. Sal cost/ cost
15,904
15,343
8,533
6,908 6,652
5,778
1,130
600
582
-1,881
-18
Robotic Lobes
VATS Lobes
Technique
(Cases)
-561
Difference
128
Robotic Lobectomy
Safe and effective
Superior oncologic profile compared to VATS
Enhanced Lymphadenectomy
High potential for more adoption of MIS techniques
Reduced morbidity, mortality & overall complications
Reduces hospital stay
Applied to wider population of patients
– Locally advanced NSCLC
– Larger Tumors
Cost effective in the right circumstances
“A Time for Choosing”
Ronald Reagan,1964 - Republican Convention
The trouble with our Liberal friends is not that they’re
gnorant it’s just that they know so much that isn’t so”