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”
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