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Cath Lab 2013: Who Would Have Thought it Would Ever Be This Way? Thomas Cath Lab 2013: Who Would Have Thought it Would Ever Be This Way? Thomas H Maloney, MHA, RCIS Richmond, VA Nurse & Technologist Symposium February 24 2013 IC-140706 -AA Feb 2013 Page 1

Tom H. Maloney, RT Within the past 12 months, the presenter or their spouse/partner Tom H. Maloney, RT Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. Company Name Boston Scientific Corp. Relationship Full Time Employee Federal law restricts the use of devices named in this presentation to sale by or on the order of a physician. Please review all directions for use including indications, contraindications, warnings, precautions and adverse events prior to clinical use.

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists The Next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 3

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots can do PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 4

1992 2013 IC-140706 -AA Feb 2013 Page 5 1992 2013 IC-140706 -AA Feb 2013 Page 5

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots can do PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 6

Transforming Interventionalists Femoralist Radialist Comprehensivist IC-140706 -AA Feb 2013 Page 7 Transforming Interventionalists Femoralist Radialist Comprehensivist IC-140706 -AA Feb 2013 Page 7

Percentage of Radial For PCI Bertrand OF, et al. JACC Cardiovasc Interv. 2010 Dec Percentage of Radial For PCI Bertrand OF, et al. JACC Cardiovasc Interv. 2010 Dec 1; 76(7): 1022 -31 IC-140706 -AA Feb 2013 Page 8 90658710 19 of 59

Radial Practice in the Future 68. 4% 50% Bertrand OF, et al. JACC Cardiovasc Radial Practice in the Future 68. 4% 50% Bertrand OF, et al. JACC Cardiovasc Interv. 2010 Dec 1; 76(7): 1022 -31 IC-140706 -AA Feb 2013 Page 9 90658710 20 of 59

Proposed framework for learning steps and competency levels for TRI. Thomas. maloney@comcast. net Consensus Proposed framework for learning steps and competency levels for TRI. Thomas. [email protected] net Consensus Document on the Radial Approach. Euro. Intervention 2013; publish-ahead-of-print January 2013 IC-140706 -AA Feb 2013 Page 10

Nurse & Tech Obtaining Radial Artery Access Arkansas Heart Hospital “Our techs are now Nurse & Tech Obtaining Radial Artery Access Arkansas Heart Hospital “Our techs are now very adept at gaining radial access on their own” Cath Lab Digest Feb. 2011: Vol. 19, No. 2: 24 -6 IC-140706 -AA Feb 2013 Page 11 11

MRMC Protocol Thomas. maloney@comcast. net Cath Lab Digest Oct. 2011: Vol. 19, No. 10: MRMC Protocol Thomas. [email protected] net Cath Lab Digest Oct. 2011: Vol. 19, No. 10: 30 -1 IC-140706 -AA Feb 2013 Page 12 12

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots can do PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 13

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Collaterals are Usually not Sufficient to Substantially Reduce Ischemia in CTO Modified from Werner Collaterals are Usually not Sufficient to Substantially Reduce Ischemia in CTO Modified from Werner GS et al, European Heart Journal 2006, courtesy Werner GS IC-140706 -AA Feb 2013 Page 15 15

SYNTAX CTO Subset Procedural characteristics Per lesion analysis CABG n=266 12 were not treated SYNTAX CTO Subset Procedural characteristics Per lesion analysis CABG n=266 12 were not treated with CABG n=254 Not Bypassed n=81 Reason not bypassed: Not intended to treat (n=12) Diseased (n=11) Inadequate conduit (n=2) Too small (n=19) Unable to find (n=1) Other (n=36) Bypassed n=173 • Overall 68. 1 % of TO were successfully bypassed • 49. 6% overall complete revascularization in CTO subset ITT, Per Lesion Serruys P, CRT 2009 [modified]; courtesy Prof Serruys and the SYNTAX investigators IC-140706 -AA Feb 2013 Page 16 16

CTO Recanalization and Angina Control Successful PCI (n) Follow-up (months) Asymptomatic (%) Olivari 2003 CTO Recanalization and Angina Control Successful PCI (n) Follow-up (months) Asymptomatic (%) Olivari 2003 248 12 88. 7 Berger 1996 139 6 87 Stewart 1993 45 12 68 Ivanhoe 1992 264 36 69 Ruocco 1992 160 24 69 Bell 1991 234 32 76 Series IC-140706 -AA Feb 2013 Page 17 17

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 18

Radiation and Cancer n 9 Cases of Brain Tumors in interventional Cardiologists – Half Radiation and Cancer n 9 Cases of Brain Tumors in interventional Cardiologists – Half Glioblastoma, Left Temporal n Case control study suggest of radiologists working with fluoroscopy OR 6. 0 for brain tumor 19 Roguin, A, et al. Eurointervention. 2012; 7: 1081 -86. IC-140706 -AA Feb 2013 Page 19

Vascular Robotic System Corindus - Cor. Path 200 Single-use Cassette Robotic Drive Interventional Cockpit Vascular Robotic System Corindus - Cor. Path 200 Single-use Cassette Robotic Drive Interventional Cockpit IC-140706 -AA Feb 2013 Page 20 Operator Console

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Operator Radiation Exposure Primary Operator dosimeter Bedside dosimeter Procedure Table Robotic Operators 61. 6 Operator Radiation Exposure Primary Operator dosimeter Bedside dosimeter Procedure Table Robotic Operators 61. 6 μGy 1. 81 μGy 97. 1% reduction (p<0. 0001) median radiation exposure to primary operator Granada J et al. JACC Int. 2011; 4: 460 -5 IC-140706 -AA Feb 2013 Page 22

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 23

Cowboy Cardiologist IC-140706 -AA Feb 2013 Page 24 Cowboy Cardiologist IC-140706 -AA Feb 2013 Page 24

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Association Between Appropriateness of Coronary Revascularization and Clinical Outcomes in Patients with Stable CAD Association Between Appropriateness of Coronary Revascularization and Clinical Outcomes in Patients with Stable CAD 2009 appropriate use criteria applied to 1, 625 patients treated in Ontario, Canada, April 2006 -March 2007. • Of 997 revascularizations: 68% were appropriate, 18% uncertain, and 14% inappropriate • 69% of patients deemed appropriate underwent revascularization vs. 45% of those judged inappropriate • In the appropriate group, revascularization reduced the 3 -year risk of death or recurrent ACS (adjusted HR 0. 61; 95% CI 0. 42 -0. 88; P = 0. 0087) • In the inappropriate group, revascularization did not reduce the 3 year risk of death or recurrent ACS (adjusted HR 0. 99; 95% CI 0. 48 -2. 02; P=0. 97) Ko DT, et al. J Am Coll Cardiol. 2012; Epub ahead of print. IC-140706 -AA Feb 2013 Page 27

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 28

Medicare Inpatient PCI’s trend Over Ten Years Of 378, 372 Medicare PCI’s performed by Medicare Inpatient PCI’s trend Over Ten Years Of 378, 372 Medicare PCI’s performed by 6443 interventionalists, 30% were performed by operators who do ≤ 40 annual PCI CCI 81: 34 -39 (2013) New York Times Business Day Section August 6 2012 IC-140706 -AA Feb 2013 Page 29

Appropriate Use Criteria (AUC) Largest Driver of PCI Decline in US and Expected to Appropriate Use Criteria (AUC) Largest Driver of PCI Decline in US and Expected to Continue 30% of PCI decline related to AUC… … and AUC expected to be a continued area of focus AUC related Source: Industry Survey Data (n=43 US ICs, 18 US hospital administrators) IC-140706 -AA Feb 2013 Page 30

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Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 32

CMS Pre-Payment Audit Demonstration (RAC) Recovery Audit Prepayment Review demonstration targeted for January 1, CMS Pre-Payment Audit Demonstration (RAC) Recovery Audit Prepayment Review demonstration targeted for January 1, 2012 on hold. CMS to provide at least 30 days notice before they begin demonstration at TBD date Demonstration will allow (not mandate) certain RACs to use the prepayment audit • Provides Medicare local authority to hold payments for certain inpatient DRG’s • • Based on Medicare Administrative Contractors (MACs) performance for claim errors Measures the “error rate” as well as other measures High error rate suggests that providers are not following Medicare rules Errors result in providers being overpaid (or underpaid) Eleven states in demonstration include FL, CA, MI, TX, NY, LA, IL, PA, OH, NC, MO • Florida began pre-payment audit January 1, 2012 ten other sates began August 2012 Initial six-months did not focus on PCI procedures • • First phase reviewed syncope and collapse claims (MS-DRG 312); other non-CV related DRGs CMS has added additional DRGs to include PCI CV-88015 -AA May 2012 IC-140706 -AA Feb 2013 Page 33 3

93458 Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary 93458 Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed Physician Payment $316 APC 080 Hospital outpatient diagnostic catheterization $2, 718 $2, 650 RVU 5. 85 92928 Transcatheter placement of an intracoronary stent(s), with coronary angioplasty when performed, single vessel C 9600 Hospital Outpatient PCI with DES Physician Payment $838 $7, 403 $604 RVU 14. 82 11. 21 **CPT 92941/92943 $677 for AMI & CTO** $7, 763 Percutaneous cardiovascular procedure with drug-eluting stent MS-DRG 246 with MCC or 4+ vessels/stents $17, 866 $18, 227 MS-DRG 247 without MCC $11, 165 $11, 497 2013 Procedural Payment Guide: CRV-131911 -AA - December 2012 IC-140706 -AA Feb 2013 Page 33

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists Structural Heart is the next frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 35

Evolution Practice Ownership by Practitioners Over the past 5 years, the number of cardiologist Evolution Practice Ownership by Practitioners Over the past 5 years, the number of cardiologist working for hospitals has more than tripled & now the number of cardiologist who are employed by hospitals and physician-owned is at parity 1% 1% 6% 6% 15% 17% Other 11% 4% Hospital 35% % Physicians Med school/Univ Gov’t 58% 5% 34% Courtesy of David Holmes MD TCT 2012 IC-140706 -AA Feb 2013 Page 36 HMO/insurance

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots and PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Employed Cardiologists The Next Frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 37 IC-140706 -AA Feb 2013 Page 31

Worldwide Cardiology Market Trends $20 B $16 B $12 B Future Segments: • TAVR Worldwide Cardiology Market Trends $20 B $16 B $12 B Future Segments: • TAVR • Hypertension • LAA Occlusion • Adult PFO/ASD Closure • Transcatheter Mitral Valve Future Segment CAGR 2010 – 2020 = 30% PCI $8 B Existing PCI CAGR $4 B 2010 – 2020 = 1 -3% $B 2010 2015 2020 • New market segments may exceed PCI market size by 2020 Source: Industry, May 2011 IC-140706 -AA Feb 2013 Page 38

Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. Who Would Have Ever Thought? 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Where Did That Go Radial Access is growing CTO’s are approachable Robots can do PCI Appropriate Use Criteria Procedure Volume Reimbursements Hospital Owned Cardiologists The Next Frontier Multi-Discipline Team Approach IC-140706 -AA Feb 2013 Page 39

TAVR Model Has Paved the Way Cath Lab Multi-Disciplinary Collaboration IC-140706 -AA Feb 2013 TAVR Model Has Paved the Way Cath Lab Multi-Disciplinary Collaboration IC-140706 -AA Feb 2013 Page 40 OR