TMR Patient Selection. Physician Training

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1 TMR Patient Selection Physician Training

2 The Clinical Need Mukherjee et al. Prognosis for untreated medically refractory patients. (JACC, 1999, Cleveland Clinical Review) Clinical Outcome for Eligible Cohort: o 500 consecutive patients referred for coronary artery disease (CAD) treatment o 3 cardiologists reviewed medical history/angiograms Findings: o 12% had inoperable CAD o > 6% are potential TMR candidates 2

3 The Clinical Need Mukherjee et al. Prognosis for untreated medically refractory patients Clinical outcome follow-up for eligible cohort. (AHJ, 2001) One year follow-up on the 59 patients ineligible for traditional methods of revascularization Event No. of Events (%) Death 10 (17%) MI 15 (26%) Rehospitalizations 76 (128%) 3

4 The Clinical Need Graham et al. Diffuse Coronary Artery Disease (CAD) Impacts Surgical Mortality Diffuse CAD can be angiographically quantified Diffuse CAD is not a variable in current models of operative risk Diffuse CAD is an independent predictor of operative mortality 1. Graham M, et al. J Thorac Cardiovasc Surg. 1999:118:

5 The Clinical Need Diffuse Coronary Artery Disease Operative mortality risk: o Independently predicted by incomplete revascularization 1,2 o Current models and national databases do not consider incomplete revascularization in predicting risk o Case-matched comparisons can be inaccurate In the subset of patients with diffuse CAD, current risk models underestimate predicted mortality Osswald B, et al. Eur J Cardiothorac Surg. 2001;20: Graham M, et al. J Thorac Cardiovasc Surg. 1999:118:

6 The Clinical Need INCOMPLETE REVASCULARIZATION!!! Occurs in 10% to 25% of CABG patients 1 o Diffusely diseased targets o Older, sicker patients being referred 1. Osswald B, et al. Eur J Cardiothorac Surg. 2001;20:

7 The Clinical Need Incomplete Revascularization!!! As reported by Prendergast, 19% of patients undergoing CABG had an anticipated graft that could not be bypassed 1 Osswald, et al., Determined: Incomplete revascularization occurred in 16% of elderly patients undergoing a CABG procedure 2 Osswald, et al., Increased mortality was found with incomplete revascularization in patients 75 years of age and was identified as an independent risk factor for death Bjork, et al., Determined: Early patency was decreased when perioperative graft blood flow was 20 ml/min. or diameter of recipient coronary artery was smaller than 1.5 mm 3 Higginbotham, et al., Determined: Patency rates of < 1.0 mm vessels was 50%, patency rates of < 2.0 mm vessels was 78%, and patency rates of 2.0 mm vessels was 100% 4 Corbineau, et al., Determined: The quality of distal runoff of the most frequently grafted vessels is a significant risk factor for CABG operative mortality 5 1. Prendergast BD, et al. UK Cardiology Osswald EH, et al. Eur J Cardiothoracic Surg Bjork VO, et al. Scand J Thorac Cardiovasc Surg Higginbotham M, et al. Aust NZ J Med Corbineau H, et al. University Hospital Center, Rennes, France

8 The Clinical Need STS registry reports 80% of current TMR procedures are performed as an adjunct to CABG As reported by Mukherjee, 2% to 7% of cardiac cathertization patients may be candidates for sole therapy TMR The availability of laser TMR may allow the cardiac surgeon to accept cases that would otherwise be considered inoperable and to respond better to intraoperative findings 1. Mukherjee D, et al. The American Journal of Cardiology

9 TMR Candidate Typical Angiogram 64 year old Obese Woman Class IV Angina at Baseline TMR, 36 channels 33 Month Follow-up: NO ANGINA Image courtesy of Keith Allen, MD, St. Vincent Hospital, Indianapolis, Indiana 9

10 Patient Selection Criteria Stable patient with severe angina CCS Class IV, refractory to medical management Regions of the myocardium demonstrating reversible ischemia which are not amenable to direct coronary revascularization (either PCI or CABG) o Patients with one or more vessels or branches that are not bypassable (small vessels mm diameter or less may be indicators) Diffuse Distal Coronary Artery Disease (diffuse atherosclerotic end-stage disease) Left ventricular ejection fraction > 30% Area of ischemia located in lower of left ventricle ( 10% reversibility of perfusion defect) Incomplete revascularization Profound physical limitations due to severe angina that produces patient/physician sense of hopelessness Diabetes 10

11 Patient Exclusion Criteria Not a treatment for congestive heart failure Does not improve shortness of breath (dyspnea) unrelated to angina Will not improve a failing pump Q-wave MI within past 3 weeks Non Q-wave MI within past 2 weeks Severely unstable patients (unweanable from I.V. anti-anginal medication) Uncontrolled ventricular tachy-arrhythmia Cardiac failure, decompensated 11

TMR Candidate Typical Angiogram Patient History: 60 year old Male,

Insulin Therapy, Peripheral Artery Disease with Claudication Treatment

Vessels in Posterior-Inferior Wall CABG X 5 TMR to Inferior-Posterior

12 TMR Candidate Typical Angiogram Patient History: 60 year old Male, Diabetic, Hypertensive, Overweight MI No History NYHA Class 3 Angina; Insulin Therapy, Peripheral Artery Disease with Claudication Treatment Strategy: Cardiac Cath: Severe 3 Vessel Disease, EF = 50%, no Graftable Vessels in Posterior-Inferior Wall CABG X 5 TMR to Inferior-Posterior Wall (21 Channels) 2 Year Follow-up, NYHA Class 1, No Cardiac Events, No Cardiac Meds 12

Disease, EF = 60%, Poor LAD and Diagonal Targets CABG X 4 TMR to Anterior Wall as

13 TMR Candidate Typical Angiogram Patient History: 62 year old Male History of Hypertension NYHA Class 3 Angina Treatment Strategy: Cardiac Cath: Severe 3 Vessel Disease, EF = 60%, Poor LAD and Diagonal Targets CABG X 4 TMR to Anterior Wall as well as Inferior Wall (18 Channels) 3 Year Follow-up, NYHA Class 1, No Cardiac Events 13

14 TMR Candidate Typical Angiogram Patient History: 55 year old Male, Diabetic MI 1989; Angioplasty x 2 Since to Open Marginal Vessel NYHA Class 3 Angina; Positive Stress Test with Ischemia in all Regions; Mild Renal Insufficiency (Creatinine = 1.9) Treatment Strategy: Cardiac Cath: 3 Vessel Disease, EF = 50%, Occluded 2 nd Marginal with No Target in that Area Bypassable CABG X 3 TMR to Lateral Wall (11 Channels) 1 Year Follow-up, NYHA Class 1, Normal Stress Exam, Normal Echocardiogram 14

Interventions: Cardiac Cath: Severe 3 Vessel Disease, Only One Vessel Bypassable (OMI), EF = 32% CABG X 1 TMR

15 TMR Candidate Typical Angiogram Patient History: 54 year old Male, Hypertensive, Hyperlipidemic, Overweight MI 09/1997; Hospitalized with Unstable Angina and Treated Medically NYHA Class 4 Angina Cardiovascular Interventions: Cardiac Cath: Severe 3 Vessel Disease, Only One Vessel Bypassable (OMI), EF = 32% CABG X 1 TMR to All Areas of the Myocardium (39 Channels) 2 Year Follow-up, NYHA Class 1, No Further Cardiac Events, Stable EF 15

TMR Candidate Typical Angiogram Patient History: 54 year old male, increasing symptoms of angina Seen by numerous CTS who felt grafting was not an option,

Cardiovascular Interventions: Cardiac Cath: Revealed extensive bridging of the left anteriordescending coronary artery with near occlusion in systole, and

16 TMR Candidate Typical Angiogram Patient History: 54 year old male, increasing symptoms of angina Seen by numerous CTS who felt grafting was not an option, nor was attempt to unroof the myocardial bridging NYHA class 3 angina; stress test demonstrated severe anterior wall ischemia with limited exercise Cardiovascular Interventions: Cardiac Cath: Revealed extensive bridging of the left anteriordescending coronary artery with near occlusion in systole, and diminished blood supply in diastole as well Sole therapy TMR to anterior wall (13 channels) 1.5 Year Follow-up, NYHA Class 1, No Cardiac Events, Normal Stress Exam 16

17 Careful Patient Selection Optimizes TMR and TMR+CABG Outcomes Low Mortality and Sustained Angina Relief Study Facts: 157 patients underwent TMR alone or combined with CABG 43% had TMR as a sole therapy and 57% had TMR as an adjunct to CABG. Of the 90 combined (TMR+CABG) procedures, 46 were performed entirely off-pump Follow-up range was years with a mean of 1.2 years Total TMR hospital experience from Utilized the Holmium:YAG TMR Laser with fiber optic Sologrip Delivery System Source: Michael Grosso, MD, St. Francis Heart Center, Wilington, DE From Hospital Experience Case Study,

18 Careful Patient Selection Optimizes TMR and TMR+CABG Outcomes Low Mortality and Sustained Angina Relief Summary of Results: Angina relief was profound an sustained 82% of patients with no angina or class 1 symptoms at follow-up. Improved patient selection over time has significantly reduced mortality rates. Current in-hospital mortality is low (4%). Off-pump adjunctive therapy mortality is only 2%. Follow-up reveals low late mortality (1.3%). Source: Michael Grosso, MD, St. Francis Heart Center, Wilington, DE From Hospital Experience Case Study, % 10% 8% 6% 4% 2% 0% 20 Cumulative Patients Treated % Annual Operative Mortality % 6.3% 4.0% 3.9% 2.2% TMR+CABG Off-Pump n=46 18

19 Careful Patient Selection Optimizes TMR and TMR+CABG Outcomes Low Mortality and Sustained Angina Relief Conclusions: These results indicate that TMR, performed as a sole therapy or as an adjunct to CABG, is safe These results suggest better outcomes with an offpump approach Careful patient selection maximizes outcomes Source: Michael Grosso, MD, St. Francis Heart Center, Wilington, DE From Hospital Experience Case Study,

20 FDA Labeling (IFU) Transmyocardial revascularization with the CardioGenesis Laser System is indicated for the treatment of stable patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amendable to direct coronary revascularization. 20

21 FDA Label Precautions and Warnings Patients who were unstable (defined as unweanable from intravenous anti-anginal medications) experienced 11% (16/150) perioperative mortality (surgery + 30 days) compared to 5% (7/132) in patients who did not require intravenous anti-anginal medications. Do not treat the myocardium in the area of a left ventricular mural thrombus because of potential for the creation of emboli. 1. CardioGenesis IFU 21

22 What should we be thinking? Good Targets CAD Bad Targets PCI CABG Medical Therapy Failure? Repeat PCI Repeat CABG Transplant Endarterectomy TMR Gene Therapy 22

23 What should we be thinking? The time to schedule a TMR procedure is not only when analyzing the angiogram but intra-operatively as well the laser should always be ready and scheduled for use More knowledge will be available intra-operatively than from the angiogram alone TMR can be used for ungraftable vessels with areas of reversible ischemia Source: Allen KB, et al. J Thorac Cardiovasc Surg

24 Proven Clinical Benefit Clinical Trials Have Shown a Clinical Benefit with the Use of TMR Primary Outcomes: o Relief of Angina by Two or More Classes o Increased Exercise Tolerance Secondary Outcomes: o Reduction in Re-Hospitalizations o Reduction in Medication Usage o Increased Event Free Survival o Increased Perfusion o Improved Quality of Life Long-Term Efficacy 24

25 Proven Clinical Benefit Proven Symptomatic Relief Dramatic Improvement in Quality of Life Significant TMR Reimbursement for Hospital and Physician The Blue Cross/Blue Shield TEC States: o In 1999: TMR Sole Therapy Improves Net Health Outcomes o In 2001: TMR+CABG Improves Net Health Outcomes Advantageous for All Stakeholders o Patient, Physician, and Healthcare System 25

26 References 1. Allen KB, et al. Comparison of Transmyocardial Revascularization with Medical Therapy in Patients with Refractory Angina. N Engl J Med. 1999;341(14): Allen KB, et al. Transmyocardial Laser Revascularization Combined with Coronary Artery Bypass Grafting: A Multi- Center, Blinded, Prospective, Randomized, Controlled Trial. J Thoracic Cardiovasc Surg. 2000;119(3): Frazier OH, et al. Transmyocardial Revascularization with a Carbon Dioxide Laser in Patients with End-Stage Coronary Artery Disease. N Engl J Med. 1999:341(14): Burkhoff D, et al. (for the ATLANTIC investigators) Transmyocardial laser revascularization compared with continued medical therapy for treatment of refractory angina pectoris: a prospective randomized trial. The Lancet. 1999;354(9182): Schofield P, et al. Transmyocardial laser revascularization in patients with refractory angina: a randomized controlled trial. The Lancet. 1999;353: Aaberge L, et al. Transmyocardial Revascularization with CO 2 Laser in Patients with Refractory Angina Pectoris (Clinical Results from the Norwegian Randomized Trial). JACC. 2000:35: Nordrehaug J, et al. 12-month data presented at AHA Annual Conference, November 2001 in Anaheim, CA. 8. Oesterle S, et al. Percutaneous transmyocardial laser revascularization for severe angina: the PACIFIC randomized trial. The Lancet. 2000;356: Perin E, et al. Percutaneous Transmyocardial Revascularization. Presented at ACC Scientific Sessions, March Allen KB, et al. 24-month patient follow-up presentation not yet presented or published. January 2001, St. Vincent Hospital, Indianapolis, IN. 11. Horvath KA, et al. Sustained Angina Relief Five Years after Transmyocardial Revascularization with a CO 2 laser. Circulation. 2001;104[supp I]:I Schnieder J, et al. Transmyocardial laser revascularization with the holmium:yag laser: loss of symptomatic improvement after 2 years. Eur J Cardiothorac Surg. 2001;19: Hughes GC, et al. Induction of Angiogenesis After TMR: A Comparison of Holmium:YAG, CO 2, and Excimer Lasers. Ann Thorac Surg. 2000;70:

27 References (cont.) 14. Carmeliet P. Mechanisms of Angiogenesis and Arteriogenesis. Nature American. 2000;6:Number 3, March Bortone AS, et al. Inflammatory Response and Angiogenesis After Percutaneous Transmyocardial Laser Revascularization. Ann Thorac Surg. 2000;70: Domkowski PW, et al. Histologic Evidence of Angiogenesis 9 Month After Transmyocardial Laser Revascularization. Circulation. 2001;103: Kohmoto T, et al. Evidence of vascular Growth Associated with Laser Treatment of Normal Canine Myocardium. Ann Thorac Surg. 2000;70: Actis Dato GM, et al. TMR and CABG: The Best Way to Obtain a Complete and a More Lasting Revascularization? Ann Thorac Surg. 2000;69: Letter to the Editor. 19. Bortone AS, et al. Instrumental Validation of Percutaneous Transmyocardial Revascularization: Follow-up Data at One Year. Ann Thorac Surg. 2000;70: Weiss SJ, et al. A Novel Approach to Surgical Revascularization of Myocardium Not Amenable to Conventional Bypass Techniques. The Journal of the Pennsylvania Association for Thoracic Surgery. 2001;9: Wiemer M, et al. Improvement of Myocardial Perfusion detected by Positron Emission Tomography (PET) in Patients with End Stage Coronary Artery Disease treated with PMR. Heart Center North Rhine-Westphalia, Bad Oeyenhausen, Germany, Pending Publication, Presented to AHA, November Minisi AJ, et al. Cardiac Nociceptive Reflexes after Transmyocardial Laser Revascularization: Implications for the Neural Hypothesis of Angina Relief. J Thorac Cardiovasc Surg. 2001;122: Yamamoto N, et al. Angiogenesis is Enhanced in Ischemic Canine Myocardium by Transmyocardial Laser Revascularization. J Am Coll Cardiol. 1998;31: Hughes GC et al. Transmyocardial Laser Revascularization Limits in vivo Adenoviral-Mediated Gene Transfer in Porcine Myocardium. Cardiovasc Res. 1999;44(1); Arora RC, et al. Transmyocardial Laser Revascularization Remodels the Intrinsic Cardiac Nervous System in a Chronic Setting. Circulation. 2001;104[suppl I]:I Copyright 2014 CryoLife, Inc. 27

MEDICAL POLICY SUBJECT: TRANSMYOCARDIAL REVASCULARIZATION

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