Clifton G - AIMRADIAL 2013 - Terumo perspective
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Clifton G - AIMRADIAL 2013 - Terumo perspective
- 1. Gary Clifton-Global Director of Cardiology Marketing VASCULAR ACCESS-THE MODERN ERA AN INDUSTRY PERSPECTIVE TERUMO INTERVENTIONAL SYSTEMS
- 3. Bleeding by Hospital Site 30 Number of Hospitals Mean 25 0.023082 Percent Hospitals Lower Quartile 20 920 0.010403 Median 0.019608 Upper Quartile 0.031337 15 10 5 0 -1-0 0-1 1-2 2-3 3-4 4-5 5-6 6-7 7-8 Bleeding Rate (%) 8-9 9-10 10-11 11-12 > 12 Marso et al. JAMA 2010;303:2156-2164
- 4. WHY IS TERUMO INVOLVED WITH RADIAL? TERUMO INTERVENTIONAL SYSTEMS
- 5. CLINICAL BENEFITS OF TR ARE ASSOCIATED WITH COST EFFECTIVENESS AND PATIENT SATISFACTION Results Metrics 1 Primary Clinical Outcome 2 Complications Procedure Success Rate Access Site Crossover Access Site Complication Major Bleeding Source Jolly et al RIVAL Jolly et al RIVAL* Kiemeneij et al RIVAL Jolly et al Vorobcsuk et al Radial Femoral 95.3% 96.6% 95.4% 95.2% 5.9% 1.4% 7.6% 2.0% 0.0% 2.0% 1.4% 3.7% 0.05% 2.3% 0.77% 2.61% 2.5% 3.8% 3.65% 6.55% 40 min 38 min 35 min 34 min 1.5 days 1.8 days 1.31 days 1.75 days 86 min (CathLab) 174 min (CathLab) 386 min (Ward) 720 min (Ward) $369.50 $446.90** $4,508 $5,213 4 Patient Satisfaction Duration of Procedure Kiemeneij et al Length of Stay Kiemeneij et al Amoroso et al Total Procedural Cost Cost Effectiveness Jolly et al Nurse Workload 3 Death, MI, or Stroke Roussanov et al Access Site Satisfaction RIVAL 90% 49% Preferred Choice Among Patients with both TR&TF experience Cooper et al 87% 2% Vorobcsuk et al RIVAL CARAFE Amoroso et al CARAFE : Superior to TF : Equivalent Majority of cases suitable for TR, with similar efficacy and less risk of AS Complications Significantly less risk of adverse bleedingevents with TR Lower cost and more efficient use of hospital resources with TR High patient satisfaction with TR approach * Inverse relationship between likelihood of access site crossover to TF and operator experience with TR [RIVAL] ** Cost for femoral cases not using a closure device. Median cost for femoral cases using a closure device was $553.40 *** Sources detailed on final slide
- 6. FINDING THE BALANCE BETWEEN INPATIENT AND OP PCI Patient Acuity a Major Factor in Determining Outpatient Outpatient Shift shift potential Case distribution Percentage of Cases Eligible to Move Outpatient Source: Cardiovascular Roundtable interviews and analysis. Shaded region represents outpatient cases Low Relative Patient Acuity High Relationship Between Acuity, Case Distribution, and Outpatient Shift CMS knows that the majority of PCI patients can be done safely as OP, but vascular access complications, or the fear thereof, have traditionally driven hospitals to keep patients overnight for observation. TERUMO INTERVENTIONAL SYSTEMS
- 7. Trend in Use of r-PCI Over Time in Overall Data Set and Key Subgroups Feldman D N et al. Circulation 2013;127:2295-2306 Copyright © American Heart Association
- 8. LEVERAGING PATIENT PREFERENCE FOR TR IS KEY TO REALIZING SYSTEMIC BENEFITS INCLUDING GREATER RESOURCE EFFICIENCY Impact of Transradial Benefits Clinical Benefits : TR Benefits : Impact of Patient Preference for TR Cost Effectivenes s Less Risk of Access Site Crossover Reduced Nurse Workload More Resource Efficiency from Higher Volume TR Requests / Referrals Patient Satisfaction Operator Expertise Greater Differentiation Marketing Advantage
- 10. SLENDER DELIVERS SOLUTIONS PATIENTS, MORE TRI… 2.62 O.D 2.46 O.D 6Fr Sheath Down Sizing 6Fr GSS Equivalent Diameter 5Fr Sheath 2.21 I.D 6Fr GSS is compatible with any 6Fr guiding catheter while maintaining an outer diameter of at 5Fr sheath Regulatory Approval #2727
- 11. SLENDER LOOKS DIFFERENT Gray on strain relief indications outer diameter of 5Fr Green on valve and dilator indicates inner diameter of 6Fr
- 12. Not All Access Can Be RadialWe Need to be Flexible PRECISION MICRO ACCESSING TERUMO INTERVENTIONAL SYSTEMS
- 13. FEATURES / BENEFITS | PINNACLE PRECISION ® Innovative 7cm Needle 21 G / 19 G Taper Bevel Cut Technology Non-Echogenic vs. Echogenic TERUMO INTERVENTIONAL SYSTEMS
- 14. FEATURES / BENEFITS | PINNACLE PRECISION ® TIF IK Sheath • TIF Tip w/ 0.021” Distal Hole o 10cm Lengths in 4Fr, 5Fr, 6Fr, 7Fr and 8Fr Sizes Up to 24% Less Insertion Force and Resistance • Seamless Dilator-to-Sheath Transition Reduces Gapping and Keeps Sheath Integrity • Excellent Flexibility for Maximum Kink Resistance • TIF Tip is Less Likely to Deform, Resulting in Easier, Safer Insertion • TERUMO INTERVENTIONAL SYSTEMS
- 15. TIF TIP WITH 0.021” END HOLE 0.021” TIF Transitions 4Fr, 5Fr, 6Fr, 7Fr, 8Fr Sizes 10cm Length TIF Tip Transitions Strong Dilator Hub Attachment – prevents dilator backout Snap Fit Stiff 4Fr and 5Fr also Hypotube incorporated into dilator tube Stiffness Transition Flexible Tip Dilator Hub Dilator Tube (blue) Sheath Tube (white) Hypotube (gray) Sheath Hub TERUMO INTERVENTIONAL SYSTEMS 15
- 16. 16 Product Comparison Competitor 1 Competitor 2 Softer material Making the tip sharper results in easier puncture but the material on the tip is so soft and thin it becomes very easy to peel Competitor 3 Making the tip sharper results in easier Puncture, but the material on the tip is so soft and thin it becomes very easy to peel Large bump at sheath tip resulting in the greatest resistance when puncturing. Clearance between sheath and dilator results in greater possibility of peel back Competitor 4 Large bump and clearance between sheath and dilator resulting in puncture difficultly and increased possibility in peel back TERUMO INTERVENTIONAL SYSTEMS
- 17. SHEATH/DILATOR INTERFACE MATTERS Notice the elimination of clearance between the sheath and the dilator. Transition is very smooth resulting in reduced possibility for distal end to peel and increasing the possibility for easier punctures TERUMO INTERVENTIONAL SYSTEMS
- 18. THE NEED FOR LARGER ACCESS SOLUTIONS TERUMO INTERVENTIONAL SYSTEMS
- 19. Despite the lower profile of new THV systems, vascular access complications remain the most frequent procedural pitfall of TF-TAVI Jilaihawi et al JACC Cardiovasc Intv 2010;3:859-66 LARGE BORE ACCESS IS ANYTHING BUT BENIGN TERUMO INTERVENTIONAL SYSTEMS
- 20. LARGE BORE BLEEDING IS WORSE! VARC Criteria Ratio between sheath OD and FA MLD >1.05 shows more VARC major complications 3X increase in 30 day Mortality rates CA++ score 0-3 Tortuousity Score 0-3 Transfemoral Aortic Valve Implantation New Criteria to Predict Vascular Complications JACC Cardiovascular Intervention 2011 Vol 4, No 8 TERUMO INTERVENTIONAL SYSTEMS
- 22. SHEATH EXPANSION AND REMOVAL OF DILATOR Hydrophyllic coating Dilator Balloon Expanded OD is 3Fr larger than ID Working length (25-35 cm) 14-24Fr TERUMO INTERVENTIONAL SYSTEMS
- 23. REMOVING THE BALLOON DILATOR TERUMO INTERVENTIONAL SYSTEMS
- 25. EXPANDABLE VS CONVENTIONAL SHEATHS Shear force Radial force TERUMO INTERVENTIONAL SYSTEMS
- 26. IN CONCLUSION It all starts with the needle puncture Sheaths are a direct source of complications We can’t do all procedures radially, and when we can’t we have to take the same care and attention to the femoral The frontier of vascular access is moving beyond femoral and radial as tibial/pedal gains popularity And when we have to access the femoral for larger sheaths, new tools and techniques are now available to minimize the opportunity for complications TERUMO INTERVENTIONAL SYSTEMS
Editor's Notes
- 9/10/2010 1:36:31 PM
- Trend in the use of r-PCI over time in the overall data set and key subgroups. Trend in the use of r-PCI over time in the overall data set (A); patients aged ≥75 and <75 years (B); men and women (C); patients with stable angina, non–ST-segment elevation acute coronary syndrome (NSTE ACS), and ST-segment elevation myocardial infarction (STEMI) (D); and patients in Northeast, West, Midwest, and South regions (E). PCI indicates percutaneous coronary intervention; Qtr, quarter; r-PCI, radial approach to percutaneous coronary intervention; and UA, unstable angina.
- Glidesheath Slender