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Chandan Devireddy MD, FACC, FSCAI Associate Professor of Medicine: Emory University

Improving TAVR Efficiencies from Diagnosis to Discharge: Identifying Aortic Stenosis and 3M Integration. Chandan Devireddy MD, FACC, FSCAI Associate Professor of Medicine: Emory University @ drdevireddy. Disclosures. Medtronic: Data Safety Monitoring Board

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Chandan Devireddy MD, FACC, FSCAI Associate Professor of Medicine: Emory University

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  1. Improving TAVR Efficiencies from Diagnosis to Discharge:Identifying Aortic Stenosis and 3M Integration Chandan Devireddy MD, FACC, FSCAIAssociate Professor of Medicine: Emory University @drdevireddy

  2. Disclosures Medtronic: Data Safety Monitoring Board ReCor Medical: Scientific Advisory Board Vascular Dynamics: Scientific Advisory Board

  3. TAVR: One Visionary First Step… April 18, 2002

  4. …Has Led to a Disruption in Cardiac Care (annualized volume)

  5. TAVR: Increased Adoption=Increased Cost • $473 billion in Medicare cuts projected over 10 yrs • TAVR v. SAVR 2012-2014: • Median LOS (6d v. 9d, p<.001) • Mean savings ($4502, p<.001) • However, TAVR availability has  AVR utilization • 90% of U.S. TAVR spending covered by Medicare • Is this sustainable? If not, what will give?ive? Patel N et al. JACC Cardiovasc Interv. 2018 Mar 26;11(6):610-612

  6. Are there ways to further minimize the invasiveness and overhead required from TAVR? • YES!: • But it requires the will to alter historical care pathways! • TARGET STEPSEvaluation of Aortic Stenosis and Procedural eligibility • TAVR procedural efficiencies • Post-procedure mobilization and preparation

  7. Optimizing Patient Pathways • Evaluate Time from Referral to Procedure • Creation of an effective and streamlined clinic • Patient selection criteria • Evaluate appropriateness for moderate sedation • Patient Length of Stay • Patient pathway • ICU Utilization vs. Avoidance

  8. Evaluate Time from Referral to Procedure • Evaluate timelines • Time from referral to testing • Visit to decision • Decision to procedure • Creation of Effective clinic • New patient clinic • Follow up clinic • APP lead clinics

  9. Creating an effective clinic • Multispecialty (CT, IC, VCC) • Block scheduling (Echo, PFT, CT) • Allow time for Education! • Allows discussion of intricacies of procedure as well as time to determine patient baseline • Functional capacity • Medical history/ Physical • Patient centered discussion of their understanding, beliefs, and shared treatment goals

  10. Patient selection criteria • Anatomic criteria • Transfemoral • Patient comorbid conditions • Frailty • Socioeconomic status • Family support to facilitate rapid d/c and home care

  11. “Failing to plan is planning to fail”- Winston Churchill • Asking questions pre-procedure can help you post-procedure • Medication compliance • Can the patient afford medications • Patient social situation • Plan for patient discharge? • Home Health needs? • Lingering questions • Setting expectations

  12. Real World Applications of the Heart Team:Patient Risk Stratification • STS score omissions • Cirrhosis, porcelain aorta, radiation, hostile chest, blood dyscrasias • Frailty • Negatively impacts recovery • Futility • Recognizing a Cohort C patient

  13. TAVR patient turnaround: How fast? • As we enter new low-risk era, need to ensure that clinic processes operate smoothly • Imaging should ideally be performed and interpreted by the heart team within a week • Heart team review of the patient should follow acquisition of diagnostic studies. • What should goal turnaround be for D2V (Door to valve)? • 2 weeks? • 4 weeks? • 8 weeks?

  14. Minimalist TAVR: Early Concepts • Not a new idea • May 2012, Durand published 151 patients with “minimalist” TF TAVR. 3.3% conversion to general anesthesia • TF TAVR becomes a “stent like” procedure • No • General Anesthesia • Hybrid Room • TEE • ICU stay

  15. Goals of Conscious Sedation TAVR • Decrease the # of people in the room • Streamline processes • Maintain superior outcomes • Decrease resource utilization and $ May 2012 Sept 2007

  16. Minimalist TAVR: Criticisms • TEE is critical to the procedure • TTE and Fluoro are a powerful combination • Complication management is surgical • Most complications are managed endovascularly • Cross-over to SAVR is uncommon for TF • Sterile environment of OR vsCath Lab • Patient and operator comfort

  17. Cost Reductions • No perfusion • No perfustionist • No primed pump • No wasted opening of OR instrumentation • Decreased staff costs • No duplication of OR staff and Cath Lab Staff • Cost of Central line, Foley catheter, TEE • Cost of complications related to foley and lines and TEE!!

  18. A Typical TAVR Procedural Flowchart Eligibility confirmed by the Heart Team Access determined *This was the plan of care for ALLpatients, no matter what the access or patient status* All cases done in Hybrid OR General Anesthesia ICU admission post TAVR Transesophageal echo

  19. Who Is a Minimalist Candidate? Eligibility confirmed by the Heart Team • Conscious sedation: • TTE • Hybrid OR vscath lab • ICU vs Floor post TAVR NO • Discuss w/Anesthesia: • General • MAC • TEE • ICU Routine Transfemoral Access? Weight < 100kg? Able to lie flat? Coronary arteries acceptable height? Any barriers to emergent intubation if required? Chronic pain? Mental status appropriate? Appropriate windows for TTE? YES

  20. ICU Utilization • Met with ICU team to evaluate post-op care • Patients typically stable • Post-op course evaluated: • Bleeding events • Vascular injury • Neurological events • Arrhythmias • Need for vasopressors/inotropes Could these patients go to the FLOOR???

  21. Patient Recovery Decision Tree:Telemetry vs ICU • No CVA/TIA • Mental status • Hemodynamically stable • No vasopressors, no inotropes • No vascular complications • No EKG changes • Heart block • Significant ST changes • ? New LBBB

  22. Is There Data to Support Moderate Sedation Procedural Approaches for TAVR?

  23. Emory Minimalist TAVR Experience Babaliaros et al. JACC CardiovascInterv. 2014 Aug;7(8):898-904

  24. Procedure Details

  25. Outcomes * Median (Interquartile range)

  26. Mid-Term Mortality with Minimalist Approach

  27. Cost Saving with Minimalist Approach $55,377±22,587 $45,485 ± 14,397

  28. UCLA: Conscious Sedation vs General Anesthesia in TAVR Patients Retrospective analysis of conscious sedation vs general anesthesia in 196 matched patients • Mortality: 1.5% overall • Trend towards lower mortality with conscious sedation • Conscious sedation= • Fewer ICU hours (30 vs 96) and total hospital days (4.9 vs 10.4; P < 0.001 for both) • Costs 28% lower in the conscious sedation group, with no differences in major adverse events Conclusions: Conscious sedation is a safe and viable option in TAVR. Toppen W, et al. PLoS One. 2017;12:e0173777.

  29. TVT: Conscious Sedation (CS) vs General Anesthesia (GA) All TF TAVRs from April 2014- June 2015 Conscious sedation captured as ITT Primary outcome: In-hospital mortality Secondary outcomes(30d): Mortality Composite (Mortality, CVA, d/c home) Hyman MC, et al. Circulation. 2017;136:2132-2140

  30. TAVR Outcomes by Anesthesia Type:(CS vsGA)

  31. German TAVR Registry (GARY)Conscious Sedation vs. GA High volume centers >273 cases/yr • 16543 pts analyzed from 2011-2014 • 49% used sedation • Propensity matching to correct for bias • Procedural complications less with conscious sedation Husser et al. J Am Coll CardiolIntv 2018;11:567–78

  32. GARY: 30d Mortality Benefit w/Conscious Sedation TAVR Husser et al. J Am Coll CardiolIntv 2018;11:567–78

  33. #MinimalisTAVR Can We Discharge Patients Next Day?

  34. 3M TAVR Study Design To evaluate the efficacy, feasibility, and safety of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway Patients undergoing elective Transfemoral TAVR Considered at increased surgical riskby the Heart Team Vancouver 3M Clinical Pathway (n = 411) Meet all anatomical, functional, and peri-procedural exclusion criteria Primary Outcomes: 1) All cause mortality or stroke at 30 days 2) The proportion of patients discharged the next day

  35. Vancouver TAVR Clinical Pathway Minimalist Peri-Procedure Approach Criteria-Driven Discharge Facilitated Post-Procedure Recovery PATIENT JOURNEY • Procedure Room • Cath Lab or Hybrid OR • Access and Closure • Percutaneous • Equipment • Peripheral IV • Radial artery monitoring • No urinary catheter • No PA catheter • Temporary Pacemaker • removed in procedure room • Anesthesia • Local anesthesia with no or minimal procedural sedation • Echocardiogram • TTE peri or post procedure Monitoring Vital Signs: Q15 x4, Q30 x2 ECG, eGFR, CBC on admission and POD1 Removal of all remaining lines < 2 hours Facilitated Recovery Bedrest x 4 hours Nurse-led mobilization Hydration, nutrition, elimination Communication Multidisciplinary communication to maintain pathway Patient and family education Implementation of pre-procedure discharge plan Monitoring Review of TTE Absence of: new persistent conduction delay vascular access complications laboratory contraindications Facilitated Recovery Return to baseline mobilization Absence of elimination issues Return to baseline hydration Communication Multidisciplinary agreement of safety for discharge Review discharge plan with family Review follow-up appointments

  36. 3M TAVR Study Inclusion and Exclusion Criteria

  37. 3M TAVR: Baseline Characteristics

  38. 3M TAVR: Primary Endpoint p = 0.05 85.0% 80.1% 80.1% 71.3% p = 0.51 Hospital Volume Hospital Volume

  39. 3M TAVR: Summary • Median age 84 years with STS score of 4.9% • 30 Day composite of Death or Stroke 2.9% • Median Hospital Length of Stay of 1 Day • Next Day Discharge in 80.1% • Discharge within 48 hrs. in 89.5% • 30 Day Readmission Rate 9.2% • Cardiac Readmission Rate 5.7% • 30 Day New Permanent Pacemaker Rate 5.7% • SAPIEN XT 4.6% and SAPIEN 3 7.1%

  40. 3M TAVR Outcomes in Perspective

  41. Is Moderate Sedation TAVR the Only Way? • TAVR procedural protocols are entirely site-specific • Operators/staff/admin must be invested in process improvement • Individual centers will have unique opportunities for cost reduction and to streamline • Above all: The patient‘s needs come first!

  42. 3M or Minimalist Philosophy Does Not Stop on the Table • 3M provided strict guidelines of post-op care to mobilize and fast track patients for early discharge • Preferable Next-Day • Key risk factors to consider for maintaining inpatient status: • Frailty • Baseline high risk/inoperable status • Unstable ECG conduction changes/bradycardia • Lack of patient social support

  43. Vancouver TAVR Clinical Pathway Minimalist Peri-Procedure Approach Criteria-Driven Discharge Facilitated Post-Procedure Recovery PATIENT JOURNEY • Procedure Room • Cath Lab or Hybrid OR • Access and Closure • Percutaneous • Equipment • Peripheral IV • Radial artery monitoring • No urinary catheter • No PA catheter • Temporary Pacemaker • removed in procedure room • Anesthesia • Local anesthesia with no or minimal procedural sedation • Echocardiogram • TTE peri or post procedure Monitoring Vital Signs: Q15 x4, Q30 x2 ECG, eGFR, CBC on admission and POD1 Removal of all remaining lines < 2 hours Facilitated Recovery Bedrest x 4 hours Nurse-led mobilization Hydration, nutrition, elimination Communication Multidisciplinary communication to maintain pathway Patient and family education Implementation of pre-procedure discharge plan Monitoring Review of TTE Absence of: new persistent conduction delay vascular access complications laboratory contraindications Facilitated Recovery Return to baseline mobilization Absence of elimination issues Return to baseline hydration Communication Multidisciplinary agreement of safety for discharge Review discharge plan with family Review follow-up appointments

  44. TAVR Next Day Discharge: PARTNER 2 Analysis • P2 S3 int-risk study, successful TF SAPIEN 3 TAVRs reviewed. • Major procedural complications rendering early discharge unlikely were excluded (n=307). • Propensity score matching with 24 variables was performed in a 1:4 ratio (EARLY vsSTANDARD discharge). Devireddy C, et al. ACC.18 Scientific Sessions, JACC 71 (11)S, March 2018

  45. PARTNER S3i Study:Next Day Discharge 30d Outcomes • After TF TAVR, next day discharge was safe • 51% pts received Gen Anesthesia! • Slight trend seen in PPM after early discharge to 30 days BUT: • No sig differences in rehosp at 30 daysor one year.   Devireddy C, et al. ACC.18 Scientific Sessions, JACC 71 (11)S, March 2018

  46. Conclusion • Moderate sedation TAVR techniques can be implemented by experienced centers with no apparent sacrifice in quality • Cost constraints may further force adoption of methods to streamline turnaround of pts evaluated for severe aortic stenosis • Data suggest decreased complications & mortality • Further work needed to identify which pts benefit most and whom to discharge early

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