What Do Low Risk Aortic Stenosis Patients Want? Paul D. Mahoney, MD, FACC Director Sentara Structural Heart and Complex Interventional Programs
Disclosures Consultant and Physician Proctor Medtronic Edwards Lifesciences Boston Scientific Research Support Medtronic (SURTAVI Trial) Edwards (PARTNER, Early TAVR)
Greetings from Norfolk, Virginia
What Do Low Risk TAVR Patients Really Want? Patients being considered for TAVR vs SAVR have changed dramatically… 75 year olds can be very active They want to Move Like Jagger…
New Concept in TAVR: Patient Centered Discussion • Patient input not part of medical decision making in original TAVR NCD • Patient specific, not procedure specific, case planning • What Patients want (and physicians need to provide): Informed consent on individual risks and benefits, and involvement in medical decision making
What do low risk AS patients want? • Primary Focus: Fix the Problem Fix the valve effectively Lowest risk of death/complication Least disruption of normal life • Critical Secondary Discussions Durability Functional Status Freedom from device associated complications • Pacemakers • Cor access • Valve in Valve suitability
What do low risk patients want: “Fix the Problem” -- TAVR vs SAVR Partner 3 Evolut Low Risk Endpoint: Death, Stroke, Rehospitalization
“TAVR Suitability in Low Risk”: We need to change the conversation … . • Concept of “Surgical Risk” is outdated This construct of only looking at surgical risk no longer serves our patient population Instead of considering surgical risk; Consider TAVR suitability • When is SAVR more suitable than TAVR? • What patient specific factors lead to favoring surgery or catheter based valve replacement in low risk patients? optimal treatment strategies individualized to patients
Lets Look at two “low Surgical Risk” AS Patients • • Patient A --- STS 2.0% Patient B --- STS 2.0% • 59 years old • 84 years old • Diabetic (insulin), Creat of 2.0 • No prior surgery, otherwise healthy • Bicuspid, calcified raphe • • Primary caretaker for husband with Low Coronary Heights • dementia Ascending aortic aneurysm we should seek optimal, individual approaches for any risk patient when considering SAVR vs TAVR!
TAVR for Any Risk Patients Who Does Well with TAVR? Calcific trileaflet aortic stenosis avoid some bicuspid aortic valves Acceptable aortic valvar complex annulus size well matched to valve size availability, avoid surgical Patient Prosthesis Mismatch, calcium patterns, ascending aortic pathology Percutaneous femoral access – strongly preferred - subclavian equivalent? Absence of unfavorable anatomies – “surgical” CAD, multi -valve disease -Kodali, TCT 2017
Targeting SAVR in lower risk patients: What makes TAVR less favorable? • Hostile aortic root complex low cor height, narrow sinuses, root enlargement, Calcium pattern, large annulus • Lack of TF Access • Concomitant surgical CAD • Patient age / Durability ???
Low Coronary Height – Risk of Coronary Occlusion Surgery favored in situations where increased risk of catastrophic complications in a lower risk patient
Hostile calcification patterns Higher risk of annular rupture with severe LVOT calcification Should be considered in SAVR vs TAVR Acc.org Annular rupture
SAVR for large annuli or unfavorable Calcification: More than Mild PVL carries survival disadvantage Annular area 817 mm2 N Engl J Med 2016; 374:1609-1620 Perimeter 102 mm Anatomy with higher risk for PVL should favor surgical approach in low risk patients
Should patient AGE and valve DURABILITY be significant considerations in low risk patients? • Need more data on THV durability out to 10- 12 years Average age of surgical valve undergoing valve in valve: 8 - 9 years
Partner 5 year data – no reintervention Mack M et al. Lancet 2015;6736(15)60308-7
What Do Low Risk Patients Want: Optimal Hemodynamics • Avoid PPM with SAVR… or TAVR Severe PPM Increased Mortality: Severe PPM vs no/Mod STS Data TVT Data Fallon et al Herrmann et al
What do low risk patients want? Freedom from TAVR Associated Long Term Issues • RV Pacing not entirely benign Mortality signal after 5 years RV pacing • Access to coronaries post implant • Suitability for TAV in TAV Cor occlusion, Sinus sequestration • Novel Techniques developing in parallel
What Does the Low Risk AS Patient Want: TAVR vs TAVR • What is the IDEAL TAVR prosthesis? Lowest Procedural Risk (anatomy) Most Durable Best HDs Lowest pacer rate Least interference with cor access Most suitable for TAV in TAV in future
2 Thank you! 0 @PaulMahoneyMD
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