Slide 1: Lessons learned from 800+ patients treated with tricuspid TEER
Lessons learned from 800+ patients treated with tricuspid TEER The TRILUMINATE Pivotal trial Jonathan G. Schwartz, MD Brian Whisenant, Matthew Price, Samir Kapadia, Peter Tadros, Wayne Batchelor, Saibal Kar, Gagan Singh, Ramon Quesada, Hursh Naik, Conrad Anson Smith, Gilbert Tang, Raj Makkar, Pinak
Slide 2: Disclosure of Relevant Financial Relationships
Disclosure of Relevant Financial Relationships Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: Nature of Financial Relationship Ineligible Company Grant/Research Supp
Slide 3: Background
Background • The TRILUMINATE Pivotal trial is a randomized, controlled trial of the treatment of symptomatic patients with severe TR with the TriClip device and includes a concurrent single-arm cohort. Primary endpoint at 1 year was met, driven by improvements in quality of life. At 2 years, a 2
Slide 4: Study Design
Study Design TRILUMINATE Pivotal After completion of randomized and Randomized arm single-arm cohorts N=572 Control N=287 Device Single-arm Continued Access Study N=285 N=200 N=412* (281 with attempted implant) (188 with attempted implant) (378 with attempted implant) N=281 N=188 N=378 Patients with
Slide 5: Baseline Characteristics
Baseline Characteristics Attempted Implant Attempted Implant Baseline Characteristic Baseline Characteristic N=847 N=847 Age (years) 79 ± 8 TR etiology Sex (female) 59% Functional 90% Atrial fibrillation 85% Degenerative 3% Mixed 4% Hypertension 85% CIED lead-related 3% HFH in previous 1 year 26% Co
Slide 6: Procedural Outcomes
Procedural Outcomes # TriClip procedures 0 10 20 30 40 50 50+ Attempted Implant Procedural Characteristic 12 sites N=847 >20 cases Implant success 98.7% Number of clips implanted 2.0 ± 0.7 TriClip generation 19 sites TriClip 18% 10-20 cases TriClip G4 82% Procedure time (minutes) 146 ± 73 Device tim
Slide 7: TriClip Frequently Placed Along A-S & P-S
TriClip Frequently Placed Along A-S & P-S Posterior <1% leaflet S-P <1% A-P <1% 8% 1% 15% Septal Anterior leaflet leaflet Commissural Mid Central A-S 40% 29% 6% For U.S. audience, see Important Safety Information referenced within. For audiences outside of the U.S.: always check the regulatory statu
Slide 8: Most Common Clipping Strategies
Most Common Clipping Strategies Zipper Multi-Plane Single Clip Mixed 30% (252/847) 24% (203/847) 19% (163/847) 11% (94/847) Multiple Clips along a single coaptation line, Single Clips along different Single Clip along any moving from a Zipper + Multi-Plane coaptation lines coaptation line commissura
Slide 9: TR and KCCQ after T-TEER
TR and KCCQ after T-TEER TR Severity KCCQ p<0.0001 Δ17±21 points, p<0.0001 100% 100 4% 13% 80% 46% 80 Patients (%) KCCQ-OS 60% 40% 60 40% 23% 82% 40 73 56 20% 42% 20 29% 2% 0% 0 Baseline 30 Day Baseline 30 Day n=769 n=769 n=814 n=814 Mild/Trace Moderate Severe Massive Torrential 1 grade reduction: 1
Slide 10: Adverse Events through 30 Days
Adverse Events through 30 Days Attempted Implant Attempted Implant Adverse Events through 30 Days Adverse Events through 30 Days N=847 N=847 Major adverse events through 30 days 0.6% All-cause mortality 0.5% Cardiovascular mortality 0.4% New-onset renal failure 0.2% Heart failure hospitalization 3.0
Slide 11: Outcomes in Patients with Transvalvular CIED Leads
Outcomes in Patients with Transvalvular CIED Leads p<0.0001 Patients with 100% 2% Characteristic transvalvular CIED leads 11% N=175 80% 53% Patients (%) Torrential Major adverse events through 30 days 60% 49% 84% Massive Cardiovascular death 0.6% 40% Severe 19% Endocarditis requiring surgery 0% Mode
Slide 12: Outcomes Across Experience
Outcomes Across Experience Cases 1-5 Cases 6-10 Cases ≥10 Outcome through 30 days N=318 N=220 N=450 Procedural Outcomes Procedure time 177 ± 76 165 ± 89 127 ± 56 Device time 106 ± 74 92 ± 60 69 ± 45 Number of clips implanted 2.2 ± 0.8 2.1 ± 0.7 2.0 ± 0.7 ICU admission 15% 10% 6% Safety Outcomes All-
Slide 13: Conclusion
Conclusion In the largest analysis of early T-TEER to date, TriClip was safe and effective, with significant improvements in qualify of life at 30 days. Low rates of mortality, heart failure hospitalizations, bleeding, conduction disturbances and device thrombosis through 30 days Safe and effect
Slide 14: Important Safety Information
For U.S. audience only. Rx Only Important Safety Information TRICLIP G5 SYSTEM Indications The TriClip G5 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or gr
Slide 15: Caution and Abbott contact information
CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference to the Instructions for Use, inside the product carton (when available) or at www.eifu.abbott for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Even
Slide 16: Abbott
Abbott