Disclosures Leslie Miller MD Second Heart Assist Chief
- Slides: 20
Disclosures Leslie Miller, MD Second Heart Assist • Chief Medical Officer of SHA • Local PI of five unrelated clinical trials • No Speakers Bureau
INITIAL TARGET POPULATION CARDIO-RENAL SYNDROME(CRS) • HF IS THE FASTEST GROWING FORM CV DISEASE • > 900, 000 NEW CASES/YEAR; 6 -7 MILLION PATIENTS IN US • 46% INCREASE IN PREVALENCE BY 2030*; COST to $72 B • 1 MILLION HOSPITALIZATIONS/ YEAR; MOST HOSP DAYS • NUMBER ONE CAUSE OF READMISSION < 30 DAYS • ALL 13 NEW DRUG TRIALS PAST 5 YEARS HAVE FAILED • 10 -15 % WORSEN RENAL FUNCTION- CARDIO-RENAL SYN • NEED A MECHANICAL SOLUTION
LIMITATIONS OF CURRENT COMPETITION • CROSSES THE AORTIC VALVE • PRECISE LOCATION REQUIRED • FREQUENT NEED TO REPOSITION • FLOW IS ONLY MEASURED ACROSS THE PUMP • DON’T MAINTAIN ARTERIAL PULSATILITY • REQUIRED HIGH PUMP SPEED (33, 000 vs 7, 500) • HEMOLYSIS • ACUTE KIDNEY INJURY
PERCUTANEOUS VADS IN DESCENDING AORTA CARDIOBRIDGE PROCYRION SECOND HEART
SECOND HEART ASSIST EVOLUTION OF CATHETER DESIGN • TALENT STENT GRAFT: 1 st Aortic Stent for Percutaneous Aortic Aneurysm Repair Strong Radial Force to Maintain Position
13. 5 Fr Impeller fully Open
Second Heart Assist Device Stent=20 mm STRONG RADIAL Opened to 22 mm FORCE LIMITS REPOSITIONING
OPEN CAGE DESIGN TO MINIMIZE THROMBOSIS
SECOND HEART MOCK LOOP TEST (13. 5 blade) • Optimal pump speed 7, 500 -10, 000 RPMs • Provided 1. 5 -2. 0 liters of true Augmented blood flow** vs Abiomed flow measured through the pump-capped at 4. 5 • 25 -50% Increase in Renal Blood Flow (0. 4 L/Min) Compared to 0. 25 L/min Procyrion • Created > 10 mm. Hg gradient above: below the device* • No clinically significant Steal observed • Reduced Cardiac Work Index • ANIMAL DATA • Significant increase urine output; No significant hemolysis
CARDIOBRIDGE ADHF STUDY N=20 BASELINE 12 HRs 24 hrs* % Change • RAP 20 18 16 - 22% • PAP 39 36 33 -14% • PCWP 25 22 20 - 22% • CI 1. 8 2. 2 2. 4 + 31% • Urine/hr 71 226 148 +150% • Mean Support Time = 18. 5 Hrs Int J Card 2018; 275 (2019) 53– 58
Cardiobridge Improvement in Urine Output Lessons from Efficacy Trial n=20 One patient made 500 ml urine 1 st hour of support
Change in Urine Output During High Risk PCI (n=6) Procyrion VAD Cath CV Interv 2019. 275; 53– 58
ADVANTAGES OF SECOND HEART • EASE OF INSERTION • NO NEED TO REPOSITION • OCCUPIES ENTIRE AORTA • LOWEST PUMP SPEED REQUIRED (7, 500) • LIMITED HEMOLYSIS • IDEAL LOCATION TO ENHANCE URINE OUTPUT • LARGEST INCREASE IN RENAL BLOOD FLOW
SECOND GENERATION of SECOND HEART ASSIST DEVICE WIRELESS POWER Disconnect Stent from Driveshaft DESCENDING AORTA 16
SECOND GENERATION SECOND HEART ASSIST DEVICE
HARMONIC VIBRATIONAL ENERGY TO PREVENT THROMBUS FORMATION
SECOND HEART ASSIST DESCENDING AORTIC VAD • Lowest Pump Speed, and Lowest Risk of Hemolysis • Greatest Increase in Renal Blood Flow/ Renal Function • Improves Hemodynamics • NO Need to Reposition the device • Indications: Cardio-Renal Syndrome • Protect Renal Function-during PCI • Chronic Heart Failure • First-in-Man Trials Paraguay 1 st Qtr; Ohio State 2 nd Qtr
SECOND HEART ADVANTAGES • Parameter Second Heart Impella Procyrion Cardiobridge • Location • RPM Speed Descnd Ao 33, 000 18, 000 0/+ +++/++++ ++ • Ease of Insert. ++++ ++ ++/+++ • Reposition None • Hemolysis 7, 500 Ao Valve Desc Ao Descd Ao 10, 000 0/+ +++ Common ? ? Rare • Renal Blood Flow ++++ ++ +++ • Acute CRS ++++ +++ • PCI ++++ ++ ++ • % Aorta filled 100%* 30% 90%
