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Repositionable Percutaneous Replacement of a Stenotic Aortic Valve through Implantation of the Lotus Valve System Discharge/7-Day Outcomes in the REPRISE.

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Presentation on theme: "Repositionable Percutaneous Replacement of a Stenotic Aortic Valve through Implantation of the Lotus Valve System Discharge/7-Day Outcomes in the REPRISE."— Presentation transcript:

1 Repositionable Percutaneous Replacement of a Stenotic Aortic Valve through Implantation of the Lotus Valve System Discharge/7-Day Outcomes in the REPRISE I Study Ian T. Meredith, MBBS, PhD On behalf of the REPRISE I Investigators Monash HEART, Southern Health & Monash University Melbourne, Australia

2 Disclosures for Ian Meredith, MBBS, PhD
Scientific advisory boards and honoraria: Boston Scientific, Medtronic, and Abbott Vascular The REPRISE I study is sponsored and funded by Boston Scientific Corporation

3 Background Transcatheter aortic valve replacement (TAVR) provides an alternative treatment for patients with severe symptomatic aortic stenosis Lower mortality at 1 year vs. medical therapya Similar 1-year survival rate vs. surgeryb Limitations with early TAVR devices Stroke, bleeding & vascular complicationsa,b Aortic regurgitation Challenges with device positioning a: Leon, et al. N Engl J Med 2010;363:1597 b: Smith, et al. N Engl J Med 2011;364:2187

4 Lotus Valve System Designed to address issues with earlier systems
Valve pre-attached to delivery system Valve functions early in deployment for controlled, precise positioning Fully retrievable and repositionable Adaptive seal designed to minimize paravalvular leak Lotus Introducer: Suitable for ≥6.0 mm femoral diameter 23 mm valve size in REPRISE I

5 Study Design REPRISE I OBJECTIVE: Assess the acute safety & performance of the Lotus Valve System (23 mm) for TAVR in symptomatic patients with calcified stenotic aortic valves who are considered high risk for surgical valve replacement DESIGN: Prospective, single-arm feasibility study PRIMARY ENDPOINT: Clinical procedural success through discharge or 7 days post-procedure, whichever comes first Defined as device success (VARC definition) without in-hospital MACCE MACCE: All-cause mortality, peri-procedural MI ≤72 hours after index procedure, major stroke, urgent or emergent conversion to surgery or repeat procedure. VARC Device Success: Leon, et al. J Am Coll Cardiol 2011, 57:253.

6 Secondary Endpoints REPRISE I
Successful repositioning of the Lotus Valve System, if attempted Successful retrieval of the Lotus Valve System, if attempted Incidence of prosthetic aortic valve regurgitation as determined by discharge TTE Central Paravalvular NOTE: ”Discharge” is defined as discharge or 7 days post-procedure, whichever comes first TTE=transthoracic echocardiography

7 Additional Measurements - 1 Discharge/7 days; 1, 3 & 6 months; 1-5 years
VARC safety composite (composite reported at 30 days) All cause mortality Major stroke Life-threatening (or disabling) bleeding Acute kidney injury Peri-procedural MI (≤72 hours) Major vascular complications Urgent/emergent conversion to surgery for valve-related dysfunction VARC efficacy composite (composite reported at 1 year) All cause mortality (>30 days) Repeat hospitalization (valve-related) Prosthetic heart valve dysfunction MI=myocardial infarction, VARC=Valve Academic Research Consortium (Leon, et al. J Am Coll Cardiol 2011, 57:253)

8 Additional Measurements - 2 Discharge/7 days; 1, 3 & 6 months; 1-5 years
Other clinical endpoints Individual components of VARC composite endpoints Valve thrombosis Endocarditis Major bleeding events MI >72 hours Minor stroke Transthoracic echocardiography Effective orifice area Mean & peak aortic gradients Peak aortic velocity Aortic regurgitation grade Cardiac function Health & functional status SF-12 & EQ-5D Quality of Life questionnaire (baseline, 6 mon & 1 year) NYHA functional class

9 REPRISE I Key Inclusion Criteria
Age ≥70 years Documented calcified native aortic stenosis AVA <1.0 cm² (or AVA index <0.6 cm²/m²) plus either MPG >40 mmHg or jet velocity >4 m/s (by echocardiography) High risk for surgical AVR STS score ≥8% or euroSCORE ≥20% or documented heart team agreement of high risk due to frailty or comorbidities Symptomatic aortic valve stenosis with NYHA Class ≥II Aortic annulus size mm 23 mm valve size used in study AVA=aortic valve area; MPG=mean pressure gradient; NYHA=New York Heart Association; STS=Society of Thoracic Surgeons

10 REPRISE I Key Exclusion Criteria
Anatomic Unicuspid or bicuspid aortic valve >2+ mitral or >2+ aortic regurgitation; prosthetic valve (any location) or ring Left ventricular ejection fraction <30% Femoral artery lumen <6.0 mm or iliac-femoral tortuosity/calcification precluding safe sheath insertion Clinical Acute myocardial infarction within 30 days CVA or TIA within 6 months or any permanent neurologic defect Dialysis dependent or Cr >3.0 mg/dL Cardiogenic shock or hemodynamic instability (e.g., requiring inotropic support) Any therapeutic invasive cardiac procedure within 30 days Gastrointestinal bleed within 3 months Life expectancy <12 months due to non-cardiac, co-morbid conditions

11 REPRISE I Study Organization
Clinical Events Committee Sergio Waxman, MD (Interventional Cardiologist, Chair) Carey Kimmelstiel, MD (Interventional Cardiologist) Gregory Smaroff, MD (Cardiothoracic Surgeon) Roberto Rodriguez, MD (Cardiothoracic Surgeon) Viken Babikian, MD (Neurologist) Echocardiography Core Lab Victor Davila-Román, MD CVR Consulting, St. Louis, MO, USA Electrocardiography Core Lab Peter J. Zimetbaum, MD Harvard Clinical Research Institute, Boston, MA, USA

12 REPRISE I Investigators
Prof. Ian Meredith (Study PI) Monash Medical Center, Melbourne 5 Patients Prof. Robert Whitbourn St. Vincent’s Hospital, Melbourne 2 Patients Prof. Stephen Worthley Royal Adelaide Hospital, Adelaide, South Australia 4 Patients

13 Study Flow Intent-To-Treat Population
Intent-To-Treat (N=11) No Lotus Valve Implanted (N=0) Lotus Valve Implanted (N=11) No Discharge/7 Days Clinical f/u (N=0) Death before Discharge/7 Days (N=0) Discharge/7 Days Clinical f/u or Death 100% (11/11) Discharge defined as “discharge of hospitalization or 7 days post-procedure (whichever comes first)”

14 Baseline Patient Characteristics
REPRISE I (N=11) Characteristic Patients Age (Years) 83.0±3.6 Gender (Female) 11/11 STS Score (%) 4.9±2.5 Logistic euroSCORE (%) 9.5±4.4 NYHA Class III or IV 5/11 Diabetes, medically treated 2/11 Hypertension, medically treated 10/11 History of coronary artery disease History of PCI or CABG History of cerebrovascular accident Atrial fibrillation Values are mean±SD or n/N CABG=coronary artery bypass graft; PCI=percutaneous coronary intervention; STS=Society of Thoracic Surgeons

15 Echocardiographic Measurements REPRISE I – Baseline (N=11) (Core Lab)
Parameter Patients Aortic valve area (cm2) 0.7±0.2 Mean aortic valve gradient (mm Hg) 53.9±20.9 Peak aortic gradient (mm Hg) 90.5±30.6 Left ventricular end systolic volume (mL) 24.9±6.6 Left ventricular end diastolic volume (mL) 66.9±11.6 Left ventricular ejection fraction (%) 62.3±7.6 Mitral regurgitation (moderate/severe) 3/11 Aortic regurgitation (moderate/severe) 4/11 Values are mean±SD or n/N

16 Frailty/Disability Threshold
Frailty, Disability, and Comorbidity REPRISE I – Baseline (N=11) Characteristic Patients Frailty/Disability Threshold Body Mass Index (kg/m2) 27.6±6.0 <19 Serum Albumin (g/dL) 3.9±0.4 <3.3 5 Meter Gait Speed (sec) 8.2±4.9 >6 Falls in the Past 6 Months 1/11 >1 Max Grip Strength Average (kg) 15.3±5.7 ≤18a Katz Index 5.9±0.3 <6 Physical Activity Scale for Elderly (0-400) 85.5±44.7 ≤93.4b; ≤31.5c Charlson Comorbidity Index Score 1.8±1.7 >3 Mini-Cognitive Assessment for Dementia 3.3±1.5 <4 a: Cutoff for women with BMI < b: Pre-frailty c: Frailty Values are mean±SD or n/N (%)

17 Procedural Characteristics REPRISE I (N=11)
Measure Outcome Total procedure time (min) 110.4±34.7 Total fluoroscopy time (min) 36.9±8.8 Total contrast used (cc) 200±74.3 Lotus Valve implanted 11/11 Symptomatic coronary obstruction 0/11 Successful valve repositioning, if attempteda 4/4 Successful valve retrieval, if attempteda N/A a: Secondary endpoint Values are mean±SD or n/N

18 Primary Endpoint – Discharge/7 Days REPRISE I (N=11)
Measure Patients Clinical Procedural Success (per patient) 9/11 Device Success 10/11 Successful access, delivery, deployment, valve positioning, delivery system retrieval 11/11 Intended valve performancea One valve implanted No MACCE through discharge or 7 daysb a: AVA >1.0 cm2 plus either a mean aortic valve gradient <20 mmHg or peak velocity <3m/sec, without moderate/ severe prosthetic valve aortic regurgitation b: Major adverse cardiovascular or cerebrovascular events including all-cause mortality, peri-procedural MI ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction Values are n/N

19 Primary Endpoint Patient Details REPRISE I
Patient A: Major Ischemic Stroke Symptoms: Expressive aphasia and dysphagia post-procedure. CT: New parieto-temporal ischemic stroke in left MCA branch MRS=3 at discharge Preliminary adjudication is major stroke; final adjudication per VARC will occur at 90 days Patient B: Gradient/Velocity Criterion Not Met Echo Core Lab: Mean gradient=22 mmHg Peak velocity=328 cm/s Valve appeared to be functioning well (AVA=1.6, LVOT/AO TVI ratio=0.51) Gradient likely increased due to a hyperdynamic state as evidenced by HR=90, increased LVOT flow (LVOT TVI: 28.5cm), relatively high LVEF (67%) and high calculated cardiac output (8 L/m)

20 Primary Endpoint: Patient B REPRISE I
Mean gradient=22 mmHg Peak velocity=328 cm/s Core lab noted that the valve appeared to be functioning well (AVA=1.6, LVOT/AO TVI ratio=0.51)

21 Aortic Regurgitation Discharge Transthoracic Echocardiography
Severe Moderate % of Patients Mild Trivial None n=8 n=10 Paravalvular Central No Moderate / Severe AR by Independent Adjudication

22 TTE Data at Baseline & Discharge/7 Days REPRISE I
Measurement Baseline (N=11) Discharge (N=11) Peak aortic velocity (cm/sec) 471.0±85.0 257.8±31.2 Peak aortic gradient (mm Hg) 90.5±30.6 27.0±6.8 Mean aortic gradient (mm Hg) 53.9±20.9 13.7±3.7 Aortic valve area (cm2) 0.7±0.2 1.5±0.2 LVEF (%) 62.3±7.6 64.1±6.6 LV end systolic volume (mL) 24.9±6.6 24.5±6.2 LV end diastolic volume (mL) 66.9±11.6 67.5±7.7 Mitral regurgitation (mod/severe) 3/11 “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first Values are mean±SD or n/N LVEF= left ventricular ejection fraction; TTE=transthoracic echocardiography

23 Mean Aortic Gradient by Patient REPRISE I (N=11)
Mean Gradient (mm Hg) Mean: 53.920.9 Patient B Normal <20 (VARC) Mean: 13.73.7 Pre-Procedure Discharge VARC=Valve Academic Research Consortium; J Am Coll Cardiol 2011, 57:253

24 Aortic Valve Area by Patient REPRISE I (N=11)
Patient B Mean: 1.50.2 Normal >1.2 (VARC) Aortic Valve Area (cm 2) Mean: 0.70.2 Pre-Procedure Discharge “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first VARC=Valve Academic Research Consortium; J Am Coll Cardiol 2011, 57:253

25 MACCE REPRISE I – Discharge/7 Days (N=11)
Characteristic Patients In-hospital MACCE 1/11 All cause mortality 0/11 Peri-procedural MI (≤72 hours) Major strokea Urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction a: Preliminary adjudication is major stroke; final adjudication per VARC will occur at 90 days “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first MACCE=major adverse cardiovascular and cerebrovascular events; MI=myocardial infarction

26 Additional Clinical Outcomes - 1 REPRISE I – Discharge/7 Days (N=11)
Characteristic Patients Minor Stroke 0/11 Transient ischemic attack Myocardial infarction Acute kidney injurya 1/11 Stage 1 Stage 2 or 3 a: Change in serum creatinine (≤72 h) compared to baseline • Stage 1: Increase in serum creatinine to % of baseline or increase of ≥ 0.3 mg/dl (≥ 26.4 μmol/L) • Stage 2: Increase in serum creatinine to % of baseline or increase between >0.3 mg/dl (>26.4 μmol/L) & <4.0 mg/dl (<354 μmol/L) • Stage 3: Increase in serum creatinine to ≥ 300% of baseline or serum creatinine of ≥ 4.0 mg/dl (≥ 354 μmol/L) with an acute increase ≥0.5 mg/dl (44 μmol/L) “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first

27 Additional Clinical Outcomes - 2 REPRISE I – Discharge/7 Days (N=11)
Characteristic Patients Vascular complications 2/11 Major 1/11 Minor Patient A: Major Vascular Complication Left femoral dissection treated with balloon angioplasty; patient also experienced a major stroke “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first

28 Additional Clinical Outcomes - 3 REPRISE I – Discharge/7 Days (N=11)
Characteristic Patients Bleeding 3/11 Life threatening/disabling 0/11 Major (not related to TAVR access) 2/11 Minor 1/11 Patient C: Major Bleed Patient developed hematoma at the site of a left brachial arterial line. Baseline Hb 6 days prior to procedure was 12.4 g/dL and nadir was 8.3 g/dL 6 days after procedure. Patient received one unit PRBCs. Patient D: Major Bleed Patient developed hematoma at the site of the right internal jugular vein sheath. Baseline Hb 1 day prior to procedure was 14.6 g/dL and nadir was 9.7 g/dL 2 days after procedure. No transfusion given. “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first TAVR=transcatheter aortic valve replacement

29 Additional Clinical Outcomes - 4 REPRISE I – Discharge/7 Days (N=11)
Characteristic Patients Conduction disturbance requiring new pacemaker 4/11 Pt Baseline Pacemaker Implant Day Indication Rhythm PR QRS IV Conduction E Sinus 180 84 Normal 5 CHB F 221 76 4 G AF 150 RBBB AF and bradycardia H 151 113 LAFB LBBB and bradycardia “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first

30 REPRISE I Summary Outcomes through Discharge/7 Days (N=11)
Clinical procedural success achieved in 9/11 patients 1 in-hospital MACCE event (major stroke – preliminary adjudicationa) 1 device failure based on 1 of 4 VARC criteria Paravalvular regurgitation (core lab adjudication at discharge): Mild (n = 2) Trivial (n = 1) None (n = 8) Mean aortic gradient improved from 53.9±20.9 mmHg (baseline) to 13.7±3.7 mm Hg (discharge) There were no deaths a: Final adjudication per protocol will occur at 90 days “Discharge” is defined as discharge or 7 days post-procedure, whichever comes first MACCE=major adverse cardiovascular & cerebrovascular events; VARC=Valve Academic Research Consortium

31 REPRISE I Conclusions Results support proof of concept with the Lotus Valve Aortic Replacement System Valve can be positioned precisely & successfully with virtually no aortic regurgitation after placement Low rate of clinical events through discharge Safety & efficacy data support further study in a larger, more rigorous trial REPRISE II Study (N=120) to begin 4Q12

32 Thank You!

33 Peak Aortic Gradient by Patient REPRISE I (N=11)
Mean: 90.530.6 Peak Gradient (mm Hg) Patient B Mean: 27.06.8 Pre-Procedure Discharge

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