Table 7: Current and planned trials Study Primary end point Comparator N Primary completion date Phase Sponsor Valve Clinical trial ID Pilot Trial: Comparison of Flow Patterns Comparison of maximum and minimum velocity, effective orifice area, percentage of turbulent flow, pressure drop between 6 months and 4 years after AVR Regular valve 20 July 2015 Medical University of Vienna Edwards Intuity valve NCT02288871 Perceval S Aortic Heart Valve Study- North America All-cause mortality 12 months NA 300 January 2016 Sorin Group USA PERCEVAL S NCT01810679 Perceval Pivotal Trial Incidence of mortality and morbidity at 3-6 months after implant NA 150 October 2009 2 and 3 Sorin Group USA PERCEVAL S NCT00860730 CAVALIER Incindence of Incidence of mortality and morbidity at 12 months NA 658 October 2014 2 and 3 Sorin Group PERCEVAL S NCT01368666 Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement (RCT) Surgical Trauma up to 3 days post operaively Minimially invasive AVR vs conventional surgery AVR 20 December 2015 2 Karolinska University Hospital Mechanical and bioprosthetic (stented or sutureless) aortic valves NCT02272621 Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE) (RCT) Cardiac function upto 40 days post procedure Minimially invasive AVR vs conventional surgery AVR 40 July 2015 2 Karolinska University Hospital Mechanical and bioprosthetic (stented or sutureless) aortic valves NCT01972555
and surgical risk because the control group comprised patients for whom sutureless AVR was not indicated. Santarpino et al (2013)() Perceval S (n = 37) SSAS Age ≥65y 18.1 81.5 Mini all sutureless AVR First enrolled Perceval S patients were part of the CAVALIER multicentre trial; later patients received Perceval S under routine use Disclosure: Financial relationship with Sorin disclosed by two of the authors (Pfeiffer and Fischlein) Design: retrospective. Propensity matched. TAVI (n = 37) 20.6 84.5 Shrestha et al (2013)() Perceval S (n = 50) Age ≥75y Small aortic roots (<22mm) 20.4 80 Mini 72% Isolated AVR Perceval group may be part of Perceval Pivotal trial and/or CAVALIER Unclear whether control group were ineligible for Perceval S or were treated prior to Perceval S being in use Unclear whether data on control patients were collected prospectively Disclosure: Institute received an unrestricted research grant from Sorin to conduct the study Design: Prospective. Baseline characteristics did not differ significantly between groups other than a marginally higher surgical risk in the Perceval S group (20.4 vs 16.7; p = 0.05) Standard AVR (n = 70) 16.7 77 Mini 4% Isolated AVR Doss et al (2012)() 3f Enable (n = 27) Severe AS 13.7 78 Full sternotomy and concomitant procedures 37% Partial sternotomy for isolated AVRs Unclear how patients were selected for treatment group 3f Enable patients may be part of larger study as reported in Martens et al. 2011() Reports initial experience with the technologies at the study centre No information provided regarding funding and conflicts of interest Design: Prospective, nonrandomised cohorts. Surgical risk significantly higher in the TAVI group TAVI (n = 29) 35.3 85 Transapical TAVI Muneretto et al (2014)() Perceval S (n=53) Severe AS 16 79 18.9% ministernotomy Design: Prospective, nonrandomised cohorts CoreValve TAVI (n=55) 20.4 81 Transfemoral
(2012)() least some patients included in other reports Publication in Abstract form No information provided regarding funding and conflicts of interest AVR = aortic valve replacement; ; EuroSCORE = European System for Cardiac Operative Risk Evaluation score; SSAS = severe, symptomatic aortic stenosis Appendix 3 Summary of clinical findings for sutureless AVR Table 13: Summary of clinical findings from comparative trials of sutureless AVR Author Device (no. patients) Mean TV gradient (mm Hg) Complications All-cause mortality (n; PV leak (severity) Permanent pacemaker implant Stroke MI Renal failure/ dialysis Bleeding complications In-hospital or 30-day 1-year Concistre et al (2013) () Perceval S (n = 97) 9.1* 1%* (moderate) 2 (6%) 2 (2%) NR RI: 3 (3%) NR 2 (2.1%) 3 (3.2%)c 3f Enable (n = 32) 11.2 16% (moderate) 2 (6%) 1 (3%) NR RI: 1 (3%) NR 1 (3.1%) 1 (3.1%)c
D’Onofrio et al (2012)() Perceval S (n = 38) 10.95 0a (moderate AR 2+/3+) 2 (5.3%) 0 0 2 (5.3%) 1 major bleed (2.6%) 0 NR TAVI (n = 38) 10.25 8% (moderate AR 2+/3+) 2 (5.3%) 0 0 1 (2.6%) 1 major bleed; 1 fatal bleed (5.3%) 2 (5.3%) NR D’Onofrio et al (2013)() Perceval S (n = 31) 11.1 19.4% (all at least mild; AR ≥1+/3) 1 (3.2%) 0 0 1 (3.2%) NR 0 NR TAVI (n = 143) 10.7 28.7% (all at least mild; AR ≥1+/3) 7 (4.9%) 4 (2.8%) 5 (3.5%) 7 (4.9%) NR 10 (7%)† NR Standard AVR (n = 112) 16.5 1.8% (all at least mild; AR ≥1+/3) 1 (0.9%) 0 1 (0.9%) 0 NR 1 (0.9%) NR Gilmanov et al (2014)() Sutureless (n = 133) 11 NR 6 (4.5%) 2 (1.5%) 2 (1.5%) 1 (0.8%) 7% requiring reexploration 1 (0.8%) Median 10mo:d 4% Standard AVR (n = 133) 12 NR 3 (2%) 0 0 0 4% requiring reexploration 2 (1.5%) 5% Pollari et al (2014)() Perceval S (n = 82) NR NR 5 (6%) 3 (4%) (including TIA) NR NR 2% requiring reexploration Mean blood tx 1.2U* 2 (2.4%) Median 13mo:d 2.5%
Standard AVR (n = 82) NR NR 7 (8.5%) 6 (7%) (including TIA) NR NR 6% requiring reexploration Mean blood tx 2.5U 3 (3.7%) 3.8% Santarpino et al (2013)() Perceval S (n = 50) 8.4 2% (PV leak 1/4) 3 (6%) NR 0 RI 2 (4%) Mean blood tx 1.1U* 2 (4%) NR Standard AVR (n = 50) 10 4% (PV leak 1/4) 4 (8%) NR 1 (2%) RI 3 (6%) 2.3U 3 (6%) NR Santarpino et al (2013)() Perceval S (n = 37) 13.3 0 (at least mild AR) 4 (10.8%) 2 (5.4%) NR 0 NR 0 Mean 19mo:d 2.7%* TAVI (n = 37) 14.2 13.5% (at least mild AR) 1 (2.7%) 2 (5.4%) NR 2 (5.4%) NR 3 (8.1%) Mean 19mo:d 13.5%* Shrestha et al (2013)() Perceval S (n = 50) 15.9 8% (Minor; grade 1) NR NR NR NR 2 major bleedb (4%) 0 5 (13%) Standard AVR (n = 70) 12.7 2% (Minor: grade 1) NR NR NR NR 2 major bleedb (2.9%) 3 (4.3%) 10 (16%) Doss et al (2012)() 3f Enable (n = 27) 9 0 (Mod/major) 0 0 NR NR NR 3 (11%) NR