Sorin Bicarbon: 17 years of clinical use

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Presentation transcript:

Sorin Bicarbon: 17 years of clinical use In press IM-00213/A

Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Study design A single center retrospective evaluation of patients receiving a Sorin Bicarbon Prosthesis (SBP) at our institution from 1994 to 2000 was performed. Patients who had undergone isolated aortic valve replacement (AVR) or isolated mitral valve replacement (MVR) were considered. Study objective The aim of the study was to evaluate the long-term results of aortic valve replacement (AVR) and mitral valve replacement (MVT) with the Sorin Bicarbon prosthesis. Italy

12.7 ± 4.0 pt-yrs (cumulative FU: 6475 pt-yrs) Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Patients characteristics Procedures distribution: N. of patients Tot. 507 M/F (%) Mean age (yrs) AVR 344 69/31 62 ± 10 MVR 163 42/58 62 ± 9 Mean FU 12.7 ± 4.0 pt-yrs (cumulative FU: 6475 pt-yrs) MVR AVR AVR procedures: MVR procedures: Italy

Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Patients characteristics - valvular lesions Patients characteristics – valve size distribution

Actuarial freedom from valve-related complications @17 yrs Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Results 30 days mortality Overall 2.7% (14 total early deaths on a total of 507 patients) AVR 2% (7 patients on a total of 344) MVR 4% (7 patients on a total of 163) Late deaths Overall 169 * AVR 128 MVR 41 * 22 (13%) were considered to be valve-related with a linearized incidence of 0.34% ± 0.07%/pt-yr. Actuarial freedom from valve-related complications @17 yrs AVR MVR - Valve-related complications ** 82% ± 5% 86% ± 5% ** Causes were: embolism in 22 (17 AVR and 5 MVR), valve thrombosis in 6 (all AVR), anticoagulant-related hemorrhages in 13 (10 AVR and 3 MVR), sudden unexpected death in 4 (1 AVR and 3 MVR), endocarditis (1 MVR), and periprosthetic leak (1 AVR).

Results – survival and freedom from valve related death graphs Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Results – survival and freedom from valve related death graphs MVR Freedom from valve-related deaths @ 17 yrs: 92 ± 4% Survival @ 17 yrs: 62 ± 6% (Patients at risk @17 yrs: 20/163) AVR Freedom from valve-related deaths @ 17 yrs: 90 ± 5% Survival @ 17 yrs: 50 ± 3% (Patients at risk @17 yrs: 20/344)

Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Results Actuarial Freedom From adverse events @ 17 yrs AVR MVR Reoperation * 98% ± 1% 100% - Endocarditis 99% ± 1% - Anticoagulation related bleeding 96% ± 1% 95% ± 3% Thromboembolism (including embolic episodes and thrombosis) 86% ± 5% 96% ± 2% * Reoperation was required in 5 patients in AVR group. The causes of reoperation were prosthetic thrombosis in 4 and periprosthetic leak in 1.

Incidence of adverse events (%/pt-yr) @ 17 yrs Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Results – incidence of adverse events Incidence of adverse events (%/pt-yr) @ 17 yrs

“[…] no cases of structural failure were recorded”. Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up - Celiento M, Filaferro L, Milano A, Anastasio G, Ferrari G, Bortolotti U. - J Thorac Cardiovasc Surg 2013 – in press Author’s Conclusions “In the present series, a low incidence of embolic events was observed”. “We have also found that other major postoperative complications, such as endocarditis and periprosthetic, leak are extremely uncommon after AVR and MVR with the SBP”. “[…] no cases of structural failure were recorded”. “[…] our results indicate that the SBP continues to show an excellent overall performance up to 17 years postoperatively”. “[…] low incidence of postoperative adverse events, and a gratifying freedom from major valve-related complications in the long term”. “[…] we conclude that the SBP remains a reliable and valid option whenever a mechanical prosthesis is indicated for both AVR and MVR”.

Sorin Bicarbon vs Competition LEGGERE: In this section you will see a summary of the clinical outcomes for Sorin Group mechanical heart valves versus the competition one.

Sorin Bicarbon vs competition Survival: Manufacturer Study AVR survival Pts at risk Sorin Bicarbon Present study 1 50% 20/344 SJM Toole2 40% 77/537 Emery3 45% n.a. Medtronic ATS Sezai4 59% 3/103 ONX Chambers5 79% 33/211 @17 yrs @15 yrs @15 yrs * @15 yrs ** @10 yrs Survival at 17 years is absolutely in favor of Sorin Bicarbon versus SJM at 15 years, and it’s in line with other competitors. * Small number of patients still at risk. ** Results @ 10 years (the longest ONX trial available).

Sorin Bicarbon vs competition Freedom from valve-related mortality: Manufacturer/Study AVR MVR Sorin Bicarbon - Present study1 90% 92% Toole – SJM2 ~ 40% ~ 42% Emery – SJM3 84.4% 86.6% Medtronic ATS4 98% 93% ONX5 @ 17 yrs @ 15 yrs @ 15 yrs @15 yrs * @10 yrs Sorin Bicarbon freedom from valve related mortality at 17 years is the highest if compared with SJM at 15 years, and it’s in line with other competitors. * Results @ 10 years (the longest ONX trial available).

Sorin Bicarbon vs competition Freedom from reoperation: Manufacturer/Study AVR MVR Sorin Bicarbon - Present trial1 98% 100% Toole – SJM2 ~ 90% Emery – SJM3 94.2% 95.3% Medtronic ATS4 90.5% ONX5 95% @ 17 yrs @ 15 yrs @ 15 yrs @15 yrs @10 yrs Sorin Bicarbon freedom from reop. at 17 years is the highest among all competition (also if compared with the shortest follow up published by ONX at 10 years).

References Sorin Bicarbon 1. “Clinical Evaluation of the Sorin Bicarbon Prosthesis at 17-year Follow-up” - Celiento M. et al. - J Thorac Cardiovasc Surg 2013 – in press St Jude Medical 2. “Twenty - Five Year Experience With the St. Jude Medical Mechanical Valve Prosthesis” - Toole JM et al. – Ann Thorac Surg 2010;89:1402-9 3. “Long - Term Follow Up of Patients Undergoing Reoperative Surgery with Aortic or Mitral Valve Replacement Using a St. Jude Medical prosthesis - Emery RW et al. – J Heart Valve Disease 2010;19:473-484 Medtronic-ATS 4. “Fifteen years of experience with ATS mechanical heart valve prostheses” - Sezai A et al. - J Thorac Cardiovasc Surg 2010;139:1494-500 ON-X 5. “Clinical event rates with the On-X bileaflet mechanical heart valve: A multicenter experience with follow-up to 12 years” - Chambers JB et al. - J Thorac Cardiovasc Surg 2013;145:420-4

Sorin Bicarbon vs SJM Adverse events Incidence of adverse events (%/pt-yr): Present study @ 17 years Toole – SJM @ 20 yrs Emery – SJM @ 20 yrs AVR MVR Bleeding 0.23 0.14 2.90 2.26 ThromboEmbolism 0.39 0.24 1.95 3.50 Endocarditis 0.00 0.05 n.a. Thrombosis 0.12 0.29 Sorin Bicarbon adverse events rates are the lowest in comparison with the longest published one from competition (SJM). Adverse events @ 17 yrs for Bicarbon and @ 20 yrs for SJM to have the closest time-frame possible comparisons.

Sorin Bicarbon vs SJM Adverse events AVR group MVR group

TAKE HOME MESSAGES At 17 years of clinical follow up Sorin Bicarbon MHVs have shown excellent results in terms of clinical improvement and freedom from complications: High freedom from valve-related deaths in both AVR (90%) and MVR (92%) groups. Good actuarial survival (50% in AVR and 62% in MVR groups). High freedom from adverse events (TE, BE and Endocarditis) and freedom from reoperation. Low rate of valve-related complications. No cases of structural valve deterioration.

TAKE HOME MESSAGES When comparing results of the present study with competition, Sorin Bicarbon shows: The highest survival rate versus St Jude Medical and in line with other competitors. The highest freedom from valve-related mortality versus St Jude Medical and in line with other competitors. The highest freedom from reoperation among ALL competitors. Better adverse events rates versus St Jude Medical (Bleeding, ThromboEmbolism and Thrombosis).

Sorin S.p.A. Via Benigno Crespi, 17 20159 Milano – Italy www.sorin.com