Trifecta Valve. Clinical Compendium. Five Year Data

Transcription

1 Trifecta Valve Clinical Compendium Five Year Data

2 Trifecta Valve Compendium INTRODUCTION The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. The valve is fabricated using a polyester-covered titanium stent. The stent, excluding the sewing cuff, is then covered with porcine pericardial tissue. This covering is designed to provide protection from mechanical wear by allowing only tissue-to-tissue contact during valve function. A silicone insert in the polyester sewing cuff is slightly contoured to conform to the shape of the native annulus. The valve leaflets are fabricated from bovine pericardium. The porcine and bovine pericardium are preserved and crosslinked in glutaraldehyde. Glutaraldehyde, formaldehyde and ethanol are used in the valve sterilization process. Additionally, the Trifecta valve is processed with Linx anticalcification treatment, an anticalcification treatment that in animal studies has demonstrated resistance to calcification in four ways.* 1-6 Table 1. Participating Study Centers United States Mayo Clinic Hospital of the University of Pennsylvania Abbott Northwestern Hospital Mission Health & Hospitals Vanderbilt University Medical Center Intermountain Medical Center Rochester, MN Philadelphia, PA Minneapolis, MN Asheville, NC Nashville, TN Salt Lake City, UT STUDY OBJECTIVE The objective of the study is to further evaluate the long-term clinical safety and effectiveness of the Trifecta valve. STUDY DESIGN The clinical study is a multicenter, prospective, nonrandomized FDA-mandated, post-approval study conducted in the United States. Subjects (n=) enrolled in this study received the Trifecta valve during the investigational (IDE) study (7-9) conducted to obtain PMA approval. Six (6) investigational centers in the United States that enrolled subjects during the IDE are participating. Subjects are followed on an annual basis. Each visit consists of a transthoracic echocardiogram (TTE) and assessments for NYHA classification, serious adverse events and general clinical status. * There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

3 SUMMARY OF SUBJECT DEMOGRAPHICS 7 The subject population in this study had the following characteristics: 99 subjects (67%) were male and 1 subjects (%) were female. Mean age was 7. years (±8.9). Age range was 9 years. Prior to implantation,.9% were NYHA functional class I,.8% class II, 7.1% class III, and.% class IV. The most common indication for aortic valve surgery was calcification (71.8%). The second most common indication for surgery was bicuspid (7.%). 7 subjects (61.%) had concomitant procedures. The most common being coronary artery bypass (6.9%). Mean preoperative BSA was. cm (±.). Figure 1. Valve Size Distribution Percentage n = 7 1 n = 11 n = 1 n = 89 7 n = 9 n = 7 Valve Size (mm) The most common size implanted was mm (1.%). FOLLOW-UP DATA AND CLINICAL RESULTS 7 Figure. NYHA over time NYHA I NYHA II NYHA III NYHA IV Percentage Preoperative n = year n= year n = Preoperatively 1.% of subjects were in NYHA Class III or IV. At one year postoperatively, 99.7% were NYHA Class I or II. At five years post-operatively, 98.% were NYHA Class I or II.

4 HEMODYNAMIC DATA The following average hemodynamic parameters were evaluated by valve size: mean gradient, effective orifice area (EOA), effective orifice area indexed (EOAI) by body surface area (see Figures 6). Average mean gradient and aortic regurgitation for all valve sizes over time are shown in Figures and 7, respectively. All echocardiograms were evaluated at an independent core laboratory to minimize interobserver variability and ensure a standard of quality interpretation. Figure. Average Mean Gradient Over Time mmhg 6 1 year n = 9 year n = 61 year n = year n = 17 Average mean gradients were stable over time for all valve sizes. Figure. Average Mean Gradient by Valve Size One year Four year mmhg Valve Size (mm) n = Average mean gradient by valve size was 1.6 mmhg at four years postoperatively.

5 Figure. Average Effective Orifice Area by Valve Size... One year Four year cm Valve Size (mm) n = Large effective orifice areas across all valve sizes reduce the risk of prosthesis-patient mismatch. Figure 6. Average Effective Orifice Area Index by Valve Size cm /m One year Four year Valve Size (mm) n = Average EOAI across all valves sizes at one year =.87 cm /m and at four years =.8 cm /m.

6 AORTIC REGURGITATION The following chart presents the total aortic valve regurgitation over time for all valve sizes. Figure 7. Aortic Regurgitation Over Time None/Trivial Mild Moderate Severe Percentage 6 n = year year year year More than 8% of subjects had no or trivial regurgitation at four years. KAPLAN-MEIER LIFE TABLE ANALYSIS 7 Figures 8 11 present the Kaplan-Meier analyses for structural valve deterioration, nonstructural valve dysfunction, paravalvular leak and stroke. The 9% confidence interval is indicated by the gold and red dashed lines, and the number of subjects at risk for each interval is shown in gray. Cumulative percent freedom from the event at five years is indicated on each graph. Figure 8. Structural Valve Deterioration Figure 9. Nonstructural Dysfunction % 99.% Percentage Free from Event 8 6 % Freedom from event Lower 9% confidence limit Upper 9% confidence limit Percentage Free from Event 8 6 % Freedom from event Lower 9% confidence limit Upper 9% confidence limit R R Years from Implant Years from Implant 6

7 Figure 1. Paravalvular Leak Figure 11. Stroke % 98.8% % Freedom from event % Freedom from event Percentage Free from Event 8 6 Lower 9% confidence limit Upper 9% confidence limit Percentage Free from Event 8 6 Lower 9% confidence limit Upper 9% confidence limit R R Years from Implant Years from Implant SUMMARY OF ADVERSE EVENTS 7 Early and late rates for serious adverse events are presented in Table. Early rates are presented as simple percentages, and rates for late events as percent per patient year %/lt pt-yr. No unanticipated device effects were reported. Table. Early and Late Adverse Event Rates Early Rate ( days) Late Rate ( 1 days) (Lt Pt-yrs = 1.) Events %* Events % / lt pt-yr Embolism Neurologic TIA 7. RIND Stroke.7. Systemic. 1.7 Thrombosis Major Bleed Endocarditis. Structural Deterioration 1.7 Nonstructural Dysfunction. Paravalvular Leak 1.7 Explant Mortality Valve-Related SUMMARY The Trifecta valve post-approval study is a large (-subject population), multicenter, prospective study. Freedom from structural valve deterioration at five years was 99.7% (9% confidence limits ). The average mean gradient by valve size was 1.6 mmhg at four years. Subjects had average EOAIs.8 cm /m at four years. 7 Preoperatively 1.% of subjects were in NYHA Class III or IV. At five years postoperatively 98.% were NYHA Class I or II. More than 8% of subjects had no or trivial regurgitation at four years. The results of the clinical study demonstrate that the St. Jude Medical Trifecta valve is a safe and effective replacement for a malfunctioning native or prosthetic aortic heart valve. The clinical safety and effectiveness of the Trifecta valve was confirmed by establishing adverse event rates, New York Heart Association functional classification and hemodynamic performance. * The early adverse rate (%) is calculated as the number of early events divided by the total number of subjects, times 1. 7

8 1. Frater RWM, Seifter E, Liao K, et al. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. Edited by Gabbay S, and Wheatley D. First Edition, Silent Partners, Inc. 1997;8:1-1.. Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and Calcification of Bioprosthetic Heart Valves. Society for Biomaterials, Sixth World Biomaterials Congress Transaction, ;1.. Vyavahare N, Hirsch D, Lerner E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Circulation. 1997;9(): Vyavahare N, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation. J Biomed Mater Res. 1998;(): Shen M, Kara-Mostefa A, Carpentier A, et al. Effect of ethanol and ether in the prevention of calcification of bioprostheses. Ann Thorac Surg. 1;71( Suppl):S Vyavahare N, Jones PL, Hirsch D, et al. Prevention of glutaraldehyde-fixed bioprosthetic heart valve calcification by alcohol pretreatment: Further mechanistic studies. J Heart Valve Dis. ;9(): St. Jude Medical. Data on File. St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota 117 USA Fax St. Jude Medical International Division One Lillehei Plaza St. Paul, Minnesota 117 USA Fax St. Jude Medical S.C., Inc. U.S. Division 6 Bee Cave Road Bldg. Two, Suite 1 Austin, TX 7876 USA Fax SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-19 Zaventem, Belgium Fax St. Jude Medical Brasil Ltda. Rua Itapeva, 8 º ao 8º andares 1- São Paulo SP Brazil Fax St. Jude Medical (Hong Kong) Ltd. Suite 168, 16/F Exchange Tower Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR Fax St. Jude Medical Japan Co., Ltd. Shiodome City Center 1F 1-- Higashi Shinbashi, Minato-ku Tokyo Japan Fax St. Jude Medical Australia Pty, Ltd. 17 Orion Road Lane Cove, NSW 66 Australia Fax SJMprofessional.com Rx Only Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications: The Trifecta Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve. Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, leak (transvalvular or perivalvular), myocardial infarction, nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other), prosthesis regurgitation, stroke, structural deterioration (calcification, leaflet tear, perforation, or other), thromboembolism and valve thrombosis. It is possible that these complications could lead to reoperation, explantation, permanent disability or death. Long-term low dose aspirin, unless contraindicated, is recommended for all patients with bioprosthetic valves. Long-term anticoagulant therapy, unless contraindicated, is recommended for all patients with bioprosthetic valves who have risk factors for thromboembolism. Please see the Instructions for Use (IFU) for a full description of indications, contraindications, side effects, precautions, warnings and Instructions for Use. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. 1 St. Jude Medical, Inc. All Rights Reserved. ID-8AEN (/1)