A North American, prospective, multicenter assessment of the Mitroflow aortic pericardial prosthesis.

BACKGROUND: The aim of the Mitroflow aortic pericardial valve study was to prospectively assess performance of the Mitroflow prosthesis among North American patients. METHODS: The study was conducted between November 2003 and December 2007 on patients requiring aortic valve replacement. The study cohort consisted of 689 patients (391 male, 298 female), with a mean age of 74.3 +/- 8.4 years, and 46.6% of whom were New York Heart Association (NYHA) class I/II preoperatively. Patients were followed at 3 to 6 months and yearly until study closure. Mean follow-up was 25.7 +/- 12 months, and total follow-up was 1,474.4 patient-years, with a maximum of 48.7 months. RESULTS: Postoperatively, more than 97% of evaluated patients were NYHA class I/II. At 3 years, 131 patients had died, for an actuarial survival of 79.1%; and the 3-year actuarial freedom from valve-related death, valve explant, all valve reoperation, and structural valve dysfunction was 97.0%, 98.1%, 97.9%, and 99.2%, respectively. Other valve-related complications included prosthetic valve endocarditis (1.4% per patient-year), thromboembolic episodes (1.3% per patient-year), major embolism (0.5% per patient-year), perivalvular leak (0.6% per patient-year), and major anticoagulation-related bleeding (0.6% per patient-year). Echocardiograms at 1 year showed mean pressure gradients averaged from 7.3 +/- 1.8 mm Hg to 13.4 +/- 5.1 mm Hg, and peak gradients averaged from 14.3 +/- 4.7 mm Hg to 26.0 +/- 9.2 mm Hg for valve sizes 27 to 19. Aortic regurgitation in patients was absent/trace (90.2%) or mild (8.7%); none was severe. CONCLUSIONS: The early results of this study show a low incidence of valve-related adverse events and excellent hemodynamic performance. Continued follow-up is needed to determine if long-term durability in North American patients is comparable to that in previous reports on the durability of the Mitroflow valve

Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement

Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices

Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissueCentral MessagePerspective

Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE. Methods: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory. Results: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild. Conclusions: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.

OBJECTIVE: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. METHODS: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. RESULTS: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm CONCLUSIONS: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses

The COMMENCE trial : 2-year outcomes with an aortic bioprosthesis with RESILIA tissue

OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory. RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively. CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™). CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01757665

Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with RESILIA tissue

BACKGROUND: The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences). METHODS: Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported. RESULTS: Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (\u3c30 \u3edays) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm CONCLUSIONS: The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.

BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device

BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880