Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO stentless aortic valve: results from an international prospective multicentre study

OBJECTIVES: The Freedom SOLO (TM) valve (Sorin Group, Italy) is a stentless aortic bioprosthesis designed for simplified implantation. The present multicentre study is the largest prospective evaluation of this prosthesis. Herein, we report on outcomes at 3-year follow-up. METHODS: From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.9 +/- 6.3 years; 45.1% females) underwent aortic valve replacement with the Freedom SOLO (TM) valve at 33 centres. Concomitant procedures (70.2% coronary artery bypass grafting) were performed in 376 patients. The cumulative follow-up included 1100 patient-years (mean 16.5 +/- 10.8 months; range: 0-40.5 months). RESULTS: Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were valve-related. Operative mortality (30 days) was 1.7%. At 3 years, overall survival was 82.6% [95% confidence interval (CI) 75.5-87.8%] and freedom from valve-related death was 95.5% (95% CI 89.2-98.2%). Linearized late event rates were 0.82%/patient-years for non-structural valve dysfunction, 0.55%/patient-years for structural valve deterioration, 1.55%/patient-years for endocarditis, 3.64%/patient-years for thromboembolism and 3.18%/patient-years for bleeding. In total, there were 22 reinterventions [19 valve explants, 2 refixations, 1 transcatheter aortic valve intervention (TAVI)] for endocarditis (11), non-structural dysfunction (9) and structural valve deterioration (2). Freedom from reintervention was 95.2% (95% CI 91.2-97.4%) at 3 years. There were no instances of valve thrombosis or haemolysis. At 1, 2 and 3 years, 97.0, 95.5 and 91.4% of patients were in NYHA class I or II. Between discharge and 3 years after surgery, mean transvalvular gradients exhibited a non-significant increase (6.5 +/- 4.3 vs 8.7 +/- 6.5 mmHg), whereas effective orifice area index remained stable (0.9 +/- 0.2 vs 0.8 +/- 0.3 cm(2)/m(2)). At 3 years, no patient presented with more than mild aortic regurgitation. Left ventricular mass index decreased significantly between discharge and 1 year after surgery (139.4 +/- 40.9 vs 122.4 +/- 35.3 g/m(2), P < 0.001) and remained unchanged thereafter. Left ventricular size and function did not change over time. CONCLUSIONS: The Freedom SOLO (TM) valve is a unique stentless pericardial bioprosthesis whose design favours haemodynamic performance and thus facilitates left ventricular reverse remodelling. In terms of survival, morbidity and functional status, it is associated with beneficial outcomes up to 3 years after surgery. Ongoing follow-up will assess the valve at the long-term course

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

TCT-77 Transcarotid Versus Subclavian/Axillary Access for Transcatheter Aortic Valve Replacement: Real-World Comparative Outcomes Utilizing the TVT Registry

Background Transfemoral (TF) access is the preferred delivery method for transcatheter aortic valve replacement (TAVR). Despite advances in TAVR technology, alternative access remains necessary in contemporary practice. Transaxillary/subclavian (TAx) has gained favor as a delivery method, although transcarotid (TC) has become the preferred alternative access for selected sites. Comparison of these approaches has been limited. Methods The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies (TVT) Registry was queried for patients undergoing TC and TAx TAVR with the Sapien 3 (Edwards, Irvine, California) THV from June 2015 through February 2019. Baseline characteristics, unadjusted procedural outcomes, 30-day echocardiography outcomes, length of stay data, and unadjusted 30-day outcomes were evaluated. Results Among the patients undergoing TC and TAx TAVR, there were 2,739 cases. Of these, 17.01% were TC and 82.99% were TAx. Important statistically significant baseline characteristics included baseline STS score (TAx 7.3, TC 7.9; p = 0.008), prior CABG (TAx 23.2%, TC 30.7%; p = 0.0006), prior PCI (TAx 39.8%, TC 45.1%; p = 0.04), and peripheral arterial disease (TAx 65.9%, TC 73.9%; p = 0.0007). Important statistically significant differences in outcome included total procedure time (TAx 131.9 min, TC 122.4 min; p \u3c 0.0001), fluoroscopy time (TAx 21.5 min, TC 17.7 min; p \u3c 0.0001), contrast volume (TAx 97.3 ml, TC 82.7 ml; p \u3c 0.0001) and ICU length of stay (TAx 25.0 h, TC 24.3 h; p = 0.01). The 30-day outcomes had very few statistical differences including mean ejection fraction (TAx 55.6%, TC 57.2%; p = 0.02), and 30-day Kansas City Cardiomyopathy Questionnaire overall summary score (TAx 70.7, TC 67.8; p = 0.03). Stroke rates approached significance (TAx 6.4%, TC 4.2%; p = 0.07), and mortality was comparable (TAx 5%, TC 4.5%; p = 0.68). Conclusion Although TAx delivery has become a dominant alternative access for TAVR, TC offers many benefits as an alternative delivery route. Shorter operative and fluoroscopy times, shorter length of stay, lower contrast volume, and avoiding left internal mammary artery injury or occlusion are clear advantages. Concerns of elevated stroke rates in TC access appear to be unfounded based on these preliminary data. When femoral access is precluded, TC should be considered a viable access strategy compared with TAx access

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

Transcarotid vs Subclavian/Axillary Access for Transcatheter Aortic Valve Replacement with SAPIEN 3.

BACKGROUND: Subclavian/Axillary (TAx) Access has become the most frequently used alternative access route for Transcatheter Aortic Valve Replacement (TAVR). Transcarotid (TC) TAVR has grown in popularity recently. Comparative data between these two contemporary access methods is lacking. METHODS: Data were extracted from the STS/ACC TVT Registry™ (June 2015 to October 2019) for patients undergoing TAVR via TC or TAx access with the SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves. Procedural, index hospitalization, and 30-day outcomes were analyzed for TC vs. TAx groups after 1:2 propensity matching of patient baseline characteristics. RESULTS: 3903 cases were included of which 801 TC and 3102 TAx procedures were compared. After 1:2 propensity matching, TC TAVR was associated with similar 30-day mortality (4.3% vs. 5.2%, P=0.34) but significantly lower risk of stroke (4.2% vs. 7.4%, HR 0.56 [95% CI:0.38-0.83] P=0.003) compared to TAx access. Other outcomes that favored TC over TAx included shorter procedure time (117.0 vs 132.4 min; P CONCLUSIONS: TC TAVR is associated with similar mortality and significant reduction in stroke compared to the subclavian/axillary approach. If femoral access is precluded, TC may be a safe, or at times, preferred avenue of transcatheter valve delivery

Transcarotid versus transthoracic access for transcatheter aortic valve replacement: A Propensity Matched Analysis

Objective Transcarotid (TC) access for transcatheter aortic valve replacement (TAVR) is emerging as an alternative to more traditional nonfemoral access options like transapical (TA) or transaortic (TAo); however, comparative data are limited. The purpose of the study was to analyze outcomes following TAVR using TC as compared to transthoracic (TA/TAo) access. Methods The Society of Thoracic Surgeons / American College of Cardiology Transcatheter Valve Therapy Registry™ was queried for patients who underwent TC, TA, or TAo TAVR with the SAPIEN 3 transcatheter heart valve between June 2015 and July 2019. Thirty-day unadjusted outcomes were evaluated and propensity score matching and logistic regression were used to compare TC access with transthoracic access. Results In the propensity matched analysis, 667 TC TAVR procedures were compared to 1334 transthoracic procedures. TC TAVR was associated with lower mortality (4.2% vs 7.7%, p=0.004), less new-onset atrial fibrillation (2.2% vs 12.1%, pConclusions TAVR using TC access is associated with lower 30-day mortality, less atrial fibrillation, shorter ICU and overall LOS, fewer readmissions, greater improvement in KCCQ scores and no significant difference in stroke or major vascular complications compared to transthoracic access

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