Long-term clinical outcomes of the Toronto stentless porcine valve: 15-year results from dual centers.

BACKGROUND AND AIM OF THE STUDY: The purpose of this study is to examine the long-term durability of the Toronto stentless porcine valve (SPV) in the aortic position (St Jude Medical, Minneapolis, MN). METHODS: We assessed the long-term clinical outcomes of 515 patients with aortic valve replacement (AVR) with the Toronto SPV from 1987 to 2001 at two centers, excluding early (<30 days) death. Median follow-up was 11.5 years (maximum 19.0 years). RESULTS: Average age was 64.2 ± 10.8 years, and females were 34% (173/515). The incidence of prosthesis-patient mismatch was low, 10.9%. Overall survival was 90.7 ± 1.3%, 75.4 ± 2.0%, and 56.8 ± 3.2% at 5, 10, and 15 years, respectively after surgery. Over the follow-up duration, 116 patients (23%) underwent repeated AVR: 90 for structural valve deterioration (SVD), 12 for endocarditis, 10 nonstructural valve dysfunction (10 aortic regurgitation due to aorta dilatation), and four for other reasons. The cumulative incidence of repeated AVR with death as a competing risk was 1.4% (95% confidence interval [CI], 0.6-2.7), 11.1% (95% CI, 8.4-14.2), and 34.4% (95% CI, 28.8-40.2) at 5, 10, and 15 years, respectively. Reoperative mortality was 5.2% (6/116). In SVD, the regurgitation type was dominant (82%). CONCLUSIONS: The Toronto SPV is associated with excellent survival and durability during the first decade of follow-up. However, regurgitation type of SVD increases from 10 years after operation with acceptable reoperative mortality. These findings may assist with prosthesis selection and reintervention strategy for failing stentless bioprosthesis.

Successful implantation of self-expanding valve for a failed stentless prosthesis.

Valve-in-valve transcatheter aortic valve implantation is currently used for failed bioprosthesis. The use of a transcatheter prosthesis in a regurgitant noncalcified root implanted Medtronic Freestyle prosthesis is particularly challenging. We present a successful transaxillary valve-in-valve implantation of a self-expandable transcatheter aortic valve prosthesis in a failed Freestyle bioprothesis implanted eleven years earlier. Tips and tricks are discussed.

Early and mid-term outcomes after aortic valve intervention in patients with previous stentless or stented bioprostheses.

BACKGROUND: Limited data are available concerning comparative outcomes of redo aortic valve interventions, including surgery after aortic valve replacement (AVR) with either stented or stentless bioprostheses. We investigated the comparative outcomes of redo aortic valve interventions, including surgery after AVR with either stented or stentless bioprostheses. METHODS: The cohort consisted of 112 patients who underwent aortic valve intervention for infective endocarditis or structural valve deterioration between 2001 and 2020. One hundred patients received a stented valve (stented group) and 12 patients received a stentless valve (stentless group) during the initial surgery. Early and late outcomes were evaluated. RESULTS: The mean [IQR] ages during the current interventions were 66 [54, 77] years in the stented group and 74 [67, 79] years in the stentless group (P = 0.13). In the stented group, aortic valve interventions included redo AVRs with stented valves (n = 54), mechanical valves (n = 26), stentless valves (n = 16), and transcatheter aortic valve implantations (n = 4). In the stentless group, redo AVRs were performed with stented valves (n = 4), mechanical valves (n = 2), stentless valves (n = 1), and transcatheter valve implantations (n = 5). Hospital mortality was observed in 2 (2%) patients in the stented group and 1 (8%) patients in the stentless group (P = 0.29). The 5-year survival was 80.8% [66.8, 88.5] in the stented group and 91.7% [53.9, 98.8] in stentless group. Statistically significant differences in thromboembolisms were observed between the groups. CONCLUSIONS: No significant differences in early and mid-term outcomes (except thromboembolism) after aortic valve interventions were detected between patients with stented and stentless AVRs.

Transcatheter aortic valve-in-surgical aortic valve for a patient with repeated healed endocarditis: a case report.

BACKGROUND: Transcatheter valve replacement is contraindicated in patients with active infective endocarditis. However, few reports suggest that it could be beneficial for high-risk surgical patients with healed infective endocarditis. Here, we report a case of a surgical transcatheter aortic valve in a patient with healed repeated prosthetic valve endocarditis using a stentless valve. CASE PRESENTATION: A 79-year-old female who underwent the Bentall procedure using a stentless valve and coronary artery bypass grafting for annuloaortic ectasia 22 years ago was hospitalized for stage II bioprosthetic valve failure. The patient had a history of prosthetic valve endocarditis three times: the first and second prosthetic valve endocarditis occurred 15 years ago, and the third prosthetic valve endocarditis occurred 3 years ago. The causative organisms were Campylobacter fetus and Enterococcus faecalis. With appropriate antibiotic therapy, the lesion was localized and healed completely without valve destruction; however, the patient developed rapid aortic regurgitation. Based on a review of the patient's history of prosthetic valve endocarditis, the absence of signs of infection, and clinical findings of transesophageal echocardiography and computed tomography, a diagnosis of structural valve deterioration with healed infective endocarditis was made. Subsequently, a transcatheter aortic valve in a surgical aortic valve using a balloon-expandable type was performed, because the patient had a high surgical risk of 12.7%. The patient's postoperative course was uneventful. At the 1-year follow-up, there were no signs of infection or valve abnormalities. CONCLUSIONS: Transcatheter valve replacement can be a treatment option for high-risk surgical patients with healed limited lesions in infective endocarditis.

A case of freestyle valve reoperation 23 years after the first operation.

We present a case of redo stentless valve operation in a 73-year-old man who underwent aortic valve replacement via the subcoronary approach with a freestyle aortic bioprosthesis 23 years ago at our institution. He was referred for surgery because an echocardiogram showed severe aortic regurgitation due to structural valve deterioration, and aortic valve replacement was planned. Severe circumferential calcification and adhesion were noted during the surgery between the freestyle and native roots. Redo-aortic valve replacement was successful despite the technical difficulty. In stentless valve reoperations following aortic valve replacement via the subcoronary method, the planning of valve-in-valve transcatheter aortic valve implantation and sutureless valve implantation may be a practical and safe strategy.

Transesophageal Echocardiogram to Guide Valve-in-Valve Transcatheter Aortic Valve Replacement of a Failed Medtronic-Freestyle Aortic Prosthesis.

Valve-in-valve transcatheter aortic valve replacement (ViV TAVR) is an appealing alternative to surgical intervention on failed aortic prosthesis with comparable safety and efficacy. ViV TAVR has proven to be a technical challenge in stentless bioprosthetic aortic valves like free style aortic valve prosthesis. In this case series of two patients we report the utility of transesophageal echocardiogram guidance to help visualize surgical annulus and TAVR deployment.

Propensity matched long-term analysis of mechanical versus stentless aortic valve replacement in the younger patient.

OBJECTIVES: The choice of prosthesis for aortic valve replacement (AVR) in younger patients remains controversial. Stentless AVR was introduced 3 decades ago, with the aim of better haemodynamics and durability than stented xenografts. The objective of this analysis was to compare the long-term outcomes to mechanical prostheses in younger patients (age ≤60 years). METHODS: All adult patients who underwent AVR due to aortic valve stenosis and/or insufficiency between 1993 and 2002 were identified. After the exclusion of patients with congenital heart defects, aortic dissections and Ross-procedures, 158 patients with stentless valves and 226 patients with bi-leaflet mechanical valves were finally included in this analysis. Sixty-six patient pairs could be included in a propensity matched analysis. Mortality and morbidity including stroke, bleeding, endocarditis and reoperation were analysed. RESULTS: Group baseline characteristics and operative data did not differ significantly after propensity matching. Hospital mortality was 0.0% in the stentless and 1.5% in the mechanical group. Total patient years/median follow-up was 2029.1/15.4 years (completeness: 100.0%, range: 0-25 years). After 20 years, actuarial survival was 47.0 ± 6.4% in the stentless and 53.3 ± 6.6% in mechanical group (P = 0.69). Bleeding, endocarditis and stroke occurred rarely and did not differ significantly between groups. After 20 years, actuarial overall freedom-from-reoperation was 45.1 ± 8.2% in the stentless group and 90.4 ± 4.1% in the mechanical group (P < 0.001). Hospital mortality while reoperation was 7.4% in the stentless group and 0% in the mechanical group (P = 1.0). CONCLUSIONS: Long-term morbidity and mortality of stentless and mechanical aortic valves were statistically not different besides a significantly higher reoperation rate after stentless AVR combined with a probably higher risk of in-hospital mortality. Thus, mechanical AVR should remain the procedure of choice in younger patients.

Stentless valves for bicuspid and tricuspid aortic valve disease.

Objective: To determine long-term survival and reoperation rate in patients with a bicuspid aortic valve (BAV) and patients with a tricuspid aortic valve (TAV) after stentless aortic valve replacement (AVR)/aortic root replacement (ARR). Methods: Between 1992 and 2014, 1293 patients underwent first AVR/ARR with a stentless aortic valve using the modified inclusion operating technique, including 741 patients with a TAV and 552 with a BAV. Using propensity scoring with 26 variables, 330 matched pairs were identified with AVR with or without ascending aorta/arch replacement. Data were obtained through chart review, surveys, and the National Death Index. Results: Patient demographics were similar in the propensity score-matched groups. Both groups had similar cardiopulmonary bypass, cross-clamp, and hypothermia circulatory arrest times, cerebral protection strategies, and rate of aortic arch replacement. The median size of implanted valves was similar (BAV: 27 mm [range, 25-29 mm] vs TAV: 27 mm [range, 25-27 mm]). Compared with the TAV group, the BAV group had a shorter hospital stay (6 days vs 7 days; P = .001) but similar 30-day mortality (1.8% vs 1.2%). The BAV group had better long-term (15-year) survival (46% vs 33%; P = .002) but a higher cumulative incidence of reoperation for structural valve deterioration (15-year: 15% vs 11%; P = .048). Cox proportional hazard analysis identified a BAV as a protective factor for long-term mortality (hazard ratio [HR], 0.71; 95% CI, 0.56-0.91; P = .006), but a risk factor for reoperation due to structural valve deterioration (HR, 1.4 [95% CI, 0.8-2.6; P = .27] in the matched cohort and 2.2 [95% CI, 1.3-3.7; P = .004] in the unmatched cohort). Conclusions: The BAV patients had better long-term survival but a higher reoperation rate compared with TAV patients after stentless AVR. Our findings suggest caution in the use of bioprostheses for BAV patients.

Successful Reoperation in 3 Cases of Failed Sorin Freedom Stentless Aortic Valve Using the LivaNova Perceval Sutureless Prosthesis.

Reoperations for deteriorated stentless bioprostheses are quite challenging procedures. Calcification of the aortic annulus and of the subcoronary root makes often impossible the removal of the failed valve, living a complex Bentall operation or a high-risk transcatheter aortic valve implantation valve-in-valve procedure as the only options, particularly in cases of small-size prostheses. The Perceval sutureless prosthesis (LivaNova PLC, London, UK) can be a valid alternative for failed stentless valve replacement. We report our experience with 3 complex cases of degenerated Sorin Pericarbon Freedom prosthesis treated successfully by means of Perceval sutureless implantation and demonstrating the reproducibility and the safety of this surgical approach.

Stentless Pericarbon Freedom Versus Stented Perimount Aortic Bioprosthesis: Propensity-Matched Long-Term Follow-Up.

OBJECTIVE: Stentless aortic valves have shown superior hemodynamic performance and faster left ventricular mass regression compared to stented bioprostheses. Yet, controversies exist concerning the durability of stentless valves. This case-matched study compared short- and long-term clinical outcomes of stentless LivaNova-Sorin Pericarbon Freedom™ (SPF) and stented Carpentier-Edwards Perimount (CEP) aortic prostheses. METHODS: From 2003 through 2006, 134 consecutive patients received aortic valve replacement with SPF at our institution. This cohort was matched, according to 20 preoperative clinical parameters, with a control group of 390 patients who received CEP prosthesis during the same time. The resulting 55 + 55 matched patients were analyzed for perioperative results and long-term clinical outcomes. RESULTS: Early mortality was 0% for both groups. Lower transvalvular gradients were found in the SPF group (10.6 ± 2.9 versus 15.7 ± 3.1 mmHg, P < 0.001). Overall late mortality (mean follow-up: 10.03 years) was similar for both groups (50.1% versus 42.8%, P = 0.96). Freedom from structural valve degeneration (SVD) at 13 years was similar for both groups (SPF = 92.3%, CEP = 73.9%, P = 0.06). Freedom from aortic valve reinterventions did not differ (SPF = 92.3%, CEP = 93.5%, P = 0.55). Gradients at 13-year follow-up remained significantly lower in SPF group (10.0 ± 4.5 versus 16.2 ± 9.5 mmHg, P < 0.001). Incidence of acute bacterial endocarditis (ABE) and major adverse cardiovascular and cerebrovascular events (MACCE) was similar. CONCLUSIONS: SPF and CEP demonstrated comparable long-term outcomes related to late mortality, SVD, aortic valve reinterventions, and incidence of ABE and MACCE. Superior hemodynamic performance of SPF over time can make this valve a suitable choice in patients with small aortic root and large body surface area.

Early outcomes of transcatheter aortic valve implantation for degenerated aortic bioprostheses in Japanese patients: insights from the AORTIC VIV study.

OBJECTIVE: The valve-in-valve procedure, in which a transcatheter heart valve (THV) is implanted into a degenerated bioprosthetic valve, is standardized for high-risk patients. However, this procedure is challenging in Japanese patients who have a small aortic annulus. We investigated the feasibility, safety, and therapeutic efficacy of the valve-in-valve procedure involving a degenerated stented bioprosthesis, stentless bioprosthesis, or THV. METHODS: We performed a single-center, non-comparative study of the aortic valve-in-valve procedure (AORTIC VIV study). Beginning in October 2016, the aortic valve-in-valve procedure was performed in seven patients with a stented bioprosthesis, in three patients with a stentless bioprosthesis, and in one patient with a THV. RESULTS: No 30-day post-procedure mortality or severe morbidities occurred. The mean echocardiographic gradient in the aortic position improved from 41 (38-48) to 17 (11-22) mmHg at 30 days (p = 0.01). No paravalvular or mild and more transvalvular leaks were detected. The New York Heart Association functional class improved from 2 (2-2.5) to 1 (1-1) at 30 days postoperatively (p = 0.01). Although the procedure failed in two patients with an implanted stentless bioprosthesis, the third patient with a stentless bioprosthesis and the one patient with a degenerated THV successfully underwent the valve-in-valve procedure. CONCLUSIONS: Feasibility, safety, and potential efficacy of the aortic valve-in-valve procedure were confirmed in selected Japanese patients with a degenerated aortic bioprosthesis. The valve-in-valve procedure for stentless bioprostheses was technically challenging.

Ten-year results of the Freedom Solo stentless heart valve: excellent haemodynamics but progressive valve dysfunction in the long term.

OBJECTIVES: Freedom Solo (FS) is a pericardial stentless heart valve showing excellent haemodynamic performance at mid-term. The aim of this study was to evaluate the long-term performance of such bioprostheses. METHODS: Between December 2004 and November 2009, 109 patients (31 men; mean age 76 ± 6 years) underwent aortic valve replacement with FS. Preoperatively, the mean NYHA class was 2.5 ± 0.7, the mean EuroSCORE II, 2.8 ± 2.5. Mean prosthesis size was 22.7 ± 1.9 mm; concomitant procedures were performed in 65 patients. Structural valve deterioration (SVD) was diagnosed according to the Valve Academic Research Consortium-2 definition. RESULTS: Two patients (1.8%) died within 30 days. Follow-up (72 ± 36 months) was 100% completed. The 1-, 5- and 10-year actuarial survival rates were 89, 73 and 42%, respectively, with 8 valve-related deaths; the actuarial freedom from SVD was 99, 93 and 76%. During 61 ± 39 months of follow-up, echocardiographic findings worsened progressively: At discharge, 3-5 and 7-9 years, the mean gradient was 8 ± 4, 12 ± 11 and 19 ± 19 mmHg ( P < 0.01); the indexed effective orifice area was 1.0 ± 0.2, 0.9 ± 0.2 and 0.8 ± 0.3 cm 2 /m 2 ( P < 0.01). Of the 13 patients who developed SVD, it was due to aortic stenosis in 11. SVD was a predictor of cardiovascular mortality at univariate analysis (HR 2.87, 1.12-7.29); 2 explanted prostheses showed massive calcium deposits with mean calcium and phosphorus contents of 234 ± 16 and 116 ± 7 mg/g dry weight, respectively. CONCLUSIONS: The FS bioprosthesis shows excellent mid-term clinical and haemodynamic results and offers an alternative to other valves, particularly in the case of a small aortic annulus. Worsening of FS performance was observed at late follow-up because of progressive SVD with stenosis, questioning whether it should be used in patients with a long life expectancy.

Surgical management of destructive aortic endocarditis: left ventricular outflow reconstruction with the Sorin Pericarbon Freedom stentless bioprosthesis†.

OBJECTIVES: The treatment of complicated aortic endocarditis with periannular abscesses and root disarrangement is a surgical challenge, and includes left ventricular outflow tract (LVOT) reconstruction with the patch technique or homograft implantation. The results of a simplified technique to reconstruct the LVOT in destructive endocarditis of either the aortic native valve or valve prosthesis with the Sorin Pericarbon Freedom stentless valve are reported. METHODS: Since August 2007, 40 patients with destructive endocarditis (mean age: 69 ± 12, 75% males, European System for Cardiac Operative Risk Evaluation II (EuroSCORE II): 19 ± 13, New York Heart Association (NYHA) class: ≥3 in all cases) have undergone LVOT reconstruction with a Sorin Pericarbon Freedom stentless bioprosthesis. Seven patients (17.5%) were in septic or cardiogenic shock preoperatively, and 18 patients (45%) suffered from moderate or severe aortic regurgitation. Eleven patients (27.5%) experienced preoperative systemic embolizations. Thirty-six cases (90%) were valve redos and 9 patients (22.5%) had concomitant procedures. The mean follow-up was 26 ± 25 months. RESULTS: One patient (2.5%) died early (<30 days) and another 3 patients never discharged died due to multiorgan failure and septic shock. Actuarial survival rate was 85 ± 6% at 1 year, and 76 ± 8% at 3 and 5 years, respectively. Twelve patients (30%) required pacemaker implantation because of atrioventricular block and 20 patients (50%) developed or showed a progression of renal failure. One patient (2.5%) had an endocarditis relapse, and 1 (2.5%) showed a mild paraprosthetic aortic leak. No patient needed reoperation. At the last echocardiographic evaluation, mean gradient, peak gradient and left ventricular ejection fraction were 7.9 ± 5.0 mmHg, 15.1 ± 7.2 mmHg and 63.3 ± 9.3%, respectively. CONCLUSIONS: The Sorin Pericarbon Freedom stentless prosthesis, with the modified technique herein described, seems to be a good option in most of cases of destructive aortic valve endocarditis. It is promptly available in different sizes, easy to implant and, due to its pericardial inflow skirt, ideal for extensive reconstruction of the LVOT with good haemodynamic performance and low risk of relapse.

Transcatheter CoreValve valve-in-valve implantation in a stentless porcine aortic valve for severe aortic regurgitation.

KEY CLINICAL MESSAGE: We describe the first valve-in-valve Corevalve transcatheter aortic valve replacement in the St. Jude Toronto stentless porcine aortic valve in the United States, which enabled this 59-year-old patient with a history of bacterial endocarditis and aortic regurgitation to avoid heart transplant with complete resolution of his severe left ventricular dysfunction.