Non-structural Valve Dysfunction Research Articles

Ten years follow-up after aortic valve replacement with bioprosthesis trifecta: a single center retrospective cohort

Abstract Introduction St. Jude’s Trifecta (TF) bioprosthesis were adopted at most centers due to their unique design and hemodynamic performance. However, concerns regarding durability have been raised and long-term follow-up studies (≥10 years) are scarce. Purpose To report hemodynamic performance as well as early and long-term results of TF valve. Material and Methods In this longitudinal, single-center study, consecutive patients that underwent surgical aortic valve replacement with TF, from July 2011 to June 2019 were included. Pre-, intra- and post-operative data, including routine and first outpatient ambulatory postoperative transthoracic echocardiogram (TTE) (median 4 months) were collected. Hospital mortality was defined as in-hospital or within the first 30 days after surgery. Survival and need for reoperation were accessed in December 2021. Median follow-up was 4 years and maximum was 10,5 years. Kaplan-Meier method was used for time-to-event outcomes (all-causes mortality and need for reoperation). Results We included 1084 patients, 54% being male, with a mean age of 74±8 years. Surgery priority was elective in 840 (78%) of cases. Most patients received a TF prothesis of size 23 (35%), followed by size 21 (30%). There were 563 (52%) multiple procedures, mostly coronary artery bypass grafting (46% within the multiple procedures). Bypass and clamping times were 86±31 minutes and 62±22 minutes, respectively for isolated procedures, and 143±27 minutes and 100±40 minutes, respectively, for multiple procedures. Hospital mortality was 6%. Excluding these patients, cumulative survival at 1-, 3-, 5- and 10-years, were, respectively, 96%, 89%, 78% and 52%. There were 27 patients who needed reoperation: 16 due to endocarditis, 5 due to structural valve deterioration (SVD) and 6 due to non-structural valve dysfunction. Freedom from reoperation at 1-, 3-, 5- and 10- years were of 99%, 98%, 98% and 95%, respectively. At follow-up TTE (n=995), transvalvular mean gradient was 11±4 mmHg and the effective orifice area mean was 2.1±0.5cm2. Patient-prosthesis mismatch occurred in 79 (9.1%), being severe in 8 (0,9%) cases. Conclusion Our findings confirm the satisfactory hemodynamics and safety profile of TF bioprosthesis. Long-term results are comparable with published TF series and there seems to be no particular sign of adverse valve-related events in our population.

Incidence and mechanisms of bioprosthetic dysfunction after transcatheter implantation of a mechanically-expandable heart valve.

The mechanically-expandable transcatheter valve is no longer commercially available, yet clinical and echocardiographic surveillance is imperative for thousands of patients who received transcatheter aortic valve implantation (TAVI) with this platform. We aimed to determine the incidence and mechanism of bioprosthetic valve dysfunction (BVD) following TAVI with mechanically-expandable valves. From 2013 to 2020, all 234 patients who underwent TAVI with the LOTUS valve were included. BVD was categorised as (i) structural valve deterioration (SVD), (ii) non-structural valve dysfunction (NSVD), (iii) clinical valve thrombosis and (iv) endocarditis, according to the Valve Academic Research Consortium-3 criteria. The mean age was 79±7 years, 60% were male, and the mean Society of Thoracic Surgeons score was 4.2±2.9%. The technical success rate was 94% and the 30-day device success rate was 78%. All-cause mortality at 1 year was 15%; median follow-up duration was 36 (IQR 18-60) months during which 47% of patients died. One hundred and three patients had ≥1 type of BVD (44%), which predominantly consisted of NSVD (39%, mostly because of ≥moderate patient-prosthesis mismatch). BVD during follow-up included endocarditis (3.4%), clinical valve thrombosis (3.4%) and SVD (1.3%). Both endocarditis and clinically apparent valve thrombosis occurred early and late after TAVI and resulted in valve-related deaths in 38% and 13% of patients, respectively. Overall, ≥moderate haemodynamic valve deterioration occurred in 5.5% and bioprosthetic failure in 7.3%, leading to valve-related deaths in 36% of cases. BVD represents a relevant health issue after TAVI with a mechanically-expandable valve. Serious but reversible causes of BVD include endocarditis and clinically apparent valve thrombosis, both carrying a time-independent hazard post-TAVI.

Reply: Reimplantation should be the gold standard to treat the regurgitant bicuspid aortic valve.

Reply: Reimplantation should be the gold standard to treat the regurgitant bicuspid aortic valve.

Rapid-deployment aortic valve replacement for patients with bicuspid aortic valve: a single-centre experience.

The benefit of rapid-deployment aortic valve replacement (RD-AVR) in patients with a bicuspid aortic valve (BAV) is controversial due to aortic root asymmetry and potential increased risk for valve dislocation and paravalvular leak. This study aimed to analyse the outcomes of surgical aortic valve replacement with a rapid-deployment bioprosthesis in patients with a BAV. Between May 2010 and December 2020, all consecutive patients who underwent RD-AVR at the Medical University of Vienna were included in our institutional database. Assessment of preoperative characteristics, operative outcomes, long-term survival and clinical events was performed. The outcomes of patients presenting with a native BAV were compared with a control group of patients with native tricuspid valve (TAV); reoperative aortic valve replacements were excluded. Out of 816 patients, who underwent RD-AVR at our institution, 107 patients with a BAV, mean age 68 (standard deviation: 8) years, were compared with a control group of 690 patients with a TAV, mean age 74 (standard deviation: 7) years; patients presenting with a BAV were significantly younger than patients with a TAV (P < 0.001). Concomitant procedures were performed in 44 (41.1%) patients in the BAV group and in 339 (49.1%) patients in the TAV group (P = 0.123); surgery of the ascending aorta was necessary in 24 (22.4%) in the BAV group, compared with 29 (4.2%) in the control group (P < 0.001). The 5-year cumulative incidence of moderate-to-severe paravalvular regurgitation in the BAV group was 10.7% [95% confidence interval (CI): 4.2-20.7%] and 3.9% (95% CI: 2.4-6.1%) in the TAV group (P = 0.057). Reoperation with valve explantation due to non-structural valve dysfunction at 5 years was 2.8% (95% CI: 0.5-8.8%) in the BAV group, compared to 1.9% (95% CI: 1.0-3.2%) in the TAV cohort (P = 0.89). The overall long-term survival rate in the BAV group was 92% (95% CI: 81-97%) at 5 years and 88% (95% CI: 73-95%), at 10 years, significantly better compared to the TAV group (log-rank test P = 0.002). RD-AVR can be performed in patients with a BAV with convincingly medical outcomes. However, a trend to increased frequency of moderate-severe paravalvular regurgitation was observed at long-term follow-up. Consequently, a different surgical approach, compared to tricuspid valves, with distinctly specific technical- and anatomical considerations and requirements, is recommended.

Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial)

The SMall Annuli Randomized To Evolut or SAPIEN (SMART) Trial was designed to compare the performance of the two most widely available commercial transcatheter aortic valve replacement (TAVR) devices in patients with symptomatic severe native aortic stenosis with a small aortic valve annulus undergoing transfemoral TAVR. Patients with small aortic valve annuli are typically female and are often underrepresented in clinical trials. The SMART Trial is an international, prospective, multi-center, randomized controlled, post-market trial. The trial will be conducted in approximately 700 subjects at approximately 90 sites globally. Inclusion criteria include severe aortic stenosis, aortic valve annulus area of ≤430 mm2 based on multi-detector computed tomography, and appropriate anatomy for both the Medtronic Evolut PRO/PRO+ self-expanding and Edwards SAPIEN 3/3 Ultra balloon-expandable devices. The primary clinical outcome composite endpoint is defined as mortality, disabling stroke or heart failure rehospitalization at 12 months. The co-primary valve function composite endpoint is defined as bioprosthetic valve dysfunction at 12 months which includes hemodynamic structural valve dysfunction, defined as a mean gradient ≥20 mmHg, non-structural valve dysfunction, defined as severe prothesis-patient mismatch or ≥moderate aortic regurgitation, thrombosis, endocarditis, and aortic valve re-intervention. Powered secondary endpoints will be assessed hierarchically. The SMART trial will be the largest head-to-head comparative trial of transfemoral TAVR using the two most widely available contemporary TAVR devices in the setting of small aortic annuli and the largest trial to enroll primarily women. URL: www.clinicaltrials.gov, Unique identifier: NCT04722250.

Midterm outcomes of aortic root surgery in patients with Marfan syndrome: A prospective, multicenter, comparative study

ObjectiveThe objective of this study was to compare midterm outcomes of aortic valve-replacing root replacement (AVR) and aortic valve-sparing root replacement (AVS) operations in patients with Marfan syndrome. MethodsPatients who met strict Ghent diagnostic criteria for Marfan syndrome and who underwent either AVR or AVS between March 1, 2005 and December 31, 2010 were enrolled in a 3-year follow-up prospective, multicenter, international registry study; the study was subsequently amended to include 20-year follow-up. Enrollees were followed clinically and echocardiographically. ResultsOf the 316 patients enrolled, 77 underwent AVR and 239 underwent AVS; 214 gave reconsent for 20-year follow-up. The median clinical follow-up time for surviving patients was 64 months (interquartile range, 42-66 months). Survival rates for the AVR and AVS groups were similar at 88.2% ± 4.4% and 95.0% ± 1.5%, respectively (P = .1). Propensity score-adjusted competing risk modeling showed associations between AVS and higher cumulative incidences of major adverse valve-related events, valve-related morbidity, combined structural valve deterioration and nonstructural valve dysfunction, and aortic regurgitation ≥2+ (all P < .01). No differences were found for reintervention (P = .7), bleeding (P = .2), embolism (P = .3), or valve-related mortality (P = .8). ConclusionsFive years postoperatively, major adverse valve-related events and valve-related morbidity were more frequent after AVS than after AVR procedures, primarily because of more frequent aortic valve dysfunction. No between-group differences were found in rates of survival, valve-related mortality, reintervention on the aortic valve, or bleeding. We plan to follow this homogenous cohort for 20 years after aortic root replacement.

Repeat aortic valve surgery: contemporary outcomes and risk stratification.

Redo aortic valve surgery (rAVS) is performed with increasing frequency, but operative mortality is usually higher compared to that associated with primary aortic valve surgery. We analysed our patients who had rAVS to determine the current outcomes of rAVS as a surgical benchmark in view of the growing interest in transcatheter valve techniques. We retrospectively reviewed 148 consecutive patients [median age 67.7 years (interquartile range 54.9-77.6); 68.2% men] who underwent rAVS following aortic valve replacement (81.6%), aortic root replacement (15%) or aortic valve repair (3.4%) between 2000 and 2018. Indications for rAVS were structural valve dysfunction (42.7%), endocarditis (37.8%), non-structural valve dysfunction (17.7%) and aortic aneurysm (2.1%). Valve replacement was performed in 69.7%, and 34 new root procedures were necessary in 23%. Early mortality was 9.5% (n = 14). Female gender [odds ratio (OR) 6.16], coronary disease (OR 4.26) and lower creatinine clearance (OR 0.95) were independent predictors of early mortality. Follow-up was 98.6% complete [median 5.9 (interquartile range 1.7-10.9) years]. Survival was 74.1 ± 3.7%, 57.9 ± 5.1% and 43.8 ± 6.1% at 5, 10 and 14 years, respectively. Cox regression analysis revealed female gender [hazard ratio (HR) 1.73], diabetes (HR 1.73), coronary disease (HR 1.62) and peripheral vascular disease (HR 1.98) as independent determinants of late survival. Despite many urgent situations and advanced New York Heart Association functional class at presentation, rAVS could be performed with acceptable early and late outcomes. Risk factors for survival were female gender, coronary disease and urgency. In this all-comers patient cohort needing rAVS, only a minority would eventually qualify for transcatheter valve-in-valve procedures.

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

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). 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). 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, respectivelyafter 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%). 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.

Long-term follow-up of the Shelhigh™ superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience.

The Shelhigh™ SuperStentless (Shelhigh, INC., Union, NJ, USA) is a stentless aortic valve bioprosthesis and aortic root valved conduit. In 2007, this device was recalled by FDA due to malfunction, and subsequently reintegrated by BioIntegral Surgical™ Few data are available over late durability of this device. We performed a long-term follow-up of Shelhigh™ devices implanted at our center. Between 2002 and 2007, 44 patients underwent aortic valve replacement with a Shelhigh™ device (40 aortic valve bioprosthesis and 4 valved conduit). We performed a clinical and echocardiographic follow-up (9.2 years±4.3). Standardized definitions of valve-related events were adopted. At discharge, maximum and mean aortic gradients averaged 36.1±11.3 and 21.0±6.8 mmHg, respectively. The 30-days mortality was 2.3%. Over the follow-up period, 29 patients died (65.9%); 2 deaths were valve related. Overall survival at 1, 5 and 10 years was 97.7%, 85.8% and 54% respectively. At last echocardiography, average transvalvular gradients had remained globally stable in the population (33.6±12 and 20.4±10.5 mmHg). Eight (19%) structural valve deterioration (SVD) events were reported. Two (5%) non-structural valve dysfunction (NSVD) events occurred (periprosthetic leak). Two (5%) infectious endocarditis events and two (5%) valve thromboses were also deplored. Three (7%) patients required re-operation (2 due to SVD and 1 due to endocarditis). The immediate hemodynamic performance of the Shelhigh™ aortic bioprostheses was unexpectedly suboptimal. Despite this, hemodynamic performance remained stable over time. Patients survival at follow-up was satisfactory, however, continued surveillance is necessary.

Safety of biological valves for aortic valve replacement: A systematic review and meta-analysis

To provide a comprehensive and contemporary overview of the long-term safety outcomes after aortic valve replacements (AVR) with conventional biological heart valve (stented or stentless). English databases (Medline, Embase, Web of Science, CENTRAL, and ClinicalTrial.gov) and Chinese databases (CNKI, VIP, WanFang, and SinoMed) were searched systemically from January 1, 2000 to January 26, 2019. Eligible randomized controlled trials, non-randomized clinical trials, cohort studies (retrospective or prospective), and unselected case series were included. Strict screening of the obtained literature was conducted to extract relevant data by two reviewers. Other inclusion criteria were studied reporting on outcomes of AVR with biological valves (stented or stentless), with or without coronary artery bypass grafting (CABG) or valve repair procedure, with mean follow-up length equal to or longer than 5 years. We excluded studies that reported only a specific patient group (e.g., patients with renal failure, or pregnancy), without the report of biological valve type, or with study population size less than 100. The meta-analysis was performed using Stata 14.0 software. In this study, 53 papers (in total 57 study groups) involving 47 803 patients were included. (1) The all-cause mortality was 6.33/100 patient-years (95%CI: 5.85-6.84). Subgroup analysis showed that the mortality rates of porcine and bovine valve prostheses were 5.69/100 patient-years (95%CI: 5.05-6.41) and 7.29/100 patient-years (95%CI: 6.53-8.13), respectively. The all-cause mortality rates for stented and stentless valve were 6.69/100 patient-years (95%CI: 6.12-7.30) and 5.21/100 patient-years (95%CI: 4.43-6.14), respectively. (2) The incidence rate of thromboembolism was 1.16/100 patient-years (95%CI: 0.96-1.40), the incidence rate of permanent pacemaker (PPM) implantation was 1.08/100 patient-years (95%CI: 0.75-1.54), the incidence rate of stroke was 0.74/100 patient-years (95%CI: 0.51-1.06), the incidence rate of structural valve dysfunction (SVD) was 0.73/100 patient-years (95%CI: 0.59-0.91), the incidence rate of major bleeding was 0.52/100 patient-years (95%CI: 0.41-0.65), the incidence rate of endocarditis was 0.38/100 patient-years (95%CI: 0.33-0.44), and the incidence rate of non-structural valve dysfunction (NSVD) was 0.20/100 patient-years (95%CI: 0.13-0.31). The total reoperation rate for biological aortic valve was 0.77/100 patient-years (95%CI: 0.65-0.91), and the SVD related reoperation rate was 0.46/100 patient-years (95%CI: 0.36-0.58). The all-cause mortality for conventional biological AVR was 6.33/100 patient-years. Thromboembolism, PPM implantation, reoperation, stroke, and SVD were major long term complications.

Minimally Invasive Aortic Valve Replacement with Sutureless Valves: Results From an International Prospective Registry

To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry. Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy (n = 266) or ministernotomy (n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients. Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%. In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.

Aortic valve repair: state of the art

Mechanical or bioprosthetic aortic valve replacement has traditionally been the treatment of choice for patients with aortic valve insufficiency. However, prosthetic valve replacement has significant limitations being associated with a substantial cumulative risk of thromboembolism, anticoagulation-related hemorrhage, prosthetic valve endocarditis, and structural or non-structural valve dysfunction requiring reoperation. In this setting, aortic valve repair, by avoiding the long-term risks associated with prosthetic valve implantation, has emerged as a valid alternative treatment to conventional aortic valve replacement. In the last decade, improvements in the understanding of the mechanisms of valve disease, development of a classification system for aortic insufficiency and advances in surgical procedures have allowed for more effective and reproducible techniques for aortic valve repair. The aim of the present review is to assess the principles, the surgical techniques, and the role of echocardiographic imaging in the setting of aortic valve repair surgery.

Hemodynamic and clinical performance of Solo stentless bioprosthetic aortic valves

ObjectiveTo report the hemodynamic profile and short- and medium-term outcomes of Freedom Solo and Solo Smart stentless aortic valves implanted at our center. MethodsBetween 2009 and 2015, all patients undergoing aortic valve replacement using Solo stentless valves at our center were enrolled. Clinical and echocardiographic follow-up was carried out six months postoperatively. Survival and major events, including structural valve deterioration and non-structural valve dysfunction, endocarditis, reoperation and stroke, were assessed through medical records or telephone interview with the referring cardiologist up to November 2015 (mean and maximum follow-up 39±22 and 78 months, respectively). ResultsPatients’ (n=345) mean age was 72±8 years, 52% were female and median euroSCORE II was 2.7 (1.5-4.7). There was no intraoperative mortality and in-hospital mortality was 2.6%. Postoperatively, mean transvalvular gradient was 11.9±4.5 mmHg and effective orifice area was 1.9±0.5 cm2. Patient-prosthesis mismatch occurred in 14% but was severe in only one patient. Cumulative survival at six years was 72%. Six patients were reoperated: three due to endocarditis, two for structural prosthesis deterioration and one because of periprosthetic fistula. Five patients suffered stroke, three had medically-treated endocarditis and one had structural valve deterioration but was not considered suitable for reoperation. None of the remainder had structural valve deterioration or non-structural valve dysfunction. ConclusionsSolo stentless aortic valves are safe to implant, with promising clinical outcomes in short- and medium-term assessment. Moreover, they show an excellent hemodynamic performance: low transvalvular gradients, large effective orifice areas and low incidence of patient-prosthesis mismatch.

Early and mid-term haemodynamic performance and clinical outcomes of St. Jude Medical Trifecta™ valve.

New models of aortic bioprostheses have proven excellent early haemodynamic profile, but their mid and long-term performance warrants further systematic assessment. The aim of this study is to report clinical and haemodynamic performance of St. Jude Medical Trifecta bioprosthesis during 5 years of implantation. We performed a single centre, retrospective, observational and descriptive study including all 556 individuals who underwent aortic valve replacement (AVR) with the Trifecta bioprosthesis (between July of 2011 and June of 2016). Survival and re-intervention were censored in February 2017. Postoperative ambulatory echocardiographic data was available for 490 patients. A complete clinical follow-up was available in 463 individuals (mean follow-up time, 27±17 months). In our sample the mean age was 73±9 years, 57.6% were male and median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 2.9 (interquartile range, 1.6-5.8). There were 301 (54.1%) combined procedures, mostly coronary artery bypass grafting in 170 (30.6%). Overall 30-days mortality was 5.4% (n=30) and cumulative survival at 5-years was 72.3%. There were 23 (4.3%) permanent pacemaker implantations. During follow-up, 5 (0.9%) patients presented non-structural valve dysfunction (NSVD) and 4 (0.8%) underwent reoperation due to prosthesis endocarditis. At the first ambulatory evaluation transvalvular mean gradient and effective orifice area (EOA) were 10.9±4.1 mmHg and 2.0±0.5 cm2, respectively. Severe patient-prosthesis mismatch (PPM) was observed in 5 (1.1%) individuals and moderate in 52 (11.3%). In a "real-world" clinical setting, our findings support the good overall mid-term haemodynamic and safety profile of the Trifecta bioprosthesis.

Mechanical aortic valve replacement in non-elderly adults: meta-analysis and microsimulation.

To support decision-making regarding prosthetic valve selection in non-elderly adults, we aim to provide a detailed overview of outcome after contemporary mechanical aortic valve replacement (AVR). A systematic review was conducted for papers reporting clinical outcome after AVR with bileaflet mechanical valves with a mean patient age ≥18 and ≤55 years, published between 1 January 1995 and 31 December 2015. Through meta-analysis outcomes were pooled and entered into a microsimulation model to calculate (event-free) life expectancy and lifetime event risk. Twenty-nine publications, encompassing a total of 5728 patients with 32 515 patient-years of follow-up (pooled mean follow-up: 5.7 years), were included. Pooled mean age at surgery was 48.0 years. Pooled early mortality risk was 3.15% (95% confidence interval (CI):2.37-4.23), late mortality rate was 1.55%/year (95%CI:1.25-1.92); 38.7% of late deaths were valve-related. Pooled thromboembolism rate was 0.90%/year (95%CI:0.68-1.21), major bleeding 0.85%/year (95%CI:0.65-1.12), nonstructural valve dysfunction 0.39%/year (95%CI:0.21-0.76), endocarditis 0.41%/year (95%CI:0.29-0.57), valve thrombosis 0.14%/year (95%CI:0.08-0.25), structural valve deterioration 0.00%/year (zero events observed), and reintervention 0.51%/year (95%CI:0.37-0.71), mostly due to nonstructural valve dysfunction and endocarditis. For a 45-year-old, for example, this translated to an estimated life expectancy of 19 years (general population: 34 years) and lifetime risks of thromboembolism, bleeding and reintervention of 18%, 15%, and 10%, respectively. This study demonstrates that outcome after mechanical AVR in non-elderly adults is characterized by suboptimal survival and considerable lifetime risk of anticoagulation-related complications, but also reoperation. Non-elderly adult patients who are facing prosthetic valve selection are entitled to conveyance of evidence-based estimates of the risks and benefits of both mechanical and biological valve options in a shared decision-making process.

Mid-term durability of the Trifecta bioprosthesis for aortic valve replacement

ObjectiveTo clarify the mid-term durability of the Trifecta bioprosthesis for aortic valve replacement (AVR). MethodsWe retrospectively analyzed the prospectively collected data of 824 consecutive implants of the Trifecta valve at a single institution. A 100% complete follow-up was available (average duration, 2.2 ± 1.3 years; range, 0.03-6.9 years; 1747.6 patient-years). Echocardiography data at discharge were recorded prospectively. ResultsOperative mortality was 3.8%; 2.7% in patients receiving isolated AVR. There were 5 valve-related early reoperations, including 1 for infective prosthetic endocarditis and 4 for nonstructural valve dysfunction. The global rate of severe patient–prosthesis mismatch was 1.26%. Overall 5-year survival was 74.9%, and freedom from valve-related death was 97.8%. The majority of deaths attributed to the valve were due to unknown causes. We observed 6 SVD events at 3.4 ± 1.6 years after surgery. At 5 years, the actuarial freedom from SVD was 98% ± 0.9% (n = 6), freedom from reintervention for SVD was 98% ± 0.9% (n = 5, including 2 transcatheter valve-in-valve), and freedom from open reoperation for SVD was 98.9% ± 0.6%. The 5-year freedom from prosthetic endocarditis was 97.7% ± 0.7% (n = 12, 6 requiring reoperation). There was 1 case of late NSVD (5-year freedom, 99.8% ± 0.2%). Freedom from hemorrhagic events was 98.6% ± 0.5% (86% occurring in patients on anticoagulants); there were no thromboembolic events at follow-up. ConclusionsThe Trifecta bioprosthesis is a reliable device for AVR. We confirm excellent immediate hemodynamic properties and a very low rate of patient–prosthesis mismatch. The absolute number of SVD cases observed remains limited; nevertheless, their timing, pathological characteristics, and clinical presentation mandate continued follow-up.

Invited Commentary

Invited Commentary

068-I * 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™ 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™ 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™ 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.

Twenty-year durability of the aortic Hancock II bioprosthesis in young patients: is it durable enough?†

There is a current trend towards the use of bioprosthetic aortic valves in the aortic position in young patients, but there is limited information on durability beyond the first decade. The Hancock II bioprosthesis has been reported to have excellent durability in patients ≥ 60 years of age. This study examines the long-term durability of the Hancock II bioprosthesis in the aortic position in patients <60 years of age. From 1982 to 2008, 304 patients aged 59 years or less underwent aortic valve replacement (AVR) with a Hancock II bioprosthesis at two centres. The mean age was 49.2 ± 9.0 years, and 79% of the patients were male. Valve function was serially assessed by echocardiography. The median follow-up was 14.6 years (maximum 27.5 years). Survival and freedom from adverse events were calculated by using a Kaplan-Meier method. Independent predictors of those events were assessed by using Cox proportional hazards analyses. Survival and freedom from repeat AVR (re-AVR) at 20 years were 57.0 ± 6.1 and 25.4 ± 4.7%, respectively. During the follow-up, 100 patients (33%) underwent re-AVR: 78 for structural valve deterioration (SVD), 11 for endocarditis, 4 for non-structural valve dysfunction and 7 for other reasons. The overall 10-, 15- and 20-year freedom from re-AVR due to SVD were 91.4 ± 2.1, 64.7 ± 4.3 and 29.1 ± 5.3%, respectively. By age group, the 20-year freedom from re-AVR due to SVD amounted to 14.1 ± 8.7% in patients younger than 40 years of age, 21.5 ± 8.5% in patients aged 40-49 and 41.4 ± 8.2% in patients between 50 and 59 (P = 0.04). The independent predictors of re-AVR due to SVD were age [odds ratio (OR): 0.72 per 10 years; 95% confidence interval (CI): 0.58, 0.90; P < 0.01] and prosthesis-patient mismatch (PPM) (effective orifice area index <0.80 cm(2)/m(2)) (OR: 1.63; 95% CI: 1.01, 2.63; P = 0.045). The Hancock II bioprosthesis for AVR in patients <60 years of age is associated with excellent durability during the first decade. However, SVD increases dramatically during the second decade and by 20 years, especially in patients aged <50 and/or with PPM. These findings may assist prosthesis selection for patients and their surgeons.

Incidence and progression of mild aortic regurgitation after Tirone David reimplantation valve-sparing aortic root replacement

The study objective was to determine whether recurrent or residual mild aortic regurgitation, which occurs after valve-sparing aortic root replacement, progresses over time. Between 2003 and 2008, 154 patients underwent Tirone David-V valve-sparing aortic root replacement; 96 patients (62%) had both 1-year (median, 12 ± 4 months) and mid-term (62 ± 22 months) transthoracic echocardiograms available for analysis. Age of patients averaged 38 ± 13 years, 71% were male, 31% had a bicuspid aortic valve, 41% had Marfan syndrome, and 51% underwent aortic valve repair, predominantly cusp free margin shortening. Forty-one patients (43%) had mild aortic regurgitation on 1-year echocardiogram. In 85% of patients (n=35), mild aortic regurgitation remained stable on the most recent echocardiogram (median, 57 ± 20 months); progression to moderate aortic regurgitation occurred in 5 patients (12%) at a median of 28 ± 18 months and remained stable thereafter; severe aortic regurgitation developed in 1 patient, eventually requiring reoperation. Five patients (5%) had moderate aortic regurgitation at 1 year, which did not progress subsequently. Two patients (2%) had more than moderate aortic regurgitation at 1 year, and both ultimately required reoperation. Although mild aortic regurgitation occurs frequently after valve-sparing aortic root replacement, it is unlikely to progress over the next 5 years and should not be interpreted as failure of the valve-preservation concept. Further, we suggest that mild aortic regurgitation should not be considered nonstructural valve dysfunction, as the 2008 valve reporting guidelines would indicate. We need 10- to 15-year follow-up to learnthe long-term clinical consequences of mild aortic regurgitation early after valve-sparing aortic root replacement.