Trifecta Valve Research Articles

Early First-Generation Trifecta Valve Failure: A Case Series and a Review of the Literature

The Trifecta valve (Abbott, St Paul, MN) has excellent hemodynamic performance with acceptable rates of freedom from structural valve degeneration. However, some recent studies have reported early Trifecta valve failure. Here, we report a case series of seven Trifecta valve failures with a review of the literature. Of 107 implantations of Trifecta bioprostheses between 2012 and 2014, we encountered seven Trifecta valve failures (6.5%). Failure of a 19-mm Trifecta valve occurred in 1 patient, failure of a 21-mm Trifecta valve occurred in 5 patients, and failure of a 23-mm Trifecta valve occurred in 1 patient. The mean duration of valve durability was 51 ± 16 months. The mean effective orifice area index on the first echocardiogram after Trifecta valve implantation was 0.96 ± 0.26. The mode of presentation was prosthetic valve stenosis in 3 patients and severe aortic regurgitation in 4 patients. Six patients underwent redo surgical aortic valve replacement. The common pathologic findings were circumferential pannus formation with noncoronary cusp tear and leaflet calcification. The rates of preoperative end-renal stage disease and postoperative prosthesis-patient mismatch were higher in patients with Trifecta valve failure. The incidence of early Trifecta valve failure was 3.1% at 48 months and 13.1% at 72 months. In our experience, early Trifecta valve failure was caused by cusp tears or leaflet calcification. Patients with end-renal stage disease and prosthesis-patient mismatch should be closely followed. Some patients with cusp tears may require urgent surgery.

Hemodynamics and reverse remodeling associated with Mosaic, Perimount and Trifecta aortic bioprostheses.

ABSTRACTIntroduction: The implantation rate of aortic bioprostheses is increasing. Their durability has improved to some extent over the years and they allow for future transcatheter valve-in-valve deployment. In the lack of long term follow up, their hemodynamic profile, i.e. transvalvular mean pressure gradient and effective orifice area indexed, and the associated left ventricular reverse remodeling indexed are useful surrogates for clinical outcomes.Areas covered: A systematic review of the literature was conducted by searching Medline, Cochrane, Scielo, Embase databases, and grey literature until July 2018 for articles that perform comparisons among the three most popular aortic bioprostheses. Six randomized and 12 non-randomized studies were included with 565 patients receiving a Mosaic, 1334 a Perimount and 557 a Trifecta valve. These articles are heterogeneous but they allow the meta-analytic comparison of the abovementioned outcomes.Expert opinion: Compared to the Perimount valve, the Mosaic is hemodynamically inferior, while the Trifecta is superior. Despite these statistically significant differences, the left ventricular mass regression indexed, that is indicative of reverse remodeling, was comparable in all groups.All patients were similarly benefited. The predilection among these valves is fueled by their hemodynamic profile but not supported by the comparable reverse remodeling.

Early results of a modified biological valved conduit for the Bentall procedure.

Few bioprosthetic valved conduits for aortic root surgery are commercially available. Long-term Warfarin therapy (mechanical), potential root calcification (xeno- or homograft valves), and the need for additional ascending aorta grafts are concerns associated with currently used valved conduits. A simplified, self-assembled bioroot conduit comprising currently available materials that facilitates future intervention and exhibits advantages of a bioprosthesis was used. From November 2015 to January 2017, 17 consecutive patients underwent urgent or elective aortic root surgery. A bioroot conduit, constructed using 28 or 30 mm of sinus of Valsalva Gelweave tube graft and a 3 to 5 mm smaller bioprosthetic Trifecta valve sewn into the sinus of Valsalva base, was preconstructed in the operating room before sternotomy. The size of the valved conduit was based on the distal ascending aorta or proximal arch and not aortic annular dimension. The bioroot was sutured to the native aortic annulus at the level of the bottom skirt of the Valsalva graft without contacting the sewing cuff of the bioprosthetic valve. All patients survived the operation and were discharged home without long-term anticoagulation therapy. The mean age was 65 ± 12 years, and 13 patients were male. The cardiopulmonary bypass duration was 169 ± 84 minutes, and the cross-clamp (XC) duration was 110 ± 32 minutes. The operation was elective in 12 patients, urgent/emergent in five, and redo in three. A simplified self-assembled bioroot Bentall conduit is appropriate for aortic root reconstruction. Use of a patient-tailored valved conduit will not prolong the cardiac ischemic time and will facilitate future valve replacement.

Trifecta Aortic Bioprosthesis: Midterm Results in 1,953 Patients From a Single Center

The St. Jude Medical Trifecta bioprosthesis (St. Jude Medical, St. Paul, MN) is a bovine pericardial valve mounted on a titanium stent. The objective of this study was to report a single-center experience with the Trifecta aortic valve. Patients undergoing aortic valve replacement (AVR) with the Trifecta valve between 2011 and 2017 at a single center were included. The primary outcome was overall survival. Secondary outcomes included operative mortality and morbidity, aortic valve reoperations, and reoperation for structural valve deterioration. Echocardiographic outcomes were evaluated. Multivariable logistic regression models were created to identify predictors of death. The study included 1,953 Trifecta valve implants. Operations included isolated AVR (45% [n= 869]), AVR plus coronary artery bypass grafting (40% [n= 771]), and AVR plus mitral valve operation (13% [n= 254]). Overall survival at 30 days, 1 year, and 5 years was 94.9%, 89.7%, and 69.8%, respectively. Overall freedom from aortic valve reintervention was 96.4% at 5 years, with an overall freedom from reoperation for structural valve deterioration of 98.7% at 5 years. For elective isolated AVRs, survival was 98.6%, 94.1%, and 77.5% at 30 days, 1 year, and 5 years, respectively. The 5-year freedom from aortic valve reintervention and reoperation for structural valve deterioration for elective isolated AVRs was 97.6% and 99.1%, respectively. Overall mean gradients were 6.8 ± 5.3 mm Hg postoperatively and remained low at 10.1 ± 6.2 mm Hg at 1 year. This is the largest series reporting on outcomes of the Trifecta valve. Our results demonstrate that this valve can be safely implanted in the aortic position with excellent midterm durability and hemodynamics.

OC10 CLINICAL AND HEMODYNAMIC PERFORMANCE OF THE THIRD-GENERATION ST. JUDE TRIFECTA AORTIC VALVE: SHORT-TERM FOLLOW-UP ANALYSIS

Background and Aim: We retrospectively analyzed the short-term outcome of the third-generation St. Jude Trifecta aortic valve. Methods: Between December 2014 and December 2017, 177 patients (mean age 75 ± 7 years, 95 males, 82 females) underwent aortic valve replacement (AVR) with St. Jude Trifecta aortic valve and were followed up to 27 ± 9 months. Results: Operative mortality was 3.4% (1.7%, isolated AVR). Three-year survival was 84% ± 6%, freedom from cardiac death 98% ± 1%. Echocardiographic variables are reported in Table. Conclusions: Trifecta valve provides favourable clinical outcome and hemodynamic performance. No early structural valve degeneration has been observed. Due to the minimal incidence of severe PPM and to the low value of mean trans-prosthetic gradient, Trifecta valve should be considered as one of the best options among the third generation biological prostheses. Longer follow-up is mandatory. Table. Echocardiographic variables and clinical status

Invited Commentary

Invited Commentary

The Prevalence of Patient-Prosthesis Mismatch Can Be Reduced Using the Trifecta Aortic Prosthesis

Some important studies have shown that patient-prosthesis mismatch is a frequent occurrence after surgical aortic valve replacement that impairs survival. The Trifecta valve (St. Jude Medical Inc, St. Paul, MN) has special architecture designed to achieve the best hemodynamic profile. The aim of this study was to determine the prevalence of mismatch when using this prosthesis. This study included 1,302 patients at 3 months postoperatively, 339 patients with a Trifecta prosthesis and 963 patients (the control group) with a Mitroflow aortic valve (Sorin Group Inc, Mitroflow Division, Vancouver, Canada). Multinomial multivariate logistic regression was calculated to estimate the association between the Trifecta prosthesis and moderate or severe patient-prosthesis mismatch. Any degree of mismatch was present in 5.9% of the Trifecta group and in 42.4% in the Mitroflow group. Moderate patient-prosthesis mismatch was present in 3.8% of the patients with a Trifecta valve and in 32.6% in the Mitroflow group. Severe mismatch was present in 2.1% of the patients with a Trifecta prosthesis and in 9.8% of the patients with a Mitroflow valve. All differences were statistically significant (p < 0.001). The odds ratio of the Trifecta prosthesis as protector against mismatch was 16.9 (95% confidence interval, 9.5 to 30.4) and 11.9 (95% confidence interval, 5.3 to 26.7) for moderate or severe mismatch, respectively. The prevalence of patient-prosthesis mismatch using the Trifecta aortic prosthesis is extraordinary low. This finding may have great clinical repercussions in patients undergoing surgical aortic valve replacement.

Early Trifecta valve failure: Report of a cluster of cases from a tertiary care referral center

BackgroundThe Trifecta valve (St Jude Medical, Inc, St Paul, Minn) was approved for commercial use by the US Food and Drug Administration in 2011. Several isolated cases have been reported since then, describing early structural valve deterioration. We report a case series of 8 Trifecta valve failures, describing patients' clinical substrate and management, and the pathologic characteristics of the explanted valves. MethodsTrifecta valve failure occurred in 7 patients (8 valves) receiving 19-mm (n = 2), 21-mm (n = 3), 23-mm (n = 1), and 25-mm (n = 2) valves. The mean duration of valve durability was 32 ± 21 months, and the most common lesion was prosthetic regurgitation. The mean Society of Thoracic Surgeons risk score for perioperative mortality at the time of reintervention was 9.75% ± 8.1%. Heart failure exacerbation was the most common presenting symptom. ResultsFive patients underwent surgical aortic valve replacement, 2 patients received valve-in-valve transcatheter aortic valve replacement, and 1 patient died of cardiogenic shock before reintervention. The most common pathologic finding in the explanted valves was a tan-yellow fibrofatty circumferential pannus adherent to the inflow portion of the Trifecta valve. ConclusionsOur findings provide further insights into the pathologic mechanisms leading to early Trifecta valve failure. In addition to tear of the noncoronary cusp of the Trifecta prosthesis described as the most common mechanism in the literature for its failure, circumferential pannus formation composed of fibrofatty tissue in the inflow portion and leaflet calcification concentrated around the posts in the outflow portion are important mechanisms contributing toward early Trifecta valve failure.

Acute Structural Failure of the Trifecta Aortic Valve Bioprosthesis

Advancements in bioprosthetic valve technology have greatly enhanced the haemodynamic performance and long-term durability of tissue valves. These features, along with the key advantage of avoiding lifelong anticoagulation, have made bioprosthetic valves increasingly attractive for clinicians and patients alike. The St Jude Trifecta valve is a novel, bovine pericardial bioprosthesis with promising early data for performance and safety. However, no prosthetic valve is perfect and prosthesis failure can occur with even the most reliable and well-designed devices. We report a case of early and acute structural deterioration (stent-post leaflet rupture) of the Trifecta valve, explanted after 33 months, in a 76-year-old male.

Aortic Valve Trifecta

Mr SM is an 83-year-old male with severe aortic regurgitation, congestive heart failure, hypertension, ischaemic heart disease s/p CABG in 2008, BPH, GERD, hypothyroidism and carotid artery occlusion. He had severe aortic stenosis and underwent a surgical AVR in 2013 (27 mm St Jude Trifecta valve). This valve was complicated by bioprosthetic valve degeneration for which he had a valve-in-valve TAVR (29 mm CoreValve) 1.5 years later. One year after his repeat TAVR, he developed acute onset dyspnoea and chest pain and was admitted to hospital. He had a NSTEMI (likely secondary to demand ischaemia) and was found to have severe aortic regurgitation. His blood cultures had been negative to date at the time of evaluation. Given his high surgical risk as a 3rd sternotomy and his haemodynamic instability, a repeat valve-in-valve TAVR was thought the best management option for him. This was performed urgently with a 26 mm Edwards XT valve via a right transfemoral approach. Since his procedure, he has had positive antibodies for Chlamydia pneumoniae. It is unclear if this indicates a current infection or just a previous exposure. Infectious disease recommended a repeat antibody test in 3 months time. In the meantime, he has been placed on long-term antibiotics. This case highlights the difficult dilemma of treating patients with degenerative bio-prosthetic valves and raises the question of why he had two early valve failures and what his long term monitoring and treatment plan should be.

Midterm Durability and Hemodynamic Performance of a Third-Generation Bovine Pericardial Prosthetic Aortic Valve: The Leipzig Experience

The Trifecta valve (St. Jude Medical, St. Paul, MN) is a stented bovine pericardial bioprosthesis for aortic valve replacement (AVR). Implantation experience and midterm follow-up of this valve have not yet been reported from a large single-center cohort. We retrospectively analyzed data from 918 patients (73.2 ± 6.5 years; logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE], 13.2 ± 14.3) who underwent AVR. Analyses addressed implantation safety, short- and long-term survival, and hemodynamic valve performance. Concomitant procedures were performed in 54.9% of the patients. Low cardiac output syndrome, postoperative bleeding requiring transfusion or reoperation, and acute renal failure requiring temporary hemodialysis occurred at rates of 4.3%, 7.0%, and 11.7%, respectively. At discharge, 44 patients (4.8%) were identified with moderate prosthesis-patient mismatch (PPM) and none was identified with severe PPM. Mean follow-up was 2.7 ± 1.6 years (maximum, 7.4 years). Survival at 30days was 88.7% and 92.0% for all patients and patients with isolated AVR, respectively; 5-year overall survival for these groups was 73.4% and 82.2%, respectively. Myocardial infarction (odds ratio [OR], 78; 95% confidence interval [CI], 20.8-294) and inotropic medication (OR, 6.8; 95% CI, 3.2-14.5) were the strongest independent predictors for long-term mortality. Five-year freedom from structural valve deterioration (SVD) was 97.9% ± 1.5%. Left ventricular ejection fraction (LVEF) after implantation was similar to baseline and was stable over time (range, 58.9%-62.3%). The mean gradient improved substantially (39.3 mm Hg at baseline versus 9.4 mm Hg at 6 months). This large single-center cohort shows the easy and safe implantation, adequate hemodynamic performance, and satisfactory durability of the Trifecta valve at midterm follow-up.

Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve

ObjectiveTo evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve. MethodsIn a multicenter, prospective, nonrandomized, follow-up study, 710 patients underwent surgical implantation of a pericardial stented aortic prosthesis (Trifecta valve; St Jude Medical, St. Paul, Minn). The valve is constructed from bovine pericardium mounted externally onto a titanium stent. Subjects were followed on an annual basis over 6 years. ResultsOperations were performed from 2007 to 2009, and mean age was 72.4 ± 9.3 years; 471 of 710 (66.3%) were men. Preoperatively, 361 of 710 (50.8%) of patients were in New York Heart Association class III or IV, and at 6 years postoperatively, 92 of 96 (95.8%) were New York Heart Association class I or II. Six years postoperatively, average mean gradient across all valve sizes was 11.0 mm Hg, and the average effective orifice area index was 0.80 cm2/m2. The proportion of patients without moderate-to-severe valvular regurgitation at 6 years was 95.2% (80/84). Six years postoperatively, freedom from valve-related mortality, nonstructural dysfunction, and paravalvular leak were 98.3%, 98.6%, and 98.9%, respectively, and freedom from reoperation due to structural valve deterioration was 97.3% (95% confidence limits, 98.6-94.7). ConclusionThese midterm results demonstrate that the Trifecta valve is a safe and effective valve substitute with excellent hemodynamic performance and durability that is maintained through the 6-year follow-up period.

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.

Pulmonary Valve Replacement With a Trifecta Valve Is Associated With Reduced Transvalvular Gradient

Outcomes after surgical pulmonary valve replacement (PVR) in patients with congenital cardiac disease are limited by long-term valve deterioration, which may be hastened by turbulent flow. The use of theTrifecta valve (St. Jude Medical, Little Canada, MN) at our institution (Duke University Medical Center, Durham, NC) appears to result in low postimplantation transvalvular gradients. This study was performed to compare the early transvalvular gradient associated with the Trifecta valve with that associated with two other valves commonly used for PVR. We performed a single institution review of patients undergoing PVR with the Perimount valve (Edwards Lifesciences, Irvine, CA), the Biocor valve (St. Jude Medical), or the Trifecta valve between November 1993 and January 2014. Multivariable linear regression modeling was used to determine the adjusted association between valve type and transvalvular gradient as determined by early postoperative echocardiography. A total of 186 patients met study criteria; 54(29%) received a Biocor valve, 87 (47%) received a Perimount valve, and 45 (24%) received a Trifecta valve. There were no baseline differences among the groups, but the peak transvalvular gradient was significantly decreased among patients with the Trifecta valve. After adjustment for age, valve size, patients' weight, and time to the assessment, as compared with the Trifecta valve, the Biocor valve was associated with a 57% higher peak valve gradient (p < 0.01), whereas the Perimount valve was associated with a 26% higher peak valve gradient (p= 0.04). PVR for congenital heart disease with the Trifecta bioprosthetic valve is associated with a reduced early transvalvular gradient. This finding may be associated with reduced valve deterioration over time.

A comparison of two forms of the continuity equation in the Trifecta bovine pericardial aortic valve.

AimTo compare the classical and simplified form of the continuity equation in small Trifecta valves.MethodsThis is a retrospective analysis of post-operative echocardiograms performed for clinical reasons after implantation of Trifecta bioprosthetic valves.ResultsThere were 60 patients aged 74 (range 38–89) years. For the valves of size 19, 21 and 23mm, the mean gradient was 11.3, 10.7 and 9.7mmHg, respectively. The effective orifice areas by the classical form of the continuity equation were 1.4, 1.7 and 1.9cm2, respectively. There was a good correlation between the two forms of the continuity equation, but they were significantly different using a t-test (P<0.00001). Results using the classical form were a mean 0.11 (s.d. 0.18)cm2 larger than those using the simple formula.ConclusionHaemodynamic function of the Trifecta valve in the small aortic root is good. There are significant differences between the classical and simplified forms of the continuity equation.

Randomized comparison of exercise haemodynamics of Freestyle, Magna Ease and Trifecta bioprostheses after aortic valve replacement for severe aortic stenosis.

The purpose of this study was to compare haemodynamics at rest and during exercise after clinically indicated aortic valve replacement (AVR) for aortic stenosis among patients randomly assigned to one of three haemodynamically excellent bioprostheses. In a single-centre, prospective trial, 60 patients undergoing clinically indicated AVR were randomly assigned to Freestyle, Magna Ease or Trifecta bioprostheses. Six months after surgery, patients underwent supine bicycle stress echocardiography for the assessment of aortic valve haemodynamics. There were 5 protocol deviations from random valve assignments, and 4 patients did not return for follow-up stress echo, yielding a study group of 56 patients {17 Freestyle, 21 Magna Ease, 18 Trifecta; median age 70 [interquartile range (IQR) 63-78 years], 37 (66%) men}. There were no statistically significant differences between groups in valve size, concomitant procedures or exercise variables. Resting haemodynamics revealed significant differences between groups in mean gradient [Freestyle 7 (IQR 5-9) mmHg, Magna Ease 9 (IQR 7-11) mmHg, Trifecta 5 (IQR 4-8) mmHg; P = 0.04], effective orifice area (EOA) [2.5 (IQR 2.2-2.7), 2.1 (IQR 1.7-2.3) and 2.6 (IQR 2.3-2.8), respectively; P = 0.02] and EOA index [1.22 (IQR 1.11-1.32), 1.02 (IQR 0.89-1.14) and 1.31 (IQR 1.00-1.42), respectively; P = 0.03]; in each case, Trifecta had better haemodynamics compared with Magna Ease. With exercise, significant differences between groups were evident in peak velocity at 50 watts and peak exercise; mean gradient at 25 watts, 50 watts and maximal exercise; and EOA at 25 watts and at peak exercise; all with haemodynamic superiority of Trifecta compared with Magna Ease. There were no statistically significant differences between Trifecta and Freestyle haemodynamics at rest or with exercise. In a prospective, randomized study comparing haemodynamics after Freestyle, Magna Ease and Trifecta, all three valves exhibited good haemodynamics at rest and with exercise. There were small but significant differences between groups, with favourable haemodynamics associated with Trifecta compared to Magna Ease, and no significant differences between Trifecta and Freestyle. The Trifecta valve appears to offer haemodynamics similar to a stentless valve without the technical complexity of stentless valve implantation. NCT01635244.

Haemodynamic performance of the small supra-annular Trifecta bioprosthesis: results from a French multicentre study

The St Jude Medical Trifecta bioprosthesis incorporates a single pericardial sheet externally mounted on a titanium stent that provides excellent haemodynamic results. The purpose of this multicentre study was to report on the haemodynamic performance and the expected lower risk of prosthesis-patient mismatch in patient with small aortic annulus diameters. The 19- and 21-mm Trifecta valves were implanted in 88 and 266 eligible patients, respectively between 2011 and 2013 at three centres in France (Angers, Rennes and Amiens). The mean age of the population was 78 ± 7 and 76 ± 6 years for 19- and 21-mm valve sizes of which 96.6 and 68% were female, respectively. The aortic valve replacement was associated with another surgery in 18.2 and 21.8% in each group, respectively. The mean follow-up was 20.3 ± 11.9 and 24 ± 11.4 months for 19- and 21-mm valves, respectively. Early all-cause mortality was 2.5% and late mortality occurred in 5.8% of patients. The mean pressure gradient and the effective orifice area at discharge and at 1 year were respectively 12.4 ± 4.6 and 14.7 ± 5.8 mmHg (P = 0.003), 1.5 ± 0.3 and 1.4 ± 0.9 cm(2) (P = 0.06) in the 19-mm valve group; 10.4 ± 3.8 and 11.7 ± 4.5 mmHg (P = 0.001), 1.8 ± 0.3 and 1.5 ± 0.4 cm(2) (P = 0.1) in the 21-mm valve group. At 1 year, only 38 (11%) and 28 (8.1%) patients presented a moderate or severe prosthesis-patient mismatch for the two groups. After univariate analysis, no risk factor of mismatch was found. The 19- and 21-mm St Jude Medical Trifecta provide excellent haemodynamic performance and the rate of moderate and severe prosthesis-patient mismatch is low.

A MATCHED-PAIRED COMPARATIVE ANALYSIS OF THE HEMODYNAMICS OF THE TRIFECTA AND PERIMOUNT AORTIC BIOPROSTHESES

A MATCHED-PAIRED COMPARATIVE ANALYSIS OF THE HEMODYNAMICS OF THE TRIFECTA AND PERIMOUNT AORTIC BIOPROSTHESES

Three-year haemodynamic performance of the St Jude Trifecta bioprosthesis.

To examine the haemodynamic performance of the St Jude Trifecta valve for aortic valve replacement (AVR) at 3 years after implantation. In a single-centre, prospective, observational, independent study, we enrolled 122 patients who had AVR using a Trifecta bioprosthesis in the July 2010-June 2011 period. A clinical and echocardiographic in-house follow-up was scheduled. In our series, 14.7% of patients received a 19-mm, 28.7% had a 21-mm, 35.2% had a 23-mm and 21.3% had a greater-size prosthesis. There were no cases of operative mortality or of valve-related complications both early and at follow-up (except one sudden unexplained death). Completeness of the 3-year echocardiographic follow-up was 80% among survivors. The average mean transvalvular gradient (mTVG) at 3 years was 14.2, 10.8, 8.6, 7.1 and 6.8 mmHg (sizes 19 to 27/29, respectively). There was no statistically significant difference between average mTVGs measured immediately after implantation versus at the 3-year follow-up in the overall population. The average peak transvalvular gradient (pTVG) at 3 years was 25, 20, 16.8, 13.9 and 14.4 mmHg (sizes 19 to 27/29, respectively). The average indexed effective orifice area (iEOA) at 3 years was 0.8, 0.9, 1, 1.3 and 1.3 cm(2)/m(2) (sizes 19-27, respectively). The rate of moderate patient-prosthesis mismatch (PPM) at 3 years was 15.7%; there were two instances of severe PPM (2.2%). All cases of PPM occurred in the 19, 21 and 23 mm size subgroups. The Trifecta valve retains its excellent haemodynamic properties at the 3-year follow-up. The rate of PPM is considerably low.

Matched Comparison of Two Different Biological Prostheses for Complete Supra-annular Aortic Valve Replacement

Objective The aim of this retrospective study was to evaluate the hemodynamic performance of the St. Jude Medical Trifecta (SJM Trifecta; St. Jude Medical, St Paul, Minnesota, United States) and the Carpentier-Edwards Perimount Magna Ease (CEPM Ease; Edwards Lifesciences, Irvine, California, United States) bioprostheses early postoperative and at 1 year. Methods From October 2007 to October 2008, a total of 61 consecutive patients underwent aortic valve replacement (AVR) with the CEPM Ease prosthesis. From a prospective cohort of 201 patients (March 2011 to January 2012) who received AVR with the SJM Trifecta valve, a matched group of 51 patients was selected. Matching was conducted 1:1 by ejection fraction, gender, age, and body surface area. A Hegar dilator was used to define the aortic tissue annulus diameter. Data were grouped on the basis of the patient's tissue annulus diameter (≤22 mm; 23-24 mm; ≥25 mm). Results Early postoperative and at 1 year mean pressure gradients (MPGs) in the various groups ranged from 7.2 ± 4.6 to 7.1 ± 2.4 mm Hg and from 10.0 ± 4.3 to 8.0 ± 2.8 mm Hg in the SJM Trifecta group and from 18.0 ± 5.0 to 12.1 ± 3.6 mm Hg and from 17.7 ± 4.5 to 11.8 ± 3.2 mm Hg in the CEPM Ease group, respectively. Likewise, effective orifice areas (EOAs) ranged from 1.7 ± 0.5 to 2.0 ± 0.5 cm(2) and from 1.5 ± 0.3 to 1.7 ± 0.4 cm(2) in the SJM Trifecta group and from 1.3 ± 0.5 to 1.9 ± 0.5 cm(2) and from 1.2 ± 0.3 to 1.8 ± 0.3 cm(2) in the CEPM Ease group, respectively. A marked left ventricular mass (LVM) regression across all annulus sizes was noted in both groups. Severe patient-prosthesis mismatch (PPM) was infrequent overall. Conclusion The SJM Trifecta valve showed lower MPGs early postoperative and at 1 year as well as higher EOA and effective orifice area index early postoperative. No significant differences were detected with regard to LVM regression and PPM.