High Post-Procedural Transvalvular Gradient or Delayed Mean Gradient Increase after Transcatheter Aortic Valve Implantation: Incidence, Prognosis and Associated Variables. The FRANCE-2 Registry.

Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG < 20 mmHg without DMGI > 10 mmHg (control); (2) PPMG < 20 mmHg with DMGI > 10 mmHg (Group 1); and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1(n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 (n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG < 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG > 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.

An odyssey of suturing cardiac wounds: Lessons from the past.

BACKGROUND AND AIM OF THE STUDY: Cardiac wounds have been described for centuries and still remain to be fatal. For a long period of time, the suturing of a myocardial laceration was thought to be absolutely impossible if not sacrilege. METHODS: It is only at the end of the 19th century that pioneers decided to defy such a dogma in desperate cases. RESULTS: Nowadays, it seems obvious that a cardiac stab wound requires emergent surgery whenever possible. CONCLUSIONS: The story of cardiac wounds highlights nicely the change of mind that is required to accept progress and new procedures in medicine.

Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves.

BACKGROUND: Aortic valve replacement (AVR) in small aortic roots remains a surgical dilemma with a higher risk of patient-prosthesis mismatch (PPM). The Perimount Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We examined the early hemodynamic performance, the mid-term outcomes of the PMEAV, and the impact of PPM on outcome and functional class. METHODS: We performed a retrospective analysis of prospectively collected in-hospital data, and a prospective single-center follow-up of 849 patients who received a 19 to 23 mm PMEAV (2008-2014). Concomitant mitral or tricuspid replacement was the exclusion criterion. Early hemodynamic features were prospectively collected; mid-term follow-up was conducted according to current guidelines. RESULTS: Size of implanted prosthesis was 19 mm in 11.5% of patients, 21 mm in 36.9%, and 23 mm in 51.5%. Operative mortality was 4.5% (3.1% for isolated AVR). The rate of severe and moderate PPMs was significantly higher in the 19 mm group. Follow-up was 99.9% complete (3.7 ± 2 years). Actuarial freedom from structural valve deterioration (SVD) at 5 years was 99.1%. At stratified Kaplan-Meier's analysis, PPM and age <70 years were associated with SVD. PPM was not associated with worse functional status (New York Heart Association class) or mortality at follow-up. CONCLUSION: This series shows satisfactory clinical outcomes of the PMEAV implanted in small aortic annuli at mid-term follow-up. Although PPM may occur in smaller sizes, it has limited clinical impact, and it is not associated with mid-term mortality or worse functional class. Few SVD events are evidenced; nonetheless, limited follow-up duration and its methodology need to be considered.

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Conventional aortic valve replacement in 2005 elderly patients: a 32-year experience.

OBJECTIVES: Considering the good immediate results reported for transcatheter aortic valve implantation in high-risk patients, the role of conventional aortic valve replacement (AVR) is being questioned, especially in elderly patients. The aim of this study was to evaluate our long-term results of conventional AVR in octogenarians. METHODS: A total of 2005 patients aged ≥80 years underwent AVR for aortic stenosis in our institution between 1978 and 2011. Of these, 1009 (50%) patients had an associated extracardiac comorbidity and 650 (32%) patients had coronary lesions. Valve replacement was the sole procedure in 1515 (76%) patients, and 396 (19%) patients had concomitant coronary artery bypass grafting. Data were collected at the time of surgery in our database, and regularly updated by mailed questionnaires and telephone contact. RESULTS: Early mortality of isolated AVR was 5.5% for the last 10 years of the series. Significant risk factors were chronic obstructive pulmonary disease, chronic renal failure, advanced cardiac disease [left or right ventricular failure, New York Heart Association (NYHA) Class IV and atrial fibrillation] and coronary disease. Long-term follow-up was 99.5% complete (9 patients lost to follow-up), totalling 8849 patient-years. Nine hundred and one patients died at late follow-up with a median survival of 7.1 years, with 7 patients becoming centenarian. Apart from older age, main late causes of death were cardiovascular (20.5%), neurological deficit (10.2%) and cancer (10.2%). Actuarial survival was 83%, 62.5% and 25% at 2, 5 and 10 years, respectively. This survival compares favourably with that of a French-matched population. Above all, 90% of late survivors reported functional improvement. Univariable and multivariable analysis identified risk factors of late death as male gender, associated comorbidity, renal failure, advanced cardiac disease, atrial fibrillation and impaired ventricular function. Coronary lesions, associated cardiac surgery and small diameter prostheses (19 or 21 mm) did not impair long-term survival. CONCLUSIONS: AVR is effective for all age groups to treat aortic stenosis. Elderly people should not be denied surgery only because of their old age as conventional AVR provides an excellent quality of life and restores life expectancy. Percutaneous valve implantation is to be considered, in cases of non-operable or high-risk patients. However, to date, open-heart surgery remains the treatment of choice for aortic stenosis for the majority of patients.

Impact of coronary artery disease in patients undergoing transcatheter aortic valve replacement: Insights from the FRANCE-2 registry.

BACKGROUND: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short- and long-term prognosis remains unclear. HYPOTHESIS: We hypothesized that the long-term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE-2) registry. METHODS: FRANCE-2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three-year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%. RESULTS: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78-1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3-year mortality (HR: 1.42; 95% CI: 1.10-1.87). CONCLUSIONS: CAD is not associated with decreased short- and long-term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long-term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial.

Predictors and prognostic impact of new left bundle branch block after surgical aortic valve replacement.

BACKGROUND: Left bundle branch block (LBBB) induces mechanical dyssynchrony that may lead to left ventricular systolic dysfunction. AIMS: To evaluate the incidence, predictors and clinical impact of new LBBB in patients undergoing surgical aortic valve replacement (SAVR). METHODS: After exclusion of patients with pre-existing LBBB, a previous pacemaker or a paced rhythm at hospital discharge, 547 consecutive patients undergoing SAVR were included. All-cause death, cardiovascular death and the combined outcome of all-cause death or a first heart failure event were assessed at 3months and 1year. Patients with and without new LBBB were compared. RESULTS: New LBBB occurred in 4.6% of patients after SAVR (compared with 16.4% of patients treated by transcatheter aortic valve implantation during the study period). Previous valve surgery and an immediate postoperative paced rhythm were independent predictors of new LBBB. At 1-year follow-up, there were no significant differences in all-cause death, cardiovascular death, or the combined outcome of all-cause death or a first heart failure event between patients with and without new LBBB. However, new LBBB was associated with a trend towards functional deterioration and more heart failure events at 1year. CONCLUSION: At 1-year follow-up, new LBBB did not have a significant impact on clinical outcome, but was associated with worse functional status and more heart failure events.

Long-term follow-up of bioprosthetic aortic valve replacement in patients aged ≤60 years.

OBJECTIVE: To address the long-term durability of bioprostheses used for aortic valve replacement (AVR) in adult patients aged ≤60 years at the time of surgery. METHODS: Through a retrospective review of a prospectively collected database, we identified 416 bioprosthetic AVRs performed between 1977 and 2013. A prospective follow-up of valve-related and non-valve-related events was performed. RESULTS: Follow-up was 98.5% complete (2423.1 patient-years; average, 6 ± 5.5 years). At 15 years, overall survival was 62.1 ± 4.4%; freedom from valve-related death was 97.1 ± 1.6%. There were 68 SVD events (11.9 ± 28.8 years after surgery). Freedom from SVD at 15 years was 48.7 ± 5.5% for Kaplan-Meier analysis and 61.4 ± 4.3% for competing-risks analysis. After stratification into age subgroups (<40 years, ≥40 and <50 years, and ≥50 and ≤60 years), we observed no significant difference in freedom from SVD (P = .50). The average delay to SVD was not statistically different among subgroups (P = .30). There were 57 reoperations for SVD (11.8 ± 5.2 years after implantation). The 15 year freedom from reoperation for SVD was 55.4 ± 5.6% by Kaplan-Meier analysis and 67.1 ± 4.2% by competing-risks analysis. After stratification by age, freedom from reoperation for SVD was comparable (P = .13). Freedom from any valve-related complication or death was 42 ± 5% by Kaplan-Meier analysis and 54.4 ± 4.1% by competing-risks analysis. CONCLUSIONS: The lifetime risk of SVD is considerable in patients aged ≤60 years at the time of bioprosthesis implantation. Nonetheless, durability remains consistent during the first decade; additional data are required for the second decade. Patients' information is pivotal for valve choice (competing-risks method).

Baseline characteristics and outcomes after transcatheter aortic-valve implantation in patients with or without previous balloon aortic valvuloplasty: Insights from the FRANCE 2 registry.

BACKGROUND: Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI). AIM: The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry. METHODS: From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders. RESULTS: Patients in the previous BAV group (n=664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade≥2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups (P=0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90-2.34; P=0.14) or 1-month to 1-year mortality. CONCLUSIONS: Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment.

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

OBJECTIVE: To clarify the mid-term durability of the Trifecta bioprosthesis for aortic valve replacement (AVR). METHODS: We 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. RESULTS: Operative 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. CONCLUSIONS: The 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.

Increased valvulo-arterial impedance differently impacts left ventricular longitudinal, circumferential, and radial function in patients with aortic stenosis: A speckle tracking echocardiography study.

BACKGROUND: In aortic stenosis (AS), the left ventricle (LV) should face an increased afterload that is due to both the stenotic aortic valve and the peripheral vascular resistance (PVR). Valvulo-arterial impedance (ZVa ) is a recently introduced parameter, which permits the evaluation of global LV afterload in AS. Aim of this study was to assess the influence of increasing ZVa on the longitudinal, circumferential, and radial components of LV mechanics. METHODS: A total of 126 patients (mean age: 80.1±12.0 years, males: 47%) with severe AS (aortic surface <1 cm2 or <0.6 cm2 /m2 ) underwent standard echocardiography to characterize aortic valve gradients, LV function, and ZVa . 2D speckle tracking echocardiography was used to estimate global longitudinal (GLS), circumferential (GCS), and radial (GRS) LV strain. RESULTS: The population was divided into four groups according to ZVa quartiles: Q1 (ZVa ≤3.43 mm Hg/mL/m2 ), Q2 (3.435.1 mm Hg/mL/m2 ). ZVa increase from Q1 to Q4 was associated with a progressive reduction in GLS and GCS (ANOVA, both P<.0001). GRS was relatively insensitive to ZVa increase, a significant reduction of GRS appearing only in Q4 patients with respect to Q1 (29.7±16.4 vs 20.7±13.2%, P=.01). CONCLUSIONS: Left ventricle myocardial fibers show a different response to afterload increase. Subendocardial fibers function is impaired earlier, whereas mid-wall circumferential fibers remain substantially unaffected, providing interesting insights into the mechanisms of LV dysfunction in AS.

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

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

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Combined Coronary Revascularization: Single-Center 10-Year Experience.

OBJECTIVE: This study aimed to assess the long-term outcome of combined coronary revascularization. METHODS: Between January 2000 and September 2010, 106 consecutive patients underwent combined coronary revascularization, either the same day or staged within 90 days. Percutaneous coronary intervention was always performed before coronary artery bypass grafting. We identified three groups as follows: one-stop combined coronary revascularization (n = 20), percutaneous coronary intervention for acute coronary syndrome before subsequent surgery (n = 39), and percutaneous coronary intervention for stable coronary artery disease before subsequent surgery (n = 47). Off-pump technique was used in all cases. RESULTS: A total of 107 angioplasties were realized (drug-eluting stents, 21; bare metal stents, 114; balloon angioplasty, 4). Percutaneous coronary intervention was mostly performed in the right coronary artery or branches (85%). The mean (SD) number of grafts was 1.9 (0.6), among them 1.8 (0.7) with arterial grafts. A total of 87.7% of the patients underwent exclusive arterial revascularization. There was one reexploration for bleeding and no in-hospital death. Eleven patients died in the follow-up. Repeat percutaneous coronary intervention was necessary for six patients and repeat surgery for one patient. The mean (SD) follow-up was 6.1 (2.7) years. Complete follow-up was obtained in 96.2% of the patients. Freedom from ischemic events (all-cause deaths, angina, acute coronary syndrome, myocardial infarction) was 86.3% (3.7%) at 5 years and 79.7% (5.2%) at 8 years (no difference between groups). Freedom from major adverse cardiac or cerebrovascular events was 88.8% (3.4%) at 5 years and 75.7% (5.2%) at 8 years (no difference between groups). CONCLUSIONS: Combined coronary revascularization increases the use of arterial grafts, with good long-term outcome.

Appraisal of Long-Term Outcomes of Tricuspid Valve Replacement in the Current Perspective.

BACKGROUND: We address the differential long-term results of tricuspid valve replacement and late valve-related events among bioprostheses versus mechanical prostheses. METHODS: In a single-institution investigation, we reviewed the patients' prospectively collected data and performed a clinical follow-up. Both the Kaplan-Meier (actuarial) and the competing risks (actual) methodologies were used. RESULTS: Overall, 188 tricuspid valve replacements were performed during 1971 to 2012. In this complex population (reoperations, 48.1%; associated procedures in 71.3%), operative mortality was 27.6% (significantly declining in recent years). A bioprosthesis was used in 82.4%. Follow-up was 10.2 ± 9.1 years (as long as 37.3 years, or 1,270 patient-years; 91.2% complete). At 15 years, freedom from structural valve deterioration was 93.3% ± 6.4% (competing risks 94.7 ± 5.1%) in the mechanical group and 85.2% ± 5.4% (competing risks 92% ± 2.9%) in the bioprostheses group (p = 0.19). Freedom from any valve-related adverse events was lower among mechanical valves versus bioprostheses (although not statistically significant). Mechanical valves showed significantly lower freedom from thromboembolic events (actuarial 62.3% ± 14.3% versus 97.7% ± 1.6%; competing risks 74.1% ± 10% versus 98% ± 1.4%; p < 0.001) and earlier adverse events (4.9 ± 4.5 versus 11.1 ± 9.4 years) than bioprostheses. There were 11 reoperations for bioprosthetic structural valve deterioration (89.8% and 94.3% actuarial and actual freedom, respectively). CONCLUSIONS: Bioprostheses for tricuspid valve replacement have a very good long-term durability. Mechanical valves display earlier and more severe morbidity at follow-up.

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

OBJECTIVES: To examine the haemodynamic performance of the St Jude Trifecta valve for aortic valve replacement (AVR) at 3 years after implantation. METHODS: 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. RESULTS: 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. CONCLUSIONS: The Trifecta valve retains its excellent haemodynamic properties at the 3-year follow-up. The rate of PPM is considerably low.

Baseline Characteristics and Prognostic Implications of Pre-Existing and New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: Results From the FRANCE-2 Registry.

OBJECTIVES: The aim of this study was to determine baseline characteristics and clinical outcomes of patients with pre-existing atrial fibrillation (AF) and of patients who presented with new-onset AF after transcatheter aortic valve implantation (TAVI). BACKGROUND: Little is known regarding the impact of AF after TAVI. METHODS: The FRANCE-2 registry included all patients undergoing TAVI (N = 3,933) in France in 2010 and 2011. New-onset AF was defined as the occurrence of AF post-procedure in a patient with no documented history of AF. RESULTS: AF was documented before TAVI in 25.8% of patients. New-onset AF was observed in 174 patients after TAVI among patients without a history of pre-existing AF (6.0%). At 1 year, the rates of all-cause death (26.5 vs. 16.6%, respectively; p < 0.001) and cardiovascular death (11.5 vs. 7.8%, respectively; p < 0.001) were significantly higher in patients with pre-existing AF compared with those without AF. Rehospitalization for worsening heart failure and New York Heart Association functional class was also higher in patients with pre-existing AF versus those without, resulting in a higher rate of combined efficacy endpoint in this group (p < 0.001). A history of stroke, surgical (nontransfemoral) approach, cardiological, and hemorrhagic procedure-related events were all independently related to the occurrence of new-onset post-procedural AF. New-onset AF in patients without pre-existing AF was associated with a higher rate of combined safety endpoint at 30 days (p < 0.001) and a higher rate of both all-cause death and combined efficacy endpoint at 1 year (p = 0.003 and p = 0.02, respectively). CONCLUSIONS: Pre-existing and new-onset AF are both associated with higher mortality and morbidity after TAVI.