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.

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.

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.

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.

Postprocedural aortic regurgitation in balloon-expandable and self-expandable transcatheter aortic valve replacement procedures: analysis of predictors and impact on long-term mortality: insights from the FRANCE2 Registry.

BACKGROUND: Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. METHODS AND RESULTS: TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P=0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery (P=0.04), larger aortic annulus (P=0.0004), and smaller prosthesis diameter (P=0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery(P=0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P=0.0001) and SE-TAVR (hazard ratio=2.11; P=0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR

Registry of transcatheter aortic-valve implantation in high-risk patients.

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Impact of pre- and post-procedural anemia on the incidence of acute kidney injury and 1-year mortality in patients undergoing transcatheter aortic valve implantation (from the French Aortic National CoreValve and Edwards 2 [FRANCE 2] Registry).

OBJECTIVES: The relationship between anemia, renal insufficiency, and the outcomes of TAVI patients has not been thoroughly studied. We aimed to evaluate the influence of pre- and post-procedural anemia on the incidence of renal insufficiency, especially AKI, and on the outcomes of TAVI. METHODS: Data from the French national TAVI registry were collected in 3,472 patients who underwent TAVI between January 2010 and December 2012. Of these 2,137 were in the no/mild anemia group, 748 were in the moderate anemia group, and 587 were in the severe anemia group before TAVI. Furthermore, we divided the 3,472 patients into three groups according to post-procedural anemia, measured as post-procedural hemoglobin (Hb) drop: <2 g/dl (n=1,633, group 1), 2 to <4 g/dl (n=1,458, group 2), and >4 g/dl (n = 381, group 3). Procedure and outcome variables were compared. RESULTS: Increased severity of anemia before TAVI was associated with significantly different rates of 1-year mortality (15%, 19%, and 24%, P<0.01), with similar differences in the incidence of AKI (5%, 8%, and 10%, P<0.01). Increased severity of Hb drop was associated with significantly different rates of 1-year mortality (16%, 18%, and 23%, P<0.01), and with similar differences in the incidence of AKI (6%, 7%, and 10%, P=0.04). Both pre- and post-procedural anemia were predictors of the incidence of AKI (OR 1.82, P<0.01; OR 1.82, P<0.01, respectively) and 1-year mortality (HR 1.44, P<0.01; HR 1.50, P<0.01, respectively). CONCLUSIONS: Both pre- and post-procedural anemia were significantly associated AKI and 1-year mortality.

Feasibility of Valve-in-Valve Procedure for Degenerated St. Jude Medical Trifecta Bioprosthesis.

The valve-in-valve (ViV) procedure is an option for patients with symptomatic structural degeneration of a bioprosthesis and excessive reoperative risk. The risk of coronary obstruction appears to be increased if ViV is performed for certain pericardial prostheses in which the leaflets are mounted outside the stent posts. Herein is described a successful ViV for a degenerated Trifecta aortic bioprosthesis, and the technical considerations for performing a ViV procedure within such types of prosthesis are considered. Emphasis is placed on the importance of preoperative investigations (computed tomography scan-based measurements of coronary ostial height and of sinus of Valsalva diameters), and on the precise deployment of the valve (transapical approach with transesophageal echocardiography control) to minimize the risk of major complications. The presence of a failing Trifecta bioprosthesis should not be considered an absolute contraindication to ViV on the basis of the risk of coronary obstruction.

Posterior leaflet P2-P1 transposition for mitral repair in a case of infective endocarditis.

Infective endocarditis represents a pathological process associated with a high mortality. The dysfunction of cardiac valves and its consequent hemodynamic deterioration often requires urgent surgery. Tissue preservation and valve repair without a substitute material may be extremely difficult. Herein, the details are reported of a safe technique used to repair a mitral valve presenting with P1 destruction caused by pneumococcal endocarditis vegetation, associated with severe mitral regurgitation. A safe repair was achieved by performing a P2 to P1 transposition, after a subvalvular apparatus analysis, followed by annular plication and ring annuloplasty. The postoperative course was uneventful, and echocardiography at discharge showed excellent mitral valve competence. Sufficient evidence was provided to demonstrate that, in these cases, it is better to repair than to replace. Hence, the present technique should be considered, whenever possible, for mitral valve surgical repair in order to avoid substitute interposition in cases of infective endocarditis.

Logistic EuroSCORE I risk analysis in aortic valve reoperations after bioprosthetic replacement.

BACKGROUND AND AIM OF THE STUDY: The aim was to evaluate the early and long-term results of redo-aortic valve replacement (AVR) for dysfunctioning bioprostheses, according to the type of bioprosthesis failure. The performance of the EuroSCORE in predicting operative mortality was addressed. METHODS: A retrospective analysis was performed of 164 patients who had undergone redo-AVR at the authors' institution. All data were collected prospectively. The type of bioprosthesis failure was categorized as either structural valve dysfunction (SVD), non-structural vale dysfunction (NSVD), or infective endocarditis (IE). The logistic EuroSCORE I was obtained, and a formal analysis of its predictive performance was conducted. RESULTS: The mean logistic EuroSCORE was 26.3 +/- 20.6%, while the observed operative mortality was 10.6%. The EuroSCORE overestimated mortality in all subgroups of indication; operative mortality was higher among the NSVD (14.7%) and IE (13.9%) groups, and lower among SVD patients (8.5%). The performance of the EuroSCORE in predicting mortality was better in SVD patients, and worse in NSVD patients (areas under the ROC curve of 0.857 and 0.751, respectively). Only patient-related factors independently predicted the operative mortality (logistic regression). The SVD patients displayed a significantly better long-term survival compared to NSVD and IE patients. Patient-related factors were seen to be the determinants of long-term survival. CONCLUSION: Redo-AVR can be performed with good early and long-term results, despite a high predicted risk. The logistic EuroSCORE I globally overestimates the risk, and its performance varies considerably according to the indication for redo-AVR. Therefore, it should not be used to determine the application of valve-in-valve procedures. The type of indication for redo-AVR (SVD, NSVD, IE) defines three different profiles of patients having distinctive early and long-term behaviors.

Transpulmonary correction of an isolated aortopulmonary window in an adult.

We describe the operative management of a 65-year-old patient with a congenital type I aortopulmonary window. At surgery, heavy calcifications on the aortic side of the defect, and close proximity with the left coronary ostium, prevented patch repair from the transaortic access. Patch closure through a combined transpulmonary approach was therefore required. This case illustrates unique features of a late-presenting aortopulmonary window.

Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.

AIMS: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis. METHODS AND RESULTS: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less. CONCLUSION: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.

Improved diagnosis of post-operative myocardial infarction by contrast echocardiography after coronary artery bypass graft surgery.

OBJECTIVE: Contrast echocardiography is a more accurate means of assessment of left ventricular (LV) regional motion compared with non-enhanced echocardiography. Despite new tests, the diagnosis of post-operative myocardial infarction (MI) remains difficult. The aim of this study was to determine whether contrast echocardiography can facilitate this diagnosis. METHODS: We performed standard and contrast echocardiography in 79 consecutive patients before and up to 10 days after they underwent isolated coronary artery bypass graft (CABG) surgery. RESULTS: The post-operative intra- and interobserver reproducibility of echocardiographic measurements of the LV ejection fraction and wall motion score was significantly higher with than without contrast enhancement. The proportion of non-visualized LV myocardial segments was significantly greater with non-enhanced (6.6%) than with contrast (0.3%) echocardiography (P< 0.0001). The mean peak serum cardiac troponin (cTnI) concentration was significantly higher in the group of patients with new wall motion abnormalities detected with contrast-enhanced echocardiography. A correlation was found (r = -0.43, P< 0.01) between peak cTnI and changes in wall motion score only when a contrast agent was used. CONCLUSION: Contrast echocardiography facilitated the detection of new LV wall motion abnormalities after CABG. This observation, added to other markers, might facilitate the diagnosis of post-operative MI.

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.

Prolonged heparin and vitamin K antagonist regimen for early non-obstructive thrombosis of mechanical mitral valve prostheses.

BACKGROUND AND AIM OF THE STUDY: Transesophageal echocardiography (TEE) has been used to document the incidence of non-obstructive thrombosis (NOT) after mechanical prosthetic mitral valve replacement (MVR). The postoperative occurrence and unpredictable evolution of NOT complicate its management. The study aim was to examine the safety and efficacy of prolonged, combined administration of heparin and vitamin K antagonists (VKA) recommended for this indication. METHODS: All patients who underwent mechanical prosthetic MVR between July 1999 and December 2004 at the authors' institution were systematically studied with TEE immediately after surgery. Patients who presented with > or = 5 mm NOT were treated with combined heparin and VKA until TEE-confirmed resolution of the thrombus. RESULTS: Among 256 patients who underwent 263 MVRs (seven reinterventions), 47 (17.9%) presenting with > or = 5 mm NOT received combined heparin and VKA for between 7 and 115 days (median 17 days). No thromboembolic or hemorrhagic events or deaths were observed during this period of observation. Four patients were treated with danaparoid and VKA because of thrombocytopenia induced by heparin before the diagnosis of NOT. Over a mean follow up of 39 months, one patient died from cancer and another from the sequelae of a stroke. In total, there were five NOT recurrences, three of which were complicated by embolic events without sequelae within eight months, and one by a recurrent stroke. In addition, three patients without demonstrable NOT recurrence suffered transient ischemic attacks. CONCLUSION: Among this small sample of patients, combined heparin and VKA was well tolerated and effective, and could prevent reoperation or thrombolysis. These observations may warrant further study in a larger patient population.

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.