Percutaneous closure of a paravalvular prosthetic mitral leak complicated by need for acute hemodialysis.

A case of a severe paravalvular mechanical mitral prosthesis leak (PVL) in a high-risk surgical patient, complicated with acute heart failure at presentation is described. Considering the high surgical risk and the specific echocardiographic features that would prevent the interventional cardiologist to have a direct access to the PVL with a traditional vascular plug or duct occluder, a percutaneous PVL closure with an Amplatzer-Amulet (Abbott, Abbott Park, Illinois, United States) LAA device (28 mm) was chosen for the contiguity of the PVL to the left atrial appendage (LAA). A new-onset hemolysis post-PVL closure and severe renal failure requiring hemodialysis occurred after the procedure, treated with surgical device removal and leak suture. To the best of our knowledge, this is the first case that describes the attempt to close a PVL, contiguous to the LAA, using the Amulet device. The attempt to close a PVL with these features with an Amplatzer-Amulet device, although promising, does not appear completely safe to reach the goal, as in our case. In our opinion, the most important reasons are that specific technical recommendations and broad experiences are lacking. Indeed, specific outcomes of this kind of approach are, to date, still unknown.

Acute lower extremity ischaemia after surgical interventricular communication closure in a newborn.

We report a 5-month-old infant who developed an unexpected acute ischaemia of the right lower limb following a surgical perimembranous interventricular communication closure. This rare case of ischaemia was due to an occlusive right common iliac artery dissection. It was early managed by angioplasty with two ABSORB® bioresorbable stents, resulted in complete revascularisation of the right leg.

TAVR Patients Requiring Anticoagulation: Direct Oral Anticoagulant or Vitamin K Antagonist?

OBJECTIVES: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND: The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.

Diabetes mellitus is not associated with worse vascular outcome following percutaneous transfemoral transcatheter aortic valve implantation.

Background: Transcatheter aortic valve implantation (TAVI) is an alternative to open surgical aortic valve replacement and the impact of diabetes on vascular outcomes is worth of investigation. The aim of our study was to determine if diabetic patients had distinct pre-operative characteristics compared to non-diabetics and to evaluate the impact of the disease on vascular outcomes.Methods: Four hundred consecutive patients who underwent TAVI with percutaneous transfemoral access were retrospectively included. Vascular outcomes were classified according to the Valve Academic Research Consortium 2 classification.Results: Seventy-eight (19.5%) patients were diabetics. Compared to non-diabetics, diabetic patients were younger and had significantly higher body mass index (29.7+/- 0.7 kg/m2 vs 26.8+/- 0.3, p < .0001), higher proportion of associated dyslipidemia (34.6% vs 11.5%, p < .0001) and arterial hypertension (60% vs 38.2%, p = .0009). Anatomical characteristics of the vascular access and procedural characteristics did not differ among the groups. No significant difference was observed in the incidence of major and minor vascular complications and 30-day post-operative mortality between diabetic and non-diabetic patients (2.6% vs 1.9%, p = .6916).Conclusion: Diabetes is not associated with worse vascular outcome following TAVI suggesting that the vascular access can be managed safely in these patients.

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.

Surgical Management of Percutaneous Transfemoral Access to Minimize Vascular Complications Related to Transcatheter Aortic Valve' Implantation.

Transcatheter aortic valve implantation (TAVI) is associated with substantial rates of vascular complications. The aim of our study is to describe the surgical management of percutaneous transfemoral access by a vascular surgeon and to report the 30-day postoperative vascular complications and mortality. Perioperative procedures to manage the femoral access site were recorded retrospectively from 220 consecutive patients who underwent TAVI. Postoperative vascular complications related to the main access were categorized according to the Valve Academic Research Consortium 2 classification. Perioperative procedures related to vascular access were performed for 56 (25.4%) patients: 6 patients required open surgical repair, 48 patients underwent endovascular stenting, and 2 patients had both procedures. The all-cause mortality was 3.6%, but no death related to a vascular complication was reported during the 30-day postoperative follow-up period. Ten (4.5%) patients developed postoperative hematomas; 2 (0.9%) of them were retroperitoneal and led to major bleeding requiring an unplanned surgical intervention. Our study underlines the utility of a multidisciplinary approach to manage the percutaneous access in TAVI for managing postoperative vascular complications.

A 7-Year Single-Center Experience of Transfemoral TAVI: Evolution of Surgical Activity and Impact on Vascular Outcome.

Transcatheter aortic valve implantation (TAVI) has become a well-established alternative to open surgery to treat aortic stenosis. We describe our 7-year TAVI experience using transfemoral access and identity changes in surgical activity and evaluate its impact on postoperative vascular outcomes. Consecutive patients (N = 340) who underwent TAVI with percutaneous transfemoral access were retrospectively included and divided into 4 quartiles according to the date of intervention. Vascular outcomes were classified according to the Valve Academic Research Consortium 2 classification. The number of patients who underwent transfemoral TAVI increased over time and their clinical characteristics evolved, with a lower Society of Thoracic Surgeons score and less comorbidities. The material used evolved and TAVI could be performed despite higher iliac calcification and tortuosity scores. With experience, the procedural time, the postoperative length of stay at hospital, and the 30-day postoperative mortality significantly decreased. No significant change was observed for vascular outcome, except for minor hematoma. We witnessed an increase in transfemoral TAVI procedure, with changes in clinical and procedural characteristics associated with an improvement in postoperative outcomes.

Angiographic Analysis of Vascular Integrity After Percutaneous Closure Using Prostar XL Device During Transcatheter Aortic Valve Implantation.

INTRODUCTION: Percutaneous closure devices are commonly used to achieve hemostasis during endovascular procedures including transcatheter aortic valve implantation (TAVI). The aim of our study was to investigate the quality of the percutaneous femoral arterial closure by Prostar XL device using a systematic peroperative angiographic control at the end of TAVI procedure. MATERIALS AND METHODS: Two hundred seventeen consecutive patients (mean age: 84 [6.5]; 112 women and 105 men) undergoing TAVI with percutaneous transfemoral access were prospectively registered in our center. Preoperative computed tomography scan was performed, and mean femoral vessel diameter was 7.9 (0.9) mm. At the end of TAVI intervention, the hemostasis was systematically achieved using the percutaneous closure device Prostar XL, without selection of patients based on anatomical criteria. An angiography with front and oblique views was performed to evaluate the quality and the safety of the closure device. Success of the percutaneous closure was defined as the absence of hemorrhage and the restitution of the arterial anatomy. Complications related to the percutaneous closure were classified as stenosis, dissection at the puncture site, suture failure, misplacement, or persistent bleeding. RESULTS: Twenty-three (10.6%) patients had complications related to arterial percutaneous closure-14 (60.8%) stenosis, 6 (26.1%) persistent bleeding, and 1 (4.3%) dissection. These lesions were accessible to endovascular treatment via a crossover procedure. One (4.3%) suture failure and 1 (4.3%) misplacement of the device, with a puncture site created above the femoral arch, were reported. The patient developed a retroperitoneal hematoma postoperatively and required transfusion of 2 units of red blood cells associated with a cutdown to remove hematoma and to repair the common femoral artery. CONCLUSION: Angiography after arterial percutaneous closure using Prostar XL device during TAVI allows detection and endovascular treatment of vascular complications and is associated with low rate of conversion to open surgery.

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.

Outcomes of the infant Ross procedure for congenital aortic stenosis followed into adolescence.

OBJECTIVES: The Ross procedure is used to treat aortic valve disease in children. The advantages include autograft growth, long-term durability, and avoidance of anticoagulation. Long-term follow-up of the Ross procedure in infancy is limited. We sought to characterize the long-term outcomes of infants undergoing the Ross procedure. METHODS: We performed a retrospective review of all patients who underwent a Ross operation at 18 months of age or younger at New-York Presbyterian and Cardiothoracic Center of Monaco from 1991 to 2010. The clinical, catheterization, and surgical records were reviewed. The most recent follow-up information, including echocardiogram and electrocardiogram, was obtained and analyzed. RESULTS: A total of 34 patients underwent a Ross procedure at a median age of 6 months (range, 4 days to 18.4 months). All had congenital aortic stenosis. All but 1 patient had undergone previous surgical or catheter-based interventions. The median follow-up was 10.6 years (range, 1.4-20.4 years). There were 4 early deaths and 1 late transplant. The freedom from right ventricular outflow tract reintervention was 85% at 5 years and 64% at 10 years. The freedom from autograft reintervention was 95.5% at 10 years. In 20 subjects, late follow-up echocardiograms showed a significant difference between the mean early and late Z scores of the autograft annulus (0.8 vs 2.4, P = .03), sinus (0.8 vs 2.8, P = .002), and sinotubular junction (1.2 vs 2.7, P = .04). Mild or less aortic insufficiency occurred in 17 subjects. None had significant aortic stenosis. CONCLUSIONS: The long-term outcomes of the Ross procedure in infants and toddlers are favorable despite moderate dilatation of the autograft. Reintervention at the right ventricular outflow tract is common.

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.).

PFO closuRE and CryptogenIc StrokE (PRECISE) registry: a multi-center, international registry.

BACKGROUND: The Premere™ PFO closure device has a special design for closure of patent foramen ovale (PFO) including a flexible distance and angulation between the right and left disc providing minimal septal distortion. The primary objective of the study was to determine the degree of risk for stroke or transient ischemic attack (TIA) in patients after Premere™ PFO closure device implantation. METHODS: In this multicenter, prospective observational registry, patients with a clinical indication for PFO closure were included. Patients had a history of stroke or TIA with right to left shunt. Follow-up visits were scheduled according to routine clinical practice. RESULTS: In 23 centers from 10 countries, 267 patients with successful device implantation were included. Assessment of right to left shunt after device implantation revealed no residual shunt in 71 %, small shunts in 16.8 %, and moderate or large residual shunts in 5.6 and 6.5 %. With common clinical practice, use of Coumadin or heparin decreased from 27 % pre- to 3 % post-implantation, while use of acetylsalicylic acid or thienopyridines increased from 64 to 95 % and 27 to 80 %, respectively; 18 % of patients were discharged with anti-platelet monotherapy. Mean follow-up was 11 ± 9 months (range 1-24 months). There was no stroke or TIA. During follow-up, there was one sudden death. Atrial fibrillation occurred in five (1.9 %) patients. One (0.4 %) patient with a thrombophilic diathesis developed a thrombus. CONCLUSIONS: In this prospective, international, multicenter PRECISE registry, the use of the Premere™ PFO closure device for closure of PFO after stroke or TIA resulted in good clinical results with no recurrent event.

Long-term follow-up of patients with first-time chest pain having 64-slice computed tomography.

A paucity of data on outcome of coronary multislice computed tomography (CT) is available. The aim of this study was to assess the long-term follow-up of 64-slice CT in a homogenous patient group. In total 222 patients (136 men, 61%, 59 ± 11 years of age) with chest pain at intermediate risk of coronary artery disease (CAD) and no previous CAD underwent 64-slice CT. Coronary lesions were considered significant or not based on a threshold of 50% luminal narrowing. Plaques were classified as calcified, noncalcified, and mixed based on type. End point during follow-up was major adverse cardiac events (nonfatal myocardial infarction, unstable angina requiring hospitalization, myocardial revascularization). Coronary plaques were detected in 162 patients (73%). Coronary artery stenosis was significant in 62 patients. Normal arteries were found in 59 patients (27%). During a mean follow-up of 5 ± 0.5 years, 30 cardiac events occurred. Annualized event rates were 0% in patients with normal coronary arteries, 1.2% in patients with nonsignificant stenosis, and 4.2% in patients with significant stenosis (p <0.01). Predictors of cardiac events were presence of significant stenosis, proximal stenosis, and multivessel disease. Noncalcified and mixed plaques had the worse prognosis (p <0.05). In conclusion, 64-CT provides long-term incremental value in patients at intermediate risk of CAD.