Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry.

BACKGROUND: Sizing for transcatheter aortic valve implantation in bicuspid aortic valves (BAV) remains controversial. METHODS AND RESULTS: The aim of the BAVARD (Bicuspid Aortic Valve Anatomy and Relationship With Devices) retrospective registry is to capture the sizing ratios used for transcatheter aortic valve implantation in BAV and analyze the second-generation prostheses geometry postimplantation. About 101 patients with BAV along with available pre- and post-transcatheter aortic valve implantation multidetector computed tomography were compared with 88 tricuspid aortic valves (TAV) patients. Preprocedural multidetector computed tomography diagnosed type 0 and type 1 BAV in, respectively, 12.9% and 86.1 % of BAV. At baseline, the ellipticity index was similar between BAV and TAV patients: 1.2±0.1 versus 1.2±0.1, P=0.09. The mean annular oversizing was, respectively, 1.14±0.04 and 1.04±0.04, P<0.001, in TAV and BAV patients. The mean prosthesis intercommissural distance, ratio was 1.03±0.1. The mean diameter of the prostheses at the annulus matched the mean perimeter-derived diameter of the aortic annulus at baseline with TAV (23.3±2.2 versus 23.6±1.9, P=0.4) and was smaller with BAV (24±2.8 versus 26.8±3.1, P<0.01), confirming 11% underexpansion in BAV. Finally, in situ, prosthesis diameter and ellipticity followed the same pattern, with stable values from the distal edge to 12 mm above, in both groups. CONCLUSIONS: Second-generation prostheses similarly reshape the aortic annulus in TAV and BAV. Prostheses keep consistent diameters from distal edge to 12 mm in TAV and BAV. Prosthesis underexpansion is constantly observed in BAV. Annular-based sizing is accurate in BAV with minimal oversizing. The intercommissural distance, 4 mm above the annulus, could be integrated in gray zones. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03495050.

Directional atherectomy with antirestenotic therapy for the treatment of no-stenting zones.

Endovascular treatment for peripheral artery occlusive disease carries unresolved problem of restenosis. Treatment modalities in areas of high mechanical stress like popliteal artery and common femoral artery remains challenging. New-generation devices improved the results of stent therapy in this anatomical territory, but could impact on future surgical options if they are needed. Vessel preparation prior to drug (paclitaxel)-coated balloons (DCB) angioplasty leads to better paclitaxel penetration into the arterial wall and improved drug uptake. The "leave nothing behind" strategies, DCB angioplasty and combined directional atherectomy (DA) and antirestenotic therapy (DAART), can theoretically overcome the problems caused by the mobility of the knee joint. However, calcified and longer lesions remain a challenging subset that is less responsive to DCBs, resulting in higher provisional stent rates. For the treatment of long and calcified femoropopliteal lesions, vessel preparation with DA before DCB angioplasty seems to be safe in mid-term follow-up and might have benefits in more challenging lesion subsets that are at higher risk for acute and chronic technical treatment failure of percutaneous transluminal angioplasty, including DCB angioplasty, such as severely calcified lesions. Treatment with DA+DCB resulted in both increased technical success and fewer flow-limiting dissections compared with treatment with DCB alone. In concept of "leave nothing behind" therapies for isolated popliteal artery lesions, DAART was associated with a higher primary patency rate than DCB angioplasty alone.

Aortic valve anatomy and outcomes after transcatheter aortic valve implantation in bicuspid aortic valves.

This original clinical research study id focused on description of baseline anatomy and outcomes after transcatheter aortic valve implantation (TAVI) in patients presenting with severe aortic stenosis (AS) and bicuspid aortic valve (BAV). We compared this BAV population with a population of patients with AS and tricuspid aortic valves after a propensity score matching developed by a multivariate logistic regression according to a non-parsimonious approach. Baseline anatomical characteristics were obtained by transthoracic echocardiography (TTE) and multi-sliced computed tomography (MSCT) and compared by chi-square and t-student tests. Outcomes were evaluated by correct fisher test at in hospital and 30 days follow-up. We found that BAV patients presents more complicated baseline anatomy as compared to patients with tricuspid valves. These anatomical features lead to higher procedural complications as the need for a second device implantation. However this does not translate into increase in mortality rate at 30 days follow-up but rather correlate to a lower device success rate.

What are the remaining limitations of TAVI?

Transcatheter aortic valve implantation (TAVI) is a recognized therapy for patients with symptomatic severe aortic stenosis (AS). TAVI is superior compared to medical therapy as for mortality in extreme-risk patients, is non-inferior or superior to surgery in high-risk patients and non-inferior to surgery in intermediate-risk patients. However, several limitations affect outcomes after TAVI. Adverse events related to this procedure, like vascular complications, need for pacemaker implantation, paravalvular regurgitation, can be factors limiting TAVI treatment in younger patients at lower risk, as well as uncertainties regarding valve durability. This review tries to figure out some of the main complications still unsolved after TAVI.

Impact of Pre-Existing Prosthesis-Patient Mismatch on Survival Following Aortic Valve-in-Valve Procedures.

OBJECTIVES: The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size). BACKGROUND: Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation. METHODS: Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality. RESULTS: Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg). CONCLUSIONS: Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Non-Vitamin K Oral Anticoagulants for Stroke Prevention in Special Populations with Atrial Fibrillation.

Atrial fibrillation (AF) is associated with an increased risk of ischemic stroke or systemic embolism compared with normal sinus rhythm. These strokes may efficiently be prevented in patients with risk factors using oral anticoagulant therapy, with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) (i.e., direct thrombin inhibitors or direct factor Xa inhibitors). Owing to their specific risk profiles, some AF populations may have increased risks of both thromboembolic and bleeding events. These AF patients may be denied oral anticoagulants, whilst evidence shows that the absolute benefits of oral anticoagulants are greatest in patients at highest risk. NOACs are an alternative to VKAs to prevent stroke in patients with "non-valvular AF", and NOACs may offer a greater net clinical benefit compared with VKAs, particularly in these high-risk patients. Physicians have to learn how to use these drugs optimally in specific settings. We review concrete clinical scenarios for which practical answers are currently proposed for use of NOACs based on available evidence for patients with kidney disease, elderly patients, women, patients with diabetes, patients with low or high body weight, and those with valve disease.

Oral anticoagulation, stroke and thromboembolism in patients with atrial fibrillation and valve bioprosthesis. The Loire Valley Atrial Fibrillation Project.

Vitamin K antagonists are currently recommended in patients with 'valvular' atrial fibrillation (AF), e. g. those having mitral stenosis or artificial heart valves. We compared thromboembolic risk in patients with 'non valvular' AF and in those with AF and biological valve replacement (valve bioprosthesis). Among 8962 AF patients seen between 2000 and 2010, a diagnosis of 'non-valvular AF' was found in 8053 (94 %). Among patients with 'valvular' AF, 549 (6 %) had a biological prosthesis. The patients with bioprosthesis were older and had a higher CHA2DS2-VASc score than those with non valvular AF. After a follow-up of 876 ± 1048 days (median 400 days, interquartile range 12-1483), the occurrence of thromboembolic events was similar in AF patients with bioprosthesis compared to those with 'non valvular' AF (hazard ratio [HR] 1.10 95 % confidence interval [CI] 0.83-1.45, p=0.52, adjusted HR 0.93, 95 %CI 0.68-1.25, p=0.61). Factors independently associated with increased risk of stroke/TE events were older age (HR 1.25, 95 %CI 1.16-1.34 per 10-year increase, p< 0.0001) and higher CHA2DS2-VASc score (HR 1.35, 95 %CI 1.24-1.46, p< 0.0001) whilst female gender (HR 0.75, 95 %CI 0.62-0.90, p=0.002), use of vitamin K antagonist (HR 0.83, 95 %CI 0.71-0.98, p=0.03) were independently associated with a lower risk of stroke/TE. Neither the presence of bioprosthesis nor the location of bioprosthesis was independent predictor for TE events. In conclusion, AF patients with bioprosthesis had a non-significantly higher risk of stroke/TE events compared to patients with non-valvular AF. Second, the CHA2DS2-VASc score was independently associated with an increased risk of TE events, and was a valuable determinant of TE risk both in AF patients with non-valvular AF as well as those with bioprosthesis, whether treated or not treated with OAC.

How to define valvular atrial fibrillation?

Atrial fibrillation (AF) confers a substantial risk of stroke. Recent trials comparing vitamin K antagonists (VKAs) with non-vitamin K antagonist oral anticoagulants (NOACs) in AF were performed among patients with so-called "non-valvular" AF. The distinction between "valvular" and "non-valvular" AF remains a matter of debate. Currently, "valvular AF" refers to patients with mitral stenosis or artificial heart valves (and valve repair in North American guidelines only), and should be treated with VKAs. Valvular heart diseases, such as mitral regurgitation, aortic stenosis (AS) and aortic insufficiency, do not result in conditions of low flow in the left atrium, and do not apparently increase the risk of thromboembolism brought by AF. Post-hoc analyses suggest that these conditions probably do not make the thromboembolic risk less responsive to NOACs compared with most forms of "non-valvular" AF. The pathogenesis of thrombosis is probably different for blood coming into contact with a mechanical prosthetic valve compared with what occurs in most other forms of AF. This may explain the results of the only trial performed with a NOAC in patients with a mechanical prosthetic valve (only a few of whom had AF), where warfarin was more effective and safer than dabigatran. By contrast, AF in the presence of a bioprosthetic heart valve or after valve repair appears to have a risk of thromboembolism that is not markedly different from other forms of "non-valvular" AF. Obviously, we should no longer consider the classification of AF as "valvular" (or not) for the purpose of defining the aetiology of the arrhythmia, but for the determination of a different risk of thromboembolic events and the need for a specific antithrombotic strategy. As long as there is no better new term or widely accepted definition, "valvular AF" refers to patients with mitral stenosis or artificial heart valves. Patients with "non-valvular AF" may have other types of valvular heart disease. One should emphasize that "non-valvular AF" does not exclude patients with some types of valvular heart disease from therapy with NOACs.

Prognostic value of CHA2DS2-VASc score in patients with 'non-valvular atrial fibrillation' and valvular heart disease: the Loire Valley Atrial Fibrillation Project.

AIMS: The CHA2DS2VASc score is a clinical risk stratification tool which estimates the risk of stroke and thromboembolism in non-valvular atrial fibrillation (AF). We aimed to establish the value of this score for risk evaluation in patients with non-valvular AF and valvular heart disease. METHODS AND RESULTS: Among 8053 patients with non-valvular AF (ESC guidelines definition), patients were categorized into Group 1 (no valve disease, n = 6851; 85%) and Group 2 (valve disease with neither rheumatic mitral stenosis nor valve prothesis, n = 1202; 15%). After follow-up of 868 ± 1043 days, 627 stroke/ thromboembolic (TE) events were recorded. Group 2 was significantly older, had a higher CHA2DS2VASc score and had a higher risk of thromboembolic events [hazard ratio (HR) 1.39; 95% CI 1.14-1.69, P = 0.001] compared with Group 1. Severe valve disease was not associated with worse prognosis for stroke/TE events. In the two groups, stroke/TE risk increased with a higher CHA2DS2VASc score. Factors independently associated with increased risk of stroke/TE events were older age (HR 1.25, 95% CI 1.14-1.36 per 10-year increase, P < 0.0001) and higher CHA2DS2VASc score (HR 1.33, 95% CI 1.23-1.45, P < 0.0001). The predictive value (c-statistic) of the CHA2DS2VASc score was similar in the two groups. CONCLUSION: In patients with non-valvular AF, left-sided valvular heart disease (excluding mitral stenosis and protheses) was associated with an increased risk of stroke/TE events. A higher CHA2DS2VASc score in these patients is likely to explain these results.