Romain Didier

Comparison of Watchman device with new oral anti-coagulants in patients with atrial fibrillation: A network meta-analysis.

BACKGROUND New oral anticoagulants (NOAC) and the Watchman device represent an alternative to warfarin for stroke prophylaxis in atrial fibrillation (AF) patients. However, no studies compare these new treatments. We performed a network meta-analysis to indirectly compare Watchman and NOACs among AF patients. METHODS We performed a MEDLINE search for studies comparing warfarin with NOACs (dabigatran, rivaroxaban, apixaban and edoxaban) or Watchman in AF patients with reported clinical outcomes. Mixed treatment comparison model generation was performed to directly and indirectly compare NOACs, warfarin and Watchman. RESULTS 14 studies with 246,005 patients were included in the analysis, among which 124,823 were treated with warfarin, 120,450 were treated with NOACs and 732 had Watchman implanted. Mean age was 72 ± 9 years, 53% were male, and mean CHADS2 score was 2.1 ± 1.6. Both NOACs and Watchman were superior to warfarin in hemorrhagic stroke prevention (OR = 0.46 [0.30-0.82] and OR = 0.21 [0.05-0.99], respectively). NOACs significantly reduced total stroke (OR = 0.78 [0.58-0.96]) and major bleeding (OR = 0.78 [0.65-0.91]) compared with warfarin. Indirect comparison between NOAC and Watchman revealed no significant differences in outcomes, though there was a trend toward higher rates of ischemic stroke with Watchman compared with NOAC (OR 2.60 [0.60-13.96]) with the opposite findings with hemorrhagic stroke (OR = 0.44 [0.09-2.14]). CONCLUSIONS NOAC therapy was superior to warfarin for multiple outcomes while Watchman reduced hemorrhagic stroke. Further studies are needed to assess Watchman versus NOAC to optimize therapy for stroke prevention in AF patients.

Body mass index association with survival in severe aortic stenosis patients undergoing transcatheter aortic valve replacement

Conflicting results have been reported regarding impact of body mass index (BMI) on outcome of transcatheter aortic valve replacement (TAVR) patients. This study evaluates the impact of BMI on 1 year mortality in patients undergoing TAVR via the transfemoral (TF) access.

Impact of transfemoral versus transapical access on mortality among patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

OBJECTIVE To compare early and late mortality of transfemoral (TF) and transapical (TA) transcatheter aortic valve replacement (TAVR) patients and assess predictors for mortality. BACKGROUND Studies have shown conflicting results regarding impact of access on outcome in severe aortic stenosis (AS) patients undergoing TAVR. METHODS AS patients undergoing TAVR between May 2007-December 2014 were included. Baseline demographic, clinical, and imaging parameters were compared according to access, and landmark analysis models were generated to assess outcomes and associated factors. RESULTS Among 648 severe AS patients undergoing TAVR, TF was used in 516 and TA in 132. Baseline characteristics between groups demonstrated lower body mass index, higher STS score, and rate of peripheral vascular disease among TA patients. Procedural complications were more common in the TA group, especially major bleeding (15% vs. 6%, p<0.001) and acute kidney injury >1 (8% vs. 1.4%, p<0.001). Landmark analysis demonstrated higher cumulative mortality rates at 30days among TA than TF patients (log-rank p<0.001), with similar mortality after 30days and up to 1-year (13% in both log-rank p=0.64). In a multivariate model, TA was an independent predictor of early mortality (HR=4.55 95% CI [12.5-1.6], p=0.003) along with pulmonary artery systolic pressure>60mmHg (HR=3.08 95% CI [7.37-1.29], p=0.01) and residual aortic regurgitation severity above mild (HR=3.99 95% CI [10.2-1.56], p=0.004). CONCLUSIONS Patients undergoing TAVR via TA have higher adjusted early mortality and similar late mortality rates compared to TF, despite higher risk profile.

Impact of Functional Versus Organic Baseline Mitral Regurgitation on Short- and Long-Term Outcomes After Transcatheter Aortic Valve Replacement

The impact of the specific etiology of mitral regurgitation (MR) on outcomes in the transcatheter aortic valve replacement (TAVR) population is unknown. This study aimed to evaluate the longitudinal changes in functional versus organic MR after TAVR in addition to their impact on survival. Consecutive patients who underwent TAVR from May 2007 to May 2015 who had baseline significant (moderate or greater) MR were included. Transthoracic echocardiography was used to evaluate the cohort at baseline, post-procedure, 30-day, 6-month, and 1-year follow-up. The primary outcomes included mortality at 30 days and 1 year. Longitudinal, mixed-model regression analyses were performed to assess the differences in the magnitude of longitudinal changes of MR, left ventricular (LV) ejection fraction, and New York Heart Association functional class. Seventy patients (44% men, mean 83 years) with moderate or greater MR at baseline (30 functional vs 40 organic) were included, with the functional group having a statistically significant mean younger age and higher rates of previous coronary artery bypass grafting. Kaplan-Meier cumulative mortality rates were similar: 30 days (10% vs 17.5%, unadjusted log-ranked p = 0.413) and 1 year (29.4% vs 23.2%, unadjusted log-ranked p = 0.746) in the functional versus organic MR groups, respectively. There were greater degrees of short- and long-term improvement in MR severity (slope difference p = 0.0008), LV ejection fraction (slope difference p = 0.0009), and New York Heart Association class (slope difference p = 0.0054) in the functional versus organic group. In conclusion, patients with significant functional versus organic MR who underwent TAVR have similar short- and long-term survival; nevertheless, those with a functional origin are more likely to have significant improvements in MR severity, LV-positive remodeling, and functional class. These findings may help strategize therapies for MR in patients with combined aortic and mitral valve disease who are undergoing TAVR.

Impact of right ventricular function on outcome of severe aortic stenosis patients undergoing transcatheter aortic valve replacement

Background Right ventricular (RV) dysfunction was shown to be associated with adverse outcomes in a variety of cardiac patients and is considered a risk factor for adverse outcome according to the updated Valve Academic Research Consortium criteria. Objective Our goal was to assess the impact of RV function at baseline on 1‐year mortality among patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). Methods All patients with severe AS treated with TAVR from May 2007 to March 2015 at our center were included in the present study, and baseline and procedural characteristics were recorded for each patient. The patients were categorized according to RV function at baseline as assessed by current guidelines, and a comparison of mortality rates up to 1 year was performed. Results Among 650 patients, 606 had adequate echocardiogram quality and 146 (24%) had RV dysfunction. There were significant differences between the 2 groups, as patients with RV dysfunction were younger (81 ± 9 vs 84 ± 7 years, P = .01) and were more likely to be male (65% vs 42%, P < .001). In addition, patients with RV dysfunction had higher rates of prior myocardial infarction (26% vs 16%, P = .02) and atrial fibrillation (51% vs 39%, P = .02). Echocardiographic parameters demonstrated higher rates of left ventricular ejection fraction <40% (40% vs 18%, P < .001), tricuspid regurgitation above moderate (16% vs 9%, P = .04), and higher pulmonary artery systolic pressure (50 ± 17 vs 44 ± 16 mm Hg, P < .001) among patients with severe AS and RV dysfunction compared with patients with normal RV function. Despite the unfavorable cardiac function, patients with severe AS undergoing TAVR have similar functional class (P = .22) and mortality rates at 1 year (27% vs 23%, log‐rank P = .45). Conclusions Patients with severe AS and RV dysfunction have similar 1‐year mortality and functional class after TAVR to patients with normal RV function. The presence of RV dysfunction does not correlate with outcome in patients with severe AS.

Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials.

Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short‐ (≤6 months) versus long‐term (≥1 year) DAPT after drug‐eluting stent (DES) placement in women and men.

Role of near-infrared spectroscopy in intravascular coronary imaging

Near-infrared spectroscopy is an intracoronary imaging modality that has been validated in preclinical and clinical studies to help quantify the lipid content of the coronary plaque and provide information regarding its vulnerability. It has the potential to develop into a valuable tool for the risk stratification of a vulnerable plaque and, furthermore, a vulnerable patient. In addition, in the future this technology may help in the development of novel therapies that impact vascular biology.

The utilisation of the cardiovascular automated radiation reduction X-ray system (CARS) in the cardiac catheterisation laboratory aids in the reduction of the patient radiation dose

AIMS The radiation exposure resulting from cardiovascular procedures may increase the risk of cancer, and/or cause skin injury. Whether the novel cardiovascular automated radiation reduction X-ray system (CARS) can help reduce the patient radiation dose in daily clinical practice remains unknown. The aim of this study was to evaluate the reduction in patient radiation dose with the use of CARS in the cardiac catheterisation laboratory (CCL). METHODS AND RESULTS This study retrospectively analysed 1,403 consecutives patients who underwent a cardiac catheterisation with coronary angiography (CA) and/or a percutaneous coronary intervention (PCI) in the Brest University Hospital over the course of one year. Patient radiation doses (dose area product and air kerma) were collected and compared between the CCL with (new CCL) and without (control CCL) CARS. Additionally, the patient radiation doses according to femoral versus radial access, procedural complexity and body mass index were compared. The radiation lesion position on the skin was assessed by automatically optimising the X-ray source to image distance (SID) and subsequently generating a radiation Dose-Map for those procedures exceeding 3 Gray of exposure. Overall, 447 patients underwent procedures in the control CCL and 956 in the new CCL. Baseline patient and procedural characteristics were similar between the two groups, with the exception of male gender and primary PCI, which were more prevalent in the new CCL group. Compared to the control CCL, the utilisation of the CARS in the new CCL resulted in a reduction of dose area product by 46% for CA, 56% for PCI alone and 54% for CA and PCI during the same procedure. Of note, radial access generated a higher radiation dose than femoral access (p<0.001). In this study, seven patients had an air kerma exceeding 3 Gray; however, only one patient had a skin dose greater than 3 Gray. CONCLUSIONS The utilisation of the CARS resulted in a significant reduction in patient radiation doses compared to the control equipment. A real-time Dose-Map may help the operator change the projection during complex procedures to reduce the patient skin dose.

Vascular access in critical limb ischemia

Currently, percutaneous endovascular intervention is considered a first line of therapy for treating patients with critical limb ischemia. As the result of remarkable development of techniques and technologies, percutaneous endovascular intervention has led to rates of limb salvage comparable to those achieved with bypass surgery, with fewer complications, even in the presence of lower rates of long-term patency. Currently, interventionalists have a multiplicity of access routes including smaller arteries, with both antegrade and retrograde approaches. Therefore, the choice of the optimal access site has become an integral part of the success of the percutaneous intervention. By understanding the technical aspects, as well as the advantages and limitations of each approach, the interventionalists can improve clinical outcomes in patients with severe peripheral arterial disease. This article reviews the access routes in critical limb ischemia, their advantages and disadvantages, and the clinical outcomes of each.

Aortic Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement With the Self-Expanding CoreValve Versus the Balloon-Expandable SAPIEN XT Valve.

The incidence of aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) in a self-expanding and a balloon-expandable system is controversial. This study aimed to examine the incidence and severity of post-TAVR AR with the CoreValve (CV) versus the Edwards XT Valve (XT). Baseline, procedural, and postprocedural inhospital outcomes were compared. The primary end point was the incidence of post-TAVR AR of any severity, assessed with a transthoracic echocardiogram, in the CV versus XT groups. A multivariate logistic regression analysis was completed to evaluate for correlates of the primary end point. The secondary end points included the change in severity of AR at 30-day and 1-year follow-up. A total of 223 consecutive patients (53% men, mean age 82 years) who had transfemoral TAVR with either a CV (n = 119) or XT (n = 104) were evaluated. The rates of post-TAVR AR in the groups were similar, and there was no evidence of more-than-moderate AR in either group. There were significant differences in the rates of intraprocedural balloon postdilation with the CV (17.1%) versus XT valve (5.8%; p = 0.009) and in the rates of intraprocedural implantation of a second valve-in-valve prosthesis with the CV (9.9%) versus XT valve (2.2%; p = 0.036). There were no significant differences in inhospital safety outcomes between the 2 groups. In conclusion, the incidence of post-TAVR AR is similar between the CV and the XT valve when performed by experienced operators using optimal intraprocedural strategies, as deemed appropriate, to mitigate the severity of AR.