Charbel Naim

Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Severely Stenotic Bicuspid Versus Tricuspid or Nonbicuspid Valves

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7±7.1 vs 79.8±7.4 years, p=0.06) and with a larger aortic annulus (25.0±1.8 vs 23.6±2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment.

TAVR-Associated Prosthetic Valve Infective Endocarditis : Results of a Large, Multicenter Registry

In this study, we report the incidence, causes, and outcomes of prosthetic valve infective endocarditis (PIE) in 2,572 consecutive patients who underwent transcatheter aortic valve replacement (TAVR) (1,191 balloon-expandable transcatheter heart valves \[THVs\] \[Edwards Sapien, Edwards Lifesciences

Comparison of First- and Second-Generation Drug-Eluting Stents in Saphenous Vein Grafts Used as Aorto-Coronary Conduits

Saphenous vein grafts (SVGs) are prone to an aggressive atherosclerotic process, and the efficacy of drug-eluting stents (DES) in treating this is still debated. In recent years, second-generation DES have been increasingly used in SVG intervention. The main objective of this study was to compare midterm clinical outcomes between first- and second-generation DES in SVGs because data regarding the use of second-generation DES in SVG are lacking. Patients treated with first-generation DES (127 patients with 143 lesions) and those treated with second-generation DES (84 patients with 100 lesions) were included in the study. Major adverse cardiac events, defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization, as well as target vessel revascularization and target lesion revascularization separately, were evaluated at 30-day, 12-month, and 18-month follow-up. Baseline characteristics were similar between the 2 groups. Older grafts were treated with second-generation DES (11.6 ± 5.3 vs 14.3 ± 6.0 years, p = 0.001). Stent length was longer in the first-generation group (34.1 ± 25.1 vs 30.5 ± 19.4 mm, p = 0.006), and maximum balloon diameter was smaller in the second-generation group (3.42 ± 0.42 vs 3.30 ± 0.41 mm, p = 0.003). Embolic protection device use was higher in the second-generation DES group (55.2% vs 72.0%, p = 0.012). At 18-month follow-up, rates of major adverse cardiac events, target vessel revascularization, and target lesion revascularization for the first- and second-generation groups were 24.4% versus 20.2% (p = 0.479), 18.1% versus 14.2% (p = 0.465), and 15.0% versus 10.7% (p = 0.373), respectively. In conclusion, second-generation DES are at least comparable with first-generation DES with regard to clinical outcomes at midterm follow-up.

First- versus second-generation drug-eluting stents for the treatment of coronary bifurcations☆

BACKGROUND Randomized controlled trials have demonstrated that second-generation drug-eluting stents (DESs) for the treatment of obstructive coronary artery disease are associated with comparable, if not improved, clinical outcomes as compared to those of their first-generation counterparts. The aim of this study was to compare the long-term clinical outcomes associated with first- versus second-generation DESs for the treatment of coronary bifurcation lesions. METHODS AND MATERIALS This was a retrospective study of consecutive de novo bifurcation lesions, excluding those at the left main, treated with either second-generation DES (everolimus-eluting or resolute zotarolimus-eluting stents) between October 2006 and October 2011 (199 bifurcation lesions in 192 patients) or first-generation DES (sirolimus-eluting or paclitaxel-eluting stents) between April 2002 and December 2005 (289 bifurcation lesions in 273 patients). RESULTS Second-generation DES use in this setting was associated with less major adverse cardiac events (MACE) (23.1% vs. 14.4%, p=0.02) as well as lower target vessel revascularization (TVR) rates (15.5% vs. 8.3%, p=0.01) at 2-year follow-up. Target lesion revascularization, both per patient (12.6% vs. 7.4%, p=0.02) and per bifurcation (11.8% vs. 7.0%, p=0.03), was also improved with second-generation DES over the same follow-up period. Propensity-score adjusted analysis suggested that second-generation DES was associated with a lower incidence of MACE (HR, 0.53; 95% CI, 0.33-0.85; p=0.01) and TVR (HR, 0.44; 95% CI, 0.24-0.83; p=0.01). CONCLUSIONS Our results suggest that the use of second-generation DES for the treatment of bifurcation lesions is associated with better clinical outcomes as compared to first-generation DES, largely due to a lower need for repeat revascularization.

The role of intravascular ultrasound and quantitative angiography in the functional assessment of intermediate coronary lesions: Correlation with fractional flow reserve

BACKGROUND The correlation between fractional flow reserve (FFR) and intravascular ultrasound (IVUS) metrics including minimal lumen area (MLA), plaque burden and morphology remain a matter of debate. METHODS Between June 2008 and May 2013, 132 intermediate stenoses in 109 patients were assessed by FFR, IVUS and quantitative angiography. Receiver-operating characteristic (ROC) curve analyses were used to identify MLA/lesion length/plaque burden cut-off values predictive of FFR <0.80. RESULTS FFR <0.80 was observed in 39 lesions. In the entire cohort, MLA value <2.70mm(2) had 79.5% sensitivity, 76.3% specificity, 0.822 area under curve (AUC), 58.5% positive predictive value, 89.9% negative predictive value and 77.3% accuracy in predicting a positive FFR. In lesions with reference diameter vessel (RVD) ≥3.0mm, the MLA cut-off value was 2.84mm(2) (sensitivity 72.2%, specificity 83.0%, AUC 0.842) whereas in lesions with RVD <3.0mm, 2.59mm(2) (sensitivity 90.5%, specificity 69.6%, AUC 0.823). A moderate correlation was observed between MLA and FFR (r=0.429, p<0.001). The cut-off lesion length predictive of FFR <0.80 was 11.0mm with a weak correlation between the two (r=-0.348, p<0.001). Plaque morphology did not significantly affect FFR (p=0.485). On multivariable analysis, MLA (OR: 0.15; 95% CI: 0.05-0.40; p<0.001) and plaque burden (OR: 1.11; 95% CI: 1.04-1.20; p<0.003) were independent predictors of FFR <0.80. CONCLUSION A modest, yet significant correlation was observed between MLA and FFR. The high negative predictive value of large MLAs (using afore-mentioned cut-off values) may provide some degree of confidence that the lesion in question is not functionally significant.

Comparison of abluminal biodegradable polymer biolimus-eluting stents and durable polymer everolimus-eluting stents in the treatment of coronary bifurcations.

To compare biodegradable polymer biolimus‐eluting (BES) with abluminal drug elution and durable polymer everolimus‐eluting (EES) stents in the treatment of bifurcation lesions.

Clinical outcomes of real‐world patients treated with an amphilimus polymer‐free stent versus new generation everolimus‐eluting stents

To compare the 1‐year clinical outcomes after implantation of the amphilimus, polymer‐free stent (Cre8) versus new generation everolimus‐eluting stents (EESs) in a real‐world patient registry.

Drug-coated balloons in interventional cardiology

Over the last few years, drug-coated balloon (DCB) therapy has emerged as a promising therapeutic intervention for the management of obstructive cardiovascular disease. The dictum of this novel technology is that effective prevention of restenosis can be achieved by the short-term transfer of antiproliferative drug to local arterial tissue by means of a single prolonged balloon angioplasty dilatation. Its main attraction is that no foreign body is implanted eliminating thus the risk of late inflammatory response to device components without preventing positive remodeling. Here, we discuss the evidence regarding the effectiveness of DCB in different lesion types and clinical settings as well as the types of DCB commercially available or under development.

Impact and natural history of postprocedural aortic regurgitation on early and midterm mortality following transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis.

Background Post-procedural aortic regurgitation (AR) negatively impacts the prognosis after trans-catheter aortic valve implantation. However, data evaluating the impact of different post-procedural AR grades (particularly mild) on clinical outcomes are still important. Aim and Methods A retrospective cohort analysis was performed on all consecutive patients with severe aortic stenosis who underwent trans-catheter aortic valve implantation between July 2008 and August 2011 in a single Institution. Aim of the study was to evaluate the impact of different post-procedural AR grades on early and mid-term clinical outcomes. Results 322 consecutive patients were evaluated. At post-procedural echocardiographic evaluation: 105 (32.6%) patients had no AR, 204 (63.4%) mild AR and 13 (4%) moderate/severe AR. In-hospital mortality was higher in patients with moderate/severe AR than in those with absent or mild AR (38.5% vs. 2.6%, P < 0.001). At a median clinical follow-up of 342 days [interquartile range 93–485] cardiovascular mortality was 2.9% in patients without AR; 13.2% in the mild AR group (P = 0.004 vs. absent AR) and 46.2% in the moderate/severe AR group (P < 0.001 vs. mild or absent AR). On multivariable analysis, post-procedural AR (hazard ratio = 2.65 absent vs. present any grade, 95% confidence interval = 1.11–6.29; P = 0.027) was an independent predictor of mid-term mortality. Conclusions The impact of post-procedural AR on outcomes after trans-catheter aortic valve implantation is proportional with its grade even in case of mild post-procedural AR compared to absent. This study confirms that every effort should be made to reduce the grade of post-procedural AR after trans-catheter aortic valve implantation with current devices.

TCT-689 Tailored Therapy in TAVI: Outcomes of a Device Selection Algorithm based on the Presence of Risk Factors for Paravalvular Regurgitation

Paravalvular regurgitation (PVR) negatively impacts prognosis after TAVI. Risk factors associated with PVR include eccentric shape of annulus, non-symmetric distribution of calcification and lack of oversizing. New generation transcatheter heart valves (THV) designed for PVR reduction has