Katsumasa Sato

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.

Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population.

To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus‐eluting stents in real‐world patients with mostly complex disease.

Clinical outcomes of a real-world cohort following bioresorbable vascular scaffold implantation utilising an optimised implantation strategy.

AIMS It has become apparent that, in comparison to metallic stents, bioresorbable vascular scaffolds (BVS) require specific implantation techniques. The aim of this study was to investigate outcomes following BVS implantation using a dedicated strategy for optimal deployment. METHODS AND RESULTS Four hundred consecutive lesions (264 patients) treated with the Absorb BVS were analysed. All procedures were performed based on the following principles: 1) aggressive lesion preparation; 2) high-pressure post-dilation; and 3) a low threshold for intravascular imaging. The majority of target lesions (74.8%) were type B2 or C lesions. Predilation (97.3%) and post-dilation (99.8%) were performed in almost all cases. The mean post-dilation pressure was 21±5 atm, and the total scaffold length per patient was 53.2±32.5 mm. Intravascular imaging was performed in the majority of cases (85.8%) and, when utilised after post-dilatation, a further intervention was required in 24.5% of lesions. The cumulative target lesion failure rates were 7.9% at one year and 11.6% at two years. Definite/probable scaffold thrombosis occurred in three patients (1.2% at one and two years). CONCLUSIONS Clinical outcomes following implantation of current-generation BVS, in a real-world population with a high prevalence of complex lesions, were acceptable when utilising our optimised implantation strategy.

Early results following everolimus-eluting bioresorbable vascular scaffold implantation for the treatment of in-stent restenosis

We read with great interest the recent article by Grasso et al. [1] onthe use of everolimus-eluting bioresorbable vascular scaffold (BVS) forthe treatment of in-stent restenosis (ISR) and we would like to shareour experience with the use of the ABSORB (BVS; Abbott Vascular,Santa Clara, California) for the treatment of this complex lesion subset.There are currently limited published data on the use of BVS in rou-tineclinicalpractice[2,3]andverylittleisknownontheperformanceofthisdevicewhenitisusedforthetreatmentofISR(definedasaluminaldiameterstenosismorethan50%withinthestentorwithin5mmofthestent edges).On this basis, we sought to investigate the feasibility and the earlyclinical outcomes following BVS implantation for the treatment ofpatients with ISR lesions.A collaborative, retrospective cohort analysis was performed onall consecutive patients that underwent percutaneous coronary inter-vention (PCI) with BVS implantation for ISR between April 2012 andDecember 2013 in 3 Italian Centers. All the patients received dualanti-platelet therapy (DAT) with aspirin 100 mg daily and clopidogrel75 mg daily at least 5 days before PCI. DAT was prescribed for at least12 months after BVS implantation. This study fulfilled local ethicalrequirements and written informed consent was obtained from allpatients before angiography and PCI. The authors of this manuscripthavecertifiedthattheycomplywiththePrinciplesofEthicalPublishingin the International Journal of Cardiology.During the study period, a total of 232 patients (295 lesions)underwent BVS implantation. Among these, 25 (10.7%) were treatedfor 30 ISR lesions with BVS implantation. The target ISR lesion was in abare-metal stent (BMS) in 16 (53.4%) while in a drug-eluting stent(DES)in14(46.6%)casesrespectively.Baselineclinical,lesion,andpro-cedural characteristics are shown in Table 1.The mean patient age was 68.3 ± 12.3 years and 20 (80%) patientswere male. Type 2 diabetes mellitus was present in 6 (24%) patients

Impact of Strut Width in Periprocedural Myocardial Infarction: A Propensity-Matched Comparison Between Bioresorbable Scaffolds and the First-Generation Sirolimus-Eluting Stent

OBJECTIVES This study aimed to assess the clinical impact of strut width (evaluated by abluminal strut surface area [ASSA]) on periprocedural myocardial infarction (PMI) and clinical outcomes in patients treated with bioresorbable scaffolds (BRS) versus first-generation sirolimus-eluting stents (SES). BACKGROUND To date, there are no reports on the impact of ASSA on PMI and clinical outcomes. METHODS We compared the impact of ASSA on outcomes and PMI in propensity-matched patients treated with BRS and SES. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the combination of all-cause mortality, follow-up myocardial infarction, and target vessel revascularization, at 30-days and 1-year follow-ups. The secondary endpoint was the incidence of PMI. RESULTS After propensity-matched analysis, 499 patients (147 BRS patients vs. 352 SES patients) were evaluated. Mean ASSA was higher in patients treated with BRS versus SES (BRS: 132.3 ± 76.7 mm(2) vs. SES: 67.6 ± 48.4 mm(2), p < 0.001). MACE was not significantly different between groups (30-days MACE: BRS: 0% vs. SES: 1.4%, p = 0.16, and 1-year MACE: BRS: 15.7% vs. SES: 11.4%, p = 0.67). The incidence of PMI was significantly higher in the BRS group (BRS: 13.1% vs. SES: 7.5%, p = 0.05). Multivariable analyses indicated that treatment of left anterior descending artery and ASSA were independent predictors of PMI. CONCLUSIONS BRS implantation, compared with SES implantation, was associated with a higher incidence of PMI. MACE at 30 days and 1 year were not significantly different. Left anterior descending artery percutaneous coronary intervention and ASSA were independent predictors of PMI.

Procedural outcomes of patients with calcified lesions treated with bioresorbable vascular scaffolds.

AIMS To compare the feasibility, procedural and clinical outcomes after implantation of bioresorbable vascular scaffolds (BVS) in patients with calcified lesions. METHODS AND RESULTS We assessed the feasibility of BVS implantation and procedural outcomes in patients with and without calcific lesions. The primary outcome was angiographic and procedural success. Secondary outcomes included major adverse cardiovascular events (MACE). Of 163 patients, 62 (38%) had calcified lesions. Patients with calcific lesions had a higher prevalence of diabetes (35.5% vs. 22.8%, p=0.078) and chronic kidney disease (31.1% vs. 13.9%, p=0.008), and higher SYNTAX scores (18.9±9.7 vs. 15.1±9.0, p=0.017). Calcific lesions required longer procedures (126.4±39.8 vs. 106.9±37.1 min, p=0.015), more frequent use of dedicated devices and IVUS. Acute gain (1.83±0.6 vs. 1.86±0.6, p=0.732) and angiographic success were similar (98% non-calcific vs. 95.2% calcific, p=0.369), whereas procedural success was reduced in patients with calcific lesions (94.1% vs. 83.9%, p=0.034) due to higher rates of periprocedural myocardial infarction (MI) (5% vs. 13.1%, p=0.067). During the median follow-up time of 14 months MACE rates (10.9% non-calcific vs. 12.9% calcific, plog-rank=0.546) were similar. CONCLUSIONS Treating calcific lesions with BVS is feasible with high angiographic success rates, at the expense of longer procedure times, aggressive lesion preparation and increased rates of periprocedural MI.

Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: Overall outcomes and comparison between provisional and planned double stenting strategy

The aim of this study was to investigate clinical outcomes of patients treated with a provisional stenting (PS) versus a double stenting (DS) strategy for coronary bifurcation lesions with bioresorbable scaffolds (BRS). There are limited data available with regards to outcomes following BRS implantation for bifurcation lesions. A total of 132 bifurcation lesions treated with BRS between 2012 and 2014 were analyzed. Of the total of 132 bifurcation lesions, 10 lesions were treated without crossover stenting. 99 lesions (81%) were treated with a PS strategy and 23 lesions (19%) with a DS strategy. The DS group consisted of patients with a greater number of true bifurcation lesions (PS 52.0% vs. DS 91.3%: P < 0.001). In the PS group, seven lesions (7.1%) were crossed‐over to T‐stenting. In the DS group, 13 lesions (57%) were treated with BRS to the side branch (SB). A hybrid stenting technique [BRS to the main branch, and metallic drug‐eluting stent (DES) to the SB] was utilized in 10 (43%) lesions. Target lesion revascularization (TLR) rates were 5.5% for PS and 11.2% for DS (P = 0.49) at 1‐year follow‐up. Definite scaffold thrombosis did not occur at the site of any bifurcation lesion. These findings suggest that BRS implantation for bifurcation lesions is technically feasible. The rates of TLR tended to be higher in the DS group compared to when a PS strategy was employed. Larger studies are eagerly awaited to determine longer‐term follow‐up of this treatment strategy.

Impact of combined supine and prone myocardial perfusion imaging using an ultrafast cardiac gamma camera for detection of inferolateral coronary artery disease.

BACKGROUND Although combined supine and prone acquisitions improve the detection of inferolateral obstructive coronary artery disease (CAD), the predictors of inaccurate detection of inferolateral ischemia have not been reported by using cadmium zinc telluride (CZT) myocardial perfusion imaging (MPI). METHODS AND RESULTS Vasodilator stress (99m)Tc tetrofosmin MPI using CZT camera and coronary angiography was performed in 322 patients within an interval of 2 months. Prone MPI was performed immediately after supine MPI. Narrowing of the luminal diameter ≥ 75% was considered significant. The presence of an abnormality on both supine and prone images was considered significant. Combined supine and prone imaging, compared with supine-only quantification, was more specific (93% vs. 72%, respectively, p<0.0001) and accurate (88% vs. 74%, p<0.0001) without compromising sensitivity (82% vs. 68%, p=0.10). The area under the curve for detecting inferolateral ischemia was 0.769 (95% CI 0.705-0.833) for supine imaging and 0.802 (95% CI 0.730-0.875) for combined supine and prone imaging (p<0.05). Multivariable analysis revealed that previous inferolateral myocardial infarction was an independent predictor of a false diagnosis (odds ratio=3.45, 95% confidence interval [CI] 1.62-7.37, p<0.001). CONCLUSIONS Combined supine and prone quantitative CZT MPI enhances the detection of inferolateral CAD without adversely affecting its sensitivity. However, we recommend inferolateral ischemia be monitored in patients with a history of previous inferolateral MI because previous inferolateral MI is a predictor of inaccurate diagnosis.

Appearance of neointima according to stent type and restenotic phase: analysis by optical coherence tomography

AIMS The features of neointima after bare metal stent (BMS) or drug-eluting stent (DES) implantation have not yet been fully characterised. The aim of this study was to investigate in-stent neointima characteristics according to stent type and restenotic phase. METHODS AND RESULTS The study included 59 consecutive patients undergoing target lesion revascularisation for in-stent restenosis (ISR) evaluated by optical coherence tomography (OCT) during the early phase (≤1 year, n=30) and late phase (>1 year, n=29) after either BMS (n=37) or DES (n=22) implantation. The OCT signal patterns of tissues at the minimal lumen area were categorised into three patterns: (1) homogeneous high-signal band, (2) heterogeneous mixed-signal band, and (3) lipid-laden intima. The predominant OCT pattern was homogeneous high-signal band in the BMS early phase (19/21 [91%]), lipid-laden intima in the BMS late phase (12/16 [76%]), and heterogeneous mixed-signal band in the DES late phase (9/13 [69%]). Heterogeneous mixed-signal band was seen more frequently in the DES early phase compared with BMS early phase (44% vs. 9%, p<0.05). CONCLUSIONS There were differences of neointima according to stent type and restenotic phase, and this may lead to a better understanding of the different mechanisms of ISR.

The use of a scoring balloon for optimal lesion preparation prior to bioresorbable scaffold implantation: a comparison with conventional balloon predilatation

AIMS Meticulous lesion preparation prior to bioresorbable vascular scaffold (BVS) implantation has been strongly recommended. The aim of this study was to investigate if there was a benefit associated with scoring balloon use in lesion preparation in comparison to conventional balloons prior to implantation of a BVS. METHODS AND RESULTS Of the lesions treated with BVS between May 2012 and July 2014, 155 lesions in the conventional balloon group and 29 lesions in the scoring balloon group were included. Procedures without predilatation and those which utilised cutting balloon or rotational atherectomy devices were excluded. Complex (B2/C lesion: 76.1% vs. 93.1%; p=0.028), restenotic (5.2% vs. 17.2%; p=0.036) and calcified (36.1% vs. 79.3%; p<0.001) lesions were more common in the scoring balloon group. Compared to the conventional balloon group, the scoring balloon group demonstrated better procedural IVUS outcomes with regard to both expansion index (defined as scaffold lumen area divided by final post-dilatation balloon cross-sectional area, 0.71 vs. 0.86; p<0.001) and eccentricity index (defined as minimal scaffold diameter divided by maximal scaffold diameter, 0.78 vs. 0.84; p<0.001). The occurrence of ischaemia-driven target lesion revascularisation at one year was similar (6.1% vs. 7.1%; p=0.87). CONCLUSIONS Lesion preparation for complex lesions using a scoring balloon appeared to facilitate optimal sizing and radially concentric expansion of BVS.