Akihito Tanaka

Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis

Background—Treatment of in-stent restenosis (ISR) is still challenging. In this setting, the use of bioresorbable vascular scaffold (BVS) seems attractive because it allows drug delivery combined with transient vessel scaffolding. We aimed to investigate the long-term results after BVS use in ISR lesions. Methods and Results—A prospective analysis was performed on all patients who underwent percutaneous coronary intervention with BVS implantation for ISR at 7 Italian Centers. Primary end point was the device-oriented composite end point (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) at the longest follow-up available. From April 2012 to June 2014, 116 patients (127 lesions) underwent percutaneous coronary intervention for ISR with BVS implantation. Among the ISR lesions, the majority were drug-eluting stent ISR (78, 61.6%), de novo ISR (92, 72.4%), and diffuse ISR (81, 63.8%). Procedural success was achieved for all (100%) patients. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan–Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5–6.5; P=0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1–14.1, P=0.843; target vessel myocardial infarction: 1.5% versus 0%, P=0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5–10.8, P=0.309). Conclusions—Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.

Migration of fractured renal artery stent.

An 80‐year‐old man received stent implantation for severe stenosis of the right renal artery. During the procedure, the proximal edge of the stent was successfully positioned at the ostium of the renal artery. After 6 months, follow‐up renal angiography showed transverse stent fracture without restenosis. The proximal part of the fractured stent had moved and protruded into the abdominal aorta. Three years later, the proximal part of the fractured stent had migrated from the renal artery to the wall of infrarenal aorta. This is the first reported case of stent migration of the renal artery caused by a complete transverse stent fracture.

Percutaneous coronary intervention with a virtual 2-Fr system†

With the improvement of percutaneous coronary intervention (PCI), the miniaturization of devices has continued. We have developed a virtual 2‐Fr system that is the slenderest system to date. The outer diameter of the system using a 4‐Fr sheathless guiding catheter is ∼2‐Fr size. We report a case successfully treated using this new system. This novel virtual 2‐Fr system has the potential to provide less invasive PCI during vascular access and to reduce patient morbidity.

Impact of post-procedural hyperglycemia on acute kidney injury after transcatheter aortic valve implantation

BACKGROUNDnPost-operative hyperglycemia, in individuals with and without diabetes, has been identified as a predictor of acute kidney injury (AKI) in patients following cardiac surgery. Whether or not this is also true for patients undergoing transcatheter aortic valve implantation (TAVI) is unknown.nnnOBJECTIVESnTo evaluate whether post-procedural glucose levels are associated with AKI after TAVI.nnnMETHODS AND RESULTSnA total of 422 consecutive patients undergoing transfemoral TAVI were included in the analysis. For each patient, plasma glucose levels were assessed at hospital admission, 4h after the procedure and daily during hospitalization. Post-procedural hyperglycemia was defined as 2 consecutive blood glucose readings ≥150mg/dL in the 72-hour period following TAVI. AKI was defined according to the VARC consensus report regarding standardized endpoint definitions. Overall, 137 (32.5%) patients developed post-procedural hyperglycemia and 138 (33%) patients developed AKI. Hyperglycemia was associated with a 2-fold higher incidence of AKI than in patients without hyperglycemia (48% vs. 25%, p<0.001). In-hospital mortality was higher in patients with hyperglycemia than in those without hyperglycemia (9.6% vs. 1.8%, p<0.001). In-hospital mortality rate was also higher in patients who developed AKI (12.7% vs. 2.7%, p<0.001). Patients with acute hyperglycemia that developed AKI had the highest in-hospital and long-term mortality rate (15% and 38%). Post-procedural hyperglycemia was an independent predictor of AKI.nnnCONCLUSIONSnPost-procedural hyperglycemia is associated with a higher incidence of AKI and mortality after TAVI. Randomized controlled trials are needed to determine whether meticulous post-procedural glycemic control following TAVI impacts upon clinical outcomes.

TCT-437 Clinical outcome of coronary bifurcation management with a “fully bioresorbable” technique. Results of the multicentre BBS study

TCT-436 Multi-Center, Post-marketing Evaluation of the Elixir DESolve Novolimus Eluting Bioresorbable Coronary Stent System: 6-month Results from the DESolve PMCF Study Holger Nef, Karl Eugen Hauptmann, Azeem Latib, Lynn Morrison, Sara Toyloy, Lynn Vandertie, Antonio Colombo Universitaetsklinikum Giessen, Giessen, Germany; Trier, Germany; EMO-GVM Centro Cuore Columbus, Milan, Italy; Elixir Medical, sunnyvale, California, United States; Elixir Medical Corporation, Sunnyvale, California, United States; Medical Devices Consultancy, Christchurch, New Zealand; San Raffaele Scientific Institute, Milan, Italy

TCT-698 Comparison of the fully repositionable and retrievable Lotus Valve and Direct Flow Medical Valve for the treatment of severe aortic stenosis: a high-volume single center experience

A limitation of first generation transcatheter aortic valve replacement (TAVR) devices was the occurrence of paravalvular leak (PVL) that when greater than mild has been demonstrated to a predictor of mortality. Second generation devices have been designed to reduce this. One technological advance

Comparison of mid-term clinical outcomes after treatment of ostial right coronary artery lesions with early and new generation drug-eluting stents: Insights from an international multicenter registry

BACKGROUNDnThere are only a limited number of studies comparing clinical outcomes after treatment of right coronary artery (RCA) aorto-ostial (AO) lesions with early (E-) and new (N-) generation drug-eluting stents (DES).nnnMETHODSnFrom January 2005 to December 2013, 334 de novo RCA AO lesions treated with DES (E-:142 lesions, N-:192 lesions) at 2 high-volume centers (Italy and Japan) were included in this study. The primary endpoint was target lesion failure (TLF) defined as composite of cardiac mortality, target vessel myocardial infarction, and target lesion revascularization (TLR).nnnRESULTSnBaseline and lesion characteristics were well balanced between the 2 groups. The size of the stents deployed (3.35±0.37mm vs 3.39±0.33mm, p=0.29) and non-compliant balloons used for post-dilatation (3.55±0.38mm vs 3.62±0.47mm, p=0.21) were similar between the two groups. The median follow-up period was 1432 (IQR: 703-2197) days in total population. The cumulative rate of TLF at 3years was significantly higher in E-DES group when compared with N-DES group (37.7% vs 14.2%, p<0.001), which was mainly driven by TLR (38.0% vs 11.0%, p<0.001). Multivariable analysis revealed that N-DES [HR 0.22 (0.13-0.38), p<0.001], stent underexpansion [HR 10.59 (6.23-17.97), p<0.001], excessive aortic stent protrusion [HR 3.12 (1.87-5.23), p<0.001], and proximal stent overlap [HR 1.74 (1.03-2.95), p=0.03] were independent predictors of TLF.nnnCONCLUSIONnFor the treatment of RCA AO lesions, N-DES were associated with a lower incidence of TLF at 3years when compared with E-DES. N-DES use and suboptimal implantation characteristics were independent predictors of TLF.

Mid-term clinical outcomes after bailout drug-eluting stenting for suboptimal drug-coated balloon results: Insights from a Milan registry

BACKGROUNDnDrug-coated balloon (DCB) is an alternative to drug-eluting stent (DES) for the treatment of small vessel or in-stent restenosis (ISR) lesions, with bailout stenting reserved for poor results after DCB inflation (residual stenosis or dissection). Data regarding bailout stenting with DES are limited. The aim of this study was to evaluate clinical outcomes after bailout stenting with DES for suboptimal DCB results.nnnMETHODSnFrom June 2009 to December 2015, patients who underwent bailout DES implantation for suboptimal results after DCB (residual stenosisu202f>u202f30% or type C-F dissection) in 2 high-volume centers in Italy were analyzed. The primary endpoint was target lesion failure (TLF) defined as composite of cardiac mortality, target vessel myocardial infarction (MI) and target lesion revascularization (TLR).nnnRESULTSnA total of 103 patients (125 lesions) were analyzed. Mean age was 68.8u202f±u202f9.5u202fyears, 21.4% were diabetic, and 92.2% underwent PCI for stable angina. The left anterior descending artery was most commonly treated (35.2%), followed by right coronary artery (17.6%) and left circumflex artery (17.6%). Lesion complexity was high (type B2/C: 88.8%) and 24.8% were ISR lesions. During the follow-up period (median: 858u202fdays [interquartile range: 467-1665]), the TLF rate was 4.3% at 1u202fyear and 15.4% at 2u202fyears, and mainly driven by TLR (3.3% at 1u202fyear, 14.5% at 2u202fyears, respectively). There were no target vessel MI or definite/probable stent thrombosis events.nnnCONCLUSIONSnBailout stenting with DES for suboptimal DCB results is a feasible and safe strategy at mid-term follow-up.

Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study)

to compare the 1‐year outcome between bioresorbable vascular scaffold (BVS), everolimus‐eluting stent (EES), and drug‐eluting balloon (DEB) for in‐stent restenosis (ISR) treatment.

A comparison of the fully repositionable and retrievable Boston Lotus and direct flow medical valves for the treatment of severe aortic stenosis: A single center experience

Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL.