Hideyuki Kawashima

Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding.

Objective To evaluate the clinical benefit of pre-procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI). Methods OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI is a prospective, multicentre, observational cohort registry, enrolling 749 patients who underwent TAVI from October 2013 to August 2015 in Japan. We identified 540 patients (median age 85 years, 68.1% female) undergoing TF-TAVI; of these, 80 had no pre-procedural antiplatelet therapy and 460 had antiplatelet therapy. The endpoints were any bleeding (life-threatening, major, and minor bleeding) and thrombotic events (stroke, myocardial infarction, and valve thrombosis) during hospitalisation. Results Patients with dual antiplatelet therapy (DAPT) had a significantly higher incidence of any bleeding than those with single antiplatelet therapy (SAPT) (36.5% vs 27.5%, p=0.049) and no antiplatelet therapy (36.5% vs 21.3%, p=0.010). Patients without pre-procedural antiplatelet therapy did not experience an increased risk of thrombotic events. In multivariable logistic regression analysis, DAPT before TF-TAVI significantly increased any bleeding compared with SAPT (OR 2.05, 95% CI 1.16 to 3.65) and no antiplatelet therapy (OR 2.30, 95% CI 1.08 to 4.90). Conclusions The current study demonstrated that DAPT before TF-TAVI increased the risk of bleeding compared with single or no antiplatelet therapy. Lower intensity antiplatelet therapy was not associated with thrombotic events. In modern practice, it might be reasonable to perform TAVI using single or no pre-procedural antiplatelet therapy with an expectation of no increase of adverse events. Trial registration number UMIN-ID; 000020423; Results.

Quantitative optical coherence tomography analysis for late in-stent restenotic lesions.

Coronary optical coherence tomography (OCT) has the potential to identify in-stent neoatherosclerosis, which is a possible risk factor for late acute coronary events after drug-eluting stent implantation. The purpose of this study was to investigate differences between mid-term and late in-stent restenosis after stent implantation by quantitative and semiautomated tissue property analysis using OCT. In total, 1063 OCT image frames of 16 lesions in 15 patients were analyzed. This included 346 frames of 6 lesions in late in-stent restenosis, which was defined as restenosis that was not detected at 6 to 12 months but ≥ 12 months after follow-up coronary angiography. Signal attenuation was circumferentially analyzed using a dedicated semiautomated software. Attenuation was assessed along 200 lines delineated radially for analysis of the in-stent restenotic lesions (between the lumen and stent contours). All lines were anchored by the image wire to avoid artifacts resulting from wire location. Stronger signal attenuation at the frame level (2.46 ± 0.78 versus 1.47 ± 0.32, P < 0.001) and higher maximum signal intensity at the lesion level (9.19 ± 0.19 versus 8.84 ± 0.32, P = 0.018) were observed in late in-stent restenotic lesions than in mid-term in-stent restenotic lesions. OCT demonstrated stronger signal attenuation and higher maximum signal intensity in late in-stent restenotic lesions than in mid-term in-stent restenotic lesions, indicating the possibility of neoatherosclerosis.

Propensity-matched comparison of percutaneous and surgical cut-down approaches in transfemoral transcatheter aortic valve implantation using a balloon-expandable valve

AIMS This study aimed to compare the clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) via a percutaneous or surgical cut-down approach. METHODS AND RESULTS Between October 2013 and July 2015, 586 patients underwent transfemoral TAVI according to the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry (percutaneous approach, n=305; surgical cut-down approach, n=281). After propensity matching, 166 patients underwent transfemoral TAVI via each approach. Major vascular complications, as defined per the Valve Academic Research Consortium-2 criteria, were found less frequently in patients who underwent a percutaneous approach (15.1% vs. 27.1%, p<0.01), and femoral artery injuries requiring surgical repair were mostly the result of a closure device failure (seven cases, 4.2%). In these patients, major bleeding was less (7.2% vs. 16.9%, p=0.01) and blood transfusion less frequent (21.1% vs. 38.0%, p<0.01); therefore, cases of acute kidney injury (AKI) were rare (6.0% vs. 15.1%, p<0.01). CONCLUSIONS Transfemoral TAVI using the percutaneous approach proved safe and feasible and resulted in fewer major vascular complications, bleeding and AKI events compared to the surgical cut-down approach.

Successful transfemoral aortic valve implantation through aortic stent graft after endovascular repair of abdominal aortic aneurysm

The patient was a 91-year-old woman presenting with severe aortic valve stenosis. Pre-procedural computed tomography scan revealed a 45-mm abdominal aortic aneurysm (AAA). Transfemoral transcatheter aortic valve implantation (TF-TAVI) was performed after endovascular aortic repair (EVAR) of the AAA. The 23-mm Edwards Sapien XT system passed through the aortic stent graft smoothly. This is the first case report showing that successful TF-TAVI can be performed through a prior abdominal aortic stent graft. TF-TAVI after EVAR of AAA is a feasible option for patients with extremely poor access.

Effect of ascending aortic dimension on acute procedural success following self-expanding transcatheter aortic valve replacement: A multicenter retrospective analysis

AIMS Self-expanding (SE) valves are characterized with long stent frame design and the radial force of the device exists both in the inflow and outflow level. Therefore, we hypothesized that device success of SE-valves may be influenced by ascending aortic dimensions (AAD). The aim of this study was to determine the influence of AAD on acute device success rates following SE transcatheter aortic valve replacement (TAVR). METHODS & RESULTS In 4 centers in the United States and Asia, 214 consecutive patients underwent SE-TAVR. Outcomes were assessed in line with Valve Academic Research Consortium criteria. AAD was defined as the sum of the short and long axis aortic diameter divided by 2. Overall, device success rate was 85.0%. Multivariate analysis revealed that increased AAD (Odds ratio 1.27) and % oversizing (Odds ratio 0.88) were found to be independent predictors of unsuccessful device implantation. The c-statistic of the model for device success was area under the curve 0.79, sensitivity 81.3% and specificity 44.0%. Co-existence of several risk factors was associated with an exponential fall to 64.2% in device success rate. For a large AAD, however, optimally oversized SE-valves (threshold 16.2%) resulted with high device success rates compared to suboptimal oversizing (88.6% vs. 64.2%, p=0.005). CONCLUSIONS Larger AAD and smaller degrees of oversizing were confirmed to be the most relevant predictors of unsuccessful device implantation following SE-valve implantations. Optimal oversizing of great significance was noted, particularly that with a large AAD.

Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy ― J2T Multicenter Registry ―

BACKGROUND Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.Methods and Results:This multi-center registry assessed the characteristics and outcomes of patients treated by RA for calcified coronary lesions between 2004 and 2015. Among 1,090 registered patients, mean age was 70±10 years and 815 (75%) were male. Sixty percent of patients had diabetes mellitus and 27.7% were receiving hemodialysis. The procedure was successful in 96.2%. In-hospital death occurred in 33 patients (3.0%), and 14 patients (1.3%) developed definite/probable stent thrombosis. During the median follow-up period of 3.8 years, the incidence of major adverse cardiac events (MACE), defined as all-cause death, acute coronary syndrome, stent thrombosis, target vessel revascularization and stroke, was 46.7%. On multivariable Cox hazard analysis, hemodialysis (HR, 2.08; 95% CI: 1.53-2.86; P<0.0001) and age (HR, 1.03; 95% CI: 1.01-1.04; P<0.0001) were strong independent predictors of MACE. Conversely, statin treatment was associated with lower incidence of MACE (P=0.035). CONCLUSIONS This study has provided the largest Japanese dataset for long-term follow-up of RA. Although RA in calcified lesions appears feasible with a high rate of procedural success, a high incidence of MACE was observed.

Timing of Susceptibility to Mortality and Heart Failure in Patients With Preexisting Atrial Fibrillation After Transcatheter Aortic Valve Implantation

The relationship between cardiac rhythm and adverse events after transcatheter aortic valve implantation (TAVI) remains unclear. To compare the prognostic impact of preexisting atrial fibrillation (AF) and new-onset AF (NOAF) after TAVI, we assessed 1,124 patients (846 with sinus rhythm [SR], 49 with NOAF, and 229 with preexisting AF) who underwent TAVI with a balloon-expandable valve from October 2013 to April 2016. The incidences of all-cause death and rehospitalization for heart failure (HF) were retrospectively evaluated. The median follow-up period was 370 days (range 188 to 613). In the Kaplan-Meier analysis, the incidences of all-cause death and rehospitalization for HF were significantly higher in patients with preexisting AF than those in patients with NOAF and SR. The multivariable analysis showed that preexisting AF was significantly associated with increased all-cause death (hazard ratio [HR] 1.54; 95% confidence interval [CI] 1.02 to 2.34) and rehospitalization for HF (HR 2.94; 95% CI 1.75 to 4.93). The landmark analysis demonstrated that patients with preexisting AF had a significantly higher incidence of rehospitalization for HF within the first 6 months after TAVI (HR 4.04; 95% CI 2.23 to 7.32), and a higher incidence of all-cause death from 6 months to 2 years after TAVI (HR 2.12; 95% CI 1.15 to 3.90). Our study demonstrated that preexisting AF increased the risk of all-cause death and rehospitalization for HF after TAVI in comparison with NOAF or SR. Moreover, there was a specific timing of susceptibility to all-cause death and rehospitalization for HF after TAVI.

Balloon Valvuloplasty for Evolut R Infolding: Useful Transesophageal Echocardiographic Monitoring for Diagnosis and Efficacy

An 89-year-old man with symptomatic severe aortic stenosis underwent 29-mm Evolut R (Medtronic, Minneapolis, Minnesota) implantation under general anesthesia. During the procedure, the Evolut R was deployed using the left subclavian artery approach. However, systemic hypotension persisted.

Incidence, Predictors, and Midterm Clinical Outcomes of Myocardial Injury After Transcatheter Aortic-Valve Implantation

Our aim was to assess the clinical effects of myocardial injury after transcatheter aortic-valve implantation (TAVI). Between October 2013 and July 2016, 157 patients underwent TAVI with Sapien XT, Sapien 3, or CoreValve prostheses at our institute. Of these, 130 patients for whom the transapical approach was not used were included in this study. Myocardial injury was defined as a peak troponin I level of ≥1.5 ng/mL within 48 hours after TAVI. We evaluated the predictors of myocardial injury and compared the clinical outcomes of 82 patients classified as the myocardial injury group and 44 patients classified as the non-myocardial injury group. The patients were aged 85 ± 6 years. Myocardial injury occurred in 82 patients (65.1%). Age (per 1 increase) (odds ratio [OR]: 1.11, 95% confidence interval [CI]: 1.01-1.22, P = 0.041), female sex (OR: 3.88, 95% CI: 1.23-12.22, P = 0.021), valve type (Sapien XT; OR: 4.22, 95% CI: 1.15-15.47, P = 0.03, Core valve; OR: 18.12, 95% CI: 2.86-114.59, P = 0.002), balloon aortic valvuloplasty as a bridge therapy (OR: 0.10, 95% CI: 0.02-0.42, P = 0.002), and left ventricular end-diastolic volume (LVEDV) (per 1 increase) (OR: 0.97, 95% CI: 0.95-0.99, P = 0.003) were associated with myocardial injury in a multivariate model. The myocardial injury group did not have a higher rate of midterm (365-day) mortality (log-rank test P = 0.57) than the non-myocardial injury group on Kaplan-Meier analysis. Myocardial injury after TAVI was not associated with midterm mortality.

TCT-685 Pre-existing Right Bundle-Branch Block Increases Risk of Death after Transcatheter Aortic Valve Implantation with a Balloon-Expandable Valve.

TCT-684 Frailty Profile is Independently Associated with Higher Cost for Patients undergoing Transcatheter Aortic Valve Replacement for Symptomatic Severe Aortic Stenosis: a Single Center Experience Jay Patel, Sandeep Banga, Min-Chul Kim, Keattiyoat Wattanakit, Marco A. Barzallo, Sudhir Mungee OSF Saint Francis Medical Center/UICOMP; OSF Saint Francis Medical Center, UICOMP, Peoria, Illinois, United States; University of Illinois College of Medicine at Peoria; OSF St. Francis Medical Center; OSF Saint Francis Medical Center/UICOMP; Heartcare Midwest, Peoria, Illinois, United States