Motoharu Araki

Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement

Background: The semiquantitative Clinical Frailty Scale (CFS) is a simple tool to assess patients’ frailty and has been shown to correlate with mortality in elderly patients even when evaluated by nongeriatricians. The aim of the current study was to determine the prognostic value of CFS in patients who underwent transcatheter aortic valve replacement. Methods: We utilized the OCEAN (Optimized Catheter Valvular Intervention) Japanese multicenter registry to review data of 1215 patients who underwent transcatheter aortic valve replacement. Patients were categorized into 5 groups based on the CFS stages: CFS 1-3, CFS 4, CFS 5, CFS 6, and CFS ≥7. We subsequently evaluated the relationship between CFS grading and other indicators of frailty, including body mass index, serum albumin, gait speed, and mean hand grip. We also assessed differences in baseline characteristics, procedural outcomes, and early and midterm mortality among the 5 groups. Results: Patient distribution into the 5 CFS groups was as follows: 38.0% (CFS 1-3), 32.9% (CFS4), 15.1% (CFS 5), 10.0% (CFS 6), and 4.0% (CFS ≥7). The CFS grade showed significant correlation with body mass index (Spearman’s &rgr;=−0.077, P=0.007), albumin (&rgr;=−0.22, P<0.001), gait speed (&rgr;=−0.28, P<0.001), and grip strength (&rgr;=−0.26, P<0.001). Cumulative 1-year mortality increased with increasing CFS stage (7.2%, 8.6%. 15.7%, 16.9%, 44.1%, P<0.001). In a Cox regression multivariate analysis, the CFS (per 1 category increase) was an independent predictive factor of increased late cumulative mortality risk (hazard ratio, 1.28; 95% confidence interval, 1.10–1.49; P<0.001). Conclusions: In addition to reflecting the degree of frailty, the CFS was a useful marker for predicting late mortality in an elderly transcatheter aortic valve replacement cohort.

Impact of preparatory coronary protection in patients at high anatomical risk of acute coronary obstruction during transcatheter aortic valve implantation.

BACKGROUND This study aimed to assess the effectiveness of preparatory coronary protection (CP) in patients considered at high risk of acute coronary obstruction (ACO) after transcatheter aortic valve implantation (TAVI). METHODS The Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry enrolled 666 consecutive patients. All patients were assessed by preprocedural multidetector computed tomography. CP using a guide wire with or without a balloon was prospectively performed according to the following criteria: 1) coronary height length from the annulus <10mm, 2) evidence of ACO during balloon aortic valvuloplasty with simultaneous aortic injection, and 3) shallow valsalva or bulky calcification on the leaflet. The incidence of ACO and other procedural outcomes were compared between the CP and non-CP groups. RESULTS CP was performed in 14.1% of all patients (94/666). ACO had an incidence of 1.5% (10/666) and mainly occurred in women (70%) and the left coronary artery (70%). The ACO rate was significantly higher in the CP group than in the non-CP group (7.4% [7/94] vs. 0.5% [3/572]; p<0.001), although notably 30% of ACO were occurred in non-CP group. All 10 ACO cases were successfully treated by catheter intervention, although periprocedural myocardial injury occurred in 42.9% of patients with CP group and 33.3% of those without CP group. Mortality and other periprocedural complications did not significantly differ between the 2 groups. CONCLUSION The preparatory CP strategy was feasible for the management of ACO during TAVI, but the complication of ACO was difficult to predict completely.

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.

Deployment of self‐expandable stents for complex proximal superficial femoral artery lesions involving the femoral bifurcation with or without jailed deep femoral artery

To (1) compare the outcome of self‐expandable stents with versus without jailed deep femoral artery (DFA) for proximal superficial femoral artery (SFA) lesions, and to (2) ascertain the fate of jailed DFA.

Predictors of non-healing in patients with critical limb ischemia and tissue loss following successful endovascular therapy

To evaluate the predictors of non‐healing in patients with critical limb ischemia (CLI) after successful endovascular therapy (EVT).

Natural history of side branches jailed by drug-eluting stents.

BACKGROUND  Stent deployment across side branch (SB) ostium is common in daily practice. The present study investigated the natural history of SBs jailed by drug-eluting stents (DES). METHODS  The thrombolysis in myocardial infarction (TIMI) flow grades of 271 consecutive SBs jailed by DES in 196 patients was assessed immediately after the procedure and at 9 months of follow-up. Patients receiving any SB intervention were excluded. RESULTS Of 271 jailed SBs, occlusion occurred in 6.27% and deterioration of flow occurred in 6.27% immediately after stenting. In patients with these SB changes, periprocedural myocardial infarction was more likely than in those without (10.0% vs. 1.8%, P = 0.017), while there was no increase of cardiac death or life-threatening complications such as stent thrombosis and Q-wave myocardial infarction (Q MI) during follow-up. At 9 months, angiography showed that one-third of the initially obstructed SBs were still occluded. In contrast, flow was maintained in almost all (98.6%) SBs with early TIMI flow grade 3 and there was no delayed occlusion of these branches. Multiple regression analysis showed that lesion complexity (Medina bifurcation class, calcification, and preprocedural TIMI grade 2 flow in the SB) and technical factors (jailing by overlapping stents) were related to SB occlusion or flow deterioration. CONCLUSIONS  Jailed SBs showing good flow after stenting had a favorable angiographic and clinical outcome after 9 months of follow-up. However, preprocedural lesion complexity and technical factors should be considered to avoid SB occlusion/flow deterioration associated with periprocedural myocardial infarction.

Predictive Factors of Re-restenosis after Repeated Sirolimus-Eluting Stent Implantation for SES Restenosis and Clinical Outcomes after Percutaneous Coronary Intervention for SES Restenosis

Sirolimus-eluting stent (SES) is established to be effective in reducing restenosis. Repeat revascularization, however, is still required in up to 5-8% of patients. In this study, we analyzed clinical and angiographic variables that might be related with SES re-restenosis and variables related with re-restenosis after repeat SES implantation for SES restenosis. We also assessed clinical outcomes at 2-year follow-up after percutaneous coronary intervention (PCI) for SES restenosis. Repeat revascularization for SES restenosis was performed in 113 patients with 140 lesions. Of the 140 lesions, follow-up coronary angiography (CAG) was performed on 117 lesions (101 patients) and revealed 46 SES re-restenotic and 71 non-re-restenotic lesions. In multivariate analysis, SES-in-SES-strategy and reference diameter before the second PCI were independent predictors of re-restenosis after PCI for SES restenosis. However, the reference diameter was the only independent predictor of re-restenosis after SES-in-SES. Major adverse cardiac events (MACE) at 2 years were found in 44 patients (43.5%), and target lesion revascularization (TLR) was performed in 33.7% of patients after SES restenosis. In conclusion, the incidence of MACE and TLR was relatively high in patients with SES restenosis, but the placement of another SES on larger-diameter vessels may be an effective strategy for the second PCI.

Gait speed can predict advanced clinical outcomes in patients who undergo transcatheter aortic valve replacement insights from a Japanese multicenter registry

Background— Gait speed reflects an important factor of frailty and is associated with an increased risk of late mortality in patients with cardiac disease. This study sought to assess the prognostic value of gait speed in elderly patients who underwent transcatheter aortic valve replacement. Methods and Results— We investigated the 5-m or 15-feet gait speed (m/sec) in 1256 patients who underwent transcatheter aortic valve implantation using data from the OCEAN-TAVI Japanese multicenter registry (Optimized Catheter Valvular Intervention–Transcatheter Aortic Valve Implantation). Baseline characteristics, procedural outcomes, and all-cause mortality were compared among groups defined by differential gait speed classification: model 1, normal (>0.83 m/sec; n=563; 44.8%), slow (0.5–0.83 m/sec; n=429; 34.2%), slowest (<0.83 m/sec; n=205; 16.3%), unable to walk (n=48; 3.8%); and model 2, classification and regression tree survival model indicating the threshold of gait speed as 0.385 m/sec (>0.385 m/sec; n=1080 versus ⩽0.385 m/sec; n=117). The cumulative 1-year mortality rate showed significant differences in the classical gait speed groups in model 1 (7.6%, 6.6%, 18.2%, and 40.7%, respectively; P<0.001) and survival classification and regression tree group in model 2 (7.7% versus 21.9%; P<0.001). The slowest walkers and those unable to walk demonstrated independent associations with increased midterm mortality after adjustment for several confounding factors (hazard ratio, 1.83, 4.28; 95% confidence interval, 1.03–3.26, 2.22–8.72; P=0.039, <0.001, respectively). Gait speed <0.385 m/sec determined by classification and regression tree also independently associated with worse prognosis (hazard ratio, 2.40; 95% confidence interval, 1.75–5.88; P=0.001). Conclusions— Gait speed using both traditional and specific classification is useful as a potential marker for predicting vulnerable patients associated with adverse clinical outcomes after transcatheter aortic valve replacement.

Impact of ultra-long second-generation drug-eluting stent implantation.

This study investigated the safety and prognosis of ultra‐long second DES (UL‐2nd DES) implantation in real‐world practice.

Comparison of aortic root anatomy and calcification distribution between Asian and Caucasian patients who underwent transcatheter aortic valve implantation.

The current transcatheter aortic valve implantation (TAVI) devices have been designed to fit Caucasian and Latin American aortic root anatomies. We evaluated the racial differences in aortic root anatomy and calcium distribution in patients with aortic stenosis who underwent TAVI. We conducted a multicenter study of 4 centers in Asia and Europe, which includes consecutive patients who underwent TAVI with preprocedural multidetector computed tomography. Quantitative assessment of aortic root dimensions, calcium volume for leaflet, and left ventricular outflow tract were retrospectively performed in a centralized core laboratory. A total of 308 patients (Asian group, n = 202; Caucasian group, n = 106) were analyzed. Compared to Caucasian group, Asian group had smaller annulus area (406.3 ± 69.8 vs 430.0 ± 76.8 mm(2); p = 0.007) and left coronary cusp diameter (30.2 ± 3.2 vs 31.1 ± 3.4 mm; p = 0.02) and lower height of left coronary artery ostia (12.0 ± 2.5 vs 13.4 ± 3.4 mm; p <0.001). Of baseline anatomic characteristics, body height showed the highest correlation with annulus area (Pearson correlation r = 0.64; p <0.001). Co-existence of lower height of left coronary artery ostia (<12 mm) and small diameter of left coronary cusp (<30 mm) were more frequent in Asian group compared with Caucasian group (35.6% vs 20.8%; p = 0.02). In contrast, there were no differences in calcium volumes of leaflet (367.2 ± 322.5 vs 359.1 ± 325.7 mm(3); p = 0.84) and left ventricular outflow tract (8.9 ± 23.4 vs 10.1 ± 23.8 mm(3); p = 0.66) between 2 groups. In conclusion, judicious consideration will be required to perform TAVI for short patients with lower height of left coronary artery ostia and small sinus of Valsalva.