Kensuke Takagi

Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after corevalve implantation and the impact of postdilatation†

Objective: To investigate the predictors of moderate‐to‐severe aortic regurgitation (AR≥2+) after CoreValve implantation and evaluate the feasibility and safety of postdilatation in reducing the degree of AR. Background: Although transcatheter aortic valve implantation is an alternative treatment for high surgical risk patients with severe aortic stenosis, post‐implantation paravalvular AR remains a complication. Methods: From July 2008 to July 2010, we enrolled 79 consecutive patients with severe aortic stenosis who underwent CoreValve implantation. Results: On univariable analysis, the predictors of AR≥2+ immediately after CoreValve implantation were: larger annulus size, low implantation, prosthesis mismatch, chronic renal insufficiency, a history of heart failure, and peripheral vascular disease. On multivariable analysis, the independent predictors of AR≥2+ were: larger annulus diameter (OR 1.78, 95%CI 1.25–2.55; P = 0.002), low implantation (OR 3.67, 95%CI 1.01–13.35, P = 0.05), and peripheral vascular disease (OR 3.54, 95%CI 1.19–10.56, P = 0.02). Post‐CoreValve implantation, AR ≥ 2 was seen in 40.5% (32/79). Twenty‐one patients underwent postdilatation with improvement in AR grade in the majority (17/21). Of the four patients who did not respond to postdilatation, two underwent valve‐in‐valve implantation. In one patient, the valve was pulled more proximally by the snare technique. The remaining 10 patients were treated conservatively. Conclusion: The appropriate strategy for treating patients with AR≥2+ depends on the causes and severity of AR post‐TAVI. This study suggests that we should carefully select the size of CoreValve prosthesis to prevent prosthesis mismatch, especially when implanted in larger annulus sizes. For valves implanted in the appropriate position, postdilatation appears effective in reducing the degree of AR.

Periprocedural and Short-Term Outcomes of Transfemoral Transcatheter Aortic Valve Implantation With the Sapien XT as Compared With the Edwards Sapien Valve

OBJECTIVES The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California). BACKGROUND The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV. METHODS All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used. RESULTS Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV. CONCLUSIONS The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application.

Predictors of cardiac death in patients with coronary chronic total occlusion not revascularized by PCI

BACKGROUND Limited data are available on clinical outcome of patients with previously failed or not attempted chronic total occlusion (CTO) recanalization by percutaneous coronary intervention (PCI). The aim of the study is to determine prevalence and predictors of cardiac death in patients with CTO not revascularized by PCI. METHODS Double-center study analyzing data of 1.345 consecutive patients with at least one CTO between 1998 and 2008. Of these, 847 patients were successfully revascularized (Revascularized group) and 498 patients were not revascularized (Not revascularized group) either due to failure of CTO-PCI (n=337) or because no attempt was made (n=161). RESULTS At 4-year clinical follow-up, Not revascularized patients had a significantly higher rate of cardiac mortality (8.5% vs. 2.5%, p<0.0001) and sudden cardiac death (2.7% vs. 0.5%, p=0.001) compared to those Revascularized. The separate adjusted Cox-model analysis made for Not revascularized patients showed the most significant independent predictors of cardiac death were: chronic renal failure [HR (CI), 6.0 (2.66-13.80)], low-LVEF [5.7 (2.84-11.58)], insulin-dependent diabetes mellitus (IDDM) 4.6 [(1.96-10.97)]. In the Revascularized group, the presence of 3-vessel disease was the only significant independent predictor of cardiac death [4.4 (1.40-13.70)]. CONCLUSIONS CTO patients Not revascularized had a significant higher rate of cardiac mortality and sudden cardiac death compared to those Revascularized. Within Not revascularized patients, the presence of low-LVEF, or CRF or IDDM was associated with an incidence of cardiac death at least 4 times higher than those without the same risk factors.

Incidence, Management, and Outcomes of Cardiac Tamponade During Transcatheter Aortic Valve Implantation: A Single-Center Study

OBJECTIVES The aim of this study was to explore the incidence, causes, and outcomes of cardiac tamponade in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND Use of TAVI is increasing, but the procedure is vulnerable to complications, given the cohort of patients. Cardiac tamponade is a possible complication, and there is a scarcity of data on the incidence and outcomes of cardiac tamponade during TAVI. METHODS All patients who sustained cardiac tamponade during or post-TAVI between 2007 and 2012 were included in the study. RESULTS Of 389 patients who underwent TAVI, 17 (4.3%) had cardiac tamponade. The mean age was 82.3 ± 3.7 years, and most were women (n = 12, 70.6%). Causes of cardiac tamponade were right ventricular perforation by temporary pacemaker (9 patients, 52.9%), annular rupture or aortic dissection (4 patients, 23.5%), and tear in the left ventricular free wall caused by Amplatz stiff wire or catheters (4 patients, 23.5%). Mortality occurred in 4 patients (23.5%), and all had tamponade caused by injury to the high-pressured left-sided circulation (left ventricle and aorta). Most patients (n = 14, 82.4%) sustained cardiac tamponade during the procedure-2 patients (11.7%) within 24 h, and 1 patient after 24 h. CONCLUSIONS Cardiac tamponade during TAVI is not frequent but is associated with high mortality rates especially when left-sided structures are involved. Meticulous handling of the equipment and improvements in the safety of currently used devices could further reduce the occurrence of this complication.

Excimer Laser LEsion Modification to Expand Non-dilatable sTents: The ELLEMENT Registry

BACKGROUND/OBJECTIVES Stent underexpansion is a risk factor for in-stent restenosis and stent thrombosis. Existing techniques to optimize stent expansion are sometimes ineffective. The aim of this study was to evaluate the effectiveness and feasibility of Excimer Laser Coronary Angioplasty (ELCA) in improving stent expansion when high-pressure non-compliant balloon inflation was ineffective. METHODS AND RESULTS ECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1mm(2) in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2±0.4 (range 0.9-2.0mm) and a mean of 62±12mJ/mm(2) at 62±21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6±0.6mm at baseline to 2.6±0.6mm post-procedure) and MSA by IVUS (3.5±1.1mm(2) to 7.1±1.9mm(2)). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%. CONCLUSIONS The ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions.

Clinical and Procedural Predictors of Suboptimal Outcome After the Treatment of Drug-Eluting Stent Restenosis in the Unprotected Distal Left Main Stem The Milan and New-Tokyo (MITO) Registry

Background— Few data are available regarding the optimal revascularization strategy for unprotected distal left main coronary artery (UDLM) in-stent restenosis (ISR). Methods and Results— Between April 2002 and December 2008, UDLM-ISR following drug-eluting stent (DES) implantation occurred in 92 of 474 patients (19.4%). Of these, 8 (8.7%) who underwent a coronary artery bypass graft (CABG) were excluded, and the remaining 84 (91.3%) who underwent percutaneous coronary intervention (PCI) (43 plain old balloon angioplasty [POBA] and 41 DES) were analyzed to assess the feasibility of PCI for UDLM-ISR. The overall cardiac death, myocardial infarction (MI), and major adverse cardiac events during the follow-up period (median, 24 months) occurred in 4, 2, and 31 patients, respectively. Repeat target lesion revascularization (TLR) occurred in 28 patients. The incidence of repeat TLR was higher following PCI with POBA than with DES (hazard ratio [HR], 2.79; 95% CI, 1.23–6.34; P=0.014). On Cox regression analysis, the independent predictors of repeat TLR were treatment with POBA (HR, 3.29; 95% CI, 1.41–7.69; P=0.006) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) >6 (HR, 2.53; 95% CI, 1.02–6.28; P=0.045). More complex lesions requiring a 2-stent strategy were associated with a higher occurrence of TLR for restenosis of the left circumflex coronary artery ostium (LCX-ISR) (HR, 2.51; 95% CI, 1.59–3.97; P=0.001) as well as repeat TLR for recurrent LCX-ISR (HR, 4.32; 95% CI, 0.97–19.20; P=0.05) compared to a 1-stent strategy. No cardiac death at 2 years occurred in patients with LCX-ISR. Conclusions— UDLM restenosis is better treated with DES than with POBA. The rate of recurrent ISR following repeat PCI was high, whereas the rates of MI and death were relatively low. Complex lesions requiring a 2-stent strategy had a higher recurrence rate at the ostial LCX but without an associated increased risk of MI and death.

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.

Impact of residual chronic total occlusion of right coronary artery on the long-term outcome in patients treated for unprotected left main disease: the Milan and New-Tokyo registry.

Background—The presence of chronic total occlusion of the right coronary artery (CTO-RCA) in patients undergoing percutaneous interventions for unprotected left main (ULM) disease may affect the prognosis. In this study, we evaluated the immediate results and follow-up of patients with ULM-percutaneous interventions and with or without associated CTO-RCA. Methods and Results—Between March 2002 and December 2008, a total of 568 consecutive patients with ULM stenosis treated with drug-eluting stent were included in this analysis. The mean EuroScore and SYNTAX scores were 4.05±2.62 and 28.12±10.82, respectively. Of these, 522 had ULM lesions without residual CTO-RCA (493 ULM without CTO-RCA+29 ULM with treated CTO-RCA), and 46 patients had residual CTO-RCA. At 1466 days (interquartile range, 1150–1917) follow-up, the cardiac-death occurred in 41 patients (7.2%). Cardiac-death was more frequently observed in patients with ULM and residual CTO-RCA as compared with those without residual CTO-RCA (adjusted hazard ratios, 2.163 [95% confidence interval, 1.018–4.597]; P=0.045). However, target lesion revascularization occurred less frequently in patients with residual CTO-RCA (adjusted hazard ratios, 0.321 [95% confidence interval, 0.13–0.794]; P=0.014), resulting in the similar major adverse cardiovascular events rates between the 2 groups. When we analyzed patients with concomitant ULM and CTO-RCA, cardiac-death was significantly higher in patients with residual as compared with treated CTO-RCA (log-rank P=0.01) despite no difference in baseline characteristics. Conclusions—Cardiac-death occurred more frequently in patients with residual CTO-RCA as compared with those without residual CTO-RCA. These findings suggest that recanalization of CTO-RCA has significant impact on the long-term cardiac-mortality in patients undergoing ULM-percutaneous interventions probably by offering reserve coronary circulation, if in-stent restenosis were to occur in the treated left main.

Procedural trauma risks longitudinal shortening of the Promus Element™ stent platform.

This case series raises further awareness of the potential for longitudinal shortening with the Promus Element™ (Boston Scientific, MN) drug‐eluting stent (DES) platform. With safety at the forefront of DES development, newer generation systems are utilizing thinner platforms with little or no polymer. Although these contemporary, ultrathin platforms also improve conformability and deliverability, specific design characteristics might inadvertently reduce longitudinal strength. To date, there are no randomized data addressing this issue in vivo for any stent platform, with opinion based on individual experience and bench testing. We report five cases of longitudinal shortening with the Promus Element stent occurring in our institution over a 15‐month period. During the same period, we experienced only isolated cases with other second generation DES platforms. Our experience supports recently published bench‐top data correlating the two‐link design of this platform with the risk of compression.

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.