Background:Hemostasis at the femoral venous access site after cryoballoon ablation (CA) for atrial fibrillation (AF) is often prolonged because of aggressive anticoagulation and the use of 15-Fr-caliber sheaths. The Nepcell S^TM(NC) is a newly developed hemostatic pad made of fibrosed calcium alginate extracted from natural seaweed. The calcium ions from the NC accelerate the clotting cascade. This single-center randomized clinical trial assessed the efficacy and safety of the NC in patients undergoing CA for AF.

Methods and Results:In all, 62 patients undergoing CA for non-valvular paroxysmal AF were randomly assigned to either the NC or control group. The primary endpoints of this study were time to hemostasis, internal hemorrhage, and rebleeding. Secondary endpoints were the length of hospital stay (LOS) and vascular complications at 1 month. The time to hemostasis was significantly shorter in NC than control group (mean [±SD] 377±216 vs. 505±241 s; P=0.031). The frequency of internal hemorrhaging (6% vs. 37%; P=0.003) and rebleeding (0% vs. 13%; P=0.033) was lower in the NC than control group, contributing to a decreased LOS in the NC group (3.56±0.67 vs. 4.23±0.73 days; P<0.001). There were no NC-related vascular complications at the 1-month echographic examination.

Conclusions:The use of NC was associated with a shorter hemostasis time and fewer bleeding complications in patients undergoing CA for AF, leading to a shorter LOS.

Background:The presence of a calcified nodule (CN) is associated with unfavorable clinical outcomes after percutaneous coronary intervention (PCI). This study clarified the optimal management of CNs by reassessing the PCI strategy in association with patient background characteristics and clinical outcomes.

Methods and Results:Among 5,332 consecutive PCI cases managed using intra-coronary imaging, CNs were found in 167 lesions (3.1%). CNs were predominantly located at the proximal or mid-right coronary artery (RCA; 62%). More than half presented clinically as acute coronary syndrome (ACS; 56%). All-cause mortality and the target lesion revascularization (TLR) rate at 1 year were 13% and 23%, respectively. Multivariate analysis revealed that hemodialysis, diabetes, and ACS were independent risk factors for all-cause death, whereas hemodialysis and RCA location were independent risk factors for TLR. Regarding the PCI strategy, not using rotational atherectomy (RA) was significantly associated with restenosis, whereas placing a drug-eluting stent (DES) was not.

Conclusions:Both hemodialysis and RCA location were strong predictors of poor outcomes after PCI for CN. Because not using RA was significantly associated with restenosis, it may be better to use RA whenever possible.

Background:Patients with cardiogenic shock due to acute myocardial infarction (AMI) can rapidly undergo veno-arterial extracorporeal membrane oxygenation (VA-ECMO) therapy to recover cardiac output and decrease mortality. However, the clinical indicators predictive of mortality in these patients remain unknown.

Methods and Results:We conducted a single-center retrospective cohort study targeting AMI patients undergoing VA-ECMO. All 63 patients undergoing VA-ECMO for AMI at the Japanese Red Cross Kumamoto Hospital between January 1, 2010 and June 30, 2020 were enrolled. An exploratory analysis was conducted using a survival tree model and variables selected in a univariate Cox proportional hazard model. The median survival time from the start of VA-ECMO was 6.3 days, and 77.8% (n=49) of patients died. Survival analysis divided patients into 3 groups based on 2 parameters at the initial medical examination: Group 1, patients with neither hyperglycemia (blood glucose ≥213 mg/dL) nor thrombocytopenia (platelets ≤145,100/μL); Group 2, patients with hyperglycemia; and Group 3, patients with hyperglycemia plus thrombocytopenia. Relative to Group 1, the risk of in-hospital mortality was significantly increased in Group 2 (hazard ratio [HR] 2.25; 95% confidence interval [CI] 1.13–4.46), and that risk further increased in Group 3 (HR 7.60; 95% CI 3.21–17.95).

Conclusions:Hyperglycemia plus thrombocytopenia on initial medical examination combinatorially increase the risk of mortality in patients with cardiogenic shock due to AMI undergoing VA-ECMO.

Background:The optimal site for measuring computed tomography (CT)-derived fractional flow reserve (FFR_CT) to detect significant coronary artery disease (CAD) remains unknown. We investigated how diagnostic performance changes with FFR_CTmeasurement site.

Methods and Results:The diagnostic performance of FFR_CT, measured 1–2 cm distal to the stenosis vs. a far-distal site, in detecting significant CAD with invasive fractional flow reserve ≤0.8 was evaluated in 254 diseased vessels from 146 patients with stable or suspected CAD diagnosed by coronary CT angiography. Receiver operating characteristic curve analysis revealed a significantly larger area under the curve for FFR_CTmeasured 1–2 cm distal to the stenosis than at a far-distal site (0.829 vs. 0.791, respectively; P=0.0305). The rate of reclassification of positive FFR_CTwas 19% for measurements made 1–2 cm distal to the stenosis, and diagnostic accuracy for FFR_CT0.71–0.80 improved from 36% to 58% (P=0.0052). Vessel-based diagnostic accuracy of FFR_CT1–2 cm distal to the stenosis and at a far-distal site was 75% and 65%, respectively (P<0.0001), with corresponding sensitivity of 87% and 94% (P=0.0039), specificity of 60% and 29% (P<0.0001), a positive predictive value of 73% and 62% (P=0.028), and a negative predictive value of 78% and 79% (P=0.958).

Conclusions:Our data suggest measuring FFR_CT1–2 cm distal to the stenosis has better diagnostic performance for detecting physiologically significant CAD.

Background:Takotsubo syndrome (TTS) in the very elderly is poorly understood. We sought to clarify the characteristics of octogenarians and nonagenarians with TTS.

Methods and Results:From 148 patients with TTS who underwent coronary angiography, 68 very elderly patients aged ≥80 years (octogenarians/nonagenarians) were compared with 80 younger patients aged ≤79 years. Emotional triggers of TTS were less frequent (7% vs. 19%; P=0.043), whereas physical triggers were more frequent (69% vs. 46%; P=0.005), in octogenarians/nonagenarians than in patients aged ≤79 years. As initial clues to the diagnosis, electrocardiogram changes were more frequent (71% vs. 46%; P=0.003) and chest pain and/or dyspnea were less common (25% vs. 51%; P=0.001) in octogenarians/nonagenarians than in patients aged ≤79 years. Twenty-nine patients had acute heart failure (AHF) as a complication. AHF was more frequently found in octogenarians/nonagenarians than in patients aged ≤79 years (29% vs. 11%, respectively; P=0.006). Cardiac death occurred in 2 octogenarians/nonagenarians; non-cardiac death occurred in 3 octogenarians/nonagenarians and in 2 patients aged ≤79 years.

Conclusions:Emotional triggers of TTS were infrequent in octogenarians/nonagenarians with TTS. AHF was common and there was significant in-hospital all-cause mortality among octogenarians/nonagenarians.

Cardiac rehabilitation (CR) is a well-known intervention for the secondary prevention of cardiovascular diseases. However, in Japan, the outpatient CR participation rate is estimated to be very low. Cardiac telerehabilitation (CTR) can be defined as a remote CR program using digital health technology to support it. Evidence regarding the use of CTR has been accumulated, and the COVID-19 pandemic has accelerated the need for CTR. Japan has sufficient potential to benefit from CTR because, nationally, digital literacy is high and the infrastructure for telemedicine is developed. To overcome several barriers, evidence of CTR in Japan, well-educated multidisciplinary CTR teams, a good combination of center-based CR and CTR, and sophisticated systems including social insurance and adequate legislation need to be developed immediately. CTR has the potential to increase the low CR participation rate in Japan. CTR also has many different effects that not only cardiologists, but also paramedics who engage in CTR, have to be aware of.

Background:Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT).

Methods and Results:The HOTFOOT study is a multicenter prospective randomized open blinded-endpoint trial that is to be conducted at 10 trial centers in Japan between February 2021 and February 2022. This study will enroll 140 patients with CLTI receiving successful EVT. Eligible participants will be allocated 1 : 1 to either the EVT+HBOT or EVT group; participants in the EVT+HBOT group will receive 30 HBOT sessions. The primary outcome is the time to complete wound healing over the 6-month follow-up. Secondary outcomes during the 6-month follow-up are the proportion of patients who achieved complete wound healing, freedom from major lower-limb amputation, amputation-free survival, and freedom from target lesion reintervention.

Conclusions:This study is expects to assess whether HBOT, in combination with successful EVT, can improve lower-limb outcomes in CLTI patients.