Comparison between tip-detection method and retrograde approach for chronic total occlusion percutaneous coronary intervention.

BACKGROUND: The tip-detection method and the retrograde approach have been acknowledged as a second-line strategies for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) when conventional antegrade wiring strategies are ineffective. The aim of this study is to compare the efficacy between both strategies for complex CTO PCI. METHODS: We retrospectively enrolled 170 consecutive CTO PCI cases and separated them into 295 adopted strategies. The rate of successful lesion crossing and its association with the time spent for each strategy were compared between the tip-detection method and the retrograde approach. RESULTS: We observed fifty-six attempts with the tip-detection methods with 46 (82.1%) successful lesion crossings. Sixty-one retrograde approaches were performed, in which 29 (47.5%) cases achieved procedural success. In the successful attempts, the wire-manipulation time was significantly shorter in the tip-detection method [20.0 (12.2-36.7) min] than the retrograde approach [35.0 (20.7-49.7) min] (p = 0.008). Cox-regression analysis showed time-dependent advantage for the tip-detection method over the retrograde approach [hazard ratio (HR) = 2.93, 95% CI = 1.84-4.67, p < 0.001]. Incomplete tip-detection CTO crossing (taking > 30 min) was seen in severely tortuous lesions [odds ratio 0.26, 95% confidence interval 0.06-0.97, p = 0.037]. CONCLUSION: The tip-detection method can reduce the wire-manipulation time for successful CTO PCI compared with the retrograde approach. However, the success rate of the tip-detection method is hampered by severe lesion tortuosity.

A randomized controlled study to evaluate the safety and feasibility of concomitant transluminal injection of foam sclerosant combined with endovenous laser ablation in patients with incompetent small saphenous veins.

OBJECTIVES: To compare foam sclerotherapy through the access sheath (transluminal foam sclerotherapy [TLFS]) combined with endovenous laser ablation (EVLA) with EVLA alone in terms of safety and one-year venous clinical severity score (VCSS) changes in patients with small saphenous vein incompetence. METHODS: During EVLA, the sheath tip was placed around the targeted tributary vein, and the sclerosant was injected via the side port. Outcomes assessed at 1 day, 1 week, 1 month, and 1 year included VCSS changes, residual or recurrent reflux, the need for secondary interventions, and other related complications. RESULTS: The change in VCSS did not reach the minimum clinically important difference. Otherwise, TLFS reduced residual or recurrent reflux of the tributary using the TLFS (3/74 legs) compared with the EVLA alone (12/77 legs) (p = .027). CONCLUSIONS: TLFS is a safe and feasible procedure that reduces residual or recurrent reflux of the tributary vein compared with truncal EVLA alone.

Impact of left atrial appendage flow velocity on thrombus resolution and clinical outcomes in patients with atrial fibrillation and silent left atrial thrombi: insights from the LAT study.

AIMS: Blood stasis is crucial in developing left atrial (LA) thrombi. LA appendage peak flow velocity (LAAFV) is a quantitative parameter for estimating thromboembolic risk. However, its impact on LA thrombus resolution and clinical outcomes remains unclear. METHODS AND RESULTS: The LAT study was a multicentre observational study investigating patients with atrial fibrillation (AF) and silent LA thrombi detected by transoesophageal echocardiography (TEE). Among 17 436 TEE procedures for patients with AF, 297 patients (1.7%) had silent LA thrombi. Excluding patients without follow-up examinations, we enrolled 169 whose baseline LAAFV was available. Oral anticoagulation use increased from 85.7% at baseline to 97.0% at the final follow-up (P < 0.001). During 1 year, LA thrombus resolution was confirmed in 130 (76.9%) patients within 76 (34-138) days. Conversely, 26 had residual LA thrombi, 8 had thromboembolisms, and 5 required surgical removal. These patients with failed thrombus resolution had lower baseline LAAFV than those with successful resolution (18.0 [15.8-22.0] vs. 22.2 [17.0-35.0], P = 0.003). Despite limited predictive power (area under the curve, 0.659; P = 0.001), LAAFV ≤ 20.0 cm/s (best cut-off) significantly predicted failed LA thrombus resolution, even after adjusting for potential confounders (odds ratio, 2.72; 95% confidence interval, 1.22-6.09; P = 0.015). The incidence of adverse outcomes including ischaemic stroke/systemic embolism, major bleeding, or all-cause death was significantly higher in patients with reduced LAAFV than in those with preserved LAAFV (28.4% vs. 11.6%, log-rank P = 0.005). CONCLUSION: Failed LA thrombus resolution was not rare in patients with AF and silent LA thrombi. Reduced LAAFV was associated with failed LA thrombus resolution and adverse clinical outcomes.

The WATCH-DM risk score estimates clinical outcomes in type 2 diabetic patients with heart failure with preserved ejection fraction.

The coexistence of heart failure is frequent and associated with higher mortality in patients with type 2 diabetes (T2DM), and its management is a critical issue. The WATCH-DM risk score is a tool to predict heart failure in patients with type 2 diabetes mellitus (T2DM). We investigated whether it could estimate outcomes in T2DM patients with heart failure with preserved ejection fraction (HFpEF). The WATCH-DM risk score was calculated in 418 patients with T2DM hospitalized for HFpEF (male 49.5%, age 80 ± 9 years, HbA1c 6.8 ± 1.0%), and they were divided into the "average or lower" (≤ 10 points), "high" (11-13 points) and "very high" (≥ 14 points) risk groups. We followed patients to observe all-cause death for 386 days (median). We compared the area under the curve (AUC) of the WATCH-DM score for predicting 1-year mortality with that of the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score and of the Barcelona Bio-Heart Failure Risk (BCN Bio-HF). Among the study patients, 108 patients (25.8%) had average or lower risk scores, 147 patients (35.2%) had high risk scores, and 163 patients (39.0%) had very high risk scores. The Cox proportional hazard model selected the WATCH-DM score as an independent predictor of all-cause death (HR per unit 1.10, 95% CI 1.03 to 1.19), and the "average or lower" risk group had lower mortality than the other groups (p = 0.047 by log-rank test). The AUC of the WATCH-DM for 1-year mortality was 0.64 (95% CI 0.45 to 0.74), which was not different from that of the MAGGIC score (0.72, 95% CI 0.63 to 0.80, p = 0.08) or that of BCN Bio-HF (0.70, 0.61 to 0.80, p = 0.25). The WATCH-DM risk score can estimate prognosis in T2DM patients with HFpEF and can identify patients at higher risk of mortality.

Influence of ultrasound transmit frequency on measurement of global longitudinal strain on 2D speckle tracking echocardiography.

The reproducibility of longitudinal strain measured by 2D speckle tracking echocardiography (2DSTE) may be affected by ultrasound settings. This study investigated the effect of transmit ultrasound frequency on global longitudinal strain (GLS) by 2DSTE. Apical, 2- and 4-chamber, and long-axis views were obtained in consecutive 162 patients using Philips ultrasound devices. Three different frequency presets were used sequentially: high resolution (HRES, 1.9 to 2.1 MHz), general (HGEN, 1.6 to 1.8 MHz), and penetration mode (HPEN, 1.3 to 1.6 MHz). GLS values were determined for each preset using the Philips Q-station software, resulting in GLS-HRES, GLS-HGEN, and GLS-HPEN. Among the 151 patients with successfully measured GLS, a significant difference in GLS was observed among the three presets (p < 0.0001). GLS-HRES (- 17.9 ± 4.4%) showed a slightly smaller magnitude compared to GLS-HGEN (- 18.8 ± 4.5%, p < 0.0001) and GLS-HPEN (- 18.8 ± 4.5%, p < 0.0001), with absolute differences of 1.1 ± 1.0% and 1.1 ± 1.2%, respectively. This variation in GLS with frequency was evident in patients with both optimal (n = 104) and suboptimal (n = 47) image quality and remained consistent regardless of ultrasound devices, ischemic etiology, or ejection fraction. In conclusion, ultrasound frequency had only a modest effect on GLS measurements. GLS may be reliably assessed in most cases regardless of the ultrasound frequency used.

Sleep apnea severity in patients undergoing atrial fibrillation ablation: Home sleep apnea-test and polysomnography comparison.

Background: Sleep apnea (SA) is highly prevalent and should be treated in patients referred for catheter ablation (CA) of atrial fibrillation (AF). Watch-type peripheral arterial tonometry (WP) for home SA testing has demonstrated a high correlation of the apnea-hypopnea index (AHI) with Polysomnography (PSG), but the evidence of its accuracy in AF patients is not adequate. Methods: This study was conducted under a retrospective, single-center, observational design. We included 464 consecutive AF patients (age 65 ± 11 years, 76.5% male, 45.0% paroxysmal-AF) who received both WP and PSG during the periprocedural period of the CA. We compared the AHI using the WP (WP-AHI) to that using PSG (PSG-AHI). Results: The WP-AHI was 25.9 ± 12.7 and PSG-AHI 31.4 ± 18.9 (r = .48). Among 325 patients with a WP-AHI < 30, 116 (35.7%) exhibited a PSG-AHI ≥ 30. Only 12.5% of the patients were indicated for continuous positive airway pressure (CPAP) treatment only by the WP-AHI, while 70.9% were indicated for CPAP by the PSG-AHI according to the Japanese health insurance system. The best cut-off value of the WP-AHI was 18.1 to predict a PSG-AHI ≥ 20 with an area under the curve of 0.72 (95% confidence interval, 0.67-0.76). Conclusions: The WP-AHI and PSG-AHI were weakly correlated in AF patients receiving CA. About one-third of the patients with moderate SA using the WP was diagnosed with severe SA evaluated by PSG. The majority required PSG for the CPAP indication.

Guide extension proximal locking method: standardization of maximum backup force in percutaneous coronary intervention.

We developed the smallest diameter guide-extension catheter (GUIDE PLUS® 5Fr) to enable a new technique, the guide-extension proximal locking method (GP-Lock), and assessed its efficacy in the present experimental and clinical study. Sufficient guide catheter backup is sometimes crucial for PCI. We developed the KIWAMI-Lock direct anchoring method to obtain the strongest backup force by locking a Kiwami® 4Fr child catheter (Terumo Corp. Tokyo, Japan) directly to the coronary artery by ballooning from outside the child catheter. However, this method is complicated due to the requirement for a child catheter. We compared the backup power of the GP-Lock method and other conventional methods in an experimental study and compared the procedural outcomes of 17 cases treated using the initial GP-Lock method with 17 cases using the recent KIWAMI-Lock method before GP-Lock. The GP-Lock method had the highest backup force among the methods examined (GP-Lock: 293.7 ± 10.2 g force (gf), KIWAMI-Lock: 270.4 ± 12.9 gf, side branch balloon anchoring technique: 182.7 ± 8.1 gf, respectively, P < 0.0001). The preparation time was significantly shorter for the GP-Lock group than the KIWAMI-Lock group (5.0 [4.0, 5.0] min vs. 11.0 [8.0, 13.0] min, respectively, P < 0.001). The GP-Lock method makes it possible to easily obtain the strongest backup force, which can overcome situations where devices cannot pass through, especially in complex PCI procedures.

Impact of Residual Functional Mitral Regurgitation After Atrial Fibrillation Ablation on Clinical Outcomes in Patients With Left Ventricular Systolic Dysfunction.

Functional mitral regurgitation (FMR) negatively impacts the prognosis in patients with atrial fibrillation (AF) and reduced left ventricular (LV) ejection fraction (LVEF). Although structural reverse remodeling after AF ablation can reduce FMR severity, the prognostic impact of FMR and its evolution remain unclear. Of 491 patients with baseline LVEF <50% who underwent first-time AF ablation, 134 patients (27%) had grade 2 to 4 FMR at baseline. Among them, 88 patients (66%) exhibited FMR improvement to grade 0 to 1 FMR 6 months after AF ablation. Conversely, among 357 with baseline grade 0 to 1 FMR, 13 patients (3.6%) exhibited FMR worsening to grade 2 to 4 FMR despite AF ablation. Assessment with multidetector computed tomography revealed that an increase in the left atrial emptying fraction (odds ratio 3.55 per 10% increase; 95% confidence interval 2.12 to 5.95) and a reduction in the LV end-diastolic volume index (1.35 per 10-ml/m2 decrease; 1.04 to 1.76) were identified as contributors to the FMR improvement. During a follow-up of 43 months, patients with postprocedural grade 2 to 4 FMR more frequently experienced hospitalizations for heart failure or cardiovascular death than those with grade 0 to 1 FMR (30.5% vs 4.6%, log-rank p <0.001). An age-adjusted multivariate Cox regression analysis including baseline and postprocedural FMR revealed that postprocedural grade 2 to 4 FMR (hazard ratio, 3.24; 95% confidence interval 1.43 to 7.35) was significantly associated with unfavorable events. In conclusion, AF ablation modified and often improved FMR severity in patients with reduced LVEF. Residual grade 2 to 4 FMR 6 months after AF ablation was associated with a poor prognosis.

Atrial Fibrillation Ablation Outcomes and Heart Failure (from the Kansai Plus Atrial Fibrillation Registry).

The impact of rhythm outcomes on heart failure (HF) hospitalizations remains unknown after radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). We sought to elucidate whether AF recurrence was associated with HF hospitalizations after AF RFCA. We conducted a large-scale, prospective, multicenter, observational study (Kansai Plus Atrial Fibrillation Registry), enrolling 5,010 consecutive patients (age 64 ± 10 years, 27.3% female, and 35.7% nonparoxysmal AF) who underwent an initial AF RFCA at 26 centers. The median follow-up duration was 2.9 years. The cumulative 3-year incidence of HF hospitalizations after the initial RFCA was 1.84% (0.69%/year). Hospitalized patients with HF were older with a higher prevalence of nonparoxysmal AF, renal dysfunction, diabetes, and underlying heart disease pre-RFCA. HF hospitalizations occurred more often in patients with than without recurrences (3.27 vs 0.84%, log-rank p <0.0001). After adjusting for confounders using a Cox model, AF recurrence remained an independent predictor of HF hospitalizations (hazard ratio [HR] 2.84, 95% confidence interval [CI] 1.80 to 4.47, p <0.0001). AF recurrence was a distinct HF hospitalization risk in patients with a left ventricular ejection fraction ≥50% (HR 4.54, 95% CI 2.38 to 8.65, p <0.0001) but not <50% (HR 1.31, 95% CI 0.65 to 2.62, p = 0.45), with significant interactions. Furthermore, patients with AF recurrences within 1 year had a greater HF hospitalization risk after 1 year (1.61% vs 0.79%, log-rank p = 0.019). In conclusion, AF recurrence after RFCA was independently associated with HF hospitalizations.

DAPagliflozin for the attenuation of albuminuria in Patients with hEaRt failure and type 2 diabetes (DAPPER study): a multicentre, randomised, open-label, parallel-group, standard treatment-controlled trial.

Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the urinary albumin-to-creatinine ratio (UACR) in patients with elevated levels of albuminuria in the presence or absence of heart failure (HF) or type 2 diabetes mellitus (T2D). However, these effects have not yet been reported in the presence of both HF and T2D. This lack of evidence prompted us to conduct a clinical trial on the effects of dapagliflozin on UACR in patients with HF and T2D. Methods: DAPPER is a multicentre, randomised, open-labeled, parallel-group, standard treatment-controlled trial that enrolled patients at 18 medical facilities in Japan. Eligible participants with both HF and T2D and aged between 20 and 85 years were randomly assigned to a dapagliflozin or control (anti-diabetic drugs other than SGLT 2 inhibitors) group with a 1:1 allocation. The primary outcome was changes in UACR from baseline after a two-year observation, and secondary endpoints were cardiovascular (CV) events and parameters related to HF. This trial was registered with the UMIN-CTR registry, UMIN000025102 and the Japan Registry of Clinical Trials, jRCTs051180135. Findings: Between 12 May 2017 and 31 March 2020, 294 patients were randomly assigned to the dapagliflozin group (n = 146) or control group (n = 148). The mean age of patients was 72.1 years and 29% were female. The mean glycated hemoglobin value was 6.9%, mean NT-proBNP was 429.1 pg/mL, mean estimated GFR was 65.7 mL/min/1.73 m2, and median UACR was 25.0 (8.8-74.6) mg/g Cr in the dapagliflozin group and 25.6 (8.2-95.0) mg/g Cr in the control group. Of the 146 patients in the dapagliflozin group, 122 completed the study, and 107 (87.7%) were taking 5 mg of dapagliflozin daily at the end of the observation period. The primary outcome did not significantly differ between the dapagliflozin and control groups. Among the secondary endpoints, the mean decrease in left ventricular end-diastolic dimensions as one of the echocardiographic parameters was larger in the dapagliflozin group than in the control group. The composite endpoint, defined as CV death or hospitalisation for CV events, hospitalisation for HF events, hospitalisation for all causes, and an additional change in prescriptions for heart failure in a two-year observation, was less frequent in the dapagliflozin group than in the control group. Interpretation: Although dapagliflozin at a dose of 5 mg daily did not reduce urinary albumin excretion in patients with HF and T2D from that in the controls, our findings suggest that dapagliflozin decreased CV events and suppressed left ventricular remodeling. Funding: AstraZeneca KK, Ono Pharmaceutical Co., Ltd.

Tip detection-antegrade dissection and reentry using intravascular ultrasound in chronic total occlusion intervention: first human case report.

Background: It has been considered impossible to perform antegrade dissection and reentry (ADR) by simply puncturing with a guidewire using the intravascular ultrasound (IVUS) observation without the support of the Stingray system. Case summary: A 78-year-old man suffered from effort angina pectoris due to a chronic total occlusion (CTO) lesion in the left circumflex coronary artery. A retry percutaneous coronary intervention for the CTO lesion was attempted at our hospital. The J-CTO score was 3. The first guidewire entered the subintimal space. We moved onto Stingray-ADR using the angiographic observation, but the guidewire could not be led into the true lumen. AnteOwl WR-IVUS (AO-IVUS) observation revealed a distal true lumen in which the inner lumen was maintained 5 mm beyond the CTO exit. We decided to perform the tip detection-ADR using the AO-IVUS observation. The tip detection method allowed the tip of the penetration wire to puncture the wall between the subintima and the true lumen in an exactly vertical direction, resulting in the successful creation of a reentry point. The CTO lesion was dilated with one drug-eluting stent, and normal antegrade blood flow was achieved. Discussion: Since the tip detection method enables accurate punctures, it may allow for ADR by simply puncturing using a guidewire. Due to this method being performed using the IVUS observation, it is likely more reliable than Stingray-ADR using the angiographic observation.

Effects of ipragliflozin on left ventricular diastolic function in patients with type 2 diabetes and heart failure with preserved ejection fraction: The EXCEED randomized controlled multicenter study.

AIM: We carried out a randomized controlled trial using ipragliflozin. We analyzed changes in diastolic function using echocardiography in patients with type 2 diabetes and heart failure with preserved ejection fraction. METHODS: We carried out an open-label, multicenter, randomized, two-arm interventional trial. A total of eligible 68 participants were randomly assigned into two groups (ipragliflozin group n = 36; conventional treatment group n = 32). Primary end-points were the change in E/e' and e'. Secondary end-points were other parameters of echocardiography, plasma NT-proBNP level, New York Heart Association class, hemoglobin A1c and blood pressure. RESULTS: After 24 weeks of follow up, E/e' decreased in both groups (ipragliflozin: 11.0 vs 10.4; conventional treatment 10.5 vs 10.1; multivariate-adjusted P = 0.95). There were no significant differences in the amount of change in E/e', e', echocardiography parameters, plasma NT-proBNP level, New York Heart Association class, hemoglobin A1c and blood pressure between the two groups. In the subgroup analysis, ipragliflozin treatment decreased in left ventricular mass index in patients aged ≥70 years and also decreased in NT-proBNP levels in patients with baseline NT-proBNP ≥400 pg/mL. CONCLUSIONS: In this randomized controlled study carried out in patients with type 2 diabetes and heart failure with preserved ejection fraction, 24-week ipragliflozin treatment did not improve left ventricular diastolic function compared with conventional treatment. As the subgroup, ipragliflozin treatment decreased in left ventricular mass index in participants aged ≥70 years. Geriatr Gerontol Int 2022; 22: 298-304.

A randomized controlled trial to evaluate the safety and efficacy of transluminal injection of foam sclerotherapy compared with ultrasound-guided foam sclerotherapy during endovenous catheter ablation in patients with varicose veins.

OBJECTIVE: We compared the safety, need for additional foam sclerotherapy, and 1-year venous clinical severity score (VCSS) improvement in the limbs of patients with chronic venous disease and great saphenous vein (GSV) reflux. These patients had undergone endovenous laser ablation (EVLA) using a 1470-nm diode laser and concurrent foam sclerotherapy (1% polidocanol) through the access sheath (transluminal injection of foam sclerotherapy [TLFS]) or EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS). METHODS: In the present study, we screened 467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (n = 103 legs; TLFS group) or UGFS with EVLA (n = 94 legs; UGFS group). The exclusion criteria were (1) recurrent varicose veins after previous intervention; (2) hypersensitivity reaction to sclerotherapy; (3) acute deep vein thrombosis; (4) serious lower limb ischemic disease; (5) a coagulation disorder; and (6) simultaneous EVLA of both GSVs and small saphenous veins. The correlations of the VCSS changes with the clinical features, such as age, sex, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, total amount of sclerosant used at the original procedure, multiple punctures (more than two) for sclerotherapy at the original procedure, the use of TLFS, and linear endovenous energy density, were estimated using logistic regression. RESULTS: No significant differences in the distribution of the CEAP classification were observed between the two groups. After 12 months of follow-up, all truncal veins were occluded. The VCSS had significantly improved in the TLFS group compared with the UGFS group (UGFS, -7.4 ± 1.8; TLFS, -8.7 ± 1.5; P < .0001). Multivariate analysis revealed that TLFS was the only significant factor for an improved VCSS (hazard ratio, 0.63; 95% confidence interval, 0.32-0.96; P < .0001). The need for additional second-stage sclerotherapy was significantly avoided in the TLFS group (n = 10; 10%) compared with the UGFS group (n = 51; 54%; P < .0001). CONCLUSIONS: TLFS combined with EVLA is a safe and feasible procedure that improves the VCSS and reduces the need for additional second-stage interventions compared with UGFS combined with EVLA.

Decrease in red cell distribution width as a useful predictor of success after catheter ablation for atrial fibrillation: a retrospective multi-center study.

Red cell distribution width (RDW) is reportedly associated with cardiovascular events, including atrial fibrillation (AF). We investigated whether the RDW values were associated with the outcomes of catheter ablation for AF. This retrospective multicenter study included 501 patients with AF (239 paroxysmal AF cases, 196 persistent AF cases, and 66 long-standing persistent AF cases) who underwent initial AF ablation between March 2017 and May 2018. The RDW values were evaluated before and at 1-3 months after the procedure. The patients were stratified based on the recurrence of AF within 1 year after the index procedure with a blanking period of 3 months into recurrence group (107 patients, 21.4%) and no-recurrence group (394 patients, 78.6%). There were no significant differences in preoperative RDW values between the groups (p = 0.37). The RDW value did not change significantly after the ablation in the recurrence group (13.55-13.60%, p = 0.37), although it decreased significantly in the no-recurrence group (13.64-13.37%, p < 0.001). Multivariate Cox proportional hazards regression analyses revealed that a postoperative change in RDW (ΔRDW) was independently associated with AF recurrence (hazard ratio 2.00, 95% confidence interval 1.42-2.76, p < 0.001). Receiver operating characteristic curve analysis revealed that a ΔRDW cut-off value of - 0.1% provided a c-statistic of 0.65 for predicting AF recurrence. Decrease in RDW during the blanking period after ablation independently predicted the 1-year success of AF ablation.