Pulmonary Vein Intervention for Severe Pulmonary Vein Stenosis After Atrial Fibrillation Ablation　- A Retrospective Cohort Study.

BACKGROUND: Pulmonary vein (PV) stenosis (PVS) is a serious complication of atrial fibrillation (AF) ablation. The objective of this study was to describe interventional treatments for PVS after AF ablation and long-term outcomes in Japanese patients.Methods and Results: This multicenter retrospective observational study enrolled 30 patients (26 [87%] male; median age 55 years) with 56 severe PVS lesions from 43 PV interventional procedures. Twenty-seven (90%) patients had symptomatic PVS and 19 (63%) had a history of a single AF ablation. Of the 56 lesions, 41 (73%) were de novo lesions and 15 (27%) were retreated. Thirty-three (59%) lesions were treated with bare metal stents, 14 (25%) were treated with plain balloons, and 9 (16%) were treated with drug-coated balloons. All lesions were successfully treated without any systemic embolic event. Over a median follow-up of 584 days (interquartile range 265-1,165 days), restenosis rates at 1 and 2 years were 35% and 47%, respectively. Multivariate Cox regression analysis revealed devices <7 mm in diameter (hazard ratio [HR] 2.52; 95% confidence interval [CI] 1.04-6.0; P=0.040) and totally occluded lesions (HR 3.33; 95% CI 1.21-9.15; P=0.020) were independent risk factors for restenosis. CONCLUSIONS: All PVS lesions were successfully enlarged by the PV intervention; however, restenosis developed in approximately half the lesions within 2 years.

Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease.

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1 year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1 year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03 mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1 year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group.

Impact of a Less Than 50% Residual Stenosis Following Vessel Preparation in Femoropopliteal Drug-Coated Balloon Angioplasty.

PURPOSE: Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention. METHODS: In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and

Effect of High-Dose Drug-Coated Balloon Repetition After Drug-Coated Balloon Failure.

PURPOSE: Although the optimal treatment for femoropopliteal (FP) drug-coated balloon (DCB) restenosis lesions remains debatable, the effectiveness of DCB repetition for DCB restenosis has been reported. However, the optimal DCB repetition strategy is not yet established. Thus, this study aimed to compare the clinical outcomes of high-dose DCB repetition with those of low-dose DCB repetition for FP DCB restenosis lesions. MATERIALS AND METHODS: This single-center, observational study used a clinical database of 677 consecutive patients undergoing FP endovascular intervention for symptomatic peripheral artery disease between December 2018 and December 2021. Of these patients, 89 cases treated with DCB repetition for FP DCB restenosis lesions were analyzed. The primary endpoint was recurrent restenosis (re-restenosis) and the secondary endpoints were recurrent target-lesion revascularization (TLR), re-occlusion, and major adverse limb events (MALE) obtained using propensity score matching. Interaction analysis was also performed to explore the effects of the baseline characteristics on the association between high- and low-dose DCB with restenosis risk. RESULTS: After propensity score matching, high-dose DCB demonstrated a significantly higher freedom from re-restenosis compared with low-dose DCB repetition at 1 year (90.4% vs 40.9%, p=0.034). In addition, freedom from re-TLR and MALE at 1 year was significantly higher in the high-dose DCB group (95.0% vs 53.3%, p=0.025; 95.0% vs 54.7%, p=0.025, respectively). Conversely, freedom rates from re-occlusion were not significantly different between the 2 groups (100.0% vs 84.0%, p=0.99). No baseline characteristics or perioperative outcomes had any significant interaction effect on the association of high-dose DCB versus low-dose DCB with restenosis risk. CONCLUSION: For FP DCB restenosis lesions, high-dose DCB repetition offered more favorable outcomes than low-dose DCB repetition. CLINICAL IMPACT: This study revealed that for femoropopliteal drug-coated balloon (DCB) restenosis lesions, high-dose DCB repetition obtained more favorable outcomes than low-dose DCB repetition. In addition, there was no significant interaction effect on the association of high- versus low-dose DCB with re-restenosis risk for the baseline characteristics and perioperative outcomes. This finding might be also a reason for choosing high-dose DCB repetition for FP DCB restenosis lesions in daily clinical practice.

Subcutaneous ICDs implantation following removal of normally functioning non-infected transvenous ICDs in two young patients.

In young patients with transvenous implantable cardioverter defibrillations (TV-ICDs), the possibility of device infection or lead fracture would be high in their long lifetimes. Furthermore, the risk of lead removal will gradually increase over the years. We reported two cases of subcutaneous ICDs implantation following removal of TV-ICDs. Patient 1, 35-year-old man, underwent TV-ICD implantation 9 years ago for idiopathic ventricular fibrillation, and Patient 2, 46-year-old man, underwent TV-ICD implantation 8 years ago for asymptomatic Brugada syndrome. In both cases, the electrical performance was stable, and there was no incidence of arrythmia or no pacing demand during the follow-up duration. Considering future risk of device infection or lead fracture, and difficulty in future lead removal, TV-ICDs were removed with sufficient informed consent, and then, subcutaneous ICDs (S-ICDs) implantation were performed as an alternative to them. Although indication of the TV-ICD removal should be carefully considered in individual cases, long-term risks leaving it in place should be also considered in the management of young patient. Learning objective: In young patient with TV-ICD, even for a normally functioning non-infected lead, S-ICD implantation following removal of the TV-ICD would represent a strategy associated with less long-term risks than leaving it in place.

Clinical outcome for heart failure hospitalizations in patients with leadless pacemaker.

Introduction: The long-term performance of leadless pacemaker (LPM) has not been well evaluated. Methods: Between September 2017 and January 2021, 929 consecutive patients who underwent pacemaker implantation were grouped according to the types of pacemakers: LPM (LPM group, n = 368) and conventional pacemaker (PM group, n = 561). Results: The median follow-up duration was 1.7 years (interquartile range 0.8-2.6 years). Hospitalization rate for heart failure in the LPM group was 9.3%, 15.6%, and 21.6% at 1, 2, 3 years, respectively. The LPM group had a significantly higher adjusted heart failure hospitalization risk than the PM group [hazard ratio (HR) 1.70, 95% confidence interval (CI) 1.09-2.64, p = .01]. More patients with symptomatic bradycardia caused by sinus node dysfunction (SND) in the LPM group (n = 150) were admitted to the hospital for heart failure compared to those in the PM group (n = 219) (HR 2.02, 95%CI 1.04-3.90, p = .03), whereas no significant difference was observed between the two groups in the patients with bradycardia caused by atrial fibrillation (LPM group, n = 71; PM group, n = 18) or atrioventricular block (LPM group, n = 147; PM group, n = 324). Conclusions: Patients who received LPM implantation had greater hospitalization risk for heart failure, compared to those who received conventional pacemaker implantation. The increased risk was mainly attributed to patients with SND.

Use of Proprotein Converse Subtilisin/Kexin Type 9 Inhibitor to Treat Cholesterol Crystal Embolisms after Catheterization: A Report of Three Cases.

Cholesterol crystal embolism (CCE) is a serious complication that occurs after cardiac and vascular procedures. CCE involves multiple organs, and the prognosis and renal function of patients is poor. Although the efficacy of steroid, statin, and low-density lipoprotein apheresis has been reported, no definitive treatment has been established. We herein report three consecutive cases treated with conventional steroid therapy with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor after catheterization. The renal function was preserved, steroid therapy was stopped, and wound healing of blue toes was achieved. PCSK9 inhibitor therapy was safe in the present patient and may be a potential treatment option for CCE.

New lesion after endovascular therapy of femoropopliteal lesions for intermittent claudication.

BACKGROUND: Although the incidence of target lesion revascularization (TLR) was decreased in patients who underwent endovascular therapy (EVT) for femoropopliteal (FP) lesions, the clinical impact of newly developed lesions could not be disqualified in those patients. METHODS: Between January 2012 and December 2018, 911 patients with intermittent claudication (IC) who have not been previously treated for this condition underwent a successful EVT for de novo FP lesions in a multicenter registry (WATERMELON registry: neW lesion AfTer EndovasculaR therapy for interMittEnt cLaudicatiON). RESULTS: The mean follow-up duration was 3.5 ± 1.9 years. At 5 years, 53% patients underwent limb revascularization, (new lesion: 42% and TLR: 31%). We developed an ordinal risk score to predict the possibility of new lesion revascularization the following risk factors: body mass index (<23 kg/m2 , 1 point), diabetes (2 points), hemodialysis (3 points), and atrial fibrillation (2 points). The patients were divided into three groups: low risk group (0-1 points: N = 283), intermediate risk group (2-3 points: N = 395), and high risk group (≥4 points: N = 233). The cumulative 5-year incidence of new lesion revascularization was 28% in the low risk group, 40% in the intermediate group, and 68% in the high risk group (p < 0.001). CONCLUSION: within 5 years after the first EVT, more than half of the patients underwent limb revascularization. Of these patients, 42% underwent new lesion revascularization. Patients with a body mass index <23 kg/m2 , diabetes, hemodialysis, and atrial fibrillation had increased risk for new lesion revascularization.

Clinical outcomes of polymer-free, paclitaxel-coated stents vs stent grafts in peripheral arterial disease patients with femoropopliteal artery lesions.

OBJECTIVE: Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings. METHODS: This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis. RESULTS: In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034). CONCLUSIONS: Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis.

Clinical impact of intravascular ultrasound-guided balloon angioplasty in patients with chronic limb threatening ischemia for isolated infrapopliteal lesion.

BACKGROUND: To estimate the impact of intravascular ultrasound (IVUS) in patients with chronic limb-threatening ischemia (CLTI) who underwent balloon angioplasty for isolated infrapopliteal lesion. METHODS: The study was performed as a single-center, prospective maintained database, retrospective analysis. Between January 2013 and December 2018, consecutive 155 CLTI patients (155 limbs) who primarily underwent balloon angioplasty for de novo isolated infrapopliteal atherosclerotic lesions with Rutherford category class 4 or 5 were identified (IVUS-guided: 92 patients, angio-guided: 63 patients) and included in the analysis. We compared clinical outcomes in IVUS-guided group with that in angio-guided group. The primary endpoint was limb salvage without any reintervention. The main secondary endpoints were wound healing rate and time to wound healing in the tissue loss group. RESULT: Patient and limb characteristics were similar between the two groups. The IVUS-guided group was treated with a larger balloon size for all types of below-the-knee vessel (p < .001), although lesion characteristics, including the QVA-measured vessel diameter, were similar between the two groups. The IVUS-guided group had a higher rate of limb salvage without any reintervention than the angio-guided group (p = 0028). Whereas limb salvage and overall survival was not significantly different. Wound healing was significantly earlier and the time to wound healing was significantly shorter (84 ± 55 days vs. 135 ± 118 days, p = .007) in the IVUS-guided group. CONCLUSION: Limb salvage rate without any reintervention in IIVUS-guided balloon angioplasty group was significantly higher than that in angio-guided balloon angioplasty group in patients with CLTI due to isolated infrapopliteal disease.

Combination therapy of heparin-bonded covered stent and bare-nitinol stent assessed by intravascular ultrasound.

To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2-28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01-1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.

Ten-year clinical outcomes for patients undergoing lower extremity endovascular interventions.

BACKGROUND: Midterm outcomes after endovascular therapy (EVT) had been well-evaluated; however, 10-year outcomes after EVT are rarely reported. METHODS: A total of 713 patients underwent successful EVT for de novo lesions without acute limb ischemia. We divided patients according to lesion location: aortoiliac lesions only (AI group; n = 260); femoropopliteal lesions with or without aortoiliac lesions (FP group; n = 336); and below-the-knee lesions with or without other lesions (BTK group; n = 117). RESULTS: The clinical follow-up rate was 91% at 10 years. All-cause mortality was significantly higher in the BTK group (75%; P < .001) than in the AI group (54%), whereas no significant difference was observed between the FP (53%; P = .76) and AI groups. Compared with patients in the AI group, those in the FP and BTK groups more often suffered from target lesion revascularization (TLR; AI 15% vs FP 50% [P < .001] or BTK 73% [P < .001]) and non-TLR (AI 37% vs FP 49% [P = .005] or BTK 54% [P < .001]); however, after adjusting for baseline characteristics, differences in the risk of non-TLR were marginal between the FP and AI groups (adjusted hazard ratio, 1.35; 95% confidence interval, 0.99-1.84; P = .051) and BTK and AI groups (adjusted hazard ratio, 1.43; 95% confidence interval, 0.91-2.25; P = .11), respectively. CONCLUSIONS: Within 10 years after EVT, more than one-half of patients with AI or FP lesions and three-fourths of patients with BTK lesions died. Although the risk of TLR after EVT for AI lesions was relatively low, non-TLR continued to occur up to 10 years, irrespective of lesion location.

Clinical impact of improvement in the ankle-brachial index after endovascular therapy for peripheral arterial disease.

Predictive ability of changes in the ankle-brachial index (ABI) after revascularization for long-term clinical outcomes remains unclear. Pre- and postprocedural ABI were recorded for 1307 consecutive patients who underwent their first successful EVT for symptomatic aortoiliac (n = 710) or femoropopliteal (n = 597) lesions. The patients were divided into two groups according to the increase in ABI: ∆ABI ≥ 0.15 (n = 980) and ∆ABI < 0.15 (n = 327). We investigated the association between ABI improvement after EVT and long-term clinical outcomes. The clinical outcome measures included all-cause mortality, myocardial infarction, stroke, target limb revascularization, EVT for target lesion revascularization, major amputation of the target limb, and a composite endpoint that included both target limb revascularization and major amputation. All-cause mortality was significantly lower in the ∆ABI ≥ 0.15 group than in the ∆ABI < 0.15 group [crude hazard ratio (HR) 0.77, 95% confidence interval (CI) 0.60-0.98, P = 0.03]; however, this was no longer statistically significant after adjusting for baseline characteristics (adjusted HR 0.82, 95% CI 0.63-1.07, P = 0.14). A composite of target limb revascularization and major amputation was less often observed at 10 years in the ΔABI ≥ 0.15 group (258 patients, 38%) compared with the ΔABI < 0.15 group (112 patients, 59%; adjusted HR 0.54, 95% CI 0.42-0.68, P < 0.001), mainly because of a lower risk of target limb revascularization (adjusted HR 0.54, 95% CI 0.42-0.69, P < 0.001). No significant interactions were noted with regard to the locations of the treated lesions (P for the interaction, 0.13) or preprocedural ABI (P for the interaction, 0.40). An increase of ABI ≥ 0.15 after successful EVT was an independent predictor for freedom from a composite of target limb revascularization and major amputation, irrespective of the locations of the treated lesions and the preprocedural ABI.

Mortality Risk Following Application of a Paclitaxel-Coated Stent in Femoropopliteal Lesions.

PURPOSE: To examine if endovascular therapy (EVT) with paclitaxel-coated stents increases the mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD). MATERIALS AND METHODS: A retrospective analysis was conducted of paclitaxel-coated stent use in the femoropopliteal segment of 1535 symptomatic (Rutherford category 2 to 4) patients treated between January 2010 and December 2016 at 4 hospitals in Japan. The risk of all-cause mortality was examined between the 285 patients (mean age 73±8 years; 213 men) treated with a paclitaxel-coated stent (PTX-coated group) and 1250 patients (mean age 73±9 years; 872 men) not exposed to a paclitaxel-coated device (PTX-free group) during EVT. Propensity score matching was employed to balance baseline characteristics. Cox proportional hazards models stratified on the quintiles of the propensity score were used to investigate paclitaxel-coated stent use and mortality risk as well as interactions among baseline variables and the main outcome. Interactions between a PXT-coated stent and subgroups of the PTX-free group (bare stent and angioplasty) were also investigated, as was the impact of paclitaxel dose on mortality risk. The results of regression analysis are reported as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: The 3-year overall survival estimates were 86.4% in the PTX-coated group vs 87.7% in the PTX-free group; the corresponding 5-year estimates were 77.5% vs 73.7%, respectively. There was no significant difference in all-cause mortality between the 2 groups (HR 0.89, 95% CI 0.66 to 1.19, p=0.41). The cause of death also showed no remarkable difference between the groups. Chronic renal failure (p=0.044) and arterial calcification (p=0.022) demonstrated a significant interaction effect on the association of the use of a PTX-coated stent with all-cause mortality. No subgroup demonstrated that the use of a paclitaxel-coated stent was associated with an increased risk of all-cause mortality. A dose dependency was not evident. CONCLUSION: Mortality risk following application of a PTX-coated stent did not increase over 5 years, irrespective of the dose. A PTX-coated stent for femoropopliteal lesions in PAD patients is a safe treatment option.

Cable externalization at the proximal portion of the superior vena cava coil in Riata implantable cardioverter defibrillator leads.

Many Riata (St. Jude Medical, St. Paul, MN, USA) implantable cardioverter defibrillator (ICD) leads have reportedly developed cable externalization. The most likely cause of cable externalization is insulation abrasion, which often occurs at the can or between the right ventricular coil and superior vena cava (SVC) coil. We report a rare case of an adult male whose ICD lead cable was externalized at the proximal portion of the SVC coil. This lead became fixed to the wall at the subclavian vein and SVC and became bent between these adhesions. Furthermore, the motion of this lead was affected by pulsation of the aortic arch. The ICD lead might develop inside-out abrasion due to mechanical stress evoked by pulsation of the aortic arch at this site. .