Transcatheter aortic valve implantation for combined aortic and mitral stenoses: Insights from the OCEAN-TAVI Registry.

AIMS: Mitral stenosis (MS) occasionally coexists with aortic stenosis (AS). Limited data are available regarding the functional class and clinical outcomes of patients who undergo transcatheter aortic valve implantation (TAVI) for combined AS and MS. This study compared the clinical outcomes in patients with and without MS who underwent TAVI for severe AS and assessed the impact of mitral annulus calcification (MAC) severity, transmitral gradient (TMG) and mitral valve area (MVA) on outcomes in patients with combined AS and MS. METHODS: We investigated patients in the OCEAN-TAVI registry who underwent TAVI. MS was defined as an MVA ≤ 1.5 cm2 or TMG ≥ 5 mmHg. The composite of all-cause death and admission for heart failure was compared between patients with and without MS. The impact of MAC, TMG and MVA on outcomes was assessed in patients with combined AS and MS. RESULTS: We identified 106 patients with MS (MAC 84%; TMG 6.4 ± 2.6 mmHg; MVA 1.10 ± 0.31 cm2) and 6570 without MS as controls. The MS group was older (85 ± 5 vs. 84 ± 5 years, P = 0.033), more of women (85 vs. 67%, P < 0.01), and had a higher risk of surgery (the Society of Thoracic Surgeons Mortality Score 8.7 ± 5.1 vs. 7.6 ± 5.9, P = 0.047) than the controls. In the MS group, the New York Heart Association Functional Class was 3 or 4 in 56% of the patients at baseline and 6% at 1 year after TAVI. Thirty-day mortality (2.8% vs. 1.3%, P = 0.18) and early composite outcomes (17% vs. 15%, P = 0.56) were comparable between patients with and without MS. During a median follow-up of 2.1 years, the presence of MS was associated with a higher incidence of adverse events compared with controls (adjusted hazard ratio [HR] 1.84; 95% confidence interval [CI] 1.34-2.51, P < 0.01), even on propensity score matched analysis (adjusted HR 1.91; 95% CI 1.14-3.22, P < 0.01). Moderate or severe MAC contributed to increased risk of adverse events in patients with MS (adjusted HR 2.89; 95% CI 1.20-6.99, P = 0.018), but TMG and MVA did not. CONCLUSIONS: In patients undergoing TAVI for severe AS, those with moderate or severe MS experienced worse outcomes after TAVI compared with those without MS. Patients with combined AS and MS sustained symptom improvement at 1-year post-TAVI. MAC severity was a useful predictor of adverse events compared with MS haemodynamics such as TMG and MVA in patients with combined AS and MS.

A case of acute kidney injury and Fanconi syndrome while taking multiple supplements, including Red Yeast Rice Cholesterol Help®.

A 62-year-old man visited his primary care physician with the complaints of loss of appetite and fatigue. He was admitted to our hospital based on a diagnosis of acute kidney injury, Fanconi syndrome as indicated by hypokalemia, hypouricemia, hypophosphatemia, elevated glucose levels in urine, and aminoaciduria. He had been taking multiple supplements, including Red Yeast Rice Cholesterol Help®, for one and a half years. After admission, all the supplements were stopped. Blood samples were collected; however, the samples were negative for diseases that could cause Fanconi syndrome. Renal biopsy revealed renal proximal tubular damage, mainly characterized by simplification of the proximal tubular epithelium. The mycotoxin, citrinin, which is reported to be produced by the mold used for producing red yeast rice, but not the mold Monascus pilosus used for Red Yeast Rice Cholesterol Help®, reportedly causes proximal tubular damage. However, although the causative agent has not been identified, it was thought that a substance similar to citrinin, produced by the mold used for Red Yeast Rice Cholesterol Help®, caused proximal tubular damage, leading to acute kidney injury and Fanconi syndrome. Hence, all supplements were stopped, and the patient was treated with oral potassium and phosphorus preparations, leading to gradual recovery of his kidney function. We herein report the first case of acute kidney injury and Fanconi syndrome in a patient taking multiple health supplements, including Red Yeast Rice Cholesterol Help®. Early discontinuation of the oral supplements was probably useful in improving the patient's kidney function.

Midterm outcomes of transcatheter aortic valve replacement in patients with active cancer.

OBJECTIVES: The clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS) and concomitant active cancer remain insufficiently explored. This study aimed to assess the midterm outcomes of TAVR in patients diagnosed with AS and active cancer. METHODS: Data from the OCEAN-TAVI, a prospective Japanese registry of TAVR procedures, was analysed to compare prognoses and clinical outcomes in patients with and without active cancer at the time of TAVR. RESULTS: Of the 2336 patients who underwent TAVR from October 2013 to July 2017, 89 patients (3.8%) had active cancer, whereas 2247 did not. Among patients with active cancer, 49 had limited-stage cancer (stage 1 or 2). The prevalent cancers identified before TAVR were colon (21%), prostate (18%), lung (15%), liver (11%) and breast (9%). Although the periprocedural complications and 30-day mortality rates were comparable between the groups, the 3-year survival rate after TAVR was notably lower in patients with active cancer (64.7%) than in those without active cancer (74.7%; p=0.016). Nevertheless, the 3-year survival rate of patients with limited-stage cancer (stage 1 or 2) did not significantly differ from those without cancer (70.6% vs 74.7%, p=0.50). CONCLUSIONS: The patients with active cancer exhibited significantly reduced midterm survival rates. However, no distinct disparity existed in those with limited-stage cancer (stage 1 or 2). Although TAVR is a viable treatment in patients with AS with active cancer, the type and stage of cancer and prognosis should be carefully weighed in the decision-making process.

Nephrotic syndrome with acute kidney injury due to combination therapy of immune checkpoint inhibitors: a case report and review of the literature.

BACKGROUND: Recent studies have focused on immune checkpoint inhibitors. Renal complications associated with the use of immune checkpoint inhibitors are uncommon compared with other immune-related adverse events. Acute interstitial nephritis accounts for most of these renal complications, with nephrotic syndrome quite rare. We herein report a case of nephrotic syndrome associated with immune checkpoint inhibitors that was more severe than that in previous cases. By comparing this case with previous reports, the possible reasons for the particular severity of this case are discussed. CASE PRESENTATION: A 75-year-old man developed nephrotic syndrome with acute kidney injury after the first combination therapy of nivolumab and ipilimumab for malignant pleural mesothelioma. The results of a kidney biopsy indicated minimal change disease with mild atherosclerosis, acute interstitial nephritis, and fusion of nearly all podocyte foot processes. Nivolumab and ipilimumab therapy were stopped, and treatment with corticosteroids was initiated. We investigated previously reported cases of nephrotic syndrome using immune checkpoint inhibitors. Seventeen cases of immune checkpoint inhibitor-related nephrotic syndrome, including ours, have been reported. Two of the 17 patients with immune checkpoint inhibitor-related nephrotic syndrome required hemodialysis treatment for acute kidney injury. Unlike many previously reported cases, the present patient was administered two different immune checkpoint inhibitors, which may be one of the reasons for the development of severe nephrotic syndrome. CONCLUSIONS: In addition to previously reported risk factors, immune checkpoint inhibitor combination therapy can exacerbate nephrotic syndrome compared to immune checkpoint inhibitor monotherapy.

High-flow arteriovenous fistula in X-linked Alport syndrome: a case report.

Most male X-linked Alport syndrome patients with COL4A5 nonsense mutations experience end-stage kidney failure by 30 years old. Although there is no definition of high-flow arteriovenous fistula, access blood flows greater than 2000 mL/min might predict the occurrence of high-output heart failure. A 50-year-old Japanese man had suffered from proteinuria at 4 years old and sensorineural hearing loss and a lenticular lens at 20 years old. He had started to receive hemodialysis treatment due to end-stage kidney disease at 22 years old. A genetic test confirmed a novel hemizygous nonsense variant COL4A5 c.2980G > T (p.Gly994Ter), and he was diagnosed with X-linked Alport syndrome. COL4A5 c.2980G > T was considered "pathogenic" according to the American College of Medical Genetics and Genomics guidelines and in vitro experiments. Shortness of breath on exertion was exaggerated, his brachial artery blood flow was over 4,236-4,353 mL/min, his cardiac output was 5,874 mL/min, and he needed radial artery banding at 51 years old. After radial artery banding surgery, the brachial artery blood flow decreased to 987-1,236 mL/min, and echocardiography showed a cardiac output at 5100 mL/min with improved E' and E/E'. His shortness of breath on exertion improved gradually. Although rare, high-output heart failure due to high-flow arteriovenous fistula should be kept in mind as a complication in X-linked Alport syndrome patients, and our patient was successfully treated with radial artery banding surgery.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial.

BACKGROUND: Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. STUDY DESIGN AND OBJECTIVES: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. CONCLUSION: The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

Bullous Pemphigoid in X-linked Alport Syndrome.

Skin lesions in X-linked Alport syndrome (XLAS) are rarely observed. Bullous pemphigoid (BP) is caused by autoantibodies against BP180, also called α1 (XVII) chain, in the basement membrane zone (BMZ). A 48-year-old man with XLAS developed tense blisters. A skin biopsy showed a cleft between the basal cell layer and dermis, with the infiltration of neutrophils and eosinophils. α1 (XVII) staining was positive on the epidermal side of α2/5 (IV) staining. Oral prednisolone improved his symptoms gradually. Abundant tense blisters on the palms and soles might suggest an important role of the α5 (IV) chain in the integrity of BMZ.

Accuracy of quantitative vessel analysis in endovascular treatment for femoropopliteal lesions.

BACKGROUND: Our aim was to evaluate the accuracy of quantitative vessel analysis (QVA) in measuring the reference vessel diameter (RVD) of femoropopliteal lesions. METHODS: Between October 2014 and September 2015, 30 consecutive femoropopliteal lesions in 25 patients who underwent endovascular therapy (EVT) under intravascular ultrasound (IVUS) guidance were analyzed. RVDs measured using QVAsheath (calibrated using a 6-Fr sheath in the common femoral artery) and QVAruler (calibrated using a ruler on the angiography table) were compared to those obtained using IVUS as the reference values. RESULTS: The mean QVAsheath-measured RVD was significantly larger than the mean IVUS-measured RVD (5.34±1.29 vs. 5.07±1.20 mm, P=0.001). In contrast, mean QVAruler-measured RVD was 4.60±1.04 mm, which was significantly smaller than both the mean IVUS- and mean QVAsheath-measured RVD (both P<0.001). Bland-Altman analysis revealed that the 95% limits of agreement versus IVUS ranged from -0.94 to 1.49 mm for QVAsheath and -1.69 to 0.76 mm for QVAruler, respectively. Agreement with tolerance of ±1.00 mm accounted for 88% of QVAsheath and 83% of QVAruler (P=0.60). The difference between QVA- and IVUS-measured RVDs was inversely correlated with the distance from the table (P=0.029 for QVAsheath and P=0.003 for QVAruler). CONCLUSIONS: The accuracy of both QVAsheath and QVAruler in measuring RVD were similarly suboptimal. Over- and under-estimation of RVD is not rare in QVA.

Surgical revision of failed MitraClip procedure for atrial functional mitral regurgitation.

The MitraClip system is used for patients with severe mitral regurgitation (MR) who are at high risk for open surgery. However, some patients need surgical revision for various complications. The acute outcome of MitraClip treatment for atrial functional MR (aFMR) is scarcely reported. Herein, we describe a rare case of an 80-year-old woman treated with a MitraClip for aFMR with mitral annular dilatation and failed leaflet adaptation. The patient suffered from single leaflet device attachment (SLDA) and posterior leaflet injury 3 days posttreatment. The patient successfully underwent mitral valve replacement. The postoperative pulmonary hypertension was markedly improved and the left atrial volume was reduced. A MitraClip should be carefully used for aFMR with mitral annular dilatation and failed leaflet adaptation as it may cause SLDA.

Risk assessment in patients with left ventricular systolic dysfunction following transcatheter aortic valve replacement.

BACKGROUND: Mortality following transcatheter aortic valve replacement (TAVR) in patients with post-procedural left ventricular systolic dysfunction remains high. We investigated clinical variables associating with worse clinical outcomes following TAVR in patients with systolic dysfunction. METHODS: We retrospectively investigated 2588 patients with severe aortic stenosis who received TAVR and were enrolled in the optimized transcatheter valvular intervention (OCEAN-TAVI) multicenter registry (UMIN000020423). The association between the clinical variables following TAVR and 2-year cardiovascular mortality was investigated among those with post-TAVR left ventricular ejection fraction less than 50%. RESULTS: A total of 298 patients (median 85 years old, 131 men) were included. The presence of moderate or greater tricuspid regurgitation following TAVR was independently associated with 2-year mortality (adjusted hazard ratio 3.41, 95% confidence interval 1.15-10.1), and significantly discriminated 2-year cardiovascular mortality (30% vs. 12%, p = 0.001). No patients with any improvement in tricuspid regurgitation had cardiovascular death. CONCLUSION: Following TAVR, the existence of significant tricuspid regurgitation was associated with cardiovascular mortality in patients with heart failure with reduced ejection fraction.

Long-Term Prognostic Value of the Society of Thoracic Surgery Risk Score in Patients Undergoing Transcatheter Aortic Valve Implantation (From the OCEAN-TAVI Registry).

The Society of Thoracic Surgeons (STS) risk model, designed to predict operative mortality after cardiac surgery, is often used for the risk assessment of patients considered for transcatheter aortic valve implantation (TAVI). We investigated the long-term prognostic value of the STS score by utilizing the data of 2588 patients undergoing TAVI from the OCEAN (Optimized CathEter vAlvular iNtervention)-TAVI Japanese multicenter registry. The patients were divided into 3 groups according to their pre-procedural STS score as follows: low-risk (STS score <4%, n = 467 [18%]), intermediate-risk (4%≤ STS score <8%, n = 1200 [46.4%]), and high-risk (8%≤ STS score, n = 921 [35.6%]). Low-risk patients were younger and were more frequently male. The prevalence of most of the comorbidities were higher in high-risk patients, while active cancer was more frequent in low-risk patients (p <0.001).The cumulative 4-year all-cause mortality rates were higher in high-risk patients (49.0%) but comparable in low-risk (22.6%) and intermediate-risk patients (28.7%) (hazard ratio [HR] for intermediate-risk versus low-risk, 1.03; 95% confidence interval [CI], 0.77 to 1.37; p = 0.85; HR for high-risk versus low-risk, 2.27; 95% CI 1.72 to 2.99; p = <0.001). Similarly, the cumulative 4-year cardiovascular mortality rates were higher in high-risk patients (20.5%) but comparable in low-risk (9.9%) and intermediate-risk patients (10.3%) (HR for intermediate-risk versus low-risk, 1.10; 95% CI, 0.68 to 1.77; p = 0.69; HR for high-risk versus low-risk, 2.33; 95% CI 1.48 to 3.67; p = <0.001). After adjustment for several confounders, STS score ≥8% was independently associated with increased long-term mortality (HR, 1.35; 95% CI, 1.08 to 1.68). In conclusion, the risk stratification according to STS score demonstrated an increased risk of long-term mortality after TAVI in high-risk patients, albeit with comparable risks in intermediate- and low-risk patients.

Usefulness of ultrasound-guided intraluminal approach for long occlusive femoropopliteal lesion.

To investigate the usefulness of ultrasound-guided (USG) intraluminal approach for femoropopliteal (FP) lesion. 64 patients (73 limbs) with de novo long occlusive (> 15 cm) FP lesions underwent USG intralumial approach from April 2012 to October 2016. Periprocedural intravascular ultrasound findings were collected. Clinical outcome and predictors of restenosis after USG intraluminal approach for de novo long occlusive FP lesion were investigated. Among the study participants, 34% were female, 50% had diabetes mellitus, and 10% received hemodialysis. Lesion and chronic total occlusion (CTO) lengths were 222 ± 55 mm and 201 ± 55 mm, respectively. Procedural success was achieved in 72 lesions (99%). Distal puncture was performed in 7 limbs (10%). The proportion of within-CTO intraplaque, subintimal, and medial routes were 87 ± 21%, 9 ± 15%, and 4 ± 11%, respectively. Primary patency was 71% and 69% at 1 and 2 years. Multivariate analysis revealed that within-CTO intraplaque route proportion [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67-0.98, p = 0.0339] and lesion length (HR 1.11; CI 1.00-1.22; p = 0.0447) were independent predictors of restenosis.USG intraluminal approach facilitated acquisition of within-CTO intraplaque route in long occlusive FP lesions and could improve clinical outcome.

A Comparative Analysis between Ultrasound-Guided and Conventional Distal Transradial Access for Coronary Angiography and Intervention.

OBJECTIVES: To compare feasibility and safety between ultrasound-guided and conventional distal transradial access (dTRA). BACKGROUND: Distal transradial access, a new technique for coronary angiography (CAG) and percutaneous coronary interventions (PCI), is safe and feasible and will become popular worldwide. Ultrasound-guided dTRA has been advocated to reduce failure rate and access-site complications. However, to date, the comparison of feasibility and safety between ultrasound-guided and conventional dTRA has not been reported. METHOD: Overall, 137 patients (144 procedures) who underwent CAG or PCI using dTRA between September 2018 and February 2019 were investigated. These patients were classified into two groups: C (dTRA with conventional punctures; 76 patients, 79 procedures) and U (dTRA with ultrasound-guided punctures; 61 patients, 65 procedures) groups. Successful procedural rate, procedural outcomes, and complication rate during hospital stays were compared between the two groups. RESULTS: The procedural success rate was significantly higher in the U group than in the C group (97% vs. 87%, P=0.0384). However, the rate of PCI, puncture time, total fluoroscopy time, the volume of contrast medium, the rate of access-site ecchymosis, and incidence of nerve disorder were similar between the two groups. Additionally, radial artery occlusion after the procedure did not occur in this study. CONCLUSION: The ultrasound-guided dTRA for CAG or PCI was associated with a lower failure rate than conventional dTRA. However, there were no significant differences in puncture time and complication rate between the two procedures.

Usefulness of a Guide Extension Catheter in Endovascular Therapy of Infrapopliteal Lesions.

Guide extension catheters have been available since 2015 for peripheral endovascular intervention. These devices are commonly used for active backup support. We successfully managed 2 cases of infrapopliteal arterial disease with the assistance of a guide extension catheter. In a patient with a posterior tibial artery occlusion, early elastic recoil occurred after balloon dilatation. We then deployed the guide extension catheter to maintain blood flow while ballooning for 15 min, resulting in good blood flow to the toes after device removal. Another patient had a severely calcified stenotic anterior tibial artery lesion. Although a guidewire could be advanced to the lesion, no device could be passed through the calcification. Using the guide extension catheter, we then safely delivered a 0.035-inch guidewire's tail to drill through the calcification. Thereafter, a balloon could be passed, and successful angioplasty was achieved. These cases illustrate the usefulness of a guide extension catheter in endovascular therapy of complex infrapopliteal lesions.

Ultra-Long Inflation in Superficial Femoral Artery Stenosis and Occluded Lesions Using Guide Liner ("Ultra SOUL"): A Case Report.

Following an era of the use of several drug-coated balloons in angioplasty, "leave nothing behind" and stentless strategies have been gaining attention. In stentless strategies, it is necessary to avoid major dissections and limit flow. Balloon dilation is an important step in vessel preparation. In this study, we report a novel predilation technique. We performed prolonged balloon inflation for >10 min after normal ballooning in a procedure to treat an occluded lesion in the superficial femoral artery (SFA). We used a guide extension catheter to avoid foot ischemia and obtained better angiographic results than those using short duration balloon inflation. We named this technique "Ultra-Long Inflation in SFA Stenosis and Occluded Lesions Using Guide Liner" or "Ultra SOUL." The Ultra SOUL technique may be considered a useful option in balloon dilation.

Differences between first-generation and second-generation drug-eluting stent regarding in-stent neoatherosclerosis characteristics: an optical coherence tomography analysis.

We compared first-generation and second-generation drug-eluting stent (DES) with respect to neoatherosclerosis using optical coherence tomography or optical frequency domain imaging. In-stent restenoses in 102 first-generation and 114 second-generation DES were retrospectively assessed. Neoatherosclerosis, which was defined as the presence of lipid-laden neointima or calcification inside a stent, was observed in 33 (27.2%) and 31 (32.4%) lesions in the first-generation and second-generation DES respectively. In the first-generation DES group, the lipid length was significantly longer (5.5 ± 3.8 vs. 3.1 ± 2.1 mm, P = 0.0007), the lipid arc was significantly larger (324 ± 70° vs. 250 ± 94°, P = 0.002), the prevalence of a 360° lipid arc was significantly greater (58 vs. 31%, P = 0.03), and the fibrous cap was significantly thinner (153 ± 85 vs. 211 ± 95 µm, P = 0.02) compared with those in the second-generation DES group. These differences remained significant after adjusting for the age of the stent (lipid length: P < 0.001; lipid arc: P = 0.019; and fibrous cap thickness: P < 0.001). The proliferation course and stability of neoatherosclerosis over time might be superior in second-generation DES.

The Impact of Decline in Activities of Daily Living (ADL) of Patients With Critical Limb Ischemia (CLI) After Endovascular Treatment.

BACKGROUND: Certain patients with critical limb ischemia (CLI) experience significant decline in activities of daily living (ADL) during hospitalization. The prognosis of decline in ADL during hospitalization remains unknown. METHODS: A retrospective analysis was performed on collected data of patients with CLI treated by endovascular treatment between April 2007 and December 2015. We evaluated CLI in patients ADL at the time of hospitalization and after discharge using the Barthel index. We classified all patients into patients with decline in ADL and stable in ADL and compared clinical outcomes (cumulative incidence of wound healing, amputation-free survival at 1 year) between the 2 groups. RESULTS: Two hundred and fifty-five consecutive patients with CLI (221 limbs), who underwent successful endovascular intervention, were enrolled in this study. Of all patients, 22 patients were classified into the decline group. The prevalence of wound, Ischemia, foot infection (WIfI) classification high grade was higher in the decline group (30.7% vs 63.6%; P < .01). The wound healing rates were worse in the decline group than in the stable group (40% vs 78% at 1 year; P < .01). The same trends were observed in the amputation-free survival (37% vs 78%; P < .01). After multivariate analysis, decline in ADL was an independent predictor of wound healing and amputation-free survival (odds ratio [OR]: 2.85, 95% confidence interval [CI]: 1.61-3.35, P < .01; OR: 2.46, 95% CI: 1.26-4.53, P = .01). CONCLUSIONS: Patients with CLI with decline in ADL during hospitalization were found to have a poor prognosis suggesting that a decline in ADL may affect the clinical outcomes.

Impact of HAS-BLED score to predict trans femoral transcatheter aortic valve replacement outcomes.

BACKGROUND: Predictors of bleeding and mortality after trans femoral transcatheter aortic valve replacement (TF-TAVR) has not been thoroughly investigated. OBJECTIVE: The aim of this study was to assess whether Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly (HAS-BLED) score has predictive value for bleeding and mortality in patients after TAVR. METHODS: Between October 2013 and April 2016, 969 patients underwent TF-TAVI were prospectively included in the OCEAN-TAVI registry from Japan. The primary outcomes were severe bleeding (including life-threatening and major bleeding defined in The Valve Academic Research Consortium-2 criteria) and mortality within 1 year after TAVR. RESULTS: Elderly (84 ± 5 years) and high surgical risk patients (The Society of Thoracic Surgery Risk Score 6.7 [4.6-9.3]) were enrolled. Severe bleeding and mortality had occurred in 177 patients (18.2%) and 66 patients (6.8%), respectively. On multivariate analysis, HAS-BLED score was associated with severe bleeding (hazard ratio [HR], 1.82; 95% confidence interval [CI], 1.41-2.00; p < 0.001) and mortality (HR, 2.04, 95% CI, 1.56-2.69, P < 0.001). A HAS-BLED score threshold of 4 points (area under the curve 0.71 for severe bleeding, 0.72 for mortality) predicted a higher rate of severe bleeding (25.3% vs. 14.4%, P < 0.001) and mortality (16.2% vs. 4.0%, P < 0.001). CONCLUSIONS: HAS-BLED score could predict the risk of severe bleeding and mortality in patients who underwent TF-TAVR independent of the presence of atrial fibrillation.

The novel echo-guided ProGlide technique during percutaneous transfemoral transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to assess clinical benefit of the Echo-guided ProGlide technique in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). BACKGROUND: The efficacy of the Echo-guided ProGlide technique during percutaneous TF-TAVI was not previously clarified. METHODS: A total of 121 consecutive patients who underwent percutaneous TF-TAVI at our institution between February 2014 and July 2017 were enrolled in this study. According to the introduction of this novel technique in March 2016, patients were divided into two groups (echo-guided group who underwent TAVI from March 2016 to July 2017, n = 63; not echo-guided group who underwent TAVI from February 2014 to February 2016, n = 58). The incidence of major vascular complications, defined per the Valve Academic Research Consortium-2 criteria, and ProGlide complications including acute femoral artery stenosis or occlusion and bleeding requiring any intervention. RESULTS: The incidence of major vascular complication and ProGlide complication were significantly lower in the echo-guided group than in not echo-guided group (1.6% vs 17.2%, P < 0.002; 1.6% vs 15.5%, P = 0.003; respectively). Use of the Echo-guided ProGlide technique was independently associated with prevention of ProGlide complications (odds ratio, 0.11; 95% confidential interval, 0.01-0.76; P = 0.03). CONCLUSIONS: This novel Echo-guided ProGlide technique was associated with a lower rate of major vascular complications, particularly ProGlide complications during percutaneous TF-TAVI.

Use of the Wound, Ischemia, foot Infection classification system in hemodialysis patients after endovascular treatment for critical limb ischemia.

OBJECTIVE: The Wound, Ischemia, foot Infection (WIfI) classification system is used to predict the amputation risk in patients with critical limb ischemia (CLI). The validity of the WIfI classification system for hemodialysis (HD) patients with CLI is still unknown. This single-center study evaluated the prognostic value of WIfI stages in HD patients with CLI who had been treated with endovascular therapy (EVT). METHODS: A retrospective analysis was performed of collected data on CLI patients treated with EVT between April 2007 and December 2015. All patients were classified according to their wound status, ischemia index, and extent of foot infection into the following four groups: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions in each group were analyzed. The prognostic value of the WIfI classification was analyzed on the basis of the wound healing rate and amputation-free survival at 1 year. RESULTS: This study included 163 consecutive CLI patients who underwent HD and successful endovascular intervention. The rate of the high-risk group (36%) was the highest among the four groups, and the proportions of very-low-risk, low-risk, and moderate-risk patients were 10%, 18%, and 34%, respectively. The mean follow-up duration was 784 ± 650 days. The wound healing rates at 1 year were 92%, 70%, 75%, and 42% in the very-low-risk, low-risk, moderate-risk, and high-risk groups, respectively (P <.01). A similar trend was observed for the 1-year amputation-free survival among the groups (76%, 58%, 61%, and 46%, respectively; P = .02). CONCLUSIONS: The WIfI classification system predicted the wound healing and amputation risks in a highly selected group of HD patients with CLI treated with EVT, with a statistically significant difference between high-risk patients and other patients.