Addition of Ezetimibe to Intensive Lipid-Lowering Therapy Is Associated With a Lower Incidence of Heart Failure in Patients With Acute Coronary Syndrome.

BACKGROUND: This study investigated whether intensive lipid-lowering therapy with pitavastatin and ezetimibe lowers the incidence of heart failure (HF) events in patients with acute coronary syndrome (ACS). METHODS AND RESULTS: In the HIJ-PROPER study, 1,734 patients with ACS were randomly assigned to either pitavastatin plus ezetimibe therapy (n=864) or pitavastatin monotherapy (n=857). We examined the incidence of HF between these 2 groups over a 3.9-year period after ACS. The primary endpoint of the study was hospitalization for HF. The mean low-density lipoprotein cholesterol levels during the follow-up period were 65.1 mg/dL in the pitavastatin plus ezetimibe group and 84.6 mg/dL in the pitavastatin monotherapy group. The incidence of HF hospitalization was significantly lower in the pitavastatin plus ezetimibe group than in the pitavastatin monotherapy group (19 [2.2%] vs. 40 [4.7%] patients; hazard ratio 0.47, 95% confidence interval 0.27-0.81; P<0.005). This trend was consistent after multivariable analysis using multiple models. CONCLUSIONS: Intensive lipid-lowering therapy with pitavastatin and ezetimibe is associated with a lower incidence of hospitalization for HF in patients with ACS.

Adverse clinical events after percutaneous coronary intervention in very elderly patients with acute coronary syndrome.

The number of very elderly patients with acute coronary syndrome (ACS) is increasing. Therefore, owing to the need for evidence-based treatment decisions in this population, this study aimed to examine the clinical outcomes during 1 year after percutaneous coronary intervention (PCI) in very elderly patients with ACS. This prospective multicenter observational study comprised 1337 patients with ACS treated with PCI, classified into the following four groups according to age: under 60, <60 years; sexagenarian, ≥60 and <69 years; septuagenarian, ≥70 and <80 years; and very elderly, ≥80 years. The primary endpoint was a composite of the first occurrence of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and bleeding within 1 year after PCI. We used the sexagenarian group as a reference and compared outcomes with those of the other groups. The incidence of the primary endpoint was significantly higher in the very elderly group than in the sexagenarian group (36 [12.7%] vs. 24 [6.9%], respectively; hazard ratio, 1.94; 95% confidence interval: 1.16-3.26; p = 0.012). The higher incidence of the primary endpoint was primarily driven by a higher incidence of all-cause death. When the multivariable analysis was used to adjust for patient characteristics and comorbidities, no difference was observed in the primary endpoint between the very elderly and sexagenarian groups (p = 0.96). The incidence of adverse events after PCI, particularly all-cause death, in very elderly patients with ACS was high. However, if several confounders are adjusted, comparable outcomes may be expected within 1 year after PCI among this population.

Differential Effect of Aortic Valve Replacement for Severe Aortic Stenosis on Hyperemic and Resting Epicardial Coronary Pressure Indices.

BACKGROUND: Coronary pressure indices to assess coronary artery disease are currently underused in patients with aortic stenosis due to many potential physiological effects that might hinder their interpretation. Studies with varying sample sizes have provided us with conflicting results on the effect of transcatheter aortic valve replacement (TAVR) on these indices. The aim of this meta-analysis was to study immediate and long-term effects of TAVR on fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). METHODS AND RESULTS: Lesion-specific coronary pressure data were extracted from 6 studies, resulting in 147 lesions for immediate change in FFR analysis and 105 for NHPR analysis. To investigate the long-term changes, 93 lesions for FFR analysis and 68 for NHPR analysis were found. Lesion data were pooled and compared with paired t tests. Immediately after TAVR, FFR decreased significantly (-0.0130±0.0406 SD, P: 0.0002) while NHPR remained stable (0.0003±0.0675, P: 0.9675). Long-term after TAVR, FFR decreased significantly (-0.0230±0.0747, P: 0.0038) while NHPR increased nonsignificantly (0.0166±0.0699, P: 0.0543). When only borderline NHPR lesions were considered, this increase became significant (0.0249±0.0441, P: 0.0015). Sensitivity analysis confirmed our results in borderline lesions. CONCLUSIONS: TAVR resulted in small significant, but opposite, changes in FFR and NHPR. Using the standard cut-offs in patients with severe aortic stenosis, FFR might underestimate the physiological significance of a coronary lesion while NHPRs might overestimate its significance. The described changes only play a clinically relevant role in borderline lesions. Therefore, even in patients with aortic stenosis, an overtly positive or negative physiological assessment can be trusted.

Optimization of Absolute Coronary Blood Flow Measurements to Assess Microvascular Function: In Vivo Validation of Hyperemia and Higher Infusion Speeds.

BACKGROUND: Reliable assessment of coronary microvascular function is essential. Techniques to measure absolute coronary blood flow are promising but need validation. The objectives of this study were: first, to validate the potential of saline infusion to generate maximum hyperemia in vivo. Second, to validate absolute coronary blood flow measured with continuous coronary thermodilution at high (40-50 mL/min) infusion speeds and asses its safety. METHODS: Fourteen closed-chest sheep underwent absolute coronary blood flow measurements with increasing saline infusion speeds at different dosages under general anesthesia. An additional 7 open-chest sheep underwent these measurements with epicardial Doppler flow probes. Coronary flows were compared with reactive hyperemia after 45 s of coronary occlusion. RESULTS: Twenty milliliters per minute of saline infusion induced a significantly lower hyperemic coronary flow (140 versus 191 mL/min; P=0.0165), lower coronary flow reserve (1.82 versus 3.21; P≤0.0001), and higher coronary resistance (655 versus 422 woods units; P=0.0053) than coronary occlusion. On the other hand, 30 mL/min of saline infusion resulted in hyperemic coronary flow (196 versus 192 mL/min; P=0.8292), coronary flow reserve (2.77 versus 3.21; P=0.1107), and coronary resistance (415 versus 422 woods units; P=0.9181) that were not different from coronary occlusion. Hyperemic coronary flow was 40.7% with 5 mL/min, 40.8% with 10 mL/min, 73.1% with 20 mL/min, 102.3% with 30 mL/min, 99.0% with 40 mL/min, and 98.0% with 50 mL/min of saline infusion when compared with postocclusive hyperemic flow. There was a significant bias toward flow overestimation (Bland-Altman: bias±SD, -73.09±30.52; 95% limits of agreement, -132.9 to -13.27) with 40 to 50 mL/min of saline. Occasionally, ischemic changes resulted in ventricular fibrillation (9.5% with 50 mL/min) at higher infusion rates. CONCLUSIONS: Continuous saline infusion of 30 mL/min but not 20 mL/min induced maximal hyperemia. Absolute coronary blood flow measured with saline infusion speeds of 40 to 50 mL/min was not accurate and not safe.

Outcomes Based on Angiographic vs Functional Significance of Complex 3-Vessel Coronary Disease: FAME 3 Trial.

BACKGROUND: The functional SYNTAX score (FSS), which incorporates functional information as assessed by fractional flow reserve (FFR), is a better predictor of outcome after percutaneous coronary intervention (PCI) in patients with less complex coronary artery disease (CAD). OBJECTIVES: This study sought to test the prognostic value of the FSS in patients with complex CAD eligible for coronary artery bypass grafting (CABG). METHODS: The FAME 3 (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) trial compared FFR-guided PCI with CABG in patients with angiographic 3-vessel CAD. In this prespecified substudy, the angiographic core laboratory calculated the SYNTAX score (SS) and then the FSS by eliminating lesions that were not significant based on FFR. Outcomes in the PCI patients based on the FSS and the SS were compared to each other and to the patients treated with CABG. RESULTS: The FSS reclassified more than one-quarter of patients from an SS >22 to an FSS ≤22. In the 50% of PCI patients who had an FSS ≤22, the primary endpoint occurred at a similar rate to patients treated with CABG (P = 0.77). The primary endpoint in patients without functionally significant 3-vessel CAD was similar to the CABG group (P = 0.97). The rate of myocardial infarction and revascularization among all deferred lesions was 0.5% and 3.2%, respectively. CONCLUSIONS: By measuring the FSS, one can identify 50% of patients who have a similar outcome at 1 year with PCI compared with CABG. Lesions deferred from PCI based on FFR have a low event rate.

Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial.

BACKGROUND: Previous studies comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with multivessel coronary disease not involving the left main have shown significantly lower rates of death, myocardial infarction (MI), or stroke after CABG. These studies did not routinely use current-generation drug-eluting stents or fractional flow reserve (FFR) to guide PCI. METHODS: FAME 3 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) is an investigator-initiated, multicenter, international, randomized trial involving patients with 3-vessel coronary artery disease (not involving the left main coronary artery) in 48 centers worldwide. Patients were randomly assigned to receive FFR-guided PCI using zotarolimus drug-eluting stents or CABG. The prespecified key secondary end point of the trial reported here is the 3-year incidence of the composite of death, MI, or stroke. RESULTS: A total of 1500 patients were randomized to FFR-guided PCI or CABG. Follow-up was achieved in >96% of patients in both groups. There was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI compared with CABG (12.0% versus 9.2%; hazard ratio [HR], 1.3 [95% CI, 0.98-1.83]; P=0.07). The rates of death (4.1% versus 3.9%; HR, 1.0 [95% CI, 0.6-1.7]; P=0.88) and stroke (1.6% versus 2.0%; HR, 0.8 [95% CI, 0.4-1.7]; P=0.56) were not different. MI occurred more frequently after PCI (7.0% versus 4.2%; HR, 1.7 [95% CI, 1.1-2.7]; P=0.02). CONCLUSIONS: At 3-year follow-up, there was no difference in the incidence of the composite of death, MI, or stroke after FFR-guided PCI with current-generation drug-eluting stents compared with CABG. There was a higher incidence of MI after PCI compared with CABG, with no difference in death or stroke. These results provide contemporary data to allow improved shared decision-making between physicians and patients with 3-vessel coronary artery disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

Cardiovascular events in patients with deferred lesions and chronic kidney disease.

No study has reported the association between the worsening of chronic kidney disease (CKD) and cardiovascular events in patients with deferred coronary artery lesions. We included patients with deferred lesions, defined as a fractional flow reserve (FFR) value > 0.80 treated with conservative medical therapy. Patients were divided into three groups: group 1, CKD stages 1-2; group 2, CKD stages 3-5; and group 3, CKD stage 5D (hemodialysis), with the clinical outcomes compared. The primary endpoint was the first occurrence of target vessel myocardial infarction, ischemia-driven target-vessel revascularization, or all-cause death. The primary endpoint was noted in 17, 25, and 36 patients in groups 1, 2, and 3, respectively. Within the three groups, the incidence rate of deferred lesions was 7.0%, 10.4%, and 32.4%, respectively. No difference was observed in the incidence of the primary endpoint between groups 1 and 2 (log-rank p = 0.16). However, the patients in group 3 had a significantly higher risk for the primary endpoint than those in groups 1 and 2 (log-rank p < 0.0001). In the multivariate Cox proportional hazards model, the patients in group 3 exhibited a higher incidence of the primary endpoint than those in group 1 (HR: 2.14; 95% CI 1.02-4.49; p < 0.01). Careful management is needed in patients undergoing hemodialysis, even if coronary artery stenosis is considered a deferred lesion.

Minimum-incision trans-subclavian transcatheter aortic valve replacement with regional anesthesia.

BACKGROUND: Minimum-incision trans-subclavian transcatheter aortic valve replacement (MITS-TAVR) is usually performed in patients who are contraindicated for transfemoral TAVR, under regional anesthesia (RA). This study aimed to evaluate the safety and efficacy of MITS-TAVR under RA compared to MITS-TAVR under general anesthesia (GA). METHODS: This single-center observational study included 44 consecutive patients who underwent MITS-TAVR under RA (RA group, n = 19) and GA (GA group, n = 25). RA was achieved using an ultrasound-guided nerve block. RESULTS: The rates of respiratory disease (RA vs. GA, 36.8 % vs. 4.0 %; p < 0.01) and dialysis (79.0 % vs. 0 %; p < 0.01) were significantly higher in the RA group. STS score was significantly higher in the RA group (RA vs. GA, 10.8 ±â€¯1.06 % vs. 7.87 ±â€¯0.93 %; p < 0.01). Both groups had a 100 % procedural success rate. The two groups showed comparable operation room stay times (RA vs. GA, 160 ±â€¯6.96 min vs. 148 ±â€¯5.90 min; p = 0.058). The mean rate of change in blood pressure, used as an index of hemodynamic stability, was significantly lower in the RA group (RA vs. GA, 19.0 ±â€¯3.4 % vs. 35.5 ±â€¯3.0 %; p < 0.01). No in-hospital deaths occurred in either group. One case of minor dissection occurred in the GA group (RA vs.GA, 0 % vs. 4.0 %, p = 0.378). The intensive care unit stay (RA vs. GA, 0.21 ±â€¯0.11 days vs. 1.24 ±â€¯0.10 days; p < 0.01) and hospital stay (RA vs. GA, 7.00 ±â€¯1.73 days vs. 12.2 ±â€¯1.44 days; p < 0.01) were significantly shorter in the RA group. CONCLUSIONS: MITS-TAVR under RA is safe and effective and might be a promising alternative approach. It could ensure intraoperative hemodynamic stability and shorten intensive care unit and hospital stays.

Prognostic Value of Measuring Fractional Flow Reserve After Percutaneous Coronary Intervention in Patients With Complex Coronary Artery Disease: Insights From the FAME 3 Trial.

BACKGROUND: We evaluate the prognostic value of measuring fractional flow reserve (FFR) after percutaneous coronary intervention (post-PCI FFR) and intravascular imaging in patients undergoing PCI for 3-vessel coronary artery disease in the FAME 3 trial (Fractional Flow Reserve versus Angiography for Multivessel Evaluation). METHODS: The FAME 3 trial is a multicenter, international, randomized study comparing FFR-guided PCI with coronary artery bypass grafting in patients with multivessel coronary artery disease. PCI was not noninferior with respect to the primary end point of death, myocardial infarction, stroke, or repeat revascularization at 1 year. Post-PCI FFR data were acquired on a patient and vessel-related basis. Intravascular imaging guidance was tracked. The primary end point is a comparison of target vessel failure (TVF) defined as a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization at 1 year based on post-PCI FFR values. Cox regression with robust SEs was used for analysis. RESULTS: Of the 757 patients randomized to PCI, 461 (61%) had post-PCI FFR measurement and 11.1% had intravascular imaging performed. The median post-PCI FFR was 0.89 [IQR' 0.85-0.94]. On a vessel-level, post-PCI FFR was found to be a significant predictor of TVF univariately (hazard ratio=0.67 [95% CI' 0.48-0.93] for 0.1 unit increase, P=0.0165). On a patient-level, the single lowest post-PCI FFR value was also found to be a significant predictor of TVF univariately (hazard ratio=0.65 [95% CI' 0.48-0.89] for 0.1 unit increase, P=0.0074). Post-PCI FFR was an independent predictor of TVF in multivariable analysis adjusted for key clinical parameters. Outcomes were similar between patients who had intravascular imaging guidance and those who did not. CONCLUSIONS: Post-PCI FFR measurement was a significant predictor of TVF on a vessel and patient level and an independent predictor of outcomes in a population with complex 3-vessel coronary artery disease eligible for coronary artery bypass grafting. The limited use of intravascular imaging did not affect outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02100722.

Clinical outcomes of endovascular therapy with vascular stents for central venous obstruction in hemodialysis patients.

BACKGROUND: Symptomatic central venous obstruction (CVO) is sometimes observed in patients undergoing hemodialysis. Angioplasty is generally performed for salvage purposes, and stent implantation is performed as a last resort to prevent permanent venous occlusion. However, published reports about the clinical outcomes of stenting for CVO have been limited by the small number of included patients and the relatively old generation of analyzed stents. This study aimed to clarify the safety and efficacy of endovascular therapy (EVT) using stents for symptomatic CVO in contemporary practice. METHODS: This retrospective review was performed between May 2012 and August 2021. We retrospectively analyzed consecutive 31 lesions (31 patients, 64 ±â€¯10.7 years old) treated with a vascular stent for elastic recoil after balloon angioplasty or recurrent stenosis <3 months after angioplasty. The primary outcome was primary patency, defined as freedom from target lesion revascularization. The secondary outcome was assisted primary patency, defined as freedom from permanent occlusion of the target stents. RESULTS: In all cases, stents were successfully deployed on the target lesions. No EVT-related complications were observed. Self-expandable and balloon-expandable stents were used in 26 and 5 lesions, respectively. The median follow-up period was 18 months (interquartile range, 7-40). Kaplan-Meier analysis revealed that the primary patency rates were 66.1 % at 6 months, 61.7 % at 12 months, and 38.4 % at 24 months after EVT. The assisted primary patency rate was 70.3 % 24 months after EVT. In the multivariate analysis, younger age was the only independent predictor of target lesion revascularization (hazard ratio: 0.92, 95 % CI: 0.85-0.99, p = 0.04). CONCLUSIONS: Stent implantation for CVO that is resistant to standard angioplasty seems safe and effective.

[Retrieval of the Ruptured Balloon during Transcatheter Aortic Valve Replacement without Complications:Report of a Case].

A 77-year-old man with a history of coronary artery bypass grafting underwent transcatheter aortic valve replacement(TAVR) via femoral artery for severe aortic stenosis(AS). Preoperative computed tomography(CT) showed there was mild calcification at the sino-tubular junction(STJ). Sapien 3 was implanted successfully, but at the end of full inflation, the balloon ruptured. The ruptured balloon was retrieved without any remnants or vascular injury. A transesophageal echocardiogram showed adequate valve deployment. TAVR with its less invasiveness has become an alternative treatment for high risk patients who cannot endure surgical aortic valve replacement(SAVR). Although there are several complications related to TAVR, they can be predicted in many cases by analysis of preoperative imaging. In this case, the rupture of the balloon was not predicted because there was no significant calcification at the STJ. Caution should be taken even though there seems to be low risk of complications by preoperative imaging modalities.

Sex differences in clinical outcomes after rotational atherectomy of calcified coronary stenoses: from multicenter registry.

BACKGROUND: Recent improvements in devices and medications may diminish the risk of adverse events following percutaneous coronary intervention (PCI) in women. However, complex calcified coronary lesions are increasingly being encountered in clinical practice, which remain challenging for contemporary PCI. Rotational atherectomy (RA) of severely calcified lesions is an option that facilitates the technical success of PCI. We aimed to examine sex differences in long-term clinical prognoses after PCI with RA in the drug-eluting stent (DES) era. METHODS AND RESULTS: We evaluated J2T ROTA registry data from 1,090 patients with severely calcified de novo coronary artery stenoses who underwent PCI using RA at 3 hospitals between 2004 and 2015. After excluding patients who received regular hemodialysis, 788 patients, including 570 men and 218 women, were ultimately analyzed. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE), which included death, acute coronary syndrome (ACS), and stroke. The women were significantly older, and presented more frequently with chronic kidney disease, ACS, atrial fibrillation, lower body mass indexes, and worse lipid profiles than the men. During the observation period, MACCE occurred in 197 patients (25%) (118 deaths, 29 strokes, and 50 ACS). In the unmatched population, women had a higher MACCE rate than men (hazard ratio: 1.48, [95% confidence interval: 1.07-2.06]). However, sex was not associated with MACCE in the propensity score-matched population. CONCLUSION: In the DES era, differences between sexes were not observed in relation to long-term MACCE in patients undergoing PCI with RA for severely calcified coronary artery stenoses.

Association between anemia and mortality in patients with acute coronary syndrome treated with percutaneous coronary intervention and contemporary lipid-lowering therapy.

Despite a clear correlation between anemia and mortality in patients with the acute coronary syndrome (ACS), anemia as a mortality predictor in patients with ACS-receiving early invasive strategy and contemporary lipid-lowering therapy has not been examined. Therefore, we aimed to evaluate the association between anemia and mortality in ACS patients treated with acute revascularization and contemporary lipid-lowering treatment. This was a post-hoc study of the Heart Institute of Japan-Proper level of Lipid-Lowering with Pitavastatin and Ezetimibe in acute coronary syndrome study, in which ACS patients with dyslipidemia were randomized to receive either pitavastatin and ezetimibe or pitavastatin monotherapy. The success rate of primary percutaneous coronary intervention (PCI) was 95.2%. Eligible patients were divided into two groups: patients with anemia (anemia group) or without anemia (non-anemia group). Anemia was defined using the World Health Organization definition hemoglobin < 12 g/dL for women and < 13 g/dL for men. We compared the mortality between the two groups using propensity scores derived from 17 baseline variables. We identified 1721 eligible patients, including 420 (24.4%) in the anemia group and 1301 (75.6%) in the non-anemia group. One-to-one propensity score-matching created 381 pairs. Both unmatched and matched analyses found significantly high mortality in the anemia group compared to the non-anemia group (unmatched 12.3% vs. 3.8%, log-rank p < 0.01; matched 11.5% vs. 6.3%, log-rank p = 0.01). In ACS patients treated with an early invasive strategy era with a high PCI success rate and concurrent contemporary lipid-lowering management, all-cause mortality was still significantly higher in anemic patients than in non-anemic patients.Trial registration: Clinical trial registration URL: http://www.umin.ac.jp/ctr . Unique identifier: UMIN00000274.

Baseline low-density lipoprotein cholesterol predicts the benefit of adding ezetimibe on statin in statin-naïve acute coronary syndrome.

We aimed to evaluate the effect of baseline low-density lipoprotein cholesterol (LDL-C) on the outcomes of patients with the acute coronary syndrome (ACS) receiving pitavastatin monotherapy or the combination of pitavastatin + ezetimibe. In the HIJ-PROPER study, 1734 ACS patients with dyslipidemia were randomly assigned to receive pitavastatin or pitavastatin + ezetimibe therapy. Statin-naïve participants (n = 1429) were divided into two groups based on the median LDL-C level (131 mg/dL) at enrollment. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina, and ischemia-driven coronary revascularization. The median follow-up was 3.2 years. In the < 131 mg/dL group (n = 686), LDL-C changes were - 34.0% and - 49.8% in the pitavastatin monotherapy and pitavastatin + ezetimibe-treated groups (P < 0.0001), respectively; in the ≥ 131 mg/dL group (n = 743), LDL-C changes were - 42.9% and - 56.4% (P < 0.0001, respectively. Kaplan-Meier analyses revealed that the primary endpoint was not significantly different between the treatment groups for the < 131 mg/dL group, however, it was significantly lower in patients treated with pitavastatin + ezetimibe in the ≥ 131 mg/dL group (Hazard ratio = 0.72, 95% confidence interval = 0.56-0.91, P = 0.007, P value for interaction = 0.012). Statin-naïve ACS patients with baseline LDL-C < 131 mg/dL did not clinically benefit from pitavastatin + ezetimibe, while patients with baseline LDL-C ≥ 131 mg/dL treated with pitavastatin + ezetimibe showed better clinical results than those treated with pitavastatin monotherapy.Clinical Trial Registration: Original HIJ PROPER study; URL: http://www.umin.ac.jp/ctr . Unique Identifier; UMIN000002742, registered as an International Standard Randomized Controlled Trial.

Successful transcatheter aortic valve in valve implantation for degenerated trifecta bioprosthesis in a patient with a coronary anomaly.

We report a case of transcatheter aortic valve implantation in a 79-year-old woman with a coronary anomaly who underwent surgical aortic valve replacement with a 23-mm Abbott Trifecta bioprosthesis. The procedure was performed in response to severe aortic stenosis caused by a bicuspid aortic valve. Computed tomography showed an anomalous origin of the right coronary artery from the left coronary sinus, with an interarterial course. Although the virtual transcatheter valve to coronary ostium distance-right coronary artery was short, the right coronary artery ostium was just behind the stent post. The externally mounted leaflet was unable to reach the coronary orifice beyond the stent post. This case highlights a successful transcatheter aortic valve implantation for stented bioprostheses with externally mounted leaflets when the virtual transcatheter valve to coronary ostium distance is shortened by a coronary anomaly.

Clinical outcomes after balloon angioplasty with Crosser device for heavily calcified common femoral and popliteal artery disease.

Data on the mid-term clinical outcomes after endovascular treatment (EVT) using a Crosser catheter (C. R. Bard, Inc.) as a crossing or flossing device for a heavily calcified lesion in the common femoral artery (CFA) or popliteal artery (PA) are lacking. The aim of this study was to investigate the safety and efficacy of EVT using a Crosser catheter for isolated and heavily calcified CFA or PA disease. We retrospectively analyzed 64 consecutive patients (72 lesions; CFA 30, PA 42) who underwent EVT for heavily calcified CFA or PA lesions with Crosser catheters between April 2015 and April 2019. The primary endpoint was clinically driven target lesion revascularization (CD-TLR). The median follow-up was 18.5 months. The mean age of the study population was 70 ± 9.5 years, with a male prevalence of 73.6%. The mean Proposed Peripheral Artery Calcification Scoring System grade was 2.9 ± 0.9. Procedure success, defined as 50% or less residual stenosis without suboptimal results, was achieved in 94.4% of lesions. There were no cases of bailout stenting or target lesion-related complications. After EVT, the 1-year CD-TLR-free rate for CFA and PA lesions was 87.4 and 76.8%, respectively. The corresponding rates at 2 years were 82.2 and 62.8%, respectively. In the multivariate analysis used to define CD-TLR predictors for CFA and PA lesions, hemodialysis was the only independent predictor (HR 3.35, 95% CI 1.02-13.95, P = 0.045). EVT with a Crosser device for heavily calcified CFA and PA lesions seems to be safe and feasible.

Utility of the minimum-incision transsubclavian approach for transcatheter aortic valve replacement on clinical outcomes in patients with small vessel anatomy.

BACKGROUND: The optimal approach for patients undergoing transcatheter aortic valve replacement (TAVR), who are contraindicated for a transfemoral (TF) approach, is still controversial. The present study aimed to evaluate the utility of the TAVR via a subclavian artery with a small diameter, by minimal incision and a double Z suture hemostasis technique using 18 Fr DrySeal Flex sheath, namely minimum-incision transsubclavian TAVR (MITS-TAVR), in patients contraindicated for the TF approach. METHODS: We included consecutive patients who underwent the MITS-TAVR (MITS group; n = 21) and TF-TAVR (TF group; n = 81) using the CoreValve Evolut R/PRO valves and examined the incidence of in-hospital adverse events and post-discharge mortality between the two groups. RESULTS: The mean body surface area was significantly smaller in the MITS group (1.33 ± 0.04 vs. 1.43 ± 0.02 m2; p = 0.045). The minimal lumen diameter of the femoral artery was significantly smaller in the MITS group (5.01 vs. 6.43 mm; p < 0.01). The lumen diameter of the left subclavian artery (LSA) in the MITS group was 4.97 ± 0.14 mm. The duration of the TAVR procedure to discharge was not significantly different (9.7 ± 2.0 days vs. 13.2 ± 1.0 days; p = 0.239). We did not experience in-hospital death in both groups, and no significant differences were observed in the incidence of major adverse cardiac and cerebrovascular events between the two groups. The post-discharge survival rate was not significantly different between the groups (at 2-year; MITS group vs. TF group = 91.0% vs. 89.0%; p = 0.725). CONCLUSIONS: The MITS-TAVR using 18 Fr Dryseal Flex sheath was safe and effective and might be a promising alternative approach even in patients with a small body and small LSA diameter, who are contraindicated to the TF approach.

Haemodynamic collapse immediately after transcatheter aortic valve implantation due to dynamic intraventricular gradient: a case report and review of the literature.

BACKGROUND: Dynamic intraventricular obstruction after transcatheter aortic valve implantation (TAVI) has been previously reported. There is a risk of haemodynamic collapse in the case of left ventricular outflow tract (LVOT) obstruction due to systolic anterior motion (SAM) of the mitral valve. CASE SUMMARY: An 83-year-old woman with aortic stenosis (AS) was referred to our hospital for TAVI. Transthoracic echocardiography revealed a severely calcified aortic valve with a peak velocity of 6.3 m/s across the valve. Acceleration of blood flow (peak velocity 2.6 m/s) at the LVOT due to a septal bulge was also seen. Transfemoral TAVI was performed, and a 29 mm Evolut PRO was implanted under general anaesthesia. After the implantation, a complete atrioventricular block with junctional rhythm developed, and refractory hypotension occurred immediately. Transoesophageal echocardiography revealed LVOT obstruction due to SAM of the mitral valve associated with severe mitral regurgitation (MR), which was not observed preoperatively. Fluid infusion and catecholamine administration were not effective. However, after performing temporary pacing from the right ventricular (RV) apex, the LVOT obstruction and severe MR improved. Her haemodynamics stabilized, and we could complete the procedure. A dual-chamber permanent pacemaker with beta-blocker administration as a longer-term treatment further improved the LVOT obstruction. The patient was finally discharged to a rehabilitation hospital. DISCUSSION: Alertness and recognition of potential LVOT obstruction after TAVI are important. Pacing from the RV apex, as well as dual-chamber pacing, comprise a less invasive and feasible therapeutic option in such cases.