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.

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.

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.

[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.

Rate Pressure Products Affect the Relationship between the Fractional Flow Reserve and Instantaneous Wave-Free Ratio.

The rate pressure product (RPP) is an index of myocardial metabolism that correlates closely with myocardial hemodynamics. The relationship between the RPP and the fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) is not known. In this study, we investigated the effects of the RPP on the FFR and iFR. We retrospectively enrolled 195 patients (259 lesions) who had undergone invasive coronary angiography and both the iFR and FFR examinations between 2012 and 2017. The RPP was defined as systolic blood pressure multiplied by the heart rate, measured prior to the iFR evaluation. The study population was divided into the low-RPP (n = 129, mean RPP: 6981 ± 1149) and high-RPP (n = 130, mean RPP: 10391 ± 1603) groups according to the median RPP. Correlations and biases between the iFR and FFR were compared. The diagnostic performance of the iFR in the groups was calculated, using FFR as the gold standard. The correlation between the iFR and FFR was higher in the high-RPP group than in the low-RPP group. The bias between the iFR and FFR in the high-RPP group was smaller than that in the low-RPP group. The best cutoff value of the iFR for predicting an FFR of 0.8 was 0.90 for all lesions, 0.93 for the low-RPP group, and 0.82 for the high-RPP group. The iFR and RPP showed a weak but a statistically significant negative correlation (R = 0.14; p = 0.029). This was not observed for the relationship between the FFR and RPP. In conclusion, the RPP affects the relationship between the FFR and iFR. With FFR as the gold standard, the iFR may underestimate and overestimate the functionality of ischemia in the low- and high-RPP groups, respectively.

Hemodynamic and Lesion Characteristics Associated with Discordance between the Instantaneous Wave-Free Ratio and Fractional Flow Reserve.

BACKGROUND: The instantaneous wave-free ratio (iFR) is an invasive coronary physiological index that is not inferior to fractional flow reserve- (FFR-) guided revascularization. The indexes of iFR and FFR are similar and closely correlated, but there are a few key differences. Previous studies suggested that patient characteristics and lesion severity could induce discordance between iFR and FFR. This study aimed to clarify the hemodynamics and lesion characteristics that influence discordance between iFR and FFR. METHODS: In this retrospective study, we enrolled 225 patients (304 lesions) who underwent clinically indicated invasive coronary angiography and both iFR and FFR examinations between 2012 and 2017. We included only patients who underwent right heart catheterization and had blood pressure and heart rates recorded immediately prior to iFR and FFR. RESULTS: Discordance (iFR ≤0.89 and FFR >0.8 or iFR >0.89 and FFR ≤0.8) was observed in 80 lesions (26.3%). The heart rate, rate-pressure product, and cardiac index tended to be higher in the iFR ≤0.89 group than in the iFR >0.89 group. These trends were not seen between the FFR ≤0.8 group and FFR >0.8 group. A multivariate analysis showed that independent predictors of iFR ≤0.89 and FFR >0.8 discordance were female sex and higher rate-pressure product. iFR >0.89 and FFR ≤0.8 discordance was rare in hemodialysis patients. CONCLUSION: Even if iFR is functionally significant in intermediate stenosis, additional FFR evaluations should be considered for women, especially those with a high rate-pressure product, to avoid unnecessary percutaneous coronary intervention. If iFR is not functionally significant with intermediate stenosis in hemodialysis patients, then further FFR evaluations are unnecessary.

Safety and Efficacy of Low-Dose Prasugrel as Part of Triple Therapy With Aspirin and Oral Anticoagulants in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention　- From the TWMU-AF PCI Registry.

BACKGROUND: Using the standard maintenance dose of prasugrel (10 mg/day) as part of triple therapy with aspirin and an oral anticoagulant (OAC) is not recommended in the current guidelines because it increases the risk of bleeding compared with clopidogrel. However, the safety and efficacy of low-dose prasugrel (3.75 mg/day) as part of triple therapy has not been reported. Methods and Results: We registered 816 consecutive patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) from January 2011 to June 2016 at 8 hospitals in Japan. We examined the clinical outcomes of patients who received either low-dose prasugrel (n=57) or clopidogrel (n=451) as part of triple therapy after PCI. The incidences of bleeding (TIMI major and minor) and major adverse cerebrocardiovascular events (MACCE; all-cause death, nonfatal myocardial infarction, stent thrombosis, unplanned revascularization, and stroke) were evaluated. The cumulative 1-year incidence of bleeding was not significantly different (prasugrel 5.6% vs. clopidogrel 8.1%, log-rank P=0.55). In addition, the cumulative 1-year incidence of MACCE was also not significantly different (prasugrel 11.5% vs. clopidogrel 12.3%, log-rank P=0.88). CONCLUSIONS: Low-dose prasugrel, as part of triple therapy, did not increase the risk of bleeding compared with clopidogrel. Therefore, it can be an alternative to clopidogrel for patients with AF undergoing PCI.

[Transcatheter Aortic Valve Replacement for Aortic Stenosis with Complicated Anatomy;Report of a Case].

An 89-year-old female was admitted with progressive dyspnea. She had history of old myocardial infarction. Echocardiography revealed severe aortic valve stenosis (AS) with bicuspid aortic valve (BAV). Computed tomography (CT) detected an ascending aortic aneurysm and a left ventricular apex aneurysm. CT confirmed the BAV with severe calcification and tight horizontal angulation. We scheduled transfemoral transcatheter aortic valve replacement (TAVR). While careful wire manipulation, the valve was successfully implanted. BAV is frequently associated with dilation of the ascending aorta. The coexistence of an ascending aortic aneurysm would indicate surgery in order to be able to treat both lesions simultaneously and to avoid catastrophic stent-related complications, such as prosthesis dislodgment and aneurysm rupture. In the present case, there was also risk of left ventricular rupture due to wire manipulation. The horizontal aorta also complicates accurate positioning of the prosthesis during TAVR. This case highlights TAVR for AS with complicated anatomy.

Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy　- J2T Multicenter Registry.

BACKGROUND: Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.Methods and Results:This multi-center registry assessed the characteristics and outcomes of patients treated by RA for calcified coronary lesions between 2004 and 2015. Among 1,090 registered patients, mean age was 70±10 years and 815 (75%) were male. Sixty percent of patients had diabetes mellitus and 27.7% were receiving hemodialysis. The procedure was successful in 96.2%. In-hospital death occurred in 33 patients (3.0%), and 14 patients (1.3%) developed definite/probable stent thrombosis. During the median follow-up period of 3.8 years, the incidence of major adverse cardiac events (MACE), defined as all-cause death, acute coronary syndrome, stent thrombosis, target vessel revascularization and stroke, was 46.7%. On multivariable Cox hazard analysis, hemodialysis (HR, 2.08; 95% CI: 1.53-2.86; P<0.0001) and age (HR, 1.03; 95% CI: 1.01-1.04; P<0.0001) were strong independent predictors of MACE. Conversely, statin treatment was associated with lower incidence of MACE (P=0.035). CONCLUSIONS: This study has provided the largest Japanese dataset for long-term follow-up of RA. Although RA in calcified lesions appears feasible with a high rate of procedural success, a high incidence of MACE was observed.

Real-world antithrombotic therapies and clinical outcomes after second-generation drug-eluting stent implantation in patients with atrial fibrillation: a multi-center cohort study.

Previous reports have focused on cardiovascular and bleeding events in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, antithrombotic treatment strategies and clinical outcomes after second-generation drug-eluting stents (DES) implantation in AF patients remain to be determined. We enrolled 244 consecutive AF patients treated with second-generation DES. The study population was derived from multi-center AF registry (including 8 centers in Japan) from 2010 to 2012. Prescription of antithrombotic agents and clinical outcomes were retrospectively examined. Ninety-two patients (37.7%) were prescribed dual antiplatelet therapy (DAPT) at discharge and 152 patients (62.3%) were given DAPT plus oral anticoagulation (OAC) with warfarin. The median follow-up period was 730 days. Kaplan-Meier analysis showed that major adverse cardiac and cerebrovascular events (MACCE) were not significantly different (2-year event rate, 17.6 vs. 13.5%, p = 0.37), but bleeding events were significantly higher in the DAPT plus OAC group than in the DAPT group (2-year event rate, 6.1 vs. 17.9%, p = 0.033). In a sub-analysis of DAPT plus OAC patients, adequate time in the therapeutic range (TTR) group (TTR ≥ 65%) was not significantly different from the suboptimal OAC group (TTR < 65%) for bleeding events, but it had a lower incidence of MACCE, resulting in better net clinical outcomes (composite of MACCE and major bleeding, 2-year event rate, 9.2 vs. 27.8%, p = 0.008). DAPT plus OAC remains more common in AF patients undergoing PCI with second-generation DES. Under adequate TTR, DAPT plus OAC showed better net clinical outcomes by reducing MACCE without increasing bleeding.

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.

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.

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.

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.

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.

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.

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.