Quantitative flow ratio versus fractional flow reserve for Heart Team decision-making in multivessel disease: the randomised, multicentre DECISION QFR trial.

BACKGROUND: Vessel-level physiological data derived from pressure wire measurements are one of the important determinant factors in the optimal revascularisation strategy for patients with multivessel disease (MVD). However, these may result in complications and a prolonged procedure time. AIMS: The feasibility of using the quantitative flow ratio (QFR), an angiography-derived fractional flow reserve (FFR), in Heart Team discussions to determine the optimal revascularisation strategy for patients with MVD was investigated. METHODS: Two Heart Teams were randomly assigned either QFR- or FFR-based data of the included patients. They then discussed the optimal revascularisation mode (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) for each patient and made treatment recommendations. The primary endpoint of the trial was the level of agreement between the treatment recommendations of both teams as assessed using Cohen's kappa. RESULTS: The trial included 248 patients with MVD from 10 study sites. Cohen's kappa in the recommended revascularisation modes between the QFR and FFR approaches was 0.73 [95% confidence interval {CI} : 0.62-0.83]. As for the revascularisation planning, agreements in the target vessels for PCI and CABG were substantial for both revascularisation modes (Cohen's kappa=0.72 [95% CI: 0.66-0.78] and 0.72 [95% CI: 0.66-0.78], respectively). The team assigned to the QFR approach provided consistent recommended revascularisation modes even after being made aware of the FFR data (Cohen's kappa=0.95 [95% CI:0.90-1.00]). CONCLUSIONS: QFR provided feasible physiological data in Heart Team discussions to determine the optimal revascularisation strategy for MVD. The QFR and FFR approaches agreed substantially in terms of treatment recommendations.

Noninvasive transthoracic doppler flow velocity and invasive thermodilution to assess coronary flow reserve.

Background: Coronary flow reserve (CFR) provides prognostication and coronary physiological information, including epicardial coronary stenosis and microvascular function. The relationship between stress transthoracic Doppler echocardiography (TDE)-derived coronary flow velocity reserve (CFRS-TDE) and thermodilution-derived coronary flow reserve (CFRthermo) before and after elective percutaneous coronary intervention (PCI) remains unclear. Methods: This single-center prospective registry study evaluated patients who underwent fractional flow reserve (FFR)-guided elective PCI for left anterior descending artery (LAD) lesions with wire-based invasive physiological measurements and pre- and post-PCI stress TDE examinations. Results: A total of 174 LAD lesions from 174 patients were included in the final analysis. A modest correlation was detected between the pre-PCI CFRS-TDE and the pre-PCI CFRthermo (r=0.383, P<0.001). The frequently used CFRS-TDE threshold of 2.0 corresponded to a pre-PCI CFRthermo of 2.18. Pre-PCI CFRS-TDE underestimated pre-PCI CFRthermo [1.89 (1.44-2.31) vs. 2.05 (1.38-2.93), P<0.001]. Both CFRS-TDE and CFRthermo increased significantly post-PCI [pre-PCI CFRS-TDE 1.89 vs. post-PCI CFRS-TDE 2.33, P<0.001; pre-PCI CFRthermo 2.05 (1.38-2.93) vs. post-PCI CFRthermo 2.59 (1.63-3.55), P<0.001]. In contrast, there was no significant relationship between changes in CFRS-TDE and changes in CFRthermo after PCI (r=0.008, P=0.915) or between post-PCI CFRS-TDE and post-PCI CFRthermo (r=0.054, P=0.482). Conclusions: Pre-PCI CFRS-TDE and CFRthermo are modestly correlated, but post-PCI CFRS-TDE and CFRthermo have no correlation. CFRS-TDE and CFRthermo are not interchangeable, particularly post-PCI, suggesting that the two metrics represent different coronary physiologies after PCI.

Diagnostic value of computed tomography myocardial perfusion imaging to detect coexisting microvascular dysfunction in patients with obstructive epicardial coronary artery disease.

Background: Computed tomography myocardial perfusion (CT-MP) has reported usefulness in assessing hemodynamically significant epicardial coronary artery lesions. However, the diagnostic ability of the absolute coronary flow using CT-MP to detect coronary microvascular dysfunction (CMD) remains elusive. This prospective cohort study aimed to assess the diagnostic value of CT-MP in evaluating coexisting CMD in patients with functionally significant epicardial coronary stenosis and to analyze the predictive factors of lesions with CMD. Methods: Sixty-eight patients with chronic coronary syndrome (CCS) and de novo single functionally significant stenosis [fractional flow reserve (FFR) ≤0.80] were studied. CMD was defined as an index of microcirculatory resistance ≥25. We compare clinical background and CT-MP findings between patients with and without CMD (CMD, n=29; non-CMD, n=39). CT-MP, and quantitative and qualitative plaque assessments were included in computed tomography angiography assessment. Logistic regression analysis was performed to predict CMD. Results: FFR, invasive wire-derived coronary flow reserve (CFRwire) and index of microcirculatory resistance were 0.68 [interquartile range (IQR), 0.59-0.74], 1.71 (IQR, 1.24-2.88), and 22.6 (IQR, 15.1-34.5), respectively. The rest and hyperemic-myocardial blood flow (MBF) and CT-MP-derived CFR (CFRCT-MP) were 0.83 (0.64-1.03) mL/min/g, 2.14 (1.30-2.92) mL/min/g, and 2.19 (1.44-3.37), respectively. In the territories with CMD, hyperemic-MBF was significantly lower than in those without [1.68 (IQR, 0.84-2.44) vs. 2.31 (IQR, 1.67-3.34) mL/min/g, P=0.015] and the prevalence of CFRCT-MP <2.0 was higher in the lesions with CMD than in those without (62.1% vs. 28.2%, P=0.011), while FFR values were similar. Fibrofatty and necrotic core component volume was greater in the vessels with CMD than in those without [31.8 (IQR, 19.0-48.9) vs. 25.1 (IQR, 17.2-32.1) mm3, P=0.045]. Multivariable logistic regression analysis showed that hyperemic-MBF and fibrofatty and necrotic core component volume were independent predictors of CMD territories [odds ratio (OR) =0.583; 95% confidence interval (CI): 0.355-0.958; P=0.033 and OR =1.040; 95% CI: 1.010-1.070; P=0.011]. Conclusions: Quantitative assessment of absolute coronary flow using pre-percutaneous coronary intervention (PCI) CT-MP, and comprehensive plaque analysis using computed tomography angiography may help detect coexisting subtended microvascular dysfunction in territories with functionally significant epicardial coronary lesions. Further studies are required to elucidate the clinical significance of coexisting CMD in patients with CCS undergoing PCI.

Preoperative Scoring System for Prediction of Early Adjacent Vertebral Body Fracture After Balloon Kyphoplasty Using X-Rays Taken in a Non-Weight-Bearing Position.

BACKGROUND: Prevention of adjacent vertebral body fracture (AVF) following balloon kyphoplasty (BKP) is a key challenge. The objective of this study was to develop a scoring system that could be more extensively and effectively used to determine the surgical indications for BKP. METHODS: The study involved 101 patients aged 60 years or older who had undergone BKP. Logistic regression analysis was used to identify risk factors for early AVF within 2 months following BKP. Scoring was based on the odds ratio for risk factors, and cut-off values were determined from the receiver operating characteristics curve. The correlation between the total scores and the incidence of early AVF, and the area under the curve for the logistic regression model predicting early AVF using the scoring system were investigated. RESULTS: 29 cases (28.7%) experienced early AVF after BKP. The scoring system was created as follows: 1) age (<75 years: 0 points (P), ≥75 years: 1P), 2) number of previous vertebral fractures (0: 0P, 1 or more: 2P), and 3) local kyphosis (<7°: 0P, ≥7°: 1P). The total scores were found to be positively correlated with the incidence of early AVF (r = 0.976, P = 0.004). The area under the curve of the scoring system for predicting early AVF was 0.796. The incidence of early AVF was 4.2% at ≤1P and 44.3% at ≥2P (P < 0.001). CONCLUSIONS: A scoring system which can be applied to a broader patient population was developed. In cases where the total score is 2P or more, alternatives to BKP should be considered.

The Relationship Between Global Sagittal Balance and the Incidence of Early Adjacent Vertebral Fractures Following Balloon Kyphoplasty.

BACKGROUND: Recently, it is widely known that global sagittal balance (GSB) influences the postoperative outcome of the spine. The purpose of this study was to investigate the relationship between GSB and the incidence of early adjacent vertebral fracture (AVF) following balloon kyphoplasty (BKP). METHODS: This study included 96 patients (19 males, 77 females, mean age 77.4 ± 5.5 years) who underwent BKP for osteoporotic vertebral fracture and who were over 60-years-old. We investigated the effect of GSB on early AVF within 2 months after surgery. Of the 96 patients, 76 patients (16 males, 60 females, mean age 77.0 ± 5.4) underwent BKP at the thoracolumbar junction (T11-L2) and were investigated independently. After the two-group comparison, logistic regression analysis was performed. RESULTS: During the observation period (18.3 ± 14.7 months), 27 of 96 patients (28.1%) suffered AVF after BKP, and 24 of 96 patients (25.0%) suffered early AVF. In the logistic regression analysis, spinopelvic parameters were not detected as significant risk factors. In cases of BKP at the thoracolumbar junction (T11-L2), 24 of 76 patients (31.6%) suffered AVF after BKP during the observation period (15.3 ± 19.5 months), and 21 of 76 patients (27.6%) suffered early AVF. Logistic regression analysis detected pelvic tilt (PT): odds ratio 1.087 (P = 0.046∗) and local kyphosis: 1.147 (P = 0.003∗) as risk factors for early AVF. The cutoff value was PT≥29° from the receiver operating characteristics curve. CONCLUSIONS: At the thoracolumbar junction (T11-L2), PT ≥29° is one of the risk factors of early AVF following BKP.

Age-related changes in the coronary microcirculation influencing the diagnostic performance of invasive pressure-based indices and long-term patient prognosis.

OBJECTIVES: Investigate age-related changes in coronary microvascular function, its effect on hyperemic and non-hyperemic indices of stenosis relevance, and its prognostic implications. BACKGROUND: Evidence assessing the effect of age on fractional flow reserve (FFR), resting mean distal intracoronary pressure/mean aortic pressure (Pd/Pa), and microcirculatory function remains scarce. METHODS: This is a post hoc study of a large prospective international registry (NCT03690713) including 1134 patients (1326 vessels) with coronary stenoses interrogated with pressure and flow guidewires. Age-dependent correlations with functional indices were analyzed. Prevalences of FFR, resting Pd/Pa, and coronary flow reserve (CFR) classification agreement were assessed. At 5 years follow-up, the relation between resting Pd/Pa, CFR, and their age-dependent implications on FFR-guided percutaneous coronary intervention (PCI) deferral (deferred if FFR > 0.80) were investigated using vessel-oriented composite outcomes (VOCO) composed of death, myocardial infarction, and repeated revascularization. RESULTS: Age correlated positively with FFR (r = 0.08, 95% confidence interval [CI]: 0.03 to 0.13, p = 0.005), but not with resting Pd/Pa (r = -0.03, 95% CI:-0.09 to 0.02, p = 0.242). CFR correlated negatively with age (r = -0.15, 95% CI: -0.21 to -0.10, p < 0.001) due to a significant decrease in maximal hyperemic flow in older patients. Patients over 60 years of age with FFR-guided deferred-PCI abnormal resting Pd/Pa or abnormal CFR had increased risk of VOCO (hazard ratio [HR]: 2.10, 95% CI: 1.15 to 4.36, p = 0.048; HR: 2.46, 95% CI:1.23 to 4.96, p = 0.011; respectively). CONLUSIONS: Aging is associated with decrease in microcirculatory vasodilation, as assessed with adenosine-based methods like CFR. In patients older than 60 years in whom PCI is deferred according to FFR > 0.80, CFR and resting Pd/Pa have an incremental value in predicting future vessel-oriented patient outcomes.

The History and Development of the Percutaneous Pedicle Screw (PPS) System.

Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) using the SEXTANT® system (Medtronic) featured the first generation of commercially available percutaneous pedicle screw (PPS) system in 2001. The innovative system has since become standard instrumentation used worldwide, and PPS is now used for long-segment minimally invasive surgery (MIS) spinal fixation from the thoracic spine to the pelvis for pathological conditions. PPS systems have been developed for approximately 20 years for the purpose of improving minimally invasive techniques, safety of instrumentation, and ease of use. The third-generation PPS systems established the insertion technique, and the development of the fourth-generation PPS systems have made great strides in minimizing the number of steps in the operative procedure. In the future, PPS systems are expected to continue making use of the latest technological advancements and to develop further with the aim of ensuring greater safety, reducing operator stress, and preventing complications such as insertion errors and infection. In this review article, we describe the historical evolution from the first-generation PPS system to the current PPS systems used today.

Minimally Invasive Spinal Treatment (MIST)-A New Concept in the Treatment of Spinal Diseases: A Narrative Review.

In the past two decades, minimally invasive spine surgery (MISS) techniques have been developed for spinal surgery. Historically, minimizing invasiveness in decompression surgery was initially reported as a MISS technique. In recent years, MISS techniques have also been applied for spinal stabilization techniques, which were defined as minimally invasive spine stabilization (MISt), including percutaneous pedicle screws (PPS) fixation, lateral lumbar interbody fusion, balloon kyphoplasty, percutaneous vertebroplasty, cortical bone trajectory, and cervical total disc replacement. These MISS techniques typically provide many advantages such as preservation of paraspinal musculature, less blood loss, a shorter operative time, less postoperative pain, and a lower infection rate as well as being more cost-effective compared to traditional open techniques. However, even MISS techniques are associated with several limitations including technical difficulty, training opportunities, surgical cost, equipment cost, and radiation exposure. These downsides of surgical treatments make conservative treatments more feasible option. In the future, medicine must become "minimally invasive" in the broadest sense-for all patients, conventional surgeries, medical personnel, hospital management, nursing care, and the medical economy. As a new framework for the treatment of spinal diseases, the concept of minimally invasive spinal treatment (MIST) has been proposed.

Efficacy of Minimally Invasive Trans-Sacral Canal Plasty between Patients with and without Failed Back Surgery Syndrome.

Background and Objectives: Clinicians are required to manage a growing number of elderly patients with several medical comorbidities, and invasive surgical treatments are sometimes not advisable for these patients. The aim of this study was to evaluate the efficacy of minimally invasive intraspinal canal treatment, trans-sacral canal plasty (TSCP), for patients with and without failed back surgery syndrome (FBSS). Materials and Methods: A multicenter analysis was conducted. TSCP was performed in patients with chronic low back pain and leg pain due to lumbar spinal disorders. An adhesiolysis by TSCP was carried out, then a mixture of steroid and local anesthesia was injected. Visual Analog Scales (VAS) for low back pain and leg pain, and complications were evaluated. Results: A total of 271 patients with a minimum 6-month follow-up were enrolled. There were 80 patients who had a history of previous lumbar spinal surgery (F group), and 191 patients without previous lumbar spinal surgery (N group). There were no significant differences in sex and age between the two groups. VAS scores for low back pain (N group/F group) preoperatively, immediately postoperatively, and 1 month, 3 months and 6 months postoperatively, were 51/52 mm, 24/26 mm, 33/34 mm, 30/36 mm, and 30/36 mm, respectively. VAS scores for leg pain were 69/67 mm, 28/27 mm, 39/41 mm, 36/43 mm, and 32/40 mm, respectively. Both VAS scores for low back pain and leg pain were significantly decreased from baseline to final follow-up in both groups (p < 0.01). However, VAS scores for leg pain at 3 months and 6 months postoperatively were significantly higher in F group (p < 0.05). There were three catheter breakages (2/3 in F group), and one dural tear in F group. Conclusions: TSCP significantly reduced both VAS scores for low back and leg pain in patients with and without FBSS. However, co-existence of intractable epidural adhesion might be associated with less improvement in FBSS.

Prognostic Value of Coronary Sinus Flow Quantification by Cardiac Magnetic Resonance Imaging in Patients With Acute Myocardial Infarction.

Background This study aimed to evaluate the prognostic value of hyperemic coronary sinus flow (h-CSF) and global coronary flow reserve (g-CFR) obtained by phase-contrast cine-magnetic resonance imaging in patients with acute myocardial infarction (MI). Methods and Results This retrospective study analyzed patients with acute MI (n=523) who underwent primary (ST-segment-elevation MI) or urgent (non-ST-segment-elevation MI) percutaneous coronary intervention. Absolute coronary sinus blood flow (CSF) at rest and during vasodilator stress hyperemia was quantified at 30 days (24-36 days) after the index infarct-related lesion percutaneous coronary intervention and revascularization of functionally significant non-infarct-related lesions. We used Cox proportional hazards regression modeling to examine the association between h-CSF, g-CFR, and major adverse cardiac events defined as all-cause death, nonfatal MI, hospitalization for congestive heart failure, and stroke. Finally, 325 patients with ST-segment-elevation MI (62.1%) and 198 patients with non-ST-segment-elevation MI (37.9%) were studied over a median follow-up of 2.5 years. The rest CSF, h-CSF, and g-CFR were 0.94 (0.68-1.26) mL/min per g, 2.05 (1.42-2.73) mL/min per g, and 2.17 (1.54-3.03), respectively. Major adverse cardiac events occurred in 62 patients, and Cox proportional hazards analysis showed that h-CSF and g-CFR were independent predictors of major adverse cardiac events (h-CSF: hazard ratio [HR], 0.64; 95% CI, 0.47-0.88; P=0.005; g-CFR: HR, 0.62; 95% CI, 0.47-0.82; P=0.001). When stratified by h-CSF and g-CFR, cardiac event-free survival was the worst in patients with concordantly impaired h-CSF (<1.6 mL/min per g) and g-CFR (<1.7) (P<0.001). Conclusions Global coronary sinus flow quantification using phase-contrast cine-magnetic resonance imaging provided significant prognostic information independent of infarction size and conventional risk factors in patients with acute MI undergoing revascularization.

Clinical determinants of coronary artery disease burden and vulnerability using optical coherence tomography co-registered with intravascular ultrasound.

OBJECTIVES: We investigated clinical determinants of disease burden and vulnerability using optical coherence tomography (OCT) co-registered with intravascular ultrasound (IVUS) in a large cohort of patients. METHODS: A total of 704 patients [44.5% with acute coronary syndromes (ACS)] underwent coronary intervention. IVUS plaque burden and OCT lipid, macrophage and calcium indices and the presence of thrombus, plaque rupture and thin-cap fibroatheroma (TCFA) were analyzed. RESULTS: Median patient age was 66 years with 81.8% men, 34.4% with diabetes mellitus and 15.5% with preadmission statins. Median lesion length was 25.7 mm, and 33.0% had a TCFA. Adjusted models indicated (1) older patient age was related to more calcium, but fewer macrophages; (2) men were related to more thrombus with plaque rupture while women had more thrombus without plaque rupture; (3) ACS presentation was related to morphological acute thrombotic events (more thrombus with/without rupture) and plaque vulnerability (more TCFA, more lipid and macrophages and larger plaque burden); (4) diabetes mellitus was related to a greater atherosclerotic disease burden (more lipid and calcium and larger plaque burden) and more thrombus without rupture; (5) hypertension was related to more macrophages; (6) current smoking was related to less calcium; and (7) renal insufficiency and preadmission statin therapy were not independently associated with IVUS or OCT plaque morphology. CONCLUSION: Patient characteristics, especially diabetes mellitus and aging, affect underlying atherosclerotic burden, among which a greater lipidic burden along with sex differences influence local thrombotic morphology that affects clinical presentation.

Effect of percutaneous coronary intervention on global hemodynamics and the prevalence of residual microvascular dysfunction.

OBJECTIVES: We aimed to examine the changes in hyperemic coronary sinus flow (CSF) and global coronary flow reserve (g-CFR) after percutaneous coronary intervention (PCI) and investigate the predictors to improve these metrics and the prevalence of residual coronary microvascular dysfunction (CMD). METHODS: This prospective, single-center study included 118 patients with stable coronary artery disease undergoing PCI for a single proximal lesion. Phase-contrast cine-cardiac magnetic resonance (PC-CMR) was used to assess hyperemic CSF (HCSF) and g-CFR, before and after PCI. Residual CMD was defined as concordantly impaired post-PCI HCSF (<2.3 ml/min/g) and g-CFR (<2.0). RESULTS: HCSF significantly increased, although 38 (32.2%) patients showed a decrease. There was no significant change in g-CFR despite fractional flow reserve (FFR) improvement in all target territories. Concordantly increased HCSF and g-CFR were effectively discriminated by adding PC-CMR-derived information to pre-PCI FFR. Residual CMD was observed in 30 (25.4%) patients and was associated with pre-PCI renal dysfunction and lower pre-PCI rest and hyperemic CSF, but not with pre-PCI regional physiological indices. CONCLUSIONS: FFR-guided PCI was associated with increased HCSF, but not with increased g-CFR. After uncomplicated PCI, one-quarter of patients showed residual CMD. Our approach may help identify patients who may benefit from increased coronary perfusion or show residual CMD.

Association between pericoronary adipose tissue attenuation and outcome after second-generation cryoballoon ablation for atrial fibrillation.

OBJECTIVES: Previous studies reported the association between inflammation and atrial fibrillation (AF). Pericoronary adipose tissue (PCAT) attenuation, PCATA, on cardiac CT angiography (CTA) reflects pericoronary inflammation. We hypothesized that the PCATA predicts AF recurrence after cryoballoon ablation (CBA) for paroxysmal and persistent AF. METHODS: We studied 364 patients (median age, 65 years) with persistent (n = 41) and paroxysmal (n = 323) AF undergoing successful first-session second-generation CBA with pre-ablation cardiac CTA. Three-vessel (3V)-PCATA was defined as the mean CT attenuation value of PCAT of all three major coronary arteries. Predictors of AF recurrence during follow-up were evaluated. RESULTS: AF recurrence after the 3-month blanking period was detected in 90 patients (24.7%) during the median follow-up of 26 (interquartile range, 19-42) months. AF recurrence was associated with prior stroke and statin use, NT-proBNP and high-sensitivity cardiac troponin-I levels, left ventricular dimension, left atrial volume index (LAVI), 3V-PCATA, and early AF recurrence during the blanking period. On multivariable Cox proportional hazard analysis, prior stroke (hazard ratio [HR], 2.208, 95% confidence interval [CI], 1.166-4.180, p = 0.015), LAVI (HR, 1.030, 95% CI, 1.010-1.051, p = 0.003), 3V-PCATA (HR, 1.034, 95% CI, 1.001-1.069, p = 0.046), and early AF recurrence (HR, 2.858, 95% CI, 1.855-4.405, p < 0.001) remained statistically significant. CONCLUSION: Pre-ablation CTA-derived 3V-PCATA, representing pericoronary inflammation, was an independent predictor of recurrence after first-session AF ablation using a second-generation cryoballoon. ADVANCES IN KNOWLEDGE: Assessment of 3V-PCATA may identify patients at high risk of AF recurrence after CBA for AF.

Effect of contrast medium versus low-molecular-weight dextran for intracoronary optical coherence tomography in renal insufficiency.

Low-molecular-weight dextran (LMWD) is considered a safe alternative to contrast media to displace blood during optical coherence tomography (OCT) imaging, but concerns remain. The purpose of this study was to investigate whether using LMWD for OCT protects against kidney injury in patients with renal insufficiency compared with contrast media. We retrospectively identified 474 patients with renal insufficiency (estimated glomerular filtration rate < 60 ml/min/1.73 m2) who underwent OCT during coronary angiography or percutaneous coronary intervention; 110 patients with LMWD plus contrast medium (LMWD group) and 364 patients with contrast medium exclusively (Contrast group). We evaluated differences between the two groups and performed propensity score-matched subgroup comparisons. Compared with the Contrast group, the LMWD group had worse baseline renal function, higher prevalence of diabetes mellitus and percutaneous coronary intervention history, higher C-reactive protein and N-terminal pro B-type natriuretic peptide levels, lower hemoglobin levels, and lower left ventricular ejection fraction. The median total volume of contrast medium in the Contrast group was 230.0 ml vs. 61.8 ml of LMWD in addition to 164.0 ml of contrast medium in the LMWD group. Renal function was consistently impaired in the LMWD group within 5 days, at 1-month, and 1-year follow-up (P < 0.001). Two propensity score-matched analyses adjusted for either total volume used or contrast media volume consistently indicated a trend toward worsening renal function in the LMWD group at the 1-year follow-up. No protective benefit for renal function from using LMWD instead of contrast media for OCT was observed in patients with renal insufficiency.

Construct Validity and Reliability of the Japanese Version of the Lumbar Stiffness Disability Index.

STUDY DESIGN: Outcome study to determine the construct validity and reliability of the Japanese version of the Lumbar Stiffness Disability Index. OBJECTIVE: The aim of this study was to evaluate the psychometric measurement properties of the Japanese version of the Lumbar Stiffness Disability Index (J-LSDI) following lumbar spinal surgery in order to assess its construct validity and reliability. SUMMARY OF BACKGROUND DATA: The LSDI was designed and validated as a tool to assess functional impacts of lumbar spine stiffness and diminished spinal flexibility. A Japanese version has been developed, but its construct validity and reliability have not been evaluated. METHODS: A Pearson correlation coefficient was calculated using flexion and extension range of motion, Oswestry Disability Index (ODI) and Tampa Scale for Kinesiophobia (TSK) as external standards to evaluate construct validity. An intraclass correlation coefficient (ICC) and a Bland-Altman analysis were used to evaluate test-retest reliability. RESULTS: A total of 244 patients following lumbar spinal surgery participated in the study. Fifty one of the 244 patients participated in the reliability study. The ICC of the J-LSDI for test-retest reliability was 0.89 (95% confidence interval, 0.79-0.93). There was no systematic error found in the results of the Bland-Altman analysis. One hundred ninety-three of the 244 patients participated in the validity study. There were significant correlations between the J-LSDI and trunk flexion range of motion (r = -0.66), extension (r = -0.51), ODI (r = 0.62), and TSK (r = 0.38). CONCLUSION: The construct validity and reliability of the Japanese version of the LSDI were confirmed. The J-LSDI can be used to evaluate lumbar stiffness and associated disability in Japanese patients following lumbar spinal surgery.Level of Evidence: 2.

Prognostic Impact of Residual Anatomic Disease Burden After Functionally Complete Revascularization.

BACKGROUND: Prognostic impact of residual anatomic disease burden after functionally complete percutaneous coronary intervention (PCI), defined by post-PCI fractional flow reserve (FFR) >0.80 would be a clinically relevant question. The current study evaluated clinical outcomes at 2 years according to residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (RSS) in patients who underwent functionally complete revascularization. METHODS: A total of 1910 patients (2095 revascularized vessels) with post-PCI FFR >0.80 were selected from the International Post-PCI FFR Registry. RSS was defined as the SYNTAX score recalculated after PCI, SYNTAX revascularization index was calculated as 100×(1-RSS/pre-PCI SYNTAX score), and post-PCI FFR was measured after completion of PCI. The primary outcome was target vessel failure (TVF; a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization) at 2 years, and risk of TVF was compared according to tertile classification of RSS (0, 1-5, and >5) and post-PCI FFR (≥0.94, 0.87-0.93, and ≤0.86). RESULTS: After PCI, SYNTAX score was changed from 10.0 (Q1-Q3, 7.0-16.0) to 0.0 (Q1-Q3, 0.0-5.0) and FFR changed from 0.70±0.12 to 0.90±0.05. TVF at 2 years occurred in 4.9%, and patients with TVF showed higher pre-PCI SYNTAX score and lower post-PCI FFR than those without. However, there were no significant differences in SYNTAX revascularization index and RSS. The risk of TVF was not different according to tertile of RSS (log-rank P=0.851). Conversely, risk of TVF was different according to tertile of post-PCI FFR (log-rank P=0.009). Multivariable model showed the risk of TVF was significantly associated with post-PCI FFR (hazard ratio, 1.091 [95% CI, 1.032-1.153]; P=0.002) but not with RSS (hazard ratio, 0.969 [95% CI, 0.898-1.045]; P=0.417). CONCLUSIONS: Among patients who underwent functionally complete revascularization, residual anatomic disease burden assessed by RSS was not related with occurrence of TVF at 2 years. These results support the importance of functionally complete revascularization rather than angiographic complete revascularization. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04012281.

Clinical significance of the presence of puff-chandelier ruptures detected by nonobstructive aortic angioscopy.

OBJECTIVE: This study aimed to investigate the prevalence and prognostic significance of atherosclerotic aortic plaques (AAPs) or specific AAP types detected by nonobstructive angioscopy (NOA) in patients who underwent percutaneous coronary intervention (PCI). BACKGROUND: Although recent studies have reported the presence of various patterns of AAPs, identified by NOA, the clinical significance of the presence of AAPs remains elusive. METHODS: In this retrospective, multicenter cohort study, a total of 167 patients who underwent PCI and intra-aortic scans with NOA were studied. The association between AAPs and the incidence of major adverse cardiac events (MACEs), including cardiac death, myocardial infarction, stroke, and clinically driven unplanned revascularizations, was assessed. RESULTS: AAPs were detected in 126 patients (75%) who underwent NOA. MACEs occurred in 28 (17%) patients during the follow-up (median 2.9 years [range 2.1-3.8]). Among all types of AAPs, only puff-chandelier rupture (PCR) showed a significant difference in frequency between patients with and those without MACEs: 21 (75%) and 49 (35%), respectively (p < .001). Multivariable Cox proportional hazard analysis revealed that PCR (hazard ratio [HR] 3.73, 95% confidence interval [CI] 1.57-8.87, p = .004) and chronic kidney disease (HR 2.97, 95% CI 1.37-6.44, p = .010) were independent predictors of MACEs. Kaplan-Meier analysis revealed that PCR was significantly associated with more frequent MACEs. CONCLUSION: The detection of PCR in the aorta using NOA was significantly associated with an increased risk of subsequent adverse events after PCI.

Factors Influencing Interbody Cage Subsidence Following Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: This is a prospective study. OBJECTIVE: The purpose of this study was to analyze the factors influencing subsidence following anterior cervical discectomy and fusion (ACDF) using a stand-alone cage. SUMMARY OF BACKGROUND DATA: The relationship between cage subsidence and cage height and material has been reported in previous studies. METHODS: Clinical and radiologic data from 78 patients, 105 levels, undergoing single-level and 2-level ACDF without plates from 2007 to 2015 were collected prospectively. Patients were followed for at least 12 months after surgery. Radiographs were obtained preoperatively, at 1 week, and at 1, 3, 6, and 12 months postoperatively to determine the presence of fusion and cage subsidence. RESULTS: There was a correlation in cage height and subsidence (Spearman P<0.05). Cage subsidence was significantly shorter in the polyetheretherketone cages than in titanium cages (P<0.05). However, when cage height was <5 mm, the difference between the 2 groups was not significant. Large subsidence (>3 mm) was observed in 17 patients, 20 levels, many of whom exhibited sinking in the first month after surgery. CONCLUSIONS: The greater the cage height, the greater the risk of cage subsidence in ACDF. Polyetheretherketone cages are superior to titanium cages for the maintenance of intervertebral height in cases where cage height is >5.5 mm. LEVEL OF EVIDENCE: Level 3.