Intergroup Differences In Baseline Characteristics Research Articles

Lower extremity arterial disease vs. coronary artery disease: mortality differences after revascularization.

Patients undergoing revascularization for lower extremity arterial disease (LEAD) may face a higher risk of mortality than those with coronary artery disease (CAD). This study aimed to characterize the difference in mortality risk between patients undergoing revascularization for LEAD and CAD and identify associated factors. The 1-year database of 10 754 patients undergoing revascularization for CAD (n = 6349) and LEAD (n = 4405) was analysed. Poisson regression models were used to characterize interpopulation differences in mortality, adjusting for baseline clinical features, including age, sex, polyvascular disease, comorbidities, medications, and vulnerabilities. Individuals with LEAD were older, were more likely to have polyvascular disease, had more comorbidities, and received fewer cardioprotective drugs than those with CAD. Vulnerabilities remained more common in the LEAD group even after adjusting for these clinical features. The crude risk ratio of mortality incidence for LEAD vs. CAD was 2.91 (95% confidence interval, 2.54-3.34), attenuated to 2.14 (1.83-2.50) after controlling for age, sex, and polyvascular disease. The percentage attenuation in the excessive mortality associated with LEAD was 29%. The stepwise addition of comorbidities, medications, and vulnerabilities as adjusting factors attenuated the incidence risk ratio to 1.48 (1.26-1.72), 1.33 (1.12-1.58), and 1.17 (0.98-1.39), respectively, and increased the percentage attenuation to 64%, 73%, and 86%, respectively. Mortality risk was almost three-fold higher in patients undergoing revascularization for LEAD than in those with CAD. The excessive mortality was considerably attributable to inter-group differences in baseline characteristics, including potentially clinically or socially modifiable factors.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

Outcomes following major thoracoabdominal cancer resection in adults with congenital heart disease.

While advances in medical and surgical management have allowed >97% of congenital heart disease (CHD) patients to reach adulthood, a growing number are presenting with non-cardiovascular malignancies. Indeed, adults with CHD are reported to face a 20% increase in cancer risk, relative to others, and cancer has become the fourth leading cause of death among this population. Surgical resection remains a mainstay in management of thoracoabdominal cancers. However, outcomes following cancer resection among these patients have not been well established. Thus, we sought to characterize clinical and financial outcomes following major cancer resections among adult CHD patients. The 2012-2020 National Inpatient Sample was queried for all adults (CHD or non-CHD) undergoing lobectomy, esophagectomy, gastrectomy, pancreatectomy, hepatectomy, or colectomy for cancer. To adjust for intergroup differences in baseline characteristics, entropy balancing was applied to generate balanced patient groups. Multivariable models were constructed to assess outcomes of interest. Of 905,830 patients undergoing cancer resection, 1,480 (0.2%) had concomitant CHD. The overall prevalence of such patients increased from <0.1% in 2012 to 0.3% in 2012 (P for trend<0.001). Following risk adjustment, CHD was linked with greater in-hospital mortality (AOR 2.00, 95%CI 1.06-3.76), as well as a notable increase in odds of stroke (AOR 8.94, 95%CI 4.54-17.60), but no statistically significant difference in cardiac (AOR 1.33, 95%CI 0.69-2.59) or renal complications (AOR 1.35, 95%CI 0.92-1.97). Further, CHD was associated with a +2.39 day incremental increase in duration of hospitalization (95%CI +1.04-3.74) and a +$11,760 per-patient increase in hospitalization expenditures (95%CI +$4,160-19,360). While a growing number of patients with CHD are undergoing cancer resection, they demonstrate inferior clinical and financial outcomes, relative to others. Novel screening, risk stratification, and perioperative management guidelines are needed for these patients to provide evidence-based recommendations for this complex and unique cohort.

Optical coherence tomography angiography features of the chorioretinal complex and choriocapillaris perfusion before and after vitrectomy with conventional versus fovea-sparing internal limiting membrane peeling for idiopathic macular hole

Purpose: To assess optical coherence tomography angiography (OCTA)-measured changes in the chorioretinal complex and choriocapillaris perfusion density in the macula before and after vitrectomy with fovea-sparing versus conventional internal limiting membrane (ILM) peeling for idiopathic macular hole (IMH). Material and Methods: Eyes with stage-2 to stage-4 holes as per the classification by Gass received 25-G vitrectomy with conventional or fovea-sparing ILM peeling and gas tamponade with 20% SF6 or 15% С3F8. IMH diameter, foveal avascular zone (FAZ) area in the deep retinal plexus and choriocapillaris perfusion density (CPD) were assessed before and 1 month after surgery. Results: Totally, 70 patients had an IMH surgery in 71 eyes. The mean age ± standard deviation (SD) was 65.7 ± 6.8 years, median IMH duration (interquartile range or IQR), 3.0 (1.0-6.0) months, median best-corrected visual acuity or BCVA (IQR), 0.19 (0.1-0.25), and median maximum IMH diameter (IQR), 673.5 (549.5–1010.5) µm. In eyes with IMH and fellow eyes, the median FAZ area (IQR) was 0.51 (0.15–0.53) mm2, and 0.46 (0.10–0.74) mm2, respectively (р = 0.49), and mean CPD ± SD, 0.11 ± 0.06, and 0.29 ± 0.13 (р = 0.0001), respectively. Thirty-four eyes received conventional ILM peeling and 37 eyes, fovea-sparing ILM peeling, and there was no significant intergroup difference in baseline characteristics. One month after surgery, IMH closure was achieved in 63/71 eyes (i.e., the closure rate was 88.7% for total operated eyes, and 88.2% and 89.2%, respectively, for eyes in conventional ILM peeling and fovea-sparing ILM peeling groups), and median BCVA (IQR) improved to 0.60 (0.4–0.8) (р = 0.00001). After IMH closure, in operated eyes, median FAZ area (IQR) decreased to 0.30 (0.12–0.6) mm2, but the difference was not significant, whereas mean CPD ± SD increased significantly from 0.11 ± 0.06 to 0.25 ± 0.10 (р = 0.0001). No significant difference in OCTA-based retinal microcirculation and choriocappillaris characteristics was observed between the conventional ILM peeling and fovea-sparing ILM peeling groups. Conclusion: The presence of macular hole is accompanied by abnormal perfusion in the choriocapillaris, but the CPD recovers after IMH closure. Postoperative CPD recovery is not influenced by the type (conventional or fovea-sparing) of ILM peeling.

Myocardial Injury After Transcatheter Mitral Valve Replacement Versus Surgical Reoperation

This study aimed to evaluate the incidence and clinical implications of myocardial injury, as determined by cardiac biomarker increase, in patients who underwent mitral bioprosthesis dysfunction treatment with transcatheter mitral valve replacement (TMVR) versus surgical mitral valve replacement reoperation (SMVR-REDO). Between 2014 and 2023, 310 patients with mitral bioprosthesis failure were included (90 and 220 patients for TMVR and SMVR-REDO, respectively). Multivariable analysis and propensity score matching were performed to adjust for the intergroup differences in baseline characteristics. Creatinine kinase-MB (CK-MB) and cardiac troponin I (cTn) were collected at baseline and 6 to 12, 24, 48, and 72 hours after intervention. The cardiac biomarkers values were evaluated in relation to their reference values. The outcomes were determined according to the Mitral Valve Academic Research Consortium criteria. CK-MB and cTn increased above the reference level in almost all patients after SMVR-REDO and TMVR (100% vs 94%, respectively), with the peak occurring within 6 to 12 hours. SMVR-REDO was associated with a two- to threefold higher increase in cardiac biomarkers. After 30 days, the mortality rates were 13.3% in the TMVR and 16.8% in the SMVR-REDO groups. At a median follow-up of 19 months, the mortality rates were 21.1% in the TMVR and 17.7% in the SMVR-REDO groups. Left ventricular ejection fraction, estimated glomerular filtration rate, CK-MB, and cTn were predictors of mortality. In conclusion, some degree of myocardial injury occurred systematically after the treatment of mitral bioprosthetic degeneration, especially after SMVR, and higher CK-MB and cTn levels were associated with increased cumulative late mortality, regardless of the approach.

The efficacy of Nigella sativa L. oil on serum biomarkers of inflammation and oxidative stress and quality of life in patients with knee osteoarthritis: A parallel triple-arm double-blind randomized controlled trial.

The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP (p = .003), MDA (p = .003), and TAC (p = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group (p < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.

Low-Dose vs High-Dose Drug-Coated Balloon for Symptomatic Femoropopliteal Artery Disease: The PROSPECT MONSTER Study Outcomes

BackgroundRandomized trials have shown comparable outcomes between second-generation low-dose drug-coated balloons (LD-DCBs) and first-generation high-dose drug-coated balloons (HD-DCBs); but the trial patients had low clinical complexity, and there were no comparisons in medically complex populations. ObjectivesThe aim of this study was to compare outcomes between an LD-DCB (Ranger; 2.0 μg/mm2) and an HD-DCB (IN.PACT; 3.5 μg/mm2) in patients with symptomatic femoropopliteal artery disease. MethodsPROSPECT MONSTER (Prospective Comparison of Second-Generation Low-Dose Drug-Coated Balloon With High-Dose Drug-Coated Balloon) was a prospective, multicenter, nonrandomized trial that prospectively collected data from 581 patients who underwent endovascular therapy with the LD-DCB (n = 370) or the HD-DCB (n = 211) for symptomatic femoropopliteal artery disease (Rutherford classes 2-5). The primary outcome was the 1-year primary patency of the LD-DCB in comparison with that of the HD-DCB, as evaluated using propensity score matching. The incidence of impaired flow after drug-coated balloon application was also evaluated. ResultsPropensity score matching extracted 163 pairs (358 and 163 patients in the LD-DCB and HD-DCB groups, respectively), with no significant intergroup difference in baseline characteristics. The 1-year primary patency rates in the matched population were similar between the LD-DCB and HD-DCB groups (87.0% [95% CI: 82.5%-91.7%] vs 81.3% [95% CI: 74.8%-88.5%]; HR: 0.93; 95% CI: 0.55-1.59; P = 0.79), as was the incidence of impaired flow (13.6% vs 9.8%; OR: 1.46; 95% CI: 0.78-2.73; P = 0.24). No baseline characteristics had any significant interaction effects on the association of the LD-DCB vs the HD-DCB and 1-year restenosis risk. ConclusionsLD-DCBs demonstrate efficacy and safety comparable with HD-DCBs in patients with complex clinical backgrounds, suggesting that drug-coated balloon treatment using a lower dose may be possible.

Clinical Impact of Additional Cilostazol Treatment on Restenosis Risk following Heparin-Bonded Stent Graft Implantation: Sub-Analysis from the Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study.

The present study investigated the effects of additional cilostazol administration on the 12-month risk of restenosis after femoropopliteal heparin-bonded stent graft implantation. This study was a sub-analysis of the Viabahn stent graft placement for femoropopliteal disease reQUIring endovaScular tHerapy (VANQUISH) study, which was a prospective multicenter study investigating patients who received Viabahn stent graft (W.L. Gore & Associates, Flagstaff, AZ, USA) and dual-antiplatelet therapy with aspirin and a thienopyridine. The comparison of clinical outcomes between subgroups with and without cilostazol treatment were performed using the propensity score-matching method to minimize the intergroup differences in baseline characteristics. Cilostazol-treated patients had a lower 12-month proportion of restenosis than cilostazol-free patients (8.2% vs 27.3%). The odds ratio of cilostazol for the 12-month restenosis was 0.27 [95% CI, 0.08 to 0.97] (p=0.045). Furthermore, the cumulative incidence rates of surgical reconstruction, target lesion revascularization and acute thrombotic occlusion (p values by the log-rank test) were 2.6% versus 1.8% (P=0.43), 5.3% versus 20.5% (P=0.067), and 0.0% versus 11.8% (P=0.0499), respectively. The rates of surgical reconstruction and target lesion revascularization (TLR) were not significantly different between both groups. Our study revealed the clinical impact of additional cilostazol treatment on the risk of restenosis and acute thrombotic occlusion following heparin-bonded stent graft implantation, while TLR and surgical reconstruction were not significantly different.

The impact of hypertonic saline on damage control laparotomy after penetrating abdominal trauma.

The inability to achieve primary fascial closure (PFC) after emergency laparotomy increases the rates of adverse outcomes including fistula formation, incisional hernia, and intraabdominal infection. Hypertonic saline (HTS) infusion improves early PFC rates and decreases time to PFC in patients undergoing damage control laparotomy (DCL) after injury. We hypothesized that in patients undergoing DCL after penetrating abdominal injury, HTS infusion would decrease the time to fascial closure as well as the volume of crystalloid required for resuscitation without inducing clinically relevant acute kidney injury (AKI) or electrolyte derangements. We retrospectively analyzed all penetrating abdominal injury patients undergoing DCL within the University of Pennsylvania Health System (January 2015-December 2018). We compared patients who received 3% HTS at 30mL/h (HTS) to those receiving isotonic fluid (ISO) for resuscitation while the abdominal fascia remained open. Primary outcomes were the rate of early PFC (PFC within 72h) and time to PFC; secondary outcomes included acute kidney injury, sodium derangement, ventilator-free days, hospital length of stay (LOS), and ICU LOS. Intergroup comparisons occurred by ANOVA and Tukey's comparison, and student's t, and Fischer's exact tests, as appropriate. A Shapiro-Wilk test was performed to determine normality of distribution. Fifty-seven patients underwent DCL after penetrating abdominal injury (ISO n = 41, HTS n = 16). There were no significant intergroup differences in baseline characteristics or injury severity score. Mean time to fascial closure was significantly shorter in HTS (36.37h ± 14.21 vs 59.05h ± 50.75, p = 0.02), and the PFC rate was significantly higher in HTS (100% vs 73%, p = 0.01). Mean 24-h fluid and 48-h fluid totals were significantly less in HTS versus ISO (24h: 5.2L ± 1.7 vs 8.6L ± 2.2, p = 0.01; 48h: 1.3L ± 1.1 vs 2.6L ± 2.2, p = 0.008). During the first 72h, peak sodium (Na) concentration (146.2mEq/L ± 2.94 vs 142.8mEq/L ± 3.67, p = 0.0017) as well as change in Na from ICU admission (5.1mEq/L vs 2.3, p = 0.016) were significantly higher in HTS compared to ISO. Patients in the HTS group received significantly more blood in the trauma bay compared to ISO. There were no intergroup differences in intraoperative blood transfusion volume, AKI incidence, change in chloride concentration (△Cl) from ICU admit, Na to Cl gradient (Na:Cl), initial serum creatinine (Cr), peak post-operative Cr, change in creatinine concentration (△Cr) from ICU admission, creatinine clearance (CrCl), initial serum potassium (K), peak ICU K, change in K from ICU admission, initial pH, highest or lowest post-operative pH, mean hospital LOS, ICU LOS, and ventilator-free days. HTS infusion in patients undergoing DCL after penetrating abdominal injury decreases the time to fascial closure and led to 100% early PFC. HTS infusion also decreased resuscitative fluid volume without causing significant AKI or electrolyte derangement. HTS appears to offer a safe and effective fluid management approach in patients who sustain penetrating abdominal injury and DCL to support early PFC without inducing measurable harm. Level III.

Change of Choroidal Microvasculature Dropout After Trabeculectomy as Assessed by Optical Coherence Tomography Angiography.

Reduction in the angular circumference of choroidal microvascular dropout (CMvD AC) was found in POAG patients after trabeculectomy. Greater percentage of IOP reduction was significantly associated with decreased CMvD AC. The purpose of this study was to investigate the change of choroidal microvasculature dropout (CMvD) after trabeculectomy and its associated factors in primary open angle glaucoma (POAG) eyes using optical coherence tomography angiography. Fifty eyes of 50 POAG participants who had preoperative CMvD and underwent trabeculectomy were prospectively enrolled. Angular circumference (AC) of CMvD was determined from choroidal layer images by optical coherence tomography angiography preoperatively and at postoperative 1 year. The cutoff for significant AC of CMvD decrease was determined by the Bland-Altman method, and accordingly, patients were divided into 2, decreased and stable/increased CMvD AC groups. Changes in intraocular pressure (IOP) and CMvD AC were compared between the groups preoperatively and at postoperative 1 year. Factors associated with CMvD AC decrease were assessed by linear regression analysis. The cutoff for significant CMvD AC decrease was 3.58 degrees; accordingly, 26 eyes (52.0%) were categorized as decreased CMvD AC group. No significant intergroup differences in baseline characteristics were found. However, the decreased CMvD AC group presented significantly lower IOP (10.7±3.7 vs. 12.9±2.6mmHg, P =0.022), lower CMvD AC (32.03±33.95% vs. 53.44±39.33%, P =0.044), and higher parapapillary choroidal vessel density ( P =0.014) compared with the increased/stable CMvD AC group at postoperative 1 year. The greater percentage of IOP reduction was significantly associated with decreased CMvD AC ( P =0.046). CMvD AC reduction associated with IOP lowering was found after trabeculectomy. The long-term clinical relevance of postoperative CMvD reduction should be further investigated.

Comparison of Clinical Outcomes in Patients Undergoing Common Femoral Thromboendarterectomy With or Without Patch Angioplasty

Surgical thrombo-endarterectomy (TEA) is the standard treatment for an occlusive lesion of the common femoral artery (CFA). However, there is limited knowledge on the need for patch angioplasty in CFA TEA. The objective of this study was to compare the peri-operative and two year results of CFA TEA with or without patch angioplasty. A multicentre retrospective observational study was performed at 34 Japanese centres. Comparisons were made between patients undergoing CFA TEA with or without patch angioplasty after propensity score matching (PSM). The primary endpoints were primary patency and freedom from target lesion revascularisation (TLR) of the TEA lesion. The secondary endpoints were hospital outcomes, limb salvage, and overall survival. Between 2018 and 2020, 428 TEA procedures (237 with patch angioplasty and 191 with primary closure) were performed. PSM extracted 151 pairs with no significant intergroup differences in baseline characteristics. Peri-operative death and complications occurred in 0.7% vs. 1.3% (p = 1.0) and 6.0% vs. 6.6% (p = 1.0), respectively. The follow up rate was 96% in a median follow up period of 14.9 months (interquartile range 8.3, 24.3). Loss of primary patency occurred in 18 patients. The two year primary patency of patch angioplasty cases was statistically significantly higher than that of primary closure cases (97.0% vs. 89.9%; p = .021). TLR was performed in 14 patients. The two year freedom from TLR in patch angioplasty cases was also statistically significantly higher than that in primary closure cases (98.6% vs. 92.9%; p = .003). During follow up, seven limbs required major amputation and 40 patients died. There was no statistically significant difference in limb salvage and survival between the two groups after PSM. This is the first report to show that patch angioplasty may decrease restenosis and target lesion revascularisation of CFA TEA lesions.

Is It Safe to Preserve Left Atrial Appendage During Maze Procedure?

The left atrial appendage (LAA) can contribute significantly to LA mechanical contraction. Nevertheless, the preventive effect of LAA occlusion during the maze procedure against cerebral infarction remains controversial. In this study, we compared the surgical, cardiac hemodynamic, and neurologic outcomes between LAA preservation and occlusion performed during the maze procedure. Between January 2015 and August 2021, 252 patients underwent the maze procedure using cryoablation at our medical center. After excluding patients according to our exclusion criteria (i.e., mechanical prosthesis implantation, preexisting LAA thrombus), LAA was preserved in 113 patients (non-occlusion group) and occluded in 75 patients (occlusion group). Outcomes were compared using propensity score matching (PSM). PSM did not reveal significant intergroup differences in baseline characteristics between the non-occlusion (n=53) and occlusion (n=53) groups. During a median follow-up of 44 months, 2 patients in the non-occlusion group (3.8%) experienced ischemic strokes. There was no significant difference in the rate of freedom from stroke (p=0.19) and major adverse cardiac events (p=0.43) between the 2 groups. Through echocardiography at 1-year follow-up, a statistically significant difference in LA mechanical contraction was observed between the non-occlusion group and occlusion group (24 of 33 [72.7%] vs. 18 of 37 [48.6%], respectively; p=0.04). In this study, preservation of the LAA during the maze procedure resulted in better LA function than LAA occlusion, with similar rates of stroke.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns)

Purpose: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. Materials and Methods: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. Results: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). Conclusions: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. Clinical Impact Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

Analgesic Efficacy of Intravenous Dexamethasone as an Adjunct to Ultrasound-Guided Paravertebral Block with Bupivacaine in Video-Assisted Thoracoscopic Surgery.

PurposeThoracic paravertebral block (TPVB) is a recommended regional analgesia during video-assisted thoracoscopic surgery (VATS). However, single-injection TPVB does not last long enough to provide sufficient acute postoperative pain relief. Continuous TPVB through a catheter is technically challenging and often unreliable. Intravenous dexamethasone extends the analgesic duration with some peripheral nerve blocks. However, data on the effect of intravenous dexamethasone on pain relief with TPVB are limited. This study aimed to assess the analgesic efficacy of intravenous dexamethasone in patients who received TPVB for VATS.Patients and MethodsIn this multicenter prospective randomized controlled trial, we recruited patients aged between 18 and 80 years with the American Society of Anesthesiologists of physical status class 1–3 and underwent elective VATS. Patients under general anesthesia randomly received 8 mg of intravenous dexamethasone (group D) or normal saline (group C). Ultrasound-guided TPVB (USG-TPVB) was performed at the T4–T5 and T6-T7 spaces. Multimodal analgesia was achieved via paracetamol, tramadol and intravenous morphine for both study groups. The primary outcome was time for the first analgesic requirement. Postoperative pain in terms of numeric rating score (NRS), total morphine consumption and postoperative nausea and vomiting (PONV) were assessed.ResultsAfter excluding one patient, 59 patients were analyzed. There were no intergroup differences in baseline characteristics. The time to first analgesic requirement was longer in group D (305 [240, 510] minutes) than in group C (270 [180, 300] minutes) (P value = 0.02). The NRS at rest and on movement was lower in group D than in group C at 12 hours but did not differ at other time points. Postoperative morphine consumption was significantly lower in group D than in group C at 6,12,24 and 48 hours. Incidences of PONV were comparable between the groups.ConclusionIntravenous dexamethasone, used as an adjunct to a single-injection USG-TPVB prolonged analgesic duration, had an opioid-sparing effect and provided better postoperative pain relief after VATS.

Cutting balloons versus conventional balloons for treating patients with coronary artery disease presenting with moderate-to-severely calcified lesions: impact on post-interventional minimum stent area

Cutting balloons are commonly used to treat patients with coronary artery disease (CAD) presenting with calcified lesions, but the efficacy of cutting balloons has not been elucidated. We aimed to investigate the impact of novel cutting balloons (Wolverine™) relative to conventional balloons on post-interventional stent expansion for coronary calcified lesions. This study was a single-center, retrospective, observational study. We analyzed 636 lesions from 543 patients with moderate-to-severely calcified CAD lesions undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention using cutting balloons or conventional balloons prior to drug-eluting stent implantation. The primary outcome was post-interventional minimum stent area (MSA) evaluated by IVUS. Propensity score matching was performed to adjust for baseline characteristics. The interaction effects between balloon type and baseline characteristics were also assessed in MSA > 5.5 mm2. Data on pairs of lesions (n = 168) were extracted with no major intergroup differences in baseline characteristics. Post-interventional MSA was not significantly different in the two groups (5.3 ± 2.0 mm2 versus 5.1 ± 1.9 mm2, P = 0.42). Subgroup analysis indicated the subgroup (calcium arc > 180°) showed the qualitative interaction of balloon type effect (P for interaction = 0.056) and the use of cutting balloons was more favorable for lesions with calcium arc ≤ 180° (adjusted odds ratio 4.10, 95% confidence interval 1.14-14.69). The use of cutting balloons did not demonstrate the beneficial effect on post-interventional MSA relative to conventional balloons for patients with CAD presenting moderate-to-severely calcified lesion. However, the use of cutting balloons was more favorable for lesions with calcium arc ≤ 180° to obtain the optimal MSA.

Comparison of clinical outcomes of tracheotomy in patients with acute cervical spinal cord injury at different timing

Respiratory failure is the leading cause of early death after acute CSCI. Tracheotomy is an effective approach to reduce mortality and improve the clinical outcomes. However, the optimal timing for tracheotomy remains controversial. Hence, the study aimed to compare the clinical outcomes of tracheotomy in patients with acute cervical spinal cord injury (CSCI) at different timing. A retrospectively review was performed of acute CSCI patients who underwent tracheotomy in the intensive care unit of Haian Hospital between January 2014 and June 2019. 124 CSCI patients were included and stratified into three groups based on the timing of tracheotomy: early group (≤4 days from initial intubation), medium group (4–10 days from initial intubation), and late group (≥10 days from initial intubation). The clinical outcomes and functional outcomes were analyzed. No significant intergroup differences in baseline characteristics were observed. The late group needed significantly longer duration of mechanical ventilation, longer ICU stay, and suffered higher ICU mortality, higher pneumonia after tracheotomy than the early and medium groups. More patients in the early and medium groups successfully weaned from mechanical ventilation. The early and medium groups achieved better improvement of JOA and NDI scores than the late group at one year after surgery and at the final follow-up. Early to medium term tracheotomy may lead to better clinical and functional outcomes in patients with acute CSCI who require prolonged mechanical ventilation.

Features of the complications for intracorporeal Billroth-I and Roux-en-Y reconstruction after laparoscopic distal gastrectomy for gastric cancer.

Recently, the Roux-en-Y procedure (R-Y) and delta-shaped Billroth-I anastomosis (DB-I) have become prevalent as intracorporeal gastroenteric anastomosis methods after laparoscopic distal gastrectomy (LDG) for gastric cancer. However, the differences in postoperative outcomes between the two methods have not been clarified. Hence, this retrospective study aimed to reveal the features of the complications of the R-Y versus DB-I after LDG. The study cohort comprised patients with gastric cancer who underwent DB-I or R-Y after LDG from January 2013 to May 2016. Patient characteristics and surgical and postoperative variables were analyzed. To compensate for intergroup differences in baseline characteristics, estimated propensity scores were used to perform one-on-one matching between the groups. A total of 564 patients were included, and propensity score matching created a matched cohort of 149 pairs in the DB-I and R-Y groups. The incidence of short-term complications such as gastrointestinal fistula classified as Clavien-Dindo grade IIIa or above was significantly greater in the DB-I group than the R-Y group (14.1% versus 4.7%, p=0.004). In contrast, the R-Y was associated with long-term complications such as internal hernia and tended to result in a slightly higher readmission rate in the R-Y group compared with the DB-I group (2.7% versus 6.0%, p=0.128). DB-I after LDG was associated with a significantly higher rate of short-term complications compared with the R-Y, whereas characteristic long-term complications tended to be observed after the R-Y. These differences should be considered during the selection of the reconstruction method and postoperative management of LDG.

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

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

The effect of rotator cuff physical exercise combined with electrically stimulated antagonist on shoulder rotator cuff strength

BackgroundAn elastic band (EB) is generally used with a low load for rotator cuff physical exercise, but the resulting increase in muscle strength is insufficient. We assessed the efficacy on external rotator muscle strength of the shoulder joint; of a hybrid training system (HTS) that resists the motion of a volitionally contracting agonist muscle using the force generated by its electrically stimulated antagonist vs. general rotator cuff exercise with EB. MethodsTwenty healthy men with no shoulder joint disorders were randomized to 6 weeks of triweekly 10-min rotator cuff exercise with HTS or EB in a clinical research laboratory. Isokinetic concentric external rotator muscle strength at angular velocities of 60°/s and 180°/s (CON60, CON180, respectively) and isokinetic eccentric external rotator muscle strength at an angular velocity of 60°/s (ECC60) were measured as rotator cuff function before and after 6 weeks of intervention. ResultsThere were no significant intergroup differences in baseline characteristics. There were statistically significant differences (p = 0.0358, p = 0.0213, respectively) in the increase in CON180 (mean ± SD) and ECC60 between the HTS group (Δ6.0 ± 6.0Nm, p = 0.015; Δ7.5 ± 4.7Nm p = 0.0007, respectively) and the EB group (Δ0.3 ± 5.2Nm, p = 0.8589; Δ1.8 ± 5.3 Nm p = 0.3133, respectively). There was a trend toward CON60 increasing in the HTS group (Δ4.7 ± 6.5Nm, p = 0.0494) which was greater than in the control group (Δ-0.9 ± 6.3Nm, p = 0.6637) (inter-group, p = 0.0677). ConclusionsThe results of this study support the conclusion that HTS is more effective for increasing external rotator muscle strength more effectively than EB. HTS would be useful for rotator cuff physical exercise.

Impact of stress myocardial blood flow as an important predictor for major adverse cardiac and cerebrovascular event in hemodialysis patients, even in patients without myocardial perfusion abnormality

Abstract Background In the clinical setting, ischemic heart disease (IHD) is a major problem not only in general patients but also in regular hemodialysis (HD) patients. Positron emission tomography (PET) is becoming a reliable modality for detecting coronary artery disease. Of course, PET illustrates myocardial perfusion (MP), PET also measures myocardial blood flow (MBF) directly. We have reported stress MBF is an independent predictor in HD population. Although some prior studies show CFR is an independent predictor for their prognosis in patients without MP abnormality, there is limited data about the predictability of stress MBF in HD patients without MP abnormality. Methods A total 438 of HD patients who undergone 13NH3PET for suspected IHD were enrolled. All patients were undergone13NH3PET at Nagoya Radiological Diagnosis Foundation. After we excluded patients whose summed stress score (SSS) &amp;lt;4, we identified 182 eligible patients. Patients were divided into two group according to the median value of CFR levels; low stress MBF group (≤2.56) and high stress MBF group (&amp;gt;2.56). We followed up them up to 4.2 years (median 2.4 years) and collected their data. We evaluated their major adverse cardiac cerebrovascular event. We performed Kaplan-Meyer analysis and multivariable cox regression models. Furthermore, we evaluated the incremental value with C-index, net reclassification improvement (NRI) and integrated discrimination improvement (IDI) when CFR added into a model with established risk factors. Result There were intergroup difference in baseline characteristics: age, gender, prior CVD and diabetes. Kaplan-Meyer analysis shows statistically intergroup difference [log rank p=0.013, hazard ratio (HR) 0.413, 95% confidential interval (CI) 0.220–0.775]. Multivariable cox regression model for MACCE shows CFR is an independent risk factor (p=0.004, HR 0.311, 95% CI 0.137–0.684). As regarding model discrimination, all of C-index (0.832 vs 0.796, p=0.15), NRI (0.513, p=0.008) and IDI (0.032, p=0.033) were greatest in a predicting model with established risk factors plus stress MBF. Conclusion The low stress MBF group has poor prognosis in MACCE comparing to the high stress MBF group. Stress MBF is an independent risk factor for MACCE. Adding stress MBF on conventional risk factors could more accurately predict MACCE in HD patients, even in patients without MP abnormality. Funding Acknowledgement Type of funding source: None