4-year Clinical Outcomes Research Articles

Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study

IntroductionRefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device.MethodsA prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD.ResultsAvailable data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux.ConclusionThese results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop’s dynamic physiologic interaction and non-encircling nature.

Mid-term outcomes and hemodynamic performance of transcatheter aortic valve implantation in bicuspid aortic valve stenosis: Insights from the bicuSpid TAvi duraBILITY (STABILITY) registry.

Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis. To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI). The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions. Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure[BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis. The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient.

Comparison of ultrasound-guided radiofrequency ablation versus thyroid lobectomy for T1bN0M0 papillary thyroid carcinoma.

To investigate and compare the clinical outcomes between radiofrequency ablation (RFA) and thyroid lobectomy (TL) for T1bN0M0 papillary thyroid carcinoma (PTC). This retrospective study evaluated 283 patients with solitary T1bN0M0 PTC treated with RFA (RFA group, 91 patients) or TL (TL group, 192 patients) from May 2014 to November 2018. The patients were regularly followed up after treatment. Local tumor progression, lymph node metastasis (LNM), recurrent tumor, persistent tumor, recurrence-free survival (RFS), treatment variables (hospitalization, procedure time, estimated blood loss, and cost), complication, and delayed surgery were compared. During the follow-up (median [interquartile ranges], 50.4 [18.0] months), no significant differences were found in the local tumor progression (4.4% vs 3.6%, p = 1.000), LNM (1.1% vs 2.1%, p = 0.917), recurrent tumor (2.2% vs 1.6%, p = 1.000), persistent tumor (1.1% vs 0%, p = 0.146), and RFS rate (95.6% vs 96.4%, p = 0.816) in the RFA and TL groups. Distant metastasis was not detected. Patients in the RFA group had a shorter hospitalization (0 vs 7.0 [3.0] days, p < 0.001), shorter procedure time (5.6 [2.9] vs 90.0 [38.5] min, p < 0.001), lower estimated blood loss (0 vs 20 [20] mL, p < 0.001), lower cost ($1972.5 [0.1] vs $2362.4 [1009.3], p < 0.001), and lower complication rate (0 vs 12/192 [6.3%], p = 0.015) than those in the TL group. No patients in the RFA group underwent delayed surgery. This study revealed comparable 4-year clinical outcomes between RFA and TL for T1bN0M0 PTC in terms of local tumor progression and RFS. As a minimally invasive modality, RFA may be a promising feasible alternative to surgery for the treatment of T1bN0M0 PTC in selected patients after strict evaluation. • No significant difference in local tumor progression and RFS was found between RFA and TL for T1bN0M0 PTC during a median follow-up period of 50.4 months. • Compared with TL, RFA led to a shorter hospitalization, lower estimated blood loss, lower cost, and lower complication rate. • RFA may be a promising feasible alternative to surgery for the treatment of T1bN0M0 PTC in selected patients after strict evaluation.

Nonplatelet thromboxane generation is associated with impaired cardiovascular performance and mortality in heart failure.

Nonplatelet thromboxane generation, stimulated largely by oxidative stress, is a novel mortality risk factor in individuals with coronary artery disease. Though inversely associated with left ventricular ejection fraction (LVEF), a potential role in the pathobiology of heart failure (HF) remains poorly defined. Nonplatelet thromboxane generation and oxidative stress were assessed by measuring urine thromboxane-B2 metabolites (TXB2-M) and 8-isoPGF2α by ELISA in 105 subjects taking aspirin and undergoing right heart catheterization for evaluation of HF, valve disease, or after transplantation. Multivariable logistic regression and survival analyses were used to define associations of TXB2-M to invasive measures of cardiovascular performance and 4-year clinical outcomes. TXB2-M was elevated (>1,500 pg/mg creatinine) in 46% of subjects and correlated with HF severity by New York Heart Association (NYHA) functional class and brain natriuretic peptide level, modestly with LVEF, but not with HF etiology. There was no association of oxidative stress to HF type or etiology but a trend with NYHA functional class. Multiple invasive hemodynamic parameters independently associated with TXB2-M after adjustment for oxidative stress, age, sex, and race with pulmonary effective arterial elastance (Ea pulmonary), reflective of right ventricular afterload, being the most robust on hierarchical analysis. Similar to Ea pulmonary, elevated urinary TXB2-M is associated with increased risk of death (adjusted HR = 2.15, P = 0.037) and a combination of death, transplant, or mechanical support initiation (adjusted HR = 2.0, P = 0.042). Nonplatelet TXA2 thromboxane generation is independently associated with HF severity reflected by invasive measures of cardiovascular performance, particularly right ventricular afterload, and independently predicted long-term mortality risk.NEW & NOTEWORTHY Nonplatelet thromboxane generation in heart failure is independently associated with risk of death, transplant, or need for mechanical support. Measurement of urine thromboxane metabolites using a clinically available assay may be a useful surrogate for invasive measurement of cardiovascular hemodynamics and performance that could provide prognostic information and facilitate tailoring of therapy in patients with heart failure. Inhibiting thromboxane generation or its biological effects is a potential strategy for improving cardiovascular performance and outcomes in heart failure.

A comparison of rituximab with cyclophosphamide in terms of efficacy and complications as induction therapy for treating granulomatosis with polyangiitis: A three-center study.

Granulomatosis with polyangiitis (GPA), formerly known as Wegner's granulomatosis, is a rare vasculitic syndrome classified under Anti-Neutrophilic Cytoplasmic Autoantibody (ANCA)-associ- ated vasculitides, which is fatal if untreated. The mainstay of treatment consists of immunosuppression using a combination of corticosteroids with either rituximab (RTX) or cyclophosphamide (CYC). We aimed to compare the 4-year clinical outcomes between patients with GPA receiving CYC and RTX as remission induction. In this retrospective cohort, we used patient data from 92 patients with GPA at two large teaching hospitals and a private clinic in Isfahan, Iran. The patients were classified based on the medi- cation they received for remission induction into RTX and CYC groups. The main outcomes were rate of death and relapse, disease activity assessed based on the Birmingham Vasculitis Activity Score (BVAS), disease-related complications, laboratory markers, and adverse-drug-reactions. Fifty-three (57.6%) patients received CYC, whereas 39 (42.4%) received RTX. The mean duration of follow-up was 3.6 (62) years. Most of patients (70%) had a successful remission, while 20.7% experi- enced a relapse and 8.7% of patients died. The rate of death and relapse did not differ between the RTX and CYC groups. Disease-related complications involved an insignificantly higher proportion of patients in the CYC (12/53) group than the RTX (4/39) group. Patients in both groups showed a signifi- cant decrease in BVAS during follow-ups irrespective of the medication exposure. The rate of adverse events was similarly low (n 1⁄4 1) in both groups. RTX and CYC were similar in inducing remission and reducing adverse clinical outcomes among patients with GPA with acceptable side effect profiles.

The safety and efficacy of Firesorb bioresorbable scaffold in first-in-man study for coronary artery disease: the four-year outcomes

Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.

TCT-315 White Blood Cell Count and 4-Year Clinical Outcomes After Left Main Coronary Artery Revascularization: Insights From the EXCEL Trial

TCT-315 White Blood Cell Count and 4-Year Clinical Outcomes After Left Main Coronary Artery Revascularization: Insights From the EXCEL Trial

TCT-311 4-Year Clinical Outcomes in High Bleeding Risk Patients After Surgical or Percutaneous Left Main Coronary Artery Revascularization: The EXCEL Trial

There is little data on long-term outcomes in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for left main coronary artery disease. In the EXCEL trial, 1,905 patients with left main coronary artery disease and low or

Efficacy of 4-year denosumab treatment alone or in combination with teriparatide in Japanese postmenopausal osteoporotic women

Purpose: This extended randomized prospective study aimed to compare the 4-year clinical outcomes of denosumab treatment alone or in combination with teriparatide in treatment-naïve postmenopausal Japanese patients with osteoporosis.Methods: Between July 2013 and December 2016, 30 eligible women from our previous study were enrolled. After newly adding 17 randomly assigned patients, 47 patients were classified into the denosumab alone group (denosumab group, n = 22) or denosumab plus teriparatide group (combination group, n = 25). Serum bone-specific alkaline phosphatase (BAP), serum tartrate-resistant acid phosphatase (TRACP)-5b, urinary cross-linked N-terminal telopeptide of type I collagen (NTX), and bone mineral density (BMD) of the lumbar 1–4 vertebrae (L-BMD) and bilateral total hips (H-BMD) were determined at the first visit and at regular time points up to 48 months of treatment to determine percentage changes.Results: BAP was significantly decreased from baseline in both groups from 24 to 48 months, with significant differences at all time points between the groups. TRACP-5b and urinary NTX were comparably decreased at every time point in both groups versus pretreatment levels. L-BMD was significantly more increased by combination therapy over denosumab alone at 24 and 30 months (21.1% increase vs. 14.2% increase at 48 months). There were no significant differences in H-BMD between the groups, although levels tended to be higher in the combination group throughout the study period (9.7% increase vs. 6.8% increase at 48 months).Conclusion: Long-term denosumab and teriparatide combination therapy represents an effective treatment option for primary osteoporosis patients with low L-BMD.

Continuous Clinical Response Is Associated With a Change of Disease Course in Patients With Moderate to Severe Ulcerative Colitis Treated With Golimumab

Responders to induction treatment sustain continuous clinical response (CCR) through 1 year in about 50% of patients in PURSUIT-M trial with golimumab maintenance in ulcerative colitis (UC). This post hoc analysis of PURSUIT-M describes the 1-year clinical, endoscopic, quality of life (QoL), and biomarker and 4-year clinical outcome in patients with sustained response to golimumab therapy for UC. We compared clinical, endoscopic, QoL, and calprotectin outcomes in CCR and non-CCR patients through 54 weeks in PURSUIT-M. Persistence on golimumab therapy and clinical response at 4 years was assessed for CCR and non-CCR patients. The relationship of colectomy with CCR status was determined. Among patients receiving golimumab maintenance, greater proportions of patients with vs without CCR at week 54 achieved clinical remission (67.1% vs 1.9%), corticosteroid-free remission (61.6% vs 1.9%), endoscopic remission (Mayo endoscopy score 0 [47.9% vs 1.3%]), and normal QoL (inflammatory bowel disease questionnaire score ≥170 [75.0% vs 24.4%]). CCR but not non-CCR patients maintained normalized calprotectin levels during maintenance. Among patients who entered the long-term extension study, a greater proportion of patients with vs without CCR maintained PGA 0 through week 216 (58% vs 42%). Colectomy was performed in 47 induction nonresponders and in 13 induction responders. None of the patients going onto colectomy achieved CCR through 54 weeks in PURSUIT-M. Continuous clinical response is associated with favorable short- and long-term clinical, endoscopic, QoL, and biomarker responses that may result in changing the course of disease and may prevent colectomy in patients with moderate to severe UC treated with golimumab. 10.1093/ibd/izy229_video1izy229.video15806022773001.

CAD/CAM cobalt-chromium alloy single crowns in posterior regions: 4-year prospective clinical study

Aim To evaluate the 4-year clinical outcomes of ceramic veneered CAD/CAM Co-Cr single crowns supported by natural teeth in posterior regions. Material and methods Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were set and tooth preparations were standardized and performed by undergraduate students under the supervision of 2 expert prosthodontists. CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were cemented using a self-etching, dual-cure resin luting agent. The patients were recalled at follow-up every 6 months after baseline evaluation, for a total observational period of 4 years. The survival and success rates of the restorations were evaluated. The technical and esthetic outcomes were examined using the United States Public Health Service criteria. The biologic outcomes were analyzed at abutments and contralateral teeth and descriptive statistics were performed. Results None of the SCs was lost at follow-up, resulting in 100% cumulative survival rate and 99.2% cumulative success rates. No losses of retention were recorded. One hundred and eighteen restorations were rated alpha in all the measured parameters. A minor chipping of the veneering porcelain was detected in 1 restoration. No significant differences between the periodontal parameters of test and control teeth were observed. Conclusions CAD/CAM Co-Cr single crowns proved to be a valid treatment option and a viable alternative to noble metal-ceramic restorations in posterior regions after 4 years of clinical function.

P3315Long-term efficacy and safety of biodegradable polymer biolimus-eluting vs. permanent polymer everolimus-eluting stents in diabetic Patients: 4-year clinical outcomes

P3315Long-term efficacy and safety of biodegradable polymer biolimus-eluting vs. permanent polymer everolimus-eluting stents in diabetic Patients: 4-year clinical outcomes

2925Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: insights from the DUTCH PEERS trial

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results.

To determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous process decompression using the Superion device. The 4-year Superion data were extracted from a randomized, controlled Food and Drug Administration investigational device exemption trial. Patients with intermittent neurogenic claudication relieved with back flexion who failed at least 6 months of nonsurgical management were enrolled. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf) and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI). At 4-year follow-up, 89 of the 122 patients (73%) provided complete clinical outcome evaluations. At 4 years after index procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success on at least 2 of 3 ZCQ domains. Individual component responder rates were 83% (74/89), 79% (70/89), and 87% (77/89) for ZCQss, ZCQpf, and ZCQps; 78% (67/86) and 66% (57/86) for leg and back pain VAS; and 62% (55/89) for ODI. Patients with Superion also demonstrated percentage improvements over baseline of 41%, 40%, 73%, 69%, and 61% for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI. Within-group effect sizes all were classified as very large (>1.0): 1.49, 1.65, 1.42, 1.12, and 1.46 for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI. Minimally invasive implantation of the Superion device provides long-term, durable relief of symptoms of intermittent neurogenic claudication for patients with moderate lumbar spinal stenosis.

Abstract P1-11-12: Re-evaluating outcomes of partial-breast irradiation using multicatheter brachytherapy for Japanese patients with breast cancer by European brachytherapy phase 3 trial

Abstract [Purpose] The Groupe European de Curietherapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) has reported the equivalent outcomes of partial-breast irradiation (PBI) using multicatheter interstitial brachytherapy (MCB) to whole-breast irradiation (WBI) in breast-conserving therapy, showing that the incidence of local recurrence was 1.44% with MCB-PBI and 0.92% with WBI. Based on the trial, MCB-PBI could be considered as an alternative method to WBI for low-risk breast cancer patients. However, it would be difficult to translate it directly into Japanese community practice. After categorization of Japanese patients using the inclusion and exclusion criteria of this trial, our databases were re-evaluated to validate the data for Japanese patients, and the possibility to extend the candidate for MCB-PBI was also investigated. [Methods] Patients undergoing BCT were retrospectively examined between November 2007 and December 2015. The technique involved an open-cavity implant with a dose of 32 Gy in eight fractions. WBI was performed with a total dose of 50 Gy in fractions of 2 Gy. The 4-year clinical outcomes of MCB-PBI were evaluated in the two distinct categories, and comparisons of outcomes between MCB-PBI and WBI were performed in patients with unfavorable features. [Results] Of a total of 501 lesions undergoing BCT, 301 lesions were treated with MCB-PBI and 200 lesions with WBI. At a median follow-up time of 52 months, the 4-year rate of ipsilateral breast tumor recurrence (IBTR)-free, disease-free, and overall survival in patients with MCB-PBI and WBI were 98.9% vs. 98.0% (p = 0.56), 97.0% vs. 95.3% (p = 0.78), and 99.6% vs. 98.2% (p = 0.38), respectively. In the exclusion cohort treated with MCB-PBI, IBTR-free and disease-free survival were significantly poorer than in the inclusion cohort.However, no significant differences in the outcomes between the two radiotherapy techniques were demonstrated with respect to either IBTR-FS (95.0% vs. 97.2%, p = 0.24), DFS (95.0% vs. 95.8%, p = 0.31), or OS (100% vs. 99.0%, p = 0.80) in patients with exclusion criteria Univariate and multivariate analysis of prognostic factors for IBTR and breast cancer eventVariablesIBTR Locoregional and distant recurrences P-value P-value UnivariateMultivariateHR (95% CI)UnivariateMultivariateHR (95% CI)Age ≥ 40 vs &amp;lt; 40years.25—2.49 (0.53–11.72) —0.90 (0.21–3.85)Axillary node negative vs. positive&amp;lt;.05&amp;lt;.054.09 (1.18–14.12)&amp;lt;.05&amp;lt;.052.75 (1.19–6.36)Margin negative vs. positive&amp;lt;.01&amp;lt;.015.58 (1.54–20.29).075.0682.55 (0.93–6.97)WBI vs. MCB-PBI.56—0.69 (0.20–2.39).78—0.89 (0.39–2.03). ConclusionsTo our knowledge, this study includes the largest cohort of Asian patients undergoing MCB-PBI. Although the retrospective chart review with relatively short follow-up time and small number of patients does not allow reaching any definite conclusion, we could expect the same outcomes by MCB-PBI as those in the GEC-ESTRO trial with respect to the tumor control only for Japanese but for Asian patients with breast cancer. Moreover, no negative impact on the outcomes of MCB-PBI as compared to WBI was not found in patients with exclusion criteria. Citation Format: Sato K, Mizuno Y, Fuchikami H, Takeda N, Kato M. Re-evaluating outcomes of partial-breast irradiation using multicatheter brachytherapy for Japanese patients with breast cancer by European brachytherapy phase 3 trial [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P1-11-12.

Efficacy of single-stage breast-conserving treatment using multicatheter partial breast brachytherapy evaluated by GEC-ESTRO phase 3 trial.

PurposeThe GEC-ESTRO has reported the equivalent outcomes of partial breast irradiation (PBI) using multicatheter interstitial brachytherapy (MCB) to whole breast irradiation (WBI) in breast-conserving therapy (BCT). We performed single-stage BCT with partial breast brachytherapy by intraoperative catheter placement. After the categorization of patients into inclusion and exclusion criteria on this trial, our databases were evaluated in order to translate it to Japanese patients.Material and methodsPatients undergoing BCT were retrospectively examined between November 2007 and December 2015. The technique is an open-cavity implant with a dose of 32 Gy in 8 fractions. The 4-year clinical outcomes of MCB-PBI were evaluated in the 2 distinct categories, and the comparison of the outcomes of MCB-PBI with WBI was performed in patients with unfavorable features.ResultsOf a total of 501 lesions undergoing BCT, 301 lesions were treated with MCB-PBI and 200 lesions with WBI. At the median follow-up time of 52 months, the 4-year rate of ipsilateral breast tumor recurrence (IBTR)-free, disease-free (DFS), and overall survival (OS) in patients with MCB-PBI and WBI were 98.9% vs. 98.0% (p = 0.56), 97.0% vs. 95.3% (p = 0.78), and 99.6% vs. 98.2% (p = 0.38), respectively. Although in exclusion cohort treated with MCB-PBI, IBTR-free, and disease-free survival were significantly worse than in inclusion cohort, non-significantly worse outcomes was demonstrated than in exclusion cohort with WBI; IBTR-free survival (95.0% vs. 97.2%, p = 0.24), and disease-free survival (95.0% vs. 95.8%, p = 0.31).ConclusionsSingle-stage BCT using MCB-PBI offered similar tumor control rates compering to WBI. However, further research is needed to define the benefit for patients with an exclusion criteria.

Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome

OBJECTIVE Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis. METHODS A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis. RESULTS Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from -2.4° preoperatively to -6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment. CONCLUSIONS The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR. Clinical trial registration no.: NCT02492724 ( clinicaltrials.gov ).

The impacts of prolonged emergency department length of stay on clinical outcomes of patients with ST-segment elevation myocardial infarction after reperfusion.

Emergency department and hospital crowding have become an increasing problem. The clinical outcomes of prolonged emergency department (ED) length of stay in acute ST-segment elevation myocardial infarction (STEMI) patients after reperfusion are still unknown. Between January 2008 and December 2011, 432 consecutive patients with STEMI undergoing primary PCI were recruited. Patients were divided into two groups: the immediate admission group (length of ED stay <8 h; IA group) and the prolonged ED stay group (length of ED stay ≧8 h; PS group). The median lengths of ED stay of the patients in both groups were 29.97 h in the PS group (n = 145, 33.6%) and 1.78 h in the IA group (n = 287, 66.4%), respectively. The age, gender, risk factors of coronary artery disease, characteristic of coronary angiography, and TIMI risk score did not differ between the two groups. During nearly 4-year clinical follow-up, the short-term and long-term clinical outcomes were similar between the two groups. B-blocker and statins were used infrequently in the ED. In addition, patients with high TIMI risk score in the PS group had higher incidence of 1-year re-MI (6.8 vs. 1.8%; p = 0.045). In the era of primary PCI for STEMI patients after reperfusion, prolonged ED length of stay may not influence clinical outcomes. Patients with high TIMI risk score in the PS group still had a trend toward worse clinical outcome after long ED stays.

In-Hospital and 4-Year Clinical Outcomes Following Transcatheter Versus Surgical Closure for Secundum Atrial Septal Defect in Adults: A National Cohort Propensity Score Analysis.

Atrial septal defect (ASD) closure is major therapy for patients with secundum ASD. Although surgical closure (SC) and transcatheter closure (TC) are usually performed in such patients, data on the long-term outcomes comparing TC and SC in adults are limited. Data on the participants of this cohort study were retrieved from Taiwan's National Health Insurance Research Database from 2004 to 2011. Secundum ASD patients > 18 years of age who underwent TC or SC were initially enrolled, and those with associated comorbidities were excluded. After propensity score matching, the clinical outcomes between the TC and SC groups were analyzed. There were 595 patients recruited in the TC group and 308 patients in the SC group. The SC group had a higher incidence of systemic thromboembolism (P < 0.001), ischemic stroke (P = 0.002), and all-cause mortality (P = 0.013) when compared with those of the TC group at the index hospitalization, and similar phenomena could also be seen in a around 4-year follow-up period after the procedures (systemic thromboembolism (P < 0.001, HR = 11.48, 95% CI: 3.29-40.05), ischemic stroke (P = 0.005, HR = 9.28, 95% CI: 1.94-44.39), and all-cause mortality (P = 0.035, HR = 2.28, 95% CI: 1.06-4.89). In addition, atrial fibrillation (P = 0.005) and atrial flutter (P = 0.049) more frequently developed in the SC group than in the TC group at the index hospitalization. The adult secundum ASD patients had lower incidence rates of systemic thromboembolism, ischemic stroke, and all-cause mortality after TC than those after SC in the 4-year follow-up after procedures. Transcatheter ASD closure should therefore be given priority.

A 10‐month angiographic and 4‐year clinical outcome of everolimus‐eluting versus sirolimus‐eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial)

We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes. There are limited data on long-term outcome after EES vs SES implantation in diabetic patients. We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up. At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28). EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.