Adjuvant (adj) bevacizumab (B) plus dose-dense (dd) doxorubicin/cyclophosphamide (AC) followed by nanoparticle albumin- bound paclitaxel (nab-p) in early stage breast cancer (BC) patients (pts): Cardiac safety

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 567-567 ◽  
Author(s):  
M. N. Dickler ◽  
T. Traina ◽  
K. Panageas ◽  
R. Steingart ◽  
C. Dang ◽  
...  
Keyword(s):  
Cardiac Death ◽  
Early Stage ◽  
Standard Of Care ◽  
Cardiac Monitoring ◽  
Cardiac Safety ◽  
Lv Dysfunction ◽  
Long Term Follow Up ◽  
One Year ◽  
Dose Dense

567 Background: Dose dense, q2 wk AC-paclitaxel (T) is superior to q3 wk therapy (Rx) (Citron, JCO 2003). The risk of congestive heart failure (CHF) with ddAC-T is not increased at <1%. In MBC, B improves PFS when added to T (Miller, SABCS 2005). It is unclear if doxorubicin plus B increases risk of CHF. Hence, we are testing the cardiac safety of ddAC-nab-p with concurrent B as adj therapy. Based upon the accepted cardiac event (CE) rate of ≤4% in trials with adj trastuzumab (an agent with known cardiac toxicity), we designed this study with similar monitoring & tolerability thresholds. The primary endpoint is cardiac safety, defined as discontinuation of B due to cardiac death from LV dysfunction or symptomatic CHF (dyspnea and LVEF<50%). Secondary endpoints: toxicity, disease-free & overall survival. Methods: Eligible pts have resected HER2(-) BC and normal LVEF. Rx consists of q2wk AC (60/600 mg/m2) ×4 then nab-p (260 mg/m2) x4 with pegfilgrastim on Day 2 plus B for one year (10mg/kg IV q2wk ×8 with chemoRx then B 15mg/kg q3wk); radiation & endocrine Rx per standard of care. MUGA obtained at baseline & mos. 2, 6, 9, 18. Pts with significant asymptomatic ↓LVEF during Rx may have B held per protocol. These pts are not counted as CEs but will have long-term cardiac monitoring. Accrual goal is 75 pts. If ≥3 CE (∼4.7%) or >1 cardiac death from LV dysfunction, B + ddAC-nab-p will not be considered safe. Results: 44 pts have enrolled, median (med) age 46.5 yrs (33–67). 28 pts have baseline & month 2 LVEF data: med baseline LVEF 68% (61–82), med LVEF at mo. 2 after ddAC+B 68% (53–75); 1 pt had an 18 point asymptomatic drop to 53% - B held but reinitiated in 4 wks with repeat LVEF 63%. 12 pts completed nab-p+B but none have reached the 6 mo. MUGA. Rx-related Gr 3/4 toxicity: neutropenia gr4 (6.8%), diarrhea gr3 (2.3%), hypertension gr3 (2.3%), neuropathy gr 3 (2.3%), fatigue gr 3 (2.3%), mucositis gr 3 (2.3%). 4 pts have withdrawn from study Rx, but only 1 due to toxicity including gr3 fatigue, mucositis & neuropathy. Conclusions: No LV dysfunction has been observed with B + ddAC-nab-p; this trial is on-going. Long-term follow-up and analysis of troponin, renin and circulating endothelial & tumor cells are planned. No significant financial relationships to disclose.

ADDRESS (ADministration of DRotrecogin alfa [activated] in Early stage Severe Sepsis) long-term follow-up: One-year safety and efficacy evaluation*

2007 ◽  
Vol 35 (6) ◽  
pp. 1457-1463 ◽  
Author(s):  
Pierre-Francois Laterre ◽  
Edward Abraham ◽  
Jonathan M. Janes ◽  
Benjamin L. Trzaskoma ◽  
Nancy L. Correll ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Drotrecogin Alfa ◽  
Early Stage ◽  
Efficacy Evaluation ◽  
Safety And Efficacy ◽  
Drotrecogin Alfa Activated ◽  
Long Term Follow Up ◽  
One Year

scholarly journals The first commercial use of the Valiant Navion stent graft system for endovascular repair of a descending thoracic aortic aneurysm

Vascular ◽  
2020 ◽  
pp. 170853812098112
Author(s):  
Cassra N Arbabi ◽  
Navyash Gupta ◽  
Ali Azizzadeh
Keyword(s):  
Stent Graft ◽  
Standard Of Care ◽  
Aortic Aneurysms ◽  
Descending Thoracic Aortic Aneurysm ◽  
Thoracic Aortic Aneurysms ◽  
Commercial Use ◽  
Early Results ◽  
Multiple Configuration ◽  
One Year

Objectives Thoracic endovascular aortic repair (TEVAR) is the standard of care for descending thoracic aortic aneurysms (DTAA), and newer generation stent grafts have significant design improvements compared to earlier generation devices. Methods We report the first commercial use of the Medtronic Valiant Navion stent graft for treatment of an 85-year-old woman with a 5.8 cm DTAA and a highly tortuous thoracic aorta. Results A percutaneous TEVAR was performed using a two-piece combination of the Valiant Navion FreeFlo and CoveredSeal stent graft configurations for zones 2–5 coverage. The devices were successfully delievered through highly tortuous anatomy and deployed, excluding the entire length of the aneurysm with precise landing, excellent apposition and no evidence of endoleak. The patient tolerated the procedure well and has had no stent graft-related complications through one-year follow-up. Conclusions Design enhancements such as a lower profile delivery system, better conformability, and a shorter tapered tip are some of the improvements to this third-generation TEVAR device. Coupled with the multiple configuration options available, this gives physicians a better tool to treat thoracic aortic pathologies in patients with challenging anatomy. The early results are encouraging, and evaluation of long-term outcomes will continue.

Long-Term Follow-Up after Radiotherapy of Hidradenitis Suppurativa

Dermatology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Jurr Boer
Keyword(s):  
Total Dose ◽  
Hidradenitis Suppurativa ◽  
Early Stage ◽  
Case Reports ◽  
Case Series ◽  
Postal Survey ◽  
Long Term Follow Up ◽  
Late Treatment

<b><i>Background:</i></b> Patients with hidradenitis suppurativa (HS) are still often disappointed with the current treatments offered and there is a clear demand for more effective options. Since the late 1990s there has been a revival in the use of radiotherapy (RT) for different benign diseases, including HS. During the past 20 years one case series and some scattered case reports have described promising results of RT. <b><i>Objectives:</i></b> To evaluate the long-term efficacy of RT in early-stage HS. <b><i>Methods:</i></b> A postal survey-based long-term follow-up with simple factual questions of partly retrospective and partly contemporary characteristics was performed. Sixty-four patients (96 axillae), diagnosed with mild to moderate HS were irradiated with a orthovoltage unit with 100 kV, 3 mm Al or 200 kV, 0.5 Cu filtering, respectively. Four to six biweekly fractional doses ranging from 0.75 to 1 Gy up to a total dose of 6 Gy in one series, and in chronic cases followed by four daily fractions of 2 Gy up to a total dose of 14 Gy, were given. Late treatment toxicity and the rate of remission of the disease were evaluated. <b><i>Results:</i></b> The overall response rate of the survey was 64.1% with 40.6% (26/64) valid, complete questionnaires. In total, 40 axillae were irradiated in these 26 patients. After a median follow-up of 40 years (range 32–52) complete remission of the lesions occurred in 34 of the 40 sites (85%). None of the 26 patients with 40 irradiated sites reported adverse effects at the time of the survey. <b><i>Conclusions:</i></b> RT appears to be an effective treatment for early and mild HS in the majority of patients. In this case series, no side effects were reported after a median follow-up period of 40 years.

Transcatheter closure of defects within the oval fossa using the Amplatzer® Septal Occluder

2002 ◽  
Vol 12 (3) ◽  
pp. 224-228 ◽  
Author(s):  
Haifa Abdul Latiff ◽  
Mazeni Alwi ◽  
Hasri Samion ◽  
Geetha Kandhavel
Keyword(s):  
Transcatheter Closure ◽  
Standard Procedure ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Term Outcome ◽  
Long Term Follow Up ◽  
One Year ◽  
The Right

This study reviewed the short-term outcome of transcatheter closure of the defects within the oval fossa using an Amplatzer® Septal Occluder. From January 1997 to December 2000, 210 patients with defects within the oval fossa underwent successful transcatheter closure. We reviewed a total of 190 patients with left-to-right shunts, assessing the patients for possible complications and the presence of residual shunts using transthoracic echocardiogram at 24 h, 1 month, 3 months and one year. Their median age was 10 years, with a range from 2 to 64 years, and their median weight was 23.9 kg, with a range from 8.9 to 79 kg. In 5 patients, a patent arterial duct was closed, and in 2 pulmonary balloon valvoplasty performed, at the same sitting. The median size of the Amplatzer® device used was 20 mm, with a range from 9 to 36 mm. The median times for the procedure and fluoroscopy were 95 min, with a range from 30 to 210 min, and 18.4 min, with a range from 5 to 144 min, respectively. Mean follow-up was 20.8 ± 12.4 months. Complete occlusion was obtained in 168 of 190 (88%) patients at 24 h, 128 of 133 (96.2%) at 3 months, and 103 of 104 (99%) at one year. Complications occurred in 4 (2.1%) patients. In one, the device became detached, in the second the device embolized into the right ventricular outflow tract, the lower end of the device straddled in the third, and the final patient had significant bleeding from the site of venupuncture. There were no major complications noted on follow-up. We conclude that transcatheter closure of defects within the oval fossa using the Amplatzer® Septal Occluder is safe and effective. Long-term follow-up is required, nonetheless, before it is recommended as a standard procedure.

Abstract 18649: Long-term Outcome and the Mechanisms of Pulmonary Antrum Radial-linear Ablation in Patients With Paroxysmal Atrial Fibrillation

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Xue Zhao ◽  
Jianqiang Hu ◽  
Yan Huang ◽  
Yawei Xu ◽  
Yanzhou Zhang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Paroxysmal Atrial Fibrillation ◽  
Holter Monitoring ◽  
Pericardial Tamponade ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Long Term Follow Up ◽  
One Year

Objectives: The aim of this study was to determine the mechanisms and effectiveness of pulmonary antrum radial-linear (PAR) ablation in comparison with pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) after a long-term follow-up. Background: The one-year follow up data suggested that PAR ablation appeared to have a better outcome over the conventional PVI for paroxysmal AF. Methods: The enrollment occurred between March, 2011, and August, 2011, with the last follow-up in May, 2014. A total of 133 patients with documented paroxysmal AF were enrolled from 5 centers and randomized to PAR group or PVI group. Event ECG recorder and Holter monitoring were conductedduring the follow-up for all patients. Results: The average procedure time was 151±23 min in PAR group and 178±43 min in PVI group ( P <0.001). The average fluoroscopy time was 21±7 min in PAR group and 27±11 min in PVI group ( P= 0.002). AF triggering foci were eliminated in 59 patients (89.4%) in PAR group, whereas, only 4 patients (6.0%) in PVI group (P<0.001).At median 36 (37-35) months of follow-up after single ablation procedure, 43 of 66 patients in PAR group (65%) and 28 of 67 patients in PVI group (42%) had no recurrence of AF off antiarrhythmic drug (AAD) (P=0.007); and 47 of 66 patients in PAR group (71%) and 32 of 67 patients in PVI group (48%) had no recurrence of AF with AAD (P=0.006). At the last follow-up, the burden of AF was significantly lower in PAR group than in PVI group (0.9% ± 2.3% vs 4.9% ± 9.9%;90th percentile, 5.5% vs 19.6%; P=0.008). No major adverse event (death, stroke, PV stenosis) was observed in all the patients except one case of pericardial tamponade. Conclusions: PAR ablation is a simple, safe, and effective strategy for the treatment of paroxysmal AF with better long-term outcome than PVI. PAR ablation might exhibit the beneficial effect on AF management through multiple mechanisms. Registration: ChiCTR-TRC-11001191

scholarly journals Meningiomas of pineal region in children

2007 ◽  
Vol 65 (4a) ◽  
pp. 1000-1006 ◽  
Author(s):  
Hamilton Matushita ◽  
Fernando Campos Pinto ◽  
José Píndaro Pereira Plese
Keyword(s):  
Clinical Presentation ◽  
Complete Removal ◽  
Pineal Region ◽  
Total Resection ◽  
Long Term Follow Up ◽  
One Year ◽  
Velum Interpositum ◽  
Transtentorial Approach

Meningiomas are uncommon tumors in children and either more rarely encountered in the pineal region. We report two cases of meningioma of the pineal region in children. One of these cases was a five years-old girl and the other a one year-old boy. No specific clinical presentation or tomographic examinations findings was identified before treatment, suggestive of a diagnosis of menigioma. The clinical and laboratory features were very similar to the most common tumors of the pineal region. Prior to the surgery, the histology of these tumors was not suspected. Both patients underwent direct surgery and complete removal was achieved by a suboccipital transtentorial approach. The tumors originated from velum interpositum in both cases. At the follow up, one case presented with recurrence six years later, and she underwent a reoperation with total resection without morbidity. Long-term follow up presented no other recurrences.

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