Long-Term Outcomes of the Coarctation of the Aorta Stent Trials

2021 ◽  
Author(s):  
Ralf J. Holzer ◽  
Kimberlee Gauvreau ◽  
Kerry McEnaney ◽  
Hanano Watanabe ◽  
Richard Ringel
Keyword(s):  
Cumulative Incidence ◽  
Antihypertensive Medication ◽  
Aortic Wall ◽  
Coarctation Of The Aorta ◽  
Aortic Aneurysms ◽  
Minimum Diameter ◽  
Stent Diameter ◽  
Wall Injury

Background: Long-term outcome data of stent-implantation for coarctation of the aorta are limited. We report up to 5 years of postimplant follow-up in patients enrolled into the COAST (Coarctation of the Aorta Stent Trial) and the COAST II trial (Covered Cheatham-Platinum Stents for Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta), evaluating the bare and Covered Cheatham-Platinum Stents for the treatment of coarctation of the aorta and associated aortic wall injury. Methods: Data was prospectively collected during the 2 multi-center studies, enrolling 248 patients (COAST: n=121, COAST II: n=127). Late follow-up data (48–60 month) was compared with immediate (1 month) and early (12 months) follow-up. Results: There was a notable decrease in the use of antihypertensive medication, from 53% at immediate, to 42% at early, and 29% at late follow-up. The cumulative incidence of stent fractures was 0% immediately, 2.9% at early, and 24.4% at late follow-up. Independent predictors for stent fractures at late follow-up were age <18 years, male sex, minimum stent diameter ≥12 mm, and use of bare metal stent. The cumulative incidence of reintervention was 1.6% at immediate, 5.1% at early, and 21.3% at late follow-up. Independent predictors for reinterventions at late follow-up were age <18 years, post implantation systolic arm-leg blood pressure gradient ≥10 mm Hg, minimum stent diameter at implantation <12 mm, and initial coarctation minimum diameter <6 mm. There were 13 patients with aortic aneurysms, with a cumulative incidence of 6.3% at late follow-up. Conclusions: Coarctation stenting is effective at maintaining obstruction relief up to 60 months postimplant with reduction in the number of patients requiring antihypertensive medication. However, an increase in-stent fractures and reinterventions were observed between medium and long-term follow-up. Covered stents appear to confer some protection from the development of stent fractures but do not provide complete protection from late aneurysm formation. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT00552812 and NCT01278303.

scholarly journals Cumulative incidence and risk factors for radiation induced leukoencephalopathy in high grade glioma long term survivors

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Robert Terziev ◽  
Dimitri Psimaras ◽  
Yannick Marie ◽  
Loic Feuvret ◽  
Giulia Berzero ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cumulative Incidence ◽  
High Grade Glioma ◽  
High Grade ◽  
Nucleotide Polymorphisms ◽  
Increased Risk ◽  
Radiation Induced ◽  
Long Term Survivors

AbstractThe incidence and risk factors associated with radiation-induced leukoencephalopathy (RIL) in long-term survivors of high-grade glioma (HGG) are still poorly investigated. We performed a retrospective research in our institutional database for patients with supratentorial HGG treated with focal radiotherapy, having a progression-free overall survival > 30 months and available germline DNA. We reviewed MRI scans for signs of leukoencephalopathy on T2/FLAIR sequences, and medical records for information on cerebrovascular risk factors and neurological symptoms. We investigated a panel of candidate single nucleotide polymorphisms (SNPs) to assess genetic risk. Eighty-one HGG patients (18 grade IV and 63 grade III, 50M/31F) were included in the study. The median age at the time of radiotherapy was 48 years old (range 18–69). The median follow-up after the completion of radiotherapy was 79 months. A total of 44 patients (44/81, 54.3%) developed RIL during follow-up. Twenty-nine of the 44 patients developed consistent symptoms such as subcortical dementia (n = 28), gait disturbances (n = 12), and urinary incontinence (n = 9). The cumulative incidence of RIL was 21% at 12 months, 42% at 36 months, and 48% at 60 months. Age > 60 years, smoking, and the germline SNP rs2120825 (PPARg locus) were associated with an increased risk of RIL. Our study identified potential risk factors for the development of RIL (age, smoking, and the germline SNP rs2120825) and established the rationale for testing PPARg agonists in the prevention and management of late-delayed radiation-induced neurotoxicity.

Abstract 13315: Long-term Risk of Cardiovascular Events Following Hospitalization for Sepsis: A Systematic Review and Meta-analysis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Leah B Kosyakovsky ◽  
Federico Angriman ◽  
Emma Katz ◽  
Neill Adhikari ◽  
Lucas C Godoy ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cumulative Incidence ◽  
Meta Analysis ◽  
Hazard Ratios ◽  
Increased Risk ◽  
Significant Difference ◽  
Sepsis Survivors ◽  
Risk Ratios

Introduction: Sepsis results in dysregulated inflammation, coagulation, and metabolism, which may contribute to increased cardiovascular disease (CVD) risk. We conducted a systematic review and meta-analysis to determine the association between sepsis and subsequent long-term CVD events. Methods: MEDLINE, Embase, and the Cochrane Controlled Trials Register and Database of Systematic Reviews were searched from inception to May 2020 to identify observational studies of adult sepsis survivors (defined by diagnostic codes or consensus definitions) measuring long-term CV outcomes. The primary outcome was a composite of myocardial infarction, CV death, and stroke. Random-effects models estimated the pooled cumulative incidence and adjusted hazard ratios of CV events relative to hospital or population controls. Odds ratios were included as risk ratios assuming <10% incidence in non-septic controls, and risk ratios were taken as hazard ratios (HR) assuming no censoring. Outcomes were analyzed at maximum follow-up (primary analysis) and stratified by time (<1 year, 1-2 years, and >2 years) since sepsis. Results: Of 11,235 abstracts screened, 25 studies (22 cohort studies, 2 case-crossover studies, and 1 case-control) involving 1,949,793 sepsis survivors were included. The pooled cumulative incidence of CVD events was 9% (95% CI; 5-14%). Sepsis was associated with an increased risk (HR 1.59, 95% CI 1.37-1.86) of CVD events at maximum follow-up ( Figure ); between-study heterogeneity was substantial (I 2 =97.3%). There was no significant difference when comparing studies using population and hospital controls. Significantly elevated risk was observed up to 5 years following sepsis. Conclusions: Sepsis survivors experience an approximately 50% increased risk of CVD events, which may persist for years following the index episode. These results highlight a potential unmet need for early cardiac risk stratification and optimization in sepsis survivors.

Long-term hematologic toxicity of 177Lu-octreotate-capecitabine-temozolomide therapy of GEPNET

2021 ◽  
Author(s):  
Murali Kesavan ◽  
Piyush Grover ◽  
Wei-Sen Lam ◽  
Phillip G Claringbold ◽  
J. Harvey Turner
Keyword(s):  
Cumulative Incidence ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
Baseline Risk ◽  
Hematologic Toxicity ◽  
Gastroenteropancreatic Neuroendocrine Tumors ◽  
Prospective Phase ◽  
Grade 3

Thirty-seven patients with advanced gastroenteropancreatic neuroendocrine tumors (GEPNETs) were treated on a prospective phase II single-center study with 4 cycles of 7.8 GBq 177Lu-octreotate combined with capecitabine and temozolomide chemotherapy (CAPTEM). Each 8-week cycle combined radiopeptide therapy with 14 days of capecitabine (1500 mg/m2) and 5 days of temozolomide (200 mg/m2). The incidence of grade ≥3 hematologic toxicity was analysed. We found that at a median follow-up of 7-years (range 1-10), 6 (16%) patients developed persistent hematologic toxicity (PHT, defined as sustained grade ≥3 hematologic toxicity beyond 36-months follow up) and 3 (8%) developed MDS/AL with a median time-to-event of 46 and 34-months respectively. Estimated cumulative incidence of MDS/AL was 11% (95% CI: 3.45 to 24.01). Development of PHT was the only significant risk factor for secondary (RR, 16; 95% CI: 2.53 to 99.55; p<0.001). The median PFS was 48 months (95% CI: 40.80-55.20) and median OS was 86 months (95% CI: 56.90-115.13). 21 deaths were recorded, including 13 (62%) due to progressive disease and all 3 (14%) patients with MDS/AL. We conclude that 177Lu-octreotate CAPTEM therapy for GEPNETs is associated with a risk of long-term hematologic toxicity. The rising cumulative incidence of MDS/AL >10% mandates for the long-term monitoring of treated patients. However, time to onset is unpredictable and incidence does not correlate with conventional baseline risk factors. Novel methods are required for stratification of prospective patients based on genetic risk.

scholarly journals Chronic Health Conditions and Late Mortality Among Survivors of Childhood Acute Myeloid Leukemia: A Report from the Childhood Cancer Survivor Study (CCSS)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1315-1315
Author(s):  
Lucie M Turcotte ◽  
John A Whitton ◽  
Wendy M. Leisenring ◽  
Todd Gibson ◽  
Rebecca M Howell ◽  
...  
Keyword(s):  
Cumulative Incidence ◽  
Myeloid Leukemia ◽  
Health Conditions ◽  
Late Mortality ◽  
Treatment Groups ◽  
Childhood Acute Myeloid Leukemia ◽  
Health Related ◽  
Related Mortality

Introduction: Five-year survival following childhood acute myeloid leukemia (AML) has doubled over the last 4 decades due to advances in treatment and supportive care, including more widespread use of hematopoietic cell transplantation (HCT). The impact on long-term morbidity and mortality among survivors is unknown. Methods: Cumulative incidence and 95% confidence intervals (CI) for overall and cause-specific late (&gt;5 years from diagnosis) mortality and CTCAE grades 3-5 chronic health conditions (CHC) were estimated among 5-year survivors of AML diagnosed &lt;21 years of age between1970-99 in the CCSS. Comparisons were made by decade of diagnosis (1970s, 1980s, 1990s) and treatment (HCT vs. chemotherapy only [chemo-only]). Cox regression models estimated hazard ratios (HR) for health-related deaths and CHC based on treatment decade and HCT status. Results: Among 927 AML survivors (median age at diagnosis 7.1 years [range 1-21 years]; median age at last follow-up 29.4 years [range 8-60 years]; 16,069 person-years of follow-up; 37% treated with HCT [15% of 1970s survivors, 36% of 1980s survivors, 44% of 1990s survivors), the 20-year cumulative incidence of all-cause mortality was 6.7% (CI 4.2-9.2%) for chemo-only survivors and 13.5% (CI 9.2-17.8%) for HCT survivors. For chemo-only survivors, the highest incidence of health-related mortality were attributable to cardiac causes (1.5%, CI 0.5-2.6), relapse (0.9%, CI 0.1-1.8), and SMN (0.6%, CI 0.0-1.2), whereas for HCT survivors the highest health-related causes of death were relapse (6.5%, CI 3.7-9.2%), SMN (1.3%, CI 0-2.5%), and pulmonary causes (0.6%, CI 0-1.5%). When treatment groups were considered in multivariable Cox models, risk for late mortality was similar for chemo-only survivors from the 1990s compared to the 1970s (HR 0.4, CI 0.1-1.4), but risk was reduced for HCT survivors from the 1990s compared to the 1970s (HR 0.2, CI 0.1-0.4). The 20-year cumulative incidence of grade 3-5 CHCs among chemo-only survivors was 26.9% (CI 23.0-30.7%) compared to 46.8% (CI 40.9-52.7%) among HCT survivors, with the highest incidence occurring for cardiovascular CHC (chemo-only, 9.7%, CI 7.1-12.2%; HCT, 10.6%, CI 7.0-14.2%), pulmonary CHC (chemo-only, 1.0%, CI 0.1-1.9%; HCT, 2.9%, CI 1.0-4.8%) and SMN (chemo-only, 0.8%, CI 0.0-1.7%; HCT, 5.7%, CI 2.9-8.6%). Incidence of overall CHC decreased in more recent decades among HCT survivors (p=0.03, Figure); however, among chemo-only survivors, CHC incidence did not significantly change by decade (p=0.12). When treatment groups were considered in adjusted models, risk for CHC was similar for those treated in the 1990s compared to the 1970s among chemo-only survivors (HR 1.5, CI 1.0-2.3) and risk estimates among HCT survivors decreased over time but did not achieve statistical significance (HR 0.6, CI 0.3-1.1). Conclusions: AML survivors treated with HCT had a reduced risk of late mortality and serious CHC in more recent treatment eras. In contrast, treatment with chemo-only was not associated with differences in mortality and serious CHC risk over time. Five-year survivors treated with chemo-only had a significantly reduced risk of health-related mortality compared with HCT survivors across all treatment eras. While treatment intensification with HCT has improved the cure rates for AML in recent decades, there remains disparity in long-term outcomes among AML survivors treated with HCT vs. chemo-only. Disclosures No relevant conflicts of interest to declare.

Outcomes of open and endovascular repair of inflammatory abdominal aortic aneurysms

Vascular ◽  
2017 ◽  
Vol 26 (2) ◽  
pp. 203-208 ◽  
Author(s):  
África Duque Santos ◽  
Andrés Reyes Valdivia ◽  
María Asunción Romero Lozano ◽  
Enrique Aracil Sanus ◽  
Julia Ocaña Guaita ◽  
...  
Keyword(s):  
Open Surgery ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Abdominal Aneurysm ◽  
Aortic Abdominal Aneurysm ◽  
Aortic Repair ◽  
Number Of Patients ◽  
Repair Group

Objective Reports on inflammatory aortic abdominal aneurysm treatment are scarce. Traditionally, open surgery has been validated as the gold standard of treatment; however, high technical skills are required. Endovascular aortic repair has been suggested as a less invasive treatment by some authors offering good results. The purpose of our study was to report our experience and outcomes in the treatment of inflammatory aortic abdominal aneurysm using both approaches. Material and methods A retrospective review and data collection of all patients treated for inflammatory aortic abdominal aneurysm between 2000 and 2015 was done in one academic center. Diagnosis of inflammatory aortic abdominal aneurysm was based on preoperative CT-scan imaging. Type of treatment, postoperative and long-term morbidity and mortality are described. Abdominal compressive symptoms (hydronephrosis) severity and relief after treatment are described. Results Thirty-four patients with intact inflammatory aortic abdominal aneurysm were included. Twenty-nine (85.3%) patients were treated by open means and the remaining five (14.7%) with endovascular aortic repair. Nearly 90% were considered high-risk patients. Median follow-up was 46 months (range 24–112). The two groups were comparable, except for the age and preoperative hydronephrosis. There was no statistical significance in blood transfusion requirements, intensive care hospitalization, 30-day and long-term mortality between the two groups. Preoperative hydronephrosis was diagnosed in four (13.8%) patients in the open surgery group and three (60%) patients in the endovascular aortic repair group. Improvement of hydronephrosis was recognized in three out of the four patients in the open repair group and two out of the three in the endovascular aortic repair group. Renal function remained stable in both groups during follow-up. Conclusions Open surgery remains a safe and valid option for the treatment of inflammatory aortic abdominal aneurysm. Although our study included a small number of patients with endovascular aortic repair treatment, results are promising. Further randomized controlled studies may be necessary to assess long-term effectiveness of endovascular aortic repair treatment in this disease.

scholarly journals Incidence and Risk Factors of Chronic Pulmonary Aspergillosis Development during Long-Term Follow-Up after Lung Cancer Surgery

2020 ◽  
Vol 6 (4) ◽  
pp. 271
Author(s):  
Sun Shin ◽  
Bo-Guen Kim ◽  
Jiyeon Kang ◽  
Sang-Won Um ◽  
Hojoong Kim ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Cumulative Incidence ◽  
Lung Cancer Surgery ◽  
Cancer Surgery ◽  
Pulmonary Aspergillosis ◽  
Factors Associated ◽  
Long Term Follow Up ◽  
Chronic Pulmonary Aspergillosis

Lung resection surgery for non-small-cell lung cancer (NSCLC) is reportedly a risk factor for developing chronic pulmonary aspergillosis (CPA). However, limited data are available regarding the development of CPA during long-term follow-up after lung cancer surgery. This study aimed to investigate the cumulative incidence and clinical factors associated with CPA development after lung cancer surgery. We retrospectively analyzed 3423 patients with NSCLC who (1) underwent surgical resection and (2) did not have CPA at the time of surgery between January 2010 and December 2013. The diagnosis of CPA was based on clinical symptoms, serological or microbiological evidences, compatible radiological findings, and exclusion of alternative diagnoses. The cumulative incidence of CPA and overall survival (OS) were estimated using the Kaplan–Meier method, and a multivariable Cox proportional hazard analysis was performed to identify factors associated with CPA development. Patients were followed-up for a median of 5.83 years with a 72.3% 5-year OS rate. Fifty-six patients developed CPA at a median of 2.68 years after surgery, with cumulative incidences of 0.4%, 1.1%, 1.6%, and 3.5% at 1, 3, 5, and 10 years, respectively. Lower body mass index (BMI), smoking, underlying interstitial lung disease, thoracotomy, development of postoperative pulmonary complications 30 days after surgery, and treatment with both chemotherapy and radiotherapy were independently associated with CPA development. The cumulative incidence of CPA after surgery was 3.5% at 10 years and showed a steadily increasing trend during long-term follow-up. Therefore, increased awareness regarding CPA development is needed especially in patients with risk factors.

scholarly journals Long-term benefit-risk balance of drug-eluting vs. bare-metal stents in daily practice: does stent diameter matter? Three-year follow-up of BASKET

2008 ◽  
Vol 30 (1) ◽  
pp. 16-24 ◽  
Author(s):  
M. Pfisterer ◽  
H. P. Brunner-La Rocca ◽  
P. Rickenbacher ◽  
P. Hunziker ◽  
C. Mueller ◽  
...  
Keyword(s):  
Bare Metal Stents ◽  
Daily Practice ◽  
Metal Stents ◽  
Bare Metal ◽  
Drug Eluting ◽  
Risk Balance ◽  
Stent Diameter ◽  
Term Benefit

Long-Term Update of Stereotactic Radiosurgery for Benign Spinal Tumors

Neurosurgery ◽  
2018 ◽  
Vol 85 (5) ◽  
pp. 708-716 ◽  
Author(s):  
Alexander L Chin ◽  
Dylann Fujimoto ◽  
Kiran A Kumar ◽  
Laurie Tupper ◽  
Salma Mansour ◽  
...  
Keyword(s):  
Stereotactic Radiosurgery ◽  
Cumulative Incidence ◽  
Standard Of Care ◽  
Incidence Rates ◽  
Spinal Tumors ◽  
Secondary Malignancy ◽  
Intracranial Tumors ◽  
Symptom Response

Abstract BACKGROUND Stereotactic radiosurgery (SRS) for benign intracranial tumors is an established standard of care. The widespread implementation of SRS for benign spinal tumors has been limited by lack of long-term data. OBJECTIVE To update our institutional experience of safety and efficacy outcomes after SRS for benign spinal tumors. METHODS We performed a retrospective cohort study of 120 patients with 149 benign spinal tumors (39 meningiomas, 26 neurofibromas, and 84 schwannomas) treated with SRS between 1999 and 2016, with follow-up magnetic resonance imaging available for review. The primary endpoint was the cumulative incidence of local failure (LF), with death as a competing risk. Secondary endpoints included tumor shrinkage, symptom response, toxicity, and secondary malignancy. RESULTS Median follow-up was 49 mo (interquartile range: 25-103 mo, range: 3-216 mo), including 61 courses with >5 yr and 24 courses with >10 yr of follow-up. We observed 9 LF for a cumulative incidence of LF of 2%, 5%, and 12% at 3, 5, and 10 yr, respectively. Excluding 10 tumors that were previously irradiated or that arose within a previously irradiated field, the 3-, 5-, and 10-yr cumulative incidence rates of LF were 1%, 2%, and 8%, respectively. At last follow-up, 35% of all lesions had decreased in size. With a total of 776 patient-years of follow-up, no SRS-related secondary malignancies were observed. CONCLUSION Comparable to SRS for benign intracranial tumors, SRS provides longer term local control of benign spinal tumors and is a standard-of-care alternative to surgical resection.

The Italian Trial of Endovascular AAA Exclusion Using the Parodi Endograft

1997 ◽  
Vol 4 (3) ◽  
pp. 299-306 ◽  
Author(s):  
Gioacchino Coppi ◽  
Roberto Moratto ◽  
Roberto Silingardi ◽  
Nicola Tusini ◽  
Roberto Vecchioni ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysms ◽  
Aortic Aneurysms ◽  
Covered Stents ◽  
The Third ◽  
Abdominal Aortic ◽  
The Mean ◽  
Distal Fixation

Purpose: To report the outcome of the prospective 11-center Italian Parodi Trial using straight and tapered endografts for the endovascular exclusion of abdominal aortic aneurysms (AAA). Methods: From April 1994 to July 1995, 27 patients were evaluated and selected for endovascular AAA exclusion. The Parodi devices were delivered through femoral arteriotomies using 18 to 22F introducers and deployed by balloon expansion of the terminal stents. Results: Of 27 cases attempted, 24 endografts (15 tube, 9 aortomonoiliac) were implanted (1 deployment and 2 access failures [11.1%] were converted). Three endoleaks (12.5%) were treated intraoperatively with covered stents, two successfully, and the third sealed within 30 days. Three (12.5%) of the 24 treated patients died in-hospital of device- (n = 2) and procedure-related (n = 1) causes; the remaining 21 patients were discharged within 8 days. Of the 8 aortomonoiliac grafts in follow-up, only 1 (12.5%) failed in the mean 23-month (range 18 to 30) follow-up; however, 4 (31%) of 13 tube graft patients were converted to surgery within 18 months. Of the 16 (66.7%) surviving endografts at 2 years, 6 (38%) showed no change in the AAA diameter, while 10 (62%) had shrunk. Conclusions: The tube graft was applicable in only about 5% of cases, and accurate endograft sizing and distal fixation were problematic. The aortomonoiliac design was not appealing to surgeons but fared better in the long term. Given the advent of newer endograft models, the Italian Parodi Trial has been terminated.

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