AMIC for traumatic focal osteochondral defect of the talar shoulder: a 5 years follow-up prospective cohort study

Abstract Background Autologous Matrix-Induced Chondrogenesis (AMIC) is addressed to osteochondral defects of the talus. However, evidence concerning the midterm efficacy and safety of AMIC are limited. This study assessed reliability and feasibility of AMIC at 60 months follow-up. We hypothesize that AMIC leads to good clinical outcome at midterm follow-up. Methods Surgeries were approached with an arthrotomy via malleolar osteotomy. A resorbable porcine I/III collagen membrane (Chondro-Gide®, Geistlich Pharma AG, Wolhusen, Switzerland) was used. Patients were followed at 24 and 60 months. The primary outcome of interest was to analyse the Foot Function Index (FFI), and the subscale hindfoot of the American Orthopaedic Foot and Ankle Score (AOFAS). Complications such as failure, revision surgeries, graft delamination, and hypertrophy were also recorded. The secondary outcome of interest was to investigate the association between the clinical outcome and patient characteristics at admission. Results Data from 19 patients were included. The mean age at admission was 47.3 ± 13.2 years, and the mean BMI 24.1 ± 4.9 kg/m2. 53% (10 of 19 patients) were female. At a mean of 66.2 ± 11.6 months, the FFI decreased at 24-months follow-up of 22.5% (P = 0.003) and of further 1.3% (P = 0.8) at 60-months follow-up. AOFAS increased at 24-months follow-up of 17.2% (P = 0.003) and of further 3.4 (P = 0.2) at 60-months follow-up. There were two symptomatic recurrences within the follow-up in two patients. There was evidence of a strong positive association between FFI and AOFAS at baseline and the same scores last follow-up (P = 0.001 and P = 0.0002, respectively). Conclusion AMIC enhanced with cancellous bone graft demonstrated efficacy and feasibility for osteochondral defects of the talus at five years follow-up. The greatest improvement was evidenced within the first two years. These results suggest that clinical outcome is influenced by the preoperative status of the ankle. High quality studies involving a larger sample size are required to detect seldom complications and identify prognostic factors leading to better clinical outcome. Level of evidence II, prospective cohort study.

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Effect of Laparoscopic Cystectomy for Ovarian Endometriomas on Ovarian Reserve, as Measured by Anti-Müllerian Hormone: A Prospective Cohort Study

Current Women s Health Reviews ◽

10.2174/1573404814666180724125608 ◽

2019 ◽

Vol 15 (3) ◽

pp. 207-213 ◽

Cited By ~ 1

Author(s):

Vaughan Marshall ◽

Thomas Ignatius Siebert

Keyword(s):

Cohort Study ◽

Prospective Cohort Study ◽

Ovarian Reserve ◽

Prospective Cohort ◽

Secondary Outcome ◽

Unilateral Disease ◽

Laparoscopic Cystectomy ◽

The Mean ◽

Ovarian Endometriomas

Background: Cystectomy for ovarian endometriomas is commonly performed, however recent publications have shown a deleterious effect of cystectomy on ovarian reserve. Objectives: The study aimed to evaluate what effect laparoscopic cystectomy for ovarian endometriomas has on the ovarian reserve. Methods: This is a prospective cohort study performing standard laparoscopic cystectomies for ovarian endometriomas. The primary outcome was the assessment of the ovarian reserve using Anti-Müllerian hormone (AMH), done pre- and six months postoperatively. Secondary outcome was spontaneous pregnancy during follow up. Results: We enrolled 59 participants. Twenty-five participants were lost to follow up and a further 3 were excluded from the analysis. The average age was 33.1 years. Thirty-one participants completed the six months follow up. The mean preoperative and postoperative AMH value was 3.21ng/mL [95% CI: 2.24 - 4.18ng/mL, SD 2.64] and 1.48ng/mL [95% CI: 1.06 - 1.91ng/mL, SD 1.17] respectively: equating to a 53.89% decline, P=0.002. Twenty participants had unilateral cysts whilst the remaining 11 had bilateral endometriomas. The mean preoperative and postoperative AMH for unilateral cysts was 3.22ng/mL [95% CI:1.93 - 4.51ng/mL, SD 2.76] and 1.82ng/mL [95% CI: 1.23 – 2.41ng/mL, SD 1.26] respectively, representing a 43.48% decrease, P=0.072. Of the 11 with bilateral endometriomas, the mean preoperative AMH was 3.19ng/mL [95% CI: 1.49 - 4.89ng/mL, SD 2.54] with 0.88ng/mL [95% CI: 0.43 - 1.33ng/mL, SD 0.67] representing the postoperative AMH, equating to a 72.41% reduction, P=0.005. Conclusion: Serum AMH is negatively affected by laparoscopic cystectomy for ovarian endometriomas, with a significant decline in ovarian reserve as measured six months postoperatively. A greater decline was seen in patients with bilateral endometriomas compared to unilateral disease.

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Cost of Living with Parkinson’s Disease over 12 Months in Australia: A Prospective Cohort Study

Parkinson s Disease ◽

10.1155/2017/5932675 ◽

2017 ◽

Vol 2017 ◽

pp. 1-13 ◽

Cited By ~ 6

Author(s):

Shalika Bohingamu Mudiyanselage ◽

Jennifer J. Watts ◽

Julie Abimanyi-Ochom ◽

Lisa Lane ◽

Anna T. Murphy ◽

...

Keyword(s):

Cohort Study ◽

Health System ◽

Prospective Cohort Study ◽

Resource Use ◽

Prospective Cohort ◽

Annual Cost ◽

Severe Disease ◽

Medicare Data ◽

The Mean

Background. Parkinson disease (PD) is a costly chronic condition in terms of managing both motor and nonmotor symptoms. The burden of disease is high for individuals, caregivers, and the health system. The aim of this study is to estimate the annual cost of PD from the household, health system, and societal perspectives. Methods. A prospective cohort study of newly referred people with PD to a specialist PD clinic in Melbourne, Australia. Participants completed baseline and monthly health resource use questionnaires and Medicare data were collected over 12 months. Results. 87 patients completed the 12-month follow-up assessments. The mean annual cost per person to the health care system was $32,556 AUD. The burden to society was an additional $45,000 per annum per person with PD. The largest component of health system costs were for hospitalisation (69% of total costs). The costs for people with moderate to severe disease were almost 4 times those with mild PD ($63,569 versus $17,537 p<0.001). Conclusion. PD is associated with significant costs to individuals and to society. Costs escalated with disease severity suggesting that the burden to society is likely to grow with the increasing disease prevalence that is associated with population ageing.

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End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty – a prospective cohort study

10.21203/rs.3.rs-33924/v4 ◽

2020 ◽

Author(s):

Kevin Ki-Wai Ho ◽

Lawrence Chun-Man Lau ◽

Wai Wang Chau ◽

Queena Poon ◽

Kwong-Yin Chung ◽

...

Keyword(s):

Cohort Study ◽

Muscle Strength ◽

Outcome Measures ◽

Prospective Cohort Study ◽

Knee Arthroplasty ◽

Prospective Cohort ◽

Functional Improvement ◽

Secondary Outcome ◽

End Stage

Abstract Background: Sarcopenia often accompanies osteoarthritis (OA), which is managed by total knee arthroplasty (TKA) in the late stage. Recent studies have suggested a higher risk of post-operative complications after TKA in sarcopenic OA subjects, but whether TKA can benefit them similar to non-sarcopenic subjects remains unexplored. This study aimed to examine the dynamic, mutual impact of sarcopenia and TKA in a one-year post-operative period.Methods: This prospective cohort study was conducted between 2015 to 2018 at our hospital. Patients with end-stage OA of the knee waiting for TKA were recruited into the study. Primary outcome measures were change in muscle strength, mass and function. Secondary outcome measures were quality of life (QOL) measurements for pain, psychological and physical health.Results: Fifty-eight patients were recruited, of which 79.3% were female and 32.8% already had sarcopenia at baseline. The average age of sarcopenic subjects and non-sarcopenic subjects was comparable (67.89±7.07 vs. 67.92±6.85; p=0.99), but sarcopenic subjects had a lower body mass index (BMI) (25.64±2.64 vs. 28.57±4.04; p=0.01). There was a statistically significant improvement in walking speed (10.24±5.35 vs. 7.69±2.68, p<0.01) and muscle strength in both sarcopenic and non-sarcopenic patients after TKA. This was accompanied by an improvement trend in muscle mass in all subjects. There was no change in handgrip power before and after TKA and subsequent follow-up (19.31±5.92 vs. 18.98±6.37 vs. 19.36±7.66; p=0.97). QOL measured before, after and at follow-up with WOMAC (total: 42.27±15.98 vs. 20.65±15.24 vs. 16.65±18.13) and SF12v2 (PCS: 33.06±8.55 vs. 38.96±8.01 vs. 40.67±7.93) revealed progressive significant improvement (both comparisons p≤0.01). Further analysis with the IPAQ also found increased engagement of high-intensity activities.Conclusions: This study showed that sarcopenia among patients with end-stage OA of the knee is not uncommon, but both sarcopenic and non-sarcopenic OA patients achieved significant clinical and functional improvement after TKA. Further studies with a larger sample size and different ethnicities could help ascertain a beneficial role of TKA in sarcopenic OA subjects.

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Validity of self-reported diagnoses of gynaecological and breast cancers in a prospective cohort study: the Japan Nurses’ Health Study

BMJ Open ◽

10.1136/bmjopen-2020-045491 ◽

2021 ◽

Vol 11 (6) ◽

pp. e045491

Author(s):

Kiyoshi Takamatsu ◽

Yuki Ideno ◽

Mami Kikuchi ◽

Toshiyuki Yasui ◽

Naho Maruoka ◽

...

Keyword(s):

Breast Cancer ◽

Cohort Study ◽

Prospective Cohort Study ◽

Predictive Value ◽

Prospective Cohort ◽

Health Study ◽

Breast Cancers ◽

Expert Review ◽

The Mean

ObjectivesTo validate the self-reported diagnoses of gynaecological and breast cancers in a nationwide prospective cohort study of nursing professionals: the Japan Nurses’ Health Study (JNHS).Design and settingRetrospective analysis of the JNHS.Participants and measuresData were reviewed for 15 717 subjects. The mean age at baseline was 41.6±8.3 years (median: 41), and the mean follow-up period was 10.5±3.8 years (median: 12). Participants are regularly mailed a follow-up questionnaire once every 2 years. Respondents who self-reported a positive cancer diagnosis were sent an additional confirmation questionnaire and contacted the diagnosing facility to confirm the diagnosis based on medical records. A review panel of experts verified the disease status. Regular follow-up, confirmation questionnaires and expert review were validated for their positive predictive value (PPV) and negative predictive value (NPV).ResultsNew incidences were verified in 37, 47, 26 and 300 cervical, endometrial, ovarian and breast cancer cases, respectively. The estimated incidence rates were 22.0, 25.4, 13.8 and 160.4 per 100 000 person-years. These were comparable with those of national data from regional cancer registries in Japan. For regular follow-up, the corresponding PPVs for cervical, endometrial, ovarian and breast cancer were 16.9%, 54.2%, 45.1% and 81.4%, and the NPVs were 100%, 99.9%, 99.9% and 99.9%, respectively. Adding the confirmation questionnaire improved the PPVs to 31.5%, 88.9%, 76.7% and 99.9%; the NPVs were uniformly 99.9%. Expert review yielded PPVs and NPVs that were all ~100%.ConclusionsGynaecological cancer cannot be accurately assessed by self-reporting alone. Additionally, the external validity of cancer incidence in this cohort was confirmed.

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End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty – a prospective cohort study

10.21203/rs.3.rs-33924/v3 ◽

2020 ◽

Author(s):

Kevin Ki-Wai Ho ◽

Lawrence Chun-Man Lau ◽

Wai Wang Chau ◽

Queena Poon ◽

Kwong-Yin Chung ◽

...

Keyword(s):

Cohort Study ◽

Muscle Strength ◽

Outcome Measures ◽

Prospective Cohort Study ◽

Knee Arthroplasty ◽

Prospective Cohort ◽

Functional Improvement ◽

Secondary Outcome ◽

End Stage

Abstract Background:Sarcopenia often accompanies osteoarthritis (OA), which is managed by total knee arthroplasty (TKA) in the late stage. Recent studies have suggested a higher risk of post-operative complications after TKA in sarcopenic OA subjects, but whether TKA can benefit them similar to non-sarcopenic subjects remains unexplored. This study aimed to examine the dynamic, mutual impact of sarcopenia and TKA in a one-year post-operative period.Methods: This prospective cohort study was conducted between 2015 to 2018 at our hospital. Patients with end-stage OA of the knee waiting for TKA were recruited into the study. Primary outcome measures were change in muscle strength, mass and function. Secondary outcome measures were quality of life (QOL) measurements for pain, psychological and physical health.Results: Fifty-eight patients were recruited, of which 79.3% were female and 32.8% already had sarcopenia at baseline. The average age of sarcopenic subjects and non-sarcopenic subjects was comparable (67.89±7.07 vs. 67.92±6.85; p=0.99), but sarcopenic subjects had a lower body mass index (BMI) (25.64±2.64 vs. 28.57±4.04; p=0.01). There was a statistically significant improvement in walking speed (10.24±5.35 vs. 7.69±2.68, p<0.01) and muscle strength in both sarcopenic and non-sarcopenic patients after TKA. This was accompanied by an improvement trend in muscle mass in all subjects. There was no change in handgrip power before and after TKA and subsequent follow-up (19.31±5.92 vs. 18.98±6.37 vs. 19.36±7.66; p=0.97). QOL measured before, after and at follow-up with WOMAC (total: 42.27±15.98 vs. 20.65±15.24 vs. 16.65±18.13) and SF12v2 (PCS: 33.06±8.55 vs. 38.96±8.01 vs. 40.67±7.93) revealed progressive significant improvement (both comparisons p≤0.01). Further analysis with the IPAQ also found increased engagement of high-intensity activities.Conclusions: This study showed that sarcopenia among patients with end-stage OA of the knee is not uncommon, but both sarcopenic and non-sarcopenic OA patients achieved significant clinical and functional improvement after TKA. Further studies with an larger sample size and different ethnicities could help ascertain a beneficial role of TKA in sarcopenic OA subjects.

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Clinical results and survivorship of the Mathys Affinis Short, Short Stem Total Shoulder Prosthesis

Bone & Joint Open ◽

10.1302/2633-1462.21.bjo-2020-0184 ◽

2021 ◽

Vol 2 (1) ◽

pp. 58-65

Author(s):

Timothy James Karssiens ◽

James Ritchie Gill ◽

Karadi Hari Sunil Kumar ◽

Søren Upton Sjolin

Keyword(s):

Cohort Study ◽

Rotator Cuff ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Clinical Results ◽

Short Stem ◽

Shoulder Prosthesis ◽

Level Of Evidence ◽

Survivorship Analysis

Aims The Mathys Affinis Short is the most frequently used stemless total shoulder prosthesis in the UK. The purpose of this prospective cohort study is to report the survivorship, clinical, and radiological outcomes of the first independent series of the Affinis Short prosthesis. Methods From January 2011 to January 2019, a total of 141 Affinis Short prostheses were implanted in 127 patients by a single surgeon. Mean age at time of surgery was 68 (44 to 89). Minimum one year and maximum eight year follow-up (mean 3.7 years) was analyzed using the Oxford Shoulder Score (OSS) at latest follow-up. Kaplan-Meier survivorship analysis was performed with implant revision as the endpoint. Most recently performed radiographs were reviewed for component radiolucent lines (RLLs) and proximal humeral migration. Results Five shoulders underwent revision surgery (3.5%); three for rotator cuff failure, one for infection, and one for component malposition. Survivorship of the implant was 95.4% (95% confidence interval 90.1% to 97.9%) at five and nine years. Mean OSS improved significantly compared to preoperative values from 19.0 (1 to 35) to 43.3 (7 to 48) (p < 0.001). Radiological analysis was undertaken for 99 shoulders. This revealed humeral RLLs in one case (1%), glenoid RLLs in 15 cases (15.2%), and radiological rotator cuff failure in 22 cases (22.2%). Conclusion This prospective cohort study shows encouraging short- to mid-term survivorship and clinical and radiological results for the Mathys Affinis Short, Short Stem Total Shoulder Prosthesis. Level of Evidence: IV Cite this article: Bone Jt Open 2021;2(1):58–65.

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Effects of different surgical modalities on the clinical outcome of patients with moyamoya disease: a prospective cohort study

Journal of Neurosurgery ◽

10.3171/2016.12.jns162626 ◽

2018 ◽

Vol 128 (5) ◽

pp. 1327-1337 ◽

Cited By ~ 20

Author(s):

Xiaofeng Deng ◽

Faliang Gao ◽

Dong Zhang ◽

Yan Zhang ◽

Rong Wang ◽

...

Keyword(s):

Cohort Study ◽

Clinical Outcome ◽

Prospective Cohort Study ◽

Moyamoya Disease ◽

Prospective Cohort ◽

Recurrent Stroke ◽

Neurological Status ◽

Free Time ◽

Significant Difference

OBJECTIVEBypass surgery is the most common treatment for moyamoya disease (MMD), but there is controversy over which surgical modality is best. The objective of this study was to evaluate the clinical outcome of patients with MMD after undergoing different surgical modalities.METHODSA series of 696 consecutive MMD patients treated between June 2009 and May 2015 were screened in this prospective cohort study. Patients who did not undergo revascularization surgeries and those who underwent different surgical modalities in bilateral hemispheres were excluded. Finally, 529 patients who were observed for at least 12 months were included: 438 patients underwent unilateral surgery, and 91 patients underwent bilateral surgery. Of these, 241 patients underwent direct bypass (DB); 81, a combined bypass (CB); and 207, an indirect bypass (IB). Three clinical outcomes were evaluated and compared between surgical groups: recurrent stroke events, modified Rankin Scale (mRS) scores, and change in the main symptoms.RESULTSThe mean follow-up period was 40 months. During the follow-up period, recurrent stroke was observed in 43 patients, including 15 patients with hemorrhage, 26 patients with ischemia (transient ischemic attack in 19 patients and infarction in 7 patients), and 2 patients with both hemorrhage and cerebral infarction. Kaplan-Meier analysis showed that patients who underwent a CB or DB had a longer ischemia-free time than those who underwent IB (p = 0.013); however, there was no significant difference in the hemorrhage-free time between the different surgical modalities (p = 0.534). A good neurological status (mRS score ≤ 2) was achieved in 495 patients (93.6%) and was significantly achieved by more children (98.2%) than adults (92.3%; p = 0.022). Surgical modalities were not significantly associated with outcome neurological status (p = 0.860). Moreover, improvement in symptoms was observed in 449 patients (84.9%) and was also significantly more common in children (93.0%) than in adults (82.7%; p = 0.006). No significant difference was observed between the different surgical modalities (p = 0.548).CONCLUSIONSCB and DB are more effective at preventing recurrent ischemic strokes than IB. However, there is no evidence that these 3 surgical modalities demonstrate significant differences in preventing recurrent hemorrhage.

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End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty – a prospective cohort study

BMC Geriatrics ◽

10.1186/s12877-020-01929-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Kevin Ki-Wai Ho ◽

Lawrence Chun-Man Lau ◽

Wai-Wang Chau ◽

Queena Poon ◽

Kwong-Yin Chung ◽

...

Keyword(s):

Cohort Study ◽

Muscle Strength ◽

Outcome Measures ◽

Prospective Cohort Study ◽

Knee Arthroplasty ◽

Prospective Cohort ◽

Secondary Outcome ◽

Link Type ◽

End Stage

Abstract Background Sarcopenia often accompanies osteoarthritis (OA), which is managed by total knee arthroplasty (TKA) in the late stage. Recent studies have suggested a higher risk of post-operative complications after TKA in sarcopenic OA subjects, but whether TKA can benefit them similar to non-sarcopenic subjects remains unexplored. This study aimed to examine the dynamic, mutual impact of sarcopenia and TKA in a one-year post-operative period. Methods This prospective cohort study was conducted between 2015 to 2018 at our hospital. Patients with end-stage OA of the knee waiting for TKA were recruited into the study. Primary outcome measures were change in muscle strength, mass and function. Secondary outcome measures were quality of life (QOL) measurements for pain, psychological and physical health. Results Fifty-eight patients were recruited, of which 79.3% were female and 32.8% already had sarcopenia at baseline. The average age of sarcopenic subjects and non-sarcopenic subjects was comparable (67.89 ± 7.07 vs. 67.92 ± 6.85; p = 0.99), but sarcopenic subjects had a lower body mass index (BMI) (25.64 ± 2.64 vs. 28.57 ± 4.04; p = 0.01). There was a statistically significant improvement in walking speed (10.24 ± 5.35 vs. 7.69 ± 2.68, p < 0.01) and muscle strength in both sarcopenic and non-sarcopenic patients after TKA. This was accompanied by an improvement trend in muscle mass in all subjects. There was no change in handgrip power before and after TKA and subsequent follow-up (19.31 ± 5.92 vs. 18.98 ± 6.37 vs. 19.36 ± 7.66; p = 0.97). QOL measured before, after and at follow-up with WOMAC (total: 42.27 ± 15.98 vs. 20.65 ± 15.24 vs. 16.65 ± 18.13) and SF12v2 (PCS: 33.06 ± 8.55 vs. 38.96 ± 8.01 vs. 40.67 ± 7.93) revealed progressive significant improvement (both comparisons p ≤ 0.01). Further analysis with the IPAQ also found increased engagement of high-intensity activities. Conclusions This study showed that sarcopenia among patients with end-stage OA of the knee is not uncommon, but both sarcopenic and non-sarcopenic OA patients achieved significant clinical and functional improvement after TKA. Further studies with a larger sample size and different ethnicities could help ascertain a beneficial role of TKA in sarcopenic OA subjects. Trial registration Registry: ClinicalTrials.gov, Registration number: NCT03579329. Date of registration: 6 July 2018. Retrospectively registered.

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Postpartum trend in blood pressure and renal function in women with severe preeclampsia and eclampsia: A prospective cohort-study at Mulago hospital, Kampala, Uganda

10.1101/562934 ◽

2019 ◽

Author(s):

Kasereka Muteke ◽

Jolly Beyeza ◽

Milton W Musaba ◽

Julius Wandabwa ◽

Paul Kiondo

Keyword(s):

Blood Pressure ◽

Renal Function ◽

Cohort Study ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Severe Preeclampsia ◽

Urine Protein ◽

The Mean ◽

Mean Time

AbstractBackgroundPreeclampsia/Eclampsia is a multisystem disorder of pregnancy with kidney involvement. Our objective was to assess the postpartum trend in blood pressure, renal function and proteinuria and, to investigate their predictors in Ugandan women with severe preeclampsia and eclampsia.MethodsThis was a prospective cohort study that involved 97 women with severe preeclampsia and Eclampsia, conducted at Mulago National referral hospital from August 2017 to April 2018. The clinical and laboratory variables were collected from the women on day1, 7, 21 and day 42 after delivery. Kaplan-Meier Survival analysis, Cox-proportional Regression and Log-Rank tests were used to compare the baseline and the follow-up variables with changes in blood pressure, renal function and urine protein.ResultsMost women (93.8%) recovered from hypertension within 6 weeks of childbirth with the mean time to resolution of 2.49 weeks (95% CI: 2.13-2.82). About 81% of the women recovered their renal function and the mean time to recovery was 24.54 days (95% CI: 20.14-28.95). Proteinuria resolved in approximately 84% of the women and the mean time resolution of urine protein of 32.85 days (95% CI: 30.31-35.39). Having multiple pregnancy versus a singleton pregnancy was associated with persistence of hypertension six weeks after child birth (P-value = 0.013).ConclusionIn this study, the blood pressure and renal function of most women with severe preeclampsia and eclampsia normalized within six weeks after childbirth. A special interdisciplinary follow up for patients with preeclampsia/eclampsia by an obstetrician and physician is needed in the postpartum period to reduce the maternal morbidity and mortality associated with this condition in our community.

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Prospective Cohort Study of the Incidence, Risk Factors and Long-Term Sequelae of Symptomatic Catheter-Related Thrombosis in Adults with Cancer.

Blood ◽

10.1182/blood.v104.11.2200.2200 ◽

2004 ◽

Vol 104 (11) ◽

pp. 2200-2200

Author(s):

Agnes Y. Lee ◽

Carolyn Webb ◽

Qing Guo ◽

Lorrie Costantini ◽

Greg Butler ◽

...

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Dwell Time ◽

History Of ◽

The Mean ◽

Catheter Related Thrombosis

Abstract Long-term indwelling central venous catheters (CVCs) are used for delivering chemotherapy, parenteral nutrition, antibiotics, and blood products, as well as for facilitating blood drawing, in many patients with malignancy. Although the important supportive role of CVCs is unquestioned, there is uncertainty regarding the prevention and treatment of catheter-related thrombosis (CRT) because there is a lack of prospective and contemporary data on the natural history of this complication. As a first step towards improving CRT management, we conducted a prospective cohort study to examine the incidence, clinical risk factors, and the long-term sequelae of symptomatic CRT in adults with cancer. Consecutive patients undergoing insertion of a CVC at a tertiary care center were enrolled and followed for the duration of their catheter-dwell time plus 4 weeks or a maximum of 52 weeks, whichever comes first. Scheduled assessments were done at weeks 1, 2, 4, 8, 12, 24, 36 and 52 weeks after insertion. Patients with symptomatic CRT were treated with anticoagulants and were followed for an additional 52 weeks from the date of CRT diagnosis. Baseline information and follow-up data regarding catheter patency, thromboprophylaxis, clinical symptoms, and thrombotic events was collected. Standardized regional guidelines for catheter care were followed and symptomatic CRT was diagnosed based on objective testing and satisfaction of prespecified criteria. Between March 2002 and July 2003, 444 patients underwent 500 catheter insertions. The mean patient age was 56 y (range 18–91 y) and 55% of patients were female. Catheters inserted included PICCs (65%), ports (18%), pheresis (11%), and Hickman catheters (6%). As of July 22, 2004, 442 patients had completed follow-up. The total catheter-dwell time was 59,959 d (median 88 d), while the total follow-up was 73,654 pt-d (median 151 d). Colorectal was the most common tumor type in 18% of patients and 41% of all patients at enrolment had metastatic solid tumor. Overall, there were 19 episodes of symptomatic CRT, representing an incidence of 4.3% (95% CI 2.6–6.6%) of patients or 0.3 CRTs per 1000 catheter-dwell days (95% CI 0.2–0.5 per 1000 d). The mean time to CRT was 53 d (range 6–162 d). Development of CRT was not associated with age, ECOG performance status, cancer treatment, catheter type, side of insertion, thromboprophylaxis, infection, or previous history of thrombosis. The only significant risk factor was ovarian cancer (P=0.02). In patients with symptomatic CRT, 89% (17/19) of CRTs were treated with anticoagulant therapy alone, 5.3% (1/19) had the catheter removed, and 5.3% (1/19) were treated with both; none had symptomatic pulmonary embolism or post-thrombotic syndrome during follow-up. In summary, the incidence of symptomatic CRT in adults with cancer is low and treatment with anticoagulant therapy alone was not associated with any serious long-term sequelae. Due to the small number of CRTs observed, larger studies are required to further evaluate risk factors and identify the optimal therapeutic approach for CRTs.

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