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1.
Cardiovasc Intervent Radiol ; 41(10): 1494-1504, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29948003

ABSTRACT

PURPOSE: There is paucity of data on patient-perceived outcomes of bleomycin sclerotherapy for low-flow vascular malformations. In this study, the long-term outcomes of bleomycin sclerotherapy were investigated in terms of quality of life (QoL) and patient-perceived changes in health. MATERIALS AND METHODS: A cohort of Dutch patients with vascular malformations treated with bleomycin sclerotherapy (June 2010-November 2015) completed a questionnaire evaluating disease symptoms, QoL (Short Form 36), patient-perceived change in health status (Global Rating of Change scales) and treatment satisfaction. QoL was assessed for the patient's status before and after treatment and was analyzed relative to an age and sex-matched Dutch reference population. Predictive factors associated with QoL and patient-perceived improvement in overall health status were assessed using multivariable linear and logistic regression analyses, respectively. RESULTS: Seventy-seven patients, with a median follow-up of 22 months, were enrolled. About half of the respondents (49.3%) indicated that they perceived (any form of) improvement in their overall health status. Most often improved were the specific health aspects 'pain' (54.5%) and 'overall severity of symptoms' (57.1%). No factors were significantly predictive for patient-perceived improvement in health with respect to the vascular malformation. Impairment in work- or study-related activities prior to sclerotherapy was found to negatively impact physical QoL at follow-up (p = 0.03). CONCLUSION: Approximately half of patients with low-flow vascular malformations indicate an improvement in overall health status following bleomycin sclerotherapy, particularly concerning pain and severity of symptoms. However, most patients only perceived little to moderate improvement to their health and desire further treatment.


Subject(s)
Bleomycin/administration & dosage , Lymphatic Abnormalities/therapy , Patient Satisfaction , Quality of Life/psychology , Sclerotherapy/methods , Vascular Malformations/therapy , Adult , Cohort Studies , Female , Follow-Up Studies , Humans , Lymphatic Abnormalities/psychology , Male , Middle Aged , Netherlands , Prognosis , Retrospective Studies , Sclerotherapy/psychology , Surveys and Questionnaires , Treatment Outcome , Vascular Malformations/psychology
3.
Eur J Vasc Endovasc Surg ; 51(4): 550-6, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26837479

ABSTRACT

OBJECTIVES: The VascuQol is a questionnaire for health related quality of life (HRQL) in patients with intermittent claudication (IC), and is frequently used to evaluate treatment effects. Yet, the interpretation of change in score on a questionnaire is not always obvious. The minimally important difference (MID) represents the smallest change in score on a questionnaire that is considered relevant by patients. This study aims to determine the MID for the VascuQol sumscore and its different domains for patients with IC. METHODS: A total of 118 participants were recruited from the SUPER study, a multicenter randomized controlled trial comparing angioplasty with supervised exercise therapy for alleviation of IC due to an iliac artery stenosis or occlusion. All patients completed the VascuQol and the Short Form 36 (SF-36) questionnaires at baseline and after 12 months of follow up. Two anchor based methods for MID calculation were applied. Two anchors were used: six global rating of change questions aimed at the VascuQol sumscore and subscales and the health transition item of the SF-36, both recorded at 12 months of follow up. RESULTS: The MID for the VascuQol sumscore ranged between 1.19 and 1.66 for improvement and 0.08 and 0.41 for deterioration. For the pain domain, MID values ranged from 1.48 to 1.91 for improvement and 0.19 to 0.34 for deterioration. Finally, for the activities domain MID values ranging from 1.55 to 2.2 and from 0.12 to 0.26 for improvement and deterioration were found, respectively. Since the correlations between the anchors and the symptom, social and emotional subscales were below the threshold of 0.3, the MID was not calculated for these subscales. CONCLUSIONS: The range of MID values found in this study is an indication of the smallest change score on the VascuQol questionnaire score that is considered relevant by patients with IC. They may help to better interpret trial results and set treatment goals.


Subject(s)
Intermittent Claudication/diagnosis , Peripheral Vascular Diseases/diagnosis , Quality of Life , Surveys and Questionnaires , Aged , Angioplasty , Emotions , Exercise Therapy , Female , Health Status , Humans , Intermittent Claudication/physiopathology , Intermittent Claudication/psychology , Intermittent Claudication/therapy , Male , Mental Health , Middle Aged , Netherlands , Peripheral Vascular Diseases/physiopathology , Peripheral Vascular Diseases/psychology , Peripheral Vascular Diseases/therapy , Predictive Value of Tests , Social Behavior , Time Factors , Treatment Outcome
4.
Eur J Vasc Endovasc Surg ; 49(6): 661-668, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25840801

ABSTRACT

OBJECTIVE: To compare the midterm re-intervention and survival rates after EVAR and OR for ruptured abdominal aortic aneurysms (RAAA). METHODS: Observational cohort study including all consecutive RAAA patients between 2004 and 2011 in 10 hospitals in the Amsterdam ambulance region. The primary end point was re-interventions within 5 years of the primary intervention. The secondary end point was death. The outcomes were estimated by survival analyses, compared using the logrank test, and subsequently adjusted for possible confounders using Cox proportional hazard models. Re-interventions were estimated in all patients and in patients who survived their hospital stay. RESULTS: Of 467 patients with a RAAA, 73 were treated by EVAR and 394 by OR. Five years after the primary intervention, the rates of freedom from re-intervention were 55% for EVAR (26/73, 95% CI: 41-69%) and 60% for OR (130/394, 95% CI: 55-66%) (p = .96). After adjustment for age, sex, comorbidity, and pre-operative hemodynamic stability, the risk of re-intervention was similar (HR 1.01, 95% CI: 0.65-1.55). The survival rates were 36% for EVAR (45/73, 95% CI: 24-47%) and 38% for OR (235/394, 95% CI: 33-43%) (p = .83). In 297 patients who survived their hospital stay, the rates of freedom from re-intervention were 66% for EVAR (15/54, 95% CI: 52-81%) and 90% for OR (20/243, 95% CI: 86-95%) (p < .01). After adjustment for age and sex, the risk of re-intervention was higher after EVAR (HR 0.27, 95% CI: 0.14-0.52). CONCLUSIONS: Five years after the primary intervention, endovascular and open repair for ruptured abdominal aortic aneurysm resulted in similar re-intervention and survival rates. However, in patients who survived their hospital stay the re-intervention rate was higher for EVAR than for OR.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Postoperative Complications/surgery , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnosis , Aortic Rupture/mortality , Blood Vessel Prosthesis Implantation/mortality , Chi-Square Distribution , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Kaplan-Meier Estimate , Male , Multivariate Analysis , Netherlands , Odds Ratio , Postoperative Complications/mortality , Proportional Hazards Models , Registries , Reoperation , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
5.
Eur J Vasc Endovasc Surg ; 49(2): 192-8, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25516530

ABSTRACT

OBJECTIVE/BACKGROUND: Arterial calcification may render the ankle-brachial index (ABI) unreliable in diabetic patients. Although guidelines recommend the toe-brachial index (TBI) for patients with falsely elevated ABI arbitrarily defined as an ABI > 1.4, arterial calcification is also common among diabetic patients with an ABI ≤ 1.4. This could result in a "falsely normalized" ABI and under-diagnosis of peripheral arterial disease (PAD). We investigated whether diabetes invalidates the ABI as opposed to the TBI, and if the TBI may therefore be more suitable for detecting PAD in diabetic patients. METHODS: The difference between ABI and TBI was compared between diabetic and non-diabetic patients with an ABI ≤ 1.4 referred to the vascular laboratory. A Bland-Altman plot was constructed to assess whether ABI-TBI differences were dependent on the magnitude of the measurements. Subgroup analyses were performed for patients with a normal ABI, and for patients with critical ischemia. RESULTS: The population comprised 161 diabetic (252 limbs) and 160 non-diabetic (253 limbs) patients (mean age 67). Median ABIs (0.79 vs. 0.80) were similar, while median TBI was 0.07 higher in diabetics (p = 0.024). The ABI-TBI difference in diabetics and non-diabetics was similar (0.32 vs. 0.35; p = .084), and was also similar for patients with a normal ABI. Moreover, ABI-TBI differences in diabetic- and non-diabetic patients overlapped, irrespective of the magnitude of the measurements. Diabetes was not associated with larger differences between ankle and toe pressures (mean difference -0.9 mmHg, 95% confidence interval -15 to 13 mmHg) among patients with critical ischemia. CONCLUSION: No evidence was found that the TBI may overcome the potentially invalidated ABI in diabetic patients with an ABI ≤ 1.4. ABI and TBI are strongly associated, and this relationship is not influenced by diabetes. Therefore, the TBI does not allow for earlier detection of ischemia in diabetes.


Subject(s)
Ankle Brachial Index , Diabetic Angiopathies/diagnosis , Peripheral Arterial Disease/diagnosis , Vascular Calcification/diagnosis , Aged , Aged, 80 and over , Arterial Pressure , Cross-Sectional Studies , Diabetic Angiopathies/physiopathology , Early Diagnosis , Female , Humans , Male , Middle Aged , Peripheral Arterial Disease/physiopathology , Predictive Value of Tests , Regional Blood Flow , Reproducibility of Results , Retrospective Studies , Severity of Illness Index , Vascular Calcification/physiopathology , Vascular Stiffness
6.
Cardiovasc Intervent Radiol ; 37(5): 1198-219, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25005565

ABSTRACT

PURPOSE: This study was designed to summarize the evidence on clinical outcomes and complications of prostatic arterial embolization (PAE) in patients with benign prostatic hyperplasia (BPH). METHODS: We searched Medline and Embase for PAE trials of patients with BPH upto November 2013. Two reviewers independently checked the inclusion and exclusion criteria and performed data extraction of study characteristics, quantitative and qualitative outcomes, and complications. RESULTS: The search yielded 562 studies, of which 9 articles with 706 patients were included. In these 9 articles, there was a possible overlap of data and the quality of 8 studies was assessed as poor. All patients had moderate-to-severe, lower urinary tract symptoms (LUTS). The mean age ranged from 63.4-74.1 years. After embolization, a decrease of the prostate volume (PV) and post void residual (PVR) was seen mainly in the first month with a further decrease up to 12 months, increasing afterwards. The prostate specific antigen (PSA) decreased up to 3 months after PAE, increasing afterwards. The peak urinary flow (Qmax) increased mainly the first month and decreased after 30 months. The international prostate symptom score (IPSS) and quality of life-related symptoms (QOL) improved mainly during the first month, with a further improvement up to 30 months. No deterioration of the international index of erectile function (IIEF) was seen after PAE. The PAE procedure seems safe. CONCLUSIONS: Although the number of studies was small, qualitatively poor, and with overlap of patients, the initial clinical outcomes as reported up to 12 months seem positive and the procedure seems safe.


Subject(s)
Embolization, Therapeutic/methods , Prostatic Hyperplasia/therapy , Humans , Male , Treatment Outcome
7.
Br J Surg ; 101(7): 794-801, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24752802

ABSTRACT

BACKGROUND: Care for patients with a ruptured abdominal aortic aneurysm (rAAA) in the Amsterdam ambulance region (The Netherlands) was concentrated into vascular centres with a 24-h full emergency vascular service in cooperation with seven referring regional hospitals. Previous population-based survival after rAAA in the Netherlands was 46 (95 per cent confidence interval (c.i.) 43 to 49) per cent. It was hypothesized that regional cooperation would improve survival. METHODS: This was a prospective observational cohort study carried out simultaneously with the Amsterdam Acute Aneurysm Trial. Consecutive patients with an rAAA between 2004 and 2011 in all ten hospitals in the Amsterdam region were included. The primary outcome was 30-day survival after admission. Multivariable logistic regression, including age, sex, co-morbidity, intervention (endovascular or open repair), preoperative systolic blood pressure, cardiopulmonary resuscitation and year of intervention, was used to assess the influence of hospital setting on survival. RESULTS: Of 453 patients with rAAA from the Amsterdam ambulance region, 61 did not undergo intervention; 352 patients were treated surgically at a vascular centre and 40 at a referring hospital. The regional survival rate was 58.5 (95 per cent c.i. 53.9 to 62.9) per cent (265 of 453). After multivariable adjustment, patients treated at a vascular centre had a higher survival rate than patients treated surgically at a referring hospital (adjusted odds ratio 3.18, 95 per cent c.i. 1.43 to 7.04). CONCLUSION: After regional cooperation, overall survival of patients with an rAAA improved. Most patients were treated in a vascular centre and in these patients survival rates were optimal.


Subject(s)
Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/mortality , Emergency Service, Hospital/organization & administration , Interinstitutional Relations , Aged , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Female , Hospital Mortality , Humans , Male , Netherlands/epidemiology , Prospective Studies , Regression Analysis , Survival Rate
8.
Eur J Vasc Endovasc Surg ; 47(5): 536-44, 2014 May.
Article in English | MEDLINE | ID: mdl-24650395

ABSTRACT

OBJECTIVE: To evaluate 1 to 48 month follow-up outcomes of different endovascular treatment strategies in below-the-knee (BTK) arterial segments in critical limb ischemia (CLI) patients. METHODS: Medline and Embase were searched (last searched on 5 November 2013) for studies of randomized controlled trials comparing either balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another. Methodological quality of each trial was assessed using a Cochrane Collaboration's tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were wound healing, quality of life, change in Rutherford classification, amputation, death, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, and event-free survival with follow-up periods of at least 1 month. RESULTS: Twelve trials including 1145 patients were identified, with 90% of patients having CLI. Six BS versus PTA and two DES versus PTA trials showed low-quality evidence of equal efficacy. One trial, comparing DEB with PTA, showed moderate-quality evidence of improved wound healing (RR 1.28; 95% CI: 1.05 to 1.56; p=.01), improvement in Rutherford classification (RR 1.32; 95% CI: 1.08 to 1.60; p=.008), and lower TLR (RR 0.41; 95% CI 0.23 to 0.74; p=.002) and binary restenosis (RR 0.36; 95% CI 0.24 to 0.54; p<.0001) in diabetic patients after 12 months. Amputation and death rate did not differ significantly. For DES versus BS, most trials showed equal efficacy between strategies. CONCLUSION: Based on low- to moderate-quality evidence, PTA with optional bailout stenting using BS should remain the preferred strategy in treating CLI patients with BTK arterial lesions. Before other strategies can be implemented, larger and high-quality RCTs assessing clinically relevant outcomes are needed.


Subject(s)
Arterial Occlusive Diseases/surgery , Popliteal Artery/surgery , Randomized Controlled Trials as Topic/methods , Stents , Humans
9.
Eur J Vasc Endovasc Surg ; 47(5): 524-35, 2014 May.
Article in English | MEDLINE | ID: mdl-24656874

ABSTRACT

OBJECTIVE: To evaluate 1 to 36 month follow-up outcomes of different endovascular treatment strategies in above-the-knee (ATK) arterial segments in patients with intermittent claudication (IC) and critical limb ischemia (CLI). METHODS: Studies indexed in Medline and Embase from 1980 to November 2013 of randomized controlled trials comparing balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another were included. Methodological quality of each trial was assessed using the Cochrane Collaboration tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were quality of life, walking capacity evaluated by treadmill or questionnaire, change in Rutherford classification, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, amputation, death, major adverse cardiac events, or event-free survival with follow-up periods of at least 1 month. RESULTS: Twenty-three trials including 3314 patients in total were identified. Eighty-five per cent patients had IC and 15% CLI. Fifteen trials showed no systematic benefit of BS over PTA. One trial comparing DES and PTA reported no significant differences in walking capacity or Rutherford classification. Four trials showed a beneficial effect on TLR rate, but not on Rutherford classification of DEB compared with PTA. In four trials DES did not systematically perform better than BS. CONCLUSION: In general, performing PTA with optional bailout stenting for ATK lesions is the preferred strategy in patients with IC. For CLI, more studies are needed for recommending an optimal treatment strategy.


Subject(s)
Arterial Occlusive Diseases/surgery , Blood Vessel Prosthesis , Endovascular Procedures/methods , Femoral Artery/surgery , Randomized Controlled Trials as Topic/methods , Humans
10.
Eur J Vasc Endovasc Surg ; 47(4): 380-7, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24485844

ABSTRACT

OBJECTIVES: In patients with a ruptured abdominal aortic aneurysm (RAAA), anatomic suitability for endovascular aneurysm repair (EVAR) depends on aortic neck and iliac artery characteristics. If the aortoiliac anatomy is unsuitable for EVAR ("hostile anatomy"), open repair (OR) is the next option. We hypothesized that the death rate for OR is higher in patients with hostile anatomy than in patients with friendly anatomy. METHODS: We conducted an observational cohort study in 279 consecutive patients with an RAAA treated with OR between 2004 and 2011. The primary endpoint was 30-day or in-hospital death. Aortoiliac anatomy (friendly vs. hostile) was determined prospectively by the vascular surgeon and the interventional radiologist treating the patient. A multivariable logistic regression analysis was done to assess the risk of dying in patients with hostile anatomy after adjustment for age, sex, comorbidity, and hemodynamic stability. RESULTS: Aortoiliac anatomy was friendly in 71 patients and hostile in 208 patients. Death rate was 38% (95% confidence interval (CI): 28 to 50%) in patients with friendly anatomy and 30% (95% CI: 24 to 37%) in patients with hostile anatomy (p = .23). After multivariable adjustment, the risk of dying was not higher in patients with hostile anatomy (adjusted odds ratio 0.744, 95% CI 0.394 to 1.404). CONCLUSION: The death rate after open repair for an RAAA is comparable in patients with friendly and hostile aortoiliac anatomy.


Subject(s)
Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/mortality , Aortic Rupture/surgery , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/pathology , Aortic Rupture/pathology , Cohort Studies , Endovascular Procedures/methods , Female , Humans , Male , Middle Aged , Risk Factors , Treatment Outcome
11.
Eur J Vasc Endovasc Surg ; 47(2): 180-6, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24290252

ABSTRACT

OBJECTIVE: Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI). METHODS: The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method. RESULTS: A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit. CONCLUSIONS: Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance.


Subject(s)
Extremities/blood supply , Ischemia/diagnosis , Quality of Life , Surveys and Questionnaires , Aged , Critical Illness , Data Interpretation, Statistical , Female , Humans , Ischemia/physiopathology , Ischemia/psychology , Ischemia/therapy , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , Time Factors , Treatment Outcome
12.
Eur J Vasc Endovasc Surg ; 46(3): 329-37, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23726770

ABSTRACT

OBJECTIVES: To evaluate the diagnostic accuracy of computed tomography angiography (CTA) in detecting arterial lesions in patients with suspected arterial injury of the upper or lower extremity due to trauma. METHODS: A systematic review and meta-analysis was carried out. Medline and Embase were searched on August 13, 2012, for studies comparing CTA with surgery, digital subtraction angiography (DSA), or follow-up, which allowed extraction of data into two-by-two tables. The methodological quality of included studies was assessed using the QUADAS tool. Summary estimates of sensitivity and specificity of CTA in identifying or excluding arterial lesions were obtained using a bivariate model. RESULTS: This review included 11 studies making up a total of 891 trauma patients. The included studies were of moderate methodological quality and at risk of misclassification and verification bias. Some 4.2% of all CTA studies were non-diagnostic. The summary estimates of sensitivity and specificity of CTA were 96.2% (95% CI 93.5-97.8%) and 99.2% (95% CI 96.8-99.8%), respectively. CONCLUSION: Despite methodological flaws, the excellent estimates of sensitivity and specificity indicate that CTA is an accurate modality for evaluating arterial lesions in patients with extremity trauma and can replace DSA.


Subject(s)
Angiography/methods , Arm Injuries/diagnostic imaging , Leg Injuries/diagnostic imaging , Peripheral Vascular Diseases/diagnostic imaging , Tomography, X-Ray Computed/methods , Vascular System Injuries/diagnostic imaging , Angiography, Digital Subtraction , Humans , Sensitivity and Specificity
13.
Eur J Vasc Endovasc Surg ; 44(2): 195-8, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22709560

ABSTRACT

Presented are three cases of volleyball players with ischaemia of the hand due to arterial emboli originating from an injured posterior circumflex humeral artery (PCHA). An operative treatment with ligation of the PCHA was performed in all patients because of the proximity of the occlusion to the axillary artery. After a rehabilitation programme, all patients could return to their previous level of competition. During overhead motion, the PCHA is prone to injury in its position overlying the humeral head and its course through the quadrilateral space. Recognition of the vascular origin of these symptoms in athletes is important to prevent serious ischaemic complications. Signs of ischaemia might be subtle and may be misdiagnosed as musculoskeletal injuries. Therefore, the examining physician must have a high index of suspicion and awareness about these injuries is important.


Subject(s)
Embolism/etiology , Hand/blood supply , Humerus/blood supply , Ischemia/etiology , Vascular System Injuries/etiology , Volleyball/injuries , Adult , Arteries/injuries , Arteries/surgery , Embolism/diagnostic imaging , Embolism/surgery , Humans , Ischemia/diagnostic imaging , Ischemia/surgery , Ligation , Male , Predictive Value of Tests , Radiography , Treatment Outcome , Vascular Surgical Procedures , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/surgery , Young Adult
14.
Eur J Vasc Endovasc Surg ; 43(4): 466-71, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22326696

ABSTRACT

INTRODUCTION: Treatment of intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improving walking distance and includes secondary prevention of cardiovascular disease. Both supervised exercise therapy (SET) and percutaneous transluminal angioplasty (PTA) have proven to be effective in increasing maximum and pain-free walking distance in IC. However, the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear. OBJECTIVE: To compare the (cost-) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction. DESIGN: In a multicentre randomised controlled trial 400 consecutive patients with IC will be randomly assigned to PTA (with additional stent placement on indication) or SET. Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year. Secondary outcomes are pain-free walking distance, functional status, generic quality of life, complications related to each of the interventions, additional interventions, treatment failures and costs (cost-effectiveness and cost-utility) after 1 year. CONCLUSION AND IMPLICATIONS: Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented (Clinical Trials.gov NCT01385774; Nederlands Trial Register NTR2776).


Subject(s)
Angioplasty , Arterial Occlusive Diseases/complications , Arterial Occlusive Diseases/therapy , Exercise Therapy , Iliac Artery , Intermittent Claudication/etiology , Intermittent Claudication/therapy , Humans , Randomized Controlled Trials as Topic/methods , Time Factors
15.
Diabetes Metab Res Rev ; 28 Suppl 1: 36-9, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22271721

ABSTRACT

Diabetic foot ulceration (DFU) is recognized as one of the most serious complications of diabetes. Active revascularisation plays a crucial role in achieving ulcer healing. Non-surgical, minimally invasive, revascularisation options for DFU have expanded over the last decade and have become a prominent tool to prevent amputation. Endovascular treatment of arterial DFU lesions is mainly concentrated in the below-the-knee arteries. The outcome of both open surgery and endovascular treatment is broadly spoken the same for the endpoints ulcer healing and limb salvage and is between 78% and 85%. The choice between endovascular treatment and open surgery should always be the outcome of a team discussion. Local expertise plays an important role in these discussions. In many institutions, the endovascular approach has currently become the first choice treatment option. The revascularisation of below-the-knee vessels needs experienced hands, team discussion and the right set of devices. Centralisation in DFU centres is therefore probably the best guaranty for the best outcome.


Subject(s)
Diabetic Foot/physiopathology , Diabetic Foot/therapy , Endovascular Procedures/methods , Peripheral Vascular Diseases/prevention & control , Vascular Surgical Procedures , Amputation, Surgical , Humans , Limb Salvage , Peripheral Vascular Diseases/surgery , Wound Healing
16.
Cardiovasc Intervent Radiol ; 35(1): 76-81, 2012 Feb.
Article in English | MEDLINE | ID: mdl-21431976

ABSTRACT

INTRODUCTION: Nonoperative management (NOM) has become the treatment of choice for hemodynamically stable patients with blunt splenic injury. Results of outcome after NOM are predominantly based on large-volume studies from level 1 trauma centers in the United States. This study was designed to assess the results of NOM in a relatively low-volume Dutch level 1 trauma center. METHODS: An analysis of a prospective trauma registry was performed for a 6-year period before (period 1) and after the introduction and implementation of splenic artery embolization (SAE) (period 2). Primary outcome was the failure rate of initial treatment. RESULTS: A total of 151 patients were reviewed. An increased use of SAE and a reduction of splenic operations during the second period was observed. Compared with period 1, the failure rate after observation in period 2 decreased from 25% to 10%. The failure rate after SAE in period 2 was 18%. The splenic salvage rate (SSR) after observation increased from 79% in the first period to 100% in the second period. During the second period, all patients with failure after observation were successfully treated with SAE. The SSR after SAE in periods 1 and 2 was respectively 100% and 86%. CONCLUSIONS: SAE of patients with blunt splenic injuries is associated with a reduction in splenic operations. The failure and splenic salvage rates in this current study were comparable with the results from large-volume studies of level 1 trauma centers. Nonoperative management also is feasible in a relatively low-volume level 1 trauma center outside the United States.


Subject(s)
Embolization, Therapeutic/methods , Spleen/injuries , Splenic Artery , Wounds, Nonpenetrating/therapy , Adult , Chi-Square Distribution , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Spleen/diagnostic imaging , Statistics, Nonparametric , Tomography, X-Ray Computed , Trauma Centers , Treatment Outcome , Wounds, Nonpenetrating/diagnostic imaging
18.
Br J Surg ; 99(1): 16-28, 2012 Jan.
Article in English | MEDLINE | ID: mdl-21928409

ABSTRACT

BACKGROUND: The aim was to summarize the results of all randomized clinical trials (RCTs) comparing percutaneous transluminal angioplasty (PTA) with (supervised) exercise therapy ((S)ET) in patients with intermittent claudication (IC) to obtain the best estimates of their relative effectiveness. METHODS: A systematic review was performed of relevant RCTs identified from the MEDLINE, Embase and Cochrane Library databases. Eligible RCTs compared PTA with (S)ET, included patients with IC due to suspected or known aortoiliac and/or femoropopliteal artery disease, and compared their effectiveness in terms of functional outcome and/or quality of life (QoL). RESULTS: Eleven of 258 articles identified (reporting data on eight randomized clinical trials) met the inclusion criteria. One trial included patients with isolated aortoiliac artery obstruction, three trials studied those with femoropopliteal artery obstruction and five included those with combined lesions. Two trials compared PTA with advice on ET, four PTA with SET, two PTA plus SET with SET and two PTA plus SET with PTA. Although the endpoints in most trials comprised walking distances and QoL, pooling of data was impossible owing to heterogeneity. Generally, the effectiveness of PTA and (S)ET was equivalent, although PTA plus (S)ET improved walking distance and some domains of QoL scales compared with (S)ET or PTA alone. CONCLUSION: As IC is a common healthcare problem, defining the optimal treatment strategy is important. A combination of PTA and exercise (SET or ET advice) may be superior to exercise or PTA alone, but this needs to be confirmed.


Subject(s)
Angioplasty, Balloon , Exercise , Intermittent Claudication/therapy , Aortic Diseases/therapy , Exercise Test , Femoral Artery/pathology , Humans , Iliac Artery/pathology , Intermittent Claudication/pathology , Intermittent Claudication/physiopathology , Intermittent Claudication/prevention & control , Outcome Assessment, Health Care , Popliteal Artery/pathology , Quality of Life , Randomized Controlled Trials as Topic , Secondary Prevention , Surveys and Questionnaires
20.
Neth J Med ; 69(6): 274-8, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21868811

ABSTRACT

The validity of uterine artery embolisation (UAE ) as an alternative treatment for hysterectomy to treat symptomatic uterine fibroids has been well established. Despite its favourable outcomes, UAE is still only marginally applied in the Netherlands. The aim of this inventory is to identify factors which either restrict or facilitate the implementation of UAE. Gynaecologists and interventional-radiologists in three hospitals in Amsterdam were interviewed by means of questionnaires. One of these hospitals had ample experience in UAE for uterine fibroids, one hospital had just started providing this treatment, and one hospital did not perform UAE. Also patients with symptomatic fibroids who were scheduled for either UAE or hysterectomy were interviewed about the counselling for UAE. The following obstacles in the implementation of UAE were found: lack of knowledge about UAE , absence of a multidisciplinary protocol, and above all, the absence of UAE as one of the treatment options in the Dutch national guideline on the management of menorrhagia. 75% of all patients claimed to be well informed about UAE by their gynaecologist. Our recommendations for the implementation of UAE are: 1) adding UAE to the Dutch guideline for the management of menorrhagia with clearly defined indications and contraindications; 2) educating gynaecologists about UAE; 3) composing a patient information leaflet and a website, and 4) arranging a protocol in a multidisciplinary team.


Subject(s)
Hysterectomy/statistics & numerical data , Leiomyoma/therapy , Menorrhagia/therapy , Uterine Artery Embolization/statistics & numerical data , Attitude of Health Personnel , Decision Making , Female , Gynecology/education , Gynecology/methods , Gynecology/standards , Humans , Interviews as Topic , Leiomyoma/complications , Leiomyoma/surgery , Menorrhagia/etiology , Menorrhagia/surgery , Netherlands , Patient Education as Topic , Patient Preference , Premenopause , Radiology, Interventional/education , Radiology, Interventional/methods , Radiology, Interventional/standards
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