Tjebbe Hagenaars

Reproducibility of volumetric quantification in intravascular ultrasound images

The reproducibility of volume measurements in intravascular ultrasound (IVUS) images derived from separate pull-back manoeuvres remains to be elucidated. Patients (n = 23) were imaged with IVUS prior to (first series) and following percutaneous transluminal angioplasty (PTA) (second series). In 15 patients, one matched vascular segment (3-4 cm in length), not subjected to PTA, was used for analysis of lumen, vessel and plaque volume using an automated contour analysis system. Volume measurements assessed by two independent observers and in the two separate series were compared. Interobserver differences in volume measurements were small (< or =0.4%), with low coefficients of variation (< or =1.7%) and high correlation coefficients (r = 1.00). Differences in volume measurements obtained in the two separate series were small (< or =2.6%), with low coefficients of variation (< or = 8.6%) and high correlation coefficients (r = 0.97-0.99). In conclusion, volume measurements derived from IVUS images are highly reproducible. Therefore, IVUS may be used to monitor the progression/regression of atherosclerotic plaque volume in a longitudinal study.

Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial

BackgroundThe traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries.AimA prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation.Methods/designA total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses.DiscussionThis trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures.Trial registrationNetherlands National Trial Register NTR2399

Effect of simvastatin on restenosis after percutaneous transluminal angioplasty of femoropopliteal arterial obstruction

This retrospective observational intravascular ultrasound study evaluated whether simvastatin therapy limits lumen area reduction 1-year after percutaneous transluminal angioplasty (PTA) by reducing reactive plaque growth, reducing reactive vasoconstriction, or both. This study showed that plaque growth is a general response 1 year after PTA regardless of the use of simvastatin; simvastatin has the potential to induce positive vascular remodeling, thereby reducing the occurrence of restenosis.

Rationale and design for the SARIS trial; effect of statin on atherosclerosis and vascular remodeling assessed with intravascular sonography

AbstractPurpose. The SARIS study (effect of Statin on Atherosclerosis and vascular Remodeling assessed with Intravascular Sonography) is a prospective randomized multicenter trial designed to assess both morphological and functional cardiovascular effects of atorvastatin. Methods. Participating centers will include 50 patients with normal to mildly elevated cholesterol levels eligible for balloon angioplasty and/or stent placement of the common iliac artery. Patients will be randomized to 1-year treatment with either low-dose (10 mg) or high-dose (80 mg) atorvastatin. The morphological effects of atorvastatin will be studied using intravascular ultrasound (IVUS); the effect of atorvastatin on both plaque volume and vascular remodeling seen at 1-year follow-up will be investigated. The functional cardiovascular effects of atorvastatin will be studied using dobutamine stress echocardiography (DSE); the effect of atorvastatin on myocardial coronary flow reserve at 6-months and 1-year follow-up will be investigated. The aims of the present study are noteworthy in respect that (1) IVUS is the only available technique to sensitively measure the effect of atorvastatin on both intimal hyperplasia and vascular remodeling, and (2) DSE is a non-invasive test to objectively quantify the effect of atorvastatin on the functionality of the coronary artery.

An Irreducible Ankle Fracture Dislocation: The Bosworth Injury

Irreducible fracture dislocations of the ankle are rare and represent true orthopedic emergencies. We present a case of a fracture dislocation that was irreducible owing to a fixed dislocation of the proximal fibular fragment posterior to the lateral ridge of the tibia. This particular type of injury, known as a Bosworth fracture dislocation, was not appreciated on the initial radiographs taken in the emergency room but was identified at urgent surgical management. The trauma mechanism, radiographs, treatment, and relevant published data are discussed in the present report.

Early experience with intravascular ultrasound in evaluating the effect of statins on femoropopliteal arterial disease: hypothesis-generating observations in humans.

The purpose of this study was to compare the vascular response seen with intravascular ultrasound (IVUS) at 1-year follow-up between statin-treated and non–statin-treated patients. Patients (n=10) undergoing percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery were studied with IVUS immediately after PTA and at 1-year follow-up. In nondilated matched vascular segments, the change in lumen, vessel, and plaque volume was assessed. In balloon-dilated matched vascular segments, the change in lumen, vessel, and plaque area was assessed. A comparison was made between statin-treated (n=5) and non–statin-treated patients (n=5) in lumen, vessel, and plaque changes. At follow-up, both statin-treated and non–statin-treated patients showed a similar increase in plaque volume at the nondilated segment (+4% and +2%, respectively). In statin-treated patients the plaque volume increase was compensated by an increase in vessel volume (+2%), resulting in an increase in lumen volume (+1%). In non–statin-treated patients, on the other hand, the increase in plaque volume was associated with a decrease in vessel volume (−2%), resulting in a decrease in lumen volume (−4%). At the balloon-dilated segment a similar trend in changes of lumen, vessel, and plaque was encountered. Differences between both groups of patients were not statistically significant. Despite the nonsignificant nature of the observation, this small retrospective IVUS study may generate the hypothesis that statin therapy may contribute to superior long-term lumen dimensions by inducing positive vascular remodeling both in nondilated and balloon-dilated vascular segments.

Reproducibility of calcified lesion quantification: a longitudinal intravascular ultrasound study.

In view of a prospective intravascular ultrasound (IVUS) study, the reproducibility of the extent of the calcified lesion in IVUS images derived from separate pull-back maneuvers was assessed. Patients (n = 34) were imaged with IVUS before and after percutaneous transluminal angioplasty (PTA) and at 1-y follow-up. In the presence of a calcified lesion, the largest arc and the length of the matched calcified lesions was assessed. Interobserver differences in arc measurements were low (< or = 0.7%), with low coefficients of variation (< or = 5.8%). Similarly, interexamination differences in arc and length measurements were small (< or = 1.1%), with low coefficients of variation (< or = 3.2%). At follow-up, a nonsignificant increase in both the arc (1.9%) and length (1.7%) of the calcified lesion was observed. This study showed that measurements of the calcified lesion are highly reproducible; changes seen at 1-y follow-up were not significant. We conclude that IVUS may be used to monitor the effect of medical intervention on the extent of the calcified lesion in a longitudinal study.

Vascular response in the femoropopliteal segment after implantation of an ePTFE balloon-expandable endovascular graft: an intravascular ultrasound study.

Purpose: To use intravascular ultrasound (IVUS) to document changes in vascular dimensions after placement of a balloon-expandable endograft. Methods: Thirteen patients (9 men; mean age 62 years, range 47–75) treated with an investigational polytetrafluoroethylene endograft for obstructive disease of the femoropopliteal segment were studied with IVUS immediately after endograft implantation and at follow-up. Corresponding IVUS cross sections were analyzed for changes in lumen, vessel, and plaque areas seen inside the endograft, in the anastomotic segment, and in the remote arterial segment. Results: A mean 6-month (range 1.5–9) follow-up was completed in 12 patients. Matched IVUS cross sections derived from within the endograft (n = 12) and at the endograft edges (n = 23) showed no change in lumen area (LA) in 17, reduction in 11, and dilatation in 7. Median changes within the endograft (+3%) were not significant (p = 0.28) and no neointima was found. Cross sections obtained at the anastomotic segment revealed a significant increase in LA (85%, p < 0.001), which was associated with a significant increase in both vessel area (VA) (42%, p < 0.001) and plaque area (PLA) (15%, p = 0.003) area. In the remote arterial segment, the change in LA was minimal (6%, p = 0.07), as were changes in the VA (9%, p = 0.04) and PLA (10%, p = 0.07). Conclusions: Following endograft placement, luminal changes within the endograft, at the endograft edges, and at the remote arterial segments were minimal. Intimal hyperplasia was not observed in the endograft. The distinct LA increase at the anastomotic segments was determined by the extent of VA and PLA change.

Progression of atherosclerosis at one-year follow-up seen with volumetric intravascular ultrasound in femoropopliteal arteries

Volume measurements derived from intravascular ultrasound (IVUS) images assessed with an automated contour analysis system are accurate and reproducible. However, it is unknown to what extent plaque volume may change at follow-up. Therefore, the purpose of this longitudinal study is to examine whether IVUS is a sensitive means to identify progression of atherosclerosis and its derived primary end point plaque volume at 1-year follow-up. Patients (n = 11) undergoing percutaneous transluminal angioplasty (PTA) of the femoropopliteal artery were studied with IVUS immediately after PTA in the same session and at 1-year follow-up. Matched, well-identified vascular segments (3 to 4 cm in length), not subjected to PTA, imaged at baseline and after 1-year follow-up, were used for calculation of the longitudinal change in lumen, vessel and plaque volume, and mean plaque thickness. The median length of the selected vascular segments was 4 cm. At follow-up (12+/-2 months) a nonsignificant increase in lumen volume (2.3+/-11%), vessel volume (2.0+/-7.0%), and plaque volume (3.0+/-5.1%) was seen; the mean plaque thickness increase was 2.2+/-5.6%. In conclusion, progression of atherosclerosis implies changes in plaque and vessel volume, resulting in lumen volume change. This observation has important implications for future clinical trials aimed at monitoring the effect of pharmacologic agents on the progression and/or regression of atherosclerosis.

Midterm follow-up of balloon-expandable ePTFE endografts in the femoropopliteal segment.

Purpose: To evaluate the midterm clinical outcome of patients treated with a balloon-expandable polytetrafluoroethylene (ePTFE) endograft for long-segment occlusive disease of the femoropopliteal segment. Methods: Eighty-nine patients (68 men; median age 69 years, range 43–81) with disabling claudication (n=73) or critical ischemia (n=16) were treated with an ePTFE endograft (mean length 29 cm) for 7 stenosis (mean length 9 cm) and 82 occlusions (mean length 19 cm) in the femoropopliteal segment. The follow-up protocol included Doppler ankle-brachial pressure measurement and duplex scanning or angiography of the endograft at 6-month intervals. Primary and secondary patency rates were analyzed. Results: At the last examination, the endograft was patent in 52 patients (median 17 months, range 7–50) and occluded in 35 (median 7 months, range 0–40);2 patients died of nonvascular causes with a patent endograft at 6.5 and 7 months. At follow-up, the primary and secondary endograft patency rates were 71% and 83% at 6 months, 57% and 69% at 1 year, 45% and 49% at 2 years, and 30% and 44% at 3 years, respectively. Conclusions: The midterm success of this new ePTFE endograft is limited; therefore, the device needs to be refined if this minimally invasive technique is to compete with conventional bypass surgery.