Publications by authors named "Johnny Kent Christensen"

8 Publications

  • Page 1 of 1

Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.

Ann Vasc Surg 2021 Apr 5. Epub 2021 Apr 5.

Department of Diagnostic and Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany.

Objectives: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation.

Methods: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention.

Results: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class.

Conclusion: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities.

Clinical Trial Registration: NCT02276313.
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http://dx.doi.org/10.1016/j.avsg.2021.02.050DOI Listing
April 2021

Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry.

Cardiovasc Intervent Radiol 2021 Feb 20;44(2):207-217. Epub 2020 Oct 20.

Division of Angiology, Department of Internal Medicine, Medical University Graz, Graz, Austria.

Purpose: After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions.

Methods: BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months.

Results: 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up.

Conclusion: The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313).
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http://dx.doi.org/10.1007/s00270-020-02663-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806550PMC
February 2021

Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III.

JACC Cardiovasc Interv 2020 10 16;13(19):2289-2299. Epub 2020 Sep 16.

Department of Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany.

Objectives: The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon.

Background: Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices.

Methods: BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6.

Results: The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates.

Conclusions: In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.
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http://dx.doi.org/10.1016/j.jcin.2020.06.059DOI Listing
October 2020

Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry.

J Endovasc Ther 2020 04 28;27(2):304-315. Epub 2020 Jan 28.

Division of Angiology, Department of Internal Medicine, Medical University Graz, Austria.

To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. BIOLUX P-III is an international, prospective, observational registry ( identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.
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http://dx.doi.org/10.1177/1526602819898804DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7082893PMC
April 2020

Lumbar artery aneurysm: A rare manifestation of vasculopathy in a patient with neurofibromatosis type 1.

Radiol Case Rep 2020 Mar 14;15(3):277-281. Epub 2020 Jan 14.

Department of Radiology, Sygehus Lillebaelt - Kolding Sygehus, Sygehusvej 24, 6000 Kolding, Denmark.

Lumbar artery aneurysms are rare but important to diagnose, since rupture can have serious consequences due to life-threatening hemorrhage. A 49-year-old male with Neurofibromatosis type 1 (NF-1) was admitted to the emergency room with abrupt onset of severe abdominal pain. Ultrasound examination was normal, noncontrast CT revealed a tapered retroperitoneal mass adjacent to the right psoas muscle. A multiphased contrast-enhanced CT scan raised suspicion of an arterial lumbar aneurysm and was confirmed by selective catheter based angiography. The patient underwent successful treatment with endovascular coiling and the patient was discharged within a few days after an uneventful course.
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http://dx.doi.org/10.1016/j.radcr.2019.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6965510PMC
March 2020

Calcified in-stent restenosis in a venous stent.

J Vasc Surg Cases 2015 Dec 7;1(4):261-263. Epub 2015 Nov 7.

Department of Vascular Surgery, Little Belt Hospital, Kolding, Denmark.

Stenting of the iliac veins has been an established treatment for improving venous runoff from the legs after thrombolysis of iliofemoral deep venous thrombosis for more than a decade, yet little is known about the long-term fate of stents in the central veins. We describe a case of heavily calcified in-stent restenosis in a 10-year-old venous stent as well as a way of treating this rare condition. With growing numbers of venous stents reaching a significant age, a need for treatment of long-term complications like the one presented here most probably will arise.
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http://dx.doi.org/10.1016/j.jvsc.2015.07.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6849886PMC
December 2015
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