MicroStent — a Novel Device Designed for Treatment of CLTI BTK.
Best Practices and Outcomes for Primary Treatment or Bailout in European HEAL Observational Study
Marco Manzi, MD1; Lieven Maene, MD2; Michael Lichtenberg, MD3; Wouter Lansink, MD4; Daniel van den Heuvel, MD5; Andrej Schmidt, MD6; Dierk Scheinert, MD7; Marianne Brodmann, MD8; Mariano Palena, MD1,8; Koen Deloose, MD7
From 1Policlinico Abano Terme Padova Italy, 2Onze Lieve Vrouwziekenhuis (OLV) Aalst Belgium, 3Karolinen Hospital Arnsberg Germany, 4Ziekenhuis Oost-Limburg (ZOL) Genk Belgium, 5St. Antonius Hospital Nieuwegein Netherlands, 6University Hospital Leipzig, Germany, 7University Hospital LKH Graz Austria, 8Maria Cecilia Hospital, Cotignola Italy, 9A.Z. St. Blasius Dendermonde Belgium.
NOTE: During the study period, Mariano Palena’s affiliation was Maria Cecilia Hospital, Catignona Italy where he enrolled some patients; however, he recently joined Dr Manzi at the Policlinico Abano Terme, Padova, Italy.
The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
The authors report that patient consent was provided for publication of the images used herein.
Manuscript accepted September 19, 2022.
Address for correspondence: Dr. Marco Manzi, Policlinico Abano Terme, Padova Italy, Email: firstname.lastname@example.org
Objective. To evaluate the technical aspects of the MicroStent, a novel device specifically designed for the treatment of chronic limb-threatening ischemia (CLTI) below the knee (BTK) when used as primary treatment or as bailout in patients enrolled in the HEAL study, a post-market multicenter European all-comers observational study. Methods. All consecutive patients enrolled were evaluated at follow-up visits at 30 days, 6 months, 12 months and 24 months, including duplex Ultrasound evaluation of the target lesion.
Evaluation included: patient demographics, target lesion characteristics, MicroStent implantation details which included primary and bailout usage, sizing, and pre- and post-dilatation strategies.
Primary outcome measures were: primary patency at 6 months and freedom from MALE and POD at 30 days. Secondary outcome measures were: device and technical success, freedom from MALE and major amputation at 6, 12 and 24 months and freedom from CD-TLR at 6, 12 and 24 months and wound healing status at 6, 12 and 24 months.
Results. In total 78 patients were enrolled and 77 were implanted with the MicroStent, representing 78 lesions and a total of 91 MicroStent devices. Patients treated had a median age of 76 (range 46-92). Rutherford category ranged from 3 to 6: 9.1% were category 3, 19.5% were category 4, 68.8% were category 5 and 2.6% were category 6.
Medical history included: diabetes 75.3%, history of CAD 29.9%, history of peripheral intervention 45.9%, history of amputation 21.6%. Median target lesion length was 45 mm (range 10-400 mm); 51.9% pre-treatment target lesion were CTOs and 59.8% were moderate to severely calcified. MicroStents were implanted as primary treatment in 52.2% for the target cases, in 47.8% of the MicroStents were implanted as bailout options. Overall primary patency (regardless of relationship to the MicroStent) was 71% at 6 months. Device related primary patency, where the MicroStent was implanted for primary treatment of the target lesion, was 96.9% at 6 months; device related primary patency, where the MicroStent was implanted as bailout option after failed treatment of the target lesion, was 100% at 6 months. Freedom from MALE and POD (regardless of relationship to the MicroStent) was 95.9% at 30 days and 90.0% at 6 months. Device success was 98.9%. Technical success was 100%. The freedom from major amputation at 30 days and 6 months were respectively 97.3% and 94.9%. The freedom from major target lesion reintervention at 30 days and at 6 months were respectively 98.6% and 96.5%.
Conclusions. Preliminary results from the HEAL Study suggest that patients requiring treatment of PAD and CLTI in the lower limb, can be safely and effectively treated with the MicroStent when used as a primary treatment or bailout option after a failed treatment of the target lesion. HEAL Study enrollment and follow-up is ongoing.
J CRIT LIMB ISCHEM 2022;2(2):Exc=Exv