PMID- 37853746
OWN - NLM
STAT- Publisher
LR  - 20231019
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
DP  - 2023 Oct 18
TI  - Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified 
      Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening 
      Ischemia.
PG  - 15266028231205421
LID - 10.1177/15266028231205421 [doi]
AB  - PURPOSE: Vessel calcification is estimated to be present in 30% to 50% of 
      patients with peripheral arterial disease (PAD) and is one of the main challenges 
      in endovascular treatment. The popliteal artery is unique compared with other 
      arteries due to its exposure to significant deformation and biomechanical stress 
      during knee motion. Intravascular lithotripsy (IVL) is a novel technique that 
      uses acoustic pressure waves to cause microfractures within the intimal and 
      medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal 
      and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the 
      purpose of this study was to describe the first follow-up outcomes of IVL in 
      popliteal and infrapopliteal arterial disease. METHODS: This prospective, 
      multicenter cohort study included all patients treated with IVL in the popliteal 
      and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex 
      ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety 
      endpoint was a composite of major adverse events (MAEs) at 30 days. Primary 
      efficacy endpoints were primary patency, limb salvage, and amputation-free 
      survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency 
      and freedom from target lesion revascularization (TLR). Endpoints were 
      distributed for patients with chronic limb-threatening ischemia (CLTI) and 
      intermittent claudication (IC) and estimated using the Kaplan-Meier method. 
      RESULTS: Between April 2021 and March 2023, 29 patients with 30 limbs were 
      treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of 
      patients, respectively. Within the 32 treated lesions, severe calcification was 
      present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four 
      MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 
      deaths, neither of which was related to the study device. The primary patency, 
      primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months 
      were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No 
      events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality 
      in patients with IC. CONCLUSIONS: This first-ever analysis on follow-up outcomes 
      of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety 
      and efficacy outcomes with a low rate of bailout stenting. CLINICAL IMPACT: 
      Vessel calcification is a common feature in peripheral arterial disease (PAD) and 
      is one of the main challenges in endovascular treatment. The popliteal artery is 
      subjected to biomechanical stress during knee motion, which makes stenting 
      unappealing and often leads to worse clinical outcomes. This study aimed to 
      describe the first follow-up outcomes of IVL in popliteal and infrapopliteal 
      arterial disease. As in line with previous studies, no relevant procedural 
      complications were found and the rate of bail-out stenting was only 12.5%. 
      Moreover, in a complex patient population, this study demonstrated promising 
      safety and efficacy outcomes. The comparison of IVL with angioplasty alone or 
      other vessel preparation devices for popliteal and infrapopliteal arterial 
      disease is warranted.
FAU - Nugteren, Michael J
AU  - Nugteren MJ
AUID- ORCID: 0000-0003-2154-4077
AD  - Department of Vascular Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The 
      Netherlands.
AD  - Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The 
      Netherlands.
FAU - Hazenberg, Constantijn E V B
AU  - Hazenberg CEVB
AD  - Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The 
      Netherlands.
FAU - Akkersdijk, George P
AU  - Akkersdijk GP
AD  - Department of Vascular Surgery, Maasstad Ziekenhuis, Rotterdam, The Netherlands.
FAU - van den Heuvel, Daniel A F
AU  - van den Heuvel DAF
AUID- ORCID: 0000-0002-6515-417X
AD  - Department of Radiology, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
FAU - Schreve, Michiel A
AU  - Schreve MA
AD  - Department of Vascular Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The 
      Netherlands.
FAU - Unlu, Cagdas
AU  - Unlu C
AD  - Department of Vascular Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The 
      Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20231018
PL  - United States
TA  - J Endovasc Ther
JT  - Journal of endovascular therapy : an official journal of the International 
      Society of Endovascular Specialists
JID - 100896915
SB  - IM
OTO - NOTNLM
OT  - CLTI
OT  - IVL
OT  - calcification
OT  - infrapopliteal
OT  - intravascular lithotripsy
OT  - peripheral arterial disease
OT  - popliteal
COIS- Declaration of Conflicting InterestsThe author(s) declared no potential conflicts 
      of interest with respect to the research, authorship, and/or publication of this 
      article.
EDAT- 2023/10/19 06:45
MHDA- 2023/10/19 06:45
CRDT- 2023/10/19 03:42
PHST- 2023/10/19 06:45 [medline]
PHST- 2023/10/19 06:45 [pubmed]
PHST- 2023/10/19 03:42 [entrez]
AID - 10.1177/15266028231205421 [doi]
PST - aheadofprint
SO  - J Endovasc Ther. 2023 Oct 18:15266028231205421. doi: 10.1177/15266028231205421.