PMID- 36896876
OWN - NLM
STAT- Publisher
LR  - 20230310
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
DP  - 2023 Mar 10
TI  - Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely 
      Calcified Common Femoral Artery Atherosclerotic Disease.
PG  - 15266028231158313
LID - 10.1177/15266028231158313 [doi]
AB  - OBJECTIVES: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) 
      angioplasty might be a valuable alternative to surgery for calcified common 
      femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months 
      performance of this treatment strategy remains unknown. This study reports on the 
      12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA 
      lesions. METHODS: This is a retrospective single-center, single-arm study. 
      Consecutive patients treated by IVL and DCB for calcified CFA disease between 
      February 2017 and September 2020 were evaluated. The primary measure outcome of 
      this analysis was primary patency. Procedural technical success (<30% stenosis), 
      freedom from target lesion revascularization (TLR), secondary patency, and 
      overall mortality were additionally analyzed. RESULTS: Thirty-three (n=33) 
      patients were included in this study. The majority presented with lifestyle 
      limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney 
      disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 
      97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) 
      and a peripheral embolization in a single patient (3%), while the bail-out 
      stenting rate amounted to 12% (n=4). No perforation was observed. The median 
      length of hospital stay was 2 days (interquartile range 2-3). At 12 months, the 
      primary patency was 72%. The freedom from TLR and the secondary patency rates 
      were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% 
      (n=25) of the patients were asymptomatic or presented with mild claudication. The 
      presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; 
      confidence interval (CI); 0.18-4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29-5.8; 
      p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13-2.63; 
      p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13-3.53; p=0.65) did not 
      influence the primary patency. CONCLUSIONS: In this study, the combination of IVL 
      and DCB angioplasty for calcified CFA disease was associated with low risk for 
      periprocedural complications, acceptable 12 months clinical outcomes, and low 
      rates of reinterventions. CLINICAL IMPACT: Intravascular lithotripsy in 
      combination with DCB angioplasty can be an alternative to surgery in highly 
      selected patients with CFA atherosclerotic disease. In this Cohort the 
      combination therapy lead to acceptable clinical results and low reintervention 
      rates at 12 months.
FAU - Stavroulakis, Konstantinos
AU  - Stavroulakis K
AUID- ORCID: 0000-0002-9775-9210
AD  - Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, 
      Munich, Germany.
FAU - Torsello, Giovanni
AU  - Torsello G
AUID- ORCID: 0000-0001-7513-5063
AD  - Department of Vascular Surgery, St. Franziskus-Hospital GmbH, Munster, Germany.
FAU - Chlouverakis, Gregory
AU  - Chlouverakis G
AD  - Biostatistics Laboratory, Department of Social Medicine, School of Medicine, 
      University of Crete, Rethymno, Greece.
FAU - Bisdas, Theodosios
AU  - Bisdas T
AD  - Department of Vascular and Endovascular Surgery, Athens Medical Center, Marousi, 
      Greece.
FAU - Damerau, Sarah
AU  - Damerau S
AD  - Department of Vascular Surgery, St. Franziskus-Hospital GmbH, Munster, Germany.
FAU - Tsilimparis, Nikolaos
AU  - Tsilimparis N
AD  - Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, 
      Munich, Germany.
FAU - Argyriou, Angeliki
AU  - Argyriou A
AUID- ORCID: 0000-0002-8075-9695
AD  - Department of Vascular Surgery, Marien Hospital Herne, Herne, Germany.
LA  - eng
PT  - Journal Article
DEP - 20230310
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  - calcification
OT  - common femoral artery
OT  - drug-coated balloon
OT  - lithotripsy
OT  - peripheral arterial disease
EDAT- 2023/03/11 06:00
MHDA- 2023/03/11 06:00
CRDT- 2023/03/10 06:43
PHST- 2023/03/10 06:43 [entrez]
PHST- 2023/03/11 06:00 [pubmed]
PHST- 2023/03/11 06:00 [medline]
AID - 10.1177/15266028231158313 [doi]
PST - aheadofprint
SO  - J Endovasc Ther. 2023 Mar 10:15266028231158313. doi: 10.1177/15266028231158313.