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Journal of Endovascular Therapy : An... Mar 2024The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated...
BACKGROUND
The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty.
PURPOSE
To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries.
METHODS
A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years.
RESULTS
Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs.
CONCLUSION
In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results.
CLINICAL TRIAL REGISTRATION
German Clinical Trials Register: DRKS00031245.
CLINICAL IMPACT
The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.
PubMed: 38546131
DOI: 10.1177/15266028241240898 -
Healthcare (Basel, Switzerland) Feb 2024The prevalence of calcium deposits in coronary arteries grows with age. Risk factors include, e.g., diabetes and chronic kidney disease. There are several underlying... (Review)
Review
The prevalence of calcium deposits in coronary arteries grows with age. Risk factors include, e.g., diabetes and chronic kidney disease. There are several underlying pathophysiological mechanisms of calcium deposition. Severe calcification increases the complexity of percutaneous coronary interventions. Invasive techniques to modify the calcified atherosclerotic plaque before stenting have been developed over the last years. They include balloon- and non-balloon-based techniques. Rotational atherectomy has been the most common technique to treat calcified lesions but new techniques are emerging (orbital atherectomy, intravascular lithotripsy, laser atherectomy). The use of intravascular imaging (intravascular ultrasound and optical coherence tomography) is especially important during the procedures in order to choose the optimal strategy and to assess the final effect of the procedure. This review provides an overview of the role of coronary calcification for percutaneous coronary interventions.
PubMed: 38470631
DOI: 10.3390/healthcare12050520 -
Catheterization and Cardiovascular... Nov 2023Severely calcified coronary lesions present a particular challenge for percutaneous coronary intervention. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Severely calcified coronary lesions present a particular challenge for percutaneous coronary intervention.
AIMS
The aim of this randomized study was to determine whether coronary intravascular lithotripsy (IVL) is non-inferior to rotational atherectomy (RA) regarding minimal stent area (MSA).
METHODS
The randomized, prospective non-inferiority ROTA.shock trial enrolled 70 patients between July 2019 and November 2021. Patients were randomly (1:1) assigned to undergo either IVL or RA before percutaneous coronary intervention of severely calcified coronary lesions. Optical coherence tomography was performed at the end of the procedure for primary endpoint analysis.
RESULTS
The primary endpoint MSA was lower but non-inferior after IVL (mean: 6.10 mm , 95% confidence interval [95% CI]: 5.32-6.87 mm ) versus RA (6.60 mm , 95% CI: 5.66-7.54 mm ; difference in MSA: -0.50 mm , 95% CI: -1.52-0.52 mm ; non-inferiority margin: -1.60 mm ). Stent expansion was similar (RA: 0.83 ± 0.10 vs. IVL: 0.82 ± 0.11; p = 0.79). There were no significant differences regarding contrast media consumption (RA: 183.1 ± 68.8 vs. IVL: 163.3 ± 55.0 mL; p = 0.47), radiation dose (RA: 7269 ± 11288 vs. IVL: 5010 ± 4140 cGy cm ; p = 0.68), and procedure time (RA: 79.5 ± 34.5 vs. IVL: 66.0 ± 19.4 min; p = 0.18).
CONCLUSION
IVL is non-inferior regarding MSA and results in a similar stent expansion in a random comparison with RA. Procedure time, contrast volume, and dose-area product do not differ significantly.
Topics: Humans; Atherectomy, Coronary; Coronary Artery Disease; Constriction, Pathologic; Prospective Studies; Coronary Angiography; Treatment Outcome; Vascular Calcification; Lithotripsy
PubMed: 37668088
DOI: 10.1002/ccd.30815 -
Journal of Endovascular Therapy : An... Jul 2023Clinical trials have demonstrated the superiority of drug-coated balloon (DCB) to noncoated balloon angioplasty for the treatment of femoropopliteal (FP) lesions. In...
PURPOSE
Clinical trials have demonstrated the superiority of drug-coated balloon (DCB) to noncoated balloon angioplasty for the treatment of femoropopliteal (FP) lesions. In those trials, the difference of primary patency between DCB and noncoated angioplasty widens especially after 6 months, speculating that the antirestenosis effect of paclitaxel is manifested after 6 months. Factors associated with restenosis after 6 months differ from those associated with restenosis within 6 months. This study aimed to elucidate the prognostic factors associated with early (within 6 months) and late (after 6 months) restenosis following DCB treatment in real-world FP practice.
MATERIALS AND METHODS
This multicenter, retrospective study analyzed 486 FP lesions (mean lesion length, 11.9±10.1 cm; chronic total occlusion, 21.0%) in 423 patients (diabetes mellitus, 59.3%; hemodialysis, 37.1%; chronic limb-threatening ischemia, 41.6%) who underwent successful DCB treatment between January 2018 and December 2019. The outcome measure was restenosis which is defined as a peak systolic velocity ratio >2.4 based on duplex ultrasound findings. Early and late restenosis were classified by the cutoff period of 6 months after the procedure. The associations of baseline and procedural characteristics with early and late restenosis were explored using Cox proportional hazards regression analysis.
RESULTS
The mean follow-up period was 25.3±12.1 months. The 6, 12, 18, and 24 month cumulative incidences of restenosis were 7.4%±2.4%, 20.9%±3.9%, 29.9%±4.5%, and 38.4%±5.1%, respectively. During the follow-up period, early and late restenosis was evident in a total of 31 lesions and 138 lesions, respectively. Multivariate analysis revealed that chronic total occlusion (hazard ratio [HR], 2.29; 95% confidence interval [CI], 1.07-4.92; p=0.033) and superficial femoral artery ostial lesion (HR, 2.73; 95% CI, 1.28-5.80; p=0.009) were significantly associated with early restenosis. On the other hand, calcification circumference over 270° (HR, 1.67; 95% CI, 1.17-2.37; p=0.004), distal external elastic membrane diameter under 5 mm assessed by intravascular ultrasound (HR, 1.90; 95% CI, 1.29-2.79; p=0.001), and involving popliteal arterial lesion (HR, 1.54; 95% CI, 1.08-2.21; p=0.017) were significantly associated with late restenosis.
CONCLUSION
The prognostic factors associated with late restenosis differed from those associated with early restenosis in the real-world FP-DCB practice.
CLINICAL IMPACT
The current multicenter, retrospective study revealed that factors associated with early restenosis differed from those with late restenosis in the real-world FP-DCB practice. CTO and SFA ostial lesion were associated with early restenosis, while severe calcification, smaller vessel, and involving popliteal arterial lesions were associated with late restenosis.Early restenosis indicates "balloon failure" and would potentially result from recoil, which primary stent implantation might be required. On the other hand, late restenosis after 6 months would be attributed to "DCB failure", with inadequate drug uptake into the arterial wall, which might be minimized by the use of atherectomy devices.
PubMed: 37477010
DOI: 10.1177/15266028231186717 -
EuroIntervention : Journal of EuroPCR... May 2024
Topics: Humans; Atherectomy, Coronary; Plaque, Atherosclerotic; Vascular Calcification; Coronary Artery Disease; Treatment Outcome
PubMed: 38776145
DOI: 10.4244/EIJ-E-24-00014 -
The American Journal of Cardiology Oct 2023Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose... (Meta-Analysis)
Meta-Analysis
Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high-/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications.
Topics: Humans; Male; Aged; Female; Lithotripsy; Stents; Endovascular Procedures; Atherectomy; Atherectomy, Coronary; Constriction, Pathologic
PubMed: 37611414
DOI: 10.1016/j.amjcard.2023.07.144 -
Vascular Medicine (London, England) Mar 2024This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries....
This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, = 0.03). Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. ().
PubMed: 38493349
DOI: 10.1177/1358863X241231943 -
Cardiovascular Intervention and... Oct 2023The concept of lifetime management has not been discussed in the field of percutaneous coronary intervention (PCI), because the durability of drug-eluting stent (DES) is... (Review)
Review
The concept of lifetime management has not been discussed in the field of percutaneous coronary intervention (PCI), because the durability of drug-eluting stent (DES) is considered to be long enough for most patients. Furthermore, even if in-stent restenosis occurs, the treatment for in-stent restenosis is simple in most cases. On the other hand, the long-term clinical outcomes after DES implantation are worse in severely calcified coronary lesions than in non-calcified lesions. Moreover, the treatment for in-stent calcified restenosis or restenosis due to stent underexpansion is not simple. The concept of lifetime management of severely calcified lesions may be necessary like that of aortic stenosis. Recently, several algorithms have been published in PCI to severely calcified lesions, partly because of the emergence of IVL. These algorithms focus on the selection of cracking and debulking devices for the preparation of stenting. However, the optimal stent expansion does not guarantee the long-term patency, when the target lesion includes calcified nodules. Stent restenosis due to calcified nodules is difficult to manage. In this review article, we propose the algorithm for severely calcified lesions focused on the shape of calcification. We do not need to hesitate stenting when multiple cracks on circumferential calcification are observed by intravascular imaging devices. However, DCB may be an option as final device in some situations, when lifetime management of severely calcified lesions is considered.
Topics: Humans; Coronary Artery Disease; Percutaneous Coronary Intervention; Angioplasty, Balloon, Coronary; Drug-Eluting Stents; Coronary Restenosis; Coronary Angiography; Treatment Outcome; Vascular Calcification; Atherectomy, Coronary
PubMed: 37542662
DOI: 10.1007/s12928-023-00950-x -
Progress in Cardiovascular Diseases Jun 2024Calcific coronary artery stenosis is a complex disease associated with adverse outcomes and suboptimal percutaneous treatment. Calcium plaque modification has emerged as... (Review)
Review
Calcific coronary artery stenosis is a complex disease associated with adverse outcomes and suboptimal percutaneous treatment. Calcium plaque modification has emerged as a key strategy to tackle the issues that accompany calcific stenosis - namely reduced device deliverability, unpredictable lesion characteristics, and difficult dilatation. Atherectomy has traditionally been the treatment modality of choice for heavily calcified coronary stenoses. Contemporary technologies have emerged to aid with planning, preparation, and treatment of calcified coronary stenosis in an attempt to improve procedural success and long-term outcomes. In this State Of The Art Review, we synthesize the body of data surrounding the diagnosis, imaging, and treatment of calcific coronary disease, with a focus on i) intravascular imaging, ii) calcific lesion preparation, iii) treatment modalities including atherectomy, and iv) updated treatment algorithms for the management of calcified coronary stenosis.
PubMed: 38925256
DOI: 10.1016/j.pcad.2024.06.007 -
Interventional Cardiology Clinics Oct 2023Persons with chronic kidney disease (CKD) are at a higher risk of developing peripheral artery disease (PAD) and its adverse health outcomes than individuals with normal... (Review)
Review
Persons with chronic kidney disease (CKD) are at a higher risk of developing peripheral artery disease (PAD) and its adverse health outcomes than individuals with normal renal function. Among patients with CKD, PAD is predominantly characterized by the calcification of the medial layer of arterial vessels in addition to intimal atherosclerosis and calcification. Vascular calcification (VC) is initiated by CKD-associated hyperphosphatemia, hypercalcemia, high concentrations of parathyroid hormone (PTH) as well as inflammation and oxidative stress. VC is widely prevalent in this cohort (>80% dialysis and 50% patients with CKD) and contributes to reduced arterial compliance and symptomatic peripheral arterial disease (PAD). The most severe form of PAD is critical limb ischemia (CLI) which has a substantial risk for increased morbidity and mortality. Percutaneous endovascular interventions with transluminal angioplasty, atherectomy, and intravascular lithotripsy are the current nonsurgical treatments for severe calcific plaque. Unfortunately, there are no randomized controlled trials that address the optimal approach to PAD and CLI revascularization in patients with CKD.
Topics: Humans; Renal Dialysis; Peripheral Arterial Disease; Vascular Calcification; Atherosclerosis; Kidney Diseases
PubMed: 37673497
DOI: 10.1016/j.iccl.2023.06.010