-
The Journal of Invasive Cardiology Jan 2023The effectiveness and safety of a contemporary combined approach that incorporates the novel intravascular lithotripsy (IVL) technology into conventional tools including...
BACKGROUND
The effectiveness and safety of a contemporary combined approach that incorporates the novel intravascular lithotripsy (IVL) technology into conventional tools including atherectomy have yet to be studied.
METHODS
We retrospectively included consecutive patients who underwent percutaneous coronary intervention (PCI) with IVL from March 2021 to February 2022. Effectiveness (residual stenosis of <30%) and safety outcomes (procedural complications and major adverse cardiovascular event [MACE] defined as a composite of all-cause death, myocardial infarction, or target vessel revascularization) were compared between patients undergoing IVL with and without atherectomy.
RESULTS
A total of 109 patients underwent IVL, of whom 33 patients (30.3%) were treated with both IVL and atherectomy and had higher risk features including reduced cardiac function and more frequent use of mechanical circulatory support. Angiographic success for calcified de novo lesions was achieved in 85.7% and 90.6% of the combined and non-atherectomy groups, respectively (P=.49). Each group had one case of coronary perforation (P=.52) while major dissection occurred in 2 cases of calcific stent underexpansion in the combined group (6.1% vs 0%; P=.09). Thirty-day MACE occurred in 4.8% of patients including 3 deaths in the atherectomy group and 1 cardiac death and 1 myocardial infarction in the non-atherectomy group (P=.16).
CONCLUSION
Procedural success and complications were similar in patients undergoing IVL with and without atherectomy when treating calcified de novo lesions. Those who required a combined approach represented a high-risk population with high mortality, suggesting that a multidisciplinary approach is needed to optimize case selection and care beyond PCI.
Topics: Humans; Percutaneous Coronary Intervention; Retrospective Studies; Treatment Outcome; Vascular Calcification; Prospective Studies; Coronary Stenosis; Myocardial Infarction; Lithotripsy; Atherectomy, Coronary; Coronary Artery Disease; Coronary Angiography
PubMed: 36495542
DOI: 10.25270/jic/22.00310 -
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 -
Journal of Vascular Surgery Aug 2021Despite published guidelines and data for Medicare patients, it is uncertain how younger patients with intermittent claudication (IC) are treated. Additionally, the... (Observational Study)
Observational Study
OBJECTIVE
Despite published guidelines and data for Medicare patients, it is uncertain how younger patients with intermittent claudication (IC) are treated. Additionally, the degree to which treatment patterns have changed over time with the expansion of endovascular interventions and outpatient centers is unclear. Our goal was to characterize IC treatment patterns in the commercially insured non-Medicare population.
METHODS
The IBM MarketScan Commercial Database, which includes more than 8 billion US commercial insurance claims, was queried for patients newly diagnosed with IC from 2007 to 2016. Patient demographics, medication profiles, and open/endovascular interventions were evaluated. Time trends were modeled using simple linear regression and goodness-of-fit was assessed with coefficients of determination (R). A patient-centered cohort sample and a procedure-focused dataset were analyzed.
RESULTS
Among 152,935,013 unique patients in the database, there were 300,590 patients newly diagnosed with IC. The mean insurance coverage was 4.4 years. The median patients age was 58 years and 56% of patients were male. The prevalence of statin use was 48% among patients at the time of IC diagnosis and increased to 52% among patients after one year from diagnosis. Interventions were performed in 14.3%, of whom 20% and 6% underwent two or more and three or more interventions, respectively. The median time from diagnosis to intervention decreased from 230 days in 2008 days to 49 days in 2016 (R = 0.98). There were 16,406 inpatient and 102,925 ambulatory interventions for IC over the study period. Among ambulatory interventions, 7.9% were performed in office-based/surgical centers. The proportion of atherectomies performed in the ambulatory setting increased from 9.7% in 2007 to 29% in 2016 (R = 0.94). In office-based/surgical centers, 57.6% of interventions for IC used atherectomy in 2016. Atherectomy was used in ambulatory interventions by cardiologists in 22.6%, surgeons in 15.2%, and radiologists in 13.6% of interventions. Inpatient atherectomy rates remained stable over the study period. Open and endovascular tibial interventions were performed in 7.9% and 7.8% of ambulatory and inpatient IC interventions, respectively. Tibial bypasses were performed in 8.2% of all open IC interventions.
CONCLUSIONS
There has been shorter time to intervention in the treatment of younger, commercially insured patients with IC, with many receiving multiple interventions. Statin use was low. Ambulatory procedures, especially in office-based/surgical centers, increasingly used atherectomy, which was not observed in inpatient settings.
Topics: Age Factors; Ambulatory Care; Atherectomy; Cardiologists; Databases, Factual; Endovascular Procedures; Female; Hospitalization; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Intermittent Claudication; Male; Medicare; Middle Aged; Practice Patterns, Physicians'; Quality Indicators, Health Care; Radiologists; Retrospective Studies; Surgeons; Time Factors; Time-to-Treatment; Treatment Outcome; United States; Vascular Surgical Procedures
PubMed: 33548437
DOI: 10.1016/j.jvs.2020.10.090 -
Catheterization and Cardiovascular... Feb 2020Evaluate sex differences in procedural net adverse clinical events and long-term outcomes following rotational atherectomy (RA). (Comparative Study)
Comparative Study Observational Study
AIM
Evaluate sex differences in procedural net adverse clinical events and long-term outcomes following rotational atherectomy (RA).
METHODS AND RESULTS
From August 2010 to 2016, 765 consecutive patients undergoing RA PCI were followed up for a median of 4.7 years. 285 (37%) of subjects were female. Women were older (mean 76 years vs. 72 years; p < .001) and had more urgent procedures (64.6 vs. 47.3%; p < .001). Females received fewer radial procedures (75.1 vs. 85.1%; p < .001) and less intravascular imaging guidance (16.8 vs. 25.0%; p = .008). After propensity score adjustment, the primary endpoint of net adverse cardiac events (net adverse clinical events: all-cause death, myocardial infarction, stroke, target vessel revascularization plus any procedural complication) occurred more often in female patients (15.1 vs. 9.0%; adjusted OR 1.81 95% CI 1.04-3.13; p = .037). This was driven by an increased risk of procedural complications rather than procedural major adverse cardiac events (MACE). Specifically, women were more likely to experience coronary dissection (4.6 vs. 1.3%; p = .008), cardiac tamponade (2.1 vs. 0.4%; p = .046) and significant bleeding (BARC ≥2: 5.3 vs. 2.3). Despite this, overall MACE-free survival was similar between males and females (adjusted HR 1.03; 95% CI 0.80-1.34; p = .81). Procedural complications during RA were associated with almost double the incidence of MACE at long-term follow-up (HR 1.92; 95% CI 1.34-2.77; p < .001).
CONCLUSION
Women may be at greater risk of procedural complications following rotational atherectomy. These include periprocedural bleeding episodes and coronary perforation leading to cardiac tamponade. Despite this, the adjusted overall long-term survival free of major adverse cardiac events was similar between males and females.
Topics: Aged; Aged, 80 and over; Atherectomy, Coronary; Cardiac Tamponade; Coronary Artery Disease; Coronary Vessels; Cross-Sectional Studies; Databases, Factual; Female; Heart Injuries; Hemorrhage; Humans; Male; Middle Aged; Progression-Free Survival; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Time Factors
PubMed: 31264314
DOI: 10.1002/ccd.28373 -
EuroIntervention : Journal of EuroPCR... Apr 2023The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. ...
BACKGROUND
The use of atherectomy during peripheral endovascular interventions (PVI) has increased dramatically, but data regarding its safety and effectiveness are lacking. Aims: This study sought to determine the long-term safety of atherectomy in contemporary practice. Methods: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery PVI from 2015-2018 were identified in a 100% sample of inpatient, outpatient, and carrier file data using procedural claims codes. The primary exposure was the use of atherectomy. Inverse probability of treatment weighting was used to adjust for measured differences in patient populations. Kaplan-Meier methods and multivariable Cox proportional hazards regression were used to compare outcomes. Results: Among 168,553 patients who underwent PVI, 59,142 (35.1%) underwent atherectomy. The mean patient age was 77.0±7.6 years, 44.9% were female, 81.9% were white, and 46.7% had chronic limb-threatening ischaemia. Over a median follow-up time of 993 days (interquartile range 319-1,377 days), atherectomy use was associated with no difference in the risk of either the composite endpoint of death and amputation (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI]: 0.97-1.01; p=0.19) or of major adverse limb events (aHR 1.02, 95% CI: 0.99-1.05; p=0.26). Patients who underwent atherectomy had a modest reduction in the risk of subsequently undergoing amputation or surgical revascularisation (aHR 0.92, 95% CI: 0.90-0.94; p<0.01) but an increase in the risk of undergoing a subsequent PVI (aHR 1.19, 95% CI: 1.16-1.21; p<0.01).
CONCLUSIONS
The use of atherectomy during femoropopliteal artery PVI was not associated with an increase in the risk of long-term adverse safety outcomes among patients with peripheral artery disease.
Topics: Humans; Female; Aged; United States; Aged, 80 and over; Male; Treatment Outcome; Risk Factors; Medicare; Atherectomy; Femoral Artery; Peripheral Arterial Disease; Retrospective Studies; Endovascular Procedures
PubMed: 36373386
DOI: 10.4244/EIJ-D-22-00609 -
Cureus Jun 2023The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US...
BACKGROUND
The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal.
METHODS
The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022.
RESULTS
A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire (66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001).
CONCLUSION
Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians to anticipate complications and escalate care appropriately.
PubMed: 37485105
DOI: 10.7759/cureus.40817 -
Interventional Cardiology 2023Although Percutaneous Coronary Intervention (PCI) has revolutionized the management of CAD, the deliverability of devices including balloons, specialty balloons, stents,...
Although Percutaneous Coronary Intervention (PCI) has revolutionized the management of CAD, the deliverability of devices including balloons, specialty balloons, stents, atherectomy catheters, thrombectomy devices, and intravascular lithotripsy devices has become a common challenge faced by interventional cardiologists. Guide Extension Catheters (GECs) have been developed and are now widely used to create improved backup support to allow the advancement of interventional equipment required for the PCI. Improved lesion preparation, plaque modification (e.g., with atherectomy), and Guide Extension Catheters (GEC), also called as Mother-Child Technique, has proven critical to procedural success in complex cases. In this review, we discuss the role and limitations of current guide extension devices, with a brief discussion of next-generation GEC.
PubMed: 38094912
DOI: No ID Found -
Medicina (Kaunas, Lithuania) Nov 2022: Peripheral arterial disease (PAD) contains a significant proportion of patients whose main pathology is located in the infragenicular arteries. The treatment of these...
: Peripheral arterial disease (PAD) contains a significant proportion of patients whose main pathology is located in the infragenicular arteries. The treatment of these patients requires a deliberate consideration due to the threat of possible complications of an intervention. In this retrospective study, the feasibility of a below-the-knee atherectomy (BTKA) via a 1.5 mm Phoenix atherectomy catheter and the patient outcome over the course of 6 months are investigated. : The data of patients suffering from PAD with an infragenicular pathology treated via 1.5 mm Phoenix™ atherectomy catheter between March 2021 and February 2022 were retrospectively analyzed. Prior to the intervention, after 2 weeks and 6 months, the PAD stages were graded and ankle-brachial-indeces (ABI) were measured. : The study shows a significant improvement of ABI, both after 2 weeks and 6 months. Additionally, the number of PAD stage IV patients decreased by 15.2% over the course of 6 months, and 18.2% of the patients improved to PAD stage IIa. Only one bleeding complication on the puncture side occurred over the whole study, and no other complications were observed. : Phoenix™ atherectomy usage in the BTKA area seems to be feasible and related to a favorable outcome in this retrospective study. .
Topics: Humans; Retrospective Studies; Feasibility Studies; Treatment Outcome; Atherectomy; Peripheral Arterial Disease; Catheters; Vascular Patency
PubMed: 36363551
DOI: 10.3390/medicina58111594 -
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 -
VASA. Zeitschrift Fur Gefasskrankheiten Sep 2022The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare...
The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare nitinol stent (BNS). This retrospective cohort study included patients with femoropopliteal artery lesions who underwent percutaneous endovascular surgery between January 2016 and June 2019. The primary outcome was the primary patency rate after 12, 24, and 36 months; the secondary outcomes comprised incidence of flow-limiting dissections, technical success, limb salvage, and all-cause death. During the study period, 110 (44%) patients underwent DA+DCB, and 140 (56%) patients underwent bare nitinol stent (BNS). There were no differences in the 12- and 24-month patency rates of the two groups (98.2% vs. 93.6% and 68.2% vs. 60.0%, both >.05). The 36-month primary patency rate in the DA+DCB group was significantly higher than that of the BNS group (27.3% vs. 15.7%, =.003). The technical success rate and all-cause death were similar between groups (>.05). Flow-limiting dissections occurred more frequently in the BNS group than in the DA+DCB group (27.9% vs. 10.9%, =.033). After adjustment for potential confounders, such as sex, smoking, hypertension, hyperlipidemia, ABI after surgery, TASC II B, lesion length ≥15 cm, two-vessel runoff, and three-vessel runoff, the HR for primary patency rate comparing BNS to DA+DCB was 2.61 (95%CI: 1.61-4.25). In this retrospective cohort study, DA+DCB was associated with a higher 30-month primary patency rate and a lower flow-limiting dissection incidence than BNS.
Topics: Alloys; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency
PubMed: 35801303
DOI: 10.1024/0301-1526/a001010