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Journal of Vascular Surgery Jun 2024Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease (PAD) treatment. We aimed to examine practice patterns...
OBJECTIVE
Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease (PAD) treatment. We aimed to examine practice patterns associated with peripheral vascular interventions (PVI) performed in the office-based laboratory (OBL) vs. outpatient hospital site of service using a nationally representative database.
METHODS
Using 100% Medicare fee-for-service claims data, we identified all patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) between 01/2017 and 12/2022. We evaluated the associations of patient and procedure characteristics with site of service using multivariable hierarchical logistic regression. We used multinomial regression models to estimate the relative risk ratios (RRR) of site of service and intervention type (angioplasty, stent, atherectomy) and intervention level (iliac, femoropopliteal, tibial) after adjusting for baseline patient characteristics and clustering by physician.
RESULTS
Of 848,526 PVI, 485,942 (57.3%) were performed in an OBL. OBL use increased significantly over time from 48.3% in 2017 to 65.5% in 2022 (P<0.001). Patients treated in OBLs were more likely to be Black (aOR 1.14, 95%CI 1.11-1.18) or other non-white race (aOR 1.13, 95%CI 1.08-1.18), have fewer comorbidities, and receive treatment for claudication vs. CLTI (aOR 1.30, 95%CI 1.26-1.33) compared to patients treated in outpatient hospital settings. Physicians with majority practice (>50% procedures) in an OBL were more likely to practice in urban settings (aOR 21.58, 95%CI 9.31-50.02), specialize in radiology (aOR 18.15, 95%CI 8.92- 36.92), and have high-volume PVI practices (aOR 2.15, 95%CI 2.10-2.29). The median time from diagnosis to treatment was shorter in OBLs, particularly for patients with CLTI (29 vs. 39 days, P<0.001). The OBL setting was the strongest predictor of patients receiving an atherectomy alone (aRRR 6.67, 95%CI 6.59-6.76) or atherectomy+stent (aRRR 10.84, 95%CI 10.64-11.05), and these findings were consistent in subgroup analyses stratified by PVI indication. OBL setting was also associated with higher risk of tibial interventions for both claudication (aRRR 3.18, 95%CI 3.11-3.25) and CLTI (aRRR 1.89, 95%CI 1.86-1.92). Average reimbursement (including procedure and facility fees) was slightly higher for OBLs compared to the hospital ($8,742/case vs. $8,459/case; P<0.001). However, in a simulated cohort resetting the OBL's intervention type distribution to that of the hospital, OBLs were associated with a hypothetical cost savings of $221,219,803 overall and $2,602 per case.
CONCLUSION
The OBL site of service was associated with greater access to care for non-white patients and shorter time from diagnosis to treatment, but more frequently performed high-cost interventions compared to the outpatient hospital setting. The benefit to patients from improved access to PAD care in OBL settings must be balanced with the potential limitations of receiving differential care.
PubMed: 38908807
DOI: 10.1016/j.jvs.2024.06.006 -
Angiology Jun 2024We investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization...
Safety and Effectiveness of Debulking for the Treatment of Infrainguinal Peripheral Artery Disease. Data From the Recording Courses of vascular Diseases Registry in 2910 Patients.
We investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization (EVR) as part of the RECording Courses of vascular Diseases (RECCORD) registry. Patient and lesion specific characteristics, including the lesion complexity score (LCS) were analyzed. The primary endpoint encompassed: (i) clinical improvement in Rutherford categories, (ii) index limb re-interventions, and (iii) major amputations during follow-up. The secondary endpoint included the need for bail-out stenting. Overall, 2910 patients were analyzed; 2552 without and 358 with debulking-assisted EVR. Patients were 72 (interquartile range (IQR) = 15) years old and 1027 (35.3%) had diabetes. Overall complication rates were similarly low in the debulking vs the non-debulking group (4.7 vs 3.2%, = .18). However, peripheral embolizations rates were low but more frequent with debulking vs. non-debulking procedures (3.9 vs 1.1%, < .001). After adjustment for clinical and lesion-specific parameters, including LCS, no differences were noted for the primary endpoint (odds ration (OR) = 0.99, 95%CI = 0.69-1.41, = .94). Bail-out stenting was less frequently performed in patients with debulking-assisted EVR (OR = 0.5, 95%CI = 0.38-0.65, < .0001). Debulking-assisted EVR is currently used in ∼12% of EVR with infrainguinal lesions and is associated with lower bail-out stent rates but higher peripheral embolization rates; no differences were found regarding index limb re-intervention and amputation rates.
PubMed: 38904281
DOI: 10.1177/00033197241263381 -
BMC Cardiovascular Disorders Jun 2024Calcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve. (Comparative Study)
Comparative Study
BACKGROUND
Calcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve.
METHODS
We evaluated the baseline clinical, procedures characteristics and outcomes of patients with severe coronary artery calcification (CAC) who underwent coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA).
RESULTS
Respectively 152 and 238 patients who underwent IVL and RA are enrolled from January 2023 to November 2023. Regarding demographic characteristics, the gender proportion, medical history of PCI and smoke history among groups reach statistical significance. Left anterior descending and right coronary artery were the main vessels treated in both groups. The 2.5 and 3.0 mm IVL balloons and 1.5 mm burr were the most commonly used. 99.3% cases were successfully implanted drug-eluting stents after IVL balloon pre-treatment, which was higher than in the group treated with RA. During hospitalization, there were no serious adverse events in the IVL group, but there were two adverse events in the RA group. Procedural complications were higher in the RA group than the IVL group (5.5% vs. 0.7%, P = 0.027).
CONCLUSIONS
IVL appears to be safe and effective for the treatment of severe CAC lesions compared to RA.
Topics: Humans; Atherectomy, Coronary; Male; Female; Lithotripsy; Vascular Calcification; Coronary Artery Disease; Aged; Treatment Outcome; Severity of Illness Index; Middle Aged; Retrospective Studies; Risk Factors; Time Factors; Drug-Eluting Stents; Coronary Angiography; Angioplasty, Balloon, Coronary; Aged, 80 and over
PubMed: 38898393
DOI: 10.1186/s12872-024-03965-1 -
The American Journal of Case Reports Jun 2024BACKGROUND Virtual reality (VR)-guided GC simulation for patients with anatomical anomalies using cardiac computed tomography (CT) has been recently reported. Rotational...
BACKGROUND Virtual reality (VR)-guided GC simulation for patients with anatomical anomalies using cardiac computed tomography (CT) has been recently reported. Rotational atherectomy (RA) for the left circumflex (LCX) ostium is challenging due to the tortuous anatomy, acute angulation, and variable vessel size compared to other lesions. The appropriate positioning and coaxiality of the guide catheter (GC) are key factors for safely performing RA. It would be beneficial if it could be simulated prior to percutaneous coronary intervention (PCI). CASE REPORT We treated a 55-year-old man with angina. We performed coronary angiography and detected an ostial calcified lesion of the LCX. We needed RA for this lesion, but PCI was very difficult and challenging. CT revealed right-sided aortic arch with stenosis of left subclavian artery from the Kommerell diverticulum at the distal part of the aortic arch. Therefore, the approach site for PCI was limited. We simulated the appropriate guide catheter and approach site for PCI by VR. PCI was successfully performed with RA, as in the VR simulation. CONCLUSIONS We successfully performed PCI for an ostial calcified lesion of the LCX in a patient with a right-sided aortic arch. Use of VR-guided GC simulation is a useful new option that can help visualize the anatomy and ensure safe procedures for complex lesions.
Topics: Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Virtual Reality; Coronary Angiography; Tomography, X-Ray Computed; Aorta, Thoracic
PubMed: 38894511
DOI: 10.12659/AJCR.944485 -
Journal of Clinical Medicine May 2024Endovascular treatment of lower-extremity peripheral disease (PAD) is associated with higher complication rates and suboptimal outcomes in women. Atherectomy has shown...
Endovascular treatment of lower-extremity peripheral disease (PAD) is associated with higher complication rates and suboptimal outcomes in women. Atherectomy has shown favourable outcomes in calcified lesions, minimising the incidence of stent placement caused by recoil or flow-limiting dissection. To date, there are no published mid-term outcomes evaluating the performance of atherectomy differentiated by sex. This study aims to evaluate sex-specific outcomes and prognostic factors affecting the results of atherectomy-assisted endovascular treatment in severe PAD. A retrospective analysis was conducted at a single centre in Germany, initiated by physicians and not sponsored by industry, on patients presenting with Rutherford categories ranging from III to V and featuring de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries. The intervention involved rotational atherectomy-assisted angioplasty utilising the Jetstream (Boston, US) device. The point of interest of this study was postinterventional clinical improvement as well as mid-term outcomes, including primary patency, over a targeted 2-year follow-up period. Statistical analysis utilised Cox regression (survival analysis) to calculate hazard ratios according to sex category. Comparative survival analysis was performed using the log-rank test and visually represented through Kaplan-Meier curves. Risk factors associated with absence of clinical improvement were examined across both sex groups utilising the chi-square or Fisher exact test, as appropriate. A total of 98 patients (103 limbs) were initially included, with >75% having moderate-to-severe lesion calcification (>50%). A total of 84 patients (97 limbs, 62 male and 35 female) proceeded to a 2-year follow-up (mean 16.4 months for males and 16.1 for females) after a successful index procedure. Age distribution, Rutherford class, diabetes, chronic kidney disease (CKD), target vessel, lesion type, and length were balanced among both groups. Similar primary patency rates, of 89% among female and 91% among male limbs, were observed ( = 0.471). Female patients exhibited a lower rate of clinical improvement based on the Rutherford scale in comparison to males (80.6% vs. 94.5%, = 0.048). CDK was the only significant prognostic factor across pooled data (odds ratio for CKD: 15.15, < 0.001). Rotational atherectomy showed comparably high rates of mid-term primary patency, with low rates of bailout stent placement. These findings highlight the beneficial use of atherectomy in female patients who are per se at risk for higher rates of complications during and after endovascular interventions.
PubMed: 38892949
DOI: 10.3390/jcm13113235 -
Journal of Endovascular Therapy : An... Jun 2024The aim of this study was to present the covered endovascular reconstruction of the iliac artery bifurcation (CERIB) technique as a revascularization option for...
PURPOSE
The aim of this study was to present the covered endovascular reconstruction of the iliac artery bifurcation (CERIB) technique as a revascularization option for aorto-iliac occlusive disease (AIOD) involving the iliac artery bifurcation.
METHODS
This was a retrospective single-center study including all patients undergoing a CERIB procedure from January 2021 until December 2022. Covered endovascular reconstruction of the iliac artery bifurcation procedures were performed percutaneously with bilateral femoral access, excepting cases where simultaneous open femoral artery reconstruction was required due to the extension of peripheral arterial occlusive disease. Standard patient, procedural, and follow-up (FU) data including survival and arterial reinterventions were gathered and analyzed.
RESULTS
A total of 13 patients were included (11/13 male, median age=70 [60-76] years). Additional open and/or endovascular procedures included endarterectomy of the femoral bifurcation (n=6), rotational atherectomy (n=2), and 1 axillary artery cutdown for upper limb access (n=1). Median operating time was 2.9 hours (1.5-4.9 hours); median radiation duration and dose were 28.4 (14.3-63.3 minutes) and 4090.6 (384.4-9430.1 cGray/cm), respectively. The stent grafts used for CERIB were BeGraft peripheral n=31, BeGraft Aortic n=4 and BeGraft peripheral plus n=1 (Bentley InnoMed GmbH, Hechingen, Germany). In 2 patients with prior stenting of the common iliac artery (CIA), only the internal and external iliac arteries (IIA and EIA) were treated in this study, and in 2 cases, additional uncovered stents were required for relining. Technical success was 100%. During a midterm FU (median 18 [4-31] months), 2 patients died from cardiovascular reasons and 1 patient with prior iliac stenting required reinterventions for recurring occlusion.
CONCLUSION
Covered endovascular reconstruction of the iliac artery bifurcation is a straightforward option for treating AIOD involving the iliac artery bifurcation that allows preservation of internal iliac artery perfusion and shows good early and midterm results. Prior iliac artery stenting may be a risk factor for early occlusion after CERIB.
CLINICAL IMPACT
Aorto-iliac occlusive disease with involvement of the internal iliac artery is encountered regularly in vascular surgical practice, but the internal iliac artery is often not included in the revascularization strategy. The present article will increase the awareness for the relevance of including the internal iliac artery in revascularization strategies and presents CERIB as another method to be added to the armamentarium of (endo-)vascular surgeons and interventionalists.
PubMed: 38880997
DOI: 10.1177/15266028241258659 -
The Canadian Journal of Cardiology Jun 2024Percutaneous coronary intervention (PCI) for lesions with eruptive calcified nodules (CNs) is associated with worse outcomes compared with that for other calcified...
BACKGROUND
Percutaneous coronary intervention (PCI) for lesions with eruptive calcified nodules (CNs) is associated with worse outcomes compared with that for other calcified lesions. We aimed to clarify the relationship between eruptive CNs at index PCI, optical coherence tomography (OCT) findings at the 8-month follow-up, and clinical outcomes using serial OCT.
METHODS
This retrospective observational study utilized data from a prospective, single-center registry. We conducted consecutive PCI for calcified lesions requiring rotational atherectomy (RA) with OCT guidance. We categorized 51 patients (54 lesions) into those with (16 patients [16 lesions]) and without eruptive CNs (35 patients [38 lesions]).
RESULTS
Post-PCI, stent expansion was comparable between the two groups, and CN-like protrusion was found in 75% of lesions with eruptive CNs. Follow-up OCT at 8 months revealed in-stent CNs in 54% of treated eruptive CN lesions, whereas lesions without eruptive CNs lacked in-stent CNs. Multivariate linear regression analysis demonstrated that eruptive CN was associated with maximum neointimal tissue (NIT) thickness (regression coefficient 0.303; 95% confidence interval: 0.057-0.549, p=0.02). Consequently, patients with eruptive CNs exhibited a higher clinically-driven target lesion revascularization (TLR) rate than did those without at 1 year (31.3% vs. 2.9%, p=0.009) and 5 years (43.8% vs. 11.4%, p=0.02). TLR primarily occurred in lesions with maximum eruptive CN arc angles>180°.
CONCLUSIONS
Following RA treatment with acceptable stent expansion, eruptive CNs before PCI correlated with greater NIT formation with in-stent CNs, resulting in a higher TLR rate, particularly in lesions with maximum eruptive CN arc angles exceeding 180°.
PubMed: 38880396
DOI: 10.1016/j.cjca.2024.06.008 -
Journal of Endovascular Therapy : An... Jun 2024Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular...
BACKGROUND
Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking.
METHODS
The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab.
RESULTS
Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment.
CONCLUSION
This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population.
CLINICAL IMPACT
In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.
PubMed: 38877777
DOI: 10.1177/15266028241255622 -
Annals of Surgical Treatment and... Jun 2024The anatomical distribution, characteristics of lesions, and treatment modalities for peripheral artery disease (PAD) are diverse. Endovascular intervention is popular...
PURPOSE
The anatomical distribution, characteristics of lesions, and treatment modalities for peripheral artery disease (PAD) are diverse. Endovascular intervention is popular for symptomatic PAD, for both intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI). We aimed to investigate the endovascular devices used by comparing patients with PAD referred for endovascular revascularization with IC and CLTI.
METHODS
We identified 736 patients with PAD enrolled in the multicenter PAD registry in South Korea from 2019 to 2022. Of these patients, 636 received endovascular treatment at the time of this study. After excluding missing data, we analyzed 506 patients with IC or CLTI. Patients' characteristics, target lesions, and endovascular device data such as type, length, balloon diameter, and stent, were examined. Procedure outcomes of the aortoiliac, femoropopliteal, and below-the-knee lesions were analyzed.
RESULTS
Patients with CLTI were more likely to have diabetes mellitus, below-the-knee interventions, and multilevel PAD than the IC group. Patients with IC had more aortoiliac artery lesions and underwent atherectomies than the CLTI group (63.3% and 61.1% 39.7% and 40.6%, respectively; P < 0.001). In patients with femoropopliteal lesions, those with CLTI were more revascularized with stents than the patients with IC, without significant differences (35.3% 29.1%, P = 0.161). Compared to the IC group, the CLTI patients showed significantly worse rates of primary patency, amputation, and mortality (P = 0.029, P < 0.001, and P < 0.001, respectively).
CONCLUSION
Among Korean patients with PAD, there is a significant difference in baseline and lesion characteristics, endovascular strategies, and short-term follow-up outcomes among those with IC and CLTI.
PubMed: 38868587
DOI: 10.4174/astr.2024.106.6.344 -
Advances in Therapy Jun 2024Pulmonary artery (PA) masses are rare. Distinguishing PA tumours from embolism is sometimes difficult, and surgical biopsy is expensive and risky. We aimed to evaluate... (Review)
Review
INTRODUCTION
Pulmonary artery (PA) masses are rare. Distinguishing PA tumours from embolism is sometimes difficult, and surgical biopsy is expensive and risky. We aimed to evaluate the efficacy of imaging-guided percutaneous endovascular biopsy (PEB) for obtaining tissues for histological diagnosis.
METHODS
We searched Cochrane, Medline, Embase, and Web of Science for PEB trials involving patients with PA masses, published from the inception of the database until August 2023.
RESULTS
We retrospectively reviewed 33 studies including 87 patients (median age 55 ± 69.3 years, 44 men) with PA masses who underwent a total of 110 PEBs. Of these patients, 34.5% (n = 38) underwent PEB-catheter aspiration (PEB-CA), 50.9% (n = 56) underwent PEB-forceps biopsy (PEB-FB) and 2.7% (n = 3) underwent PEB-directional atherectomy (PEB-DA). The most common histological aetiology of PA masses was mesenchymal tumours (n = 67, 75.9%). Tumour embolism (n = 6, 6.9%) and pulmonary embolism (n = 3, 3.4%) were the second and third most common types of PA masses, respectively. The technical success rates of PEB-CA, PEB-FB and PEB-DA were 92.1%, 94.6% and 100% (p = 0.796), respectively. Histopathological analysis provided clinical diagnostic success rates of 44.7%, 85.7% and 100% for PEB-CA, PEB-FB and PEB-DA (p < 0.001), respectively. In pairwise comparison, PEB-FB had a higher success rate in pathological diagnosis than PEB-CA (p = 0.000). Apart from one patient suffering from haemorrhagic cardiac tamponade, no other complications occurred.
CONCLUSION
Imaging-guided PEB is a safe and effective technique for the early pathological diagnosis of PA masses.
PubMed: 38861217
DOI: 10.1007/s12325-024-02903-z