Atherectomy Combined with Balloon Angioplasty versus Balloon Angioplasty Alone for de Novo Femoropopliteal Arterial Diseases: A Systematic Review and Meta-analysis of Randomised Controlled Trials.

OBJECTIVE: The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions. METHODS: The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. The methodological quality of the included studies was evaluated with the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to assess the level of evidence for each outcome. The fixed effects model was chosen to combine the data when I2 < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results. RESULTS: Four RCTs were included. The meta-analysis showed that atherectomy combined with BA was associated with improved technical success rate (risk ratio [RR] 0.22, 95% confidence interval [CI] 0.13-0.38, p < .001; I2 = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07-0.32, p < .001; I2 = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13-0.47, p < .001; I2 = 0; high quality). No statistically significant difference was found in target lesion revascularisation (TLR), primary patency, mortality, major adverse event (MAE), or ankle brachial index (ABI) after one year follow up. CONCLUSION: Compared with BA alone, atherectomy combined with BA may not improve primary patency, TLR, mortality rate, or ABI, but may reduce the need for bailout stenting and the incidence of flow limiting dissection and increase the technical success rate in FP arterial diseases. More studies are warranted to further confirm the conclusion.

Impact of office-based laboratories on physician practice patterns and outcomes after percutaneous vascular interventions for peripheral artery disease.

BACKGROUND: Percutaneous vascular interventions (PVIs) for peripheral artery disease have shifted from hospital-based facilities to office-based laboratories (OBLs). The transition to OBLs is due to a variety of factors such as technology advancement, increased efficiency, and financial incentives. We evaluated the impact of physicians switching to OBLs use from hospital-based facilities on procedure volume, procedure type, and patient outcomes. METHODS: We identified patients with PVI for lower extremity peripheral artery disease from 2006 to 2013 in a 20% Medicare sample and identified physicians who transitioned from predominantly hospital-based facilities to OBLs (switch physicians) and compared them with those who did not use OBLs (control physicians). The main outcomes investigated were average number of PVIs at 30 days and 1 year and atherectomy usage. Patient outcomes included above-ankle amputation, major adverse limb events, and death. We used a difference-in-difference model to control for time effects in a multivariate regression model, reported as an odds ratio (OR) and 95% confidence interval (CI). RESULTS: The cohort comprised 292 switch physicians, who treated 7134 patients (3888 before OBL use and 3246 after transitioning to OBLs), and 3715 control physicians treating 54,213 patients (36,327 in the preperiod and 17,886 in the postperiod). Switch and control physicians both treated more patients with lower extremity wounds during the study period; however, this increase was greater for control physician (0.7% vs 5.5%, P < .001). On average, patients treated by switch physicians had 0.05 (95% CI, 0.03-0.07; P < .001) underwent more PVIs within 30 days and 0.12 more PVIs (95% CI, 0.08-0.16; P < .001) within 1 year of the initial revascularization procedure after the physician transitioned to an OBL. Similarly, patients treated by switch physicians underwent 0.02 (95% CI, 0.01-0.03; P = .002) more atherectomy procedures at 30 days and 0.03 (95% CI, 0.01-0.05; P = .008) more atherectomy procedures at 1 year. Transitioning to OBLs was also associated with a decreased risk in above-ankle amputation at 30 days (OR, 0.58; 95% CI, 0.38-0.97; P = .009) and 1 year (OR, 0.75; 95% CI, 0.60-0.95; P = .01). However, no statistical difference was observed for major adverse limb events and mortality rates at 30 days and 1 year because patients treated by switch and control physicians experienced similar decreases. CONCLUSIONS: Transitioning to OBLs was associated higher 30-day and 1-year PVI rates and atherectomy rates. Although transitioning to OBLs was associated with lower rates of above-ankle amputations, switch physicians treated a lower number of patients with lower extremity wounds.

Utilization and in-hospital outcomes associated with atherectomy in the treatment of peripheral vascular disease: An observational analysis from the National Inpatient Sample.

Objective Percutaneous revascularization for patients with peripheral arterial disease has become a treatment of choice for many symptomatic patients. The presence of severe arterial calcification presents many challenges for successful revascularization. Atherectomy is an adjunctive treatment option for patients with severe calcification undergoing percutaneous intervention. We sought to analyze the impact of atherectomy on in-hospital outcomes, length of stay, and cost in the percutaneous treatment of peripheral arterial disease. Methods Patients with lower extremity peripheral arterial disease undergoing percutaneous revascularization were assessed, utilizing the National Inpatient Sample (2012-2014) and appropriate International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedural codes. Patients who were not treated with atherectomy ( n = 51,037) were compared to those treated with atherectomy ( n = 11,408). Propensity score-matched analysis was performed to address baseline differences. Results After performing propensity score-matched analysis, 11,037 patients were included in each group. Utilization of atherectomy was associated with lower in-hospital mortality (2% vs. 1.4% p = 0.0006). All secondary outcomes were lower when using atherectomy except acute renal failure. Length of stay was slightly lower when using atherectomy (7.2 vs. 7.0 days, p = 0.0494). However, median cost was higher in patients treated with atherectomy ($21,589 vs. $24,060, p = <0.0001). Conclusion The use of atherectomy was associated with significantly decreased in-hospital mortality, adverse events, and length of stay. Though, cost associated with atherectomy use is increased, this is offset by decreased in-hospital adverse outcomes. Appropriate use of atherectomy devices is an important tool in revascularization of peripheral arterial disease in select patients.

Short-term outcomes of excisional atherectomy in lower limb arterial disease.

BACKGROUND: Endovascular interventions are increasingly utilized in managing occlusive peripheral vascular disease. Angioplasty and stenting remain the mainstay of endovascular management; however, newer treatment modalities such as excisional atherectomy provide the clinician with additional treatment options. While demonstrating promising results in available trials, a paucity of data exist regarding peripheral atherectomy. The purpose of this retrospective clinical study was to assess the efficacy and safety of excisional atherectomy with the TurboHawk atherectomy device (Covidien/ev3, Plymouth, MN, USA) in the treatment of lower limb peripheral vascular disease and to evaluate the learning curve involved in the institution of a new treatment modality. METHODS: A retrospective analysis was performed on all patients undergoing atherectomy for symptomatic lower limb peripheral vascular disease by a single clinician between November 2011 and June 2013. Forty-seven vessels on 28 legs in 24 patients were treated during the period. RESULTS: Atherectomy was possible in 98% of cases. The 6- and 12-month primary patency was 72.6 and 58.9%, respectively. The primary-assisted patency was 93.2% at 6 months and 74.6% at 12 months. There were significantly greater patency rates in the TransAtlantic Inter-Society Consensus A + B lesions and a non-significant trend towards improved patency rates in claudicants versus critical limb ischaemia. There were four instances of embolization and four cases of dissection. CONCLUSION: Excisional atherectomy provides a further option for the minimally invasive management of peripheral vascular disease. It has similar patency rates to established endovascular therapies and should be considered among the treatment options in patients with favourable pathology.

[GeCAS registry. Sense and purpose of a carotid percutaneous transluminal angioplasty register in the era of obligatory quality assurance]. / GeCAS-Register. Sinn und Zweck eines Carotis-PTA-Registers im Zeitalter der obligaten Qualitätssicherung.

Clinical registries have become increasingly more important tools for scientists as well as for medical admission boards worldwide during recent years due to the ability to investigate the safety and efficacy of a therapeutic method in the general population under real world conditions. The clinical benefit of current registry data seems to be particularly high in a treatment method, such as carotid artery stenting (CAS) where safety and efficacy, especially in daily clinical practice, could not be totally clarified by several randomized clinical trials (RCT). For this reason the new multidisciplinary, multicenter and prospective German Carotid Artery Registry (GeCAS) was founded in January 2011 for continuing quality control in CAS in clinical practice in Germany. The GeCAS registry is a fusion of two large German CAS registries, the ALKK-CAS registry and the PROCAS registry, which were conducted by cardiologists, angiologists and radiologists and operated from 1996 until December 2010. However, a general duty of documentation (BQS) of every CAS procedure exists throughout Germany since January 2012. In contrast to optional documentation of CAS within the GeCAS registry, the nationwide and obligatory documentation is strictly focused on the main issues, such as indications and between hospital comparisons of outcome of patients. In the GeCAS registry data collection is generally more extensive and also includes a 30-day and 10-year follow-up. Compared to the BQS institute, benchmarking reports of GeCAS are more detailed and are made available to every participating hospital on a biannual basis. This generates an image of the current reality of CAS in Germany in addition to the nationwide obligatory documentation. Furthermore, data of the GeCAS registry is the basis for research work (e.g. publications and presentations), for generating new hypotheses and for technical development in CAS in Germany. Consequently, the existence of a multicenter and multidisciplinary CAS registry, such as the GeCAS registry, is considered necessary and medically useful.

National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.

INTRODUCTION: Advances in endovascular interventions have expanded the options available for the invasive treatment of lower extremity peripheral arterial disease (PAD). Whether endovascular interventions substitute for conventional bypass surgery or are simply additive has not been investigated, and their effect on amputation rates is unknown. METHODS: We sought to analyze trends in lower extremity endovascular interventions (angioplasty and atherectomy), lower extremity bypass surgery, and major amputation (above and below-knee) in Medicare beneficiaries between 1996 and 2006. We used 100% samples of Medicare Part B claims to calculate annual procedure rates of lower extremity bypass surgery, endovascular interventions (angioplasty and atherectomy), and major amputation between 1996 and 2006. Using physician specialty identifiers, we also examined trends in the specialty performing the primary procedure. RESULTS: Between 1996 and 2006, the rate of major lower extremity amputation declined significantly (263 to 188 per 100,000; risk ratio [RR] 0.71, 95% confidence interval [CI] 0.6-0.8). Endovascular interventions increased more than threefold (from 138 to 455 per 100,000; RR = 3.30; 95% CI: 2.9-3.7) while bypass surgery decreased by 42% (219 to 126 per 100,000; RR = 0.58; 95% CI: 0.5-0.7). The increase in endovascular interventions consisted both of a growth in peripheral angioplasty (from 135 to 337 procedures per 100,000; RR = 2.49; 95% CI: 2.2-2.8) and the advent of percutaneous atherectomy (from 3 to 118 per 100,000; RR = 43.12; 95% CI: 34.8-52.0). While radiologists performed the majority of endovascular interventions in 1996, more than 80% were performed by cardiologists and vascular surgeons by 2006. Overall, the total number of all lower extremity vascular procedures almost doubled over the decade (from 357 to 581 per 100,000; RR = 1.63; 95% CI: 1.5-1.8). CONCLUSION: Endovascular interventions are now performed much more commonly than bypass surgery in the treatment of lower extremity PAD. These changes far exceed simple substitution, as more than three additional endovascular interventions were performed for every one procedure declined in lower extremity bypass surgery. During this same time period, major lower extremity amputation rates have fallen by more than 25%. However, further study is needed before any causal link can be established between lower extremity vascular procedures and improved rates of limb salvage in patients with PAD.

Estimation of wall shear stress dynamic fluctuations in intracranial atherosclerotic lesions using computational fluid dynamics.

OBJECTIVE: Intracranial stenosis (IS) is associated with significant morbidity and mortality from hypoperfusion and thromboembolism. We used computational fluid dynamic methods to analyze luminal patterns of wall shear stress (WSS), a known critical modulator of endothelial function, within patient-based IS lesions undergoing percutaneous angioplasty and stenting. METHODS: High-resolution three-dimensional rotational angiographic data sets were reconstructed to yield a fine-resolution computational mesh allowing application of pulsatile computational fluid dynamic analysis with a non-Newtonian realistic model of blood. WSS and its gradient were analyzed spatiotemporally in five IS lesions before and after percutaneous angioplasty and stenting. RESULTS: WSS within the stenosis reached average shear magnitudes of 1870 +/- 783 dyn/cm with rapidly reversing direction to oscillating low values in the recirculation zone. WSS vectors revealed complex dynamic directional and amplitude oscillations not seen in healthy segments with time-dependent convergence and divergence strips sweeping back and forth across the lesion during the cardiac cycle. These areas also underwent extreme temporal WSS oscillation of 2052 +/- 909 dyn/cm over a short time interval. The endothelial mechanotransductive response to such extreme WSS magnitudes and gradients, which were normalized by percutaneous angioplasty and stenting in the current study, remains undefined. CONCLUSION: Computational fluid dynamic analysis of IS has uncovered a complex and hostile microhemodynamic environment characterized by wide and rapid shear variations in time and space. Characterization of the mechanical forces acting on the wall can help in determining the molecular transduction response of the luminal endothelium to these extreme stresses and may lead to better understanding of the hemodynamic contribution to stenosis pathophysiology.

Excimer laser assisted angioplasty for critical limb ischemia: results of the LACI Belgium Study.

BACKGROUND: The purpose of this study was to assess the safety and efficacy of translating into national practice methodology for infrainguinal excimer laser-assisted angioplasty, for the treatment of critical limb ischemia in poor surgical bypass candidates. METHODS: A prospective five centre Belgian registry enrolled 48 patients, who presented with 51 chronic critically ischemic limbs (Rutherford category 4, 5 or 6) and were poor candidates for bypass surgery. Treatment included crossing the occlusion or stenosis by conventional guidewire followed by excimer laser angioplasty with, or without, adjunctive balloon angioplasty or stenting. A step-by-step technique was used in cases where the guidewire could not pass the occluded site. The primary endpoint was limb salvage, at 6 months, of the treated limb. RESULTS: Initial treatment was successful in all 51 limbs. By 6 months there had been six deaths, six minor and four major amputations and further intervention was required in four patients. Among survivors, limb salvage rate at 6 month was 38/42 (90.5%), with freedom from critical limb ischemia in 86%. CONCLUSIONS: This Belgian study of excimer laser assisted angioplasty, in high-risk patients who were poor candidates for surgical re-vascularisation, had a low incidence of surgical re-interventions and limb salvage rate in excess of 90%.

Glycoprotein IIb/IIIa receptor inhibitors in percutaneous coronary intervention and acute coronary syndrome.

OBJECTIVE: To review the contemporary role of the glycoprotein (GYP) IIb/IIIa receptor inhibitors abciximab, eptifibatide, and tirofiban in patients undergoing percutaneous coronary intervention (PCI) and those with an acute coronary syndrome (ACS), and to provide an algorithm based on currently available evidence for specific agents. DATA SOURCES: Primary articles were identified by a MEDLINE search (1966-January 2003); references cited in these articles provided additional resources. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified from data sources were considered for relevant information; this article primarily addresses large, controlled or comparative studies, and meta-analyses. DATA SYNTHESIS: The role of GYP IIb/IIIa inhibitors in patients undergoing PCI and those with ACS has progressed markedly. To date, abciximab has the most robust data in patients undergoing PCI, particularly high-risk individuals. In PCI patients with lower risk (e.g., elective stenting), eptifibatide is a reasonable first-line option. Data do not support tirofiban for routine use in patients undergoing PCI. For individuals with signs and symptoms of ACS, specifically unstable angina or non-ST-segment elevation myocardial infarction (MI), eptifibatide or tirofiban is recommended in high-risk patients when a conservative approach is used (PCI is not planned). Abciximab is not recommended in this situation. In patients with ST-segment elevation MI (STEMI), abciximab is the only GYP IIb/IIIa inhibitor evaluated in large, well-designed investigations. For medical management in combination with a fibrinolytic agent, the role of abciximab remains unclear. For patients undergoing primary PCI for the management of STEMI, the available evidence supports the use of abciximab, albeit further investigation is warranted. CONCLUSIONS: The role of GYP IIb/IIIa inhibitors in clinical cardiology continues to evolve. Choice of the agent depends on situation of use, patient-specific characteristics and risk stratification, and, in the case of ACS, chosen management strategy (medical management or intervention).

Long term results after rotation angioplasty and catheter atherectomy. A retrospective analysis.

Rotationangioplasty and catheter atherectomy using the TEC device was performed in 33 patients with peripheral arterial occlusive disease. Thirty-five femoral or popliteal artery occlusions could be recanalized with an initial patency of 100%. After 5 years the patients were re-evaluated by clinical examination, colour duplex scanning and in 5 cases by intra-arterial angiography. According to life table analysis there was no patent femoral or popliteal vessel after 5 years in those patients treated initially for rest pain or ischemic tissue loss. 82% of those treated for claudication had a re-occluded artery. In 5 cases a major amputation was necessary. 42% of those patients who were initially treated far disabling claudication had a severe deterioration of their functional status with development of critical ischemia. In 9 of these cases reconstructive arterial surgery was required which failed in one patient with subsequent limb loss. In the retrospective study presented patients with occlusions up to 30 cm and more were treated. Combining two interventional techniques there is a high initial success rate with poor long term results. Therefore these devices should be reserved for high risk patients who would not tolerate reconstructive vascular surgery. They should not be used in patients with claudication although even extensive occlusions can be recanalized there is an imminent danger of causing significant deterioration of the patients functional status.

Results of directional peripheral atherectomy with reference to histology, histochemistry, and ultrastructure.

One hundred patients with symptomatic peripheral vascular disease were treated with a directional atherectomy catheter; 153 lesions comprising 98 stenoses and 55 occlusions were located in the iliac (n = 22), superficial femoral (n = 114), popliteal (n = 16), and anterior tibial (n = 1) arteries. The majority of these patients were poor candidates for balloon angioplasty because of the complexity of lesions. There were 70 eccentric and 28 concentric lesions and 55 occlusions (mean length 4.2 +/- 2.9 cm). Acute success rate was 94% for both stenoses and occlusions. Four patients were treated in both lower extremities. The stenoses were reduced from 85 +/- 12% to 12 +/- 10% acutely (occlusions 100% to 9 +/- 9%). Six-month angiographic follow-ups were performed in 81% of treated patients, the others refusing angiography. Mean stenosis after six months was 33 +/- 25% (occlusions 44 +/- 28%). Restenosis (> 50%) was found in 20% of treated lesions: 26% in concentric lesions, 8% in eccentric lesions, and 32% in occluded vessels. Treatment of peripheral vascular disease with the atherectomy device is safe and effective therapy with good long-term results. These results were obtained in complex lesions with 55 occlusions. Atherectomy seems to be particularly beneficial in the treatment of eccentric and complex stenoses and is not limited by occlusion or calcification. Furthermore, insight into the pathogenesis of arteriosclerosis and the development of restenosis is enabled by analysis of removed plaque material.

Generalized model of restenosis after conventional balloon angioplasty, stenting and directional atherectomy.

OBJECTIVES: This study was designed to extend the results of a quantitative model originally developed for restenosis after stenting or atherectomy to include restenosis after conventional balloon angioplasty. BACKGROUND: We have previously described a continuous regression model that explains late (6-month) lumen narrowing as the difference between the immediate gain and the subsequent normally distributed late loss in lumen diameter after Palmaz-Schatz stenting or directional atherectomy. METHODS: Lumen diameter was measured immediately before and after coronary intervention on 524 consecutive lesions including those treated by Palmaz-Schatz stenting (102), directional atherectomy (134) and conventional balloon angioplasty (288). Of these lesions, 475 (91%) underwent follow-up angiography 3 to 6 months after treatment. The immediate increase in lumen diameter produced by the intervention (immediate gain) and the subsequent reduction in lumen diameter between the time of intervention to follow-up angiography (late loss) were examined. Association between demographic or angiographic variables and continuous measures of restenosis (late lumen diameter or late percent stenosis) was tested with linear regression techniques; a traditional binary measure of restenosis (late diameter stenosis > or = 50%) was evaluated with logistic regression analysis. RESULTS: Regression models relating late lumen diameter to the immediate lumen result were successfully fitted to all segments studied. According to these models, three indexes of restenosis (late lumen diameter, late percent stenosis and binary restenosis) were found to depend solely on the immediate lumen diameter after the procedure and the immediate residual percent stenosis, but not on the specific intervention used. Moreover, the late loss in lumen diameter was found to vary directly with the immediate gain provided by an intervention, and the "loss index" (a measure that corrects for differences in immediate gain) was uniform among all three interventions. CONCLUSIONS: The quantitative model originally developed for restenosis after stenting or atherectomy may thus be generalized to include conventional balloon angioplasty. It shows that the apparent differences in restenosis among the three interventions studied are due solely to differences in the immediate result provided and not to differences in the behavior of subsequent late loss. Moreover, although the late loss in lumen diameter was found to correlate with differences in the immediate gain provided by an intervention, the "loss index" (a measure that corrects for differences in acute gain) was uniform across all three interventions. It is thus the immediate result (and not the procedure used to obtain that result) that determines late outcome after coronary intervention.