Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial.

BACKGROUND: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions. METHODS: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions. The primary study end point was the 6-month primary patency of the target lesion detected by angiography and duplex ultrasound. Secondary end points included clinically driven target vessel revascularization, amputation rates, and changes in Rutherford-Becker class at 1 year. A core laboratory provides independent analyses for all scheduled and unscheduled duplex ultrasound examinations and angiographies, and a research institute ensured independent data collection. RESULTS: The mean target lesion length was 179.7±98.2 mm. Nine patients (11.3%) died during the follow-up period. At 6 months, primary patency was 49% (n=18) with DA+DCB versus 34% (n=12) with DCB alone (P=0.241), and clinically driven target vessel revascularization was 8% (n=3) versus 14% (n=5; P=0.475), respectively. At 1 year, the target lesion revascularization rates were 30% (n=10) versus 43% (n=12; P=0.308), the median in Rutherford-Becker class was 2 (0.25­5) versus 5 (0.25­5; P=0.329), and amputation rates were 22% (n=8) versus 32% (n=11; P=0.618) in the DA+DCB group and the DCB group, respectively. CONCLUSIONS: Treatment of long infrapopliteal artery lesions with DA+DCB versus DCB alone leads to comparable clinical and technical results at 6 months and 1 year. REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01763476.

The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions.

Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel. Use of limus drugs was limited by a short residency time in the vessel wall. Besides the drug, the SELUTION SLR™ drug-eluting balloon system consists of a coating formulation of four excipients. The first excipient is a biodegradable polymer (poly(lactic-co-glycolic acid)) that is intermixed with the sirolimus to form micro-reservoirs and regulates drug release via matrix degradation. This review summarizes the existing pre-clinical and clinical literature on treatment of femoropopliteal artery lesions with the SELUTION SLR DCB.

Outcomes of directional atherectomy for common femoral artery disease.

BACKGROUND: Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard. AIMS: The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions. METHODS: A retrospective analysis of patients who underwent DA of the CFA between March 2009 and June 2017 was performed. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdTLR). Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (ABI), and Rutherford-Becker class (RBC) during follow-up. RESULTS: This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR. CONCLUSIONS: The use of DA for the treatment of CFA lesions leads to promising midterm results with an acceptable complication rate.

Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience.

Background: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. Patients and methods: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. Results: Overall 624 patients with femoropopliteal lesions were included in this study. Of those, 197 patients were treated with POBA without crossover to a paclitaxel coated device during follow-up and 427 patients with DCB angioplasty. Mean follow-up time was 33.3 ± 25.4 months. Mortality incidence was 81.7% (95% confidence interval [95% CI]: 76.1-86.8) after POBA and 59.0% (95% CI: 54.6-63.9) after DCB (p < 0.001). Multivariate logistic regression analysis revealed type of treatment (POBA vs. DCB, (hazard ratio [HR]: 0.332, 95% CI: 0.215-0.514, p < 0.001), age per year (HR: 1.065, 95% CI: 1.046-1.087, p < 0.001), coronary heart disease (HR: 1.969, 95% CI: 1.323-2.930, p = 0.001), renal insufficiency (HR: 1.583, 95% CI: 1.079-2.323, p = 0.019), stroke (HR: 2.505, 95% CI: 1.431-4.384, p = 0.001) as predictors for all-cause mortality. In the subgroup excluding octogenarians, mortality predictors were type of treatment (HR: 0.463, 95% CI: 0.269-0.796, p = 0.005), age per year (HR: 1.035, 95% CI: 1.002-1.069, p = 0.038), coronary heart disease (HR: 2.082, 95% CI: 1.274-3.400, p = 0.003), stroke (HR: 2.203, 95% CI: 1.156-4.197, p = 0.016) and renal insufficiency (HR: 2.201, 95% CI: 1.357-3.571, p < 0.001). Conclusions: This monocentric retrospective analysis showed no survival disadvantage for patients in Rutherford-Becker stage 5 after treatment with paclitaxel-coated balloons.

Evaluation of mortality following paclitaxel drug-coated stent angioplasty of femoropopliteal lesions in real world.

OBJECTIVES: To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice. BACKGROUND: A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices. METHODS: Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who underwent DES angioplasty or uncoated balloon or stent angioplasty of femoropopliteal lesions with a follow-up of 3-7 years. RESULTS: From 2010 to 2016 8,377 patients were treated with femoropopliteal lesions. This analysis included 599 patients. Three-hundred-three patients were treated with an uncoated device and 296 patients with a DES. The mean follow-up period was 51.80 ± 23.40 months (range 0-84). For the entire cohort mortality incidence was 32.3% after uncoated treatment and 22.6% after DES (p < .033). For the entire cohort multivariate logistic regression analysis revealed age (p < .001), diabetes mellitus (p = .010), renal insufficiency (p = .001) and RBC 4 (p < .001) as independent predictors for mortality. After propensity score matching mortality incidence was 32.5% after uncoated treatment and 24.1% after DES (p = .264). After propensity score matching, independent mortality predictors were age (p < .001), hyperlipidemia (p = .035), diabetes mellitus (p = .018) and RBC 4 (p < .001). Kaplan-Meier analysis showed that higher paclitaxel dosage was associated with lower mortality. CONCLUSION: In real world, long-term mortality rate was lower after DES angioplasty than after treatment with uncoated devices. Mortality predictors were co-morbidities, risk factors, and disease severity.

Evaluation of Mortality Following Paclitaxel Drug-Coated Balloon Angioplasty of Femoropopliteal Lesions in the Real World.

OBJECTIVES: This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice. BACKGROUND: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices. METHODS: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed. RESULTS: Overall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007). CONCLUSIONS: In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.

Accuracy of Carotid Artery Stenosis Quantification with 4-D-Supported 3-D Power-Doppler versus Color-Doppler and 2-D Blood Velocity-Based Duplex Ultrasonography.

Assessment of the severity of internal carotid artery stenosis is relevant to therapeutic decisions. Direct measurement of stenosis in static three-dimensionally rendered ultrasonographic color-Doppler images after an orientation with 4-D gray-scale views (4D/3D-C-US) was recently observed to be metrically non-inferior to angiography. In the study described here, power-Doppler (Christian Doppler was a physicist) ultrasonography (4D/3D-P-US) was prospectively compared with angiography, 4D/3D-C-US and 2-D duplex ultrasonography (DUS) in a similar fashion using blinded observers. Percentage stenosis was measured in 36 patients. Continuous percentage stenosis measures (standard deviation of difference and concordance correlation coefficient) between angiography and 4D/3D-P-US did not differ from the results between angiography observers (p > 0.05). Dichotomous diagnosis with 4D/3D-P-US resulted in κ values similar to the inter-rater agreement of angiography and the inter-method agreement of 4D/3D-C-US and DUS compared with angiography. Binary accuracy did not differ between 4D/3D-P-US, 4D/3D-C-US and DUS (p > 0.5). In conclusion, stenosis grading using 4D/3D-P-US exhibited non-inferior inter-method agreement with angiography at good accuracies, similar to 4D/3D-C-US and DUS.

Improved Carotid Stenosis Quantification on Novel 4D/3D-Doppler Ultrasonography Indexing to the Common Carotid Artery.

PURPOSE: The accuracy of internal carotid artery stenosis (ICAS) quantification depends on the method of stenosis measurement, impacting therapeutic decisions and outcomes. The NASCET method references the stenotic to the distal ICAS lumen, the ECST method to the local outer and the common carotid artery (CC) method to the CC diameter. Direct morphometric stenosis measurement with four-dimensionally guided three-dimensional ultrasonography (4D/3DC-US) demonstrated good validity for the commonly used NASCET method. The NASCET definition has clinically relevant drawbacks. Our purpose was to investigate the validity of the ECST and CC methods. MATERIALS AND METHODS: 4D/3DC-US percent-stenosis measures of 103 stenoses (80 patients) were compared to quantitative catheter angiography and duplex ultrasonography (DUS) in a blinded fashion. RESULTS: The 4D/3DC-US versus angiography intermethod standard deviation of differences (SDD, n = 103) was lower for the CC method (5.7 %) compared to the NASCET (8.1 %, p < 0.001) and ECST methods (9.1 %, p < 0.001). Additionally, it was lower than the NASCET angiography interrater SDD of 52 stenoses (SDD 7.2 %, p = 0.047) and non-inferior for the ECST method (p = 0.065). Interobserver analysis of equivalent grading methods showed no differences for the SDDs between angiography and 4D/3DC-US observers (p > 0.076). Binary comparison to angiography showed equal Kappa values > 0.7 and an accuracy ≥ 85 % for the NASCET and CC methods, higher than for the ECST method. The binary accuracy of ICAS grading did not differ from DUS for all methods. CONCLUSION: The new 4D/3DC-US CC method is an accurate and well reproducible alternative to the NASCET and ECST methods and offers potential for clinical application.

The SAPPHIRE criteria, history of myocardial infarction and diabetes predict adverse outcomes following carotid endarterectomy similar to stenting.

AIMS: Identifying factors associated with worse outcome following carotid endarterectomy (CEA) is important to improve prevention of major adverse cardiovascular and cerebrovascular events (MACCE), yet rarely used for registries. We intended to identify predictors of MACCE following CEA as recently analysed for stenting. METHODS AND RESULTS: Patients undergoing CEA at 2 centers over 13 years were entered into a database. Baseline clinical characteristics, procedural factors and a panel of clinical and lesion-related high-risk features (SHR) and exclusion criteria (SE), empirically compiled for stratification in the SAPPHIRE trial, were differentially analysed using Cox regressions. The analysis included 748 operations; 262 (35%) asymptomatic, 208 (28%) with previous strokes, and 278 (37%) with transient ischemic attacks (TIA). The overall 30-day MACCE rate was 6.7%, 5.0% in asymptomatic and 7.6% in symptomatic patients. Previous MI (HR 2.045, p = 0.022), diabetes (HR 2.111, p = 0.011) and symptomatic patients (HR 2.045, p = 0.044) were independently associated with MACCE. SE patients (n = 81) had a MACCE rate of 13.6%; the MACCE rate of the remainder dropped to 5.8% (4.7% in asymptomatic and 6.5% in symptomatic patients). Hazard ratio for SHR patients was 2.069 (CI 1.087-3.941) and 2.389 for SE (CI 1.223-4.666), each compared to all patients with lower risk and adjusted for symptomatic status. Among SHR and SE criteria NYHA 3-4, contralateral occlusions and intraluminal thrombus were significant determinants and MI < 4 weeks before CEA showed a strong trend (p = 0.05). CONCLUSION: Patients identified by SHR and SE criteria, prior MI and diabetes warrant increased attention to prevent MACCE following CEA.

4-Dimensionally Guided 3-Dimensional Color-Doppler Ultrasonography Quantifies Carotid Artery Stenosis With High Reproducibility and Accuracy.

OBJECTIVES: The purpose was to analyze the agreement and binary accuracy of the degree of internal carotid artery stenosis (ICAS) as determined by 4-dimensionally (4D) real-time gray-scale guided 3-dimensional (3D) color-Doppler ultrasonography (3DC-US) (4D/3DC-US) compared with catheter angiography (CA) and duplex ultrasonography (DUS). This study hypothesized that 4D/3DC-US is noninferior to CA and DUS in grading ICAS in selected patients. BACKGROUND: Clinical stratification in patients with ICAS largely depends on a patient's symptomatic status and the degree of stenosis. METHODS: Screening with 4D/3DC-US was prospectively performed in 93 study patients (with 122 ICASs), thus yielding 80 patients for analysis (with 103 ICASs) after excluding patients with insufficient image quality, previous revascularization, and contraindications to CA. The ultrasound examination (10 MHz) consisted of consensus conform DUS examination and independent real-time 4D-guided gray-scale views for orientation followed by static 3DC-US NASCET (North American Symptomatic Carotid Endarterectomy Trial) percent stenosis quantification using off-line multiplanar rendering. Multiplanar selective CA of the same ICASs was quantified with dedicated software in a blinded fashion. RESULTS: Quantitative CA of 103 stenoses with a mean degree of 65 ± 17% was compared with 4D/3DC-US, with a resulting concordance correlation coefficient of 0.89 and a standard deviation of differences (SDD) of 8.1% at a bias of +1.7%. Binary 50% and 70% stenosis detection with 4D/3DC-US revealed a sensitivity of 97% and 87%, respectively, and a specificity of 92% and 84%, respectively. Interobserver SDD for CA of 52 stenoses (7.2%) did not differ from SDD for 4D/3DC-US and CA (p = 0.274). Accuracy of 50% stenosis detection by 4D/3DC-US was tendentially higher compared with DUS (96% vs. 91%). CONCLUSIONS: The 4D/3DC-US method provides reliable and accurate stenosis quantification and binary classification with good diagnostic accuracy compared with CA and DUS.

Duplex derived intrarenal resistance index correlates with invasive pressure gradient measurements in detecting relevant unilateral renal artery stenosis.

BACKGROUND: The purpose of this study was to assess the correlation between the transstenotic pressure gradient as determined by a pressure wire and the decrease in the intrarenal resistance index (RI) > 0.05 measured by duplex ultrasound in significant unilateral renal artery stenosis (RAS). Intravascular ultrasound (IVUS) was correlated to the angiographic degree of RAS. PATIENTS AND METHODS: In 17 patients, transstenotic pressure gradient measurements, IVUS and RI measurements were obtained before and after stenting. After stenting, graded stenosis was created by progressive balloon catheter inflation. Stenosis severity was expressed as the ratio of the distal pressure (Pd) corrected for aortic pressure (Pa). The balloon inflation pressure was adjusted to create a stenosis with Pd/Pa ratio 1.0 to 0.7. In parallel, RI measurements were performed in the affected kidney and compared to the contralateral kidney for the calculation of the side-difference in RI. IVUS was performed to correlate the cross-sectional degree of stenosis with quantitative angiography (QA). RESULTS: In 60 out 68 measurements, the RI difference (decline > 0.05) correlated with a Pd/Pa ratio < 0.9; this correlation was significant by linear regression analysis (p < 0.001). The preinterventional mean degree of stenosis was 63.4 % + 16.1 (24.6 - 84.6 %) as assessed by QA and 76.7 % + 13.2 % (47 - 92 %) as assessed by IVUS, showing a significant correlation (p < 0.035). CONCLUSIONS: In unilateral RAS, a drop in RI > 0.05 as compared to the unaffected kidney correlates to an invasively measured Pd/Pa ratio < 0.9, which is regarded as a significant pressure gradient associated with increased renin production, which promotes renovascular hypertension. QA underestimates RAS severity as compared to IVUS.

History of transient ischaemic attack, myocardial infarction and hyperlipidaemia affects outcome following carotid artery stenting.

AIMS: This prospective registry study was intended to evaluate outcomes and predictors of adverse events following carotid artery stenting (CAS). METHODS AND RESULTS: Patients received neurological and duplex exams before CAS, prior to discharge and at 30- and 180-day follow-up. Multiple regression analysis included patient- and procedure-related characteristics. The MACCE endpoint comprised stroke, myocardial infarction and death. Three hundred and seventy-five consecutive patients underwent CAS between 1998 and 2011. Mean age was 69±9.1 years; 53% were symptomatic within the preceding six months. Mean time to CAS was 23 days in patients with TIA and 31 days with stroke (p=0.029). The MACCE rate was 1.6% during intervention and 4.0%, 5.6% and 5.9% at discharge, day 30 and day 180, respectively. TIA occurred in 31 cases (9.6%) within 30 days. A history of TIA was independently associated with MACCE (OR: 2.88; p=0.04). Furthermore, a history of hyperlipidaemia (OR: 4.02, p=0.029), MI (OR: 2.93, p=0.007) and age ≥70 (OR: 1.89, p=0.033) were independent predictors for the combined endpoint MACCE plus TIA. CONCLUSIONS: TIA is an underappreciated adverse event following CAS. Pre-procedural TIA was an independent risk factor for adverse outcomes, while stroke was not, probably related to the timing of the procedure relative to the index event.

Novel Approaches to the Management of Advanced Peripheral Artery Disease: Perspectives on Drug-Coated Balloons, Drug-Eluting Stents, and Bioresorbable Scaffolds.

Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.

Drug-coated balloons: how should we incorporate into our practice in treating superficial femoral artery lesions?

OPINION STATEMENT: Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoro-popliteal lesions. Even for more complex femoro-popliteal lesions such as long lesions and in-stent restenosis, single-center studies and small randomized studies have shown promising mid-term technical and clinical results. This review article summarizes the current knowledge about DCBs in femoro-popliteal interventions, supplements published guidelines with evidence-based recommendations, and discusses still unresolved needs.

Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions.

PURPOSE: To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions. METHODS: A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100-450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100-350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories. RESULTS: In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category. CONCLUSION: DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Renal artery stenosis: Up-date on diagnosis and treatment.

Significant renal artery stenosis (RAS) can cause or result in deterioration of arterial hypertension and may promote the development of renal insufficiency. The activation of the renin-angiotensin-aldosterone system results in structural heart disease and may impact patient survival. Technical improvements of diagnostic and interventional endovascular tools have led to a more widespread use of endoluminal renal artery revascularization and extension of the indications for this type of therapy during the past two decades. Whereas balloon angioplasty is still the method of choice for the treatment of fibromuscular dysplasia, stent implantation is indicated in ostial atherosclerotic RAS. However, none of the so far published or presented randomized controlled trials could prove a beneficial outcome of RAS revascularization compared to medical management. As a result of these negative trials including the largest published trial to date, the ASTRAL trial, referrals to endovascular renal artery revascularization have declined and, moreover, reimbursement of these procedures has become a matter of debate. Crucial for a clinical benefit following revascularization of RAS is proper patient selection, revascularization being only indicated after proof of hemodynamic relevance of RAS. This article summarizes the appropriate diagnostic work-up of patients with suspected RAS, discusses the limitations of the results published so far and their impact on the indication for RAS revascularization.

Challenging anatomy, how to treat or not to treat?

Several position statements provided recommendations regarding the anatomical conditions qualifying for renal denervation catheter application based on the HTN-1 and HTN-2 trials. This manuscript summarises anatomical access artery and renal artery conditions which qualify for catheter-based renal denervation according to the instructions for use and those where treatment is not yet generally recommended, mostly due to limitations of the catheter technologies currently available, e.g., no current device is approved for brachial or radial access.

Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries.

BACKGROUND: Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates. The outcome might be improved in conjunction with drug-coated balloon angioplasty. METHODS: In this retrospective study, restenotic lesions of the femoropopliteal arteries were treated with directed atherectomy in 89 lesions of consecutive patients (58% male; mean age, 69 ± 11 years). All patients received adjunctive treatment with conventional balloon percutaneous angioplasty (PTA; n = 60) or drug-coated balloon angioplasty (DCB; n = 29). RESULTS: Lesion location was in the stent (DCB [n = 27] vs PTA [n = 36]) and in native restenotic vessels (DCB [n = 2] vs PTA [n = 25]). The 1-year Kaplan-Meier freedom from restenosis estimates (95% confidence intervals) in the DCB and PTA groups were 84.7% (70.9%-98.5%) and 43.8% (30.5%-57.1%), respectively. In a multivariable Cox model for restenosis, DCB treatment had a hazard ratio (95% confidence interval) of 0.28 (0.12-0.66; P = .0036) compared with the PTA group. In the multivariable model for procedural success, the effect of treatment did not differ between PTA and DCB (P = .134). CONCLUSIONS: The combination of directed atherectomy with adjunctive DCB is associated with a better event-free survival at 12 months of follow-up compared with PTA after directed atherectomy.

Rotational and aspiration atherectomy for infrainguinal in-stent restenosis.

BACKGROUND: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. PATIENTS AND METHODS: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex. RESULTS: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. CONCLUSIONS: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

Endovascular treatment for extensive aortoiliac artery reconstruction: a single-center experience based on 1712 interventions.

PURPOSE: To determine the clinical and technical outcomes following endovascular therapy for aortoiliac occlusive disease, including complex reconstruction of the aortic bifurcation. METHODS: A retrospective database search identified 1184 consecutive patients (864 men; mean age 64±10 years) who underwent 1712 procedures to treat target lesions in the distal aorta and iliac arteries from September 1996 to December 2006. The intended strategy was to open only one femoral access site primarily, so a second puncture was needed only for the kissing balloon technique at the aortic bifurcation. The primary endpoint was a 1-year duplex-based primary patency; secondary endpoints included acute technical success (residual stenosis <30%), secondary patency, and target lesion revascularization (TLR). Results were stratified by lesion morphology, which was classified according to the TransAtlantic Inter-Society Consensus (TASC II) document. RESULTS: Most of the interventions were done in the iliac arteries (n=1337); 292 cases involved the aortic bifurcation, and 83 cases were in the distal aorta/aortic bifurcation. The mean follow-up was 3.24 years (range 0-12.7). In the entire study cohort, the 12- and 24-month restenosis, TLR, and primary/secondary patency rates did not differ among TASC II A-D subgroups. The symptom-driven TLR in the entire cohort was 8% and 9% at the 12- and 24-month follow-up, leading to secondary patency rates of 96% and 91% in the entire cohort. Outcomes for complex interventions in the distal aorta or aortic bifurcation did not differ significantly compared to the total cohort. The overall survival without restenosis, amputation, or surgery in TASC II subgroups A+B was higher (69.6%±1.5%) compared to TASC II C+D lesions (62.8%±1.9%, p=0.001). CONCLUSION: The indication for percutaneous intervention in aortoiliac occlusive disease can be extended to complex TASC C and D lesions in experienced endovascular centers, even if complex reconstruction of the distal aorta or the aortic bifurcation is indicated.