Residual Angiographic Stenosis Research Articles

The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore – 12 Months Results of the PRISTINE Registry

PurposeThe aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore.MethodsPRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis < 30%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest.ResultsSeventy five patients were included. There were 50 (68.0%) males; mean age, 69.0 ± 10.7 years. CLTI severity was based on the Rutherford Scale (R5 = 51; R6 = 17). Significant co-morbidities included diabetes mellitus (n = 68; 91.0%) and end-stage renal failure (n = 28; 37.0%). 112 atherosclerotic lesions were treated (TASC II D = 58 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4 ± 13.9 cm. Primary vessel patencies at 6 and 12 months were 64/86 (74%) and 43/74 (58%) and freedom from clinically driven TLR were 72/86 (84%) and 55/74 (74%) respectively. AFS was 61/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1 ± 0.55 at baseline to 1.1 ± 2.05 (p < 0.05) at one year and there was a wound healing rate of 38/48 (79%) at the same timepoint.ConclusionsThe Selution SLR™ drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS.Level of EvidenceLevel 2b, Individual Cohort Study.Graphical

RotaTripsy Risk and Rewards: Findings from a Registry of Patients Undergoing Combined Rotational Atherectomy and Intravascular Lithotripsy

Background: Heavily calcified coronary artery lesions are a therapeutic challenge for interventional cardiologists worldwide. Recently, RotaTripsy has gained popularity as a calcium modification technique prior to stent implantation. In this procedure, operators employ rotational atherectomy to debulk luminal calcium alongside intravascular lithotripsy to fracture deeper concentric calcifications. Aims: To identify the demographics and outcomes of patients undergoing RotaTripsy. Methods: Baseline clinical characteristics, procedural details and in-hospital and 30-day outcomes were recorded and reported for a registry of patients in whom combined rotational atherectomy and intravascular lithotripsy were performed in one procedure at the discretion of the primary operator at one high-volume tertiary centre. Results: Over 2020–2022, 57 consecutive patients underwent RotaTripsy during percutaneous coronary intervention. In this cohort, 23 (40%) had acute coronary syndrome and three (5.3%) had an ST-elevation MI. Additionally, 10 (18%) were on dialysis, 20 (35%) had unprotected left main coronary artery/left main coronary artery equivalent lesions, seven (12%) had acute heart failure and nine (16%) required intraprocedural intra-aortic balloon pump support. Of the procedures, 51 (89.5%) were successful, defined as successful stent implantation and &lt;30% residual angiographic stenosis without in-hospital major adverse cardiac events. Complications included slow/no-reflow (six patients; 11%), cerebrovascular events (three patients; 5.3%), in-hospital MI (three patients; 5.3%) and mortality (three patients; 5.3%). The 30-day MI rate was 5.3% (three patients) and the mortality rate was 7.0% (four patients). Conclusion: RotaTripsy was successful in facilitating stent delivery and restoring flow, even in a relatively sick cohort. Nevertheless, complication rates were high, reflecting the challenge of treating these complex patients.

Clinico-radiological features of intracranial atherosclerosis-related large vessel occlusion prior to endovascular treatment

The identification of large vessel occlusion with underlying intracranial atherosclerotic disease (ICAS-LVO) before endovascular treatment (EVT) continues to be a challenge. We aimed to analyze baseline clinical-radiological features associated with ICAS-LVO that could lead to a prompt identification. We performed a retrospective cross-sectional study of consecutive patients with stroke treated with EVT from January 2020 to April 2022. We included anterior LVO involving intracranial internal carotid artery and middle cerebral artery. We analyzed baseline clinical and radiological variables associated with ICAS-LVO and evaluated the diagnostic value of a multivariate logistic regression model to identify ICAS-LVO before EVT. ICAS-LVO was defined as presence of angiographic residual stenosis or a trend to re-occlusion during EVT procedure. A total of 338 patients were included in the study. Of them, 28 patients (8.3%) presented with ICAS-LVO. After adjusting for confounders, absence of atrial fibrillation (OR 9.33, 95% CI 1.11–78.42; p = 0.040), lower hypoperfusion intensity ratio (HIR [Tmax > 10 s/Tmax > 6 s ratio], (OR 0.69, 95% CI 0.50–0.95; p = 0.025), symptomatic intracranial artery calcification (IAC, OR .15, 95% CI 1.64–26.42, p = 0.006), a more proximal occlusion (ICA, MCA-M1: OR 4.00, 95% CI 1.23–13.03; p = 0.021), and smoking (OR 2.91, 95% CI 1.08–7.90; p = 0.035) were associated with ICAS-LVO. The clinico-radiological model showed an overall well capability to identify ICAS-LVO (AUC = 0.88, 95% CI 0.83–0.94; p < 0.001). In conclusion, a combination of clinical and radiological features available before EVT can help to identify an ICAS-LVO. This approach could be useful to perform a rapid assessment of underlying etiology and suggest specific pathophysiology-based measures. Prospective studies are needed to validate these findings in other populations.

Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up

BackgroundIntravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment. MethodsIn a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used. ResultsAmong 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05). ConclusionIVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.

Optical coherence tomography to guide percutaneous coronary intervention of the left main coronary artery: the LEMON study.

Intravascular ultrasound (IVUS)-guided PCI improves the prognosis of left main stem (LMS) PCI and is currently recommended by international guidelines. Although OCT resolution is greater than that of IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data. This pilot study aimed to analyse the feasibility, safety and impact of OCT-guided LMS PCI. This prospective, multicentre trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria). Seventy patients were included in the final analysis (median age: 72 [64-81] years, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86% of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant strut malapposition in 24% of the cases. OCT guidance modified the operators' strategy in 26% of the patients. The rate of one-year survival free from major adverse clinical events was 98.6% (97.2-100). This pilot study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.

Use of distal protection filter device for rescue mechanical thrombectomy for symptomatic free-floating thrombus of the cervical internal carotid artery.

Intraluminal free floating thrombus (FFT) of the cervical internal carotid artery (ICA) is a potentially high-risk lesion for recurrent ischemic strokes, with no single optimal treatment established. To describe a novel interventional technique for mechanical thrombectomy of intraluminal free floating thrombus using a distal protection filter device and aspiration. We identified two cases where anticoagulation was contraindicated in patients with intraluminal FFT and minimal underlying stenosis. In both cases, a distal protection device was used to extract the thrombus under proximal flow arrest and aspiration. Mechanical thrombectomy was successful in both cases, one with "en bloc" removal of the thrombus and one with piecemeal removal. Neither case showed any residual angiographic stenosis or atherosclerotic disease. Mechanical thrombectomy using a distal protection device is a novel and technically feasible approach for select cases of cervical intraluminal thrombus. This may represent a therapeutic option in select cases with high risk of anticoagulation and in the unusual subset of younger patients with minimal atherosclerotidc disease.

One-year outcome of the paclitaxel-eluting Legflow balloon catheter in the treatment of long and complex femoropopliteal lesions.

The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions. The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6% at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year. If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

One-year outcome of the everolimus-eluting, balloon-expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in CLI patients.

The aim of this study was to investigate the efficacy of the balloon expandable Promus Element and Promus Element Plus stents (both Boston Scientific, Marlborough, MA, USA), coated with everolimus, in the treatment of short, focal infrapopliteal lesions. The PREVENT study was a prospective, multicenter, non-randomized, single arm study evaluating the safety and efficacy of the Promus Element and Promus Element Plus stent in the treatment of stenotic or occlusive lesions ≤40 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). A total of 70 study subjects were enrolled in a period of 26 months, between November 2012 and December 2014. The mean age was 77.84±6.62 years (62-90 years) and 47 patients were men (67.1%). Mean lesion length was 22.83±8.78 mm (5-40 mm). Twenty percent of the lesions were occluded, whereas 80.00% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography. Secondary outcomes included hemodynamic primary patency on duplex ultrasound (PSV ratio ≤2.4), limb salvage and freedom from target lesion revascularization (TLR). Technical and procedural success (<30% residual angiographic stenosis without major complications) was achieved in all 70 cases (100%). Primary patency was 93.8% at 6 months and 86.2% at 1 year. Freedom from TLR was 93% at 1 year. Limb salvage rate at 12-month follow-up, defined as absence of major amputation, was 100%. This study shows the safety and efficacy of the everolimus-eluting, balloon expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in patients with critical limb ischemia.

Clinical Experience with Very High-Pressure Dilatation for Resistant Coronary Lesions.

Calcific coronary lesions can be so resistant to prevent symmetric stent dilatation with high risk of ISR/thrombosis. The aim of the current study is to evaluate the safety and efficacy of super high-pressure dilatation (>30-to-45Atm) using a dedicated NC-balloon (OPN, SIS-Medical-AG, Winterthur-Switzerland). We retrospectively evaluated 326 consecutive undilatable lesions in which conventional NC-balloons failed to achieve adequate post-dilatation luminal gain. After the failed attempt an OPN-balloon was inflated up to achieve a uniform balloon expansion (maximal dilatation pressure of 45-50 Atm). Lesions were divided into two groups according to the final inflation pressure: Group-I: lesion responsive to 30-40Atm and Group-2:>40 Atm. Angiographic success was defined as residual angiographic stenosis<30% assessed by visual estimation with TIMI3-flow. Procedural success was defined as the achievement of angiographic success without any MACE. Angiographic success was achieved in 97.5%, procedural success in 96.6%; 53% of the lesions were responsive to a slower inflation pressure (Group I) while in the remaining 47%, the optimal expansion required a pressure > 40ATM (Group II). In 3 patients coronary rupture occurred after balloon inflation and was successfully treated with stent implantation with a final TIMI3-flow. The OPN alone was able to achieve adequate expansion in >90%. 0.9% days MACE were reported. The OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.

Impact of Angiographic Residual Stenosis on Clinical Outcomes After New-Generation Drug-Eluting Stents Implantation: Insights From a Pooled Analysis of the RESET and NEXT Trials.

BackgroundPrevious intravascular ultrasound studies suggested the association of stent underexpansion with increased risk of stent thrombosis and restenosis. However, no previous study has addressed the association of the suboptimal angiographic result with target‐lesion revascularization (TLR) in patients receiving new‐generation drug‐eluting stents (DES).Methods and Results RESET (Randomized evaluation of sirolimus‐eluting versus everolimus‐eluting stent trial) and NEXT (NOBORI biolimus‐eluting versus XIENCE/PROMUS everolimus‐eluting stent trial) are prospective, multicenter, randomized “DES versus DES” trials; 3196 patients and 3235 patients were enrolled in the RESET and NEXT, respectively. Using the pooled individual patient‐level data, the current study population consisted of 3679 patients who received single‐lesion treatment using new‐generation DES such as everolimus‐eluting stent and biolimus‐eluting stent. The study population was divided into 3 groups according to the residual in‐stent % diameter stenosis (%DS) after stent implantation by offline quantitative coronary angiography assessed in a core angiographic laboratory (optimal group: %DS <10%, intermediate group: %DS=10% to 20%, suboptimal group: %DS ≧20%). The cumulative 3‐year incidence of TLR was significantly higher in the suboptimal group than in the intermediate and optimal groups (9.8% versus 5.8% versus 5.7%, log‐rank P=0.004). Even after adjusting for the clinical, angiographic, and procedural characteristics, the excess TLR risk of the suboptimal group relative to the optimal group remained significant (hazard ratio: 1.65, 95% confidence interval, 1.14–2.41, P=0.009). The excess TLR risk of the suboptimal group relative to the optimal group was consistently seen across all the subgroups including heavy calcification.ConclusionsThe residual angiographic in‐stent %DS ≥20% was associated with increased risk for TLR in patients treated with the new‐generation DES.

Anomalous connection of the right coronary artery with interarterial course: Preliminary prospective experience of stenting in a selected adult population

Anomalous connections of the coronary arteries (ANOCOR) with interarterial course raise therapeutic problems. Current guidelines recommend a surgical repair for right ANOCOR with evidence of ischemia. The lack of controlled studies and the scarcity of long-term data may explain an underutilization of surgical treatment. A percutaneous approach may provide an interesting alternative in a selected adult population. To assess the feasibility and safety of preaortic segment stenting in right ANOCOR with interarterial course. Stenting was proposed according to predefined criteria (age > 30 years, symptoms or documented ischemia, no history of aborted sudden death, ostial ovoid shape) for patients referred to an expert group. All patients underwent selective coronary angiography and coronary computed tomography. Evaluation by intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was recommended. Ten patients were prospectively included between 2014 and 2016, mean age 56 years (35–81). Two patients had acute coronary syndrome, five had stable angina, two were asymptomatic with positive stress test and one had syncope. An intramural segment was identified in half of the patients. Stenting was successful with residual angiographic stenosis < 50% in all procedures, 90% of drug-eluting stents, mean fluoroscopic time of 18 min, 70% of IVUS or OCT guidance, mean troponin at 24 hours of 0.58 μg/L and no periprocedural complication. Follow-up at 6 months was uneventful in all but one patient requiring a new hospitalization at 5 months for persistent angina reported to a vasospastic angina ( Fig. 1 ). Preaortic segment stenting of right ANOCOR with interarterial course appears feasible and safe in this preliminary experience. A longer follow-up and a more important population are needed to know whether this technique is suitable for a next therapeutic algorithm.

Indications and immediate and long-term results of a novel pericardium covered stent graft: Consecutive 5 year single center experience.

The use of covered stent grafts during percutaneous coronary intervention (PCI) is a life saving solution to seal acute iatrogenic vessel rupture. However, the presence of an impenetrable mechanical barrier is also appealing during treatment of friable coronary plaques but the synthetic PTFE-membrane that might trigger excessive neointimal proliferation has limited its elective-use. Pericardium tissue may offer an appealing "natural" alternative. Aim of our study is to report the consecutive 5-year single center experience with the use of pericardium-covered stents (PCS) (ITGI-Medical, Israel) in a variety of emergency and elective applications. Nineteen consecutive patients undergoing implantation of PCS at the Royal Brompton in the last 5-years. Reasons for PCS implantation included treatment of degenerated vein grafts, large coronary aneurysms, and acute iatrogenic vessel rupture. Angiographic success, defined as the ability of the device to be deployed in the indexed lesion with no contrast extravasation with residual angiographic stenosis <30% and a final thrombolysis in myocardial infarction (TIMI)-3 flow was achieved in all cases. Procedural success, defined as the achievement of angiographic success without any major adverse cardiovascular event (MACE) was achieved in 94.7% of patients. In-stent restenosis (ISR) was observed in 26.3% and all patients underwent successful target vessel revascularization with DES (mean time to restenosis 9.0 ± 4.0 months). At a mean follow-up of 32.5 ± 23.3 months no acute or late stent thrombosis was observed. PCSs were effective in the treatment of friable embolization-prone coronary plaques, sealing of acute iatrogenic vessel rupture and exclusion of large aneurysms with no thrombosis but high target lesion revascularization.

Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study

Thrombus is highly prevalent in patients with recent symptoms (< 6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions. Angiographic operator assessment and volumetric core lab quantitation of the thrombus were performed at baseline and after excimer laser but prior to definitive treatment of the vessel to evaluate thrombus resolution. Consecutive patients were prospectively enrolled at a single site. Procedural success was defined as achieving a residual stenosis of <30% after final treatment with no intraprocedural complications requiring additional treatment. 20 consecutive patients were enrolled in this study (8 males, mean age 69.5±11.1 years). Based on patients symptom onset, 12 patients were subacute (> 24 h, < 30 days), and 8 chronic (between 1 to 6 months). 15/20 (75%) had restenotic occlusions. Due to the long, occlusive nature of these lesions, only 8 patients had complete intravascular ultrasound images at each time point which allowed volumetric analysis by the core lab. There was no statistical difference in plaque/thrombus volume between baseline (pretreatment) and excimer laser (P=.68). There was however a significant reduction in residual angiographic stenosis post laser alone (100% vs. 66.75%±23.9%, P=.001). Procedural success was 100%. There were no deaths or amputations. Bail out stenting was performed in 10/20 (50%) patients. Embolic filters were used in 15/20 (75%) of patients. Macrodebris>2 mm were seen in 85.7% of filters. There was no in-hospital or 30-day reocclusion of the treated vessel but one patient had a vascular access complication (small AV fistula) conservatively managed. No other serious adverse events were noted. Using the excimer laser appears safe in this small feasibility study of subacute and chronic thrombotic occlusions. Angiographically, there was a significant reduction in percent stenosis with the laser alone. The limited IVUS data did not show a reduction in plaque/thrombus volume but the number of interpretable ultrasounds was small. Further data are needed to address the effectiveness of the laser in treating these thrombotic occlusions and its advantages over balloon angioplasty.

E0672 Treatment of atherosclerotic renal artery stenosis involving renal artery bifurcations

ObjectiveTo investigate the efficacy of kissing stent or kissing balloon technique for renal artery bifurcation with atherosclerotic renal artery stenosis.MethodsThere were five patients included, who were with atherosclerotic renal artery...

Utilization of excimer laser debulking for critical lesions unsuitable for standard renal angioplasty

The energy emitted by ultraviolet laser is avidly absorbed in atherosclerotic plaques. Conceptually, it could be applied for debulking of selected atherosclerotic renal artery stenoses. We describe early experience with revascularization of critical renal artery lesions deemed unsuitable for standard renal angioplasty. Institutional Review Board permission to conduct the data analysis was obtained. Among 130 percutaneous renal artery interventions with balloon angioplasty and adjunct stenting, there were 12 (9%) patients who underwent laser debulking prior to stenting. These patients presented with critical (95+/-3.5% stenoses) lesions (11 de novo, 1 stent restenosis) deemed unsuitable for standard renal angioplasty because of marked eccentricity and presence of thrombus. Indications for intervention included preservation of kidney function, treatment of uncontrolled hypertension, management of congestive heart failure, and treatment of unstable angina. Blood pressure and estimated glomerular filtration rate (eGFR) were measured pre- and 3 weeks post-intervention. A baseline angiographic stenosis of 95+/-3.5% was reduced to 50+/-13% with laser debulking. There were no laser-induced complications. Post-stenting the angiographic residual stenosis was 0%. The mean gradient across the lesions was reduced from baseline 85+/-40 to 0 mmHg. A normal post-intervention antegrade renal flow was observed in all patients. Baseline mean systolic BP of 178+/-20 mmHg decreased to 132+/-12 mmHg (P<0.0001) and mean diastolic pressure of 85+/-16 mmHg reduced to 71+/-9 mmHg (P = 0.01). A pre-intervention mean eGFR of 47.7+/-19 ml/min/1.73 m(2) increased to 56+/-20.4 ml/min/1.73 m(2) (P = 0.05) post-procedure. The interventions were not associated with major renal or cardiac adverse events. During follow-up one patient developed transient contrast-induced nephropathy. Debulking of select renal artery stenoses with laser angioplasty followed by adjunct stenting is feasible. Further prospective, randomized studies will be required to explore the role of debulking and laser angioplasty in renal artery revascularization.

Cutting Balloon Angioplasty in Percutaneous Carotid Interventions

To report a prospective feasibility study of cutting balloon angioplasty (CBA) applied in the predilation phase of carotid artery stenting (CAS) in highly calcified lesions. From January 2003 to February 2007, 178 consecutive patients (109 men; mean age 73.1+/-7.3 years) with highly calcified carotid lesions underwent CAS with CBA applied as a pre-specified strategy in the predilation phase of the procedure. All steps in the procedure were performed under cerebral filter protection. The cutting balloon ranged in diameter from 3 to 4 mm and was inflated at nominal pressures in the target lesion. Pre-CBA dilation with a low-profile coronary balloon was performed only when the cutting balloon was not able to cross the lesion. Selection of the filters and stents was at the operator's discretion. Primary endpoints were the all stroke and death rates at 30 days and 6 months. Secondary endpoints included cutting balloon success (positioning and full balloon inflation), CAS technical success (residual angiographic stenosis <30%), CAS procedural success (technical success and no complications), and in-hospital major complications. Cutting balloon success was achieved in all 178 patients. In 32 (18.0%), pre-CBA dilation was necessary due to inability to cross the lesion with the cutting balloon initially. CAS technical success was achieved in all patients. One (0.6%) patient suffered transient neurological intolerance due to flow cessation from massive debris in the distal filter; this event was completely resolved after the filter was removed (CAS procedural success 99.4%). One patient suffered a major stroke at day 15 (0.6% 30-day all stroke and death rate). At the 6-month follow-up, 174 (97.7%) patients were evaluated; 1 patient died from myocardial infarction at day 35, and 2 patients died from non-neurological or cardiac causes at days 103 and 158. The cumulative all stroke and death rate was 2.2%. These data suggest that CBA performed during the predilation phase of CAS in highly calcified lesion is a safe and useful method to prepare this lesion subset for stenting.

Randomized trial of predilation versus direct stenting for treatment of carotid artery stenosis

Background A controversial aspect of carotid artery stenting (CAS) is the placement of a stent with or without predilation. The study was designed to test the hypothesis that direct stenting (DS) was not inferior to CAS with predilation. Methods Elective CAS with filter protection was performed in 205 consecutive, unselected patients with carotid artery stenosis (> 50% if symptomatic and ≥ 75% if asymptomatic by Doppler assessment) who were randomly assigned to CAS with predilation ( n = 100) or direct stenting (DS, n = 105). Filter and stent selection were left to the operator's discretion. The study end-point was the angiographic success, defined as ≤ 30% angiographic residual stenosis after CAS without abnormal angiographic findings in cerebral circulation and without cross-over to predilation in the DS group. Results At baseline, patient clinical characteristics and stenosis anatomic features did not differ between groups. Angiographic success was 99% and 97%, p = 0.33, in predilation and DS, respectively. No cross-over to predilation occurred in the DS group. Procedural time was shorter in DS as compared to predilation (24.3 ± 7% versus 19.9 ± 6%, p = 0.001) and visible debris were more frequently captured in predilation as compared to DS (50% versus 36%, p = 0.003). No peri-procedural and 30-day death or major stroke occurred in both groups. Minor stroke and TIA rates were similar in either group (2% versus 0% and 8% versus 5.7%, p = ns, respectively). Conclusion In an unselected, consecutive series of patients submitted to CAS, DS is a feasible technique and is not inferior to CAS with predilation.

Initial Experience with Directed Laser Atherectomy Using the Clirpath Photoablation Atherectomy System and Bias Sheath in Superficial Femoral Artery Lesions

To report a safety and efficacy study of directed excimer laser atherectomy with the Bias Sheath guiding catheter to create larger lumens in the superficial femoral artery (SFA). Fourteen patients (9 men; mean age 66+/-9 years, range 46-76) with chronic lower limb ischemia (Rutherford class 2 to 5) referable to SFA stenoses were treated with the 8-F-compatible Bias Sheath and a 1.7- or 2.0-mm laser catheter. Eight (57%) lesions were de novo and 6 (43%) were in-stent restenoses (ISR). Mean diameter stenosis was 96%+/-8% (range 80%-100%; 10 total occlusions), and mean lesion length was 126+/-78 mm (range 30-290). The primary study endpoint was laser success, defined as <50% angiographic residual stenosis post-laser, without major perforations. The primary endpoint was achieved in 8 (57%) lesions; all patients underwent additional balloon angioplasty, which achieved an angiographic residual stenosis <30% in all. Three lesions could not be completely traversed with the study device. Two dissections were detected after Bias Sheath application; 1 required stenting. There were 2 embolic events (specific to the antegrade device design); both were treated with aspiration therapy. Intravascular ultrasound (IVUS)-based minimal lumen diameters were 0.23+/-0.2 mm (range 0-1.0) at baseline and 3.2+/-0.8 mm after Bias Sheath application. Rutherford category improved at 1 month in 10 (71%) patients. One patient remained unchanged, another worsened (category 2 to 3), 1 died, and the fourth was not examined. The ankle-brachial index improved from 0.41+/-0.18 at baseline to 0.79+/-0.19 at discharge and to 0.80+/-0.19 at 1 month. Primary 1-month patency (<50% restenosis by duplex) was 85% (11/13 lesions). SFA lesions, including ISR, can be treated in the majority of cases with directed laser atherectomy, significantly reducing plaque burden as measured by IVUS. Embolization was attributed to device-specific features of the prototype antegrade sheath design, which was discontinued. Larger studies are mandatory to document the long-term technical and clinical impact of this new device.

Cryoplasty for the Treatment of Femoropopliteal Arterial Disease: Results of a Prospective, Multicenter Registry

Despite suboptimal results, angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease. One hundred two patients with claudication and lesions of the superficial femoral and popliteal arteries of no greater than 10 cm were studied. All patients were treated with a primary strategy of stand-alone cryoplasty with use of the PolarCath cryoplasty system. The primary endpoints of the study were acute technical success and clinical patency at 9 months. Technical success was defined as the ability to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. Clinical patency was defined as freedom from target lesion revascularization within 9 months. Primary patency was defined by a duplex US systolic velocity ratio no greater than 2.0. A total of 102 patients were enrolled at 16 centers. Of those treated, 31% had diabetes and 31% were active cigarette smokers. The majority of the lesions were confined to the superficial femoral artery (84.3%) and 14.7% presented with total occlusions. The mean vessel diameter treated was 5.5 mm +/- 0.5, the mean stenosis diameter was 87% +/- 10%, and the mean lesion length was 4.7 cm +/- 2.6. The technical success rate was 85.3% with a mean residual stenosis after cryoplasty of 11.2% +/- 11.2% (P < .05 vs baseline). Clinical patency in this group was 82.2%, as only 16 patients required target lesion revascularization during the 9-month surveillance period. Primary patency determined by duplex US was 70.1%. Cryoplasty demonstrated a high degree of acute angiographic success and a low frequency of target lesion revascularization. The patency rate observed compares favorably to that previously documented with conventional angioplasty.

Carotid artery stenting: is there a need to revise ultrasound velocity criteria?

Ultrasound (US) velocity criteria have not been well-established for patients undergoing carotid artery stenting (CAS). A potential source of error in using US after CAS is that reduced compliance in the stented artery may result in elevated velocity relative to the native artery. We measured arterial compliance in the stented artery, and developed customized velocity criteria for use early after CAS. US was performed before and within 3 days after CAS, and after 1 month in a subset of 26 patients. Post-procedural peak systolic velocity (PSV) and end-diastolic velocity (EDV) of the internal carotid artery (ICA), PSV/EDV ratio, and internal carotid artery to common carotid artery ratio (ICA/CCA) were recorded. These were compared with degree of in-stent residual stenosis determined at carotid angiography performed at the completion of CAS. Peterson's elastic modulus (Ep) and compliance (Cp) of the ICA were determined in a subgroup of 20 patients at the distal end of the stent and in the same region in the native ICA before stenting. Ninety CAS procedures were analyzed. Mean (+/-SD) angiographic residual stenosis after CAS was 5.4 +/- 9.1%, whereas corresponding PSV by US was 120.4 +/- 32.4 cm/s; EDV, 41.4 +/- 18.6 cm/s; PSV/EDV ratio, 3.3 +/- 1.2; and ICA/CCA ratio, 1.6 +/- 0.5. PSV was unchanged at 1 month. Post-CAS PSV and ICA/CCA ratio correlated most with degree of stenosis (P <.0001 for both). Only six patients demonstrated in-stent residual stenosis 20% or greater, but the standard US threshold of PSV 130 cm/s or greater (validated for >20% ICA stenosis in our laboratory) categorized 38 of 90 patients as having stenosis 20% or greater. Receiver operator curve analysis demonstrated that a combined threshold of PSV 150 cm/s or greater and ICA/CCA ratio 2.16 or greater were optimal for detecting residual stenosis of 20% or greater, with sensitivity 100%, specificity 98%, positive predictive value 75%, and negative predictive value 100%. After placement of a stent, the ICA demonstrated significantly increased Ep (1.2 vs 4.4 x 10(3) mm Hg; P =.004) and decreased Cp (9.8 vs 3.2 %mm Hg x 10(-2); P =.0004). Currently accepted US velocity criteria validated in our laboratory for nonstented ICAs falsely classified several stented ICAs with normal diameter on carotid angiograms as having residual in-stent stenosis 20% or greater. We propose a new criterion that defines PSV less than 150 cm/s, with ICA/CCA ratio less than 2.16, as the best correlate to a normal lumen (0%-19% stenosis) in the recently stented ICA. This was associated with increased stiffness of the stented ICA (increased Ep, decreased Cp). These preliminary results suggest that placement of a stent in the carotid artery alters its biomechanical properties, which may cause an increase in US velocity measurements in the absence of a technical error or residual stenotic disease.