Adjunctive Balloon Angioplasty Research Articles

Orbital Atherectomy Prior to Drug-Coated Balloon Angioplasty in Calcified Infrapopliteal Lesions: A Randomized, Multicenter Pilot Study

Purpose: Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency. Materials and Methods: This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared. Results: Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups. Conclusion: The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions.

Mechanical revascularization using Solitaire AB device for acute limb ischemia secondary to popliteal and infrapopliteal embolic occlusion.

ObjectiveAcute limb ischemia is one of the most common arterial emergencies. The data of mechanical revascularization using Solitaire AB device coupled with thromboaspiration for the treatment of popliteal and infrapopliteal acute limb ischemia are limited. The aim of this study was to review the preliminary safety and effectiveness.MethodsWe performed a single-center retrospective review of patients with popliteal and infrapopliteal acute limb ischemia treated with Solitaire AB device coupled with thromboaspiration from February 2019 to May 2020. Adjunctive balloon angioplasty was performed to correct coexisting atherosclerotic stenosis. Technical success was defined as successful deployment of the Solitaire AB device across the occlusive segment and successful retrieval without the use of adjunctive catheter-directed thrombolysis or balloon angioplasty. Clinical success was defined as the relief of symptoms related to acute limb ischemia. Follow-up outcomes were also reviewed.ResultsThere were 15 consecutive patients who underwent 16 Solitaire AB devices. Technical success was achieved in 11 (73.3%) patients. Of the unsuccessful patients, double-stent retrievers were employed in 1 (6.7%) patient. Two patients who encountered residual clots in distal small arteries underwent adjunctive catheter-directed thrombolysis. An adjunctive balloon angioplasty was required in 1 (6.7%) patient. All patients had notable acute limb ischemia symptom relief after the procedures. Clinical success was achieved in 14 (93.3%) patients. Besides one patient encountered minor amputation, the major amputation was prevented in all patients. No device-related complications or distal embolization events were recorded during the procedures. At the follow-up of 12 months, all surviving patients remained symptom-free, the patency was achieved in 12 (80%) patients and the limb salvage was 100%.ConclusionsPreliminary outcomes suggest that mechanical revascularization using Solitaire AB device coupled with manual thromboaspiration appears to be a rapid, safe, and effective modality that appears to reduce the requirement for catheter-directed thrombolysis.Advances in knowledgeThese findings may add a promising recanalization therapy for acute embolic occlusion of the acute limb ischemia secondary to popliteal and infrapopliteal arteries.

Application of manual aspiration thrombectomy in the treatment of deep vein thrombosis in cancer patients: Descriptive retrospective cohort study.

ObjectivesTo determine the outcomes and feasibility of endovascular treatment, mainly based on manual aspiration thrombectomy (MAT) with adjunctive percutaneous balloon angioplasty with or without stent deployment, for treatment of symptomatic ilio-femoral deep vein thrombosis (IFDVT) in cancer patients.Materials and methodsIn this retrospective cohort study, 135 consecutive patients (56 men; mean age, 63 years; 149 limbs) with acute (n = 113; 83.7%) and subacute to chronic (n = 22; 16.3%) symptomatic IFDVT underwent MAT-based endovascular treatment. Among them, adjunctive balloon angioplasty and stent placement was performed in 94 patients. Technical and clinical success regarding stage and cause of DVT was assessed.ResultsTechnical success (complete thrombus removal without residual thrombus or stenosis) was achieved in 89.6%, and subjective symptom improvement was stated by 71.5% of treated patients. The primary patency rates were 88.1%, 81.6%, 76.0%, 74.1% and 69.1% at 1, 3, 6, 12, and 30 months, respectively. Recurrent IFDVT occurred in 19.3% (26/135) of patients, 0.79 cases per patients-years of follow up. According to the analysis by causes of IFDVT, recurrence rate was 19.3% (11/57), 21.2% (12/57), and 14.3% (3/21) in unknown, compression/invasion of the vein by cancerous mass, and May-Thurner syndrome groups, respectively (p = 0.798). No procedure-related complication developed.ConclusionsEndovascular treatment based on MAT is a feasible treatment option with favorable outcomes and minimal risk of complication in cancer patients with symptomatic IFDVT.

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study

Background Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non–flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. Materials and Methods We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). Results Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, <90° in 13.8%, 90° to 180° in 20.7%, and >180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. Conclusion The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.

Emergency tips recanalisation and gastroesophageal varices embolisation with an ethylene vinyl alcohol copolymer agent (Squid) and detachable coils

Transjugular intrahepatic portosystemic shunt (TIPS) is currently indicated as first therapeutic option in the main complications of portal hypertension, including bleeding gastroesophageal varices and refractory ascites. In case of bleeding gastroesophageal varices, an adjuvant embolisation within TIPS can be useful to prevent rebleeding. In the present technical note, the management in emergency of a patient with haemorrhagic shock due to bleeding gastroesophageal varices and occluded TIPS is reported. TIPS recanalisation with an adjunctive stent and high-pressure balloon angioplasty and gastroesophageal varices embolisation using detachable coils and a non-adhesive liquid embolic agent were performed during the same emergent procedure. After the procedure, clinical stabilisation of the patient was achieved, with blood transfusions suspension and Blakemore tube removal. At 6 months, regular TIPS patency at colour Doppler and no rebleeding episodes were recorded. To our knowledge, whilst coils are routinely used for varices embolisation, non-adhesive liquid embolic agents have been never mentioned. Liquid embolic agents seem to provide a stable plug strengthening the embolising action of the coils. Further studies involving a cohort of patients with long-term follow-up will be necessary to confirm whether this association can be more effective than coils alone in gastroesophageal varices embolisation.

Adjunctive drug-coated balloon vs percutaneous transluminal angioplasty after atherectomy in common femoral artery diseases: a comparative study

Purpose Recent reports examined the efficacy of adjuvant techniques, such as drug-eluting balloon (DEB) inflation and percutaneous plain balloon angioplasty (POBA), in improving the long-term patency rate after atherectomy for common femoral artery (CFA) disease. The authors conducted the present comparative trial to compare the 6-month patency rate of adjuvant DEB inflation vs POBA after atherectomy of CFA disease. Materials and methods The authors conducted a retrospective comparative study on 80 patients with CFA disease who presented to the operating theaters of Vascular Surgery Department of Aswan University Hospital during the period from February 2016 to February 2018. Patients were allocated in equal ratio to one of the following groups: group DEB and group POBA. Results There were no statistically significant differences between studied groups in terms of procedure characteristics (P>0.05). Regarding the primary outcome of the present study, the DEB ad POBA groups had comparable rate of patency at 1 month (92.5 vs 100%, respectively), 6 months (87.5 vs 95%, respectively), and 12 months (72.5 vs 75%, respectively; P>0.05). There were no statistically significant differences between studied groups in terms of complications (P>0.05). Conclusion Both adjuvant DEB and POBA are effective modalities in improving the long-term patency rate in patients undergoing atherectomy for CFA lesions. This study demonstrated that both techniques achieved high success rate, with low incidence of procedure-related complications. Nonetheless, larger studies are still needed to confirm the findings.

Excimer laser atherectomy combined with drug-coated balloon angioplasty for the treatment of chronic obstructive femoropopliteal arterial disease.

The aim of the present retrospective study was to evaluate the feasibility, safety and the primary results following application of excimer laser atherectomy (ELA) combined with adjunctive drug-coated balloon angioplasty (DCBA) as the first-line endovascular treatment for patients with chronic obstructive femoropopliteal arterial disease. The baseline characteristics and angiographic variables of all patients who underwent ELA for stable chronic obstructive femoropopliteal arterial disease at Tianjin First Central Hospital (Tianjin, China) between May and December 2017 were collected. Information on clinical characteristics, including the 12-month primary patency rate, technical success rate, procedural success rate, bailout stenting rate, target lesion revascularization and major adverse events, was obtained following review of the patients' medical records. A descriptive analysis was performed on all variables. Kaplan-Meier curves were plotted for the primary patency rate. The present study included 17 consecutive patients (age, 68.9±7.4 years; 94.1% males) who were followed up for 12 months after the intervention. Adjunctive BA was performed in 100% of the cases. The occlusion length was 23.3±8.9 cm (range, 5.6–40.5 cm). The technical success rate was 100% and the procedural success rate was 88.2%. Bailout stenting was required in 5 of the 17 patients (29.4%) and the 12-month primary patency rate was 82.4%. The clinically driven target lesion revascularization rate was 5.9% at 12 months. An embolic protection device was used in 23.5% of the patients. The following adverse events were reported: Distal embolization requiring treatment, 5.9% (1 patient with embolic protection device); and flow-limiting dissection requiring treatment, 5.9%. In the present study, there were no major adverse events (all-cause death, unplanned major amputation or target lesion revascularization) at 30 days after the intervention. Therefore, ELA combined with adjunctive DCBA for the treatment of chronic obstructive femoropopliteal arterial disease appears to be safe, practicable and associated with a high procedural success rate; furthermore, endoluminal-driven atherectomy may effectively reduce the requirement for stent placement in the lower limb arteries and is associated with long-term patency.

TCT-675 Direct Stenting Versus Adjunctive Balloon Angioplasty for Saphenous Vein Graft Percutaneous Coronary Intervention

Direct stenting without pre- or post-dilation has been advocated for saphenous vein graft (SVG) percutaneous coronary intervention (PCI) to decrease the incidence of periprocedural myocardial infarction (MI) and target lesion revascularization (TLR). In an analysis of the DIVA (Drug-Eluting Stents

Clinical outcomes of manual aspiration thrombectomy for Ilio-femoral venous thrombosis in cancer patients.

e23145 Background: To determine the outcomes and feasibility of manual aspiration thrombectomy (MAT) for treatment of symptomatic ilio-femoral deep vein thrombosis (IFDVT) in cancer patients. Methods: In this retrospective study, one hundred and thirty-five consecutive patients (56 men; mean age, 63 years; 149 limbs) with acute (n = 113; 83.7%), subacute (n = 14; 10.4%), and chronic (n = 8; 5.9%) symptomatic IFDVT underwent MAT-based endovascular treatment, with adjunctive balloon angioplasty and stent placement performed in 94 patients. Degree of thrombus removal on venography and symptom improvement was assessed for evaluation of technical and clinical success, respectively. Results: Technical success (thrombus removal &gt; 50%) was achieved in 90.4%, and clinical success was observed in 71.5%. The primary patency rates were 88.1%, 81.6%, 76.0%, 74.1% and 69.1% at 1, 3, 6, 12, and 30 months, respectively. Recurrent IFDVT occurred in 19.3% of patients, 0.79 cases per patients-years of follow up. According to the analysis by causes of IFDVT, recurrent rate was 19.3%, 21.2%, and 14.3% in unknown, compression/invasion of the vein by cancerous mass, and May-Thurner syndrome groups, respectively (p = 0.798). No procedure-related complication developed. Conclusions: MAT is a feasible treatment option with favorable outcomes and minimal risk of complication in cancer patients with symptomatic IFDVT.

TCTAP A-050 Acute and Mid-term Results of Directional Coronary Atherectomy (DCA) Adjunctive Drug-coated Balloon (DCB) Angioplasty

Drug-eluting stent (DES) has reduced clinical events, however, long-life dual antiplatelet therapy is the problem for the patients who need a surgical operation or anticoagulant therapy. Neo-atherosclerosis inside stents has remained unsolved events. In Japan directional coronary atherectomy (DCA)

300.07 Inter-Core Lab Variability in Assessing Dissections in Femoropopliteal Arteries as Seen on Intravascular Ultrasound

Angiography underestimates the presence and depth of dissections seen following atherectomy and adjunctive balloon angioplasty of femoropopliteal arteries. The i-Dissection classification was recently introduced to evaluate the circumference (<180 degrees, ≥ 180 degrees) and depth (A to C from

Efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease.

Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success. To evaluate the additive efficacy of drug coated balloon in treating CFA disease. Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound. Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency. Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment.

TCT-25 Insights Into The Mechanisms of Action of The Rotational Atherectomy: An Oct Study

The aim of our study is to characterize, using OCT, the morphologic features of calcific plaques after rotational atherectomy, adjunctive balloon angioplasty and stenting. A total of 57 consecutive patients who had undergone angioplasty using rotational atherectomy were included. The 67 lesions

CRT-100.54 Insights Into The Mechanisms Of Action Of The Rotational Atherectomy: An OCT Study

The aim of our study is to characterize, using OCT, the morphologic features of calcific plaques after rotational atherectomy, adjunctive balloon angioplasty and stenting. A total of 57 consecutive patients who had undergone angioplasty using rotational atherectomy were included. The 67 lesions

Alterations of Blood Flow Through Arteries Following Atherectomy and the Impact on Pressure Variation and Velocity.

Simulations were made of the pressure and velocity fields throughout an artery before and after removal of plaque using orbital atherectomy plus adjunctive balloon angioplasty or stenting. The calculations were carried out with an unsteady computational fluid dynamic solver that allows the fluid to naturally transition to turbulence. The results of the atherectomy procedure leads to an increased flow through the stenotic zone with a coincident decrease in pressure drop across the stenosis. The measured effect of atherectomy and adjunctive treatment showed decrease the systolic pressure drop by a factor of 2.3. Waveforms obtained from a measurements were input into a numerical simulation of blood flow through geometry obtained from medical imaging. From the numerical simulations, a detailed investigation of the sources of pressure loss was obtained. It is found that the major sources of pressure drop are related to the acceleration of blood through heavily occluded cross sections and the imperfect flow recovery downstream. This finding suggests that targeting only the most occluded parts of a stenosis would benefit the hemodynamics. The calculated change in systolic pressure drop through the lesion was a factor of 2.4, in excellent agreement with the measured improvement. The systolic and cardiac-cycle-average pressure results were compared with measurements made in a multi-patient study treated with orbital atherectomy and adjunctive treatment. The agreements between the measured and calculated systolic pressure drop before and after the treatment were within 3%. This excellent agreement adds further confidence to the results. This research demonstrates the use of orbital atherectomy to facilitate balloon expansion to restore blood flow and how pressure measurements can be utilized to optimize revascularization of occluded peripheral vessels.

JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries

Purpose: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment. Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9±11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4±13.1 cm. The primary effectiveness outcome was acute success (≤30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory. Results: Treated length was 19.5±12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6±3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months. Conclusion: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results.

Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis

Rotational atherectomy with the use of the JetStream XC device is indicated for treatment of infrainguinal arterial obstructive disease. The number of blades-up (BU) runs needed for optimal tissue debulking in femoropopliteal in-stent restenosis (ISR) is unknown. In the present series, 6 patients (15 lesions) were treated for femoropopliteal ISR with the JetStream XC device. Minimal luminal diameter or percent stenosis improved significantly from baseline after 2 BU runs, but no further gain was seen between 2 and 4 BU runs (P > .05). However, adjunctive balloon angioplasty reduced percent stenosis significantly following BU runs. In conclusion, the JetStream XC device achieved optimal acute angiographic results in treating femoropopliteal ISR following 2 BU runs and adjunctive balloon angioplasty.

Laser Atherectomy for Treatment of Femoropopliteal In-Stent Restenosis

Purpose: To investigate if laser atherectomy with adjunctive balloon angioplasty can improve endovascular treatment outcomes for femoropopliteal in-stent restenosis (ISR). Methods: A dual center study included 135 symptomatic patients (mean age 71 years; 76 men) who underwent endovascular treatment of femoropopliteal ISR between 2006 and 2013. Of these, 54 (40%) were treated with laser atherectomy and the remaining 81 patients with balloon angioplasty alone. Angiographic images were reviewed for lesion morphology and characteristics, TransAtlantic InterSociety Consensus (TASC) II classification, and distal runoff. Class I ISR was defined as focal lesions ≤50 mm, class II ISR as lesions >50 mm, and class III ISR as stent total occlusion. Recurrent ISR was determined by a peak systolic velocity ratio >2.4 by duplex ultrasound. Results: Patients treated with laser atherectomy had longer mean ISR lesion length (222 vs 114 mm, p<0.001) and more class III ISR (69% vs 20%, p=0.001). There was no association between laser atherectomy and rates of recurrent restenosis or occlusion for patients with class I/II ISR, but there was a significantly lower rate of target lesion revascularization at 2 years among patients treated with laser atherectomy (14% vs 44%, p=0.05). In comparison, patients with class III ISR treated with laser atherectomy had lower rates of recurrent restenosis at 1 year (54% vs 91%, p=0.05) and 2 years (69% vs 100%, p=0.05). Patients with class III ISR treated with laser atherectomy also had lower rates of recurrent in-stent occlusion at 2-year follow-up (33% vs 71%, p=0.04). Conclusion: When used to treat complex ISR, including in-stent occlusions, laser atherectomy with adjunctive balloon angioplasty may be associated with improved patency.

Percutaneous transluminal rotational atherectomy for coronary artery disease

This is an update of the review on 'Percutaneous transluminal rotational atherectomy for coronary artery disease' first published in The Cochrane Library Issue 4, 2003. Percutaneous transluminal coronary rotational atherectomy (PTCRA) debulks atherosclerotic plaque from coronary arteries using an abrasive burr. On rotation, the burr selectively removes hard tissue. PTCRA has been used both as an alternative to and in conjunction with balloon angioplasty to open up blocked coronary arteries.Its ongoing effectiveness and safety compared with other modes of removing atherosclerotic plaques is reviewed. To assess the effects of PTCRA for coronary artery disease in patients with non-complex and complex lesions (e.g. ostial, long or diffuse lesions or those arising from in-stent re-stenosis) of the coronary arteries. For the original review, we searched the Heart Group Specialised Register; The Cochrane Library to Issue 2, 2001; and MEDLINE, CINAHL, EMBASE and Current Contents to December 2002 and reviewed reference lists for relevant articles. For the current review, we searched the same registries from 2002 to 2012 and reviewed reference lists for relevant articles. We included randomised and quasi-randomised controlled trials of PTCRA compared with placebo, no treatment or another intervention and excluded cross-over trials. Two review authors independently extracted data and assessed the risk of bias of the studies identified.Data were extracted independently by two review authors. We asked authors of trials to provide information when missing data were encountered. Statistical summaries used risk ratios (RR) and weighted mean differences. We included 12 trials enrolling 3474 patients.The overall risk of bias was unclear for the majority of articles due to a lack of reported data; however, the authors determined that this would be unlikely to impact negatively as most data outcomes were objective (e.g. death vs. no death). There was no evidence of the effectiveness in improving patient outcomes of PTCRA in non-complex lesions.In complex lesions, there were no statistically significant differences in re-stenosis rates at six months (RR 1.05; 95% confidence interval (CI) 0.83 to 1.33) and at one year (RR 1.21; 95% CI 0.95 to 1.55) in those receiving PTCRA with adjunctive balloon angioplasty (PTCA) (PTCRA/PTCA) compared to those receiving PTCA alone. Morphological characteristics distinguishing complex lesions have not been examined in parallel-arm randomised controlled trials. The evidence for the effectiveness of PTCRA in in-stent re-stenosis is unclearCompared to angioplasty alone, PTCRA/PTCA did not result in a statistically significant increase in the risk of major adverse cardiac events (myocardial infarction (MI), emergency cardiac surgery or death) during the in-hospital period (RR 1.27; 95% CI 0.86 to 1.90). Compared to angioplasty, PTCRA was associated with nine times the risk of an angiographically detectable vascular spasm (RR 9.23; 95% CI 4.61 to 18.47), four times the risk of perforation (RR 4.28; 95% CI 0.92 to 19.83) and about twice the risk of transient vessel occlusions (RR 2.49; 95% CI 1.25 to 4.99) while angiographic dissections (RR 0.48; 95% CI 0.34 to 0.68) and stents used as a bailout procedure (RR 0.29; 95% CI 0.09 to 0.87) were less common. When conventional PTCA is feasible, PTCRA appears to confer no additional benefits. There is limited published evidence and no long-term data to support the routine use of PTCRA in in-stent re-stenosis. Compared to angioplasty alone, PTCRA/PTCA did not result in a higher incidence of major adverse cardiac events, but patients were more likely to experience vascular spasm, perforation and transient vessel occlusion. In certain circumstances (e.g. patients ineligible for cardiac surgery, those with architecturally complex lesions, or those with lesions that fail PTCA), PTCRA may achieve satisfactory re-vascularisation in subsequent procedures.

Safety and One-Year revascularization outcome of excimer laser ablation therapy in treating in-stent restenosis of femoropopliteal arteries: A retrospective review from a single center

Treatment of in-stent restenosis of the femoropopliteal (FP) arteries is challenging with a high rate of restenosis. Excimer laser atherectomy (ELA) has a theoretical advantage of ablating restenotic tissue and reducing or delaying the need for repeat revascularization. We present a retrospective analysis from our center on the outcomes of ELA in the treatment of in-stent restenosis of the FP arteries. Demographic, clinical, angiographic and procedural data were collected on all patients that underwent ELA for in-stent restenosis from February 2005 to April 2010 at a single medical center. Major adverse events and one-year target lesion revascularization (TLR) and target vessel revascularization (TVR) were obtained by reviewing of medical records. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TLR were plotted. 40 consecutive patients (mean age 67.7±9.0years, 57.5% males) were included and followed for 1year. Adjunctive balloon angioplasty was performed in 100% at a mean pressure of 12.4±2.9atm. Acute procedural success (<30% angiographic residual narrowing) occurred in 92.5% of patients. Embolic filter protection (EFP) was used in 57.5% of patients. Bailout stenting was 50.0%. Macrodebris was noted in 65.2% of filters. The following adverse events were reported: distal embolization (DE) requiring treatment 2.5% (1 patient with no EFP); planned minor amputation 2.6%, planned major amputation 2.6%, total death 7.7% (all cardiac related). One perforation occurred treated successfully with stenting and balloon inflation. At one year, TLR and TVR occurred in 48.7% and 48.7% respectively. ELA has an overall favorable acute result in treating in-stent restenosis of the FP arteries. At one year TLR and TVR remain clinically significant. DE also occurs significantly with ELA and is effectively prevented with EFP.