Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis

BackgroundDirect stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA).MethodsORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA.ResultsProcedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively).ConclusionsOrbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.     

Impact of age following treatment of severely calcified coronary lesions with the orbital atherectomy system: 3-year follow-up

ObjectivesWe investigated the safety and efficacy of coronary orbital atherectomy to treat severely calcified lesions prior to stenting based upon age.BackgroundThe ORBIT II study reported the safety and efficacy with orbital atherectomy in 443 patients with severely calcified lesions. Elderly patients undergoing percutaneous coronary intervention may be at increased risk for major adverse cardiac events (MACE) and death compared with younger patients.MethodsPatients were stratified according to age (≥75 year old [174/443, 39.3%] vs. <75 year old [269/443, 60.7%]). The MACE rate, defined as cardiac death, myocardial infarction (CK-MB > 3X ULN), and target vessel revascularization, was examined at 30-day and 3-year follow-up.ResultsElderly and non-elderly groups had similar rates of procedural (87.9% vs. 89.5%, p = 0.64) and angiographic success (91.4% vs. 91.4%, p = 1.00). Severe angiographic complications were also similar in both groups (6.9% vs. 7.4%, p = 1.00). There was no statistically significant difference in MACE rates in the elderly and younger groups at 30 days (10.9% vs. 10.1%; p = 0.76) and 3 years (27.8% vs. 20.7%, p = 0.13). The individual endpoints of cardiac death (9.1% vs. 5.1%, p = 0.14), myocardial infarction (13.4% vs. 9.7%, p = 0.27), and target vessel revascularization (10.6% vs. 10.0%, p = 0.91) were also similar in both groups at 3 years.ConclusionsThe rates of adverse clinical events in elderly patients who underwent orbital atherectomy were low and similar to the non-elderly patients, suggesting that it could be a reasonable treatment strategy for elderly patients with severely calcified lesions.     

Orbital Atherectomy for the Treatment of Long (≥25–40 mm) Severely Calcified Coronary Lesions: ORBIT II Sub-Analysis

BackgroundOrbital atherectomy (OA) is an effective method of lesion preparation of severely calcified vessels prior to stent deployment. Long calcified lesions may lead to higher risk of post-procedural complications, yet the optimal treatment strategy has not been established. In this study we sought to determine the safety and efficacy of OA in patients with long (≥25–40 mm) calcified target lesions.MethodsORBIT II was a single-arm trial that enrolled 443 patients at 49 U.S. sites. De novo, severely calcified coronary lesions were treated with OA prior to stenting. Patients treated with the OA device were stratified into two groups according to target lesion length as visually estimated by the investigator: those with short (<25 mm; N = 314) vs. long (≥25–40 mm; N = 118) lesions. Lesions >40 mm were excluded per protocol. The primary endpoint was the 3-year major adverse cardiac event (MACE) rate, defined as a composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).ResultsThe 3-year MACE rates in patients with short (<25 mm) vs. long (≥25–40 mm) lesions were 21.1% vs. 29.9% respectively (p = 0.055). The rate of cardiac death (6.5% vs. 7.8%, p = 0.592) and TVR (8.5% vs. 13.7%, p = 0.153) did not significantly differ. The rate of MI (CK-MB > 3× ULN) at 3 years was significantly higher in patients with long (≥25–40 mm) lesions (9.0% vs. 17.0%, p = 0.024), with the majority occurring in-hospital (7.0% vs. 13.6%, p = 0.037).ConclusionsPatients with long (≥25–40 mm) calcified target lesions had similar outcomes in terms of MACE at 3 years despite higher rates of MI, which mostly occurred in-hospital. Using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25 mm) and long (≥25–40 mm) groups. Further studies are warranted to determine how OA compares to focal force balloon angioplasty, rotational atherectomy and other novel treatment options for long severely calcified lesions.Summary for annotated table of contentsPercutaneous coronary intervention of long calcified lesions is inherently more complex and higher risk and may require more intensive lesion preparation. This sub-analysis of ORBIT II revealed that orbital atherectomy treatment of longer (≥25–40 mm) lesions was associated with a higher rate of MACE at 30 days, but not at 3 years. This difference, however, was driven primarily by a higher in-hospital non-Q-wave MI rate; using the more contemporary SCAI definition of MI, there was no significant difference in rates of MI between the short (<25 mm) and long (≥25–40 mm) groups.     

Orbital Atherectomy for Treatment of Severely Calcified Coronary Artery Bifurcation Lesions: A Multicenter Analysis

ObjectiveThis study evaluated the safety and efficacy of orbital atherectomy (OA) for the treatment of severely calcified coronary artery bifurcation lesions.BackgroundPercutaneous coronary intervention (PCI) of severely calcified coronary artery lesions is associated with lower procedural success and higher rates of target lesion failure compared to non-calcified lesions. OA is an effective treatment for calcified coronary artery lesions prior to stent implantation. However, there is little data regarding the safety and efficacy of OA in patients with coronary artery bifurcation lesions.MethodsData were obtained from analysis of patients with severe coronary artery calcification who underwent OA and coronary stent implantation at ten high-volume institutions. Data were pooled and analyzed to assess peri-procedural outcomes and 30-day major adverse cardiac events (MACE).ResultsA total of 1156 patients were treated with OA and PCI. 363 lesions were at a coronary artery bifurcation. There were no statistically significant differences in baseline characteristics between the bifurcation and non-bifurcation groups. In the bifurcation group, treatment involved the left anterior descending artery and its branches more frequently and right coronary artery less frequently. After propensity score matching, the 30-day freedom from MACE was not statistically significant between the two groups.ConclusionIn this multicenter cohort analysis, patients with severely calcified coronary bifurcation lesions had low rates of MACE and target vessel revascularization at 30 days at rates comparable to non-bifurcation lesions. This analysis demonstrates that OA is safe and effective for complex coronary lesions at both bifurcation and non-bifurcation locations.     

Rotational atherectomy for fibro‐calcific coronary artery disease in drug eluting stent era: Procedural outcomes and angiographic follow‐up results

Objectives: The aim of this study was to examine the binary re‐stenosis rates, procedural success, and in hospital outcomes following treatment of fibro‐calcified coronary lesion with rotational atherectomy in drug eluting stent era. Background: Binary restenosis rates have remained high with the use of bare metal stents following rotational atherectomy in calcified lesions. There is limited data available following rotational atherectomy in drug eluting stent era. Methods: We evaluated the procedural and angiographic outcomes following a consecutive series of 516 procedures treated with rotational atherectomy followed by stenting. We compared the results between Rota + Drug eluting stent (DES) and Rota + bare metal stent (BMS) groups. Results: Procedural success was achieved in 97.1% of the lesions with overall low in hospital adverse events (death in 1.1%, Q MI in 1.3%, Non Q MI in 5.3%, and urgent repeat PCI in 0.4%). There was significant reduction in the binary restenosis rates following Rota + DES use as compared to Rota + BMS use (11% vs. 28.1%, P < 0.001; OR = 3.17, 95% CI: 1.76–5.93) and similar reduction was seen in the target lesion revascularization (10.6% vs. 25%, P = 0.001; OR = 2.81, 95% CI: 1.53–5.14). We have identified ostial lesions, chronic total occlusion lesions, and use of bare metal stents as independent predictors of restenosis in this group of patients. Conclusions: Rotational atherectomy can be performed with high success rates and low complications, and rotational atherectomy followed by drug eluting stent implantation significantly reduces binary restenosis rates in fibrocalcific lesions as compared to rotational atherectomy and bare metal stents. © 2010 Wiley‐Liss, Inc.     

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement

BackgroundCoronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR).MethodsRetrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)].ResultsThere were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively.ConclusionsIn this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided.Table of contents summaryThere is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.     

Outcomes after Atherectomy Treatment of Severely Calcified Coronary Bifurcation Lesions: A Single Center Experience

BackgroundCoronary bifurcation and calcified lesions account for 15–20% and 6%–20% of percutaneous coronary interventions (PCI), respectively. Treatment of these lesions is associated with high periprocedural complication rates and unfavorable long-term clinical outcomes, including high rates of revascularization. This retrospective, single-center study evaluated the outcomes of atherectomy treatment for heavily calcified coronary bifurcation lesions.MethodsPatients who underwent a coronary atherectomy procedure to treat a heavily calcified lesion between January 2010 and March 2016 at Metropolitan Heart and Vascular Institute (Minneapolis, MN) were included in this retrospective study. Data were stratified to compare atherectomy treatment of coronary bifurcation lesions vs non-bifurcation lesions. Additionally, data were compared based on type of atherectomy utilized during the index procedure, either orbital (OAS) or rotational (RA) atherectomy. Major adverse cardiac events (MACE), defined as a composite of death, myocardial infarction (MI), and target vessel revascularization (TVR), were assessed at 30 days post-procedure.ResultsAmong the 177 patients treated with atherectomy, 72 patients had bifurcation lesions. Compared to patients with non-bifurcation lesions, patients with bifurcation lesions were more likely to have a history of prior PCI or coronary artery bypass grafting. Bifurcation lesions required a higher volume of contrast. There were similar low rates of slow flow/no-reflow (2.8% bifurcations vs 1.0% non-bifurcation; p = 0.355). The 30-day rates of death (1.4% vs 1.9%; p = 0.794), MI (0% vs 0%; p = NA), and TVR (0% vs 1.0%; p = 0.406) were similar in patients with bifurcation lesions versus those without, respectively. An atherectomy sub-analysis (OAS vs RA) of the patients with bifurcation lesions showed that OAS utilization was associated with shorter procedure time (81 min vs 109 min; p = 0.026) and fluoroscopy time (18 min vs 27 min; p = 0.007) compared to RA, respectively—no significant differences in baseline demographic or lesion characteristics were noted in the bifurcation atherectomy sub-groups, except for higher beta/calcium blocker use in RA bifurcation subjects.ConclusionsThe results of this study demonstrated that atherectomy treatment in patients with heavily calcified coronary bifurcation lesions is feasible, resulting in similar low 30-day MACE rates as compared to patients with non-bifurcation lesions. In addition, in this study OAS utilization versus RA in bifurcation lesions was associated with significantly shorter procedure and fluoroscopy time. Further studies are needed to assess the safety and efficacy of atherectomy in patients with severely calcified bifurcation lesions.Summary for annotated table of contentsThis retrospective, single-center study evaluated the outcomes of orbital and rotational atherectomy treatment for heavily calcified coronary bifurcation lesions as compared to non-bifurcation lesions. The results demonstrate that atherectomy treatment in patients with heavily calcified coronary bifurcation lesions is feasible, resulting in similarly low 30-day MACE rates as compared to patients with non-bifurcation lesions. In addition, in this study OAS utilization versus RA in bifurcation lesions was associated with significantly shorter procedure and fluoroscopy time.     

Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions

Objective: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) for the treatment of de novo calcified coronary lesions. Background: Severely calcified coronary arteries pose an ongoing treatment challenge. Stent placement in calcified lesions can result in stent under expansion, malapposition, and procedural complications. OAS treatment may change calcified lesion compliance to reduce procedural complications and facilitate stent placement. Methods: The ORBIT I trial, a prospective, nonrandomized study, was conducted in two centers in India. Fifty patients with de novo calcified coronary lesions were enrolled. Patients were treated with the OAS followed by stent placement. Results: The average age of the patients was 57.4 years and 90% were male. Mean lesion length was 13.4 mm. The average number of OAS devices used per patient was 1.3. Device success was 98%, and procedural success was 94%. The cumulative major adverse cardiac event rate was 4% in‐hospital (two non–Q‐wave myocardial infarctions), 6% at 30 days (one additional non–Q‐wave myocardial infarction leading to target lesion revascularization), and 8% at 6 months (one additional event of cardiac death). Angiographic complications were observed in seven patients (six dissections and one perforation). Conclusion: The ORBIT I trial suggests that the OAS may offer an effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult to treat patients. A larger trial is required to establish safety and overall effectiveness of the OAS in treating calcified coronary lesions. © 2012 Wiley Periodicals, Inc.     

Outcomes After Coronary Orbital Atherectomy at Centers Without On-Site Surgical Backup: Diabetics Versus Non-Diabetics and Impact of Access Site

Background/purposeThere is limited data available on atherectomy usage in hospitals or centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the in-hospital and 30-day outcomes of complex PCI patients (including diabetics) treated with coronary orbital atherectomy (OA) at centers without on-site surgical back-up.Methods/materialsAll comers treated with OA at two centers without on-site surgical backup were included. Baseline, procedure, and outcome data were compared in diabetic and non-diabetic patients. The impact of transfemoral (TFA) versus transradial (TRA) vascular access was also assessed.ResultsOf the 221 patients treated with OA, 43% were diabetics. The diabetes and no-diabetes groups had similar baseline demographic and lesion characteristics, except for the higher rate of chronic kidney disease seen in the diabetics. Overall, there was a high freedom from major adverse cardiac events (MACE; in-hospital: 99.5%; 30-day: 98.6%), as well as a high success in stent delivery (99.5%) and procedural success (97.3%). The rate of angiographic complications was low in both the diabetes and no-diabetes groups (3.1% vs. 1.6%, p = 0.450). TFA and TRA were used in 36% and 64% of the patients, respectively—resulting in low angiographic complications in both groups (3.8% vs. 1.4%, p = 0.263).ConclusionsDespite the complexity of patient co-morbidities and the presence of heavily calcified lesions, the results indicate that coronary OA can be used safely and effectively without on-site surgical back-up. OA treatment resulted in a high rate of successful stent delivery and procedural success, as well as low rates of angiographic complications and MACE, in diabetic and non-diabetic patients, regardless of access site.Table of contents summaryThere is limited data available on atherectomy usage in centers without on-site surgical backup. The purpose of this retrospective analysis was to gain further knowledge by analyzing the outcomes of complex PCI patients (including diabetics) treated with coronary orbital atherectomy (OA) at centers without on-site surgical back-up. The impact of transfemoral (TFA) versus transradial (TRA) vascular access was also assessed. Despite the complexity of patient co-morbidities and the presence of heavily calcified lesions, the results indicate that coronary OA can be used safely and effectively without on-site surgical back-up. OA treatment resulted in a high rate of successful stent delivery and procedural success, as well as low rates of angiographic complications and major adverse cardiac events, in diabetic and non-diabetic patients, regardless of access site (TFA or TRA).     

Safety of Same-Day Discharge after Percutaneous Coronary Intervention with Orbital Atherectomy

BackgroundSeverely calcified lesions present many challenges to percutaneous coronary intervention (PCI). Orbital atherectomy (OA) aids vessel preparation and treatment of severely calcified coronary lesions. Same-day discharge (SDD) after PCI has numerous advantages including cost savings and improved patient satisfaction. The aim of this study is to evaluate the safety of SDD among patients treated with OA in a real-world setting.MethodsThis was a single-center retrospective analysis of patients undergoing OA. In-hospital and 30-day outcomes were assessed for major adverse cardiac events (MACE), device-related events and hospital readmissions.ResultsThere were 309 patients treated with OA of whom 94 had SDD (30.4%). Among SDD patients, there were no acute procedural complications and all patients were safely discharged on the day of the procedure. MACE at 30 days occurred in 1 patient (1.06%) due to major bleeding in the setting of a gastric arteriovenous malformation. There were 8 patients with unplanned 30-day readmissions (8.5%).ConclusionSDD after OA in patients with heavily calcified lesions appears to be safe, with low rates of adverse events and readmissions in select patients. In patients with SDD treated with OA, unplanned readmission occurred at a similar rate to the statewide average 30-day PCI readmission rate. Larger studies are needed to confirm the safety of this treatment paradigm and the potential cost savings.     

Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub‐analysis

Objectives

We sought to assess the clinical outcomes when intravascular ultrasound (IVUS) was used prior to orbital atherectomy treatment (OA) versus angiography alone for lesion assessment.

Background

Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with high rates of major adverse cardiac events (MACE). IVUS provides additional diagnostic information to optimize PCI.

Methods

ORBIT II was a single‐arm study of 443 patients with de novo, severely calcified coronary lesions treated with OA before stent placement. Patients with IVUS imaging prior to OA (N = 35) were compared to patients without IVUS imaging for initial lesion assessment (N = 405). In this post‐hoc sub‐analysis procedural outcomes and the 3‐year MACE rate were evaluated.

Results

The rates of severe angiographic complications were low in patients with and without IVUS imaging prior to OA. There was a significant reduction in the number of stents used in patients with IVUS imaging prior to OA (1.0 ± 0.2 vs 1.3 ± 0.6; P = 0.006) and increased post‐OA mean minimal lumen diameter (MLD) (1.6 ± 0.6 mm vs 1.2 ± 0.5 mm; P < 0.001). The 3‐year MACE rate was similar in both groups (IVUS: 14.3% vs No IVUS: 24.2%; P = 0.26).

Conclusions

There were significantly fewer stents placed, increased post‐OA MLD, and similar 3‐year MACE outcomes in patients with IVUS assessment of the degree of lesion calcification prior to OA as compared to patients with angiographic assessment of the degree of lesion calcification. Further studies are needed to determine the optimal integration of intravascular imaging with OA.

     

Lower restenosis rate with stenting following aggressive versus less aggressive rotational atherectomy

The present study evaluated the acute and follow-up results of stenting following aggressive rotational atherectomy compared with stenting following less aggressive rotational atherectomy. Recent work has demonstrated that stenting following rotational atherectomy is a promising strategy for complex and calcified lesions. However, there is little information available regarding the optimal procedural technique of rotational atherectomy to be employed before stent implantation. Between May 1995 and February 1997, 162 lesions in 126 patients were stented following rotational atherectomy because of the presence of severe calcification on fluoroscopy or intravascular ultrasound (95%). The lesions were divided as to whether aggressive rotational atherectomy was performed or not. Aggressive rotational atherectomy, defined as the use of a final burr size ≥2.25 mm and/or final burr/vessel ratio ≥0.8, was performed in 56 lesions. A less aggressive rotational atherectomy strategy was performed in 106 lesions. Procedural Q-wave (8.9% vs. 1.9%, P < 0.05) and non–Q-wave (11% vs. 1.9%, P < 0.05) myocardial infarctions were observed more frequently after aggressive rotational atherectomy; there was no significant difference in the incidence of other procedural complications. Although there was no significant difference in minimal lumen diameter after the procedure (3.11 ± 0.68 vs. 2.99 ± 0.48 mm, NS), at follow-up a greater minimal lumen diameter was observed in the lesions treated with aggressive rotational atherectomy compared to those treated with less aggressive rotational atherectomy (2.12 ± 1.31 vs. 1.56 ± 0.89 mm, P < 0.01). Restenosis rates were 50.0% in the lesions treated without aggressive rotational atherectomy and 30.9% in those treated with aggressive rotational atherectomy (P < 0.05). There was no significant difference in the incidence of restenosis with a focal pattern between the two groups (25.0% vs. 21.4%, NS). In contrast, restenosis with a diffuse pattern was lower in lesions treated with aggressive rotational atherectomy than in those without aggressive rotational atherectomy (9.5% vs. 25.0%, P < 0.05). Aggressive rotational atherectomy followed by stenting is a promising strategy to reduce the restenosis rate in calcified lesions. However, the aggressive strategy is associated with an increased risk of procedural myocardial infarction. Cathet. Cardiovasc. Intervent. 46:406–414, 1999. © 1999 Wiley-Liss, Inc.     

Orbital atherectomy system in treating calcified coronary lesions: 3-Year follow-up in first human use study (ORBIT I trial)

Background/PurposeThe ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Severely calcified coronary arteries pose ongoing treatment challenges. Stent placement in calcified lesions can result in stent under expansion, malapposition and procedural complications. OAS treatment may be recommended to facilitate coronary stent implantation in these difficult lesions.Materials/MethodsFifty patients with de novo calcified coronary lesions were enrolled in the ORBIT I trial. Patients were treated with the OAS followed by stent placement. Our institution treated 33/50 patients and continued follow-up for 3 years.ResultsAverage age was 54.4 years and 90.9% were males. Mean lesion length was 15.9 mm. The average number of OAS devices used per patient was 1.3. Procedural success was achieved in 97% of patients. Angiographic complications were observed in five patients (two minor dissections, one major dissection and two perforations). The cumulative major adverse cardiac event (MACE) rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, and 18.2% at 3 years. The MACE rate included two in-hospital non Q-wave myocardial infarctions (MI), one additional non Q-wave MI at 30 days leading to target lesion revascularization (TLR), and three cardiac deaths.ConclusionsThe ORBIT I trial suggests that OAS treatment may offer an effective method to modify calcified coronary lesion compliance to facilitate optimal stent placement in these difficult-to-treat patients with acceptable levels of safety up to 3 years post-index procedure.     

Effectiveness of rotational atherectomy of right coronary artery ostial stenosis

Balloon angioplasty and stenting of right coronary ostial stenosis may frequently be impeded by lesion calcification, whereas rotational atherectomy, which ablates calcified plaque, should treat these lesions effectively. Accordingly, we evaluated procedural success and longterm clinical outcome of rotational atherectomy of right coronary ostial stenosis. Procedural data were obtained from a comprehensive interventional registry and follow-up information was obtained by chart review and patient enquiry. All patients who developed recurrent angina underwent angiographic restudy. During a 5-year interval, 119 patients underwent rotational atherectomy of right coronary ostial stenosis. Multilesion interventions were performed in 55% of patients. Ostial lesions were 3.73+/-3.69 mm in length (mean +/- SD), and 57.1% were significantly calcified. Reference vessel diameter was 3.42+/-0.56 mm. Maximum burr:artery ratio was 0.64+/-0.1 with adjunct balloon angioplasty in 89.1% and adjunct stenting in 9.2%. Procedural success (<50% residual stenosis without major complication) was 97.5%, with 1.7% uncomplicated failure and 0.8% Q-wave infarction. Maximum residual stenosis was 15+/-17%. During 6-month follow-up, available in 94% of patients, 82.7% remained angina-free, 10.9% developed recurrent angina due to right coronary ostial restenosis, and 6.4% developed recurrent angina due to another lesion. Two years after intervention, target lesion revascularization rate was 16%. Predictors of symptomatic angiographic restenosis were dissection >10 mm, final minimal luminal diameter <2.5 mm, lesion length >10 mm, restenotic lesion, and diabetes. We conclude that rotational atherectomy of right coronary ostial stenosis results in excellent acute procedural success and in low incidence of clinical recurrence, with a high proportion of patients remaining angina-free 2 years after intervention.     

Comparison of Early and Recent Results With Rotational Atherectomy

Objectives. We compared an early registry of rotational atherectomy with a recent registry to examine the evolution of patient profiles, lesion characteristics and procedural outcomes for patients treated with rotational atherectomy.Background. With increased experience, the selection of patients and lesions treated with a device matures. This study documents the changes in the application of rotational atherectomy.Methods. The patient characteristics and procedural outcomes from two multicenter patient registries—Registry I: 2,953 procedures, 3,717 lesions from 1988 to 1993; and Registry II: 200 procedures, 268 lesions from 1994—were analyzed and compared.Results. There was an increase in the average age of the patients (63 vs. 65 years, p < 0.02) and the proportion of patients with unstable angina (42.9% vs. 56.5%, p < 0.01) or previous coronary artery bypass graft surgery (18.8% vs. 24.5%, p < 0.05) in Registry II. Registry II included fewer left anterior descending coronary lesions (46.5% vs. 32.8%, p < 0.01), more type B and C lesions (83.1% vs. 91.8%, p < 0.01), more eccentric lesions (69.0% vs. 79.5%, p < 0.01) and more calcified lesions (50.3% vs. 69.4%, p < 0.01). Complications, including urgent bypass surgery, Q and non–Q wave myocardial infarction, dissection, acute occlusion and perforation, were similar in the two groups. However, mortality increased from 1.0% to 3.0% (p < 0.05) in Registry II.Conclusions. Comparison of recent and early patients treated with rotational atherectomy revealed an increase in the complexity of patients and lesions. Although the rate of death was increased, the overall rate of major complications was not significantly changed (4.7% vs. 6.0%, p = NS).(J Am Coll Cardiol 1997;29:353–7)     

Directional coronary atherectomy in women compared with men

The influence of gender on the procedural outcome of directional coronary atherectomy (DCA) is controversial. This study of 373 consecutive patients (418 lesions) undergoing DCA demonstrates that the procedural success rate of DCA is significantly lower in women compared with men (72.7 vs. 82.9%, p = 0.011). Women have significantly smaller coronary arteries than men (2.5 mm vs. 2.7 mm, p = 0.028) and were older than men (66 vs. 61 years, p = 0.0001). Multivariate analysis identifies small coronary vessel size rather than female gender per se as an independent predictor of poor procedural outcome. Procedural success rates in women with coronary vessel size ≥ 2.5 mm is significantly higher (92.2%) than in women with coronary vessel size < 2.5 mm (73.1%), and parallels that in men with vessel size ≥ 2.5 mm (89.3%). Inability to engage the ostium of the coronary artery adequately with the guiding catheter and to cross the lesion with the atherectomy device is significantly more common in women compared with men. Major ischemic complication rates are similar in women and men (8.5 vs. 8.7%). Groin complications are significantly more common in women compared with men (13.5 vs. 2.9%). We conclude that procedural success rates in women may be improved by careful patient selection, with particular attention to small vessel size. DCA is best performed in vessels > 2.5 mm in diameter.     

Orbital atherectomy for symptomatic lower extremity disease

Background. Plaque‐debulking technologies have been proposed as alternative treatment options for peripheral arterial disease. Orbital atherectomy (OA), using the DiamondBack360® device, has emerged as one promising modality. Methods. We evaluated the safety and efficacy of OA in the first 200 lesions treated at our institution. Patient demographics, clinical characteristics, and lesion and procedural variables were collected and analyzed. The primary safety endpoint was the 30‐day major adverse events (MAE), including death, myocardial infarction, stroke, unplanned amputation, or target lesion revascularization. Other safety endpoints included access‐site complications, occurrence of dissections, perforations, distal embolization, spasm, and hemolysis. The efficacy endpoints were procedural success, need for adjunctive therapy, and improvement in ankle‐brachial index. Multivariate analysis was performed to find independent predictors of the safety endpoints. Results. One hundred seventeen (58.5%) lesions were femoral, 31 (15.5%) were popliteal, and 52 (26.0%) were tibial. The procedural success (residual stenosis ≤30%) was comparable between the femoral and tibial lesions (86.3% vs. 92.5%, P = 0.18), but significantly lower for the popliteal lesions when compared with femoral and tibial (64.7% vs. 86.3%, P = 0.058, and 64.7% vs. 92.5%, P = 0.007 respectively). MAE at 30‐days occurred in 3 (2.2%) procedures, and major access‐site complications also occurred in 3 (2.2%). There were 31 (15.5%) dissections; independent predictors were diabetes mellitus (OR: 7.3, P = 0.008), crown‐to‐RVD ratio <0.6 (OR: 11.6, P = 0.005), and atherectomy time >360 sec (OR: 11.8, P = 0.001). There were 2 (1.0%) distal embolizations, 6 (3.0%) arterial spasms, and no perforations. Laboratory evidence of hemolysis was noted in 33.8% of cases. Conclusion. Orbital atherectomy allows for a significant procedural success, limited need for stenting, and favorable safety profile. © 2010 Wiley‐Liss, Inc.     

Orbital atherectomy for severely calcified lesions: More dissections in women but similar 30‐day outcomes to men

• Calcified lesions are associated with lower rates of successful percutaneous coronary intervention (PCI), greater stent thrombosis, and increased target vessel revascularization. Women undergoing PCI are more often older than men and likely to present with severe lesion calcification.
• The ORBIT II study, for the first time compares the effect of the orbital atherectomy system (OAS) in men and women undergoing PCI for severely calcified lesions. Although the adjusted risk of severe dissections was higher in women, the incidence of in‐hospital and 30‐day outcomes was similar to men.
• Randomized comparisons of the OAS with rotational atherectomy and with stenting without atherectomy are needed to further elucidate sex‐based differences in calcified lesion PCI.

     

Peripheral Artery Disease in Vulnerable Patient Populations: Outcomes of Orbital Atherectomy in Native Americans Compared to Non-Native Americans. A Single-Center Experience in Rural Oklahoma

Background/purposeAlthough the incidence of peripheral artery disease (PAD) and amputations is higher in Native Americans (NA) than Caucasians, the study of revascularization NA is limited, resulting in their under representation in clinical studies. Orbital atherectomy (OA) is widely utilized for endovascular revascularization of significantly calcified peripheral arteries and has been shown to improve limb salvage rates.Methods/materialsA cohort of 74 consecutive PAD subjects undergoing OA treatment was retrospectively analyzed via Kaplan Meier (KM) and Propensity Score Matched (PSM) analysis.ResultsA significant proportion of the subjects were NA (16.2%). Compared to the non-NA, the NA had higher numerical baseline rates of wounds, dialysis, chronic kidney disease (CKD), and critical limb ischemia, but were numerically less likely to smoke and had similar rates of diabetes. There were very high rates of severe calcification (100% vs. 87%) and pre-procedure diameter stenosis (99% vs. 95%) in both groups. The NA and non-NA had good angiographic outcomes, resulting in low rates of post-procedure residual diameter stenosis (10% vs. 11%). Lastly, KM analysis indicated high freedom from amputation in both groups at 1 year (89% vs. 95%), as well as in the PSM subjects (89% vs. 100%).ConclusionsDespite numerically higher rates of co-morbidities at baseline (e.g., CKD, dialysis, and presence of non-healing wounds), the NA underwent successful revascularization with OA, resulting in high freedom from amputation at 1-year. Given the small sample size of NA, these results may not be generalizable—thus, larger studies on NA are warranted.     

Planned Versus Bailout Rotational Atherectomy: A Systematic Review and Meta-Analysis

Background/purposeRotational atherectomy (RA) plays a central role in the treatment of heavily calcified coronary artery lesions. Our aim was to compare periprocedural characteristics and outcomes of planned (PA) vs. bailout (BA) rotational atherectomy.MethodsWe conducted a systematic review and performed a meta-analysis on studies which compared PA vs. BA strategy.ResultsFive studies fulfilled the inclusion criteria, pooling a total of 2120 patients. There was no difference in procedural success, PA vs. BA risk ratio (RR) 1.03 and 95% confidence interval (95% CI) 0.99–1.07. Compared to BA, PA was associated with a shorter procedural time [mean difference (MD) -25.88 min, 95% CI -35.55 to −16.22], less contrast volume (MD -43.71 ml, 95% CI -69.17 to −18.25), less coronary dissections (RR 0.50, 95% CI 0.26–0.99), fewer stents (MD -0.20, 95% CI -0.29 to −0.11), and a trend favouring less periprocedural myocardial infarctions (MI) (RR 0.77, 95% CI 0.54–1.11). There was no difference in major adverse cardiovascular events on follow-up (RR 1.04, 95% CI 0.62–1.74), death (RR 0.98, 95% CI 0.59–1.64), MI (RR 1.16, 95% CI 0.62–2.18), target vessel revascularization (RR 1.40, 95% CI 0.83 to 2.36), stroke (RR 1.50, 95% CI 0.46–4.86) or stent thrombosis (RR 0.82, 95% CI 0.06–10.74); all PA vs. BA comparisons.ConclusionsCompared to bailout RA, planned RA resulted in significantly shorter procedural times, less contrast use, lesser dissection rates and fewer stents used. The bailout RA approach appears to enhance periprocedural risk, but there is no difference on mid-term outcomes.