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.     

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.     

Feasibility and clinical outcomes of rotational atherectomy for heavily‐calcified side branches of complex coronary bifurcation lesions in the real‐world practice of the drug‐eluting stent era

Objectives

To evaluate the outcomes of rotational atherectomy for heavily‐calcified side branches of coronary bifurcation lesions.

Background

Side‐branch (SB) preservation is clinically important but technically challenging in heavily‐calcified non‐left main true bifurcation lesions. SB rotational atherectomy (SB RA) is sometimes mandatory but the clinical outcomes are not well studied.

Methods

We retrospectively studied the outcomes of patients who underwent RA at our institute for heavily calcified, balloon‐uncrossable or—undilatable SB lesions over an approximately 5‐year period (January 2011 to September 2016).

Results

Two hundred and forty‐four patients underwent main vessel only RA (SB?MV + RA group) and another 48 patients underwent SB RA (SB + MV ± RA group) for 49 side branches. The demographic variables were comparable between the two groups. However, patients underwent SB RA experienced more SB perforations and greater acute contrast‐induced nephropathy (CIN). Among the SB RA patients, 30 (62.5%) underwent RA for both SB and MV (SB + MV + RA subgroup), whereas the other 18 underwent SB only RA (SB + MV?RA subgroup). Patients in these two subgroups could be completed with similar procedural, fluoroscopic durations, and contrast doses. The long‐term MACE rate of SB RA was 27.1% over a mean follow‐up period of 25.1 months with no differences between the two subgroups.

Conclusions

RA for SB preservation in complex and heavily‐calcified bifurcation lesions was feasible with high success rate and quite favorable long‐term outcomes in the drug‐eluting stent (DES) era. Given the higher rates in SB perforation and acute CIN, we recommend that SB RA should be conducted by experienced operators.

     

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.     

Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis

Background/purposeOrbital atherectomy is an effective treatment strategy to modify severely calcified coronary lesions prior to stent placement. Traversing a severely calcified subtotal occlusion with the crown may be more challenging compared with a less severely stenotic lesion. The purpose of this ORBIT II subanalysis was to evaluate outcomes post-orbital atherectomy (OA) treatment of lesions with ≥95% stenosis.Methods/materialsORBIT II, a single-arm, prospective, multicenter trial, enrolled 443 subjects with severely calcified coronary lesions. Patients with chronic total occlusions were excluded from the trial. Subjects with the OA device activated were stratified based on pre-procedure percent stenosis: ≥95% stenosis (N = 91) and <95% stenosis (N = 341). Procedural success and 3-year major adverse cardiac event (MACE) rates were compared.ResultsThe severe angiographic complications rates were 6.6% and 6.7% in the ≥95% and <95% stenosis groups, respectively. There was no significant difference in procedural success (94.5% vs. 88.3%, p = 0.120). 3-year MACE rates were similar (27.1% vs. 22.5%, p = 0.548), as were the rates of cardiac death (5.7% vs. 7.1%, p = 0.665) and MI (7.9% vs. 12.1%, p = 0.244). The TVR rate was higher in the ≥95% stenosis group (19.1% vs. 7.5%, p = 0.004).ConclusionsIn ORBIT II, OA treatment of lesions with ≥95% stenosis resulted in a high rate of procedural success. Although the 3-year revascularization rate was higher in the ≥95% stenosis group, it is not unexpected given the challenge of treating such complex lesions. The results of this analysis suggest that OA may be a reasonable treatment strategy for tight, severely calcified subtotal occlusions.SummaryThe purpose of this ORBIT II subanalysis was to evaluate outcomes post-orbital atherectomy (OA) treatment of lesions with ≥95% stenosis. In ORBIT II, OA treatment of lesions with ≥95% stenosis resulted in a high rate of procedural success. Although the 3-year revascularization rate was higher in the ≥95% stenosis group, it is not unexpected given the challenge of treating such complex lesions. The results of this analysis suggest that OA may be a reasonable treatment strategy for tight, severely calcified subtotal occlusions.     

Rotational atherectomy in the drug-eluting stent era: a recent single-center experience

IntroductionPercutaneous coronary intervention (PCI) of heavily calcified lesions is a challenge for the interventional cardiologist and is associated with a high rate of restenosis and target lesion revascularization (TLR). Adequate lesion preparation by rotational atherectomy followed by drug-eluting stent implantation has shown favorable results.ObjectiveTo report the recent experience of our center with rotational atherectomy (RA) of complex and heavily calcified coronary lesions.MethodsWe retrospectively analyzed consecutive patients who underwent PCI with RA in our center between January 2009 and December 2010. A total of 42 patients were included, 65% of whom had been previously refused for coronary artery bypass grafting due to unfavorable coronary anatomy or high surgical risk. RA was performed using the standard Boston Scientific Rotablator^® system. The procedure was performed ad-hoc in 50% of patients and transradial access was used in 35%. Data were collected on immediate post-procedural events and major cardiac events during follow-up – cardiovascular death, myocardial infarction, TLR and recurrent angina.ResultsOf 1650 PCIs performed in a 23-month period from January 2009, 42 (2.5%) involved RA, a total of 42 patients (mean age 70.3±10.1 years, 67% male, 55% diabetic), three of whom had left main disease, six had three-vessel disease, 18 had two-vessel disease and the other 15 had single-vessel disease. Of the lesions treated, 71% were >20 mm long and classified in 69% of cases as type C according to the ACC/AHA lesion classification, 4% being chronic total occlusions. The left anterior descending artery was treated in 56% of the procedures. The mean number of burrs used per lesion was 1.3 and a total of 69 stents were implanted, 81% of which were drug-eluting. During follow-up three patients had recurrent angina, one required TLR and two died due to a cardiovascular event. There was significant clinical improvement in 83% of patients.ConclusionsThis study demonstrates that rotational atherectomy followed by stenting in heavily calcified lesions can nowadays be performed with high success rates and few complications, extending the possibility of coronary revascularization to a greater number of patients.     

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.     

Comparison of Bailout and Planned Rotational Atherectomy for Heavily Calcified Coronary Lesions: A Single‐Center Experience

Objectives

The aim of this study was to compare outcomes of bailout and planned rotational atherectomy (RA) in the treatment of calcified coronary lesions.

Background

Current guidelines recommend RA as a bailout procedure for calcified or fibrotic lesions that cannot be adequately dilated before stenting. Nonetheless, planned RA is sometimes performed in certain challenging anatomies.

Methods

Data of patients treated with RA between 2002 and 2014 at a single‐center registry were retrospectively analyzed. The bailout RA group included patients where RA was employed after failure of balloon dilatation or stent delivery. Planned RA included patients where RA was employed electively without previous device failure.

Results

The study comprised 204 patients (221 lesions) and 308 patients (338 lesions) treated with bailout or planned RA, respectively. Angiographic success was achieved in the majority of cases, but was lower in the bailout RA group (93.7% vs. 97.6%, P = 0.02). Coronary dissections occurred more frequently in the bailout RA group (8.6% vs. 4.4%, P = 0.04), mean contrast amount was higher (279 ± 135 mL vs. 202 ± 92 mL, P < 0.001), and fluoroscopy time and procedural duration were longer in that group (32 min [IQR 21–51] vs. 18 min [IQR 14–28], P < 0.001 and 111 ± 50 min vs. 76 ± 35 min, P < 0.001, respectively). In‐hospital death and myocardial infarction were not significantly different between the groups (2.9% vs. 1.3%, P = 0.21 and 6.9% vs. 4.2%, P = 0.19). In‐hospital major adverse cardiac events (MACE) were higher in the bailout RA group (10.3% vs. 5.5%, P = 0.04). The 2‐year estimated rates of MACE (25.2% vs. 28.7%, log rank P = 0.52) and its components death, myocardial infarction, and target vessel revascularization were not significantly different between the groups. Equivalence of 2‐year MACE rates was also seen in all examined subgroups.

Conclusion

Shortened procedural duration and reduction of coronary dissections were observed with planned RA for selected lesions. However, this strategy does not affect long‐term clinical outcomes.

     

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.     

Rotablation in the Drug Eluting Era: Immediate and Long‐Term Results from a Single Center Experience

The aim of this study was to investigate the immediate and long‐term outcome of patients who were treated with rotational atherectomy (RA) to facilitate the delivery of drug eluting stents (DES) in heavily calcified lesions. We analyzed 150 consecutive patients who underwent RA and subsequently DES implantation in our institution. The patients had heavily calcified coronary artery lesions requiring plaque modification prior to conventional angioplasty and stent implantation. Rotational atherectomy was performed using the standard Boston Scientific Rotablator^® system. A 2‐burr stepped approach was selected in most of the cases. Following successful modification of the plaque, the angioplasty was performed with a balloon at low pressure to avoid dissection and a DES was implanted. The mean follow up period was 3 years (max. 78 months). Follow‐up data included all cause death, stroke, myocardial infarction (MI), recurrent angina, re‐hospitalization, target lesion revascularization (TLR), target vessel revascularization (TVR), and long‐term duration of dual antiplatelet therapy. The rate of recurrent angina and MI during follow up was low (3.3%) and the overall major adverse cardiac events (MACE) rate was 11.3%. No MACE occurred during hospitalization. There was no relationship between discontinuation of clopidogrel and occurrence of death or MI. The combined approach of RA‐DES has a favorable effect when dealing with heavily calcified lesions in both the angiographic and clinical outcomes. No safety concerns are observed up to 6 years. (J Interven Cardiol 2010;23:249–253)     

Fracking the Code to Complete Revascularization

• Provisional use of rotational atherectomy (RA) is indicated for procedural success in heavily calcified lesions.
• In the current study, RA use at three high volume percutaneous coronary intervention (PCI) centers between 2005 and 2013 was 1.4%. MACE rate was 17.8% at median follow‐up of 22 months. Peripheral vascular disease (PVD), diabetes mellitus (DM), acute coronary syndrome (ACS), and SYNTAX > 23 were found to be independently associated with MACE.
• With increasing complexity of disease and SYNTAX score, there is usually an increase in severity of calcification and need for atherectomy. Complete revascularization with residual SYNTAX reduced to < 8 is associated with improved outcomes. Incompleteness of revascularization in patients with SYNTAX > 33 rather than procedural success of the target vessel with atherectomy may have contributed to the adverse outcomes.

     

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 lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients.

BACKGROUND: Previous studies have demonstrated similar efficacy of the drug-eluting stent (DES) in patients with and without calcified lesions. However, most of the randomized trials have excluded patients with severe calcified lesions. This study aimed to examine the impact of lesion calcium on clinical and angiographic outcome after sirolimus-eluting stent (SES) implantation in real-world patients. METHODS: Consecutive 380 patients with 556 lesions treated with SES were enrolled. Lesions were divided into Calc lesions (moderate or sever calcification; 195 lesions) and non-Calc lesions (none or mild calcification; 361 lesions) according to the lesion calcium. Quantitative coronary angiography (QCA) parameters, binary restenosis rate (%restenosis), target lesion revascularization (TLR) rate, and major adverse cardiac events (MACE) during follow-up were compared between the two groups. All patients were contacted at 1, 6, and 12 months after the procedure. RESULTS: Lesion success rate was similar in the two groups. %Restenosis (9.2% vs. 3.6%; P<.05) and TLR (7.3% vs. 2.8%; P<.05) were significantly higher in Calc lesions. Stent thrombosis was observed in 0.7% of overall lesions with no difference between the two groups. The MACE rate in Calc patients (13.8%) was significantly higher than in non-Calc patients (6.1%). By multivariate analysis, hemodialysis (HD) and requirement of rotational atherectomy (RA) were predictive factors of TLR in the Calc lesions. CONCLUSIONS: Coronary lesions with calcification comprise a high-risk cohort and are associated with a higher TLR and binary restenosis rates in real-world patients treated with SES. Moreover, patients with calcified lesions and on HD are associated with higher MACE rate.     

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.     

120例无保护左主干冠状动脉病变药物洗脱支架术的临床疗效和随访研究

目的探讨药物洗脱支架(DES)在无保护左主干冠状动脉(LMCA)病变的疗效。方法回顾性分析符合条件连续的120例无保护LMCA病变患者行DES的疗效,将其分为分叉病变组(80例)和非分叉病变组(40例)两组,根据病变特点行单支架术或双支架术,分析其支架术的操作特点,住院期间及出院后随访其主要心脏不良事件(MACE,包括死亡、非致死性心肌梗死及靶病变重建)及支架内血栓形成(ST)的情况。结果两组间的临床基线情况差异无统计学意义,共106(88.3%)例患者完成随访,分叉病变组更多使用血管内超声(IVUS)指导治疗(但P>0.05),分叉病变组33例行双支架术,非分叉病变组5例行双支架术(P=0.001),住院期间无MACE及支架内血栓(ST)发生,出院随访平均(26.3±14.5)个月,MACE11例(9.2%),总共死亡3例(2.8%),都是SYNTAX积分及EuroSCORE均属高危的患者,非致死性心肌梗死2例(1.9%),靶病变重建(TLR)6例(5.7%),造影再狭窄6例(占造影随访患者的15.8%),两组ST各1例,两组间MACE差异无统计学意义(7.5%比12.5%,χ2=0.801,P=0.503)。结论在选择性患者行DES治疗无保护LMCA病变不论是否分叉病变近远期的安全性和有效性可以接受。     

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).     

Assessment of outcome of bifurcation lesions and non-bifurcation lesions treated in the CAVEAT trial. CAVEAT investigator group

Registry data suggests that bifurcation lesions are associated with reduced success during percutaneous revascularization. We studied 1012 CAVEAT patients to compare procedural outcomes in patients with and without bifurcation lesions whose target vessel was treated with either atherectomy or angioplasty. Bifurcation lesions have increased angiographic complexity and interventions on them are associated with lower acute procedural success rates compared to non-bifurcation lesions. Subgroup analysis suggests that atherectomy treatment of bifurcation lesions improves acute procedural success rates and lowers restenosis rates compared to angioplasty treatment of bifurcation lesions but atherectomy of bifurcation lesions is associated with higher acute complication rates than angioplasty of bifurcation lesions.     

Predictors of In-Hospital Adverse Outcomes after Rotational Atherectomy: Impact of the Target Vessel SYNTAX Score

BackgroundRotational atherectomy (RA) is an established treatment of calcified lesions, but has some inherent procedural hazards. However, predictors of in-hospital adverse outcomes after RA are poorly investigated.ObjectiveTo explore the predictors of in-hospital adverse outcomes after RA and to introduce the target vessel SYNTAX score (tvSS) as a potential causal variable.MethodsPatients who underwent RA at our center (n = 323) were divided into two groups according to the occurrence of in-hospital adverse outcomes (a composite of residual stenosis ≥30%, persistent slow flow, dissection requiring additional stenting beyond the primary lesion, perforation, burr entrapment, and in-hospital major adverse cardiac events [MACE]).ResultsIn-hospital adverse outcomes were more frequent in patients with severely-tortuous target vessels or lesions >20 mm, while aorto-ostial and bifurcation lesions, as well as chronic total occlusion rates, were equally distributed among patients with and without adverse outcomes. TvSS was 18 [13–24] vs. 12 [8–17] in patients with vs. without in-hospital adverse outcomes (p < 0.001). A tvSS cut-off value of 15 showed 73% sensitivity and 62% specificity for predicting in-hospital adverse outcomes. TvSS emerged as an independent predictor for in-hospital adverse outcomes along with bailout RA and reduced left ventricular ejection fraction (LVEF). However, after one year, the occurrence of in-hospital adverse outcomes was not associated with an increase in the MACE rate (log-rank p = 0.857).ConclusionIn-hospital adverse outcomes are higher in patients with more complex target vessel anatomies as indicated by a higher tvSS. Bailout RA and reduced LVEF emerged as additional predictors of in-hospital adverse outcomes.     

冠状动脉严重钙化病变旋磨术后植入药物洗脱长支架的长期临床疗效观察

目的 探讨冠状动脉（简称“冠脉”）旋磨术联合药物洗脱长支架用于治疗严重冠脉钙化病变的安全性及有效性。方法 入选2010年1月至12月因严重冠脉钙化而行冠脉旋磨术联合药物洗脱长支架植入治疗的患者。观察患者的手术成功率,围术期并发症及术后主要心血管事件（包括心源性死亡、心肌梗死、靶病变血运重建）的发生率。结果 共21例严重冠脉钙化病变患者接受了冠脉旋磨术联合药物洗脱长支架植入治疗,年龄（65.2±6.9）岁。合并高血压病16例（76.2%）,糖尿病7例（33.3%）,肾功能不全1例（4.8%）。旋磨部位共植入35枚国产药物支架（1.75枚/部位）,最短支架长度为28mm,病变部位平均支架总长度为48（29～66）mm,仅1例因旋磨头未能通过病变而放弃,手术成功率为95.2%（20/21）。术中1例出现冠脉痉挛,1例出现胸痛伴心率减慢;术后1例出现消化道出血。住院期间无心血管事件发生,平均随访26个月,仅1例（4.8%）患者于术后第2个月发生急性心肌梗死,余患者病情稳定。结论 冠脉旋磨术联合药物洗脱长支架植入术治疗严重冠脉钙化病变可取得很高的手术成功率,是治疗钙化病变安全、有效的方法。     

经桡动脉行冠状动脉斑块旋磨和药物支架置入术治疗严重钙化病变的安全有效性

目的:探讨经桡动脉行冠状动脉斑块旋磨术和药物洗脱支架置入术,治疗严重钙化病变的临床效果。方法:回顾性分析我院2010年1月至2011年1月,经桡动脉行冠状动脉斑块旋磨术和药物洗脱支架置入术,冠心病患者的89例临床资料。并分析其手术特点、并发症及主要不良心血管事件(包括全因死亡、非致死性心肌梗死、靶血管血运重建)。结果:89例(100%)患者均成功经桡动脉行冠状动脉斑块旋磨术,并置入药物洗脱支架。术中共有8例(9.0%)患者发生并发症,经处理后取得良好的效果。术后随访(22.21±4.73)个月,主要不良心血管事件的发生率为12.4%。结论:经桡动脉行冠状动脉斑块旋磨术和药物洗脱支架置入术,治疗严重钙化病变是一种安全、有效的治疗方法。