Evan Shlofmitz

Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices

ABSTRACT Introduction: The presence of severe coronary artery calcification is associated with higher rates of angiographic complications during percutaneous coronary intervention (PCI), as well as higher major adverse cardiac events compared with non-calcified lesions. Incorporating orbital atherectomy (OAS) for effective preparation of severely calcified lesions can help maximize the benefits of PCI by attaining maximal luminal gain (or stent expansion) and improve long-term outcomes (by reducing need for revascularization). Areas covered: In this manuscript, the prevalence, risk factors, and impact of coronary artery calcification on PCI are reviewed. Based on current data and experience, the authors review orbital atherectomy technique and best practices to optimize lesion preparation. Expert Commentary: The coronary OAS is the only device approved for use in the U.S. as a treatment for de novo, severely calcified coronary lesions to facilitate stent delivery. Advantages of the device include its ease of use and a mechanism of action that treats bi-directionally, allowing for continuous blood flow during treatment, minimizing heat damage, slow flow, and subsequent need for revascularization. The OAS technique tips reviewed in this article will help inform interventional cardiologists treating patients with severely calcified lesions.

State of the art: evolving concepts in the treatment of heavily calcified and undilatable coronary stenoses - from debulking to plaque modification, a 40-year-long journey.

Since the first balloon angioplasty by Andreas Grüntzig 40 years ago, interventional cardiology has witnessed the introduction of countless tools and techniques that have significantly contributed to broadening the application of percutaneous coronary interventions (PCI) in unprecedented anatomic settings. Heavily calcified, fibrotic coronary stenosis has traditionally represented a very challenging scenario for PCI, and a very common indication for surgical revascularisation. This was mostly due to the difficulty in adequately dilating these lesions and/or to the inability to deliver and implant stents appropriately, which is often associated with high rates of procedural complications and suboptimal long-term clinical outcomes. Thanks to dedicated cutting and scoring balloons and to atherectomy devices, the treatment of most fibrotic and heavily calcified stenoses has become feasible and safe. Interventional cardiologists have learned how best to apply these tools through better patient and lesion selection, and also as a result of improved technology and techniques. In this review, we describe a 40-year-long journey that has evolved from the initial stand-alone debulking strategy to the currently applied coronary plaque modification, with the main objective of optimising drug-eluting stent delivery and implantation, translating into significantly improved patient outcomes.

Outcomes of patients with severely calcified aorto-ostial coronary lesions who underwent orbital atherectomy

OBJECTIVES We assessed the feasibility and safety of orbital atherectomy in patients with severely calcified aorto-ostial coronary artery lesions. BACKGROUND The treatment of calcified aorta-ostial coronary artery lesions is technically challenging. Orbital atherectomy can potentially damage the guiding catheter if it is not retracted sufficiently during treatment of ostial lesions. Orbital atherectomy can also excessively whip if the guiding catheter is not close enough to the ostium to provide sufficient support. Several techniques can be performed to successfully treat ostial lesions with orbital atherectomy. METHODS Our retrospective multicenter registry included 548 real-world patients who underwent orbital atherectomy, 59 (10.8%) of whom underwent treatment for aorto-ostial coronary artery lesions (left main artery [n = 35] and right coronary artery [n = 24]). The primary endpoint was the rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), defined as the occurrence of death, myocardial infarction, target vessel revascularization, and stroke. RESULTS The primary endpoint was similar in patients with and without ostial lesions (3.4% vs 2.2%, P = 0.2), as were the 30-day rates of death (1.7% vs 1.4%, P = 0.7), myocardial infarction (1.7% vs 1.0%, P = 0.3), target vessel revascularization (0% vs 0%, P > 0.91), and stroke (0% vs 0.2%, P > 0.9). Angiographic complications and stent thrombosis did not occur in patients with ostial lesions. CONCLUSIONS Despite its technical challenges, orbital atherectomy appears to be a feasible and safe treatment option for calcified aorto-ostial coronary lesions.

Orbital atherectomy treatment of severely calcified coronary lesions in patients with impaired left ventricular ejection fraction: one-year outcomes from the ORBIT II study

AIMS Percutaneous coronary intervention (PCI) of severe coronary artery calcification (CAC) is challenging. The ORBIT II study demonstrated the safety and efficacy of orbital atherectomy (OA) in patients with severe CAC. Microparticulate liberated during OA may disturb the coronary microcirculation. In the present study, we evaluated OA treatment in patients with left ventricular systolic dysfunction. METHODS AND RESULTS Patients were grouped by left ventricular ejection fraction (LVEF): 26-40% (n=33), 41-50% (n=90), and >50% (n=314). Procedural success was similar (LVEF 26-40%: 90.9%, LVEF 41-50%: 88.9%, LVEF >50%: 88.4%). Rates of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target vessel revascularisation, were similar in the LVEF 26-40%, 41-50%, and >50% groups, respectively, at 30 days (9.1%, 7.8%, 11.5%) and one year (18.2%, 19.1%, 16.0%). Although the 30-day cardiac death rate was 0% in patients with left ventricular dysfunction, one-year cardiac death was higher compared with patients with preserved left ventricular systolic function. CONCLUSIONS No patient with left ventricular systolic dysfunction experienced cardiac death at 30 days suggesting that OA was well tolerated without haemodynamic complication. However, one-year cardiac death was higher in patients with left ventricular systolic dysfunction, consistent with previous studies demonstrating the association between reduced left ventricular function and increased mortality after PCI.

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study)

BACKGROUND Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. METHODS A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. RESULTS After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. CONCLUSION In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time.

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.

Safety of orbital atherectomy in patients with left ventricular systolic dysfunction

OBJECTIVES We evaluated the angiographic and clinical outcomes in patients with severely calcified lesions and systolic dysfunction who underwent orbital atherectomy (OA). We hypothesized that OA would provide similar outcomes in patients with systolic dysfunction compared with patients with preserved systolic function. BACKGROUND Systolic dysfunction is associated with an increased risk of adverse clinical events after percutaneous coronary intervention (PCI). The effects of OA in patients with systolic dysfunction are unknown. METHODS Our analysis retrospectively analyzed 438 patients (n = 69 with EF ≤ 40%) who underwent OA. The primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days. RESULTS There were no significant differences between patients with preserved versus reduced systolic function in terms of dissections (0.9% vs. 1.6%, P = 0.51), perforation (0.3% vs. 3.2%, P = 0.07), or no reflow (0.3% vs. 3.2%, P = 0.07). Patients with systolic dysfunction had higher rates of the composite of 30-day MACCE (1.1% vs. 8.7%, P = 0.002) and the individual end points of death (0.3% vs. 7.2%, P < 0.001), and myocardial infarction (0.5% vs. 4.3%, P = 0.03). The rates of target vessel revascularization (0% vs. 0%, P = 1), stroke (0.3% vs. 0%, P > 0.9), and stent thrombosis (0.8% vs. 1.4%, P = 0.5) were low in both groups and did not differ. CONCLUSION Plaque modification with OA was safe and well tolerated in patients with systolic dysfunction. In this high-risk cohort, adverse clinical outcomes occurred more frequently than in a lower risk population.

Outcomes of patients with myocardial infarction who underwent orbital atherectomy for severely calcified lesions

OBJECTIVES This study analyzed the outcomes of patients who presented with non-ST-elevation myocardial infarction (NSTEMI) and subsequently underwent orbital atherectomy for severe coronary artery calcification (CAC). BACKGROUND Patients who present with NSTEMI have increased risk for death and recurrent MI after percutaneous coronary intervention (PCI). Patients with severe CAC have worse outcomes after PCI.Orbital atherectomy modifies calcified plaque, facilitating stent delivery and optimizing stent expansion. There are no data on these patients who present with NSTEMI who undergo orbital atherectomy. METHODS Of the 454 consecutive real-world patients who underwent orbital atherectomy in our retrospective multicenter registry, 51 patients (11.2%) presented with NSTEMI. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30days. RESULTS Patients with NSTEMI had a higher prevalence of chronic kidney disease, lower mean ejection fraction, and required more vessels to be treated. The primary endpoint was similar in patients who presented with and without NSTEMI (2.0% vs. 2.2%, p=0.9), as were the 30-day rates of death (2.0% vs. 1.2%, p=0.67), MI (0% vs. 1.2%, p=0.42), target vessel revascularization (0% vs. 0%, p>0.91), and stroke (0% vs. 0.2%, p=0.72). The rates of angiographic complications and stent thrombosis rate were low in both groups. CONCLUSIONS Despite having worse baseline characteristics, patients who presented with NSTEMI and subsequently underwent orbital atherectomy had similar clinical outcomes compared with patients without NSTEMI.

SAFETY OF SAME-DAY DISCHARGE AFTER PERCUTANEOUS CORONARY INTERVENTION WITH ORBITAL ATHERECTOMY

Severely 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

IMPACT OF SMALL DEVICE USE IN THE PROXIMAL LAD VERSUS OTHER CORONARY SEGMENTS ON LONG-TERM CLINICAL OUTCOMES: AN ADAPT-DES SUB-ANALYSIS

Proximal LAD (PLAD) vessel diameter is rarely <3 mm. We hypothesized that pts who undergo PCI with an undersized stent would have worse outcomes compared to an appropriately sized stent, and that the impact of undersized stents would be greatest in the PLAD. ADAPT-DES was a prospective, non-