Richard Shlofmitz

Impact of severity of renal dysfunction on determinants of in‐hospital mortality among patients undergoing percutaneous coronary intervention

Background: Chronic kidney disease (CKD) is a known prognostic indicator of poor outcomes following percutaneous coronary intervention (PCI) for coronary artery disease. However, it is unclear whether other predictors of mortality differ among patients with varying degrees of renal impairment. Thus, we aimed to identify determinants of in‐hospital mortality which are specific to patients with preserved renal function, moderate CKD, or end stage renal disease (ESRD) on dialysis, undergoing PCI. Methods: The study population included 25,018 patients who underwent PCI between January 1, 2004, and December 31, 2007, at four New York State hospitals. The primary endpoint of the study was in‐hospital mortality. Results: A total of 474 (1.9%) patients had ESRD on dialysis, 6,596 (26.4%) had moderate CKD (GFR<60 ml/min/1.73m2), and 17,948 (71.7%) had preserved renal function (GFR>60 ml/min/1.73m2). Patients with ESRD and moderate CKD were older, more often male, and had higher rates of prior coronary revascularization, peripheral vascular disease, congestive heart failure, prior stroke, and diabetes than those with preserved function. All‐cause in‐hospital mortality rates were significantly higher in patients with ESRD and moderate CKD compared to patients with GFR >60ml/min/1.73m2 (2.1% and 1.3%, respectively vs. 0.3%, p < 0.001). In multivariable analysis, ESRD (OR: 3.68, 95% CI 1.62–8.36) and moderate CKD (OR: 2.92, 95% CI 1.91–4.46) were independently associated with higher rates of in‐hospital mortality. Independent predictors of mortality were markedly distinct in each group and included female gender and myocardial infarction within the past 72 hr in the ESRD group, versus left ventricular ejection fraction, peripheral vascular disease, congestive heart failure, emergency PCI, and absence of prior PCI in the moderate CKD group and age, prior bypass graft surgery, congestive heart failure, emergency PCI, and absence of prior myocardial infarction in patients with preserved renal function Conclusions: Patients with moderate CKD or ESRD undergoing PCI have an approximately threefold increase in the risk of in‐hospital mortality compared with patients with preserved renal function, with radically different mortality predictors existing for varying levels of renal function.

Association of health insurance status with presentation and outcomes of coronary artery disease among nonelderly adults undergoing percutaneous coronary intervention

OBJECTIVE The aim of this study was to determine if insurance status is associated with adverse outcomes in patients with coronary artery disease. METHODS A cohort of 13,456 patients who underwent percutaneous coronary intervention (PCI) between January 1, 2004, and December 31, 2007, at 4 New York State teaching hospitals was retrospectively studied. The primary outcome of interest was in-hospital mortality from any cause. RESULTS Of the 13,456 patients studied, 11,927 (88.6%) were insured by private carriers, 1,036 (7.7%) patients were covered by Medicaid, and 493 (3.7%) were uninsured. Uninsured and Medicaid patients tended to be younger and more often nonwhite and Hispanic. They had a higher prevalence of congestive heart failure and worse left ventricular function. Compared with privately insured patients, uninsured and Medicaid patients had increased all-cause mortality (1.2% and 0.9%, respectively, vs 0.3%; P < .001). For all patients, lack of insurance (OR 3.02, 95% CI 1.10-8.28) and Medicaid (OR 4.39, 95% CI 1.93-9.99) were independently associated with mortality. Lack of insurance (OR 5.02, 95% CI 1.58-15.93) and Medicaid (OR 4.55, 95% CI 1.19-17.45) were also independently associated with increased mortality in patients undergoing emergent PCI. CONCLUSION Lack of insurance and Medicaid insurance are both independently associated with an increased risk of in-hospital mortality after PCI for coronary artery disease.

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial

BACKGROUND/PURPOSE The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). METHODS/MATERIALS ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. RESULTS The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. CONCLUSIONS In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. SUMMARY The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.

Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight from the ORBIT II trial.

We report 2‐year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type. Background: The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions. Methods: ORBIT II was a single‐arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30‐day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first‐generation drug‐eluting stent [DES], or second‐generation DES). The 2‐year MACE rate and its components were compared between groups. Results: In the ORBIT II study cohort, 2‐year rates of MACE, cardiac death, and target vessel revascularization were 19.4%, 4.3%, and 8.1%, respectively. Two year data were available in 419 of 443 patients (94.6%) with median follow up time of 25.1 months. Stent‐type data were available in 435 of the 443 patients (98.2%). Six patients received stents of more than one type and were excluded from the stent type comparisons. Among the 429 patients included in the stent comparison analyses, 43 patients (10.0%) received BMS, 74 (17.2%) received first‐generation DES, and 312 (72.7%) received second‐generation DES. The 1 and 2‐year target lesion revascularization rates were lower among patients receiving first‐generation (1.4% and 6.3%) and second‐generation (3.9% and 5.0%) DES compared to patients receiving BMS (15.3% and 15.3%), respectively (1 year: P = 0.007; 2 year: P = 0.047). Higher diameter stenosis and the use of BMS were independently associated with the occurrence of MACE and TVR at 2 years. Conclusions: OAS remained safe and effective for patients with de novo, severely calcified lesions at 2 years in the ORBIT II study. Adverse ischemic events were significantly higher with BMS compared with DES.

Characteristics of early versus late in-stent restenosis in second-generation drug-eluting stents: an optical coherence tomography study

AIMS In-stent restenosis (ISR) is an important cause of drug-eluting stent (DES) failure and target vessel revascularisation. In this study we aimed to evaluate differences between early and late-presenting restenosis in second-generation DES using optical coherence tomography (OCT). METHODS AND RESULTS Overall, 171 cases of second-generation DES ISR with a follow-up OCT minimum lumen area <3.0 mm2 were included: 33.3% of patients (n=57) had early ISR, and 66.7% (n=114) had late ISR (duration from stent implantation >1 year). Minimum stent area (MSA) <4.0 mm2, neointimal thickness <100 µm, and heterogeneous neointimal hyperplasia (NIH) were more prevalent in early ISR, whereas NIH with neoatherosclerosis trended towards being more frequent for late ISR (28.9% vs. 15.8%, p=0.06). Multivariable analysis revealed that duration from implantation >2 years, absence of statin use, and NIH >50% were independent predictors for neoatherosclerosis (all p<0.05). CONCLUSIONS OCT morphological characteristics of second-generation DES ISR differ between early and late presentation. Early ISR was associated with MSA <4.0 mm2, while neoatherosclerosis contributed more commonly to late ISR.

Guiding Light: Insights Into Atherectomy by Optical Coherence Tomography

Coronary calcification presents multiple technical challenges in percutaneous coronary intervention (PCI) and is associated with suboptimal procedural results and an increase in subsequent adverse clinical events [(1)][1]. Currently, there is no standardized evidence-based strategy for PCI of

Quantification by optical coherence tomography imaging of the ablation volume obtained with the Orbital Atherectomy System in calcified coronary lesions

AIMS Recently, favourable procedural 30-day and one-year outcomes with the Diamondback 360 Orbital Atherectomy System (OAS) in the treatment of severely calcified lesions have been reported. The purpose of this study was to assess the therapeutic mechanism and efficacy of the OAS with optical coherence tomography (OCT) imaging. METHODS AND RESULTS This was an observational imaging study in 18 patients with complex calcified coro-nary artery lesions who underwent percutaneous coronary intervention with the OAS. Pre-OAS and post-OAS OCT analyses demonstrated that the minimum lumen area (MLA) increased from 2.07±0.66 mm2 to 2.38±0.68 mm2 with a lumen volume increase of 9.68±17.22 mm3 in the ablated segment with a length of 30.7±13.1 mm. The maximal vessel injury (dissection) involved the intima in 39% and the media in 6% of the study population. To eliminate the influence of post-OAS vasoconstriction, the ablation area was measured with the interpolated original lumen surface by comparing the endoluminal border of the pre-OAS image. The ablation area at the maximal ablated cross-section was 0.55±0.41 mm2, and the ablation volume by OAS was 2.68±2.80 mm3. CONCLUSIONS OAS effectively ablated coronary calcified tissue with some degree of intimal dissection. OCT imaging can be used to assess the total ablation volume after orbital atherectomy.

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.