Impact of Lesion Preparation Technique on Side Branch Compromise in Calcified Coronary Bifurcations: A Subgroup Analysis of the PREPARE-CALC Trial.

OBJECTIVES: To analyze the impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions. BACKGROUND: The impact of different techniques of lesion preparation of severely calcified coronary bifurcation lesions is poorly investigated. METHODS: We performed an as-treated analysis on 47 calcified bifurcation lesions treated with scoring/cutting balloons (SCB) and 68 lesions treated with rotational atherectomy (RA) in the PREPARE-CALC trial. Compromised side branch (SB) as assessed in the final angiogram was the primary outcome measure and was defined as any significant stenosis, dissection, or thrombolysis in myocardial infarction flow <3. RESULTS: True bifurcation lesions were present in 49% vs. 43% of cases in the SCB and RA groups, respectively. After stent implantation, SB balloon dilatation was necessary in around one-third of cases (36% vs. 38%; p = 0.82), and a two-stent technique was performed in 21.3% vs. 25% (p = 0.75). At the end of the procedure, the SB remained compromised in 15 lesions (32%) in the SCB group and 5 lesions (7%) in the RA group (p = 0.001). Large coronary dissections were more frequently observed in the SCB group (13% vs. 2%; p = 0.02). Postprocedural levels of cardiac biomarkers were significantly higher in patients with a compromised SB at the end of the procedure. CONCLUSIONS: In the PREPARE-CALC trial, side branch compromise was more frequently observed after lesion preparation with SCB as compared with RA. Consequently, in calcified bifurcation lesions, an upfront debulking with an RA-based strategy might optimize the result in the side branch.

Formation of Calcified Nodule as a Cause of Early In-Stent Restenosis in Patients Undergoing Dialysis.

Background Dialysis is an independent risk factor for in-stent restenosis (ISR) after stent implantation in coronary arteries. However, the characteristics of ISR in patients undergoing dialysis remain unclear, as there are no histological studies evaluating the causes of this condition. The aim of the present study was to investigate the causes of ISR between patients who are undergoing dialysis and those who are not by evaluating tissues obtained from ISR lesions using directional coronary atherectomy. Methods and Results A total of 29 ISR lesions from 29 patients included in a multicenter directional coronary atherectomy registry of 128 patients were selected for analysis and divided into a dialysis group (n=8) and a nondialysis group (n=21). Histopathological evaluation demonstrated that an in-stent calcified nodule was a major histological characteristic of ISR lesions in the dialysis group and the prevalence of an in-stent calcified nodule was significantly higher in the dialysis group compared with the nondialysis group (75% versus 5%, respectively; P<0.01). On the other hand, the prevalence of an in-stent lipid-rich plaque was significantly lower in the dialysis group compared with the nondialysis group (0% versus 43%, respectively; P=0.03). In all cases with an in-stent calcified nodule, the underlying calcification before stent implantation was moderate to severe. When tissue characteristics were stratified according to duration post-stent implantation, an in-stent calcified nodule in the dialysis group was mainly observed within 1 year after stent implantation. Conclusions In-stent calcified nodules are a common cause of ISR in patients undergoing dialysis and are observed within 1 year after stent implantation, suggesting different causes of ISR between patients undergoing dialysis and those who are not.

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.

Short-term and long-term clinical outcomes of rotational atherectomy in resistant chronic total occlusion.

OBJECTIVES: To evaluate the short- and long-term clinical outcomes of RA in CTO coronary intervention. BACKGROUND: The application of rotational atherectomy (RA) may improve the success rate of percutaneous recanalization of chronic total occlusion (CTO) with heavy calcification. METHODS: From January 2011 to September 2014, we enrolled 285 patients with CTO who underwent successful percutaneous coronary intervention (PCI). Resistant CTO lesions were defined as those with heavy calcifications as well as those that no devices are able to pass after guide wire crossing. RESULTS: All patients with resistant CTO lesions (n = 26) were successfully treated by RA without major complications, except 1 patient complicated with coronary perforation and treated by surgery successfully (success rate: RA group vs non-RA group: 96.2%, vs 89.5%, P = 0.038). Compared to the non-RA group, the patients in the RA group were older (P = 0.028), had higher J-CTO scores (P = 0.001), and needed longer stents (P = 0.001). All patients were followed up for a mean period of 3.4 ± 2.3 years, and the 1-year and long-term clinical outcomes of the RA group were excellent and comparable with those not receiving RA in multivariate analysis adjusted for multiple variables. CONCLUSION: The treatment of RA is safe and feasible for resistant CTO lesions with heavy calcification. The short- and long-term clinical outcomes of the treatment of RA were excellent and comparable with those not needing RA for CTO PCI.

Coronary Atherectomy in the United States (from a Nationwide Inpatient Sample).

Contemporary real-world data on clinical outcomes after utilization of coronary atherectomy are sparse. The study cohort was derived from Healthcare Cost and Utilization Project Nationwide Inpatient Sample database from year 2012. Percutaneous coronary interventions including atherectomy were identified using appropriate International Classification of Diseases, 9th Revision diagnostic and procedural codes. Two-level hierarchical multivariate mixed models were created. The primary outcome was a composite of in-hospital mortality and periprocedural complications; the secondary outcome was in-hospital mortality. Hospitalization costs were also assessed. A total of 107,131 procedures were identified in 2012. Multivariate analysis revealed that atherectomy utilization was independently predictive of greater primary composite outcome of in-hospital mortality and complications (odds ratio 1.34, 95% confidence interval 1.22 to 1.47, p <0.001) but was not associated with any significant difference in terms of in-hospital mortality alone (odds ratio 1.22, 95% confidence interval 0.99 to 1.52, p 0.063). In the propensity-matched cohort, atherectomy utilization was again associated with a higher rate of complications (12.88% vs 10.99%, p = 0.001), in-hospital mortality +a ny complication (13.69% vs 11.91%, p = 0.003) with a nonsignificant difference in terms of in-hospital mortality alone (3.45% vs 2.88%, p = 0.063) and higher hospitalization costs ($25,341 ± 353 vs $21,984 ± 87, p <0.001). Atherectomy utilization during percutaneous coronary intervention is associated with a higher rate of postprocedural complications without any significant impact on in-hospital mortality.

Surgical treatment for Ellis type 3 coronary perforation during percutaneous catheter intervention.

BACKGROUND: Coronary perforation (CP) is a rare, but sometimes lethal, complication of percutaneous catheter intervention (PCI). We reviewed surgically-treated cases of type 3 CP during PCI. METHODS AND RESULTS: From 2007 to 2010, 5 patients underwent surgical repair for type 3 CP (3 men, 2 women; mean age, 74 years). The mean number of diseased coronary branches was 2.6 and the mean SYNTAX score was 45. The target lesions were the left anterior descending artery in 4 cases and the right coronary artery in 1 case. Types of American Heart Association/American College of Cardiology classification were type B2 in only one case and type C in 4 cases. The causes of perforation were balloon inflation in 4 patients and rotational atherectomy in 1 patient. The in-hospital mortality rate was 20%. In the cases of CP associated with balloon inflation, coronary lacerations were so severe that re-bleeding occurred even if the covered stent could temporarily achieve hemostasis, and percutaneous cardiopulmonary support and emergency surgery were required. CONCLUSIONS: CP induced by balloon inflation tends to result in a serious condition compared with rotablator-induced CP. Surgery should be immediately performed even after covered stent implantation if there is any possibility of re-bleeding in the case of balloon-induced type 3 CP.

Efficacy of the RADPAD protective drape during real world complex percutaneous coronary intervention procedures.

The RADPAD is a lead-free surgical drape containing bismuth and barium that has been demonstrated to reduce scatter radiation exposure to primary operators during fluoroscopic procedures. It is not known to what degree the RADPAD reduces radiation exposure in operators who perform highly complex percutaneous coronary intervention (PCI) requiring prolonged fluoroscopic screening times. Sixty consecutive patients due to undergo elective complex PCI involving rotational atherectomy, multivessel PCI, or chronic total occlusions were randomized in a 1:1 pattern to have their procedures performed with and without the RADPAD drape in situ. Dosimetry was performed on the left arm of the primary operator. There were 40 cases of chronic total occlusion, including 28 with contralateral injections; 15 cases involving rotational atherectomy; and 5 cases of multivessel PCI. There was no significant difference in screening times or dose-area products between the 2 patient groups. Primary operator radiation dose relative to screening time (RADPAD: slope = 1.44, R² = 0.25; no RADPAD: slope = 4.60, R² = 0.26; analysis of covariance F = 4.81, p = 0.032) and dose-area product (RADPAD: slope = 0.003, R² = 0.26; no RADPAD: slope = 0.011, R² = 0.52; analysis of covariance F = 12.54, p = 0.008) was significantly smaller in the RADPAD cohort compared to the no-RADPAD group. In conclusion, the RADPAD significantly reduces radiation exposure to primary operators during prolonged, complex PCI cases.

Safety and efficacy of bivalirudin for percutaneous coronary intervention with rotational atherectomy.

BACKGROUND: Although bivalirudin use in percutaneous coronary intervention (PCI) results in less bleeding compared to unfractionated heparin (UFH) use, its safety in patients undergoing rotational atherectomy (RA) is unknown. METHODS: A cohort of 503 patients who underwent PCI with RA from 2000 to 2009 was studied. Patients receiving bivalirudin (n = 322) were compared to those (n = 181) treated with UFH +/- glycoprotein IIb/IIIa inhibitor (GPI) as PCI anticoagulation. Safety was assessed by the frequency of major bleeding (hematocrit drop > or =15%, intracerebral or gastro-intestinal bleeding) and need for transfusion. Efficacy was assessed by a composite end-point of in-hospital death, Q wave myocardial infarction (MI) or urgent coronary artery bypass graft (CABG). RESULTS: Those in the bivalirudin group were older, more hypertensive, and had greater body mass index. The UFH group was more likely to have prior MI, prior CABG, and an acute coronary syndrome at baseline. GPI was used in 93 patients (52%) of the UFH group. No difference was found between groups for the composite of death/Q wave MI/urgent CABG (1.9% vs. 1.7%, respectively, in bivalirudin vs. UFH group; P = 0.2). The frequency of major bleeding (2.2% vs. 1.7%; P = 0.8) or transfusion (5.6% vs. 8.7%; P = 0.9) was also similar between groups. After adjustment, bivalirudin use was not associated with a reduction in death/Q wave MI/urgent CABG, major bleeding, or transfusion compared to UFH. CONCLUSION: Bivalirudin use seems to be as safe and effective as UFH in patients undergoing RA.

Intervencionismo coronario en lesiones severamente calcificadas mediante aterectomía rotacional y stent liberador de paclitaxel: resultados tras un año de seguimiento / Percutaneous coronary intervention in heavily calcified lesions using rotational atherectomy and paclitaxel-eluting stents: outcomes at one year

Las lesiones severamente calcificadas dificultan el intervencionismo coronario. La aterectomía rotacional permite tratar estas lesiones y los stents liberadores de paclitaxel (SLP) reducen la reestenosis a largo plazo. Se evaluó retrospectivamente el resultado de la aterectomía rotacional y los SLP en lesiones severamente calcificadas en 50 pacientes consecutivos. Se estudió la mortalidad y la revascularización de la lesión tratada tras 1 año (mediana, 14 meses; intervalo intercuartílico, 8,75-25,5). El 52% eran mayores de 70 años; el 68%, varones; el 52% tenía síndrome coronario agudo; el 80%, enfermedad multivaso y un 44% recibió abciximab. Hubo 2 muertes intrahospitalarias, 3 en el seguimiento (una cardiaca) y 3 (6%) casos de revascularización de la lesión tratada. A 1 año, la supervivencia libre de muerte cardiaca fue del 94% y la supervivencia libre de revascularización de la lesión tratada, del 94%; esto muestra que la estrategia de SLP y aterectomía rotacional en lesiones severamente calcificadas proporciona excelentes resultados (AU)

Heavily calcified lesions present a challenge for percutaneous coronary intervention. With rotational atherectomy, it is possible to treat these lesions and paclitaxel-eluting stents (PESs) reduce the risk of restenosis over the long term. This retrospective study investigated clinical outcomes with rotational atherectomy and PESs in 50 consecutive patients with heavily calcified lesions. Mortality and target lesion revascularization at 1 year (median, 14 months; interquartile range, 8.75-25.5 months) were recorded. Some 52% of patients were aged over 70 years, 68% were male, 52% had acute coronary syndrome, 80% had multivessel disease and 44% were receiving abciximab. Two patients died in hospital, three died during follow-up (one cardiac death) and 3 (6%) underwent target lesion revascularization. At 1 year, the survival rate free of cardiac death was 94% and the survival rate free of target lesion revascularization was 94%. These findings demonstrate that the combination of rotational atherectomy and PESs gives excellent results in heavily calcified lesions (AU)

Directional coronary atherectomy: a time for reflection. Should we let it go?

A series of interventional tools have emerged since the advent of percutaneous coronary angioplasty. Several are fundamental and used routinely, while others less favourable have fallen short of mainstream therapy and/or have settled as a niche device. We present an overview of the evolution of directional coronary atherectomy (DCA), a unique device that was originally conceived in 1984 to solve the limitations of balloon angioplasty. Unfortunately, we have witnessed its use fall significantly out of favour due to premature and controversial study results. In many interventional laboratories DCA is no longer available. However, we strongly feel that allowing DCA to join the list of extinct interventional tools would be very unfortunate. We, herein, present a series of complex percutaneous coronary procedures to illustrate the convenience of DCA use as a lesion-specific niche device. Finally, DCA offers a valuable distinct clinical research function as it allows for in vivo pathological coronary tissue examination. In conclusion, we plead for its continued production and use as an interventional niche device for the wellbeing of our patients.

Cost-effectiveness of fluvastatin following successful first percutaneous coronary intervention.

BACKGROUND: In the LIPS (Lescol Intervention Prevention Study), fluvastatin 80 mg/day reduced the risk of major adverse cardiac events (MACE) by 22% versus placebo (p = 0.01) following successful first percutaneous coronary intervention (PCI) in patients with stable or unstable angina or silent ischemia. The cost-effectiveness of such therapy is unknown. OBJECTIVE: To evaluate the cost-effectiveness of fluvastatin following successful first PCI from a US healthcare system perspective. METHODS: We used a Markov model to estimate expected outcomes and costs of 2 alternative treatment strategies following successful first PCI in patients with stable or unstable angina or silent ischemia: (1) diet/lifestyle counseling plus immediate fluvastatin 80 mg/day; and (2) diet/lifestyle counseling only, with initiation of fluvastatin 80 mg/day following occurrence of future nonfatal MACE. The model was estimated with data from LIPS and other published sources. Cost-effectiveness was calculated as the ratio of the difference in expected medical-care costs to the expected difference in life-years (LYs) and quality-adjusted life-years (QALYs) alternatively. RESULTS: Treatment with fluvastatin following successful first PCI was found to increase life expectancy by 0.78 years (QALYs 0.68). Cost-effectiveness of fluvastatin following successful first PCI is 13 505 dollars per LY (15 454 dollar per QALY) saved. Ratios are lower for patients with diabetes (9396 dollar per LY; 10 718 dollar per QALY) and those with multivessel disease (9662 dollar per LY; 11 076 dollar per QALY). Findings were robust with respect to changes in key model parameters and assumptions. CONCLUSIONS: Fluvastatin therapy following PCI is cost-effective compared with other generally accepted medical interventions.

Exploration of a bayesian updating methodology to monitor the safety of interventional cardiovascular procedures.

Appropriate methods for monitoring of the safety of medical devices introduced into clinical practice have been elusive to develop and implement. A novel approach is the application of Bayesian updating, which incorporates existing knowledge regarding event rates into the estimation of risk. This framework has been shown in other domains to be data efficient and to address some of the limitations of conventional statistical methods. In this article, the authors propose a methodologic framework for developing initial prior probability distributions in risk-stratified patient groups and a mechanism for incorporating accumulating procedure safety experience. In addition, they use this methodology to retrospectively analyze the clinical outcomes of 309 patients undergoing an infrequent interventional cardiology procedure, rotational atherectomy. These exploratory analyses demonstrate the feasibility of Bayesian updating applied to medical device safety evaluation and indicate that the methodology is capable of generating stable estimates of risk in a variety of patient risk groups.

A contemporary overview of percutaneous coronary interventions. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR).

The American College of Cardiology (ACC) established the National Cardiovascular Data Registry (ACC-NCDR) to provide a uniform and comprehensive database for analysis of cardiovascular procedures across the country. The initial focus has been the high-volume, high-profile procedures of diagnostic cardiac catheterization and percutaneous coronary intervention (PCI). Several large-scale multicenter efforts have evaluated diagnostic catheterization and PCI, but these have been limited by lack of standard definitions and relatively nonuniform data collection and reporting methods. Both clinical and procedural data, and adverse events occurring up to hospital discharge, were collected and reported according to uniform guidelines using a standard set of 143 data elements. Datasets were transmitted quarterly to a central facility for quality-control screening, storage and analysis. This report is based on PCI data collected from January 1, 1998, through September 30, 2000.A total of 139 hospitals submitted data on 146,907 PCI procedures. Of these, 32% (46,615 procedures) were excluded because data did not pass quality-control screening. The remaining 100,292 procedures (68%) were included in the analysis set. Average age was 64 +/- 12 years; 34% were women, 26% had diabetes mellitus, 29% had histories of prior myocardial infarction (MI), 32% had prior PCI and 19% had prior coronary bypass surgery. In 10% the indication for PCI was acute MI < or =6 h from onset, while in 52% it was class II to IV or unstable angina. Only 5% of procedures did not have a class I indication by ACC criteria, but this varied by hospital from a low of 0 to a high of 38%. A coronary stent was placed in 77% of procedures, but this varied by hospital from a low of 0 to a high of 97%. The frequencies of in-hospital Q-wave MI, coronary artery bypass graft surgery and death were 0.4%, 1.9% and 1.4%, respectively. Mortality varied by hospital from a low of 0 to a high of 4.2%. This report presents the first data collected and analyzed by the ACC-NCDR. It portrays a contemporary overview of coronary interventional practices and outcomes, using uniform data collection and reporting standards. These data reconfirm overall acceptable results that are consistent with other reported data, but also confirm large variations between individual institutions.

Safety and efficacy of percutaneous coronary interventions performed immediately after diagnostic catheterization in northern new england and comparison with similar procedures performed later.

"Ad hoc" percutaneous coronary interventions (PCIs)-those performed immediately after diagnostic catheterization-have been reported in earlier studies to be safe with a suggestion of higher risk in certain subgroups. Despite increasing use of this strategy, no data are available in recent years with new device technology. We studied use of an ad hoc strategy in a large regional population to determine its use and outcomes compared with staged procedures. A database from the 6 centers performing PCIs in northern New England and 1 center in Massachusetts was analyzed. During 1997, excluding only patients requiring emergency procedures or those with a prior PCI, 4,136 PCIs were performed, 1,748 (42.3%) of these being ad hoc procedures. Patients having ad hoc procedures were less likely to have peripheral vascular disease, renal failure, prior myocardial infarction, or coronary artery bypass surgery, congestive heart failure, or poor left ventricular function, and more likely to have received preprocedural intravenous heparin or nitroglycerin or to have required an urgent procedure. Narrowings treated during ad hoc procedures were less frequently types B and C or in saphenous vein grafts. Adjusted rates of clinical success were not different between ad hoc and non-ad hoc procedures (93.7% vs 93.6%); there was no difference in the incidence of death (0.6% vs 0.5%), emergency (0. 9% vs 0.8%) or any (1.4% vs 0.8%) coronary artery bypass surgery, or myocardial infarction (2.6% vs 2.0%). As currently practiced in our region, ad hoc intervention is used selectively with outcomes similar for ad hoc and non-ad hoc procedures.

Contemporary trends in coronary intervention: a report from the Registry of the Society for Cardiac Angiography and Interventions.

This report of the Registry for the Society for Cardiac Angiography and Interventions provides data on the trends in coronary interventional procedures from the time period June 1966 through December 1998. A total of 19,510 consecutive coronary interventional procedures were recorded. Over this time period, significant trends in coronary stent implantation were recorded along with a decreasing reliance on balloon angioplasty as sole therapy. Patients with acute myocardial infarction comprised an increased fraction of all procedures. Almost half of all interventions were performed in patients with multivessel disease. Finally, decreasing rates of in-hospital death and emergent bypass surgery compared to prior reports from the registry characterize the current practice of interventional cardiology. Cathet. Cardiovasc. Intervent. 49:19-22, 2000.

Evolving trends in interventional device use and outcomes: results from the National Cardiovascular Network Database.

BACKGROUND: Although multiple new coronary interventional devices have been approved for marketing in the United States, use of these technologies in general clinical practice and their associated outcomes have not been reported. METHODS AND RESULTS: Using the National Cardiovascular Network's Coronary Interventional Database, we examined temporal trends in the use and outcomes of coronary stents, lasers, directional atherectomy, and rotational atherectomy devices at 12 US hospitals between January 1994 and December 1997 (n = 76,904). Over this period, the percentage of cases involving coronary stents rose more than 12-fold (from 5.4% in 1994 to 69.0% in 1997). In contrast, use of atherectomy-type devices declined significantly. Device selection was strongly influenced by the patient's coronary anatomy and procedural indication, but less by age, sex, or race. Device use also varied significantly among individual centers (4-fold variation among sites in stent use and 6-fold variation in atherectomy use) even after adjusting for patient characteristics. Although overall mortality rates were unchanged during this 4-year period, procedural success rates have improved and complication rates have declined significantly. Lengths of postprocedure hospital stay also fell significantly for all patients undergoing coronary intervention in this time period. CONCLUSIONS: Percutaneous interventional strategies are rapidly changing with the explosive growth of coronary stent use and the decline in use of atherectomy devices. Patient outcomes, including complication rates and postprocedure lengths of stay, have also improved as the new interventional strategies have been refined in clinical practice.