Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients.

OBJECTIVES: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). METHODS: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. RESULTS: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. CONCLUSIONS: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. TRIAL REGISTRATION NUMBER: NCT01940120.

Predictors of Successful Hybrid-Approach Chronic Total Coronary Artery Occlusion Stenting: An Improved Model With Novel Correlates.

OBJECTIVES: The aim of this study was to develop a hybrid approach-specific model to predict chronic total coronary artery occlusion (CTO) percutaneous coronary intervention success, useful for experienced but not ultra-high-volume operators. BACKGROUND: CTO percutaneous coronary intervention success rates vary widely and have improved with the "hybrid approach," but current predictive models for success have major limitations. METHODS: Data were obtained from consecutively attempted patients from 7 clinical sites (9 operators, mean annual CTO volume 61 ± 17 cases). Angiographic analysis of 21 lesion variables was performed centrally. Statistical modeling was performed on a randomly designated training group and tested in a separate validation cohort. The primary outcome of interest was technical success. RESULTS: A total of 436 patients (456 lesions) met entry criteria. Twenty-five percent of lesions had prior failed percutaneous coronary interventions at the site. The right coronary artery was the most common location (56.4%), and mean occlusion length was 24 ± 20 mm. The initial approach was most often antegrade wire escalation (70%), followed by retrograde (22%). Success was achieved in 79.4%. Failure was most closely correlated with presence of an ambiguous proximal cap, and in the presence of an ambiguous proximal cap, specifically defined collateral score (combination of Werner and tortuosity scores) and retrograde tortuosity. Without an ambiguous proximal cap, poor distal target, occlusion length >10 mm, ostial location, and 1 operator variable contributed. Prior failure, and Werner and tortuosity scores alone, were only weakly correlated with outcomes. The basic 7-item model predicted success, with C statistics of 0.753 in the training cohort and 0.738 in the validation cohort, the later superior (p < 0.05) to that of the J-CTO (Multicenter CTO Registry of Japan) (0.55) and PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (0.61) scores. CONCLUSIONS: Success can be reasonably well predicted, but that prediction requires modification and combination of angiographic variables. Differences in operator skill sets may make it challenging to create a powerful, generalizable, predictive tool.

Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.

BACKGROUND: The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. OBJECTIVES: The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. METHODS: Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. RESULTS: In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. CONCLUSIONS: The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

Improved functional status and quality of life in prohibitive surgical risk patients with degenerative mitral regurgitation after transcatheter mitral valve repair.

BACKGROUND: Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported. OBJECTIVES: This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR. METHODS: A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies. RESULTS: A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 [n = 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced. CONCLUSIONS: TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956).

Left main coronary artery stenosis: a meta-analysis of drug-eluting stents versus coronary artery bypass grafting.

OBJECTIVES: The goal of this study was to provide a systematic review comparing the long-term outcomes of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass graft surgery (CABG) for unprotected left main coronary artery (UPLM) stenosis. BACKGROUND: One-year outcomes from randomized controlled trials, observational studies, and pooled analyses have demonstrated the safety and efficacy of PCI of the UPLM when compared with CABG. However, there remain concerns over the sustainability of PCI with DES at longer follow-up. METHODS: Studies published between January 2000 and December 2012 of PCI versus CABG for UPLM stenosis were identified using an electronic search and reviewed using meta-analytical techniques. RESULTS: Twenty-four studies comprising 14,203 patients were included in the analysis. There was no significant difference for all-cause mortality between PCI or CABG at 1 year (odds ratio [OR]: 0.792, 95% confidence interval [CI]: 0.53 to 1.19), 2 years (OR: 0.920, 95% CI: 0.67 to 1.26), 3 years (OR: 0.94, 95% CI: 0.60 to 1.48), 4 years (OR: 0.84, 95% CI: 0.53 to 1.33), and 5 years (OR: 0.79, 95% CI: 0.57 to 1.08). The need for target vessel revascularization (TVR) was significantly higher in patients undergoing PCI at all time points. The occurrence of stroke, however, was significantly less frequent in patients treated with PCI. The occurrence of nonfatal myocardial infarction showed a statistically significant trend towards a lower incidence in CABG patients at 1 year (OR: 1.62, 95% CI: 1.05 to 2.50), 2 years (OR: 1.60, 95% CI: 1.09 to 2.35), and 3 years (OR: 2.06, 95% CI: 1.36 to 3.1). There was no significant difference in combined major adverse cardiovascular and cerebrovascular events between the 2 groups. CONCLUSIONS: Our findings suggest that PCI with DES is a safe and durable alternative to CABG for the revascularization of UPLM stenosis in select patients at long-term follow-up.

Cause of death within 30 days of percutaneous coronary intervention in an era of mandatory outcome reporting.

OBJECTIVES: This study sought to ascertain causes of death and the incidence of percutaneous coronary intervention (PCI)-related mortality within 30 days. BACKGROUND: Public reporting of 30-day mortality after PCI without clearly identifying the cause may result in operator risk avoidance and affect hospital reputation and reimbursements. Death certificates, utilized by previous reports, have poor correlation with actual cause of death and may be inadequate for public reporting. METHODS: All patients who died within 30 days of a PCI from January 2009 to April 2011 at a tertiary care center were included. Causes of death were identified through detailed chart review using Academic Research Consortium consensus guidelines and compared with reported death certificates. The causes of death were divided into cardiac and noncardiac and PCI and non-PCI-related categories. RESULTS: Of the 4,078 PCI, 81 deaths (2%) occurred within 30 days. Of these, 58% died of cardiac and 42% of noncardiac causes. However, only 42% of 30-day deaths were attributed to PCI-related complications. Patients with non-PCI-related, compared with PCI-related, death presented with a higher incidence of cardiogenic shock (15 of 47 [32%] vs. 2 of 34 [6%]; p < 0.01) and cardiac arrest (19 of 47 [40%] vs. 1 of 34 [3%]; p < 0.01). Death certificates had only 58% accuracy (95% confidence interval: 45% to 72%) for classifying patients as experiencing cardiac versus noncardiac death. CONCLUSIONS: Less than one-half of 30-day deaths are attributed to a PCI-related complication. Death certificates are inaccurate and do not report PCI-related deaths, which may represent a better marker of PCI quality.

Outcomes of culprit versus multivessel PCI in patients with multivessel coronary artery disease presenting with ST-elevation myocardial infarction complicated by shock.

BACKGROUND: The optimal revascularization strategy in patients with multivessel coronary artery disease (MVCAD) who present with ST-elevation myocardial infarction (STEMI) and shock is undefined. We aimed to determine differences in survival among patients with MVCAD presenting with STEMI complicated by shock treated with percutaneous coronary intervention (PCI) of the infarct-related artery alone (culprit-only PCI) versus multivessel PCI (MVPCI). METHODS: Patients with MVCAD and STEMI complicated by shock who underwent PCI between January 1, 2002 and May 31, 2010 were identified (n = 199). Differences in survival between patients undergoing culprit-only PCI versus MVPCI were assessed using a multiphase survival model and propensity matching. RESULTS: MVPCI was used in 22% of patients (n = 43). Patient characteristics were similar in the groups, although more patients treated with MVPCI met the National Cardiovascular Data Registry definition of shock. Death was higher in patients treated with MVPCI at 1 month (27% vs 46%) and 8 years (65% vs 75%; P=.04). The early risk of death was higher in the patients treated with MVPCI when compared to patients treated with culprit-only PCI (coefficient: 0.66 ± 0.25; P=.009), but not the late risk of death (coefficient: -0.18 ± 0.58; P=.70). However, in a propensity-matched cohort (n = 64), there were no differences in the risk of death over the early (coefficient: 0.50 ± 0.37; P=.16) or late phase (P>.90). CONCLUSION: Patients undergoing MVPCI for STEMI-related shock are clinically different than those treated with culprit PCI only; however, after risk adjustment both groups have similar short- and long-term outcomes. Prospective studies are needed to determine the optimal revascularization strategy in this high-risk population.

Percutaneous mitral valve repair in the initial EVEREST cohort: evidence of reverse left ventricular remodeling.

BACKGROUND: Percutaneous repair of mitral regurgitation (MR) permits examination of the effect of MR reduction without surgery and cardiopulmonary bypass on left ventricular (LV) dimensions and function. The goal of this analysis was to determine the extent of reverse remodeling at 12 months after successful percutaneous reduction of MR with the MitraClip device. METHODS AND RESULTS: Of 64 patients with 3 and 4+ MR who achieved acute procedural success after treatment with the MitraClip device, 49 patients had moderate or less MR at 12-month follow-up. Their baseline and 12-month echocardiograms were compared between the group with and without LV dysfunction. In patients with persistent MR reduction and pre-existing LV dysfunction, there was a reduction in LV wall stress, reduced LV end-diastolic volume, LV end-systolic volume and increase in LV ejection fraction in contrast to those with normal baseline LV function, who showed reduction in LV end-diastolic volume, LV wall stress, no change in LV end-systolic volume, and a fall in LV ejection fraction. CONCLUSIONS: Patients with pre-existing LV dysfunction demonstrate reverse remodeling and improved LV ejection fraction after percutaneous mitral valve repair. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00209339, NCT00209274.

Percutaneous coronary revascularization in coronary artery disease: lessons from a single center experience.

OBJECTIVES: To determine the role of percutaneous coronary intervention (PCI) and its impact on mortality in coronary artery disease (CAD). BACKGROUND: It's unclear whether PCI provides benefit in patients with CAD outside of acute settings. We sought to determine the role of PCI and its effect on mortality in patients with similar entry criteria to prior RCTs and compare outcomes with medical treatment. METHODS: Using institutional diagnostic catheterization database of consecutive patients undergoing coronary angiography from 1/2004 to 1/2010, we examined records for patients with a positive stress test and >70% coronary stenosis or symptoms of angina and >80% coronary stenosis. We excluded those with acute coronary syndromes, low ejection fraction (EF), history of CABG, and CABG following index catheterization. We stratified patients by treatment and performed unadjusted and propensity matched analyses. The outcome was all-cause mortality obtained from the social security death index. RESULTS: We identified 3,375 patients using study inclusion criteria. Mean age was 65 ± 11 years and 69% (n = 2,332) were men. Mean EF was 55% ± 8%. In the unadjusted cohort, 1,265 patients received medical management and 2,110 received PCI. The unadjusted analysis revealed significantly better survival in PCI patients (P < 0.0001) (HR: 0.51; 95% confidence interval (CI), 0.41-0.63). Propensity matching was performed for 1,580 patients and analysis showed better survival among patients receiving PCI (0 = 0.04) (HR: 0.74; 95% CI, 0.55-0.98). PCI continued to show better survival after excluding patients with malignancy (P = 0.03) and unstable angina (P = 0.007). CONCLUSIONS: This single center registry analysis demonstrated better survival in stable CAD patients undergoing PCI compared to medical management alone. These data suggest there may be a benefit of PCI beyond symptom relief. Future randomized trials are needed to further understand the role of PCI in broader patient populations.

Intervention of Saphenous Vein Graft Chronic Total Occlusion.

Interventions on vein graft occlusions are technically feasible procedures but carry significant risk for periprocedural complications and demonstrate questionable long-term patency. For those circumstances in which recanalization of a graft occlusion is warranted, the authors have highlighted some of the procedural considerations and available techniques that may help maximize chances for success. This should not be mistaken for a wholesale endorsement of vein graft chronic total occlusion interventions. Before undertaking a procedure of this complexity, the operator must put strong consideration into the risks, benefits, and alternatives for a given patient.

Establishing the cost-effectiveness of percutaneous coronary intervention for chronic total occlusion in stable angina: a decision-analytic model.

BACKGROUND: In the setting of chronic stable angina, successful percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) has been shown to produce significant symptom improvement with some evidence for survival benefit. However, the economic basis for this procedure has not been established compared with optimal medical treatment (OMT) of chronic stable angina. OBJECTIVE: The aim of this study was to determine the cost-effectiveness of CTO-PCI in chronic stable angina using a Markov model. DESIGN: The transition probabilities, utilities and costs related to CTO-PCI and OMT used to inform the model were derived from literature and our experience. Implications with respect to cost and quality of life were calculated. Sensitivity analyses were based on factors noted to influence model outcome. RESULTS: In the reference case, mean age 60 years, rate of successful CTO-PCI 67.9%, and mean transition probabilities, utilities and costs as defined by literature and clinical experience, the strategy of CTO-PCI incurred higher costs relative to OMT (US$31 512 vs US$27 805), but also accumulated greater quality-adjusted life-years (QALYs) (2.38 vs 1.99), yielding a cost-effectiveness ratio of US$9505 per QALY. Sensitivity analyses showed the utility of OMT and utilities postsuccessful and postunsuccessful CTO-PCI to be the most influential drivers of outcome. Procedural success held limited influence over model outcome at particular utility threshold values. CONCLUSIONS: On the basis of the supporting evidence, this decision-analytic model suggests that CTO-PCI is cost-effective in a patient population with severe symptoms. Quality-of-life metrics should be employed in future appropriateness criteria developed for CTO-PCI.

Acute effect of percutaneous MitraClip therapy in patients with haemodynamic decompensation.

AIMS: To evaluate the haemodynamic effect of acute procedural success (APS) after MitraClip therapy in patients with haemodynamic decompensation. METHODS AND RESULTS: Of 107 patients, 79 achieved APS after MitraClip implantation. The increase in cardiac index (CI) was primarily detected in patients with a low baseline CI (2.0 ± 0.5 to 2.5 ± 5 L/min/m(2), P < 0.001). There was a decrease in left ventricular end-diastolic pressure (LVEDP) (20 ± 5 to 13 ± 5 mmHg, P = 0.002) and mean pulmonary capillary wedge pressure (PCWPm) (20 ± 4 to 16 ± 5 mmHg, P = 0.001) in patients with values >15 mmHg at baseline, and a decrease in mean pulmonary artery systolic (PAPm) (36 ± 4 to 29 ± 7 mmHg P = 0.003) in those with values >30 mmHg before the MitraClip procedure. Patients with decompensation compared with patients with compensation experienced significant reduction in LVEDP (-8.3 ± 11.9 mmHg vs. -0.2 ± 4.5 mmHg, P = 0.009), a reduction in PCWPm (-3.5 ± 5.6 mmHg vs. 1.9 ± 4.7 mmHg, P < 0.001), and a reduction in PAPm (-8 ± 9 mmHg vs. 3 ± 6 mmHg, P < 0.001). CONCLUSION: The favourable haemodynamic effects of MitraClip therapy on CI were primarily detected in patients with low CI before the procedure, and improvements in left-sided filling pressure and PAP were primarily seen in those with elevated values at baseline.

Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques: results of the FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial.

OBJECTIVES: This study sought to examine the efficacy and safety of 3 novel devices to recanalize coronary chronic total occlusions (CTOs). BACKGROUND: Successful percutaneous coronary intervention (PCI) of CTOs improves clinical outcome in appropriately selected patients. CTO PCI success, however, remains suboptimal. METHODS: A new crossing catheter and re-entry system was evaluated in a prospective, multicenter, single-arm trial of CTO lesions refractory to standard PCI techniques. The primary efficacy endpoint was the frequency of true lumen guidewire placement distal to the CTO (technical success). RESULTS: Enrollment included 147 patients with 150 CTOs. The mean lesion length was 41 ± 17 mm. A crossing catheter crossed 56 lesions into the distal true lumen, and a re-entry catheter facilitated tapered-wire cannulation of the distal lumen in 59 CTOs initially crossed subintimally (77% technical success). Success in the first 75 CTOs was 67%, rising to 87% in the last 75 CTOs. Mean fluoroscopy and procedure times were 45 ± 16 min and 90 ± 12 min, respectively, each significantly shorter than in historical controls (p < 0.0001 for both). Coronary perforation occurred in 14 cases (9.3%), requiring treatment in 3 cases (prolonged balloon inflation, with additional coil embolization in 1 case). No tamponade or hemodynamic instability occurred. Six patients had periprocedural non-ST-segment elevation myocardial infarction. No emergency surgery, ST-segment elevation myocardial infarction, or cardiac reintervention occurred. Two deaths occurred within 30 days, neither as a direct result of the procedure. The 30-day major adverse cardiac event rate was 4.8%. CONCLUSIONS: In CTOs failing standard techniques, use of a new crossing and re-entry system results in a high success rate without increasing complications.

Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study.

OBJECTIVES: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND: Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. METHODS: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. RESULTS: Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). CONCLUSIONS: The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; NCT00209274).

Subintimal guidewire tracking during successful percutaneous therapy for chronic coronary total occlusions: insights from an intravascular ultrasound analysis.

OBJECTIVES: We sought to determine the frequency of subintimal guidewire tracking during successful percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) and to better understand the procedural implications of this event. BACKGROUND: Successful PCI for chronic CTO is associated with improved outcomes in patients with ischemia. While subintimal guidewire tracking resulting in failure to cross is recognized as the major mode of failure for CTO PCI, the implications of subintimal guidewire tracking during successful CTO PCI are unknown. METHODS: Between March 2007 and October 2007, 26 consecutive patients, each with one de-novo CTO lesion successfully crossed with a guidewire were included in the analysis. Intravascular ultrasound (IVUS) was performed in each CTO vessel after guidewire crossing. Cases were classified as having definite subintimal wire tracking or no clear evidence of subintimal wire tracking based on analysis of IVUS images. RESULTS: Subintimal wire tracking occurred in 45% of cases. In cases where subintimal wire tracking was present, a previous attempt at CTO PCI was more common (42% vs. 7%, P ≤ 0.05). Subintimal wire tracking was also associated with significantly longer final mean stent length (71 vs. 50 mm), procedure time (122 vs. 69 min), fluoroscopy time (47 vs. 22 min), and contrast dose (300 vs. 199 mL, P ≤ 0.05 for all). There was one perforation in the subintimal group which was successfully treated with stent placement. CONCLUSIONS: Subintimal wire tracking occurs frequently during successful PCI for CTO and is associated with increased lesion and procedural complexity.

Informed Consent of the Chronic Total Occlusion Patient.

This article focuses on the general principles of informed consent, then highlights the particular risks associated with chronic total occlusion interventions. The goal is to provide a basic framework for the interventional cardiologist to use when having consent discussions with his or her patients.

Initial experience with a dedicated coronary re-entry device for revascularization of chronic total occlusions.

OBJECTIVE: The aim of this registry was to evaluate a new device designed to facilitate antegrade guidewire re-entry into the true lumen of a chronic total coronary occlusion (CTO) from the adjacent subintimal space. BACKGROUND: Successful recanalization of CTOs results in clinical improvement in appropriately selected patients. CTO intervention is time- and resource-consuming, and a simplified approach enabling antegrade guidewire re-entry into the distal true lumen might improve success. METHODS: Patients with CTO and ischemia were entered into a prospective registry regardless of lesion characteristics. If wire manipulation resulted in subintimal wire entrapment, a new re-entry tool (a 2.5-mm flat subintimal balloon with two exit ports offset by 180°) was used as a platform to attempt guidewire penetration into the distal true lumen. The primary endpoint assessed was successful device-guided re-entry. Standard techniques were then utilized to open the CTO. RESULTS: In 40 consecutive CTO lesions attempted, 19 resulted in subintimal wire entrapment (mean occlusion length 44 mm). Sixteen of these 19 were successfully crossed with an antegrade guidewire into the distal true lumen using the new device (84%). One patient with unsuccessful re-entry was subsequently recanalized with a retrograde technique. All crossed lesions were stented (17/17), resulting in TIMI 3 flow without major complications. Two cases were unsuccessful. One patient had a grade I coronary perforation requiring no treatment. CONCLUSIONS: A new device to recanalize CTOs complicated by subintimal wire entrapment can be used successfully by experienced operators. Further study of this coronary re-entry device is ongoing.

Comparison of outcomes of unprotected left main versus multivessel coronary artery interventions.

Left main coronary artery (LMCA) percutaneous coronary intervention (PCI) has emerged as an appealing alternative to bypass surgery for significant LMCA disease, especially in high-risk candidates. PCI for unprotected LMCA stenosis is currently designated a class IIb indication. Direct comparisons between unprotected LMCA PCI and multivessel PCI are lacking. We aimed to determine the incremental risk associated with unprotected LMCA PCI compared to multivessel PCI. We queried the Cleveland Clinic PCI database to identify patients who underwent unprotected LMCA PCI from 2003 through 2009 and compared these to patients undergoing multivessel PCI in the same period. Patients undergoing PCI for acute myocardial infarction were excluded. Mortality was derived using the Social Security Death Index. Short-term (≤30-day) mortality rates in the LMCA PCI group (n = 468, 1.9%) were similar to the death rate in the multivessel PCI group (n = 1,973, 1.3%, p = 0.3). There was no significant difference in adjusted mortality between the 2 study groups. Stratifying LMCA PCI by the number of concomitant vessel territories treated, there was no significant difference in mortality in any LMCA PCI category (LMCA only, LMCA + 1-vessel PCI, LMCA + multivessel PCI) compared to multivessel PCI. In conclusion, there was comparable short-term and long-term mortality in the LMCA PCI and multivessel PCI groups. LMCA stenting did not appear to incur incremental risk compared to multivessel PCI.