Jimmy MacHaalany

Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: Results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial

OBJECTIVES PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). BACKGROUND Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. METHODS Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. RESULTS A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm(2) or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm(2) (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04). CONCLUSIONS Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.

Successive transradial access for coronary procedures: Experience of Quebec Heart-Lung Institute

BACKGROUND Transradial approach (TRA) for cardiac catheterizations and interventions improves clinical outcomes compared with transfemoral access, and its use is increasing worldwide. However, there are limited data on successive use of same artery for repeat procedures. METHODS Between May 2010 and May 2011, all consecutive patients undergoing a repeat TRA procedure (≥2) were retrospectively identified. Success rates and reasons for failure to use ipsilateral radial artery for repeat access were identified. RESULTS A total of 519 patients underwent 1,420 procedures. In 480 patients (92%), right radial artery was used as initial access, and left radial artery, in 39 patients. All patients underwent ≥2 procedures; 218 patients, ≥3; 87 patients, ≥4; 39 patients, ≥5; 19 patients, ≥6; 11 patients, ≥7; and 5 patients, ≥8 procedures. Two patients had, respectively, 9 and 10 procedures. The success rate for second attempt was 93%, 81% for third, and declining to 60% for ≥8. Linear regression analysis estimated a 5% failure rate for each repeat attempt (R(2) = 0.87, P = .007). The main reason for failure was related to clinical radial artery occlusion (RAO) including absent or faint pulse, poor oximetry, and failed puncture. All patients with clinical RAO were asymptomatic. By multivariate analysis, female gender (odds ratio [OR] 3.08, 95% CI 1.78-5.39, P < .0001), prior coronary artery bypass graft (OR 5.26, 95% CI 2.67-10.42, P < .0001), and repeat radial access (OR 2.14, 95% CI 1.70-2.76, P < .0001) were independent predictors of radial access failure. CONCLUSION Successive TRA is both feasible and safe in most cases for up to 10 procedures. However, failure rate for TRA increases with successive procedures, primarily due to clinical RAO. Strategies to minimize the risks of chronic clinical RAO and allow repeat use of ipsilateral radial artery need to be further defined.

Fatal Late Migration of Viacor Percutaneous Transvenous Mitral Annuloplasty Device Resulting in Distal Coronary Venous Perforation

We present the case of a patient with dilated ischemic cardiomyopathy and severe mitral regurgitation. Due to several comorbidities, he underwent percutaneous transvenous mitral annuloplasty. Postoperatively, he complained of atypical chest pain. He was treated for pericarditis and died suddenly 10 days after the procedure. Autopsy showed distal perforation of the anterior interventricular vein with migration of the device on the diaphragm.

Deadly association of cardiogenic shock and chronic total occlusion in acute ST-elevation myocardial infarction

BACKGROUND The association between cardiogenic shock and 1 or >1 chronic total occlusion (CTO) in unselected patients presenting with ST-elevation myocardial infarction (MI) (STEMI) has not been characterized. METHODS Patients with STEMI referred with or without cardiogenic shock were categorized into no CTO, 1 CTO, and >1 CTO. The primary end point was the 30-day mortality. RESULTS Between 2006 and 2011, 2,020 consecutive patients were included. A total of 141 patients (7%) presented with cardiogenic shock on admission. The prevalence of 1 CTO and >1 CTO in a non-infarct-related artery was 23% and 5%, respectively, among patients with shock compared with 6% and 0.5% in patients without shock (P < .0001). Independent predictors of cardiogenic shock included left main-related MI (odds ratio [OR] 6.55, 95% CI 1.39-26.82, P = .019), CTO (OR 4.20, 95% CI 2.64-6.57, P < .001), creatinine clearance <60 mL/min (OR 3.41, 95% CI 2.32-4.99, P < .0001), and left anterior descending-related MI (OR 2.20, 95% CI 1.51-3.23, P < .0001). Thirty-day mortality was 100% in shock patients with >1 CTO, 65.6% with 1 CTO, and 40.2% in patients without CTO (P < .0001). After adjustment for left ventricular ejection fraction and renal function, CTO remained an independent predictor for 30-day mortality (hazard ratio [HR] 1.83; 95% CI 1.10-3.01, P = .02). CONCLUSION In patients with STEMI, CTO was strongly associated with cardiogenic shock on admission. In this setting, mortality was substantially higher in patients with 1 CTO and exceedingly high in those with >1 CTO. The presence of CTO was an independent predictor of early mortality.

Early and late outcomes after primary percutaneous coronary intervention by radial or femoral approach in patients presenting in acute ST-elevation myocardial infarction and cardiogenic shock

BACKGROUND Although radial approach is increasingly used in percutaneous coronary interventions (PCIs) including in acute myocardial infarction (MI), patients with cardiogenic shock have been excluded from comparisons with femoral approach. The aim of our study was to compare clinical outcomes in patients undergoing primary PCI with cardiogenic shock by radial and femoral approach. METHODS AND RESULTS From 2,663 patients presenting with ST-elevation MI in 2 large volume radial centers, we identified 197 patients (7.4%) with signs of cardiogenic shock immediately before undergoing primary PCI. Radial approach was used in 55% of cases when at least 1 radial artery was weakly palpable, either spontaneously or after intravenous noradrenaline bolus. Patients in the radial group were older (69 ± 12 vs 64 ± 12 years, P = .010), had less diabetes (13% vs 26%, P = .028), and required less often intubation prior PCI (42% vs 66%, P = .0006) or intraaortic balloon pump (36% vs 55%, P = .0096). Mortality at 1 year was 44% in the radial group and 64% in the femoral group (P = .0044). Independent predictors of late mortality included radial approach (hazard ratio [HR] 0.65, 95% CI 0.42-0.98, P = .041), the use of glycoprotein IIb-IIIa receptor inhibitors (HR 0.63, 95% CI 0.40-0.96, P = .032), baseline creatinine ≥110 μmol/L (HR 3.34, 95% CI 2.20-5.12, P < .0001), initial glycemia >200 mg/dL (HR 2.02, 95% CI 1.34-3.11, P = .0008), and age >65 years (HR 1.80, 95% CI 1.18-2.79, P = .006). CONCLUSION Radial approach was safe and feasible in more than half of the patients with ST-elevation MI and cardiogenic shock treated by primary PCI. After adjustment for baseline and procedural characteristics, radial approach remained associated with better survival. However, prognosis of patients undergoing primary PCI in cardiogenic shock remains poor.

Benefit of Bivalirudin Versus Heparin After Transradial and Transfemoral Percutaneous Coronary Intervention

Bivalirudin, a direct thrombin inhibitor, has been shown to reduce major bleeding and provide a better safety profile compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) through transfemoral access. Data pertaining to the clinical benefit of bivalirudin compared to UFH monotherapy in patients undergoing transradial PCI are lacking. The present study sought to compare the in-hospital net clinical adverse events, including death, myocardial infarction, target vessel revascularization, and bleeding, for these 2 antithrombotic regimens for all patients at a tertiary care, high-volume radial center. From April 2009 to February 2011, all patients treated with bivalirudin were matched by access site to those receiving UFH. The patients in the bivalirudin group (n = 125) were older (72 ± 13 years vs 66 ± 11 years; p <0.0001), more often had chronic kidney disease (51% vs 30%; p = 0.0012), and more often underwent primary PCI (30% vs 14%, p <0.0037) than the UFH-treated patients (n = 125). A radial approach was used in 71% of both groups. The baseline bleeding risk according to Mehrans score was similar in both groups (14 ± 9 vs 15 ± 8, p = 0.48). In-hospital mortality was 2% in both groups (p = 1.00). No difference in net clinical adverse events or ischemic or bleeding complications was detected between the 2 groups. Bivalirudin reduced both ischemic and bleeding events in femoral-treated patients, but no such clinical benefit was observed in the radial-treated patients. In conclusion, as periprocedural PCI bleeding avoidance strategies have become paramount to optimize the clinical benefit, the interaction between bivalirudin and radial approach deserves additional investigation.

Effect on door-to-balloon time of immediate transradial percutaneous coronary intervention on culprit lesion in ST-elevation myocardial infarction compared to diagnostic angiography followed by primary percutaneous coronary intervention.

Door-to-balloon (DTB) time is an important metric in primary percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction to optimize clinical outcomes. The aim of this study was to compare the impact of immediate PCI on culprit lesions in patients with ST-segment elevation myocardial infarctions versus diagnostic angiography followed by PCI on DTB times and procedural data at a high-volume tertiary care radial center. All patients who underwent primary PCI <12 hours after symptom onset were studied. Procedural data and all-cause mortality were assessed in all patients. The primary outcome was DTB time. From January 2006 to June 2011, 1,900 patients were included and divided into 2 groups: 562 patients (30%) underwent primary PCI followed by contralateral diagnostic angiography, and 1,338 patients (70%) underwent diagnostic angiography before primary PCI. No significant differences were observed in baseline characteristics. Left anterior descending coronary artery-related ST-segment elevation myocardial infarctions were more often found in patients who underwent PCI first (54% vs 34%, p <0.0001). Overall, there was a reduction of 8 minutes in DTB time between patients who underwent PCI first and those who underwent angiography first (32 minutes [interquartile range 24 to 52] vs 40 minutes [interquartile range 30 to 69], respectively, p <0.0001). After adjustment, immediate PCI remained an independent predictor of DTB time ≤90 minutes (odds ratio 2.42, 95% confidence interval 1.70 to 3.52, p <0.0001). There were no differences in early and late clinical outcomes. In conclusion, a strategy of transradial direct PCI of the infarct-related artery in selected patients before complete coronary angiography was associated with a benefit of 8 minutes in DTB time. Further study is required to determine whether this strategy can favorably affect clinical outcomes.

Prevalence, predictors and clinical impact of unique and multiple chronic total occlusion in non-infarct-related artery in patients presenting with ST-elevation myocardial infarction

Objectives To investigate the predictors and impact on long-term survival of one chronic total occlusion (CTO) or multiple CTOs in patients presenting with ST-elevation myocardial infarction (STEMI). Design Single-centre retrospective observational study. Setting University-based tertiary referral centre. Patients Between 2006 and 2011, a total of 2020 consecutive patients referred with STEMI were categorised into single vessel disease, multivessel disease (MVD) without CTO, with one CTO or with multiple CTOs. Intervention Primary percutaneous coronary intervention. Main outcome measure The primary end-point was the 1-year mortality. Results The prevalence of single vessel disease, MVD without CTO, with one CTO or with multiple CTOs was 70%, 22%, 7.2% and 0.8%, respectively. Independent clinical predictors for the presence of CTO were cardiogenic shock (OR 5.05; 95% CI 3.29 to 7.64), prior myocardial infarction (OR 2.06; 95% CI 1.35 to 3.09), age >65 years (OR 1.94; 95% CI 1.40 to 2.71) and history of angina (OR 1.94; 95% CI 1.29 to 2.87). Mortality was worse in patients with multiple CTOs (76.5%) compared with those with one CTO (28.1%) or without CTO (7.3%) (p<0.0001). After adjustment for left ventricular ejection fraction and renal function, MVD was an independent predictor for 1-year mortality (HR: 1.81; 95% CI 1.18 to 2.77, p=0.007), but CTO was not (HR: 1.07; 95% CI 0.66 to 1.73, p=0.78). Conclusions Simple clinical factors are associated with the presence of CTO in non-infarct-related artery in patients presenting with STEMI. In these patients, long-term survival was independently associated with MVD, left ventricular ejection fraction and renal function, but not with CTO per se.

Prediction and impact of failure of transradial approach for primary percutaneous coronary intervention

Objectives To determine predictors of failure of transradial approach (TRA) in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), and develop a novel score specific for this population. Methods Consecutive patients with STEMI undergoing primary PCI in a tertiary care high-volume radial centre were included. TRA-PCI failure was categorised as primary (primary transfemoral approach (TFA)) or crossover (from TRA to TFA). Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. Clinical outcomes up to 1 year were assessed. Results From January 2006 to January 2011, 2020 patients were studied. Primary TRA-PCI failure occurred in 111 (5%) patients and crossover to TFA in 44 (2.2%) patients. Independent predictors of TRA-PCI failure were: weight ≤65 kg (OR: 3.0; 95% CI 1.9 to 4.8, p<0.0001), physician with ≤5% TFA conversion (OR: 0.45; 95% CI 0.2 to 0.9, p=0.033), and physician with ≥10% conversion to TFA (OR: 2.2; 95% CI 1.2 to 3.7, p=0.005), intra-aortic balloon pump (OR: 2.0; 95% CI 0.9 to 4.3, p=0.066), cardiogenic shock (OR: 2.8; 95% CI 1.4 to 5.6, p=0.0035), endotracheal intubation (OR: 107; 95% CI 42 to 339, p<0.0001), creatinine >133 μmol/L (OR: 3.6; 95% CI 1.9 to 6.8, p<0.0001), age ≥75 (OR: 1.7; 95% CI 1.0 to 2.9, p=0.031), prior PCI (OR: 2.6; 95% CI 1.5 to 4.5, p=0.0009), hypertension (OR: 1.8; 95% CI 1.2 to 2.9, p=0.009). An integer risk score ranging from −1 to 12 was developed, and predicted TRA-PCI failure from 0% to 100% (c-statistic of 0.868; 95% CI 0.866 to 0.869). Mortality at 1 year remained significantly higher after TRA-PCI failure (adjusted OR 2.2; 95% CI 1.2 to 3.9, p=0.011). Conclusions In a high-volume radial centre, the incidence of TRA-PCI failure is low and can be accurately predicted using a 9-variables risk score. Since outcomes after TRA-PCI failure remained inferior, further effort to maximise the use of radial approach for primary PCI should be investigated.

Comparison of radiation exposure during transradial diagnostic coronary angiography with single- or multi-catheters approach.

To compare radiation exposure during transradial diagnostic coronary angiography (DCA) using standard single‐ or multi‐catheters with different shapes.