The Benefits Conferred by Radial Access for Cardiac Catheterization Are Offset by a Paradoxical Increase in the Rate of Vascular Access Site Complications With Femoral Access: The Campeau Radial Paradox.

OBJECTIVES: The purpose of this study was to assess whether the benefits conferred by radial access (RA) at an individual level are offset by a proportionally greater incidence of vascular access site complications (VASC) at a population level when femoral access (FA) is performed. BACKGROUND: The recent widespread adoption of RA for cardiac catheterization has been associated with increased rates of VASCs when FA is attempted. METHODS: Logistic regression was used to calculate the adjusted VASC rate in a contemporary cohort of consecutive patients (2006 to 2008) where both RA and FA were used, and compared it with the adjusted VASC rate observed in a historical control cohort (1996 to 1998) where only FA was used. We calculated the adjusted attributable risk to estimate the proportion of VASC attributable to the introduction of RA in FA patients of the contemporary cohort. RESULTS: A total of 17,059 patients were included. At a population level, the VASC rate was higher in the overall contemporary cohort compared with the historical cohort (adjusted rates: 2.91% vs. 1.98%; odds ratio [OR]: 1.48, 95% confidence interval [CI]: 1.17 to 1.89; p = 0.001). In the contemporary cohort, RA patients experienced fewer VASC than FA patients (adjusted rates: 1.44% vs. 4.19%; OR: 0.33, 95% CI: 0.23 to 0.48; p < 0.001). We observed a higher VASC rate in FA patients in the contemporary cohort compared with the historical cohort (adjusted rates: 4.19% vs. 1.98%; OR: 2.16, 95% CI: 1.67 to 2.81; p < 0.001). This finding was consistent for both diagnostic and therapeutic catheterizations separately. The proportion of VASCs attributable to RA in the contemporary FA patients was estimated at 52.7%. CONCLUSIONS: In a contemporary population where both RA and FA were used, the safety benefit associated with RA is offset by a paradoxical increase in VASCs among FA patients. The existence of this radial paradox should be taken into consideration, especially among trainees and default radial operators.

Percutaneous paravalvular leak reduction: procedural and long-term clinical outcomes.

BACKGROUND: Significant paravalvular leak (PVL) after prosthetic replacement can result in hemolysis and/or congestive heart failure (CHF). Percutaneous PVL reduction (PPVR) represents an alternative to repeat surgery for a selected population. The purpose of this study was to assess the procedural and long-term clinical efficacy of percutaneous PPVR and its effect on survival free of rehospitalization for CHF, surgical reintervention, and death. METHODS: We analyzed a cohort of 56 consecutive patients who underwent 61 PPVRs in our institution between June 2001 and December 2010. Procedural success was defined as a reduction in regurgitation severity free from procedural complications. Patients were followed-up for vital status, clinical events, and symptoms. RESULTS: Patients were aged 65 ± 11 years, with an average logistic EuroSCORE of 19 ± 14%. Indications for PPVR included CHF (61%), hemolysis (9%), or both (30%), caused by mitral (n = 44) or aortic (n = 12) PVL. Procedural success was achieved in 75% of cases. Three major complications, including 2 deaths, occurred during the initial 30-day follow-up in the 42 patients who were treated with a device. After adjusting for the logistic EuroSCORE, prosthesis type (mitral vs aortic), and time interval since the last valve surgery, a successful PPVR was associated with a better survival free of rehospitalisation for CHF, need for surgical reintervention, and death compared with patients with a failed PPVR. (hazard ratio = 0.34; 95% confidence interval, 0.17-0.71). CONCLUSIONS: PPVR is associated with a reasonable rate of procedural success and favourable cardiovascular outcomes, and represents an appropriate option when technically possible.

Description and assessment of a common reference method for fluoroscopic and transesophageal echocardiographic localization and guidance of mitral periprosthetic transcatheter leak reduction.

OBJECTIVES: This study sought to describe and compare a novel fluoroscopic method and a 2-dimensional transesophageal echocardiographic (TEE) method to localize mitral periprosthetic leaks (PPLs) for transcatheter reduction. BACKGROUND: Transcatheter reduction of significant regurgitation represents a modern and attractive alternative to surgery for the treatment of mitral PPL in high-risk patients. Accurate localization and precise communication between the echocardiographer and the interventional cardiologist are essential for procedural success. METHODS: We analyzed TEE and fluoroscopic studies of patients with mitral PPL who underwent multiplane 2-dimensional TEE-guided transcatheter reduction in our institution. Periprosthetic leaks were routinely localized using the "surgeon's-view" time-clock method during periprocedural TEE assessments. The 2-dimensional TEE examinations were later retrospectively reviewed by an echocardiographer blinded to procedural TEE findings. A corresponding surgeon's-view time-clock method was plotted for fluoroscopic PPL localization. Using this fluoroscopic method, offline fluoroscopic images were reviewed by an independent interventional cardiologist blinded to TEE results. Agreement between methods was evaluated. RESULTS: Complete imaging data were available for analysis in 20 patients who, between 2002 and 2009, underwent transcatheter reduction in which the defect was successfully crossed. There was excellent agreement between procedural TEE and retrospective TEE review for PPL localization (100%; p < 0.0001) and between fluoroscopic and procedural TEE localization (90%; 95% confidence interval [CI]: 77% to 100%; p = 0.0003). In the 2 cases where there was disagreement, fluoroscopic PPL localization was adjacent to TEE localization. CONCLUSIONS: The surgeon's-view time-clock method of localizing PPL using 2-dimensional TEE is highly reproducible and allows fluoroscopic localization using the same reference system with very good agreement.

Effect on bleeding, time to revascularization, and one-year clinical outcomes of the radial approach during primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

The radial approach during percutaneous coronary intervention (PCI) has been reported to reduce the incidence of bleeding complications. However, the radial approach still accounts for <10% of procedures worldwide and only 1% in the United States. Our objective was to compare the effect of radial versus femoral vascular access on the time to reperfusion, incidence of bleeding complications, and overall clinical outcomes in the setting of primary PCI. We prospectively collected data on all patients undergoing primary PCI at the Montreal Heart Institute from April 1, 2007 to March 30, 2008. The time to revascularization and major bleeding were prespecified as a co-primary end point, and major adverse cardiac events, including death, myocardial infarction, and target vessel revascularization within 12 months, were considered a secondary end point. A total of 489 patients were included in the present longitudinal cohort study, 234 in the femoral group and 254 in the radial group. In the propensity-adjusted model, the use of the femoral approach was a strong independent predictor of bleeding (odds ratio 4.22, 95% confidence interval 3.17 to 10.60). No significant difference between the radial and femoral groups was observed relative to the time to revascularization (21.4 +/- 11.8 minutes vs 22.8 +/- 10.3 minutes, respectively; p = 0.68). Moreover, the radial approach was associated with a decreased risk of major adverse cardiac events (odds ratio 0.31, 95% confidence interval 0.10 to 0.94). In conclusion, primary PCI using the radial approach was associated with a fourfold reduction in major bleeding, without compromising the time to revascularization. Moreover, the radial approach was associated with a significant reduction in major adverse cardiac events at 12 months.

Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant.

OBJECTIVE: This study evaluated human feasibility and acute efficacy of a novel percutaneous transvenous mitral annuloplasty (PTMA) device (Viacor) placed temporarily in the coronary sinus (CS): the implant allows in-situ incremental adjustment to optimally reduce the anterior-posterior mitral annulus (MA) dimension, and improve leaflet co-aptation and reducing mitral regurgitation (MR). BACKGROUND: Surgical annuloplasty remains the standard treatment of severe ischemic MR but its application is limited by high morbidity and mortality. The effectiveness of PTMA device (Viacor) to reduce MR in the short-term has been demonstrated in animals studies but not in humans. METHODS: Symptomatic patients with ischemic MR graded 2+ to 4+ requiring surgical mitral annuloplasty were screened. Patients with any mitral leaflet or mitral apparatus abnormality were excluded. Preoperatively, under general anesthesia and transesophageal echocardiography guidance, a temporary PTMA device was placed via the right internal jugular or subclavian vein. RESULTS: Four patients were studied. After device placement and adjustment, regurgitant volume was substantially reduced (45.5 +/- 24.4 to 13.3 +/- 7.3 ml) via MA anterior-posterior diameter reduction (40.75 +/- 4.3 to 35.2 +/- 1.6 mm) in 3 patients. In one patient, the PTMA device could not be deployed due to extreme angulated anatomy. CONCLUSIONS: PTMA in human is feasible and reduces ischemic MR (to grade 1+) by reducing MA anterior-posterior diameter. Temporary placement of the PTMA device may assist in the development of permanent implants and ensure optimal efficacy.

Reduced pulmonary clearance of endothelin in congestive heart failure: a marker of secondary pulmonary hypertension.

BACKGROUND: Endothelin-1 (ET-1) levels are elevated in congestive heart failure (CHF) in relation with the severity of pulmonary hypertension. We evaluated whether a reduced pulmonary ET-1 clearance could contribute to this elevation. METHODS AND RESULTS: We determined pulmonary ET-1 clearance in 24 patients with CHF in relation with hemodynamics, plasma ET-1, and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. Pulmonary ET-1 extraction, measured by the single bolus indicator-dilution technique, was reduced to 32 +/- 14% in comparison to historic controls (47 +/- 7%). Plasma ET-1 clearance by the lungs (924 +/- 588 mL/min) was also much lower than in controls (1424 +/- 79 mL/min). Clearance correlated inversely with mean pulmonary artery pressure (PAP, r = -.47, P = .017) and pulmonary capillary wedge pressure (r = -.47, P = .017) and positively with the rate of left ventricular (LV) relaxation LV -dP/dt (r = .593, P = .004). After multivariate analysis, only mean PAP and LV -dP/dt were independently correlated with ET-1 clearance (r = -.40, P = .03, and r = .55, P = .005, respectively). Plasma ET-1 levels did not correlate with clearance (r = .038, P = .86), and there was no significant arteriovenous ET-1 gradient. There was a mild nonsignificant correlation between plasma ET-1 and pulmonary artery systolic pressure (r = .38, P = .06), but a strong correlation with right atrial pressure (r = .696, P < .0001) and NT-proBNP levels (r = .51, P = .001), which were maintained after multivariate linear regression (r = .60, P = .001, and r = .32, P = .04, respectively). CONCLUSION: Pulmonary ET-1 clearance is reduced in CHF in relation with the severity of pulmonary hypertension. This reduced clearance does not significantly modulate plasma ET-1 levels. Whether this is only a marker of secondary pulmonary hypertension or could modulate pulmonary vascular tone will require further studies.

Identification of atrial tissue in pulmonary veins using intravascular ultrasound.

BACKGROUND: Atrial fibrillation (AF) is initiated by ectopic beats originating in the sleeve of atrial tissue in pulmonary veins (PVs). Circumferential ablation of PVs can, thus, result in a cure of AF. Identification of this PV arrhythmogenic tissue has been exclusively on the basis of electrophysiologic recordings. The purpose of this study was to visualize this tissue using intravascular ultrasound (IVUS). Methods and results In all, 15 patients undergoing AF ablation had IVUS studies of their PVs. A total of 21 veins had a wall thickness less than 0.1 mm, whereas 31 veins had well-demarcated areas of thickening measuring 0.81 +/- 0.32 mm. Electrophysiologic recordings from these thickened areas showed typical high-frequency potentials associated with arrhythmogenic atrial tissue in the PVs. Ectopic beats initiating AF always originated from these areas. PVs without thickening on IVUS did not have these potentials. CONCLUSIONS: IVUS permits visualization of atrial tissue in the PVs, and arrhythmogenic PVs are qualitatively and quantitatively different from nonarrhythmogenic PVs.