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Campelo-Parada, Francisco

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  • Publication
    Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction : a safety and proof-of-principle cohort study
    (Elsevier, 2016-03-26) Campelo-Parada, Francisco; Abdul-Jawad Altisent, Omar; Rodés-Cabau, Josep; Bergeron, Sébastien; Amat Santos, Ignacio J.; Del Trigo, Maria; Bernier, Mathieu; Pibarot, Philippe; Eigler, Neal; Puri, Rishi; Rozenfeld, Erez; Regueiro, Ander; Abraham, William T.
    Background: In patients with heart failure, interventions to reduce elevated left atrial pressure improve symptoms and reduce the risk of hospital admission. We aimed to assess the safety and potential efficacy of therapeutic left-to-right interatrial shunting in patients with heart failure with reduced ejection fraction. Methods: We did this proof-of-principle cohort study at one centre in Canada. Patients (aged =18 years) with New York Heart Association (NYHA) class III chronic heart failure with reduced ejection fraction were enrolled under the Canadian special access programme. Shunt implants were done after transseptal catheterisation with transoesophageal echocardiographic guidance under general anaesthesia. Patients had clinical and echocardiography evaluations at baseline and months 1 and 3 after shunt implantation. Findings: Between Oct 10, 2013, and March 27, 2015, we enrolled ten patients. The device was successfully implanted in all patients; no device-related or procedural adverse events occurred during follow-up. Transoesophageal echocardiography at 1 month showed that all shunts were patent, with no thrombosis or migration. From baseline to 3 month follow-up, we recorded improvements in NYHA classification (from class III to class II in seven [78%] of nine patients, from class III to class I in one [11%] patient, and no change in one [11%] patient; p=0·0004); quality of life, as assessed by the Duke Activity Status Index (from a mean score of 13 [SD 6·2] to 24·8 [12·9]; p=0·016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 44·3 [SD 9·8] to 79·1 [13·0]; p=0·0001); and 6 min walk test distance (from a mean of 244 m [SD 112] to 318 m [134]; p=0·016). Pulmonary capillary wedge pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) at 3 months (p=0·035), with no changes in right atrial pressure, pulmonary arterial pressure, or pulmonary resistance. No patient was admitted to hospital for worsening heart failure. One (10%) patient was admitted to hospital with gastrointestinal bleeding at month 1; one (10%) patient died after incessant ventricular tachycardia storm, which led to terminal heart failure 2 months post-procedure. Interpretation: This first-in-man experience with an implanted left-to-right interatrial shunt demonstrates initial safety and early beneficial clinical and haemodynamic outcomes in patients with heart failure with reduced ejection fraction. Further large-scale randomised studies are warranted.
  • Publication
    Incidence, timing, and predictors of valve hemodynamic deterioration after transcatheter aortic valve replacement : multicenter registry
    (Elsevier Biomedical, 2016-02-16) Campelo-Parada, Francisco; Muñoz, Antonio; Dahou, Abdellaziz; Wijeysundera, Harindra C.; Dumont, Éric; Abdul-Jawad Altisent, Omar; Cheema, Asim; Nombela-Franco, Luis; Gutierrez, Enrique; Rodés-Cabau, Josep; Serra, Vicenç; Paradis, Jean-Michel; Kefer, Joelle; Amat Santos, Ignacio J.; Del Trigo, Maria; Benitez, Luis M.; Pibarot, Philippe; Mewa, Jumana; Puri, Rishi; Jiménez-Quevedo, Pilar; Alnasser, Sami; Garcia del Blanco, Bruno; Dager, Antonio
    Background: Scarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR).Objectives: This study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR.Methods: This multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a =10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment.Results: The overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD.Conclusions: There was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD.
  • Publication
    Self-expanding Portico valve versus balloon-expandable SAPIEN XT valve in patients with small aortic annuli : comparison of hemodynamic performance.
    (Spanish Society of Cardiology, 2016-05-01) Campelo-Parada, Francisco; Dahou, Abdellaziz; Webb, John G. (John Graydon); Dumont, Éric; Dvir, Danny; Abdul-Jawad Altisent, Omar; Côté, Mélanie; Rodés-Cabau, Josep; DeLarochellière, Robert; Thompson, Chris; Mohammadi, Siamak; Leipsic, Jonathon; Paradis, Jean-Michel; Stub, Dion; Pasian, Sergio; Doyle, Daniel; Del Trigo, Maria; Pibarot, Philippe; Puri, Rishi
    Introduction and objectives: The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis. Methods: Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6±1.3mm by transthoracic echocardiography and 21.4±1.2mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory. Results: There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4±3.7mmHg; Portico: 9.8±1.1mmHg; P=.49) and effective orifice areas (SAPIEN XT: 1.36±0.27cm(2); Portico, 1.37±.29cm(2); P=.54). Rates of severe prosthesis-patient mismatch (effective orifice area<0.65cm(2)/m(2)) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P=.56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively; P=.90). Conclusions: Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required.
  • Publication
    Predictors and impact of myocardial injury after transcatheter aortic valve replacement : a multicenter registry.
    (Elsevier Biomedical, 2015-11-10) Campelo-Parada, Francisco; Dumont, Éric; Muñoz, Antonio; Abdul-Jawad Altisent, Omar; Lemos, Pedro A.; Côté, Mélanie; Nombela-Franco, Luis; Serra, Vicenç; Rodés-Cabau, Josep; Brito, Fabio Sandoli de; Amat Santos, Ignacio J.; Abizaid, Alexandre; Del Trigo, Maria; Sarmento-Leite, Rogério; Urena Alcazar, Marina; Pibarot, Philippe; Cheema, Asim; Puri, Rishi; Ruel, Marc; Barbosa Ribeiro, Henrique; Nietlispach, Fabian; Maisano, Francesco; Moris, Cesar; Valle, Raquel del; Jiménez-Quevedo, Pilar; Alonso-Briales, Juan H.; Gutiérrez, Hipólito; García del Blanco, Bruno; Perin, Marco Antonio; Siqueira, Dimytri; Bernardi, Guilherme
    BACKGROUND : Cardiac biomarker release signifying myocardial injury post-transcatheter aortic valve replacement (TAVR) is common, yet its clinical impact within a large TAVR cohort receiving differing types of valve and procedural approaches is unknown. OBJECTIVES : This study sought to determine the incidence, clinical impact, and factors associated with cardiac biomarker elevation post TAVR. METHODS : This multicenter study included 1,131 consecutive patients undergoing TAVR with balloon-expandable (58%) or self-expandable (42%) valves. Transfemoral and transapical (TA) approaches were selected in 73.1% and 20.3% of patients, respectively. Creatine kinase-myocardial band (CK-MB) measurements were obtained at baseline and at several time points within the initial 72 h post TAVR. Echocardiography was performed at baseline and at 6- to 12-month follow-up. RESULTS : Overall, 66% of the TAVR population demonstrated some degree of myocardial injury as determined by a rise in CK-MB levels (peak value: 1.6-fold [interquartile range (IQR): 0.9 to 2.8-fold]). A TA approach and major procedural complications were independently associated with higher peak of CK-MB levels (p < 0.01 for all), which translated into impaired systolic left ventricular function at 6 to 12 months post TAVR (p < 0.01). A greater rise in CK-MB levels independently associated with an increased 30-day, late (median of 21 [IQR: 8 to 36] months) overall and cardiovascular mortality (p < 0.001 for all). Any increase in CK-MB levels was associated with poorer clinical outcomes, and there was a stepwise rise in late mortality according to the various degrees of CK-MB increase after TAVR (p < 0.001). CONCLUSIONS : Some degree of myocardial injury was detected in two-thirds of patients post TAVR, especially in those undergoing TA-TAVR or presenting with major procedural complications. A greater rise in CK-MB levels associated with greater acute and late mortality, imparting a negative impact on left ventricular function.
  • Publication
    Left atrial decompression using unidirectional left-to-right interatrial shunt : initial experience in treating symptomatic heart failure with preserved ejection fraction with the W-Wave device
    (American College of Cardiology, 2015-05-01) Campelo-Parada, Francisco; Abdul-Jawad Altisent, Omar; Rodés-Cabau, Josep; Bergeron, Sébastien; Amat Santos, Ignacio J.; Del Trigo, Maria; Bernier, Mathieu; Verheye, Stefan; Pibarot, Philippe; Keren, Gad; Puri, Rishi; Katzenellenbogen, Rotem; Rozenfeld, Erez; Abraham, William T.
  • Publication
    Myocardial injury after transaortic versus transapical transcatheter aortic valve replacement
    (Little, Brown & Co.,, 2015-06-01) Campelo-Parada, Francisco; Dahou, Abdellaziz; Carrasco, José Luis; Dumont, Éric; Abdul-Jawad Altisent, Omar; Rodés-Cabau, Josep; Le Ven, Florent; DeLarochellière, Robert; Mohammadi, Siamak; Paradis, Jean-Michel; Amat Santos, Ignacio J.; Doyle, Daniel; Del Trigo, Maria; Urena Alcazar, Marina; Pibarot, Philippe; Allende, Ricardo; Puri, Rishi; Barbosa Ribeiro, Henrique
    Background : The release of cardiac biomarkers of myocardial injury after transcatheter aortic valve replacement (TAVR) is common, but no data exist on patients undergoing TAVR through a transaortic approach. We aimed to evaluate the incidence and prognostic significance of the increase in cardiac biomarkers in nontransfemoral TAVR candidates, comparing transaortic and transapical approaches. Methods : After excluding patients deemed suitable for transfemoral TAVR, 251 consecutive patients (transaortic, 45; transapical, 206) were prospectively evaluated. Creatine kinase–myocardial band and cardiac troponin T levels were measured at baseline and at 6, 12, 24, 48, and 72 hours after TAVR. Baseline and 6- to 12-month echocardiographic and clinical follow-up were performed. Results : After TAVR, cardiac troponin T increased above the upper normal values in all patients (peak value 0.64 µg/L [IQR, 0.39 to 1.03 µg/L]), whereas creatine kinase–myocardial band levels increased in 88% of patients (transaortic 51%, transapical 96%, p < 0.001; peak value 20.1 µg/L [interquartile range, 14.3 to 31.6 µg/L]). Compared with the transaortic approach, the transapical approach was associated with a greater rise in both cardiac biomarkers (p < 0.001 for both), and a lesser improvement in left ventricular ejection fraction (p = 0.058) and global longitudinal strain (p = 0.039) at 6- to 12-month follow-up. Greater increases of cardiac troponin T levels were independently associated with 30-day and 1-year overall and cardiovascular mortality (p < 0.001 for all). A 15-fold rise in cardiac troponin T levels was the optimal threshold for determining poorer outcomes (p < 0.001). Conclusions : Periprocedural TAVR-related myocardial injury in nontransfemoral candidates was demonstrated in all patients, but the transapical approach was associated with significantly greater myocardial injury compared with the transaortic approach. A higher degree of myocardial injury translated into reduced left ventricular function improvement and lower early and midterm survival rates.
  • Publication
    Incidence and risk factors of hemolysis after transcatheter aortic valve implantation with a balloon-expandable valve
    (Elsevier, 2015-06-01) Campelo-Parada, Francisco; Laroche, Vincent; DeLarochellière, Hugo; Laflamme, Louis; Dumont, Éric; Abdul-Jawad Altisent, Omar; Côté, Mélanie; Rodés-Cabau, Josep; DeLarochellière, Robert; Mohammadi, Siamak; Paradis, Jean-Michel; Laflamme, Jérôme; Doyle, Daniel; Del Trigo, Maria; Urena Alcazar, Marina; Pibarot, Philippe; Puri, Rishi
    There are currently no data evaluating the hematologic and biocompatibility profile of transcatheter aortic valves in vivo. We evaluated the incidence, predictive factors, and clinical consequences associated with hemolysis post-transcatheter aortic valve implantation (TAVI). A total of 122 patients who underwent TAVI with a balloon-expandable valve were included. Baseline blood sampling and echocardiography, followed by early post-TAVI echocardiography and repeat blood sampling, at 6 to 12 months post-TAVI were performed. Hemolysis post-TAVI was defined according to the established criteria. The incidence of hemolysis post-TAVI was 14.8% yet no patient experienced severe hemolytic anemia requiring transfusion. Compared with the nonhemolysis group, those with hemolysis demonstrated significant reductions in hemoglobin (p = 0.012), were more frequently women (67% vs 34%, p = 0.016), and had a higher incidence of post-TAVI severe prosthesis-patient mismatch (PPM) (44% vs 17%, p = 0.026). The rate of mild or more prosthetic valve regurgitation did not significantly differ between those patients with and without hemolysis (56% vs 37%, p = 0.44). Wall shear rate (WSR) and energy loss index (ELI), both indirect measures of shear stress, were higher (p = 0.039) and lower (p = 0.004), respectively, in those patients with hemolysis. Increasing PPM severity was also associated with significant stepwise WSR increments and ELI decrements (p <0.01 for both). In conclusion, subclinical hemolysis occurred in 15% of patients following TAVI. Although prosthetic valve regurgitation had no impact on hemolysis, a novel association between PPM and hemolysis was found, likely driven by higher shear stress as determined by WSR and ELI. These hematologic and biomechanical findings may have long-term clinical implications and could affect future transcatheter aortic valve design.
  • Publication
    Cardiovascular magnetic resonance to evaluate aortic regurgitation after transcatheter aortic valve replacement
    (Elsevier, 2016-08-09) Campelo-Parada, Francisco; Orwat, Stefan; Dahou, Abdellaziz; Hayek, Salim; Abdul-Jawad Altisent, Omar; Larose, Éric; Babaliaros, Vasilis; Rodés-Cabau, Josep; Le Ven, Florent; Ribeiro, Henrique Barbosa; Pasian, Sergio; Pibarot, Philippe; Clavel, Marie-Annick; Puri, Rishi; Lerakis, Stamatios A.; Baumgartner, Helmut
    Background: Residual aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR) is associated with greater mortality; yet, determining AR severity post-TAVR using Doppler echocardiography remains challenging. Cardiovascular magnetic resonance (CMR) is purported as a more accurate means of quantifying AR; however, no data exist regarding the prognostic value of AR as assessed by CMR post-TAVR. Objectives: This study sought to evaluate the effect of AR assessed with CMR on clinical outcomes post-TAVR. Methods We included 135 patients from 3 centers. AR was quantified using regurgitant fraction (RF) measured by phase-contrast velocity mapping CMR at a median of 40 days post-TAVR, and using Doppler echocardiography at a median of 6 days post-TAVR. Median follow-up was 26 months. Clinical outcomes included mortality and rehospitalization for heart failure. Results: Moderate-severe AR occurred in 17.1% and 12.8% of patients as measured by echocardiography and CMR, respectively. Higher RF post-TAVR was associated with increased mortality (hazard ratio: 1.18 for each 5% increase in RF [95% confidence interval: 1.08 to 1.30]; p < 0.001) and the combined endpoint of mortality and rehospitalization for heart failure (hazard ratio: 1.19 for each 5% increase in RF; 95% confidence interval: 1.15 to 1.23; p < 0.001). Prediction models yielded significant incremental predictive value; CMR performed a median of 40 days post-TAVR had a greater association with post-TAVR clinical events compared with early echocardiography (p < 0.01). RF =30% best predicted poorer clinical outcomes (p < 0.001 for either mortality or the combined endpoint of mortality and heart failure rehospitalization). Conclusions: Worse CMR-quantified AR was associated with increased mortality and poorer clinical outcomes following TAVR. Quantifying AR with CMR may identify patients with AR who could benefit from additional treatment measures.