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  • PublicationRestreint
    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.
  • PublicationAccès libre
    Transcatheter aortic valve implantation in patients with small aortic annuli using a 20 mm balloon-expanding valve
    (BMJ, 2016-08-17) Bélanger-de Villers, Simon; Byrne, Jonathan; Rodés-Cabau, Josep; Muller, Ralf; Pelletier Beaumont, Émilie; Baumbach, Hardy; Pibarot, Philippe; Puri, Rishi; Eltchaninoff, Hélène; Cheema, Asim; Regueiro, Ander; Dubois, Christophe; Pelletier, Marc L.; Ihlberg, Leo; Wijeysundera, Harindra C.; Cerillo, Alfredo; Götberg, Matthias; Klaaborg, Kaj-Erik; Blanco-Mata, Roberto; Edwards, Richard; Gandolfo, Caterina; Muir, Douglas; Meucci, Francesco; Sinning, Jan-Malte; Stella, Pieter; Veulemans, Verena; Virtanen, Marko; Thoenes, Martin
    Background: While transcatheter aortic valve implantation (TAVI) is established for treating high-operative risk surgical aortic valve replacement candidates, until recently the smallest transcatheter heart valve (THV) measured 23 mm, posing greater risk for annular rupture and THV failure in patients with aortic stenosis (AS) with small aortic annuli (=20 mm). Objectives: In the setting of a multicentre registry, we report on the safety, efficacy and early clinical outcomes of the SAPIEN XT 20 mm balloon-expanding THV. Results: Among TAVI 55 recipients (n=30 for native AS, n=25 for a valve-in-valve procedure (V-in-V)), median age and Society of Thoracic Surgeons score were 85 (81 to 87) years and 7.8 (4.7 to 12.4)%, respectively. Mean and minimum annular diameters were 19±1 and 17±2 mm, respectively, in native patients with AS, and 17±1 mm (internal diameter) in V-in-V recipients. Successful device implantation rate was 96%, with no procedural-related death. Overall in-hospital-30-day death, stroke and major bleeding rates were 5%, 2% and 9%, respectively. In native AS TAVI recipients, mean transaortic gradient decreased from 54±20 to 12±5 mm Hg (p<0.001), and from 45±17 to 24±8 mm Hg (p<0.001) in V-in-V recipients. Severe prosthesis-patient mismatch (PPM) rates were 10% and 48% in native AS and V-in-V TAVI recipients, respectively (p=0.03). Post-TAVI, the rate of moderate aortic regurgitation was 7% and 0% in native AS and V-in-V TAVI recipients, respectively. Conclusions: TAVI with the 20 mm SAPIEN XT THV appears safe and technically feasible, with acceptable short-term clinical outcomes and low rates of severe PPM in those with native AS.