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Joseph J Vettukattil - One of the best experts on this subject based on the ideXlab platform.
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atrial septostomy with a predefined diameter using a novel occlutech atrial Flow Regulator improves symptoms and cardiac index in patients with severe pulmonary arterial hypertension
Catheterization and Cardiovascular Interventions, 2017Co-Authors: Ramasamy Rajeshkumar, Sreeja Pavithran, Kothandam Sivakumar, Joseph J VettukattilAbstract:Objectives A novel Occlutech atrial Flow Regulator (AFR) implantation gives an atrial septal predefined predictable fenestration. Background Atrial septostomy relieves syncope in pulmonary arterial hypertension (PAH) by improving left heart filling, cardiac output and systemic oxygen transport despite hypoxia. Symptoms recur when small fenestrations close spontaneously. Methods AFR was implanted after informed consent in patients with severe PAH presenting with syncope and right heart failure. Symptoms, hemodynamics, echocardiographic parameters, brain natriuretic peptide (BNP) levels and device patency were serially documented. Results Twelve patients aged 28.3 ± 8.5 years with severe PAH underwent AFR implantation. All procedures were successful without any major complications. All patients had relief of syncope and 6-min walk distance improved significantly from 377.3 ± 33.2 to 423 ± 31.32 m. The cardiac index (2.36 ± 0.52 to 2.89 ± 0.56 L/min/m2) and systemic oxygen transport (367.5 ± 75.5 to 428.0 ± 67.1 ml/min/m2) also showed a significant improvement. Inferior caval vein congestion and pericardial effusion reduced due to improvement in heart failure, but other echocardiographic parameters of right ventricular function did not show significant change. The reduction in BNP levels too did not reach statistical significance. The device was patent in all patients at a median follow-up of 189 days (range 10–296 days) resulting in a significant reduction of oxygen saturations from 98 ± 0.18 to 85.26 ± 2.86% after exercise. Conclusions AFR implantation was feasible and safe in all patients with PAH. There was a significant improvement of symptoms, six-minute walk distance, cardiac index and systemic oxygen transport. The device maintained patency in short-term follow-up and the resultant hypoxia was tolerated well.
Rajiv Chaturvedi - One of the best experts on this subject based on the ideXlab platform.
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transcatheter creation of a potts shunt with the occlutech atrial Flow Regulator feasibility in a pig model
International Journal of Cardiology, 2021Co-Authors: Sokleng Kang, Juan Contreras, Rajiv ChaturvediAbstract:Abstract Background Creation of a Potts shunt, a connection between the left pulmonary artery (LPA) and descending aorta (DAo), improves functional status and survival in drug-refractory suprasystemic pulmonary arterial hypertension. We investigated a new approach to transcatheter Potts shunt creation in pigs. Methods and results In six pigs, a steerable SureFlex sheath was used to optimize the trajectory of perforation from the DAo into LPA using a 0.035″ radiofrequency wire. The combination of a larger perforation, stiffer radiofrequency wire and smooth dilator-to-sheath transition allowed sheath entry into the LPA without requiring an arterio-venous wire circuit. The Occlutech Atrial Flow Regulator (AFR), a double-disc device with a central fenestration, was deployed through this sheath with apposition of the distal disc to the posterior LPA wall and the proximal disc to the anterior DAo wall. The AFR is compliant and crumpling of the central fenestration was resolved by balloon dilation. It was feasible to implant a stent within the fenestration (n = 3). Aortography confirmed a left-to-right shunt through the AFR without contrast extravasation. Autopsy demonstrated anchoring of both discs against the vessel walls, patency of the fenestration and secure placement of the stent with no intra-thoracic bleeding. Conclusions In an acute pig model, we have demonstrated the feasibility of creating a transcatheter Potts shunt with a simplified technique using a steerable sheath, a double-disc device with a central fenestration that acts as the shunt channel and optional stenting of the fenestration.
Ramasamy Rajeshkumar - One of the best experts on this subject based on the ideXlab platform.
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atrial septostomy with a predefined diameter using a novel occlutech atrial Flow Regulator improves symptoms and cardiac index in patients with severe pulmonary arterial hypertension
Catheterization and Cardiovascular Interventions, 2017Co-Authors: Ramasamy Rajeshkumar, Sreeja Pavithran, Kothandam Sivakumar, Joseph J VettukattilAbstract:Objectives A novel Occlutech atrial Flow Regulator (AFR) implantation gives an atrial septal predefined predictable fenestration. Background Atrial septostomy relieves syncope in pulmonary arterial hypertension (PAH) by improving left heart filling, cardiac output and systemic oxygen transport despite hypoxia. Symptoms recur when small fenestrations close spontaneously. Methods AFR was implanted after informed consent in patients with severe PAH presenting with syncope and right heart failure. Symptoms, hemodynamics, echocardiographic parameters, brain natriuretic peptide (BNP) levels and device patency were serially documented. Results Twelve patients aged 28.3 ± 8.5 years with severe PAH underwent AFR implantation. All procedures were successful without any major complications. All patients had relief of syncope and 6-min walk distance improved significantly from 377.3 ± 33.2 to 423 ± 31.32 m. The cardiac index (2.36 ± 0.52 to 2.89 ± 0.56 L/min/m2) and systemic oxygen transport (367.5 ± 75.5 to 428.0 ± 67.1 ml/min/m2) also showed a significant improvement. Inferior caval vein congestion and pericardial effusion reduced due to improvement in heart failure, but other echocardiographic parameters of right ventricular function did not show significant change. The reduction in BNP levels too did not reach statistical significance. The device was patent in all patients at a median follow-up of 189 days (range 10–296 days) resulting in a significant reduction of oxygen saturations from 98 ± 0.18 to 85.26 ± 2.86% after exercise. Conclusions AFR implantation was feasible and safe in all patients with PAH. There was a significant improvement of symptoms, six-minute walk distance, cardiac index and systemic oxygen transport. The device maintained patency in short-term follow-up and the resultant hypoxia was tolerated well.
Paitazoglou Christina - One of the best experts on this subject based on the ideXlab platform.
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The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction
'Europa Digital & Publishing', 2019Co-Authors: Paitazoglou Christina, Ozdemir Ramazan, Pfister Roman, Bergmann, Martin W., Bartunek Jozef, Kilic Teoman, Lauten Alexander, Schmeisser Alexander, Zoghi Mehdi, Anker StefanAbstract:Aims: Reducing elevated left atrial pressure with an atrial septum shunt device is a possible treatment option in symptomatic heart failure patients. This study aimed to investigate the safety and feasibility of the Atrial Flow Regulator (AFR) in heart failure patients. Methods and results: AFR-PRELIEVE is a prospective, non-randomised, open-label, multicentre study in patients with symptomatic heart failure NYHA Class III or IV and pulmonary capillary wedge pressure (PCWP) >= 15 mmHg at rest or >= 25 mmHg at exercise irrespective of left ventricular ejection fraction (EF >= 15%). Here we report on procedural and three-month follow-up data for a total of thirty-six enrolled patients. Sixteen (44.5%) patients with reduced EF (HFrEF: EF 15-39%) and twenty (55.5%) patients with preserved EF (HFpEF: EF >= 40%) were enrolled. Implantation success rate and device patency with left-right shunt was 100% (post procedure and at three months) in both patient groups, with one SADE in the HFpEF group which completely resolved. Three (3/36, 8.3%) patients were hospitalised for worsening of heart failure (two HFrEF patients, one HFpEF patient). Individual patients from both the HFrEF and HFpEF groups showed improvement in symptoms and surrogate parameters of heart failure (NYHA class, six-minute walking distance, Kansas City Cardiomyopathy Questionnaire, PCWP, NT-proBNP). Conclusions: Implantation of the AFR device in heart failure patients is feasible and safe; shunt patency at three months was confirmed in the study. The atrial shunt improved symptoms and surrogate parameters of heart failure in some but not all patients in both the HFpEF and HFrEF groups
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The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction
'Europa Digital & Publishing', 2019Co-Authors: Paitazoglou Christina, Ozdemir Ramazan, Pfister Roman, Bergmann, Martin W., Bartunek Jozef, Kilic Teoman, Mahfoud FelixAbstract:Zoghi, Mehdi/0000-0002-8156-2675;WOS: 000490322500006PubMed: 31130524Aims: Reducing elevated left atrial pressure with an atrial septum shunt device is a possible treatment option in symptomatic heart failure patients. This study aimed to investigate the safety and feasibility of the Atrial Flow Regulator (AFR) in heart failure patients. Methods and results: AFR-PRELIEVE is a prospective, non-randomised, open-label, multicentre study in patients with symptomatic heart failure NYHA Class III or IV and pulmonary capillary wedge pressure (PCWP) >= 15 mmHg at rest or >= 25 mmHg at exercise irrespective of left ventricular ejection fraction (EF >= 15%). Here we report on procedural and three-month follow-up data for a total of thirty-six enrolled patients. Sixteen (44.5%) patients with reduced EF (HFrEF: EF 15-39%) and twenty (55.5%) patients with preserved EF (HFpEF: EF >= 40%) were enrolled. Implantation success rate and device patency with left-right shunt was 100% (post procedure and at three months) in both patient groups, with one SADE in the HFpEF group which completely resolved. Three (3/36, 8.3%) patients were hospitalised for worsening of heart failure (two HFrEF patients, one HFpEF patient). Individual patients from both the HFrEF and HFpEF groups showed improvement in symptoms and surrogate parameters of heart failure (NYHA class, six-minute walking distance, Kansas City Cardiomyopathy Questionnaire, PCWP, NT-proBNP). Conclusions: Implantation of the AFR device in heart failure patients is feasible and safe; shunt patency at three months was confirmed in the study. the atrial shunt improved symptoms and surrogate parameters of heart failure in some but not all patients in both the HFpEF and HFrEF groups.Occlutech S.A.The study was funded by Occlutech S.A
Sokleng Kang - One of the best experts on this subject based on the ideXlab platform.
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transcatheter creation of a potts shunt with the occlutech atrial Flow Regulator feasibility in a pig model
International Journal of Cardiology, 2021Co-Authors: Sokleng Kang, Juan Contreras, Rajiv ChaturvediAbstract:Abstract Background Creation of a Potts shunt, a connection between the left pulmonary artery (LPA) and descending aorta (DAo), improves functional status and survival in drug-refractory suprasystemic pulmonary arterial hypertension. We investigated a new approach to transcatheter Potts shunt creation in pigs. Methods and results In six pigs, a steerable SureFlex sheath was used to optimize the trajectory of perforation from the DAo into LPA using a 0.035″ radiofrequency wire. The combination of a larger perforation, stiffer radiofrequency wire and smooth dilator-to-sheath transition allowed sheath entry into the LPA without requiring an arterio-venous wire circuit. The Occlutech Atrial Flow Regulator (AFR), a double-disc device with a central fenestration, was deployed through this sheath with apposition of the distal disc to the posterior LPA wall and the proximal disc to the anterior DAo wall. The AFR is compliant and crumpling of the central fenestration was resolved by balloon dilation. It was feasible to implant a stent within the fenestration (n = 3). Aortography confirmed a left-to-right shunt through the AFR without contrast extravasation. Autopsy demonstrated anchoring of both discs against the vessel walls, patency of the fenestration and secure placement of the stent with no intra-thoracic bleeding. Conclusions In an acute pig model, we have demonstrated the feasibility of creating a transcatheter Potts shunt with a simplified technique using a steerable sheath, a double-disc device with a central fenestration that acts as the shunt channel and optional stenting of the fenestration.