The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Presence of Major vascular complications
研究概览
简要总结
TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation. Optimizing transcatheter valve performance by intra-procedural hemodynamic evaluation of AR and residual transvalvular gradient remains of high clinical importance.
详细描述
Continuous technological development and procedural refinements are important to further reduce TAVR peri-procedural complications, facilitate the minimalist strategy and improve clinical outcomes following TAVR. Residual aortic regurgitation (AR) has been one of the main drawbacks of TAVR. TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation.
Various actions could be undertaken to minimize AR and its consequences, either intraprocedural (balloon post-dilation, implantation of a second valve) or during follow-up (diuretic treatment, closest clinical follow-up or percutaneous leakage closure). Thus, an accurate diagnosis of the presence and severity of residual AR post-TAVR is key to implement the proper measures and optimize clinical outcomes.
The use of cardiac imaging remains the gold standard for evaluating AR post-TAVR, limitations of contrast amount along with the subjectivity of AR evaluation by aortic angiography, and the challenges of echocardiography at the time of the TAVR procedure represent a significant drawback. Thus, alternative tools for evaluating the presence and severity of AR would be very helpful in this setting.
Current data supports the implementation of hemodynamic measurements during TAVR procedures in order to improve the clinical decision-making process following valve implantation. However, these actions entail an inherent risk associated with the exchange of catheter-wires. The use of a support guidewire with pressure measurement capabilities would facilitate the hemodynamic evaluation of transcatheter valve performance in a safer and more rapid manner.
The new SAVVY guidewire, with both dedicated pacing properties and allowing a continuous hemodynamic pressure monitoring during the procedure, is a unique system in the field and may represent an important step forward in the process of optimizing the TAVR procedure while facilitating procedural steps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe symptomatic AS undergoing a TAVR procedure.
排除标准
- •Failure to provide signed informed consent.
- •Extremely calcified aortic valve (Agatston score >3000 AU)
- •Extremely horizontal aorta.
- •Severe septal hypertrophy (interventricular septum >15 mm as measured by TTE).
- •Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta.
- •Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life threatening complication.
- •Young patients (<18 Years) and pregnant women
结局指标
主要结局
Presence of Major vascular complications
时间窗: Periprocedural
Major vascular complications related to the SAVVY guidewire are defined as stroke, bleeding or left ventricular perforation
Number of transcatheter valve malpositioning
时间窗: Periprocedural
Pacing capture failure translating into valve malpositioning. Valve malpositiong will be evaluated by a landing site to low or too high, leading to hemodynamically unfavorable results.
Presence of Major complications
时间窗: Periprocedural
Presence of major complications related to the SAVVY guidewire including (i) guidewire kink hindering or preventing the advancement of the transcatheter valve system
Number of valve embolization
时间窗: Periprocedural
Pacing capture failure translating into valve embolization
Number of effective rapid pacing run
时间窗: Periprocedural
Effective rapid pacing will be defined as an adequate ventricular pacing capture for a minimum of 10 seconds, with no capture loss, and leading to a reduction of aortic pressure of at least 50%, with/or a systolic pressure value \<60 mmHg. Efficacy will be assessed by the physician.
Number of accurate ventricular pressure
时间窗: Periprocedural
Accurate ventricular pressure will be defines as a pressure wire measurements similar (differences \<5 mmHg) to those obtained simultaneously with a pigtail catheter in the same cavity or vascular segment (differences \<5 mmHg in SBP, differences \<5 mmHg in LVEDP).
次要结局
未报告次要终点
研究者
Josep Rodes-Cabau
Principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
