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Abstract：
To assess the safety and efficacy of the Wattson temporary pacing guidewire.
Transcatheter aortic valve replacement (TAVR) requires a guidewire for device delivery and generally requires temporary pacing wire for burst and back-up pacing. The Wattson wire provides concomitant support and bipolar pacing without the need to place a temporary venous pacemaker (TVP).
This was a single-center nonrandomized prospective clinical trial enrolling 20 patients. The primary endpoint was defined as successful rapid pacing and transcatheter heart valve (THV) delivery with no loss of capture. Safety, qualitative and quantitative secondary outcomes were also analyzed.
Mean age was 77.4 ± 9.0 years. Mean Society of Thoracic Surgery (STS) score was 3.0 ± 1.5%. All patients received a balloon-expandable valve via a transfemoral approach. All patients met the primary end-point. One patient (5%) had balloon predilatation and six patients (30%) had postdilatation, all using the wire. Mean pacing threshold was 2.2 ± 1.2 mA that was evaluated prior to placing an insulating catheter over the wire. One patient required TVP placement and subsequent permanent pacemaker implantation due to complete heart block post THV deployment. There were no incidences of cardiac perforation or tamponade. One patient required valve reintervention, which was not related to the device.
The Wattson wire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe THV delivery in this patient cohort. It has the potential to make TAVR a safer and more efficient procedure.
Transcatheter aortic valve replacement (TAVR) requires a guidewire for device delivery and generally requires temporary pacing wire for burst and back-up pacing. The Wattson wire provides concomitant support and bipolar pacing without the need to place a temporary venous pacemaker (TVP).
This was a single-center nonrandomized prospective clinical trial enrolling 20 patients. The primary endpoint was defined as successful rapid pacing and transcatheter heart valve (THV) delivery with no loss of capture. Safety, qualitative and quantitative secondary outcomes were also analyzed.
Mean age was 77.4 ± 9.0 years. Mean Society of Thoracic Surgery (STS) score was 3.0 ± 1.5%. All patients received a balloon-expandable valve via a transfemoral approach. All patients met the primary end-point. One patient (5%) had balloon predilatation and six patients (30%) had postdilatation, all using the wire. Mean pacing threshold was 2.2 ± 1.2 mA that was evaluated prior to placing an insulating catheter over the wire. One patient required TVP placement and subsequent permanent pacemaker implantation due to complete heart block post THV deployment. There were no incidences of cardiac perforation or tamponade. One patient required valve reintervention, which was not related to the device.
The Wattson wire offered predictable guidewire support with concomitant reliable bipolar pacing at low thresholds to allow safe THV delivery in this patient cohort. It has the potential to make TAVR a safer and more efficient procedure.
摘要：
评估Wattson临时起搏导丝的安全性和有效性。
经导管主动脉瓣置换术(TAVR)需要用于装置输送的引导线，通常需要用于突发和备用起搏的临时起搏线。Wattson导线提供伴随支持和双极起搏，而无需放置临时静脉起搏器（TVP）。
这是一项单中心非随机前瞻性临床试验，纳入20名患者。主要终点定义为成功的快速起搏和经导管心脏瓣膜（THV）输送，无夺获损失。安全,还分析了定性和定量次要结局.
平均年龄为77.4±9.0岁。胸外科学会（STS）平均评分为3.0±1.5％。所有患者均通过经股动脉入路接受球囊扩张瓣膜。所有患者均符合主要终点。1例（5%）有球囊扩张，6例（30%）有球囊扩张，所有使用电线。平均起搏阈值为2.2±1.2mA，在导线上放置绝缘导管之前进行评估。一名患者需要放置TVP并随后植入永久性起搏器，原因是THV部署后心脏完全阻滞。没有发生心脏穿孔或填塞。一名患者需要瓣膜再介入,这与设备无关。
Wattson导丝提供可预测的导丝支持，同时在低阈值下进行可靠的双极起搏，以便在该患者队列中安全输送THV。它有可能使TAVR成为更安全，更有效的程序。
经导管主动脉瓣置换术(TAVR)需要用于装置输送的引导线，通常需要用于突发和备用起搏的临时起搏线。Wattson导线提供伴随支持和双极起搏，而无需放置临时静脉起搏器（TVP）。
这是一项单中心非随机前瞻性临床试验，纳入20名患者。主要终点定义为成功的快速起搏和经导管心脏瓣膜（THV）输送，无夺获损失。安全,还分析了定性和定量次要结局.
平均年龄为77.4±9.0岁。胸外科学会（STS）平均评分为3.0±1.5％。所有患者均通过经股动脉入路接受球囊扩张瓣膜。所有患者均符合主要终点。1例（5%）有球囊扩张，6例（30%）有球囊扩张，所有使用电线。平均起搏阈值为2.2±1.2mA，在导线上放置绝缘导管之前进行评估。一名患者需要放置TVP并随后植入永久性起搏器，原因是THV部署后心脏完全阻滞。没有发生心脏穿孔或填塞。一名患者需要瓣膜再介入,这与设备无关。
Wattson导丝提供可预测的导丝支持，同时在低阈值下进行可靠的双极起搏，以便在该患者队列中安全输送THV。它有可能使TAVR成为更安全，更有效的程序。
