Transseptal puncture performed with the new needle-free ‘SafeSept’ guidewire: a multicentre experience

Chow, Anthony; Cobb, Vanessa; Sepahpour, Ali; McCready, James

doi:10.1007/s10840-019-00608-w

Cited by 12 publications

(8 citation statements)

References 14 publications

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“…Multicenter analysis has previously established the utility of the SafeSept® transseptal guidewire for TSP, and the present study found that the wire mitigated the risk of TSP‐related tamponade, independent of operator expertize [adjusted OR: 0.22 (0.08–0.62)] 18 . In our experience, the guidewire's narrow calibre and its propensity for crossing the thinnest part of the interatrial septum reduces the likelihood of inadvertent, traumatic pericardial or aortic puncture.…”

Section: Discussionsupporting

confidence: 56%

Transseptal puncture for left atrial ablation: Risk factors for cardiac tamponade and a proposed causative classification system

Maclean

Mahtani

Roelas

et al. 2022

Cardiovasc electrophysiol

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Aims Cardiac tamponade is a high morbidity complication of transseptal puncture (TSP). We examined the associations of TSP‐related cardiac tamponade (TRCT) for all patients undergoing left atrial ablation at our center from 2016 to 2020. Methods and Results Patient and procedural variables were extracted retrospectively. Cases of cardiac tamponade were scrutinized to adjudicate TSP culpability. Adjusted multivariate analysis examined predictors of TRCT. A total of 3239 consecutive TSPs were performed; cardiac tamponade occurred in 51 patients (incidence: 1.6%) and was adjudicated as TSP‐related in 35 (incidence: 1.1%; 68.6% of all tamponades). Patients of above‐median age [odds ratio (OR): 2.4 (1.19–4.2), p = .006] and those undergoing re‐do procedures [OR: 1.95 (1.29–3.43, p = .042] were at higher risk of TRCT. Of the operator‐dependent variables, choice of transseptal needle (Endrys vs. Brockenbrough, p > .1) or puncture sheath (Swartz vs. Mullins vs. Agilis vs. Vizigo vs. Cryosheath, all p > .1) did not predict TRCT. Adjusting for operator, equipment and demographics, failure to cross the septum first pass increased TRCT risk [OR: 4.42 (2.45–8.2), p = .001], whilst top quartile operator experience [OR: 0.4 (0.17–0.85), p = .002], transoesophageal echocardiogram [TOE prevalence: 26%, OR: 0.51 (0.11–0.94), p = .023], and use of the SafeSept transseptal guidewire [OR: 0.22 (0.08–0.62), p = .001] reduced TRCT risk. An increase in transseptal guidewire use over time (2016: 15.6%, 2020: 60.2%) correlated with an annual reduction in TRCT (R2 = 0.72, p < .001) and was associated with a relative risk reduction of 70%. Conclusions During left atrial ablation, the risk of TRCT was reduced by operator experience, TOE‐guidance, and use of a transseptal guidewire, and was increased by patient age, re‐do procedures, and failure to cross the septum first pass.

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Section: Discussionsupporting

confidence: 56%

Transseptal puncture for left atrial ablation: Risk factors for cardiac tamponade and a proposed causative classification system

Maclean

Mahtani

Roelas

et al. 2022

Cardiovasc electrophysiol

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“…Use of a transseptal guidewireMulticenter analysis has previously established the utility of the SafeSept ® transseptal guidewire for TSP, and the present study found that the wire mitigated the risk of TSP-related tamponade, independent of operator expertize [adjusted OR: 0.22 (0.08-0.62)] 18. In our experience, the guidewire's narrow calibre and its propensity for crossing the thinnest part of the interatrial septum reduces the likelihood of inadvertent, traumatic pericardial or aortic puncture.Furthermore, by positioning the transseptal guidewire within the left upper pulmonary vein before advancing the puncture needle and sheath across the septum, use of the wire also diminishes the risk of left atrial appendage perforation during TSP.…”

mentioning

confidence: 51%

Transseptal puncture for left atrial ablation: risk factors for cardiac tamponade and a proposed causative classification system

Roelas

Vyas

Maclean

et al. 2022

European Heart Journal

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Background Cardiac tamponade is a high morbidity complication of transseptal puncture (TSP). Purpose We examined the associations of TSP-related cardiac tamponade (TRCT) for all patients undergoing left atrial ablation at our centre from 2016–2020. Methods Patient and procedural variables were extracted retrospectively. Cases of cardiac tamponade were scrutinised to adjudicate TSP culpability. Adjusted multivariate analysis examined predictors of TRCT. Results 3,239 consecutive TSPs were performed; cardiac tamponade occurred in 51 patients (incidence: 1.6%) and was adjudicated as TSP-related in 35 (incidence: 1.1%; 68.6% of all tamponades). Patients of above-median age (OR 2.4 (1.19–4.2), p=0.006) and those undergoing re-do procedures (OR 1.95 (1.29–3.43, p=0.042) were at higher risk of TRCT. Of the operator-dependent variables, choice of transseptal needle (Endrys vs Brockenbrough, p>0.1) or puncture sheath (Swartz vs Mullins vs Agilis vs Vizigo vs Cryosheath, all p>0.1) did not predict TRCT. Adjusting for operator, equipment and demographics, failure to cross the septum first pass increased TRCT risk (OR 4.42 (2.45–8.2), p=0.001), whilst top quartile operator experience (OR 0.4 (0.17–0.85, p=0.002), transoesophageal echocardiogram (TOE prevalence: 26%, OR 0.51 (0.11–0.94), p=0.023), and use of the SafeSept guidewire (OR 0.22 (0.08–0.62), p=0.001) reduced TRCT risk. An increase in SafeSept wire use over time (2016: 15.6%, 2020: 60.2%) correlated with an annual reduction in TRCT (R2=0.72, p<0.001) and was associated with a relative risk reduction of 70%. Conclusions During left atrial ablation, the independent predictors of TRCT were patient age, re-do procedure, operator experience, unsuccessful first pass, TOE-guidance, and use of the SafeSept wire. A novel classification system for the causes of cardiac tamponade is proposed (table 1); this may be of interest to clinical trialists or auditors evaluating patient safety. Funding Acknowledgement Type of funding sources: None.

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“…A transseptal wire (Safesept, Pressure Products, San Pedro, CA, USA) is safe and effective in gaining LA access without a need for transseptal needle or exchange for a standard guidewire. 736 In a large, retrospective single-center analysis, it was shown to significantly reduce the risk of transseptal puncture-related cardiac tamponade. 737 A newer technology is an RF wire that can be used to cross the septum and provide support for the transseptal sheath (Versacross, Boston Scientific).…”

Section: Procedural Management and Techniquesmentioning

confidence: 99%

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation

Tzeis,

Gerstenfeld,

Kalman

et al. 2024

Europace

101

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In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

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Transseptal puncture performed with the new needle-free ‘SafeSept’ guidewire: a multicentre experience

Cited by 12 publications

References 14 publications

Transseptal puncture for left atrial ablation: Risk factors for cardiac tamponade and a proposed causative classification system

Transseptal puncture for left atrial ablation: Risk factors for cardiac tamponade and a proposed causative classification system

Transseptal puncture for left atrial ablation: risk factors for cardiac tamponade and a proposed causative classification system

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation

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