No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Transcatheter creation of atrial septal perforation using a radiofrequency Transseptal system: Novel approach as an alternative to Transseptal needle puncture
Abstract
Indications for the transseptal approach to the left side of the heart have recently broadened, as it provides a therapeutic access for both left-sided catheter ablation and also percutaneous transvenous valvular intervention. Despite rising demand for transseptal procedures, the technique and device used for this purpose have remained essentially unchanged over the past 4 decades. The possibilities of failure of puncturing distorted and thickened atrial septal tissue or risks of complications related to cardiac perforation remain limitations of the technique. A new radiofrequency catheter provides an alternative approach to create a controlled transseptal perforation. We applied this technique to a series of patients and evaluated its feasibility as an alternative to conventional transseptal needle puncture.
... 16 -18 Radiofrequency perforation of the target area in the septum allows for precise puncturing and potentially a decreased incidence of free wall perforations and unnecessary cardiac muscle activation leading to arrhythmias. 19 Cardiac magnetic resonance imaging is considered by many authorities to be the gold standard for the evaluation of RV function, and therefore it would certainly be helpful in the evaluation of septostomy patients pre-and postprocedure. Animal data suggest that cardiac magnetic resonance imaging can be used to guide AS, but no such data exist in humans. ...
... 21 Patients who survive AS usually live to experience significant improvement of their symptoms at 2 to 4 weeks, as evidenced by both their WHO class (improved from 3.57 ± 0.6 to 2.07 ± 0.3) and performance on the 6minute walk test (6MWT; improved from 107 ± 127 m to 217 ± 108 m). 19 Other symptoms such as syncope and signs of RV failure such as edema and ascites improve in close to 90% of patients. 8 Brain natriuretic peptide (BNP) levels were also reported to improve post-AS (Table 1). ...
... For the first 48 hours after an uncomplicated procedure, all patients need to be observed in an intensive care unit setting where hemodynamic monitoring can be performed on a continuous basis. 19 Supplemental oxygen availability is mandatory, as the most feared complication is systemic hypoxia, which can be catastrophic if uncontrolled. Fortunately, devastating post-AS hypoxia has been salvaged by using inhaled iloprost until the patient was stabilized and weaned off of the medication, and this approach may be used if needed. ...
Pulmonary arterial hypertension (PAH) is a rare disease, but it boasts significant morbidity and mortality. Although remarkable achievements have been made in the medical treatment of PAH, there is a role for invasive or surgical procedures in patients with progressive disease despite optimal medical therapy or with no access to such therapy. Atrial septostomy creates a right-to-left intracardiac shunt to decompress the overloaded right ventricle. Despite significant advances to validate and improve this palliative procedure, as well as recent reports of improved outcomes, it is only slowly being adopted. This article aims to detail the history, indications, contraindications, procedural techniques, and outcomes of atrial septostomy. We will also shed light on some of the newer interventions, inspired by the same physiological concept, that are being evaluated as potential palliative modalities in patients with PAH.
© 2015 Wiley Periodicals, Inc.
... Transseptal catheterization is performed using the percutaneous technique from the right femoral vein as previously described [40,41] . Biplane fluoroscopy, if available, is the ideal imaging system. ...
... A detailed description of the procedure is well outlined in the article by Roelke et al. [40] . The use of transesophageal or intracardiac echocardiography add on the safety and success of the procedure [40,41] . When positioned at the target septal spot, the tip of the Brockenbrough needle is advanced into the left atrium under continuous fluoroscopic, echocardiographic and pressure monitoring. ...
Since its introduction in 1982, percutaneous mitral balloon valvuloplasty (PMV) has been used successfully as an alternative to open or closed surgical mitral commissurotomy in the treatment of patients with symptomatic rheumatic mitral stenosis. PMV is safe and effective and provides sustained clinical and hemodynamic improvement in patients with mitral stenosis. The immediate and long-term results appear to be similar to those of surgical mitral commissurotomy. Proper patient selection is an essential step for being able to predict the immediate results of PMV. Candidates for PMV require precise assessment of the mitral valve morphology. The Wilkin’s echocardiographic score (Echo-Sc) is currently the most widely used method for predicting PMV outcome. Leaflet mobility, leaflet thickening, valvular calcification, and sub valvular disease are each scored from 1 to 4. An inverse relationship exists between the Echo-Sc and PMV success. Both immediate and intermediate follow-up studies have shown that patients with Echo-Sc ≤ 8 have superior results, significantly greater survival, and event free survival compared to patients with Echo-Sc > 8. We identified other clinical and morphologic predictors of PMV success that include age, pre-PMV mitral valve area, history of previous surgical commissurotomy, and mitral regurgitation (MR), and post-PMV variables (e.g., post-PMV MR ≥ 3 + and pulmonary artery pressure), that may be used in conjunction with the Echo-Sc to optimally identify candidates for PMV. This concept demonstrates a multifactorial nature of the prediction of immediate and long-term results. Other echocardiographic scores have been developed for the screening of potential candidates for PMV. They include a unique score that take into account the length of the chordae. A novel quantitative score that included the ratio of the commissural areas over the maximal excursion of the leaflets from the annulus in diastole. The components of this score include mitral valve area ≤ 1 cm², maximum leaflet displacement ≤ 12 mm, commissural area ratio ≥ 1.25, and sub valvular involvement. Finally, a score that is able to identify patients who are more likely to develop significant mitral regurgitation post-PMV. This score takes into account the distribution (even or uneven) of leaflet thickening and calcification, the degree and symmetry of commissural disease, and the severity of subvalvular disease. The transvenous transseptal approach is the most widely used PMV technique. The two major techniques of PMV are the double-balloon technique and the Inoue technique which are equally effective techniques of PMV. Encouraging results of PMV have been reported in special mitral stenosis population cohorts including pregnant women, patients with previous surgical commissurotomy, patients with atrial fibrillation, patients with pulmonary hypertension, elderly patients, patients with calcific mitral stenosis, and patients with associated aortic regurgitation. To summarize, PMV is the preferred form of therapy for relief of mitral stenosis for a selected group of patients with symptomatic mitral stenosis and suitable valve anatomy for valvuloplasty. Patients with Echo-Sc ≤ 8 have the best results, particularly if they are young, are in normal sinus rhythm, have no pulmonary hypertension, and have no evidence of calcification of the mitral valve under fluoroscopy. The immediate and long-term results of PMV in this group of patients are similar to those reported after surgical mitral commissurotomy. Patients with Echo-Sc > 8 have only a 50% chance to obtain a successful hemodynamic result with PMV, and the long-term follow-up results are worse than those from patients with Echo-Sc ≤ 8. In patients with Echo-Sc ≥ 12, it is unlikely that PMV could produce good immediate or long-term results and they preferably should undergo mitral valve replacement. However, PMV could be considered in these patients if they are high-risk or unqualified surgical candidates.
... Because of some anatomical variations in the interatrial septum (size, thickness, elasticity, or aneurysm), the transseptal needle puncture can be difficult at times, even for experienced physicians. Newer methods for transseptal puncture have been described [3], including the use of radiofrequency (RF) energy for transseptal puncture, either by delivering RF with manual contact [4][5][6][7][8][9] or by using a powered RF transseptal needle [10][11][12][13]. ...
... This needle requires a specific RF generator. Other groups have performed a similar procedure using either electrocautery assistance or RF from an ablation catheter [4][5][6][7][8][9]. The procedure was effective in all patients and without complications related to the RF transseptal puncture. ...
Patients undergoing left atrial ablation require transseptal puncture, which can be challenging, even for experienced physicians. This study compared the efficacy and safety of radiofrequency (RF) energy transseptal punctures to conventional approach.
Patients requiring transseptal puncture for left atrial access were included using either conventional approach or the NRG™ RF transseptal needle as first attempt. Procedure time for transseptal access, fluoroscopy time, crossover, and safety of both techniques were compared.
A total of 241 transseptal punctures were performed in 148 consecutive patients (114 men, 54 ± 10 years, left atrial volume 32 ± 10 ml/m(2)) who underwent 157 procedures with left atrial access, mainly for atrial fibrillation. It was a repeat transseptal procedure in 49 patients. Procedures were guided by transesophageal echocardiography. RF transseptal puncture was planned in 119 procedures. RF was delivered in 98 procedures (82%) for 139/187 punctures: 48 punctures did not require RF, including 25 punctures performed by exposing the needle tip, 22 through patent foramen ovale, and 1 RF delivery failure by the generator. Average time for RF transseptal was 4.8 ± 2.8 min compared to 7.5 ± 8.5 min for conventional approach (p = 0.045). Fluoroscopy time was 1.8 ± 1.3 min for RF transseptal and 2.9 ± 2.8 min for standard approach (p = 0.043). Four patients required crossover to RF transseptal needle in the conventional group (p = 0.003). One tamponade occurred at the end of procedure in a patient using the RF needle, and one interatrial septum dissection with aortic root hematoma occurred in the conventional group.
Transseptal needle puncture using RF energy can be performed safely and quickly under imaging guidance.
... The atraumatic distal " J " shape of the needle wire and the stiffness of the wire in combination with its distal position in one of the left-sided pulmonary veins enables the operator to firmly cross the atrial septum with the dilator and the sheath sequentially, if necessary (e.g., thickened and/or fibrotic atrial septum), since the needle wire itself does not reduce the forces necessary to cross the septum in such cases. In the literature, there is one other technique which is able to reduce the stretching forces applied to the septum during the puncture: some groups described a technique that facilitates transseptal puncture by applying brief pulses of radiofrequency energy from a standard electrosurgical cautery generator through the needle tip, thus penetrating the septum91011, while others use a specifically designed catheter for radiofrequency transseptal puncture (Toronto Transseptal Catheter, Baylis Medical Company, Inc, Montreal, Canada) [10, 11]. Most groups limit this technique to patients where a conventional puncture of the septum is difficult or unsuccessful, as it was in our series of patients [9]. ...
... The atraumatic distal " J " shape of the needle wire and the stiffness of the wire in combination with its distal position in one of the left-sided pulmonary veins enables the operator to firmly cross the atrial septum with the dilator and the sheath sequentially, if necessary (e.g., thickened and/or fibrotic atrial septum), since the needle wire itself does not reduce the forces necessary to cross the septum in such cases. In the literature, there is one other technique which is able to reduce the stretching forces applied to the septum during the puncture: some groups described a technique that facilitates transseptal puncture by applying brief pulses of radiofrequency energy from a standard electrosurgical cautery generator through the needle tip, thus penetrating the septum91011, while others use a specifically designed catheter for radiofrequency transseptal puncture (Toronto Transseptal Catheter, Baylis Medical Company, Inc, Montreal, Canada) [10, 11]. Most groups limit this technique to patients where a conventional puncture of the septum is difficult or unsuccessful, as it was in our series of patients [9]. ...
An increasing number of patients undergo left atrial ablation procedures, since several approaches have proven efficacy in the treatment of atrial fibrillation. Although transseptal catheterization was generally shown be a safe technique, it harbors the principal risk of cardiac injury. Therefore, there is a need for a safe and effective tool to enable transseptal puncture in difficult cases as well.
In 158 consecutive patients, a transseptal puncture was intended for mapping and ablation of left atrial tachycardias. In seven patients of this series transseptal puncture using different sheaths and needle designs, the operators failed to cross the interatrial septum as a result of severe tenting. Three patients were known to have a septal aneurysm; a redo procedure was performed in two patients. In the remaining patients, there was no obvious explanation for the difficulty in crossing the interatrial septum conventionally. In all seven patients, a 120-cm-long nitinol guidewire ("needle wire") with a 0.014-inch diameter was used to cross the atrial septum with the following idea: after tenting the fossa ovalis with the transseptal dilator and the Brockenbrough needle positioned just inside the tip, effortless advancement of the needle wire perforates the membranous fossa. Unsupported by the needle and dilator, the tip of the wire immediately assumes a "J" shape, rendering it incapable of further tissue penetration after its entry into the left atrium. In all seven patients, the needle wire could be placed into a left pulmonary vein. In five patients, a single attempt was sufficient to reach the left atrium with the wire, two patients needed two and three attempts, respectively. No complications occurred.
Additional use of a needle wire to perform transseptal puncture in a subset of patients at higher risk for complications appears safe and effective.
... 7 A built-in retractable blade (knife) cuts the lower margin of the patent foramen ovale (PFO) which is followed by balloon atrial septostomy. More recently, static balloon angioplasty, 6,8,9 stents, [10][11][12] Brockenbrough atrial septal puncture, 12 radiofrequency ablation [13][14][15] and cutting balloons were applied to create and/or enlarge the atrial defects 4 . In most patients conventional balloon atrial septostomy is all that is necessary to palliate TGA patients until surgery. ...
Not available DOI: http://dx.doi.org/10.3329/uhj.v8i1.116678 University Heart Journal Vol. 8, No. 1, January 2012
... Radiofrequency (RF) assisted perforation of the atrial septum is as an alternative to conventional needle puncture in infants and children with congenital heart disease. [1,2] Indications for left atrial access include hemodynamic measurements (left atrial pressure and trans-mitral pressure gradient) and therapeutic interventions (atrial septoplasty and balloon atrial septostomy). [3][4][5] Hypoxemia in the presence of an intact/ very restrictive atrial septum and univentricular heart, requires the rapid creation of an atrial communication. ...
Radiofrequency (RF) assisted perforation of the atrial septum was performed successfully in three infants using a 0.035 RF wire deployed through a Williams right posterior catheter. Balloon atrial septoplasty was performed over the 0.035 RF wire in two of them, shortening the procedural time. © 2016 Annals of Pediatric Cardiology | Published by Wolters Kluwer - Medknow.
... Although the conventional needle may provide more immediate tactile feedback and has a longer track record of success, the RF needle may be more effective in cases of an elastic, aneurysmal, or thickened interatrial septum. 8 In addition, safety concerns have been raised as more plastic particle shavings were observed after introduction of the Brockenbrough versus the RF needle through the dilator and sheath, suggesting that there may be a risk of plastic particle embolization with the conventional needle. 9 A large retrospective study found that the RF needle was faster, more effective, and safer in achieving LA access, 10 but a randomized prospective comparison to the conventional needle has not been performed. ...
Transseptal puncture is a critical step in achieving left atrial (LA) access for a variety of cardiac procedures. Although the mechanical Brockenbrough needle has historically been used for this procedure, a needle employing radiofrequency (RF) energy has more recently been approved for clinical use. We sought to investigate the comparative effectiveness of an RF versus conventional needle for transseptal LA access.
In this prospective, single-blinded, controlled trial, 72 patients were randomized in a 1:1 fashion to an RF versus conventional (BRK-1) transseptal needle. In an intention-to-treat analysis, the primary outcome was time required for transseptal LA access. Secondary outcomes included failure of the assigned needle, visible plastic dilator shavings from needle introduction, and any procedural complication. The median transseptal puncture time was 68% shorter using the RF needle compared with the conventional needle (2.3 minutes [interquartile range {IQR}, 1.7 to 3.8 minutes] versus 7.3 minutes [IQR, 2.7 to 14.1 minutes], P=0.005). Failure to achieve transseptal LA access with the assigned needle was less common using the RF versus conventional needle (0/36 [0%] versus 10/36 [27.8%], P<0.001). Plastic shavings were grossly visible after needle advancement through the dilator and sheath in 0 (0%) RF needle cases and 12 (33.3%) conventional needle cases (P<0.001). There were no differences in procedural complications (1/36 [2.8%] versus 1/36 [2.8%]).
Use of an RF needle resulted in shorter time to transseptal LA access, less failure in achieving transseptal LA access, and fewer visible plastic shavings.
http://www.clinicaltrials.gov. Unique identifier: NCT01209260.
... İşlemin transözofajiyal veya intrakardiyak ekokardiyografi rehberliğinde yapılması daha güvenli olabilmektedir (28,30). Yine radiofrekans enerji sistemlerinin bu grup hastada kullanılması teorik olarak; ponksiyon yerinde kesin kontrol sağlaması, çevre dokuda minimal termal etki oluşturması ve sinir, kas hücrelerini daha az uyararak aritmi riskini azaltması nedeniyle faydalı olabilir (29). Kademeli balon diltasyonunda işlem sırasında sağ ve sol kalp kateterizasyonu ile hemodinamik parametreler takip edilmelidir. ...
Despite the fact that remarkable improvements have been achieved in quality of life and survival through increasing number of specific medical treatment alternatives in severe pulmonary hypertension, many patients have resistance to medical treatment. Atrial septostomy is considered as a palliative procedure in severe pulmonary hypertension to relieve symptoms of severe pulmonary hypertension by reducing right ventricular preload and increasing systemic flow. Gradual balloon dilatation and blade balloon atrial septostomy are the most frequently used methods. If atrial septostomy is performed in experienced medical centers, it provides clinical improvement and even has tendency to extend life expectancy in patients with pulmonary hypertension resistant to medical treatment.
... [24][25][26] Based on the same premise, a radiofrequency transseptal system has been developed for piercing resistant septums (Baylis Medical, Montreal, Canada). 27,28 A specific radiofrequency transseptal catheter is inserted through a dedicated sheath-dilator assembly, then brought into contact with the fossa ovalis and short bursts of low-voltage energy are delivered, allowing access in the left atrium. In case of highly resistant fossae, apart from the option of radiofrequency puncture, a 0.014-inch, sharp-tipped, J-shaped transseptal guidewire (Safe Sept, Pressure Products, Inc., San Pedro, CA, USA) 29 or a more sharp BRK needle type (BRK-1 extra sharp) can be used. ...
Transseptal catheterization is used by interventional cardiologists to gain access in the left atrium. This technique was initially introduced for left-sided pressure measurements and has been integrated in a variety of procedures including left atrial ablations and percutaneous mitral valvuloplasties. The establishment of catheter ablation of atrial fibrillation as an effective treatment strategy has brought transseptal catheterization back to the limelight. Technique refinements, introduction of adjunctive imaging tools, and enrichment of available technical equipment have simplified the procedure. In the present article we review the technique of transseptal catheterization, presenting tips and caveats that could be of value for safe and successful transseptal punctures.
... Justino et al (11) used the technique in the treatment of a child with congenital heart disease via the creation of a transseptal defect. There is also increasing evidence of its use for percutaneous left heart access (3,12). Therefore, to date, published reports on RF perforation have focused on its use for cardiac applications. ...
Treatment with radiofrequency (RF) energy can be used to ablate or perforate tissues. The latter involves lower power, higher voltage, and much shorter treatment time, and it is thought to induce much less collateral tissue damage. To date, RF perforation has been successfully used for various cardiac interventions; however, to our knowledge, there has not been a report of its use for peripheral vascular disease. This report describes the successful recanalization of a longstanding occlusion of a left subclavian vein in a 73-year-old woman with polycystic kidney disease and end-stage renal disease undergoing chronic hemodialysis treatment via an upper-extremity arteriovenous fistula. Multiple previous attempts at mechanical recanalization were unsuccessful. Recanalization was achieved by RF perforation with use of a PowerWire RF guide wire.
Transseptal left atrial catheterization is routinely used for many common catheter‐based interventions. Tools for transseptal catheterization have advanced over the recent years. Such tools include imaging advances with intracardiac echocardiology as well as an array of needles, wires, and dilators to achieve transseptal access with greater ease and safety. This review will discuss the contemporary tools for transseptal catheterization and guidance for difficult cases. This article is protected by copyright. All rights reserved.
Background:
Application of electrocautery to a metal guidewire is used by some operators to perform transseptal puncture (TSP). Commercially available dedicated radiofrequency (RF) guidewires may represent a better alternative. This study compares the safety and effectiveness of electrified guidewires to a dedicated RF wire.
Methods:
TSP was performed on freshly excised porcine hearts using an electrified 0.014″ or 0.032″ guidewire under various power settings and was compared to TSP using a dedicated RF wire with 5 W power (0.035″ VersaCross RF System, Baylis Medical). The primary endpoint was the number of attempts required to achieve TSP. Secondary endpoints included the rate of TSP failure, TSP consistency, the effect of the distance between the tip of the guidewire and the tip of the dilator, and effect of RF power output level. Qualitative secondary endpoints included tissue puncture defect appearance, thermal damage to the TSP guidewire or dilator, and tissue temperature using thermal imaging.
Results:
The RF wire required on average 1.10 ± 0.47 attempts to cross the septum. The 0.014″ electrified guidewire required an overall mean of 2.17 ± 2.36 attempts (2.0 times as many as the RF wire; p < .01), and the 0.032″ electrified guidewire required an overall mean of 3.90 ± 2.93 attempts (3.5 times as many as the RF wire; p < .01). Electrified guidewires had a higher rate of TSP failure, and caused larger defects and more tissue charring than the RF wire. Thermal analysis showed higher temperatures and a larger area of tissue heating with electrified guidewires than the RF wire.
Conclusion:
Fewer RF applications were required to achieve TSP using a dedicated RF wire compared to an electrified guidewire. Smaller defects and lower tissue temperatures were also observed using the RF wire. Electrified guidewires required greater energy delivery and were associated with equipment damage and tissue charring, which may present a risk of thrombus, thermal injury, or scarring.
Background: There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles.
Objectives:To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States.
Methods:We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure.
Results:The final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG).
Conclusions:Needle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.
Background:
Atrial transseptal puncture (TSP) for cardiac catheterization procedures remain challenging in children and adults with complex congenital heart disease (CHD).
Objectives:
We sought to evaluate our experience using radiofrequency (RF) current via surgical electrocautery needle for TSP to facilitate diagnostic and interventional procedures.
Methods:
Retrospective chart review of all patients (pts) who underwent TSP using RF energy (10-25 W) via surgical electrocautery from three centers from January 2011 to January 2017 were evaluated. Echocardiograms were reviewed to define the atrial septum as normal and complex (thin aneurysmal, thick/fibrotic, synthetic patch material, and extra cardiac conduit).
Results:
A total of 54 pts underwent 55 successful TSP. Median age was 12.5 years (1 day-54 years) and weight was 52.7 kg (2-162). Indications for TSP included; EP study and ablation procedures in structurally normal hearts (n = 24) and in complex atrial septum/CHD and structural heart disease pts (n = 30): Electrophysiology study and ablation in 4, diagnostic catheterization in 9, and interventional procedures in 17 pts were performed. Atrial TSP was successful in 54/55 (98%). Atrial perforation with tiny-small pericardial effusion not requiring intervention was noted in 2 pts. TSP was unsuccessful in one critically ill neonate with unobstructed TAPVR and restricted atrial septum who experienced cardiac arrest requiring CPR, ECMO, and emergent surgery.
Conclusions:
RF current delivery using surgical electrocautery for TSP is a feasible and an effective option in patients with complex CHD for diagnostic, interventional, and electrophysiology procedures.
Due to an increased understanding of the functional anatomy of the mitral valve (MV) and the heterogeneous pathophysiology of mitral regurgitation (MR), over the past two decades, a huge variety of percutaneous treatment for MR have been successfully developed to treat high-risk patients who are usually not surgical candidate. In most cases, they represent the noninvasive conversion of a surgical procedure into a percutaneous one.
Objectives:
Our objectives were to assess for differences between standard and radiofrequency (RF) needle in procedural times, success, and spatial accuracy.
Background:
Targeted transseptal (TS) puncture is essential for structural heart interventions. Spatial accuracy of standard versus RF needle has not been reported.
Methods:
Consecutive patients undergoing structural heart interventions requiring TS puncture were studied retrospectively. A standard needle was alternated with a RF needle. Procedural success and times were recorded. Measurements based on intraprocedural transesophageal echocardiograms of the intended versus final TS crossing site were obtained. Pre-puncture and maximal tenting of the septum were also recorded.
Results:
Twenty-five patients underwent standard needle and 27 RF TS access. All RF needle attempts to cross were successful without an assistance wire. Three standard needle patients required assisted crossing. After failed TS access, two patients had successful RF TS access. TS procedural times significantly favored the RF needle for time from septum to puncture (P = 0.02). Both standard and RF access yielded accurate crossing with no significant differences between the intended and actual crossing site. Maximal tenting was significantly less with the RF needle (P = 0.004). There were no major complications.
Conclusions:
In the hands of an experienced operator, there were no major clinically significant differences between the standard and RF needle approaches. However, procedural unassisted crossing success was higher with the RF needle approach as compared to standard needle. Procedural times and degree of septum tenting favored the RF over standard needle. Accuracy was similar with both approaches. RF was a successful strategy when standard needle failed. There were no major complications with either TS puncture strategy. © 2016 Wiley Periodicals, Inc.
Introduction
This study aimed to evaluate the safety and efficacy of utilising an innovative radiofrequency (RF) powered flexible needle to achieve transseptal puncture (TSP).
Methods and results
A RF powered flexible needle (Toronto catheter, Baylis Medical Company Inc.) associated with a stiffer dilator (Torflex Superstrong, Baylis Medical Company Inc.) was used in 125 consecutive patients referred for left sided ablations (mean age = 55.6, male = 86.5%) and compared with a standard transseptal set (BRK needle, SL0 sheath and dilator, St Jude Medical, Inc.) used in the previous 100 patients (mean age = 56, male 82%). TSP was achieved in 95/100 patients in the Brockenbrough group and in all 125 patients in the Toronto group (p = 0.01) despite an equivalent proportion of difficult situations (8 and 9% respectively) and patients with a prior TSP (17% vs 24%). 7/100 Needle related events (failure, aborted attempt or pericardial effusion) occurred in the Brockenbrough group and none in the Toronto group (p = 0.01). The Toronto needle crossed the septum at the first attempt in 123/125 (98.4%) patients and the Brockenbrough needle in 84/95 (88%) patients (p < 0.001).
Conclusion
Our data suggest that the Toronto RF powered flexible needle is safer and more efficient than a standard Brockenbrough needle and can be used not only in difficult situations but routinely to achieve TSP.
This article summarizes the current literature regarding surgical interventions in pulmonary hypertension, excluding chronic thromboembolic pulmonary hypertension. The article discusses the use of atrial septostomy in patients meeting criteria as well as single, double, and heart-lung transplantation.
The antegrade approach for aortic valve interventions is well known but has not been widely used for transcatheter aortic valve replacement procedures. We encountered a patient with no possibility of retrograde access due to a totally occluded abdominal aorta who had a failed attempt at apical TAVR. We describe antegrade approach TAVR despite occlusion of the abdominal aorta, with the arterial limb of the requisite veno-arterial loop was created using bilateral arm access, a novel version of the previously described antegrade approach. © 2013 Wiley Periodicals, Inc.
Background:
Patients with congenital heart disease carry a high burden of arrhythmias and may pose special challenges when these arrhythmias are addressed invasively. We sought to describe our early experience with radiofrequency (RF) needle transseptal perforation to facilitate ablation procedures in this population.
Methods:
Retrospective chart review to identify all cases of attempted transseptal access with a commercial RF needle at Children's Hospital Boston between February 2007 and January 2010.
Results:
A total of 10 patients had attempted RF transseptal perforation. Median age was 27 years. Five patients had undergone atrial switch procedures (Mustard/Senning), four had undergone Fontan operations, and one had atrial septal defect repair. The indication for left atrial access was mapping/ablation of atrial flutter in nine cases, and left-sided accessory pathway in one case. The RF needle was chosen primarily in eight of 10 cases, whereas in the remaining two cases RF was used only after failed attempts with a conventional Brockenbrough needle. Septal material was atrial muscle in five cases, pericardium in three, and synthetic fabric in two. In nine of 10 patients, RF transseptal perforation was successful, including both patients in whom a conventional needle had failed. There were no clinically significant complications.
Conclusions:
RF transseptal perforation can be an effective method of obtaining left atrial access for electrophysiologic procedures in patients with complex congenital heart disease, including cases where a conventional Brockenbrough needle has failed.
Aims:
Unlike most diagnostic procedures, the MitraClip® therapy requires precise positioning of transseptal access to ensure a successful procedure. Radiofrequency-based transseptal puncture has been developed to reduce complications and improve precision of septal access. We report our experience utilising surgical diathermy-based transseptal puncture for MitraClip implantation.
Methods and results:
Between October 2008 and April 2010, 72 patients underwent MitraClip therapy. Diathermy-assisted transseptal access was performed in 66 patients, under echocardiographic guidance, by manual contact of the diathermy blade with the Brockenbrough needle at the groin. Rate of successful puncture, time from femoral vein puncture to transseptal access and rate of complications were analysed. Diathermy-assisted puncture was successful in all cases. Time from femoral vein access to transseptal puncture was 16 ± 19 min. There was one suboptimal septal puncture position (too low), and there was one coronary artery air embolism. There were no cases of intraprocedural pericardial effusion or arrhythmias.
Conclusions:
Surgical diathermy-based transseptal puncture may be a safe and effective alternative to either conventional or RF-based septal crossing. It improves precision of the septal access and may reduce the risk of bleeding complications. This technique is now routinely used at our institution for all MitraClip procedures.
Transseptal puncture has been performed in adults and children for decades. However, transseptal puncture can be challenging especially in pediatric patients because of an elastic septum and small atria. In adults, dedicated radiofrequency (RF) to facilitate transseptal puncture has become routine.
We wanted to assess whether RF could be used routinely in children to facilitate transseptal procedure.
The study population included all children referred to our electrophysiology lab who underwent an ablation requiring a transseptal puncture over a period of 10 months. RF was applied at the time of transseptal puncture. The source of RF was standard surgical electrocautery device with the electrosurgical pen in direct contact with the transseptal needle applied for a short period of time during transseptal puncture. RF output was set initially at 30 W in cut mode. All procedures were performed under general anesthesia. Patients were followed for possible complications.
Thirteen patients (ages 11.6 ± 3.6 years, range 5-17 years, five boys) were included. One patient had left ventricular tachycardia, and the remainder had a supraventricular tachycardia with a left-sided accessory pathway. In all but two patients, a single attempt with an RF output of 30 W applied for less than 2 seconds was sufficient to cross the septum. In two patients, three attempts were needed with a last successful attempt using 35 W. No complications were observed either acutely or during the follow-up.
Transseptal puncture facilitated by RF energy can be performed in children routinely and safely.
The objective of this study was to demonstrate the safety and efficacy of a new transseptal needle design with a radiofrequency (RF) tip combined with the ease of use of the needle configuration. Background: RF transseptal puncture to enter the left heart, with a RF wire-catheter system is a successful technique in patients with complex access using a standard transseptal needle.
The RF transseptal needle (NRG™ Transseptal Needle; Baylis Medical, Montreal, Canada) was designed for RF percutaneous transseptal access to the left heart. Eight pigs underwent transvenous cardiac catheterization with baseline intracardiac electrograms and right atrial pressure waveforms. Transseptal RF puncture was performed followed by left atrial pressure waveform monitoring.
An intracardiac electrogram was recorded in each animal while dragging the needle tip from the superior caval vein across the atrial septum and into the inferior caval vein. Contrast staining of the atrial septum was accomplished in all animals, with subsequent RF septal puncture. After 0.1 sec, impedance increased from 300 to 1,200 Ohms with the creation of a vapor layer, and voltage increased steadily to a threshold of 230 volts over the first 0.4 sec. This dielectric breakdown results in tissue vaporization and tissue perforation. The needle's location within the left atrium was confirmed by the pressure waveform and contrast injection. Repeated RF punctures with the NRG™ was compatible with various manufactures transseptal sheaths.
RF puncture of the interatrial septum using the NRG™ Transseptal Needle facilitates an alternative effective technique to enter the left atrium. © 2010 Wiley-Liss, Inc.
Transseptal puncture is performed using a long needle advanced from the femoral approach. A radiofrequency catheter has been developed that delivers a short burst of radiofrequency energy and creates a micro puncture in the interatrial septum. We describe a case in which the distal radiofrequency electrode broke and became embedded in the interatrial septum.
Although it has been shown that a transseptal (TS) puncture in the electrophysiology laboratory is associated with a high success and a low complication rate, this procedure remains challenging particularly in difficult septum anatomies (aneurismal septum and thick septum) and during repeat TS catheterization. Radiofrequency (RF) electrocautery current delivery through the TS needle has been shown to facilitate the TS puncture. The aim of this study was to verify prospectively the feasibility, safety, and outcome of RF energy delivery associated with the standard TS technique in patients undergoing a challenging TS puncture.
Over a 14-month period, 162 consecutive patients underwent left atrial (LA) arrhythmia ablation in our centre. Among them, we enrolled 18 patients who failed LA access after two TS puncture attempts. In these patients, an RF delivery through TS (RF-TS) needle approach was used to reach the LA. All 18 patients had a successful RF-TS at the first attempt. A transoesophageal echocardiography (TEE) guidance and fluoroscopy views were used in all patients. No acute complications were reported. There have been no clinical sequelae after 10 +/- 4 months of follow-up following the RF-TS approach. Challenging TS punctures were more frequent in repeat LA catheterization when compared with the first LA catheterization, respectively, in 35% (13 of 37) and 4% (5 of 125) of the patients.
Radiofrequency electrocautery delivery associated with the standard TS approach is a safe and reproducible technique to reach the left atrium, using the TEE guidance. This technique is helpful during repeat TS catheterization and in the presence of anatomical atrial septum abnormalities.
The purpose of this study was to determine the safety and efficacy of using a novel radiofrequency (RF) powered transseptal needle to perform transseptal puncture (TSP).
TSP was performed in 35 consecutive patients undergoing left-sided catheter ablation (mean age = 51 years; male = 71%) using a RF powered transseptal needle (NRG, Adult Large and Standard Curve C1, 71 cm, Baylis Medical Company, Inc.). Prior TSP had been performed in 34% of patients. The transseptal apparatus was positioned with the tip of the dilator engaged in the fossa ovalis. RF energy was delivered to the tip of the transseptal needle using a proprietary RF generator at 10 W for 2 seconds as gentle pressure was applied to the needle.
In 5 of the 41 TSPs, the needle crossed into the left atrium before RF energy was delivered. In 35 of the remaining 36 punctures, the needle was successfully advanced into the left atrium after application of RF current. In 1 patient, the TSP with the powered needle was unsuccessful but was accomplished using a standard needle. The only complication was a transient right atrial thrombus, which occurred in 2 patients.
A radiofrequency powered transseptal needle can be used to perform TSP safely and successfully without the need for significant mechanical force, even in patients who have undergone TSP previously. Additional studies are needed to determine whether a powered transseptal needle should be used routinely.
Transseptal puncture with a conventional mechanical technique can fail because of a resistant interatrial septum. We evaluated the efficacy and safety of a new method to cross-resistant septae by transmitting radiofrequency (RF) energy through the transseptal needle.
Among 269 consecutive transseptal punctures, 13 (5%) were unsuccessful in 12 different patients (11 men aged 52+/-12 years) using the conventional Brockenbrough technique. All 12 patients had previously undergone at least 1 transseptal catheterization. The needle position in relation to the fossa ovalis was assessed by fluoroscopy in orthogonal views and was confirmed with contrast injection and by visualizing the characteristic "tenting" of the fossa ovalis. Before using RF energy, there were a median of 6 unsuccessful attempts to perforate the septum conventionally, with 1 pericardial puncture (with a nonsignificant effusion). RF transseptal puncture was then performed by delivering unipolar RF with manual contact between the ablation catheter and the proximal extremity of the needle at the patient's groin. RF transseptal puncture was achieved at the first attempt in all patients within a median of 1 second (interquartile range, 1 to 4) and without any complication. The only parameter predictive of a septum resistant to conventional puncture was the total number of transseptal catheterizations (3.2+/-1 versus 1.8+/-1, P<0.001).
Transmission of RF energy from the ablation catheter up to the tip of the transseptal needle provides an easy and safe method for piercing the fossa ovalis when the conventional approach fails because of a resistant septum.
Neonates with hypoplastic left heart syndrome (HLHS) and intact atrial septum (IAS) usually present with severe acidosis and hypoxemia that necessitate immediate intervention to create an atrial septal defect (ASD). Transcatheter creation of an ASD in these patients requires transseptal puncture of a thickened atrial septum in the setting of a very small left atrium. We report on a novel method of perforating the atrial septum using radio-frequency energy in combination with a transseptal needle to facilitate transseptal puncture and subsequent stent placement in a very thick atrial septum of a newborn with HLHS/IAS and a small left atrium.
The left atrium (LA) is the most difficult cardiac chamber to access percutaneously. Although it can be reached via the left ventricle and mitral valve, manipulation of catheters that have made two 180° turns is cumbersome. The transseptal puncture permits a direct route to the LA via the intra-atrial septum and systemic venous system. Previously the technique was used infrequently by cardiologists for mitral valvuloplasty and ablation in the left heart; however, the explosion of interest in catheter ablation of atrial fibrillation (AF) has meant the transseptal puncture is a routine skill of the modern cardiac electrophysiologist. This article looks at the practical aspects of this important procedure, particularly as applied to the cardiac electrophysiologist.
The transseptal puncture was developed by Ross, Braunwald and Morrow at the National Heart Institute (now the National Heart, Lung, and Blood Institute), Bethseda in the late 1950s to allow left heart catheterisation, principally for the evaluation of valvular heart disease.1 Early problems were difficulty cannulating the left ventricle, injecting sufficient volume of contrast for imaging, and inadvertent aortic puncture. Important refinements were made to the needle and catheter such that Brockenbrough’s description of the technique in 1962 differs little from that used now.2 Mullins developed a combined catheter and dilator set designed precisely to fit over the Brockenbrough needle, which gives a smooth taper from the tip of the needle, over the dilator to the shaft of the sheath.3 The terms Brockenbrough needle and Mullins sheath are often used by operators generically when referring to transseptal needles and sheaths, respectively; however, there is a range of equipment available from several manufacturers, often designed for specific applications—for example, catheter ablation of AF.
Access to the LA is needed for catheter ablation, percutaneous mitral valvuloplasty, and occasionally left heart catheterisation where an accurate …
Intracardiac Echo-Guided Radiofrequency Catheter.
Patients with atrial septal defect (ASD) are at higher risk for atrial fibrillation (AF) even after repair. Transseptal access in these patients is perceived to be difficult. We describe the feasibility, safety, and efficacy of pulmonary vein antral isolation (PVAI) in these patients.
We prospectively compared post-ASD/patent foramen ovale (PFO) repair patients (group I, n = 45) with age-gender-AF type matched controls (group II, n = 45). All the patients underwent PVAI through a double transseptal puncture with a roving circular mapping catheter technique guided by intracardiac echocardiography (ICE). The short-term (3 months) and long-term (12 month) failure rates were assessed.
In group I, 23 (51%) had percutaneous closure devices and 22 (49%) had a surgical closure. There was no significant difference between group I and II in the baseline characteristics. Intracardiac echo-guided double transseptal access was obtained in 98% of patients in group I and in 100% of patients in group II. PVAI was performed in all patients, with right atrial flutter ablation in 7 patients in group I and in 4 patients in group II. Over a mean follow-up of 15 +/- 4 months, group I had higher short-term (18% vs 13%, P = 0.77) and long-term recurrence (24% vs 18%, P = 0.6) than group II. There was no significant difference in the perioperative complications between the two groups. Echocardiography at 3 months showed interatrial communication in 2 patients in group I and 1 patient in group II, which resolved at 12 months.
Percutaneous AF ablation using double transseptal access is feasible, safe, and efficacious in patients with ASD and PFO repairs.
Surgical therapies for the treatment of pulmonary arterial hypertension typically are reserved for patients who are deemed to be refractory to medical therapy and have evidence of progressive right-sided heart failure. Atrial septostomy, a primarily palliative procedure, may stave off hemodynamic collapse from right-sided heart failure long enough to permit a more definitive surgical treatment such as lung or combined heart-lung transplantation. This article discusses indications for and results of atrial septostomy and lung and heart-lung transplantation in patients who have pulmonary arterial hypertension.
We describe a new approach that may enhance safety of atrial transseptal puncture using a commercially available laser catheter that is capable of perforation only when energized. We test this approach in swine.
Despite wide application, conventional needle transseptal puncture continues to risk inadvertent nontarget perforation and its consequences.
We used a commercial excimer laser catheter (0.9-mm Clirpath, Spectranetics). Perforation force was compared in vitro with a conventional Brockenbrough needle. Eight swine underwent laser transseptal puncture under X-ray fluoroscopy steered using a variety of delivery catheters.
The 0.9-mm laser catheter traversed in vitro targets with reduced force compared with a Brockenbrough needle. In vitro, the laser catheter created holes that were 25-30% larger than the Brockenbrough needle. Laser puncture of the atrial septum was successful and accurate in all animals, evidenced by oximetry, pressure, angiography, and necropsy. The laser catheter was steered effectively using a modified Mullins introducer sheath and using two different deflectable guiding catheters. The mean procedure time was 15 +/- 6 min, with an average 3.0 +/- 0.8 sec of laser activation. There were no adverse sequelae after prolonged observation. Necropsy revealed discrete 0.9-mm holes in all septae.
Laser puncture of the interatrial septum is feasible and safe in swine, using a blunt laser catheter that perforates tissues in a controlled fashion.
Pulmonary vein isolation (PVI) is widely practiced for treating atrial fibrillation. Transseptal access is necessary with one or even more transseptal sheaths to perform PVI.
In this prospective study, 31 patients were examined with transesophageal echocardiography before, immediately after and in a 3-, 6- and 12-month follow-up period for evaluation of iatrogenic atrial septal defect (iASD). All patients underwent PVI with double transseptal puncture.
An iASD was detected in 27/31 patients (87%) with a maximum diameter of 1.0 mm. After 3 months, the iASDs were completely closed in 26/27 (96.3%) patients. In 1/27 (3.7%) patients, there was an iASD detectable even after 12 months. Clinically no patient suffered from cerebral or cardiac embolism in the follow-up period.
We were only able to find small iASDs with left to right shunting after PVI but none with right to left shunting. iASDs following PVI show a high spontaneous closure rate already at 3 months of follow-up and are not associated with an increased rate of paradoxical embolism.
A new method for the measurement of left atrial pressure in man is described. In 13 patients the interatrial septum was punctured by means of a flexible needle passed through a cardiac catheter which had been introduced from the saphenous vein and positioned with its tip against the fossa ovalis. No complications were observed after the procedures. The advantages of the technique and its present and projected usefulness are discussed.
Transseptal perforation using radiofrequency energy was performed successfully in a patient with congenital heart disease and a thickened interatrial septum. This was followed by balloon dilatation of the atrial septal defect. Radiofrequency is presented as a alternative to standard transseptal needle puncture. Cathet Cardiovasc Intervent 2001;54:83–87. © 2001 Wiley-Liss, Inc.
A new technique for transseptal left heart catheterization utilizing the Transseptal Introducer Set in 520 patients is described in detail. The age range of these patients was 3 months to 40 years with 30% of the patients less than 2 years old and 28% less than 10 kilograms in weight. The safety and advantages of the technique are emphasized. The introducer set and new technique make transseptal left heart catheterization a safe, versatile, and dependable approach to all areas of the left heart, particularly in infants and children with complex congenital heart lesions.
Percutaneous transvenous mitral commissurotomy (PTMC) with the Inoue balloon has had increasing use internationally since its introduction in 1984. This device was designed specifically for mitral commissurotomy and differs substantially from conventional large diameter peripheral arterial or valvuloplasty balloon catheters. It is constructed of two layers of latex with a nylon mesh in between. The latex is extremely compliant, whereas the nylon mesh limits the maximum inflated diameter of the balloon and also gives it a unique shape and set of inflation characteristics. The balloon inflates in three stages. The front half inflates first, creating the appearance of a balloon flotation catheter. The proximal half of the balloon inflates next, creating an hourglass shape. When straddling across the valve, this allows self-positioning of the balloon. Finally, the center portion inflates, resulting in commissurotomy. The technique of commissurotomy involves introducing the balloon into the left atrium over a guidewire and then passing it into the left ventricle with the distal portion of the balloon inflated in a manner analogous to crossing the tricuspid valve with a pulmonary artery flotation catheter. Thus a guidewire is not used to enter the left ventricle with this technique. Increasing inflation volumes allow a single balloon catheter to be inflated to a variety of sizes, allowing stepwise dilatation of the mitral valve in a manner analogous to coronary angioplasty. This report describes the performance of this technique in detail, with practical approaches to many common problems encountered during PTMC.
Radio frequency (RF) current delivered through a thin catheter can be used to perforate the pulmonary valve or the atrial septum to treat pulmonary atresia in newborns. To understand better the mechanisms of RF perforation, a numerical model is developed, and experiments are performed in isolated canine cardiac tissue. The model consists of a cylindrical domain with a tissue layer between two blood layers. The finite-difference method is used to compute both the potential and temperature distributions. When the tissue temperature exceeds 100 degrees C in all points that are directly in front of the catheter, these points are considered to be instantly vaporised, and the catheter advances over these points. The computed temperature time course coincides with measured temperature at small voltages (< 16 V). Simulated perforation occurs when the voltage exceeds a threshold of 70-80 V for a catheter diameter of 0.30-0.44 mm, which coincides with experimental observations in the myocardium. A voltage exceeding this perforation threshold tends to decrease tissue damage. Shorter electrodes (0.7 mm as against 2.4 mm) with smaller diameters produce a more rapid perforation. In conclusion, numerical simulations provide insights into aspects of RF perforation, such as electrode size, current, speed of perforation and collateral damage.
Percutaneous aortic valvuloplasty produces acute hemodynamic and clinical improvement in patients with aortic stenosis who are poor candidates for surgical valve replacement. The benefits of this procedure are mitigated by the high restenosis rates and 1--2 year mortality, in addition to significant vascular complications associated with the large arterial puncture necessary for retrograde arterial approaches. We describe the use of suture closure techniques to reduce the vascular morbidity associated with this procedure. We reviewed 31 consecutive patients who underwent percutaneous aortic valvuloplasty and suture closure with the Perclose device between April 1998 and September 2000. After diagnostic catheterization using 6--8 French (Fr) sheaths, an 8 or 10 Fr Perclose device was preloaded into the artery and the untied sutures left in place. A 12.5 or 14 Fr sheath was passed over the wire, through the sutures. The sutures were tied at the conclusion of the procedure, in conjunction with sheath removal. Twenty-seven out of 31 patients (87%) had successful suture closure of the arteriotomy and did not require prolonged bed rest, manual compression or a compression device. There were 4 failures of percutaneous suture closure, requiring conventional manual compression and bed rest for hemostasis. No patient required surgical repair of the arteriotomy, nor were there any limb complications. Compared to 39 consecutive prior patients who had their arterial puncture managed with manual compression, length of stay was shorter (2.2 days versus 5.3 days) and fewer patients received blood transfusions (0% versus 29%). Preloaded suture closure of the arterial puncture is a useful technique for achieving hemostasis after removal of the large sheaths used for percutaneous valvuloplasty, and reduces the post-procedure patient discomfort and prolonged bed rest associated with this procedure.
Catheter-directed perforation of cardiac tissue with radiofrequency (RF) energy has expanded the horizon of the interventional cardiologist dealing with congenital heart disorders. The focus of the following discussion will be to detail the biophysical basis behind RF perforation and review its application in the management of congenital heart lesions.
Septoplasty of the atrial septum was performed with sequential balloon dilation following radiofrequency-assisted perforation of an intact atrial septum in two newborn infants with hypoplastic left heart syndrome and one with double-outlet right ventricle.
A new method for the measurement of left atrial pressure in man is described. In 13 patients the interatrial septum was punctured by means of a flexible needle passed through a cardiac catheter which had been introduced from the saphenous vein and positioned with its tip against the fossa ovalis. No complications were observed after the procedures. The advantages of the technique and its present and projected usefulness are discussed.
Experiences with 450 transseptal left heart catheterizations are reviewed. There were no mortalities in this series, and the only significant complication was accidental puncture of the aorta in three patients. The equipment and technic employed in the current method, by which a radiopaque catheter of large caliber is introduced into the left ventricle, are described in detail. The advantages of this modification are outlined.
- Seldinger