Comparison between the novel diamond temp and the classical 8-mm tip ablation catheters in the setting of typical atrial flutter

Ramak, Robbert; Lipartiti, Felicia; Mojica, Joerelle; Monaco, Cinzia; Bisignani, Antonio; Eltsov, Ivan; Sorgente, Antonio; Capulzini, Lucio; Paparella, Gaetano; Deruyter, Bernard; Iacopino, Saverio; Motoc, Andreea; Luchian, Maria–Luiza; Osório, Thiago Guimarães; Overeinder, Ingrid; Bala, Gezim; Almorad, Alexandre; Ströker, Erwin; Sieira, Juan; Jordaens, Luc; Brugada, Pedro; Asmundis, Carlo de; Chierchia, Gian‐Battista

doi:10.1007/s10840-022-01152-w

Cited by 6 publications

(8 citation statements)

References 26 publications

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“…The in vitro compatibility assessment is a crucial step, which must be done prior to clinical trials ( 3 , 4 ). In the current study a previously developed universal method for compatibility assessment was used ( 1 ).…”

Section: Discussionmentioning

confidence: 99%

“…The catheter operates in temperature control mode and a dedicated RF generator (RFG), titrates rapidly the delivered power to the target temperature. The dual composite ablation tip behaves as a single electrode during ablation and electrically insulation of the tip allows for high-resolution EGM sensing ( 3 , 4 ).…”

Section: Methodsmentioning

confidence: 99%

“…The novel DiamondTemp TM ablation system (DTA), (Medtronic Inc, Minneapolis, MN) and EnSiteX TM EP System (Abbott, St. Paul, MN) are both CE-Marked and FDA approved medical devices ( 3 , 4 ). The DTA has been validated by its manufacturer only in combination with previous version of EnSite System—EnSite Precision TM System (Abbott, St. Paul, MN) ( 5 ).…”

Section: Introductionmentioning

confidence: 99%

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Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

Pannone

Eltsov

Ramak

et al. 2023

Front. Cardiovasc. Med.

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BackgroundThe novel DiamondTemp ablation system (DTA) and EnSiteX mapping System (EAM) are both CE-Marked and FDA approved medical devices. The DTA has been validated by its manufacturer only in combination with previous version of EnSite System—EnSite Precision. The aim of this study was to evaluate compatibility of DTA with EnSite X with a previously developed protocol.MethodsThree configurations were tested: 3.1. Medtronic Generator connection Box (GCB) and AmpereConnect cable; 3.2. the Medtronic GCB-E and electrogram out cable from GCB to EAM; 3.3. Direct connection of DTA to EAM using intracardiac out cable with no GCB.ResultsThe previously developed universal method for compatibility assessment of ablation catheters and navigation systems was used with success for assessing DTA and EnSite X EAM compatibility, with reproducible results. Accuracy of DTA visualization with different setups was evaluated with a phantom model measuring distances between DTA and reference points. DTA is compatible with EnSiteX EAM with a safety and reliability profile guaranteed, if within the described specifications. In particular, careful setup is mandatory to achieve good clinical outcomes as only setup 3.2 is viable for both NavX and Voxel Mode and demonstrated satisfactory results and accuracy. Setup 3.3 showed a significant shift immediately after catheter insertion. Catheter position was away from baseline points and the dislocation increased during the radiofrequency delivery.ConclusionsPreviously developed method for compatibility assessment of ablation catheters and navigation systems has been used for a new EAM. DTA is compatible with EnSiteX EAM with proper configuration.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

Pannone

Eltsov

Ramak

et al. 2023

Front. Cardiovasc. Med.

Self Cite

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show abstract

“…The catheter operates in a temperature control mode and a dedicated RF generator (RFG) titrates rapidly the delivered power to the target temperature. The dual composite ablation tip behaves as a single electrode during ablation and the electrical insulation of the tip allows for high-resolution EGM sensing ( 3 , 4 ).…”

Section: Methodsmentioning

confidence: 99%

Universal Method of Compatibility Assessment for Novel Ablation Technologies With Different 3D Navigation Systems

Pannone

Eltsov

Ramak

et al. 2022

Front. Cardiovasc. Med.

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BackgroundNew technologies for ablation procedures are often produced by different companies with no cross-compatibility out of the box. This is not a negligible clinical problem since those separately developed devices are often used together. The aim of this study was to develop a bench-testing method to assess compatibility between the DiamondTemp ablation system (DTA) and the Rhythmia electroanatomic mapping system (EAM).MethodsDifferent setups were tested. DTA was connected to the Rhythmia EAM using the following configurations: 3.1. An Ensite EPT GenConnect box (GCB) and Rhythmia Maestro GCB (Maestro GCB, native Rhythmia setup); 3.2. The Medtronic GCB-E and Maestro GCB; 3.3. The Medtronic GCB-E out via the Medtronic GCB-E directly to the Rhythmia at box 1 (pin A61 to A64).ResultsThe DTA location was represented in real-time on the Rhythmia EAM. A proper tracking of the DTA was observed in all setups tested by visual comparison of physical catheter movements and its representation on EAM. In configuration 3.1, a significant shift was observed after the first radio frequency (RF) application; however, further applications caused no further shift. In setup 3.2, no significant shift was observed. The setup 3.3 showed a massive shift in the catheter position before ablation compared to baseline points acquired using the Orion catheter as a reference.ConclusionsA universal and reproducible solution for compatibility testing between the various mapping systems and the ablation catheters has been described. DTA has been demonstrated as compatible with Rhythmia EAM with satisfactory results if a specific setup is used.

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“…The rationale behind this technique is an improved impact of direct resistive heating and reduction of less effective and potentially harmful conductive heating through shorter application times [ 2 ]. With its technical specifications, the DT catheter combines high ablation power levels with a direct temperature feedback, demonstrating its efficiency in preclinical models, cavotricuspid isthmus ablation (CTI) [ 3 ] and ventricular tachycardia ablation [ 4 ]. Recently, a novel electroanatomical mapping system (EnSite X; Abbott, Abbott Park, North Chicago, Illinois, USA) became commercially available allowing for omnipolar and ultra-high-resolution mapping.…”

Section: Introductionmentioning

confidence: 99%

First clinical experience using the DiamondTemp catheter and a novel omnipolar high-resolution mapping system for atrial fibrillation ablation

et al. 2023

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Comparison between the novel diamond temp and the classical 8-mm tip ablation catheters in the setting of typical atrial flutter

Cited by 6 publications

References 26 publications

Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

Universal Method of Compatibility Assessment for Novel Ablation Technologies With Different 3D Navigation Systems

First clinical experience using the DiamondTemp catheter and a novel omnipolar high-resolution mapping system for atrial fibrillation ablation

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