• This record comes from PubMed

Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies

. 2024 Mar 30 ; 26 (4) : .

Language English Country Great Britain, England Media print

Document type Clinical Trial, Journal Article, Multicenter Study

Persistent link   https://www.medvik.cz/link/pmid38582974

Grant support
Adagio Medical Inc

AIMS: The ultra-low-temperature cryoablation (ULTC) ablation system using -196°C N2 cryogen has been reported to create lesions with freeze duration-dependent depth titratable to over 10 mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). METHODS AND RESULTS: This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1-9) to 0, IQR (0-2). CONCLUSION: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. CLINICAL TRIAL REGISTRATION: NCT04893317.

See more in PubMed

Scott  M, Baykaner  T, Bunch  TJ, Piccini  JP, Russo  AM, Tzou  WS  et al.  Contemporary trends in cardiac electrophysiology procedures in the United States, and impact of a global pandemic. Heart Rhythm O2  2023;4:193–9. PubMed PMC

Eckardt  L, Doldi  F, Busch  S, Duncker  D, Estner  H, Kuniss  M  et al.  10-year follow-up of interventional electrophysiology: updated German survey during the COVID-19 pandemic. Clin Res Cardiol  2023;112:784–94. PubMed PMC

Molitor  N, Yalcinkaya  E, Auricchio  A, Burri  H, Delacretaz  E, Kühne  M  et al.  Swiss national registry on catheter ablation procedures: changing trends over the last 20 years. J Clin Med  2021;10:3021. PubMed PMC

Guandalini  GS, Liang  JJ, Marchlinski  FE. Ventricular tachycardia ablation: past, present, and future perspectives. JACC Clin Electrophysiol  2019;5:1363–83. PubMed

Littrup  PJ, Babkin  A. Evolving concepts: Near-critical cooling-based technologies. In: Bredikis  A, Wilber  D (eds). Cryoablation of Cardiac Arrhythmias. Philadelphia: Elsevier; 2011. p107–115.

Bourier  F, Takigawa  M, Lam  A, Vlachos  K, Ramirez  FD, Martin  CA  et al.  Ultralow temperature cryoablation: safety and efficacy of preclinical atrial and ventricular lesions. J Cardiovasc Electrophysiol  2021;32:570–7. PubMed

Marchlinski  FE, Callans  DJ, Gottlieb  CD, Zado  E. Linear ablation lesions for control of unmappable ventricular tachycardia in patients with ischemic and nonischemic cardiomyopathy. Circulation  2000;101:1288–96. PubMed

Hutchinson  MD, Gerstenfeld  EP, Desjardins  B, Bala  R, Riley  MP, Garcia  FC  et al.  Endocardial unipolar voltage mapping to detect epicardial ventricular tachycardia substrate in patients with nonischemic left ventricular cardiomyopathy. Circ Arrhythm Electrophysiol  2011;4:49–55. PubMed PMC

De Potter  T, Klaver  M, Babkin  A, Iliodromitis  K, Hocini  M, Cox  J  et al.  Ultra-low temperature cryoablation for atrial fibrillation: primary outcomes for efficacy and safety: the cryocure-2 study. JACC Clin Electrophysiol  2022;8:1034–9. PubMed

De Potter  T, Balt  JC, Boersma  L, Sacher  F, Neuzil  P, Reddy  V  et al.  First-in-human experience with ultra-low temperature cryoablation for monomorphic ventricular tachycardia. JACC Clin Electrophysiol  2023;9:686–91. PubMed

Dewland  TA, Higuchi  S, Venkateswaran  R, Lee  C, Gerstenfeld  EP. AB-452672-2 ultra-low temperature cryoablation versus ultra-low temperature cryoablation combined with pulsed field ablation in a swine ventricular infarct model. Heart Rhythm  2023;20:S92–3.

Ding  WY, Pearman  CM, Bonnett  L, Adlan  A, Chin  SH, Denham  N  et al.  Complication rates following ventricular tachycardia ablation in ischaemic and non-ischaemic cardiomyopathies: a systematic review. J Interv Card Electrophysiol  2022;63:59–67. PubMed PMC

Igarashi  M, Nogami  A, Fukamizu  S, Sekiguchi  Y, Nitta  J, Sakamoto  N  et al.  Acute and long-term results of bipolar radiofrequency catheter ablation of refractory ventricular arrhythmias of deep intramural origin. Heart Rhythm  2020;17:1500–7. PubMed

Stevenson  WG, Wilber  DJ, Natale  A, Jackman  WM, Marchlinski  FE, Talbert  T  et al.  Irrigated radiofrequency catheter ablation guided by electroanatomic mapping for recurrent ventricular tachycardia after myocardial infarction: the multicenter thermocool ventricular tachycardia ablation trial. Circulation  2008;118:2773–82. PubMed

Marchlinski  FE, Haffajee  CI, Beshai  JF, Dickfeld  TL, Gonzalez  MD, Hsia  HH  et al.  Long-term success of irrigated radiofrequency catheter ablation of sustained ventricular tachycardia: post-approval THERMOCOOL VT trial. J Am Coll Cardiol  2016;67:674–83. PubMed

Tokuda  M, Kojodjojo  P, Tung  S, Tedrow  UB, Nof  E, Inada  K  et al.  Acute failure of catheter ablation for ventricular tachycardia due to structural heart disease: causes and significance. J Am Heart Assoc  2013;2:e000072. PubMed PMC

US FDA Premarket Approval Application (PMA) Number: P110016/S080. 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110016S080B.pdf (29 March 2024).

Tung  R, Xue  Y, Chen  M, Jiang  C, Shatz  DY, Besser  SA  et al.  First-line catheter ablation of monomorphic ventricular tachycardia in cardiomyopathy concurrent with defibrillator implantation: the PAUSE-SCD randomized trial. Circulation  2022;145:1839–49. PubMed

Della Bella  P, Baratto  F, Vergara  P, Bertocchi  P, Santamaria  M, Notarstefano  P  et al.  Does timing of ventricular tachycardia ablation affect prognosis in patients with an implantable cardioverter defibrillator? Results from the multicenter randomized PARTITA trial. Circulation  2022;145:1829–38. PubMed

Willems  S, Tilz  RR, Steven  D, Kaab  S, Wegscheider  K, Geller  L  et al.  Preventive or deferred ablation of ventricular tachycardia in patients with ischemic cardiomyopathy and implantable defibrillator (BERLIN VT): a multicenter randomized trial. Circulation  2020;141:1057–67. PubMed

Zeppenfeld  K, Tfelt-Hansen  J, de Riva  M, Winkel  BG, Behr  ER, Blom  NA  et al.  2022 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J  2022;43:3997–4126. PubMed

Packer  DL, Wilber  DJ, Kapa  S, Dyrda  K, Nault  I, Killu  AM  et al.  Ablation of refractory ventricular tachycardia using intramyocardial needle delivered heated saline-enhanced radiofrequency energy: a first-in-man feasibility trial. Circ Arrhythm Electrophysiol  2022;15:e010347. PubMed PMC

Cronin  EM, Bogun  FM, Maury  P, Peichl  P, Chen  M, Namboodiri  N  et al.  2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Heart Rhythm  2020;17:e2–154. PubMed PMC

Reddy  VY, Reynolds  MR, Neuzil  P, Richardson  AW, Taborsky  M, Jongnarangsin  K  et al.  Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med  2007;357:2657–65. PubMed PMC

Kuck  KH, Schaumann  A, Eckardt  L, Willems  S, Ventura  R, Delacretaz  E  et al.  Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet  2010;375:31–40. PubMed

Tan  MC, Ang  QX, Yeo  YH, Deshmukh  A, Scott  LR, Hussein  AA, et al.  Thirty-day readmission after catheter ablation for ventricular tachycardia: associated factors and outcomes. J Interv Card Electrophysiol  2023;in press. 10.1007/s10840-023-01614-9 PubMed DOI

Rattan  R, Singh  V, Bedi  P, Bumrah  K, Singh  R, Sharma  A. Causes and predictors of hospital readmissions after ischemic ventricular tachycardia ablation. Int J Med Res Prof  2020;6:29–34.

Muser  D, Liang  JJ, Pathak  RK, Magnani  S, Castro  SA, Hayashi  T  et al.  Long-term outcomes of catheter ablation of electrical storm in nonischemic dilated cardiomyopathy compared with ischemic cardiomyopathy. JACC Clin Electrophysiol  2017;3:767–78. PubMed

Bianchi  S, Cauti  FM. Ablation of ventricular tachycardia in 2021. Eur Heart J Suppl  2021;23:E25–e27. PubMed PMC

John  M, Rook  A, Post  A, Mersman  A, Allen  W, Schramm  C  et al.  Bipolar ablation’s unique paradigm: duration and power as respectively distinct primary determinants of transmurality and steam pop formation. Heart Rhythm O2  2020;1:290–6. PubMed PMC

See more in PubMed

ClinicalTrials.gov
NCT04893317

Find record

Citation metrics

Archiving options