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Uninterrupted apixaban therapy vs. warfarin during AF ablation: A question of safety and efficacy

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Catheter ablation is increasingly being performed for patients with paroxysmal and persistent atrial fibrillation (AF). Atrial fibrillation ablation carries a significant risk of thromboembolism and bleeding due to thrombus formation in the left atrium and intraprocedural conversion from AF to sinus rhythm. Multiple strategies are commonly employed peri-AF ablation to reduce the risk of thromboembolic complications, including the use of transesophageal echocardiography, intracardiac echocardiography, irrigated ablation catheters, and intraprocedural anticoagulation. [1]

Historically, patients treated with vitamin k antagonists (VKA) would typically discontinue this medication and be bridged with low-molecular-weight heparin prior to ablation. However, recent recommendations state that patients undergoing an AF ablation can safely undergo the procedure without discontinuation. [1]

Direct oral anticoagulants (DOACs), have emerged as an increasingly common therapy for thromboembolism prevention in AF. However, strategies for its use in the setting of AF ablation have been varied and may be associated with an increased incidence of thromboembolism. [2]

A recent multicenter study published in The American Journal of Cardiology evaluated the safety and efficacy of uninterrupted apixaban versus warfarin anticoagulation in the periprocedural AF ablation setting. [3] There were no thromboembolic events in the apixaban group or the VKA group. There were no significant differences observed in major bleeding endpoints, minor bleeding, pericardial effusion or groin hematoma. Interestingly, the heparin requirement was the same for both warfarin and apixaban; however, while the periprocedural activated clotting time (ACT) in warfarin group was significant, minimum ACT throughout AF ablation was lower. This might suggest that periprocedural apixaban anticoagulation leads to a more consistent ACT in this setting.

Similar comparisons have been made with other DOACs, although study protocols may differ slightly and there is no direct comparison to assess the role, safety and efficacy of each DOAC. There has been conflicting data, with Steinberg et al, [2] and Sardar et al, [4] demonstrating an increase in neurologic complications with dabigatran compared to VKA. This is contrary to the meta-analysis conducted by Honhloser et al, [5] and Providencia et al, [6] who demonstrated no significant differences in the composite of neurologic and bleeding complications between the dabigatran and uninterrupted VKA groups.

There is even less data for Rivaroxaban, although results of prospective observational [7] and randomised [8] trials with uninterrupted rivaroxaban suggest that this therapy appears to be as safe and efficacious in preventing bleeding and thromboembolic events in patients undergoing AF ablation as uninterrupted warfarin therapy.

More recent data from the RE-CIRCUIT (no increase in thromboembolic endpoints; major bleeding reduction with uninterrupted dabigatran) and AEIOU (no differences in thromboembolic or bleeding endpoints with apixaban-either uninterrupted or interrupted by a single dose- or warfarin) trials are also reassuring, and reinforce that in the near future catheter ablation could possibly move towards uninterrupted DOAC anticoagulation to prevent the difficulties with variable INRs.

However, one must emphasize the need for more information to guide the periprocedural use of both DOACs and VKAs in the real-world setting.

This cardionote was prepared by Dr Amelia Carro-Hevia (Spain) and published simultaneously on Cardio Debate and CardioMaster websites, as part of an ongoing collaboration between the two educational platforms. For more information on Cardiomaster please visit www.cardiomaster.net

REFERENCES:

  1. Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017;33(5):369-409.
  2. Steinberg BA, Hasselblad V, Atwater BD, Bahnson TD, Washam JB, Alexander JH, et al. Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: a meta-analysis of observational studies. J Interv Card Electrophysiol. 2013;37 (3):213–21.
  3. Shah RR, Pillai A, Schafer P, Meggo D, McElderry T, et al. Safety and Efficacy of Uninterrupted Apixaban Therapy Versus Warfarin During Atrial Fibrillation Ablation. Am J Cardiol. 2017;120(3):404-407.
  4. Sardar P, Nairooz R, Chatterjee S, Wetterslev J, Ghosh J, Aronow WS. Meta- analysis of risk of stroke or transient ischemic attack with dabigatran for atrial fibrillation ablation. Am J Cardiol. 2014;113(7):1173-7.
  5. Hohnloser SH, Camm AJ. Safety and efficacy of dabigatran etexilate during catheter ablation of atrial fibrillation: a meta-analysis of the literature. Europace. 2013;15(10):1407-11.
  6. Providencia R, Albenque JP, Combes S, Bouzeman A, Casteigt B, Combes N, et al. Safety and efficacy of dabigatran versus warfarin in patients undergoing catheter ablation of atrial fibrillation: a systematic review and meta-analysis. Heart. 2014;100(4):324-35.
  7. Lakkireddy D, Reddy YM, Di Biase L, Vallakati A, Mansour MC, Santangeli P, et al. Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol.2014;63(10):982-8.
  8. Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber D et al; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015;36(28):1805-11.
  9. Calkins H, Willems S, Gerstenfeld EP, Verma A, Schilling R, Hohnloser SH, Okumura K, Serota H, Nordaby M, Guiver K, Biss B, Brouwer MA, Grimaldi M; RE-CIRCUIT Investigators. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017;376(17):1627-1636.
  10. 10.- Reynolds MR, Allison JS, Natale A, et al. A prospective randomized trial of apixaban dosing during atrial fibrillation of ablation: the AEIOU (Apixaban Evaluation of Interrupted or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation) Trial. Heart Rhythm Society (HRS) Scientific Sessions 2017; May 11, 2017; Chicago, IL. Abstract C-LBCT01-05

VASCULAR APPROACHES FOR TRANSCATHETER AORTIC VALVE IMPLANTATION

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Transcatheter aortic valve implantation (TAVI) is a relatively new method to treat patients with severe symptomatic aortic stenosis (AS). TAVI represents a minimally invasive alternative to the current standard treatment for AS, which is surgical aortic valve replacement (AVR).

A recent study published in the Journal of Thoracic Disease, explores the practical aspects for those who deal with TAVI implantation. [1] Here, the authors describe two main steps required to guide the procedure and achieve the desired benefits with minimal complications.

Firstly, assessing patients’ eligibility for TAVI is of utmost importance. Identification of high or prohibitive surgical risk for the patient should rely on the clinical judgment of a Heart Team in conjunction with information from the patient and family, comorbidities and surgical risk scores.

The paper also guides clinicians through the steps required to successfully select the vascular approach, highlighting the value of imaging tests and comparing the findings, advantages and indications of multidetector computed tomography, magnetic resonance and angiography, depending on the vascular segment considered and the renal function of a given candidate. Other imaging modalities are also discussed, including: transthoracic/ transaesophageal echocardiography, intravascular ultrasound, transcarotid/transcranial ultrasonography, cerebrovascular magnetic resonance angiogram.

Secondly, the paper provides a framework with key issues and considerations in performing the procedure through different access routes: (1) transfemoral, (2) transaortic, (3) trans-subclavian (4) transapical, and (5) other approaches (transcarotid, transcaval, and antegrade aortic).

Procedural details include anaesthesia administration, assessment of optimal fluoroscopic views for device deployment, anticoagulation, possible annular predilation, valve delivery and deployment, and post-deployment valve assessment. Vascular complications and other difficulties might be minimised with the aid of these recommendations.

Regarding anaesthetic approaches, in 2014 a subanalysis of the French Aortic National CoreValve and Edwards 2 Registry compared the outcomes in patients who underwent transfermoral TAVI under general anaesthetic (GA) and local anaesthetic (LA). [2] In this subanalysis 2326 patients were analysed. It was found that the outcomes (device success and cumulative 30-day survival rates) were similar in both groups, however postprocedural aortic regurgitation was more common in LA than GA (19.1 versus 15.0%, P = 0.015).

Both anaesthetic approaches have their pros and cons. General anaesthetic allows full control over respiration and ensures patient immobility, but it also carries risks such as haemodynamic instability, which may not be tolerated well in elderly patients. Local anaesthetic is considered more comfortable in elderly patients, and being awake during the procedure enables the rapid detection of stroke and other vascular complications. However, there is an increased incidence of postprocedural aortic regurgitation. [2]

However, TAVI is one of the most rapidly expanding technologies in medical care today, and as our population ages, we will see increasing numbers of people with severe AS. It is important to provide guidance on optimal use of this treatment, as this much-welcomed paper clearly intends to do so. [1]

This cardionote was prepared by Dr Amelia Carro-Hevia (Spain) and published simultaneously on Cardio Debate and CardioMaster websites, as part of an ongoing collaboration between the two educational platforms. For more information on Cardiomaster please visit www.cardiomaster.net

REFERENCES:

  1. Pascual I, Carro A, Avanzas P, Hernández-Vaquero D, Díaz R, Rozado J, Lorca R, Martín M, Silva J, Morís C. Vascular approaches for transcatheter aortic valve implantation. J Thorac Dis. 2017;9(Suppl 6):S478-S487
  2. Oguri A, Yamamoto M, Mouillet G, et al. Clinical outcomes and safety of transfermoral aortic valve implantation under general versus local anesthesia. Subanalysis of the French Aortic National CoreValve and Edwards 2 Registry. Circulation: Cardiovascular Interventions 2014; 7: 602-10.