International Journal of Cardiovascular ResearchISSN: 2324-8602

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Research Article, Int J Cardiovas Res Vol: 6 Issue: 2

Safety of Percutaneous Left Atrial Appendage Occlusion in Patients with Atrial Fibrillation after Acute Coronary Syndrome: A Single Center Experience

Giovanni Ciccarelli, Chiara D’Amico, Mattia Izzo, Giovanni Cimmino, Alberto Morello and Paolo Golino*
Department of Cardio-Thoracic and Respiratory Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy
Corresponding author : Paolo Golino
Department of Cardio-Thoracic and Respiratory Sciences, Section of Cardiology, University of Campania “Luigi Vanvitelli”, Naples, Italy
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Received: December 08, 2016 Accepted: January 11, 2017 Published: January 19, 2017
Citation: Ciccarelli G, D’Amico C, Izzo M, Cimmino G, Morello A, et al. (2017) Safety of Percutaneous Left Atrial Appendage Occlusion in Patients with Atrial Fibrillation after Acute Coronary Syndrome: A Single Center Experience. Int J Cardiovasc Res 6:2. doi: 10.4172/2324-8602.1000302

Abstract

Aims: In patients with atrial fibrillation (AF) and indication to Dual Antiplatelet Therapy (DAPT) for Acute Coronary Syndrome (ACS), triple therapy is recommended. However, this issue is still largely debated. Percutaneous Left Atrial Appendage (LAA) occlusion may represent an alternative therapeutic approach in this subset of patients, as it could lead to a reduction in the incidence of bleeding. Nevertheless, due to lack of clinical evidence, this approach does not represent the gold standard treatment for these patients. The objective of this study is to evaluate the safety of percutaneous LAA occlusion in patients with Atrial Fibrillation and indication of concomitant DAPT for ACS. Methods and Results: Fifteen AF-patients with indications to anticoagulant and DAPT after ACS underwent LAA occlusion with Amplatzer Cardiac Plug (ACP) or Amulet ACP (St. Jude) from October 2014 to May 2016. Procedural success was achieved in 14/15 patients, while in 1 patient a clinically non-relevant pericardial effusion was registered before the trans-septal puncture, without implantation of the device. No peri-procedural death, major bleeding and dislocation or thrombi of the device were recorded. During a median follow-up of 182 days (interquartile range [IQR]: 169 to 183 days), one peri-procedural minor bleeding and two non cardiovascular death were described. Conclusions: LAA occlusion represents a relatively safe procedure for patients with atrial fibrillation and the need of DAPT due to ACS. Randomized trials should be designed to evaluate the efficacy and safety of this procedure in this clinical setting.

Keywords: Left atrial appendage occlusion; Dual antiplatelet therapy; Structural heart intervention; Acute coronary syndrome; Percutaneous coronary intervention

Keywords

Left atrial appendage occlusion; Dual antiplatelet therapy; Structural heart intervention; Acute coronary syndrome; Percutaneous coronary intervention

Introduction

Currently, there is a large consensus for the post-discharge treatment of patients with Acute Coronary Syndromes (ACS) who should receive Dual Antiplatelet Therapy (DAPT) for 12 months [1]. In particular, the association of ASA plus Ticagrelor or Prasugrel (third-generation P2Y12 inhibitors) represents a first-choice therapy as suggested by current guidelines, unless contraindicated, while Clopidogrel should be used if the newer P2Y12 inhibitors are contraindicated or not available [1].
The estimated prevalence of atrial fibrillation (AF) in adults is 2.8% overall (on an age- and sex-adjusted basis), 3.3% in males (ageadjusted) and 2.4% in females (age-adjusted) [2].
About 20–30% of patients with AF have concomitant ischemic heart disease that requires percutaneous coronary intervention (PCI) with stenting, and many develop an ACS requiring PCI with stent implantation [3]. Non-valvular AF patients with CHA2DS2- VASc ≥ 2 (CHA2DS2-VASc ≥ 3 in case of female patients) require a long-life therapy with new oral anticoagulant (NOAC) or vitamin K antagonists (OAC) to prevent cardio-embolic stroke, the incidence of which is about 5% per year [4].
Compared to Clopidogrel, Ticagrelor and Prasugrel ensure a more effective and stronger antiplatelet activity reducing thrombotic risk, despite a substantial increase in bleeding rate [5]. At present, however, there is no study supporting the efficacy and safety of the association of the newer P2Y12 inhibitors and (N)OAC. Accordingly, these associations should be avoided (class of evidence III C) [1].
In patients with Atrial Fibrillation and concomitant indication to DAPT for ACS or elective stent implantation, the association of a (N) OAC and ASA plus clopidogrel for a period of 1-6 months is recommended, taking into account the bleeding risk. However, these indications have a class of evidence C [1], which means lack of clinical studies.
During the last few years, a new attractive technique to reduce the incidence of cardio-embolic stoke in patients with AF has been developed, represented by Left Atrial Appendage (LAA) occlusion. LAA is a tubular blindended structure with different lobes and variable morphology and represents a particularly low flow area, with an increased incidence in thrombus formation [6], estimated as 90% of the overall thrombi in non-valvular AF patients [7].
Currently, three devices have been approved for LAA occlusion: the Watchman (Boston Scientific), the WaveCrest (Coherex Medical), and the Amulet ACP (St. Jude Medical, Plymouth, MN, USA). Randomized non-inferiority trials highlighted the efficacy of percutaneous closure of the LAA, demonstrating that LAA closure is non-inferior to warfarin therapy in reducing cardio-embolic stroke rate with a lower bleeding risk [8]. Furthermore, in the PROTECT AF trial after 3.8 years of follow-up, patients with non valvular AF at elevated risk for stroke treated with percutaneous LAA occlusion, met criteria for both non-inferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular [9].
A Recent Consensus Statement suggests that in patients with Atrial Fibrillation and the need of prolonged DAPT, LAA occlusion should be considered as a possible alternative approach [10]. However, at present, no studies are available in order to demonstrate the safety and efficacy of this procedure in this subset of patients.
Thus, the objective of this study was to evaluate the safety of percutaneous LAA occlusion in fifteen AF patients with indication to DAPT after an ACS.

Methods

From October 2014 to May 2016 we have performed fifteen procedures of LAA occlusion with the Amplatzer Cardiac Plug (ACP) or AMULET device (St. Jude Medical), in patients with AF Fibrillation and indication to OAC (CHA2DS2-VASc ≥ 2) and the concomitant need of DAPT due to a recent occurrence of ACS.
The implantation of the device was performed according to standard procedure, in average 42 ± 31 days after ACS. Before the procedure, patients underwent TEE to exclude thrombi in the left atrium and to size the LAA. A written informed consent was obtained in all subjects. Pre operative treatment consisted of 300-325 mg aspirin daily, loading dose of 300 mg clopidogrel and Heparin 0.5 mg/ kg twice/day (LMWH) since PCI.
Clinical follow-up were planned after three months, in which also a TEE was performed, and six months after LAA occlusion.

Results

Indication for LAA occlusion was an ACS in the previous 12 months in all patients included.
The mean age was 74 ± 6 y.o. All patients had Atrial fibrillation (7/15 Paroxysmal, 4/15 Persistent, 4/15 Chronic). The mean CHA2DS2-VASc was 4.5 ± 1.3, while the mean HASBLEED was 3.4 ± 0.9. The most common size implanted was 20 mm (Table 1).
Table 1: Baseline characteristic of the patients.
Procedural success was achieved in 14/15 (93.3%) patients. A clinically non-relevant pericardial effusion before the trans-septal puncture was the only peri-procedural complication recorded in this population. In this patient, the LAA device was not implanted.
Median follow-up time was 182 days (interquartile range [IQR]: 169 to 183 days). TEE showed a trivial peri-device leak only in 1/15 patient after three months.
No dislocations and thrombi device-related were reported, as well as ischemic stroke affected the patients and cardiovascular death.
According to TIMI bleeding score, one minor bleeding was registered, represented by an episode of epistasis. A total of 2/15 non cardiovascular death was recorded at follow-up.
After LAA occlusion, 9/15 patients were treated with Asa+Clopidogrel, 3/15 with Asa/Ticagrelor, 1/15 with Asa+Prasugrel and 1/15 with Indobufen+clopidogrel due to Asa allergy for at least six months. The patient in whom the device was not implanted, continued DAPT with clopidogrel and ASA plus OAC.

Discussion

Recent studies have highlighted that TT causes a significant and clinically relevant increase in bleeding events, as compared to double therapy [11], particularly in patients with a high HAS-BLED score. Moreover, it is known that bleeding commonly occurs within the first month of triple therapy in the majority of patients [12], and the combination of oral anticoagulants and antiplatelet therapies is associated with a high annual risk (4-16%) of fatal and non-fatal bleeding episodes.
In compliance with the 2014 ESC Guidelines on Myocardial Revascularization of European Society of Cardiology, all patient with ACS and AF with CHA2DS2-VASc ≥ 2 should be treated with OAC and Dual Antiplatelet Therapy (Clopidogrel plus ASA); however, a French Registry has highlighted that only 30% of patients with ACS and AF were guideline adherent [13].
The main indication for LAA occlusion is represented by relative or absolute contraindication to (N)OACs in patients with AF and a CHA2DS2-VASc ≥ 1 or ≥ 2 [14].
At the same time, a new possible indication has been proposed. Patients with an increased bleeding risk under systemic anticoagulation (i.e. Triple therapy in ACS patients or after elective PCI and AF), indeed, could benefit from the LAA occlusion taking advantage of hypothetical reduced bleeding risk due to the fact that, in this way, can be avoided the use of anticoagulant and, at the same time, in particular in the context of ACS, ASA could be associated to the new P2Y12 inhibitors, reducing the thrombotic risk. However, the data supporting these indications are scarce.
A multicenter experience with ACP involving 1047 patients has demonstrated a procedural success in 97.3% of cases. In our study, the procedural success was achieved in 93,3% (14/15 patients) of cases. No death device related was reported.
This finding reinforced the indication of LAA occlusion in patient with AF and the need of DAPT for ACS, showing the relative safety of the procedure in this setting of patient and, at the same time, a low incidence of adverse events.

Study Limitations

This study shows some limitations. First of all, it is not randomized and all the patients were treated in a single center. Therefore, the number of patients included is small and not powered to demonstrate the safety of the procedure.

Conclusion

Despite triple therapy in ACS and AF-patients is recommended and, in particular, OAC long-life must be continued when indicated, several study have demonstrated a significant underuse of this strategy [15]. This finding is related, probably, to the clinical characteristics of the patients that are often elders or with other comorbidities that discourage the Physician to expose them to a higher bleeding risk. On the other hand, there is a clear lack of evidences about the correct duration of TT and, in particular, about use of third-generation P2Y12 receptor-antagonist in association with OAC, that doesn’t allow an appropriate antithrombotic therapy with more effective drugs as compared to clopidogrel.
LAA occlusion in this setting is a relatively safe procedure and could be represent a new therapeutic strategy. Furthermore, after LAA occlusion, therapy with (N) OACs should be stopped, allowing treatment with a new P2Y12 inhibitors (ticagrelor 90 mg or prasugrel 60 mg) or clopidogrel plus aspirin 100 mg up to 12 months after the ACS, then ASA long-life.
This scenario still represents an unmet clinical need and randomized trial must be performed in order to better clarify this issue.

Ethical Approval

All procedures performed in studies were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

References

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