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Neth Heart J|既往大出血或不符合口服抗凝条件的房颤患者的左心耳封堵

Left atrial appendage closure in atrial fibrillation patients with prior major bleeding or ineligible for oral anticoagulation

Neth Heart J Original ArticleEarly Recent, June 11, 201910.1007/s12471-019-1295-5本文由“天纳”临床学术信息人工智能系统自动翻译

Aims

Oral anticoagulation (OAC) reduces the ischaemic stroke risk in patients with atrial fibrillation (AF), but in turn leads to an increased risk of adverse bleeding events. Alternatively, left atrial appendage closure (LAAC) using a mechanical device might overcome these bleeding complications. However, evidence regarding LAAC in patients at high bleeding risk is scarce. This study evaluates the clinical features of AF patients with previous bleeding that underwent LAAC.口服抗凝剂(OAC)可降低房颤(AF)患者的缺血性卒中风险,但反过来会增加不良出血事件的风险。使用机械装置的左心耳封堵术(LAAC)可以克服这些出血并发症。然而,关于LAAC在高出血风险患者中的证据很少。本研究评估了房颤患者既往接受LAAC出血的临床特点。

Methods

In this retrospective cohort study patients with previous major bleeding or a bleeding predisposition scheduled for transcatheter LAAC were included. The frequency and type of previous bleeding events and prevalence of bleeding and ischaemic stroke during follow-up were evaluated.在这项回顾性队列研究中,纳入了既往有大出血或经导管LAAC出血倾向的患者。评估随访期间既往出血事件的频率和类型以及出血和缺血性卒中的发生率。

Results

A total of 73 patients (58% male, age 72.1 ± 7.2 years; CHA2DS2-VASc 4.5 [3.0–5.0]; HAS-BLED 4.0 [3.0–4.0]; 46% paroxysmal AF) were included. Previous bleeding occurred from intracranial (n = 50, 69%), gastro-intestinal (n = 13, 18%) or multiple (n = 16, 22%) foci. After OAC discontinuation due to bleeding, 19% suffered subsequent stroke. LAAC was successful in 96% of patients. During a median of almost 3 years’ follow-up recurrent major bleeding occurred in 4 patients (5.5%) despite OAC discontinuation in 93.2%. A total of 6 ischaemic strokes were observed, resulting in an annualised stroke rate of 2.9% compared to a calculated expected stroke rate of 6.7%.共纳入73例患者(58%男性,年龄72.1岁±7.2岁;CHA2DS2-VASc 4.5[3.0-5.0];HAS-BLED出血评分4.0[3.0-4.0];46%阵发性房颤)。既往出血发生于颅内(n=50,69%)、胃肠(n=13,18%)或多发(n=16,22%)病灶。因出血停药后,19%的患者随后发生卒中。在96%的患者中,LAAC是成功的。尽管OAC停药率为93.2%,但在近3年的随访中,4例患者(5.5%)出现了复发性大出血。总共观察到6例缺血性卒中,其年化卒中率为2.9%,而计算出的预期卒中率为6.7%。

Conclusions

Percutaneous LAAC may provide an alternative strategy to long-term OAC therapy in AF patients with a high bleeding risk. During follow-up, both ischaemic stroke and recurrent bleeding rates were lower than expected based on the CHA2DS2-VASc and HAS-BLED scores respectively.经皮LAAC可能为房颤患者的长期OAC治疗提供一种替代策略,其出血风险很高。在随访期间,根据CHA2DS2 VASC和HAS-BLED评分,缺血性卒中和复发性出血率均低于预期。

What’s new?

Left atrial appendage closure (LAAC) provides an alternative to long-term oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) patients.左心耳关闭术(LAAC)为预防房颤(AF)患者中风提供了长期口服抗凝剂(OAC)的替代方案。LAAC may reduce stroke risk and eliminate the need for OAC therapy in patients ineligible for OAC.对于不符合OAC要求的患者,LAAC可降低中风风险,并消除OAC治疗的必要性。We present one of the larger registries of patients with previous major bleeding or very high bleeding risk that underwent transcatheter LAAC.我们提出了一个更大的注册患者以前的大出血或非常高的出血风险,接受了经导管LAAC。During long-term follow-up, stroke and bleeding rates were lower than expected based on CHA2DS2-VASc and HAS-BLED scores respectively, despite discontinuation of OAC in 93.2% of patients.在长期随访中,尽管93.2%的患者停止OAC治疗,但基于CHA2DS2 VASC和HAS-BLED评分,卒中和出血率均低于预期。Percutaneous LAAC may provide an alternative strategy to long-term OAC therapy in AF patients with a very high bleeding risk or a history of major bleeding.经皮LAAC可为房颤患者的长期OAC治疗提供一种替代策略,其出血风险非常高或有严重出血史。

IntroductionThromboembolic clots formed in the left atrial appendage account for up to 90% of atrial fibrillation (AF)-related strokes in patients with AF [1]. Although oral anticoagulation (OAC) therapy with vitamin K antagonists (VKA) significantly reduces the risk of stroke, this is associated with an increased risk of adverse (major) bleeding events. Even the non-VKA OACs (NOACs) are associated with an increased bleeding risk [2, 3, 4, 5, 6]. Moreover, patients with a history of major bleeding or contra-indications for OAC have always been excluded from the randomised trials.在房颤患者中,左心耳形成的血栓栓塞血栓占房颤(AF)相关卒中的90%。尽管口服维生素K拮抗剂(VKA)抗凝(OAC)治疗可显着降低中风风险,但这与不良(主要)出血事件的风险增加有关。即使是非VKA OAC(NOAC)也会增加出血风险[2,3,4,5,6]。此外,有严重出血史或OAC禁忌症的患者总是被排除在随机试验之外。Stroke prevention strategies are particularly challenging in patients in whom (N)OAC is contra-indicated. The need for OAC should be based on a careful individualised assessment of both stroke and bleeding risk, indicated as CHA2DS2-VASc and HAS-BLED score respectively [7]. Left atrial appendage closure (LAAC) using a mechanical device can provide an alternative to lifelong anticoagulation. Two large-scale randomised controlled trials have demonstrated the safety and efficacy of the Watchman device compared to long-term OAC therapy for stroke prevention [8, 9]. However, in these trials only patients without contra-indications for long-term OAC were included. Evidence for LAAC in patients with a history of major bleeding under (N)OAC is scarce, yet this is expected in the designated patient population in whom this therapy may be considered in current ESC guidelines [10]. In this observational cohort study, we report the clinical features of a real-world series of consecutive patients with previous major bleeding or very high bleeding risk that underwent transcatheter LAAC in our centre. The aim of the study was to show the procedural efficacy and safety and long-term outcome >对于那些(n)OAC禁忌的患者,中风预防策略尤其具有挑战性。OAC的需求应基于对中风和出血风险的仔细的个体化评估,分别表示为CHA2DS2 VASC和HAS-BLED评分[7]。使用机械装置的左心耳关闭术(LAAC)可以提供终身抗凝的替代方法。两项大规模随机对照试验表明,与长期OAC治疗相比,Watchman装置预防中风的安全性和有效性[8,9]。然而,在这些试验中,只包括没有长期OAC禁忌症的患者。在有(n)OAC下大出血史的患者中,LAAC的证据很少,但在当前的ESC指南[10]中可以考虑这种治疗的指定患者人群中,这是可以预料的。在这项观察性队列研究中,我们报告了在我们中心接受经导管LAAC治疗的既往严重出血或出血风险极高的一系列连续患者的临床特征。本研究的目的是在所选的房颤患者人群中展示手术的有效性、安全性和长期结果数据,这些患者过去因严重出血问题寻求OAC的替代方案,目前文献中的证据非常有限。

MethodsIn this retrospective single-centre cohort study, consecutive patients scheduled for percutaneous LAAC, with non-valvular AF and contra-indications to OAC therapy, including previous major bleeding and very high tendency to fall, were included. Patients who underwent stand-alone LAAC as well as patients scheduled for a combined procedure with catheter ablation (CA) followed by LAAC were included.在这项回顾性单中心队列研究中,连续的经皮LAAC患者,包括非瓣膜性房颤和OAC治疗禁忌症,包括以前的大出血和非常高的跌倒倾向。包括接受独立LAAC的患者以及计划进行导管消融术(CA)联合手术并随后进行LAAC的患者。

Data collection

Data on percutaneous LAAC are collected prospectively by means of a web-based database. We recorded the rate and type of previous bleeding events, management of anticoagulation after bleeding, peri-procedural characteristics and prevalence of major bleeding and ischaemic stroke during follow-up.通过基于网络的数据库前瞻性地收集经皮LAAC的数据。我们记录了既往出血事件的发生率和类型、出血后抗凝治疗、围手术期特征以及随访期间大出血和缺血性卒中的发生率。

Patient and procedural management

All patients visited a cardiologist-electrophysiologist for evaluation of eligibility for percutaneous LAAC. Patients with an indication for LAAC were evaluated in multidisciplinary team meetings.所有患者都拜访了心脏病学家电生理学家,以评估经皮LAAC的合格性。在多学科小组会议上对有LAAC适应症的患者进行评估。Transoesophageal echocardiography (TOE) was performed in all patients prior to the procedure to evaluate the LAA anatomy and to exclude intracardiac thrombus.所有患者在术前均行经食管超声心动图(TOE)检查,以评估LAA解剖结构并排除心内血栓。LAAC could be performed by either of the available percutaneous techniques used in our centre, Watchman (Boston Scientific, Natick, MA, USA) or Amplatzer Amulet (Abbott, Minneapolis, MN, USA). The choice of technique was left to the physician’s discretion.LAAC可通过我们中心、Watchman(波士顿科学公司、纳蒂克公司、马萨诸塞州)或Amplatzer Amulet(阿伯特公司、明尼阿波利斯公司、明尼苏达州、美国)使用的任何一种经皮技术进行。技术的选择由医生决定。If patients were scheduled for the combined procedure, CA was performed prior to LAAC. All patients underwent post-procedural chest radiography to confirm the proper position of the device.如果患者被安排进行联合手术,则在LAAC前进行CA。所有患者均接受术后胸部X光检查以确认装置的正确位置。

Follow-up

All patients were seen by their treating cardiologist-electrophysiologist in the outpatient clinic 3 and 12 months after the procedure. In addition, regular telephone interviews were performed.术后3个月和12个月,所有患者都在门诊接受治疗的心脏病学家电生理学检查。此外,还定期进行电话采访。Rhythm monitoring was performed through electrocardiograms (ECGs) and Holter recordings at 6 and 12 months of follow-up. Patients with symptoms suggestive of recurrent atrial arrhythmias were encouraged to obtain symptom-driven ECG recordings.在随访6个月和12个月时,通过心电图(ECG)和动态心电图记录进行心律监测。鼓励有反复房性心律失常症状的患者获得症状驱动的心电图记录。

Antithrombotic therapy

The recommended post-implant regimen consisted of (1) clopidogrel and aspirin for 1–3 months (for Amplatzer devices) and for 6 months (for Watchman devices) post-implantation, (2) aspirin indefinitely.推荐的植入后方案包括(1)氯吡格雷和阿司匹林,1-3个月(用于安培酮装置)和6个月(用于看守装置)植入后,(2)阿司匹林无限期。However, the choice and duration of post-implant antithrombotic medication was not mandatory and was left to the physician.然而,植入后抗血栓药物的选择和持续时间不是强制性的,而是留给医生。TOE was repeated between 45 and 60 days post-procedure to evaluate device position, residual flow and thrombus formation.术后45-60天重复足趾,以评估器械位置、残余流量和血栓形成。

Outcome

In this observational cohort study, we report on the incidence of ischaemic stroke during clinical follow-up. In the absence of a control group, the observed stroke rate was compared to the predicted stroke rate based on the CHA2DS2-VASc score [11].在这项观察性队列研究中,我们报告了临床随访期间缺血性卒中的发生率。在没有对照组的情况下,观察到的中风率与基于CHA2DS2 VASC评分的预测中风率进行比较[11]。Secondary outcome included procedural success, peri-procedural complications up to 30 days, management of antithrombotic medication, freedom from atrial tachyarrhythmias and major bleeding during follow-up.次要结果包括手术成功率、30天内的围手术期并发症、抗血栓药物治疗、无房性心律失常和随访期间的大出血。Major bleeding was defined as bleeding type 3 or greater according to the BARC criteria [12].根据BARC标准[12],大出血定义为3或更大的出血类型。

Results

Patient selection and characteristics

Between 2010 and 2016, a total of 135 patients were scheduled for percutaneous LAAC in our institution, of whom 73 were included in this study. Patient characteristics at baseline are shown in Tab. 1.2010年至2016年,我院共安排135例经皮LAAC患者,其中73例纳入本研究。基线的患者特征如表1所示。Table 1

Total no. of patients

73

Age, years ± SD

72.1 ± 7.2

Male

42 (58%)

Paroxysmal AF

32 (44%)

Persistent or long-standing persistent AF

41 (56%)

CHADS 2

3.0 [2.0–4.0]

CHA 2 DS 2 -VASc

4.5 [3.0–5.0]

HAS-BLED

4.0 [3.0–4.0]

History of stroke

30 (41%)

History of bleeding

70 (96%)

Intracranial bleeding

50 (69%)

Gastro-intestinal bleeding

13 (18%)

Pulmonary bleeding

2 (3%)

Other bleeding site

17 (33%)

Multiple bleeding sites

16 (22%)

Indefinite OAC withdrawal after bleeding

63 (86%)

Stroke after OAC withdrawal

14 (19%)

Stand-alone LAAC procedure

45 (61.6)

Combined CA and LAAC

28 (38.4)

Device type

 
Watchman 69 (94.5)
Amplatzer Amulet 4 (5.5)

Successful LAAC

70 (95.9)
Complete LAA closure 67 (95.7)
Minimal residual flow 3 (4.3)

Number of devices used

1.0 [1.0–1.0]

Total procedure time, min

92 ± 34

Total procedure time stand-alone, min

78 ± 31

Fluoroscopy time, min

11 ± 5

Major 30-day complications

6 (8.2)
Pericardial effusion 0 (0.0)
Intracoronary air embolus 1 (1.4)
Device embolisation 2 (2.7)
Stroke 1 (1.4)
TIA 2 (2.7)
Death 0 (0.0)

Minor 30-day complications

3 (4.1)
Groin haematoma 3 (4.1)

AF atrial fibrillation, CA catheter ablation, LAA left atrial appendage, LAAC left atrial appendage closure, OAC oral anticoagulation, TIA transient ischaemic attack

Previous bleeding, stroke, and antithrombotic management

Details of the prior bleeding events are shown in Tab. 1. Seventy patients (96%) had a history of previous major bleeding. Three patients (4%) were considered ineligible for OAC due to severe thrombocytopenia or elevated falling risk due to narcolepsy and post-dystrophic muscular dystrophy. In the majority of patients (86%) oral antithrombotic therapy had been discontinued or never started. Fourteen patients (19%) suffered a stroke after OAC withdrawal.先前出血事件详情见表1。70名患者(96%)有先前大出血史。三名患者(4%)因严重血小板减少或因嗜睡症和营养不良后肌营养不良导致跌倒风险升高而被认为不符合OAC。大多数患者(86%)已停止或从未开始口服抗血栓治疗。14名患者(19%)在停药后中风。

Procedural characteristics

Procedural characteristics are shown in Tab. 1. LAAC was performed as a stand-alone procedure in 45 of 73 patients (62%). In 28 patients LAAC was combined with CA.程序特征见表1。在73例患者中有45例(62%)采用LAAC作为独立程序。在28例患者中,LAAC与CA结合。Implantation of the LAAC device was unsuccessful in 3 patients: one device dislocation to the left ventricular outflow tract during the procedure and 2 patients with unsuitable anatomy. In 70 patients (95.9%) an LAAC device could be implanted, leading to successful LAAC in all 70.在3例患者中,LAAC装置植入失败:1例装置在手术过程中移位至左心室流出道,2例不合适的解剖结构。70例患者(95.9%)可植入LAAC装置,导致70例患者成功接受LAAC。Serious peri-procedural complications up to 30 days occurred in 6 (8.2%) patients (2 patients with a combined procedure, 4 patients with a stand-alone LAAC procedure).6例(8.2%)患者(2例联合手术,4例独立LAAC手术)出现严重的围手术期并发症达30天。Peri-procedural dislocation of the Watchman device occurred in 2 patients (2.7%); in one patient a new device could be successfully implanted in the LAA. Two transient ischaemic attacks (TIAs) and one ischaemic stroke were reported to occur within 24 h of the procedure. TOE was performed in all these patients, showing complete closure of the LAA with no residual flow and no device thrombus. In the patient with a stroke, left atrial thrombus had been seen on TOE after the ablation sheath was exchanged for the Watchman sheath. Despite an extra 5,000 IU of heparin, this patient suffered an ischaemic stroke hours after the procedure with residual complaints. No peri-procedural major bleeding, pericardial effusion, tamponade or death occurred. Minor groin haematoma was seen in 3 patients (4.1%).2例患者(2.7%)出现了守望者装置的围手术期脱位;1例患者A新装置可以成功植入LAA。术后24小时内发生两次短暂性缺血发作(TIA)和一次缺血卒中。所有这些患者都进行了足趾检查,显示LAA完全闭合,无残余血流和装置血栓。在中风患者中,消融鞘与守望者鞘交换后,脚趾上出现左房血栓。尽管额外增加了5000国际单位的肝素,但该患者在手术后数小时出现缺血性中风,并伴有残余投诉。无围手术期大出血、心包积液、心包填塞或死亡。3例患者(4.1%)出现轻微腹股沟血肿。

Transoesophageal echocardiographic follow-up

TOE was performed within 45–60 days in 69 of 70 (98.6%) patients with a successfully implanted LAAC device, showing successful sealing of the LAA in 68 of 69 (98.5%) and significant residual flow in 1 of 69. No device thrombi were found.70例成功植入LAAC装置的患者中,69例(98.6%)在45-60天内完成了脚趾手术,69例(98.5%)中68例(98.5%)显示了LAA的成功闭合,69例中1例显示了明显的残余流量。找不到设备血栓。

Antithrombotic therapy management

Table 2 shows pre- and post-implant oral antithrombotic therapy in all 73 patients.表2显示了73例植入前和植入后口服抗血栓治疗。Table 2
  Pre-procedural 3 months End of FU

VKA

8 (11.0%) 5 (6.8%) 2 (2.7%)

NOAC

1 (1.4%) 1 (1.4%) 3 (4.1%)

DAPT

0 (0.0%) 16 (21.9%) 6 (8.2%)

SAPT

36 (49.3%) 45 (61.6%) 52 (71.2%)

None

28 (38.3%) 6 (8.2%) 10 (13.7%)

VKA vitamin K antagonist, NOAC non-vitamin K antagonist oral anticoagulation, DAPT dual antiplatelet therapy, SAPT single antiplatelet therapy, FU follow-up

After 35.5 months of follow-up, only 5 patients were still receiving VKA (2) or NOAC (3) therapy. Fifty-eight patients were on either single (71%) or dual (8%) antiplatelet therapy, while 10 patients (14%) were receiving no antithrombotic medication at all.随访35.5个月后,只有5例患者仍在接受vka(2)或noac(3)治疗。58名患者接受单次(71%)或双次(8%)抗血小板治疗,10名患者(14%)根本没有接受抗血栓药物治疗。

Clinical outcome

Table 3 shows the clinical outcome of the patients after a median follow-up period of 35.5 months.表3显示了患者在35.5个月的中位随访期后的临床结果。

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Left atrial appendage closure in atrial fibrillation patients with prior major bleeding or ineligible for oral anticoagulation

Neth Heart J Original ArticleEarly Recent, June 11, 201910.1007/s12471-019-1295-5

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