|Year : 2020 | Volume
| Issue : 3 | Page : 139-147
Five-year outcomes after left atrial appendage closure using LAmbre: From a premarket registered case-series study
Shuang Li1, Jing-Ying Zhang1, Xiang Li2, Xian-Lin Zhang3, Yun-Lan Lu2, Yi-Qian Wang2, Dong-Dong Zhao1, Qiang Ming1, Kai Tang1, Wei Chen1, Meng-Yun Zhu1, Yat-Yin Lam4, Ya-Wei Xu1
1 Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
2 Department of Nursing, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China
3 Department of Cardiology, The First Affiliated Hospital of Bengbu Medical College, Anhui Province, China
4 Division of Cardiology, Department of Medicine and Therapeutics, Clinical Sciences Building Prince of Wales Hospital, Hong Kong SAR, China
|Date of Submission||13-Jul-2020|
|Date of Acceptance||17-Sep-2020|
|Date of Web Publication||30-Sep-2020|
Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, No. 301, Middle Yanchang Road, Shanghai 200072
Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, No. 301, Middle Yanchang Road, Shanghai 200072
Division of Cardiology, Department of Medicine and Therapeutics, Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR
Source of Support: None, Conflict of Interest: None
Objectives: Percutaneous left atrial appendage (LAA) closure has been demonstrated to be an alternative to oral anticoagulation for the prevention of ischemic stroke in non-valvular atrial fibrillation (AF) patients using WATCHMAN. However, few data are available for the novel LAmbre occluder, especially long-term data. This study aimed to evaluate the feasibility of the LAmbre LAA occluder, over more than 5 years of follow-up. Methods: This study included 66 consecutive AF patients implanted with the LAmbre device from April 2014 to October 2015 in our center. Patients received 3-month dual antiplatelet therapy, and single therapy thereafter. Patients were followed-up until July 7, 2020. Results: The mean CHA2DS2-VASc and HAS-BLED scores were 6.0 ± 1.6 and 3.0 ± 0.8, respectively. The implantation success rate was 98.5%. No death, stroke, major bleeding, or device-related severe events were observed within 7 days of the procedure. Adequate LAA sealing was observed in 98.3% and 98.2% of patients at, 3- and 12-month follow-up echocardiographic examinations, respectively. After a mean follow-up of 67 ± 12.1 months, all-cause death was observed as 2.5 per 100 patient-years (n = 9). Equivalent values for ischemic stroke and major bleeding were 1.9 per 100 patient-years (n = 7) and 0.8 per 100 patient-years (n=3), respectively, both significantly lower than the cumulative expected rates according to risk factors. Conclusions: In patients with AF, the protocol of LAAC with the LAmbre device plus antiplatelet therapy was feasible and associated with few ischemic and bleeding events in the periprocedural period and in long-term follow-up of over 5 years.
Keywords: Atrial fibrillation, Left Atrial Appendage Closure, LAmbre, Safety, Feasibility
|How to cite this article:|
Li S, Zhang JY, Li X, Zhang XL, Lu YL, Wang YQ, Zhao DD, Ming Q, Tang K, Chen W, Zhu MY, Lam YY, Xu YW. Five-year outcomes after left atrial appendage closure using LAmbre: From a premarket registered case-series study. Cardiol Plus 2020;5:139-47
|How to cite this URL:|
Li S, Zhang JY, Li X, Zhang XL, Lu YL, Wang YQ, Zhao DD, Ming Q, Tang K, Chen W, Zhu MY, Lam YY, Xu YW. Five-year outcomes after left atrial appendage closure using LAmbre: From a premarket registered case-series study. Cardiol Plus [serial online] 2020 [cited 2020 Oct 25];5:139-47. Available from: https://www.cardiologyplus.org/text.asp?2020/5/3/139/296822
Shuang Li, Jing-Ying Zhang and Xiang Li contributed equally and shared as the co-first authors.
| Introduction|| |
For the first time, the well-designed randomized PROTECT-AF trial , showed that a percutaneous left atrial appendage closure (LAAC) device (WATCHMAN, Boston Scientific Corp., Minnesota, USA) was not inferior to warfarin treatment for the prevention of embolic stroke in patients with non-valvular AF (NVAF). The AMPLATZER Cardiac Plug (ACP)/Amulet (St. Jude Medical, Minnesota, USA) device were additional dedicated LAAC devices that were demonstrated to be effective..
However, although these devices are generally safe, they are associated with some complications or limitations (pericardial effusion, major bleeding, peri-device residual shunt, etc.). To try to limit these complications we developed a new-generation self-expanding left atrial appendage (LAA) occluder, the LAmbre device (Lifetech Scientific Corp., Shenzhen, China),, that has received approval of the Conformité Européenne mark and the Chinese Food and Drug Administration. Currently, few outcome data ,,,, have been published regarding the clinical performance of the LAmbre device in NVAF patients who are at risk of ischemic stroke. The objectives of this study were to retrospectively assess the technical feasibility, safety, and efficacy of using the LAmbre device in all-comer, high-risk, NVAF patients.
| Methods|| |
This study was planned to retrospectively analyze the data from a registered, single-center, premarket case-series study (NCT 03147391), which included 66 consecutive AF patients on whom LAAC with LAmbre occluders was conducted from April 2014 to October 2015 in our center. The first 53 cases were recruited for a 12-month multi-center clinical trial , from April 2014 to August 2014 in our center. Another 13 cases were continuously recruited according to a premarket clinical program in Shanghai Tenth People's Hospital from August 2015 to October 2015. Informed consent was obtained from all studied patients, and the study was approved by the Ethics Committee of Shanghai Tenth People's Hospital. This study was planned retrospectively for the analysis of periprocedural and follow-up data until July 7, 2020.
For inclusion, all patients met the following criteria: either paroxysmal AF with episodes of transient ischemic attack (TIA)/ischemic stroke or persistent/long-standing persistent AF; CHA2 DS2-VASc score ≥2 (male ≥2, female ≥3); unsuitable for long-term warfarin treatment (contraindications for anticoagulant drugs, intolerance to warfarin, refusal to take warfarin long-term, or unable to have regular international normalized ratio [INR] tests for personal reasons); willing to receive, and tolerant of, dual antiplatelet therapy (DAPT), specifically 100 mg aspirin daily and 75 mg clopidogrel daily, for at least 3 months.
The assessment of exclusion criteria,, preoperative imaging tests including transesophageal echocardiography (TEE) and standard implantation procedure , were described previously. Successful LAA sealing with the LAmbre device was defined as device implantation with a peri-device residual leak jet ≤3 mm in width, according to the manufacturer's criterion.,,,,
Antithrombotic therapy and follow-up
During device implantation, DAPT to facilitate device endothelialization was prescribed for approximately 3 months. Follow-up was performed by clinical visits or phone contact at 3, 6, and 12 months and twice-yearly thereafter. The presence of device-related thrombosis(DRT) and peri-device leakage was evaluated by TEE at 3- and 12-month follow-up examinations. If the 3-month TEE revealed no severe residual flow or device thrombus, DAPT was stopped, and either aspirin or clopidogrel was continued thereafter or according to the individualized prescriptions of the patient's doctor.
The primary outcome was defined as all-cause death. The other important outcomes also included were the composite safety and efficacy end-points (all-cause death, ischemic stroke, major bleeding, or other device-related severe complications) and successful sealing of the LAA. Event rates were defined as the number of events per 100 patient-years.
Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed as a percentage. Comparisons between observed and expected rates according to risk factors of thromboembolic (CHA2 DS2-VASc score ,) and bleeding events (HAS-BLED score ,) were assessed using binomial tests. Kaplan-Meier curves used to analyze cumulative outcomes (all-cause death, ischemic stroke, and major bleeding) were conducted in GraphPad Prism (Version 8.01, GraphPad Software, San Diego, USA).
| Results|| |
Baseline and pre-procedural characteristics
Baseline characteristics and risk factors of the study participants are shown in [Table 1]. The enrolled patients had high rates of persistent/long-standing persistent AF (84.5%) and history of ischemic stroke (68.2%) or TIA (12.1%); thus, they had a high risk of stroke onset or recurrence (mean CHA2 DS2-VASc score 6 ± 1.6). However, a limited proportion of patients received good oral anticoagulation for stroke prevention (18.2% received either warfarin with an INR 2-3 or new oral anticoagulants).
Peri-procedural imaging findings and outcomes
The main peri-procedural findings and acute results are shown in [Table 2]. Spontaneous echo contrast in the left atrium (LA) or LAA was not an exclusion criterion and was found in approximately one quarter of subjects by TEE. The mean LA diameter was 45.4 mm or 48.4 mm in transthoracic echocardiography (TTE) and TEE, respectively.
The immediate success of LAAC was 98.5% (65/66), and 87.9% (58/66) of cases were without peri-device residual flow. The one failed LAAC case had a peri-device jet of 4.5 mm. The mean operation time for LAAC (39 min), and the limited number of cases of device replacement (12.1%) or device recapture/redeployment (48.5%) needed to achieve successful closure, indicated excellent performance of the device. The distribution of LAmbre device sizes was approximately normal [Table 2] and [Figure 1]; the most frequent sizes were 26 and 28 mm (over half of the devices).
|Figure 1: The distribution of LAmbre size. X-axis: The size of the LAmbre device, from 16 mm to 38 mm; Y-axis: the number of each size used|
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There were no cases of periprocedural stroke, TIA, severe pericardial effusion, major bleeding needing blood transfusion, or device-associated severe events during the procedure or the hospitalization period. The most common complication was asymptomatic mild self-terminating pericardial effusion (n = 15, 22.7%).
Three- and twelve-month TEE was performed in 87.9% (58/66) and 83.3% (55/66) of the “in-time-window” participants, respectively. The acute peri-device jet >3 mm was still present in 3- and 12-month follow-up TEE. The patient received DAPT in the first 48 months and aspirin thereafter, according to her general practitioner's prescription. She was free of ischemic events up to the latest follow-up timepoint of 74 months. Of note, in 7 patients, peri-device leakage had significantly increased after 12 months, 5 (7.6%) of whom had no leakage either immediately or at 3 months after the procedure. Of the 7 cases, one had a peri-device jet of 4.5 mm immediately after the procedure, which persisted over 12 months, and another 6 had peri-device jets that were less than 3 mm. None of the patients with residual leakage had cardioembolic events. There were no cases of device thrombosis or late device embolization.
Antiplatelet therapy and follow-up
According to the protocol, 58 patients (87.9%) who received the 3-month follow-up TEE test had stopped DAPT and either aspirin or clopidogrel was continued thereafter. The other 8 cases, who were either intolerant or refused to conduct the TEE test, were given single antiplatelet drugs directly.
At the last follow-up time point, 18 patients (15.45%) had stopped antiplatelet drugs, only one was given an anticoagulant (Dabigatran), and 47 were still taking antiplatelet drugs [Table 3].
Follow-up clinical endpoints
The follow-up outcomes are shown in [Table 3]. The mean follow-up duration was 67 ± 12.1 months.
Nine patients died during the follow-up period between the 23rd and 59th months after the LAAC procedure. The all-cause death rate was 2.5 per 100 patient-years. The average age of death was 81 ± 5.1 (68.4–87.6) years. Of the 9 subjects who died, 5 suffered from heart failure or heart-failure-related complications, which were judged as cardiovascular deaths (1.4 per 100 patient-years). An 80-year-old female died as a result of major bleeding and its complications secondary to cardielcosis in the 59th month after the LAAC procedure. At that time, she had stopped the antiplatelet or anticoagulant drugs for some months. Another 3 patients died due to diabetes mellitus-related complications, prostate cancer, and septic shock caused by bacterial pneumonia, respectively. No case was classed as neurologic death.
Three major bleeding events were observed, representing a rate of 0.8 per 100 patient-years. The first case was the 80-year old female mentioned previously. The other two cases suffered from an intracranial hemorrhage in the 11th and 42nd months after the procedure, respectively, and recovered well. They were both receiving 100 mg aspirin daily at the time of the event. The former continued to take aspirin after recovery and the latter stopped antiplatelet therapy, according to the neurologist's prescription.
A total of 7 patients suffered from ischemic stroke (1.9 per 100 patient-years). Of these, none were in the 1st 3 months, 2 were in the 1st year, 2 were in the 2nd year, one was in the 3rd year, one was in the 4th year, and one was in the 5th year after the LAAC procedure. Five cases were diagnosed as lacunar cerebral infarction by senior neurologist teams, and through head magnetic resonance imaging, and they recovered well. Another two were symptomatically hemiplegic. One had two episodes of ischemic stroke; the first happened in the 8th month after the LAAC. A TEE test was conducted without revealing DRT or significant peri-device residual flow >3 mm in the 14th month and she subsequently received 75 mg clopidogrel daily. However, she suffered another large ischemic stroke, after which a craniotomy operation was conducted and she took 110 mg dabigatran twice a day thereafter, according to her doctor's prescription. The second case suffering from “sudden poor left limb movement” was judged as having suffered “ischemic stroke” without the confirmation of head imaging, and thereafter took 75 mg clopidogrel daily, according to her neurologist's prescription. Of note, among these 7 patients, 6 had received both 3- and 12-month TEE tests without DRT or significant peri-device residual flow >3 mm being identified. Since the final patient was judged to be intolerant of TEE (a large hematoma was present in the posterior pharyngeal wall after the LAAC procedure), he received chest computed tomography, which showed no significant movement of the LAA occluder.
Expected versus observed ischemic stroke and major bleeding events and survival curves
The cumulative observed rates of both ischemic stroke and major bleeding were significantly lower than the expected rates according to risk factors (both P < 0.001). For rates of ischemic stroke, the observed rate was 6.9 per 100 patient-years and the expected thromboembolic rate according to CHA2 DS2-VASc score , was up to 48.8 per 100 patient-years. For rates of major bleeding, the observed rate was 2.4 per 100 patient-years and the expected bleeding events according to HAS-BLED score , was up to 34.6 per 100 patient-year [Figure 2].
|Figure 2: Expected versus observed ischemic stroke and major bleeding events. Expected rates of ischemic stroke and bleeding events in the study population based on CHA2DS2-VASc and HAS-BLED scores, respectively, compared with the cumulative observed rates during the complete study period|
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The Kaplan-Meier survival curves at 3 years illustrating the percentage of patients free of death, ischemic stroke, and major bleeding are shown in [Figure 3].
|Figure 3: Survival curves after left atrial appendage closure with the LAmbre device. Kaplan-Meier survival curves showing the percentage of patients free of death, ischemic stroke, and major bleeding|
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| Discussion|| |
Clinical experience of LAAC with the LAmbre LAAC system is scarce., To the best of our knowledge, this pilot registry was the first to show that the LAmbre device can provide a safe, feasible, and favorable long-term outcome. In this study, most patients were assigned to receive DAPT for at least 3 months after the LAAC and then single therapy thereafter. As both LAmbre and ACP are double-disc occluders for closing the LAA's proximal segment, the antithrombotic strategy for LAmbre was based on that of ACP.
LAAC with LAmbre: Potential preferred design and satisfactory clinical results
The LAmbre device includes some preferred design features, such as two types (common type: the diameter of the sealing disc is 4–6 mm larger than the fixed disc; asymmetrical type: the diameter of the sealing disc is 4–6 mm larger than the fixed disc) and many collections of different sizes of sealing and fixed disc, that may have resulted in better clinical translation. When compared with two other widely-used devices, the WATCHMAN and ACP/Amulet, the LAmbre has many more sizes, that cover a wider threshold of LAA ostium, and the smallest delivery sheath, which may result in fewer bleeding events. No deep sheath seating or proximal device deployment is necessary, so the procedures are likely to reduce major effusions due to LAA perforation. A pilot small multi-center pilot study  found that occluding a large LAA (ostium ≥31 mm for the WATCHMAN or landing zone ≥31 mm for the Amulet), while not possible using the WATCHMAN or Amulet, could be successfully completed using a LAmbre device. On the other hand, a greater size range means more potentially preferred selections, which leads to a high percentage of device replacement or redeployment during the implantation procedure, as well as a longer learning curve until becoming an experienced operator.
In this study, LAAC with the LAmbre device was associated with a high rate of procedural success (98.5%) and no severe periprocedural complications. Although a learning curve exists for each kind of LAAC device, the LAmbre device was promising at its early stage of clinical implantation. The WATCHMAN has reported successful LAACs for 90.9% to 99.3% of cases, with a rate of ischemic stroke of 1.2 to 2.2 events per 100 patient-years.,,, The ACP has reported successful LAACs for 95.0% to 98.1% of cases.,, In addition, the shorter operative time and the lower number of device replacement or recapture/redeployment cases in order to achieve successful closure indicates the excellent operability of the LAmbre device.
This study showed that LAAC with the LAmbre device was associated with a low rate of ischemic stroke at a mean follow-up of 32 months (2.2 per 100 patient-years), which was lower than the event rate expected on the basis of the characteristics of the study population based on CHADS2 or CHA2 DS2-VASc scores.,
Antiplatelet, not anticoagulant
This study indicates that dual- and single-antiplatelet therapy following LAAC with the LAmbre device was associated with only a few embolic events or device thrombosis, suggesting that LAAC with the LAmbre might be a promising therapeutic alternative for patients who are not suitable candidates for long-term anticoagulant therapies. This finding might be associated with the LAmbre's preferred designer-modified operability.
Left atrial appendage closure
Mild residual leaks after percutaneous LAAC have been reported in 32% and 16.2% of patients after WATCHMAN  and ACP  implantations, respectively. In this study, performing LAAC with the LAmbre device, the rate of residual flow (7/66 cases, 10.6%) appears lower. This difference may be due to the soft material of the LAmbre frame and the capacity for complete recapture and redeployment, which contribute to better sealing of the LAA. However, in one case we observed a peri-device jet of 4.5 mm that was consistently present at the 3- and 12-month TEE re-examinations. Of note, as many as 5 patients (7.6%) with no leaks either immediately or at the 3-month TEE after the procedure developed significant peri-device leakage by the 12-month TEE examination. When first reported, this finding could not be explained by incomplete device endothelialization or LAA contraction immediately after implantation., We speculate whether single antiplatelet therapy was not able to consolidate the neointimal endothelialization on the surface of the disc that covered the outside of the LAA ostium. Is it simply a case of needing better TEE pictures, or a matter of device movement, erosion, or structural failure? Fortunately, none of the patients with residual leaks had cardioembolic events. There were no cases of device thrombosis or late device embolization. Importantly, the presence of mild residual leaks was not associated with any cardioembolic events, which is consistent with the results of previous studies.,
Study strengths and limitations
The limitations of this analysis on peri-procedural outcomes include the observational, single-center nature of the design and the limited sample size. The rate of expected events was based on historical controls, which have not been validated in the present population. The relatively small sample size does not provide enough power to detect differences in clinical outcomes, but is sufficiently promising to stimulate prospective, multi-center, controlled trials that will hopefully confirm these preliminary findings.
Furthermore, we mentioned that 22.7% (15/66) of patients had slight or mild pericardial effusion during hospitalization after the LAmbre implantation, and 14.5% (8/55 receiving the TEE test) still had this at the 12-month follow-up. This non-serious, asymptomatic phenomenon has rarely been reported. We speculate whether this mild self-terminating pericardial effusion could not be explained by proposed mechanisms, as so far the major large trials have focused on pericardial tamponade or serious pericardial effusion.,, In addition, this study showed that observed annual rates of ischemic stroke and major bleeding events were significantly lower than expected based on CHA2 DS2-VASc and HAS-BLED scores. This is similar to the result of an ACP study  and a 1-year study of EWOLUTION, the “real-world” study of the WATCHMAN device, but inconsistent with the PROTECT-AF and PREVAIL studies,,, the two randomized trials comparing anticoagulation and LAAC. Thus, real rates of embolic and bleeding events of the population in the absence of LAAC might differ from these estimates. These results on LAAC with LAmbre implantation will have to be confirmed by randomized trials.
| Conclusions|| |
This study included 66 consecutive AF patients implanted with the LAmbre device, those received 3-month dual antiplatelet therapy and single therapy thereafter. The implantation success rate was 98.5%. No death, stroke, major bleedings, or device-related severe events were observed within 7 days of the procedure. Adequate LAA sealing was observed in 98.3% and 98.2% of patients at 3- and 12-month follow-up echocardiographic examinations respectively. In a mean follow-up of 67 ± 12.1 months, all-cause death, ischemic stroke and major bleeding were observed as 2.5 per 100 patient-years (n = 9), 1.9 per 100 patient-years (n = 7) and 0.8 per 100 patient-years (n = 3). This study showed that, for patients with AF, the protocol of LAAC with the LAmbre device plus antiplatelet therapy was feasible and associated with few ischemic and bleeding events in the periprocedural period and in long-term follow-up of over 5-years.
The authors gratefully acknowledged the assistance of Prof. Jean-Jacques BLANC and Jean-Claude DAUBERT of encouragement and reviewing the paper. The authors warmly thanked Dr Jue Wang, a attending doctor and Qiang Li, a fellow doctor, of neurology of Shanghai Tenth People's Hospital for special assessments in neurological examinations, analyses of patients' head imaging and designing the patients' therapeutic schedules. We also gratefully thanked the organization of American Journal Experts (AJE) for language polishing and editing.
Financial support and sponsorship
This work was partly supported by a funding from National Natural Science Foundation of China for Shuang Li (NO. 81800441), a funding from Shanghai Science and Technology Committee for Wei Chen (NO.16411965700) and a “incubation” fund from Shanghai Tenth People's Hospital of Shuang Li [grant numbers: SYGZRPY2017029].
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]