Combined transcatheter aortic valve replacement and left atrial appendage occlusion in patients ineligible for oral anticoagulation: A case series

Abstract

Patients presenting with aortic stenosis and atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are commonly at increased risk for stroke and bleeding complications. Concomitant left atrial appendage occlusion (LAAO) after TAVR may be an alternative to oral anticoagulation (OAC).

Between 2018 and 2022, 7 consecutive patients who were ineligible for OAC underwent simultaneous TAVR and LAAO. The mean age was 84.9 ± 4.9 years. The mean CHA2DS2-VASc, HAS-BLED, and STS predicted risk of mortality scores were 5.9 ± 0.7, 3.9 ± 1.1, and 8.8 ± 3.4%, respectively. The median follow-up time was 23 (1 to 27) months. All procedures achieved technical success and no adverse events were observed during follow-up. This case series shows that concomitant TAVR and LAAO is feasible and safe among patients with severe aortic stenosis and AF who are deemed ineligible for OAC.

Learning objectives

Atrial fibrillation is the most common arrhythmia in the transcatheter aortic valve replacement (TAVR) population. In those who experience major or life-threatening bleeding, mortality is doubled. We report a case series of 7 concomitant left atrial appendage occlusions (LAAO) after TAVR in patients ineligible for oral anticoagulation. All procedures achieved technical success and no adverse events were observed. The simultaneous approach with TAVR and LAAO was feasible and safe in this case series.

Introduction

Atrial fibrillation (AF) is one of the most frequent comorbidities among patients undergoing transcatheter aortic valve replacement (TAVR), ranging from 16% up to 51% [1]. Of note, balancing the risk of cardioembolic and bleeding events in this high-risk population represents a major clinical challenge. Therefore, left atrial appendage occlusion (LAAO) offers a nonpharmacological option for embolic protection in patients with non-valvular AF undergoing TAVR, obviating the need for oral anticoagulation (OAC) [2]. This has been shown to be feasible and with good clinical outcomes, nonetheless, there has been limited experience with the performance of the combined approach of TAVR and LAAO in the same procedure. We report a case series of 7 high bleeding risk patients (Table 1) with severe aortic stenosis (AS) and AF undergoing both TAVR and LAAO in the same procedure.

Table 1.

Demographic, clinical and procedural characteristics of patients undergoing concomitant TAVR and LAAO.

Case number	1	2	3	4	5	6	7	Overall
Age	83	93	84	87	78	81	88	84.9 ± 4.9
Gender	Female	Male	Male	Male	Female	Female	Female	57% Female
CHAD2S2VASc score	5	5	6	6	6	6	7	5.9 ± 0.7
HAS-BLED score	4	4	5	5	2	3	4	3.9 ± 1.1
STS PROM (%)	7,3	8,2	6,4	6,6	10,5	6,8	15,8	8.8 ± 3.4
Aortic prosthesis	Acurate Neo	Sapien 3	Sapien 3	Sapien 3	Acurate Neo	Acurate Neo 2	Evolut Pro	43% BE; 57% SE
LAAO prosthesis	Watchman	Lambre	Lambre	Watchman	Lambre	Watchman FLX	Watchman FLX	43% Lambre; 57%Wachtman
Indication for LAAO	HBR and GI bleeding	HBR and GI bleeding	GI bledding	GI bledding	GI bledding	GI bledding	HBR and GI bleeding	100% Previous GI bleeding
Technical Success	Yes	Yes	Yes	Yes	Yes	Yes	Yes	100%
Device Success	Yes	Yes	Yes	Yes	Yes	Yes	Yes	100%
FUP (months)	27	24	26	23	12	2	1	23
Late FUP Adverse Event	No	No	No	No	No	No	No	0%
Discharge antithrombotic therapy	SAPT (clopidogrel)	DAPT	DAPT	DAPT	SAPT (clopidogrel)	SAPT (aspirin)	SAPT (clopidogrel)	DAPT (43%); SAPT (57%)

HBR, high bleeding risk; GI bleeding, gastrointestinal bleeding; DOAC, direct oral anticoagulant; STS, The Society of Thoracic Surgeons; PROM, predicted risk of mortality; SAPT, single antiplatelet therapy; BE, balloon-expandable; SE, self-expandable; DAPT, dual antiplatelet therapy; FUP, follow up; LAAO, left atrial appendage occlusion; TAVR, transcatheter aortic valve replacement.

Case reports

Case 1: An 83-year-old woman, with past medical history of permanent AF, hypertension, stage 3a chronic kidney disease, evolved with worsening heart failure [New York Heart Association (NYHA) III] symptoms due to AS. The CHA₂DS₂VASc score was 5 and the HAS-BLED score was 4. Anticoagulation was contraindicated due to frailty, increased risk of falls, and previous gastrointestinal (GI) bleeding. The cardiac computed tomography (CT) and transesophageal echocardiogram (TEE) evaluation indicated that the patient had a calcified bicuspid aortic valve and was a good candidate for transfemoral TAVR. The chicken-wing LAA morphology and size were also acceptable for LAAO. Considered high-risk for surgical aortic valve replacement (SAVR), TAVR and LAAO were both indicated. Accordingly, a 27 mm Acurate Neo transcatheter heart valve (THV) (Boston Scientific, Natick, MA, USA) was successfully implanted followed by LAAO using a 30 mm Watchman (Boston Scientific) device, as shown in Fig. 1A and B. The patient was discharged on day two on clopidogrel monotherapy. Clinical follow-up obtained after 27 months was uneventful.

Fig. 1.

Left atrial appendage occlusion immediately after transcatheter aortic valve replacement (TAVR). Images on the left-hand side (A, C, E, G, I) depict left atrial appendage angiography performed immediately after TAVR in five consecutive patients. Images on the right-hand side (B, D, F, H, J) show left atrial appendage occluders securely in place with no flow into the appendages.

Case 2: A 93-year-old male patient, with a history of hypertension, diabetes, severe AS, and permanent AF was admitted due to syncope and a traumatic subdural hematoma. The patient was not on OAC because of previous GI bleeding. The intracranial hemorrhage was managed in a conservative manner. The CHA₂DS₂VASc score was 5 and the HAS-BLED score was 4. The cardiac CT and TEE evaluation indicated him to be a good candidate for transfemoral TAVR, with a favorable anatomy (windsock morphology) for LAAO. The procedure was successfully performed using a 26 mm Sapien 3 THV (Edwards Lifesciences, Irvine, CA, USA) and a 28 × 34 mm Lambre LAA occluder (Lifetech, Shenzhen, China), as depicted in Fig. 1C and D. The patient was discharged 4 days after the procedure on dual antiplatelet therapy (DAPT). Clinical follow-up after 2 years showed reduction of functional disabilities and no adverse events.

Case 3: An 84-year-old male patient, with a history of paroxysmal AF, prior embolic stroke, coronary artery disease with multivessel coronary stenting, actinic rectitis secondary to radiation therapy for prostate cancer, duodenectomy due to a neoplastic lesion and anemia, presented with heart failure symptoms (NYHA III) due to severe AS associated with left ventricular dysfunction (ejection fraction of 36%). The CHA₂DS₂VASc score was 6 and the HAS-BLED score was 5. Despite the very high-risk for cardioembolic events, the patient was on clopidogrel monotherapy and OAC was contraindicated because of frequent rectal bleeding. The cardiac CT and TEE evaluation indicated him to be a good candidate for transfemoral TAVR with LAA morphology (windsock) and size favorable for LAAO. TAVR was performed using a 29 mm Sapien 3 THV and LAAO was accomplished using a 26 × 34 mm Lambre occluder (Fig. 1E and F). Two days after the procedure, the patient presented with severe GI bleeding and argon plasma coagulation was needed to control the hemorrhage. He was discharged 16 days after the procedure on DAPT, without any additional adverse event. Clinical follow-up after 26 months was uneventful.

Case 4: An 87-year-old male patient, with a history of hypertension, diabetes, permanent AF with two previous ablations and coronary artery disease with multivessel stenting, presented with heart failure symptoms (NYHA III) due to severe AS and severe GI bleeding. Clopidogrel and OAC were suspended. The CHA₂DS₂VASc score was 6 and the HAS-BLED score was 5. A cardiac CT and TEE indicated that the patient was a good candidate for transfemoral TAVR and the LAA size and morphology (windsock) were favorable for LAAO. The procedure was successfully performed using a 26 mm Sapien 3 THV and 33 mm Watchman device (Fig. 1G and H). The patient was discharged 3 days after the procedure on DAPT. Clinical follow-up after 23 months showed no adverse event.

Case 5: A 78-year-old female patient, with a medical history of hypertension, permanent AF, heart failure symptoms (NYHA III), presented to the emergency room with GI bleeding. OAC was immediately suspended. The CHA₂DS₂VASc score was 6 and the HAS-BLED score was 2. Cardiac CT and TEE were performed and the anatomy was deemed suitable for transfemoral TAVR and LAAO (windsock morphology). The procedure was successfully performed using a 23 mm Acurate Neo THV and 24 × 30 mm Lambre LAA occluder (Fig. 1I and J). The patient was discharged 3 days later on clopidogrel monotherapy. Clinical follow-up after 1 year showed no adverse events.

Case 6: An 81-year-old woman, with a history of permanent AF and previous pacemaker implantation, presented with heart failure class NYHA III due to severe AS. CHA2DS2VASc and HAS-BLED scores were 6 and 3, respectively. She was on rivaroxaban, despite previous episodes of GI bleeding. After a careful study of the cardiac CT and TEE, anatomy was considered favorable and she underwent transfemoral TAVR with a 25 mm Acurate Neo 2 and LAAO (windsock morphology) with a 27 mm Watchman FLX (Fig. 2A and B). Both procedures were performed with use of the Sentinel (Boston Scientific) cerebral protection device and, at the end of the intervention, debris was collected by the filters (Fig. 2C and D). She was discharged 10 days after the procedure on aspirin monotherapy. No adverse events were detected after 2 months of follow-up.

Fig. 2.

Left atrial appendage (LAA) occlusion immediately after transcatheter aortic valve replacement (TAVR) with cerebral protection. Left atrial appendage angiography performed immediately after TAVR (A, E) in two consecutive cases, with complete occlusion after implantation of the Watchman FLX device (B, F). Sentinel cerebral protection device positioned in the left carotid artery and brachiocephalic trunk (arrows) with the transcatheter heart valve and LAA occluder in place (C, G). Debris collected by the filters at the end of the combined procedures (D, H).

Case 7: An 88-year-old female patient, with a medical history of permanent AF, presented to the emergency room with heart failure symptoms (NYHA IV). She was not on OAC due to previous GI bleeding. Her CHA2DS2VASc score was 6 and the HAS-BLED score was 2. Cardiac CT and TEE were performed and the anatomy was judged suitable for transfemoral TAVR and LAA occlusion (chicken-wing morphology). The procedure was successfully performed using a 26 mm Evolut Pro THV (Medtronic, Minneapolis, MN, USA) and a 27 mm Watchman FLX occluder (Fig. 2E and F). A Sentinel cerebral protection system was used and, at the end of the combined procedure, debris was captured by the filters (Fig. 2G and H). The patient was discharged 3 days later, on clopidogrel monotherapy. Clinical follow-up after 30 days showed no adverse events.

Discussion

The main finding derived from this small case series is that TAVR and LAAO performed in the same procedure is feasible and can be considered a good therapeutic option for highly selected patients with severe symptomatic aortic stenosis and AF, especially for those at high-bleeding risk or with a formal contraindication for OAC [3]. In our series, all patients were simultaneously at moderate to high risk for SAVR and high risk for cardioembolic and bleeding adverse events. The indications for LAAO were based on the ineligibility to OAC due to the high bleeding risk in all cases.

One potential disadvantage of the combined approach of TAVR and LAAO in the same procedure is the need for general anesthesia and TEE, which precludes the use of the contemporary minimalistic approach for TAVR, with conscious sedation and transthoracic echocardiogram. To overcome this limitation, the use of intracardiac echocardiogram can be a valuable imaging tool for guiding both procedures under conscious sedation [4]. Also, because of the need for an additional venous access, transseptal puncture, increase in procedural time, and contrast volume utilization, LAAO immediately after TAVR might increase the risk of adverse events. In the Prevail randomized trial, LAAO-related complications occurred in 4.2% [2]. Therefore, we believe that the combined TAVR and LAAO procedure should be performed only by experienced operators and in selected patients unsuitable for OAC, after surpassing the learning curve of both procedures. In a pilot study comparing patients undergoing concomitant TAVR and LAAO with patients undergoing isolated TAVR, the combined approach was safe and did not result in a significant increase in adverse events [2]. In our series, there were no procedural complications and technical success was achieved in all cases. The question remains, however, if concomitant procedures are preferable to a staged approach, as described in a case report by Bogunovic et al. [5]. Concomitant procedures have the potential advantages of the immediate protection against stroke and bleeding complications and seems more friendly for older and multimorbid patients. The ongoing randomized Watch-TAVR study (NCT03173534) will give us additional information regarding the safety of the combined TAVR and LAAO procedure and the efficacy of this approach.

The optimal postprocedural pharmacologic strategy for patients undergoing combined TAVR and LAAO remains unknown. The current recommendation for antithrombotic therapy after TAVR in patients without a chronic indication for oral anticoagulation is single antiplatelet therapy, due to its reduced risk of bleeding complications as compared to DAPT [6,7]. Also, a recent randomized trial showed that the use of a direct oral anticoagulant for the prevention of thrombotic complications in this clinical scenario is associated with increased mortality and bleeding risk as compared to antiplatelet therapy [8], that might further boost the benefit of occluding the LAA after TAVR to avoid OAC. With regard to LAAO, the standard antithrombotic treatment applied in randomized trials with the Watchman device included a transition of 6 weeks of warfarin, which is also being applied in the Watch-TAVR trial. However, for patients at high-bleeding risk, the ASAP and EWOLUTION registries suggested that single antiplatelet therapy (SAPT) or DAPT can be safely used, with device thrombus occurring in a proportion of patients similar to that seen in prior studies using OAC [9,10]. More definitive answers regarding the optimal antithrombotic regimen after LAAO in patients not eligible for OAC will have to wait for the ongoing ASAP-TOO trial (NCT02928497). In the meantime, considering that the combined TAVR and LAAO procedure is mostly indicated for patients at high-bleeding risk or with a formal contraindication for OAC, we believe that the antithrombotic regimen used in the present case series with SAPT or DAPT, without the transition with OAC, should be preferred for this selected population. Regarding the long-term safety of this strategy, our patients were followed for a median time of 23 months after the combined procedure and no thrombotic or hemorrhagic adverse events were observed.

Finally, due to its recent availability, our last two patients were treated with cerebral protection with the Sentinel (Boston Scientific) device, and, in both cases, embolic debris was captured by the filters. Since both TAVR and LAAO are associated with a non-negligible risk of stroke, the use of cerebral protection devices might become the standard of care for this combined approach.

Conclusion

In the present case series, the combined procedure of TAVR and LAAO followed by SAPT or DAPT without the transition with OAC was feasible and safe, with high technical success and no adverse events during the follow-up. Future studies are needed to clarify if this strategy will be the standard of care for patients with severe AS and AF undergoing TAVR who are deemed ineligible for OAC.

Declaration of competing interest

Dr. Ribeiro: proctor for Medtronic, Edwards Lifesciences, and Boston Scientific.

Dr. Abizaid: proctor for Boston Scientific.

Dr. de Brito Jr.: proctor for Boston Scientific, Edwards Lifesciences, and Medtronic.