indian heart journal 67 (2015) s4–s6
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Percutaneous left atrial appendage closure for stroke prevention in India: The beginning of a new era§ Atrial ﬁbrillation (AF) is the most common sustained cardiac arrhythmia. It is estimated that over 35 million individuals are affected worldwide and only in the US, the prevalence of AF is expected to rise to between 6 and 12 million in 2050.1 Patients with AF have a 5-fold increase risk of stroke, which represents the ﬁrst cause of long-term disability and the third cause of death in this patient population.2 The incidence of AF increases exponentially with age, and elderly patients have a higher percentage of strokes attributed to AF.3 For several years, oral anticoagulation (OAC) with vitamin K antagonists (VKAs) has represented the mainstay of treatment for stroke prevention in patients with AF. However, due to the narrow therapeutic window and bleeding concerns, VKAs have been historically underused. Many physicians have then looked at the advent of the new oral anticoagulants (NOACs) as the answer to achieve a balance between the risk of thromboembolism and the risk of bleeding in patients with AF. Indeed, as compared to warfarin, NOACs have been shown to not only reduce the risk of stroke but also to reduce the rate of major bleeding, in particular intracranial (IC) bleeding.4 However, the occurrence of major bleeding with NOACs has not disappeared, ranging between 1.6% and 3.11% per year (Fig. 1). Moreover, although the rate of IC bleeding has been signiﬁcantly reduced with NOACs, some of them are associated with an increased risk of gastrointestinal bleeding. Other concerns with OAC include patients with high risk of falls, renal and liver dysfunctions (who were typically excluded from NOACs studies), and those requiring dual antiplatelet therapy after stenting. It is also important to underscore that despite their more predictable anticoagulant effect and ease of use, the percentage of permanent treatment discontinuation with these new drugs in recent pivotal randomized trials remained high between 21% and 33%, which was similar to the rate of discontinuation seen with warfarin (Fig. 2). These recognized limitations of OAC have deﬁned several compelling reasons as to why device closure of the left atrial appendage (LAA) has emerged as an attractive and important concept. The rationale for LAA closure stems from observational studies showing that in patients with non-valvular AF, the vast majority (>90%) of
thrombus is located in the LAA.5 The goal of this technique is to address the unmet needs of stroke prevention in AF that persist despite recent advances in OAC therapy. Currently, the two most commonly used LAA closure devices are the Watchman device (Boston Scientiﬁc, Plymouth, MN, US) and the Amplatzer Cardiac Plug (ACP)/Amulet (St. Jude Medical, Minneapolis, MN, US). In the PROTECT-AF trial, 707 patients with AF and eligible for OAC treatment were randomly assigned in a 2-to-1 ratio to receive the Watchman device or warfarin.6 At 18 months follow-up, the noninferiority margin for the primary composite end point of stroke, cardiovascular death, and systemic embolism was met, though adverse events were more common in the device group, mostly related to procedural complications. The safety issue with Watchman implantation was further investigated by the smaller randomized PREVAIL trial, which showed a dramatic reduction in procedural complications, although the prespeciﬁed end-point for noninferiority against warfarin was not met.7 Recently, 4year results of PROTECT-AF demonstrated superiority of the
Fig. 1 – Rates of major bleeding in recent randomized trials NOAC vs warfarin.
§ This editorial is pertaining to the article: Percutaneous left atrial appendage closure in AF using Amplatzer Cardiac Plug: First single center experience from India.
indian heart journal 67 (2015) s4–s6
availability of OAC therapy, especially in rural populations, the clinical need for an alternative therapy such as LAA closure in India is evident. Although it can be viewed initially as an expensive therapy, the majority of LAA closure costs are borne in the ﬁrst year, while costs of OAC continue to increase over many years.10 Thus, LAA closure may represent an opportunity for savings to healthcare systems in the long term. By implementing this breakthrough technology in India, Shetty and colleagues should be commended for paving the way to a better future for stroke prevention in Indian patients.
Conﬂicts of interest Dr Adel Aminian and Dr Apostolos Tzikas are consultants and proctors for SJM. Dr Georges Khalil has none to declare Fig. 2 – Permanent treatment discontinuation in recent randomized trials NOAC vs warfarin.
Watchman device in all-cause mortality and stroke reduction compared to optimal medical treatment with warfarin.8 Based on the results of these two randomized trials, the Watchman device received approval by the US Food and Drug Administration in March 2015 as an option for high-risk AF patients seeking an alternative to warfarin. The ACP has a large real-world experience over the past 5 years. In an international multicenter ACP registry, 1047 patients were included and followed for a mean of 13 months.9 The main indications for LAA closure were a history of previous major bleeding and patients at high-bleeding risk. This study showed a high procedural success rate of 97.3% and periprocedural major adverse event rates of 4.97%. Annual rates of stroke, systemic thromboembolism, and major bleeding were 0.9%, 2.3%, and 2.1%, respectively. Due to this growing body of evidence demonstrating efﬁcacy for stroke prevention and acceptable safety outcomes, LAA closure has progressively gained worldwide acceptance as a valid alternative to OACs, mainly in patients who have a contraindication to this therapy. In this issue, Shetty and colleagues describe the ﬁrst reported clinical experience of LAA closure in India. Using the ACP, LAA closure was performed in 10 consecutive patients with AF over a 3-month period. Indications for LAA closure were the presence of a high-bleeding risk (based on the HASBLED score), labile INR, or drug incompliance. Procedural success was achieved in all patients with no procedural complication and no adverse event during short-term followup. The procedural steps for successful device implantation are clearly described, underscoring the importance of a careful and systematic methodology including adequate transseptal puncture technique, accurate sizing of the landing zone for device deployment, and checklist assessment of optimal device position before ﬁnal release. Despite being a singlecenter experience with a limited number of patients, these results are encouraging and should be regarded as a pioneer clinical experience in India. With one of the largest population of patients with AF in the world and with issues regarding the
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indian heart journal 67 (2015) s4–s6
Adel Aminian* Georges Khalil Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium Apostolos Tzikas AHEPA University Hospital, Thessaloniki, Greece
*Corresponding author E-mail address: [email protected]
(A. Aminian) Available online 21 October 2015 http://dx.doi.org/10.1016/j.ihj.2015.07.023 0019-4832/ # 2015 Published by Elsevier B.V. on behalf of Cardiological Society of India.