The NCDR Left Atrial Appendage Occlusion Registry Freeman, James V.; Varosy, Paul; Price, Matthew J. ...
Journal of the American College of Cardiology,
04/2020, Letnik:
75, Številka:
13
Journal Article
Recenzirano
Odprti dostop
Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.
The purpose of this ...study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.
The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.
A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.
The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.
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Key Points
Closure technology has expanded modestly since the dawn of transcatheter aortic valve replacement (TAVR)—most improvements in outcomes have come from evolving techniques, smaller TAVR ...devices, better operator skills, and lower risk patients.
The MANTA device adapts a well‐established sandwiching of a resorbable anchor and collagen plug to large‐bore closure.
The choice of large‐bore closure devices will remain one of the operator's preference pending a sufficiently powered randomized trial.
Summary Background In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of ...percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation. Methods Adult patients with non-valvular atrial fibrillation were eligible for inclusion in this multicentre, randomised non-inferiority trial if they had at least one of the following: previous stroke or transient ischaemic attack, congestive heart failure, diabetes, hypertension, or were 75 years or older. 707 eligible patients were randomly assigned in a 2:1 ratio by computer-generated randomisation sequence to percutaneous closure of the LAA and subsequent discontinuation of warfarin (intervention; n=463) or to warfarin treatment with a target international normalised ratio between 2·0 and 3·0 (control; n=244). Efficacy was assessed by a primary composite endpoint of stroke, cardiovascular death, and systemic embolism. We selected a one-sided probability criterion of non-inferiority for the intervention of at least 97·5%, by use of a two-fold non-inferiority margin. Serious adverse events that constituted the primary endpoint for safety included major bleeding, pericardial effusion, and device embolisation. Analysis was by intention to treat. This study is registered with Clinicaltrials.gov , number NCT00129545. Findings At 1065 patient-years of follow-up, the primary efficacy event rate was 3·0 per 100 patient-years (95% credible interval CrI 1·9–4·5) in the intervention group and 4·9 per 100 patient-years (2·8–7·1) in the control group (rate ratio RR 0·62, 95% CrI 0·35–1·25). The probability of non-inferiority of the intervention was more than 99·9%. Primary safety events were more frequent in the intervention group than in the control group (7·4 per 100 patient-years, 95% CrI 5·5–9·7, vs 4·4 per 100 patient-years, 95% CrI 2·5–6·7; RR 1·69, 1·01–3·19). Interpretation The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation. Funding Atritech.
Stitching your way to venous hemostasis Turi, Zoltan G.
Catheterization and cardiovascular interventions,
July 2020, 2020-07-00, 20200701, Letnik:
96, Številka:
1
Journal Article
Recenzirano
Key Points
Venous compression using a purse string suture is a potential alternative to device suture of the venotomy or to the more extensively described Figure of 8 closure technique.
The technique ...is likely to prove cost effective although the optimal methodology and overall risk remain to be determined.
A general comment regarding the common femoral vein: it is a fragile structure. All venous closure techniques require special care not to obstruct, lacerate or sever the vein and operators should be vigilant for both bleeding and thrombosis.
Closing up after TAVR Turi, Zoltan G.
Catheterization and cardiovascular interventions,
May 1, 2020, 2020-05-01, 2020-05-00, 20200501, Letnik:
95, Številka:
6
Journal Article
Recenzirano
Key Points
Techniques for vascular access and closure are highly heterogeneous and continue to evolve.
The combination of suture and collagen plug closure has theoretical benefits but also potential ...additive risk.
It is, however, hard to state firmly that there is promising safety and efficacy claims should be made with caution when based on small single site series.
Patients with post-acute sequela of COVID-19 (PASC) often report symptoms of orthostatic intolerance and autonomic dysfunction. Numerous case reports link postural orthostatic tachycardia syndrome ...(POTS) to PASC. No prospective analysis has been performed.
This study performed head-up tilt table (HUTT) testing in symptomatic patients with PASC to evaluate for orthostatic intolerance suggestive of autonomic dysfunction.
We performed a prospective, observational evaluation of patients with PASC complaining of poor exertional tolerance, tachycardia with minimal activity or positional change, and palpitations. Exclusion criteria included pregnancy, pre-PASC autonomic dysfunction or syncope, or another potential explanation of PASC symptoms. All subjects underwent HUTT.
Twenty-four patients with the described PASC symptoms were included. HUTT was performed a mean of 5.8 ± 3.5 months after symptom onset. Twenty-three of the 24 had orthostatic intolerance on HUTT, with 4 demonstrating POTS, 15 provoked orthostatic intolerance (POI) after nitroglycerin, 3 neurocardiogenic syncope, and 1 orthostatic hypotension. Compared with those with POTS, patients with POI described significantly earlier improvement of symptoms.
This prospective evaluation of HUTT in patients with PASC revealed orthostatic intolerance on HUTT suggestive of autonomic dysfunction in nearly all subjects. Those with POI may be further along the path of clinical recovery than those demonstrating POTS.
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Percutaneous balloon mitral valvuloplasty (PBMV), once the most complex of percutaneous cardiac procedures and essentially the first adult structural heart intervention, set the stage for a host of ...new technologies. Randomized studies comparing PBMV to surgery were the first to provide a high-level evidence base in structural heart. The devices used have changed little in 40 years, but the advent of improved imaging and the expertise gained in interventional cardiology has provided some additional procedural safety. However, with the decline in rheumatic heart disease, PBMV is being performed in fewer patients in industrialized nations; in turn, these patients have more comorbidities, less favorable anatomy, and thus a higher rate of procedure-related complications. There remain relatively few experienced operators, and the procedure is distinct enough from the rest of the structural heart intervention world that it has its own steep learning curve. This article reviews the use of PBMV in a variety of clinical settings, the influence of anatomic and physiologic factors on outcomes, the changes in the guidelines, and alternative approaches. PBMV remains the procedure of choice in patients with mitral stenosis with ideal anatomy and a useful tool in patients with less than ideal anatomy who are poor surgical candidates. In the 40 years since its first performance, PBMV has revolutionized the care of mitral stenosis patients in developing countries and remains an important option for suitable patients in industrialized nations.
Key Points
Large bore access and closure of the femoral artery has the potential to cause or accelerate local vascular disease
The implications of accelerated disease could be substantial
Further ...investigation is needed to assess the true short‐ and long‐term effects
Key Points
The evidence that StarClose is associated with a higher complication rate than Perclose is reasonable if less than robust.
Closure results are affected by access technique.
The rationale ...for using closure devices in small hole puncture is questionable both from a clinical as well as financial standpoint.
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