Abstract
Aims
To determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score).
Methods and results
Data were extracted from the National Inpatient Sample for calendar years 2016–20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18–1.35, and aOR 1.88, 95% CI 1.73–2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11–1.25, and aOR 1.54, 95% CI 1.44–1.66, respectively).
Conclusion
A higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.
Keywords: Left atrial appendage occlusion, Stroke risk, CHA2DS2-VASc score, Outcomes, Complications
Graphical Abstract
Graphical Abstract.
What’s new?
Majority of percutaneous left atrial appendage occlusion (LAAO) device implantations occurred in patients with an elevated baseline stroke risk.
The prevalence of pericardial effusion requiring intervention was higher in patients with increased CHA2DS2-VASc score.
CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications and prolonged length of stay after percutaneous LAAO device implantation.
Introduction
Atrial fibrillation (AF) is the most common sustained arrythmia encountered in clinical practice with an estimated prevalence of 5.2 million in the USA.1 Patients with AF are at an increased risk of stroke.2 Current guidelines recommend the CHA2DS2-VASc score in selecting candidates that would benefit from appropriate oral anticoagulant (OAC) therapy for preventing stroke.3
Percutaneous left atrial appendage occlusion (LAAO) is an alternative strategy to minimize the risk of stroke in select AF patients that are unable to tolerate long-term OAC therapy.4 The majority of the randomized clinical trial evidence supporting the LAAO procedure is limited to patients who are at a lower risk of stroke.5,6 The landmark PROTECT-AF (percutaneous closure of the LAA vs warfarin therapy for prevention of stroke in patients with atrial fibrillation) trial had almost two-thirds of the patients with a CHADS2 score of ≤2,5 whereas less than half of the patients in the PREVAIL (prospective randomized evaluation of the Watchman LAA closure device in patients with atrial fibrillation vs long-term warfarin therapy) trial had a CHADS2 score > 2.6 It is important to examine whether the outcomes of the LAAO procedure observed in patients with a lower stroke risk are similar to those with a higher stroke risk.
To fill these important knowledge gaps, we conducted this retrospective study using a large national US administrative database and compared procedural complications and inpatient outcomes between patients with different baseline risks of stroke as defined by their CHA2DS2-VASc score.
Methods
Data source
Data from the National Inpatient Sample (NIS) were used for the purpose of our current study. We analysed the NIS database from years 2016–20 for LAAO device implantations. 2016 was taken as a start year for our study because the Watchman device was approved by the Food and Drug Administration in March of 2015. The NIS is made possible by a federal-state-industry partnership sponsored by the Agency for Healthcare Research and Quality. The NIS is derived from non-federal hospitals in all states and can be used for computing national estimates of healthcare utilization, costs, and outcomes.7 The NIS provides discharge weights that are used for estimation of disease and procedure trends nationally. Owing to the de-identified nature of the NIS dataset, the need for informed consent and institutional review board approval is waived. The NIS adheres to the 2013 Declaration of Helsinki for conduction of human research.
Study population
Percutaneous LAAO device implantations were identified using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) code of 02L73DK. This code has been extensively validated in earlier studies for extraction of percutaneous LAAO device implantations from the administrative datasets.8–13 Patients younger than 18 years and those with missing demographic data were excluded. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). Centers for Medicare and Medicaid Services (CMS) mandates the CHA2DS2-VASc score of 3 or greater for the purpose of LAAO device reimbursement, and therefore, we excluded patients with a CHA2DS2-VASc score of ≤2 in the primary analysis (however, supplementary data comparing baseline characteristics and in-hospital outcomes of AF patients undergoing percutaneous LAAO are provided in which stratification was done on the basis of a CHA2DS2-VASc score of 3 or greater and CHA2DS2-VASc score < 3
please see Supplementary material online).14 Baseline characteristics, procedural complications, and inpatient outcomes including mortality (reported as a distinct categorical variable in the dataset), length of stay, and hospitalization costs were compared in LAAO device recipients based on baseline CHA2DS2-VASc score. We also analysed independent association of higher CHA2DS2-VASc score with outcomes of overall complications, major complications (defined as composite of pericardial effusion requiring intervention, cardiac arrest, ischaemic stroke/transient ischaemic attack, haemorrhagic stroke, systemic embolism, myocardial infarction, and peripheral vascular complications, which included arteriovenous fistula, pseudoaneurysm, access site haematoma, retroperitoneal bleeding, and venous thromboembolism), inpatient mortality, prolonged hospital stay (defined as length of stay > 1 day), and increased hospitalization cost (median hospitalization cost > 25 275$). For computing hospitalization costs, the cost-to-charge ratio files supplied by the Healthcare Cost and Utilization Project were applied to the total hospital charges and adjusted for inflation to December 2020.
Statistical analysis
Descriptive statistics are presented as frequencies with percentages for categorical variables and as median with inter-quartile range (IQR) for continuous variables. Baseline characteristics were compared using a Pearson χ2 test and Fisher exact test for categorical variables and the Kruskal–Wallis H test for continuous variables. For crude comparison of procedural complications and in-hospital outcomes among the study groups, the Pearson χ2 test was used. For the assessment of the independent association of CHA2DS2-VASc scores of 4 and ≥5 with outcomes including overall complications, major complications, inpatient mortality, length of stay > 1 day, and median hospitalization cost > 25 275$, a single-step multivariable logistic regression model was used. Age, sex, race/ethnicity, and 29 Elixhauser comorbidities (heart failure, valvular disease, pulmonary circulation disease, peripheral vascular disease, paralysis, neurological disorders, chronic pulmonary disease, diabetes without complications, diabetes with chronic complications, hypothyroidism, hypertension, renal failure, liver disease, peptic ulcer, acquired immune deficiency syndrome, lymphoma, metastatic cancer, solid tumour without metastasis, collagen vascular disease, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, chronic blood loss anaemia, deficiency anaemia, alcohol abuse, drug abuse, psychoses, and depression) were used for adjustment. All of these covariates were identified a priori based on prior literature and authors’ best clinical judgement. A P-value of <0.05 was considered statistically significant. All statistical analyses were performed using SPSS version 26 (IBM Corp, Armonk, NY) and R version 3.6. Because of the complex survey design of the NIS, sample weights, strata, and clusters were applied to raw data to generate national estimates. The NIS brief on statistical methodology attested that data were missing at random and any such missing data were not imputed in our study.7
Results
Out of 89 300 weighted cases of percutaneous LAAO device implantation, a total of 73 795 patients with CHA2DS2-VASc ≥ 3 and no missing demographic data were included in the final study cohort (please see Figure 1). Of these encounters, 27 255 (36.9%) had a CHA2DS2-VASc score of 3, 27 295 (37.0%) had a CHA2DS2-VASc score of 4, and 19 245 (26.1%) had a CHA2DS2-VASc score of ≥5. Baseline characteristics of the study population are shown in Table 1. In the overall cohort, ∼47.8% of patients were women. The approximate breakdown of patients by race is as follows: 85% White, 4% Black, 4.5% Hispanic, 1.2% Asian or Pacific Islander, 0.3% Native American, and 1.6% of other race.
Figure 1.
Flow sheet showing the process of patient selection.
Table 1.
Baseline characteristics of the study population stratified on the basis of stroke risk
| Variable no. (%) | CHA2DS2-VASc score 3 [n = 27 255 (36.9%)] | CHA2DS2-VASc score 4 [n = 27 295 (37.0%)] | CHA2DS2-VASc score ≥ 5 [n = 19 245 (26.1%)] | P-value |
|---|---|---|---|---|
| Age [median (IQR)] years | 75 (71–81) | 75 (71–81) | 75 (71–81) | <0.01 |
| Females | 7740 (28.4) | 13 775 (50.5) | 13 725 (71.3) | <0.01 |
| Age | ||||
| ȃ<65 | 1420 (5.2) | 520 (1.9) | 175 (0.9) | |
| ȃ65–74 | 11 325 (41.6) | 6045 (22.1) | 2575 (13.4) | |
| ȃ≥75 | 14 510 (53.2) | 20 730 (75.9) | 16 495 (85.7) | |
| Race/ethnicity | ||||
| ȃWhite | 23 385 (88.6) | 23 345 (88.4) | 16 100 (86.7) | <0.01 |
| ȃBlack | 975 (3.7) | 1110 (4.2) | 865 (4.7) | |
| ȃHispanic | 1120 (4.2) | 1225 (4.6) | 950 (5.1) | |
| ȃAsian or Pacific Islander | 350 (1.3) | 290 (1.1) | 250 (1.3) | |
| ȃNative American | 95 (0.4) | 95 (0.4) | 65 (0.3) | |
| ȃOther | 465 (1.8) | 335 (1.3) | 350 (1.9) | |
| Comorbidities | ||||
| ȃBlood loss anaemia | 410 (1.5) | 630 (2.3) | 450 (2.3) | <0.01 |
| ȃCongestive heart failure | 5475 (20.1) | 11 780 (43.2) | 12 790 (66.5) | <0.01 |
| ȃCoagulopathy | 1120 (4.1) | 1035 (3.8) | 710 (3.7) | 0.04 |
| ȃChronic pulmonary disease | 5500 (20.2) | 6520 (23.9) | 5505 (28.6) | <0.01 |
| ȃCoronary artery disease | 230 (0.8) | 980 (3.6) | 5670 (29.5) | <0.01 |
| ȃDiabetes | 3420 (12.5) | 5535 (20.3) | 6605 (34.3) | <0.01 |
| ȃRenal failure | 6020 (22.1) | 7295 (26.7) | 5430 (28.2) | <0.01 |
| ȃHypertension | 23 125 (84.8) | 26 145 (95.8) | 18 830 (97.8) | <0.01 |
| ȃLiver disease | 750 (2.8) | 630 (2.3) | 485 (2.5) | <0.01 |
| ȃObesity | 4710 (17.3) | 4550 (16.7) | 3535 (18.4) | <0.01 |
| ȃPeripheral vascular disorders | 1125 (4.1) | 2390 (8.8) | 4190 (21.8) | <0.01 |
| ȃValvular disease | 1300 (4.8) | 1810 (6.6) | 1450 (7.5) | <0.01 |
| ȃWeight loss | 65 (0.2) | 125 (0.5) | 115 (0.6) | <0.01 |
| Hospital location | ||||
| ȃRural | 460 (1.7) | 600 (2.2) | 480 (2.5) | <0.01 |
| ȃUrban non-teaching | 2860 (10.5) | 2865 (10.5) | 2005 (10.4) | |
| ȃUrban teaching | 23 935 (87.8) | 23 830 (87.3) | 16 760 (87.1) | |
| Hospital size | ||||
| ȃSmall | 460 (1.7) | 600 (2.2) | 480 (2.5) | <0.01 |
| ȃMedium | 2860 (10.5) | 2865 (10.5) | 2005 (10.4) | |
| ȃLarge | 23 935 (87.8) | 23 830 (87.3) | 16 760 (87.1) | |
| Median income quartile | ||||
| ȃ0–25th | 5565 (20.7) | 6005 (22.3) | 4435 (23.3) | <0.01 |
| ȃ26–50th | 6975 (26.0) | 7170 (26.6) | 5220 (27.4) | |
| ȃ51–75th | 7545 (28.1) | 7410 (27.5) | 5175 (27.2) | |
| ȃ76–100th | 6780 (25.2) | 6375 (23.6) | 4215 (22.1) | |
With an increase in CHA2DS2-VASc score (3 vs. 4 vs. ≥ 5), there was a corresponding increase in the prevalence of important comorbidities such as renal failure (22.2% vs. 26.7% vs. 28.2%
P < 0.01), peripheral vascular disease (4.1% vs. 8.8% vs. 21.8%
P < 0.01), and weight loss (0.2% vs. 0.5% vs. 0.6%
P < 0.01).
Crude LAAO procedure-related complications stratified based on CHA2DS2-VASc score are shown in Table 2. The prevalence of overall complications increased in AF patients undergoing percutaneous LAAO implantation with increased CHA2DS2-VASc score (14.1% in patients with a CHA2DS2-VASc score of ≥5% vs. 9.4% in patients with a CHA2DS2-VASc score of 4 vs. 7.4% in patients with a CHA2DS2-VASc score of 3, P < 0.01). Similarly, the prevalence of pericardial effusion requiring intervention was also higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5% vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). The prevalence of any neurological complication was also higher with increased CHA2DS2-VASc score (2.9% in patients with a score of ≥5% vs. 0.3% in patients with a score of 4 vs. 0.1% in patients with a score of 3, P < 0.01).
Table 2.
Complications in patients undergoing left atrial appendage occlusion stratified on the basis of stroke risk
| Variable no. (%) | CHA2DS2-VASc score 3 [n = 27 255 (36.9%)] | CHA2DS2-VASc score 4 [n = 27 295 (37.0%)] | CHA2DS2-VASc score ≥ 5 [n = 19 245 (26.1%)] | P-value |
|---|---|---|---|---|
| Overall complications (%) | 2015 (7.4) | 2560 (9.4) | 2710 (14.1) | <0.01 |
| Major complications (%)a | 1350 (5.0) | 1680 (6.2) | 1515 (7.9) | <0.01 |
| Any cardiovascular complication | 590 (2.2) | 850 (3.1) | 650 (3.4) | <0.01 |
| Cardiac arrest/CPR procedure code | 35 (0.1) | 45 (0.2) | 35 (0.2) | 0.31 |
| Pacemaker implantation | 85 (0.3) | 95 (0.3) | 110 (0.6) | <0.01 |
| ST elevation myocardial infarction | NR | 30 (0.1) | NR | NR |
| Non-ST elevation myocardial infarction | 280 (1.0) | 415 (1.5) | 265 (1.4) | <0.01 |
| Pericardial effusion requiring intervention | 215 (0.8) | 290 (1.1) | 265 (1.4) | <0.01 |
| Cardiac tamponade | 105 (0.4) | 215 (0.8) | 200 (1.0) | <0.01 |
| Pericarditis | 30 (0.1) | 55 (0.2) | 30 (0.2) | <0.01 |
| Cardiogenic shock | 55 (0.2) | 65 (0.2) | 50 (0.3) | 0.412 |
| Any systemic complication | 25 (0.1) | 40 (0.1) | 50 (0.3) | <0.01 |
| Anaphylaxis | NR | NR | NR | NR |
| Arterial embolism | NR | 20 (0.1) | 35 (0.2) | <0.01 |
| Septic shock | 15 (0.1) | NR | NR | NR |
| Any peripheral vascular complication | 360 (1.3) | 545 (2.0) | 575 (3.0) | <0.01 |
| AV fistula | 30 (0.1) | 55 (0.2) | 30 (0.2) | 0.23 |
| Pseudoaneurysm | 55 (0.2) | 90 (0.3) | 110 (0.6) | <0.01 |
| Haematoma | 110 (0.4) | 140 (0.5) | 155 (0.8) | <0.01 |
| Retroperitoneal bleeding | 20 (0.2) | 15 (0.1) | 15 (0.1) | 0.58 |
| Venous thromboembolism | 50 (0.2) | 80 (0.3) | 65 (0.3) | <0.01 |
| Dissection | NR | NR | 45 (0.2) | NR |
| Any neurological complication | 25 (0.1) | 80 (0.3) | 555 (2.9) | <0.01 |
| Haemorrhagic stroke | 15 (0.1) | 40 (0.1) | 200 (1.0) | <0.01 |
| Ischaemic stroke | NR | 25 (0.1) | 200 (1.0) | <0.01 |
| Transient ischaemic attack | NR | 15 (0.1) | 175 (0.9) | <0.01 |
| Any gastrointestinal (GI) or haematological complication | 915 (3.4) | 1070 (3.9) | 1000 (5.2) | <0.01 |
| GI bleeding | 595 (2.2) | 630 (2.3) | 595 (3.1) | <0.01 |
| Bleeding during the procedure | 20 (0.1) | 25 (0.1) | 20 (0.1) | 0.53 |
| Need for blood transfusion | 320 (1.2) | 465 (1.7) | 470 (2.4) | <0.01 |
| Any pulmonary complications | 475 (1.7) | 690 (2.5) | 685 (3.6) | <0.01 |
| Respiratory failure | 215 (0.8) | 305 (1.1) | 400 (2.1) | <0.01 |
| Pneumothorax | 5 (0.0) | 0 (0.0) | 15 (0.1) | <0.01 |
| Pleural effusion | 80 (0.3) | 95 (0.3) | 105 (0.5) | <0.01 |
| Pneumonia bacterial | 35 (0.1) | 85 (0.3) | 95 (0.5) | <0.01 |
| Long-term ventilation requirement | 15 (0.1) | 25 (0.1) | 55 (0.3) | <0.01 |
Less than 11 data were not reported as per HCUP recommendations and labelled as NR (not reported) where applicable.
Composite of cardiac arrest, ischaemic stroke, haemorrhagic stroke, TIA, arterial embolism, myocardial infarction (NSTEMI & STEMI), major bleeding, pericardial effusion requiring intervention, and peripheral vascular complications.
Crude inpatient outcomes after LAAO device implantation stratified based on CHA2DS2-VASc score are shown in Table 3. A CHA2DS2-VASc score of ≥5 was associated with increased mortality at discharge and with non-home discharge compared to CHA2DS2-VASc scores of 4 or 3 (0.3% vs. 0.1%, P < 0.01, and 4.7% vs. 2.4% vs. 1.6%, P < 0.01, respectively).
Table 3.
In-hospital outcomes after left atrial appendage occlusion stratified on the basis of stroke risk
| Variable no. (%) | CHA2DS2-VASc score 3 [n = 27 255 (36.9%)] | CHA2DS2-VASc score 4 [n = 27 295 (37.0%)] | CHA2DS2-VASc score >/=5 [n = 19 245 (26.1%)] | P-value |
|---|---|---|---|---|
| Died at discharge | 35 (0.1) | 35 (0.1) | 60 (0.3) | <0.01 |
| Home/routine/self-care | 26 790 (98.4) | 26 605 (97.6) | 18 285 (95.3) | <0.01 |
| Non-home discharges | 425 (1.6) | 650 (2.4) | 895 (4.7) | |
| Resource utilization, median (IQR) | ||||
| ȃLength of stay, days | 1 (1–1) | 1 (1–1) | 1 (1–1) | <0.01 |
| ȃCost of hospitalization, $ | 25 072.57 (19 081–31 683) | 25 255.69 (19 751–31 961) | 25 677.27 (20 017–32 567) | <0.01 |
Less than 11 data were not reported as per HCUP recommendations.
To analyse the independent association of CHA2DS2-VASc scores of 4 and ≥5 with important outcomes, multivariable logistic regression models were created by adjusting for potential confounders and are shown in Figure 2. CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18–1.35, and aOR 1.88, 95% CI 1.73–2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11–1.25, and aOR 1.54, 95% CI 1.44–1.66, respectively) after percutaneous LAAO device implantation.
Figure 2.
Unadjusted and adjusted association of CHA2DS2-VASc scores of 4 and ≥5 with outcomes of mortality, overall complications, major complications, prolonged length of stay, and increased hospitalization costs in patients undergoing percutaneous left atrial appendage occlusion.
Discussion
The main findings of our current investigation are as follows: (i) the real-world prevalence of percutaneous LAAO device implantation in patients with an elevated stroke risk was reasonably higher as ∼63% of such implantations in our cohort occurred in patients with CHA2DS2-VASc scores of 4 and ≥5, (ii) the prevalence of important comorbidities was higher in patients with CHA2DS2-VASc scores of 4 and ≥5, and (iii) a higher CHA2DS2-VASc score was associated with an increased likelihood of procedure-related complications and increased resource utilization after LAAO device implantation.
Percutaneous LAAO device implantation is a viable strategy to minimize stroke risk in select AF patients who are intolerant to long-term OAC therapy.15 The pivotal trials comparing percutaneous LAAO device implantation using an earlier-generation Watchman device with warfarin had limited participation of AF patients with an elevated stroke risk.5,6 In the PROTECT-AF trial, approximately two-thirds of patients had a CHADS2 score of ≤2. The follow-up PREVAIL trial also primarily involved low stroke risk patients as less than half of the patients enrolled in this trial had a CHADS2 score > 2. In our real-world cohort of LAAO device implantation from the contemporary US practice, we found that >60% of such implantations occurred in patients with an elevated baseline stroke risk (CHA2DS2-VASc scores of 4 and ≥5). We also found increased risk of procedural complications after LAAO implantation in patients with elevated CHA2DS2-VASc score, and implanting physicians should strive to minimize such complications in order to make these devices safer for all patient groups. In fact, studies have shown significant reduction in LAAO procedural complications with increased operator and institutional experience since its approval in the USA in 2015.10
To the best of our knowledge, this is the first large-scale study comparing outcomes after percutaneous LAAO device implantation in AF patients based on the CHA2DS2-VASc score. Earlier studies have analysed the ability of the CHA2DS2-VASc score in predicting outcomes after invasive cardiovascular procedures. In a study of 633 consecutive patients undergoing transcatheter aortic valve implantation (TAVI), Orvin et al.16 demonstrated that the rates of both stroke and mortality were significantly higher with increasing CHA2DS2-VASc score at 1 year after the index procedure (P = 0.012 and P = 0.025, respectively). They also demonstrated that each single-point increase in CHA2DS2-VASc score was associated with a 38% increase in the 1 year combined endpoint of mortality or stroke (P = 0.022
C index 0.615). In another study of >500 patients undergoing percutaneous coronary intervention, Parfrey et al.17 demonstrated that patients with CHA2DS2-VASc score ≥ 5 had higher mortality rates at 1 year (P = 0.002) and long-term (P < 0.001).
Our results also demonstrated that CHA2DS2-VASc scores of 4 and ≥5 were associated with an increased likelihood of overall complications (aOR 1.26, 95% CI 1.18–1.35, and aOR 1.88, 95% CI 1.73–2.04, respectively) after percutaneous LAAO device implantation. The rate of pericardial effusion requiring intervention was higher in patients with CHA2DS2-VASc scores of 4 and ≥5 when compared to CHA2DS2-VASc scores of 3 after LAAO device implantation. Serious pericardial effusion is one of the most dreaded complications of percutaneous LAAO device implantation, and the incidence was close to 5% in the pivotal PROTECT-AF trial.5 With greater operator experience and improvement in device design, the rate of pericardial effusion requiring intervention continues to decline in contemporary practice after LAAO device implantation.18 Our dataset is not granular in assessment of causative aetiologies for pericardial effusion in patients with a higher CHA2DS2-VASc score, and additional studies are needed to determine the mechanism of pericardial effusion in patients with such baseline elevated stroke risk.
Limitations
The results of our study should be interpreted in the context of the following key limitations. First, the NIS does not contain information on post-LAAO antiplatelet and anticoagulation strategy, which can be variable in patients with different stroke risks. Second, the NIS relies on ICD codes for disease and procedure identification which may be subjected to errors. It is, however, worth pointing out that the NIS has a robust quality control programme that minimizes miscoding and ensures data integrity. Third, the NIS censor outcomes at discharge and patients are not longitudinally followed, and hence, long-term outcomes of stroke and bleeding complications after LAAO implantation cannot be determined from the dataset. Additionally, comparisons cannot be made based on hospital or implanting physician volume as the NIS does not inform on such parameters. Fourth, the NIS only caters to inpatient admissions and does not provide information on outpatient encounters. However, it should be noted that inpatient admission is often required for reimbursement of a LAAO device implantation,19 and hence, our study constitutes a well-representative national sample of LAAO implantations in the USA in the contemporary period.
Conclusion
In contemporary real-world US practice, a significant proportion of percutaneous LAAO device implantations occurred in AF patients with baseline elevated stroke risk (CHA2DS2-VASc scores of 4 and ≥5). A higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO device implantations.
Supplementary material
Supplementary material is available at Europace online.
Supplementary Material
Contributor Information
Lydia Fekadu Messele, Division of Cardiovascular Medicine—Section of Cardiac Electrophysiology, University of California Davis School of Medicine, 4860 Y St. Suite 2800, Sacramento, CA 95817, USA.
Muhammad Zia Khan, Division of Cardiovascular Medicine, West Virginia University Heart & Vascular Institute, Morgantown, WV, USA.
Douglas Darden, Division of Cardiology, Kansas City Heart Rhythm Institute, Overland Park, KS, USA.
Siddharth Agarwal, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Satyam Krishan, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Deepak Kumar Pasupula, Division of Cardiovascular Medicine, MercyOne North Iowa Medical Center, Mason City, IA, USA.
Zain Ul Abideen Asad, Department of Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Sudarshan Balla, Division of Cardiovascular Medicine, West Virginia University Heart & Vascular Institute, Morgantown, WV, USA.
Gagan D Singh, Division of Cardiovascular Medicine—Section of Cardiac Electrophysiology, University of California Davis School of Medicine, 4860 Y St. Suite 2800, Sacramento, CA 95817, USA.
Uma N Srivatsa, Division of Cardiovascular Medicine—Section of Cardiac Electrophysiology, University of California Davis School of Medicine, 4860 Y St. Suite 2800, Sacramento, CA 95817, USA.
Muhammad Bilal Munir, Division of Cardiovascular Medicine—Section of Cardiac Electrophysiology, University of California Davis School of Medicine, 4860 Y St. Suite 2800, Sacramento, CA 95817, USA.
Funding
None declared.
Data availability
The data that support the results of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data that support the results of this study are available from the corresponding author upon reasonable request.