Abstract
Background
The use of mechanical circulatory support (MCS) devices with transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (mTEER) is occasionally required; however, outcomes data are lacking.
Methods
We utilized the Nationwide Inpatient Sample database to identify hospital admissions of adults treated with TAVR and mTEER, with or without MCS, between 2018 and 2021.
Results
We identified 330,055 patients undergoing TAVR and mTEER, with 3240 in the MCS group and 326,815 in the non-MCS group. From 2018 to 2021, there was a steady increase in procedural volume (P for trend <0.001). Utilization of MCS remained stable (P for trend: total 0.096). The use of any MCS modality was associated with a >26-fold increase in mortality (1.01% vs 26.82%, P < 0.001). Mortality remained steadily high with MCS use (P for trend = 0.08). Length of stay and cost of hospitalization were higher in the MCS group (P < 0.05 for both).
Conclusion
The use of MCS in patients undergoing TAVR or mTEER was associated with higher mortality, morbidity, and healthcare utilization; however, causation cannot be determined given the inherent limitations of the dataset.
Keywords: Mechanical circulatory support, mitral transcatheter edge-to-edge repair, transcatheter aortic valve replacement
Transcatheter valve interventions have arisen as acceptable alternatives to surgical intervention in valvular heart disease.1 However, rare but potentially catastrophic complications during these procedures (such as major vascular complications, pericardial effusion, coronary obstruction, acute severe paravalvular regurgitation, annular rupture, left ventricular outflow tract obstruction, ventricular arrhythmias, or prosthesis embolization) can cause rapid circulatory collapse.2–4 Temporary mechanical circulatory support (MCS) can be an important bridging therapy while these complications are being addressed. Moreover, MCS can be used to support patients with hemodynamic instability prior to their valve interventions.5,6
While MCS use with transcatheter aortic valve replacement (TAVR) has been previously described, an up-to-date analysis that includes other transcatheter valve interventions, such as mitral transcatheter edge-to-edge repair (mTEER), is lacking.7,8 Understanding the characteristics of this vulnerable, high-risk population is particularly important with several of these interventions becoming the standard of care. We therefore aimed to leverage a large, contemporary dataset to study the predictors, trends, and outcomes of MCS utilization in patients undergoing TAVR and mTEER.
METHODS
We utilized the Nationwide Inpatient Sample (NIS) database to identify patients who underwent transcatheter valve interventions, with or without MCS, between January 1, 2018, and December 31, 2021. The NIS, a component of the Healthcare Cost and Utilization Project (HCUP), is maintained by the Agency for Healthcare Research and Quality. It contains deidentified administrative data on approximately 7 million hospitalizations annually from 47 states and the District of Columbia, representing 97% of the US population. Trend weights supplied by HCUP allow for nationally representative longitudinal analysis. Due to the publicly available and deidentified nature of the data, institutional review board approval and informed consent were not required.
We included adult patients (≥18 years) who underwent TAVR and mTEER identified via ICD-10-PCS procedure codes (Supplemental Table 1). Patients were stratified by MCS use into those who received intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist device (PVAD). Patients who received more than one MCS device were excluded.
Outcomes assessed included in-hospital mortality (during the index hospitalization during which the procedure was performed), acute kidney injury, hemodialysis, major bleeding, blood transfusion, acute respiratory failure, sepsis, pneumonia, vascular complications, stroke, and pericardial complications. Secondary outcomes were hospital length of stay and total hospitalization cost.
Descriptive statistics were used to summarize baseline characteristics and outcomes. Categorical variables were compared using Pearson’s chi-square or Fisher’s exact test; continuous variables were analyzed using analysis of variance or Kruskal-Wallis tests, as appropriate. Multivariable logistic regression was performed using forward selection to identify independent predictors of MCS use and adverse outcomes, adjusting for relevant baseline characteristics. Adjustments were not performed for several analyses; unadjusted P values should be interpreted as hypothesis generating. Analyses were performed in STATA version 18 following HCUP guidelines.
RESULTS
Baseline characteristics
Among 330,055 patients undergoing TAVR and mTEER, 3240 (1.0%) received MCS and 326,815 (99.0%) did not. Compared with non-MCS patients, those receiving MCS were more likely to be male (62.9% vs 56.3%, P < 0.001). MCS patients had a significantly higher prevalence of congestive heart failure (87.8% vs 72.5%), chronic kidney disease (47.3% vs 33.6%), anemia (57.6% vs 28.0%), protein-energy malnutrition (18.2% vs 2.4%), and history of percutaneous coronary intervention (PCI) (3.3% vs 0.2%) (all P < 0.001). They were also more likely to be treated at teaching hospitals (94.0% vs 89.5%) and have private insurance (15.3% vs 9.1%). Conversely, they had lower rates of smoking, dyslipidemia, and obstructive sleep apnea (P < 0.05 for all). Additional baseline characteristics are detailed in Table 1.
Table 1.
Baseline characteristics of patients receiving transcatheter procedures with or without mechanical circulatory support, National Inpatient Sample, 2018 to 2021
| Variable | No MCS (N = 326,815) | MCS (N = 3240) | P value |
|---|---|---|---|
| Age category (years) | <0.001 | ||
| 18–44 | 979 (0.3%) | 59 (1.8%) | |
| 45–64 | 22,054 (6.8%) | 581 (17.9%) | |
| ≥65 | 303,782 (93.0%) | 2600 (80.3%) | |
| Race/ethnicity | <0.001 | ||
| White | 275,278 (84.2%) | 2401 (74.1%) | |
| Black | 14,737 (4.5%) | 293 (9.0%) | |
| Hispanic | 15,902 (4.9%) | 221 (6.8%) | |
| Other | 20,652 (6.3%) | 324 (10.0%) | |
| Insurance | <0.001 | ||
| Medicare | 289,390 (88.6%) | 2490 (76.9%) | |
| Medicaid | 5908 (1.8%) | 185 (5.7%) | |
| Private insurance | 29,784 (9.1%) | 495 (15.3%) | |
| Self-pay | 1471 (0.5%) | 69 (2.1%) | |
| Female | 142,822 (43.7%) | 1202 (37.1%) | <0.001 |
| Smoking | 131,352 (40.2%) | 897 (27.7%) | <0.001 |
| Alcohol use | 4050 (1.2%) | 99 (3.1%) | <0.001 |
| Congestive heart failure | 236,620 (72.5%) | 2844 (87.8%) | <0.001 |
| Chronic kidney disease | 109,740 (33.6%) | 1533 (47.3%) | <0.001 |
| Dyslipidemia | 241,414 (74.0%) | 1713 (52.9%) | <0.001 |
| Obesity | 67,079 (20.5%) | 599 (18.5%) | 0.19 |
| Coronary artery disease | 220,152 (67.4%) | 2152 (66.5%) | 0.61 |
| History of stroke | 6799 (2.1%) | 72 (2.2%) | 0.78 |
| COPD | 66,641 (20.4%) | 631 (19.5%) | 0.52 |
| Diabetes mellitus | 119,260 (36.5%) | 1179 (36.4%) | 0.99 |
| History of PCI | 718 (0.2%) | 108 (3.3%) | <0.0001 |
| Infective endocarditis | 326 (0.1%) | 23 (0.7%) | <0.0001 |
| Cardiac arrhythmia | 74,233 (22.7%) | 851 (26.3%) | 0.03 |
| Peripheral artery disease | 24,062 (7.4%) | 324 (10.0%) | 0.007 |
| Hospital teaching status | <0.001 | ||
| Teaching | 292,171 (89.5%) | 3046 (94.0%) | |
| Nonteaching | 34,444 (10.5%) | 194 (6.0%) | |
| Protein-energy malnutrition | 7812 (2.4%) | 590 (18.2%) | <0.001 |
| Coagulopathy | 1176 (0.4%) | 36 (1.1%) | <0.001 |
| Pulmonary hypertension | 196 (0.1%) | 5 (0.1%) | 0.41 |
| Hypothyroidism | 58,154 (17.8%) | 518 (16.0%) | 0.23 |
| Liver cirrhosis | 6461 (2.0%) | 50 (1.5%) | 0.39 |
| Obstructive sleep apnea | 49,621 (15.2%) | 401 (12.4%) | 0.047 |
| Anemia | 91,208 (28.0%) | 1865 (57.6%) | <0.001 |
COPD indicates chronic obstructive pulmonary disease; PCI, percutaneous coronary intervention.
Utilization trends
Between 2018 and 2021, the annual volume of TAVR and mTEER increased from 63,055 to 98,000 (P < 0.001) (Table 2). Overall MCS use remained stable during the study period (0.9% to 1.0%, P = 0.10). Among MCS types, IABP use increased slightly (0.4% to 0.6%, P = 0.03), while ECMO and PVAD usage did not change significantly (P = 0.71 and P = 0.72, respectively) (Supplemental Table 2). When stratified by procedure type, overall MCS utilization remained stable with TAVR, but increased steadily with mTEER (P = 0.02), driven by increasing IABP utilization (1.6% to 2.1%, P = 0.02). IABP utilization also increased in TAVR (0.28% to 0.38%, P = 0.05). ECMO and PVAD use remained stable across both procedures. The proportion of every mechanical circulatory support device utilized for TAVR versus mTEER is shown in Figure 1.
Table 2.
Utilization trends of different mechanical circulatory support devices for each transcatheter procedure
| Procedure | Type | 2018 | 2019 | 2020 | 2021 | Total | P value |
|---|---|---|---|---|---|---|---|
| TAVR | IABP | 155 (0.3%) | 210 (0.3%) | 270 (0.4%) | 325 (0.4%) | 960 | 0.045 |
| ECMO | 35 (0.10%) | 200 (0.3%) | 95 (0.1%) | 100 (0.1%) | 430 | 0.66 | |
| PVAD | 190 (0.3%) | 200 (0.3%) | 210 (0.2%) | 230 (0.3%) | 830 | 0.19 | |
| Total | 380 (0.7%) | 610 (0.8%) | 575 (0.7%) | 655 (0.8%) | 2220 | 0.54 | |
| mTEER | IABP | 110 (1.6%) | 180 (1.7%) | 225 (2.0%) | 265 (2.1%) | 780 | 0.02 |
| ECMO | 0 (0.0%) | 0 (0.0%) | 20 (0.2%) | 10 (0.1%) | 30 | N/A | |
| PVAD | 50 (0.7%) | 25 (0.2%) | 60 (0.5%) | 75 (0.6%) | 210 | 0.61 | |
| Total | 160 (1.6%) | 205 (1.7%) | 305 (2.0%) | 350 (2.1%) | 1020 | 0.02 |
ECMO indicates extracorporeal membrane oxygenation; IABP, intra-aortic balloon pump; mTEER, mitral transcatheter edge-to-edge repair; PVAD, percutaneous ventricular assist device; TAVR, transcatheter aortic valve replacement.
Figure 1.
The proportion of every mechanical circulatory support device utilized for the entire study population, as well as for transcatheter aortic valve replacement and mitral transcatheter edge-to-edge repair separately.
Predictors of MCS use
Independent predictors of MCS use included older age, cardiogenic shock (odds ratio [OR] 64.89, 53.32–78.98), congestive heart failure (OR 7.27, 5.36–9.86), treatment at a teaching hospital (OR 3.85, 2.65–5.60), anemia (OR 1.51, 1.27–1.8), protein-energy malnutrition (OR 1.55, 1.23–1.94), chronic kidney disease (OR 1.22, 1.03–1.44), coronary artery disease (OR 1.77, 1.45–2.16), and prior PCI (OR 2.06, 1.29–3.28) (Table 3). Black race was inversely associated with MCS use (OR 0.53, 0.40–0.71). When stratified by procedure type, cardiogenic shock, age, anemia, coronary artery disease, and prior PCI predicted MCS use only in the TAVR subgroup, whereas chronic kidney disease predicted MCS use only in the mTEER subgroup.
Table 3.
Predictors of mechanical circulatory support use
| Variable | TAVR and mTEER |
TAVR only |
mTEER only |
||||||
|---|---|---|---|---|---|---|---|---|---|
| aOR | 95% CI | P value | aOR | 95% CI | P value | aOR | 95% CI | P value | |
| Age | 2.26 | 1.81–2.83 | <0.001 | 3.00 | 2.25–3.99 | <0.001 | 1.41 | 1.00–1.98 | 0.05 |
| Race/ethnicity (Ref: White) | |||||||||
| Black | 0.53 | 0.40–0.71 | <0.001 | 0.42 | 0.28–0.62 | <0.001 | 0.77 | 0.51–1.18 | 0.23 |
| Hispanic | 0.67 | 0.47–0.96 | 0.03 | 0.56 | 0.36–0.88 | 0.012 | 0.98 | 0.53–1.83 | 0.95 |
| Other | 0.98 | 0.74–1.29 | 0.87 | 0.77 | 0.54–1.11 | 0.16 | 1.51 | 0.99–2.32 | 0.06 |
| Female | 0.90 | 0.77–1.06 | 0.23 | 0.84 | 0.69–1.02 | 0.08 | 1.12 | 0.83–1.51 | 0.45 |
| Teaching hospital | 3.85 | 2.65–5.60 | <0.001 | 4.98 | 3.28–7.55 | <0.001 | 2.40 | 1.34–4.33 | 0.003 |
| Anemia | 1.51 | 1.27–1.80 | <0.001 | 1.60 | 1.29–1.97 | <0.001 | 1.33 | 0.99–1.79 | 0.06 |
| Protein-energy malnutrition | 1.55 | 1.23–1.94 | <0.001 | 1.38 | 1.04–1.84 | 0.026 | 1.97 | 1.38–2.81 | <0.001 |
| Alcohol use | 1.04 | 0.66–1.64 | 0.87 | 1.08 | 0.63–1.85 | 0.77 | 0.97 | 0.46–2.05 | 0.93 |
| Insurance (Ref: Medicare) | |||||||||
| Medicaid | 0.96 | 0.65–1.42 | 0.84 | 0.76 | 0.44–1.33 | 0.34 | 1.15 | 0.67–1.98 | 0.60 |
| Private | 1.10 | 0.85–1.41 | 0.48 | 1.22 | 0.90–1.65 | 0.21 | 0.90 | 0.57–1.42 | 0.66 |
| Self-pay/Other | 1.38 | 0.80–2.39 | 0.24 | 1.53 | 0.77–3.03 | 0.23 | 1.18 | 0.46–3.04 | 0.74 |
| Obesity | 1.06 | 0.86–1.30 | 0.60 | 1.00 | 0.78–1.28 | 0.99 | 1.16 | 0.80–1.68 | 0.43 |
| CHF | 7.27 | 5.36–9.86 | <0.001 | 5.01 | 3.58–7.02 | <0.001 | 32.09 | 13.57–75.90 | <0.001 |
| Arrhythmia | 1.08 | 0.90–1.30 | 0.42 | 0.99 | 0.78–1.25 | 0.92 | 1.30 | 0.95–1.76 | 0.1 |
| CKD | 1.22 | 1.03–1.44 | 0.02 | 1.13 | 0.92–1.38 | 0.25 | 1.44 | 1.05–1.98 | 0.03 |
| Pulmonary hypertension | 1.56 | 0.21–11.38 | 0.66 | 0.72 | 0.57–0.92 | 0.008 | 0.68 | 0.48–0.98 | 0.041 |
| History of PCI | 2.06 | 1.29–3.28 | 0.003 | 0.69 | 0.56–0.86 | 0.001 | 0.90 | 0.65–1.24 | 0.51 |
| CAD | 1.77 | 1.45–2.16 | <0.001 | 1.97 | 1.12–3.47 | 0.02 | 2.26 | 0.98–5.23 | 0.06 |
| Cardiogenic shock | 64.89 | 53.32–78.98 | <0.001 | 58.01 | 45.59–73.82 | <0.001 | 1.21 | 0.89–1.64 | 0.22 |
aOR indicates adjusted odds ratio; CAD, coronary artery disease; CHF, congestive heart failure; CI, confidence interval; CKD, chronic kidney disease; mTEER, mitral transcatheter edge-to-edge repair; PCI, percutaneous coronary intervention; TAVR, transcatheter aortic valve replacement.
Clinical outcomes of MCS use
Mortality was highest with ECMO (50.0%), followed by PVAD (30.8%) and IABP (18.1%, Supplemental Table 3). The use of any MCS modality was associated with a > 26-fold increase in in-hospital mortality (26.8% vs 1.0%; adjusted OR 25.29 [19.69–32.48], P < 0.001). MCS use was associated with a significantly increased risk of acute kidney injury (adjusted odds ratio [aOR] 8.36), acute respiratory failure (aOR 11.95), sepsis (aOR 5.56), major bleeding (aOR 2.94), blood transfusion (aOR 3.60), vascular complications (aOR 3.39), stroke (aOR 2.35), pneumonia (aOR 2.75), pericardial complications (aOR 6.53), and hemodialysis (aOR 2.04) (all P < 0.001). Outcomes were similarly worse with MCS use in both the TAVR and mTEER subgroups (Table 4 and Supplemental Table 4).
Table 4.
Outcomes of TAVR and mTEER with and without use of mechanical circulatory support
| Outcome |
TAVR and mTEER
|
TAVR only
|
mTEER only
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
No MCS
(N = 326,815) |
MCS (N = 3240) |
Total
(N = 330,055) |
P value | No MCS (N = 286,780) | MCS (N = 2220) | Total (N = 289,000) | P value | No MCS (N = 40,035) | MCS (N = 1020) | Total (N = 41,055) | P value | |
| Mortality | 3299 (1.0%) | 869 (26.8%) | 4168 (1.3%) | <0.001 | 2783 (1.0%) | 610 (27.5%) | 3393 (1.2%) | <0.001 | 520 (1.3%) | 255 (25.0%) | 775 (1.9%) | <0.001 |
| AKI | 30,202 (9.3%) | 1863 (57.5%) | 32,065 (9.7%) | <0.001 | 24,739 (8.6%) | 1135 (51.1%) | 25,874 (9.0%) | <0.001 | 5516 (13.8%) | 725 (71.1%) | 6241 (15.2%) | <0.001 |
| Pericardial complications |
2092 (0.6%) | 166 (5.1%) | 2258 (0.7%) | <0.001 | 1893 (0.7%) | 155 (7.0%) | 2048 (0.7%) | <0.001 | 204 (0.5%) | 10 (1.0%) | 214 (0.5%) | 0.36 |
| Major bleeding |
31,182 (9.5%) | 1126 (34.7%) | 32,308 (9.8%) | <0.001 | 28,777 (10.0%) | 815 (36.7%) | 29,592 (10.2%) | <0.001 | 2422 (6.0%) | 310 (30.4%) | 2732 (6.7%) | <0.001 |
| Blood transfusion |
14,261 (4.4%) | 724 (22.3%) | 14,985 (4.5%) | <0.001 | 12,788 (4.5%) | 540 (24.3%) | 13,328 (4.6%) | <0.001 | 1489 (3.7%) | 185 (18.1%) | 1674 (4.1%) | <0.001 |
| Acute respiratory failure |
13,038 (4.0%) | 1507 (46.5%) | 14,545 (4.4%) | <0.001 | 10,819 (3.8%) | 970 (43.7%) | 11,789 (4.1%) | <0.001 | 2271 (5.7%) | 540 (52.9%) | 2811 (6.8%) | <0.001 |
| Hemodialysis | 9370 (2.9%) | 397 (12.2%) | 9767 (3.0%) | <0.001 | 7886 (2.8%) | 250 (11.3%) | 8136 (2.8%) | <0.001 | 1473 (3.7%) | 145 (14.2%) | 1618 (3.9%) | <0.001 |
| Vascular complications |
4122 (1.3%) | 176 (5.4%) | 4298 (1.3%) | <0.001 | 3842 (1.3%) | 130 (5.9%) | 3972 (1.4%) | <0.001 | 2442 (6.1%) | 45 (4.4%) | 2487 (6.1%) | <0.001 |
| Stroke | 5229 (1.6%) | 161 (4.9%) | 5390 (1.6%) | <0.001 | 4962 (1.7%) | 115 (5.2%) | 5077 (1.8%) | <0.001 | 2602 (6.5%) | 45 (4.4%) | 2647 (6.5%) | <0.001 |
| Sepsis | 2451 (0.8%) | 417 (12.8%) | 2868 (0.9%) | <0.001 | 2008 (0.7%) | 235 (10.6%) | 2243 (0.8%) | <0.001 | 444 (1.1%) | 180 (17.7%) | 624 (1.5%) | <0.001 |
| Pneumonia | 3613 (1.1%) | 241 (7.4%) | 3854 (1.2%) | <0.001 | 3011 (1.1%) | 125 (5.6%) | 3136 (1.1%) | <0.001 | 552 (1.4%) | 115 (11.3%) | 667 (1.6%) | <0.001 |
AKI indicates acute kidney injury; mTEER, mitral transcatheter edge-to-edge repair; TAVR, transcatheter aortic valve replacement.
Outcome trends
Overall mortality in patients undergoing transcatheter valve procedures decreased slightly from 1.4% in 2018 to 1.1% in 2021 (P = 0.20), with a declining trend in TAVR-related mortality (P = 0.05) (Table 5). Mortality among MCS recipients showed a nonsignificant downward trend. Complication rates, including infection, vascular, and pericardial complications, remained largely stable across MCS types over the study period (Supplemental Table 5).
Table 5.
Trends of in-hospital mortality in patients undergoing TAVR and mTEER stratified by type of intervention
| Category | Variable | 2018 | 2019 | 2020 | 2021 | Total | P value |
|---|---|---|---|---|---|---|---|
| Procedure | TAVR | 1.3% | 1.2% | 1.2% | 1.0% | 1.2% | 0.05 |
| mTEER | 2.2% | 1.6% | 2.3% | 1.6% | 1.9% | 0.67 | |
| Total | 1.4% | 1.2% | 1.3% | 1.1% | 1.3% | 0.20 | |
| MCS use | No | 1.1% | 0.9% | 1.0% | 0.9% | 1.0% | 0.22 |
| Yes | 34.3% | 29.6% | 29.6% | 18.1% | 26.8% | 0.08 |
MSC indicates mechanical circulatory support; mTEER, mitral transcatheter edge-to-edge repair; TAVR, transcatheter aortic valve replacement.
Length of stay and cost
Patients requiring MCS had markedly longer hospital stays compared to non-MCS patients (mean 15.2 vs 3.4 days) and incurred significantly higher hospitalization costs ($565,396 vs $218,243). These differences persisted across all years but remained stable over time within each group (Supplemental Table 6).
DISCUSSION
In this nationally representative study of 330,055 patient admissions for TAVR and mTEER, we report several significant findings regarding the use of MCS in this patient population. Despite a steady increase in these procedures with stable mortality, the utilization of MCS in this population was low (1%) and remained relatively stable throughout the study period. More than a quarter of the patients requiring MCS died during the index hospitalization. Patterns and predictors of MCS use were distinct between TAVR and mTEER. Acknowledging that causality cannot be inferred from these results given the limitations of the NIS dataset, MCS use was associated with a > 26-fold increase in mortality and greater resource utilization.
Patterns of MCS use with TAVR and mTEER appear distinct from trends seen in cardiogenic shock populations. Notably, IABP use remained steady from 2018 to 2021, contrasting with its declining use in cardiogenic shock due to heart failure or acute myocardial infarction.9 Utilization of IABP was more frequent with mTEER compared to TAVR, and cardiogenic shock predicted MCS use only in TAVR cases. This may reflect more intraprocedural IABP use during mTEER to improve leaflet coaptation and hemodynamics.10,11 In contrast, other MCS devices showed no significant change in use, differing from the rising PVAD use for cardiogenic shock.9 These trends suggest different indications and patient profiles for MCS use with transcatheter valve procedures.
Our findings highlight opportunities for improvement. Mortality among patients receiving MCS during transcatheter valve procedures has not declined, consistent with trends observed in broader cardiogenic shock populations.9,12 Vascular complications have also remained high, and they are known to associate with significant in-hospital mortality.13,14 Recent retrospective studies and randomized controlled trials have shown a mortality reduction with PVAD in cardiogenic shock secondary to acute myocardial infarction, despite the higher risk of vascular complications.15–17 Future studies could clarify if similar outcomes can be observed within patients undergoing transcatheter valve interventions if PVAD is used as the MCS device of choice (when indicated).
While our study provides important national-level insights, it is important to interpret these findings in the context of the inherent limitations of the NIS database. First, the NIS lacks granular clinical detail, such as hemodynamic parameters, imaging findings, device specifics, or periprocedural management strategies. As a result, our ability to adjust for important confounders such as procedural complexity, patient frailty, and the precise indication for MCS initiation is limited. Timing of MCS initiation can significantly affect outcomes; however, this information was also not available within this database.18 Most importantly, the temporal association between MCS, valve interventions, and outcomes could not be discerned. This raises the possibility of significant residual confounding in our estimates of the association between MCS use and adverse outcomes.
Second, the cross-sectional design of the NIS prevents causal inference. The strong association between MCS use and worse outcomes could possibly reflect the underlying severity of illness and selection bias, rather than a direct effect of MCS itself. Many patients in the study experienced complications such as vascular injury, pericardial issues, or infection that may have both necessitated MCS and contributed to poorer outcomes. Moreover, MCS use with TAVR was associated with higher rates of cardiogenic shock, stroke, acute kidney injury, and pneumonia, similar to prior reports.7,19
Third, as an administrative claims database, the NIS depends on accurate coding of diagnoses and procedures. Miscoding or underreporting may lead to misclassification and biased estimates of MCS use and outcomes. Additionally, the NIS only captures in-hospital events, so longer-term outcomes like 30-day or 1-year survival and readmissions are unknown. Finally, because the NIS excludes federal hospitals and only samples discharges, the findings may not fully generalize to all US centers, and regional or institutional variations in MCS use cannot be completely accounted for.
In conclusion, the use of MCS in patients undergoing TAVR and mTEER in the United States between 2018 and 2021 was associated with a 26-fold increase in mortality, greater morbidity, and greater utilization of healthcare resources. However, causation cannot be determined given the inherent limitations of the dataset. Trends in specific MCS device utilization in this population may differ from those of the general cardiogenic shock population. Further research is needed to improve the safety and cost-effectiveness of MCS with transcatheter valve interventions, as well as identify the ideal MCS for these patients.
Supplementary Material
Disclosure statement/Funding
The authors report no funding or conflicts of interest.
References
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