Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied. METHODS: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies. RESULTS: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA2DS2-VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; Pnoninferiority<0.001). CONCLUSIONS: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534.

Transcatheter aortic valve replacement in aortic regurgitation: The U.S. experience.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can be an effective option for high-risk Aortic Regurgitation (AR) patients. Although international experiences of TAVR for AR are published, U.S. data are limited. This study sought to report the short-term outcomes of TAVR in AR in the U.S. METHODS: Study cohorts were derived from the Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016-17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/permanent pacemaker placement (PPM), open-heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders. RESULTS: 915 patients from the NIS (male-71%, age ≥65-84.2%) and 822 patients from the NRD (male-69.3%, age ≥65-80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7%, and 30-day mortality was 3.3%. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18-19% with paravalvular leak (4-7%) being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas peripheral vascular disease was a predictor of increased valvular complications and CHB/PPM. CONCLUSION: TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as the standard treatment in AR.

Effect of percutaneous paravalvular leak closure on hemolysis.

OBJECTIVE: To study the effect of percutaneous paravalvular leak closure on hemolysis. BACKGROUND: Although transcatheter PVL closure reduces heart failure and mortality in symptomatic patients with paravalvular leaks (PVL), little is known about its effect on hemolysis. METHODS: We retrospectively analyzed patients undergoing transcatheter mitral or aortic PVL closure (January 2005-December 2016) at Mayo Clinic. Patients with anemia or abnormal hemolysis markers (LDH, haptoglobin) were included in the analysis. The primary outcome was defined as hemoglobin increase ≥ 1.5 mg/dL, decrease in LDH above median or improvement in haptoglobin. Univariate and multivariate binary logistic regression modeling were used to determine predictors of successful treatment of hemolysis. RESULTS: Final study population included 168 patients (130 [77%] mitral, 38 [23%] aortic PVL). Primary outcome occurred in 70 patients (42%). Hemoglobin increased by 1.74 ± 1.69 mg/dL in patients who reached primary outcome. 57/168 (34%) patients required blood transfusion prior to PVL closure compared to 35/168 (21%) postprocedure. The mean reduction in LDH was 403 U/L. Multivariate regression showed that patients with mechanical valves were more likely to have successful outcome (P = 0.044). CONCLUSION: Percutaneous PVL closure is associated with modest improvement in hemolysis markers, increase in hemoglobin levels and reduction in blood transfusion requirements. This benefit is most significant in patients with mechanical valves.

A hybrid technique for treatment of commissural primary mitral regurgitation.

BACKGROUND: MitraClip is an effective transcatheter therapy for mitral regurgitation (MR). However, MitraClip is challenging in commissural MR and the optimal therapeutic approach is unclear. METHODS: We describe a case series of six consecutive patients with severe commissural primary mitral regurgitation who underwent MitraClip insertion followed by an Amplatzer Vascular Plug (AVP) II occluder between the commissure and the MitraClip. RESULTS: The procedure was successful in all patients. MR was reduced from severe to mild/trivial in 50% and moderate in 50% of cases. On 30-day follow-up, NYHA class had improved from III (6 patients) to I (2 patients), II (2 patients), and III (2 patients). The mean transmitral gradient was 2.5 ± 1.8 mmHg at baseline and 4.8 ± 2.6 mmHg following the procedure. One patient developed hemolysis immediately post procedure. The other five patients remained well during a median follow-up of 20 months (range 5-50 months) with no reported device dislodgement. CONCLUSIONS: Elective treatment of severe commissural MR with a laterally or medially placed MitraClip coupled with an AVP II occluder between the clip and the commissure is feasible and safe. This approach may provide a useful management alternative in selected patients.

Procedural trends, outcomes, and readmission rates pre-and post-FDA approval for MitraClip from the National Readmission Database (2013-14).

BACKGROUND: There are sparse clinical data on the procedural trends, outcomes and readmission rates following FDA approval and expansion of Transcatheter mitral valve repair/MitraClip® . Whether a complex new technology can be disseminated safely and quickly is controversial. METHODS: The study cohort was derived from the National Readmission Data (NRD) 2013-14. MitraClip® was identified using appropriate International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. The primary outcome was a composite of in-hospital mortality + procedural complications. Secondary outcome included 30-day readmissions. Hierarchical two level logistic models were used to evaluate study outcomes. RESULTS: Our analysis included 2003 MitraClip® procedures. Overall in-hospital mortality was 3.9%. As expected, there was a significant increase in procedural volume post-FDA approval. Importantly, a corresponding downward trend in mortality and procedural complications was observed. Significant predictors of in-hospital mortality and procedural complications included the use of vasopressors (P <0.001) and hemodynamic support (P < 0.001). Higher hospital volume (≥10 MitraClips/year) was associated with lower in-hospital mortality and complications (P = 0.02). There were 304 (15.1%) 30-day readmissions, with heart failure being the most common cause of readmission. Elective procedures had lower in-hospital mortality (P < 0.001) and lower readmission rates (P = 0.011) compared with nonelective procedures. CONCLUSION: A significant increase in MitraClip® procedural volumes occurred post-FDA approval. Overall morbidity and mortality were low and trended downwards. Hospital procedure volume ≥10 cases were associated with lower mortality and overall complication rates. These data suggest a successful roll out of a very complex novel structural heart procedure.

Left atrial pressure and predictors of survival after percutaneous mitral paravalvular leak closure.

BACKGROUND: Data on the clinical utility of left atrial (LA) hemodynamic monitoring during percutaneous mitral interventions are limited. OBJECTIVES: To evaluate the association between intraprocedural LA pressures during percutaneous mitral paravalvular leak (PVL) closure and long term survival. METHODS: Patients who underwent mitral PVL repair with invasive LA pressure monitoring were divided at baseline to three tertiles based on their mean final LA pressure (<25%; 25-30%; >30% of mean systolic blood pressure). Primary outcome was all-cause mortality. RESULTS: 134 patients (mean age 68 ± 12 years) were studied. Over 3 year mean follow-up, 81 (38%) patients died. The cumulative probability of death at 3 years was significantly higher among patients in the highest LA pressure tertile (56 ± 8% vs. 28 ± 5%, log rank P < 0.001). More than mild residual mitral regurgitation (MR) by transesophageal echocardiography (TEE) was associated with a 2.5-fold increased risk of death and patients in the highest LA pressure tertile had 2.2-fold higher mortality (P < 0.001 and = 0.003 respectively). After adjustment for residual MR by TEE, each 10% acute procedural reduction in LA pressures was associated with a significant 9% reduced risk of death (P = 0.023). Multivariate Cox regression with adjustment for multiple predictors of death showed that patients in lower LA pressure tertiles had 59% lower mortality (P = 0.003). CONCLUSION: Lower LA pressure following mitral PVL closure is an independent predictor of improved survival, even after adjustment for residual MR. LA pressure monitoring may be a useful tool for procedural guidance during mitral PVL closure.

Impact of Glycoprotein IIb/IIIa Inhibitors Use on Outcomes After Lower Extremity Endovascular Interventions From Nationwide Inpatient Sample (2006-2011).

OBJECTIVE: The aim of our study was to study the impact of glycoprotein IIb/IIIa inhibitors (GPI) on in-hospital outcomes. BACKGROUND: There is paucity of data regarding the impact of GPI on the outcomes following peripheral endovascular interventions. METHODS: The study cohort was derived from Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database between the years 2006 and 2011. Peripheral endovascular interventions and GPI utilization were identified using appropriate ICD-9 Diagnostic and procedural codes. Two-level hierarchical multivariate mixed models were created. The study outcomes were: primary (in-hospital mortality and amputation studied separately) and secondary (composite of in-hospital mortality and postprocedural complications). Hospitalization costs were also assessed. RESULTS: GPI utilization (OR, 95% CI, P-value) was independently predictive of lower amputation rates (0.36, 0.27-0.49, <0.001). There was no significant difference in terms of in-hospital mortality (0.59, 0.31-1.14, P 0.117), although GPI use predicted worse secondary outcomes (1.23, 1.03-1.47, 0.023). Following propensity matching, the amputation rate was lower (3.2% vs. 8%, P < 0.001), while hospitalization costs were higher in the cohort that received GPI ($21,091 ± 404 vs. 19,407 ± 133, P < 0.001). CONCLUSIONS: Multivariate analysis revealed GPI use in peripheral endovascular interventions to be suggestive of an increase in composite end-point of in-hospital mortality and postprocedural complications, no impact on in-hospital mortality alone, significantly lower rate of amputation, and increase in hospitalization costs. © 2016 Wiley Periodicals, Inc.

Variability in utilization of drug eluting stents in United States: Insights from nationwide inpatient sample.

OBJECTIVES: We studied the trends and predictors of drug eluting stent (DES) utilization from 2006 to 2011 to further expound the inter-hospital variability in their utilization. BACKGROUND: We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) between 2006 and 2011 using ICD-9-CM procedure code, 36.06 (bare metal stent) or 36.07 (drug eluting stents) for Percutaneous Coronary Intervention (PCI). Annual hospital volume was calculated using unique identification numbers and divided into quartiles for analysis. METHODS AND RESULTS: We built a hierarchical two level model adjusted for multiple confounding factors, with hospital ID incorporated as random effects in the model. About 665,804 procedures (weighted n = 3,277,884) were analyzed. Safety concerns arising in 2006 reduced utilization DES from 90% of all PCIs performed in 2006 to a nadir of 69% in 2008 followed by increase (76% of all stents in 2009) and plateau (75% in 2011). Significant between-hospital variation was noted in DES utilization irrespective of patient or hospital characteristics. Independent patient level predictors of DES were (OR, 95% CI, P-value) age (0.99, 0.98-0.99, <0.001), female(1.12, 1.09-1.15, <0.001), acute myocardial infarction(0.75, 0.71-0.79, <0.001), shock (0.53, 0.49-0.58, <0.001), Charlson Co-morbidity index (0.81,0.77-0.86, <0.001), private insurance/HMO (1.27, 1.20-1.34, <0.001), and elective admission (1.16, 1.05-1.29, <0.001). Highest quartile hospital (1.64, 1.25-2.16, <0.001) volume was associated with higher DES placement. CONCLUSION: There is significant between-hospital variation in DES utilization and a higher annual hospital volume is associated with higher utilization rate of DES. © 2015 Wiley Periodicals, Inc.

Septal Ablation and Hypertrophic Obstructive Cardiomyopathy: 7 Years US Experience.

BACKGROUND: Septal ablation (SA) is a key modality for left ventricular outflow tract gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM) patients with refractory symptoms. The primary objective of our study was to evaluate post-procedural mortality, complications, length of stay (LOS), and cost of hospitalization following SA. METHODS: We queried the Nationwide Inpatient Sample (NIS) between 2005 and 2011 using the ICD9 procedure code of 37.34 for ablation of heart tissue. Only adult patients with HOCM (ICD-9-CM: 425.1) were included. Patients with any arrhythmia diagnosis or open surgical ablation procedure code were excluded. Hierarchical mixed effects models were generated in order to identify the independent multivariate predictors of outcomes. RESULTS: A total of 358 SAs were available for analysis. There was no reported mortality during the study period; permanent pacemaker implantation rate was 8.7%. Highest hospital volume tertile (OR, 95%CI, P- value) predicted significantly lower post-procedural complications (0.51, 0.26-0.98, P = 0.04). Univariate analysis of highest versus lowest tertile of hospital volume showed significant decrease in LOS (2.6 days vs. 3.8 days, P<0.01) and non-significant decrease hospitalization costs (16,800$ vs. 19,500$, P = 0.29). CONCLUSIONS: SA is a safe procedure and associated with low peri- procedural mortality rate. A higher burden of baseline comorbidities is associated with worse outcomes while higher annual hospital volume is associated with lower rate of post-procedural complications, length of stay, and cost of care following SA.

Intravascular Ultrasound in Lower Extremity Peripheral Vascular Interventions: Variation in Utilization and Impact on In-Hospital Outcomes From the Nationwide Inpatient Sample (2006-2011).

PURPOSE: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. METHODS: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. RESULTS: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI -$167 to +$2833, p=0.082). CONCLUSION: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.

Percutaneous Coronary Intervention: Relationship Between Procedural Volume and Outcomes.

Percutaneous coronary intervention (PCI) is an integral treatment modality for acute coronary syndromes (ACS) as well as chronic stable coronary artery disease (CAD) not responsive to optimal medical therapy. This coupled with studies on the feasibility and safety of performing PCI in centers without on-site surgical backup led to widespread growth of PCI centers. However, this has been accompanied by a recent steep decline in the volume of PCIs at both the operator and hospital level, which raises concerns regarding minimal procedural volumes required to maintain necessary skills and favorable clinical outcomes. The 2011 ACC/AHA/SCAI competency statement required PCI be performed by operators with a minimal procedural volume of >75 PCIs annually at high-volume centers with >400 PCIs per year, a number which was relaxed in the 2013 ACC/AHA/SCAI update to >50 PCIs/operator/year in hospitals with >200 PCIs annually to coincide with reduction in national PCI volume. Recent data suggests that many hospitals do not meet these thresholds. We review data on the importance of volume as a vital quality metric at both an operator and hospital level in determining procedural outcomes following PCI.

Influence of same-day admission on outcomes following transcatheter aortic valve replacement.

BACKGROUND: Since elective transcatheter aortic valve replacements (TAVRs) can be performed on the day of admission, i.e., Day 0, or on the next day of admission, i.e., Day 1, we sought to investigate if there is an advantage to either approach. METHODS: We performed a retrospective cohort study, using the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012 and identified subjects undergoing endovascular (Transfemoral/Transaortic) TAVRs using the ICD-9-CM procedure code of 35.05. The cohort was divided based on the day of the TAVR performed, i.e., Day 0 or 1. The cost of the hospitalization and length of stay were the primary outcomes, with in-hospital mortality and procedural complications as the secondary outcomes. We identified a total of 843 TAVRs. Propensity matched models were created. The mean age of the study cohort was 82 years. RESULTS: In a propensity-matched dataset, TAVRs performed on Day 0 were associated with a lower cost ($51,126 ± 1184 vs $57,703 ± 1508, p < 0.0001) and length of stay (mean days, standard error: 5.87 ± 0.25 vs 7.20 ± 0.29, p < 0.001) compared to Day 1. In-hospital mortality plus complication rates were relatively similar with no difference between Days 0 and 1 (31.5% vs 34.1%, p = 0.47, respectively). CONCLUSIONS: Endovascular TAVRs performed on the same day of admission are associated with lower hospitalization costs and length of stay, and similar mortality and complication rates compared to those performed on the next day of admission.

Impact of annual operator and institutional volume on percutaneous coronary intervention outcomes: a 5-year United States experience (2005-2009).

BACKGROUND: The relationship between operator or institutional volume and outcomes among patients undergoing percutaneous coronary interventions (PCI) is unclear. METHODS AND RESULTS: Cross-sectional study based on the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample between 2005 to 2009. Subjects were identified by International Classification of Diseases, 9(th) Revision, Clinical Modification procedure code, 36.06 and 36.07. Annual operator and institutional volumes were calculated using unique identification numbers and then divided into quartiles. Three-level hierarchical multivariate mixed models were created. The primary outcome was in-hospital mortality; secondary outcome was a composite of in-hospital mortality and peri-procedural complications. A total of 457,498 PCIs were identified representing a total of 2,243,209 PCIs performed in the United States during the study period. In-hospital, all-cause mortality was 1.08%, and the overall complication rate was 7.10%. The primary and secondary outcomes of procedures performed by operators in 4(th) [annual procedural volume; primary and secondary outcomes] [>100; 0.59% and 5.51%], 3(rd) [45-100; 0.87% and 6.40%], and 2(nd) quartile [16-44; 1.15% and 7.75%] were significantly less (P<0.001) when compared with those by operators in the 1(st) quartile [≤15; 1.68% and 10.91%]. Spline analysis also showed significant operator and institutional volume outcome relationship. Similarly operators in the higher quartiles witnessed a significant reduction in length of hospital stay and cost of hospitalization (P<0.001). CONCLUSIONS: Overall in-hospital mortality after PCI was low. An increase in operator and institutional volume of PCI was found to be associated with a decrease in adverse outcomes, length of hospital stay, and cost of hospitalization.

Asthma: Hospitalization Trends and Predictors of In-Hospital Mortality and Hospitalization Costs in the USA (2001-2010).

BACKGROUND: In the last decade, the proportion of people with asthma in the USA grew by nearly 15%, with 479,300 hospitalizations and 1.9 million emergency department visits in 2009 alone. The primary objective of our study was to evaluate in-hospital outcomes in patients admitted with asthma exacerbation in terms of mortality, length of stay (LOS) and hospitalization costs. METHODS: We queried the HCUP's Nationwide Inpatient Sample (NIS) between 2001 and 2010 using the ICD9-CM diagnosis code 493 for asthma (n = 760,418 patients). The NIS represents 20% of all hospitals in the USA. Multivariate logistic regression analysis was used to evaluate predictors of in-hospital mortality. LOS and hospitalization costs were also analyzed. RESULTS: The overall LOS was 3.9 days and as high as 8.3 days in patients requiring mechanical ventilation. LOS has decreased in recent years, though it continues to be higher than in 2001. The hospitalization cost increased steadily over the study period. The overall in-hospital mortality was 1% and as high as 9.8% in patients requiring mechanical ventilation. Multivariate predictors of longer LOS, higher hospitalization costs and in-hospital mortality included increasing age and hospitalizations during the winter months. Private insurance was predictive of lower hospitalization costs and LOS as well as lower in-hospital mortality. CONCLUSION: Asthma continues to account for significant in-hospital mortality and resource utilization, especially in mechanically ventilated patients. Age, admissions during winter months and the type of insurance are independent predictors of in-hospital outcomes.

Utilization of catheter-directed thrombolysis in pulmonary embolism and outcome difference between systemic thrombolysis and catheter-directed thrombolysis.

OBJECTIVE: The aim of the study was to assess the utilization of catheter-directed thrombolysis (CDT) and its comparative effectiveness against systemic thrombolysis in acute pulmonary embolism (PE). BACKGROUND: Contemporary real world data regarding utilization and outcomes comparing systemic thrombolysis with CDT for PE is sparse. METHODS: We queried the Nationwide Inpatient Sample from 2010 to 2012 using the ICD-9-CM diagnosis code 415.11, 415.13, and 415.19 for acute PE. We used propensity score analysis to compare outcomes between systemic thrombolysis and CDT. Primary outcome was in-hospital mortality. Secondary outcome was combined in-hospital mortality and intracranial hemorrhage (ICH). RESULTS: Out of 110,731 patients hospitalized with PE, we identified 1,521 patients treated with thrombolysis, of which 1,169 patients received systemic thrombolysis and 352 patients received CDT. After propensity-matched comparison, primary and secondary outcomes were significantly lower in the CDT group compared to systemic thrombolysis (21.81% vs. 13.36%, OR 0.55, 95% CI 0.36-0.85, P value = 0.007) and (22.89% vs. 13.36%, OR 0.52, 95% CI 0.34-0.80, P value = 0.003), respectively. The median length of stay [7 days, interquartile range (IQR) (5-9 days) vs. 7 days, IQR (5-10 days), P = 0.17] was not significant between the two groups. The CDT group had higher cost of hospitalization [$17,218, IQR ($12,272-$23,906) vs. $23,799, IQR ($17,892-$35,338), P < 0.001]. Multivariate analysis identified increasing age, saddle PE, cardiopulmonary arrest, and Medicaid insurance as independent predictors of in-hospital mortality. CONCLUSIONS: CDT was associated with lower in-hospital mortality and combined in-hospital mortality and ICH.

Effect of Hospital Volume on Outcomes of Transcatheter Mitral Valve Repair: An Early US Experience.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is a complex procedure for patients with mitral regurgitation who cannot get surgery. However, there is a lack of data on how hospital volumes affect these outcomes. METHODS: We performed a cross sectional study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012 and identified subjects using the ICD-9-CM procedure code of 35.97, which was introduced in October 2010 for percutaneous mitral valve repair if present in the primary or secondary procedure field. Hospital volumes were divided into tertiles. The primary outcome was a composite of in-hospital mortality and peri-procedural complications. Length of stay and hospitalization cost were also assessed. RESULTS: A total of 95 (weighted n = 475) TMVR procedures were identified. The mean age of the overall cohort was 70 years; 43.2% were female and 63.2% had a significant baseline burden of co-morbidities. The composite of in-hospital mortality and peri-procedural complications decreased with increasing TMVR hospital volume: 48.7% in the first tertile, 17.4% in the second tertile, and 9.1% in the third tertile. Additionally, we saw a decrease in the length of stay and a trend in decrease in the hospitalization cost. CONCLUSION: In hospitals performing TMVR, higher hospital volumes are associated with a reduction in a composite of in-hospital mortality and post-procedural complications, in addition to the shorter length of stay.

Racial disparities in left main stenting: insights from a real world inner city population.

BACKGROUND: Left main coronary artery (LMCA) disease is associated with significant cardiovascular mortality. The data on patient characteristics' predicting outcomes after LMCA revascularization is sparse. METHODS: A retrospective study of 227 patients with LMCA disease documented on coronary angiography from March 2000 to December 2008. Data included demographic variables, co-morbidities, cardiac function, and medications. Race was self-identified. The study outcome was a composite end-point including myocardial infarction (MI) and all-cause mortality. Cox proportional hazard analysis was performed to study the effect of various patient attributes including race and gender on the composite end-point. RESULTS: Baseline characteristics were specifically compared between individuals who had the study outcome versus those who did not. Mean age was higher in the group with study outcomes when compared to the group without any outcomes (64.3 ± 11.8 years versus 59.2 ± 13.6 years; p = 0.013). After the final multivariate regression analysis, only African American (AA) race and age were found to be independent predictors of adverse cardiac outcome at the end of the first year (race-hazard ratio (HR) 3.82, 95% confidence interval (CI) 1.38-10.62, p = 0.010; age-HR 1.08, 95% CI 1.04-1.13, p < 0.001) and at the end of the study (race-HR 2.71, 95% CI 1.44-5.10, p = 0.002; age-HR 1.03, 95% CI 1.01-1.08, p = 0.017). CONCLUSION: In our study of patients with unprotected LMCA disease, AA race, and age were significantly predictive of poor prognosis following revascularization, while gender had no predictive value in prognosticating cardiovascular mortality.

Transcatheter Aortic Valve Implantation in Mixed Aortic Valve Disease: A Multicenter Study.

Mixed aortic valve disease (MAVD), defined by the concurrent presence of aortic stenosis (AS) and insufficiency is frequently seen in patients who have undergone transcatheter aortic valve implantation (TAVI). However, studies comparing the outcomes of TAVI in MAVD versus isolated AS have demonstrated conflicting results. Therefore, we aim to assess the outcomes of TAVI in patients with MAVD in comparison with those with isolated severe AS. Patients who underwent native valve TAVI for severe AS at 3 tertiary care academic centers between January 2012 and December 2020 were included and categorized into 3 groups based on concomitant aortic insufficiency (AI) as follows: group 1, no AI; group 2, mild AI; and group 3, moderate to severe AI. Outcomes of interest included all-cause mortality and all-cause readmission rates at 30 days and 1 year. Other outcomes include bleeding, stroke, vascular complications, and the incidence of paravalvular leak at 30 days after the procedure. Of the 1,588 patients who underwent TAVI during the study period, 775 patients (49%) had isolated AS, 606 (38%) had mild AI, and 207 (13%) had moderate to severe AI. Society of Thoracic Surgeons risk scores were significantly different among the 3 groups (5% in group 1, 5.5% in group 2, and 6% in group 3, p = 0.003). Balloon-expandable valves were used in about 2/3 of the population. No statistically significant differences in 30-day or 1-year all-cause mortality and all-cause readmission rates were noted among the 3 groups. Post-TAVI paravalvular leak at follow-up was significantly lower in group 1 (2.3%) and group 2 (2%) compared with group 3 (5.6%) (p = 0.01). In summary, TAVI in MAVD is associated with comparable outcomes at 1 year compared with patients with isolated severe AS.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Red cell distribution width and risk of peripheral artery disease: analysis of National Health and Nutrition Examination Survey 1999-2004.

Red cell distribution width (RDW) is an independent predictor of the 10-year estimated risk of coronary heart disease (CHD) events. However, RDW's association with peripheral artery disease (PAD) - a CHD risk equivalent - has not been evaluated to date. In this cross-sectional study, we examined 6950 participants of the National Health and Nutrition Examination Survey, 1999-2004. PAD was defined as an ankle-brachial index below 0.9 (n = 618). RDW was divided into quartiles (Q) (Q1: ≤ 12.2; Q2: 12.3-12.5; Q3: 12.6-13.0; Q4: ≥ 13.1) and PAD risk was compared across these quartiles using adjusted multivariate logistic regression. A graded increase in prevalent PAD with increasing RDW quartiles was observed (4.2% in Q1 vs 13.9% in Q4; test of trend p < 0.001). Risk of PAD was significantly higher (odds ratio (OR) 1.19, 95% confidence interval (CI): 1.06-1.34; p = 0.003) after adjusting for age, sex, race, body mass index, hypertension, hyperlipidemia, diabetes, smoking, estimated glomerular filtration rate, C-reactive protein, hemoglobin, mean corpuscular volume, and nutritional factors (folate, iron and vitamin B(12)) deficiencies with each unit (0.1) increase in RDW. Upon receiver-operating characteristics analysis, the predictive accuracy of the American College of Cardiology / American Heart Association (ACC/AHA)-defined PAD screening criteria (for a high-risk population) was 0.657 at best, but improved significantly (0.727) after addition of RDW (p < 0.0001). In conclusion, higher levels of RDW are independently associated with a higher risk of PAD and can significantly improve the risk prediction beyond that estimated by ACC/AHA-defined PAD screening criteria.