Ninety-Day Risk-Standardized Home Time as a Performance Metric for Cardiac Surgery Hospitals in the United States.

BACKGROUND: Assessing hospital performance for cardiac surgery necessitates consistent and valid care quality metrics. The association of hospital-level risk-standardized home time for cardiac surgeries with other performance metrics such as mortality rate, readmission rate, and annual surgical volume has not been evaluated previously. METHODS: The study included Medicare beneficiaries who underwent isolated or concomitant coronary artery bypass graft, aortic valve, or mitral valve surgery from January 1, 2013, to October 1, 2019. Hospital-level performance metrics of annual surgical volume, 90-day risk-standardized mortality rate, 90-day risk-standardized readmission rate, and 90-day risk-standardized home time were estimated starting from the day of surgery using generalized linear mixed models with a random intercept for the hospital. Correlations between the performance metrics were assessed using the Pearson correlation coefficient. Patient-level clinical outcomes were also compared across hospital quartiles by 90-day risk-standardized home time. Last, the temporal stability of performance metrics for each hospital during the study years was also assessed. RESULTS: Overall, 919 698 patients (age 74.2±5.8 years, 32% women) were included from 1179 hospitals. Median 90-day risk-standardized home time was 71.2 days (25th-75th percentile, 66.5-75.6), 90-day risk-standardized readmission rate was 26.0% (19.5%-35.7%), and 90-day risk-standardized mortality rate was 6.0% (4.0%-8.8%). Across 90-day home time quartiles, a graded decline was observed in the rates of in-hospital, 90-day, and 1-year mortality, and 90-day and 1-year readmission. Ninety-day home time had a significant positive correlation with annual surgical volume (r=0.31; P<0.001) and inverse correlation with 90-day risk-standardized readmission rate (r=-0.40; P <0.001) and 90-day risk-standardized mortality rate (r=-0.60; P <0.001). Use of 90-day home time as a performance metric resulted in a meaningful reclassification in performance ranking of 22.8% hospitals compared with annual surgical volume, 11.6% compared with 90-day risk-standardized mortality rate, and 19.9% compared with 90-day risk-standardized readmission rate. Across the 7 years of the study period, 90-day home time demonstrated the most temporal stability of the hospital performance metrics. CONCLUSIONS: Ninety-day risk-standardized home time is a feasible, comprehensive, patient-centered metric to assess hospital-level performance in cardiac surgery with greater temporal stability than mortality and readmission measures.

Transcatheter edge-to-edge repair for mitral regurgitation using PASCAL or MitraClip.

BACKGROUND: There is a paucity of data regarding the comparative efficacy and safety of Mitral valve transcatheter edge-to-edge repair (MTEER) using the PASCAL or MitraClip systems for patients with mitral regurgitation (MR). METHODS: An electronic search was conducted for MEDLINE, COCHRANE, and EMBASE, through February 2023, for studies comparing the clinical outcomes of MTEER using PASCAL versus MitraClip systems among patients with severe MR. The primary study outcome was residual MR ≤ 2 at discharge. Data were pooled using a random-effects model. RESULTS: The final analysis included six studies with a total of 1581 patients, with a weighted follow-up period of 3.5 months. Two studies only included patients with degenerative MR, while the remaining studies included both degenerative and functional MR. There was no significant difference in procedure duration between MTEER with the PASCAL or MitraClip systems. There was no difference in residual MR ≤ 2 at discharge (94.7% vs. 91.9%; odds ratio [OR]: 1.44; 95% confidence interval [CI]: 0.92-2.27) or residual MR ≤ 2 at the mid-term follow-up (94.6% vs. 91.0%, p = 0.05) among the PASCAL versus MitraClip systems. There was no difference between both groups in residual MR ≤ 1 at discharge (73.1% vs. 63.8%, p = 0.12), while there was greater incidence of residual MR ≤ 1 at midterm follow-up with the PASCAL system (71.3% vs. 56.2%, p < 0.001). There was no difference between the PASCAL and MitraClip MTEER systems in technical success (97.0% vs. 97.9%, p = 0.15), procedural success (89.1% vs. 87.1%, p = 0.78), single leaflet detachment (1.8% vs. 1.4%, p = 0.55), or all-cause mortality (3.6% vs. 4.6%, p = 0.71). CONCLUSION: In this meta-analysis, we demonstrated comparable efficacy and safety between the PASCAL and MitraClip MTEER systems at short- and mid-term assessments. Randomized trials are warranted to evaluate the comparative long-term outcomes between both MTEER systems.

The Cardiovascular Manifestations of COVID-19.

The Coronavirus 2019 (COVID-19) pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) virus, has resulted in unprecedented morbidity and mortality worldwide. While COVID-19 typically presents as viral pneumonia, cardiovascular manifestations such as acute coronary syndromes, arterial and venous thrombosis, acutely decompensated heart failure (HF), and arrhythmia are frequently observed. Many of these complications are associated with poorer outcomes, including death. Herein we review the relationship between cardiovascular risk factors and outcomes among patients with COVID-19, cardiovascular manifestations of COVID-19, and cardiovascular complications associated with COVID-19 vaccination.

Sex-related differences in the trends and outcomes of trans-septal transcatheter mitral valve replacement: Insights from the National Readmissions Database.

BACKGROUND: There is a paucity of data regarding the sex-related differences in the trends and outcomes of trans-septal transcatheter mitral valve replacement (TS-TMVR). METHODS: The Nationwide Readmissions Database (2015-2018) was queried for admissions for TS-TMVR. Propensity matched analysis was conducted to compare outcomes with hospitalizations for TS-TMVR among women versus men. The main study outcome was in-hospital mortality. RESULTS: Our final analysis included 2063 hospitalizations for TS-TMVR; of whom, 58.1% were women. The proportion of women among those undergoing TS-TMVR increased from 50% in 2015 to 60.2% in 2018 (Ptrend = 0.04). Compared with men, women undergoing TS-TMVR were slightly younger, and had a distinct profile of comorbidities. After matching, there was no significant difference in in-hospital mortality among women versus men undergoing TS-TMVR (7.8% vs. 6.1%, OR = 1.30; 95% CI: 0.79-2.13). Subgroup analyzes showed an interaction toward higher mortality with women versus men among patients with CKD (Pinteraction = 0.07). There were no significant differences between women and men in in-hospital complications or length of stay after TS-TMVR. Compared with men, women undergoing TS-TMVR were more likely to be discharged to a nursing facility (17.7% vs. 11.5%, p = 0.01) and had higher rates of 30-day readmissions (22.4% vs. 13.6%, p = 0.01). CONCLUSION: This nationwide analysis showed an increase in the proportion of women among patients undergoing TS-TMVR during the study years. There were no differences in in-hospital mortality, in-hospital complications, or length of stay between both sexes following TS-TMVR. Women were more likely to be discharged to nursing facilities and had higher rates of readmission at 30 days even after propensity matching.

Transcatheter edge-to-edge repair of the tricuspid valve: The US experience.

OBJECTIVES: To examine the trends in utilization and outcomes of tricuspid valve (TV) transcatheter edge-to-edge repair (TEER). BACKGROUND: Surgery for isolated tricuspid regurgitation is associated with high morbidity and mortality and is rarely performed. TV TEER is an attractive alternative. METHODS: The Nationwide Readmissions Database was queried using the International Classification of Diseases, 10th Revision, procedure code for TV TEER for years 2016-2019. The main outcomes were trends in utilization and in-hospital all-cause mortality. RESULTS: We identified 918 hospitalizations for TV TEER. There was an uptrend in its utilization from 13 cases in the first quarter of 2016 to 122 cases in the last quarter of 2019 (p trend < 0.001). Concomitant mitral valve (MV) TEER was performed in 42.1% of admissions. The overall in-hospital mortality was 2.1%. Surgical TV replacement was needed in 1.1% of admissions; none of them died during the index hospitalization. Unplanned rehospitalizations were common at 30 days (15.7%); 38.2% of those were due to heart failure. There was no difference in in-hospital mortality between isolated TV TEER and combined MV and TV TEER (1.7% vs. 2.6%, p = 0.359). However, admissions receiving combined procedure had lower length of stay and urgent readmission rate. CONCLUSION: The current study showed that there was an increase in the utilization of TV TEER over 2016-2019 in the United States. TV TEER was associated with low rates of in-hospital mortality; however, the rate of urgent readmission remains high, mainly due to heart failure.

Early versus late discharge after transcatheter aortic valve replacement and readmissions for permanent pacemaker implantation.

OBJECTIVE: To examine the rate of readmission for permanent pacemaker (PPM) implantation with early versus late discharge after transcatheter aortic valve replacement (TAVR). BACKGROUND: There is a current trend toward early discharge after TAVR. However, paucity of data exists on the impact of such practice on readmissions for PPM implantation. METHODS: The Nationwide Readmission Database 2016-2018 was queried for all hospitalizations where patients underwent TAVR. Hospitalizations were stratified into early (Days 0 and 1) versus late (≥Day 2) discharge groups. Observations in which PPM was required in the index admission were excluded. Multivariable regression analyses involving patient- and hospital-related variables were utilized. The primary outcome was 90-day readmission for PPM implantation. RESULTS: The final analysis included 68,482 TAVR hospitalizations, 20,261 (29.6%) with early versus 48,221 (70.4%) with late discharge. Early discharge after TAVR increased over the study period (16.2% in 2016 vs. 37.9% in 2018, Ptrend < 0.01). Nevertheless, 90-day readmission for PPM implantation remained stable (1.8% in 2016 vs. 2.0% in 2018, Ptrend = 0.32). The 90-day readmission rate for PPM implantation (2.0% vs. 1.8%; adjusted odds ratio: 1.15; 95% confidence interval: 0.95-1.39; p = 0.15) and median time-to-readmission (5 days [interquartile range, IQR 3-9] vs. 5 days [IQR 3-14], p = 0.92) were similar with early versus late discharge. Similar rates were observed regardless of whether readmission was elective versus not. Early discharge was associated with lower hospitalization cost ($39,990 ± $13,681 vs. $46,750 ± $18,218, p < 0.01) compared with late discharge. CONCLUSION: In patients who did not require PPM during the index TAVR hospitalization, the rate of readmission for PPM implantation was similar with early versus late discharge.

In-hospital outcomes of transesophageal versus intracardiac echocardiography guided left atrial appendage closure.

BACKGROUND: Transesophageal echocardiogram (TEE) is the preferred imaging modality to guide transcatheter left atrial appendage closure (LAAC). Intracardiac echocardiography (ICE) has evolved as a less invasive alternative to TEE. Several observational studies have shown similar success rates and perioperative complications between TEE and ICE for LAAC. OBJECTIVES: We sought to examine the temporal trends and patient characteristics of TEE versus ICE use in LAAC using a national database. We also evaluated hospital outcomes including periprocedural complications, mortality, and length of hospital stay. METHODS: This is a retrospective analysis of data from the National Readmission Database, collected from 2016 to 2018. The primary outcome was major adverse events (MAE) defined as in-hospital mortality, cardiac arrest, pericardial effusion with or without tamponade, pericardiocentesis or window pericardiocentesis and pericardial window, pericardial effusion and tamponade, and hemorrhage requiring transfusion. RESULTS: Trend analysis showed that TEE-guided LAAC increased from 96.6% in 2016 to 98.4% in 2018 (relative increase, 1.9%), while ICE-guided LAAC decreased from 3.4% to 1.6% during the same period (relative decrease, 53%, p for trend = 0.08). In the unmatched cohorts, the MAE was significantly lower in TEE-guided LAAC compared to ICE-guided LAAC (6.5% vs. 9.3%, p = 0.022). In the propensity score matching analysis, MAE remained significant (5.6% vs. 9.4%, p < 0.001). The incidence of pericardial effusion with or without tamponade remained significantly lower in the TEE group (2.3% vs. 5.8%, p < 0.001). Length of stay (3.4 vs. 1.9 days, p < 0.001) and hospitalization cost ($34,826 vs. $20,563, p < 0.001) remained significantly lower for TEE-guided LAAC. CONCLUSIONS: Compared to ICE, the incidence of MAE was significantly lower for TEE-guided LAAC, driven mainly by less pericardial effusion events. Large-scale randomized trials are needed to confirm the findings of the current and previous studies.

Impact of COVID-19 on Management Strategies for Coronary and Structural Heart Disease Interventions.

PURPOSE OF REVIEW: The COVID-19 pandemic has created unprecedented challenges globally, with significant strain on the healthcare system in the United States and worldwide. In this article, we review the impact of COVID-19 on percutaneous coronary interventions and structural heart disease practices, as well as the impact of the pandemic on related clinical research and trials. We also discuss the consensus recommendations from the scientific societies and suggest potential solutions and strategies to overcome some of these challenges. FINDINGS: With the limited resources and significant burden on the healthcare system during the pandemic, changes have evolved in practice to provide care to the highest risk patients while minimizing unnecessary exposure during elective surgical or transcatheter procedures. The COVID-19 crisis has significantly impacted the management of patients with acute coronary syndromes, chronic coronary syndromes, and structural heart disease.

The transseptal puncture experience: Safety insights from FDA MAUDE database.

BACKGROUND: There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles. OBJECTIVES: To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States. METHODS: We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure. RESULTS: The final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG). CONCLUSIONS: Needle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.

Outcomes with catheter-directed thrombolysis compared with anticoagulation alone in patients with acute deep venous thrombosis.

OBJECTIVE: The authors aimed to investigate the benefits and risks of catheter-directed thrombolysis (CDT) in acute deep venous thrombosis (DVT). BACKGROUND: The role of CDT in the management of DVT is evolving. Data on CDT versus anticoagulation alone in acute DVT is sparse. METHODS: We performed a systematic review and meta-analysis of published studies that compared CDT to anticoagulation alone in patients with acute DVT. RESULTS: We included 11 studies (four randomized control trials [RCTs] and seven observational studies) with a total of 8,737 patients. During hospital stay, patients who received CDT had higher odds of major bleeding (2.5% vs. 1.6%; OR 1.46, 95% CI [1.07, 1.98], p = .02), blood transfusion (10.8% vs. 6.2%; OR 1.8, 95% CI [1.52, 2.13], p < .001), and thromboembolism (15.5% vs. 10%; OR 1.67, 95% CI [1.47, 1.91], p < .001) compared with anticoagulation alone. At 6-month follow-up, patients who received CDT had higher venous patency (71.1% vs. 37.7%; OR 5.49, 95% CI [2.63, 11.5], p < .001) and lower postthrombotic syndrome (PTS; 27% vs. 40.7%; OR 0.44, 95% CI [0.22, 0.86], p = .02). During a mean follow-up duration of 30.5 ± 28 months, CDT group continued to have higher venous patency (79.6% vs. 71.8%; OR 3.79, 95% CI [1.54, 9.32], p = .004) and lower PTS (44.7% vs. 50.5%; OR 0.43, 95% CI [0.23, 0.78], p = .006), but no difference in thromboembolism. CONCLUSION: Compared with anticoagulation alone, CDT for patients with acute DVT was associated with a higher risk of complications, but a higher rate of venous patency and lower risk of postthrombotic syndrome at 2.5 years follow-up.

North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic's impact on vascular procedural volumes and outcomes has not been fully characterized. METHODS: Volume and outcome data before (1/2019 - 2/2020), during (3/2020 - 4/2020), and following (5/2020 - 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative (VQI). Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression. RESULTS: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods. CONCLUSION: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.

Association Between COVID-19 Diagnosis and In-Hospital Mortality in Patients Hospitalized With ST-Segment Elevation Myocardial Infarction.

IMPORTANCE: There has been limited research on patients with ST-segment elevation myocardial infarction (STEMI) and COVID-19. OBJECTIVE: To compare characteristics, treatment, and outcomes of patients with STEMI with vs without COVID-19 infection. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of consecutive adult patients admitted between January 2019 and December 2020 (end of follow-up in January 2021) with out-of-hospital or in-hospital STEMI at 509 US centers in the Vizient Clinical Database (N = 80 449). EXPOSURES: Active COVID-19 infection present during the same encounter. MAIN OUTCOMES AND MEASURES: The primary outcome was in-hospital mortality. Patients were propensity matched on the likelihood of COVID-19 diagnosis. In the main analysis, patients with COVID-19 were compared with those without COVID-19 during the previous calendar year. RESULTS: The out-of-hospital STEMI group included 76 434 patients (551 with COVID-19 vs 2755 without COVID-19 after matching) from 370 centers (64.1% aged 51-74 years; 70.3% men). The in-hospital STEMI group included 4015 patients (252 with COVID-19 vs 756 without COVID-19 after matching) from 353 centers (58.3% aged 51-74 years; 60.7% men). In patients with out-of-hospital STEMI, there was no significant difference in the likelihood of undergoing primary percutaneous coronary intervention by COVID-19 status; patients with in-hospital STEMI and COVID-19 were significantly less likely to undergo invasive diagnostic or therapeutic coronary procedures than those without COVID-19. Among patients with out-of-hospital STEMI and COVID-19 vs out-of-hospital STEMI without COVID-19, the rates of in-hospital mortality were 15.2% vs 11.2% (absolute difference, 4.1% [95% CI, 1.1%-7.0%]; P = .007). Among patients with in-hospital STEMI and COVID-19 vs in-hospital STEMI without COVID-19, the rates of in-hospital mortality were 78.5% vs 46.1% (absolute difference, 32.4% [95% CI, 29.0%-35.9%]; P < .001). CONCLUSIONS AND RELEVANCE: Among patients with out-of-hospital or in-hospital STEMI, a concomitant diagnosis of COVID-19 was significantly associated with higher rates of in-hospital mortality compared with patients without a diagnosis of COVID-19 from the past year. Further research is required to understand the potential mechanisms underlying this association.

Impact of COVID-19 pandemic on patients with ST-segment elevation myocardial infarction: Insights from a British cardiac center.

The current study aimed to examine the impact of COVID-19 pandemic on patient-related delay with ST-segment elevation myocardial infarction (STEMI) at a tertiary center in the United Kingdom. The study demonstrated a significant delay in symptom-to-first medical contact and a higher cardiac troponin-I level on admission in patients with STEMI during the COVID-19 pandemic versus the pre-COVID era.

Outcomes of urgent versus nonurgent transcatheter aortic valve replacement.

BACKGROUND: There is a paucity of data regarding the outcomes of transcatheter valve replacement (TAVR) performed in an urgent clinical setting. METHODS: The Nationwide Inpatient Sample (NIS) database years 2011-2014 was used to identify hospitalizations for TAVR in the urgent setting. Using propensity score matching, we compared patients who underwent TAVR in nonurgent versus urgent settings. RESULTS: Among 42,154 hospitalizations in which TAVR was performed, 10,114 (24%) underwent urgent TAVR. There was an uptrend in the rate of urgent TAVR procedures (p = .001). The rates of in-hospital mortality among this group did not change during the study period (p = .713). Nonurgent TAVR was associated with lower mortality (odds ratio [OR] = 0.78; 95% confidence interval [CI]: 0.69-0.89, p < .001) compared with urgent TAVR. Nonurgent TAVR was associated with lower incidence of cardiogenic shock (OR = 0.46; 95%CI: 0.40-0.53 p < .001), use of mechanical circulatory support devices (OR = 0.69; 95%CI: 0.59-0.82, p < .001), AKI (OR = 0.60; 95%CI: 0.56-0.64 p < .001), hemodialysis (OR = 0.67; 95%CI: 0.56-0.80 p < .001), major bleeding (OR = 0.94; 95%CI: 0.89-0.99 p = .045) and shorter length of stay (7.08 ± 6.317 vs. 12.39 ± 9.737 days, p < .001). There was no difference in acute stroke (OR = 0.96; 95%CI: 0.81-1.14, p = .636), vascular complications (OR = 1.07; 95%CI: 0.89-1.29, p = .492), and pacemaker insertions (OR = 0.92; 95%CI: 0.84-1.01, p = .067) between both groups. Among those undergoing urgent TAVR, subgroup analysis showed higher mortality in patients ≤80 years (p = .033), women (p < .001), chronic kidney disease (p = .001), heart failure (p < .001), and liver disease (p = .003). CONCLUSION: In this large nationwide analysis, almost a quarter of TAVR procedures were performed in the urgent settings. Although urgent TAVR was associated with higher mortality and increased complications compared with nonurgent TAVR, the absolute difference in in-hospital mortality was not remarkably higher. Thus, urgent TAVR can be considered as a reasonable approach when indicated.

Outcomes with retrograde versus antegrade chronic total occlusion revascularization.

OBJECTIVES: The aim of the study was to evaluate the outcomes of retrograde versus antegrade approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The retrograde approach has increased the success rate of CTO PCI but has been associated with a higher risk for complications. METHODS: We conducted a meta-analysis of studies published between 2000 and August 2019 comparing the in-hospital and long-term outcomes with retrograde versus antegrade CTO PCI. RESULTS: Twelve observational studies (10,240 patients) met our inclusion criteria (retrograde approach 2,789 patients, antegrade approach 7,451 patients). Lesions treated with the retrograde approach had higher J-CTO score (2.8 vs. 1.9, p < .001). Retrograde CTO PCI was associated with a lower success rate (80.9% vs. 87.4%, p < .001). Both approaches had similar in-hospital mortality, urgent revascularization, and cerebrovascular events. Retrograde CTO PCI was associated with higher risk of in-hospital myocardial infarction (MI; odds ratio [OR] 2.37, 95% confidence intervals [CI] 1.7, 3.32, p < .001), urgent pericardiocentesis (OR 2.53, 95% CI 1.41-4.51, p = .002), and contrast-induced nephropathy (OR 2.12, 95% CI 1.47-3.08; p < .001). During a mean follow-up of 48 ± 31 months retrograde crossing had similar mortality (OR 1.79, 95% CI 0.84-3.81, p = .13), but a higher incidence of MI (OR 2.07, 95% CI 1.1-3.88, p = .02), target vessel revascularization (OR 1.92, 95% CI 1.49-2.46, p < .001), and target lesion revascularization (OR 2.08, 95% CI 1.33-3.28, p = .001). CONCLUSIONS: Compared with antegrade CTO PCI, retrograde CTO PCI is performed in more complex lesions and is associated with a higher risk for acute and long-term adverse events.

Outcomes with drug-coated balloons in small-vessel coronary artery disease.

BACKGROUND: Percutaneous coronary intervention (PCI) of small-vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug-coated balloons (DCBs) in SVD has received limited study. OBJECTIVES: To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. METHODS: We performed a meta-analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. RESULTS: Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow-up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug-eluting stents (DES). During a mean follow-up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04-0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08-0.37, P = <0.00001) compared with noncoated balloon angioplasty. CONCLUSION: The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

Outcomes with cilostazol after endovascular therapy of peripheral artery disease.

The role of cilostazol after endovascular therapy (EVT) of peripheral artery disease (PAD) remains unclear. We conducted a meta-analysis for all studies reporting the outcomes of cilostazol after EVT of PAD from January 2000 through November 2018 with the outcomes of interest including primary patency, major adverse limb events (MALE), target lesion revascularization (TLR), and major amputation. We included eight studies (three randomized controlled trials (RCTs) and five observational studies) with a total of 3846 patients (4713 lesions). During a mean follow-up duration of 12.5 ± 5 months, the use of cilostazol was associated with higher primary patency (OR 2.28, 95% CI (1.77, 2.94), p < 0.001, I2 = 24%), lower risk of TLR (OR 0.37, 95% CI (0.26, 0.52), p < 0.001, I2 = 0%), and lower risk of major amputation (OR 0.15, 95% CI (0.04, 0.62), p = 0.008, I2 = 0%). The use of cilostazol in RCTs was associated with significantly higher odds of primary patency compared with observational studies (OR 3.37 vs 2.28, p-interaction = 0.03). After further subgroup analysis, cilostazol remained associated with higher primary patency regardless of the use of anticoagulants (warfarin) (p-interaction = 0.49). We conclude that the use of cilostazol after EVT of femoropopliteal and iliac lesions is associated with improved primary patency and lower risk of major amputation and TLR. The favorable impact of cilostazol is independent of the use of warfarin. PROSPERO identifier: CRD42018092715.

Improved stent expansion with prolonged compared with short balloon inflation: A meta-analysis.

BACKGROUND: Despite evidence from individual studies suggesting that prolonged inflation improves coronary stent expansion, relatively shorter inflation times are commonly employed in clinical practice. METHODS: We performed an electronic search of PubMed, Web of Science, Cochrane, and CINAHL databases to retrieve outcome studies comparing prolonged versus short inflation times during stent deployment. Outcomes studied included minimal stent diameter (MSD) and minimal stent area (MSA). Standardized mean difference (SMD) was used to estimate the effect sizes for these continuous variables. RESULTS: Seven studies with a total of 341 patients (415 lesions; mean age 67.6 years; 82% male) were included. Drug-eluting stents were used in 89 ± 15% of coronary lesions. Prolonged stent inflation was associated with increased minimal stent diameter (2.93 ± 0.34 mm vs. 2.72 ± 0.28 mm; SMD = 0.42; 95% CI 0.25-0.59; P < 0.001) and minimal stent area (5.99 ± 1.21 mm2 vs. 5.17 ± 0.87 mm2 ; SMD = 0.46; 95% CI 0.19-0.73; P = 0.001) compared with shorter duration stent inflation. This difference remained significant in sensitivity analyses that excluded studies with very prolonged inflation duration or multiple stent balloon inflations. CONCLUSION: Despite differences in duration and methodology, prolonged stent inflation is associated with improved expansion compared with shorter duration. The effect of this optimization recommends randomized trials to determine whether long-term outcomes can be improved by this simple technical modification.

Deferred or immediate stent implantation for primary percutaneous coronary intervention: A meta-analysis of randomized trials.

OBJECTIVES: To perform a meta-analysis of randomized trials comparing a deferred versus immediate stenting strategy for primary percutaneous coronary intervention (PCI). BACKGROUND: Deferred stent implantation has emerged as a potential strategy aiming to reduce the thrombus burden and improve micro-vascular reperfusion during primary PCI. METHODS: Electronic databases were searched for randomized trials that compared a deferred stent implantation versus immediate stent implantation strategy in patients undergoing primary PCI. Random effects risk ratios (RR) were estimated for the outcomes of interest. RESULTS: Four trials with 1,570 patients were included. A deferred stent implantation strategy was associated with a lower incidence of no-/slow reflow (RR 0.49, 95% confidence interval [CI] 0.24-0.96), and improved myocardial blush grade 3 (RR 1.42, 95% CI 1.14-1.77). At a mean follow up of 34 ± 15 months, both strategies were associated with a similar risk of all-cause mortality (RR 0.85, 95% CI 0.58-1.24), cardiovascular mortality (RR 0.84, 95% CI 0.48-1.45), reinfarction (RR 1.54, 95% CI 0.43-5.49), and stent thrombosis (RR = 0.35, 95% CI 0.04-3.35, P = 0.36). CONCLUSION: In patients undergoing primary PCI, deferred stent implantation is associated with improvement in surrogate outcomes, but does not appear to improve clinical outcomes. Future randomized trials are encouraged to identify the patient population who might benefit from a deferred stent implantation strategy (e.g., high thrombus burden).