Is off-pump coronary artery bypass grafting superior to drug-eluting stents for the treatment of coronary artery disease? A meta-analysis of randomized and nonrandomized studies

Background

As drug-eluting stent (DES) has almost overcome the disadvantage of frequent restenosis, off-pump coronary artery bypass grafting (OPCAB) has been introduced to avoid complications of cardiopulmonary bypass. However, which approach may promise better outcomes for patients with coronary artery disease remains controversial.

Methods

Three databases were searched. The outcomes of interest were major adverse cardiac and cerebrovascular events (MACCE), all-cause death, target vessel revascularization (TVR), repeat revascularization (RRV), myocardial infarction (MI), and cerebrovascular events (CVE). The relative risk (RR) was calculated as the summary statistic.

Results

11,452 patients from 22 studies were included, of which 4949 patients underwent OPCAB and 6503 patients received DES. The cumulative rates of MACCE (RR [95% CI] = 0.43 [0.34, 0.54], P < 0.00001), all-cause death (RR [95% CI] = 0.56 [0.33, 0.96], P = 0.03), TVR (RR [95% CI] = 0.33 [0.21, 0.53], P < 0.00001), RRV (RR [95% CI] = 0.22 [0.11, 0.42], P < 0.00001) and MI (RR [95% CI] = 0.13 [0.05, 0.29], P < 0.00001) at 3 years were all lower in OPCAB group. The incidences of in-hospital death (RR [95% CI] = 1.31 [0.81, 2.13], P = 0.27) and MI (RR [95% CI] = 1.03 [0.60, 1.78], P = 0.92) were not different between groups, but the rate of in-hospital CVE was lower (RR [95% CI] = 2.6355 [1.0033, 6.9228], P = 0.05) in DES group.

Conclusions

OPCAB presents better long-term outcomes of MACCE, all-cause mortality, TVR, RRV and MI but uncertain outcome of postoperative CVE without influencing the incidences of in-hospital death and MI.     

Impella Support Versus Intra-Aortic Balloon Pump in Acute Myocardial Infarction Complicated by Cardiogenic Shock: A Meta-Analysis

BackgroundAcute myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high mortality rates. Data has shown that intra-aortic balloon pump (IABP) support does not provide a survival benefit over optimal medical therapy in AMICS. Despite lack of supportive evidence, IABP is still commonly used in these clinical situations. The Impella percutaneous ventricular assist device (PVAD) (Abiomed, Denver, MA) rapidly deploys superior mechanical circulatory support (MCS) in patients with AMICS. However, the safety and efficacy of Impella in AMICS is a matter of ongoing investigation, and its role in AMICS management is not yet fully established.MethodsThe databases of Pubmed, EMBASE and Cochrane Central databases were searched from inception to March 2020. Relevant randomized trials and observational studies comparing Impella versus IABP in AMICS were identified and a meta-analysis was performed using the random effect model. The efficacy endpoint of interest was short-term mortality (defined as in-hospital or 30-day mortality). The safety endpoints of interest were major bleeding, limb complications, stroke and hemolysis.ResultsA total of 2 randomized trials and 5 observational studies with 3921 patients were included. No difference in short-term mortality between the two groups [RR 1.08, 95% CI 0.87–1.33, P = 0.49] was found. For safety endpoints, Impella was associated with significantly higher incidence of major bleeding [RR: 2.03, 95% CI 1.56–2.64, P < 0.0001], limb complications [RR: 3.67, 95% CI 1.56–8.65, P = 0.003] as well as hemolysis [RR: 9.46, 95% CI 1.75–51.22, P = 0.009] compared with IABP. No significant difference was observed for the incidence of stroke [RR: 1.07 95% CI 0.34–3.31 P = 0.91].ConclusionImpella support in AMICS patients was associated with a significantly increased risk of bleeding, limb complications and hemolysis without an improved short-term survival advantage compared with IABP.     

Right Heart Catheterization Timing and Outcomes of Cardiogenic Shock: Analysis from the National Readmission Database

Recent studies showed significant mortality benefit with right heart catheterization (RHC) use in cardiogenic (CS). The optimal timing of RHC in those patients is unknown owing to the lack of available data. The Nationwide Readmission Database 2016-2018 was queried for hospitalizations with CS. We excluded patients presented with cardiac arrest or with a history of ventricular assist devices or heart transplantation. Complex samples multivariable logistic, cox, and linear regression models were used to determine the association between RHC timing in the index admission (<2 days [early RHC] vs ≥ 2 days [late RHC]) and in-hospital outcomes (mortality, acute kidney injury [AKI], mechanical circulatory device use [MCD], index length of stay [LOS], hospital charges), and all-cause 30-day readmissions. A total of 46,963 hospitalizations [18,632 in the early group and 28,332 in the late group] were included in this analysis. RHC was more likely to happen in large teaching hospitals. Although there was no difference in mortality (adjusted odds ratio [aOR]: 1.05; Confidence interval [CI] 0.97-1.14; P= 0.233). Patients in the early RHC group had a lower incidence of AKI (aOR: 0.69; CI: 0.64-0.74; P < 0.01), higher rate of MCS use (aOR:1.67; CI:1.54-1.81; P < 0.001), shorter LOS (aβ :-6.2; CI -6.62 to -5.77; P <.001), lower hospital charges, and lower readmission rates (adjusted hazards ratio [aHR]: 0.91; CI: 0.84- 0.98; P = 0.01) compared to the late RHC group. Early RHC was associated with decreased incidence of AKI, decreased LOS, total charges, and readmission rates with no difference in survival. Subgroup analysis of patients who did not receive MCS during the index admission showed similar outcomes albeit with increased mortality. Further randomized controlled trials are needed to validate these results.     

Trends in the Incidence of In-Hospital Mortality,Cardiogenic Shock,and Utilization of Mechanical Circulatory Support Devices in Myocarditis (Analysis of National Inpatient Sample Data, 2005–2014)

BackgroundMyocarditis may be associated with hemodynamic instability and portends a poor prognosis when associated with cardiogenic shock (CS). There are limited data available on the incidence of in-hospital mortality, CS, and utilization of mechanical circulatory support (MCS) devices in these patients.MethodsWe queried the 2005–2014 National Inpatient Sample databases to identify all patients aged >18 years with myocarditis in the United States.ResultsThe number of reported cases of myocarditis per 1 million gradually increased from 95 in 2005 to 144 in 2014 (Pfor trend <.01). The trend and incidence of endomyocardial biopsy remained the same despite the increase in clinical diagnosis. Overall, in-hospital mortality was 4.43% of total admissions without a change in overall trend over the study period. We also observed a significant increase in the incidence of CS from 6.94% in 2005 to 11.99% in 2014 (Pfor trend <.01). There was a parallel increase in the utilization of advanced MCS devices during the same time period such as extracorporeal membrane oxygenation or percutaneous cardiopulmonary support (0.32% in 2005 to 2.1% in 2014; P< .01) and percutaneous ventricular assist devices such as Impella/tandem heart (0.176% in 2005 to 1.75% in 2014; P< .01).ConclusionAlthough the incidence of myocarditis has increased in the last decade, the in-hospital mortality has remained the same despite increases in the incidence of CS, possibly reflecting the benefits of increased usage of advanced MCS devices. We noted that increasing age, presence of multiple comorbidities and CS were associated with an increase in in-patient mortality.     

Sex Difference in Clinical and Management Outcomes in Patients With Takotsubo Syndrome: A Systematic Review and Meta-Analysis

Takotsubo syndrome (TTS) is being increasingly recognized globally with a female sex predilection. However, sex-related differences in clinical outcomes are yet to be identified. Therefore, we aim to investigate the sex differences in clinical outcomes in patients with TTS. We included cohort studies retrieved from the Web of Science, SCOPUS, EMBASE, PubMed, and Cochrane until September 14, 2022. The risk ratio (RR) for dichotomous outcomes with the corresponding 95% confidence interval (CI) was used. The study protocol was registered in PROSPERO with ID: CRD42022363349. Thirteen retrospective cohort studies, with a total of 104,410 patients were included. Men had a higher risk of in-hospital mortality (RR: 2.42 with 95% CI [1.53, 3.83], P = 0.0002), long-term mortality (RR: 1.59 with 95% CI [1.40, 1.80], P = 0.00001), cardiogenic shock (RR: 1.65 with 95% CI [1.52, 1.79], P = 0.00001), arrhythmia (RR: 1.70 with 95% CI [1.56, 1.86], P = 0.00001), and acute kidney injury (RR: 1.71 with 95% CI [1.50, 1.96]. P = 0.00001), as compared with women. However, no significant difference was observed in stroke (RR: 1.22 with 95% CI [0.78, 1.89], P = 0.39), left ventricular thrombus (RR: 0.96 with 95% CI [0.40, 2.33], P = 0.93), and TTS recurrence (RR: 1.11 with 95% CI [0.68, 1.82], P = 0.67) between men and women. Despite women having a higher incidence of TTS, men have higher morbidity and mortality rates. Hence, further studies are necessary to identify the pathophysiological factors of this sex difference in clinical outcomes, including hormonal and psychological variables.     

Impella Versus Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Cardiogenic Shock

BackgroundPercutaneous ventricular assist devices and extracorporeal membrane oxygenation (ECMO) are increasingly used for mechanical circulatory support (MCS) in patients with acute myocardial infarction with cardiogenic shock (AMI-CS) in hospitals throughout the United States.MethodsUsing the National Inpatient Sample from October 2015 to December 2017, we identified hospital admissions that underwent percutaneous coronary intervention (PCI) and non-elective Impella or ECMO placement for AMI-CS using ICD-10 codes. Propensity-score matching was performed to compare both groups for primary and secondary outcomes.ResultsWe identified 6290 admissions for AMI-CS who underwent PCI and were treated with Impella (n = 5730, 91%) or ECMO (n = 560, 9%) from October 2015 to December 2017. After propensity-match analysis, the ECMO cohort had significantly higher in-hospital mortality (43.3% vs 26.7%, OR: 2.10, p = 0.021). The incidence of acute respiratory failure and vascular complications were significantly lower in the Impella cohort. We observed a shorter duration of hospital stay and lower hospital costs in the Impella cohort compared to those who received ECMO.ConclusionsIn AMI-CS, the use of Impella was associated with better clinical outcomes, fewer complications, shorter length of hospital stay and lower hospital cost compared to those undergoing ECMO placement.     

Blalock-Taussig Shunt versus Ductal Stent in the Palliation of Duct Dependent Pulmonary Circulation; A Systematic Review and Metanalysis

In infants with ductal dependent pulmonary blood flow, Blalock-Taussig (BT) shunt and Patent Ductus Arteriosus (PDA) stent, are two palliative procedures aimed to restore circulation. A systematic review and metanalysis was performed on studies comparing PDA stents and BT shunts, in accordance with PRISMA guidelines. Meta-analysis revealed the following; (1) a reduced risk of mortality [RR = 0.585 [0.399-0.859], (P = 0.006)], (2) a reduced risk of complications [RR = 0.523 [0.318-0.860], (P = 0.011), and (3) a reduced risk of ECMO use [R = 0.267 [0.101-0.706] (P = 0.008)], all in the stent group. Additionally, stent group showed higher post procedure oxygen saturation [SMD = 1.307 [95% CI 1.065-1.550], (P < 0.001)], and Nakata index [SMD = 0.679 95% CI [0.513 to 0.845], (P < 0.001)]. PDA stenting presents a viable alternative to BT shunt procedure with better post procedure stability.     

Percutaneous Mechanical Circulatory Support in Post–Myocardial Infarction Cardiogenic Shock: A Systematic Review and Meta-analysis

BackgroundCardiogenic shock (CS) complicates 5%-10% of acute myocardial infarction (AMI) and is the leading cause of early mortality. It remains unclear whether percutaneous mechanical support (pMCS) devices improve post-AMI CS outcome.MethodsA systematic review of original studies comparing the effect of pMCS on AMI-CS mortality was conducted with the use of Medline, Embase, Google Scholar, and the Cochrane Library databases.ResultsOf 8672 records, 50 were retained for quantitative analysis. Four additional references were added from other sources. Four references reported a significant mortality reduction with intra-aortic balloon pump (IABP) in patients with failed primary percutaneous coronary intervention (pPCI) or managed with thrombolysis. Meta-analyses showed no advantage of Impella over conventional therapy (pooled OR 0.55, 95% CI 0.20-1.46; I² = 0.85) and increased mortality compared with IABP (pooled OR 1.32; 95% CI 1.08-1.62; I² = 0.85). No study reported a mortality advantage for extracorporeal membrane oxygenation (ECMO) over conventional therapy, IABP, or Impella support. Early mortality might be improved with the addition of IABP or Impella to ECMO. Bleeding Academic Research Consortium ≥ 3 bleeding was increased with every pMCS strategy.ConclusionsThe current evidence is of poor to moderate quality, with only 1 in 5 included articles reporting randomised data and several reporting unadjusted outcomes. Yet, there is some evidence to favour IABP use in the setting of thrombolysis or with failed pPCI, and adding IABP or Impella should be considered for patients requiring ECMO.     

Increased Travel Time to the Tertiary Centre Is Associated With Decreased Long-term Survival Following Ascending Aortic Operations

BackgroundThe association between travel time from tertiary care centre and outcomes after ascending thoracic aortic surgery is unknown. We determined the effect of travel time from the tertiary care centre on outcomes in ascending aortic repair in Nova Scotia.MethodsA retrospective analysis of patients undergoing elective and emergent ascending thoracic aortic operations from 2005 to 2015 was carried out. Patient’s residential geographic coordinates were used to calculate travel time to the tertiary care centre, and patients who resided < 1 hour vs ≥ 1 hour were compared. Multivariable logistic regression was performed to determine the effect of travel time on in-hospital outcomes. Cox-proportional hazard modelling and Kaplan-Meier survival estimates were created to determine the effect on long-term survival.ResultsA total of 476 patients underwent ascending thoracic aortic surgery from 2005 to 2015. Patients who resided < 1 hour from the tertiary care centre vs patients who resided ≥ 1 hour had similar rates of in-hospital mortality (4.4% vs 6.1%, P = 0.42), in-hospital composite complications (66.7% vs 67.7%, P = 0.80), hospital length of stay (median 9 days; interquartile range [7-16] vs 10 [7-17], P = 0.41), and discharge disposition other than home (9.7% vs 11.7%, P = 0.55). Compared with patients who resided < 1 hour from the tertiary centre, patients who resided ≥ 1 hour were at higher risk for long-term mortality (hazard ratio, 2.19; 95% confidence interval, 1.13-4.28; P = 0.02).ConclusionsPatients who reside remotely from the tertiary centre experience equivalent in-hospital outcomes but decreased long-term survival following ascending aortic operations. These findings may guide resource expansion for postoperative follow-up.     

Early Transcatheter or Surgical Aortic Valve Replacement Versus Conservative Management in Asymptomatic Patients With Severe Aortic Stenosis: A Systematic Review and Meta-analysis

The merits of conservative management vs early intervention in patients with asymptomatic severe aortic stenosis remains unknown. Digital databases (MEDLINE, Google Scholar, and Embase) were searched for all relevant studies from inception through September 2022. Studies comparing conservative management with early intervention were compared using a random-effects model to calculate risk ratios (RRs) with 95% confidence interval (CI). A total of 12 studies comprising 3624 asymptomatic aortic stenosis patients (1747 receiving surgery, and 1877 receiving conservative treatment) were included in the analysis. The average follow-up time was 4.45 (IQR 3.5-5) years. Early intervention was associated with a significantly reduced risk of cardiac (RR 0.42, 95% CI 0.25-0.72; P = 0.001; I² = 54%), non-cardiac (RR 0.46, 95% CI 0.32-0.68; P < 0.0001; I² = 0%), all-cause mortality (RR 0.40, 95% CI 0.32-0.51; P < 0.00001; I² = 58%), heart failure hospitalization (RR 0.21, 95% CI 0.13-0.36; P < 0.00001; I² = 0%), sudden cardiac death (RR 0.29, 95% CI 0.12-0.66; P = 0.004, I² = 24%), and MACE (RR 0.46, 95% CI; 0.28-0.75; P = 0.002; I² = 68%), compared with conservative management. There was no significant difference in the 30-day mortality (RR 0.63, 95% CI 0.19-2.04; P = 0.44; I² = 28%), myocardial infarction (RR 0.44, 95% CI 0.19-1.06; P = 0.07, I²=0%), and 90-day mortality (RR 0.68, 95% CI 0.20-2.37; P = 0.55; I² = 61%) between the 2 groups. This meta-analysis shows statistically significant reductions in the risk for all-cause mortality, cardiac specific mortality, non-cardiac mortality, heart failure hospitalization, MACE, and sudden cardiac death among asymptomatic aortic stenosis patients who underwent early intervention as opposed to conservative management.     

Routine Glycoprotein IIb/IIIa Inhibitor Therapy in ST-Segment Elevation Myocardial Infarction: A Meta-analysis

BackgroundGuidelines recommend adjunct glycoprotein IIb/IIIa inhibitors (GPIs) only in selected patients with acute ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate routine GPI use in STEMI treated with primary percutaneous coronary intervention.MethodsOnline databases were searched for randomized controlled trials of routine GPI vs control therapy in STEMI. Data from retrieved studies were abstracted and evaluated in a comprehensive meta-analysis. Twenty-one randomized controlled trials with 8585 patients were included: 10 trials randomized tirofiban, 9 abciximab, 1 trial eptifibatide, and 1 trial used abciximab+tirofiban; only 1 trial used dual antiplatelet therapy with prasugrel/ticagrelor.ResultsRoutine GPI use was associated with a significant reduction in all-cause mortality at 30 days (2.4% [GPI] vs 3.2%; risk ratio [RR], 0.72; P = 0.01) and 6 months (3.7% vs 4.8%; RR, 0.76; P = 0.02), and a reduction in recurrent myocardial infarction (1.1% vs 2.1%; RR, 0.55; P = 0.0006), repeat revascularization (2.5% vs 4.1%; RR, 0.63; P = 0.0001), thrombolysis in myocardial infarction flow <3 after percutaneous coronary intervention (5.4% vs 8.2%; RR, 0.61; P < 0.0001), and ischemic stroke (RR, 0.42; P = 0.04). Major (4.7% vs 3.4%; RR, 1.35; P = 0.005) and minor bleedings (7.2% vs 5.1%; RR, 1.39; P = 0.006) but not intracranial bleedings (0.1% vs 0%; RR, 2.7; P = 0.37) were significantly increased under routine GPI.ConclusionsRoutine GPI administration in STEMI resulted in a reduction in mortality, driven by reductions in recurrent ischemic events—however predominantly in pre-prasugrel/ticagrelor trials. Trials with contemporary STEMI management are needed to confirm these findings.     

Arrhythmic Events and Mortality in Patients With Cardiogenic Shock on Inotropic Support: Results of the DOREMI Randomized Trial

BackgroundInotropic support is widely used in the management of cardiogenic shock (CS). Existing data on the incidence and significance of arrhythmic events in patients with CS on inotropic support is at high risk of bias.MethodsThe Dobutamine Compared to Milrinone (DOREMI) trial randomized patients to receive dobutamine or milrinone in a double-blind fashion. Patients with and without arrhythmic events (defined as arrhythmias requiring intervention or sustained ventricular arrhythmias) were compared to identify factors associated with their occurrence, and to examine their association with in-hospital mortality and secondary outcomes.ResultsNinety-two patients (47.9%) had arrhythmic events, occurring equally with dobutamine and milrinone (P = 0.563). The need for vasopressor support at initiation of the inotrope and a history of atrial fibrillation were positively associated with arrhythmic events, whereas predominant right ventricular dysfunction, previous myocardial infarction, and increasing left ventricular ejection fraction were negatively associated with them. Supraventricular arrhythmic events were not associated with mortality (relative risk [RR], 0.97; 95% confidence interval [CI], 0.68-1.40; P = 0.879) but were positively associated with resuscitated cardiac arrests and hospital length of stay. Ventricular arrhythmic events were positively associated with mortality (RR, 1.66; 95% CI, 1.13-2.43; P = 0.026) and resuscitated cardiac arrests. Arrhythmic events were most often treated with amiodarone (97%) and electrical cardioversion (27%), which were not associated with mortality.ConclusionsClinically relevant arrhythmic events occur in approximately one-half of patients with CS treated with dobutamine or milrinone and are associated with adverse clinical outcomes. Five factors may help to identify patients most at risk of arrhythmic events.     

Transcatheter Aortic Valve Replacement in Low-Risk Patients: A Meta-Analysis of Randomized Controlled Trials

IntroductionTranscatheter aortic valve replacement (TAVR) has become the standard treatment option for patients with symptomatic severe aortic stenosis (AS) with high surgical risk and a reasonable option for intermediate surgical risk as an alternative to surgical aortic valve replacement (SAVR). The role of TAVR in lower risk patients is less established but has been the focus of recent randomized controlled trials (RCTs). We performed a meta-analysis of RCTs to assess TAVR outcomes among low surgical risk patients.Methods and resultsSystematic search of RCTs was done using PubMed, EMBASE, and Cochrane Library databases. Statistical analysis was performed with RevMan v5.3 software using a random effects model to report risk ratio (RR) with 95% confidence interval (CI). A total of three RCTs including 2698 patients (1375 TAVR and 1323 SAVR) were analyzed. Compared to SAVR, TAVR was not associated with all-cause mortality [RR 0.86 (95% CI 0.61–1.19); P = 0.36; I² = 8%] or stroke [RR 0.82 (0.48–1.43); P = 0.49; I² = 42%]. However, TAVR was significantly associated with lower risk of acute kidney injury [RR 0.27 (0.13–0.54); P = 0.0002; I² = 0%], new-onset atrial fibrillation [RR 0.26 (0.18–0.39); P < 0.00001; I² = 80%], and life-threatening or disabling bleeding [RR 0.35 (0.22–0.55); P < 0.00001; I² = 57%], but a higher risk of moderate-severe paravalvular leak [RR 4.40 (1.22–15.86); P = 0.02; I² = 26%] and permanent pacemaker insertion [RR 2.73 (1.41–5.28); P = 0.003; I² = 83%].ConclusionsThere is no difference in all-cause mortality or stroke between TAVR and SAVR, but TAVR is associated with lower risk of other perioperative complications except for moderate-severe paravalvular leak and the need for permanent pacemaker implantation.     

Dysphagia,Short-Term Outcomes,and Cost of Care After Anterior Cervical Disc Surgery

Dysphonia and dysphagia are common complications of anterior cervical discectomy (ACD). We sought to determine the relationship between dysphagia and in-hospital mortality, complications, speech therapy/dysphagia training, length of hospitalization, and costs associated with ACD. Discharge data from the Nationwide Inpatient Sample for 1,649,871 patients who underwent ACD of fewer than four vertebrae for benign acquired disease between 2001 and 2010 were analyzed using cross-tabulations and multivariate regression modeling. Dysphagia was reported in 32,922 cases (2.0 %). Speech therapy/dysphagia training was reported in less than 0.1 % of all cases and in only 0.2 % of patients with dysphagia. Dysphagia was significantly associated with age ≥65 years (OR = 1.5 [95 % CI 1.4–1.7], P < 0.001), advanced comorbidity (OR = 2.3 [2.0–2.6], P < 0.001), revision surgery (OR = 2.7 [2.3–3.1], P < 0.001), disc prosthesis placement (OR = 1.5 [1.0–2.0], P = 0.029), and vocal cord paralysis (OR = 11.6 [8.3–16.1], P < 0.001). Dysphagia was a significant predictor of aspiration pneumonia (OR = 8.6 [6.7–10.9], P < 0.001), tracheostomy (OR = 2.3 [1.6–3.3], P < 0.001), gastrostomy (OR = 30.9 [25.3–37.8], P < 0.001), and speech therapy/dysphagia training (OR = 32.0 [15.4–66.4], P < 0.001). Aspiration pneumonia was significantly associated with in-hospital mortality (OR = 15.9 [11.0–23.1], P < 0.001). Dysphagia, vocal cord paralysis, and aspiration pneumonia were significant predictors of increased length of hospitalization and hospital-related costs, with aspiration pneumonia having the single largest impact on length of hospitalization and costs. Dysphagia is significantly associated with increased morbidity, length of hospitalization, and hospital-related costs in ACD patients. Despite the known risk of dysphagia in ACD patients and an established role for the speech-language pathologist in dysphagia management, speech-language pathology intervention appears underutilized in this population.     

Short- and Long-term Outcomes in Dialysis Patients Undergoing Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-analysis

BackgroundTranscatheter aortic valve implantation (TAVI) has become the main treatment for symptomatic severe aortic stenosis, but patients on dialysis have been excluded from major randomized controlled trials. Our aim was to compare mortality and procedure-related complications after TAVI in patients with end-stage renal disease (ESRD) on dialysis vs those without.MethodsEMBASE and MEDLINE were searched through November 2019 to investigate the comparative outcomes between patients with ESRD on dialysis and those without who underwent TAVI. The main outcomes were short-term (30-day/in-hospital) mortality and procedural complications, and long-term (>6 months) all-cause mortality.ResultsOur search identified 10 observational studies enrolling 128,094 (5399 on dialysis) patients who underwent TAVI. Dialysis patients had a significantly higher rate of short-term and long-term mortality than nondialysis patients (odds ratio [95% confidential interval]: 2.18 [1.64-2.89], P < 0.001, I² = 60%; 1.91 [1.46-2.50], P < 0.001, I² = 80%, respectively). In addition, dialysis patients had significantly higher rates of short-term life-threatening and/or major bleeding, permanent pacemaker implantation, and device failure compared with nondialysis patients (odds ratio [95% confidential interval]: 1.90 [1.24-2.90], P < 0.001, I² = 67%; 1.33 [1.15-1.53], P < 0.001, I² = 0%; 2.08 [1.05-4.10], P = 0.03, respectively), but did not have significantly higher rates of vascular complications and stroke.ConclusionDialysis patients had significantly higher rates of short- and long-term mortality, short-term life-threatening and/or major bleeding, permanent pacemaker implantation, and device failure compared with nondialysis patients. Careful selection of patients who would benefit from TAVI among patients with ESRD requiring dialysis is necessary to prevent high rates of postprocedural complications.     

Aortic Root Enlargement Is Safe and Reduces the Incidence of Patient-Prosthesis Mismatch: A Meta-analysis of Early and Late Outcomes

BackgroundAortic root enlargement (ARE) may be an important adjunct to aortic valve replacement (AVR) to prevent patient-prosthesis mismatch and facilitate future valve-in-valve transcatheter AVR (TAVR). However, the early safety and late benefits of adding surgical ARE to AVR remain controversial.MethodsMEDLINE and EMBASE were searched from 1946 to 2018 for articles comparing patients undergoing AVR+ARE with those undergoing AVR alone. A random-effects meta-analysis was performed to compare early and late clinical outcomes.ResultsA total of 2570 AVR+ARE and 5,991 AVR patients were included from 9 observational studies. There was no difference in early mortality (relative risk [RR] 1.21; 95% confidence interval [CI], 0.94-1.54; P = 0.13). Both cardiopulmonary bypass (mean difference [MD] 20 minutes; 95% CI, 15-25; P < 0.01) and aortic cross-clamp time (MD 14 minutes; 95% CI, 11-17, P < 0.01) were higher following AVR+ARE. There was no difference in the risk of permanent pacemaker implantation (RR 1.02; 95% CI, 0.83-1.25; P = 0.86), reoperation for bleeding (RR 1.05; 95% CI, 0.84-1.32; P = 0.64), or stroke (RR 0.93; 95% CI, 0.68-1.27; P = 0.65). The risk of moderate (indexed effective orifice area [iEOA] < 0.85 cm²/m²) and severe (iEOA < 0.65 cm²/m²) patient-prosthesis mismatch (PPM) was lower with AVR+ARE (RR 0.65; 95% CI, 0.51-0.83; P < 0.01) and RR 0.36; 95% CI, 0.16-0.82; P = 0.01, respectively). There was no difference in late mortality (incidence rate ratio [IRR] 1.05; 95% CI, 0.87-1.27; P = 0.59) at mean 7.8-year follow-up in 5 studies.ConclusionsSurgical ARE is a safe adjunct to AVR in selected patients that does not increase early adverse events and results in less patient-prosthesis mismatch. This strategy allows for a larger valve size at the time of implantation, an important consideration for potential future valve-in-valve procedures in the era of TAVR.     

Efficacy of Mechanical Circulatory Support Used Before Versus After Primary Percutaneous Coronary Intervention in Patients with Cardiogenic Shock From ST-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis

BackgroundOptimal timing to initiate mechanical circulatory support (MCS) in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) remains unclear with studies showing conflicting results on whether to start before or after primary percutaneous coronary intervention (PPCI). This study aims to examine the association between mortality and MCS initiated before vs after PPCI in patients with STEMI complicated by CS.MethodsWe systematically searched PubMed, Embase, and Scopus for abstracts and full-text articles from inception to October 2021. Studies were included if they evaluated the association of mortality in patients who initiated MCS (specifically intra-aortic balloon pump (IABP), Impella, and venoarterial extracorporeal membrane oxygenation (VA-ECMO)) before PPCI versus after PPCI, specifically in patients with STEMI complicated by CS. Data were integrated using the random-effects models.ResultsTen studies involving 1,352 patients (956, 203, and 193 patients underwent IABP, Impella, and VA-ECMO respectively) with STEMI complicated by CS were included. There was no difference in mortality using IABP before or after PPCI ([OR] 1.77, 95% CI 0.77–1.61, I2 = 27%, p = 0.57). Nevertheless, Impella and VA-ECMO started before PPCI were significantly associated with a reduced risk of mortality compared to that started after PPCI ([OR] 0.49, 95% CI 0.26–0.92, I2 = 0%, p = 0.03 and [OR] 0.29, 95% CI 0.14–0.62, I2 = 0%, p = 0.001, respectively).ConclusionsIn patients with STEMI complicated by CS undergoing PPCI, the use of IMPELLA or VA-ECMO prior to PPCI significantly decreased mortality, in contrast to IABP, in which no difference in mortality was found between using it before or after PPCI. More rigorous studies are needed to clarify this association.     

Usefulness of Impella support in different clinical settings in cardiogenic shock

BACKGROUNDThe Impella pump has emerged as a promising tool in patients with cardiogenic shock (CS). Despite its attractive properties, there are scarce data on the specific clinical setting and the potential role of Impella devices in CS patients from routine clinical practice.METHODSThis is an observational, retrospective, single center, cohort study. All consecutive patients with diagnosis of CS and undergoing support with Impella 2.5^®, Impella CP^® or Impella 5.0^® from April 2015 to December 2020 were included. Baseline characteristics, management and outcomes were assessed according to CS severity, age and cause of CS. Main outcome measured was in-hospital mortality. RESULTSA total of 50 patients were included (median age: 59.3 ± 10 years). The most common cause of CS was acute coronary syndrome (ACS) (68%), followed by decompensation of previous cardiomyopathy (22%). A total of 13 patients (26%) had profound CS. Most patients (54%) improved pulmonary congestion at 48 h after Impella support. A total of 19 patients (38%) presented significant bleeding. In-hospital mortality was 42%. Among patients with profound CS (n = 13), five patients were previously supported with venoarterial extracorporeal membrane oxygenation. A total of eight patients (61.5%) died during the admission, and no patient achieved ventricular recovery. Older patients (≥ 67 years, n = 10) had more comorbidities and the highest mortality (70%). Among patients with ACS (n = 34), 35.3% of patients had profound CS; and in most cases (52.9%), Impella support was performed as a bridge to recovery. In contrast, only one patient from the decompensated cardiomyopathy group (n = 11) presented with profound CS. In 90.9% of these cases, Impella support was used as a bridge to cardiac transplantation. There were no cases of death. CONCLUSIONSIn this cohort of real-life CS patients, Impella devices were used in different settings, with different clinical profiles and management. Despite a significant rate of complications, mortality was acceptable and lower than those observed in other series.

Cardiogenic shock (CS) is a severe clinical condition which includes systemic hypotension and tissue hypoperfusion secondary to cardiac dysfunction with adequate or elevated filling pressures, and is commonly associated to a poor prognosis.^[1] Clinical practice guidelines^[2] recommend the use of inotropic drugs and vasopressors in order to maintain organ perfusion, early revascularization in cases due to acute coronary syndrome (ACS) and the use of mechanical circulatory support (MCS) in refractory cases.^[1,2] However, despite all these measures, mortality remains high in most series.^[3] The use of inotropic drugs and vasopressors increases myocardial oxygen consumption and proarrhythmic risk,^[4] and the use of MCS is associated with a high rate of complications^[5]. A better prognosis has been consistently observed in high volume centers with full availability of percutaneous coronary intervention (PCI), MCS, intensive cardiac care unit and especifically trained shock teams.^[6–10] Given the complexity of these patients, current guidelines recommend to organize the care of CS in different center networks according to the severity of patients.^[2]As stated before, MCS has emerged during the last years as a promising tool in critically ill patients with refractory CS. The ideal device in patients with CS requires an easy and quick insertion, the ability to unload left ventricle (LV) and increase cardiac output in order to restore tissue hypoperfusion. In this sense, the Impella devices (Abiomed Inc., Massachusetts, USA), consists of a transvalvular axial pump with femoral or axillary insertion that collects blood from the LV and ejects it directly into the ascending aorta.^[3] The Impella device provides MCS with an increase in mean arterial pressure, an increase in cardiac output and peak coronary blood flow while unloading LV, reducing end-diastolic volume, wall stress and oxygen consumption, thus favoring myocardial recovery.^[1,3] However, despite these attractive properties, there are scarce data on the specific clinical setting to use Impella devices and the efficacy and complications in its use in real world. Most publications report experience in high risk PCI or after acute myocardial infarction complicated by CS.^[11]Therefore, the aim of this study was to collect the results and complications of the use of Impella devices in a real world high complexity CS referral center over a five-year period in non-selected patients with CS of any etiology.     

Predictors of In-hospital Mortality and Acute Myocardial Infarction in Thrombotic Thrombocytopenic Purpura

Background

Despite the widespread availability of plasmapheresis as a therapy, thrombotic thrombocytopenic purpura is associated with significant morbidity and mortality. There is a paucity of data on the predictors of poor clinical outcome in this population. Acute myocardial infarction is a recognized complication of thrombotic thrombocytopenic purpura. Little is known about the magnitude of this problem, its risk factors, and its influence on mortality in patients hospitalized with thrombotic thrombocytopenic purpura.

Methods

We used the 2001-2010 Nationwide Inpatient Sample database to identify patients aged ≥18 years with the diagnosis of thrombotic thrombocytopenic purpura (International Classification of Diseases, 9^th Revision, Clinical Modification [ICD-9-CM] code 446.6) who also received therapeutic plasmapheresis (ICD-9-CM code 99.71) during the hospitalization. Patients with acute myocardial infarction were identified using the Healthcare Cost and Utilization Project Clinical Classification Software code 100. Stepwise logistic regression was used to determine independent predictors of in-hospital mortality and acute myocardial infarction in thrombotic thrombocytopenic purpura patients.

Results

Among the 4032 patients (mean age 47.5 years, 67.7% women, and 36.9% white) with thrombotic thrombocytopenic purpura who also underwent plasmapheresis, in-hospital mortality was 11.1%. Independent predictors of increased in-hospital mortality were older age (odds ratio [OR] 1.03; 95% confidence interval [CI], 1.02-1.04; P <.001), acute myocardial infarction (OR 1.89; 95% CI, 1.24-2.88; P = .003), acute renal failure (OR 2.75; 95% CI, 2.11-3.58; P <.001), congestive heart failure (OR 1.66; 95% CI, 1.17-2.34; P = .004), acute cerebrovascular disease (OR 2.68; 95% CI, 1.87-3.85; P <.001), cancer (OR 2.49; 95% CI, 1.83-3.40; P <.001), and sepsis (OR 2.59; 95% CI, 1.88-3.59; P <.001). Independent predictors of acute myocardial infarction were older age (OR 1.03; 95% CI, 1.02-1.04; P <.001), smoking (OR 1.60; 95% CI, 1.14-2.24; P = .007), known coronary artery disease (OR 2.59; 95% CI, 1.76-3.81; P <.001), and congestive heart failure (OR 2.40; 95% CI, 1.71-3.37; P <.001).

Conclusion

In this large national database, patients with thrombotic thrombocytopenic purpura had an in-hospital mortality rate of 11.1% and an acute myocardial infarction rate of 5.7%. Predictors of in-hospital mortality were older age, acute myocardial infarction, acute renal failure, congestive heart failure, acute cerebrovascular disease, cancer, and sepsis. Predictors of acute myocardial infarction were older age, smoking, known coronary artery disease, and congestive heart failure.     

Meta-analysis of 14 trials comparing bypass grafting vs drug-eluting stents in diabetic patients with multivessel coronary artery disease

Background and aimClinical trials have reported lower mortality and repeated revascularization rate in diabetic patients treated with coronary artery bypass grafting (CABG) as compared to percutaneous revascularization. However, these studies were conducted in the era of bare-metal stents. Therefore, we performed a meta-analysis to compare CABG to PCI with drug-eluting stents (DES) in diabetic patients with multivessel and/or left main disease.Methods and resultsThe literature was scanned by formal search of electronic databases (Medline, EMBASE, and Cochrane databases), and major international scientific session abstracts from 2000 to 2013. Primary endpoint was mortality. A total of 14 (4 randomized and 10 non-randomized) trials were finally included, with a total of 7072 patients. Up to 5 years follow-up, CABG was associated with a reduction in mortality (7.3% vs 10.4%, OR[95%CI] = 0.65[0.55–0.77], p < 0.0001; phet = 0.00001), with similar results in both RCTs (OR[95%CI] = 0.64[0.50–0.82], p = 0.0005) and NRCTs (OR[95%CI] = 0.75[0.6–0.94)], p = 0.01) (p int = 0.93). A significant relationship was observed between risk profile and benefits in mortality with CABG (p < 0.001). CABG reduced target vessel revascularization (TVR; 5.2% vs 15.7%, OR[95%CI] = 0.30[0.25–0.36], p < 0.00001, p het = 0.02), with a relationship between risk profile and the benefits from CABG as compared to DES (p < 0.0001). CABG was associated with a lower rate of MACCE (14.9% vs 22.9%, OR[95%CI] = 0.59[0.51–0.67], p < 0.00001, p het<0.00001) but higher risk of CVA (3.6% vs 1.4%, OR[95%CI] = 2.34[1.63–3.35], p < 0.00001, p het = 0.71).ConclusionsThe present meta-analysis demonstrates that among diabetic patients with multivessel disease and/or left main disease, CABG provides benefits in mortality and TVR, especially in high-risk patients but it is counterbalanced by a higher risk of stroke. Future trials are certainly needed in the era of new DES and improved antiplatelet therapies.