Trends of utilization and outcomes after transcatheter and surgical aortic valve replacement on chronic dialysis.

BACKGROUND AND AIM: Trends of utilization and outcomes of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for patients on chronic dialysis (CD) are not well described. We aimed to assess the trends in utilization and outcomes of TAVR and SAVR on CD. METHODS: Nationwide Readmission Databases from 2013 to 2017 was analyzed. International Classification of Diseases Clinical Modification 9 and 10 codes were used to identify diagnoses and procedures. A multivariable regression model was used to compare the outcomes expressed as adjusted odds ratio (aOR) and 95% confidence interval (CI). RESULTS: A total of 5731 TAVR and 6491 SAVR were performed in patients with CD, respectively. The volume of TAVR increased by approximately four-folds and SAVR increased by approximately 33%. However, amongst patients with CD, the percentage of TAVR increased, whereas that of SAVR decreased (p < .001 for all). In 2016 and 2017, TAVR volume surpassed that of SAVR on CD. In-hospital mortality remained similar in TAVR (aOR: 0.92; 95% CI: 0.79-1.07; p-trend = .23) whereas it increased significantly in SAVR (aOR: 1.14: 95% CI: 1.05-1.25, p-trend = .002). In 2017, in-hospital mortality and 30-day readmission were significantly higher in TAVR among CD than non-CD patients. CONCLUSION: Despite increased use of TAVR among CD, there still is an opportunity for improvement in outcome of aortic valve replacement for those on CD.

Percutaneous closure of left ventricle pseudoaneurysm using 3D printed heart model for procedure planning: A novel approach.

Left ventricle pseudoaneurysm is a rare complication of myocardial infarction that carries a high risk of mortality. In this report, we present a case of successful percutaneous closure of left ventricle pseudoaneurysm using 3D printing for procedure guidance.

Transradial versus transfemoral percutaneous coronary intervention of left main disease: A systematic review and meta-analysis of observational studies.

OBJECTIVES: To assess the efficacy and safety of transradial (TR) versus transfemoral (TF) percutaneous coronary intervention (PCI) in left main (LM) lesion. BACKGROUND: TR-PCI is the preferred approach compared with TF approach because of less bleeding risk. LM-PCI is often challenging because of the anatomical complexity and uniqueness of supplying a large myocardium territory. We performed a systematic review and meta-analysis to assess the safety and efficacy of TR-PCI compared with TF-PCI of the LM lesions. METHODS: A comprehensive literature search of PUBMED, EMBASE, and Cochrane database was conducted to identify studies that reported the comparable outcomes between both approaches. Odds ratio (OR) and 95% confidence interval (CI) was calculated using the Mantel-Haenszel method. RESULTS: A total of eight studies were included in the quantitative meta-analysis. TR-PCI resulted in lower bleeding risk (OR 0.31, 95%CI 0.18-0.52, P < 0.01, I2 = 0%) while maintaining similar procedural success rate, target lesion revascularization, myocardial infarction, stent thrombosis, and all-cause mortality during the study follow-up period. CONCLUSIONS: TR-PCI may achieve similar efficacy with decreased bleeding risk compared to TF-PCI in LM lesions. When operator experience and anatomical complexity are favorable, TR approach is an attractive alternative access over TF approach in LM-PCI.

Does mild paravalvular regurgitation post transcatheter aortic valve implantation affect survival? A meta-analysis.

BACKGROUND: To assess the impact of post transcatheter aortic valve implantation (TAVI) mild paravalvular regurgitation (PVR) on mortality. More than moderate PVR after TAVI has decreased with the advent of new-generation prosthetic valves. However, mild PVR remains common and its clinical impact has been inconsistent. We aimed to assess the impact of mild PVR through meta-analysis. METHODS AND RESULTS: A systematic literature search was conducted through PUBMED and EMBSE. Manuscripts that reported hazard ratio (HR) with 95% confidence interval (CI) for clinical outcome of interest (all-cause and cardiac mortality) has been included. Random-effects model was used for calculation of HR. A total of 25 articles including total of 21,018 patients were finally included for quantitative synthesis (meta-analysis). Our pooled analysis demonstrated higher all-cause mortality in patients with mild PVR compared to none/trivial PVR (HR 1.26, 95%CI 1.11-1.43, I2 =45%, p < 0.001) (follow up duration range 6 months to 5 years). Significant heterogeneity among studies was observed (p for heterogeneity = 0.005). Egger's test showed no evidence of publication bias. Cardiovascular mortality was increased in patients with mild PVR compared with none/trivial PVR (HR 1.28, 95%CI 1.05-1.57, I2 =8%, p = 0.02) (follow up duration range 1-3 years). CONCLUSIONS: Mild PVR was associated with increased all-cause and cardiovascular mortality after TAVI. Whether further interventions in mild PVR is of benefit, has yet to be determined.

A systematic review of reported cases of combined transcatheter aortic and mitral valve interventions.

OBJECTIVES: To summarize the published data of combined transcatheter aortic and mitral valve intervention (CTAMVI). BACKGROUND: CTAMVI, a combination of either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve-in-valve (TAViV) and transcatheter mitral valve replacement (TMVR), transcatheter mitral valve-in-valve/valve-in-ring (TMViV/ViR), or percutaneous mitral valve repair (PMVR) is an attractive alternative in high-surgical risk patients with combined aortic and mitral valve disease. However, its procedural details and clinical outcomes have not been well described. METHODS: We performed a systematic review of all the published articles from PUBMED and EMBASE. RESULTS: A total of 37 studies with 60 patients were included. The indication for CTAMVI was high or inoperable surgical risk and symptomatic severe aortic stenosis (92%) or severe aortic regurgitation (8%) combined with moderate to severe/severe mitral stenosis (30%) or moderate/severe mitral regurgitation (65%) or both (5%). In majority of the cases, aortic valve intervention was performed prior to the mitral valve. Mortality rate were 25% for TAVR + TMVR (range 42 days to 10 months), 17% for TAVR + TMViV/ViR (range 13 days to 6 months), 0% for TAViV + TMViV/ViR (range 6-365 days), and 15% for TAVR/ViV + PMVR (range 17 days to 419 days). Significant (more than moderate) paravalvular regurgitation post-procedure was rare. CONCLUSIONS: CTAMVI appears to confer reasonable clinical outcome. Further large study is warranted to clarify the optimal strategy, procedural details and clinical outcomes in the future.

Hospital outcomes of transcatheter versus surgical aortic valve replacement in female in the United States.

OBJECTIVES: To assess the in-hospital mortality and complications in female between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). BACKGROUND: Female is one of the risk factors for increased adverse events in cardiac surgery. METHODS AND RESULTS: Nationwide Inpatient Sample database was queried from 2011 to 2014 for patients who underwent TAVR or SAVR in female patients. The primary endpoint was in-hospital all-cause mortality and second endpoints were perioperative complications. We performed a propensity score analysis to calculate the adjusted odds ratio (OR) for each outcome. Patients who had concomitant cardiac surgery and those who had TAVR or SAVR mainly for aortic regurgitation were excluded. Our query from 2011 to 2014 resulted in a total of 3,067 TAVR and 18,594 SAVR in female patients. TAVR patients were in general elder and had a higher burden of comorbidities. The primary endpoint was similar between TAVR and SAVR (4.2% vs. 3.9%, OR 1.0, P = 0.89). Compared to SAVR, female TAVR patients had less hemorrhage requiring transfusion (12% vs. 21%, OR 0.41, P < 0.001), perioperative cardiac arrest and nonfatal myocardial infarction (9.8% vs. 17%, OR 0.38, P < 0.001), respiratory complication (1.6% vs. 4.4%, OR 0.28, P < 0.001), post-op sepsis (1.7% vs. 2.9%, OR 0.65, P = 0.03), acute myocardial infarction (3.0% vs. 4.9%, OR 0.60, P < 0.001), and acute kidney injury (15% vs. 18%, OR 0.62, P < 0.001). Conversely, female TAVR patients had significantly increased risk of new pacemaker implantation (11% vs. 5.9%, OR 1.7, P < 0.001) and use of extracorporeal membrane oxygenation (0.66% vs. 0.24%, OR 2.8, P < 0.001). TAVR patients had less nonroutine discharge. The median hospital cost was significantly higher in TAVR than SAVR (median $51,274 vs. $43,677, P < 0.001) but the length of stay was shorter (mean 7.8 days vs. 10.5 days). CONCLUSIONS: TAVR may be a better option for those patients with underlying comorbidities that predispose them at higher risk for complications that was less observed in TAVR group. However, higher cost and increased risk of need for extracorporeal membrane oxygenation, although rare, should be taken into consideration upon deciding the optimal mode for aortic valve replacement.

Hospital teaching status and trascatheter aortic valve replacement outcomes in the United States: Analysis of the national inpatient sample.

BACKGROUND: Evidence suggests that medical service offerings vary by hospital teaching status. However, little is known about how these translate to patient outcomes. We therefore sought to evaluate this gap in knowledge in patients undergoing Transcatheter aortic valve replacement (TAVR) in the United States. METHODS: This study was conducted using the National Inpatient Sample (NIS) in the United States from 2011 to 2014. Teaching status was classified, as teaching vs. nonteaching and endpoints were clinical outcomes, length of stay and cost. Procedure-related complications were identified via ICD-9 coding and analysis was performed via mixed effect model. RESULTS: An estimated 33,790 TAVR procedures were performed in the U.S between 2011 and 2014, out of which 89.3% were in teaching hospitals. Mean (SD) age was 81.4 (8.5) and 47% were females. There was no significant difference between teaching versus nonteaching hospitals in regards to the primary outcome of in-hospital mortality and secondary outcomes of several cardiovascular and other end points except for a high rates of acute kidney injury (AKI) (OR: 1.34 [95% CI, 1.04-1.72]) and lower rate for use of mechanical circulatory support devices in teaching vs. nonteaching centers. The mean length of stay was significantly higher in teaching hospitals (7.7 days) vs. nonteaching hospitals (6.8 days) (P = 0.002) and so was the median cost of hospitalization (USD 50,814 vs. USD 48, 787, P = 0.02) for teaching vs. nonteaching centers. CONCLUSION: Most TAVR related short-term outcomes including all cause in-hospital mortality are about the same in teaching and nonteaching hospitals. However, AKI, length of hospital stay and TAVR related cost were significantly higher in teaching than nonteaching hospitals. There was more use of mechanical circulatory support in nonteaching than teaching hospitals.

Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry.

BACKGROUND: Patients with left main (LM) coronary artery disease are increasingly being treated with percutaneous revascularization (PCI). The safety, feasibility, and efficacy of unprotected LM intervention (ULMI) with hemodynamic support by Impella device have not been evaluated previously. OBJECTIVE: Using a large retrospective single center database from the USpella registry, we evaluated the safety, feasibility, and potential benefits of periprocedural left ventricular assist with axial flow Impella 2.5 and Impella CP (Abiomed Inc. Danvers, Mass) during ULMI. METHODS: We analyzed a total of 127 consecutive patients who received hemodynamic support with Impella (2.5 or CP) for ULMI from August 2008 to July 2015. Safety, feasibility and efficacy end points included procedural success rates, in-hospital and 30-day major adverse cardiovascular event (MACE) rates. RESULTS: Among 127 patients who received hemodynamic support for ULMI (mean age 69.98 ± 10.7 years, 71% men, and mean left ventricular ejection fraction 28.74 ± 15.55%, Society of Thoracic Surgeons' mortality/morbidity 4/23%) the in-hospital and 30 days mortality rates were 1.43% (2/140) and 2.1% (3/141), respectively. The average baseline and post PCI (residual) syntax scores were 31.4 and 7.86, respectively, (P < 0.001). Only one patient (0.8%) had vascular complication that required surgery; 2.36% (3/127) had hematoma and 3.9% (5/127) had bleeding that required transfusion. CONCLUSION: This large singe center retrospective evaluation of USpella registry substantiates and strongly supports the feasibility, safety, and hemodynamic usefulness of Impella device for ULMI with acceptable in-hospital and 30-day MACE rates. © 2017 Wiley Periodicals, Inc.

Transcatheter aortic valve implantation in the United States: Predictors of early hospital discharge.

BACKGROUND: There is a concerted push for adopting a minimalist strategy with emphasis on early hospital discharge for patients undergoing Transcatheter aortic valve implantation (TAVI). However, studies on discharge patterns and predictors of early discharge (≤3 days post-TAVI) are sparse, in the United States. METHODS: We analyzed using Healthcare Utilization Project, Nationwide Inpatient Sample database, 2011-2012. A total of 7321 TAVI procedures were identified. We compared in-hospital outcomes between early and late discharge cohorts, and determined the predictors of early discharge. Correlation of costs and post-TAVI length of stay was also performed. RESULTS: Early discharge rate post-TAVI was about 21% in the United States, in 2011-2012. Overall mean age was 81 years. In-hospital adverse outcomes post-TAVI were higher in late discharge cohort (P < 0.001). Mean length of stay post-TAVI (7.7 days vs 2.6 days) and costs ($208 752 vs $157 663) were significantly higher in late discharge than early discharge cohort. Females, bleeding, blood transfusions, stroke, permanent pacemakers, mechanical circulatory support, acute kidney injury were associated with significantly lower adjusted odds for early discharge. Transfemoral TAVI approach, prior aortic valvuloplasty, and procedure year 2012 were associated with significantly higher odds for early discharge. We observed positive correlation between costs of hospitalization and post-TAVI length of stay (R = 0.58; P < 0.001). CONCLUSIONS: Females, bleeding, blood transfusions, stroke, permanent pacemakers, mechanical circulatory support devices, renal failure were associated with lower odds for early discharge. Transfemoral approach and prior aortic valvuloplasty increased the likelihood for early discharge. Post-TAVI length of stay was associated with significantly higher hospitalization costs.

Hospital Readmission after Aortic Valve Replacement: Impact of Preoperative Heart Failure.

BACKGROUND AND AIM OF THE STUDY: Large-scale data of heart failure (HF) readmission after aortic valve replacement (AVR) are limited. METHODS: A total of 40,751 Medicare beneficiaries >65 years who underwent primary isolated AVR between 2000 and 2004 were included in the study. Preoperative HF was defined using ICD-9-CM diagnostic codes from the index admission and any hospitalization during the preceding year. Cumulative readmission incidences over five years were computed for those patients with and without preoperative HF, while adjusting for propensity scores. RESULTS: The median patient age was 76 years. At 30 days, all-cause readmission was 21.5% and HF readmission was 3.9%. Patients with preoperative HF had higher postoperative HF readmission rates compared to those without (30 days, 6.3% versus 2.2%; one year, 13.9% versus 4.4%; five years, 6.6% versus 10.3%, p = 0.0001). The incremental risk of HF on readmission was >2 following adjustment. In patients with preoperative HF, the number of admissions was associated with increased postoperative HF readmissions. At 30 days, patients with no preoperative HF admissions had a HF readmission rate of 5.3%, while those with one, two, three and four or more preoperative HF admissions had rates of 8.2%, 11.9%, 13.8% and 17.4%, respectively. This trend persisted over the five-year follow up period. CONCLUSIONS: Postoperative HF readmission accounted for about one-fifth of all-cause readmissions after AVR in Medicare beneficiaries. Preoperative HF significantly contributed to postoperative readmission, both all-cause and HF-specific, which likely limits the symptomatic benefit of surgery. These data support early aortic valve intervention prior to the development of clinically apparent HF.

Longitudinal systolic strain profiles and outcomes in peripartum cardiomyopathy.

OBJECTIVE: Peripartum cardiomyopathy (PPCM) is a rare cause of heart failure that develops in the last month of pregnancy or within 5 months of delivery. Longitudinal systolic strain has been shown to be impaired in HF patients with both preserved and depressed EF, but has not previously characterized in patients with PPCM. METHODS: The purpose of our study was to investigate the prognosis and recovery in patients with PPCM and use 2D strain imaging to characterize regional and global LV strain in patients with PPCM. Between 2009 and 2014, we identified 47 newly diagnosed patients with PPCM and reduced EF (rPPCM), and 14 patients within the first 4 weeks postpartum who presented with signs and symptoms of HF, and elevated BNP/pro-NT-BNP, but preserved LVEF (pPPCM). We compared the echocardiographic characteristics of the patients with rPPCM and pPPCM with 14 healthy controls. RESULTS: All-cause mortality was 10.6% (5/47) and rehospitalization for HF rate was 31.9% (15/47) at a median follow-up of 12.5 months (range: 1-60 months) in the rPPCM group. In 25.5% (12/47) of patients with rPPCM, there was no recovery or worsening of LVEF, while complete and partial (more than 10% increase but less than 55%) recovery was seen in 57.4% (27/47) and 17% (8/47) of patients, respectively. Global and longitudinal strain (GLS) values were not independent predictors of all-cause mortality or the composite endpoint of all-cause mortality, rehospitalization, or no LVEF recovery in these patients. GLS and segmental strain were significantly lower in the preserved EF group compared with controls but higher compared with PPCM with reduced EF. CONCLUSION: Global and segmental longitudinal strain parameters were significantly reduced in PPCM patients.

Meta-Analysis Comparing the Incidence of Infective Endocarditis Following Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement.

Infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) is a rare but life-threatening complication. Paravalvular regurgitation, compression of native leaflets, and space between transcatheter valve prosthesis and native valves could dispose TAVI recipients at increased risk of IE compared with SAVR. To assess the comparative risk of IE between TAVI and SAVR, we performed a systematic review and meta-analysis. A literature search of PUBMED and EMBASE was performed to identify randomized controlled trials that reported the event rate of IE in both TAVI and SAVR. A Mantel-Haenszel method and a random-effects model was used to calculate the odds ratio (OR) and 95% confidence interval (CI). The studied outcomes were early (at 1-year), late (>1-year), and overall IE (postprocedure to longest follow-up) in TAVI versus SAVR. We performed subgroup analysis based on valve-type (self or balloon-expandable) and surgical risk (high or intermediate). A total of 4 studies with 3,761 (1,895 TAVI and 1,866 SAVR) patients were included. The incidence of early IE, (3 studies, 0.86% vs 0.73%, OR 1.17, 95% CI 0.51 to 2.65, p = 0.71, I2 = 0%), late IE (mean follow-up 2.0 years) (3 studies, 1.3% vs 0.6%, OR 1.85, 95% CI 0.81 to 4.20, p = 0.42, I2 = 0%), and overall IE (mean follow-up 3.4 years) (4 studies, 2.0% vs 1.3%, OR 1.44, 95% CI 0.85 to 2.43, p = 0.18, I2 = 0%) was similar between TAVI and SAVR. Subgroup analysis suggested that in intermediate surgical risk cohort, there was a trend toward increased risk of overall IE in TAVI (2.3% in TAVI and 1.2% in SAVR, OR 1.92, 95% CI 0.99 to 3.72, p = 0.05 I2 = 0%). In this meta-analysis, we did not find an increased risk of IE in TAVI compared with SAVR. Appropriate preventative measure and early recognition of IE in these cohorts are important.

MicroRNAs in Atrial Fibrillation.

MicroRNAs (miRNAs) are small non-coding RNAs, involved in regulation of post-transcriptional gene expression. They exert key role not only in physiology and normal development of the cardiovascular system but also in cardiovascular disease development and progression. Recent animal and human studies of tissue specific miRNAs have suggested a role in structural and electrical remodeling in atrial fibrillation (AF). Their emerging role as biomarkers and potential therapeutic targets in patients with AF is discussed in this review.

Predictors of Hospital Cost After Transcatheter Aortic Valve Implantation in the United States: From the Nationwide Inpatient Sample Database.

We aimed to identify risk factors of high hospitalization cost after transcatheter aortic valve implantation (TAVI). TAVI expenditure is generally higher compared with surgical aortic valve replacement. We queried the Nationwide Inpatient Sample database from January 2011 to September 2015 to identify those who underwent endovascular TAVI. Estimated cost of hospitalization was calculated by merging the Nationwide Inpatient Sample database with cost-to-charge ratios available from the Healthcare Cost and Utilization Project. Patients were divided into quartiles (lowest, medium, high, and highest) according to the hospitalization cost, and multivariable regression analysis was performed to identify patient characteristics and periprocedural complications associated with the highest cost group. A total of 9,601 TAVI hospitalizations were identified. Median in-hospital costs of the highest and lowest groups were $82,068 and $33,966, respectively. Patients in the highest cost group were older and more likely women compared with the lowest cost group. Complication rates (68.4% vs 22.5%) and length of stay (median 10 days vs 3 days) were both approximately 3 times higher and longer, respectively, in the highest cost group. Co-morbidities such as heart failure, peripheral vascular disease, atrial fibrillation, anemia, and chronic dialysis as well as almost all complications were associated with the highest cost group. The complications with the highest incremental cost were acute respiratory failure requiring intubation ($28,209), cardiogenic shock ($22,401), and acute kidney injury ($16,974). Higher co-morbidity burden and major complications post-TAVI were associated with higher hospitalization costs. Prevention of these complications may reduce TAVI-related costs.

Endovascular Therapy for Rheumatic Mitral and Aortic Valve Disease: Review Article.

Rheumatic heart disease remains a major cause of significant mortality and morbidity in the developing world. Rheumatic mitral and aortic stenosis are the two most common valvular sequelae of acute rheumatic fever. Open surgical procedures with either valve replacement or surgical commissurotomy have largely been replaced by percutaneous commissurotomy and balloon valvuloplasty for selected patients since the early 1980s. The purpose of our review is to examine the literature for any recent advancement in procedural techniques of balloon valvuloplasty for selected patients with rheumatic mitral and or aortic stenosis. Our search indicates that, in general, the volume of recent publications on this important topic is rather scanty with no major changes in the fundamentals of procedural techniques and or primary indications for balloon valvuloplasty of a rheumatic valve stenosis. Percutaneous balloon valvuloplasty/commissurotomy remains the main stay of therapy for rheumatic valvular stenosis in selected patients with favorable valve anatomy.

Comparison of outcomes in new-generation versus early-generation heart valve in transcatheter aortic valve implantation: A systematic review and meta-analysis.

BACKGROUND: New-generation (NG) valves for transcatheter aortic valve implantation (TAVI) has recently been widely used in real-world practice, yet its comparative outcomes with early-generation (EG) valves remain under-explored. METHODS: An electronic literature search using PUBMED and EMBASE was conducted from inception to April 2017 for matched-cohort studies. Articles that compared the outcomes of NG vs. EG valves post TAVI with at least one of the following clinical outcome reported were included: all-cause mortality, major or life-threatening bleeding, major vascular complications (MVC), significant (more than moderate) paravalvular regurgitation (PVR), cerebrovascular events, significant (stage 2 or 3) acute kidney injury (AKI) and new permanent pacemaker implantation (PPI) that occurred either in-hospital or within 30-days. RESULTS: A total of 6 observational matched-cohort studies with 585 and 647 patients included in NG and EG valves, respectively, were included. EG valves were associated with a lower incidence of major or life-threatening bleeding (5.7% vs. 15.7%, p<0.00001), significant paravalvular regurgitation (5.3% vs. 14.4%, p=0.001), and significant AKI (4.4% vs. 7.5, p=0.03). All-cause mortality (3.5% vs. 5.0, p=0.43), cerebrovascular events (3.4% vs. 2.3%, p=0.34) and new PPI (11.0% vs. 14.6%, p=0.52) were similar between the two groups. NG demonstrated lower tendency of MVC (2.5% vs. 7.2, p=0.09) compared to EG valves. CONCLUSIONS: NG demonstrated lower rates of significant AKI, significant PVR and major or life-threatening bleeding while all-cause mortality, new PPI, and cerebrovascular events remained similar compared to EG valves.

Meta-Analysis Comparing Patent Foramen Ovale Closure Versus Medical Therapy to Prevent Recurrent Cryptogenic Stroke.

New evidence suggests that closure of a patent foramen ovale (PFO) plus medical therapy (MT; antiplatelet or anticoagulation) is superior to MT alone to prevent recurrent cryptogenic stroke. We performed a meta-analysis of randomized controlled trials that compared PFO closure plus MT with MT alone in patients with cryptogenic stroke. The efficacy end points were recurrent stroke, transient ischemia attack, and death. The safety end points were major bleeding and newly detected atrial fibrillation. Trials were pooled using random effects and fixed effects models. A trial sequential analysis was performed to assess if the current evidence is sufficient. Risk ratios (RR) were calculated for pooled estimates of risk. Five randomized controlled trials (3,440 patients) were included. Mean follow-up was 4.1 years. PFO closure reduced the risk of recurrent stroke by 58% (RR 0.42, 95% CI 0.20 to 0.91, p = 0.03). The number needed to treat was 38. The cumulative Z-line crossed the trial sequential boundary, suggesting there is adequate evidence to conclude that PFO closure reduces the risk of recurrent stroke by 60%. PFO closure did not reduce the risk of transient ischemia attack (RR 0.78, 95% CI 0.53 to 1.15, p = 0.21), mortality (RR 0.74, 95% CI 0.35 to 1.60, p = 0.45), or major bleeding (RR 0.96, 95% CI 0.42 to 2.20, p = 0.93); it did increase the risk of atrial fibrillation (RR 4.69, 95% CI 2.17 to 10.12, p <0.0001).

Renin-Angiotensin System Inhibitors vs Other Antihypertensives in Hypertensive Blacks: A Meta-Analysis.

The purpose of this study was to assess the effects of renin-angiotensin system (RAS) inhibitors vs other antihypertensive agents on cardiovascular outcomes in hypertensive black patients. The authors performed a systematic review and meta-analysis of studies that compared the effects of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) with calcium channel blockers (CCBs), diuretics, and ß-blockers in hypertensive black patients on cardiovascular outcomes. A total of 38,983 patients with a mean age of 60 years and mean follow-up of 4 years were included in our meta-analysis. No significant differences were found in all-cause mortality, myocardial infarction, heart failure, and cardiovascular mortality rates among patients treated with RAS inhibitors compared with CCBs, diuretics, and ß-blockers. The incidence of stroke was significantly increased in patients treated with RAS inhibitors compared with CCBs (odds ratio, 1.56; 95% confidence interval, 1.31-1.87 [P<.00001]; I2 =0%) and diuretics (odds ratio, 1.59; 95% confidence interval, 1.16-2.17 [P=.004]; I2 =56%) but not ß-blockers.

A remarkable case of late-onset biatrial bacterial endocarditis of the Gore HELEX septal occluder.

The HELEX septal occluder (W.L. Gore & Associates, Newark, DE, USA) is a popular closure device for patent foramen ovale (PFO) and secundum atrial septal defect (ASD). Composed of a versatile polymer and a wire frame, it has been used for nearly a decade. A 50-year-old African American man with a PFO repaired 5 years previously with the HELEX was admitted to our hospital with methicillin-resistant Staphylococcus aureus bacteremia. A transesophageal echocardiogram demonstrated large mobile vegetations on the left and right atrial aspects of the occluder. Cardiothoracic surgery was consulted for removal of the vegetations and device, but hesitated owing to concurrent foot osteomyelitis and concern for re-infection of a potential replacement device. The patient was persistently bacteremic, his course complicated by septic pulmonary and cerebral emboli, but eventually cleared his infection on antibiotic therapy. Seventy days since admission, the patient was discharged to a rehabilitation facility. The case illustrates that infection is possible years after PFO/ASD closure despite a theoretical neoendothelialization within 6 months of implantation. Furthermore, it accentuates the success of timely and aggressive medical treatment, thereby averting high-risk open cardiac surgery. .