Predictors of outcomes in patients with obesity following mitral valve surgery.

Objective: Few studies have assessed the outcomes of mitral valve surgery in patients with obesity. We sought to study factors that determine the in-hospital outcomes of this population to help clinicians provide optimal care. Methods: A retrospective analysis of adult patients with obesity who underwent open mitral valve replacement or repair between January 1, 2012, and December 31, 2020, was conducted using the National Inpatient Sample. Weighted logistic regression and random forest analyses were performed to assess factors associated with mortality and the interaction of each variable. Results: Of the 48,775 patients with obesity, 34% had morbid obesity (body mass index ≥40), 55% were women, 66% underwent elective surgery, and 55% received isolated open mitral valve replacement or repair. In-hospital mortality was 5.0% (n = 2430). After adjusting for important covariates, a greater risk of mortality was associated with older patients (adjusted odds ratio [aOR], 1.24; 95% CI, 1.08-1.43), higher Elixhauser comorbidity score (aOR, 2.10; 95% CI, 1.87-2.36), prior valve surgery (aOR, 1.63; 95% CI, 1.01-2.63), and more than 2 concomitant procedures (aOR, 2.83; 95% CI, 2.07-3.85). Lower mortality was associated with elective admissions (aOR, 0.70; 95% CI, 0.56-0.87) and valve repair (aOR, 0.58; 95% CI, 0.46-0.73). Machine learning identified several interactions associated with early mortality, such as Elixhauser score, female sex, body mass index ≥40, and kidney failure. Conclusions: The complexity of presentation, comorbidities in older and female patients, and morbid obesity are independently associated with an increased risk of mortality in patients undergoing open mitral valve replacement or repair. Morbid obesity and sex disparity should be recognized in this population, and physicians should consider older patients and females with multiple comorbidities for earlier and more opportune treatment windows.

Changes in fibrinolytic activity and coagulation factors after epicardial left atrial appendage closure in patients with atrial fibrillation.

Background: The left atrial appendage (LAA) is known to be the primary source of thrombus formation in atrial fibrillation (AF). We investigate whether epicardial LAA occlusion (LAAO) from the cardiovascular system has an effect on coagulation and prothrombotic status in AF. Methods: Twenty-two patients with nonvalvular AF, who were not currently receiving oral anticoagulation (OAC) therapy, participated in a single-center prospective study. We measured fibrinogen and plasminogen levels along with plasma fibrin clot permeability, clot lysis time (CLT) and endogenous thrombin potential (ETP) before the LAAO procedure, at discharge and 1 month afterward. Results: One month after the LAAO procedure, plasma fibrin clot permeability improved by 39.3% as measured by clots prepared from peripheral blood (P=0.019) and also after adjustment for fibrinogen (P=0.027). Higher plasma fibrin clot permeability was associated with improved clot susceptibility to lysis (r=-0.67, P=0.013). CLT was reduced by 10.3% (P=0.0020), plasminogen activator inhibitor-1 antigen levels were reduced by 52% (P=0.023) and plasminogen activity was increased by 8.9% (P=0.0077). A trend toward decreased thrombin generation, reflected by a decreased ETP and peak thrombin generated was also observed 1 month after LAAO procedure (P=0.072 and P=0.087, respectively). No differences were observed in tissue-type plasminogen activator and thrombin-activatable fibrinolysis inhibitor plasma levels (both P>0.05). Conclusions: Obtained results seem to confirm that LAA plays a key role in thrombogenesis. Elimination of LAA from the circulatory system may improve fibrin clot permeability and susceptibility to fibrinolysis in peripheral blood.

In-Hospital Outcomes and Trends of Tricuspid Valve Surgery in Heart Transplant Patients.

INTRODUCTION: Tricuspid valve (TV) regurgitation is the most common valvular pathology after orthotopic heart transplant (OHT). The number of transplants being performed is increasing with patients living longer after heart transplant. Data on TV surgery in OHT recipients is limited. METHODS: We sought to analyze the outcomes of patients undergoing TV surgery from a large diverse, multicentric, nationwide cohort using the Nationwide Inpatient Sample (NIS) database. RESULTS: A total of 42,766 TV repair or replacement (bioprosthetic and mechanical) involving adult patients (age ≥18 years) between 2007 and September 2015 were identified. Of these, 366 were performed in patients with OHT. TV repair was the most common surgery performed in both groups (OHT group and native heart group). Compared to the native group, patients with OHT had a significantly higher incidence of cardiogenic shock (20 vs. 11%, p = 0.024), acute kidney injury (AKI) (59 vs. 30%, p < 0.001), and AKI requiring hemodialysis (13 vs. 4%, p < 0.001). Also, the mean length of stay for the index admission was significantly longer in the OHT group (27 vs. 17 days, p = 0.008). The mortality rate was similar between the two groups (7 vs. 8%, p = 0.753). The number of TV surgeries performed in OHT patients from 2007 to 2014 have remained stable (p = 0.803) compared to those in native heart patients which showed a significantly increasing trend (p = 0.019) during the same time period. CONCLUSIONS: TV surgery remains an important treatment modality among the OHT population and carries a similar mortality during index hospitalization as that in native heart patients undergoing TV surgery.

Long-term effect of anticoagulation following left atrial appendage occlusion with the LARIAT device in patients with nonvalvular atrial fibrillation: impact on thromboembolism, bleeding and mortality. Real life data.

INTRODUCTION: Indications for left atrial appendage occlusion (LAAO) are varied and patients require individual management strategies. However, currently no guidelines exist for postprocedure oral anticoagulation (OAC) after an LAAO procedure. AIM: To evaluate the effect of OAC on thromboembolism, bleeding and mortality following the LAAO procedure for patients with AF. MATERIAL AND METHODS: One hundred and thirty-nine consecutive patients with nonvalvular atrial fibrillation (NVAF) who underwent LAAO with the LARIAT device were followed for at least 40 months. Decisions about OAC and its modifications were individualized based on clinical presentation, patient and physician preferences. RESULTS: Following LAAO, 52 (41%) patients did not receive OAC (No-OAC group) and 75 (59%) patients received OAC (OAC group), without any intergroup differences in CHADS2, CHA2DS2-VASc score or other thromboembolic risk factors. The median HAS-BLED score was higher in the OAC-group (median 3 (3-4) vs. 3 (2-4), p = 0.014). During a median follow-up time of 51 (43-57) vs. 55 (48-59) months in the No-OAC group and in the OAC group (p = 0.19) there were no significant differences between groups in ischemic stroke/TIA, 0 (0%) vs. 2 (2.7%), other thromboembolic events, 0 (0%) vs. 1 (1.3%), life-threatening, disabling or major events, 2 (3.7%) vs. 2 (2.7%), or annual mortality rate, 1.9% vs. 0.9%, respectively. CONCLUSIONS: There is no need for OAC after the LAAO procedure. Omitting OAC after an LAAO procedure in AF patients: (1) has similar stroke prevention rates as patients on OAC, (2) has similar bleeding prevention rates as patients on OAC, (3) has similar safety endpoints and long-term efficacy as patients on OAC.

Incidence and causes of in-hospital outcomes and 30-day readmissions after percutaneous left atrial appendage closure: A US nationwide retrospective cohort study using claims data.

BACKGROUND: Percutaneous left atrial appendage closure (pLAAC) emerged as an option for stroke prevention in patients with atrial fibrillation ineligible for long-term anticoagulation. Real-world data on pLAAC's in-hospital and 30-day readmission measures are limited. OBJECTIVE: We sought to report the nationwide incidence of the above outcomes using 2016 claims data. METHODS: We used the National Inpatient Sample for in-hospital outcomes and Nationwide Readmissions Database for readmissions. We identified hospitalizations with a primary diagnosis of atrial fibrillation and pLAAC procedure by using International Classification of Diseases, Tenth Revision codes and compared the outcomes mentioned above between the endocardial and epicardial cohorts. Statistical analyses were performed using R 3.3.2. RESULTS: Among 5480 pLAAC procedures (endocardial: 5145; epicardial: 335), the in-hospital mortality was 0.3%. Endocardial left atrial appendage closure (LAAC) had lower complications (8.5% vs 25.4%; P < .001) and shorter length of stay median [interquartile range] 1 [1-1] day vs 2 [1-3] days; P < .001) but higher hospitalization cost (24.13 [18.45-30.17] × 1000 dollars vs 21.21 [14.03-27.86] × 1000 dollars; P = .016). The most common complications include pericardial (endocardial vs epicardial: 3% vs 10.4%; P < .001) and renal failure (1.4% vs 6.0%; P = .004). Epicardial LAAC had higher 30-day unplanned readmissions (19.5% vs 8.3%; P = .001), with the most common reason being pericarditis and/or effusion (33.9%). CONCLUSION: Endocardial LAAC had lower complications and 30-day readmissions but higher hospitalization cost. Although epicardial LAAC showed higher complications, given recent improvements in its technique, and postprocedural care demonstrated a significant reduction in pericardial complications, more contemporary data comparing these outcomes are needed.

Impact of left atrial appendage occlusion on left atrial function-The LAFIT Watchman study.

BACKGROUND: Left atrial (LA) strain and strain rate (SR) analysis by two-dimensional speckle tracking echocardiography is a novel way of LA function assessment. From prior study, we know that LA appendage closure with LARIAT appears to improve LA function. OBJECTIVE: The purpose of this study was to assess the impact of LAA closure via Watchman device on LA function via strain and volumetric analyses using two-dimensional speckle tracking echocardiography (2D-STE). METHODS: Twenty-five patients who underwent Watchman device implantation (WDI) were included. LA function parameters (volumetric, strain indices) were calculated from apical four chamber views with the reference point set at QRS using 2D-STE before and after WDI. LA expansion index, strain and strain rate during ventricular systole represent LA reservoir function. Passive emptying fraction, strain and strain rate during early ventricular diastole represent LA conduit function. RESULTS: Mean age was 76 ± 6.9 years with 60% males. There was significant improvement in conduit function (LA passive emptying fraction; post 28.6 (21.9-35.9) vs pre 21.0 (13.8-34.7), p = 0.032), reservoir function (LA expansion index; post 75.3 (52.3-98.0) vs pre 58.1 (37.8-85.2), p = 0.026), and booster function (LA active emptying fraction; post 13.3 (9.7-29.9) vs pre 12.6 (8.8-25.5), p = 0.04) by volumetric indices. No significant improvement was noted with strain indices in conduit function (SRe; post - 0.56 (0.43-0.93) vs pre - 0.58 (0.46-0.87); p = 0.518) and reservoir function (SRs; post + 0.58 (0.28-0.40) vs pre + 0.52 (0.35-0.86); p = 0.851). CONCLUSIONS: WDI resulted in discrepancy of volumetric and strain indices in LA function assessment.

National Trends, Gender, Management, and Outcomes of Patients Hospitalized for Myocarditis.

Myocarditis is a major cause of acute and chronic cardiomyopathy. Data on patient characteristics utilization of healthcare, and outcomes of myocarditis-related hospitalizations are limited. We sought to analyze the outcomes of patients hospitalized with myocarditis from a large diverse, multicentric, nationwide cohort using Nationwide Inpatient Sample database. A total of 27,129 hospitalizations involving adult patients (age ≥ 18 years) with the primary discharge diagnosis of myocarditis from years 2007 through 2014 were included and patients who had diagnosis of myocardial infarction or coronary syndromes (including unstable angina) during the same hospitalization were excluded. More men were hospitalized compared with women (66% vs 34%, p <0.05). Patients hospitalized were young with a mean age of 37.3 ± 18.8 years with women being older compared with men (45.2 ± 20.9 vs 33.2 ± 16.2, p <0.001). In-hospital complications of cardiogenic shock and ventricular fibrillation/cardiac arrest occurred in 6.5% and 2.5% of hospitalizations, respectively, with females being affected significantly more than males (10.2% vs 4.6%; 3.6% vs 2%, respectively, p <0.001 for both comparisons). A total of 640 (2.4%) patients died during index hospitalization. Mortality was significantly higher in females compared with males (3.5% vs 1.8%; p <0.001). Multiple logistic regression analysis demonstrated female gender as an independent predictor of in-hospital mortality (odds ratio: 1.69, 95% confidence interval: 1.1 to 2.6; p = 0.007). In conclusion, myocarditis-related hospitalizations have increased during the study years and mostly affect young population with no significant co-morbidities. Female gender remains at high risk for myocarditis-related complications and in-hospital mortality.

Percutaneous ventricular assist device in ventricular tachycardia ablation: a systematic review and meta-analysis.

BACKGROUND: There is a lack of compelling data regarding the benefit of percutaneous ventricular assist devices (PVAD) in patients undergoing ventricular tachycardia (VT) ablation. The study aims to conduct a meta-analysis comparing the safety and efficacy of PVAD versus no-PVAD (N-PVAD) during VT ablation. METHODS: Studies meeting criteria were systematically reviewed. Baseline characteristics and clinical outcomes were extracted and analyzed. A meta-analysis was performed using random-effects model to calculate risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI). RESULTS: The meta-analysis included five retrospective, observational studies consisting of 2026 patients (PVAD group-284 patients versus N-PVAD group-1742 patients). The PVAD group was sicker with significantly higher VT storm, lower LVEF and greater proportion of NYHA class ≥ III than N-PVAD (p < 0.050). The acute procedural success [RR 0.95, 95% CI, (0.89-1.00), p = 0.070], VT recurrence [RR 0.94, 95% CI, (0.66-1.34), p = 0.740] and mortality [RR 1.28, 95% CI, (0.43-3.83), p = 0.660] were similar on follow-up between PVAD versus N-PVAD. PVAD group also had significantly higher complications [RR 1.83, 95% CI (1.21-2.76), p = 0.004] and longer fluoroscopy [MD + 7.31 min, 95% CI (0.91-13.71), p = 0.030] and procedure time [MD + 71.41 min, 95% CI (31.67-111.14), p < 0.001] than N-PVAD. CONCLUSION: Patients receiving PVAD support during VT ablation were sicker with no significant difference in acute procedural success, VT recurrence, and mortality compared with N-PVAD. PVAD support was also associated with higher complications and longer fluoroscopy and procedure time. A prospective randomized controlled trial will identify if using PVAD support in unstable patients undergoing VT ablation will impact clinical outcomes.

Dofetilide Initiation and Implications of Deviation From the Standard Protocol - A Real World Experience.

BACKGROUND: Manufacturer/federal drug administration (FDA) recommends inpatient initiation of dofetilide with the manufacturer providing an initiation algorithm. The outcomes of algorithm deviation have not been reported outside of clinical trials. OBJECTIVE: We sought to perform a chart review of all the patients admitted for inpatient initiation of dofetilide to report on the incidence of protocol deviations and their implications. METHODS: We performed a retrospective review of all patients over a 15-month periodwho were initiated on dofetilide for the very first time or reinitiated on dofetilide after a break of three months or more at our institution. We assessed data about patients who were given dofetilide without adherence to the protocol (i.e. protocol deviation). RESULTS: A total of 189 patients were included in the study with a median age of 66 ± 9 years. Mean baseline QTc interval was 436 ± 32 msec, and 61% (116/189) were in atrial fibrillation (AF) at the time of dofetilide initiation. In 9% (17/189) of patients, the drug was discontinued due to intolerance or inefficacy. Therapy in 49% (93/189) of patients was noted to deviate from manufacturer recommended protocol with deviations more than once in some patients during the same hospitalization. Baseline QTc exceeding 440 msec(>500msec in conduction abnormalities) was the most frequent deviation (25%; 47/189).Ventricular tachyarrhythmia occurred in 4% (7/189) of patients, did not differ between patients, and occurred with and without protocol deviations (5% vs 2%; p = 0.27). CONCLUSIONS: In our retrospective study, there were frequent deviations from the manufacturer-recommended algorithm guidelines for dofetilideinitation, primarily due to prolonged baseline QTc interval. The impact of these protocol deviations on drug discontinuation was uncertain; however, significant adverse events were higher in the deviation group compared to the group that fully adhered to the protocol. Further multicenter studies are warranted to clarify our findings.

Assessment of DNA Damage After Ionizing Radiation Exposure in Patients Undergoing Cardiac Resynchronization Therapy Device Implantation or Atrial Fibrillation Ablation (The RADAR Study).

BACKGROUND: There is limited data regarding effect of prolonged radiation exposure during electrophysiological (EP) procedures on direct DNA damage. Comet test has shown to assess DNA damage following radiation exposure. METHODS: We performed a single-center prospective observational study assessing direct DNA damage using the quantitative comet assay in patients undergoing cardiac resynchronization (CRT) and atrial fibrillation (AF) catheter ablation procedures. Venous comet assay was performed pre, immediately post procedure and at 3-month duration in twenty-two (N=22) patients who underwent catheter ablation for symptomatic AF and fourteen (N=14) patients who underwent CRT implantation. RESULTS: The median [interquartile range (IQR)] fluoroscopy time, radiation dose and dose area product (DAP) were 34.3 (27.97 - 45.48) minutes, 853.07 (611.36 - 1334.76) mGy and 16,994.10 (9,023.65 - 58,845.00) UGym2 in the ablation group and 30.05 (18.75 - 37.33) minutes, 345.00 (165.09 - 924.79) mGy and 11,837.20 [7182.67 - 35567.75] UGym2 in the CRT group. When compared with pre-procedure, there was a statistically significant increase in median (IQR) DNA migration on comet assay in the ablation group immediately post procedure [+6.55 µm (0.78, 10.25, p=0.02)] that subsequently decreased at 3 months [-1.00 µm (-2.20, 0.78), p=0.03] but not in the CRT group. CONCLUSION: There was a significant increase in DNA damage as detected by comet assay immediately post procedure that normalized at 3 months in patients undergoing AF ablation. Further large prospective studies are warranted to evaluate the impact of this prolonged radiation exposure and DNA damage on long-term follow up.

National Trends and Procedural Complications from Endomyocardial Biopsy: Results from the National Inpatient Sample, 2007-2014.

AIM: The aim of this study is to report recent trends in the performance of endomyocardial biopsy (EMB) and its in-hospital complications (and their predictors) in the United States (US). METHOD: We analyzed Nationwide Inpatient Sample (NIS) database from years 2007 through 2014 to identify patients who underwent EMB. Once identified, the patients were subdivided into those with no history of heart transplant (HT) (cohort 1) and those with history of HT (cohort 2). We then studied the major complication of pericardial effusion, hemopericardium or/and cardiac tamponade that required a pericardiocentesis or a pericardial window (CTRPD) following the EMB procedure. RESULTS: We observed a steady increase in the in-patient EMB procedures, with more EMB procedures being performed in males and in Caucasians. In cohort 1, the CTRPD was higher (0.70%) as compared to cohort 2 (0.19; p = 0.01). CTRPD in women was higher compared to men (0.94 vs. 0.53% p = 0.022). Most of the EMB procedures are performed in teaching hospitals. The CTRPD rate was significantly higher in the nonteaching hospitals when compared to teaching hospitals in both cohort 1 and cohort 2 (3.4 vs. 0.53% and 1 vs.0.18%, respectively; p = 0.01 and < 0.001, respectively). The overall mortality in cohort 1 was 4.3% as compared to 2.5% in cohort 2; p = 0.01. In cohort 1, the mortality was significantly higher in the group that had EMB-related complications versus the group without the complications (20 vs. 2.5%; p < 0.001). CONCLUSION: There has been an increase in the number of EMB procedures in the US in recent years. Though the overall risk of CTRPD is very low, the risk is significantly higher in cohort 1, women, and in nonteaching hospitals. The study results provide data benchmarks for assessing EMB outcomes in the US.

Long term outcomes after left atrial appendage closure with the LARIAT device-Stroke risk reduction over five years follow-up.

INTRODUCTION: Left atrial appendage closure (LAAC) with LARIAT offers an alternative to oral anticoagulation (OAC) for patients with atrial fibrillation. The aim of this study was to present long-term clinical outcomes of LAAC in these patients (AF). MATERIAL AND METHODS: A prospective, single-center study was performed in 139 patients undergoing LAAC with Lariat. Thromboembolic events, severe bleeding and mortality rate were recorded. The reduction in risk of thromboembolism and bleeding after LAAC was calculated. RESULTS: The mean CHADS2-score was 1.8 ± 1.0, mean CHA2DS2-VASc score was 2.9 ± 1.6 and HAS-BLED score was 3.1 ± 1.1. After 428.4 patient-years of follow-up (mean 4.2±1.0 years), the thromboembolism rate was 0.6% with a calculated thromboembolism risk reduction of 81%. The severe bleeding rate was 0.8%; calculated bleeding risk reduction was 78%. The overall mortality rate was 1.6%. CONCLUSIONS: Long-term outcomes show that LAAC with Lariat is a safe and effective treatment for stroke prevention and bleeding risk reduction in AF patients with a high level of underlying risk.

Acute Coronary Syndromes in Heart Transplant Recipients (from a National Database Analysis).

With an expanding and aging heart transplant population, the incidence of acute coronary syndromes (ACS) is expected to increase. Our study aims to report current trends in in-hospital management and outcomes in heart transplant recipients presenting with ACS. We conducted an analysis of the National Inpatient Sample (2007 to 2014) to study the trends in hospitalization, in-hospital management, and outcomes in heart transplant recipients with a primary diagnosis of ACS. We included patients with ST elevation myocardial infarction (STEMI), non-STEMI (NSTEMI) and those with unstable angina pectoris (UAP). A total of 1,621 ACS (NSTEMI/UAP-76% vs STEMI-24%) hospitalizations were identified. Despite 1,327 (81%) of patients who underwent left heart catheterization, coronary revascularization was performed in only 576 patients (36%). Mortality was significantly higher in patients presenting with STEMI versus NSTEMI/UAP (28% vs 11%, respectively; p <0.05) and those who did not undergo revascularization (19% vs 7%; p <0.05). Cardiogenic shock (CS) was diagnosed in 14.5% patients. Mechanical circulatory support utilization was higher in CS group compared with non-CS group (69% vs 2.8%; p <0.05), as was in-hospital mortality (39% vs 10%; p <0.05). Repeat transplantation during the index hospitalization was done in 4.5% of ACS patients. In conclusion, in heart transplant recipients, ACS is associated with a high incidence of CS and in-hospital mortality. Aggressive treatment strategy that includes revascularization, mechanical circulatory support use (in those developing CS), and urgent retransplantation in suitable candidates seems to lead to better results than a more conservative strategy.

Epicardial Left Atrial Appendage Exclusion Reduces Blood Pressure in Patients With Atrial Fibrillation and Hypertension.

BACKGROUND: Percutaneous left atrial appendage exclusion (LAAE) has evolved as an alternative strategy for stroke prevention in atrial fibrillation (AF). Recent observational data have suggested that epicardial LAAE can have substantial impact on arrhythmia burden and hemodynamic profile. OBJECTIVES: The authors aimed to study the impact of epicardial versus endocardial LAAE on systemic blood pressure in hypertensive AF patients. METHODS: This was a prospective, nonrandomized study comparing 247 patients who underwent epicardial LAAE with 124 patients with endocardial exclusion. Clinical outcomes were measured at 3 months and 1 year. Primary outcome was improvement in systolic blood pressure (SBP) between both groups compared with baseline. Secondary outcome included changes in diastolic pressures (DBP), serum electrolytes, and creatinine. RESULTS: There was no significant difference in baseline SBP between epicardial and endocardial groups. SBP was significantly lower in the epicardial group both at 3 months (122 ± 11.8 mm Hg vs. 129.7 ± 8.2 mm Hg; p < 0.001) and 1 year (123 ± 11.6 mm Hg vs. 132.2 ± 8.8 mm Hg; p < 0.001) compared with the endocardial group. An adjusted multivariate linear mixed effects model demonstrated that epicardial LAAE significantly decreased SBP by 7.4 mm Hg at 3 months and by 8.9 mm Hg at 1 year (p < 0.0001). There was a trend toward lower DBP with epicardial LAAE at 3 months by 1.3 mm Hg (p = 0.2) and at 1 year by 1.8 mm Hg (p = 0.09). There was no significant difference in serum electrolytes and creatinine between both groups. CONCLUSIONS: In hypertensive AF patients, epicardial LAAE significantly decreases SBP both at 3 and 12 months compared with endocardial exclusion.

Midterm outcomes of transmyocardial laser revascularization with intramyocardial injection of adipose derived stromal cells for severe refractory angina.

INTRODUCTION: Refractory angina has limited effective therapeutic options and often contributes to frequent hospitalizations, morbidity and impaired quality of life. AIM: We sought to examine midterm results of a bio-interventional therapy combining transmyocardial laser revascularization (TMLR) and intramyocardial injection of adipose derived stem cells (ADSC) in patients with refractory angina not amenable to percutaneous or surgical revascularization. MATERIAL AND METHODS: We included 15 patients with severe refractory angina and anterior wall ischemia who were ineligible for revascularization strategies. Adipose tissue was harvested and purified, giving the stem cell concentrate. All patients underwent left anterior thoracotomy and TMLR using a low-powered holmium : yttrium-aluminum-garnet laser and intramyocardial injection of ADSC using a combined delivery system. RESULTS: No deaths or major adverse cardiovascular or cerebrovascular events were observed in the 6-month follow-up. Mean ejection fraction increased from 35% to 38%, and mean Canadian Cardiovascular Society Angina Score decreased from 3.2 to 1.4, with decreased necessity of nitrate usage. Seventy-three percent of patients reported health improvement particularly regarding general health and bodily pain. Improvement in endocardial movement, myocardial thickening and stroke volume index (35.26 to 46.23 ml/m2) on cardiac magnetic resonance imaging (MRI) was observed in 3 patients who had repeat CMR imaging after 6 months. CONCLUSIONS: Our study suggested that interventional therapy combining TMLR with intramyocardial implantation of ADSC may reduce symptoms and improve quality of life in patients with refractory angina. These early findings need further validation in large scale randomized controlled trials.

Prophylactic catheter ablation of ventricular tachycardia in ischemic cardiomyopathy: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Catheter ablation is proven to be an effective strategy for drug refractory ventricular tachycardia (VT) in ischemic cardiomyopathy. However, the appropriate timing of VT ablation and identifying the group of patients that may receive the greatest benefit remains uncertain. There is limited data on the effect on prophylactic catheter ablation (PCA) in the prevention of implantable cardioverter defibrillator (ICD) therapy, electrical storm, and mortality. METHODS: We performed a comprehensive literature search through November 1, 2017, for all eligible studies comparing PCA + ICD versus ICD only in eligible patients with ischemic cardiomyopathy. Clinical outcomes included all ICD therapies including ICD shocks and electrical storm. Additional outcomes included all-cause mortality, cardiovascular mortality, and complications. RESULTS: Three randomized controlled trials (RCTs) (N = 346) met inclusion criteria. PCA was associated with a significantly lower ICD therapies (OR 0.49; CI 0.28 to 0.87; p = 0.01) including ICD shocks [OR 0.38; CI 0.22 to 0.64; p = 0.0003) and electrical storm (OR 0.55; CI 0.30 to 1.01; p = 0.05) when compared with ICD only. There was no significant difference in all-cause mortality (OR 0.77; CI 0.41 to 1.46; p = 0.42), cardiovascular mortality (OR 0.49; CI 0.16 to 1.50; p = 0.21), and major adverse events (OR 1.45; CI 0.52 to 4.01; p = 0.47) between two groups. CONCLUSION: These results suggest prophylactic catheter ablation decreases ICD therapies, including shocks and electrical storm with no improvement in overall mortality. There is a need for future carefully designed randomized clinical trials.

Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation: The DEFLECT GUT study.

BACKGROUND: Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. OBJECTIVE: The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. METHODS: We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180). RESULTS: Mean deviation of trailing edge of esophagus with EsoSure was 2.45 ± 0.9 cm (range 1-4.5). LET rise >1°C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 ± 0.59 vs non-ED 1.66 ± 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. CONCLUSION: Mechanical displacement of the esophagus with EsoSure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.

Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. RESULTS: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. CONCLUSIONS: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.

Exercise induced complete atrioventricular block: Utility of exercise stress test.

Exercise induced complete atrioventricular block (EIAVB) is a relatively uncommon condition. This phenomenon is clinically important because it can mimic symptoms of other cardiovascular conditions and may be associated with exercise intolerance and subsequent syncope. A 76year old man with long-standing hypertension and diabetes mellitus presented with recurrent episodes of lightheadedness and syncope with physical activity. ECG showed sinus rhythm with first degree atrioventricular block. Echocardiography did not show any valvular disease causing his symptoms. Coronoary angiographic evaluation revealed non-obstructive coronary artery disease. Because of the exertional nature of his symptoms, a symptom-limited treadmill exercise test was performed which revealed EIAVB. A permanent dual chamber pacemaker was implanted and his symptoms resolved completely.