Faculty Bibliography
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Journal of thoracic & cardiovascular surgery. 2020:159(6):2230-2240.e15.DOI: 10.1016/j.jtcvs.2019.06.040
Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation
OBJECTIVE:The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. METHODS:We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. RESULTS:In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. CONCLUSIONS:The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.
PMID: 31375378
ISSN: 1097-685x
CID: 5451272
Comorbid Conditions and Health-Related Quality of Life in Ambulatory Heart Failure Patients: REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life REVIVAL)
BACKGROUND:Patients with heart failure (HF) often have multiple chronic conditions that may impact health-related quality of life (HRQOL) despite HF therapy. We sought to determine the association between noncardiac comorbidities and HRQOL in ambulatory patients with advanced HF. METHODS:Baseline data from 373 subjects in REVIVAL (Registry Evaluation of Vital Information for Ventricular Assist Devices in Ambulatory Life) were analyzed using multivariable general linear models to evaluate the relationship between comorbidities and HRQOL (EuroQol Visual Analogue Scale, EQ-5D-3L Index Score, and Kansas City Cardiomyopathy Questionnaire). The primary independent variables were a comorbidity index (sum of 14 noncardiac conditions), a residual comorbidity index (without depression), and depression alone. The median (25th to 75th percentile) number of comorbidities was 3 (2-4). RESULTS:=0.001) HRQOL. The residual comorbidity index was not associated with HRQOL when depression included in the model independently, while depression was associated with HRQOL across all measures. Participants with depression (versus without) scored on average 13 points (95% CI, 8-17) lower on the EuroQol Visual Analogue Scale, 0.15 points (95% CI, 0.12-0.18) lower on the EQ-5D Index, and 24.9 points (95% CI, 21.2-28.5) lower on the Kansas City Cardiomyopathy Questionnaire overall summary score. CONCLUSIONS:While noncardiac comorbidities were prevalent in ambulatory advanced HF patients, only depression was associated with decreased generic and HF-specific HRQOL. Other than depression, the presence of noncardiac comorbidities should not impact expected gains in HRQOL following ventricular assist device implantation, provided the conditions are not a contraindication to implant. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01369407.
PMID: 32418478
ISSN: 1941-3297
CID: 4443672
PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure: Results of the PRIME-HF Trial
BACKGROUND:Ivabradine is guideline-recommended to reduce heart failure (HF) hospitalization in patients with stable chronic HF with reduced ejection fraction (EF). Ivabradine initiation following acute HF has had limited evaluation, and there are few randomized data in US patients. The PredischaRge initiation of Ivabradine in the ManagEment of Heart Failure (PRIME-HF) study was conducted to address predischarge ivabradine initiation in stabilized acute HF patients. METHODS:PRIME-HF was an investigator-initiated, randomized, open-label study of predischarge initiation of ivabradine versus usual care. Eligible patients were hospitalized for acute HF but stabilized, with EF ≤35%, on maximally tolerated β-blocker and in sinus rhythm with heart rate ≥70 beats/min. Ivabradine was acquired per routine care. The primary end point was the proportion of patients on ivabradine at 180 days. Additional end points included heart rate change, patient-reported outcomes, β-blocker use/dose, and safety events (symptomatic bradycardia and hypotension). RESULTS:Overall, 104 patients (36% women, 64% African American) were randomized, and the study was terminated early because of funding limitations. At 180 days, 21 of 52 (40.4%) of patients randomized to predischarge initiation were treated with ivabradine compared with 6 of 52 (11.5%) randomized to usual care (odds ratio 5.19, 95% CI 1.88-14.33, P = .002). The predischarge initiation group experienced greater reduction in heart rate through 180 days (mean -10.0 beats/min, 95% CI -15.7 to -4.3 vs 0.7 beats/min, 95% CI -5.4 to 6.7, P = .011). Patient-reported outcomes, β-blocker use/dose, and safety events were similar (all P > .05). CONCLUSIONS:Ivabradine initiation prior to discharge among stabilized HF patients increased ivabradine use at 180 days and lowered heart rates without reducing β-blockers or increasing adverse events. As the trial did not achieve the planned enrollment, additional studies are needed.
PMID: 32217365
ISSN: 1097-6744
CID: 4777862
Clinical Characteristics of Hospitalized Covid-19 Patients in New York City
Background/UNASSIGNED:The coronavirus 2019 (Covid-19) pandemic is a global public health crisis, with over 1.6 million cases and 95,000 deaths worldwide. Data are needed regarding the clinical course of hospitalized patients, particularly in the United States. Methods/UNASSIGNED:Demographic, clinical, and outcomes data for patients admitted to five Mount Sinai Health System hospitals with confirmed Covid-19 between February 27 and April 2, 2020 were identified through institutional electronic health records. We conducted a descriptive study of patients who had in-hospital mortality or were discharged alive. Results/UNASSIGNED:, 1,121 (51%) patients remained hospitalized, and 1,078 (49%) completed their hospital course. Of the latter, the overall mortality was 29%, and 36% required intensive care. The median age was 65 years overall and 75 years in those who died. Pre-existing conditions were present in 65% of those who died and 46% of those discharged. In those who died, the admission median lymphocyte percentage was 11.7%, D-dimer was 2.4 ug/ml, C-reactive protein was 162 mg/L, and procalcitonin was 0.44 ng/mL. In those discharged, the admission median lymphocyte percentage was 16.6%, D-dimer was 0.93 ug/ml, C-reactive protein was 79 mg/L, and procalcitonin was 0.09 ng/mL. Conclusions/UNASSIGNED:This is the largest and most diverse case series of hospitalized patients with Covid-19 in the United States to date. Requirement of intensive care and mortality were high. Patients who died typically had pre-existing conditions and severe perturbations in inflammatory markers.
PMCID:7277011
PMID: 32511655
ISSN: n/a
CID: 5193892
Impact of Socioeconomic Factors on Patient Desire for Early LVAD Therapy Prior to Inotrope Dependence
BACKGROUND:Worsening heart failure (HF) and health-related quality of life (HRQOL) have been shown to impact the decision to proceed with left ventricular assist device (LVAD) implantation, but little is known about how socioeconomic factors influence expressed patient preference for LVAD. METHODS AND RESULTS/RESULTS:Ambulatory patients with advanced systolic HF (n=353) reviewed written information about LVAD therapy and completed a brief survey to indicate whether they would want an LVAD to treat their current level of HF. Ordinal logistic regression analyses identified clinical and demographic predictors of LVAD preference. Higher NYHA class, worse HRQOL measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), lower education level, and lower income were significant univariable predictors of patients wanting an LVAD. In the multivariable model, higher NYHA class (OR 1.43, CI 1.08 - 1.90, p=0.013) and lower income level (OR 2.10, CI 1.18 - 3.76, p=0.012 for <$40,000 vs. >$80,000) remained significantly associated with wanting an LVAD. CONCLUSION/CONCLUSIONS:Among ambulatory patients with advanced systolic HF, treatment preference for LVAD was influenced by level of income independent of HF severity. Understanding the impact of socioeconomic factors on willingness to consider LVAD therapy may help tailor counseling towards individual needs.
PMID: 31809791
ISSN: 1532-8414
CID: 4219112
Fulminant Versus Acute Nonfulminant Myocarditis in Patients With Left Ventricular Systolic Dysfunction
BACKGROUND:Fulminant myocarditis (FM) is a form of acute myocarditis characterized by severe left ventricular systolic dysfunction requiring inotropes and/or mechanical circulatory support. A single-center study found that a patient with FM had better outcomes than those with acute nonfulminant myocarditis (NFM) presenting with left ventricular systolic dysfunction, but otherwise hemodynamically stable. This was recently challenged, so disagreement still exists. OBJECTIVES/OBJECTIVE:This study sought to provide additional evidence on the outcome of FM and to ascertain whether patient stratification based on the main histologic subtypes can provide additional prognostic information. METHODS:A total of 220 patients (median age 42 years, 46.3% female) with histologically proven acute myocarditis (onset of symptoms <30 days) all presenting with left ventricular systolic dysfunction were included in a retrospective, international registry comprising 16 tertiary hospitals in the United States, Europe, and Japan. The main endpoint was the occurrence of cardiac death or heart transplantation within 60 days from admission and at long-term follow-up. RESULTS:Patients with FM (n = 165) had significantly higher rates of cardiac death and heart transplantation compared with those with NFM (n = 55), both at 60 days (28.0% vs. 1.8%, p = 0.0001) and at 7-year follow-up (47.7% vs. 10.4%, p < 0.0001). Using Cox multivariate analysis, the histologic subtype emerged as a further variable affecting the outcome in FM patients, with giant cell myocarditis having a significantly worse prognosis compared with eosinophilic and lymphocytic myocarditis. In a subanalysis including only adults with lymphocytic myocarditis, the main endpoints occurred more frequently in FM compared with in NFM both at 60 days (19.5% vs. 0%, p = 0.005) and at 7-year follow up (41.4% vs. 3.1%, p = 0.0004). CONCLUSIONS:This international registry confirms that patients with FM have higher rates of cardiac death and heart transplantation both in the short- and long-term compared with patients with NFM. Furthermore, we provide evidence that the histologic subtype of FM carries independent prognostic value, highlighting the need for timely endomyocardial biopsy in this condition.
PMID: 31319912
ISSN: 1558-3597
CID: 4016042
Effects of Induction on the Risk of Post-Transplant De Novo DSA [Meeting Abstract]
Purpose: Nearly 30% of heart transplant recipients develop de novo donor-specific antibodies post-transplant, leading to an increased risk of antibody mediated rejection, graft failure, and death. Given poor response rates to therapies targeting dnDSA once present, therapies preventing dnDSA altogether could impact transplant outcomes. It remains unclear if the use of induction therapy at the time of transplant mitigates the risk of dnDSA development. The present study attempts to address this question in a multicenter, retrospective analysis. Method(s): Multicenter, retrospective analysis of 319 heart transplant recipients from 4 participating centers in the U.S. The primary endpoint was the development of dnDSA. Result(s): In the overall cohort, 206 of 319 (65%) patients received induction therapy at the time of transplant, with 200 (62%) receiving basiliximab and 6 (3%) receiving thymoglobulin. Overall 93 of 319 (29%) patients developed dnDSA post-transplant. The use of induction therapy reduced the risk of dnDSA (Kaplan Meier log rank p = 0.009, Figure 1). When assessing induction type, basiliximab reduced the risk of dnDSA compared to no induction, whereas thyroglobulin did not (Figure 2). However, in a multivariable Cox Regression model incorporating the use of an LVAD as BTT, the use of any induction was no longer statistically significant. Conclusion(s): Although induction therapy, particularly with basiliximab, reduces the risk of dnDSA post-heart transplant in univariate analysis, this effect is no longer significant in a model incorporating LVAD as BTT.
EMBASE:2001695836
ISSN: 1053-2498
CID: 3794482
Risk of dnDSA with Various MCS Devices as Bridge-to-Transplant [Meeting Abstract]
Purpose: Previous reports have suggested an association between pre-transplant mechanical circulatory support (MCS) and an increased risk for post-transplant de novo donor specific antibodies (dnDSA). However, it is unclear if specific MCS devices pose a greater risk for dnDSA. The present study seeks to better understand the risk of dnDSA posed by a variety of MCS devices in a multicenter, collaborative study. Method(s): Multicenter, retrospective analysis of 319 heart transplant recipients from 4 U.S. centers between 2011 - 2017. The primary outcome was the development of post-transplant dnDSA. Result(s): 145 of 319 (45%) patients were supported with durable MCS devices prior to transplant, including 47 Heartware (HVAD), 73 Heartmate II (HM2), and 25 total artificial hearts (TAH). MCS patients had a higher risk of dnDSA compared to those transplanted without mechanical support (37% vs. 23%, p = 0.006; Kaplan Meier log rank p < 0.001, Figure 1). No significant differences were seen between the devices in the risk of dnDSA (Heartware 36%, Heartmate II 38%, and TAH 32%, p = 0.848). However, when compared to patients transplanted without MCS support, patients bridged with HVAD and HM2 devices had higher risk for dnDSA, whereas no difference was seen between TAH to no MCS (Figure 2). Conclusion(s): Pre-transplant MCS is associated with higher risk for dnDSA. Similar risk is seen regardless of device type; however, the risk associated with TAH was not significantly increased compared to no MCS.
EMBASE:2001695765
ISSN: 1053-2498
CID: 3794492
Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial
AIMS:Obesity is present in up to 45% of patients with heart failure (HF). Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, facilitates weight loss in obese patients. The efficacy of liraglutide as a weight loss agent among patients with HF and reduced ejection fraction (HFrEF) and a recent acute HF hospitalization remains unknown. METHODS AND RESULTS:The Functional Impact of GLP-1 for Heart Failure Treatment study randomized 300 patients with HFrEF (ejection fraction ≤ 40%), both with and without diabetes and a recent HF hospitalization to liraglutide or placebo. The primary outcome for this post hoc analysis was the change in weight from baseline to last study visit. We conducted an 'on-treatment' analysis of patients with at least one follow-up visit on study drug (123 on liraglutide and 124 on placebo). The median age was 61 years, 21% were female, and 69% of patients had New York Heart Association functional Class III or IV symptoms. The median ejection fraction was 25% (25th, 75th percentile 19-32%). Liraglutide use was associated with a significant weight reduction [liraglutide -1.00 lbs vs. placebo 2.00 lbs; treatment difference -4.10 lbs; 95% confidence interval (CI) -7.94, -0.25; P = 0.0367; percentage treatment difference -2.07%, 95% CI -3.86, -0.28; P = 0.0237]. Similar results were seen after multivariable adjustments. Liraglutide also significantly reduced triglyceride levels (liraglutide 7.5 mg/dL vs. placebo 12.0 mg/dL; treatment difference -33.1 mg/dL; 95% CI -60.7, -5.6; P = 0.019). CONCLUSIONS:Liraglutide is an efficacious weight loss agent in patients with HFrEF. These findings will require further exploration in a well-powered cardiovascular outcomes trial.
PMCID:6300815
PMID: 30120812
ISSN: 2055-5822
CID: 3688982
Right Ventricular Dysfunction in Acute Myocardial Infarction Complicated by Cardiogenic Shock: a Hemodynamic Analysis of the SHould We Emergently Revascularize Occluded Coronaries for Cardiogenic shocK (SHOCK) Trial and Registry
BACKGROUND: The prevalence and significance of right ventricular dysfunction (RVD) in patients with cardiogenic shock due to acute myocardial infarction (AMI-CS) has not been well characterized. We hypothesized that RVD is common in AMI-CS and associated with worse clinical outcomes. METHODS AND RESULTS: We retrospectively analyzed patients with available hemodynamics enrolled in the SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK (SHOCK) Trial (n=139) and Registry (n=258) to identify RVD in AMI-CS. RVD was defined by an elevated central venous pressure (CVP), elevated CVP/ pulmonary capillary wedge pressure (PCWP) ratio, decreased pulmonary artery pulsatility index (PAPi), and decreased right ventricular stroke work index (RVSWI). A p value of less than 0.01 was used to infer significance. In both the SHOCK trial and registry, 38% and 37% of patients had RVD, however RVD was not associated with 30-day or 6-month survival (HR 1.51 (0.92, 2.49) p=0.10). RV failure using inclusion criteria from the Recover Right Trial for RV failure (RR-RVF) requiring percutaneous mechanical circulatory support included an elevated CVP, CVP/PCWP ratio, and a low cardiac index despite >/=1 inotrope or vasopressor. In both the SHOCK trial and registry, 45% (n=63/139) and 38% (n=98/258) of patients met RR-RVF criteria respectively. The RR-RVF criteria were not significantly associated with 30-day mortality in the registry cohort (HR 1.44 (1.01,2.04), p=0.04), or in the trial cohort (HR 1.51(0.92,2.49), p=0.10). CONCLUSIONS: Hemodynamically defined RVD is common in AMI-CS. Routine assessment with PA catherization allows detection of RVD; however, further work is needed to identify interventions that will result in improved outcomes for these patients.
PMID: 29032225
ISSN: 1532-8414
CID: 2743242
