Previous studies of the association between acute cellular rejection and cardiac allograft vasculopathy (CAV) have yielded conflicting conclusions. We explored a possible association between acute ...cellular rejection and the extent of CAV, and we found a potential confounding variable that may obscure such an association.
We investigated 140 patients (mean age, 51 ± 11 years) who underwent serial intravascular ultrasound examinations at baseline and at 1 year after heart transplantation to assess CAV as change in maximal intimal thickness (CMIT). Patients were classified according to the presence or absence of biopsy-proven myocardial fibrosis. We used a standard biopsy-scoring system and a novel biopsy-scoring system, developed in our institution, to assess acute cellular rejection. Using univariate analysis, we found that CMIT was not associated with acute cellular rejection in the overall patient population (
n = 140). However, we observed a correlation between CMIT and acute cellular rejection (standard method,
r = 0.30,
p = 0.01; novel method,
r = 0.51,
p < 0.0001) in patients who had no evidence of ischemic injury or fibrosis in their biopsy specimens (
n = 57). Step-wise multiple regression showed that the rejection score derived from our novel method was associated more closely with the CMIT than was that derived from the traditional method.
This data indicate that the presence of myocardial fibrosis masks an actuarial association between acute cellular rejection and the development of de novo allograft vasculopathy. As previously suspected, myocardial fibrosis is a marker for non–immune-mediated graft injury independently associated with an increased incidence of CAV.
The study was done to prospectively measure the echocardiographic, hemodynamic and clinical outcomes after partial left ventriculectomy (PLV).
Although PLV can improve symptoms of advanced heart ...failure, immediate postoperative echocardiographic findings remain abnormal.
Fifty-nine patients with cardiomyopathy and advanced heart failure underwent PLV and concomitant mitral valve surgery between May 1996 and December 1997. Thirty-nine percent were on inotropic therapy. All were New York Heart Association (NYHA) functional class III or IV. Mechanical circulatory support (LVAD) and transplant were provided for rescue therapy when hemodynamic compromise occurred. Patients were followed for a mean of 405+/-168 days, and clinical, echocardiographic and hemodynamic measures were obtained preoperatively, immediately postoperatively, and at 3 and 12 months prospectively.
Comparing preoperative and 12-month postoperative values in event-free survivors, we found: NYHA functional class improved from 3.6 to 2.1, p < 0.0001; peak oxygen consumption increased from 10.8 to 16.0 ml/kg/min, p < 0.0001; LV ejection fraction increased from 13+/-6.0% to 24+/-6.9%, p < 0.0001; LV end diastolic diameter decreased from 8.2+/-1.03 to 6.2+/-0.64 cm, p < 0.0001, and volume was reduced from 167+/-60 to 105+/-38 ml/m2, p = 0.02. Central hemodynamics did not normalize after surgery.
Partial left ventriculectomy can provide structural remodeling of the heart that may result in temporary improvement in clinical compensation. However, perioperative failures and the return of heart failure limit the propriety of this procedure.
Objectives The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial ...setting are comparable to other available devices for the same indication. Background After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. Methods The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device Thoratec Corporation) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. Results Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. Conclusions The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.
Abstract Objectives This study sought to determine the relationship of KIM-1 levels with adverse clinical outcomes in acute decompensated heart failure (ADHF). Background Kidney injury molecule ...(KIM)-1 is a biomarker expressed by the nephron in acute tubular injury, and is a sensitive and specific marker for early acute kidney injury. Although commonly measured in urine, KIM-1 levels are also detectable in plasma, but its clinical and prognostic utility in ADHF is unknown. Methods Baseline, 48- to 72-h, and 30-day KIM-1 plasma levels were measured in 874 subjects in the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial. Multivariable logistic and Cox models were used to assess the relationship between KIM-1 levels and outcomes during and after ADHF. Results The median circulating KIM-1 level at baseline was 375.4 pg/ml (interquartile range IQR: 237.0 to 633.1 pg/ml), at 48 to 72 h was 373.7 pg/ml (IQR: 220.3 to 640.5 pg/ml), and at 30 days was 382.6 pg/ml (IQR: 236.5 to 638.0 pg/ml). There were no associations between KIM-1 levels and any 30-day outcomes. In univariable analysis, both baseline and follow-up KIM-1 were associated with greater 180-day mortality risk. However, after adjusting for blood urea nitrogen or creatinine in addition to established risk predictors from ASCEND-HF, higher KIM-1 at all time points during hospitalization was not associated with in-hospital or post-discharge outcomes (all p > 0.05), but KIM-1 levels measured at 30 days were associated independently with 180-day mortality (hazard ratio: 1.49; p = 0.04). Conclusions In our study cohort, circulating KIM-1 at baseline and during hospitalization was not associated with adverse clinical outcomes in ADHF after adjusting for standard indices of kidney function.
A recent randomized clinical study established the safety of the angiotensin receptor-neprilysin inhibitor (ARNI), sacubitril-valsartan (S/V), in patients hospitalized with acute decompensated heart ...failure after achieving hemodynamic stability. Transitioning patients in cardiogenic shock managed with pulmonary artery catheters directly from intravenous vasoactive (i.e. vasodilators or inotropes) drugs to S/V represents a potentially novel use for ARNIs. The tolerability and hemodynamic characteristics of S/V in patients with cardiogenic shock has not been previously established.
A single-center, retrospective analysis of all patients with heart failure and a reduced ejection fraction (HFrEF) (EF <40%) who had been newly initiated on S/V in the cardiac intensive care units (CICUs) was performed. All patients had pulmonary artery catheters placed on admission to the CICU and at the time of S/V initiation. Baseline characteristics, co-morbidities, and laboratory values were collected. Hemodynamic data from pulmonary catheters was gathered both on admission to the CICU and post initiation of S/V. The tolerability, safety, and reasons for discontinuation was characterized through chart review.
Twenty-two patients in the CICUs with HFrEF were started on S/V. The baseline characteristics, pertinent lab values, and hemodynamic profile (CI, SVR), are presented (Image 1). Ninety-five percent (n=21) of patients were on either of sodium nitroprusside, milrinone, dobutamine, or a combination these agents, at the time of initiation. Seventy-seven percent (n=17/22) patients were discharged on S/V with improved hemodynamics (Image 1,2). Hypotension was the most common reason for discontinuation (n=4) however one patient had both acute kidney injury and hypotension (n=1); no patients had hyperkalemia or death (n=0) (Image 2). Two of five intolerant patients were initiated on moderate (49-51) dose S/V.
The novel use S/V as oral vasodilator therapy in patients with cardiogenic shock shows favorable hemodynamic impact and tolerability. Long term tolerability and outcomes are required.
With the current global pandemic, implementation of telemedicine transitional care programs has increased across healthcare systems. These programs are also important in the care of patients with ...chronic comorbidities such as advanced heart failure (HF), where novel cost-effective measures are increasingly sought to improve patient-related outcomes and healthcare utilization. This study explored the impact of tailored, telemedicine-based HF care coordination (HFCC) on 12-month survival and healthcare utilization after hospital discharge. We hypothesized that HFCC improves 12-month mortality and healthcare utilization.
Adults (n=1994) admitted with acute decompensated HF at our center from March 2015-December 2016 underwent HFCC (n=277) vs standard care only (non-HFCC, n=1717) for up to 30-days after hospital discharge. Cardiac nurse-led HFCC provided education, coaching, and coordination of medications and HF care needs. HFCC was delivered mainly by telemedicine supplemented with in-person visits as deemed necessary by routine care providers. Survival outcomes, emergency room (ER) visits, and hospital readmissions were evaluated within 12 months of discharge from index hospitalization.
The study cohort (mean age of 62 ± 15 years) was predominantly Caucasian males (both ≥68%), with a Charlson Comorbidity Index of 5 3, 5. The majority were discharged home (90% HFCC vs 84% non-HFCC, p=0.53). The HFCC cohort had a longer index hospital stay (7 5, 10 vs 5 3, 9 days, p<0.001). HFCC was associated with reduced ER visits (hazard ratio HR 0.59 95% CI 0.40, 0.74, p=0.00004) within 12-months post-discharge, but not hospital readmissions (HR 0.92 95% CI 0.76, 1.11, p=0.40). Overall, 26 patients (9.4%) and 153 patients (8.9%) died in the HFCC and non-HFCC cohorts, respectively (p=0.81). Survival time post-discharge was 334.2 vs 349.0 days in the HFCC vs non-HFCC cohort, respectively (p=0.82).
Telemedicine-based transitional care programs such as HFCC can significantly reduce the burden of ER visits during the first year after HF hospitalization. Our analysis did not reveal a benefit on subsequent hospitalization or mortality within 12-months post-discharge. Future studies are warranted to examine the impact of HFCC on guideline-directed medical therapies and additional long-term outcomes.
PIONEER-HF established the safety of the angiotensin receptor-neprilysin inhibitor (ARNI), sacubitril-valsartan (S/V), in patients hospitalized with acute decompensated heart failure after achieving ...hemodynamic stability. We have previously shown that transitioning patients in ADHF with low cardiac output directly from intravenous (IV) vasoactive (i.e. vasodilators or inotropes) drugs to ARNI can be done safely with tolerance to one-month follow-up. Here we further characterize the acute hemodynamic impact of ARNI therapy after patients have been optimized on IV vasoactive therapy.
A single-center, retrospective analysis of all patients with HFrEF (EF<40%) who had been newly initiated on ARNI therapy in the cardiac intensive care units (CICUs) was performed. Baseline characteristics, vasoactive therapy, dosing, and limited follow-up data is presented (Table 1a). Hemodynamic data were gathered and compared upon CICU admission, post optimization with IV vasoactive therapy, and at least 12 hours post initiation of ARNI therapy and weaned from IV therapy. Twenty-three patients with HFreF and cardiac index below 2.2 L/min/m2 were admitted to the CICU and were initiated on ARNIs. All patients who tolerated ARNI (n=18) were weaned off vasoactive medications prior to transfer out of CICU. Patients maintained their significant improvement in Cardiac Index and reduction in SVR/PVR on transition from IV inotropic and vasodilator therapy to oral ARNI (Table 1b, Fig 1a, 1c). There was no difference in PCWP or MAP between IV vasoactive and ARNI phases of care (Table 1b, Fig 1b). There was an increase in Pulmonary Artery Pulsatility index (PAPi) with ARNI therapy compared to the IV vasoactive phase of care (Table 1b, Fig 1d)
ICU patients can be successfully bridged from vasoactive IV therapy to oral ARNI with sustained improvement in cardiac index garnered from vasoactive agents. We also observed improvement in PAPI along with maintenance of LV/RV unloading with ARNI. These encouraging findings merit prospective validation of ARNI compared to more commonly used oral vasodilators in ICU care.
The HVAD Left Ventricular Assist Device Teuteberg, Jeffrey J., MD; Slaughter, Mark S., MD; Rogers, Joseph G., MD ...
JACC. Heart failure,
October 2015, Letnik:
3, Številka:
10
Journal Article
Recenzirano
Odprti dostop
Abstract Objectives The purpose of this study was to determine the risk factors for ischemic in hemorrhage cerebrovascular events in patients supported by the HeartWare ventricular assist device ...(HVAD). Background Patients supported with left ventricular assist devices are at risk for both ischemic and hemorrhagic cerebrovascular events. Methods Patients undergoing implantation with a HVAD as part of the bridge-to-transplant trial and subsequent continued access protocol were included. Neurological events (ischemic cerebrovascular accidents ICVAs and hemorrhagic cerebrovascular accidents HCVAs) were assessed, and the risk factors for these events were evaluated in a multivariable model. Results A total of 382 patients were included: 140 bridge-to-transplant patients from the ADVANCE (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) clinical trial and 242 patients from the continued access protocol. Patients had a mean age of 53.2 years; 71.2% were male, and 68.1% were white. Thirty-eight percent had ischemic heart disease, and the mean duration of support was 422.7 days. The overall prevalence of ICVA was 6.8% (26 of 382); for HCVA, it was 8.4% (32 of 382). Pump design modifications and a protocol-driven change in the antiplatelet therapy reduced the prevalence of ICVA from 6.3% (17 of 272) to 2.7% (3 of 110; p = 0.21) but had a negligible effect on the prevalence of HVCA (8.8% 24 of 272 vs. 6.4% 7 of 110; p = 0.69). Multivariable predictors of ICVA were aspirin ≤81 mg and atrial fibrillation; predictors of HCVA were mean arterial pressure >90 mm Hg, aspirin ≤81 mg, and an international normalized ratio >3.0. Eight of the 30 participating sites had established improved blood pressure management (IBPM) protocols. Although the prevalence of ICVA for those with and without IBPM protocols was similar (5.3% 6 of 114 vs. 5.2% 14 of 268; p = 0.99), those with IBPM protocols had a significantly lower prevalence of HCVA (1.8% 2 of 114 vs. 10.8% 29 of 268; p = 0.0078). Conclusions Anticoagulation, antiplatelet therapy, and blood pressure management affected the prevalence of cerebrovascular events after implantation of the HVAD. Attention to these clinical parameters can have a substantial impact on the occurrence of serious neurological events. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure ADVANCE; NCT00751972 )
Objectives The purpose of this study was to describe the long-term course of left ventricular remodeling induced by cardiac resynchronization therapy (CRT), adjusting for the confounding effect of ...patient loss due to disease. Background Reverse remodeling has been identified as the primary mechanism of improved symptoms and outcome in heart failure patients. Methods A total of 313 consecutive patients who underwent CRT with available baseline echocardiograms and subsequent clinical and echocardiographic follow-up were included in the analysis. Long-term follow-up included all-cause mortality, heart transplantation, and implantation of a left ventricular assist device. Longitudinal data analysis of left ventricular end-systolic volume index (LVESVi) was performed to adjust for the confounding effect of patient loss during follow-up. Results Patients with uneventful survival had a lower baseline LVESVi (Δ = 8.6 ml/m2 , SE = 4.6 ml/m2 , p < 0.0001) and a decreased LVESVi by −0.11 ml/m2 /day during first 6 months, whereas the LVESVi remained unchanged in patients with adverse events (p < 0.0001). Beyond 6 months, the LVESVi remained unchanged in patients with uneventful survival, whereas the LVESVi continued to increase in those with adverse events at a rate of 0.01 ml/m2 /day (p < 0.0001). Predictors of reverse remodeling were nonischemic etiology, female sex, and a wider QRS duration (p < 0.0001, p = 0.014, and p = 0.001, respectively). In the majority of patients, 6 months indicates a break point after which reverse remodeling becomes significantly less pronounced. Conclusions CRT patients with uneventful survival show a significant decrease in the LVSVi at 6 months and generally maintain this response in the long term. Those with adverse outcomes are characterized by left ventricular dilation despite CRT.
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