Patisiran Treatment in Patients with Transthyretin Cardiac Amyloidosis.

BACKGROUND: Transthyretin amyloidosis, also called ATTR amyloidosis, is associated with accumulation of ATTR amyloid deposits in the heart and commonly manifests as progressive cardiomyopathy. Patisiran, an RNA interference therapeutic agent, inhibits the production of hepatic transthyretin. METHODS: In this phase 3, double-blind, randomized trial, we assigned patients with hereditary, also known as variant, or wild-type ATTR cardiac amyloidosis, in a 1:1 ratio, to receive patisiran (0.3 mg per kilogram of body weight) or placebo once every 3 weeks for 12 months. A hierarchical procedure was used to test the primary and three secondary end points. The primary end point was the change from baseline in the distance covered on the 6-minute walk test at 12 months. The first secondary end point was the change from baseline to month 12 in the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score (with higher scores indicating better health status). The second secondary end point was a composite of death from any cause, cardiovascular events, and change from baseline in the 6-minute walk test distance over 12 months. The third secondary end point was a composite of death from any cause, hospitalizations for any cause, and urgent heart failure visits over 12 months. RESULTS: A total of 360 patients were randomly assigned to receive patisiran (181 patients) or placebo (179 patients). At month 12, the decline in the 6-minute walk distance was lower in the patisiran group than in the placebo group (Hodges-Lehmann estimate of median difference, 14.69 m; 95% confidence interval [CI], 0.69 to 28.69; P = 0.02); the KCCQ-OS score increased in the patisiran group and declined in the placebo group (least-squares mean difference, 3.7 points; 95% CI, 0.2 to 7.2; P = 0.04). Significant benefits were not observed for the second secondary end point. Infusion-related reactions, arthralgia, and muscle spasms occurred more often among patients in the patisiran group than among those in the placebo group. CONCLUSIONS: In this trial, administration of patisiran over a period of 12 months resulted in preserved functional capacity in patients with ATTR cardiac amyloidosis. (Funded by Alnylam Pharmaceuticals; APOLLO-B ClinicalTrials.gov number, NCT03997383.).

99m Technetium-pyrophosphate bone scan: A potential biomarker for the burden of transthyretin amyloidosis in skeletal muscle: A preliminary study.

INTRODUCTION/AIMS: Transthyretin amyloidosis (ATTR) proteins can infiltrate skeletal muscle and infrequently cause a myopathy. 99m Technetium-pyrophosphate (99m Tc-PYP) is a validated biomarker for cardiac involvement in variant and wild-type ATTR (ATTRv and ATTRwt, respectively). The aim of this study was to test the hypothesis that 99m Tc-PYP is a biomarker for muscle burden of ATTR. METHODS: Radioisotope uptake in the deltoid muscles of patients with ATTR was compared to uptake in control subjects without amyloidosis in a retrospective study. 99m Tc-PYP scans were evaluated in 11 patients with ATTR (7 ATTRv, 4 ATTRwt) and 14 control subjects. Mean count (MC) values were measured in circular regions of interest (ROIs) 2.5-3.8 cm2 in area. Tracer uptake was quantified in the heart, contralateral chest (CC), and deltoid muscles. RESULTS: Tracer uptake was significantly higher over the deltoids and heart but not the CC, in patients with ATTR than in control subjects. MC values were 120.1 ± 43.7 (mean ± SD) in ATTR patients and 78.9 ± 20.4 in control subjects over the heart (p = 0.005), 73.3± 21.0 and 63.5 ± 14.4 over CC (p = 0.09), and 37.0 ± 11.7 and 26.0 ± 7.1 averaged over both deltoid muscles (p = 0.014). DISCUSSION: 99m Tc-PYP is a potential biomarker for ATTR amyloid burden in skeletal muscle.

The prognostic role of advanced hemodynamic variables in patients with left ventricular assist devices.

BACKGROUND: Invasive hemodynamic variables obtained from right heart catheterization have been used for risk-stratifying patients with advanced heart failure (HF). However, there is a paucity of data on the prognostic value of invasive hemodynamic variables in patients with left ventricular assist devices (LVAD). We hypothesized that cardiac power output (CPO), cardiac power efficiency (CPE), and left ventricular stroke work index (LVSWI) can serve as prognostic markers in patients with LVADs. METHODS: Baseline hemodynamic data from patients who had LVAD ramp studies at our institution from 4/2014 to 7/2018 were prospectively collected, from which advanced hemodynamic variables (CPO, CPE, and LVSWI) were retrospectively analyzed. Univariate and multivariable analyses were performed for hemocompatibility-related adverse events (HRAE), HF admissions, and mortality. RESULTS: Ninety-one participants (age 61 ± 11 years, 34% women, 40% Black or African American, and 38% ischemic cardiomyopathy) were analyzed. Low CPE was significantly associated with mortality (HR 2.42, 95% CI 1.02-5.74, p = 0.045) in univariate analysis and Kaplan-Meier analysis (p = 0.04). Low LVSWI was significantly associated with mortality (HR 2.13, 95% CI 1.09-4.17, p = 0.03) in univariate analysis and Kaplan-Meier analysis (p = 0.02). CPO was not associated with mortality. CPO, CPE, and LVSWI were not associated with HRAE or HF admissions. CONCLUSIONS: Advanced hemodynamic variables can serve as prognostic indicators for patients with LVADs. Low CPE and LVSWI are prognostic for higher mortality, but no variables were associated with HF admissions or HRAEs.

Clinical outcomes of grafted vs. percutaneous axillary intra-aortic balloon pump support as a bridge to transplantation: a propensity score-matched analysis.

OBJECTIVES: The purpose of this study is to investigate the early and late outcomes of axillary intra-aortic balloon pump (IABP) implantation as a bridge to heart transplantation, comparing the grafted technique with the percutaneous technique. METHODS: Between July 2009 and January 2020, 163 patients underwent an axillary IABP insertion as a bridge to heart transplantation. Among them, 97 patients underwent axillary IABP implantation through a graft sutured onto the axillary artery (Group A) and 66 patients underwent percutaneously (Group B). Propensity matching identified 53 matched pairs for analysis (C-statistics 0.741). The primary outcomes of interest included IABP-related complications, success rate of a bridge to transplantation, in-hospital mortality, and late survival. RESULTS: In the propensity-score matched cohort, there were no significant differences in the baseline characteristics between the two groups. The operation time was significantly longer in Group A than in Group B (141.5 ± 38.3 min vs 42.7 ± 19.3 min, p < 0.01). The complication rates including stroke, re-exploration for bleeding, and aortic event were not significantly different between Group A and B. However, Group A required more transfusion and re-exploration for bleeding. The success rate of a bridge to transplantation was similar between Group A (47/53, 88.7%) and Group B (47/53, 88.7%). There were no significant differences in in-hospital mortality and late survival between two groups. CONCLUSION: In the propensity score matching analysis, there were not any significant differences between the two groups in IABP-related complications, in-hospital mortality, and late survival. The percutaneous technique provided a shorter operation time and less requirement of transfusion and re-exploration for bleeding compared to the grafted technique. The percutaneous technique might be favorable when feasible.

Proximal ascending aorta size is associated with the incidence of de novo aortic insufficiency with left ventricular assist device.

We sought to assess the impact of the aortic root geometry on developing de novo aortic insufficiency (AI) in patients undergoing left ventricular assist device (LVAD). In total, 114 patients underwent LVAD implantation between February 2016 and January 2020 were included in this study (HeartMate3 N = 68, HeartWare N = 46). Significant aortic insufficiency was defined as mild-to-moderate or greater in echocardiography. The cohort was divided into two groups; those who developed significant AI (Group AI: n = 13) and did not (Group non-AI: n = 101). The primary outcomes of interest included late survival and predictors for significant AI. The patients in Group AI were older than Group non-AI (62.6 ± 11.9 vs 51.3 ± 14.0 years, p < 0.01). The diameter of proximal ascending aorta in Group AI was larger than Group non-AI (31.0 ± 5.0 vs 27.4 ± 4.3 mm, p < 0.01). Aortic valve remained closed in 53.8% in Group AI and 36.6% in Group non-AI (p = 0.24). The late survival was not significantly different between the groups (67.1% vs 76.0% at 3 years, log rank = 0.97). The Cox hazard model showed that larger proximal ascending aortic diameter/BSA (HR 1.55, CI 1.19-2.04, p < 0.01) and not-opening aortic valve (HR 4.73, CI 1.43-16.9, p = 0.01) were independent risk factors for significant AI. The cutoff value of proximal ascending aortic diameter/BSA was 15.5 (area under curve: 0.770, sensitivity: 0.69, specificity: 0.79). Dilated proximal ascending aorta at the time of LVAD surgery and not-opening aortic valve during follow-up were associated with the incidence of de novo significant AI.

Significant vascular complications in percutaneous axillary intra-aortic balloon pump.

OBJECTIVE: Axillary Intra-aortic balloon pump (IABP) has been increasingly utilized for hemodynamic support in heart failure patients. Vascular complications associated with axillary IABP such as dissection or rupture are relatively rare but not negligible that could negatively affect clinical outcomes. We summarized our experiences. METHODS: This is a retrospective study reviewing of all patients receiving an axillary IABP between June 2016 and November 2020. A total of 199 patients underwent percutaneous axillary IABP placement. 6 patients (6/199, 3.0%) were complicated with arterial/aortic dissection or rupture during the procedures or the course of treatment. We described their clinical presentations and outcomes. RESULTS: Vascular complications included acute type A aortic dissection in 2 patients, descending aortic rupture in 1 patient, abdominal aortic rupture along with type B aortic dissection in 1 patient, and the localized left subclavian artery dissection in 2 patient. 2 type A aortic dissection cases were surgically treated: 1 with emergent left ventricle assist device and ascending aorta replacement, the other with emergent left ventricle assist device. Emergent endovascular treatment was successfully performed in 2 aortic rupture cases. The left subclavian artery dissection cases were managed medically. The postoperative/treatment course was uneventful in all patients. CONCLUSION: Percutaneous axillary IABP therapy can cause significant vascular complications. Early diagnosis and prompt treatment would be the key to improve the clinical outcomesv.

Postoperative tolvaptan use in left ventricular assist device patients: The TOLVAD randomized pilot study.

PURPOSE: Tolvaptan, a selective vasopressin type-2 antagonist, has been shown to increase serum sodium (Na) and urine output in hyponatremic left ventricular assist device (LVAD) patients in retrospective studies. In this prospective randomized pilot study, we aimed to assess the efficacy of tolvaptan in this population. METHODS: We conducted a prospective, randomized, non-blinded pilot study of LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L) (NCT05408104). Eligible participants were randomized to receive tolvaptan 15 mg daily in addition to usual care versus usual care alone. The primary outcome was a change in Na level and estimated glomerular filtration rate (eGFR), from the first post-operative day of hyponatremia (the day of randomization) to discharge. RESULTS: A total of 33 participants were enrolled, and 28 underwent randomization (median age 55 [IQR 50-62]), 21% women, 54% Black, 32% ischemic cardiomyopathy, median baseline Na 135 (IQR 134-138). Fifteen participants were randomized to tolvaptan (TLV) and 13 were randomized to usual care alone (No-TLV). Mean change in Na from randomization to discharge in the TLV group was 2.7 mEq/L (95%CI 0.7-4.7, p = 0.013) and 1.8 (95%CI 0.5-4.0, p = 0.11) in the No-TLV group, though baseline and final Na levels were similar between groups. The mean change in eGFR was 2.6 ml/min/1.73 m2 (95%CI 10.1-15.3, p = 0.59) in TLV versus 7.5 ml/min/1.73 m2 (95%CI 5.2-20.2, p = 0.15) in No-TLV. TLV participants had significantly more urine output than No-TLV patients during their first 24 h after randomization (3294 vs 2155 ml, p = 0.043). CONCLUSION: TLV significantly increases urine output, with nominal improvement in Na level, in hyponatremic post-operative LVAD patients without adversely impacting renal function.

Aortic Pulsatility Index: A Novel Hemodynamic Variable for Evaluation of Decompensated Heart Failure.

BACKGROUND: Right heart catheterization for invasive hemodynamics has shown only modest correlation with clinical outcomes. We designed a novel hemodynamic variable that incorporates ventricular output and filling pressure. We anticipated that the aortic pulsatility index (API) would correlate with clinical outcomes in patients with heart failure. METHODS AND RESULTS: We retrospectively analyzed consecutive patients undergoing right heart catheterization with milrinone drug study at our institution (February 2013 to November 2019). The API was calculated as (systolic blood pressure - diastolic blood pressure)/pulmonary capillary wedge pressure. The primary outcome was freedom from advanced therapies, defined as the need for inotropes, temporary mechanical circulatory support, a left ventricular assist device, or orthotopic heart transplantation, or death at 30 days. A total of 224 patient encounters, age 57 years (48-66 years; 34% women; 31% ischemic cardiomyopathy) were included. In univariable analysis, lower baseline API was significantly associated with progression to advanced therapies or death at 30-days (odds ratio 0.43, 95% confidence interval 0.30-0.61; P < .001) compared with those on continued medical management. Receiver operator characteristic analysis specified an optimal cutpoint of 1.45 for API. A Kaplan-Meier analysis indicated an association of API with the primary outcome (79% for API ≥ 1.45 vs 48% for API < 1.45). In multivariable analysis, higher API was strongly associated with freedom from advanced therapies or death (odds ratio 0.38, 95% confidence interval 0.22-0.65, P ≤ .001), even when adjusted for baseline characteristics and routine right heart catheterization measurements. CONCLUSIONS: The API is a novel invasive hemodynamic measurement that is associated independently with freedom from advanced therapies or death at 30-day follow-up.

Early experience of COVID-19 in 2 heart transplant recipients: Case reports and review of treatment options.

The coronavirus disease 2019 (COVID-19) pandemic poses special challenges to immunocompromised transplant patients. Given the paucity of proven data in treating COVID-19, management of these patients is difficult, rapidly evolving, and mainly based on anecdotal experience. We report 2 cases of heart transplant (HT) recipients with COVID-19. The first is a 59-year-old female with HT in 2012 who presented on March 20, 2020 with fever, hypoxia, and ground-glass opacities on chest X-ray. She quickly progressed to acute hypoxic respiratory failure and vasoplegic shock. Despite reduction in immunosuppression and treatment with tocilizumab, intravenous immunoglobulin, hydroxychloroquine, lopinavir/ritonavir, and broad-spectrum antibiotics, she ultimately died from multiorgan failure. The second case is a 75-year-old man with HT in 2000 who presented on April 2, 2020 after curbside testing revealed positive COVID-19. Given a milder presentation compared to the first patient, antimetabolite was discontinued and only hydroxychloroquine was started. Because of a lack of clinical improvement several days later, tocilizumab, methylprednisolone, and therapeutic anticoagulation were initiated. The patient clinically improved with decreasing oxygen requirements and was discharged home. These 2 cases highlight the wide range of different presentations of COVID-19 in HT recipients and the rapidity with which the management of these patients is evolving.

Discordance Between Clinical Assessment and Invasive Hemodynamics in Patients With Advanced Heart Failure.

BACKGROUND: Historically, invasive hemodynamic guidance was not superior compared to clinical assessment in patients admitted with acute decompensated heart failure (ADHF). This study assessed the accuracy of clinical assessment vs invasive hemodynamics in patients with ADHF. METHODS AND RESULTS: We conducted a prospective cohort study of patients admitted with ADHF. Prior to right-heart catheterization (RHC), physicians categorically predicted right atrial pressure, pulmonary capillary wedge pressure, cardiac index and hemodynamic profile (wet/dry, warm/cold) based on physical examination and clinical data evaluation (warm = cardiac index > 2.2 L/min/m2; wet = pulmonary capillary wedge pressure > 18 mmHg). We collected 218 surveys (of 83 cardiology fellows, 55 attending cardiologists, 45 residents, 35 interns) evaluating 97 patients. Of those patients, 46% were receiving inotropes prior to RHC. The positive and negative predictive values of clinical assessment compared to RHC for the cold and wet subgroups were 74.7% and 50.4%. The accuracy of categorical prediction was 43.6% for right atrial pressure, 34.4% for pulmonary capillary wedge pressure and 49.1% for cardiac index, and accuracy did not differ by clinician (P > 0.05 for all). Interprovider agreement was 44.4%. Therapeutic changes following RHC occurred in 71.1% overall (P < 0.001). CONCLUSIONS: Clinical assessment of patients with advanced heart failure presenting with ADHF has low accuracy across all training levels, with exaggerated rates of misrecognition of the most high-risk patients.

Surgical device exchange provides improved clinical outcomes compared to medical therapy in treating continuous-flow left ventricular assist device thrombosis.

The purpose of this study is to compare clinical outcomes of left ventricular assist device (LVAD) patients with device thrombosis who underwent device exchange (DE) or medical therapy (MT) alone. Consecutive patients undergoing LVAD implant between July 2008 and December 2017 were included. Device thrombosis was diagnosed with comprehensive assessments including ramp test, laboratory data, device parameters, and clinical presentations. First, MT was initiated in all patients. After MT, DE was considered if device thrombosis was refractory to initial MT, and it caused end-organ impairment and/or hemodynamic instability. Among 319 consecutive LVAD patients, 43 patients (13.5%) were diagnosed with device thrombosis. DE was performed in 28 patients (DE group); device explant was performed in 1 patient. MT was continued in 14 patients (MT group). In-hospital mortality was significantly lower in the DE group than the MT group (3.6% [1/28] vs. 28.6% [4/14], P = .0184). One-year survival was significantly better in the DE group (74.0% vs. 30.1%; log-rank = .001), and freedom from cerebrovascular accident (CVA) at 1 year was greater in the DE group (87.1% vs. 47.7%; log-rank = .004). DE was associated with improved 1-year survival and fewer CVAs. Surgical intervention, if feasible, is recommended for LVAD device thrombosis.

Correction to: A subcostal approach is favorable compared to sternotomy for left ventricular assist device exchange.

In the original publication, the title of the article was published incorrectly.

Improvement in Biventricular Cardiac Function After Ambulatory Counterpulsation.

BACKGROUND: The NupulseCV intravascular ventricular assist system (iVAS), which consists of a durable pump placed through the subclavian artery, provides extended-duration ambulatory counterpulsation. This study investigated the effect of iVAS on biventricular cardiac function. METHODS AND RESULTS: We reviewed all heart failure patients who received iVAS implantation as a bridge to transplantation or a bridge to candidacy since April 2016 as part of the iVAS first-in-humans and subsequent feasibility study. We compared data of transthoracic echocardiography performed just before implantation (without iVAS support) and again at 30 days or just before explantation (on iVAS support). Eighteen patients (58.8 ± 7.4 years old and 15 male) received iVAS support for 53 ± 43 days. Fourteen patients were bridged to cardiac replacement therapy after 35 ± 19 days and the remaining 4 patients had been supported for 118 ± 41 days. There were no deaths during iVAS support. At 30 days, there was a significant improvement in left ventricular ejection fraction (16.5% ± 11.9% vs 24.4% ± 12.8%; P = .007) and marked reduction in left atrial size (62.7 ± 35.7 mL/m2 vs 33.8 ± 17.2 mL/m2; P < .001). Right ventricular fractional area change improved dramatically (25.4% ± 12.9% vs 42.1% ± 12.4%; P < .001). All other right ventricular and right atrial parameters improved significantly as well (size, tricuspid annular plane systolic excursion, and velocity of tricuspid annular systolic motion). CONCLUSIONS: Improvement in biventricular cardiac function was observed after 30 days of iVAS support. Further studies should examine the use of this technology as a bridge to recovery.

A histopathologic schema to quantify the burden of cardiac amyloidosis: Relationship with survival and echocardiographic parameters.

BACKGROUND: Despite routine use of echocardiographic parameters to evaluate the severity of cardiac amyloidosis (CA), this methodology has not been well validated. We developed a histopathologic schema for quantifying CA burden and evaluated its relationship with clinical outcomes. Additionally, echocardiographic parameters were tested as potential noninvasive indices of CA burden. METHODS: We retrospectively studied 59 patients with CA (17 light chain, 42 transthyretin) who underwent endomyocardial biopsies. Light microscopy with staining was used to categorize CA burden as mild-to-moderate (<50%) or high (≥50%). Kaplan-Meier survival analysis was performed for the two groups. In 34 patients with good-quality echocardiograms, we measured left ventricular volumes, ejection fraction (EF), interventricular septal thickness (IVSt), posterior wall thickness (PWt), LV mass, lateral e'-velocity, and global longitudinal strain (GLS). These parameters were compared between the two groups. RESULTS: Thirty-five patients had mild-to-moderate and 24 severe amyloid burden. Kaplan-Meier curves demonstrated a trend toward worse mortality with high CA burden, which was more common and associated with higher mortality specifically in transthyretin-type patients. Echocardiography-derived IVSt, PWt, and LV mass were directly related to CA burden, while LV EF, e'-velocity, and GLS magnitude were inversely related to CA burden. CONCLUSIONS: Our findings provided a signal that CA burden is a clinically important entity with potentially valuable prognostic information. Echocardiographic parameters of LV anatomy and function correlate with histopathologic burden of CA, which is inversely related to survival. Further studies are needed to determine whether these parameters could be used as imaging biomarkers of treatment-related changes in CA burden.

A subcostal approach is favorable compared to sternotomy for left ventricular assist device exchange field of research: artificial heart (clinical).

This is a single-center retrospective study to summarize clinical outcomes of patients requiring surgical continuous-flow left ventricular assist device (HeartMate II) exchange. The patients who underwent HeartMate II exchange were divided into two groups either via a subcostal approach (SC group) or a full sternotomy (FS group). The exclusion criteria of a subcostal approach for device exchange included the presence of outflow graft obstruction, and/or the need for concomitant cardiac procedures. Among 277 consecutive patients who underwent HeartMate II implantation from July 2008 to December 2015, 25 patients (9.0%) required device exchange (SC group; N = 13, FS group; N = 12). The SC group, compared to the FS group, had a shorter operative time (200.6 ± 31.4 min vs 534.2 ± 123.9 min; P < 0.001), shorter cardiopulmonary bypass time (33.1 ± 22.0 min vs 151.5 ± 53.1 min; P < 0.001), fewer blood transfusion (0.31 ± 0.48 units vs 4.67 ± 3.65 units; P = 0.002). The SC group had lower incidence of postoperative prolonged intubation (> 24 h) (7.7% vs 90.9%, P < 0.001), tracheostomy (0.0% vs 41.7%, P = 0.015), acute kidney injury requiring dialysis (0.0% vs 33.3%, P = 0.039). In-hospital mortality was 0.0% (0/13) in the SC group and 16.7% (2/12) in the FS group (P = 0.220). In conclusion, a subcostal approach was associated with shorter operative time, fewer blood transfusions, and less postoperative complications, compared to full sternotomy. A subcostal approach, if feasible, is preferred for HeartMate II device exchange.

Long-Acting Octreotide Reduces the Recurrence of Gastrointestinal Bleeding in Patients With a Continuous-Flow Left Ventricular Assist Device.

BACKGROUND: Recurrent gastrointestinal bleeding is one of the most significant adverse events in patients with left ventricular assist devices (LVADs). METHODS: We enrolled LVAD patients who had received an intramuscular injection of 20 mg octreotide every 4 weeks as secondary prevention for recurrent gastrointestinal bleeding despite conventional medical therapies and repeated transfusions. The frequency of gastrointestinal bleeding and other associated clinical outcomes before and during octreotide therapy were compared. RESULTS: Thirty LVAD patients (66.4 ± 8.8 years old, 16 men [53%]) received octreotide therapy for 498.8 ± 356.0 days without any octreotide-associated adverse events. The frequency of gastrointestinal bleeding was decreased significantly during octreotide therapy (from 3.4 ± 3.1 to 0.7 ± 1.3 events/year; P < .001), accompanied by significant reductions in red blood cell and flesh frozen plasma transfusions, days in hospital, and need for endoscopic procedures (P < .05 for all). CONCLUSIONS: Octreotide therapy reduced the frequency of recurrent gastrointestinal bleeding and may be considered for secondary prevention.

Consequences of Retained Defibrillator and Pacemaker Leads After Heart Transplantation-An Underrecognized Problem.

BACKGROUND: Cardiovascular implantable electronic devices (CIEDs) are common in patients undergoing heart transplantation (HT), and complete removal is not always possible at the time of transplantation. METHODS: We retrospectively assessed the frequency of retained CIED leads and clinical consequences in consecutive HT patients from 2013 to 2016. Clinical outcomes included bacteremia, upper-extremity deep venous thrombosis (UEDVT), lead migration, and inability to perform magnetic resonance imaging (MRI). RESULTS: A total of 138 patients (55 ± 11 years of age, 76% male) were identified; 37 (27%) had retained lead fragments (RLFs) at discharge. Patients with RLFs were older, had longer lead implantation time before HT, and a higher prevalence of dual-coil CIED leads compared with those without RLFs (P < .05 for all). Lead implantation time was identified as an independent predictor for RLFs (P < .05). Patients with RLFs had a higher frequency of DVT compared with the non-RLF group during the 1-year study period (42% vs 21%; P < .04). There was no difference in bacteremia. Fourteen patients (38%) could not undergo clinically indicated MRI. CONCLUSION: RLFs after HT occur commonly and are associated with a higher rate of UEDVT and limit the use of MRI. Although no significant difference was found in the rates of bacteremia between the groups, this finding might be explained by the overall low incidence. Patients with risk factors for RLFs should be identified before transplantation, and complete lead removal should be considered with a multidisciplinary approach.

Decoupling Between Diastolic Pulmonary Arterial Pressure and Pulmonary Arterial Wedge Pressure at Incremental Left Ventricular Assist Device (LVAD) Speeds Is Associated With Worse Prognosis After LVAD Implantation.

BACKGROUND: Decoupling between diastolic pulmonary arterial pressure (dPAP) and pulmonary arterial wedge pressure (PAWP) is an index of pulmonary vasculature remodeling and provides prognostic information. Furthermore, decoupling may change during incremental left ventricular assist device (LVAD) speed changes. METHODS AND RESULTS: In this prospective study, patients underwent an echocardiographic and hemodynamic ramp test after LVAD implantation and were followed for 1 year. The change in decoupling (dPAP - PAWP) between the lowest and highest LVAD speeds during the ramp test was calculated. Survival and heart failure admission rates were assessed by means of Kaplan-Meier analysis. Eighty-seven patients were enrolled in the study: 54 had a Heartmate II LVAD (60.8 ± 9.3 years of age and 34 male) and 33 had an HVAD LVAD (58.6 ± 13.2 years of age and 20 male). Patients who experienced greater changes in decoupling (Δdecoupling >3 mm Hg) had a persistently elevated dPAP at incremental LVAD speed and had worse 1-year heart failure readmission-free survival compared with the group without significant changes in the degree of decoupling (41% vs 75%; P = .001). CONCLUSIONS: An increase in decoupling between dPAP and PAWP at incremental LVAD speed changes was associated with worse prognosis in LVAD patients.

Echocardiographic Predictors of Hemodynamics in Patients Supported With Left Ventricular Assist Devices.

BACKGROUND: The assessment of hemodynamics in patients supported with left ventricular assist devices (LVADs) is often challenging. Physical examination maneuvers correlate poorly with true hemodynamics. We assessed the value of novel transthoracic echocardiography (TTE)-derived variables to reliably predict hemodynamics in patients supported with LVAD. METHODS AND RESULTS: A total of 102 Doppler-TTE images of the LVAD outflow cannula were obtained during simultaneous invasive right heart catheterization (RHC) in 30 patients supported with continuous-flow LVADs (22 HMII, 8 HVAD) either during routine RHC or during invasive ramp testing. Properties of the Doppler signal though the outflow cannula were measured at each ramp stage (RS), including the systolic slope (SS), diastolic slope (DS), and velocity time integral (VTI). Hemodynamic variables were concurrently recorded, including Doppler opening pressure (MAP), heart rate (HR), right atrial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure (PCWP), Fick cardiac output (CO) and systemic vascular resistance (SVR). Univariate and multivariate regression analyses were used to explore the dependence of PCWP, CO, and SVR on DS, SS, VTI, MAP, HR, and RS. Multivariate linear regression analysis revealed significant contributions of DS on PCWP (PCWPpred = 0.164DS + 4.959; R = 0.68). Receiver operating characteristic (ROC) curve analysis revealed that PCWPpred could predict an elevated PCWP ≥18 mm Hg with a sensitivity (Sn) of 94% and specificity (Sp) of 85% (area under the ROC curve 0.88). CO could be predicted by RS, VTI, and HR (COpred = 0.017VTI + 0.016HR + 0.12RS + 2.042; R = 0.61). COpred could predict CO ≤4.5 L/min with Sn 73% and Sp 79% (AUC 0.81). SVR could be predicted by MAP, VTI, and HR (SVRpred = 15.44MAP - 5.453VTI - 6.349HR + 856.15; R = 0.84) with Sn 84% and Sp 79% (AUC 0.91) to predict SVR ≥1200 dyn-s/cm5. CONCLUSIONS: Doppler-TTE variables derived from the LVAD outflow cannula can reliably predict PCWP, CO, and SVR in patients supported with LVADs and may mitigate the need for invasive testing.