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Targeted blood pressure (BP) control is a goal of left ventricular assist device medical management, but the interpretation of values obtained from noninvasive instruments is challenging. In the MOMENTUM 3 Continued Access Protocol, paired BP values in HeartMate 3 (HM3) patients were compared from arterial (A)-line and Doppler opening pressure (DOP) (319 readings in 261 patients) and A-line and automated cuff (281 readings in 247 patients). Pearson (R) correlations between A-line mean arterial (MAP) and systolic blood pressures (SBP) were compared with DOP and cuff measures according to the presence (>1 pulse in 5 seconds) or absence of a palpable radial pulse. There were only moderate correlations between A-line and noninvasive measurements of SBP (DOP R = 0.58; cuff R = 0.47) and MAP (DOP R = 0.48; cuff R = 0.37). DOP accuracy for MAP estimation, defined as the % of readings within ± 10 mmHg of A-line MAP, decreased from 80% to 33% for DOP ≤ 90 vs. >90 mmHg, and precision also diminished (mean absolute difference [MAD] increased from 6.3 ± 5.6 to 16.1 ± 11.4 mmHg). Across pulse pressures, cuff MAPs were within ±10 mmHg of A-line 62.9%-68.8% of measures and MADs were negligible. The presence of a palpable pulse reduced the accuracy and precision of the DOP-MAP estimation but did not impact cuff-MAP accuracy or precision. In summary, DOP may overestimate MAP in some patients on HM3 support. Simultaneous use of DOP and automated cuff and radial pulse may be needed to guide antihypertensive medication titration in outpatients on HM3 support.

Contains fulltext : 249977.pdf (Publisher’s version ) (Closed access) BACKGROUND: It is important to evaluate whether a new treatment for heart failure with reduced ejection fraction (HFrEF) provides additive benefit to background foundational treatments. As such, we aimed to evaluate the efficacy and safety of empagliflozin in patients with HFrEF in addition to baseline treatment with specific doses and combinations of disease-modifying therapies. METHODS: We performed a post-hoc analysis of the EMPEROR-Reduced randomised, double-blind, parallel-group trial, which took place in 520 centres (hospitals and medical clinics) in 20 countries in Asia, Australia, Europe, North America, and South America. Patients with New York Heart Association (NYHA) classification II-IV with an ejection fraction of 40% or less were randomly assigned (1:1) to receive the addition of either oral empagliflozin 10 mg per day or placebo to background therapy. The primary composite outcome was cardiovascular death and heart failure hospitalisation; the secondary outcome was total heart failure hospital admissions. An extended composite outcome consisted of inpatient and outpatient HFrEF events was also evaluated. Outcomes were analysed according to background use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs), as well as β blockers and mineralocorticoid receptor antagonists (MRAs) at less than 50% or 50% or more of target doses and in various combinations. This study is registered with ClinicalTrials.gov, NCT03057977. FINDINGS: In this post-hoc analysis of 3730 patients (mean age 66·8 years [SD 11·0], 893 [23·9%] women; 1863 [49·9%] in the empagliflozin group, 1867 [50·1%] in the placebo group) assessed between March 6, 2017, and May 28, 2020, empagliflozin reduced the risk of the primary outcome (361 in 1863 participants in the empagliflozin group and 462 of 1867 in the placebo group; HR 0·75 [95% CI 0·65-0·86]) regardless of background therapy or its target doses for ACE inhibitors or ARBs at doses of less than 50% of the target dose (HR 0·85 [0·69-1·06]) and for doses of 50% or more of the target dose (HR 0·67 [0·52-0·88]; p(interaction)=0·18). A similar result was seen for β blockers at doses of less than 50% of the target dose (HR 0·66 [0·54-0·80]) and for doses of 50% or more of the target dose (HR 0·81 [0·66-1·00]; p(interaction)=0·15). Empagliflozin also reduced the risk of the primary outcome irrespective of background use of triple therapy with an ACE inhibitor, ARB, or ARNI plus β blocker plus MRA (given combination HR 0·73 [0·61-0·88]; not given combination HR 0·76 [0·62-0·94]; p(interaction)=0·77). Similar patterns of benefit were observed for the secondary and extended composite outcomes. Empagliflozin was well tolerated and rates of hypotension, symptomatic hypotension, and hyperkalaemia were similar across all subgroups. INTERPRETATION: Empagliflozin reduced serious heart failure outcomes across doses and combinations of disease-modifying therapies for HFrEF. Clinically, these data suggest that empagliflozin might be considered as a foundational therapy in patients with HFrEF regardless of their existing background therapy. FUNDING: Boehringer Ingelheim and Eli Lilly and Company.

Introduction The management of incidental cardiac shunts at the time of orthotopic heart transplantation (OHT) is rarely described in literature. We present a case involving surgical correction of a partial anomalous pulmonary venous connection (PAPVC) at the time of OHT. Case Report The patient is a 65-year-old woman with a history of idiopathic dilated cardiomyopathy (diagnosed in 2010), and a PAPVC. She was diagnosed with the PAPVC incidentally after a right heart catheterization. CT angiogram confirmed an anomalous connection of her right superior and middle pulmonary veins to her superior vena cava (SVC). Serial echocardiograms showed a left ventricular ejection fraction of 20 to 25% and mild pulmonary hypertension. Her right atrium and ventricle were mildly dilated in size and her right ventricular function remained normal. In the year preceding her OHT she developed NYHA class III-IV symptoms and frequent episodes of decompensated heart failure, necessitating advanced cardiac therapies. Ultimately she underwent OHT with concomitant PAPVC repair. At the time of transplantation, the recipient's SVC was divided above the anomalous vein and a pericardial patch was applied to the orifice created on the right atrium. The recipient right atrium and interatrial septum were constructed into an atrial baffle with bovine pericardium, which was then anastomosed to the donor left atrium with a surgically created atrial septal defect in the fossa ovalis. Afterwards, the transplantation proceeded using the standard bicaval technique with the donor left atrium connected to recipient left atrium and the atrial baffle. There were no intra-operative complications, and the patient did well post-operatively. Summary PAPVCs typically cause shunting of oxygenated blood to the right atrium. For patients with clinically significant PAPVCs, surgical correction may be necessary and usually involves a Warden procedure, which can require reconstruction of the right atrial appendage. In patients undergoing PAPVC repair at the time of bicaval OHT, the recipient SVC is anastomosed to donor SVC which is simpler technically than atrial reconstruction and offers better outcomes regarding arrhythmias and tricuspid regurgitation. Furthermore, this maintains adequate pulmonary and systemic venous outflow into the atria. To our knowledge, this is the first reported case of PAPVC repair at the time of OHT in the US.

The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrants evaluation.FC (New York Heart Association [NYHA] and 6-minute walk test [6MWT]) and HR-QOL (European Quality of Life [EQ-5D-5L] and the Kansas City Cardiomyopathy [KCCQ]) assessments were obtained at baseline and 6 months after HeartMate 3 (HM3, n = 151; Abbott, Abbott Park, IL) or HeartMate II (HMII, n = 138; Abbott) implant as part of the MOMENTUM 3 clinical trial. Metrics were compared between devices and in those with and without events. The proportion of patients "living well on an LVAS" at 6 months, defined as alive with satisfactory FC (NYHA I/II or 6MWT300 meters) and HR-QOL (overall KCCQ50), was evaluated.Although the median (25th-75th percentile) patient KCCQ (change for HM3: +28 [10-46]; HMII: +29 [9-48]) and EQ-5D-5L (change for HM3: -1 [-5 to 0]; HMII: -2 [-6 to 0]) scores improved from baseline to 6 months (p0.05), there were no differences between devices (p0.05). Likewise, there was an equivalent improvement in 6MWT distance at 6 months in HM3 (+94 [1-274] meters] and HMII (+188[43-340 meters]) from baseline. In patients with SAEs (n = 188), 6MWTs increased from baseline (p0.001), but gains for both devices were less than those without SAE (HM3: +74 [-9 to 183] meters with SAE vs +140 [35-329] meters without SAE; HMII: +177 [47-356] meters with SAE vs +192 [23-337] meters without SAE, both p0.003). SAEs did not affect the 6-month HR-QOL scores. The "living well" end point was achieved in 145 HM3 (63%) and 120 HMII (68%) patients (p = 0.44).Gains in HR-QOL and FC were similar early after HM3 and HMII implant. 6MWT improvements were attenuated in patients experiencing SAEs, but HR-QOL metrics did not change. The development of left ventricular assist device-specific HR-QOL tools is needed to better characterize the effect of SAEs on a patient's well-being.MOMENTUM 3 clinical trial #NCT02224755.

Purpose Targeted blood pressure (BP) control is a goal of LVAD medical management, but the interpretation of values obtained from automated cuffs and Doppler opening pressure (DOP) is challenging. The aim herein is to compare BP values obtained using arterial line (A-Line) and noninvasive measures in patients on HeartMate 3 support. Methods In the MOMENTUM 3 Continued Access Protocol, paired BP values from A-Line and DOP (354 readings in 277 patients) and A-Line and automated cuff (296 readings in 256 patients) were obtained (>90% ≤7 days postop). Pearson (R) correlations between A-Line and cuff systolic blood pressure (SBP), mean arterial pressure (MAP), and DOP were assessed. A-Line and noninvasive BP measurements in the absence or presence of a palpable radial pulse (>1 in 5 seconds) were also compared. Results There were moderate correlations between A-Line SBP and DOP (R=0.63) and A-Line MAP and DOP (R=0.53) (Fig. A, B). DOP was 4±10 mmHg higher than A-Line MAP and 8±11 mmHg lower than A-Line SBP. When DOP was ≤90 mmHg, the mean absolute difference between DOP and A-Line MAP was 6 ± 6 mmHg compared to 10 ± 9 mmHg between DOP and A-Line SBP. At higher pressures, the disparity between DOP and A-Line MAP increased. The presence of a palpable pulse and high pulse pressure reduced DOP accuracy (Fig. C, D). With a palpable pulse, only 64% DOP values were within 10 mmHg of the A-Line MAP. The correlations between cuff SBP to A-line SBP and cuff MAP to A-Line MAP were poor (Fig. E, F, R=0.36-0.45), but the presence of a palpable pulse and high pulse pressure improved cuff accuracy (Fig. G,H). With a palpable pulse, 71% of cuff MAP values were within 10 mmHg of A-Line. Conclusion On average, DOP is lower than A-Line SBP and higher than A-Line MAP. In patients with DOP ≤90 mmHg or without a radial pulse, it may be reasonable to interpret DOP as the MAP. The presence of a palpable pulse or high pulse pressure reduces DOP accuracy but improves cuff MAP accuracy. When DOP is >90 mmHg, DOP should not be interpreted as MAP; cuff measures may yield greater accuracy.

Purpose A Molecular Microscope System (MMDx) has been developed to detect the presence of T cell mediated (TCMR) and antibody mediated rejection (AMR) with the use of mRNA transcripts. Transplant Cardiologists treat grade pAMR 2 or above per the ISHLT guidelines. Using MMDx we assessed the antibody mediated rejection transcript levels in pAMR1 (H+) and pAMR2 endomyocardial biopsies (EMB) to evaluate if there is a difference in the amount of myocardial injury. Methods Prospectively unselected heart transplant recipients who underwent an EMB after transplant from 12/2018 to 8/2019 at our center and had a MMDx were reviewed. MMDx was performed in 73 recipients with 20 recipients having a grade pAMR1 (H+) and 8 recipients a grade pAMR2. Results 20 recipients had a total of 30 episodes of pAMR1 (H+) rejection and an abnormal MMDx. 8 recipients had a total of 9 episodes of pAMR2 rejection and an abnormal MMDx. Three of the four AMR endoscripts were elevated in both groups with DSAST and NKS having a 8 to 9 times increase over baseline and eDSAST a 2.5 to 3 times increase over baseline. There was NS difference in the level of elevation of the four AMR endoscripts between the two groups. Conclusion MMDx shows that the amount of myocardial injury in pAMR1 (H+) rejection is the same as in pAMR2 rejection. Despite the difference in the histology between the two endomyocardial AMR grades, pAMR1 (H+) should be treated.

Purpose Circulating cell free DNA (cfDNA) rises in response to cell apoptosis and necrosis. The cell damage that occurs in rejection or myocardial injury results in a release of donor DNA into the circulation of the recipient and an increase in the level of dd-cfDNA (donor derived cell free DNA) making it a biomarker for myocardial injury that occurs in heart transplant rejection. Allosure®measures dd-cfDNA and has been validated in heart transplant recipients using histologic diagnosis of myocardial rejection. Transplant Cardiologists treat grade pAMR2 rejection or above per ISHLT guidelines. Using Allosure®we assessed the antibody mediated rejection dd-cfDNA levels in pAMR1(H+) and pAMR2 histologic endomyocardial biopsies (EMB) to evaluate if there is a difference in the amount of myocardial injury. Methods Prospectively unselected heart transplant recipients who underwent an EMB after transplant from 6/2019 to 8/2020 at our center and had a concomitant Allosure®were reviewed. We compared the Allosure®value in histologic pAMR0, pAMR1(H+) and pAMR2 rejection. Results 95 recipients had a concomitant EMB and Allosure®. 63 recipients had a grade pAMR0 with a Allosure®of 0.14 ±0.04 %, 22 recipients a grade pAMR1(H+) rejection with a Allosure®of 2.06 ±1.39 % and 10 recipients a grade pAMR2 rejection with a Allosure®of 2.03 ±1.58 %. The difference in Allosure®between pAMR0 and pAMR1(H+) was significant at p Conclusion Allosure®level indicates that the amount of myocardial injury or cell death in pAMR1 (H+) rejection is the same as grade pAMR2 rejection. Despite the difference in the histologic findings between the two endomyocardial AMR grades, pAMR1(H+) should be treated.

Purpose A Molecular Microscope System (MMDx) has been developed to detect the presence of T cell mediated (TCMR) and antibody mediated rejection (AMR) with the use of mRNA transcripts. Transplant Cardiologists treat grade pAMR2 or above per the ISHLT guidelines. Using MMDx we assessed the antibody mediated rejection transcript levels in pAMR1 (H+) and pAMR2 endomyocardial biopsies (EMB) to evaluate if there is a difference in the amount of myocardial injury. Methods Prospectively unselected heart transplant recipients who underwent an EMB after transplant from 12/2018 to 8/2019 at our center and had a MMDx were reviewed. MMDx was performed in 73 recipients with 20 recipients having a grade pAMR1(H+) and 8 recipients a grade pAMR2 rejection. Results 20 recipients had a total of 30 episodes of pAMR1(H+) rejection and an abnormal MMDx. Eight recipients had a total of nine episodes of pAMR2 rejection and an abnormal MMDx. Three of the four AMR endoscripts were elevated in both groups with DSAST and NKS having a 8 to 9 times increase over baseline and eDSAST a 2.5 to 3 times increase over baseline. There was NS difference in the degree of elevation of the four AMR endoscripts between the two groups. pAMR1 (H+) pAMR2DSAST Conclusion MMDx shows that the amount of myocardial injury in pAMR1(H+) rejection is the same as in pAMR2 rejection. Despite the difference in the histology between the two endomyocardial AMR grades, pAMR1(H+) should be treated.

The left ventricular assist device (LVAD) has rapidly evolved as a reliable mechanism for supporting patients with advanced heart failure. Here we present two patients that developed transient, severe left ventricular hypertrophy (LVH) following LVAD implantation. Patient 1 was a 56 year old woman

Optimal timing of left ventricular assist device (LVAD) implantation in critically ill patients remains uncertain. Multiple studies have demonstrated that implantation of LVADs in hemodynamically stable patients with preserved end-organ function leads to better outcomes. Although seemingly intuitive, this concept highlights the importance of patient selection and the optimal timing of LVAD implantation in critically ill patients. A 35 year-old gentleman with a past medical history of morbid obesity and alcohol abuse presented from an outside hospital. He was initially diagnosed with a cardiomyopathy eight years prior to admission, although demonstrated recovery of his left ventricular ejection fraction (LVEF) after guideline directed medical therapy. He subsequently stopped his medications five years prior to admission and had been doing well. He initially presented to the other institution with shortness of breath and progressive dyspnea on exertion. A cardiac catheterization was performed and demonstrated nonobstructive coronary artery disease. An echocardiogram demonstrated severe biventricular failure with an estimated LVEF of 10%, severe mitral regurgitation and an elevated RVSP of 40%. An Impella 3.5 was placed and the patient was aggressively diuresed. Despite ongoing management, the patient developed multi-organ failure with a peak total bilirubin of 65.5 mg/dL and a creatinine of 4.27 mg/dL. He was transferred to our institution for advanced therapy. Given his morbid obesity and findings of progressively worsening multi-organ failure, immediate surgical intervention was deferred. With placement of an Impella 5 and continued aggressive medical management, he made daily improvement. Multiple selection committee discussions were held regarding the optimal timing of intervention on the previously healthy 35 year old gentleman. Temporary LVAD support with the Impella 5 was maintained for a total of 5 weeks while his respiratory, renal, liver and nutritional function were addressed. The patient was found with significant azotemia and anuria which ultimately improved with supportive medical care and continuous renal replacement therapy. Prior to LVAD implantation, CRRT was no longer required. A HeartMate 3 was ultimately implanted on day 42 of his hospitalization and the patient continued to make excellent progress in recovery. It is unclear what led to the patient's decline in cardiac function, although his morbid obesity, continued alcohol use and cessation of medical therapy likely all contributed. It Is impossible to determine whether earlier intervention would have changed his outcome. Regardless, this case highlights the importance of careful patient selection and multidisciplinary decision-making for timing of LVAD implantation.