Extracorporeal membrane oxygenation support in refractory cardiogenic shock: treatment strategies and analysis of risk factors.

Two centrifugal pumps, the RotaFlow (Maquet, Jostra Medizintechnik AG, Hirrlingen, Germany) and Levitronix CentriMag (Levitronix LCC, Waltham, MA, USA), used in central or peripheral veno-arterial extracorporeal membrane oxygenation (ECMO) support systems have been investigated, in terms of double-center experience, as treatment for patients with refractory cardiogenic shock (CS). Between January 2006 and December 2012, 228 consecutive adult patients were supported on RotaFlow (n=213) or CentriMag (n=15) ECMO, at our institutions (155 men; age 58.3±10.5 years, range: 19-84 years). Indications for support were: failure to wean from cardiopulmonary bypass in the setting of postcardiotomy (n=118) and primary donor graft failure (n=37); postacute myocardial infarction CS (n=27); acute myocarditis (n=6); and CS on chronic heart failure (n=40). A peripheral ECMO setting was established in 126 (55.2%) patients while it was established centrally in 102 (44.7%). Overall mean support time was 10.9±9.7 days (range: 1-43 days). Eighty-four (36.8%) patients died on ECMO. Overall success rate, in terms of survival on ECMO (n=144), weaning from mechanical support (n=107; 46.9%), bridge to mid-long-term ventricular assist device (n=6; 2.6%), and bridge to heart transplantation (n=31; 13.5%), was 63.1%. One hundred twenty-two (53.5%) patients were successfully discharged. Stepwise logistic regression identified blood lactate level and MB isoenzyme of creatine kinase (CK-MB) relative index at 72 h after ECMO initiation, and number of packed red blood cells (PRBCs) transfused on ECMO as significant predictors of mortality on ECMO (P=0.010, odds ratio [OR]=2.94; 95% confidence interval [CI]=1.10-3.14; P=0.010, OR=2.82, 95% CI=1.014-3.721; and P=0.011, OR=2.69; 95% CI=1.06-4.16, respectively). Central ECMO population had significantly higher rate of continuous veno-venous hemofiltration need and bleeding requiring surgery events compared with the peripheral ECMO setting population. No significant differences were seen by comparing the RotaFlow and CentriMag populations in terms of device performance. At follow-up, persistent heart failure with left ventricle ejection fraction (LVEF)≤40% was a risk factor after hospital discharge. Patients with a poor hemodynamic status may benefit from rapid central or peripheral insertion of ECMO. The blood lactate level, CK-MB relative index, and PRBCs transfused should be strictly monitored during ECMO support. In addition, early ventricular assist device placement or urgent listing for heart transplant should be considered in patients with persistent impaired LVEF after ECMO.

Use of mechanical circulatory support devices in end-stage heart failure patients.

BACKGROUND: Mechanical circulatory support (MCS) is the standard therapy for the management of acute or chronic end-stage heart failure. We report on our two-center experience with MCS therapy. METHODS: Between January 2000 and December 2012, 116 adult patients (mean age 56.8 ± 9.9 years, range: 31 to 76 years) were primarily supported on temporary or long-term ventricular assist devices (VADs) or total artificial hearts (TAHs) at our institutions. Temporary extracorporeal radial VAD support was established in 50 patients (43.1%) (Group A) whereas 66 (56.8%) patients received long-term paracorporeal and intracorporeal VAD or TAH (Group B). LVAD support was established in 63 patients (54.3%), with BVAD/TAH support in 29 (25%). A temporary CentriMag was the only device adopted as an isolated RVAD support, being placed in 24 patients (20.6%). RESULTS: In Group A, the overall mean support time was 10.2 ± 6.6 days (range: 3 to 43 days) and the overall success rate was 55.1% (27 patients). The mean LVAD support time was 357 ± 352.3 days (range: 1 to 902 days) in Group B and 98 ± 82.6 days (range: 8 to 832 days) in BVAD/TAH patients, with success rates of 72.5% (37 patients) and 46.6% (seven patients), respectively. The heart transplantation (Htx) rate for both groups combined was 25.8% (n = 30). The overall one- and five-year survival rates after Htx were 73.3% and 60%, respectively. CONCLUSIONS: When a decision to treat with VAD or TAH is made early, either modality can be used as an alternative to Htx, affording comparable early to mid-term outcomes.

Prediction of right ventricular failure after left ventricular assist device implantation: role of vasodilator challenge.

AIMS: Pulmonary artery pulsatility index (PAPi) is an indicator of right ventricular (RV) function and an independent predictor of right ventricular failure (RVF) following left ventricular assist device (LVAD) implantation. Administration of vasodilator challenge during right heart catheterization (RHC) could reduce RV workload allowing a better assessment of its functional reserve. METHODS AND RESULTS: Patients undergoing LVAD implantation at our Institution between May 2013 and August 2021 were enrolled. Only patients who had undergone RHC and vasodilator challenge with sodium nitroprusside were analyzed. We collected all available clinical, instrumental, and haemodynamic parameters, at baseline and after nitroprusside infusion and evaluated potential associations with post-LVAD RVF. Of the 54 patients analyzed, 19 (35%) developed RVF after LVAD implantation. Fractional area change (FAC) (OR: 0.647, CI: 0.481-0.871; P = 0.004), pulmonary artery systolic pressure (PASP) (OR: 0.856, CI: 0.761-0.964; P = 0.010), and post-sodium nitroprusside (NTP) PAPi (OR: 0.218, CI: 0.073-0.653; P = 0.006) were independent predictors of post-LVAD RVF. The model combining FAC, PASP, and post-NTP PAPi demonstrated a predictive accuracy of 90.7%. Addition of post-NTP PAPi significantly increased the predictive accuracy of the European Registry for Patients with Mechanical Circulatory Support right-sided heart failure risk score [79.4 vs. 70.4%; area under the curve (AUC): 0.841 vs. 0.724, P = 0.022] and the CRITT score (79.6% vs. 74%; AUC: 0.861 vs. 0.767 P = 0.033). CONCLUSION: Post-NTP PAPi has observed to be an independent predictor of RVF following LVAD implantation. Dynamic assessment of PAPi using a vasodilator challenge may represent a method of testing RV functional reserve in candidates for LVAD implantation. Larger and prospective studies are needed to confirm this hypothesis.

Optimizing the Safety Profile of Everolimus by Delayed Initiation in De Novo Heart Transplant Recipients: Results of the Prospective Randomized Study EVERHEART.

BACKGROUND: Although everolimus potentially improves long-term heart transplantation (HTx) outcomes, its early postoperative safety profile had raised concerns and needs optimization. METHODS: This 6-month, open-label, multicenter randomized trial was designed to compare the cumulative incidence of a primary composite safety endpoint comprising wound healing delays, pericardial effusion, pleural effusion needing drainage, and renal insufficiency events (estimated glomerular filtration rate ≤30/mL/min per 1.73 m) in de novo HTx recipients receiving immediate everolimus (EVR-I) (≤144 hours post-HTx) or delayed everolimus (EVR-D) (4-6 weeks post-HTx with mycophenolate mofetil as a bridge) with reduced-dose cyclosporine A. Cumulative incidence of biopsy-proven rejection ≥ 2R, rejection with hemodynamic compromise, graft loss, or death was the secondary composite efficacy endpoint. RESULTS: Overall, 181 patients were randomized to the EVR-I (n = 89) or EVR-D (n = 92) arms. Incidence of primary safety endpoint was higher for EVR-I than EVR-D arm (44.9% vs 32.6%; P = 0.191), mainly driven by a higher rate of pericardial effusion (33.7% vs 19.6%; P = 0.04); wound healing delays, acute renal insufficiency events, and pleural effusion occurred at similar frequencies in the study arms. Efficacy failure was not significantly different in EVR-I arm versus EVR-D arm (37.1% vs 28.3%; P = 0.191). Three patients in the EVR-I arm and 1 in the EVR-D arm died. Incidence of clinically significant adverse events leading to discontinuation was higher in EVR-I arm versus EVR-D arm (P = 0.02). CONCLUSIONS: Compared with immediate initiation, delayed everolimus initiation appeared to provide a clinically relevant early safety benefit in de novo HTx recipients, without compromising efficacy.

Calculation of the ALMA Risk of Right Ventricular Failure After Left Ventricular Assist Device Implantation.

Right ventricular failure after continuous-flow left ventricular assist device (LVAD) implantation is still an unsolved issue and remains a life-threatening event for patients. We undertook this study to determine predictors of the patients who are candidates for isolated LVAD therapy as opposed to biventricular support (BVAD). We reviewed demographic, echocardiographic, hemodynamic, and laboratory variables for 258 patients who underwent both isolated LVAD implantation and unplanned BVAD because of early right ventricular failure after LVAD insertion, between 2006 and 2017 (LVAD = 170 and BVAD = 88). The final study patients were randomly divided into derivation (79.8%, n = 206) and validation (20.1%, n = 52) cohorts. Fifty-seven preoperative risk factors were compared between patients who were successfully managed with an LVAD and those who required a BVAD. Nineteen variables demonstrated statistical significance on univariable analysis. Multivariable logistic regression analysis identified destination therapy (odds ratio [OR] 2.0 [1.7-3.9], p = 0.003), a pulmonary artery pulsatility index <2 (OR 3.3 [1.7-6.1], p = 0.001), a right ventricle/left ventricle end-diastolic diameter ratio >0.75 (OR 2.7 [1.5-5.5], p = 0.001), an right ventricle stroke work index <300 mm Hg/ml/m (OR 4.3 [2.5-7.3], p < 0.001), and a United Network for Organ Sharing modified Model for End-Stage Liver Disease Excluding INR score >17 (OR 3.5 [1.9-6.9], p < 0.001) as the major predictors of the need for BVAD. Using these data, we propose a simple risk calculator to determine the suitability of patients for isolated LVAD support in the era of continuous-flow mechanical circulatory support devices.

[Left ventricular assist device recipients at risk of right ventricular failure: the role of a planned temporary biventricular support]. / Impianto di dispositivo di assistenza ventricolare sinistra in pazienti a rischio di insufficienza ventricolare destra: ruolo di un supporto biventricolare temporaneo pianificato.

BACKGROUND: When patients at high risk for failure of isolated left ventricular assist device (LVAD) support are identified, biventricular assist device implantation is suggested as a primary option. Results of a planned temporary right ventricular mechanical support (RVAD) placement in high-risk LVAD recipients have been reported and analyzed. METHODS: Between 2009 and 2011, 10 consecutive adult patients (9 men; age range 31-69 years), with preoperative evidence of moderate to severe biventricular failure, were supported simultaneously with an axial flow HeartMate II (Thoratec Corp., Pleasanton, California) LVAD and a temporary CentriMag (Levitronix LCC, Waltham, Massachusetts) RVAD as a primary option at our institution. Indications for support at implantation were ischemic dilated cardiomyopathy in 6 cases and idiopathic dilated cardiomyopathy in 4. Planned temporary RVAD insertion was defined as RVAD support placement at the same time as LVAD placement. RESULTS: Nine patients were successfully weaned from temporary RVAD support after an average time of 18.6 days (range 3-43 days) and discharged from hospital. One patient died due to respiratory failure. RVAD removal was performed through a minimally invasive approach without repeat sternotomy in 6 patients. None of the patients required a permanent RVAD support. CONCLUSIONS: When patients at high risk for failure of isolated LVAD support are identified, temporary biventricular assist device implantation is advised to improve the outcome of such a vulnerable patient population.

Simultaneous temporary CentriMag right ventricular assist device placement in HeartMate II left ventricular assist system recipients at high risk of right ventricular failure.

An approach is reported for right ventricle temporary mechanical support in long-term axial left ventricular assist device (LVAD) patients preoperatively judged at high risk of right ventricular (RV) failure. The timing for RV assist device (RVAD) weaning and the technique for its removal through a right mini-thoracotomy are described. This strategy provides a good outcome in LVAD recipients avoiding the risk of immediate postoperative RV failure.

Video-assisted minimally invasive mitral valve surgery: external aortic clamp versus endoclamp techniques.

OBJECTIVE: : Video-assisted minimally invasive mitral valve surgery can be performed through different approaches. The aim of the study was to report our early results and compare the external transthoracic aortic clamping with the endoaortic balloon occlusion techniques according to our experience. METHODS: : Between January 2000 and March 2010, 138 patients (103 women, aged 58.4 ± 10.2 years) underwent video-assisted mitral valve surgery through a right thoracotomy. Cardiopulmonary bypass was instituted by femoral arterial and bicaval cannulation with active venous drainage and normothermia; cardioplegic arrest achieved with intermittent blood cardioplegia. In group A (93 patients, 68 women, aged 58.8 ± 7.8 years, 72 MV replacement, 21 MV repair), aortic clamping was achieved using the external transthoracic aortic clamp. In group B (45 patients, 35 women, aged 58.1 ± 11.4 years, 33 MV replacement, 12 MV repair), aortic clamping was achieved with endoaortic balloon occlusion. RESULTS: : Intraoperative procedure-associated problems were experienced in one patient (0.7%) in group A (one conversion to sternotomy for pleural adhesions and bad exposure). At a mean follow-up of 36 ± 18 months, 135 patients (97.8%) were in New York Heart Association class I to II, with satisfactory echocardiographic follow-up. In group A, two patients had noncardiac-related deaths. No perioperative deaths were observed in both groups. There were four (2.8%) transient ischemic attacks and one (0.7%) peripheral ischemic event (group A) during the early postoperative period. Mitral valve repair patients had a 5-year freedom from reoperation of 100% in both groups. There was no significant difference between the two groups regarding preoperative variables, such as age, sex, New York Heart Association class, and left ventricular ejection fraction (P > 0.05). Postoperative levels of myocardial cytonecrosis enzymes (MB fraction, creatine kinase, and troponine I) as well as operative time, extracorporeal circulation, and aortic cross-clamping times or ventilation and intensive care unit times were not significantly different between the two groups (P > 0.05). More microembolic events were observed in group A than in group B (total 143.4 ± 30.6 per patient vs 78.9 ± 28.6 per patient) by means of continuous automated intraoperative transcranial Doppler evaluations (P < 0.05) applied to part of population. CONCLUSIONS: : Both techniques proved safe and comparable with low risk of morbidity and mortality. Patients undergoing endoclamp technique resulted to be less subject to embolism.