Dabigatran etexilate in a vitamin-K antagonist non responder patient during Heartware HVAD support.

We report a case of a patient supported with a HeartWare left ventricular assist device for idiopathic cardiomyopathy who was resistance to vitamin-K antagonists three months after implantation. The patient initially started low-molecular-weight heparin therapy and then, after the onset of an ischemic stroke, switched to dabigatran etexilate (DE). The patient had progressive recovery of cardiac function for which the device was explanted. No thrombotic or bleeding events occurred during DE therapy.

Left Ventricular Unloading during Peripheral Extracorporeal Membrane Oxygenator Support: A Bridge To Life In Profound Cardiogenic Shock.

A limit of peripheral veno-arterial Extracorporeal Membrane Oxigenator (VA-ECMO) is the inadequate unloading of the left ventricle. The increase of end-diastolic pressure reduces the possibility of a recovery and may cause severe pulmonary edema. In this study, we evaluate our results after implantation of VA-ECMO and Transapical Left Ventricular Vent (TLVV) as a bridge to recovery, heart transplantation or long-term left ventricular assit devices (LVAD). From 2011 to 2014, 24 consecutive patients with profound cardiogenic shock were supported by peripheral VA-ECMO as bridge to decision. In all cases, TLVV was implanted after a mean period of 12.2 ± 3.4 hours through a left mini-thoracotomy and connected to the venous inflow line of the VA-ECMO. Thirty-day mortality was 37.5% (9/24). In all patients, hemodynamics improved after TLVV implantation with an increased cardiac output, mixed venous saturation and a significant reduced heart filling pressures (p < .05). Recovery of the cardiac function was observed in 11 patients (11/24; 45.8%). Three patients were transplanted (3/24; 12.5%) and three patients (3/24; 12.5%) underwent LVAD implantation as destination therapy, all these patients were discharged from the hospital in good clinical conditions. In these critical patients, systematic TLVV improved hemodynamic seemed to provide better in hospital survival and chance of recovery, compared to VA-ECMO results in the treatment of cardiogenic shock reported in the literature . TLVV is a viable alternative to standard VA-ECMO to identify the appropriate long-term strategy (heart transplantation or long-term VAD) reducing the risk of treatment failure. A larger and multicenter experience is mandatory to validate these hypothesis.

Clinical and Prognostic Role of Noninvasive Hemodynamic Assessment in Left Ventricular Assist Device Carriers.

Persistence of heart failure symptoms or suboptimal hemodynamic is a frequent condition in LVAD carriers, associated with adverse outcome. Invasive hemodynamic optimization was associated with a better outcome. Our group recently validated an echocardiographic protocol to noninvasively assess hemodynamics of LVAD patients. Aim of this prospective study was to investigate its utility in clinical practice and its prognostic role. From February 2016 to February 2019 fifty-five LVAD carriers (HVAD/HM3 34/21; age 61 ± 10 years, 89% males; INTERMACS profile at LVAD implantation ≤3 68%). A two-phased protocol was performed. First, the patient underwent clinical evaluation. Second, an echo-Doppler blinded to clinical data was performed. Clinical and echo-Doppler evaluation both identified patients with "optimal hemodynamic profile" (normal left and right estimated atrial pressures) versus other profiles. clinical evaluation overestimated the presence of an optimal profile compared with echo-Doppler (83% vs. 59%). The presence of overt heart failure identified patients with the highest risk of adverse outcomes (death or hospitalization for HF at 6 months: HR 15, 95% CI, 5.5-39, P < 0.001). An optimal profile by echo-Doppler was associated with a better outcome among patients without overt heart failure (death or hospitalization for HF at 6 months: HR 0.08, 95% CI, 0.01.5-0.64, P < 0.02). After echo-Doppler, the clinician modified treatment in 46 cases (37%). Noninvasive evaluation of hemodynamics by echo-Doppler adds significant prognostic information in LVAD patients without overt HF and is a valuable tool to tailor treatment in the outpatient follow-up of LVAD carriers. Visual abstract: http://links.lww.com/ASAIO/A783.

[Management of cardiogenic shock: a proposal for a shared protocol]. / Gestione dello shock cardiogeno: una proposta di percorso integrato.

Cardiogenic shock (CS) is a complex and relatively rare disease. Whilst its mortality remains unacceptably high, a multidisciplinary approach based on pre-established and shared protocols may improve prognosis and ensure appropriate resource allocation. Comprehensive hemodynamic assessment and monitoring as well as tailored, goal-directed medical therapy are part of an optimal management. Moreover, mechanical support devices may be helpful as they sustain hemodynamics to a greater extent as compared to inotropes and vasopressors, while lacking their cardiotoxic effects. Therefore, they are increasingly used in CS patients. In 2019, a new protocol for the management of patients with CS was adopted at the Ospedale Policlinico San Martino (HSM) in Genoa, Italy. Following in the footsteps of similar international experiences, the HSM protocol aims at streamlining the management of these high-risk patients improving the cooperation among healthcare specialists, and also addressing the key issues of mechanical support device implantation and appropriate referral for palliative care.

Minimally Invasive Approach to Correct Anomalous Inferior Vena Cava Connection to the Left Atrium.

Anomalous drainage of the inferior vena cava into the left atrium is a rare congenital condition. A 20-year-old girl was referred for recurrent transient ischemic attacks. Transthoracic echocardiography revealed a large ostium secundum atrial septal defect, and computed tomography showed anomalous drainage of the inferior vena cava into the left atrium. Through a right mini-thoracotomy, the opening of the inferior vena cava into the atrium was identified under the inferior edge of the interatrial septum, draining into the left atrium, and redirected to the right atrium, using a pericardial patch to reconstruct the atrial septum. Postoperative course was uneventful. Right mini-thoracotomy approach was effective in correcting the anomalous drainage of the inferior vena cava into the left atrium.

Noninvasive Assessment of Hemodynamic Status in HeartWare Left Ventricular Assist Device Patients: Validation of an Echocardiographic Approach.

OBJECTIVES: The aim of this prospective study was to validate an echocardiographic protocol derived from 5 HeartWare left ventricular assist device (HVAD) patients for the noninvasive evaluation of right atrial pressure (RAP) and left atrial pressure (LAP) in HVAD patients. BACKGROUND: Echocardiography is an invaluable tool to optimize medical treatment and pump settings and also for troubleshooting residual heart failure. Little is known about the echocardiographic evaluation of hemodynamic status in HVAD patients. METHODS: Right heart catheterization and Doppler echocardiography were performed in 35 HVAD patients. Echocardiography-estimated RAP (eRAP) was assessed using inferior vena cava diameter, hepatic venous flow analysis, and tricuspid E/e' ratio. Echocardiography-estimated LAP was assessed using E/A ratio, mitral E/e' ratio, and deceleration time. RESULTS: eRAP and estimated LAP significantly correlated with invasive RAP and LAP (respectively, r = 0.839, p < 0.001, and r = 0.889, p < 0.001) and accurately detected high RAP and high LAP (respectively, area under the curve 0.94, p < 0.001, and area under the curve 0.91, p < 0.001). High eRAP was associated with high LAP (area under the curve 0.92, p < 0.001) and correlated with death or hospitalization at 180 days (odds ratio: 8.2; 95% confidence interval: 1.1 to 21.0; p = 0.04). According to estimated LAP and eRAP, patients were categorized into 4 hemodynamic profiles. Fifteen patients (43%) showed the optimal unloading profile (normal eRAP and normal wedge pressure). This profile showed a trend toward a lower risk for adverse cardiac events at follow-up (odds ratio: 0.2; 95% confidence interval: 0.1 to 1.0; p = 0.05) compared with other hemodynamic profiles. CONCLUSIONS: Doppler echocardiography accurately estimated hemodynamic status in HVAD patients. This algorithm reliably detected high RAP and LAP. Notably, high RAP was associated with high wedge pressure and adverse outcome. The benefit of noninvasive estimation of hemodynamic status in the clinical management of patients with left ventricular assist devices needs further evaluation.

HeartMate 3 left ventricular assist device minimally invasive off-pump implantation.

With advancements in mechanical circulatory support technology, and limitations in donor supply for heart transplantation, the use of left ventricular assist devices (LVADs) has increased significantly in recent years. Multiple studies have shown that minimally invasive cardiac surgery can improve outcomes, with shorter hospital stays, decreased morbidity, faster recovery and ambulation, and lower total hospital costs. The current generation of centrifugal continuous-flow pumps is miniaturized and makes minimally invasive approaches increasingly practicable. Lateral surgical access to the ventricle allows off-pump implantation with minimal risk of blood loss, reducing the risk of air embolism and difficult de-airing. Off-pump implantation reduces hemodilution, systemic inflammatory response syndrome due to extracorporeal circulation, and the negative effects of pulmonary hypertension and right ventricular dysfunction in the perioperative period. Minimally invasive lateral access is encouraged in cases of bridge-to-transplant to avoid the risks associated with resternotomy.  We describe the surgical technique for minimally invasive implantation of the HeartMate 3 (Abbott, USA) left ventricular assist device (LVAD), avoiding sternotomy and cardiopulmonary bypass. Our surgical approach was based on a left minithoracotomy for the LVAD implantation and a right thoracotomy for the outflow graft anastomosis to the ascending aorta.

Thrombosis in left ventricular assistance device with centrifugal technology: is early thrombolysis a better solution?

BACKGROUND: Continuous flow left ventricular assistance devices (CF-LVADs) have revolutionized the treatment of advanced heart failure. Pump replacement for thrombosis is a high-risk procedure with a high perioperative mortality rate with possible recurrence. We aim to summarize our experience using a conservative approach with medical therapy. METHODS: We retrospectively reviewed records of patients who experienced pump thrombosis after LVAD implantation with HeartWare HVAD at our institution, from November 2010 to March 2016. Device thrombosis (DT) was divided into suspected (SDT) and confirmed (CDT). A conservative approach using thrombolysis and heparin was used in all patients. RESULTS: A total of 32 HeartWare HVAD pumps were implanted. Mean age was 59 ± 10 years and the mean time on mechanical support was 19.29 months (±14.06). Pump thrombosis occurred in 7 patients (0.14 patients/year) after a mean time of 733 (231-1,606) days after LVAD implantation. Three out of 7 cases had thrombosis recurrence (43%). Overall 19 episodes were recorded (0.38 event per patient/year). Eighteen out of 19 thrombolytic treatments were successful (94.7%). No patient required LVAD replacement or transfusion of blood products. There was no significant difference in terms of survival between patients who experienced thrombotic events and patients who did not. No major complications related to thrombolysis were recorded. CONCLUSIONS: Systemic thrombolysis plus heparin was an excellent therapeutic option. Early intervention in clinically stable patients without signs of heart failure but with indirect signs of device thrombosis has led to better outcomes.

Low incidence of gastrointestinal bleeding and pump thrombosis in patients receiving the INCOR LVAD system in the long-term follow-up.

BACKGROUND: Left ventricular assist device (LVAD) implantation improves survival and quality of life in patients with advanced heart failure (HF). Despite these advantages, LVADs are not free from risks. Among all adverse events (AE), pump thrombosis and bleeding, especially of the gastrointestinal (GI) tract, have been reported to occur with increasing frequency in some CF-LVADs. The INCOR LVAD system is a third-generation, continuous flow, axial pump with active magnetic levitation, avoiding the potential downsides of mechanical bearings. METHODS: The aim of this retrospective study was to review the Italian clinical experience with the INCOR LVAD and to determine the prevalence of GI bleeding and pump thrombosis. All patients implanted between January 2006 and May 2012 were considered eligible. RESULTS: The total population consisted of 42 patients. LVAD indication was BTT in 36 (86%) and DT in 6 (14%) patients; 31 patients (74%) were INTERMACS class 1 or 2. Mean support time was 525 ± 570 days. The 1-year and 2-year survival rates were 74% and 60%, respectively. The most frequent AE was driveline infection (0.33 events PPY) followed by stroke with consequence (0.17 events PPY), sepsis (0.07 events PPY), and right HF (0.05 events PPY). No episodes of pump thrombosis or GI bleeding were observed. CONCLUSIONS: In this cohort of high-risk, advanced HF patients, the INCOR LVAD provided effective support with improved survival. Moreover, the absence of GI bleeding and pump thrombosis demonstrates a favorable characteristic of this device. Further prospective studies are needed to confirm these data.

A simple device to secure ventricular assist device driveline and prevent exit-site infection.

OBJECTIVES: Driveline infections are one of the most common and important complications in patients with left ventricular assist device (LVAD). One of the causes favouring the development of this complication is the traumatism of the exit site, which occurs in response to movement of the driveline. In this work, we present a simple and feasible method to immobilize the driveline at the level of the exit site. METHODS: From April 2013 until November 2013, 6 patients underwent implantation of HeartWare LVAD (HVAD) for an end-stage heart failure. When the patient has begun to mobilize after the implantation of the device, we have combined the use of two components with the aim of securing the driveline to the patient's skin: a StatLock system and a silicone suture. RESULTS: No case of local traumatism and no case of local infection at the driveline were observed during the follow-up. No patient reported pain or swelling at the driveline exit site. All patients were satisfied with their quality-of-life and they do not report any limitations in their daily activities. CONCLUSIONS: One of the major long-term complications in patients with LVAD is the development of infections of the exit site of the driveline. The trauma of this skin region promotes the onset and maintenance of an inflammatory process and local infectious. Avoiding excessive mobilization of the driveline is likely to reduce the incidence of infections of the exit site and improve the quality-of-life.

Advanced heart failure in critical patients (INTERMACS 1 and 2 levels): ventricular assist devices or emergency transplantation?

OBJECTIVE: For patients in advanced heart failure, emergency transplantation or ventricular assist devices (VADs) are possible strategies. The aim of this single-centre, retrospective study was to evaluate early and long-term results for these two strategies. METHODS: From 2005 to 2011, we analysed 49 INTERMACS level 1 and 2 patients, who were divided into the following two groups: group A comprised 26 patients on the waiting list for heart transplantation with urgent conditions; and group B comprised 23 patients who underwent VAD implantation as a bridge to candidacy. RESULTS: In group A, 25 patients underwent transplantation. In group B, 19 patients were supported with left VAD and four with biventricular VAD. Of these 23 patients, 13 underwent transplantation (mean time 279 ± 196 days). The 30 day mortality was 42.3 and 4.3% in group A and B, respectively. Survival at 6 and 12 months was significantly better in group B than in group A (87 vs 53%, P = 0.018 at 6 months; and 77 vs 48%, P = 0.045 at 12 months). CONCLUSION: Improved outcomes may justify the use of mechanical assistance devices as a bridge to candidacy or bridge to transplantation in INTERMACS 1 and 2 patients in order to avoid high-risk transplants. Evaluation of long-term multicentre outcomes is needed to assess future strategies.

Successful replacement of a detached pedestal during support with Jarvik 2000.

Infection in patients supported with left ventricular assist devices (LVAD) is common and it can limit widespread implantation of mechanical assistance as destination therapy (DT). The infection-resistance power delivery system could improve longevity and quality of life. The Jarvik 2000 (Jarvik Heart, New York, NY, USA) driveline design showed a prolonged infection-free survival and a better quality of life compared to those patients supported with traditional LVAD with an abdominal cable. We report a singular driveline complication in a 71-year-old patient supported with a Jarvik 2000. A new retroauricular pedestal was successfully repositioned after the detachement of the first one.