3D Virtual modelling, 3D printing and extended reality for planning of implant procedure of short-term and long-term mechanical circulatory support devices and heart transplantation.

Introduction: The use of three-dimensional (3D) reconstruction and printing technology, together with extended reality applied to advanced heart failure adult patients with complex anatomy, is rapidly spreading in clinical practice. We report practical experience with application to acute and chronic heart failure: planning and performing mechanical circulatory device insertion or heart transplantation. Methods: From November 2019 until February 2022, 53 3D virtual biomodels were produced for intervention planning (using Virtual/Augmented Reality and/or 3D printing), following a specific segmentation and preprocessing workflow for biomodelling, in patients with advanced heart failure due to structural heart disease or cardiomyopathies. Four of those patients were complex cases requiring mechanical circulatory support implant procedures in our center. Results: One short-term and three long-term ventricular assist device system were successfully clinically implanted after application of this technique. In other two cases with extremely high procedural risk, visualized after application of this multimodality imaging, heart transplantation was elected. Conclusion: 3D printing based planning and virtual procedure simulation, are of great importance to select appropriate candidates for mechanical circulatory support in case of complex patient anatomy and may help to diminish periprocedural complications. Extended reality represents a perspective tool in planification of complex surgical procedures or ventricular assist device insertion in this setting.

Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. AIMS: We aimed to evaluate the safety and feasibility of Myval in NCAR. METHODS: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. RESULTS: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047). CONCLUSIONS: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

VA-ECMO rescue therapy in propofol infusion syndrome after cardiac surgery.

INTRODUCTION: Propofol infusion syndrome (PRIS) is a rare entity that could lead to profound cardiogenic shock (CS). Mitochondrial toxicity and sympathetic blockade are the mechanisms leading to CS in PRIS. CASE REPORT: We present a 22-year-old woman who developed refractory CS due to PRIS after aortic valve replacement surgery secondary to Coxiella infective endocarditis. She was rescued with VA-ECMO (veno-arterial extracorporeal membrane oxygenation) and was discharged 2 months later with no cardiac dysfunction. DISCUSSION: PRIS diagnosis is difficult even though propofol is frequently used in critical care units. Abrupt refractory CS in patients with recent use of high doses of propofol (> 4 mg/Kg/h) together with rhabdomyolysis should raise the suspicion. Diagnostic confirmation is based on muscle biopsy and fat enzyme analysis. CONCLUSION: Propofol withdrawal and support therapies-including VA-ECMO-are the treatment of choice in severe PRIS. VA-ECMO could increase survival as a bridge to recovery due to reversibility of PRIS.

Cardiogenic shock code 2023. Expert document for a multidisciplinary organization that allows quality care.

Despite the efforts made to improve the care of cardiogenic shock (CS) patients, including the development of mechanical circulatory support (MCS), the prognosis of these patients continues to be poor. In this context, CS code initiatives arise, based on providing adequate, rapid, and quality care to these patients. In this multidisciplinary document we try to justify the need to implement the SC code, defining its structure/organization, activation criteria, patient flow according to care level, and quality indicators. Our specific purposes are: a) to present the peculiarities of this condition and the lessons of infarction code and previous experiences in CS; b) to detail the structure of the teams, their logistics and the bases for the management of these patients, the choice of the type of MCS, and the moment of its implantation, and c) to address challenges to SC code implementation, including the uniqueness of the pediatric SC code. There is an urgent need to develop protocolized, multidisciplinary, and centralized care in hospitals with a large volume and experience that will minimize inequity in access to the MCS and improve the survival of these patients. Only institutional and structural support from the different administrations will allow optimizing care for CS.

Challenges in cannulation of left ventricular apex for temporary circulatory support: a case report.

Apical cannulation of a left ventricle for temporary support is still challenging, especially in case of prolonged support due to donor organ shortage. Traditional cannulation techniques with the cannula being directly inserted into the left ventricle cavity are technically easy, but prone to hemorrhage during circulatory support, unsafe for a prolonged support (over than 30 days) and limits the possibility to ambulate patient due to risk for cannula dislocation and related life-threatening bleeding. We describe a case of temporary left ventricular assist device placement in a 59-year-old male patient being on veno-arterial extracorporeal membrane oxygenation support secondary to acute myocardial infarction. We present a very simple technique to secure insertion of an apical left ventricular cannula using patch of soft Teflon felt. Handmade created apical soft Teflon cuff is than fixed using twelve 4/0 prolene sutures supported with pledgets. This gives better fixation to apical myocardium (especially in case of fragile tissue after acute infarction) and secure intracavitary length of inflow cannula in a controlled mode, thus better than purse-string sutures only. Using anti-adhesive membrane, further dissection during heart transplant procedure was uneventful. This technique allowed safe circulatory support and patient ambulation in the ward during 85 days until heart transplantation.

Clinical use of percutaneous mechanical circulatory assistance in a patient with end-stage right-sided heart failure and massive tricuspid insufficiency due to congenital heart disease: first-in-the-world case report.

BACKGROUND: Due to improvement in the management of patients with congenital heart disease (CHD), the likelihood of their survival to adulthood is increasing. A relevant population suffers end-stage right ventricular failure (RVF) in their 3rd-4th decade of life. Hence, heart transplantation is still gold standard of treatment of end-stage heart failure, mechanical circulatory assistance has become a valuable tool in the bridging to heart transplant or definitive therapy. Use of implantable short-term or long-term devices is reported by others. However, within this clinical context, presence of significant tricuspid regurgitation (TR) or CHD is used as exclusion criteria for insertion of a percutaneous right ventricular circulatory support. CASE SUMMARY: We described a 36-year-old patient diagnosed with Ebstein's anomaly and severe TR who is admitted to hospital due to RVF refractory to standard medical treatment. After case presentation to the heart team, an Impella RP device insertion was scheduled, in spite of the presence of TR or CHD after evaluation of pulmonary valve competency and 3D reconstruction with virtual device implantation. During support, the patient improved clinically and haemodynamically. Due to device displacement to the right ventricle, it was bedside explanted after 30 days of support. After mechanical unloading during 30 days patients' right ventricle recovered partially, permitting patient to improve his functional class. DISCUSSION: Although TR and CHD are exclusion criteria for the implantation of the Impella RP device, we report clinical experience in patient with Ebstein's anomaly and severe TR supported with percutaneous device as bridge to heart transplantation during 30 days.

Acoustic spectral analysis for determining pump thrombosis in rotary blood pumps.

Implantation of rotary blood pumps is an established treatment for end-stage heart failure. Anticoagulation is routinely used for reducing pump thrombosis, but this severe complication still occurs in 5-8% of patients. In 105 patients, the sound produced by the left ventricular assist device HeartWare HVAD was prospectively and sequentially recorded. The acoustic spectra calculated by runtime fast Fourier transformation were investigated. Results were compared with respect to patients without thrombotic complications (97 patients) and those with signs of pump thrombosis (8 patients). All eight pumps exchanged were opened and investigated. Thrombus formation was confirmed in all eight exchanged pumps. The existence of a sound peak with the threefold frequency of the pump speed correlated with the presence of thrombi inside the pump (p < 0.001). An increase in the sound amplitude of the rotary frequency of approximately 75% compared to previous measurements also denotes pump thrombosis. Analysis of the acoustic spectrum of the HVAD pump can be used as a reliable method to detect pump thrombosis. The appearance of third harmonics indicates the presence of thrombotic particles independently of previous baseline measurements. The goal of this study is to define and validate such a method.

Load dependency of right ventricular performance is a major factor to be considered in decision making before ventricular assist device implantation.

BACKGROUND: Left ventricular assist devices (LVADs) provide better outcome than biventricular devices, but it is a challenge to predict the impact of LV mechanical unloading on postoperative right ventricular (RV) function preoperatively. We assessed the load dependency in RV performance before and after LVAD implantation aiming to improve preoperative decision making. METHODS AND RESULTS: Laboratory, echocardiography, and right heart catheterization data collected from 205 patients before LVAD implantation were tested for relationship with postoperative RV function. Comparing patients with different time-course of RV function after LVAD implantation, we found significant differences (P<0.01) in preoperative RV end-diastolic short-/long-axis and long-axis/length-area ratios, tricuspid annulus peak systolic velocity, RV peak longitudinal global systolic strain rate, systolic pressure gradient between RV and right atrium (ΔPRV-RA), tricuspid regurgitation velocity-time integral, and pulmonary arterial pressure between patients with and without postoperative RV failure. High predictive values for postoperative RV failure were found for end-diastolic short-/long-axis ratio ≥ 0.6, tricuspid annulus peak systolic velocity <8 cm/s, and peak systolic longitudinal strain rate <0.6/s in patients with maximum ΔPRV-RA <35 mm Hg. These parameters also seemed predictive for RV failure in patients with tricuspid regurgitation grade >2 and pulmonary arterial pressure <50 mm Hg. End-diastolic short-/long-axis ratio <0.6, tricuspid annulus peak systolic velocity ≥ 8 cm/s, and peak systolic longitudinal strain rate ≥ 0.6 in patients with maximum ΔPRV-RA ≥ 35 mm Hg showed high predictive values for postoperative freedom from RV failure. The RV load adaptation index seemed particularly predictive for RV function after LVAD implantation. CONCLUSIONS: RV geometry and velocity of contraction before LVAD implantation become more predictive for postoperative RV function and can improve decision making before VAD implantation if preoperative RV pressure load and tricuspid regurgitation are also considered.

Temporary right ventricular mechanical support in high-risk left ventricular assist device recipients versus permanent biventricular or total artificial heart support.

Early planned institution of temporary right ventricular assist device (RVAD) support with the CentriMag (Levitronix LLC, Waltham, MA, USA) in left ventricular assist device (LVAD) recipients was compared with permanent biventricular assist device (BVAD) or total artificial heart (TAH) support. Between 2007 and 2011, 77 patients (age range: 25-70 years) with preoperative evidence of biventricular dysfunction (University of Pennsylvania score >50; University of Michigan score >5) were included. Forty-six patients (38 men; median age 54.5 years, range: 25-70 years) underwent LVAD placement combined with temporary RVAD support (group A); in 31 patients (25 men; median age 56.7 years, range: 28-68 years), a permanent BVAD or TAH implantation (group B) was performed. Within 30 days, 12 patients from group A (26.08%) and 14 patients from group B (45.1%) died on mechanical support (P = 0.02). Thirty patients (65.2%) in group A were weaned from temporary RVAD support and three (6.5%) underwent permanent RVAD (HeartWare, Inc., Framingham, MA, USA) placement. A total of 26 patients (56.5%) were discharged home in group A versus 17 (54.8%) in group B (P = 0.56). Three patients (8.5%) received heart transplantation in group A and six (19.3%) in group B (P = 0.04). In group A, 90-day and 6-month survival was 54.3% (n = 25) versus 51.6% (n = 16) in group B (P = 0.66). In group A, 1-year survival was 45.6% (n = 21) versus 45.1% (n = 14) in group B (P = 0.81). The strategy of planned temporary RVAD support in LVAD recipients showed encouraging results if compared with those of a similar permanent BVAD/TAH population. Weaning from and removal of the temporary RVAD support may allow patients to be on LVAD support only despite preoperative biventricular dysfunction.

Thrombosis and cable damage in the HeartWare pump: clinical decisions and surgical technique.

Exchange of the HeartWare HVAD made necessary by thrombosis or cable damage is rare, but it is a complex procedure associated with morbidity. Less invasive exchange procedures may contribute to faster postoperative recovery and early mobilization. Between September 2009 and April 2012, 225 patients (median age 55.4 years, range 7-82 years, 40 of them women) were supported with the HeartWare HVAD at our institution. Cumulative follow-up in all 225 patients was 151.9 patient/years. In six patients, early pump thrombosis (<30 days) requiring pump exchange occurred after a median time of 7 (2-9) days. In six patients, late pump thrombosis requiring pump exchange occurred after a median of 380 (84-705) days. The overall incidence was 5.3% with 0.079 thromboses per year. In two instances of accidental cable damage as a result of massive external mechanical impact, pump exchange was necessary. We describe a safe and less invasive technique for the explantation and exchange of the HeartWare HVAD through a left thoracotomy. Pump thrombosis of the HeartWare HVAD is a very rare condition caused mostly by new onset of heparin-induced thrombocytopenia type II, mismanagement of anticoagulation, or hypercoagulability in the case of severe sepsis. Since the introduction of the sintered inflow cannula no early thrombosis has occurred. Pump exchange in the case of hemolysis should not be delayed. The cable of the HeartWare HVAD is very reliable and breaks only after excessive external impact. A minimally invasive approach for pump exchange on cardiopulmonary bypass for pump thrombosis and off-pump for cable damage or pump explantation is recommended.

Outcomes of HeartWare Ventricular Assist System support in 141 patients: a single-centre experience.

OBJECTIVES: A third-generation ventricular assist device, the HeartWare Ventricular Assist System, has demonstrated its reliability and durability in animal models and clinical experience. However, studies of a large series of applications are still lacking. We evaluate the safety and efficacy of the HeartWare pump in 141 patients with end-stage heart failure at a single centre. METHODS: A total of 141 patients (116 men and 25 women with a mean age of 52 years) in New York Heart Association (NYHA) Class IV received implantation of the HeartWare Ventricular Assist System between August 2009 and April 2011 at the Deutsches Herzzentrum Berlin. The outcomes were measured in terms of laboratory data, adverse events, NYHA functional class and survival during device support. RESULTS: The HeartWare system provided an adequate haemodynamic support for patients both inside and outside the hospital. NYHA class improved to I-II. Organ function and pulmonary vascular resistance improved significantly. In this cohort of patients, 14 patients underwent heart transplantation, one had had the device explanted following myocardial recovery, one had changed to another assist device, 81 were on ongoing support and 44 died. The overall actuarial survival rates at 6 and 12 months were 70 and 67%, respectively, and the 3-, 6- and 12-month survival rates on a left ventricular assist device (LVAD) support for bridge to transplantation patients were 82, 81 and 79%, respectively. Infection and bleeding were the main adverse events. Four patients underwent an LVAD exchange for pump thrombosis. CONCLUSIONS: The HeartWare system provides a safe and effective circulatory support in a population with a wide range of body surface areas, with a satisfactory actuarial survival time and an improved quality of life. It can be used for univentricular or biventricular support, being implanted into the pericardial space with simplified surgical techniques.