LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

Aortic Valve Repair with External Annuloplasty in Bicuspid versus Tricuspid Aortic Valve Patients.

Surgical repair for regurgitant bicuspid aortic valve (BAV) is promising but underutilized due to perceived complexities and lack of long-term data. This study evaluated the efficacy of valve-sparing root remodeling (VSRR) or isolated valve repair combined with calibrated external ring annuloplasty in BAV versus tricuspid aortic valve (TAV) patients. All patients operated on for aortic regurgitation and/or aneurysm at our institution between 2014 and 2022 were included and entered into the Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry (AVIATOR). Patients with successful repair at index surgery (100% in the BAV group, 93% in the TAV group, p = 0.044) were included in a systemic follow-up with echocardiography at regular intervals. Among 132 patients, 58 were in the BAV (44%) and 74 in the TAV group (56%). There were no inter-group differences in preoperative patient characteristics, except BAV patients being significantly younger (47 ± 18 y vs. 60 ± 14 y, p < 0.001) and having narrower aortic roots at the level of sinuses (41 ± 6 mm vs. 46 ± 13 mm, p < 0.001) and sinotubular junctions (39 ± 10 mm vs. 42 ± 11, p = 0.032). No perioperative deaths were recorded. At four years, there was no significant difference in terms of overall survival (96.3% BAV vs. 97.2% TAV, p = 0.373), freedom from valve reintervention (85.2% BAV vs. 93.4% TAV, p = 0.905), and freedom from severe aortic regurgitation (94.1% BAV vs. 82.9% TAV, p = 0.222). Surgical repair of BAV combined with extra-aortic annuloplasty can be performed with low perioperative morbidity and mortality and excellent mid-term results which are comparable to TAV repair.

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis-A Multicentre Real-World Experience.

BACKGROUND: Bicuspid aortic valve (BAV) affects approximately 1.5% of the general population and is seen in nearly 50% of candidates for aortic valve replacement (AVR). Despite increasingly utilised transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) patients, its use among patients with severe bicuspid AS is limited as BAV is a heterogeneous disease associated with multiple and complex anatomical challenges. AIM: To investigate the one-year outcomes of TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., Vapi, India) in patients with severe bicuspid AS. METHODS AND RESULTS: We collected data from consecutive patients with bicuspid AS who underwent TAVI with the Myval THV and had at least one-year follow-up. Baseline characteristics, procedural, and 30-day echocardiographic and clinical outcomes were collected. Sixty-two patients were included in the study. The median age was 72 [66.3, 77.0] years, 45 (72.6%) were males, and the mean STS PROM score was 3.2 ± 2.2%. All TAVI procedures were performed via the transfemoral route. The median follow-up duration was 13.5 [12.2, 18.3] months; all-cause mortality was reported in 7 (11.3%) patients and cardiovascular hospitalisation in 6 (10.6%) patients. All-stroke was reported in 2 (3.2%), permanent pacemaker implantation 5 (8.3%), and myocardial infarction 1 (1.6%) patients. The echocardiographic assessment revealed a mean pressure gradient of 10 [8, 16.5] mmHg, effective orifice area 1.7 [1.4, 1.9] cm2, moderate AR in 1 (2%), mild AR in 14 (27%), and none/trace AR in 37 (71%). In total, 1 patient was diagnosed with valve thrombosis (2.1%), Stage II (moderate) haemodynamic deterioration was seen in 3 (6.4%), and stage III (severe) haemodynamic deterioration in 1 (2.1%) patient. CONCLUSIONS: TAVI with the Myval THV in selected BAV anatomy is associated with favourable one-year hemodynamic and clinical outcomes.

Transcatheter valve-in-valve or valve-in-ring implantation with a novel balloon-expandable device in patients with bioprosthetic left side heart valves failure: 1-year follow-up from a multicenter experience.

BACKGROUND: Transcatheter aortic and mitral valve-in-valve (ViV) or valve-in-ring (ViR) implantation into failed bioprosthetic heart valves (BHVs) or rings represents an appealing, less invasive, treatment option for patients at high surgical risk. Nowadays, few data have been reported on the use of balloon-expandable Myval (Meril Life Science, Vapi, India) transcatheter heart valve (THV) for the treatment of degenerated BHVs or rings. We aimed at evaluating the early and mid-term clinical outcomes of patients with left side heart bioprosthesis deterioration treated with transcatheter ViV/ViR implantation using Myval THV. METHODS: 97 consecutive patients with symptomatic, severe aortic(n=33) and mitral(n=64) BHVs/ring dysfunction underwent transcatheter aortic ViV and mitral ViV/ViR implantation with Myval THV. RESULTS: Technical success was achieved in 95 (98%) of the patients. Two cases of acute structural trans-catheter mitral ViV/ViR dysfunction requiring a second THV implantation were reported. At 30-day, a significant reduction in prosthetic trans-valvular pressure gradients and increase in valve areas were seen following both aortic and mitral ViV/ViR implantation. Overall survival at 15 months (IQR 8-21) was 92%. Patients undergoing mitral ViV/ViR had a relatively worse survival compared with those undergoing aortic ViV implantation (89% vs. 97% respectively; HR:2.7,CI:0.33-22.7;p=0.34). At longest follow-up available a significant improvement in NYHA functional class I and II was observed in patients with aortic and mitral ViV/ViR implantation(93.8% and 92.1%). CONCLUSIONS: Despite high surgical risk, transcatheter ViV/ViR implantation for failed left side heart bioprosthesis can be performed safely using Myval THV with a high success rate and low early and mid-term mortality and morbidity.

Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience.

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI's procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Comparison between OPCABG and CABG Surgical Revascularization Using Transit Time Flow Measurement (TTFM).

OBJECTIVE: To compare the intraoperative quality of coronary anastomoses performed with or without cardiopulmonary bypass using transit time flow measurement (TTFM) parameters. METHODS: We collected data from 588 consecutive patients who underwent surgical revascularization. We retrospectively reviewed data from two groups: 411 with cardiopulmonary bypass (CABG group) and 177 off-pump (OPCABG group). Transit time flow measurement parameters: mean graft flow (MGF), pulsatile index (PI), and diastolic filing (DF) were measured for each graft and patient. RESULTS: Patients in the OPCABG group had higher EuroSCORE compared with the CABG group (3.53 ± 2.32 versus 2.84 ± 2.15, P = .002). Overall comparison of TTFM parameters showed no statistical difference between the two surgical techniques except for PI in circumflex artery territory, which was higher in the OPCABG group for all types of grafts 3.0 ± 4.9 versus 2.4 ± 2.0 in, P = .026. CONCLUSION: The comparison between OPCABG and CABG in this study showed comparable results with both surgical techniques. PI was higher in the OPCABG group in harder-to-reach vessel territories. Measurement of transit time may improve the quality, safety, and efficacy of coronary artery bypass grafting and should be considered as a routine procedure.

The Dark Side of the Heart: Cardiovascular Manifestation of Ochronosis.

Alkaptonuria is rare genetic disorder of tyrosine metabolism manifesting with signs of tissue pigmentation, dark urine, and ochronotic arthropathies. Commonly undiscovered by late adulthood, alkaptonuria can manifest as cardiac ochronosis with cardiovascular disorders such as valvulopathies, but rarely coronary artery disease. This case report describes 2 patients with aortic stenosis and coronary artery disease in whom alkaptonuria was diagnosed during open heart surgery.

Immunoglobulin G4 Inflammatory Aortic Aneurysm Mimicking Acute Aortic Syndrome.

Immunoglobulin-G4-related disease (IgG4RD) is a novel clinical entity characterized by lymphoplasmacytic infiltrates presenting as an excessive fibrosis such as retroperitoneal inflammatory pseudotumor but rarely affecting the heart or the aorta. We describe a case of IgG4RD with multifocal aortic involvement presenting as an acute aortic syndrome.

Isolated Tricuspid Valve Libman-Sacks Endocarditis in Systemic Lupus Erythematosus with Secondary Antiphospholipid Syndrome.

Libman-Sacks endocarditis, one of the most prevalent cardiac presentations of systemic lupus erythematosus, typically affects the aortic or mitral valve; tricuspid valve involvement is highly unusual. Secondary antiphospholipid syndrome increases the frequency and severity of cardiac valvular disease in systemic lupus erythematosus. We present the case of a 47-year-old woman with lupus and antiphospholipid syndrome whose massive tricuspid regurgitation was caused by Libman-Sacks endocarditis isolated to the tricuspid valve. In addition, we discuss this rare case in the context of the relevant medical literature.

Successful treatment of annular rupture during transcatheter aortic valve implantation.

Annular rupture presents a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). Although it can be subtle and subclinical in presentation, most severe forms present with hemodynamic instability and represent true emergencies requiring a more invasive treatment, even conventional surgery. We present a case of successful treatment of annular rupture by left ventricular outflow tract patch and surgical aortic valve replacement.

Ventricular tachycardia: ominous sign of devastating prosthetic aortic valve dehiscence.

Prosthetic valve endocarditis (PVE) is the most feared complication after valve implantation. It usually results in substantial morbidity and mortality in the postoperative period. An adverse effect on the annulus can cause conduction disturbances in the atrioventricular (AV) node, resulting in a high-degree AV block. This study describes a case of PVE that predominantly presented with sustained monomorphic ventricular tachycardia, which indicated a severe clinical course of PVE caused by a significant displacement of the aortic valve prosthesis. In our opinion, a very pronounced flap valve motion of the dehisced valve probably caused, in the critical moment, coronary artery blood flow limitation by means of coronary microembolization, which produced temporary ischemia and provoked sustained ventricular tachycardia. Furthermore, disturbances of rhythm such as ventricular tachycardia in the setting of endocarditis indicate a high-risk condition and should mandate fast and thorough noninvasive diagnostic procedures to obtain correct diagnosis even in the case of mild, slowly progressing disease.

Cardiac surgery-associated acute kidney injury: risk factors analysis and comparison of prediction models.

OBJECTIVES: Cardiac surgery-associated acute kidney injury (AKI) is a well-known factor influencing patients' long-term morbidity and mortality. Several prediction models of AKI requiring dialysis (AKI-D) have been developed. Only a few direct comparisons of these models have been done. Recently, a new, more uniform and objective definition of AKI has been proposed [Kidney Disease: Improve Global Outcomes (KDIGO)-AKI]. The performance of these prediction models has not yet been tested. METHODS: Preoperative demographic and clinical characteristics of 1056 consecutive adult patients undergoing cardiac surgery were collected retrospectively for the period 2012-2014. Multivariable logistic regression analysis was used to determine the independent predictors of AKI-D and the KDIGO-AKI stages. Risk scores of five prediction models were calculated using corresponding subgroups of patients. The discrimination of these models was calculated by the c-statistics (area under curve, AUC) and the calibration was evaluated for the model with the highest AUC by calibration plots. RESULTS: The incidence of AKI-D was 3.5% and for KDIGO-AKI 23% (17.3% for Stage 1, 2.1% for Stage 2 and 3.6% for Stage 3). Older age, atrial fibrillation, NYHA class III or IV heart failure, previous cardiac surgery, higher preoperative serum creatinine and endocarditis were independently associated with the development of AKI-D. For KDIGO-AKI, higher body mass index, older age, female gender, chronic obstructive pulmonary disease, previous cardiac surgery, atrial fibrillation, NYHA class III or IV heart failure, higher preoperative serum creatinine and the use of cardiopulmonary bypass were independent predictors. The model by Thakar et al. showed the best performance in the prediction of AKI-D (AUC 0.837; 95% CI = 0.810-0.862) and also in the prediction of KDIGO-AKI stage 1 and higher (AUC = 0.731; 95% CI = 0.639-0.761), KDIGO-AKI stage 2 and higher (AUC = 0.811; 95% CI = 0.783-0.838) and for KDIGO-AKI stage 3 (AUC = 0.842; 95% CI = 0.816-0.867). CONCLUSIONS: The performance of known prediction models for AKI-D was found reasonably well in the prediction of KDIGO-AKI, with the model by Thakar having the highest predictive value in the discrimination of patients with risk for all KDIGO-AKI stages.

Off-pump myocardial revascularization attenuates endothelin-1 expression in systemic, pulmonary, and coronary circulation.

OBJECTIVE: The objective of this study was to evaluate the influence of cardiopulmonary bypass (CPB) on endothelin-1 (ET-1) expression in various circulation compartments in patients undergoing myocardial revascularization. METHODS: A total of 30 patients were randomized to undergo myocardial revascularization with (CABG, n = 15) or without (OPCAB, n = 15) CPB. Samples were taken preoperatively, after establishing CPB and after CPB (CABG group), prior to and after revascularization (OPCAB group), and 6 and 24 h postoperatively. Values of ET-1 were compared between groups at all time points and correlated with postoperative cardioselective enzyme values and clinical parameters. RESULTS: In OPCAB group, ET-1 levels did not significantly vary between time points. In CABG group, ET-1 levels were significantly elevated vs. baseline in arterial: ART-T2 vs. ART-T0 (1.83 ± 1.81 vs. 0.76 ± 1.07 fmol/mL, p = 0.05), pulmonary: SG-T2 vs. SG-T0 (2.70 ± 2.75 vs. 0.39 ± 0.28 fmol/mL, p < 0.001) and SG-T3 vs. SG-T0 (1.56 ± 0.28 vs. 0.39 ± 0.28 fmol/mL, p < 0.001), and coronary circulation CS-T2 vs. CS-T1 (1.12 ± 0.49 vs. 0.27 ± 0.09 fmol/mL, p = 0.01). ET-1 levels were significantly higher in CABG group in all vascular compartments: ART-T2 (1.83 ± 1.81 vs. 0.17 ± 0.16 fmol/mL, p = 0.02), ART-T4 (0.99 ± 0.56 vs. 0.24 ± 0.12 fmol/mL, p = 0.01), SG-T1 (0.59 ± 0.15 vs. 0.25 ± 0.13 fmol/mL, p = 0.01), SG-T2 (2.70 ± 2.75 vs. 0.30 ± 0.24 fmol/mL, p = 0.004), SG-T3 (1.56 ± 0.28 vs. 0.35 ± 0.31 fmol/mL, p < 0.001), SG-T4 (1.34 ± 0.11 vs. 0.34 ± 0.16 fmol/mL, p < 0.001), and CS-T2 (1.12 ± 0.49 vs. 0.12 ± 0.12 fmol/mL, p = 0.004). Coronary sinus ET-1 level after CPB (CS-T2) in CABG group correlated positively with troponin-I level 24 h postoperatively (r(2) = 0.802, p = 0.02) CONCLUSION: Off-pump myocardial revascularization attenuates ET-1 expression in all investigated vascular compartments. Elevated coronary ET-1 levels after CPB in CABG group correlate with troponin-I levels 24 h postoperatively.

Aortic valve endocarditis in a transplanted heart after urethral instrumentation.

Endocarditis represents a rare but life-threatening condition after heart transplantation. Recent American Heart Association guidelines recognize cardiac transplant patients with valvulopathy as high risk for endocarditis, but acknowledge that there were not sufficient data to make a recommendation for prophylaxis. Also, genitourinary procedures were no longer considered a risk factor for endocarditis in the most recent guidelines. We present a patient who acquired aortic valve endocarditis of the intact valve, after multiple urethral instrumentation 2 years after heart transplantation, who was successfully treated by aortic valve replacement and prolonged antibiotic therapy.

[Recovery after long-term pulsatile mechanical circulatory support in patient with chronic heart failure: a case report]. / Oporavak nakon dugotrajne mehanicke cirkulatorne potpore u bolesnika s kronicnim zatajivanjem srca: prikaz bolesnika.

Use of mechanical circulatory support (MCS) is a part of today's standard therapy in the treatment of end-stage heart failure. In this paper we describe characteristics of Thoratec pVAD device for MCS, implantation techniques, as well as the most important advantages and complications of application of the device. We present a 41-year-old patient with dilatated cardiomyopathy, who was the first recipient ofparacorporeal left ventricular assist device (LVAD) in the Republic of Croatia due to end-stage heart failure. After heart function recovery the patient was successfully weaned from MCS after 130 days of support.

Echocardiography in detecting implantable cardioverter defibrillator lead endocarditis: case report.

Lead endocarditis is an infrequent but potentially lethal complication of implantable cardioverter defibrillator (ICD) implantation. We report a case of a 53-year-old man with ICD who was admitted to our hospital because of fever, chills, shivering, headache and malaise. Transthoracic echocardiography detected a structure highly suspect of vegetation located on the ICD lead. Transesophageal echocardiography showed a 20x12 mm mobile vegetation attached to the ICD lead in the right atrium. The infection was caused by methicillin-resistant Staphylococcus epidermidis (MRSE), which was isolated from blood cultures. Treatment consisted of surgical removal of the ICD lead and placement of new epicardial ICD leads. Three years afterwards, the patient remained asymptomatic. To our knowledge, this is the first such case reported from Croatia.

Asymptomatic calcifying fibrous pseudotumor compressing heart cavities.

Calcifying fibrous pseudotumor is a rare benign lesion composed mostly of dense hyalinized colagen with multiple dystrophic or psammomatous calcifications and variable lymphoplasmacytic infiltrate. Children and young adults are most commonly affected by this tumor of uncertain pathogenesis. This is a case of an asymptomatic young woman with calcifying fibrous pseudotumor of the pericardium compressing heart cavities. Partial resection and marsupialization of the mass was performed.