Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.

Introduction: Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria. Material and methods: A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey (n = 128), Italy (n = 58), and Greece (n = 21) (mean [standard deviation] 81 (7) years, 94 [45%] men; 73% NYHA III or IV; EuroSCORE II 5.2% [2.4%]); all patients underwent TAVI with Myval. Patients were followed up at 1 year and 2 years after implantation. Clinical and procedural outcomes were defined according to VARC-3 criteria. Results: Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%. Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.

Long-Term Observational Study of the Isolated Ostial Diagonal Stenosis in Patients with Chronic Coronary Syndrome.

OBJECTIVE: Isolated ostial diagonal stenoses are very rare lesions in which percutaneous intervention could cause significant vessel compromise, and the long-term results have been reported in a few studies. This study sought the characteristics and long-term follow-up of the patients with isolated osteal diagonal stenosis regarding percutaneous coronary intervention and presence of angina. METHODS: The study was an observational retrospective study conducted between January 2014 and December 2020. A total of 9769 patients who underwent coronary angiography were analyzed, and 87 patients had isolated diagonal stenosis. The patients were evaluated according to treatment modality and angina severity in long-term pattern. RESULTS: Median follow-up time was 36 months. A total of 54 (83.1%) patients were followed up with only medical treatment, and 11 (16.9%) patients underwent revascularization in addition to medical treatment. The degree of stenosis of the diagonal artery was significantly higher in the percutaneous coronary intervention group than medical group (P = 0.002) and the patients with wider reference diameter of diagonal artery complaint of more angina (P = 0.007). Class I angina was significantly higher in percutaneous coronary intervention group than medical and the patients with no angina were significantly higher in medical group than percutaneous coronary intervention group. CONCLUSION: Percutaneous coronary intervention was mainly performed for diagonal arteries with a higher degree of stenosis; however, the patients who underwent percutaneous coronary intervention had angina more than 50% rates. Furthermore, the patients with ongoing angina had a larger diameter of the diagonal artery regardless of the type of treatment.

Effect of percutaneous closure on atrium and appendage functions in patients with secundum atrial septal defects.

BACKGROUND: The study aimed to assess the impact of percutaneous transcatheter atrial septal defect (ASD) closure on atrium and atrial appandage functions among patients with ostium secundum ASDs. METHODS: A total of 101 patients (34,7% male, 65,3% female, 37,6 ± 12) with the diagnosis of ostium secundum type ASD underwent transthorasic (TTE) and transesophageal echocardiography (TEE) before and six months after percutaneous transcatheter ASD closure. Pulmonary venous flow and atrial appendage flow velocities were obtained from the TEE recordings. The offline evaluation of the global and segmental atrial appendage strains were evaluated with speckle tracking echocardiography (STE) via EchoPac 6,3 (GE Vingmed, Horten, Norway). RESULTS: Mean values of pulmonary artery pressure, right ventricular, left atrium, left ventricular end-diastolic and end-systolic diameters were significantly decreased 6 months after ASD closure. Statistically significant changes were documented in pulmonary venous and left atrial appendage flow velocities after ASD closure. Both left and right atrial appendage flow velocities and global strains of atrial appandages were improved after ASD closure. The mean left atrial appendage global strain value was - 11.45 ± 4.13% before the procedure, this value was - 16.82 ± 3.78% sixth months after the procedure (P < 0.001).The mean right atrial appendage global strain was - 13.31 ± 4.84% before the procedure and - 18.53 ± 4.69% sixth months after the procedure (P < 0.001). CONCLUSION: Left and right atrial appendage flow velocities and global strains of left and right atrial appandage can be improved after transcatheter ASD closure. Percutaneous transcatheter closure of ASDs not only improves atrial and left ventricular dimensions but also have a positive impact on left and right atrial appandage functions.

Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry.

BACKGROUND: Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure. METHODS: Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. RESULTS: We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (P=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (P=0.371); and clinical success rates of 70.3% and 88.0%, respectively (P=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; P=0.002; 3.6 [1.1-11.1]; P=0.036; and 3.7 [1.2-11.9]; P=0.025; respectively). CONCLUSIONS: Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05089136.

Procedural Tools and Technics for Transcatheter Paravalvular Leak Closure: Lessons from a Decade of Experience.

Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and hemolysis. Surgical PVL closure carries high risks. Transcatheter implantation of occluding devices in PVL is a lower risk but challenging procedure. Of the available devices, only two have been specifically approved in Europe for transcatheter PVL closure (tPVLc): the Occlutech® Paravalvular Leak Device (PLD) and Amplatzer™ ParaValvular Plug 3 (AVP 3). Here, we review the various tools and devices used for tPVLc, based on three observational registries including 748 tPVLc procedures performed in 2005-2021 at 33 centres in 11 countries. In this case, 12 registry investigators with over 20 tPVLc procedures each described their practical tips and tricks regarding imaging, approaches, delivery systems, and devices. They considered three-dimensional echocardiography to be the cornerstone of PVL assessment and procedure guidance. Anterograde trans-septal mitral valve and retrograde aortic approaches were used in most centres, although some investigators preferred the transapical approach. Hydrophilic-coated low-profile sheaths were used most often for device deployment. The AVP 3 and PLD devices were chosen for 89.0% of procedures. Further advances in design and materials are awaited. These complex procedures require considerable expertise, and experience accumulated over a decade has no doubt contributed to improve practices.

Predictive Value of Lymphocyte-to-monocyte Ratio in Patients with Contrast-induced Nephropathy After Percutaneous Coronary Intervention for Acute Coronary Syndrome.

BACKGROUND AND OBJECTIVES: Lymphocyte-to-monocyte ratio (LMR) has emerged as a new indirect marker of inflammation, which is associated with adverse outcomes in cardiovascular diseases. The aim of this study was to evaluate whether admission LMR is associated with contrast-induced nephropathy (CIN) in patients who underwent percutaneous coronary intervention for acute coronary syndrome (ACS). METHODS: A total of 873 patients were assessed. LMR was calculated via dividing lymphocyte count by monocyte count. RESULTS: LMR was significantly lower in the with-CIN group. ROC analysis showed that the LMR ratios <2.52 predicted CIN development with sensitivity of 66.3% and specificity of 55.8%. Multivariate analysis showed that eGFR, admission glucose, and LMR were independent predictors of CIN in patients with ACS. CONCLUSION: LMR is an easily accessible marker and could be used as a predictor of CIN in patients with ACS undergoing percutaneous coronary intervention.

One-year results of the first-in-man study investigating the Atrial Flow Regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study.

AIMS: Attenuating exercise-induced elevated left atrial pressure with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF). METHODS AND RESULTS: PRELIEVE was a prospective, non-randomised, multicentre, first-in-man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg during exercise. Here, we provide follow-up data up to 1 year after implantation of the Atrial Flow Regulator (AFR) device. The AFR was successfully implanted in 53 patients (HFrEF n = 24 and HFpEF n = 29). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolisation into the left atrium, which required surgical removal. One patient experienced a serious procedure-related adverse event (post-procedural bleeding and syncope). All patients with sufficient echocardiography readout confirmed device patency with left-right shunt both at 3 (n = 47/51, 92%) and 12 (n = 45/49, 92%) months. At 3 months, rest PCWP decreased by 5 (-12, 0) mmHg (P = 0.0003, median Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of pulmonary artery pressure. Six (6/53, 11%) patients were hospitalised for worsening of HF and three (3/53, 6%) patients died. We observed improvements in New York Heart Association functional class, 6-min walking distance and quality of life (Kansas City Cardiomyopathy Questionnaire) in certain patients. CONCLUSIONS: Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the 1-year follow-up, with clinical improvements in certain patients.

[Turkish Cardiology Association Consensus Report: COVID-19 Pandemic and Cardiovascular Diseases (May 13, 2020)]. / Türk Kardiyoloji Dernegi Uzlasi Raporu: COVID-19 Pandemisi ve Kardiyovasküler Hastaliklar Konusunda Bilinmesi Gerekenler (13 Mayis 2020).

In December 2019, in the city of Wuhan, in the Hubei province of China, treatment-resistant cases of pneumonia emerged and spread rapidly for reasons unknown. A new strain of coronavirus (severe acute respiratory syndrome coronavirus-2 [SARS-CoV-2]) was identified and caused the first pandemic of the 21st century. The virus was officially detected in our country on March 11, 2020, and the number of cases increased rapidly; the virus was isolated in 670 patients within 10 days. The rapid increase in the number of patients has required our physicians to learn to protect both the public and themselves when treating patients with this highly infectious disease. The group most affected by the outbreak and with the highest mortality rate is elderly patients with known cardiovascular disease. Therefore, it is necessary for cardiology specialists to take an active role in combating the epidemic. The aim of this article is to make a brief assessment of current information regarding the management of cardiovascular patients affected by COVID-19 and to provide practical suggestions to cardiology specialists about problems and questions they have frequently encountered.

[Consensus Report from Turkish Society of Cardiology: COVID-19 and Cardiovascular Diseases. What cardiologists should know. (25th March 2020)]. / Türk Kardiyoloji Dernegi Uzlasi Raporu: COVID-19 Pandemisi ve Kardiyovasküler Hastaliklar Konusunda Bilinmesi Gerekenler (25 Mart 2020).

In December 2019, in the city of Wuhan, in the Hubei province of China, treatment-resistant cases of pneumonia emerged and spread rapidly for reasons unknown. A new strain of coronavirus (severe acute respiratory syndrome coronavirus-2 [SARS-CoV-2]) was identified and caused the first pandemic of the 21st century. The virus was officially detected in our country on March 11, 2020, and the number of cases increased rapidly; the virus was isolated in 670 patients within 10 days. The rapid increase in the number of patients has required our physicians to learn to protect both the public and themselves when treating patients with this highly infectious disease. The group most affected by the outbreak and with the highest mortality rate is elderly patients with known cardiovascular disease. Therefore, it is necessary for cardiology specialists to take an active role in combating the epidemic. The aim of this article is to make a brief assessment of current information regarding the management of cardiovascular patients affected by COVID-19 and to provide practical suggestions to cardiology specialists about problems and questions they have frequently encountered.

The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the Atrial Flow Regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction.

AIMS: Reducing elevated left atrial pressure with an atrial septum shunt device is a possible treatment option in symptomatic heart failure patients. This study aimed to investigate the safety and feasibility of the Atrial Flow Regulator (AFR) in heart failure patients. METHODS AND RESULTS: AFR-PRELIEVE is a prospective, non-randomised, open-label, multicentre study in patients with symptomatic heart failure NYHA Class III or IV and pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg at exercise irrespective of left ventricular ejection fraction (EF ≥15%). Here we report on procedural and three-month follow-up data for a total of thirty-six enrolled patients. Sixteen (44.5%) patients with reduced EF (HFrEF: EF 15-39%) and twenty (55.5%) patients with preserved EF (HFpEF: EF ≥40%) were enrolled. Implantation success rate and device patency with left-right shunt was 100% (post procedure and at three months) in both patient groups, with one SADE in the HFpEF group which completely resolved. Three (3/36, 8.3%) patients were hospitalised for worsening of heart failure (two HFrEF patients, one HFpEF patient). Individual patients from both the HFrEF and HFpEF groups showed improvement in symptoms and surrogate parameters of heart failure (NYHA class, six-minute walking distance, Kansas City Cardiomyopathy Questionnaire, PCWP, NT-proBNP). CONCLUSIONS: Implantation of the AFR device in heart failure patients is feasible and safe; shunt patency at three months was confirmed in the study. The atrial shunt improved symptoms and surrogate parameters of heart failure in some but not all patients in both the HFpEF and HFrEF groups.

Bendopnea and Its Clinical Importance in Outpatient Patients with Pulmonary Arterial Hypertension.

PURPOSE: Bendopnea is a recently reported novel symptom in patients with heart failure (HF) defined as shortness of breath when bending forward. It has been demonstrated that bendopnea is associated with advanced symptoms and worse outcomes. The aim of this study was to assess the presence of bendopnea and its clinical importance with regards to functional status, hemodynamic and echocardiographic characteristics in outpatient pulmonary arterial hypertension (PAH) patients. METHODS: We conducted this prospective observational study of 53 patients who were admitted to our PAH clinic for routine control visits. We determined the presence of bendopnea and analyzed hemodynamic parameters, World Heart Organization (WHO) functional class, transcutaneous oxygen saturation, 6-minute walking distance (6-MWD), N-terminal pro-brain natriuretic peptide (NT-proBNP) and right ventricular (RV) function indicators in patients with and without bendopnea. RESULTS: Bendopnea was present 33.9% of the PAH patients. The mean age was higher in the patients with bendopnea than in those without bendopnea, but the difference was not significant (p = 0.201). The patients with bendopnea had a lower 6-MWD and higher NT-proBNP level (p < 0.001), and worse WHO functional class symptoms (p = 0.010). Mean right atrial pressure, pulmonary artery pressure, and pulmonary vascular resistance were higher in the patients with bendopnea. The patients with bendopnea had a more dilated RV end-diastolic diameter and lower tricuspid annular plane systolic excursion value (p < 0.001 and p = 0.001, respectively). CONCLUSIONS: Bendopnea was associated with worse functional capacity status, hemodynamic characteristics and RV function in our outpatient PAH patients.

Biventricular Noncompaction Cardiomyopathy Accompanied by Severe Pulmonary Valvular Stenosis and Patent Foramen Ovale.

Myocardial non-compaction (NC) is a rare genetic cardiomyopathy commonly believed to develop an intrauterine arrest of endomyocardial morphogenesis. NC is characterized by markedly hypertrabeculations in left ventricle or both ventricles with deep intertrabecular recesses. NC is usually seen isolated, but sometimes other congenital heart abnormalities may accompany to the myocardial NC. In this article we have presented an adult patient with biventricular myocardial NC cardiomyopathy accompanied by severe valvular pulmonary stenosis and patent foramen ovale.

New Pulmonary Valvuloplasty Technique by Use of an Hourglass-Shaped Balloon in 3 Adults with Severe Pulmonary Valve Stenosis.

Percutaneous balloon pulmonary valvuloplasty is the preferred therapy for pulmonary valve stenosis. However, the designs of the cylindrical balloons historically used for valvuloplasty have limitations, especially in patients who have large pulmonary annular diameters. The hourglass-shaped V8 Aortic Valvuloplasty Balloon may prove to be an effective alternative. The balloon has 2 large bulbous segments that are separated by a narrowed waist. The geometric shape is maintained throughout inflation, improving fixation and enabling broader leaflet opening. We present our first experience with the V8 balloon in 3 adults who had severe, symptomatic pulmonary valve stenosis. In addition to describing their cases, we detail our sizing technique for pulmonary valvuloplasty with the V8 balloon. Our successful results suggest that the V8 balloon is efficient and safe for balloon pulmonary valvuloplasty in adults with severe pulmonary valve stenosis.

Percutaneous Antegrade Trans-Septal Closure of Mitral Paravalvular Leak without Creation of an Arteriovenous Wire Loop in Patients with Coexistent Mechanical Aortic Valve.

BACKGROUND: Various approaches such as antegrade trans-septal, retrograde transfemoral and transapical techniques have been used to close mitral paravalvular leak (PVL) in patients with an aortic prosthesis. During the implementation of these techniques, an arteriovenous guidewire loop is often created for device delivery. However, passing through a mechanical aortic valve may cause hemodynamic compromise and prolong the procedure. To date, no studies have evaluated antegrade mitral PVL closure without the use of an arteriovenous wire loop in patients with a mechanical aortic prosthesis. Herein is described a different mitral PVL closure technique by means of a trans-septal approach without construction of an arteriovenous guidewire loop in this type of patient. METHODS: Four patients (two males, two females; mean age 57 ± 10 years; range: 46-67 years) with severe mitral PVL and a mechanical aortic prosthesis were referred for percutaneous closure of a mitral PVL. All patients underwent antegrade trans-septal mitral PVL closure without the creation of an arteriovenous wire loop. Data prospectively collected included assessments from preoperative and postoperative two- and three-dimensional transesophageal echocardiography (TEE). RESULTS: Preoperative TEE demonstrated severe mitral PVL in all four patients. All patients experienced a substantial reduction in symptoms associated with the marked reduction in PVL following repair. There were no procedural complications. The median procedural time was 113 min (range: 50-145 min) and median fluoroscopy time was 23 min (range: 17-25 min). CONCLUSIONS: An alternative, safe, effective and efficient mitral PVL closure approach in patients with a mechanical aortic prosthesis has been devised. This technique can prevent aortic valve dysfunction, reduce costs, and also decrease complication rates.

Transcatheter aortic valve implantation: a revolution in the therapy of elderly and high-risk patients with severe aortic stenosis.

Transcatheter aortic valve implantation (TAVI) represents a real revolution in the field of interventional cardiology for the treatment of elderly or high-risk surgical patients with severe symptomatic aortic valve stenosis. Today, TAVI seems to play a key and a reliable role in the treatment of intermediate and maybe low-risk patients with severe aortic stenosis. TAVI has also evolved from a complex and hazardous procedure into an effective and safe therapy by the development of new generation devices. This article aims to review the background and future of TAVI, clinical trials and registries with old and new generation TAVI devices and to focus on some open issues related to post-procedural outcomes.