Isolated pulmonary valve endocarditis.

Isolated pulmonary valve endocarditis (IPE) is a rare form of infectious endocarditis. This article reports the case of a 49-year-old patient with IPE who was initially admitted with suspected cholecystitis. After vegetations were detected by transthoracic (TTE) and transesophageal echocardiography (TEE), antibiotic therapy in accordance with the antibiogram was primarily attempted; however, due to persistently elevated infection parameters and structural valve damage a pulmonary valve replacement was eventually performed.

Three-year outcomes of surgical valve replacement with Dafodil™ pericardial bioprosthesis: Dafodil™-1 trial.

Background: The Dafodil™-1 trial was designed to evaluate the clinical safety and performance of Dafodil™ pericardial bioprosthesis for replacing diseased native or prosthetic aortic or mitral valves in patients with advanced valvular heart disease (VHD). Methods: The Dafodil™-1 trial was a prospective, multicenter, first-in-human clinical trial. Patients were enrolled if they had advanced VHD requiring aortic valve replacement (AVR) or mitral valve replacement (MVR) with or without concomitant valve surgery and having surgical risk scores <4%. Major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI), and stroke; and hemodynamics were analyzed. Results: A total of 136 patients (aortic: 67 and mitral: 69) were enrolled in the trial (with mean age-AVR group: 60.2 ± 8.3 years and MVR group: 49.7 ± 14.4 years). A total of 134 patients (aortic: 66 and mitral: 68) completed the 3-year follow-up (total 300 per 100 patient-years of follow-up). The AVR group demonstrated a significant reduction in the mean pressure gradients from 51.2 ± 24.1 mmHg at baseline to 11.1 ± 6.0 mmHg at the 3-year follow-up (p < 0.0001). The mean effective orifice area (EOA) improved from baseline (0.9 ± 0.6 cm2) to 3-year follow-up (1.8 ± 0.4 cm2) (p < 0.0001). In the MVR group, the mean indexed EOA (iEOA) increased significantly from baseline (0.7 ± 0.4 cm2/m2) to 3-year follow-up (1.1 ± 0.4 cm2/m2) (p < 0.001). There was significant improvement in New York Heart Association functional class and mean SF-12 scores in both groups. At 3-year follow-up, the MACE incidence was 2.3% per 100 patient-years (1.3% strokes per 100 patient-years and 1.3% deaths per 100 patient-years) for AVR group and 4.7% per 100 patient-years (0.6% strokes per 100 patient-years and 4.0% deaths per 100 patient-years) for MVR group. No cases of MI, structural valve deterioration and prosthetic valve endocarditis were reported. The AVR and MVR groups achieved 89.6% and 79.7% MACE-free survival, respectively at 3-year follow-up. Conclusions: The Dafodil™-1 trial demonstrated satisfactory outcomes of clinical safety, hemodynamic performance, and quality-of-life metrics. Additionally, no incidence of structural valve deterioration and very low rates of valve thrombosis during the 3-year follow-up period of Dafodil™-1 first-in-human trial indicated acceptable valve durability up to three years and similar outcomes are warranted for longer follow-ups as a primary goal. Clinical Trial Registration Number: https://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=18377&EncHid=&userName=CTRI/2017/07/009008, CTRI/2017/07/009008.

Surgical Aortic Valve Replacement and Renal Dysfunction: From Acute Kidney Injury to Chronic Disease.

Background: Surgical aortic valve replacement (SAVR) is often complicated by acute kidney injury (AKI). Identifying patients at risk of AKI is important to start nephroprotective strategies or renal replacement therapy (RRT). This study investigated the incidence and risk factors of post-operative AKI in SAVR patients. Chronic kidney disease (CKD) developed in the post-cardiac-surgery follow-up period was also assessed. Methods: A total of 462 SAVR patients were retrospectively enrolled. The primary endpoint was the occurrence rate of AKI after surgery. Kidney recovery, during two planned outpatient clinic nephrological visits within 12 months after the surgery, was assessed. Results: A total of 76 patients experienced an AKI event. A Kaplan-Meier analysis revealed that subjects with CKD stage IV had a time to progression of 2.7 days, compared to patients with stages I-II, who were characterized by the slowest progression time, >11.2 days. A Cox regression indicated that CKD stages predicted a higher risk of AKI independently of other variables. During their ICU stay, 23 patients died, representing 5% of the population, most of them requiring RRT during their ICU stay. A severe CKD before the surgery was closely related to perioperative mortality. During the follow-up period, 21 patients with AKI worsened their CKD stage. Conclusions: AKI represents a common complication for SAVR patients in the early post-operative period, prolonging their ICU stay, with negative effects on survival, especially if RRT was required. Pre-operative CKD >3 stage is an independent risk factor for AKI in patients undergoing SAVR.

An unusual angiogram finding in a patient with rheumatic heart disease.

A woman in her early fifties with a known case of severe rheumatic mitral stenosis presented to the out-patient department with increasing breathlessness.

Risk of Infective Endocarditis Post-transcatheter Pulmonary Valve Replacement Versus Surgical Pulmonary Valve Replacement: A Systematic Review.

Pulmonary valve replacement (PVR) is the most common cardiac operation in adult patients with congenital heart disease (ACHD). It can improve right ventricular outflow tract (RVOT) obstruction, typically due to pulmonary valve stenosis or regurgitation. PVR can be performed surgically (open-heart) and through a transcatheter (percutaneous) method, which is minimally invasive and is associated with shorter hospitalization stays. However, following PVR, infectious endocarditis (IE) can complicate the recovery process and increase mortality in the long term. IE is a rare but deadly multi-organ system condition caused by microorganisms traversing the bloodstream from a specific entry point. It can have many presentations, such as splinter hemorrhages, fevers, and vegetation on valves that lead to stroke consequences. This paper aims to evaluate the differences in the rate, etiology, manifestations, treatment, and outcomes of IE following surgical and transcatheter PVR, as the goal is to perform a procedure with few complications. In both approaches, Staphylococcus aureus was the most common microorganism that affected the valves, followed by Streptococcus viridians. Research has shown that surgical pulmonary valve replacement (SPVR) has a decreased risk of IE following surgery compared to TPVR. However, TPVR is preferred due to the reduced overall risk and complications of the procedure. Despite this, the consensus on mortality rates does differ. Future research should consider the type of valves used for transcatheter pulmonary valve replacement (TPVR), such as Melody valves versus Edward Sapien valves, as their IE rates vary significantly.

Double valve replacement in a case of Hedinger syndrome.

Hedinger Syndrome or carcinoid heart disease is a rare cardiac complication of neuroendocrine tumors (NET) affecting the tricuspid and pulmonary valves. Following is a case description of a patient undergoing treatment for a neuroendocrine tumor with liver metastasis, referred with symptomatic tricuspid valve regurgitation and pulmonary valve stenosis for surgical valve replacement. Planned surgical valve replacement was successfully performed before the onset of severe right ventricular failure or pulmonary hypertension in this case of carcinoid heart disease. An interdisciplinary approach and regular follow up is recommended in such cases.

Three-year survival of transcatheter versus surgical aortic valve replacement in dialysis.

To highlight the trends of surgical (open) aortic valve replacement (SAVR) as well as to compare the outcome between transcatheter aortic valve replacement (TAVR) and SAVR in elderly dialysis patients. TAVR has evolved as an effective alternative to surgery (SAVR) for aortic stenosis. We identified dialysis-dependent patients who underwent SAVR or TAVR from 2000 to 2015 from the United States Renal Data System using ICD-9 codes. We defined high-risk surgical patients as age over 70 or older. The primary endpoint was survival at 3 years and we compared the outcome between SAVR and TAVR groups using inverse probability of treatment weighting (IPTW). A total of 4332 and 1280 dialysis patients underwent SAVR and TAVR, respectively, during the study period. Among SAVR cohort, 3312 patients underwent SAVR before June 2012 and 1020 after June 2012. In-hospital mortality was significantly worse before 2012 (14.6% vs. 11.3% after 2012, p = 0.007) as well as estimated 3-year mortality (69.1% vs. 60.3% after 2012, p < 0.001). After June 2012, the TAVR cohort was older and had more comorbidities including coronary artery disease and congestive heart failure compared to the SAVR cohort. After IPTW, in-hospital mortality was significantly lower after TAVR versus SAVR (odds ratio 0.38 [95% confidence interval [CI], 0.27-0.52], p < 0.001). However, TAVR had a significantly higher risk of 3-year mortality than SAVR (hazard ratio 1.24 [95% CI 1.1-1.39], p < 0.001). TAVR may be a reasonable and potentially preferable alternative to SAVR in the elderly dialysis population in the short-term period.

The Efficacy of Resin Hemoperfusion Cartridge on Inflammatory Responses during Adult Cardiopulmonary Bypass.

AIM: This study aimed to evaluate the efficacy of the resin hemoperfusion device (HA380 hemoperfusion cartridge) on inflammatory responses during adult cardiopulmonary bypass (CPB). METHODS: Sixty patients undergoing surgical valve replacement were randomized into the HP group (n = 30) with an HA380 hemoperfusion cartridge in the CPB circuit or the control group (n = 30) with the conventional CPB circuit. The results of routine blood tests, blood biochemical indexes, and inflammatory factors were analyzed at V0 (pre-CPB), V1 (CPB 30 min), V2 (ICU 0 h), V3 (ICU 6 h), and V4 (ICU 24 h). RESULTS: The HP group had significantly lower levels of IL-6, IL-8, and IL-10. Significant estimation of group differences in the generalized estimating equation (GEE) models was also observed in IL-6 and IL-10. The HP group had significantly lower levels of creatinine (Cr), aminotransferase (AST), and total bilirubin (TBil) compared to the control group. The estimation of differences of Cr, AST, and TBil all reached statistical significance in GEE results. The HP group had significantly less vasopressor requirement and shorter mechanical ventilation time and ICU stay time as compared to the control group. CONCLUSION: The HA380 hemoperfusion cartridge could effectively reduce the systemic inflammatory responses and improve postoperative recovery of patients during adult CPB.

Two-Year Clinical Follow-Up Assessment of the Novel Cingular Surgical Bovine Pericardial Valve.

Objectives: To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis. Methods: A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory. Results: The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm2. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm2 and 1.8 ± 0.2 cm2 were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm2, respectively. There was no significant change between 1-year and 2-year hemodynamic performance. Conclusions: The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.

Improving the Uptake of Transcatheter Aortic Valve Replacement in Ontario.

Background The rising costs of healthcare delivery globally and the increasing research production rate create immense opportunities for implementing novel and more effective medical interventions that significantly benefit patient outcomes. However, the successful uptake of medical innovations is complex and often extremely contextual based on many sociopolitical and economic factors. These barriers to implementation can delay or derail new practices, procedures, products, and pharmaceuticals. Understanding the barriers to the successful implementation of medical innovations and the best practices and strategies to mitigate them is an extremely important area for translational research in health sciences. This study examines the barriers and potential challenges in implementing medical innovations and the possible preemptive measures that can be addressed early to increase the use of life-saving medical innovations. We consider the importance of appropriate, timely, and user-defined implementation techniques as a critical component of the successful uptake of medical innovations and use the uptake of transcatheter valve replacement therapy (TAVR), which is an alternative life-saving intervention for patients at risk for surgical complications, in Ontario, Canada as the practical case study of the challenges and potential instructive opportunities to establish best practices for systematic and effective innovation uptake. Methodology In addition to contextual and informal investigations, a small pilot survey of decision-makers across the University of Toronto-affiliated teaching hospitals helped compare and contrast the barriers to medical innovation uptake (in the literature) with the suggested barriers to the successful implementation of TAVR. This study looks primarily at the role of funding, physician preference, clinical guidelines, and patient comorbidities as decision-making factors contributing to TAVR uptake. The study also explores how the differences and similarities of TAVR uptake related to the decision-making factors above can help develop recommended strategies to address future implementation barriers. Results We observed that the decision-makers across the surveyed institutions refer patients with intermediate to high risk for surgery for TAVR. Funding and physician preference were identified as possible barriers to TAVR uptake, with underlying comorbidities of patients being a primary decision determinant for TAVR referral. Physician preferences were based on multiple factors such as clinical judgment, patient comorbidities, clinical guidelines, knowledge, TAVR, and surgical valve replacement skills. Conclusions To the best of our knowledge, this study is one of the first to use the Toronto Translational Thinking Framework to assess an innovative treatment uptake in the Ontario healthcare system. Although the study sample size was 11 and did not reflect the views of all decision-makers regarding TAVR use in Ontario, the survey reflected participants who directly make decisions regarding TAVR use, strengthening the credibility of the survey results. The insights from this study are intended to inform both the continued implementation of TAVR and to contribute to a broader field of investigation that aims to identify and operationalize the principles and best practices of translational research that may contribute to the efficacy of implementing other medical innovations in Ontario hospitals and beyond.

Antithrombotic Treatment After Surgical and Transcatheter Heart Valve Repair and Replacement.

New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of antithrombotic therapy after surgical or transcatheter heart valve repair and replacement increasingly complex. Moreover, due to a lack of large randomized controlled trials many recommendations for antithrombotic therapy are based on expert opinion, reflected by divergent recommendations in current guidelines. Therefore, decision-making in clinical practice regarding antithrombotic therapy for prosthetic heart valves is difficult, potentially resulting in sub-optimal patient treatment. This article compares the 2017 ESC/EACTS and 2020 ACC/AHA guidelines on the management of valvular heart disease and summarizes the available evidence. Finally, we established a convenient consensus on antithrombotic therapy after valve interventions based on over 800 annual cases of surgical and transcatheter heart valve repair and replacement and a multidisciplinary team discussion between the department of cardiovascular diseases and cardiac surgery of the University Hospitals Leuven, Belgium.

Detecting native and bioprosthetic aortic valve disease using 18F-sodium fluoride: Clinical implications.

Calcific aortic valve disease is the most common valvular disease and confers significant morbidity and mortality. There are currently no medical therapies that successfully halt or reverse the disease progression, making surgical replacement the only treatment currently available. The majority of patients will receive a bioprosthetic valve, which themselves are prone to degeneration and may also need replaced, adding to the already substantial healthcare burden of aortic stenosis. Echocardiography and computed tomography can identify late-stage manifestations of the disease process affecting native and bioprosthetic aortic valves but cannot detect or quantify early molecular changes. 18F-fluoride positron emission tomography, on the other hand, can non-invasively and sensitively assess disease activity in the valves. The current review outlines the pivotal role this novel molecular imaging technique has played in improving our understanding of native and bioprosthetic aortic valve disease, as well as providing insights into its feasibility as an important future research and clinical tool.

Ethical Dilemma: Should Continuous Intravenous Drug Use Affect Appropriate Management in Prosthetic Valve Endocarditis?

Drug use is a major challenge that negatively impacts many aspects of health. The issue of drug use is growing with every passing day. Efforts to mitigate its use are countered by even more people succumbing to the intravenous drug use due to their relatively easy availability and patients' poor insight into their medical condition. Infective endocarditis (IE) is a condition with high mortality and morbidity. It requires prolonged treatment with antibiotics, and, under some special circumstances, surgical management is also necessitated. Intravenous drug users who get valve replacement after index IE episode may continue to use drugs despite our utmost efforts to prevent it. They can subsequently develop prosthetic valve endocarditis (PVE), which is one of the indications for surgical valve replacement, hence requiring a redo surgery. However, their irregular behavior can create reservations while considering a repeat valvular surgery and delay the appropriate treatment. This can increase morbidity and mortality from PVE in intravenous drug users with otherwise no or few comorbidities.

Long-Term Durability of Transcatheter Valves: The Importance of Accurate Data.

As transcatheter valves are offered to progressively lower-risk patients, it is increasingly important to have accurate data about durability. Structural valve deterioration (SVD) implies an adverse change in the morphology of the leaflets and function of the valve compared with the state at implantation. However, a recent European statement allows SVD to be defined solely by a threshold mean gradient ≥20 mm Hg. Absolute mean gradients above this threshold may be observed immediately after implantation and represent patient-prosthesis mismatch and not SVD. This paper describes a definition of SVD more in keeping with routine clinical practice, incorporating a change in leaflet morphology and an increase in the grade of transvalvar regurgitation or an increase in gradient from the post-implantation study.

One-year outcome with a bovine pericardial valve.

Objectives: To evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements. Methods: Between March 2016 and October 2017, 197 patients (mean age, 66.9 ± 4.9 years; 40.6% were women) underwent aortic valve replacement and mitral valve replacement and were implanted with the Cingular bovine pericardial valve (Shanghai Cingular Biotech Corporation, Shanghai, China) in a prospective, multicenter, single-arm trial in China. A total of 161 aortic and 49 mitral prostheses were implanted. Patients were followed up to 1 year. The primary end point was the 1-year overall rate of valve-related complications, including thromboembolic event, valve thrombosis, major hemorrhage event, major perivalvular leak, and prosthetic valve endocarditis. Results: The 1-year overall rate of valve-related complications was 0.5% (95% confidence interval, 0.1%-3.7%). The 1-year survival was 96.4%. The mean gradient and effective orifice area for aortic prostheses at 1 year postoperatively were 12.8 ± 4.4 mm Hg and 1.9 ± 0.3 cm2, respectively. Particularly, the mean gradients and effective orifice area for 19 mm and 21 mm sizes of aortic prostheses at 1 year were 17.0 ± 3.8 mm Hg and 1.6 ± 0.2 cm2, 13.1 ± 4.0 mm Hg and 1.8 ± 0.1 cm2, respectively. Patient-prosthesis mismatch occurred in only 1.3% patients for aortic valve implantation at 1 month. No structural valve deterioration and no endocarditis occurred. Conclusions: The Cingular bovine pericardial valve was safe and effective for surgical aortic and mitral valve replacement. The 1-year rate of valve-related complications was very low. Early hemodynamic performance was excellent even for the small aortic root.

Trans-catheter paravalvular leak closure: a single-centre experience.

INTRODUCTION: A significant paravalvular leak (PVL) is estimated in at least 1-3% of patients undergoing surgical aortic and/or mitral valve replacement. Surgical repair of a PVL is associated with a 30-day mortality of approximately 10%. Percutaneous closure of PVL has emerged as an alternative to surgical repair. AIM: We sought to examine the clinical outcomes of patients treated with percutaneous closure of PVL at an Irish tertiary referral centre. METHODS: A prospective registry was used to record patient and procedural characteristics at the time of the PVL procedure. Medical records were retrospectively reviewed to assess clinical outcomes during the index hospitalisation and at follow-up. RESULTS: A total of 26 PVL procedures were performed in 21 patients (mean age 68 ± 13 years, 76% male). Heart failure (HF), haemolysis (HL) or a combination of both was the presenting symptoms in 62%, 24% and 14% of patients, respectively. In the entire cohort, clinical success was achieved in 18 patients (86%). Clinical success was achieved more frequently when HF was the clinical indication compared to HL (100% versus 66%). Among patients presenting with isolated HF (n = 13), the mean NYHA class at baseline and follow-up was 2.5± 0.7 and 1.4± 0.7, respectively. Thirty-day mortality was 0%. There was one (3.8%) major adverse procedural complication (stroke). A total of six deaths (28%) occurred during follow-up (22 ± 13.4 months). CONCLUSIONS: Patients with PVL represent a high-risk patient cohort. Percutaneous PVL offers a safe alternative to surgical PVL repair and appears particularly effective in those patients who present primarily with HF.

Prognosis of Patients With Severe Aortic Stenosis After the Decision to Perform an Intervention.

INTRODUCTION AND OBJECTIVES: Current therapeutic options for severe aortic stenosis (AS) include transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). Our aim was to describe the prognosis of patients with severe AS after the decision to perform an intervention, to study the variables influencing their prognosis, and to describe the determinants of waiting time > 2 months. METHODS: Subanalysis of the IDEAS (Influence of the Severe Aortic Stenosis Diagnosis) registry in patients indicated for TAVI or SAVR. RESULTS: Of 726 patients with severe AS diagnosed in January 2014, the decision to perform an intervention was made in 300, who were included in the present study. The mean age was 74.0 ± 9.7 years. A total of 258 (86.0%) underwent an intervention: 59 TAVI and 199 SAVR. At the end of the year, 42 patients (14.0%) with an indication for an intervention did not receive it, either because they remained on the waiting list (34 patients) or died while waiting for the procedure (8 patients). Of the patients who died while on the waiting list, half did so in the first 100 days. The mean waiting time was 2.9 ± 1.6 for TAVI and 3.5 ± 0.2 months for SAVR (P = .03). The independent predictors of mortality were male sex (HR, 2.6; 95%CI, 1.1-6.0), moderate-severe mitral regurgitation (HR, 2.6; 95%CI, 1.5-4.5), reduced mobility (HR, 4.6; 95%CI, 1.7-12.6), and nonintervention (HR, 2.3; 95%CI, 1.02-5.03). CONCLUSIONS: Patients with severe aortic stenosis awaiting therapeutic procedures have a high mortality risk. Some clinical indicators predict a worse prognosis and suggest the need for early intervention.

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).