Arsène Basmadjian

The Amplatzer™ Cardiac Plug 2 for left atrial appendage occlusion: novel features and first-in-man experience.

Percutaneous left atrial appendage (LAA) closure is becoming a frequently performed procedure for patients with atrial fibrillation and high haemorrhagic risk. The Amplatzer™ Cardiac Plug (ACP) is one of the most commonly used devices for this purpose. Despite high success rate and low procedure risk associated with the ACP, a second generation of the device is now available. The new ACP has been designed to facilitate the implantation process, improve sealing performance and further reduce the risk of complications. The present report focuses on the novel features of the second generation of the Amplatzer™ Cardiac Plug (ACP 2 or Amulet™) and describes the first-in-man experience.

Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: First in man experience with a temporary implant

Objective: This study evaluated human feasibility and acute efficacy of a novel percutaneous transvenous mitral annuloplasty (PTMA™) device (Viacor) placed temporarily in the coronary sinus (CS): the implant allows in‐situ incremental adjustment to optimally reduce the anterior–posterior mitral annulus (MA) dimension, and improve leaflet co‐aptation and reducing mitral regurgitation (MR). Background: Surgical annuloplasty remains the standard treatment of severe ischemic MR but its application is limited by high morbidity and mortality. The effectiveness of PTMA device (Viacor) to reduce MR in the short‐term has been demonstrated in animals studies but not in humans. Methods: Symptomatic patients with ischemic MR graded 2+ to 4+ requiring surgical mitral annuloplasty were screened. Patients with any mitral leaflet or mitral apparatus abnormality were excluded. Preoperatively, under general anesthesia and transesophageal echocardiography guidance, a temporary PTMA device was placed via the right internal jugular or subclavian vein. Results: Four patients were studied. After device placement and adjustment, regurgitant volume was substantially reduced (45.5 ± 24.4 to 13.3 ± 7.3 ml) via MA anterior–posterior diameter reduction (40.75 ± 4.3 to 35.2 ± 1.6 mm) in 3 patients. In one patient, the PTMA device could not be deployed due to extreme angulated anatomy. Conclusions: PTMA in human is feasible and reduces ischemic MR (to grade 1+) by reducing MA anterior–posterior diameter. Temporary placement of the PTMA device may assist in the development of permanent implants and ensure optimal efficacy.

Novel therapeutic aspects of percutaneous aortic valve replacement with the 21F CoreValve Revalving™ System

Aims: Percutaneous aortic valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe aortic stenosis (AS). We investigated whether novel therapeutic approaches may facilitate AVR outcomes for high‐risk patients. Methods and Results: Eleven patients [n = 6 (54%) men] aged 82 ± 10 years underwent PAVR after being refused for open surgery. The mean±SD AV area and left ventricular ejection fraction (LVEF) of these patients was 0.56 ± 0.19 cm2 and 49 ± 17%, respectively, with severe functional limitation (NYHA class III (n = 8) and IV (n = 3)). One patient underwent PAVR combined with simultaneous percutaneous coronary intervention (PCI). Two male patients needed left iliac artery angioplasty. A percutaneous ventricular assist device (PVAD) was used in the most recent case. Compared with pre‐PAVR, mean AV area (1.3 ± 0.4 cm2; P < 0.001) and LVEF (56 ± 11%; P < 0.001) increased. One man had a peri‐procedural stroke and died 5 days post‐PAVR. Four other patients died within 4 months of hospital discharge. The median duration of survival of the survivors was 305 (range 249–431) days. Conclusions: Novel percutaneous techniques facilitate CoreValve PAVR (21 Fr.). Future lower profile devices (e.g. 18 Fr. Generation III CoreValve) should permit inclusion of a broader spectrum of high‐risk patients. PAVR may evolve toward a full percutaneous approach.

Influence of leukopenia on collateral flow, reperfusion flow, reflow ventricular fibrillation, and infarct size in dogs.

Leukocytes contribute to myocardial damage during ischemia and reperfusion. However, the mechanism involved has not been clearly elucidated. The purpose of the present study was to determine whether leukocyte-induced myocardial damage is flow mediated. In open-chest dogs submitted to 2 hours of ischemia, area at risk, infarct size, and regional myocardial blood flow before, during, and after ischemia were measured. Leukopenia was induced by a two-step method (chemotherapy and antineutrophil serum) in a group of 14 dogs as compared to a control group of 18 dogs. The relation of infarct size to the major determinants of infarct size was analyzed by uni- and multilinear regressions. Seven control dogs had ventricular fibrillation at reperfusion compared to one dog with leukopenia. In the group with leukopenia the mean infarct size was smaller (31.1 +/- 5.8% of area at risk) than in the control group (47.7 +/- 2.9, p = 0.02). In addition, the two multiple linear regression equations were significantly different (p = 0.01). Myocardial blood flow to the central ischemic zone did not change significantly between 20 and 120 minutes of ischemia in the control dogs (n = 12; subendocardial = 0.08 +/- 0.03 vs 0.07 +/- 0.03 ml/min/gm; subepicardial = 0.20 +/- 0.07 vs 0.20 +/- 0.05 ml/min/gm) and in the dogs with leukopenia (n = 12; 0.07 +/- 0.02 vs 0.07 +/- 0.02 ml/min/gm and 0.15 +/- 0.004 vs 0.18 +/- 0.04 ml/min/gm). A similar reduction in myocardial blood flow was observed after 6 hours of reperfusion in the control dogs (0.34 +/- 0.07 ml/min/gm vs 1.02 +/- 0.11 at baseline, p less than 0.01) and in the dogs with leukopenia (0.25 +/- 0.04 vs 0.81 +/- 0.08 ml/min/gm, p less than 0.01). It was concluded that the leukocyte-dependent myocardial injury did not appear to be mediated through a flow mechanism during either ischemia or reperfusion.

Left atrial appendage occlusion: Initial experience with the Amplatzer™ Amulet™☆

BACKGROUND The Amplatzer™ Amulet™ (Amulet) is the evolution of the Amplatzer™ Cardiac Plug, a dedicated device for percutaneous left atrial appendage (LAA) occlusion. The new device has been designed to facilitate the implantation process, improve the sealing performance and further reduce the risk of complications. The objective of the study was to describe the initial experience with the Amplatzer Amulet for percutaneous LAA occlusion. METHODS This was a prospective single-center study of patients undergoing percutaneous LAA occlusion. The indication for LAA closure was a formal contraindication for oral anticoagulation or previous history of stroke due to INR lability. All procedures were done under general anesthesia and transesophageal echocardiography (TEE) guidance. Transthoracic echocardiography was performed 24h after the procedure in order to rule out procedural complications before discharge. Further follow-up was done with a clinical visit and TEE at 1-3 months. RESULTS Between July-2012 and June-2013, 25 patients with a mean CHA2DS2-VASC of 4.3 ± 1.7 underwent LAA occlusion with the Amplatzer Amulet. The device was successfully implanted in 24 patients (96%) without any procedural stroke, pericardial effusion or device embolization. None of the patients presented any clinical event at follow-up. Follow-up TEE showed complete LAA sealing in all patients with no residual leaks >3mm and no device embolization. One patient (4.1%) presented a device thrombosis at follow-up without clinical expression. CONCLUSION In this initial series of patients, the Amulet showed a remarkable acute and short-term performance in terms of feasibility and safety as depicted by the high successful implantation rate and the low incidence of complications.

Role of Transesophageal Echocardiography in Percutaneous Aortic Valve Replacement with the CoreValve Revalving System

Percutaneous aortic valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe aortic stenosis (AS). We examined the role of transesophageal echocardiography (TEE) in PAVR. TEE was used initially to assess the native valve and aortic root, and served as a guide during PAVR. Following prosthetic valve deployment, TEE was used to assess valve function. Eleven patients aged 82 ± 10 years with NYHA III–IV underwent PAVR. Periprocedural TEE gave immediate information on prosthetic position and function, LV function, mitral regurgitation, pericardium, and thoracic aorta anatomy. There was excellent visual agreement between fluoroscopic and TEE images of prosthetic positioning and deployment. TEE facilitated the detection and management of procedure‐related complications. Compared with pre‐PAVR, AV area (0.56 ± 0.19 cm2 vs. 1.3 ± 0.4 cm2; P < 0.001) and LVEF (49 ± 17% vs. 56 ± 11%; P < 0.001) increased. TEE provides key anatomical and functional information, and serves as a diagnostic guide for complications, which may arise during PAVR.

Percutaneous Paravalvular Leak Reduction: Procedural and Long-term Clinical Outcomes

BACKGROUND Significant paravalvular leak (PVL) after prosthetic replacement can result in hemolysis and/or congestive heart failure (CHF). Percutaneous PVL reduction (PPVR) represents an alternative to repeat surgery for a selected population. The purpose of this study was to assess the procedural and long-term clinical efficacy of percutaneous PPVR and its effect on survival free of rehospitalization for CHF, surgical reintervention, and death. METHODS We analyzed a cohort of 56 consecutive patients who underwent 61 PPVRs in our institution between June 2001 and December 2010. Procedural success was defined as a reduction in regurgitation severity free from procedural complications. Patients were followed-up for vital status, clinical events, and symptoms. RESULTS Patients were aged 65 ± 11 years, with an average logistic EuroSCORE of 19 ± 14%. Indications for PPVR included CHF (61%), hemolysis (9%), or both (30%), caused by mitral (n = 44) or aortic (n = 12) PVL. Procedural success was achieved in 75% of cases. Three major complications, including 2 deaths, occurred during the initial 30-day follow-up in the 42 patients who were treated with a device. After adjusting for the logistic EuroSCORE, prosthesis type (mitral vs aortic), and time interval since the last valve surgery, a successful PPVR was associated with a better survival free of rehospitalisation for CHF, need for surgical reintervention, and death compared with patients with a failed PPVR. (hazard ratio = 0.34; 95% confidence interval, 0.17-0.71). CONCLUSIONS PPVR is associated with a reasonable rate of procedural success and favourable cardiovascular outcomes, and represents an appropriate option when technically possible.

Long-Term Results With Triple Valve Surgery

BACKGROUND Whether to use biological or mechanical prostheses and whether to repair or replace the tricuspid valve during primary and reoperative triple valve surgery remains controversial. The objective of the present study was to review our experience with primary and reoperative triple valve surgery using CarboMedics (CM) and Carpentier-Edwards (C-E) heart valves. METHODS All 73 patients undergoing triple valve surgery since 1982 were prospectively followed at the Montreal Heart Institute valve clinic. Aortic valve replacement was performed with CM prostheses (57 patients) and with C-E prostheses (16 patients). Mitral valve replacement was performed with mechanical prostheses (56 patients) and with biological valves (14 patients). Mitral valve repair was done in 3 patients. Tricuspid valve annuloplasty or commissurotomy or both were performed in 66 patients and the tricuspid valve was replaced in 7 patients. Patient survival, complications, and the type of valve procedures were analyzed. RESULTS Thirty patients averaging 62+/-10 years of age underwent primary triple valve surgery and 43 patients averaging 60+/-10 years of age underwent reoperative triple valve surgery (p = 0.5). Tricuspid repair consisted of annuloplasty with the Bex linear reducer (n = 47), the C-E ring (n = 13), or the De Vega technique (n = 5). Tricuspid valve replacement was done using the C-E pericardial prostheses. The 30-day mortality was 17% and 12% in patients with primary and reoperative surgery, respectively (p = 0.5) and patient survival averaged 80%+/-7%, 75%+/-8%, and 41%+/-15%, and 70%+/-7%, 57%+/-9%, and 50%+/-10%, respectively 1, 5, and 10 years following surgery (p = 0.5). The freedom rate from thromboembolism and from bleeding complications were 87%+/-6% and 95%+/-3% in primary and reoperative patients, respectively, 5 years following surgery. CONCLUSIONS Triple valve surgery, either as a primary or a reoperative procedure, results in acceptable long-term survival with both mechanical and biological prostheses.

Exercise Testing and Stress Imaging in Valvular Heart Disease

The role of exercise testing and stress imaging in the management of patients with valvular heart disease (VHD) is reviewed in this article. The American College of Cardiology/American Heart Association and the European Society of Cardiology/European Association of Cardiothoracic Surgery have recently put emphasis on the role of exercise testing to clarify symptom status and the use of stress imaging to assess the dynamic component of valvular abnormalities and unmask subclinical myocardial dysfunction that could be missed at rest. Recent studies have demonstrated the incremental prognostic value of exercise echocardiography for asymptomatic patients with severe aortic stenosis, moderate-severe mitral stenosis, and severe primary mitral regurgitation. In patients with low-flow, low-gradient aortic stenosis, dobutamine stress echocardiography is recommended to differentiate true severe from pseudosevere aortic stenosis. Data on the prognostic value of stress echocardiography in aortic regurgitation and functional mitral regurgitation are less robust. Data are sparse on the use of stress imaging in right-sided VHD, however recent studies using stress cardiovascular magnetic resonance imaging offer some prognostic information. Although the strongest recommendations for surgical treatment continue to be based on symptom status and resting left ventricular repercussions, stress imaging can be useful to optimize risk stratification and timing of surgery in VHD. Randomized clinical trials are required to confirm that clinical decision-making based on stress imaging can lead to improved outcomes.

2010 Canadian Cardiovascular Society/Canadian Society of Echocardiography Guidelines for Training and Maintenance of Competency in Adult Echocardiography

Guidelines for the provision of echocardiography in Canada were jointly developed and published by the Canadian Cardiovascular Society and the Canadian Society of Echocardiography in 2005. Since their publication, recognition of the importance of echocardiography to patient care has increased, along with the use of focused, point-of-care echocardiography by physicians of diverse clinical backgrounds and variable training. New guidelines for physician training and maintenance of competence in adult echocardiography were required to ensure that physicians providing either focused, point-of-care echocardiography or comprehensive echocardiography are appropriately trained and proficient in their use of echocardiography. In addition, revision of the guidelines was required to address technological advances and the desire to standardize echocardiography training across the country to facilitate the national recognition of a physicians expertise in echocardiography. This paper summarizes the new Guidelines for Physician Training and Maintenance of Competency in Adult Echocardiography, which are considerably more comprehensive than earlier guidelines and address many important issues not previously covered. These guidelines provide a blueprint for physician training despite different clinical backgrounds and help standardize physician training and training programs across the country. Adherence to the guidelines will ensure that physicians providing echocardiography have acquired sufficient expertise required for their specific practice. The document will also provide a framework for other national societies to standardize their training programs in echocardiography and will provide a benchmark by which competency in adult echocardiography may be measured.