[Show abstract][Hide abstract] ABSTRACT: 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 (ACC/AHA) and the European Society of Cardiology/European Association of Cardiothoracic Surgery (ESC/EACTS) 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 CMR 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.
The Canadian journal of cardiology 09/2014; 30(9). DOI:10.1016/j.cjca.2014.03.013 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
Effective closure performance for patent foreamen ovale (PFO) has been suggested to be one of the factors that plays a relevant role in future clinical outcomes following stroke or transient ischemic attack.
Between January 2009 and June 2012, all consecutive patients undergoing transcatheter PFO closure in our institution using the AmplatzerTM PFO Occluder (APO), Biostar®, GORE® HELEX and GORE® Septal Occluder (GSO) were included. Closure performance was assessed by transesophageal echocardiography (TEE) 4 months after the index procedure.
193 patients were included in the study. Patient distribution was as follows: 1) 48 GSO (24.8%), 2) 34 Helex (17.6%), 3) 74 APO (38.3%) and 4) 37 Biostar (19.1%). No complications occurred during device implantation. During clinical follow-up (20.8 ± 13.2 months), 2 (1.1%) patients had a stroke, 3 (1.7%) patients had a peripheral embolism and 8 (4.7%) patients presented with a documented atrial arrhythmia. There were no significant differences in clinical outcomes among the devices. TEE follow-up revealed higher closure rates with GSO (92.6%) and Biostar (93.7%) compared to Helex (74.2%; p=0.031 and p=0.034 respectively) and APO (76.4%; p=0.036 and p=0.041 respectively).
The GSO and Biostar showed better closure rates than Helex and APO at 4 months. PFO closure is a safe procedure with a low rate of clinical events at follow-up.
The Canadian journal of cardiology 06/2014; 30(6). DOI:10.1016/j.cjca.2014.03.015 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
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 1-3months.
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.
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.
International journal of cardiology 03/2014; 174(3). DOI:10.1016/j.ijcard.2014.03.154 · 4.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate intra-procedural imaging with transesophageal echocardiography and angiography during left atrial appendage occlusion using the Amplatzer™ Cardiac Plug with regard to sizing and final device shape.
Left atrial appendage ostium dimensions and diameter at a depth of 10mm from the ostium were measured by transesophageal echocardiography (0-180°) and angiography (RAO 30° - Cranial 20°) in consecutive patients undergoing left atrial appendage occlusion using the ACP with an oversizing strategy of 10-20% relative to the baseline measurements. After delivery, ACP dimensions were measured and device shape was assessed.
Twenty-seven consecutive patients underwent successful uncomplicated left atrial appendage closure with Amplatzer™ Cardiac Plug. We found a significant difference between the largest and smallest left atrial appendage diameter measured with transesophageal echocardiography (22.3±4.2 vs. 18.1±4.1mm, p<0.001). By the end of the procedure (by angiography), ACP had an optimal shape in 17 patients (63%), a strawberry-like shape in 7 patients (26%), and a square-like shape in 3 patients (11%). ACP was oversized on average by 1.5±2.7 and 3.3±2.3mm compared to transesophageal echocardiography and angiography, respectively. The final shape of the device was not significantly associated with the degree of oversizing.
We found a considerable variability in the assessment of the left atrial appendage, using transesophageal echocardiography and angiography. The degree of Amplatzer™ Cardiac Plug expansion within the left atrial appendage and the final shape of the device were not associated with the degree of oversizing.
Archivos de cardiología de México 03/2014; 84(1). DOI:10.1016/j.acmx.2013.05.006
[Show abstract][Hide abstract] ABSTRACT: Stroke is a major contributor to population morbidity and mortality. Cardiac thromboembolic sources are an important potential cause of stroke. Left atrial appendage (LAA) thromboembolism in association with atrial fibrillation is a major contributor to stroke occurrence, particularly in elderly individuals. Patent foramen ovale (PFO) acts as a potential conduit from the right-sided circulation to the brain, and has been suggested to be an important factor in cryptogenic stroke in the young patients. Advances in interventional cardiology have made it possible to deal with these potential stroke sources (LAA and PFO), but the available methods have intrinsic limitations that must be recognized. Furthermore, the potential value of LAA and PFO closure depends on our ability to identify when the target structure is importantly involved in stroke risk; this is particularly challenging for PFO. This article addresses the clinical use of PFO and LAA closure in stroke prevention. We discuss technical aspects of closure devices and methods, questions of patient selection, and clinical trials evidence. We conclude that for PFO closure, the clinical trials evidence is thus far negative in the broad cryptogenic stroke population, but closure might nevertheless be indicated for selected high-risk patients. LAA closure has an acceptable balance between safety and efficacy for atrial fibrillation patients with high stroke risk and important contraindications to oral anticoagulation. Much more work needs to be done to optimize the devices and techniques, and better define patient selection for these potentially valuable procedures.
The Canadian journal of cardiology 01/2014; 30(1):87-95. DOI:10.1016/j.cjca.2013.11.008 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
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.
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).
PPVR is associated with a reasonable rate of procedural success and favourable cardiovascular outcomes, and represents an appropriate option when technically possible.
The Canadian journal of cardiology 11/2013; 29(11):1422-8. DOI:10.1016/j.cjca.2013.07.800 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims: To describe the initial experience with the GORE® septal occluder (GSO), a new septal occluder for the treatment of atrial septal defects (ASD) and patent foramen ovale (PFO). Methods and results: This was a prospective single-centre review of patients undergoing percutaneous closure for a PFO or ASD with the GSO. A clinical evaluation and follow-up echocardiography were performed at three months with transoesophageal echocardiography (TEE) in case of PFO and transthoracic echocardiography (TTE) in ASDs. Between July 2011 and February 2012, thirty-eight patients underwent PFO (n=29) or ASD (n=9) closure with the GSO using TEE (n=36, 94.7%) or intracardiac echocardiography (n=2, 5.3%) guidance. In PFOs, three-month TEE was available in 24 patients and showed no residual shunt in 18 (75%), bubble shunt in two (8.3%) and bubble shunt after Valsalva in four (16.7%). In ASDs, three-month TTE showed no shunt in eight patients (88.8%) and residual shunt in one patient (11.2%). There was no device embolisation, air embolism, procedure-related stroke or pericardial effusion. No neurological events occurred during the follow-up period. Conclusions: This initial experience with the new GSO device has demonstrated acceptable safety with no procedural complications and acceptable efficacy with low rates of residual shunting at three-month follow-up.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 09/2013; 9(5):629-35. DOI:10.4244/EIJV9I5A100 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To describe the particular assessment and closure strategy that was followed in patients with left atrial appendages (LAA) with an early and severe bend.
The presence of a chicken-wing morphology with an early and severe bend constitutes one of the most difficult anatomical settings for transcatheter LAA occlusion.
Between November 2009 and December 2012, patients who presented chicken-wing LAA with an early (<20 mm from the ostium) and severe bend (<180°) were identified and included in the analysis. A particular implanting strategy consisting of deploying the distal lobe of the device inside the chicken-wing bend was used in all cases.
Among 42 patients who underwent LAA occlusion during the study period, 5 (12%) presented the pre-specified anatomy. Following the mentioned implanting strategy, all patients underwent successful LAA occlusion using the Amplatzer Cardiac Plug (n = 2) and the Amplatzer Amulet (n = 3). Successful occlusion was achieved in all patients. None of them presented any procedural complication. Follow-up transesophageal echocardiography at 3 months showed successful LAA sealing in all patients and no device embolization or thrombosis.
According to our results, the pre-specified closing implantation technique for chicken-wing LAAs with an early and severe bend might be a valid strategy for this challenging anatomical setting. Further cases will be necessary to confirm the results.
[Show abstract][Hide abstract] ABSTRACT: Objectives:
Mediastinal drainage following cardiac surgery with traditional large-bore plastic tubes can be painful and cumbersome. This study was designed to determine whether prolonged drainage (5 days) with a silastic tube decreased the incidence of significant pericardial effusion and tamponade following aortic or valvular surgery.
One hundred and fifty patients undergoing valvular or aortic surgery in a tertiary cardiac surgery institution were randomized to receive a conventional mediastinal tube plus a silastic Blake drain (n = 75), or two conventional tubes (n = 75). Conventional drains were removed on postoperative day (POD) 1, while Blake drains were removed on POD 5. The primary end-point was the combined incidence of significant pericardial effusion (≥ 15 mm) or tamponade through POD 5. Secondary end-points included total mediastinal drainage, postoperative atrial fibrillation (AF) and pain.
Analysis was performed for 67 patients in the Blake group and 73 in the conventional group. There was no difference between the two groups in the combined end-point of significant effusion or tamponade (7.4 vs 8.3%, P = 0.74), or in the incidence of AF (47 vs 46%, P = 0.89). Mean 24-h drainage was greater in the Blake group than in the conventional group (749 ± 444 ml vs 645 ± 618 ml, P < 0.01). Overall incidence of significant pericardial effusion at 30 days was 12.1% (n = 17), with 5% (n = 7) requiring drainage. The Blake group had a numerically lower incidence of effusion requiring drainage at POD 30 (3.0 vs 6.8%, P = 0.44). Postoperative pain was similar between groups.
In patients undergoing ascending aortic or valvular surgery, prolonged drainage with silastic tubes is safe and does not increase postoperative pain. There was no difference between the Blake and conventional drains with regard to significant pericardial effusion or tamponade in this cohort; however, this conclusion is limited by the low overall incidence of the primary outcome in this cohort.
Interactive Cardiovascular and Thoracic Surgery 04/2013; 17(1). DOI:10.1093/icvts/ivt123 · 1.16 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Although percutaneous left atrial appendage (LAA) closure is becoming a common procedure worldwide, there are still some anatomic limitations. The size of the LAA is one of the current limitations as the most popular devices do not allow the closure of very large LAAs. The new Amplatzer Cardiac Plug 2, also called "Amulet," has been redesigned not only to improve delivery and safety but also to allow the closure of larger LAAs. The present report describes the successful closure of a very large LAA using the Amulet.
The Canadian journal of cardiology 03/2013; 29(10). DOI:10.1016/j.cjca.2012.12.022 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 01/2013; 8(9):1094-8. DOI:10.4244/EIJV8I9A167 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background:
The Amplatzer Cardiac Plug (ACP) is a relatively new system for left atrial appendage (LAA) closure. In general, the particular design of the device and the variability of the LAA anatomy make the sizing process challenging. The objective of our study was to analyze the impact of the shape and sizing of the device on the presence of follow-up leaks.
The shape was evaluated by angiography and classified as "strawberry-like", "square-like" and "tire-like". The presence of peri-device leaks was assessed by transesophageal echocardiography (TEE) and graded as: 1) severe, 2) major, 3) moderate, 4) minor and 5) absent.
Twenty five patients were included. Overall, the device was oversized by 3.38 ± 2.26 mm and 1.58 ± 2.75 mm in relation to the largest angiographic and TEE diameter respectively. None of the patients presented any intra-procedural complication. After discharge, one patient was admitted for cardiac tamponade and another for stroke. In both, the device was optimally deployed. Follow-up TEE was done after a mean time of 7.9 ± 5.9 months. The presence of a leak was associated with a lower degree of device over-sizing by TEE (0.06 ± 3.31 mm if leak vs. 2.73 ± 1.85 mm if no leak; p=0.04) and a trend towards by angiography (2.39 ± 3.06 mm if leak vs. 3.98 ± 1.57 mm if no leak; p=0.16). The shape of the device was not associated with the presence of TEE leaks. Neither the shape nor the presence of leaks was associated with worse clinical outcomes.
Although the shape and sizing of the device were not linked to any particular clinical outcome, we found an association between a lower degree of over-sizing and the presence of follow-up leaks.
International journal of cardiology 12/2012; 168(2). DOI:10.1016/j.ijcard.2012.10.031 · 4.04 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the impact of a pharmacist-led warfarin patient self-management program on quality of life and anticoagulation control compared with management in a physician-led specialized anticoagulation clinic.
Prospective, randomized, controlled, open-label trial.
Tertiary care academic medical center.
A total of 114 patients aged 18-75 years who were followed at a specialized anticoagulation clinic, had received warfarin for at least 6 months, and were expected to continue warfarin for a minimum of 4 months.
All patients attended an educational session on anticoagulation provided by a pharmacist. Patients randomized to the self-management group (58 patients) also received practical training to use the CoaguChek XS device and a self-management dosing algorithm. Patients in the control group (56 patients) continued to undergo standard management at the anticoagulation clinic.
Patients completed a validated quality-of-life questionnaire and the validated Oral Anticoagulation Knowledge test at the beginning and end of the study. The quality of anticoagulation control was evaluated by using the time spent in therapeutic range. After 4 months of follow-up, a significant improvement in the self-management group was observed compared with the control group in four of the five quality-of-life topics (p<0.05). Improvements in knowledge were observed in both groups after the training session and persisted after 4 months (p<0.05 for all). The time spent in the therapeutic range (80.0% in the self-management group vs 75% in the control group, p=0.79) and in the extended therapeutic range ([target international normalized ratio ± 0.3] 93.2% in the self-management group vs 91.1% in the control group, p=0.30) were similar between groups.
A self-management warfarin program led by pharmacists resulted in significant improvement in the quality of life of patients receiving warfarin therapy as well as a reduction in the time required for anticoagulation monitoring, while maintaining a level of anticoagulation control similar to a high-quality specialized anticoagulation clinic.