Perceval valve intermediate outcomes: a systematic review and meta-analysis at 5-year follow-up.

OBJECTIVES: New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one such alternative. Whilst short-term data is promising, limited mid-term outcomes exist, until now. This is the first systematic review and meta-analysis to evaluate mid-term outcomes in the Perceval Valve in isolation. METHODS: A systematic literature review of 5 databases was performed. Articles included evaluated echocardiographic and mortality outcomes beyond 5 years in patients who had undergone Perceval Valve AVR. Two reviewers extracted and reviewed the articles. Weighted estimates were performed for all post-operative and mid-term data. Aggregated Kaplan Meier curves were reconstructed from digitised images to evaluate long-term survival. RESULTS: Seven observational studies were identified, with a total number of 3196 patients analysed. 30-day mortality was 2.5%. Aggregated survival at 1, 2, 3, 4 and 5 years was 93.4%, 89.4%, 84.9%, 82% and 79.5% respectively. Permanent pacemaker implantation (7.9%), severe paravalvular leak (1.6%), structural valve deterioration (1.5%), stroke (4.4%), endocarditis (1.6%) and valve explant (2.3%) were acceptable at up to mid-term follow up. Haemodynamics were also acceptable at up mid-term with mean-valve gradient (range 9-13.6 mmHg), peak-valve gradient (17.8-22.3 mmHg) and effective orifice area (1.5-1.8 cm2) across all valve sizes. Cardiopulmonary bypass (78 min) and Aortic cross clamp times (52 min) were also favourable. CONCLUSION: To our knowledge, this represents the first meta-analysis to date evaluating mid-term outcomes in the Perceval Valve in isolation and demonstrates good 5-year mortality, haemodynamic and morbidity outcomes. KEY QUESTION: What are the mid-term outcomes at up to 5 years follow up in Perceval Valve Aortic Valve Replacement? KEY FINDINGS: Perceval Valve AVR achieves 80% freedom from mortality at 5 years with low valve gradients and minimal morbidity. KEY OUTCOMES: Perceval Valve Aortic Valve Replacement has acceptable mid-term mortality, durability and haemodynamic outcomes.

Long-Term Results of the RAPCO Trials.

BACKGROUND: An internal thoracic artery graft to the left anterior descending artery is standard in coronary bypass surgery, but controversy exists on the best second conduit. The RAPCO trials (Radial Artery Patency and Clinical Outcomes) were designed to compare the long-term patency of the radial artery (RA) with that of the right internal thoracic artery (RITA) and the saphenous vein (SV). METHODS: In RAPCO-RITA (the RITA versus RA arm of the RAPCO trial), 394 patients <70 years of age (or <60 years of age if they had diabetes mellitus) were randomized to receive RA or free RITA graft on the second most important coronary target. In RAPCO-SV (the SV versus RA arm of the RAPCO trial), 225 patients ≥70 years of age (or ≥60 years of age if they had diabetes mellitus) were randomized to receive RA or SV graft. The primary outcome was 10-year graft failure. Long-term mortality was a nonpowered coprimary end point. The main analysis was by intention to treat. RESULTS: In the RA versus RITA comparison, the estimated 10-year patency was 89% for RA versus 80% for free RITA (hazard ratio for graft failure, 0.45 [95% CI, 0.23-0.88]). Ten-year patient survival estimate was 90.9% in the RA arm versus 83.7% in the RITA arm (hazard ratio for mortality, 0.53 [95% CI, 0.30-0.95]). In the RA versus SV comparison, the estimated 10-year patency was 85% for the RA versus 71% for the SV (hazard ratio for graft failure, 0.40 [95% CI, 0.15-1.00]), and 10-year patient survival estimate was 72.6% for the RA group versus 65.2% for the SV group (hazard ratio for mortality, 0.76 [95% CI, 0.47-1.22]). CONCLUSIONS: The 10-year patency rate of the RA is significantly higher than that of the free RITA and better than that of the SV. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00475488.

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches.

OBJECTIVE: To define the benefit of sutureless and rapid deployment valves in current minimally invasive approaches in isolated aortic valve replacement. METHODS: A panel of 28 international experts with expertise in both minimally invasive aortic valve replacement and rapid deployment valves was constituted. After thorough literature review, the experts rated evidence-based recommendations in a modified Delphi approach. RESULTS: No guideline could be retrieved. Thirty-three clinical trials and 9 systematic reviews could be identified for detailed text analysis to obtain a total of 24 recommendations. After rating by the experts 12, final recommendations were identified: preoperative computed tomographic scan as well as intraoperative transesophageal echocardiography are highly recommended. Suitable annular sizes are 19 to 27 mm. There is a contraindication for bicuspid valves only for type 0 and for annular abscess or destruction due to infective endocarditis. The use of sutureless and rapid deployment valves reduces extracorporeal circulation and aortic cross-clamp time and leads to less early complications as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions, paravalvular leakages and aortic regurgitation, and renal replacement therapy, respectively. These clinical outcomes result in reduced intensive care unit and hospital stay and reduced costs. The use of sutureless and rapid deployment valves will lead to a higher adoption rate of minimally invasive approaches in aortic valve replacement. Respect should be taken to a necessary short learning curve for both sutureless and minimally invasive programs. CONCLUSIONS: Sutureless and rapid deployment aortic valve replacement together with minimally invasive approaches offers an attractive option in aortic valve placement for patients requiring biological valve replacement.

Sutureless, rapid deployment valves and stented bioprosthesis in aortic valve replacement: recommendations of an International Expert Consensus Panel.

OBJECTIVES: After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves. METHODS: Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts. RESULTS: Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves. CONCLUSION: The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.

Epicardial wave mapping in human long-lasting persistent atrial fibrillation: transient rotational circuits, complex wavefronts, and disorganized activity.

OBJECTIVES: To characterize the nature of atrial fibrillation (AF) activation in human persistent AF (PerAF) using modern tools including activation, directionality analyses, complex-fractionated electrogram, and spectral information. BACKGROUND: The mechanism of PerAF in humans is uncertain. METHODS AND RESULTS: High-density epicardial mapping (128 electrodes/6.75 cm(2)) of the posterior LA wall (PLAW), LA and RA appendage (LAA, RAA), and RSPV-LA junction was performed in 18 patients with PerAF undergoing open heart surgery. Continuous 10 s recordings were analysed offline. Activation patterns were characterized into four subtypes (i) wavefronts (broad or multiple), (ii) rotational circuits (≥2 rotations of 360°), (iii) focal sources with centrifugal activation of the entire mapping area, or (iv) disorganized activity [isolated chaotic activation(s) that propagate ≤3 bipoles or activation(s) that occur as isolated beats dissociated from the activation of adjacent bipole sites]. Activation at a total of 36 regions were analysed (14 PLAW, 3 RSPV-LA, 12 LAA, and 7 RAA) creating a database of 2904 activation patterns. In the majority of maps, activation patterns were highly heterogeneous with multiple unstable activation patterns transitioning from one to another during each recording. A mean of 3.8 ± 1.6 activation subtypes was seen per map. The most common patterns seen were multiple wavefronts (56.2 ± 32%) and disorganized activity (24.2 ± 30.3%). Only 2 of 36 maps (5.5%) showed a single stable activation pattern throughout the 10-s period. These were stable planar wavefronts. Three transient rotational circuits were observed. Two of the transient circuits were located in the posterior left atrium, while the third was located on the anterior surface of the LAA. Focal activations accounted for 11.3 ± 14.2% of activations and were all short-lived (≤2 beats), with no site demonstrating sustained focal activity. CONCLUSION: Human long-lasting PerAF is characterized by heterogeneous and unstable patterns of activation including wavefronts, transient rotational circuits, and disorganized activity.

Choice of conduits for coronary artery bypass grafting: craft or science?

Long-term patency of a bypass graft is an important determinant in reducing morbidity and increasing survival after coronary bypass surgery. The purpose of this review is to analyse factors contributing to improved outcomes of commonly used conduits. Progress has been limited by the lack of uniform definitions of graft failure and development of appropriate statistical models. Evolving techniques for assessing patency at more frequent intervals has provided insight into the time and sites of early disease. The explosion of scientific knowledge of graft physiology has added to improving harvest, storage and early protection procedures thereby reducing early morbidity. Similarly, the understanding and management of risk factors have contributed to graft durability and possibly survival. Conduits have different characteristics and applications, which are patient dependent. Competitive flow remains a problem especially with arterial conduits; functional studies as opposed to anatomy of the target artery may improve understanding of the contribution of the collateral circulation. Selected patency data provide comparison between grafts. The role of the second internal thoracic artery graft is the subject of the Arterial Revascularisation Trial. Off-pump bypass procedures and patient characteristics affect conduit selection. Stroke is a major complication, which can be minimised by avoiding the aorta especially during off-pump surgery. There are few randomised controlled trials on the late outcomes comparing different bypass grafts and between bypass grafting and current percutaneous intervention methods. Accurate reporting of outcomes of graft patency will improve the scientific content and emphasise the importance of surgery in the management of coronary disease.

New ablation techniques for atrial fibrillation and the minimally invasive cryo-maze procedure in patients with lone atrial fibrillation.

Atrial fibrillation (AF) is associated with significant morbidity and mortality. Medical management is often palliative but new ablation techniques have enabled curative approaches. Catheter-based ablation has limited success, whilst surgical approaches are widely applicable with favourable results. The minimally invasive Cryo-Maze (MICM) replicates the lesions of the Cox-Maze procedure using cryotherapy. We present our retrospective review of all Cryo-Maze procedures performed at East Carolina University, from October 2003 to January 2006, with analysis of all MICM's for lone AF, via a small right inframammary incision. A total of 41 patients (29 male, 12 female, age 61.6+/-9.7 years) with lone AF underwent an MICM as a primary operation. There were no deaths or early or late strokes. At discharge 36 patients (87.8%) were in sinus. At six weeks, this ratio had increased to 90.2% (37/41). The rate of SR continued to improve and for those out three months, the rate increased to 92.7% (38/41). At six months, 87.2% (34/39) were in SR. SR was seen in 20/23 patients with follow-up beyond one year (87.0%). In conclusion, surgical ablation techniques that replicate the Cox-Maze procedure are associated with high rates of sinus rhythm beyond one year, with wide application. AF is a curable condition, using a combination of catheter-based and surgical approaches. Newer surgical ablation devices allow minimally invasive approaches.

Robotic mitral surgery at East Carolina University: a 6 year experience.

BACKGROUND: Robotic mitral valve repair using the da Vinci telemanupilation system has become the standard of care at many centres worldwide. We perform the first robotic MV repair in the United States in the year 2000. This article reviews our 6 year experience and current technique of robotic MV repair as well as future trends in the field. METHODS: Retrospective review of our initial 200 robotic MV repairs. Patient demographics, operative times, type of repairs, morbidities, mortality, success of the repair including need for reoperations were reviewed. RESULTS: The average age was 57 +/- 0.9 years. Average time for CPB was 156 minutes and for cross clamp 119 minutes. There was one operative death (0.5%) with no device related complications. Postoperative TEE demonstrated no MR in 187 (93.5%) patients, trace MR in 6 (3%) patients, moderate MR in 5 (2.5%) patients, and SAM in 2 (1%) patients. Five (2.5%) patients required reoperation for failed repairs. CONCLUSIONS: Robotic MV repair operations are safe with excellent early results. Follow-up studies are needed to determine repair longevity. We must continue to improve the current technology in order to develop the next generation of tools that will facilitate robotic MV repairs.

Do angiographic results from symptom-directed studies reflect true graft patency?

BACKGROUND: Coronary artery graft patency results have been obtained from repeat angiograms in patients who presented with evidence of ischemia. The purpose of this study is to compare protocol-directed angiographic results from a randomized clinical trial with symptom-directed angiography in nontrial patients. METHODS: Repeat angiography after primary isolated coronary artery bypass grafting was performed in 337 of 2,259 patients between July 1996 and September 2004. Patients were divided into two groups: 596 graft angiograms in 192 trial patients were compared with 389 graft angiograms in 142 nontrial patients. The mean interval from surgery was 1,306 +/- 800 days versus 1,119 +/- 777 days, respectively. Grafting techniques were similar in both groups except that the right internal thoracic artery was used almost exclusively as a free graft in the trial patients. Angiographic outcomes were defined as patent (stenosis <80%) or failure (stenosis > or =80%, occlusion, or the string sign). Comparisons of trial versus nontrial grafts were made using a generalized linear mixed model. Five-year estimates of graft patency were made using survival analyses accounting for interval censoring. RESULTS: The odds ratio for graft failure for nontrial compared with trial patient grafts was 2.6 (95% confidence interval, 1.6 to 4.3; p < 0.001). Cumulative patency estimates for all grafts at 5 years were trial 91% versus nontrial 83%, p = 0.004. Five-year estimates for individual conduits were left internal thoracic artery, 99% versus 92%, p = 0.002; right internal thoracic artery, 86% versus 87%, p = 0.8; radial artery, 87% versus 86%, p = 0.6; and saphenous vein, 86% versus 56%, p = 0.003. CONCLUSIONS: Graft patency rates were superior in the trial compared with nontrial patients. Symptom-directed graft failure rates were approximately double those of trial patients.