1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study.

Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm2 at discharge remaining stable up to 1 year. No moderate or severe leakages were present at discharge or at 1 year. NYHA class improved by ≥ 1 level in 55.1% of the patients at discharge and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval sutureless valve in Japanese patients were favorable. This valve offers a promising alternative to conventional biological AVR in this Japanese population.

Modified Implant Technique of Perceval Sutureless Valve in Congenital Type 0 Bicuspid Valve Stenosis.

The Perceval sutureless valve has gained in popularity for treating degenerative aortic valve stenosis but not for congenital type 0 bicuspid aortic valve owing to anatomic challenges. We modified implant techniques following the four principles of ECHO-an acronym for elasticity, circularity, height, and orientation-to prevent paravalvular leakage and malposition.

Anatomical circumstances and aortic cross-clamp time in minimally invasive aortic valve replacement.

OBJECTIVES: Prolonged operative times, potentially leading to increased morbidity, are a possible drawback of minimally invasive aortic valve replacement. The aim of this study was to assess the impact of anatomical circumstances in the chest on aortic cross-clamp time. METHODS: This retrospective study included 68 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve via right-anterior thoracotomy or with ministernotomy. Anatomical variables were measured during preoperative computer tomography scans. RESULTS: Aortic cross-clamp time was shorter in those having ministernotomy than in the right-anterior thoracotomy group (41.1 vs 52.3 min; P < 0.001). Cardiopulmonary bypass (CPB) time was not significantly different between groups (P = 0.09). A multivariable linear-regression model (P = 0.018) showed the aortic dextroposition variable to be a significant predictor of the aortic cross-clamp method and CPB times (P = 0.005 and P = 0.003) independent of other anatomical variables in the right thoracotomy group (10 mm deviation from optimal position prolonged the times for 240 and 600 s). For the whole cohort, a correlation between aortic valve dimensions and operative times was found (P = 0.046, P = 0.009). A linear-regression model (P = 0.046) predicted 90 s longer aortic cross-clamp time and 231 s longer CPB time for every 1 mm smaller aortic valve diameter. CONCLUSIONS: The anatomical variables are associated with the operative times in minimally invasive aortic valve replacement with sutureless valves. Considering this association, preplanning the procedure is recommended.

Oversizing Increases Pacemaker Implantation Rate After Sutureless Minimally Invasive Aortic Valve Replacement.

OBJECTIVE: Cardiac conduction system disturbances potentially leading to permanent pacemaker implantation are significant postoperative complications after aortic valve replacement. The aim of this study was to assess the impact of sutureless prosthetic valve oversizing on permanent pacemaker implantation rate. METHODS: This multicenter retrospective study included 306 patients who underwent minimally invasive aortic valve replacement with the Perceval sutureless valve. Oversizing was determined by the implanted valve size indexed to body surface area. Data were analyzed with a multivariable logistic regression model. RESULTS: This study confirmed excellent postoperative results for minimally invasive aortic valve replacement with right anterior minithoracotomy approach and rapid deployment sutureless valves. Mortality rate was 1%. Eighteen (5.9%) patients received a new permanent pacemaker. Multivariable logistic regression model (P = 0.05) found oversizing as significant risk factor (P = 0.017) for permanent postoperative pacemaker implantation independent of patient age. There was a significant negative correlation between the indexed implanted valve size and the mean and peak postoperative transvalvular gradients (P < 0.001). CONCLUSIONS: Oversizing of sutureless prosthetic aortic valves is a risk factor for postoperative permanent pacemaker implantation. Proper sizing of Perceval is important to avoid complications and ensure optimal valve performance.

Cardiac autonomic regulation and PR interval determination for enhanced atrial fibrillation risk prediction after cardiac surgery.

BACKGROUND: Changes in cardiac autonomic regulation and P-wave characteristics are associated with the occurrence of atrial fibrillation. The purpose of this study was to evaluate whether combined preoperative non-invasive determination of cardiac autonomic regulation and PR interval allows for the identification of patients at risk of new-onset atrial fibrillation after cardiac surgery. METHODS: RR, PR and QT intervals, and linear and non-linear heart rate variability parameters from 20 min high-resolution electrocardiographic recordings were determined one day before surgery in 150 patients on chronic beta blockers undergoing elective coronary artery bypass grafting, aortic valve replacement, or both, electively. RESULTS: Thirty-one patients (21%) developed postoperative atrial fibrillation. In the atrial fibrillation group, more arterial hypertension, a greater age, a higher EuroSCORE II, a higher heart rate variability index (pNN50: 9 ±â€¯20 vs. 4 ±â€¯10, p = 0.050), a short PR interval (156 ±â€¯23 vs. 173 ±â€¯31 ms; p = 0.011), and a reduced short-term scaling exponent of the detrended fluctuation analysis (DFA1, 0.96 ±â€¯0.36 vs. 1.11 ±â€¯0.30 ms; p = 0.032) were found compared to the sinus rhythm group. Logistic regression modeling confirmed PR interval, DFA1 and age as the strongest preoperative predictors of postoperative atrial fibrillation (area under the receiver operating characteristic curve = 0.804). CONCLUSIONS: Patients developing atrial fibrillation after cardiac surgery presented with severe cardiac autonomic derangement and a short PR interval preoperatively. The observed state characterizes both altered heart rate regulation and arrhythmic substrate and is strongly related to an increased risk of postoperative atrial fibrillation.

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.

Fluoroless catheter ablation of various right and left sided supra-ventricular tachycardias in children and adolescents.

Electrophysiology study (EPS) and catheter ablation (CA) in children and adolescents carries a potentially harmful effect of radiation exposure when performed with the use of fluoroscopy. Our aim was to evaluate the feasibility, safety and effectiveness of fluoroless EPS and CA of various supra-ventricular tachycardias (SVTs) with the use of the 3D mapping system and intracardiac echocardiography (ICE). Forty-three consecutive children and adolescents (age 13 ± 3 years) underwent fluoroless EPS and CA for various supra-ventricular tachycardias. A three-dimensional (3D) mapping system NavX™ was used for guidance of diagnostic and ablation catheters in the heart. ICE was used as a fundamental imaging tool for transseptal punctures. Acute procedural success rate was 100 %. There were no procedure related complications and short-term follow up (10 ± 3 months) revealed 93 % arrhythmia free survival rate. Fluoroless CA of various SVTs in the paediatric population is feasible, safe and can be performed successfully with 3D mapping system and ICE.

Long-Term Success for the Convergent Atrial Fibrillation Procedure: 4-Year Outcomes.

BACKGROUND: The objective of this single-center study was to report long-term efficacy outcomes of the convergent procedure for the treatment of atrial fibrillation. METHODS: Outcomes for the convergent procedure were determined by clinical presentation and interrogating implanted loop recorders. Rhythm status and required interventions for atrial fibrillation recurrence (antiarrhythmic drugs, cardioversions, and repeat ablations) were quantified 1 to 4 years after the procedure. Long-term outcomes, atrial fibrillation burden quantified with continuous monitoring, and patient baseline characteristics were analyzed and reported. RESULTS: Seventy-six consecutive patients with paroxysmal (5%), persistent (16%), or longstanding atrial fibrillation (79%) underwent the convergent procedure between January 2009 and July 2013. Clinical presentation in sinus rhythm at isolated timepoints was 88% at 6 months, 85% at 1 year, 85% at 2 years, 84% at 3 years, and 81% at 4 years of follow-up. Total patients requiring repeat catheter ablation was 18% through 4 years. Single procedure 1-year success (freedom from atrial fibrillation/atrial flutter/atrial tachycardia through 1 year and off antiarrhythmic drugs) was 56%; and long-term success (freedom from atrial fibrillation/atrial flutter/atrial tachycardia through at least 36 months and off antiarrhythmic drugs) was 45%. CONCLUSIONS: Four-year outcomes for the convergent procedure are promising and demonstrate the ability to maintain sinus rhythm in a predominantly persistent and longstanding atrial fibrillation population. Increasing the extent of posterior ablation should be evaluated for patients with enlarged atria to account for the potential increase in fibrosis distribution and other atrial remodeling markers that produce arrhythmogenic substrates.

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.

Severe Cardiac Autonomic Derangement and Altered Ventricular Repolarization Pave the Way to Postoperative Atrial Fibrillation.

OBJECTIVE: Postoperative atrial fibrillation (POAF) is a frequent complication after heart surgery. It has been shown that cardiac autonomic derangement plays a significant role in the genesis of atrial fibrillation (AF) and that AF might also be promoted by altered repolarization. Thus, the aim of our study was to determine the levels of cardiac autonomic modulation and repolarization properties in patients developing POAF. METHODS: Seventy-nine patients scheduled for aortic and/or coronary artery bypass grafting surgery with cardiopulmonary bypass were enrolled prospectively. High-resolution 20-minute electrocardiogram recordings were obtained day before surgery to determine P, PR, QT, and QTc intervals, as well as linear (time and frequency domain) and nonlinear heart rate variability parameters (fractal dimension and detrended fluctuation analysis). QTc interval was calculated using Framingham correction. RESULTS: Twenty-nine patients developed POAF (AF group), and 50 did not (non-AF group). Groups were similar regarding demographics, surgery type, and perioperative characteristics, except for older age in the AF group. QT and QTc intervals (Framingham) were longer in the AF group [442 (44) vs 422 (28) milliseconds, P = 0.018; and 448 (44) vs 431 (24) milliseconds, P = 0.031 and P = 0.019, respectively]. Time domain heart rate variability parameter PNN50 (percentage of pairs of adjacent NN intervals differing >50 milliseconds) was higher [14% (21%) vs 8% (16%), P = 0.015], and nonlinear parameter detrended fluctuation analysis α2 was lower in the AF group [0.81 (0.21) vs 0.91 (0.20), P = 0.031]. CONCLUSIONS: Profound cardiac autonomic derangement, suggestive of parasympathetic excessive modulation, exists preoperatively in patients inclined to POAF after cardiac surgery, whereby parameters PNN50 and α2 differentiated the AF from the non-AF group. Prolonged QTc intervals are associated with an increased risk of POAF.

Endoaortic Clamping Does Not Increase the Risk of Stroke in Minimal Access Mitral Valve Surgery: A Multicenter Experience.

BACKGROUND: Some controversy exists regarding the safety of endoaortic balloon clamping in minimal access isolated mitral valve surgery (MIMVS). The aim of this European multicenter study was to analyze the results in 10 experienced centers and compare the outcomes with published data. METHODS: The most recent 50 consecutive MIMVS cases from 10 European surgeons who had performed at least 100 procedures were prospectively collected and retrospectively analyzed. All procedures were performed through right minithoracotomy with femoral cannulation and endoaortic balloon occlusion. In-hospital and 30-day outcomes were studied. Mortality and stroke rates were compared with published median sternotomy and MIMVS outcomes. RESULTS: Mean age was 63.2 ± 12.5 years, 289 (57.8%) were male, mean logistic European system for cardiac operative risk evaluation was 6.1 ± 6.2, and 53 (10.6%) procedures had cardiac reoperations. Concomitant procedures were performed in 126 (25.9%) cases. Three patients (0.6%) required conversion to full sternotomy. Ten patients (2.0%) necessitated endoaortic balloon clamping conversion (8 to external clamping), and re-exploration for bleeding was necessary in 24 (4.8%) cases. Mean aortic cross-clamp and cardiopulmonary bypass times were 85.6 ± 30.1 and 129.5 ± 40.2 min, respectively, and were significantly longer for concomitant procedures (p < 0.001). There were no aortic dissections and no deep venous thromboses. Operative mortality (none neurologic) and major stroke occurred in 7 (1.4%) and 4 (0.8%) patients, respectively. These rates compared favorably with the published literature on isolated primary mitral valve surgery (MVS) through sternotomy or minithoracotomy (mortality rates 0.2% to 11.6%, stroke rates 0.6% to 4.4%). CONCLUSIONS: Once procedural proficiency is acquired, endoaortic balloon clamping in MIMVS is a safe and effective technique. Despite the fact that this patient cohort also includes combined and redo procedures, the observed mortality and stroke rate compared favorably with the existing literature on primary isolated mitral valve surgery irrespective of the approach.

Sutureless aortic valve replacement: a systematic review and meta-analysis.

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) has emerged as an innovative alternative for treatment of aortic stenosis. By avoiding the placement of sutures, this approach aims to reduce cross-clamp and cardiopulmonary bypass (CPB) duration and thereby improve surgical outcomes and facilitate a minimally invasive approach suitable for higher risk patients. The present systematic review and meta-analysis aims to assess the safety and efficacy of SU-AVR approach in the current literature. METHODS: Electronic searches were performed using six databases from their inception to January 2014. Relevant studies utilizing sutureless valves for aortic valve implantation were identified. Data were extracted and analyzed according to predefined clinical endpoints. RESULTS: Twelve studies were identified for inclusion of qualitative and quantitative analyses, all of which were observational reports. The minimally invasive approach was used in 40.4% of included patients, while 22.8% underwent concomitant coronary bypass surgery. Pooled cross-clamp and CPB duration for isolated AVR was 56.7 and 46.5 minutes, respectively. Pooled 30-day and 1-year mortality rates were 2.1% and 4.9%, respectively, while the incidences of strokes (1.5%), valve degenerations (0.4%) and paravalvular leaks (PVL) (3.0%) were acceptable. CONCLUSIONS: The evaluation of current observational evidence suggests that sutureless aortic valve implantation is a safe procedure associated with shorter cross-clamp and CPB duration, and comparable complication rates to the conventional approach in the short-term.

Sutureless Aortic Valve Replacement International Registry (SU-AVR-IR): design and rationale from the International Valvular Surgery Study Group (IVSSG).

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) is an innovative approach which shortens cardiopulmonary bypass and cross-clamp durations and may facilitate minimally invasive approach. Evidence outlining its safety, efficacy, hemodynamic profile and potential complications is replete with small-volume observational studies and few comparative publications. METHODS: Minimally invasive aortic valve surgery and high-volume SU-AVR replacement centers were contacted for recruitment into a global collaborative coalition dedicated to sutureless valve research. A Research Steering Committee was formulated to direct research and support the mission of providing registry evidence warranted for SU-AVR. RESULTS: The International Valvular Surgery Study Group (IVSSG) was formed under the auspices of the Research Steering Committee, comprised of 36 expert valvular surgeons from 27 major centers across the globe. IVSSG Sutureless Projects currently proceeding include the Retrospective and Prospective Phases of the SU-AVR International Registry (SU-AVR-IR). CONCLUSIONS: The global pooling of data by the IVSSG Sutureless Projects will provide required robust clinical evidence on the safety, efficacy and hemodynamic outcomes of SU-AVR.

European experience of the convergent atrial fibrillation procedure: multicenter outcomes in consecutive patients.

BACKGROUND: The objective of this collaborative, multicenter, European effort was to evaluate the outcomes of the convergent procedure for the treatment of persistent and long-standing persistent atrial fibrillation (AF) in consecutive patients at 4 European centers. METHODS: Outcomes of consecutive patients, undergoing the convergent procedure at 4 European centers, were evaluated in this study. Epicardial ablation was performed before endocardial ablation. Convergent procedure outcomes were recorded by interrogation of implanted loop recorders or Holter monitors. Rhythm status and required interventions (antiarrhythmic drugs, cardioversions, and repeat ablations) were quantified 6 and 12 months after the procedure. Outcomes, monitoring type, and patient baseline characteristics were analyzed and reported. RESULTS: Seventy-three consecutive patients presenting with persistent AF (30.1%) or long-standing persistent AF (69.9%) underwent the convergent procedure between January 2010 and December 2011. At 6 months, 82% (56/68) were in sinus rhythm. At 12 months, 80% (53/66) were in sinus rhythm; single-procedure maintenance of sinus rhythm without postblanking period interventions was 76% (50/66); 52% (34/66) were in sinus rhythm and not receiving antiarrhythmic drugs. CONCLUSIONS: This multicenter European collaborative effort demonstrated that the convergent procedure is a safe and efficacious treatment option for persistent and long-standing persistent AF.

Understanding coronary artery bypass transit time flow curves: role of bypass graft compliance.

OBJECTIVES: Low mean bypass graft flow (Q) and high pulsatility index (PI) measured by the transit time flow measurement method are not specific for anastomotic stenosis, but occur with competitive flow and poor coronary run-off. We hypothesized that graft compliance is responsible for these changes and that flow measured at the proximal end of the coronary bypass can be viewed as a sum of the graft capacitive flow and flow that passes through the distal anastomosis. METHODS: Transit time flow measurements (TTFMs) of 15 left internal thoracic artery (LITA) to LAD bypass grafts and 10 saphenous vein grafts (SVGs) to either the right coronary artery (RCA) or posterior descending artery (PDA) were analysed. The TTFM was performed on the proximal and distal end of the graft, and proximally with distal occlusion of the graft. Low mean bypass graft flow PI and diastolic filling (DF) measured distally and proximally were compared, and graft compliance was estimated. RESULTS: Diastolic filling was higher distally in every single case (LITA-LAD: distal DF 76 ± 12% vs proximal 66 ± 13%, P = 0.005; SVG-RCA/PDA: distal 72 ± 15% vs proximal 63 ± 12%, P = 0.018). There were no significant differences in Q and PI. Subtracting the distal from the proximal flow gave a result identical to the proximal TTFM in distally occluded grafts, confirming the presence of graft capacitive flow. Graft compliance estimated from the flow of distally occluded grafts was 0.99 ± 0.47 µl/mmHg for LITA grafts and 0.78 ± 0.42 µl/mmHg for SVG grafts. CONCLUSIONS: The study confirmed that the TTFM measured at the proximal end of the coronary bypass could be viewed as a sum of graft capacitive flow and the flow that passes through the distal anastomosis. Graft capacitive flow increases the systolic and decreases the diastolic TTFM when measured at the proximal end of the graft. It explains the higher DF when the TTFM is measured at the distal end of the graft and the increase in the PI at the proximal end when Q decreases. As the influence of graft capacitive flow on the PI in low Q can be eliminated by performing the TTFM at the distal end of the graft, we believe that the value of PI is clinically irrelevant.

Influence of type of aortic valve prosthesis on coronary blood flow velocity.

BACKGROUND: Severe aortic valve stenosis is associated with high resting and reduced hyperemic coronary blood flow. Coronary blood flow increases after aortic valve replacement (AVR); however, the increase depends on the type of prosthesis used. The present study investigates the influence of type of aortic valve prosthesis on coronary blood flow velocity. METHODS: The blood flow velocity in the left anterior descending coronary artery (LAD) and the right coronary artery (RCA) was measured intraoperatively before and after AVR with a stentless bioprosthesis (Sorin Freedom Solo; n = 11) or a bileaflet mechanical prosthesis (St. Jude Medical Regent; n = 11). Measurements were made with an X-Plore epicardial Doppler probe (Medistim, Oslo, Norway) following induction of hyperemia with an adenosine infusion. Preoperative and postoperative echocardiography evaluations were used to assess valvular and ventricular function. Velocity time integrals (VTI) were measured from the Doppler signals and used to calculate the proportion of systolic VTI (SF), diastolic VTI (DF), and normalized systolic coronary blood flow velocities (NSF) and normalized diastolic coronary blood flow velocities (NDF). RESULTS: The systolic proportion of the LAD VTI increased after AVR with the St. Jude Medical Regent prosthesis, which produced higher LAD SF and NSF values than the Sorin Freedom Solo prosthesis (SF, 0.41 ± 0.09 versus 0.29 ± 0.13 [P = .04]; NSF, 0.88 ± 0.24 versus 0.55 ± 0.17 [P = .01]). No significant changes in the LAD velocity profile were noted after valve replacement with the Sorin Freedom Solo, despite a significant reduction in transvalvular gradient and an increase in the effective orifice area. AVR had no effect on the RCA flow velocity profile. CONCLUSION: The coronary flow velocity profile in the LAD was significantly influenced by the type of aortic valve prosthesis used. The differences in the LAD velocity profile probably reflect differences in valve design and the systolic transvalvular flow pattern.

A first-in-man study of the role of flexible robotics in overcoming navigation challenges in the iliofemoral arteries.

OBJECTIVE: Current interventional techniques rely heavily on operator familiarity with catheters and wires and on physician skills in effectively navigating through and managing target lesions. A novel robotic technology allows endovascular specialists to remotely control catheter tip deflection and advancement and to coordinate manipulation of currently available wires. The aim of this study was to successfully demonstrate feasibility and safety of navigation to and treatment of iliac and femoral artery lesions using Hansen Medical's vascular control catheter (VCC). METHODS: A total of 20 limbs were included in this analysis for a first-in-man trial of the VCC and vascular catheter control system. The local Institutional Review Board approved the trial, and all patients included had symptomatic femoropopliteal occlusive disease. Preoperative imaging was available on all patients. Target lesions in the contralateral superficial femoral artery ranged from mild stenosis to chronic total occlusions (TransAtlantic Inter-Society A through D). Exclusion criteria included previously treated iliac and femoral lesions in the symptomatic leg and a body mass index >35. The operators comprised three experienced interventionalists (two vascular surgeons and an interventional radiologist) and a novice (cardiac surgeon). The primary end point of the study was to demonstrate successful cannulation of the target vessel (ie, navigation to the lesion with wire and catheter) with the Hansen VCC, with no device-related serious adverse events. Secondary end points were to assess the ability to treat lesions using the flexible catheter defined by successful insertion of a guidewire, angiography of the target vessel, delivery of balloon, and/or stent. Procedure times and radiation delivered were analyzed for the group and by operator, and t-test was performed to determine statistical significance. Complications were assessed by clinical examination and ultrasound. RESULTS: Lesions were successfully and safely cannulated in all limbs treated. The VCC performed as designed in all cases. All interventionalists, regardless of experience, navigated the VCC with ease. However, statistically significant differences in navigation time and radiation per case were observed between the experienced and inexperienced interventionalists. There were no access site complications (hematoma, thrombosis, pseudoaneurysm) as evaluated by ultrasound. CONCLUSIONS: This initial experience in flexible robotics demonstrates that this technology is both efficacious and safe in the arterial tree. Although robotics provides superior maneuverability compared with current techniques, endovascular experience is crucial to taking full advantage of the extra capabilities. Valuable future considerations will include off-the-wall (center lumen) navigation with three-dimensional imaging.

Intraoperative left subclavian artery occlusion with left hand ischaemia and steal syndrome in the left internal thoracic artery.

We present a case of a 62-year old man with a left main stenosis, left coronary artery dominance, normal ejection fraction and no valvular pathology, and status post right carotid artery stenting, who was scheduled for elective coronary revascularization. We performed off-pump coronary revascularization, anastomosing the left internal thoracic artery to the left anterior descending artery, and three separate saphenous vein grafts to the intermediate artery and the first and second obtuse marginals, respectively. Proximally, the right internal thoracic artery was used as the inflow for all three venous grafts due to a heavily calcified ascending aorta. During the construction of the distal anastomoses to the obtuse marginals, the arterial pressure in the left radial artery suddenly dropped. The left hand was found to be pale and pulseless. A femoral artery catheter was placed for pressure monitoring and the anastomoses were completed as planned. Intraoperative transit-time graft flow measurement showed a reversed flow in the left internal thoracic artery. Postoperatively, angiography was performed showing a subtotal stenosis of the proximal left subclavian artery. The artery was dilated and stented. The postoperative course was uneventful and the patient was discharged on the 12th postoperative day.

Importance of evaluating conduction block in radiofrequency ablation for atrial fibrillation.

OBJECTIVE: Atrial fibrillation (AF) is the most frequently diagnosed cardiac arrhythmia. Anti-arrhythmic drugs may be used to suppress ectopic foci and interrupt reentry circuits, but are often insufficient to treat recurrent AF and have a number of adverse effects. Alternative therapies, such as catheter and surgical ablation, have been explored. This investigation examines the importance of assessing exit block when performing surgical ablation during beating-heart treatment of AF. METHODS: This was an evaluation of pooled data from multicenter prospective results obtained in AF patients who received ablation with a new, irrigated, vacuum-integrated device that creates linear lesions during beating-heart/open-chest or minimally invasive, port-access procedures. Electrocardiogram or Holter data were collected intra-operatively and at 1, 3, 6, and 12 months. Outcomes were also evaluated for patients who were or 'were not' tested for exit block following the ablation procedure. RESULTS: A total of 93 patients were treated (61 open-chest surgeries, 32 port-access procedures). There were no device-related complications and no operative mortality. At 341 days' average follow-up, 71/86 (83%) patients were free from AF, 66/86 (77%) were in sinus rhythm, and 60/86 (70%) were free from AF and off Class I and III anti-arrhythmic drugs (AADs). At 12 months, 23/23 (100%) patients with exit block confirmed were AF free compared with 13/21 (62%) patients with exit block not tested (p≤0.01, Fisher's exact test); 20/23 (87%) were in sinus rhythm compared with 12/21 (57%) patients with exit block not tested (p≤0.05, Fisher's exact test); and 20/23 (87%) were AF free without Class I and III AADs compared with 10/21 (48%) patients with exit block not tested (p≤0.01, Fisher's exact test). Both open-chest and port-access procedures yielded decreases in left-atrial size from baseline to 6 months' follow-up. Patients undergoing port-access procedures also observed an increase in left-ventricular ejection fraction, which was also significant at 6 months. CONCLUSION: Patients in whom exit block was confirmed following an ablation procedure were more likely to have successful clinical outcomes. Since testing for exit block must be performed on a beating heart, total epicardial beating-heart ablation may provide an important treatment for AF, providing intra-operative feedback indicative of long-term outcomes.