Impact of the indexed effective orifice area on mid-term cardiac-related mortality after aortic valve replacement

Background There has been ongoing controversy as to whether prosthesis-patient mismatch (PPM, defined as indexed effective orifice area (EOAI) <0.85 m(2)/cm(2)) influences mortality after aortic valve replacement (AVR). In most studies, PPM is anticipated by reference tables based on mean EOAs as opposed to individual assessment. These reference values may not reflect the actual in vivo EOAI and hence, the presence or absence of PPM may be based on false assumptions. Objective To assess the impact of small prosthesis EOA on survival after aortic valve replacement AVR. Methods 645 patients had undergone an AVR between 2000 and 2007 entered the study. All patients underwent transthoracic echocardiography for determination of the actual EOAI within 6 months postoperatively. In order to predict time from surgery to death a proportional hazards model for competing risks (cardiac death vs death from other causes) was used. EOAI was entered as a continuous variable. Results PPM occurred in 40% of the patients. After a median follow-up of 2.35 years, 92.1% of the patients were alive. The final Cox regression model showed a significantly increased risk for cardiac death among patients with a smaller EOAI (HR=0.32, p=0.022). The effect of EOAI on the 2-5 year mortality risk was demonstrated by risk plots. Conclusions In contrast to previous studies these EOAI values were obtained through postoperative echocardiography, substantially improving the accuracy of measurement, and the EOAI was modelled as a continuous variable. There was a significantly improved survival for larger EOAIs following AVR. Strategies to avoid PPM should become paramount during AVR

Neurologic sequelae of the donor arm after endoscopic versus conventional radial artery harvesting

ObjectiveEndoscopic radial artery harvesting remarkably improves cosmetic results after coronary artery bypass surgery. The aim of this study was to investigate neurologic sequelae of the donor arm compared with those occurring after the conventional harvesting technique.MethodsFifty-three patients who had undergone endoscopic radial artery harvesting were followed up 1 year after the coronary artery bypass operation by means of questionnaire analysis and clinical neurologic investigation (ENDO group). Fifty-three patients who had conventional radial artery harvesting during the same time frame served as control subjects (OPEN group).ResultsPostoperative wound revision was required in 4 patients of the OPEN group (P = .045 vs the ENDO group). Neurologic symptoms of the donor arm were present in 22 (OPEN group) versus 34 (ENDO group) patients (P = .020): a lesion of the superficial radial nerve was shown in 12 (OPEN group) versus 24 (ENDO) patients (P = .014), and a lesion of the lateral antebrachial cutaneous nerve occurred only in the control group in 12 patients (P < .001). Paraesthesia without impaired sensibility was present in 3 (OPEN group) versus 10 (ENDO group) patients (P = .038). Clinical investigation revealed that temperature, pain, and touch sensation, as well as spatial discrimination, were equally impaired in symptomatic patients, whereas vibration sensation was not affected.ConclusionAfter endoscopic radial artery harvesting, impaired sensibility in the region of the superficial radial nerve and paresthesia are more frequent than after the open procedure. However, in contrast to the sequelae of the open procedure, wound revision and injury of the lateral antebrachial cutaneous nerve did not occur. Because of the excellent cosmetic results and avoidance of wound complications, we have opted to use endoscopic radial artery harvesting as the technique of choice, despite the higher incidence of sensory disturbances

Exercise hemodynamics of bovine versus porcine bioprostheses: A prospective randomized comparison of the mosaic and perimount aortic valves

ObjectiveThis prospective randomized study compares a porcine with a bovine bioprosthesis in the aortic position with regard to hemodynamic performance during exercise.MethodsBetween August of 2000 and December of 2002, 136 patients underwent aortic valve replacement with the porcine Medtronic Mosaic (n = 66) or the bovine Carpentier-Edwards Perimount (n = 70) bioprosthesis. Transthoracic echocardiography was performed to assess hemodynamic and dimensional data preoperatively and 10 months postoperatively; the latter follow-up included stress echocardiography with treadmill exercise.ResultsAt rest and during exercise (25 and 50 W), there was a significant difference in mean pressure gradient between the bovine and the porcine valves with labeled sizes 21 and 23, with superiority of the Perimount prosthesis. There was no difference in effective orifice area and incidence of patient-prosthesis mismatch among all sizes. The left ventricular mass index decreased significantly within 10 months postoperatively in the size 23 bovine group and the size 25 porcine group.ConclusionsOur data show a significant superiority of pressure gradients for the bovine bioprosthesis, especially with small valve sizes, when compared with the porcine device, which is more distinctive during exercise

Feasibility of the Engager™ aortic transcatheter valve system using a flexible over-the-wire design

OBJECTIVES The aim was to investigate the safety and feasibility of the redesigned Engager™ transcatheter aortic valve implantation (TAVI) system. METHODS Transapical aortic valve implantation with the Engager™ valve prosthesis was intended in 11 patients, and performed in 10. Endpoints were defined according to the valve academic research consortium recommendations for reporting outcomes of TAVI in clinical trials. RESULTS All 10 patients were implanted successfully. No devicerelated or delivery system complications like coronary obstruction or aortic dissection emerged. One patient (10%) died from non-device-related reasons at post-operative day 23 of multi-organ failure. The invasively measured peak-to-peak gradient after valve implantation was 7.1±3.5mmHg. In 90%, there was no or only trivial (≤grad I) aortic regurgitation due to paravalvular leakage. In 10% of the patients, aortic regurgitation grade I-II was observed. At 30-day follow up, the mean gradient was 15.6±4.9mmHg, and no more than a mild transvalvular and paravalvular aortic regurgitation was seen as assessed by transthoracic echocardiography. CONCLUSIONS Application of the Engager™ TAVI system is safe and feasible. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and was successful in all patients. No device or delivery-system-related complications emerged. Safety and feasibility endpoints were met. Good results concerning the aortic valve performance after implantation and at 30-day follow up were ascertained. These results encouraged the start of a European Pivotal trial including patients to dat

Predictors for New-Onset Complete Heart Block After Transcatheter Aortic Valve Implantation

ObjectivesThe aim of this study was to identify risk factors for new-onset atrioventricular (AV) block requiring pacemaker (PM) implantation after transcatheter aortic valve implantation (TAVI).BackgroundHigh-grade AV block and consecutive PM implantation are frequent complications following TAVI.MethodsFor logistic regression analysis, we included 159 patients (mean age: 81 ± 6 years, EuroSCORE: 22 ± 13%) who underwent TAVI (n = 116 transfemoral, n = 4 via subclavian artery, n = 37 transapical, n = 2 transaortic) between June 2007 and January 2009 and who had no previously implanted PM.ResultsThirty-five patients (22%) developed new-onset post-operative AV block with the need of PM implantation. Logistic regression revealed a 2-fold increased risk for new-onset AV block in patients in whom a large valve is implanted in a small annulus (32% pacemaker implantations, odds ratio [OR]: 2.378, p = NS), a 4-fold increased risk with the implantation of the CoreValve (Medtronic, Minneapolis, Minnesota) versus the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) (27% pacemaker implantations, OR: 3.781, p = NS), and a 5-fold increased risk for patients who exhibit an AV block episode instantly during the implantation procedure (49% pacemaker implantations, OR: 4.819, p = 0.001). Pre-existing ECG alterations were not identified as risk factors for AV block after transcatheter aortic valve implantation.ConclusionsWe assume that conduction tissue impairment is provoked by mechanical compression with large prostheses in smaller annuli or in the larger area of the CoreValve covering the outflow tract and may appear instantly during the implantation procedure. Continuous post-operative electrocardiogram monitoring should be performed for at least 3 days in all patients after TAVI procedures and until discharge in patients with increased risk for this complication

Patency rates of endoscopically harvested radial arteries one year after coronary artery bypass grafting

ObjectivesTo improve patients’ acceptance of the radial artery as a graft for coronary revascularization, we introduced an endoscopic harvesting technique. The aim of this study was to assess graft quality 1 year after the operation.MethodsIn 50 patients who underwent endoscopic radial artery harvesting for coronary artery bypass grafting, 64-slice computed tomography, electrocardiography, and echocardiography were utilized to assess graft patency and left ventricle function at a 1-year follow-up. In addition, the influencing factors of radial artery graft patency were evaluated. Radial artery patency was compared with a control group from our database.ResultsAny patency of endoscopically harvested radial artery grafts was 78% (39/50) and perfect patency was 72% (36/50) 1 year after coronary revascularization. The implanting surgeon and graft harvester, patient factors, graft properties, medication, and target territory did not influence the patency rates of the radial artery graft. The only significant and strong parameter to predict perfect graft patency was the severity of the target vessel stenosis (P < .001). In patients with a target vessel stenosis of 90% or greater, radial artery graft patency was 90.3% (28/31). Patency rates of endoscopically (72%) and conventionally (74%) harvested radial arteries were not different (P = .822).ConclusionsPatency rates 1 year after endoscopic radial artery harvesting are comparable to the open technique. On the basis of our results, we attempt to use the radial artery as a bypass graft only for target coronary arteries with 90% or greater stenosis. We recommend endoscopic harvesting as the technique of choice to harvest the radial artery

Structure of multidisciplinary heart teams, a survey based heart team study.

OBJECTIVES Multidisciplinary approach is well established in various disciplines, with evidence highlighting improved patient outcomes. The objective of this survey was to determine the real world practice of heart teams across Europe. METHODS The survey was drafted after a consensus opinion from the authors. The survey was sent to cardiac surgeons and cardiologist identified through electronic search. The survey link and the information sheet were sent through email followed by survey completion reminders. The survey responses were cumulated and analysed. RESULTS Among 2188 invited clinicians, 220 clinicians from 26 countries took part in the survey (response rate 10%). The completion rate for the survey questions was 85%. 140 (64%) were cardiac surgeons and 80 (36%) were cardiologists. The heart team meeting frequency was weekly according to 104 (55%) respondents. This was conducted face to face according to 139 (73%) of the responses. Eighty seven (56%) of the respondents reported 10% - 20% of patients undergoing percutaneous coronary intervention (PCI) were discussed at the heart team meeting. Seventy nine (47%) respondents had ad hoc PCI institutional guidelines. Fifty four (32%) respondents reported an audit process for the heart team decisions. CONCLUSIONS This survey suggests that there is marked variability in the infra-structure and execution of heart teams in different institutions. The results of the survey suggest a need to formulate guidelines on composition and execution of heart teams which may result in an increase in transparency of decision-making within different institutions in reporting and comparing outcomes

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

OBJECTIVES The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study. BACKGROUND Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce. METHODS FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients. RESULTS Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low. CONCLUSIONS The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low