TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale.

BACKGROUND: Patients with severe aortic stenosis (AS) frequently present with concomitant obstructive coronary artery disease (CAD). In those, current guidelines recommend combined coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) as the preferred treatment option, although this surgical approach is associated with a high rate of clinical events. Combined transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) with or without FFR have evolved as a valid alternative for cardiac surgery in patients with AS and multivessel or advanced CAD. To date, no dedicated trial has prospectively evaluated the outcomes of a percutaneous versus surgical treatment for patients with both severe AS and CAD. AIMS: To investigate whether fractional-flow reserve (FFR)-guided PCI and TAVI is noninferior to combined CABG and SAVR for the treatment of severe AS and multivessel or advanced CAD. METHODS: The Transcatheter Valve and Vessels (TCW) trial (clinicaltrial.gov: NCT03424941) is a prospective, randomized, controlled, open label, international trial. Patients ≥ 70 years with severe AS and multivessel (≥ 2 vessels) or advanced CAD, deemed feasible by the heart team for both; a full percutaneous or surgical treatment, will be randomised in a 1:1 fashion to either FFR-guided PCI followed by TAVI (intervention arm) vs. CABG and SAVR (control arm). The primary endpoint is a patient-oriented composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve reintervention, and life threatening or disabling bleeding at 1 year. The TCW trial is powered for noninferiority, and if met, superiority will be tested. Assuming a primary endpoint rate of 30% in the CABG-SAVR arm, with a significance level α of 5%, a noninferiority limit delta of 15% and a loss to follow-up of 2%, a total of 328 patients are needed to obtain a power of 90%. The primary endpoint analysis is performed on an intention-to-treat basis. SUMMARY: The TCW Trial is the first prospective randomized trial that will study if a less invasive percutaneous treatment for severe AS and concomitant advanced CAD (i.e., FFR-guided PCI-TAVI) is noninferior to the guidelines recommended approach (CABG-SAVR).

Decision Making during the Learning Curve of Minimally Invasive Mitral Valve Surgery: A Focused Review for the Starting Minimally Invasive Surgeon.

Minimally invasive mitral valve surgery is evolving rapidly since the early 1990's and is now increasingly adopted as the standard approach for mitral valve surgery. It has a long and challenging learning curve and there are many considerations regarding technique, planning and patient selection when starting a minimally invasive program. In the current review, we provide an overview of all considerations and the decision-making process during the learning curve.

Aortic Regurgitation Index Ratio Is a Strong Predictor of 1-Year Mortality After Transcatheter Aortic Valve Implantation Using Self-Expanding Devices.

Grading paravalvular leak (PVL) at the time of transcatheter aortic valve implantation (TAVI) deployment is challenging. Per-procedural invasive hemodynamic measurements could serve to optimize PVL grading and predict outcome after TAVI. The aim of this study was to compare hemodynamic measures of paravalvular leak and their prognostic relevance in self-expanding TAVI devices. Between December 2008 and December 2017 consecutive patients treated for severe symptomatic aortic valve stenosis with self-expanding devices were prospectively studied. Peri-procedural hemodynamic measurements, echocardiographic data as well as clinical follow-up according to VARC-2 criteria were prospectively collected. Diastolic delta (DD), heart rate adjusted DD, aortic regurgitation index (ARI) and ARI ratio were calculated and assessed for their association with 1-year mortality. A total of 651 patients were studied. Moderate or severe paravalvular leakage was found in 4.8% of patients. ARI ratio < 0.6 (hazard ratio 1.96 [1.23-3.12], P = 0.005) was the best independent predictor of 1-year mortality. This study confirms the value of hemodynamic measures, specifically ARI ratio, for prognostication, potentially supporting procedural decision-making with regard to PVL.

Transcatheter aortic valve replacement during the COVID-19 pandemic-A Dutch single-center analysis.

BACKGROUND AND AIM OF THE STUDY: The coronavirus disease 2019 (COVID-19) pandemic has put an enormous strain on healthcare systems and intensive care unit (ICU) capacity, leading to suspension of most elective procedures, including transcatheter aortic valve replacement (TAVR). However, deferment of TAVR is associated with significant wait-time mortality in patients with severe aortic valve stenosis. Conversely, there is currently no data available regarding the safety and feasibility of a continued TAVR program during this unprecedented crisis. The aim of this study is to evaluate the safety and feasibility of patients undergoing TAVR during the COVID-19 pandemic in our center, with specific emphasis on COVID-19 related outcomes. METHODS: All patients who underwent TAVR in our center between February 27, 2020, and June 30, 2020, were evaluated. Clinical outcomes were described in terms of Valve Academic Research Consortium 2 definitions. Patient follow-up was done by chart review and telephone survey. RESULTS: A total of 71 patients have undergone TAVR during the study period. Median age was 80 years, 63% were men, and 25% were inpatients. Procedural success was 99%. After TAVR, 30% involved admission to the ICU, and 94% were ultimately discharged to the cardiac care unit on the same day. Two patients (3%) had confirmed COVID-19 a few days after TAVR, and both died of COVID-19 pneumonia within 2 weeks after hospital discharge. CONCLUSIONS: A continued TAVR program during the COVID-19 pandemic is feasible despite limited hospital resources. However, COVID-19 related mortality after TAVR is of concern.

The impact of circulation in a heart-lung machine on function and survival characteristics of red blood cells.

Extracorporeal circulation is accompanied by changes in red blood cell morphology and structural integrity that affect cell function and survival, and thereby may contribute to the various side effects of heart-lung machine-assisted surgery. Our main objectives were to determine the effect of circulation of red blood cells in a stand-alone extracorporeal circuit on several parameters that are known to be affected by, as well as contribute to red blood cell aging. As a source of RBCs, we employed blood bank storage units of different ages. In order to assess the relevance of our in vitro observations for the characterization of extracorporal circulation technology, we compared these changes in those of patients undergoing extracorporeal circulation-assisted cardiac surgery. Our results show that circulation in a heart-lung machine is accompanied by changes in red blood cell volume, an increase in osmotic fragility, changes in deformability and aggregation behavior, and alterations in the exposure of phosphatidylserine and in microvesicle generation. RBCs from 1-week-old concentrates showed the highest similarities with the in vivo situation. These changes in key characteristics of the red blood cell aging process likely increase the susceptibility of red blood cells to the various mechanical, osmotic, and immunological stress conditions encountered during and after surgery in the patient's circulation, and thereby contribute to the side effects of surgery. Thus, aging-related parameters in red blood cell structure and function provide a foundation for the validation and improvement of extracorporeal circulation technology.

Feasibility and Outcomes of Transcatheter Aortic Valve Implantation Using the Left Axillary Artery as Primary Access Site.

BACKGROUND: The femoral artery is generally used as primary access for transcatheter aortic valve implantation. However, peripheral artery disease often precludes femoral access. The purpose of this study was to describe clinical outcome of transcatheter aortic valve implantation using the left axillary artery (LAA) as primary access site. METHODS: From December 2008 until June 2016, data on all consecutive patients treated with a Medtronic device through the LAA at our hospital were registered, and outcome was prospectively collected according to the updated Valve Academic Research Consortium-2 criteria. Mortality check was performed nationally. RESULTS: In total, 362 patients were included (median age 80 years [range, 76 to 84]; logistic European System for Cardiac Operative Risk Evaluation 17% ± 12%). Successful axillary access was achieved in 99%. Medtronic CoreValve (86%) and Evolut R (14% [Medtronic, Minneapolis, MN]) were implanted. Major vascular complications occurred in 5% of patients, 1% was LAA related. Life-threatening bleeding and major bleeding were observed in 2% and 10%, respectively. Additional complications were new left bundle branch blood (30%), new permanent pacemaker (11%), and stroke (1%). There were 6 procedural deaths (2%) and 19 deaths (5%) within 30 days. One-year mortality rate was 19%. CONCLUSIONS: This is the first study reporting outcome after transcatheter aortic valve implantation using the LAA as default access. We conclude that it is highly feasible and safe with low rates of major vascular complications, bleeding, and stroke.

Intracardiac cement embolism resulting in tricuspid regurgitation.

Bone cement leakage is a common complication after percutaneous kyphoplasty. In rare cases, leakage into the venous system occurs, which can be life-threatening, especially when it embolizes the heart. Here, we present a case of cement embolization of the right ventricle with tricuspid valve involvement. A 69-year-old woman with an asymptomatic severe tricuspid valve regurgitation was referred to our department. She had a history of balloon kyphoplasty because of osteoporotic collapsed vertebrae in 2010. Echocardiography showed a foreign body attached to the right ventricle, prolapsing into the right atrium and causing a severe tricuspid valve regurgitation. The foreign body was surgically removed, and the tricuspid valve was replaced with a biological valve. The foreign body was analysed by scanning electron microscopy and element analysis. Zirconium was identified within the foreign body, which is an additive in bone cement used in orthopaedic surgery. Intracardiac cement embolism following percutaneous kyphoplasty is a rare but life-threatening complication. Here, we present a case of tricuspid valve destruction caused by the long-term presence of an intracardiac foreign body, specifically a cement embolus.

Frequency and prognosis of new bundle branch block induced by surgical aortic valve replacement.

OBJECTIVES: Recently, transcatheter aortic valve implantation has been introduced, but one of its complications is left bundle branch block (LBBB), a conduction disturbance that has been associated with increased mortality. We investigated the incidence and fate of both right bundle branch block (RBBB) and LBBB after aortic valve replacement (AVR) using a retrospective analysis. We also studied the predictive value of both disorders for all-cause mortality. METHODS: All patients who underwent AVR, with or without concomitant coronary artery bypass grafting surgery, between 2002 and 2010 in our centre were included. All-cause mortality was compared between patients who did and those who did not develop persistent new bundle branch block (BBB) within 7 days postoperatively. Patients were not eligible if one of their electrocardiogram (ECG) recordings prior to AVR showed a BBB or pacemaker activity. A postoperative period of 3-12 months was used to collect follow-up ECGs. RESULTS: Of the 2279 AVR patients, 2033 patients were eligible for analysis. After excluding patients lacking baseline or follow-up ECG (n = 269), 1764 patients remained for analysis. Early LBBB and RBBB occurred in 71 (4.0%) and 92 (5.2%) patients, respectively. At follow-up, LBBB was persistent in 29 patients (1.6%) and RBBB in 74 patients (4.2%). During a median follow-up of 4.5 (2.4-6.5) years, the mortality rate was 16.3% (n = 271) in patients without BBB, 24.1% (n = 7) in patients with persistent LBBB and 18.9% (n = 14) in patients with persistent RBBB (log-rank P = 0.49). Though, in univariate analysis, the hazard ratio for mortality was 1.54 and 1.10 for LBBB and RBBB, respectively, the small numbers precluded identifying AVR-induced LBBB and RBBB as a predictor of mortality. CONCLUSIONS: In the current practice of AVR, persistent postoperative LBBB and RBBB occur infrequently (∼ 5% of cases), a percentage less than half of that in current transcatheter aortic valve implantation procedures. Given the adverse effects of LBBB, the lower prevalence of procedure-induced LBBB in AVR should be taken into account while deciding which valve replacement procedure is chosen for a patient.

Clonal heterogeneity of thymic B cells from early-onset myasthenia gravis patients with antibodies against the acetylcholine receptor.

Myasthenia gravis (MG) with antibodies against the acetylcholine receptor (AChR-MG) is considered as a prototypic autoimmune disease. The thymus is important in the pathophysiology of the disease since thymus hyperplasia is a characteristic of early-onset AChR-MG and patients often improve after thymectomy. We hypothesized that thymic B cell and antibody repertoires of AChR-MG patients differ intrinsically from those of control individuals. Using immortalization with Epstein-Barr Virus and Toll-like receptor 9 activation, we isolated and characterized monoclonal B cell lines from 5 MG patients and 8 controls. Only 2 of 570 immortalized B cell clones from MG patients produced antibodies against the AChR (both clones were from the same patient), suggesting that AChR-specific B cells are not enriched in the thymus. Surprisingly, many B cell lines from both AChR-MG and control thymus samples displayed reactivity against striated muscle proteins. Striational antibodies were produced by 15% of B cell clones from AChR-MG versus 6% in control thymus. The IgVH gene sequence analysis showed remarkable similarities, concerning VH family gene distribution, mutation frequency and CDR3 composition, between B cells of AChR-MG patients and controls. MG patients showed clear evidence of clonal B cell expansion in contrast to controls. In this latter aspect, MG resembles multiple sclerosis and clinically isolated syndrome, but differs from systemic lupus erythematosus. Our results support an antigen driven immune response in the MG thymus, but the paucity of AChR-specific B cells, in combination with the observed polyclonal expansions suggest a more diverse immune response than expected.

8 years' experience with robotic thymectomy for thymomas.

BACKGROUND: The accuracy of a three-dimensional robotic-assisted videothoracoscopic approach may favor a radical resection of thymomas. The aim of this study was to demonstrate the feasibility of the robotic approach by reporting 8 years experience in a single referral center of surgical treatment of thymomas. METHODS: We retrospectively analyzed all consecutive patients who underwent a thymectomy from April 2004 to April 2012. We analyzed the procedure time, morbidity, mortality, conversions, hospitalization, freedom from recurrence, time to progression, and overall survival. RESULTS: From 2004 until 2012, a total of 138 robotic procedures for mediastinal tumors were performed in our center, of which 37 patients with a mean age of 57.3 years underwent a thymectomy for a thymoma. Histological analysis revealed four type A thymomas (10.8 %), seven type AB thymomas (18.9 %), seven type B1 thymomas (18.9 %), fourteen type B2 thymomas (37.8 %), four type B3 thymomas (10.8 %), and one thymus carcinoma (2.7 %). The Masaoka­Koga stages were as follows: stage I in twenty patients (54 %), stage IIA in five patients (13.5 %), stage IIB in eight patients (21.6 %), stage III in three patients (8.1 %), and stage IVa in one patient (2.7 %). The mean overall procedure time was 149 min (range 88­353). No surgical mortality was reported, and there were no peri-operative complications. No conversions were needed for surgical complications. In three cases, a conversion to sternotomy was preferred by the surgeon because tumor invasion in greater vessels was suspected. Two patients (5.4 %) suffered from a myasthenic crisis postoperatively and required prolonged mechanical ventilation. One patient (2.7 %) underwent a procedure for a thoracic herniation 6 months following thymectomy. The median hospitalization was 3 days. The follow-up analysis showed an overall survival of 100 % and tumor recurrence in one patient (2.7 %). CONCLUSIONS: Robotic thymectomies are safe in patients with early-stage thymomas. Robotic surgery may also be feasible for some selected advanced thymomas.

Prevalence, factors associated with, and prognostic effects of preoperative anemia on short- and long-term mortality in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: There is scant information on the prevalence and factors associated with preoperative anemia in patients undergoing transcatheter aortic valve implantation (TAVI) and whether it is associated with mortality. We sought to determine the prevalence and factors associated with preoperative anemia in addition to the prognostic effects of the various levels of preoperative hemoglobin level on mortality in patients undergoing TAVI. METHODS AND RESULTS: Ten-center observational study encompassing 1696 patients with aortic stenosis who underwent TAVI was conducted. Anemia was defined by the World Health Organization criteria (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men). The prevalence of preoperative anemia was 57%. Patient-related factors associated with preoperative anemia were (descending order of odds ratio [95% confidence interval]) as follows: anemia-related medication (4.90 [3.08-7.80]), history of heart failure (1.77 [1.43-2.20]), male sex (1.69 [1.32-2.16]), mitral regurgitation grade ≥III (1.61 [1.15-2.25]), history of malignancy (1.44 [1.03-2.09]), and peripheral vascular disease (1.33 [1.04-1.70]). The creatinine clearance was inversely associated with preoperative anemia (odds ratio, 0.92 [0.87-0.97]). In multivariable analyses, preoperative anemia was not associated with 30-day mortality (1.72 [0.96-3.12]; P=0.073) but showed the strongest association with 1-year mortality with a hazard ratio (95% confidence interval) of 2.78 (1.60-4.82) in patients with hemoglobin <10 g/dL. Patients with anemia received ≥1 blood transfusion 2× more often, but the indication of transfusion was unrelated to overt bleeding in 60%. Blood transfusion was associated with mortality at 30 days (odds ratio, 1.25 [95% confidence interval, 1.08-3.67]) and during follow-up (hazard ratio, 1.09 [95% confidence interval, 1.03-1.14]). CONCLUSIONS: Preoperative anemia is prevalent in >50% of patients undergoing TAVI. Various baseline factors were related to anemia, which in turn was associated with 1-year mortality. Patients with anemia received more transfusions but mostly for indications unrelated to overt bleeding, whereas transfusion was independently associated with both early and 1-year mortality. These findings indicate that optimization of baseline factors related to preoperative anemia, in addition to more strict criteria of the use of blood products, may improve outcome after TAVI.

Hybrid coronary revascularization as a safe, feasible, and viable alternative to conventional coronary artery bypass grafting: what is the current evidence?

The "hybrid" approach to multivessel coronary artery disease combines surgical left internal thoracic artery (LITA) to left anterior descending coronary artery (LAD) bypass grafting and percutaneous coronary intervention of the remaining lesions. Ideally, the LITA to LAD bypass graft is performed in a minimally invasive fashion. This review aims to clarify the place of hybrid coronary revascularization (HCR) in the current therapeutic armamentarium against multivessel coronary artery disease. Eighteen studies including 970 patients were included for analysis. The postoperative LITA patency varied between 93.0% and 100.0%. The mean overall survival rate in hybrid treated patients was 98.1%. Hybrid treated patients showed statistically significant shorter hospital length of stay (LOS), intensive care unit (ICU) LOS, and intubation time, less packed red blood cell (PRBC) transfusion requirements, and lower in-hospital major adverse cardiac and cerebrovascular event (MACCE) rates compared with patients treated by on-pump and off-pump coronary artery bypass grafting (CABG). This resulted in a significant reduction in costs for hybrid treated patients in the postoperative period. In studies completed to date, HCR appears to be a promising and cost-effective alternative for CABG in the treatment of multivessel coronary artery disease in a selected patient population.

Minimally invasive mitral valve surgery: a systematic review.

In the recent years minimally invasive mitral valve surgery (MIMVS) has become a well-established and increasingly used option for managing patients with a mitral valve pathology. Nonetheless, whether the purported benefits of MIMVS translate into clinically important outcomes remains controversial. Therefore, in this paper we provide an overview of MIMVS and discuss results, morbidity, mortality, and quality of life following mitral minimally invasive procedures. MIMVS has been proven to be a feasible alternative to the conventional full sternotomy approach with low perioperative morbidity and short-term mortality. Reported benefits of MIMVS include also decreased postoperative pain, improved postoperative respiratory function, reduced surgical trauma, and greater patient satisfaction. Finally, compared to standard surgery, MIMVS demonstrated comparable efficacy across a range of long-term efficacy measures such as freedom from reoperation and long-term survival.

Left ventricular strain in chronic ischemic mitral regurgitation in relation to mitral tethering pattern.

BACKGROUND: The aim of this retrospective study was to explore whether different tethering patterns in chronic ischemic mitral regurgitation have different distributions of left ventricular (LV) systolic longitudinal, circumferential, and radial strain before and after mitral valve repair. METHODS: Sixty-one patients with chronic ischemic mitral regurgitation who underwent mitral repair were divided on the basis of the preoperative anterior/posterior tethering angle ratio (cutoff value, 0.76). There were 29 patients with symmetric (group 1) and 32 with asymmetric (group 2) preoperative tethering patterns. Assessment of longitudinal peak systolic strain was performed offline by applying speckle-tracking imaging to the apical two-chamber, three-chamber, and four-chamber views of the left ventricle. Peak systolic radial and circumferential strain was obtained from short-axis views at the basal, middle, and apical levels. Twenty healthy subjects served as controls. RESULTS: In group 1, baseline LV strain was impaired in all LV segments, with the worst values in the anterolateral, anterior, and inferolateral segments at the midventricular and basal levels. In contrast, asymmetric patients showed higher values in the inferior and inferoseptal walls and values closer to normal in the other segments. After surgery, all strain measurements showed significant improvements in all LV segments in group 2, whereas in Group 1, strain worsened in the inferoseptal, inferior, and anteroseptal walls and did not change in the other segments. CONCLUSIONS: Patients with baseline symmetric tethering patterns showed more extensive abnormal strain, which was observed in all LV segments and was not reverted by surgery. These findings require confirmation in additional larger studies.

Left atrial strain and strain rate before and following restrictive annuloplasty for ischaemic mitral regurgitation evaluated by two-dimensional speckle tracking echocardiography.

AIMS: We retrospectively evaluated left atrial (LA) strain and strain rate (SR) before and after undersized mitral ring annuloplasty (UMRA) for chronic ischaemic mitral regurgitation (CIMR) with two-dimensional speckle-tracking echocardiography. METHODS AND RESULTS: Left atrial volumes, LA reservoir, LA conduit, LA contractile phases, and LA ejection fraction (LAEF) were measured in 95 CIMR patients who underwent coronary bypass grafting and UMRA. Left atrial peak global strain (ε), LA reservoir (SRp), LA conduit (SRE), and LA contractile phase (SRA) strain rates were obtained at the baseline and at the follow-up (median 41.5 months, interquartile range 23-61). Based on the recurrence of mitral regurgitation (MR) at the follow-up, the patients were divided into two groups: patients with (group MR+, n = 30) or without (group MR-, n = 65) recurrent MR. Twenty age-and gender-matched healthy adults were controls. In the MR- group, baseline ε (P < 0.001), SRP (P < 0.001), SRE (P < 0.001), and SRA (P < 0.001) were enhanced, while in MR+ group, ε (P < 0.001), SRP (P = 0.03), SRE (P = 0.03), and SRA (P = 0.003) were worse than controls. At the follow-up, none of these indices changed in the MR+ group while all returned to normal values in patients belonging to the MR- group. Left atrial deformation correlated with corresponding volumetric parameters. Furthermore, we found a direct correlation between SRE and early peak diastolic velocity (E) (ρ = 0.52, P = 0.02) and E-wave deceleration time (ρ = 0.50, P = 0.02). Finally, there was a strong correlation between ε, SRP, and SRA (ρ = 0.72, P < 0.001 and ρ = 0.79, P < 0.001, respectively) and SRE (ρ = 0.69, P < 0.001 and ρ = 0.71, P < 0.001, respectively). Finally, ε, SRP, and SRE (all, P < 0.001) were co-factors associated to recurrent MR. CONCLUSION: Left atrial peak global strain, peak systolic SR, and peak early diastolic SR were cofactors associated to recurrent MR. The assessment of LA strain and SR, in addition to other echocardiographic parameters, can be helpful in detecting patients undergoing UMRA who are unlikely to benefit from annuloplasty.

Tethering symmetry reflects advanced left ventricular mechanical dyssynchrony in patients with ischemic mitral regurgitation undergoing restrictive mitral valve repair.

BACKGROUND: We evaluated the papillary muscle systolic dyssynchrony (DYS-PAP) using two-dimensional speckle tracking echocardiography (2D-STE) in patients with chronic ischemic mitral regurgitation (CIMR) showing different preoperative leaflet pattern and investigated the impact of baseline tethering pattern in the prediction of significant post-repair desynchronized papillary muscle contraction. METHODS: We recruited 152 CIMR consecutive patients (64.4% male, mean age 65.9 ± 7.1 years) who survived coronary artery bypass grafting (CABG) and (undersized mitral ring annuloplasty, performed between 2001and 2010. The assessment of DYS-PAP was performed preoperatively and at follow-up (median 41.5 months [IQR 23-61]) by 2D-STE in the apical 4-chamber view for anterolateral papillary muscle and apical long-axis view for posteromedial papillary muscle). Based on the cutoff value (anterior-posterior tethering angle ratio α/ß ≥ 0.76) patients were classified in 2 groups; symmetrical (group 1, n = 73, mean α/ß = 0.81 ± 0.6) and asymmetrical preoperative tethering pattern (group 2, n = 79, mean α/ß = 0.66 ± 0.4). RESULTS: Recurrent MR occurred in 67.1% (n = 49) in group 1 versus 3.8% (n = 3) in group 2 (p < 0.001). Comparing both groups at baseline, patients in group 1 had higher DYS-PAP (57.7 ± 5.3 vs 29.8 ± 2.4 ms in group 2, p < 0.001) that significantly worsened at follow-up (78.1 ± 8.8 ms, p < 0.001 versus baseline), whereas in group 2 it improved (26.6 ± 6.0 ms, p < 0.001 versus baseline). Tethering symmetry significantly correlated with DYS-PAP (r = 0.90, p < 0.001) and it was a strong multivariable predictor of significant postoperative DYS-PAP (odds ratio 4.2; 95% confidence level 3.4 to 5.2, p < 0.001). CONCLUSIONS: Tethering symmetry is an easy and immediate tool to identify CIMR patients with advanced DYS-PAP who are unlikely to benefit from mitral repair with undersized mitral ring annuloplasty.

Systolic papillary muscle dyssynchrony predicts recurrence of mitral regurgitation in patients with ischemic cardiomyopathy (ICM) undergoing mitral valve repair.

OBJECTIVE: We investigated the impact of papillary muscle dyssynchrony (DYS-PAP) in predicting recurrent mitral regurgitation (MR) in patients with ischemic cardiomyopathy (ICM) undergoing undersized mitral ring annuloplasty (UMRA). METHODS: One hundred forty-four ICM patients (left ventricular ejection fraction <35%) in sinus rhythm undergoing UMRA between January 2001 and December 2010 at three Institutions (University Hospital, Maastricht, The Netherlands; Careggi Hospital, Florence, Italy; Civic Hospital, Brescia, Italy) were recruited. The primary endpoint was the recurrence of MR at the latest echocardiographic study defined as insufficiency ≥2+ in patients with no/trivial MR at discharge. The assessment of DYS-PAP was performed by applying two-dimensional (2D) speckle-tracking imaging. RESULTS: In patients with MR recurrence, DYS-PAP significantly worsened (84.1 ± 8.8 msec vs.65.4 ± 8.8 msec at baseline, P < 0.001) whereas in patients with no MR recurrence, DYS-PAP did not vary (22.3 ± 5.3 msec vs. 25.9 ± 7.2 msec at baseline, P = 0.8). Recurrent MR was positively correlated with preoperative DYS-PAP (P < 0.001), baseline anterior mitral leaflet tethering angle α (P < 0.001) and tethering symmetry index α/ß before surgery (P < 0.001). There was no significant correlation between MR recurrence and other echocardiographic parameters. Logistic regression analysis revealed that baseline values of DYS-PAP (OR: 5.4 [95% CI: 3.1-7.7], P < 0.001), α (OR: 5.0 [2.6-6.7], P < 0.001), and α/ß (OR: 3.9 [2.5-5.7], p < 0.001) were predictors of recurrent MR. A DYS-PAP value ≥ 58 msec predicted recurrence of MR with 100% sensitivity and 83% specificity (area under the curve [AUC]: 0.92 [0.7-1], P < 0.001). CONCLUSIONS: A DYS-PAP cutoff value of 58 msec is useful to identify patients in whom UMRA is likely to fail. That way decision making in ischemic functional MR might be facilitated.

Importance of anterior leaflet tethering in predicting recurrence of ischemic mitral regurgitation after restrictive annuloplasty.

OBJECTIVE: We investigated the relationship between anterior mitral leaflet (AML) tethering and recurrent ischemic mitral regurgitation (MR) after restrictive annuloplasty. We also explored whether the effect of AML tethering was secondary to modifications in left ventricular size and geometry. METHODS: The study population consisted of 435 consecutive patients with chronic ischemic MR who survived combined coronary artery bypass grafting and undersized mitral ring annuloplasty performed at 3 institutions (University Hospital, Maastricht, The Netherlands; Careggi Hospital, Florence, Italy; and Civic Hospital, Brescia, Italy) from 2001 to 2008. The median follow-up was 44.7 months (interquartile range 25.9-66.4). The patients were divided by the baseline measurements into quintiles of AML tethering angle α' as follows: group 1, normal/slight AML tethering; group 2, mild AML tethering; group 3, moderate AML tethering; group 4, moderate-to-severe AML tethering; and group 5, severe AML tethering. RESULTS: Recurrence of MR was significantly greater in patients with moderate-to-severe (28.3%) and severe (39.4%) AML tethering (P < .001). A strong correlation was found between α' (r = 0.83, P < .001) and recurrent MR but a weak correlation with the posterior mitral angle ß' (r = 0.12, P = .05). On logistic regression analysis corrected for other echocardiographic risk factors, moderate-severe AML tethering or worse (adjusted odds ratio, 3.6; 95% confidence interval, 3.0-4.1; P < .001) was a strong predictor of MR recurrence. Compared with patients with ß' of 45 or greater, those with severe and moderate-severe AML tethering had more than 3.7 and 1.7 times greater odds of MR recurrence, respectively. No significant interactions were found between α' and the indexes of left ventricular function and geometry. CONCLUSIONS: Preoperative moderate-severe AML tethering or worse was strongly associated with MR recurrence. Thus, assessment of leaflet tethering should be incorporated into clinical risk assessment and prediction models.

Randomized clinical trial comparing a thermosensitive polymer (LeGoo) with conventional vessel loops for temporary coronary artery occlusion during off-pump coronary artery bypass surgery.

BACKGROUND: During off-pump coronary artery bypass graft (OPCABG) surgery, a bloodless surgical field is mandatory for visualization and construction of optimal coronary anastomoses. Presently used temporary vascular occluders are known to cause endothelial dysfunction and vessel injury. The present prospective multicenter randomized clinical trial evaluates safety and efficacy of a novel thermosensitive polymer (LeGoo) as an atraumatic temporary vascular occluder. METHODS: Between July 2008 and February 2010, 110 patients undergoing OPCABG were randomized between LeGoo (LG) and conventional vessel loops (VL) for coronary artery occlusion during construction of the distal anastomosis. A semiquantitative 4-point scale was used to evaluate the degree of bloodless surgical field and surgical comfort. Duration of coronary artery occlusion was also recorded. Safety during the operation and ensuing 30 days was evaluated by a composite endpoint of major adverse cardiac events that consisted of death from all causes, graft occlusion, myocardial infarction, and low cardiac output. RESULTS: Fifty-six patients (117 distal anastomoses) were randomly assigned to LG and 54 patients (122 anastomoses) to VL. There were 2 anastomoses crossed over from LG to the control arm, and 3 from control to LG. Five anastomoses in LG patients were treated with an alternative device (shunts). Satisfactory hemostasis was achieved in 88.0% of LG anastomoses (103 of 117) compared with 60.7% of VL anastomoses (74 of 122; p < 0.001). Mean total anastomotic time was 12.8 minutes in the LG group and 15.1 minutes in the VL group (p < 0.001). This difference was more pronounced for arteries on the posterior and lateral than on the anterior walls of the heart. Composite adverse events were similar in the two groups: 3 of 48 LG patients and 3 of 46 VL patients. There was 1 death in the LG group. One patient in the LG group and 1 in the VL arm had a myocardial infarction. No operation was converted from OPCABG to CABG with cardiopulmonary bypass. CONCLUSIONS: LeGoo is a safe and effective temporary coronary occluder during OPCABG. It provided a dry surgical field for visualization of the anastomotic field and surgical comfort more frequently than conventional vessel loops. In addition, anastomotic times were shorter with LG. Major cardiac adverse events were similar in the LG and VL arms.

Occupational radiation dose during transcatheter aortic valve implantation.

OBJECTIVES: To examine the occupational radiation dose during transcatheter aortic valve implantation (TAVI) in both transfemoral and transapical approach. BACKGROUND: Interventional fluoroscopic guided cardiac procedures lead inevitably to radiation exposure of workers, which over time may be associated with an increased incidence of cancer and cataract. METHODS: Using thermoluminescence dosimeters, the radiation dose of the cardiothoracic surgeon, cardiologist, and two assistants was measured on the apron at chest height and on both feet. In addition, dose measurements were performed on the hands of the two operators and on the eyes of the cardiothoracic surgeon. This study involved 11 transapical and 11 transfemoral TAVIs. The effective dose was estimated from the dose measured on the apron. RESULTS: In the transapical TAVI the cardiothoracic surgeon received a significantly higher equivalent hand dose (average ± SD), 1.9 ± 0.6 mSv, equivalent foot dose, 0.57 ± 0.31 mSv, equivalent eye dose, 0.11 ± 0.06 mSv, and effective dose, 0.03 ± 0.02 mSv, than any staff member in the transfemoral TAVI, with highest average doses of 0.03 ± 0.02 mSv, 0.22 ± 0.19 mSv, 0.03 ± 0.01 mSv, and 0.003 ± 0.005 mSv, respectively. CONCLUSIONS: This study provides hitherto unavailable data on the radiation exposure of staff during transfemoral and transapical TAVIs. Relatively high doses were observed in the transapical approach. The dose of the right hand of the cardiothoracic surgeon will reach the annual limit within about 250 procedures per year, implying that hand dose measurements should become standard and that the number of procedures performed by the cardiothoracic surgeon involving X-rays may have to be limited.