Risk Factors for Postoperative Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement: Results from the RADAR Registry.

INTRODUCTION: Rapid deployment aortic valve replacement has been recently introduced in clinical practice. Different studies have reported a significant reduction in surgical times with excellent hemodynamic profiles and short-term results. However, an increase in permanent pacemaker requirements compared with conventional aortic valve replacement has been described. Nevertheless, risk factors for postoperative pacemaker implantation are not well known. The aim of this study is to report our early outcomes with rapid deployment aortic valve replacement within the RADAR Registry, especially focusing on risk factors for postoperative pacemaker implantation. METHODS: Between April 2012 and January 2016, 164 patients undergoing isolated or combined aortic valve replacement with Edwards INTUITY Elite (Edwards Lifesciences, Irvine, CA, USA) were included in the RADAR Registry. Pre-, intra- and postoperative clinical data results and complications were recorded, especially focusing on risk factors for the development of postoperative complete or high-grade AV block requiring pacemaker implantation. Patients were followed up for up to 1 year with evaluation of clinical and echocardiographic outcomes. RESULTS: A total of 164 consecutive patients were included in this study, where 128 patients (78.05%) had an isolated aortic valve replacement (group 1) and 36 (21.95%) a concomitant procedure (group 2). The surgical approach was ministernotomy in 61 patients (37.20%) and median sternotomy in 100 patients (60.98%). Complications with valve implantation were observed in three patients. Postoperative complete or high-degree AV block requiring a permanent pacemaker implantation developed in ten patients (6.9%). Seven patients died in-hospital (4.27%). No significant differences between groups were found in terms of stroke, postoperative infection, mortality, atrial fibrillation and postoperative atrioventricular block. Seven patients presented acute renal impairment (5.51%) in group 1 versus seven patients (20%) in group 2 (p = 0.007). In multivariate analysis, low weight and preoperative arrhythmia (atrial fibrillation, bifascicular block, left bundle branch block) emerged as risk factors for postoperative AV block requiring a pacer. In median follow-up of 1 year, seven (4.27%) patients died, and no cases of structural valve deterioration or endocarditis were observed. Significant patient-prosthesis mismatch was found in seven (4.27%) patients. CONCLUSION: Initial experience with rapid deployment aortic valve replacement in the RADAR Registry demonstrates low rates of implantation complications and good perioperative and 1-year clinical and echocardiographic outcomes. Incidence of postoperative AV block requiring a pacer correlated with low weight and preoperative arrythmias (atrial fibrillation, bifascicular block and left bundle branch block). Avoidance of oversizing and careful consideration of implantation of this technology in patients with pre-existing arrythmias could minimize the risk for postoperative pacemaker implantation.

Spanish experience with heart transplants from controlled donation after the circulatory determination of death using thoraco-abdominal normothermic regional perfusion and cold storage.

Heart transplantation from controlled donation after the circulatory determination of death (cDCDD) may help to increase the availability of hearts for transplantation. During 2020, four heart transplants were performed at three different Spanish hospitals based on the use of thoraco-abdominal normothermic regional perfusion (TA-NRP) followed by cold storage (CS). All donors were young adults <45 years. The functional warms ischemic time ranged from 8 to 16 minutes. In all cases, the heart recovered sinus rhythm within 1 minute of TA-NRP. TA-NRP was weaned off or decreased <1L within 25 minutes. No recipient required mechanical support after transplantation and all were immediately extubated and discharged home (median hospital stay: 21 days) with an excellent outcome. Four livers, eight kidneys, and two pancreata were also recovered and transplanted. All abdominal grafts recipients experienced an excellent outcome. The use of TA-NRP makes heart transplantation feasible and allows assessing heart function before organ procurement without any negative impact on the preservation of abdominal organs. The use of TA-NRP in cDCDD heart donors in conjunction with cold storage following retrieval can eliminate the need to use ex situ machine perfusion devices, making cDCDD heart transplantation economically possible in other countries.

Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial.

INTRODUCTION: Cardiac adipose tissue is a source of progenitor cells with regenerative capacity. Studies in rodents demonstrated that the intramyocardial delivery of cells derived from this tissue improves cardiac function after myocardial infarction (MI). We developed a new reparative approach for damaged myocardium that integrates the regenerative properties of cardiac adipose tissue with tissue engineering. In the adipose graft transposition procedure (AGTP), we dissect a vascularised flap of autologous pericardial adipose tissue and position it over the myocardial scarred area. Following encouraging results in acute and chronic MI porcine models, we performed the clinical trial (NCT01473433, AdiFLAP trial) to evaluate safety in patients with chronic MI undergoing coronary artery bypass graft. The good safety profile and trends in efficacy warranted a larger trial. STUDY DESIGN: The AGTP II trial (NCT02798276) is an investigator initiated, prospective, randomised, controlled, multicentre study to assess the efficacy of the AGTP in 108 patients with non-revascularisable MI. Patients will be assigned to standard clinical practice or the AGTP. The primary endpoint is change in necrotic mass ratio by gadolinium enhancement at 91 and 365 days. Secondary endpoints include improvement in regional contractibility by MRI at 91 and 365 days; changes in functional MRI parameters (left ventricular ejection fraction, left and right ventricular geometric remodelling) at 91 and 365 days; levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) at 7, 91 and 365 days; appearance of arrhythmias from 24 hour Holter monitoring at 24 hours, and at 91 and 365 days; all cause death or re-hospitalisation at 365 days; and cardiovascular death or re-hospitalisation at 365 days. ETHICS AND DISSEMINATION: The institutional review board approved the trial which will comply with the Declaration of Helsinki. All patients will provide informed consent. It may offer a novel, effective and technically simple technique for patients with no other therapeutic options. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02798276, pre-results.

The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: A detailed assessment of calcium within the aortic root may provide important additional information regarding the risk of aortic root injury during transcatheter heart valve replacement (TAVR). OBJECTIVE: We sought to delineate the effect of calcium volume and distribution on aortic root injury during TAVR. METHODS: Thirty-three patients experiencing aortic root injury during TAVR with a balloon-expandable valve were compared with a control group of 153 consecutive TAVR patients without aortic root injury (as assessed by post-TAVR multidetector CT). Using commercial software to analyze contrast-enhanced pre-TAVR CT scans, calcium volume was determined in 3 regions: (1) the overall left ventricular outflow tract (LVOT), extending 10 mm down from the aortic annulus plane; (2) the upper LVOT, extending 2 mm down from the annulus plane; and (3) the aortic valve region. RESULTS: Calcium volumes in the upper LVOT (median, 29 vs 0 mm(3); P < .0001) and overall LVOT (median, 74 vs 3 mm(3); P = .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; P = .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, P = .028) and redilatation (likelihood ratio test, P = .015) improved prediction of aortic root injury by upper LVOT calcium volume. CONCLUSION: Calcification of the LVOT, especially in the upper LVOT, located below the noncoronary cusp and extending from the annular region, is predictive of aortic root injury during TAVR with a balloon-expandable valve.

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry.

OBJECTIVES: This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND: Very little data exist on CO following TAVI. METHODS: This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS: Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS: Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Anatomical and procedural features associated with aortic root rupture during balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: Aortic root rupture is a major concern with balloon-expandable transcatheter aortic valve replacement (TAVR). We sought to identify predictors of aortic root rupture during balloon-expandable TAVR by using multidetector computed tomography. METHODS AND RESULTS: Thirty-one consecutive patients who experienced left ventricular outflow tract (LVOT)/annular/aortic contained/noncontained rupture during TAVR were collected from 16 centers. A caliper-matched sample of 31 consecutive patients without annular rupture, who underwent pre-TAVR multidetector computed tomography served as a control group. Multidetector computed tomography assessment included short- and long-axis diameters and cross-sectional area of the sinotubular junction, annulus, and LVOT, and the presence, location, and extent of calcification of the LVOT, as well. There were no significant differences between the 2 groups in any preoperative clinical and echocardiographic variables. Aortic root rupture was identified in 20 patients and periaortic hematoma in 11. Patients with root rupture had a higher degree of subannular/LVOT calcification quantified by the Agatston score (181.2±211.0 versus 22.5±37.6, P<0.001), and a higher frequency of ≥20% annular area oversizing (79.4% versus 29.0%, P<0.001) and balloon postdilatation (22.6% versus 0.0%, P=0.005). In conditional logistic regression analysis for the matched data, moderate/severe LVOT/subannular calcifications (odds ratio, 10.92; 95% confidence interval, 3.23-36.91; P<0.001) and prosthesis oversizing ≥20% (odds ratio, 8.38; 95% confidence interval, 2.67-26.33; P<0.001) were associated with aortic root contained/noncontained rupture. CONCLUSIONS: This study demonstrates that LVOT calcification and aggressive annular area oversizing are associated with an increased risk of aortic root rupture during TAVR with balloon-expandable prostheses. Larger studies are warranted to confirm these findings.

Minimally invasive aortic valve surgery. A safe and useful technique beyond the cosmetic benefits.

INTRODUCTION AND OBJECTIVES: The aim of this study was to compare the in-hospital clinical outcomes of minimally invasive, isolated aortic valve replacement vs median sternotomy. METHODS: Between 2005 and 2012, 615 patients underwent aortic valve replacement at a single institution, 532 by a median sternotomy (E group) and 83 by a J-shaped ministernotomy (M group). RESULTS: No significant differences were found between the E and M groups in terms of age (69.27 [9.31] years vs 69.40 [10.24] years, respectively), logistic EuroSCORE (6.27 [2.91] vs 5.64 [2.17], respectively), size of implanted valve prosthesis (21.94 [2.04] mm vs 21.79 [2.01] mm, respectively), or the incidence of diabetes, hypercholesterolemia, high blood pressure, or chronic obstructive pulmonary disease. Mean cardiopulmonary bypass time was 102.90 (41.68) min for the E group vs 81.37 (25.41) min for the M group (P<.001). Mean cross-clamp time was 77.31 (29.20) min vs 63.45 (17.71) min for the S and M groups, respectively (P<.001). Mortality in the E group was 4.88% (26). There were no deaths in the M group (P<.05). The E group was associated with longer intensive care unit and hospital stays: 4.17 (5.23) days vs 3.22 (2.01) days (P=.045) and 9.58 (7.66) days vs 7.27 (3.83) days (P<.001), respectively. E group patients had more postoperative respiratory complications (42 [8%] vs 1 [1.2%]; P<.05). There were no differences when postoperative hemodynamic, neurologic, and renal complications, systemic infection, and wound infection were analyzed. CONCLUSIONS: In terms of morbidity, mortality, and operative times, outcomes after minimally invasive surgery for aortic valve replacement are at least comparable to those achieved with median sternotomy. The length of the hospital stay was reduced by minimally invasive surgery in our single-institution experience. The retrospective nature of this study warrants further randomized prospective trials to validate our results.

Midterm clinical and echocardiographic results with patch glue repair of left ventricular free wall rupture.

BACKGROUND: Left ventricular free wall rupture (LVFWR) is a dramatic complication after myocardial infarction. We present our mid-term clinical and echocardiographic results of LVFWR with an epicardial patch without cardiopulmonary bypass. METHODS: From February 1993 to May 2001, 17 patients underwent surgery for LVFWR. The mean age+/-SD of 12 males and 5 females was 68+/-10 years. All patients presented for emergency surgery with cardiac tamponade confirmed on echocardiography. After opening the chest and identification of the site of rupture, a Goretex patch was fashioned and applied with enbucrilate surgical glue. RESULTS: Effective control of bleeding was achieved in all cases. There were no on-table deaths. The operative (30 day) mortality was 23.5% (4/17). One death occurred because of patch failure, two because of cardiogenic shock, and one from pneumonia. On follow-up at a median of 2.2 years (interquartile range, 1.1 to 4.3 years), two further deaths occurred, one from myocardial infarction and another of undetermined etiology. Echocardiography did not reveal any evidence of restriction to left ventricular free wall motion. CONCLUSIONS: Patch glue repair is expedient, simple and effective; with no adverse effects on mid-term ventricular dynamics. In view of superior published results to infarctectomy and repair with extra corporeal circulation, it should be considered to be the initial procedure of choice for the surgical repair of LVFWR.

Surgery for left ventricular free wall rupture: patch glue repair without extracorporeal circulation.

Left ventricular free wall rupture is a dramatic complication after myocardial infarction. We present our experience with the simple, expedient technique of patch glue repair without extracorporeal circulation. Access is obtained via median sternotomy. Evacuation of blood and haematoma is undertaken and a Goretex patch exceeding the size of infarct is fashioned. The patch is applied to the epicardium using enbrucrilate surgical glue instilled with gentle pressure against the beating heart. We performed this technique on 17 patients from 1993 to 2001, with a operative (30-day) mortality of 23.5% with a post-discharge survival of 85% at 2.2 years.

[Aortic valve replacement in patients over 70 years old: determinants of early death]. / Recambio valvular aórtico en pacientes mayores de 70 años: determinantes de mortalidad temprana.

INTRODUCTION AND OBJECTIVES: There is controversy regarding the risk factors associated with early death in geriatric patients undergoing aortic valve replacement. We analyzed the risks in these patients and established an accurate model for predicting in-hospital mortality. PATIENTS AND METHOD: Univariate and multivariate analyses were made of the risk factors associated with early death in a group of 129 patients older than 70 years who underwent aortic valve replacement (May 1994-June 2001). The variables obtained by multivariate logistic regression were combined to produce an equation for the prediction of early death. The equation was tested using a receiver operating characteristic curve. RESULTS: Univariate analysis identified four factors related to early death: NYHA III-IV (p < 0.0001), ejection fraction < 40% (p < 0.05), aortic regurgitation (p < 0.05) and high left ventricular mass index (p < 0.05). Multivariate analysis revealed three independent risk factors: NYHA III-IV (p < 0.01), aortic regurgitation (p < 0.05), and small body surface area (p < 0.05). A lower mortality was observed in patients with a larger body surface area (0% for > 1.90 m2, 20% for < 1.40 m2). The estimated mortality with the predictive model was 7.06%, which was similar to the observed mortality of 7.80% (area under the ROC curve 0.87) and better than estimates obtained with the EuroSCORE (6.5%; area under the ROC curve 0.56). CONCLUSIONS: Risk factors associated with early death after aortic valve replacement in geriatric patients include functional status, aortic regurgitation, and small body surface area. Our model based on these factors accurately predicted operative mortality in our patients. Gender, prosthesis size, and pump time were not identified as risk factors.

[Right atrial myxoma in a patient with antiphospholipid antibodies]. / Mixoma auricular derecho en paciente con anticuerpos antifosfolipídicos positivos.

A 28 year-old asymptomatic male with previously detected elevation of antiphospholipid antibodies (aPL) had a right atrial mass diagnosed by transthoracic echocardiography. Although the morphological characteristics were highly suggestive of myxoma, due to the presence of aPL elevation it had to be differentiated from atrial thrombus. The patient underwent surgery and a 3 x 4 cm mass with its large base attached to the interatrial septum was removed. Histopathological examination confirmed that it was a myxoma. On follow-up, the patient was asymptomatic and antiphospholipid antibodies became undetectable.

[Advantages of off-pump coronary bypass surgery in high-risk patients]. / Ventajas de la revascularización miocárdica sin circulación extracorpórea en pacientes de riesgo.

INTRODUCTION AND OBJECTIVES: Myocardial revascularization without cardiopulmonary bypass has been shown to reduce operative morbi-mortality. We report our recent experience with this novel technique in order to evaluate its theoretical advantages in comparison with conventional surgery. PATIENTS AND METHODS: This retrospective analysis included 547 consecutive patients undergoing isolated myocardial revascularization from December 1997 through November 2000. One hundred twenty-one off-pump patients were compared to 426 undergoing cardiopulmonary bypass. Logistic regression analysis was performed to find predictors of mortality, transfusion, postoperative atrial fibrillation and length of hospital stay. RESULTS: Off-pump patients were at greater risk: they were older, with a lower ejection fraction and a higher prevalence of unstable angina, heart failure and associated comorbidity. Off-pump surgery reduced transfusions (1 1 vs 1,9 2 blood units; p < 0.0001) and postoperative hospital stays (8.9 5 vs 11,3 7 days; p < 0.001). The off-pump group showed a trend toward reduced morbidity but the technique did not decrease hospital mortality. Cardiopulmonary bypass was an independent predictor of blood transfusion and longer hospital stay. Short-term follow-up revealed no significant differences in recurring angina or patency rates. CONCLUSIONS: Off-pump coronary bypass surgery is a good option in high-risk patients because it reduces the incidence of perioperative transfusion and the length of hospitalization. Furthermore, it showed a trend toward reduced morbidity. Mortality was not significantly higher in spite of the higher risk of the patients. Long-term longitudinal follow-up is mandatory to assess the true effectiveness of this technique.