Ross procedure: valve function, clinical outcomes and predictors after 25 years' follow-up.

OBJECTIVE: To describe long-term outcomes of the Ross procedure in a single center and retrospective series after 25 years follow-up. METHODS: From 1997-2019 we included all consecutive patients who underwent Ross procedure at our center. Clinical and echocardiographic evaluations were performed at least yearly. Echocardiographic valvular impairment was defined as at least moderate autograft or homograft dysfunction. Reintervention outcomes included surgical and percutaneous approach. RESULTS: 151 Ross procedures were performed (mean age 28±12years, 21 %<16years, 70 %male). After 25 years follow-up (median 18 years, interquartile range 9-21, only 3 patients lost) 12 patients died (8 %); Autograft, homograft or any valve dysfunction were present in 38(26 %), 48(32 %) and 75(51 %), respectively; and reintervention in 22(15%), 17(11%) and 38(26 %) respectively. At 20 years of follow-up, probabilities of survival free from autograft, homograft or any valve dysfunction were 63 %, 60 % and 35 %; and from reintervention, 80 %, 85 % and 67 %, respectively. The learning curve period (first 12 cases) was independently associated to autograft dysfunction (HR 2.78, 95 %CI:1.18-6.53, p = 0.02) and reintervention (HR 3.76, 95 %CI: 1.46-9.70, p = 0.006). Larger native pulmonary diameter was also an independent predictor of autograft reintervention (HR 1.22, 95 %CI:1.03-1.45, p = 0.03). Homograft dysfunction was associated with younger age (HR 5.35, 95 %CI: 2.13-13.47, p<0.001) and homograft reintervention, with higher left ventricle ejection fraction (HR 1,10, 95 %CI:1.02-1.19, p<0.02). CONCLUSIONS: In this 25 years' experience after the Ross procedure, global survival was high, although autograft and homograft dysfunction and reintervention rates were not negligible. Clinical and echocardiographic variables can identify patients with higher risk of events in follow up.

Randomised, double-blind, placebo-controlled clinical trial for evaluating the efficacy of intracoronary injection of autologous bone marrow mononuclear cells in the improvement of the ventricular function in patients with idiopathic dilated myocardiopathy: a study protocol.

BACKGROUND: Cellular therapies have been increasingly applied to diverse human diseases. Intracoronary infusion of bone marrow-derived mononuclear cells (BMMNC) has demonstrated to improve ventricular function after acute myocardial infarction. However, less information is available about the role of BMMNC therapy for the treatment of dilated myocardiopathies (DCs) of non-ischemic origin. This article presents the methodological description of a study aimed at investigating the efficacy of intracoronary injection of autologous BMMNCs in the improvement of the ventricular function of patients with DC. METHODS: This randomised, placebo-controlled, double-blinded phase IIb clinical trial compares the improvement on ventricular function (measured by the changes on the ejection fraction) of patients receiving the conventional treatment for DC in combination with a single dose of an intracoronary infusion of BMMNCs, with the functional recovery of patients receiving placebo plus conventional treatment. Patients assigned to both treatment groups are monitored for 24 months. This clinical trial is powered enough to detect a change in Left Ventricular Ejection Fraction (LVEF) equal to or greater than 9%, although an interim analysis is planned to re-calculate sample size. DISCUSSION: The study protocol was approved by the Andalusian Coordinating Ethics Committee for Biomedical Research (Comité Coordinador de Ética en Investigación Biomédica de Andalucia), the Spanish Medicines and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios), and is registered at the EU Clinical Trials Register (EudraCT: 2013-002015-98). The publication of the trial results in scientific journals will be performed in accordance with the applicable regulations and guidelines to clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02033278 (First Posted January 10, 2014): https://clinicaltrials.gov/ct2/show/NCT02033278 ; EudraCT number: 2013-002015-98, EU CT Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002015-98 . Trial results will also be published according to the CONSORT statement at conferences and reported peer-reviewed journals.

Prosthetic Mitral Surgical Valve in Transcatheter Aortic Valve Replacement Recipients: A Multicenter Analysis.

OBJECTIVES: The aim of this study was to determine the prognosis and specific complications of patients with prosthetic mitral valves (PMVs) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is performed relatively often in patients with PMVs, but specific risks are not well described. METHODS: A multicenter analysis was conducted, including patients with severe symptomatic aortic stenosis who underwent TAVR at 10 centers. Patients' clinical characteristics and outcomes were evaluated according to the presence of a PMV. RESULTS: The mean age of the study population (n = 2,414) was 81 ± 8 years, and 48.8% were men. A total of 91 patients (3.77%) had PMVs. They were more commonly women, younger, and had higher surgical risk. PMVs were implanted a median of 14 years before TAVR, and most patients had mechanical prostheses (73.6%). Eighty-six patients (94.5%) were on long-term vitamin K inhibitor therapy, and bridging antithrombotic therapy was administered in 59 (64.8%). TAVR device embolization occurred in 6.7% (vs. 3.3% in the non-PMV group; p = 0.127), in all instances when distance between the PMV and the aortic annulus was <7 mm. Mortality rates did not show a difference, but the rate of bleeding was higher in patients with PMV (24.2% vs. 16.1%; p = 0.041), even in those treated via the transfemoral approach (22.2% vs. 13.9%; p = 0.048). Indeed, bleeding complications, prior atrial fibrillation, chronic obstructive pulmonary disease, surgical risk, and New York Heart Association functional class were independent predictors of mortality. CONCLUSIONS: TAVR presents similar mortality irrespective of the presence of a PMV. However, patients with PMVs had higher bleeding risk that was independently associated with higher mortality. Risk for valve embolization was relatively high, but it occurred only in patients with PMV-to-aortic annulus distances <7 mm.

Five-year results from a prospective multicentre study of percutaneous pulmonary valve implantation demonstrate sustained removal of significant pulmonary regurgitation, improved right ventricular outflow tract obstruction and improved quality of life.

AIMS: Percutaneous pulmonary valve implantation (PPVI) is used to treat patients with dysfunctional pulmonary valve conduits. Short- and longer-term results from multiple trials have outlined haemodynamic improvements. Our aim was to report the long-term results, including quality of life, from a multicentre trial in Europe and Canada. METHODS AND RESULTS: From October 2007 to April 2009, 71 patients (24 female; median age 19.0 [IQR: 14.0 to 25.0] years) were enrolled in a prospective cohort study. PPVI was performed successfully in 63 patients. At five-year follow-up four patients had died. Moderate and severe pulmonary regurgitation were completely resolved in all except one patient, who needed re-PPVI. Outflow tract obstruction improved significantly from a mean pressure gradient of 37.7±12.1 mmHg before PPVI to 17.3±9.7 mmHg at five-year follow-up; however, 11 patients needed treatment for restenosis. The EQ-5D quality of life utility index and visual analogue scale scores were both significantly improved six months post PPVI and remained so at five years. CONCLUSIONS: Five-year results following PPVI demonstrate resolved moderate or severe pulmonary regurgitation, improved right ventricular outflow tract obstruction, and improved quality of life.

Restenosis After Everolimus-eluting Vascular Scaffolding. Angiographic and Optical Coherence Tomography Characterization.

INTRODUCTION AND OBJECTIVES: Coronary restenosis after bioresorbable vascular scaffold (BVS) implantation is infrequent and little information is available on the main characteristics of these lesions. The aim of this study was to assess restenotic lesions by using optical coherence tomography (OCT). METHODS: We studied 330 patients with coronary artery disease who received 398 BVS to treat 380 lesions. These patients were clinically and angiographically evaluated at follow-up and OCT was carried out on detection of restenosis. RESULTS: After a follow-up of 19 ± 10 months, 18 restenotic lesions were detected in 17 patients (5.4%). Depending on the time of presentation, most cases of restenosis were late or very late (9 ± 4 months). The most frequent angiographic pattern was focal restenosis in 12 (67%) patients, which was mainly located at the proximal border in 9 (75%) whether involving the scaffold or not. The homogeneous pattern was infrequent, occurring in 3 (25%) lesions and was only visualized in 3 out of 6 cases of restenosis located at the margin. When the focal restenosis was located in the platform, OCT showed a heterogeneous or layered pattern. Finally, diffuse restenosis was observed in 6 patients (33%). In diffuse restenosis, OCT revealed a lipid-laden or layered tissue structure and the presence of microvessels or microcalcification, potentially suggesting a neoatherosclerotic process. CONCLUSIONS: After a mean follow-up of 19 months, the restenosis rate was 5.4%. Most restenotic lesions were focal, located at the proximal border. Diffuse restenosis mostly occurred late or very late and most showed signs suggestive of neoatherosclerosis.

Pulmonary homograft stenosis in the Ross procedure: Incidence, clinical impact and predictors in long-term follow-up.

BACKGROUND: The Ross procedure is used in the treatment of selected patients with aortic valve disease. Pulmonary graft stenosis can appear in the long-term follow-up after the Ross intervention, but the factors involved and its clinical implications are not fully known. AIM: To describe the incidence, clinical impact and predictors of homograft stenosis and reintervention after the Ross procedure in a prospective series in a tertiary referral hospital. METHODS: From 1997 to 2009, 107 patients underwent the Ross procedure (mean age: 30±11 years; 69% men; 21 aged<18 years), and were followed for echocardiographic homograft stenosis (peak gradient>36mmHg) and surgical or percutaneous homograft reintervention. RESULTS: After 15 years of follow-up (median: 11 years), echocardiographic and clinical data were available in 91 (85%) and 104 (98%) patients, respectively: 26/91 (29%) patients developed homograft stenosis; 10/104 (10%) patients underwent 13 homograft reintervention procedures (three patients underwent surgical replacement, three received a percutaneous pulmonary valve and one needed stent implantation). The other three patients underwent two consecutive procedures in follow-up; one died because of a procedure-related myocardial infarction. Rates of survival free from homograft stenosis and reintervention at 1, 5 and 10 years were 96%, 82% and 75% and 99%, 94% and 91%, respectively. Paediatric patients had worse survival free from homograft stenosis (hazard ratio [HR] 3.50, 95% confidence interval [CI]: 1.56-7.90; P=0.002), although there were no significant differences regarding reintervention (HR: 2.01, 95% CI: 0.52-7.78; P=0.31). Younger age of homograft donor was also a stenosis predictor (HR: 0.97, 95% CI: 0.94-0.99; P=0.046). CONCLUSIONS: The probabilities of homograft stenosis and reintervention 10 years after the Ross procedure were 29% and 10%, respectively; only one patient had a reintervention-related death. Younger donor and recipient age were associated with a higher rate of stenosis.

Structural Damage of Jailed Guidewire During the Treatment of Coronary Bifurcation Lesions: A Microscopic Randomized Trial.

OBJECTIVES: The study sought to compare the safety (resistance to damage) and efficacy (ability to cross the side branch) of polymer-coated and non-polymer-coated guidewires in the jailed wire technique used during the percutaneous treatment of bifurcation lesions. BACKGROUND: The jailed wire technique is a useful strategy in the treatment of bifurcation lesions by provisional stenting. However, these wires can be damaged or even be broken during their removal. METHODS: We performed a randomized study in patients with bifurcation lesions treated by provisional stenting. The jailed wire technique was mandatory, and the types of guidewires, polymer-coated (n = 115) and non-polymer-coated (n = 120), were randomized. After the procedures, the wires were evaluated by stereoscopic microscopy. The induced damage in the wires was classified as follows: no damage, mild, moderate, or severe. RESULTS: The clinical characteristics were similar between patients treated with polymer-coated or non-polymer-coated wires. Polymer-coated wires were significantly (p < 0.001) more resistant to retrieval damage (only 2 wires showed mild damage) than were non-polymer-coated wires. However, 63 (55%) of the non-polymer-coated wires were damaged; 37 (32%), 24 (21%), and 2 (2%) had mild, moderate, and severe damage, respectively. Additionally, the jailed length of the wire was a factor contributing to the degree of wire damage. The time of side branch wiring was shorter in the polymer-coated wire group (19 ± 40 s vs. 42 ± 72 s; p < 0.05). CONCLUSIONS: Jailed wires during interventional procedures of bifurcation lesions commonly showed microscopic damage. Polymer-coated wires were more resistant to retrieval damage and were more efficient in crossing the side branch ostium than non-polymer-coated wires. (Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Stereoscopic Microscopy Study; NCT02516891).

Predictors of Very Late Events After Percutaneous Mitral Valvuloplasty in Patients With Mitral Stenosis.

Data on long-term outcomes of percutaneous mitral valvuloplasty (PMV) are still scarce. In addition, the persistence of pulmonary hypertension (PH) after PMV is a complication for which mechanisms and prognostic implications are unclear. Our aims were (1) to report the long-term outcomes of patients with rheumatic mitral stenosis treated with PMV; (2) to determine the risk factors for long-term poor outcomes; and (3) to analyze the prevalence and predictors of persistent PH. We prospectively enrolled 532 patients who underwent PMV from 1987 to 2011 at 2 hospitals. The following end points were assessed after PMV: all-cause mortality, mitral reintervention, a composite end point of all-cause mortality and mitral reintervention, and PH persistence. Survival status was available for 97% patients; the median follow-up was 10 years (interquartile range 4 to 18 years). Procedural success was achieved in 85% patients. During the follow-up, 21% patients died and 27% required mitral reintervention. Before PMV, 74% patients had PH that persisted after PMV in 45% of patients (p <0.001). Unfavorable valve anatomy (Wilkins score >8) and post-PMV mean pulmonary arterial pressure (PAP) were independent predictors of all-cause mortality, mitral reintervention, and the composite end point. Post-PMV mean PAP was significantly correlated with a mitral valve area (MVA) <2.5 cm(2) (p <0.001); in addition, on the echocardiographic follow-up, MVA was an independent predictor of systolic PAP (p <0.001). In conclusion, PMV represents an advantageous therapeutic option for patients with mitral stenosis in terms of long-term outcomes. Unfavorable valve anatomy and persistent PH were the most important predictors of long-term outcomes. The persistence of PH is associated with the MVA obtained after PMV.

Effects of Mitral Annulus Remodeling Following MitraClip Procedure on Reduction of Functional Mitral Regurgitation.

INTRODUCTION AND OBJECTIVES: The percutaneous mitral valve repair procedure (MitraClip) appears to reduce mitral annulus diameter in patients with functional mitral regurgitation, but the relationship between this and regurgitation severity has not been demonstrated. The aim of this study was to determine the effect of mitral annulus remodeling on the reduction of mitral regurgitation in patients with functional etiology. METHODS: The study included all patients with functional mitral regurgitation treated with MitraClip at our hospital until January 2015. Echocardiogram (iE33 model, Philips) was performed in all patients immediately after device positioning. Changes in the mitral annulus correlated with mitral regurgitation severity, as assessed using the effective regurgitant orifice area. RESULTS: The study included 23 patients (age, 65±14 years; 74% men; left ventricular ejection fraction, 31%±13%; systolic pulmonary artery pressure, 47±10 mmHg). After the procedure, the regurgitant orifice area decreased by 0.30 cm2±0.04 cm2 (P<.0005), from a baseline of 0.49 cm2±0.09 cm2. Anteroposterior diameter decreased by 3.14 mm±1.01 mm (P<.0005) from a baseline of 28.27 mm±4.9 mm, with no changes in the intercommissural diameter (0.50 mm±0.91 mm vs 40.68 mm±4.7 mm; P=.26). A significant association was seen between anteroposterior diameter reduction and regurgitant orifice area reduction (r=.49; P=.020). CONCLUSIONS: In patients with functional mitral regurgitation, the MitraClip device produces an immediate reduction in the anteroposterior diameter. This remodeling may be related to the reduction in mitral regurgitation.

Bioresorbable Vascular Scaffold for the Treatment of Coronary Bifurcation Lesions: Immediate Results and 1-year Follow-up.

INTRODUCTION AND OBJECTIVES: The treatment of coronary lesions with a bioresorbable vascular scaffold has been shown to be effective. However there is little information about its use in bifurcations. The aim of this study was to analyze the safety and efficacy of the bioresorbable scaffold in the treatment of coronary bifurcation lesions. METHODS: From January 2012 to January 2015, we used a bioresorbable vascular scaffold to treat 194 patients with 230 bifurcation lesions. The scaffold geometry was examined by intracoronary imaging techniques in 145 bifurcations (65%). In all, 78% of the bifurcations were evaluated angiographically during follow-up (computed tomography angiography in 138 and coronary angiography in 41). RESULTS: The most common clinical presentation was acute coronary syndrome (81%). The most frequent type of bifurcation was 1,1,1 (34%). A simple approach was the chosen strategy in 221 bifurcations (96%). In 90 of these lesions, the side branch was postdilated through the cells of the platform and, in 3 cases, strut fractures were observed in optical coherence tomography. Procedural success was achieved in all patients. There was 1 case of subacute thrombosis and 1 sudden cardiac death during the first month. The duration of angiographic follow-up was 7.3±1.6 months and that of clinical follow-up, 14±6 months. Twelve (5%) restenoses were documented and revascularized. During follow-up, 2 patients (1%) had an infarction in another territory and another 2 patients (1%) died; the remaining patients had a symptom-free follow-up. The incidence of thrombosis was 1.3%. CONCLUSIONS: Treatment of bifurcation coronary lesions using a provisional approach is feasible and safe, with a low rate of adverse events.

Patency of coronary side branches covered by an everolimus-eluting bioresorbable vascular scaffold: clinical outcomes and computed tomography scan follow-up.

AIMS: The behaviour of side branches (SBs) covered by a bioresorbable vascular scaffold (BVS) is not well known. This study analysed the rate of side branch occlusion (SBO) immediately after BVS implantation, its clinical impact, predictors of SBO and the fate of such SBs at follow-up. METHODS AND RESULTS: We assessed 140 patients with 346 jeopardised SBs divided into three groups: small (<1 mm, n=181), intermediate (1-2 mm, n=102) and large (>2 mm, n=63). SBO was defined as a TIMI flow 0 or 1. Computed tomography was scheduled at six months for patients with jailed SBs >1 mm. Immediate occlusion occurred in 31 (9%) SBs: 22 (12%) small, 8 (8%) intermediate and one (1.6%) large, while post-procedural SBO was 5.5%. In-hospital events included one thrombosis (0.7%) and eight non-Q-wave myocardial infarctions (6%). After 17±3 months, one patient died (0.7%) and six patients needed repeat revascularisation (4%). Re-evaluation showed no late SBO at 7±3 months. Predictors of SBO were: small SBs (OR 2.06, 95% CI: 1.08-4.63; p<0.05) and stenosis >50% at the origin (OR 17.22, 95% CI: 7.79-38.10; p<0.01). CONCLUSIONS: The incidence of SBO and its clinical impact were low when SBs >1 mm were covered. These favourable results were maintained at midterm.

Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

AIMS: Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). METHODS AND RESULTS: From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P < 0.01). Its incidence also increased from 1.4/1000 of all pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P < 0.05). Mean age of patients was 68 years, and 80% were male. Causative microorganisms predominantly were Staphylococci (84%: Staphylococcus aureus 48%, Staphylococcus epidermidis 36%). Rate of severe complications was high: persistent sepsis in 60% of cases, heart failure in 20%, and stroke in 12%. Device was removed in 19 patients (76%), mostly by surgery (18 of the 19 cases). Early mortality was 24% (33% of medically, 21% of surgically treated patients, P = 0.82). CONCLUSION: Infective endocarditis on pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high.

Direct bioresorbable vascular scaffold implantation: Feasibility and midterm results.

OBJECTIVES: To analyze the feasibility and safety of direct bioresorbable vascular scaffold (BVS) implantation without previous balloon dilation. BACKGROUND: Lesion preparation through predilation is recommended before BVS implantation. There is no information on the routine use of direct BVS implantation. METHODS AND RESULTS: One hundred fifty-three patients with a total of 200 coronary lesions, were treated with BVS. A baseline intravascular ultrasound study (IVUS) was performed in 171 lesions (86%), and after BVS implantation, the quality of scaffolding was assessed with an additional IVUS (83, 41%) or optical coherence tomography (77, 38%). Elective predilation was conducted in 50 lesions. In 150 lesions, direct BVS implantation was attempted. In 129 lesions (86%), the BVS was implanted successfully, and in the remaining 21 (14%), direct implantation failed. In these cases, the scaffolds were retrieved and successfully implanted after balloon angioplasty. Longer and C-type lesions, and a larger plaque burden, were associated with failure to directly cross the lesion. Balloon postdilation was needed in 34% of the lesions. Ten patients (6.6%) had a periprocedural myocardial infarction. One patient (0.6%) died 60 days after BVS implantation due to thrombosis of the scaffold. At follow-up, target lesion revascularisation was needed in eight patients (5%). After 12 ± 3 months, the remaining patients were symptom-free. CONCLUSIONS: Direct BVS implantation is safe and feasible in most soft coronary plaques.

Atrioventricular Conduction Changes After CoreValve Transcatheter Aortic Valve Implantation.

INTRODUCTION AND OBJECTIVES: Conduction disturbances often occur after CoreValve transcatheter aortic valve implantation. The aim was to analyze which cardiac conduction changes occur in patients with aortic stenosis treated with this type of prosthesis. METHODS: A total of 181 patients with severe aortic stenosis treated with this prosthesis and studied by electrocardiography between April 2008 and December 2013 were selected. A subgroup of 137 (75.7%) consecutive patients was studied by intracardiac electrocardiogram before and after prosthesis implantation. The primary endpoint of the study was the need for a permanent pacemaker within 72 hours after prosthesis implantation. Numerous variables to predict this possibility were analyzed. RESULTS: Following implantation, PR and QRS intervals were increased from 173±47 ms to 190±52ms (P < .01) and from 98±22ms to 129±24 ms (P < .01), whereas the A-H and H-V intervals were prolonged from 95±39ms to 108±41ms (P < .01) and from 54±10ms to 66±23ms (P < .01). A total of 89 (49%) patients had new-onset left bundle-branch block, and 33 (25%) required a pacemaker within the first 72hours. The independent predictors for a pacemaker were baseline right bundle-branch block and prosthetic depth. Intracardiac intervals had no predictive value. In addition, 13 patients required a pacemaker after 72 hours. CONCLUSIONS: CoreValve prosthesis implantation has a high incidence of conduction disturbance, with left bundle-branch block being the most common. A total of 25% of patients required a permanent pacemaker. The need for a pacemaker was related to baseline right bundle-branch block and prosthetic depth.