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1.
Heart ; 106(16): 1244-1251, 2020 08.
Article in English | MEDLINE | ID: mdl-32005676

ABSTRACT

BACKGROUND: The timing of onset and associated predictors of late new conduction disturbances (CDs) leading to permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI) are still unknown, however, essential for an early and safe discharge. This study aimed to investigate the timing of onset and associated predictors of late onset CDs in patients requiring PPI (LCP) following TAVI. METHODS AND RESULTS: We performed retrospective analysis of prospectively collected data from five large volume centres in Europe. Post-TAVI electrocardiograms and telemetry data were evaluated in patients with a PPI post-TAVI to identify the onset of new advanced CDs. Early onset CDs were defined as within 48 hours after procedure, and late onset CDs as after 48 hours. A total of 2804 patients were included for analysis. The PPI rate was 12%, of which 18% was due to late onset CDs (>48 hours). Independent predictors for LCP were pre-existing non-specific intraventricular conduction delay, pre-existing right bundle branch block, self-expandable valves and predilation. At least one of these risk factors was present in 98% of patients with LCP. Patients with a balloon-expandable valve without predilation did not develop CDs requiring PPI after 48 hours. CONCLUSIONS: Safe early discharge might be feasible in patients without CDs in the first 48 hours after TAVI if no risk factors for LCP are present.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Arrhythmias, Cardiac/therapy , Cardiac Pacing, Artificial , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/mortality , Arrhythmias, Cardiac/physiopathology , Cardiac Pacing, Artificial/adverse effects , Cardiac Pacing, Artificial/mortality , Databases, Factual , Europe , Female , Humans , Length of Stay , Male , Patient Discharge , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome
2.
Int J Cardiol ; 299: 49-55, 2020 01 15.
Article in English | MEDLINE | ID: mdl-31378382

ABSTRACT

BACKGROUND: Coronary Aneurysms are a focal dilatation of an artery segment >1.5-fold the normal size of adjacent segments. Although some series have suggested a prevalence of 0.3-12%, data are lacking. In addition, they are not mentioned in practice guidelines. Our aim was investigate its prevalence, management and long-term outcomes. METHODS AND RESULTS: The coronary artery aneurysm registry (CAAR) involved 32 hospitals across 9 countries in America and Europe. We reviewed 436,467 consecutive angiograms performed over the period 2004-2016. Finally, 1565 patients were recruited. Aneurysm global prevalence was 0.35%. Most patients were male (78.5%) with a mean age of 65 years and frequent cardiovascular risk factors. The main indication for angiogram was an acute coronary syndrome, 966 cases. The number of aneurisms was ≤2 per patient in 95.8% of the cases, mostly saccular, most frequently found in the left anterior descending and with numbers proportional with coronary stenosis. Aortopathies were related with more aneurysms too. Most patients received any revascularization procedure (69%), commonly percutaneous (53%). After a median follow-up of 37.2 months, 485 suffered a combined event (MACE) and 240 died. Without major differences comparing CABG vs PCI, MACE and death were more frequent in patients who received bare metal stents. CONCLUSIONS: Coronary artery aneurysms are not uncommon. Usually, they are associated with coronary stenosis and high cardiovascular risk. Antiplatelet therapy seems reasonable and a percutaneous approach is safe and effective.


Subject(s)
Coronary Aneurysm/diagnostic imaging , Coronary Aneurysm/therapy , Internationality , Registries , Aged , Coronary Aneurysm/epidemiology , Coronary Angiography/methods , Coronary Angiography/trends , Female , Follow-Up Studies , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/methods , Platelet Aggregation Inhibitors/therapeutic use
3.
Cardiovasc Revasc Med ; 20(2): 126-132, 2019 02.
Article in English | MEDLINE | ID: mdl-29779973

ABSTRACT

AIMS: We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. METHODS AND RESULTS: We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography (primary analysis) and transthoracic echocardiography (secondary analysis). In mildly calcified roots paravalvular regurgitation incidence was similar for all transcatheter heart valves (SEV 8.4%; BEV 9.1%; MEV 2.0% p = 0.27). Conversely, in heavily calcified roots paravalvular regurgitation incidence was significantly higher with SEV (SEV 45.9%; BEV 0.0%; MEV 0.0% p < 0.001). When paravalvular regurgitation was assessed by TTE, the overall findings were similar although elliptic aortic roots were associated with more paravalvular regurgitation with SEV (20.5% vs. BEV 4.5% vs. MEV 3.2%; p = 0.009). CONCLUSIONS: In heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones. These findings may support patient-tailored transcatheter heart valve selection. CLASSIFICATIONS: Aortic stenosis; multislice computed tomography; transcatheter aortic valve replacement; paravalvular aortic regurgitation. CONDENSED ABSTRACT: We sought to evaluate the interaction of different aortic root phenotypes with self-expanding (SEV), balloon-expandable (BEV) and mechanically expanded (MEV) and the impact on significant aortic regurgitation. We included 392 patients with a SEV (N = 205), BEV (N = 107) or MEV (N = 80). Aortic annulus eccentricity index and calcification were measured by multi-slice CT scan. Paravalvular aortic regurgitation was assessed by contrast aortography and transthoracic echocardiography. We found that in heavily calcified aortic roots, significant paravalvular aortic regurgitation is more frequent with SEV than with BEV or MEV, but similar in mildly calcified ones.


Subject(s)
Aortic Valve Insufficiency/etiology , Aortic Valve Stenosis/surgery , Aortic Valve/pathology , Aortic Valve/surgery , Calcinosis/surgery , Heart Valve Prosthesis , Hemodynamics , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Aortography/methods , Balloon Valvuloplasty/adverse effects , Calcinosis/diagnostic imaging , Calcinosis/physiopathology , Computed Tomography Angiography , Echocardiography , Humans , Multidetector Computed Tomography , Prosthesis Design , Retrospective Studies , Risk Factors , Severity of Illness Index , Treatment Outcome
4.
Cardiovasc Revasc Med ; 19(6S): 21-26, 2018 09.
Article in English | MEDLINE | ID: mdl-29934066

ABSTRACT

BACKGROUND: The optimal management of patients with multivessel coronary artery disease (MVD) admitted with STEMI is under debate. CABG is rarely performed, even on ideal candidates. A provisional PCI without stent implantation may allow complete surgical revascularization (CSR) in a subset of patient that we sought to identify in this study. METHODS: Patients with STEMI from April 2014 to October 2016 were evaluated and those with a TIMI flow <3 in the culprit vessel, and an additional stenosis of >70% in an epicardial vessel or sidebranch >2.5 mm were selected. Epidemiological variables, surgical risk scores and SYNTAX and SYNTAX II scores were analyzed. All the selected patients were discussed in a post hoc heart-team, and predictors of 12-month events were also analyzed. RESULTS: Seventy-two (19.0%) accomplished MVD criteria. Mean SYNTAX was 19 ±â€¯13 points and SYNTAX II score recommended CABG in 12 patients (16.7%) and heart-team discussion in 60 (83.3%). All patients were discussed in a post hoc heart-team, which concluded that 21 (29.2%) patients could have been good candidates for CSR. After one year follow-up, SYNTAX II PCI > 40 was found to be the sole independent predictor for 12-month events (OR 12.9 [2.7-62.1], p = 0.001). CONCLUSIONS: MVD and STEMI with a SYNTAX II PCI > 40 should be discussed in an ad-hoc heart team, after a provisional revascularization of the culprit vessel, and should be considered for CSR, especially when the RCA is the culprit artery and there is a complex disease in the left coronary artery.


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease/surgery , Coronary Stenosis/surgery , ST Elevation Myocardial Infarction/surgery , Aged , Aged, 80 and over , Clinical Decision-Making , Coronary Angiography , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/mortality , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Stenosis/diagnostic imaging , Female , Humans , Male , Middle Aged , Patient Selection , Postoperative Complications/mortality , Predictive Value of Tests , Retrospective Studies , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/mortality , Severity of Illness Index , Time Factors , Treatment Outcome
5.
Circ Cardiovasc Interv ; 11(3): e005727, 2018 03.
Article in English | MEDLINE | ID: mdl-29870383

ABSTRACT

BACKGROUND: Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. METHODS AND RESULTS: This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score-matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P=0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P=0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P=0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03-1.17; P=0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47-6.56; P=0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate <60 mL/min and Child-Pugh B or C). CONCLUSIONS: These findings suggested that TAVR is a feasible treatment for severe aortic stenosis in patients with early-stage liver disease or as bridge therapy before a curative treatment of the hepatic condition. Patients with Child-Pugh class B-C, especially in combination with renal impairment, had a very low survival rate, and TAVR should be carefully considered to avoid a futile treatment. These results may contribute to improve the clinical decision-making process and management in patients with liver disease.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Liver Cirrhosis/mortality , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Canada , Chronic Disease , Clinical Decision-Making , Europe , Feasibility Studies , Female , Humans , Liver Cirrhosis/diagnosis , Liver Cirrhosis/therapy , Male , Postoperative Complications/mortality , Propensity Score , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome
6.
Europace ; 20(12): 1981-1988, 2018 12 01.
Article in English | MEDLINE | ID: mdl-29688322

ABSTRACT

Aims: To correlate dynamics in electrical conduction after transcatheter aortic valve implantation (TAVI) with need for permanent pacemaker implantation (PPM) and assess implications for early discharge. Methods and results: Daily electrocardiograms after TAVI were analysed for rhythm and conduction times and were correlated with PPM. Transcatheter aortic valve implantation was performed in 291 consecutive patients with three contemporary transcatheter heart valve designs: Medtronic CoreValve (n = 111), Edwards Sapien XT (n = 29) and Sapien 3 (n = 72), and Boston Lotus (n = 79). We considered two cohorts: (A) Patients with normal baseline conduction; and (B) patients with pre-existent conduction disturbances. Based on QRS dynamics, three patterns were discerned: stable normal QRS duration, transient QRS prolongation, and persistent QRS prolongation. In Cohort B, QRS dynamics did not correlate with PPM. In contrast, in Cohort A, QRS dynamics and PPM appeared highly correlated. Neither patients with stable normal QRS duration (0/47), nor patients with transient QRS prolongation required PPM (0/26). All PPMs occurred in patients with persistent QRS prolongation until discharge (27/85). Persistent QRS prolongation was typically seen with Lotus and CoreValve, whereas stable normal QRS duration was typically seen with Sapien XT and Sapien 3. Conclusion: Three distinct patterns of QRS dynamics can be discerned after TAVI and their predictive probabilities for PPM strongly relate to the baseline conduction status. Patients with normal conduction at baseline and stable QRS duration after TAVI are potentially eligible for early discharge.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Arrhythmias, Cardiac/therapy , Cardiac Pacing, Artificial , Heart Conduction System/physiopathology , Heart Rate , Length of Stay , Pacemaker, Artificial , Patient Discharge , Transcatheter Aortic Valve Replacement/adverse effects , Action Potentials , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Stenosis/physiopathology , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , Arrhythmias, Cardiac/physiopathology , Databases, Factual , Electrocardiography , Female , Heart Valve Prosthesis , Hemodynamics , Humans , Male , Prosthesis Design , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/instrumentation , Treatment Outcome
8.
EuroIntervention ; 13(17): 1995-2002, 2018 04 20.
Article in English | MEDLINE | ID: mdl-29360062

ABSTRACT

AIMS: The aim of this study was to describe the incidence, mechanisms, management and outcomes of intracardiac shunts (ICS) following TAVI. METHODS AND RESULTS: This was a multicentre registry across 10 centres aimed at gathering all cases of ICS (1.1%) including infection-related (IRICS, 0.3%) or aseptic (AICS, 0.8%) shunts. Patients presented porcelain aorta (24% vs. 6.8%, p=0.024) and had been treated with predilation (88% vs. 68.5%, p=0.037) or post-dilation (59.1% vs. 19.3%, p<0.001) more often. Median time from intervention to diagnosis of ICS was 10 days (IQR: 2-108), being longer for IRICS (171 [63-249] vs. 3 [1-12] days, p=0.002). Interventricular septum (55.6%) and anterior mitral leaflet (57.2%) were the most common locations for AICS and IRICS, respectively. Most patients (76%) developed heart failure but 64% were medically managed. Seven patients (38.9%) underwent percutaneous closure of AICS. The in-hospital mortality rate was 44% (IRICS 100%, AICS 27.8%) compared to global TAVI recipients (8.1%, p<0.001). At one-year follow-up, 76% of the patients had died. ICS, logistic EuroSCORE, and moderate-severe residual aortic regurgitation were independent predictors of death. CONCLUSIONS: Post-TAVI ICS are an uncommon complication independently associated with high early mortality. Currently, most therapeutic alternatives yield poor results but percutaneous closure of AICS was feasible and is a promising alternative.


Subject(s)
Intraoperative Complications , Mitral Valve/injuries , Postoperative Complications , Prosthesis-Related Infections , Transcatheter Aortic Valve Replacement/adverse effects , Ventricular Septum/injuries , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/surgery , Female , Follow-Up Studies , Heart Failure/diagnosis , Heart Failure/etiology , Heart Failure/mortality , Hospital Mortality , Humans , Incidence , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Intraoperative Complications/therapy , Male , Mitral Valve/diagnostic imaging , Outcome and Process Assessment, Health Care , Postoperative Complications/classification , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/therapy , Prognosis , Prosthesis-Related Infections/epidemiology , Prosthesis-Related Infections/etiology , Prosthesis-Related Infections/therapy , Registries/statistics & numerical data , Risk Factors , Spain/epidemiology , Tomography, X-Ray Computed/methods , Transcatheter Aortic Valve Replacement/methods , Ventricular Septum/diagnostic imaging , Wound Closure Techniques/statistics & numerical data
9.
Catheter Cardiovasc Interv ; 91(3): 410-416, 2018 02 15.
Article in English | MEDLINE | ID: mdl-28544782

ABSTRACT

BACKGROUND: Amphilimus sirolimus-eluting stents (A-SES) represent a novel elution technology in the current era of drug-eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A-SES as compared to new-generation drug-eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A-SES as compared with zotarolimus-eluting stents (ZES) in a real-world, all-comers setting. STUDY DESIGN: ReCre8 is a prospective multicenter randomized clinical trial evaluating the clinical outcomes of A-SES as compared with ZES in all-comers requiring percutaneous coronary intervention. Patients are randomized 1:1 to receive either A-SES or ZES. On-site block-randomization is stratified by diabetes mellitus, and troponin status to perform prespecified subanalyses. Patients receive 1-month of dual antiplatelet therapy (DAPT) when troponin-negative, or 12-months of DAPT when troponin-positive. The primary endpoint is target-lesion failure at 1-year follow-up. A total of 1,532 patients will be enrolled to demonstrate clinical noninferiority of A-SES with at least 80% power, a noninferiority margin of 3.5% and a type-I-error of 0.05. CONCLUSIONS: ReCre8 (NCT02328898) is the first randomized multicenter trial with a head-to-head comparison of A-SES as compared with ZES to investigate the clinical safety and efficacy of these new-generation DES in a real-world, all-comers population.


Subject(s)
Cardiovascular Agents/administration & dosage , Coronary Artery Disease/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/instrumentation , Sirolimus/analogs & derivatives , Coronary Artery Disease/diagnostic imaging , Equivalence Trials as Topic , Humans , Multicenter Studies as Topic , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Prosthesis Design , Randomized Controlled Trials as Topic , Risk Factors , Sirolimus/administration & dosage , Time Factors , Treatment Outcome
10.
J Am Heart Assoc ; 6(3)2017 Mar 03.
Article in English | MEDLINE | ID: mdl-28258051

ABSTRACT

BACKGROUND: Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. METHODS AND RESULTS: We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. CONCLUSIONS: Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up.


Subject(s)
Aortic Valve Stenosis/surgery , Bundle-Branch Block/therapy , Heart Valve Prosthesis/adverse effects , Pacemaker, Artificial , Postoperative Complications/epidemiology , Transcatheter Aortic Valve Replacement/adverse effects , Aged, 80 and over , Aortic Valve Stenosis/complications , Bundle-Branch Block/complications , Electrocardiography , Female , Follow-Up Studies , Hospitals, High-Volume/statistics & numerical data , Humans , Incidence , Male , Retrospective Studies , Risk Factors , Survival Rate/trends , Time Factors
11.
Clin Cardiol ; 40(8): 580-585, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28337781

ABSTRACT

Coronary artery aneurysm is defined as a coronary dilation that exceeds the diameter of adjacent segments or the diameter of the patient's largest normal coronary vessel by 1.5×. It is an uncommon disease that has been diagnosed with increasing frequency since the widespread appearance of coronary angiography. The published incidence varies from 1.5% to 5%, suggesting male dominance and a predilection for the right coronary artery. Although several causes have been described, atherosclerosis accounts for ≥50% of coronary aneurysms in adults. Reported complications include thrombosis and distal embolization, rupture, and vasospasm, causing ischemia, heart failure, or arrhythmias. The natural history and prognosis remain unknown, as definitive data are scarce. Controversies persist regarding the use of medical management (antithrombotic therapy) or interventional/surgical procedures. Only some case reports or small case series are available about this condition. The Coronary Artery Aneurysm Registry (CAAR; http://www.ClinicalTrials.gov NCT02563626) is a multicenter international ambispective registry that aims to provide insights on anatomic, epidemiologic, and clinical aspects of this substantially unknown entity. In addition, the registry will assess management strategies (conservative, interventional, or surgical) and their short- and long-term results in a large cohort of patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov. Unique identifier: NCT02563626.


Subject(s)
Cooperative Behavior , Coronary Aneurysm , International Cooperation , Registries , Research Design , Coronary Aneurysm/diagnostic imaging , Coronary Aneurysm/epidemiology , Coronary Aneurysm/therapy , Coronary Angiography , Cuba , Europe , Humans , Predictive Value of Tests , Prognosis , Risk Factors , Time Factors , United States , Uruguay
12.
J Cardiovasc Surg (Torino) ; 58(4): 598-605, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28128540

ABSTRACT

BACKGKGROUND: The aim of this paper was to explore the determinants of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using multi-slice computed tomography (MSCT) instead of echocardiography-guided sizing. METHODS: Determinants of AR were assessed in 313 consecutive patients who underwent TAVI with the Medtronic (MCS, N.=259) or Edwards Sapien or XT (ESV, N.=54) using MSCT-guided sizing. AR was assessed by angiography immediately after TAVI (N.=313, Sellers) and by echocardiography at discharge (N.=285, VARC-2). Distinction was made between patients with grade 0-1 and grade ≥2 AR post-TAVI. RESULTS: AR≥2 post-TAVI was seen in 91 patients or 29% (MCS 85/259: 33% vs. ESV 6/54:11%) by angiography and 94 patients or 33% (MCS 87/239:36% vs. ESV 7/46:15%) by echocardiography. By univariable analysis, patients with AR≥2 post TAVI had more AR≥2 at baseline (70% vs. 52%, P=0.003), a larger mean and maximal annulus diameter (25.0 [23.5-26.3] vs. 24.0 [22.6-26.0], P=0.025 and 27.9±2.7 mm vs. 27.0±2.8 mm, P=0.018, respectively) and a higher Agatston Score (3.9 [2.9-5.3] vs. 2.6 [1.8-3.8], P≤0.001). AR≥2 post-TAVI was more frequent after MCS than ESV (33% vs. 11%, P=0.001). There was no difference in nominal valve size relative to the patient's annulus, nor depth of implantation. By propensity score adjusted multivariable analysis, AR≥2 at baseline (odds 2.407 [95% CI: 1.472-3.938]) but above all MCS (odds: 6.047 [95% CI; 1.307- 27.976]) were independent determinants of AR≥2 post-TAVI. The latter was also confirmed by propensity score adjusted multivariable analysis in the echocardiography population (N.=285) (odds: 5.259 [95% CI; 1.070-25.851]). CONCLUSIONS: AR≥2 is more prevalent after MCS valve implantation and is an independent determinant of AR also when using MSCT guided-sizing.


Subject(s)
Aortic Valve Insufficiency/etiology , Aortic Valve Stenosis/therapy , Aortic Valve/diagnostic imaging , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Multidetector Computed Tomography , Prosthesis Design , Aged , Aged, 80 and over , Aortic Valve/physiopathology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Chi-Square Distribution , Echocardiography, Doppler , Female , Humans , Logistic Models , Male , Multivariate Analysis , Odds Ratio , Predictive Value of Tests , Propensity Score , Risk Factors , Treatment Outcome
15.
Int J Cardiol ; 216: 9-15, 2016 Aug 01.
Article in English | MEDLINE | ID: mdl-27135150

ABSTRACT

BACKGROUND: The interaction of left ventricular outflow tract (LVOT) and transcatheter heart valve (THV) is complex and may be device design specific. We sought to study LVOT characteristics and its relation with permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). METHODS: We studied 302 patients with a median age of 81years [75-84]. Computed tomography was used to assess LVOT in terms of amount of calcium, perimeter and device size relative to LVOT. RESULTS: We implanted a Medtronic CoreValve (MCS) in 203 patients, Edwards-Sapien XT (ESV-XT) in 38, Edwards-Sapien S3 (ESV-S3) in 26 and Lotus in 35 patients. Sixty-eight patients (22.5%) received a new PPI within 30days after the index procedure. The incidence of PPI was 22.7% with MCS, 10.5% with ESV-XT, 26.9% with ESV-S3 and 31.4% with Lotus. By multivariate analysis RBBB at baseline (OR 2.9 [1.2-6.9, p=0.014), second generation valves (OR 2.1 [1.0-4.5], p=0.048), DOI (OR 1.20 per 1mm increment, [1.09-1.31], p<0.001) and LVOT sizing (OR per 1% increment 1.03 [1.01-1.07], p=0.022) were associated with need for PPI. Sensitivity analyses suggest that a lesser degree of LVOT oversizing triggers PPI with second generation THVs vs. first generation THVs. CONCLUSIONS: More LVOT oversizing is associated with a higher need for permanent pacemaker implantation after TAVR, even more so with deeper THV implants and next generation devices (ESV-S3 and Lotus). Sizing algorithms should focus more on LVOT dimensions to reduce PPI.


Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/methods , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Algorithms , Aortic Valve Insufficiency/diagnostic imaging , Echocardiography , Female , Heart Valve Prosthesis Implantation/statistics & numerical data , Humans , Incidence , Male , Pacemaker, Artificial , Prosthesis Design , Tomography, X-Ray Computed , Transcatheter Aortic Valve Replacement/statistics & numerical data , Treatment Outcome
16.
Int J Cardiovasc Imaging ; 32(7): 1021-9, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27139459

ABSTRACT

To study the determinants of image quality of rotational angiography using dedicated research prototype software for motion compensation without rapid ventricular pacing after the implantation of four commercially available catheter-based valves. Prospective observational study including 179 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with either the Medtronic CoreValve (MCS), Edward-SAPIEN Valve (ESV), Boston Sadra Lotus (BSL) or Saint-Jude Portico Valve (SJP) in whom rotational angiography (R-angio) with motion compensation 3D image reconstruction was performed. Image quality was evaluated from grade 1 (excellent image quality) to grade 5 (strongly degraded). Distinction was made between good (grades 1, 2) and poor image quality (grades 3-5). Clinical (gender, body mass index, Agatston score, heart rate and rhythm, artifacts), procedural (valve type) and technical variables (isocentricity) were related with the image quality assessment. Image quality was good in 128 (72 %) and poor in 51 (28 %) patients. By univariable analysis only valve type (BSL) and the presence of an artefact negatively affected image quality. By multivariate analysis (in which BMI was forced into the model) BSL valve (Odds 3.5, 95 % CI [1.3-9.6], p = 0.02), presence of an artifact (Odds 2.5, 95 % CI [1.2-5.4], p = 0.02) and BMI (Odds 1.1, 95 % CI [1.0-1.2], p = 0.04) were independent predictors of poor image quality. Rotational angiography with motion compensation 3D image reconstruction using a dedicated research prototype software offers good image quality for the evaluation of frame geometry after TAVI in the majority of patients. Valve type, presence of artifacts and higher BMI negatively affect image quality.


Subject(s)
Angiography/methods , Aortic Valve Stenosis/therapy , Aortic Valve/diagnostic imaging , Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Artifacts , Body Mass Index , Cardiac Catheterization/instrumentation , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/instrumentation , Humans , Image Interpretation, Computer-Assisted , Imaging, Three-Dimensional , Logistic Models , Male , Multivariate Analysis , Odds Ratio , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Reproducibility of Results , Software , Treatment Outcome
17.
Rev. esp. cardiol. (Ed. impr.) ; 69(4): 392-400, abr. 2016. ilus, tab, graf
Article in Spanish | IBECS | ID: ibc-152030

ABSTRACT

Introducción y objetivos: Se sabe que los factores relacionados con el paciente y con la intervención se asocian con insuficiencia aórtica después de un implante percutáneo de válvula aórtica. No obstante, también puede causarla una interacción específica entre el dispositivo y el huésped como consecuencia de las propiedades biomecánicas de las válvulas, con independencia de los factores clínicos. El objetivo de este estudio es esclarecer el papel de la geometría de la válvula en la aparición de insuficiencia aórtica después del implante de las válvulas Medtronic CoreValve® y Edwards SAPIEN®. Métodos: Se llevó a cabo un estudio observacional que incluyó a 134 pacientes tratados con implante percutáneo de válvula aórtica empleando las válvulas Medtronic CoreValve® y Edwards SAPIEN®. El análisis geométrico se realizó en tres niveles predefinidos de ambas válvulas mediante angiografía rotacional con compensación de movimiento usando un programa informático específicamente desarrollado para este fin. Se estableció una distinción entre los pacientes con insuficiencia aórtica nula o leve y los pacientes con insuficiencia aórtica moderada o grave según la ecocardiografía. Resultados: Las características basales eran similares con ambas válvulas. A pesar del mayor uso de predilatación en el grupo de CoreValve® (el 95,2 frente al 82,0%; p = 0,012), el mayor exceso de tamaño de prótesis/anillo aórtico (perímetro, el 114 ± 7% frente al 103 ± 7%; p < 0,001) y la misma profundidad de implante (seno no coronario, 7 ± 4 frente a 8 ± 2 mm; seno coronario izquierdo, 8 ± 4 frente a 8 ± 2 mm), esta válvula tuvo menos expansión (el 83 ± 7% frente al 92 ± 4%; p < 0,001) y fue más excéntrica (el 82 ± 8% frente al 95 ± 3%; p < 0,001) que la válvula Edwards SAPIEN®, también tras introducir un ajuste de la excentricidad respecto a la excentricidad del anillo valvular del paciente (el 4 ± 13% frente al 21 ± 11%; p < 0,001). La excentricidad y la excentricidad ajustada se asociaron con insuficiencia aórtica moderada o grave. Conclusiones: Independientemente de los factores relacionados con el paciente y con la intervención, existe una interacción entre dispositivo y huésped que es específica del dispositivo y explica la insuficiencia aórtica existente después de un implante percutáneo de válvula aórtica (AU)


Introduction and objectives: Patient- and procedure-related factors are known to be associated with aortic regurgitation after transcatheter aortic valve implantation. Nevertheless, this entity may also be caused by a specific device-host interaction due to the biomechanical properties of the valves, independently of clinical factors. We sought to elucidate the role of frame geometry in the occurrence of aortic regurgitation after Medtronic CoreValve and Edwards SAPIEN valve implantation. Methods: We conducted an observational study encompassing 134 patients undergoing transcatheter aortic valve implantation with the Medtronic CoreValve and Edwards SAPIEN valve. Frame analysis was performed at 3 predefined levels of both valves by rotational angiography using dedicated motion compensation software. A distinction was made between patients with no-to-mild and moderate-to-severe aortic regurgitation by echocardiography. Results: Baseline characteristics were similar between the 2 valves. Despite greater use of predilation in the CoreValve (95.2% vs 82.0%; P = .012), more oversizing (perimeter, 114 ± 7% vs 103 ± 7%;P < .001), and the same depth of implantation (noncoronary sinus, 7 ± 4 vs 8 ± 2 mm; left coronary sinus, 8 ± 4 vs 8 ± 2 mm), it was less expanded and more eccentric than the Edwards SAPIEN (83 ± 7% vs 92 ± 4%; P < .001 and 82 ± 8% vs 95 ± 3%; P < .001, respectively) and when eccentricity was adjusted for the patient's annulus eccentricity (4 ± 13% vs 21 ± 11%;P < .001). Eccentricity and adjusted eccentricity were associated with moderate-to-severe aortic regurgitation. Conclusions: Independently of patient- and procedure-related factors, there is a device-specific device-host interaction that explains aortic regurgitation after transcatheter aortic valve implantation (AU)


Subject(s)
Humans , Aortic Valve Insufficiency/epidemiology , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve Stenosis/surgery , Angiography/methods , Postoperative Complications , Severity of Illness Index , Echocardiography
19.
EuroIntervention ; 11(12): 1428-31, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26999682

ABSTRACT

AIMS: Our aim was to illustrate the pragmatic use of pre-procedural multislice computed tomography (MSCT) to facilitate fluoroscopy guidance of transcatheter mitral valve interventions. METHODS AND RESULTS: A dedicated software package (3mensio Structural Heart) is used to analyse MSCT studies and localise anatomical entities by fluoroscopy which would otherwise be invisible (e.g., interatrial septum, paravalvular leaks, mitral leaflets), and to provide optimal C-arm gantry angles to facilitate crucial steps of catheter-based mitral interventions. For any given anatomical structure that has been identified by MSCT scan, a line of perpendicularity can be drawn representing an infinite combination of RAO-LAO with cranial-caudal angles. Safety and ergonomic considerations drive the selected angulation to be used in the cathlab. The location of the fossa ovalis can be projected onto the fluoroscopy screen to help direct the needle for transseptal puncture. For MitraClip implantations a C-arm gantry projection that is either coaxial or perpendicular to the mitral coaptation plane helps to orientate the clip before entering the left ventricle to grasp the mitral leaflets. A periprosthetic mitral leak can be localised relative to the prosthesis in the proposed C-arm angle. Pre-procedural MSCT is thus complementary to transoesophageal echocardiography for transcatheter mitral interventions. CONCLUSIONS: Determination of optimal C-arm angulations helps localise anatomical entities by fluoro-scopy and may expedite complex mitral interventions.


Subject(s)
Cardiac Catheterization/methods , Mitral Valve/diagnostic imaging , Multidetector Computed Tomography , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Echocardiography, Doppler, Color , Echocardiography, Transesophageal , Equipment Design , Fluoroscopy , Humans , Mitral Valve/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/physiopathology , Predictive Value of Tests , Punctures , Radiographic Image Interpretation, Computer-Assisted , Radiography, Interventional/methods , Software , Treatment Outcome
20.
JACC Cardiovasc Interv ; 9(5): 508-12, 2016 Mar 14.
Article in English | MEDLINE | ID: mdl-26965945
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