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1.
Heart Lung Circ ; 31(8): 1134-1143, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35365428

ABSTRACT

BACKGROUND: Current imaging techniques may inadequately rule out coronary artery obstruction (CAO), a potentially fatal complication during transcatheter aortic valve replacement (TAVR). Advancements in three-dimensional (3D)-printing allow the development of models capable of replicating cardiac anatomy and predicting CAO. We sought to simulate TAVR utilising 3D-printed cardiac models to improve CAO risk assessment and procedural safety. METHODS: Thirteen (13) patients with aortic stenosis at high-risk of CAO during TAVR were selected for 3D-printed modelling. The relevant anatomy for TAVR was precisely reconstructed with Materialise Heart Print-Flex (Materialse, Leuven, Belgium) technology. An appropriately sized valve prosthesis was deployed in each 3D-model and coronary ostia assessed for obstruction. RESULTS: Model-derived results were compared to clinical outcomes in 13 cases. One high-risk case underwent TAVR resulting in left main obstruction and subsequent stenting. This outcome was accurately predicted by the 3D-model simulation. Two (2) high-risk TAVR cases were abandoned following transient CAO during balloon aortic valvuloplasty (BAV). The 3D-model simulations correlated with these findings, demonstrating CAO either by a calcium nodule or the native valve leaflet. In another two cases, BAV was uncertain, however the 3D-simulation demonstrated patency and successful TAVR was undertaken. In remaining cases, no obstruction was demonstrated in-vitro, and all underwent uncomplicated TAVR. CONCLUSIONS: In this proof-of-concept study, 3D-model TAVR simulation correlates well to clinical outcomes. 3D-models of patients at high-risk of CAO may be utilised in pre-procedural planning to accurately predict this complication. As lower-risk surgical cohorts are considered for TAVR, 3D-models may minimise complications leading to safer patient outcomes.


Subject(s)
Aortic Valve Stenosis , Coronary Occlusion , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Coronary Occlusion/surgery , Coronary Vessels/surgery , Heart Valve Prosthesis/adverse effects , Humans , Printing, Three-Dimensional , Prosthesis Design , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Treatment Outcome
3.
Heart Lung Circ ; 29(12): 1839-1846, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32712017

ABSTRACT

BACKGROUND: To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk. METHODS: Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint. RESULTS: At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling). CONCLUSION: SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Cardiac Catheterization/methods , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnosis , Australia , Echocardiography , Female , Femoral Artery , Humans , Male , Prospective Studies , Prosthesis Design , Risk Factors , Severity of Illness Index , Treatment Outcome
5.
Heart Lung Circ ; 28(3): 464-470, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30170916

ABSTRACT

BACKGROUND: Mitral valve procedures remain a surgical challenge in the presence of extensive annular calcification, which presents a formidable technical challenge. Aggressive debridement is limited by risk of serious complications and the technical complexity of pericardial patch reconstruction of the debrided area. METHODS: An open surgical approach with a transcatheter valve allows the valve to be placed under direct visualisation to facilitate positioning and to evaluate the likelihood of both perivalvular leakage and atrioventricular disruption. The open approach has the additional advantage of performing concomitant surgeries like other valve procedures, arrhythmias surgeries and coronary bypass. RESULTS: We present our experience with open surgical mitral valve replacement (MVR) using transcatheter valve in different patients requiring varied procedures. These patients were not suitable for MVR using standard prosthetic valve and techniques. They were also not suitable for percutaneous MVR because of heavily calcified anterior mitral leaflet and the other concomitant procedures required. CONCLUSIONS: Open MVR with a transcatheter balloon-expandable valve can avoid the need for technically challenging and high-risk decalcification of mitral annulus. These novel techniques using transcatheter valves can be successful in complex cases where standard prosthetic valves are impossible to implant in a heavily calcified mitral annulus.


Subject(s)
Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Mitral Valve Stenosis/surgery , Mitral Valve/surgery , Aged , Aged, 80 and over , Australia , Echocardiography , Female , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Stenosis/diagnosis , Prosthesis Design
6.
Heart Lung Circ ; 27(4): 513-516, 2018 Apr.
Article in English | MEDLINE | ID: mdl-28533099

ABSTRACT

BACKGROUND: Early degeneration of prosthetic aortic valve in transcatheter aortic valve replacement (TAVR) is a rare complication. METHOD: We report the case of a 75-year-old woman who presented with severe calcific stenosis of Edwards SAPIEN-XT valve implanted only 4 years previously. She is a Jehovah's Witness and has background of Sjogren's syndrome with secondary cryoglobulinaemic vasculitis. She was not a suitable candidate for valve-in-valve TAVR in view of early prosthetic valve failure by calcification. RESULT: She underwent surgical explantation of the Sapiens XT valve and mechanical aortic valve replacement. CONCLUSION: To our knowledge, this is the first time that early TAVR valve degeneration and failure of an Edwards SAPIEN-XT valve was reported which required surgical replacement with a mechanical valve.


Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Heart Valve Prosthesis/adverse effects , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aortic Valve/diagnostic imaging , Aortic Valve Insufficiency/diagnosis , Aortic Valve Insufficiency/etiology , Aortic Valve Stenosis/diagnosis , Echocardiography , Female , Humans , Prosthesis Failure , Reoperation
8.
Coron Artery Dis ; 27(5): 344-9, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27097120

ABSTRACT

BACKGROUND: The optimal timing of angiography and percutaneous coronary intervention (PCI) in patients with non-ST elevation acute coronary syndromes (NSTEACS) remains uncertain. We sought to assess clinical characteristics and outcomes of patients in real-world contemporary practice who have early versus delayed PCI for NSTEACS. METHODS: We analyzed baseline clinical and procedural characteristics of 4307 patients with NSTEACS who underwent PCI from the Melbourne Interventional Group registry. Patients were assigned to the early PCI group if intervention was performed within a calendar day of presentation. The delayed PCI group received an intervention after one calendar day, but within the index admission. We assessed 30 days and 12-month mortality, myocardial infarction, target vessel revascularization, and major adverse cardiovascular events. The safety endpoint was in-hospital bleeding. RESULTS: Of the 4307 patients, 2210 (51%) received early PCI. The delayed PCI group were older (67±12 vs. 64±12, P<0.01), more likely to have biomarker elevation (70 vs. 66%, P<0.01), and had more comorbidities. There was no difference in efficacy at 30 days between the groups. At 12 months, delayed PCI was associated with higher mortality (4.6 vs. 3.3%, P=0.02), myocardial infarction (7.9 vs. 5.2%, P<0.01), and MACE (15.5 vs. 12.4%, P<0.01). On multivariate analysis, delayed PCI was not associated with increased mortality at 12 months (odds ratio 0.95, 95% confidence interval 0.7-1.3). CONCLUSION: In patients with stable NSTEACS treated with PCI, delayed intervention was performed in those who were older and had higher risk features. However, there appears to be no mortality hazard for these high-risk patients where PCI is delayed beyond the first 24 h after presentation and performed within the index admission.


Subject(s)
Non-ST Elevated Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Time-to-Treatment , Age Factors , Aged , Chi-Square Distribution , Comorbidity , Coronary Angiography , Female , Hemorrhage/etiology , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Non-ST Elevated Myocardial Infarction/diagnostic imaging , Non-ST Elevated Myocardial Infarction/mortality , Odds Ratio , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Victoria
9.
J Cardiovasc Comput Tomogr ; 9(5): 382-92, 2015.
Article in English | MEDLINE | ID: mdl-26164109

ABSTRACT

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.


Subject(s)
Aortic Diseases/complications , Aortic Valve Stenosis/therapy , Aortic Valve/pathology , Calcinosis/therapy , Cardiac Catheterization/adverse effects , Heart Injuries/etiology , Heart Valve Prosthesis Implantation/adverse effects , Kyphoplasty/adverse effects , Vascular Calcification/complications , Vascular System Injuries/etiology , Aged , Aged, 80 and over , Aortic Diseases/diagnosis , Aortic Valve/diagnostic imaging , Aortic Valve/injuries , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnosis , Aortography/methods , Calcinosis/complications , Calcinosis/diagnosis , Cardiac Catheterization/methods , Case-Control Studies , Female , Heart Injuries/diagnosis , Heart Valve Prosthesis Implantation/methods , Humans , Male , Multidetector Computed Tomography , Predictive Value of Tests , Risk Assessment , Risk Factors , Severity of Illness Index , Treatment Outcome , Vascular Calcification/diagnosis , Vascular System Injuries/diagnosis
11.
Eur Thyroid J ; 2(1): 65-7, 2013 Mar.
Article in English | MEDLINE | ID: mdl-24783040

ABSTRACT

A 55-year-old male on long-term amiodarone therapy presented with ischaemic chest pain and recurrent unwitnessed syncope. Interrogation of his internal cardiac defibrillator, which had been inserted 4 years earlier, revealed two episodes of ventricular fibrillation, the timing of which corresponded to his syncopal events. Severe spontaneous coronary artery vasospasm was observed on coronary angiogram. Thyroid function testing revealed severe hyperthyroidism with a diagnosis of type 2 amiodarone-induced thyrotoxicosis (AIT) subsequently made. Treatment with prednisolone therapy was commenced and thyroid function rapidly normalized. Prednisolone was weaned without recurrence of hyperthyroidism and on last review, 6 months after initial presentation, he remains free from further chest pain and arrhythmias. Our patient's presentation is a very rare case of AIT-associated coronary artery spasm and documented ischaemic ventricular fibrillation with fortunate survival.

12.
J Cardiovasc Comput Tomogr ; 6(6): 406-14, 2012.
Article in English | MEDLINE | ID: mdl-23127390

ABSTRACT

BACKGROUND: Computed tomography (CT) annular measurements are predictive of paravalvular regurgitation after transcatheter aortic valve replacement (TAVR) which is a predictor of mortality and morbidity. OBJECTIVES: To demonstrate the rationale and potential implications of new CT sizing recommendations for TAVR. METHODS: The CT sizing recommendations aim to ensure routine transcatheter heart valve (THV) oversizing of the aortic annular area [(THV external area/systolic annular area - 1) × 100; range, 1%-20%; target, 10%-15%]. Consecutive patients (n = 120) underwent CT before TAVR with balloon-expandable valves sized by transesophageal echocardiography (TEE). Retrospectively, the CT-recommended THV size was compared with the actual size implanted. RESULTS: Compared with TEE, application of the newly developed CT-based sizing recommendations would have led to implantation of a larger valve in 33.3% (40/120), no change in valve size in 55.8% (67/120), and a smaller valve in 10.8% (13/120). In patients when CT recommended a larger valve, the incidence of at least moderate paravalvular regurgitation was 25% (10/40) compared with 4.5% (3/67; P < 0.01) when both TEE and CT recommendations were in agreement. Using diastolic versus systolic CT measurements results in 20% of patients receiving smaller THVs. TEE sizing resulted in 33.3% (40/120) of valves being undersized (THV area < CT systolic annular area) with a mean annular oversizing of 9.4% ± 17.4% (range: -21.5% to 65.9%) without annular rupture. In contrast, the CT sizing recommendations results in mean annular oversizing of 13.9% ± 8.0% (range, 1.3%-29.8%). CONCLUSION: These CT sizing recommendations enable standardized moderate overexpansion of the aortic annulus. Clinical outcomes from these recommendations are being prospectively assessed in a multicenter trial.


Subject(s)
Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Echocardiography, Transesophageal/methods , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Tomography, X-Ray Computed/methods , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Cardiac Catheters , Clinical Trials as Topic , Female , Humans , Male , Patient Selection , Preoperative Care/methods , Prosthesis Design , Prosthesis Fitting , Reproducibility of Results , Sensitivity and Specificity
13.
J Am Coll Cardiol ; 60(19): 1864-75, 2012 Nov 06.
Article in English | MEDLINE | ID: mdl-23062535

ABSTRACT

OBJECTIVES: This study sought to evaluate the long-term outcomes after transcatheter aortic valve implantation (TAVI) in the Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability. BACKGROUND: Very few data exist on the long-term outcomes associated with TAVI. METHODS: This was a multicenter study including 339 patients considered to be nonoperable or at very high surgical risk (mean age: 81 ± 8 years; Society of Thoracic Surgeons score: 9.8 ± 6.4%) who underwent TAVI with a balloon-expandable Edwards valve (transfemoral: 48%, transapical: 52%). Follow-up was available in 99% of the patients, and serial echocardiographic exams were evaluated in a central echocardiography core laboratory. RESULTS: At a mean follow-up of 42 ± 15 months 188 patients (55.5%) had died. The causes of late death (152 patients) were noncardiac (59.2%), cardiac (23.0%), and unknown (17.8%). The predictors of late mortality were chronic obstructive pulmonary disease (hazard ratio [HR]: 2.18, 95% confidence interval [CI]: 1.53 to 3.11), chronic kidney disease (HR: 1.08 for each decrease of 10 ml/min in estimated glomerular filtration rate, 95% CI: 1.01 to 1.19), chronic atrial fibrillation (HR: 1.44, 95% CI: 1.02 to 2.03), and frailty (HR: 1.52, 95% CI: 1.07 to 2.17). A mild nonclinically significant decrease in valve area occurred at 2-year follow-up (p < 0.01), but no further reduction in valve area was observed up to 4-year follow-up. No changes in residual aortic regurgitation and no cases of structural valve failure were observed during the follow-up period. CONCLUSIONS: Approximately one-half of the patients who underwent TAVI because of a high or prohibitive surgical risk profile had died at a mean follow-up of 3.5 years. Late mortality was due to noncardiac comorbidities in more than one-half of patients. No clinically significant deterioration in valve function was observed throughout the follow-up period.


Subject(s)
Cardiac Catheterization/trends , Equipment Design/trends , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/trends , Aged , Aged, 80 and over , Canada/epidemiology , Cardiac Catheterization/mortality , Equipment Design/mortality , Female , Follow-Up Studies , Heart Valve Diseases/mortality , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Prognosis , Prospective Studies , Survival Rate/trends , Time Factors , Treatment Outcome , Ultrasonography
14.
JACC Cardiovasc Interv ; 5(5): 525-532, 2012 May.
Article in English | MEDLINE | ID: mdl-22625191

ABSTRACT

OBJECTIVES: This study sought to evaluate the structural integrity of balloon-expandable stents used in transcatheter aortic valve replacement. BACKGROUND: Underexpansion, deformation, or fracture of stent frames may affect transcatheter heart valve (THV) function and durability. METHODS: Patients >1 year after transcatheter aortic valve replacement underwent multidetector computed tomography. Geometry of the stent frame was assessed for circularity; eccentricity; minimum and maximum external diameter; and expansion at the inflow, mid-stent, and outflow levels, as well as for stent fracture. THV noncircularity was defined as stent eccentricity >10% (1 - minimum diameter/maximum diameter) and THV underexpansion when expansion <90% (multidetector computed tomography derived external valve area/nominal external valve area). Echocardiography was performed after implantation and annually. RESULTS: Fifty patients underwent multidetector computed tomography at an average of 2.5 ± 0.9 years after transcatheter aortic valve replacement (35 Sapien, 8 Sapien XT, and 7 Cribier-Edwards valves [all Edwards Lifesciences, Irvine, California). The mean external diameter for the 23- and 26-mm valves was 23.3 ± 0.9 mm and 25.9 ± 0.9 mm, respectively. Circularity was present in 96% (48 of 50) and median eccentricity was 2.0% (interquartile range: 1.2% to 3.0%). Mean THV expansion was 104.1 ± 7.4%, which increased from stent inflow to outflow (100.8 ± 7.6% vs. 108.1 ± 6.9%, p < 0.001). Stent fracture was not observed. Underexpanded valves (8% [4 of 50]) and noncircular valves (4% [2 of 50]) demonstrated stable hemodynamic function on annual echocardiography. CONCLUSIONS: Balloon-expandable aortic valves have excellent rates of circularity with low eccentricity and maintain full expansion without stent fracture at an average 2.5 years after implantation.


Subject(s)
Aortic Valve Stenosis/therapy , Cardiac Catheterization/instrumentation , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Multidetector Computed Tomography , Prosthesis Failure , Stents , Aged , Aged, 80 and over , Analysis of Variance , British Columbia , Cardiac Catheterization/adverse effects , Echocardiography , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Predictive Value of Tests , Prosthesis Design , Time Factors , Treatment Outcome
15.
JACC Cardiovasc Interv ; 5(5): 540-551, 2012 May.
Article in English | MEDLINE | ID: mdl-22625193

ABSTRACT

OBJECTIVES: The aim of this study was to compare the incidence and predictive factors of complete atrioventricular block (AVB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR). BACKGROUND: No data exist on the need for PPI after TAVI versus SAVR in patients with similar baseline electrocardiographic (ECG) findings. METHODS: A total of 411 patients with severe aortic stenosis (AS) and no prior pacemaker who underwent TAVI with the balloon-expandable Edwards valve (Edwards Lifesciences, Irvine, California) were matched (1:1) with 411 elderly patients with severe AS who underwent isolated SAVR on the basis of baseline ECG findings. The incidence, reasons, and predictive factors for PPI within 30 days after the procedure were compared between groups. RESULTS: Mean age was similar in both groups (p = 0.11), and the TAVI group had a higher Society of Thoracic Surgeons score (p < 0.001). The rate of new PPI was higher after TAVI (7.3%) compared with SAVR (3.4%), p = 0.014. Complete AVB and severe symptomatic bradycardia, respectively, were the reasons for PPI in the TAVI (5.6% and 1.7%, respectively) and SAVR (2.7% and 0.7%, respectively) groups (p = 0.039 for complete AVB, p = NS for symptomatic bradycardia). The presence of baseline right bundle branch block was the only variable associated with PPI in the TAVI group (odds ratio: 8.61, 95% confidence interval: 3.14 to 23.67, p < 0.0001), whereas no variable was found in the SAVR group. CONCLUSIONS: Transcatheter aortic valve implantation was associated with a higher rate of complete AVB and PPI compared with SAVR in elderly patients with severe AS and similar baseline ECG findings. The presence of baseline right bundle branch block correlated with the need for PPI in the TAVI group.


Subject(s)
Aortic Valve Stenosis/therapy , Arrhythmias, Cardiac/therapy , Cardiac Catheterization/instrumentation , Cardiac Pacing, Artificial , Catheters , Electrocardiography , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Pacemaker, Artificial , Age Factors , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnosis , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , Atrioventricular Block/diagnosis , Atrioventricular Block/etiology , Atrioventricular Block/therapy , Bradycardia/diagnosis , Bradycardia/etiology , Bradycardia/therapy , Bundle-Branch Block/diagnosis , Bundle-Branch Block/etiology , Bundle-Branch Block/therapy , Canada , Cardiac Catheterization/adverse effects , Chi-Square Distribution , Equipment Design , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Logistic Models , Male , Odds Ratio , Propensity Score , Prosthesis Design , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment Outcome
16.
JACC Cardiovasc Interv ; 5(5): 571-577, 2012 May.
Article in English | MEDLINE | ID: mdl-22625197

ABSTRACT

OBJECTIVES: This study sought to evaluate outcomes after implantation of a second transcatheter heart valve (THV-in-THV) for acute THV failure. BACKGROUND: Aortic regurgitation after transcatheter aortic valve replacement (TAVR) may be valvular due to prosthetic leaflet dysfunction or paravalvular due to poor annular sealing. METHODS: Patients undergoing aortic balloon-expandable TAVR at 3 centers were prospectively evaluated at baseline, intraprocedurally, at hospital discharge, and annually. RESULTS: Of 760 patients undergoing TAVR, 21 (2.8%) received a THV-in-THV implant due to acute, severe regurgitation. Aortic regurgitation was paravalvular in 18 patients and transvalvular in the remaining 3 patients. THV-in-THV implantation was technically successful in 19 patients (90%) and unsuccessful in 2 patients (10%), who subsequently underwent open heart surgery. Mortality at 30 days and 1 year was 14.3% and 24%, respectively. After successful THV-in-THV, mean aortic valve gradient fell from 37 ± 12 mm Hg to 13 ± 5 mm Hg (p < 0.01); aortic valve area increased from 0.64 ± 0.14 cm(2) to 1.55 ± 0.27 cm(2) (p < 0.01); and paravalvular aortic regurgitation was none in 4 patients, mild in 13 patients, and moderate in 2 patients. At 1-year follow-up, 1 patient had moderate and the others had mild or no paravalvular leaks. The mean transvalvular gradient was 15 ± 4 mm Hg, which was higher than in patients undergoing conventional TAVR (11 ± 4 mm Hg, p = 0.02). CONCLUSIONS: THV-in-THV implantation is feasible and results in satisfactory short- and mid-term outcomes.


Subject(s)
Aortic Valve Insufficiency/therapy , Aortic Valve Stenosis/therapy , Cardiac Catheterization/instrumentation , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Prosthesis Failure , Acute Disease , Aged , Aged, 80 and over , Aortic Valve Insufficiency/diagnosis , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/mortality , Aortic Valve Stenosis/mortality , Canada , Cardiac Catheterization/mortality , Chi-Square Distribution , Echocardiography, Doppler, Color , Echocardiography, Transesophageal , Feasibility Studies , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/mortality , Humans , Kaplan-Meier Estimate , Male , Ohio , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Retreatment , Risk Assessment , Risk Factors , Severity of Illness Index , Time Factors , Treatment Failure
17.
JACC Cardiovasc Interv ; 5(5): 582-590, 2012 May.
Article in English | MEDLINE | ID: mdl-22625199

ABSTRACT

OBJECTIVES: This study sought to report on the pathology of transcatheter aortic valves explanted at early and late time points after transcatheter aortic valve implantation. BACKGROUND: Information on pathological findings following transcatheter aortic valve implantation is scarce, particularly late after transcatheter aortic valve implantation. METHODS: This study included 20 patients (13 men, median age 80 years [interquartile range: 72 to 84] years) with previous transcatheter aortic valve implantation with a valve explanted at autopsy (n = 17) or surgery (n = 3) up to 30 months after implantation (10 transapical and 10 transfemoral procedures). RESULTS: Structural valve degeneration was not seen, although fibrous tissue ingrowth was observed at later time points with minimal effects on cusp mobility in 1 case. Minor alterations in valve configuration or placement were observed in up to 50% of cases, but they were not accompanied by substantial changes in valve function or reliably associated with chest compressions. Vascular or myocardial injury was common, especially within 30 days of transcatheter aortic valve implantation (about 69%), with the latter associated with left coronary ostial occlusion by calcified native aortic valve tissue in 2 cases. Mild to severe myocardial amyloidosis was present in nearly 33% of cases and likely played a role in the poor outcome of 3 patients. Endocarditis, migration of the valve, and embolization during the procedure led to surgical valve removal. CONCLUSIONS: Structural degeneration was not seen and minor alterations of valve configuration or placement did not affect valve function and were not reliably caused by chest compressions. Vascular or myocardial injury is very common early after transcatheter aortic valve implantation and myocardial amyloidosis represents a relatively frequent potentially significant comorbid condition.


Subject(s)
Aortic Valve Stenosis/therapy , Cardiac Catheterization/adverse effects , Cardiovascular Diseases/etiology , Heart Valve Prosthesis Implantation/adverse effects , Aged , Aged, 80 and over , Amyloidosis/etiology , Amyloidosis/pathology , Aortic Valve/pathology , Aortic Valve/surgery , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/mortality , Autopsy , British Columbia , Cardiac Catheterization/mortality , Cardiomyopathies/etiology , Cardiomyopathies/pathology , Cardiovascular Diseases/mortality , Cardiovascular Diseases/pathology , Cardiovascular Diseases/surgery , Cause of Death , Device Removal , Endocarditis/etiology , Endocarditis/pathology , Female , Foreign-Body Migration/etiology , Foreign-Body Migration/pathology , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Middle Aged , Myocardium/pathology , Time Factors , Treatment Outcome
18.
J Am Coll Cardiol ; 59(23): 2068-74, 2012 Jun 05.
Article in English | MEDLINE | ID: mdl-22483326

ABSTRACT

OBJECTIVES: The aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR. BACKGROUND: Little is known of the influence of MR on outcomes after TAVR. METHODS: The outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers. RESULTS: Patients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥ 40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation. CONCLUSIONS: Moderate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.


Subject(s)
Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/therapy , Heart Valve Prosthesis Implantation/mortality , Heart Valve Prosthesis Implantation/methods , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/therapy , Aged , Aged, 80 and over , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnostic imaging , Bioprosthesis , British Columbia , Cardiac Catheterization/methods , Cohort Studies , Echocardiography, Doppler , Female , Follow-Up Studies , Heart Valve Prosthesis , Humans , Kaplan-Meier Estimate , Male , Minimally Invasive Surgical Procedures/methods , Minimally Invasive Surgical Procedures/mortality , Mitral Valve Insufficiency/complications , Mitral Valve Insufficiency/diagnostic imaging , Odds Ratio , Predictive Value of Tests , Proportional Hazards Models , Prosthesis Failure , Retrospective Studies , Risk Assessment , Severity of Illness Index , Statistics, Nonparametric , Survival Analysis , Time Factors , Treatment Outcome
19.
Circ Cardiovasc Interv ; 5(2): 247-52, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22438432

ABSTRACT

BACKGROUND: Identifying the optimal fluoroscopic projection of the aortic valve is important for successful transcatheter aortic valve replacement (TAVR). Various imaging modalities, including multidetector computed tomography (MDCT), have been proposed for prediction of the optimal deployment projection. We evaluated a method that provides 3-dimensional angiographic reconstructions (3DA) of the aortic root for prediction of the optimal deployment angle and compared it with MDCT. METHODS AND RESULTS: Forty patients undergoing transfemoral TAVR at St Paul's Hospital, Vancouver, Canada, were evaluated. All underwent preimplant 3DA and 68% underwent preimplant MDCT. Three-dimensional angiographic reconstructions were generated from images of a C-arm rotational aortic root angiogram during breath-hold, rapid ventricular pacing, and injection of 32 mL contrast medium at 8 mL/s. Two independent operators prospectively predicted perpendicular valve projections. The implant angle was chosen at the discretion of the physician performing TAVR. The angles from 3DA, from MDCT, the implant angle, and the postdeployment perpendicular prosthesis view were compared. The shortest distance from the postdeployment perpendicular prosthesis projection to the regression line of predicted perpendicular projections was calculated. All but 1 patient had adequate image quality for reproducible angle predictions. There was a significant correlation between 3DA and MDCT for prediction of perpendicular valve projections (r=0.682, P<0.001). Deviation from the regression line of predicted angles to the postdeployment prosthesis view was 5.1±4.6° for 3DA and 7.9±4.9° for MDCT (P=0.01). CONCLUSIONS: Three-dimensional angiographic reconstructions and MDCT are safe, practical, and accurate imaging modalities for identifying the optimal perpendicular valve deployment projection during TAVR.


Subject(s)
Aortic Valve Stenosis/diagnosis , Aortic Valve/diagnostic imaging , Heart Valve Prosthesis Implantation , Imaging, Three-Dimensional , Multidetector Computed Tomography , Aortic Valve/pathology , Aortic Valve Stenosis/surgery , Cardiac Catheterization , Coronary Angiography/methods , Feasibility Studies , Fluoroscopy , Humans , Prognosis , Prospective Studies
20.
J Am Coll Cardiol ; 59(14): 1287-94, 2012 Apr 03.
Article in English | MEDLINE | ID: mdl-22365423

ABSTRACT

OBJECTIVES: This study sought to analyze multidetector computed tomography (MDCT) 3-dimensional aortic annular dimensions for the prediction of paravalvular aortic regurgitation (PAR) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Moderate or severe PAR after TAVR is associated with increased morbidity and mortality. METHODS: A total of 109 consecutive patients underwent MDCT pre-TAVR with a balloon expandable aortic valve. Differences between transcatheter heart valve (THV) size and MDCT measures of annular size (mean diameter, area, and circumference) were analyzed concerning prediction of PAR. Patients with THV malposition (n = 7) were excluded. In 50 patients, MDCT was repeated after TAVR to assess THV eccentricity (1 - short diameter/long diameter) and expansion (MDCT measured THV area/nominal THV area). RESULTS: Moderate or severe PAR (13 of 102) was associated with THV undersizing (THV diameter - mean diameter = -0.7 ± 1.4 mm vs. 0.9 ± 1.8 mm for trivial to mild PAR, p < 0.01). The difference between THV size and MDCT annular size was predictive of PAR (mean diameter: area under the curve [AUC]: 0.81, 95% confidence interval [CI]: 0.68 to 0.88; area: AUC: 0.80, 95% CI: 0.65 to 0.90; circumference: AUC: 0.76, 95% CI: 0.59 to 0.91). Annular eccentricity was not associated with PAR (AUC: 0.58, 95% CI: 0.46 to 0.75). We found that 35.3% (36 of 102) and 45.1% (46 of 102) of THVs were undersized relative to the MDCT mean diameter and area, respectively. THV oversizing relative to the annular area was not associated with THV eccentricity or underexpansion (oversized vs. undersized THVs; expansion: 102.7 ± 5.3% vs. 106.1 ± 5.6%, p = 0.03; eccentricity: median: 1.7% [interquartile range: 1.4% to 3.0%] vs. 1.7% [interquartile range: 1.1% to 2.7%], p = 0.28). CONCLUSIONS: MDCT-derived 3-dimensional aortic annular measurements are predictive of moderate or severe PAR following TAVR. Oversizing of THVs may reduce the risk of moderate or severe PAR.


Subject(s)
Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/prevention & control , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Cardiac Catheterization/methods , Heart Valve Prosthesis Implantation/methods , Postoperative Complications/diagnostic imaging , Aged , Aged, 80 and over , Analysis of Variance , Aortic Valve Insufficiency/etiology , Cardiac Catheterization/adverse effects , Cohort Studies , Echocardiography, Transesophageal/methods , Female , Follow-Up Studies , Heart Valve Diseases/diagnosis , Heart Valve Diseases/surgery , Humans , Imaging, Three-Dimensional , Male , Minimally Invasive Surgical Procedures/adverse effects , Minimally Invasive Surgical Procedures/methods , Postoperative Complications/prevention & control , Predictive Value of Tests , Preoperative Care/methods , Retrospective Studies , Risk Assessment , Severity of Illness Index , Statistics, Nonparametric , Tomography, X-Ray Computed , Treatment Outcome
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