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1.
J Am Geriatr Soc ; 69(2): 494-499, 2021 02.
Article in English | MEDLINE | ID: mdl-33068017

ABSTRACT

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a minimally invasive, life-saving treatment for patients with severe aortic valve stenosis that improves quality of life. We examined cardiac output and cerebral blood flow in patients undergoing TAVI to test the hypothesis that improved cardiac output after TAVI is associated with an increase in cerebral blood flow. DESIGN: Prospective cohort study. SETTING: European high-volume tertiary multidisciplinary cardiac care. PARTICIPANTS: Thirty-one patients (78.3 ± 4.6 years; 61% female) with severe symptomatic aortic valve stenosis. MEASUREMENTS: Noninvasive prospective assessment of cardiac output (L/min) by inert gas rebreathing and cerebral blood flow of the total gray matter (mL/100 g per min) using arterial spin labeling magnetic resonance imaging in resting state less than 24 hours before TAVI and at 3-month follow-up. Cerebral blood flow change was defined as the difference relative to baseline. RESULTS: On average, cardiac output in patients with severe aortic valve stenosis increased from 4.0 ± 1.1 to 5.4 ± 2.4 L/min after TAVI (P = .003). The increase in cerebral blood flow after TAVI strongly varied between patients (7% ± 24%; P = .41) and related to the increase in cardiac output, with an 8.2% (standard error = 2.3%; P = .003) increase in cerebral blood flow per every additional liter of cardiac output following the TAVI procedure. CONCLUSION: Following TAVI, there was an association of increase in cardiac output with increase in cerebral blood flow. These findings encourage future larger studies to determine the influence of TAVI on cerebral blood flow and cognitive function.


Subject(s)
Aortic Valve Stenosis/physiopathology , Brain , Cerebrovascular Circulation , Quality of Life , Transcatheter Aortic Valve Replacement/methods , Aged , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/psychology , Aortic Valve Stenosis/surgery , Brain/blood supply , Brain/diagnostic imaging , Cardiac Output , Cohort Studies , Female , Humans , Magnetic Resonance Imaging/methods , Male , Netherlands/epidemiology , Outcome Assessment, Health Care , Severity of Illness Index
3.
J Am Coll Cardiol ; 74(22): 2758-2767, 2019 12 03.
Article in English | MEDLINE | ID: mdl-31562908

ABSTRACT

BACKGROUND: Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes. OBJECTIVES: This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade. METHODS: The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex. RESULTS: We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time. CONCLUSIONS: In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Catheterization, Peripheral/methods , Risk Assessment/methods , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Europe/epidemiology , Female , Femoral Artery , Humans , Male , Postoperative Complications , Prognosis , Prospective Studies , Risk Factors , Sex Distribution , Sex Factors , Survival Rate/trends
4.
Int J Cardiovasc Imaging ; 35(11): 2123-2133, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31312998

ABSTRACT

Chronic silent brain infarctions, detected as new white matter hyperintensities on magnetic resonance imaging (MRI) following transcatheter aortic valve implantation (TAVI), are associated with long-term cognitive deterioration. This is the first study to investigate to which extent the calcification volume of the native aortic valve (AV) measured with cardiac computed tomography angiography (CTA) predicts the increase in chronic white matter hyperintensity volume after TAVI. A total of 36 patients (79 ± 5 years, median EuroSCORE II 1.9%, Q1-Q3 1.5-3.4%) with severe AV stenosis underwent fluid attenuation inversion recovery (FLAIR) MRI < 24 h prior to TAVI and at 3 months follow-up for assessment of cerebral white matter hyperintensity volume (mL). Calcification volumes (mm3) of the AV, aortic arch, landing zone and left ventricle were measured on the CTA pre-TAVI. The largest calcification volumes were found in the AV (median 692 mm3) and aortic arch (median 633 mm3), with a large variation between patients (Q1-Q3 482-1297 mm3 and 213-1727 mm3, respectively). The white matter hyperintensity volume increased in 72% of the patients. In these patients the median volume increase was of 1.1 mL (Q1-Q3 0.3-4.6 mL), corresponding with a 27% increase from baseline (Q1-Q3 7-104%). The calcification volume in the AV predicted the increase of white matter hyperintensity volume (Δ%), with a 35% increase of white matter hyperintensity volume, per 100 mm3 of AV calcification volume (SE 8.5, p < 0.001). The calcification volumes in the aortic arch, landing zone and left ventricle were not associated with the increase in white matter hyperintensity volume. In 72% of the patients new chronic white matter hyperintensities developed 3 months after TAVI, with a median increase of 27%. A higher calcification volume in the AV was associated with a larger increase in the white matter hyperintensity volume. These findings show the potential for automated AV calcium screening as an imaging biomarker to predict chronic silent brain infarctions.


Subject(s)
Aortic Valve Stenosis/surgery , Cerebral Infarction/etiology , Leukoencephalopathies/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnostic imaging , Asymptomatic Diseases , Cerebral Infarction/diagnostic imaging , Chronic Disease , Computed Tomography Angiography , Coronary Angiography/methods , Female , Humans , Leukoencephalopathies/diagnostic imaging , Magnetic Resonance Imaging , Male , Prospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
5.
JACC Cardiovasc Interv ; 12(10): 911-920, 2019 05 27.
Article in English | MEDLINE | ID: mdl-31122347

ABSTRACT

OBJECTIVES: This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians. BACKGROUND: The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR. METHODS: The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM. RESULTS: A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0. CONCLUSIONS: In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Catheterization, Peripheral , Femoral Artery , Transcatheter Aortic Valve Replacement , Age Factors , 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 , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Female , Hemodynamics , Humans , Male , Postoperative Complications/etiology , Punctures , Randomized Controlled Trials as Topic , Recovery of Function , Registries , Risk Assessment , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Trauma Severity Indices , Treatment Outcome
6.
Circ Cardiovasc Interv ; 12(3): e007546, 2019 03.
Article in English | MEDLINE | ID: mdl-30871358

ABSTRACT

BACKGROUND: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke. METHODS AND RESULTS: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m2 (odds ratio, 1.7; 95% CI, 1.0-2.8; P=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4-8.1; P<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%; P<0.001) and major or life-threatening bleedings (12% versus 7%; P=0.002) at 30-day follow-up. CONCLUSIONS: In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03588247.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Catheterization, Peripheral/adverse effects , Femoral Artery , Stroke/epidemiology , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Catheterization, Peripheral/mortality , Clinical Trials as Topic , Female , Humans , Incidence , Male , Punctures , Registries , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/mortality , Time Factors , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome
7.
Eur. heart j ; 40(5): 456-465, Fev. 2019. tabela, gráfico
Article in English | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1024767

ABSTRACT

AIMS: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. METHODS AND RESULTS: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analyzed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). CONCLUSION: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial. (AU)


Subject(s)
Angioplasty, Balloon , Transcatheter Aortic Valve Replacement
8.
Catheter Cardiovasc Interv ; 93(4): E248-E254, 2019 03 01.
Article in English | MEDLINE | ID: mdl-30208263

ABSTRACT

OBJECTIVES: The aim of this study was to assess the predictive value of PMA measurement for mortality. BACKGROUND: Current surgical risk stratification have limited predictive value in the transcatheter aortic valve implantation (TAVI) population. In TAVI workup, a CT scan is routinely performed but body composition is not analyzed. Psoas muscle area (PMA) reflects a patient's global muscle mass and accordingly PMA might serve as a quantifiable frailty measure. METHODS: Multi-slice computed tomography scans (between 2010 and 2016) of 583 consecutive TAVI patients were reviewed. Patients were divided into equal sex-specific tertiles (low, mid, and high) according to an indexed PMA. Hazard ratios (HR) and their confidence intervals (CI) were determined for cardiac and all-cause mortality after TAVI. RESULTS: Low iPMA was associated with cardiac and all-cause mortality in females. One-year adjusted cardiac mortality HR in females for mid-iPMA and high-iPMA were 0.14 [95%CI, 0.05-0.45] and 0.40 [95%CI, 0.15-0.97], respectively. Similar effects were observed for 30-day and 2-years cardiac and all-cause mortality. In females, adding iPMA to surgical risk scores improved the predictive value for 1-year mortality. C-statistics changed from 0.63 [CI = 0.54-0.73] to 0.67 [CI: 0.58-0.75] for EuroSCORE II and from 0.67 [CI: 0.59-0.77] to 0.72 [CI: 0.63-0.80] for STS-PROM. CONCLUSIONS: Particularly in females, low iPMA is independently associated with an higher all-cause and cardiac mortality. Prospective studies should confirm whether PMA or other body composition parameters should be extracted automatically from CT-scans to include in clinical decision making and outcome prediction for TAVI.


Subject(s)
Aortic Valve Stenosis/surgery , Body Composition , Frailty/diagnostic imaging , Multidetector Computed Tomography , Psoas Muscles/diagnostic imaging , Sarcopenia/diagnostic imaging , Transcatheter Aortic Valve Replacement/mortality , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Female , Frailty/mortality , Frailty/physiopathology , Health Status , Humans , Male , Predictive Value of Tests , Psoas Muscles/physiopathology , Retrospective Studies , Risk Assessment , Risk Factors , Sarcopenia/mortality , Sarcopenia/physiopathology , Sex Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
9.
Eur Heart J ; 40(5): 456-465, 2019 02 01.
Article in English | MEDLINE | ID: mdl-30590565

ABSTRACT

Aims: The aim of this study was to compare clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with balloon-expandable (BE) valves vs. self-expandable (SE) valves. Transcatheter aortic valve implantation is a minimally invasive and lifesaving treatment in patients with aortic valve stenosis. Even though BE-valves and SE-valves are both commonly used on a large scale, adequately sized trials comparing clinical outcomes in patients with severe aortic valve stenosis treated with BE-valves compared with SE-valves are lacking. Methods and results: In this CENTER-collaboration, data from 10 registries or clinical trials, selected through a systematic search, were pooled and analysed. Propensity score methodology was used to reduce treatment selection bias and potential confounding. The primary endpoints were mortality and stroke at 30 days follow-up in patients treated with BE-valves compared with SE-valves. Secondary endpoints included clinical outcomes, e.g. bleeding during hospital admission. All outcomes were split for early-generation BE-valves compared with early-generation SE-valves and new-generation BE-valves with new-generation SE-valves. The overall patient population (N = 12 381) included 6239 patients undergoing TAVI with BE-valves and 6142 patients with SE-valves. The propensity matched population had a mean age of 81 ± 7 years and a median STS-PROM score or 6.5% [interquartile range (IQR) 4.0-13.0%]. At 30-day follow-up, the mortality rate was not statistically different in patients undergoing TAVI with BE-valves compared with SE-valves [BE: 5.3% vs. SE: 6.2%, relative risk (RR) 0.9; 95% confidence interval (CI) 0.7-1.0, P = 0.10]. Stroke occurred less frequently in patients treated with BE-valves (BE: 1.9% vs. SE: 2.6%, RR 0.7; 95% CI 0.5-1.0, P = 0.03). Also, patients treated with BE-valves had a three-fold lower risk of requiring pacemaker implantation (BE: 7.8% vs. SE: 20.3%, RR 0.4; 95% CI 0.3-0.4, P < 0.001). In contrast, patients treated with new-generation BE-valves more frequently experienced major and life-threatening bleedings compared with new-generation SE-valves (BE: 4.8% vs. SE: 2.1%, RR 2.3; 95% CI 1.6-3.3, P < 0.001). Conclusion: In this study, which is the largest study to compare valve types in TAVI, we demonstrated that the incidence of stroke and pacemaker implantation was lower in patients undergoing transfemoral TAVI with BE-valves compared with SE-valves. In contrast, patients treated with new-generation BE-valves more often suffered from major or life-threatening bleedings than patients with new-generation SE-valves. Mortality at 30-days was not statistically different in patients treated with BE-valves compared with SE-valves. This study was a propensity-matched analysis generated from observational data, accordingly current outcomes will have to be confirmed in a large scale randomized controlled trial.


Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Pacemaker, Artificial/statistics & numerical data , Prosthesis Design , Stroke/epidemiology , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/surgery , Conversion to Open Surgery/statistics & numerical data , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Observational Studies as Topic , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Propensity Score , Registries , Stroke/etiology , Transcatheter Aortic Valve Replacement/methods , Transcatheter Aortic Valve Replacement/mortality
10.
Open Heart ; 5(2): e000833, 2018.
Article in English | MEDLINE | ID: mdl-30275956

ABSTRACT

Aims: In this study, we examined the effects of the routinely administration of benzodiazepines on reducing periprocedural anxiety versus no premedication. Methods: In this open label study, we enrolled 1683 patients undergoing diagnostic coronary angiograms (CAG) or percutaneous coronary interventions (PCI). Randomisation was simulated by systematically allocating patients in monthly rotational periods to lorazepam 1 mg/sl, oxazepam 10 mg/po, diazepam 5 mg/po, midazolam 7.5 mg/po or no premedication. Anxiety was measured at four different time points using the one-item Visual Analogue Scale for Anxiety (VAS score) ranging from 0 to 10. The primary outcome was the difference in anxiety reduction (ΔVAS, preprocedure to postprocedure), between the different premedication strategies versus no premedication. Results: Anxiety reduction was larger in patients premedicated with lorazepam (ΔVAS=-2.0, SE=1.6, P=0.007) or diazepam (ΔVAS=-2.0, SE=1.5, p=0.003) compared with patients without any premedication (ΔVAS=-1.4, SE=1.2). The use of midazolam or oxazepam did not lead to a significant reduction in anxiety compared with patients who did not receive premedication. Additionally, a high number of patients treated with midazolam (N=39, 19.8%) developed side effects. Conclusions: In this study, the use of lorazepam or diazepam was associated with a significant, but modest anxiety reduction in patients undergoing CAG or PCI. This study does not support the standard use of oxazepam or midazolam as premedication to reduce anxiety.

12.
Trends Cardiovasc Med ; 28(6): 412-418, 2018 08.
Article in English | MEDLINE | ID: mdl-29428159

ABSTRACT

Transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis is associated with an improvement of clinical outcomes, quality of life, and self-sufficiency. The most feared TAVI-related complication is the occurrence of stroke. In order to reduce peri-procedural cerebral embolizations, diverse cerebral protection devices have been developed. These devices work though deflection or filtering of emboli, and are in different stages of testing. Silent cerebral infarctions identified by diffusion-weighted magnetic resonance imaging (DW-MRI) are used as surrogate primary outcomes, but the clinical significance is still unclear. This review provides a synopsis of the diverse cerebral protection devices and summarizes the current evidence on their efficacy during TAVI.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Embolic Protection Devices , Intracranial Embolism/prevention & control , Stroke/prevention & control , Transcatheter Aortic Valve Replacement/instrumentation , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Diffusion Magnetic Resonance Imaging , Humans , Intracranial Embolism/diagnostic imaging , Intracranial Embolism/etiology , Prosthesis Design , Risk Factors , Stroke/diagnostic imaging , Stroke/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
15.
Circ Cardiovasc Interv ; 10(11)2017 Nov.
Article in English | MEDLINE | ID: mdl-29089313

ABSTRACT

BACKGROUND: Interventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD's efficacy in a real-world situation. METHODS AND RESULTS: In the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in mGy·cm2), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD (P=0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD (P<0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD (P=0.009). CONCLUSIONS: In clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03139968.


Subject(s)
Cardiac Catheterization , Cardiologists , Occupational Exposure/prevention & control , Percutaneous Coronary Intervention , Radiation Dosage , Radiation Exposure/prevention & control , Radiation Protection/instrumentation , Radiography, Interventional , Radiologists , Surgical Drapes , Aged , Cardiac Catheterization/adverse effects , Double-Blind Method , Female , Humans , Male , Middle Aged , Netherlands , Occupational Exposure/adverse effects , Occupational Health , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Protective Factors , Radiation Exposure/adverse effects , Radiation Injuries/etiology , Radiation Injuries/prevention & control , Radiation Monitoring , Radiography, Interventional/adverse effects , Risk Assessment , Risk Factors
16.
Open Heart ; 4(1): e000569, 2017.
Article in English | MEDLINE | ID: mdl-28861274

ABSTRACT

OBJECTIVE: Left ventricular remodelling following a ST-segment elevated myocardial infarction (STEMI) is an adaptive response to maintain the cardiac output despite myocardial tissue loss. Limited studies have evaluated long term ventricular function using cardiac magnetic resonance imaging (CMR) after STEMI. METHODS: Study population consisted of 155 primary percutaneous coronary intervention treated first STEMI patients. CMR was performed at 4±2 days, 4 months and 24 months follow-up. Patients were treated with beta-blockers, ACE-inhibitors or AT-II- inhibitors, statins and dual antiplatelet according to current international guidelines. RESULTS: Mean left ventricular ejection fraction (LVEF) at baseline was 44%±8%. Twenty-one per cent of the study population had an increase of more than 5.0% after 4 months of follow-up and 21% of the cohort had a decrease of more than 5.0%. Patients with long-term LVEF deterioration have significantly larger end-systolic volumes than patients with improvement of LVEF (61±23 mL/m2 compared with 52±21 mL/m2, p=0.02) and less wall thickening in the remote zone. Patients with LVEF improvement had significantly greater improvement in wall thickening in the infarct areas and in the non-infarct or remote zone. CONCLUSION: Contrary to previous studies, we demonstrate that myocardial remodelling after STEMI is a long-term process. Long-term LVEF deterioration is characterised by an increase in end-systolic volume and less wall thickening in the remote zones. Patients with LVEF improvement exhibit an increase in left ventricular wall thickening both in the infarct as well as in the remote zones. TRIAL REGISTRATION: The HEBE study is registered in The Netherlands Trial Register #NTR166 (www.trialregister.nl) and the International Standard Randomised Controlled Trial, #ISRCTN95796863 (https://c-d-qn9pqajji.sec.amc.nl).

17.
Int J Cardiol ; 228: 926-930, 2017 Feb 01.
Article in English | MEDLINE | ID: mdl-27912201

ABSTRACT

BACKGROUND: High levels of anxiety are associated with worse outcomes in coronary artery disease patients. Little is known about anxiety levels in patients undergoing coronary procedures. Our objective is to examine the levels of anxiety in patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI) during the different phases of hospital stay and to evaluate which patient characteristics are associated with increased anxiety. METHODS: Patients undergoing CAG or PCI between April 2009 and April 2010 were included in this prospective cohort study. Anxiety levels were measured using the self reported Visual Analogue Scale (VAS) of Anxiety, ranging from 0 to 100. VAS anxiety scores were obtained at hospital intake, pre- and post-procedure, and at hospital discharge. Multivariate linear regression analyses were performed to assess correlations between baseline characteristics and anxiety levels at the different time points. RESULTS: In total 2604 patients were included, with 70.4% male participants with a mean age of 65±12years. VAS anxiety scores were highest pre-procedure (44.2±27.0mm). Female patients reported a significantly higher pre procedure VAS anxiety score (50.4±26.5) compared to males (41.5±26.8, p=0.02). Other factors associated with higher levels of anxiety at different time points were age<65years, low level of education and an acute primary PCI. CONCLUSION: In the largest cohort to date, we examined anxiety among patients undergoing PCI or CAG was highest immediately around the procedure, particularly in patients aged <65years, of female gender, undergoing primary PCI, or with a lower level of education. Better pre-procedural information or pharmacological strategies may reduce anxiety in these patients.


Subject(s)
Anxiety/diagnosis , Cardiac Catheterization/psychology , Coronary Angiography/psychology , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Percutaneous Coronary Intervention/psychology , Adult , Age Factors , Aged , Anxiety/epidemiology , Cardiac Catheterization/methods , Cohort Studies , Coronary Angiography/methods , Female , Humans , Incidence , Linear Models , Male , Middle Aged , Multivariate Analysis , Pain Measurement , Percutaneous Coronary Intervention/methods , Prospective Studies , Risk Assessment , Severity of Illness Index , Sex Factors
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