Intraoperative hypotension and delirium among older adults undergoing transcatheter aortic valve replacement.

BACKGROUND: Postoperative delirium (POD) is a frequently observed complication after transcatheter aortic valve replacement (TAVR). The effects of intraoperative hypotension (IOH) on POD occurrence are currently unclear. METHODS: A retrospective observational cohort study of patients who underwent TAVR was conducted. We predefined IOH as area under the threshold (AUT) of five mean arterial blood pressures (MBP), varying from <100 to <60 mmHg. The AUT consisted of the combination of duration and depth under the MBP thresholds, expressed in mmHg*min. All MBP AUTs were computed based on the complete procedure, independent of procedural phase or duration. RESULTS: This cohort included 675 patients who underwent TAVR under general anesthesia (n = 128, 19%) or procedural sedation (n = 547, 81%). Delirium occurred mostly during the first 2 days after TAVR, and was observed in n = 93 (14%) cases. Furthermore, 674, 672, 663, 630, and 518 patients had at least 1 min intraoperative MBP <100, <90, <80, <70, and <60 mmHg, respectively. Patients who developed POD had higher AUT based on all five MBP thresholds during TAVR. The penalized adjusted odds ratio varied between 1.08 (99% confidence interval [CI] 0.74-1.56) for the AUT based on MBP < 100 mmHg and OR 1.06 (99% CI 0.88-1.28) for the AUT based on MBP < 60 mmHg. CONCLUSIONS: Intraoperative hypotension is frequently observed during TAVR, but not independently associated with POD after TAVR. Other potential factors than intraoperative hypotension may explain the occurrence of delirium after TAVR.

Predictors of clinical outcome following transcatheter aortic valve implantation: a prospective cohort study.

OBJECTIVE: In recent years, transcatheter aortic valve implantation (TAVI) has become the treatment of choice for patients with symptomatic aortic valve stenosis considered to be at increased or high surgical risk. The aim of this study was to identify predictors of postoperative adverse events in older adults undergoing TAVI. METHODS: A prospective observational cohort study of patients who were referred to a geriatric outpatient clinic for a geriatric assessment prior to TAVI was conducted. The outcomes were mortality and hospital readmission within 3 months of TAVI and the occurrence of major postoperative complications during hospitalisation according to the Clavien-Dindo classification. These three outcomes were also combined to a composite outcome. Univariate and multivariate logistic regression analyses were performed to identify predictors of the outcomes and composite outcome of adverse events. RESULTS: This cohort included 490 patients who underwent TAVI (mean age 80.7±6.2 years, 47.3% male). Within 3 months of TAVI, 19 (3.9%) patients died and 46 (9.4%) patients experienced a hospital readmission. A total of 177 (36.1%) patients experienced one or more major complications according to the Clavien-Dindo classification during hospitalisation and 193 patients (39.4%) experienced the composite outcome of adverse events. In multivariate analyses, cognitive impairment was identified as an independent predictor of major postoperative complications (OR 2.16; 95% CI 1.14 to 4.19) and the composite outcome of adverse events (OR 2.40; 95% CI 1.21 to 4.79). No association was found between the other variables and the separate outcomes and composite outcome. CONCLUSION: Cognitive impairment is associated with postoperative adverse events in older patients undergoing TAVI. Therefore, it is important to screen for cognitive impairment prior to TAVI and it is recommended to include this in current TAVI guidelines.

Efficacy of Coronary Sinus Reducer in Patients With Non-revascularized Chronic Total Occlusions.

The coronary sinus reducer (CSR) has been introduced as therapy for patients with refractory angina with no other treatment options. Aim of this study is to investigate the efficacy of the CSR in patients with refractory angina and presence of coronary chronic total occlusions (CTO). In this multicentre, international retrospective study, patients undergoing CSR implantation were screened and divided in 2 groups according to the presence/absence of CTO lesions. Baseline and clinical characteristics were analyzed in the 2 groups. Primary-outcome consisted of the variation in Canadian Cardiovascular Society (CCS) class at 6-month follow-up. Between January 2014 and December 2018, 205 patients with refractory angina were consecutively treated with the study device in the participating centers, 103 (50.2%) of which had a CTO lesion at coronary angiogram and formed the CTO-group. Baseline characteristics of the study population were well balanced between the 2 groups. CSR was successfully implanted in all cases. Baseline CCS class was 3  ±  0.5 in the CTO-group versus 3.1  ±  0.6 in the non-CTO group (p = 0.45), and improved at follow-up to 1.6  ±  0.9 versus 2  ±  1.1 respectively (p <0.01), with a significantly higher improvement in CCS class in the CTO-group (1.4  ±  0.9 vs 1.1  ±  1 respectively, p = 0.01). Any improvement in CCS class was registered in 79 (80.6%) CTO-patients, while a significantly lower percentage (65 patients, 66.3%) of the non-CTO patients reported benefits in CCS class (p = 0.03). In conclusions, patients suffering from refractory angina with non-revascularized CTO lesions have a better response to CSR implantation than patients without CTOs. CSR implantation should be considered a valid complementary therapy to CTO-PCI in these patients.

Impact of baseline cigarette smoking status on clinical outcome after transcatheter aortic valve replacement.

OBJECTIVES: To explore the prevalence of smoking, and its association with clinical and mortality outcome among patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Less data exist regarding the effect of baseline smoking status on clinical and mortality outcome among patients undergoing TAVR. METHODS: Consecutive patients who underwent TAVR at two high volume Dutch centers were included. Smoking status was prospectively questioned by a structured interview at admission. Primary endpoint was 1-year all-cause mortality after TAVR. RESULTS: A total of 913 consecutive patients (80.1 ± 7.6 years; logistic EuroSCORE: 16.5 ± 9.9%) who underwent TAVR for severe aortic valve stenosis were included. There were 47% (n = 432) males, and 57% (n = 522) never-smokers, and 35% (n = 317) prior-smokers, and 8% (n = 74) current-smokers. Smokers (i.e., prior-smokers or current-smokers) were younger compared to never-smokers (78.9 ± 7.9 and 76.4 ± 8.0 vs. 81.3 ± 7.1, P < 0.000, respectively). Median follow-up time was 365 (interquartile range [IQR]: 280-365) days. Overall, prior-smoking was not associated with all-cause mortality at 1-year following TAVR (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.55-1.23). After stratification according to sex, male prior-smokers showed better 1-year survival after TAVR than male never-smokers (12% vs. 20%; P = 0.018, respectively, HR 0.52, 95% CI 0.29-0.89), while this reversed effect was not observed among female prior-smokers versus female never-smokers after TAVR (HR 1.70, 95% CI 0.95-3.05). CONCLUSIONS: Overall, baseline prior-smokers had similar 1-year mortality outcome after TAVR compared with baseline never-smokers. However, there was a reversed association between baseline prior-smoking status and 1-year mortality after TAVR among males, which could partially be explained due to the favorable baseline characteristics.

Ex Vivo Pilot Study of Cardiac Magnetic Resonance Velocity Mapping for Quantification of Aortic Regurgitation in a Porcine Model in the Presence of a Transcatheter Heart Valve.

Accuracy of aortic regurgitation (AR) quantification by magnetic resonance (MR) imaging in the presence of a transcatheter heart valve (THV) remains to be established. We evaluated the accuracy of cardiac MR velocity mapping for quantification of antegrade flow (AF) and retrograde flow (RF) across a THV and the optimal slice position to use in cardiac MR imaging. In a systematic and fully controlled laboratory ex vivo setting, two THVs (Edwards SAPIEN XT, Medtronic CoreValve) were tested in a porcine model (n = 1) under steady flow conditions. Results showed a high level of accuracy and precision. For both THVs, AF was best measured at left ventricular outflow tract level, and RF at ascending aorta level. At these levels, MR had an excellent repeatability (ICC > 0.99), with a tendency to overestimate (4.6 ± 2.4% to 9.4 ± 7.0%). Quantification of AR by MR velocity mapping in the presence of a THV was accurate, precise, and repeatable in this pilot study, when corrected for the systematic error and when the best MR slice position was used. Confirmation of these results in future clinical studies would be a step forward in increasing the accuracy of the assessment of paravalvular AR severity.

Postoperative Delirium in Individuals Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

OBJECTIVES: To evaluate the incidence of in-hospital postoperative delirium (IHPOD) after transcatheter aortic valve replacement (TAVR). DESIGN: Systematic review and meta-analysis. SETTING: Elective procedures PARTICIPANTS: Individuals undergoing TAVR. MEASUREMENTS: A literature search was conducted in PubMed, Embase, BioMedCentral, Google Scholar, and the Cochrane Central Register of Controlled Trials (up to December 2017). All observational studies reporting the incidence of IHPOD after TAVR (sample size > 25) were included in our meta-analysis. The reported incidence rates were weighted to obtain a pooled estimate rate with 95% confidence interval (CI). RESULTS: Of 96 potentially relevant articles, 31 with a total of 32,389 individuals who underwent TAVR were included in the meta-analysis. The crude incidence of IHPOD after TAVR ranged from 0% to 44.6% in included studies, with a pooled estimate rate of 8.1% (95% CI=6.7-9.4%); heterogeneity was high (Q = 449; I = 93%; pheterogeneity < .001). The pooled estimate rate of IHPOD was 7.2% (95% CI=5.4-9.1%) after transfemoral (TF) TAVR and 21.4% (95% CI=10.3-32.5%) after non-TF TAVR. CONCLUSION: Delirium occurs frequently after TAVR and is more common after non-TF than TF procedures. Recommendations are made with the aim of standardizing future research to reduce heterogeneity between studies on this important healthcare problem. J Am Geriatr Soc 66:2417-2424, 2018.

Evaluation of Cognitive Function Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with procedural-related neurological events and acute cognitive decline. However, data on the effect of TAVR on mid-term cognitive outcome are scarce. Therefore, we aimed to assess the impact of TAVR on mid-term cognitive outcome using different neurocognitive test batteries. METHODS: Patients with severe aortic valve stenosis scheduled for TAVR were enrolled. Cognitive assessment was performed at baseline and 4 months post-TAVR using an eight-word verbal-learning test ("Immediate Recall Memory Test" [IRMT], "Delayed Recall Memory Test" [DRMT], "Recognition of Verbal Information Test" [RVIT]), global cognitive function ("Mini Mental State Examination" [MMSE]), and executive function ("Trail Making Test" [TMT], "Clock-Drawing Test" [CDT]). RESULTS: A total of 30 patients (age: 81±6years, logistic EuroSCORE: 19±10%) completed the follow-up cognitive assessments. Postoperatively, 17% (n=5) developed delirium, 13% (n=4) received permanent pacemaker, and there were no cerebrovascular events. Mean hospital duration time was 5±2 days. Patients (n=22) who did not complete the follow-up cognitive assessments had comparable baseline, procedural and hospital outcome. At follow-up there was a significant improvement in IRMT (27±5 vs. 30±4, p=0.016), with a trend toward improved DRMT (4±2 vs. 5±2, p=0.079). Moreover, patients with lower baseline MMSE and IRMT improved significantly during the follow-up. CONCLUSIONS: Transcatheter aortic valve replacement was associated with an improved IRMT during follow-up. Both MMSE and IRMT were significantly improved among those with lower baseline scores.

Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

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.

Percutaneous Device to Narrow the Coronary Sinus: Shifting Paradigm in the Treatment of Refractory Angina? A Review of the Literature.

Refractory angina pectoris is defined as a chronic debilitating condition characterized by the presence of chronic anginal symptoms due to a severe obstructive and/or diffuse coronary artery disease that cannot be controlled by the combination of medical therapy and/or revascularization (percutaneous or surgical). In addition, the presence of myocardial ischemia as a cause of the symptoms must have been documented. The coronary sinus reducer (CSR) is a recently introduced percutaneous device to treat patients with severe anginal symptoms refractory to optimal medical therapy and not amenable to conventional revascularization. The purpose of this review is to describe the current evidence from available studies measuring the clinical effect of the CSR implantation on the health and well-being of patients with refractory angina.

Incidence, Predictive Factors, and Effect of Delirium After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The purpose of this study was to investigate the incidence, predictive factors, and effect of post-operative delirium (POD) among patients treated by transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients undergoing operations that involve valve replacement appear at higher risk of POD than patients subjected to coronary artery bypass surgery alone. In patients with severe aortic stenosis undergoing TAVR, little is known regarding the potential impact of POD on the clinical outcomes. METHODS: A retrospective observational cohort study of 268 consecutive patients who underwent TAVR at our institute was conducted. Delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition criteria. The primary outcome of this study was the presence of in-hospital POD after TAVR. RESULTS: The incidence of POD after TAVR was 13.4% (n = 36). Of these cases, 18 were associated with post-procedural complications, including major vascular complications/bleeding (n = 4), stroke (n = 3), acute kidney injury (n = 3), atrial fibrillation (n = 4), and infectious disease (n = 4). POD was most frequently diagnosed on the second day after TAVR (interquartile range [IQR]: 1 to 5 days) and was associated with prolonged in-hospital stay regardless of complications (in uncomplicated TAVR: 6 days [IQR: 5 to 10 days] vs. 5 days [IQR: 4 to 5 days]; p < 0.001; and in complicated TAVR: 9 days [IQR: 8 to 15 days] vs. 6 days [IQR: 5 to 9 days]; p < 0.001). Predictors of POD were nontransfemoral (transapical/transaortic) access (odds ratio [OR]: 7.74; 95% confidence interval [CI]: 3.26 to 18.1), current smoking (OR: 3.99; 95% CI: 1.25 to 12.8), carotid artery disease (OR: 3.88; 95% CI: 1.50 to 10.1), atrial fibrillation (OR: 2.74; 95% CI: 1.17 to 6.37), and age (OR: 1.08; 95% CI: 1.00 to 1.17, per year increase). After a median follow-up of 16 months (IQR: 6 to 27 months), POD remained an independent predictor of mortality in patients undergoing transfemoral TAVR compared with the nontransfemoral TAVR (hazard ratio: 2.81; 95% CI: 1.16 to 6.83 vs. hazard ratio: 0.43; 95% Cl: 0.10 to 1.76), adjusted for possible confounders in a time-dependent Cox-regression model (i.e., age, sex, Logistic EuroSCORE and the occurrence of complications). CONCLUSIONS: POD after TAVR has an incidence of around 13% and occurs early in the post-operative course. Nontransfemoral access is strongly associated with the occurrence of POD. Patients who develop POD show prolonged in-hospital stay and impaired long-term survival.

[Innovative therapies for the treatment of refractory angina: the Reducer, a percutaneous device to narrow the coronary sinus]. / Terapie innovative per il trattamento dell'angina refrattaria: il Reducer, dispositivo percutaneo di restringimento del seno coronarico venoso.

Refractory angina is a chronic condition characterized by the presence of disabling symptoms due to severe obstructive coronary artery disease that is not improved by a combination of medical therapy and percutaneous or surgical revascularization. Mortality rates associated with this condition are quite low in clinically stable patients on optimal medical therapy, but rehospitalization rates remain high. This mandates the need for new therapies targeting an improvement of symptoms in this population, taking into account also the potential impact in terms of healthcare and costs. The increase in coronary sinus pressure seems to reduce myocardial ischemia leading to a redistribution of blood flow to the ischemic territories. The coronary sinus Reducer is a percutaneous implantable device, made of a stainless steel hourglass-shaped stent, designed to achieve controlled narrowing of the coronary sinus and to increase its upstream pressure. In various studies, the Reducer was safely implanted percutaneously via the right jugular vein in patients with refractory angina who were not amenable to revascularization and was associated with an improvement in anginal symptoms and ischemia. These results support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.

Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison.

BACKGROUND: The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. METHODS AND RESULTS: Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118). Forty-four (89.8%) S3-THV patients were matched to 66 (55.9%) SXT-THV patients (mean age 80.3±8.4 and 80.5±7.8 years, median EuroSCORE 15.8 and 16.5%, respectively). In the S3-THV and SXT-THV groups, transfemoral approach (77.3% versus 78.8%) and postdilatation rates (15.9% versus 12.1%) were similar. Predischarge echocardiography demonstrated a lower incidence of ≥mild AR (15.9% versus 46.2%, P=0.003) for the S3-THV, despite reduced annulus area to prosthesis oversizing (8.2±5.1 versus 18.2±10.7%, P=0.001). Transfemoral access site-related life-threatening or major bleedings and vascular complications were absent in the S3-THV group (0% versus 7.7%, P=0.15). No differences were observed in pacemaker implantation rate (9.8% versus 8.8%, P=0.94) and 30-day mortality (both 5%). CONCLUSIONS: In this retrospective, propensity score-matched analysis, the S3-THV performed superiorly to the SXT-THV, as demonstrated by improved valve patency and increased transfemoral access safety.

[10 years of transcatheter aortic valve implantation: an overview of the clinical applicability and findings]. / 10 jaar transkatheter-aortaklepvervanging: een overzicht van de klinische toepasbaarheid en bevindingen.

Aortic valve stenosis is a common heart valve disorder in adults. Its prevalence increases with age and is therefore especially seen in older patients. Thirty to forty per cent of patients with symptomatic aortic valve stenosis are not referred for surgical valve replacement because of high age, their medical history or comorbidities. In 2002, the first transcatheter aortic valve implantation (TAVI) was carried out in an inoperable patient. Since 2012, TAVI has been included in international guidelines for heart valve diseases as a treatment strategy in symptomatic patients at a high risk of complications and a life expectancy of more than one year. Decision-making about which treatment is preferable takes a multidisciplinary approach. Important complications of TAVI are bleeding, renal function disorder, stroke, conduction abnormalities, valve insufficiency and death. TAVI procedures are carried out in the Netherlands only in cardiac centres in which specific expertise is present in the areas of structural cardiovascular disease. Scientific research is important for further developments and improvements.