Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands.

BACKGROUND: There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population. METHODS: A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses. RESULTS: TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses. CONCLUSIONS: Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.

Spontaneously Resolved Systolic Anterior Motion of Native Mitral Valve Leaflet After Transcatheter Mitral Valve Replacement.

Systolic anterior motion of a mitral leaflet can occur by various mechanisms and it is one of the causes of left ventricular outflow tract obstruction after transcatheter mitral valve replacement. We present a case of systolic anterior motion that resolved spontaneously as the anterior mitral leaflet adhered to the prosthesis. (Level of Difficulty: Intermediate.).

Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis.

OBJECTIVES: The use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis of randomised CEP trials, focusing on a clinically relevant reduction in disabling stroke. METHODS: A systematic search was applied to three electronic databases, including trials that randomised TAVI patients to CEP versus standard treatment. The primary outcome was the risk of disabling stroke. Outcomes were presented as relative risk (RR), absolute risk differences (ARDs), numbers needed to treat (NNTs) and the 95% credible intervals (CrIs). The minimal clinically important difference was determined at 1.1% ARD, per expert consensus (NNT 91). The principal Bayesian meta-analysis was performed under a vague prior, and secondary analyses were performed under two informed literature-based priors. RESULTS: Seven randomised studies were included for meta-analysis (n=3996: CEP n=2126, control n=1870). Under a vague prior, the estimated median RR of CEP use for disabling stroke was 0.56 (95% CrI 0.28 to 1.19, derived ARD 0.56% and NNT 179, I2=0%). Although the estimated posterior probability of any benefit was 94.4%, the probability of a clinically relevant effect was 0-0.1% under the vague and informed literature-based priors. Results were robust across multiple sensitivity analyses. CONCLUSION: There is a high probability of a beneficial CEP treatment effect, but this is unlikely to be clinically relevant. These findings suggest that future trials should focus on identifying TAVI patients with an increased baseline risk of stroke, and on the development of new generation devices. PROSPERO REGISTRATION NUMBER: CRD42023407006.

Type A aortic dissection: optimal annual case volume for surgery.

BACKGROUND AND AIMS: The current study proposes a novel volume-outcome (V-O) meta-analytical approach to determine the optimal annual hospital case volume threshold for cardiovascular interventions in need of centralization. This novel method is applied to surgery for acute type A aortic dissection (ATAAD) as an illustrative example. METHODS: A systematic search was applied to three electronic databases (1 January 2012 to 29 March 2023). The primary outcome was early mortality in relation to annual hospital case volume. Data were presented by volume quartiles (Qs). Restricted cubic splines were used to demonstrate the V-O relation, and the elbow method was applied to determine the optimal case volume. For clinical interpretation, numbers needed to treat (NNTs) were calculated. RESULTS: One hundred and forty studies were included, comprising 38 276 patients. A significant non-linear V-O effect was observed (P < .001), with a notable between-quartile difference in early mortality rate [10.3% (Q4) vs. 16.2% (Q1)]. The optimal annual case volume was determined at 38 cases/year [95% confidence interval (CI) 37-40 cases/year, NNT to save a life in a centre with the optimal volume vs. 10 cases/year = 21]. More pronounced between-quartile survival differences were observed for long-term survival [10-year survival (Q4) 69% vs. (Q1) 51%, P < .01, adjusted hazard ratio 0.83, 95% CI 0.75-0.91 per quartile, NNT to save a life in a high-volume (Q4) vs. low-volume centre (Q1) = 6]. CONCLUSIONS: Using this novel approach, the optimal hospital case volume threshold was statistically determined. Centralization of ATAAD care to high-volume centres may lead to improved outcomes. This method can be applied to various other cardiovascular procedures requiring centralization.

Iliofemoral Tortuosity Increases the Risk of Access-Site-Related Complications After Aortic Valve Implantation and Plug-Based Access-Site Closure.

Background: Access-site-related complications are often related to high-risk anatomy and technical pitfalls and impair the outcomes of transfemoral aortic valve implantations (TAVIs). Calcification and tortuosity are widely recognized risk factors, and their impact on procedural planning is left to the implanting experts' discretion. To facilitate decision-making, we introduced a quantitative measure for iliofemoral tortuosity and assessed its predictive value for access-site-related vascular and bleeding complications. Methods: We performed a single-centre prospective cohort study of consecutive, percutaneous transfemoral TAVI performed between April 2019 and March 2020. Medical history and all-cause mortality were extracted from the electronic patient files. Arterial anatomy and calcifications were evaluated using 3mensio Structural Heart software. The primary outcome was access-site-related vascular or bleeding complications. Results: In this elderly, intermediate-risk population, we registered the primary outcome in 43 patients (39%), and major access-site complications in 10 patients (9.2%). Complete hemostasis was achieved in 77 patients (70.6%), by the application of the MANTA plug alone. In the group with access-site-related adverse events, compared with the group without, the tortuosity index was higher median (26% interquartile range [IQR 18%-33%] vs median 19% [IQR 13%-29%], respectively; P = 0.012), as was maximal angulation median (50° [IQR 40°-59°] vs median 43° [IQR 36°-51°], respectively; P = 0.026) were higher. Both variables had a significant effect on our primary outcome, with odds ratios (OR) of 3.1 (tortuosity, P = 0.005) and 2.6 (angulation, P = 0.020). The degree of angulation was a predictor of major complications too (odds ratio 7 [1.4-34.8]; P = 0.017). Conclusions: Steeper angles and greater arterial elongation increase the risk of vascular and bleeding complications after femoral TAVI with the utilization of a plug-based closure device.

Introduction: Les complications liées au site d'accès qui sont souvent associées à une anatomie qui expose à des risques élevés et aux pièges techniques nuisent aux résultats cliniques des implantations valvulaires aortiques par cathéter (TAVI) par voie fémorale. Il est largement reconnu que la calcification et la tortuosité sont des facteurs de risque. Par conséquent, leurs conséquences sur la planification interventionnelle sont laissées à la discrétion des experts en implantation. Pour faciliter la prise de décision, nous avons mis en place une mesure quantitative de tortuosités iliofémorales et évalué sa valeur prédictive sur la survenue de complications vasculaires et hémorragiques liées au site d'accès. Méthodes: Nous avons réalisé une étude de cohorte prospective unicentrique de TAVI percutanées par voie fémorale consécutives effectuées entre avril 2019 et mars 2020. Nous avons extrait les antécédents médicaux et la mortalité toutes causes confondues des dossiers médicaux électroniques. Nous avons évalué l'anatomie artérielle et les calcifications à l'aide du logiciel 3mensio Structural Heart. Le critère de jugement principal était les complications vasculaires ou hémorragiques liées au site d'accès. Résultats: Dans cette population âgée exposée à un risque intermédiaire, nous avons enregistré le critère de jugement principal de 43 patients (39 %), et les principales complications du site d'accès de 10 patients (9,2 %). Soixante-dix-sept patients (70,6 %) ont obtenu l'hémostase complète par la seule application du bouchon MANTA. L'indice de tortuosité était plus élevé dans le groupe qui avait subi des événements défavorables liés au site d'accès que dans le groupe qui n'avait pas subi d'événements défavorables (26 % [18 %-33 %] vs 19 % [13 %-29 %], respectivement; P = 0,012). Il en était de même pour l'angulation maximale (50° [40°-59°] vs 43° [36°-51°], respectivement; P = 0,026) qui était plus grande. Les deux variables ont eu des effets significatifs sur le critère de jugement principal, soit des rapports de cotes (RC) de 3,1 (tortuosité, P = 0,005) et de 2,6 (angulation, P = 0,020). Le degré d'angulation était aussi un prédicteur de complications majeures (rapport de cotes 7 [1,4-34,8]; P = 0,017). Conclusions: Des angles plus prononcés et une plus grande élongation des artères augmentent le risque de complications vasculaires et hémorragiques après la TAVI par voie fémorale lors de l'utilisation d'un dispositif de fermeture à bouchon.

An unanticipated prolonged baseline ACT during cardiac surgery due to factor XII deficiency.

Factor XII (FXII) deficiency is a congenital disorder inherited as an autosomal recessive condition. In his heterozygous form, it is relatively common in the general population. However, a total absence of FXII as seen in homozygous patients, is rare, with an incidence of approximately 1/1,000,000 individuals. Surprisingly, FXII deficiency is rather associated with thromboembolic complications. Patients do not experience a higher risk of surgical bleeding despite a markedly prolonged activated partial thromboplastin time. Given its low incidence in the general population, the finding of an unknown FXII deficiency is rare during cardiac surgery. This unique case describes a patient with an unanticipated prolonged baseline activated clotting time (ACT) during cardiac surgery in which his bleeding history and rotational thromboelastometry tracings lead us to the diagnosis of a FXII deficiency. The finding of a hypocoagulable INTEM tracing and a concurrent normal EXTEM tracing in a sample of a patient with prolonged ACT and adverse anamnestic bleeding history should prompt clinicians to consider a FXII deficiency. It may help clinicians in further perioperative management where there is not enough time to wait for the results of individual coagulation factor testing.

Incidence and Predictors of Permanent Pacemaker Implantation after Transcatheter Aortic Valve Procedures: Data of The Netherlands Heart Registration (NHR).

Atrioventricular conduction disturbance leading to permanent pacemaker (PM) implantation is a frequent and relevant complication after transcatheter aortic valve implantation (TAVI). We aimed to evaluate the rate of post-TAVI permanent PM implantation over time and to identify the predictive factors for post-TAVI PM. The data were retrospectively collected by the Netherlands Heart Registration (NHR). In total, 7489 isolated TAVI patients between 2013 and 2019 were included in the final analysis. The primary endpoint was a permanent PM implantation within 30 days following TAVI. The incidence of the primary endpoint was 12%. Post-TAVI PM showed a stable rate over time. Using multivariable logistic regression analysis, age (OR 1.01, 95% CI 1.00-1.02), weight (OR 1.00, 95% CI 1.00-1.01), creatinine serum level (OR 1.15, 95% CI 1.01-1.31), transfemoral TAVI approach (OR 1.34, 95% CI 1.11-1.61), and TAVI post-dilatation (OR 1.58, 95% CI 1.33-1.89) were shown to be independent predictors of PM. Male sex (OR 0.80, 95% CI 0.68-0.93) and previous aortic valve surgery (OR 0.42, 95% CI 0.26-0.69) had a protective effect on post-TAVI PM. From a large national TAVI registry, some clinical and procedural factors have been identified as promoting or preventing post-TAVI PM. Further efforts are required to identify high-risk patients for post-TAVI PM and to reduce the incidence of this important issue.

Urgent transcatheter aortic valve implantation in an all-comer population: a single-centre experience.

BACKGROUND: When compared with older reports of untreated symptomatic aortic valve stenosis (AoS), urgent transcatheter aortic valve implantation (u-TAVI) seems to improve mortality rates. We performed a single centre, retrospective cohort analysis to characterize our u-TAVI population and to identify potential predictors of worse outcomes. METHODS: We performed a retrospective analysis of 631 consecutive TAVI patients between 2013 and 2018. Of these patients, 53 were categorized as u-TAVI. Data was collected from the local electronic database. RESULTS: Urgent patients had more often a severely decreased left ventricular ejection fraction (LVEF < 30%) and increased creatinine levels (115.5 [88-147] vs 94.5 [78-116] mmol/l; p = 0.001). Urgent patients were hospitalised for 18 [10-28] days before and discharged 6 [4-9] days after the implantation. The incidence of peri-procedural complications and apical implantations was comparable among the study groups. Urgent patients had higher in-hospital (11.3% vs 3.1%; p = 0.011) and 1-year mortality rates (28.2% vs 8.5%, p < 0.001). An increased risk of one-year mortality was associated with urgency (HR 3.5; p < 0.001), apical access (HR 1.9; p = 0.016) and cerebrovascular complications (HR 4.3; p = 0.002). Within the urgent group, the length of pre-hospital admission was the only significant predictor of 1-year mortality (HR 1.037/day; p = 0.003). CONCLUSIONS: Compared to elective procedures, u-TAVI led to increased mortality and comparable complication rates. This detrimental effect is most likely related to the length of pre-procedural hospitalisation of urgent patients.

Reducing surgical cancellations: a successful application of Lean Six Sigma in healthcare.

OBJECTIVE: The COVID-19 pandemic emphasises the need to use healthcare resources efficient and effective to guarantee access to high-quality healthcare in an affordable manner. Surgical cancellations have a negative impact on these. We used the Lean Six Sigma (LSS) methodology to reduce cardiac surgical cancellations in a University Medical Center in the Netherlands, where approximately 20% of cardiac surgeries were being cancelled. METHOD: A multifunctional project team used the data-driven LSS process improvement methodology and followed the 'DMAIC' improvement cycle (Define, Measure, Analyse, Improve, Control). Through all DMAIC phases, real-world data from the hospital information system supported the team during biweekly problem-solving sessions. This quality improvement study used an 'interrupted time series' study design. Data were collected between January 2014 and December 2016, covering 20 months prior and 16 months after implementation. Outcomes were number of last-minute coronary artery bypass graft cancellations, number of repeated diagnostics, referral to treatment time and patient satisfaction. Statistical process control charts visualised the change and impact over time. Students two-sample t-test was used to test statistical significance. A p<0.05 was considered as statistically significant. RESULTS: Last-minute cancellations were reduced by 50% (p=0.010), repeated preoperative diagnostics (X-ray) declined by 67% (p=0.021), referral to treatment time reduced by 35% (p=0.000) and patient Net Promoter Score increased by 14% (p=0.005). CONCLUSION: This study shows that LSS is an effective quality improvement approach to help healthcare organisations to deliver more safe, timely, effective, efficient, equitable and patient-centred care. Crucial success factors were the use of a structured data-driven problem-solving approach, focus on patient value and process flow, leadership support and engagement of involved healthcare professionals through the entire care pathway. Ongoing monitoring of key performance indicators is helpful in engaging the organisation to maintain continuous process improvement and sustaining long-term impact.

Occurrence and Persistency of Conduction Disturbances during Transcatheter Aortic Valve Implantation.

Background and Objectives: Conduction disturbances such as left bundle branch block (LBBB) and complete atrio-ventricular block (cAVB) are relatively frequent complications following trans-catheter aortic valve implantation (TAVI). We investigated the dynamics of these conduction blocks to further understand luxating factors and predictors for their persistency. Materials and Methods: We prospectively included 157 consecutive patients who underwent a TAVI procedure. Electrocardiograms (ECGs) were obtained at specific time points during the TAVI procedure and at follow-up until at least six months post-procedure. Results: Of the 106 patients with a narrow QRS complex (nQRS) before TAVI, ~70% developed LBBB; 28 (26.4%) being classified as super-transient (ST-LBBB), 20 (18.9%) as transient (T-LBBB) and 24 (22.6%) as persistent (P-LBBB). Risk of LBBB was higher for self-expandable (SE) than for balloon-expandable (BE) prostheses and increased with larger implant depth. During the TAVI procedure conduction disturbances showed a dynamic behavior, as illustrated by alternating kinds of blocks in 18 cases. Most LBBBs developed during balloon aortic valvuloplasty (BAV) and at positioning and deployment of the TAVI prosthesis. The incidence of LBBB was not significantly different between patients who did and did not undergo BAV prior to TAVI implantation (65.3% and 74.2%, respectively (p = 0.494)). Progression to cAVB was most frequent for patients with preexisting conduction abnormalities (5/34) patients) and in patients showing ST-LBBB (6/28). Conclusions: During the TAVI procedure, conduction disturbances showed a dynamic behavior with alternating types of block in 18 cases. After a dynamic period of often alternating types of block, most BBBs are reversible while one third persist. Patients with ST-LBBB are most prone to progressing into cAVB. The observation that the incidence of developing LBBB after TAVI is similar with and without BAV suggests that a subgroup of patients has a substrate to develop LBBB regardless of the procedure.

Permanent pacemaker implantation following transcatheter aortic valve implantation using self-expandable, balloon-expandable, or mechanically expandable devices: a network meta-analysis.

AIMS: Permanent pacemaker implantation (PPI) still limits the expansion of indications for transcatheter aortic valve implantation (TAVI). Comparison between different systems remains scarce. We aimed to determine the impact of the device type used on post-TAVI PPI. METHODS AND RESULTS: A systematic literature review was performed to identify studies reporting the use of balloon-expandable valve (BEV), self-expandable valve (SEV), and mechanically expandable valve (MEV) and post-TAVI PPI. A network meta-analysis was used to compare TAVI mechanisms (Analysis A) and transcatheter heart valves (Analysis B) with respect to post-TAVI PPI. Analysis A included 40 181 patients with a pooled PPI rate of 19.2% in BEV, 24.7% in SEV, and 34.8% in MEV. Balloon-expandable valve showed lower risk compared to either SEV or MEV and SEV demonstrated lower risk for PPI than MEV. Implantation of BEV was associated with 39% and 62% lower PPI rate with respect to SEV and MEV. Implantation of SEV was associated with 38% lower PPI rate with respect to MEV. Analysis B included 36.143 patients with the lowest pooled PPI rate of 9.6% for Acurate Neo or others, and the highest pooled PPI rate of 34.3% for Lotus. CoreValve, Evolut Portico, and Lotus influenced significantly PPI rate, while Sapien group did not. CONCLUSION: Implantation of BEV and also SEV were associated with lower post-TAVI PPI rate, while MEV were associated with higher post-TAVI PPI. Patient tailored-approach including devices characteristics may help to reduce post-TAVI PPI and to allow TAVI to take the leap towards extension of use in younger patients. PROSPERO NUMBER: CRD42021238671.

Incidence and predictors of permanent pacemaker implantation after surgical aortic v alve replacement: Data of the Netherlands Heart Registration (NHR).

OBJECTIVE: Permanent pacemaker implantation (PPI) after surgical aortic valve replacement (SAVR) remains a frequent complication. Predictors, however, have been mainly investigated in single-center studies. Therefore, nationwide data were used to identify patients-and procedural risk factors for postoperative PPI. MATERIALS AND METHODS: Data were retrospectively collected from the Netherlands Heart Registration (NHR). Patients enrolled in the NHR undergoing isolated SAVR from 2013 to 2019 were analyzed. Primary endpoint was in-hospital PPI during hospitalization after SAVR. RESULTS: From the NHR database, 5600 patients with symptomatic aortic valve stenosis were included in the study. Crude incidence of post-SAVR PPI was 4.0%. Backward regression analysis identified previous cardiac surgery (odds ratio [OR]: 1.80; 95% confidence interval [CI]: 1.18-2.76), extra-corporeal circulation time (OR: 1.01; 95% CI: 1.00-1.01), vasopressor use (OR: 2.66; 95% CI: 1.79-3.96) and in-hospital cardiac conduction abnormalities (OR: 4.48; 95% CI: 3.36-5.98) as potential predictors for PPI. Across the time, PPI after SAVR significantly increased (OR: 1.11; 95% CI: 1.03-1.21). CONCLUSIONS: From this nationwide analysis, PPI after SAVR remains a low but increasingly frequent complication. Several predictive factors for postoperative PPI after SAVR have been identified and might be useful for patient informed consent about potential adverse event rate.

Impact of Bundle Branch Block on Permanent Pacemaker Implantation after Transcatheter Aortic Valve Implantation: A Meta-Analysis.

Data regarding the impact of infra-Hisian conduction disturbances leading to permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) remain limited. The aim of this study was to determine the impact of right and/or left bundle branch block (RBBB/LBBB) on post-TAVI PPI. We performed a systematic literature review to identify studies reporting on RBBB and/or LBBB status and post-TAVI PPI. Study design, patient characteristics, and the presence of branch block were analyzed. Odds ratios (ORs) with 95% CI were extracted. The final analysis included 36 studies, reporting about 55,851 patients. Data on LBBB were extracted from 33 studies. Among 51,026 patients included, 5503 showed pre-implant LBBB (11.9% (10.4%-13.8%)). The influence of LBBB on post-TAVI PPI was not significant OR 1.1474 (0.9025; 1.4588), p = 0.2618. Data on RBBB were extracted from 28 studies. Among 46,663 patients included, 31,603 showed pre-implant RBBB (9.2% (7.3%-11.6%)). The influence of RBBB on post-TAVI PPI was significant OR 4.8581 (4.1571; 5.6775), p < 0.0001. From this meta-analysis, the presence of RBBB increased the risk for post-TAVI PPI, independent of age or LVEF, while this finding was not confirmed for patients experimenting with LBBB. This result emphasizes the need for pre-operative evaluation strategies in patient selection for TAVI.

Effective Distance between Aortic Valve and Conduction System Is an Independent Predictor of Persistent Left Bundle Branch Block during Transcatheter Aortic Valve Implantation.

Background and objectives: Persistent left bundle branch block (P-LBBB) has been associated with poor clinical outcomes of transcatheter aortic valve implantation (TAVI) procedures. We hypothesized that the distance from the aortic valve to the proximal conduction system, expressed as the effective distance between the aortic valve and conduction system (EDACS), can predict the occurrence of P-LBBB in patients undergoing a TAVI procedure. Materials and methods: In a retrospective study, data from 269 patients were analyzed. EDACS was determined using two longitudinal CT sections. Results: Sixty-four of the patients developed P-LBBB. EDACS ranged between -3 and +18 mm. EDACS was significantly smaller in P-LBBB than in non-P-LBBB patients (4.6 (2.2-7.1) vs. 8.0 (5.8-10.2) mm, median values (interquartile range); p < 0.05). Receiver operating characteristic analysis showed an area under the curve of 0.78 for predicting P-LBBB based on EDACS. In patients with EDACS of ≤3 mm and >10 mm, the chance of developing P-LBBB was ≥50% and <10%, respectively. Conclusions: A small EDACS increases the risk for the development of P-LBBB during TAVI by a factor of >25. As EDACS can be measured pre-procedurally, it may be a valuable additional factor to weigh the risks of transcatheter and surgical aortic valve replacement.

Do Women Require Less Permanent Pacemaker After Transcatheter Aortic Valve Implantation? A Meta-Analysis and Meta-Regression.

Background Limited clinical evidence and literature are available about the potential impact of sex on permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI). The aim of this work was to evaluate the relationship between sexes and atrioventricular conduction disturbances requiring PPI after TAVI. Methods and Results Data were obtained from 46 studies from PubMed reporting information about the impact of patient sex on PPI after TAVI. Total proportions with 95% Cls were reported. Funnel plot and Egger test were used for estimation of publication bias. The primary end point was 30-day or in-hospital PPI after TAVI, with odds ratios and 95% CIs extracted. A total of 70 313 patients were included, with a cumulative proportion of 51.5% of women (35 691 patients; 95% CI, 50.2-52.7). The proportion of women undergoing TAVI dropped significantly over time (P<0.0001). The cumulative PPI rate was 15.6% (95% CI, 13.3-18.3). The cumulative rate of PPI in women was 14.9% (95% CI, 12.6-17.6), lower than in men (16.6%; 95% CI, 14.2-19.4). The risk for post-TAVI PPI was lower in women (odds ratio, 0.90; 95% CI, 0.84-0.96 [P=0.0022]). By meta-regression analysis, age (P=0.874) and ventricular function (P=0.302) were not significantly associated with PPI among the sexes. Balloon-expandable TAVI significantly decrease the advantage of women for PPI, approaching the same rate as in men (P=0.0061). Conclusions Female sex is associated with a reduced rate of PPI after TAVI, without influence of age or ventricular function. Balloon-expandable devices attenuate this advantage in favor of women. Additional investigations are warranted to elucidate sex-based differences in developing conduction disturbances after TAVI.

One-year pacing dependency after pacemaker implantation in patients undergoing transcatheter aortic valve implantation: Systematic review and meta-analysis.

Objectives: Atrioventricular conductions disturbances, requiring permanent pacemaker implantation (PPI), represent a potential complication after transcatheter aortic valve implantation (TAVI), However, little is known about the pacemaker dependency after PPI in this patient setting. This systematic review analyses the incidence of PPI, the short-term (1-year) pacing dependency, and predictors for such a state after TAVI. Methods: We performed a systematic search in PUBMED, EMBASE, and MEDLINE to identify potentially relevant literature investigating PPI requirement and dependency after TAVI. Study data, patients, and procedural characteristics were extracted. Odds ratio (OR) with 95% confidence intervals were extracted. Results: Data from 23 studies were obtained that included 18,610 patients. The crude incidence of PPI after TAVI was 17% (range, 8.8%-32%). PPI occurred at a median time of 3.2 days (range, 0-30 days). Pacing dependency at 1-year was 47.5% (range, 7%-89%). Self-expandable prosthesis (pooled OR was 2.14 [1.15-3.96]) and baseline right bundle branch block (pooled OR was 2.01 [1.06-3.83]) showed 2-fold greater risk to maintain PPI dependency at 1 year after TAVI. Conclusions: Although PPI represents a rather frequent event after TAVI, conduction disorders have a temporary nature in almost 50% of the cases with recovery and stabilization after discharge. Preoperative conduction abnormality and type of TAVI are associated with higher PPI dependency at short term.

Protracted aortic valve closure during peripheral veno-arterial extracorporeal life support: is intra-aortic balloon pump an effective solution?

BACKGROUND: Left ventricular (LV) afterload increase with protracted aortic valve (AV) closure may represent a complication of veno-arterial extracorporeal membrane oxygenation (V-A ECMO). The aim of the present study was to assess the effects of an intra-aortic balloon pump (IABP) to overcome such a hemodynamic shortcoming in patients submitted to peripheral V-A ECMO. METHODS: Among 184 adult patients who were treated with peripheral V-A ECMO support at Medical University Center Maastricht Hospital between 2007 and 2018, patients submitted to IABP implant for protracted AV closure after V-A ECMO implant were retrospectively identified. All clinical and hemodynamic data, including echocardiographic monitoring, were collected and analyzed. RESULTS: During the study period, 10 subjects (mean age 60 years old, 80% males) underwent IABP implant after peripheral V-A ECMO positioning due to the diagnosis of protracted AV closure and inefficient LV unloading as assessed by echocardiography and an absence of pulsation in the arterial pressure wave. Recovery of blood pressure pulsatility and enhanced LV unloading were observed in 8 patients after IABP placement, with no significant differences in the main hemodynamic parameters, inotropic therapy or in the ECMO flow (p=0.48). The weaning rate in this patient subgroup (mean ECMO duration 8 days), however, was only 10%, with another patient finally transplanted, leading to a 20% survival-to-hospital discharge. CONCLUSION: IABP placement was an effective solution in order to reverse the protracted AV closure and impaired LV unloading observed during peripheral V-A ECMO support. However, the impact on the weaning rate and survival needs further investigations.

In-hospital outcome of post-cardiotomy extracorporeal life support in adult patients: the 2007-2017 Maastricht experience.

OBJECTIVES: The use of post-cardiotomy extracorporeal life support (PC-ECLS) has increased worldwide over the past years but a concurrent decrease in survival to hospital discharge has also been observed. We analysed use and outcome of PC-ECLS at the Maastricht University Medical Center. DESIGN: A retrospective study of a single-centre PC-ECLS cohort. Patient characteristics and in-hospital outcomes were evaluated. SETTING: Patients who underwent PC-ECLS due to intra- or peri-operative cardiogenic shock or cardiac arrest were included. Descriptive statistics were analysed and frequency analysis and testing of group differences were performed. PARTICIPANTS: Eighty-six patients who received PC-ECLS between October 2007 and June 2017 were included. The mean age of the population was 65 years (range, 31-86 years), and 65% were men. MAIN OUTCOME MEASURES: Survival rates were calculated and PC-ECLS management data and complications were assessed. RESULTS: Pre-ECLS procedures were isolated coronary artery bypass grafting (CABG) (22%), isolated valve surgery (16%), thoracic aorta surgery (4%), a combination of CABG and valve surgery (21%) or other surgery (24%). PC-ECLS was achieved via central cannulation in 17%, peripheral cannulation in 65%, or by a combination in 17%. The median duration of PC-ECLS was 5.0 days (IQR, 6.0 days). Weaning was achieved in 49% of patients, and 37% survived to discharge. Post-operative bleeding (overall rate, 42%) showed a trend towards a reduced rate over more recent years. CONCLUSIONS: Our experience confirms an increased use of PC-ECLS during the last 10 years and shows that, by carefully addressing patient management and complications, survival rat e may be satisfactory, and improved outcome may be achieved in such a challenging ECLS setting.

Modalities and Effects of Left Ventricle Unloading on Extracorporeal Life support: a Review of the Current Literature.

INTRODUCTION/AIM: Veno-arterial extracorporeal membrane oxygenation (V-A ECMO) support is increasingly used in refractory cardiogenic shock and cardiac arrest, but is characterized by a rise in afterload of the left ventricle (LV) which may ultimately either further impair or delay cardiac contractility improvement. The aim of this study was to provide a comprehensive overview regarding the different LV venting techniques and results currently available in the literature. METHODS: A systematic literature search was performed in the PubMed database: 207 articles published between 1993 and 2016 were included. Papers dealing with pre-clinical studies, overlapping series, and association with other assist devices were excluded from the review, with 45 published papers finally selected. Heterogeneous indications for LV unloading were reported. The selected literature was divided into subgroups, according to the location or the performed procedure for LV venting. RESULTS: Case reports or case series accounted for 60% of the papers, while retrospective study represented 29% of them. Adult series were present in 67%, paediatric patients in 29%, and a mixed population in 4%. LV unloading was performed percutaneously in 84% of the cases. The most common locations of unloading was the left atrium (31%), followed by indirect unloading (intra-aortic balloon pump) (27%), trans-aortic (27%), LV (11%), and pulmonary artery (4%). Percutaneous trans-septal approach was reported in 22%. Finally, the unloading was conducted surgically in 16%,with open chest surgery in 71%, and minimally invasive surgery in 29% of surgical cases. CONCLUSION: Nowadays, only a few data are available about left heart unloading in V-A ECMO support. Despite the well-known controversy, IABP remains widely used in combination with V-A ECMO. Percutaneous approaches utilizing unloading devices is becoming an increasingly used option. However, further studies are required to establish the optimal LV unloading method.

Reservations about the Selvester QRS score in left bundle branch block - Experience in patients with transcatheter aortic valve implantation.

BACKGROUND: The Selvester QRS score (S-score) estimates myocardial scar using electrocardiographic criteria. We evaluated the S-score for left bundle branch block (LBBB). MATERIAL AND METHODS: Studied were 36 patients who developed persistent LBBB upon transcatheter aortic valve implantation (TAVI, TAVI-LBBB group) and 36 matched patients with persistent narrow QRS (TAVI-nQRS group). Electrocardiograms were recorded before and briefly after TAVI and during ~6months follow-up. S-score was calculated using criteria for hypertrophic (in absence of LBBB) or LBBB hearts. RESULTS: In TAVI-LBBB patients correlation between S-scores pre-TAVI and post-TAVI was absent (R2=0.023). High S-scores post-TAVI occurred in patients with low pre-TAVI scores. Pre-post TAVI scores correlated weakly in TAVI-nQRS (R2=0.182), indicating a possible influence of ventricular unloading by TAVI. In both groups S-scores at post-TAVI and follow-up compared reasonably (R2=0.389 and R2=0.386), indicating reproducibility in more stable conditions. CONCLUSION: This study indicates that the use of the LBBB S-score criteria overestimates scar size and that caution is recommended in the use of the score in patients with LBBB.