Features and Outcomes of Females and Males Requiring Postcardiotomy Extracorporeal Life Support.

BACKGROUND: Although cardiogenic shock requiring extracorporeal life support (ECLS) after cardiac surgery is associated with high mortality, the impact of sex on outcomes of post-cardiotomy ECLS remains unclear with conflicting results in literature. We compare patient characteristics, in-hospital outcomes, and overall survival between females and males requiring post-cardiotomy ECLS. METHODS: This retrospective, multicentre (34 centres), observational study included adults requiring post-cardiotomy ECLS between 2000 and 2020. Pre-operative, procedural, and ECLS characteristics, complications, and survival were compared between females and males. Association between sex and in-hospital survival was investigated through mixed-Cox proportional hazards models. RESULTS: This analysis included 1823 patients [females:40.8%; median age:66.0 (interquartile range:56.2-73.0 years)]. Females underwent more mitral (females:38.4%, males:33.1%, p=0.019) and tricuspid (females:18%, males:12.4%, p<0.001) valve surgery, while males had more coronary artery surgery (females:45.9%, males:52.4%, p=0.007). ECLS implantation was more common intra-operatively in females (females:64.1%, males:59.1%) and post-operatively in males (females:35.9%, males:40.9%, p=0.036). Ventricular unloading (females:25.1%, males:36.2%, p<0.001) and intra-aortic balloon pump (females: 25.8%, males:36.8%, p<0.001) were most frequently used in males. Females suffered more post-operative right ventricular failure (females:24.1%, males:19.1%, p=0.016) and limb ischemia (females:12.3%, males:8.8%, p=0.23). In-hospital mortality was 64.9% in females and 61.9% in males (p=0.199) with no differences in 5-year survival (females:20%, 95%CI:17-23; males:24%, 95%CI:21-28;p=0.069). Crude hazard ratio for in-hospital mortality in females was 1.12 (95%CI: 0.99-1.27,p=0.069) and did not change after adjustments. CONCLUSIONS: This study demonstrates that females and males requiring post-cardiotomy ECLS have different pre-operative and ECLS characteristics, as well as complications, without a statistical difference in in-hospital and 5-year survival.

Bilateral Femoral Cannulation Is Associated With Reduced Severe Limb Ischemia-Related Complications Compared With Unilateral Femoral Cannulation in Adult Peripheral Venoarterial Extracorporeal Membrane Oxygenation: Results From the Extracorporeal Life Support Registry.

OBJECTIVES: Peripheral venoarterial extracorporeal membrane oxygenation (ECMO) with femoral access is obtained through unilateral or bilateral groin cannulation. Whether one cannulation strategy is associated with a lower risk for limb ischemia remains unknown. We aim to assess if one strategy is preferable. DESIGN: A retrospective cohort study based on the Extracorporeal Life Support Organization registry. SETTING: ECMO centers worldwide included in the Extracorporeal Life Support Organization registry. PATIENTS: All adult patients (≥ 18 yr) who received peripheral venoarterial ECMO with femoral access and were included from 2014 to 2020. INTERVENTIONS: Unilateral or bilateral femoral cannulation. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the occurrence of limb ischemia defined as a composite endpoint including the need for a distal perfusion cannula (DPC) after 6 hours from implantation, compartment syndrome/fasciotomy, amputation, revascularization, and thrombectomy. Secondary endpoints included bleeding at the peripheral cannulation site, need for vessel repair, vessel repair after decannulation, and in-hospital death. Propensity score matching was performed to account for confounders. Overall, 19,093 patients underwent peripheral venoarterial ECMO through unilateral ( n = 11,965) or bilateral ( n = 7,128) femoral cannulation. Limb ischemia requiring any intervention was not different between both groups (bilateral vs unilateral: odds ratio [OR], 0.92; 95% CI, 0.82-1.02). However, there was a lower rate of compartment syndrome/fasciotomy in the bilateral group (bilateral vs unilateral: OR, 0.80; 95% CI, 0.66-0.97). Bilateral cannulation was also associated with lower odds of cannulation site bleeding (bilateral vs unilateral: OR, 0.87; 95% CI, 0.76-0.99), vessel repair (bilateral vs unilateral: OR, 0.55; 95% CI, 0.38-0.79), and in-hospital mortality (bilateral vs unilateral: OR, 0.85; 95% CI, 0.81-0.91) compared with unilateral cannulation. These findings were unchanged after propensity matching. CONCLUSIONS: This study showed no risk reduction for overall limb ischemia-related events requiring DPC after 6 hours when comparing bilateral to unilateral femoral cannulation in peripheral venoarterial ECMO. However, bilateral cannulation was associated with a reduced risk for compartment syndrome/fasciotomy, lower rates of bleeding and vessel repair during ECMO, and lower in-hospital mortality.

Impact of COVID-19 on incidence and outcomes of post-infarction mechanical complications in Europe.

OBJECTIVES: Post-acute myocardial infarction mechanical complications (post-AMI MCs) represent rare but life-threatening conditions, including free-wall rupture, ventricular septal rupture and papillary muscle rupture. During the coronavirus disease-19 (COVID-19) pandemic, an overwhelming pressure on healthcare systems led to delayed and potentially suboptimal treatments for time-dependent conditions. As AMI-related hospitalizations decreased, limited information is available whether higher rates of post-AMI MCs and related deaths occurred in this setting. This study was aimed to assess how COVID-19 in Europe has impacted the incidence, treatment and outcome of MCs. METHODS: The CAUTION-COVID19 study is a multicentre retrospective study collecting 175 patients with post-AMI MCs in 18 centres from 6 European countries, aimed to compare the incidence of such events, related patients' characteristics, and outcomes, between the first year of pandemic and the 2 previous years. RESULTS: A non-significant increase in MCs was observed [odds ratio (OR) = 1.15, 95% confidence interval (CI) 0.85-1.57; P = 0.364], with stronger growth in ventricular septal rupture diagnoses (OR = 1.43, 95% CI 0.95-2.18; P = 0.090). No significant differences in treatment types and mortality were found between the 2 periods. In-hospital mortality was 50.9% and was higher for conservatively managed cases (90.9%) and lower for surgical patients (44.0%). Patients admitted during COVID-19 more frequently had late-presenting infarction (OR = 2.47, 95% CI 1.24-4.92; P = 0.010), more stable conditions (OR = 2.61, 95% CI 1.27-5.35; P = 0.009) and higher EuroSCORE II (OR = 1.04, 95% CI 1.01-1.06; P = 0.006). CONCLUSIONS: A non-significant increase in MCs incidence occurred during the first year of COVID-19, characterized by a significantly higher rate of late-presenting infarction, stable conditions and EuroSCORE-II if compared to pre-pandemic data, without affecting treatment and mortality.

On-Support and Postweaning Mortality in Postcardiotomy Extracorporeal Membrane Oxygenation.

BACKGROUND: Postcardiotomy venoarterial extracorporeal membrane oxygenation (VA ECMO) is characterized by discrepancies between weaning and survival-to-discharge rates. This study analyzes the differences between postcardiotomy VA ECMO patients who survived, died on ECMO, or died after ECMO weaning. Causes of death and variables associated with mortality at different time points are investigated. METHODS: The retrospective, multicenter, observational Postcardiotomy Extracorporeal Life Support Study (PELS) includes adults requiring postcardiotomy VA ECMO between 2000 and 2020. Variables associated with on-ECMO mortality and postweaning mortality were modeled using mixed Cox proportional hazards, including random effects for center and year. RESULTS: In 2058 patients (men, 59%; median age, 65 years; interquartile range [IQR], 55-72 years), weaning rate was 62.7%, and survival to discharge was 39.6%. Patients who died (n = 1244) included 754 on-ECMO deaths (36.6%; median support time, 79 hours; IQR, 24-192 hours), and 476 postweaning deaths (23.1%; median support time, 146 hours; IQR, 96-235.5 hours). Multiorgan (n = 431 of 1158 [37.2%]) and persistent heart failure (n = 423 of 1158 [36.5%]) were the main causes of death, followed by bleeding (n = 56 of 754 [7.4%]) for on-ECMO mortality and sepsis (n = 61 of 401 [15.4%]) for postweaning mortality. On-ECMO death was associated with emergency surgery, preoperative cardiac arrest, cardiogenic shock, right ventricular failure, cardiopulmonary bypass time, and ECMO implantation timing. Diabetes, postoperative bleeding, cardiac arrest, bowel ischemia, acute kidney injury, and septic shock were associated with postweaning mortality. CONCLUSIONS: A discrepancy exists between weaning and discharge rate in postcardiotomy ECMO. Deaths occurred during ECMO support in 36.6% of patients, mostly associated with unstable preoperative hemodynamics. Another 23.1% of patients died after weaning in association with severe complications. This underscores the importance of postweaning care for postcardiotomy VA ECMO patients.

Heterogeneity in Clinical Practices for Post-Cardiotomy Extracorporeal Life Support: a Pilot Survey from the PELS-1 Multicenter Study.

BACKGROUND: High-quality evidence for post-cardiotomy extracorporeal life support (PC-ECLS) management is lacking. This study investigated the real-world PC-ECLS clinical practices. METHODS: This cross-sectional, multi-institutional, international pilot survey explored center organization, anticoagulation management, left ventricular unloading, distal limb perfusion, PC-ECLS monitoring and transfusions practices. Twenty-nine questions were distributed among 34 hospitals participating in the Post-cardiotomy Extra-Corporeal Life Support Study. RESULTS: Of the 32 centers [16 low-volume (50%); 16 high-volume (50%)] that responded, 16 (50%) had dedicated ECLS specialists. Twenty-six centers (81.3%) reported using additional mechanical circulatory supports. Anticoagulation practices were highly heterogeneous: 24 hospitals (75%) reported using patient's bleeding status as a guide, without a specific threshold in 54.2% of cases. Transfusion targets ranged 7-10 g/dL. Most centers used cardiac venting on a case-by-case basis (78.1%) and regular distal limb perfusion (84.4%). Nineteen (54.9%) centers reported dedicated monitoring protocols including daily echocardiography (87.5%), Swan-Ganz catheterization (40.6%), cerebral near-infrared spectroscopy (53.1%) and multimodal assessment of limb ischemia. Inspection of the circuit (71.9%), oxygenator pressure drop (68.8%), plasma free hemoglobin (75%), d-dimer (59.4%), lactate dehydrogenase (56.3%) and fibrinogen (46.9%) are used to diagnose hemolysis and thrombosis. CONCLUSIONS: This study shows remarkable heterogeneity in clinical practices for PC-ECLS management. More standardized protocols and better implementation of available evidence are recommended.

Novel cannulation strategy with a bidirectional cannula for distal limb perfusion during peripheral veno-arterial extracorporeal life support: A preliminary, single-centre study.

INTRODUCTION: Limb ischemia is a severe complication of peripheral veno-arterial extracorporeal life support (V-A ECLS). Several techniques have been developed to prevent this, but it remains a major and frequent adverse event (incidence: 10-30%). In 2019, a new cannula with bidirectional flow (retrograde towards the heart and antegrade towards the distal limb) has been introduced. A single-centre experience with this cannula in patients undergoing peripheral V-A ECLS is herewith reported. METHODS: This prospective observational study included adults (≥18 years) undergoing V-A ECLS from January 2021 to October 2022 with the use of a bidirectional femoral artery cannula. Primary outcome was limb ischemia requiring intervention during cardio-circulatory support. Secondary outcomes were compartment syndrome, limb amputation, cannulation site bleeding, need for other surgical intervention due to cannula related complications, duplex ultrasound parameters from the femoral vessels, and in-hospital survival. RESULTS: Twenty-two consecutive patients were included. During extracorporeal life support (ECLS) support, limb ischemia requiring intervention occurred in one patient (4.5%) and no patients developed a compartment syndrome, or required a fasciotomy or amputation. Significant bleeding was reported in two patients (9%) due to slight cannula dislodgement, easily solved with cannula repositioning. In-hospital survival was 63.6%. CONCLUSIONS: The bidirectional cannula is associated with a low risk for limb ischemia-related complications compared to current literature, and apparently represents a safe alternative to dedicated distal perfusion cannula. Further studies are warranted to confirm these preliminary findings.

Variables associated with in-hospital and postdischarge outcomes after postcardiotomy extracorporeal membrane oxygenation: Netherlands Heart Registration Cohort.

OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) for postcardiotomy cardiogenic shock has been increasingly used without concomitant mortality reduction. This study aims to investigate determinants of in-hospital and postdischarge mortality in patients requiring postcardiotomy ECMO in the Netherlands. METHODS: The Netherlands Heart Registration collects nationwide prospective data from cardiac surgery units. Adults receiving intraoperative or postoperative ECMO included in the register from January 2013 to December 2019 were studied. Survival status was established through the national Personal Records Database. Multivariable logistic regression analyses were used to investigate determinants of in-hospital (3 models) and 12-month postdischarge mortality (4 models). Each model was developed to target specific time points during a patient's clinical course. RESULTS: Overall, 406 patients (67.2% men, median age, 66.0 years [interquartile range, 55.0-72.0 years]) were included. In-hospital mortality was 51.7%, with death occurring in a median of 5 days (interquartile range, 2-14 days) after surgery. Hospital survivors (n = 196) experienced considerable rates of pulmonary infections, respiratory failure, arrhythmias, and deep sternal wound infections during a hospitalization of median 29 days (interquartile range, 17-51 days). Older age (odds ratio [OR], 1.02; 95% CI, 1.0-1.04) and preoperative higher body mass index (OR, 1.08; 95% CI, 1.02-1.14) were associated with in-hospital death. Within 12 months after discharge, 35.1% of hospital survivors (n = 63) died. Postoperative renal failure (OR, 2.3; 95% CI, 1.6-4.9), respiratory failure (OR, 3.6; 95% CI, 1.3-9.9), and re-thoracotomy (OR, 2.9; 95% CI, 1.3-6.5) were associated with 12-month postdischarge mortality. CONCLUSIONS: In-hospital and postdischarge mortality after postcardiotomy ECMO in adults remains high in the Netherlands. ECMO support in patients with higher age and body mass index, which drive associations with higher in-hospital mortality, should be carefully considered. Further observations suggest that prevention of re-thoracotomies, renal failure, and respiratory failure are targets that may improve postdischarge outcomes.

Awake extracorporeal life support and physiotherapy in adult patients: A systematic review of the literature.

OBJECTIVE: The Awake Extracorporeal Life Support (ECLS) practice combined with physiotherapy is increasing. However, available evidence for this approach is limited, with unclear indications on timing, management, and protocols. This review summarizes available literature regarding Awake ECLS and physiotherapy application rates, practices, and outcomes in adults, providing indications for future investigations. METHODS: Four databases were screened from inception to February 2021, for studies reporting adult Awake ECLS with/without physiotherapy. Primary outcome was hospital discharge survival, followed by Extracorporeal Membrane Oxygenation (ECMO) duration, extubation, Intensive Care Unit stay. RESULTS: Twenty-nine observational studies and one randomized study were selected, including 1,157 patients (males n = 611/691, 88.4%) undergoing Awake ECLS. Support type was reported in 1,089 patients: Veno-Arterial ECMO (V-A = 39.6%), Veno-Venous ECMO (V-V = 56.8%), other ECLS (3.6%). Exclusive upper body cannulation and femoral cannulation were applied in 31% versus 69% reported cases (n = 931). Extubation was successful in 63.5% (n = 522/822) patients during ECLS. Physiotherapy details were given for 676 patients: exercises confined in bed for 47.9% (n = 324) patients, mobilization until standing in 9.3% (n = 63) cases, ambulation performed in 42.7% (n = 289) patients. Femoral cannulation, extubation and V-A ECMO were mostly correlated to complications. Hospital discharge survival observed in 70.8% (n = 789/1114). CONCLUSION: Awake ECLS strategy associated with physiotherapy is performed regardless of cannulation approach. Ambulation, as main objective, is achieved in almost half the population examined. Prospective studies are needed to evaluate safety and efficacy of physiotherapy during Awake ECLS, and suitable patient selection. Guidelines are required to identify appropriate assessment/evaluation tools for Awake ECLS patients monitoring.

Surgical repair of post-infarction ventricular free-wall rupture in the Netherlands: data from a nationwide registry.

Background: Ventricular free-wall rupture (VFWR) is an infrequent but catastrophic complication of acute myocardial infarction (AMI). Most reports about outcome after surgical treatment are single-center experiences. We examined the early and mid-term outcomes after surgical repair of post-AMI VFWR using the Netherlands Heart Registration (NHR) database. Methods: We included data from NHR patients (>18 years old) who underwent surgery for post-AMI VFWR between 2014 and 2019. The primary end-point was in-hospital mortality. Secondary outcomes included postoperative complications and mid-term survival. Results: The study included 148 patients (54.7% male, mean age 66.5±11.1 years). Critical preoperative status was found in 62.6% of subjects. In-hospital mortality was 31.1% (46 of 148). Multivariable analysis identified female sex [odds ratio (OR), 5.49; 95% confidence interval (CI): 2.24-13.46] and critical preoperative status (OR, 4.06; 95% CI: 1.36-12.13) as independent predictors of in-hospital mortality. The overall median postoperative follow-up was 2.2 (interquartile range, 0.7-3.8) years. Overall survival rates at three and five years were 58.9% and 55.7%, respectively. Among hospital survivors, only 15 (14.7%) patients died during follow-up, with a five-year survival rate of 80.8%. Conclusions: In-hospital mortality after surgical repair of post-AMI VFWR is considerable. Female sex and preoperative critical status are independent predictors of early postoperative (in-hospital) death. Logistic EuroSCORE I can reliably predict in-hospital mortality (optimal cut-off >33%). Mid-term follow-up of patients surviving in-hospital course shows excellent results.

Effects of concomitant coronary artery bypass grafting on early and late mortality in the treatment of post-infarction mechanical complications: a systematic review and meta-analysis.

Background: Mechanical complications of acute myocardial infarction represent life-threatening events, including ventricular septal rupture (VSR), left ventricular free-wall rupture (LVFWR) and papillary muscle rupture (PMR). In-hospital mortality is high, even when prompt surgery can be offered. The role of concomitant coronary artery bypass grafting (CABG) in the surgical treatment of these conditions is still debated. Methods: A systematic review of the literature, from 2000 onwards, about these complications was performed, analyzing data of subjects receiving versus not-receiving concomitant CABG. Primary outcome was early mortality. Secondary outcome was late mortality for hospital survivors. Subgroup analysis for VSR, LVFWR and PMR was also performed. Results: Thirty-six studies were identified, including 4,321 patients (mostly VSR-related). Preoperative coronarography was performed in 92.2% of the cases, showing single-vessel disease in 54.3% of patients. Concomitant CABG rate was 49.0%. Early mortality was 32.6% and late mortality was 40.0% with 5.2 years of mean follow-up. The analysis showed no difference in early (OR 0.96; P=0.60) or late mortality (RR 0.91; P=0.49) between CABG and non-CABG group. In subgroup analysis, concomitant CABG was associated with significantly lower mortality at long term for PMR (RR 0.42; P=0.001), although it showed a higher, but not significant, mortality in VSR (RR 1.24; P=0.20). Conclusions: Concomitant CABG in the treatment for post-infarction mechanical complications showed no significant impact on both early and late mortality, although deserving some distinctions among different types of complication and single versus multiple vessel disease. However, larger, dedicated studies are required to provide more consistent data and evidence.

Temporary mechanical circulatory support for COVID-19 patients: A systematic review of literature.

OBJECTIVE: Myocardial damage occurs in up to 25% of coronavirus disease 2019 (COVID-19) cases. While veno-venous extracorporeal life support (V-V ECLS) is used as respiratory support, mechanical circulatory support (MCS) may be required for severe cardiac dysfunction. This systematic review summarizes the available literature regarding MCS use rates, disease drivers for MCS initiation, and MCS outcomes in COVID-19 patients. METHODS: PubMed/EMBASE were searched until October 14, 2021. Articles including adults receiving ECLS for COVID-19 were included. The primary outcome was the rate of MCS use. Secondary outcomes included mortality at follow-up, ECLS conversion rate, intubation-to-cannulation time, time on ECLS, cardiac diseases, use of inotropes, and vasopressors. RESULTS: Twenty-eight observational studies (comprising both ECLS-only populations and ECLS patients as part of larger populations) included 4218 COVID-19 patients (females: 28.8%; median age: 54.3 years, 95%CI: 50.7-57.8) of whom 2774 (65.8%) required ECLS with the majority (92.7%) on V-V ECLS, 4.7% on veno-arterial ECLS and/or Impella, and 2.6% on other ECLS. Acute heart failure, cardiogenic shock, and cardiac arrest were reported in 7.8%, 9.7%, and 6.6% of patients, respectively. Vasopressors were used in 37.2%. Overall, 3.1% of patients required an ECLS change from V-V ECLS to MCS for heart failure, myocarditis, or myocardial infarction. The median ECLS duration was 15.9 days (95%CI: 13.9-16.3), with an overall survival of 54.6% and 28.1% in V-V ECLS and MCS patients. One study reported 61.1% survival with oxy-right ventricular assist device. CONCLUSION: MCS use for cardiocirculatory compromise has been reported in 7.3% of COVID-19 patients requiring ECLS, which is a lower percentage compared to the incidence of any severe cardiocirculatory complication. Based on the poor survival rates, further investigations are warranted to establish the most appropriated indications and timing for MCS in COVID-19.

Permanent pacemaker implantation after valve and arrhythmia surgery in patients with preoperative atrial fibrillation.

BACKGROUND: Among patients referred for cardiac surgery, atrial fibrillation (AF) is a common comorbidity and a risk factor for postoperative arrhythmias (eg, sinus node dysfunction, atrioventricular heart block), including those requiring permanent pacemaker (PPM) implantation. OBJECTIVE: The purpose of this study was to evaluate the prevalence and long-term survival of postoperative PPM implantation in patients with preoperative AF who underwent valve surgery with or without concomitant procedures. METHODS: Presented analysis pertains to the HEIST (HEart surgery In atrial fibrillation and Supraventricular Tachycardia) registry. During the study period, 11,949 patients underwent valvular (aortic, mitral, or tricuspid valve replacement or repair) surgery and/or surgical ablation (SA) and were stratified according to postoperative PPM status. RESULTS: PPM implantation after surgery was necessary in 2.5% of patients, with significant variation depending on the type of surgery (from 1.1% in mitral valve repair to 3.3% in combined mitral and tricuspid valve surgery). In a multivariate logistic regression model, tricuspid intervention (P <.001), cardiopulmonary bypass time (P = .024), and endocarditis (P = .014) were shown to be risk factors for PPM. Over long-term follow-up, PPM was not associated with increased mortality compared to no PPM (hazard ratio 0.96; 95% confidence interval 0.77-1.19; P = .679). SA was not associated with PPM implantation. However, SA improved survival regardless of PPM status (log rank P <.001). CONCLUSION: In patients with preoperative AF, the need for PPM implantation after valve surgery or SA is not an infrequent outcome, with SA not affecting its prevalence but actually improving long-term survival.

Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial.

OBJECTIVES: Sutureless aortic valves demonstrated non-inferiority to standard stented valves for major cardiovascular and cerebral events at 1 year after aortic valve replacement. We aim to assess the factors correlating with permanent pacemaker implantation (PPI) in both cohorts. METHODS: PERSIST-AVR is a prospective, randomized, open-label trial. Patients undergoing aortic valve replacement were randomized to receive a sutureless aortic valve replacement (Su-AVR) or stented sutured bioprosthesis (SAVR). Multivariable analysis was performed to identify possible independent risk factors associated with PPI. A logistic regression analysis was performed to estimate the risk of PPI associated to different valve size. RESULTS: The 2 groups (Su-AVR; n = 450, SAVR n = 446) were well balanced in terms of preoperative risk factors. Early PPI rates were 10.4% in the Su-AVR group and 3.1% in the SAVR. PPI prevalence correlated with valve size XL (P = 0.0119) and preoperative conduction disturbances (P = 0.0079) in the Su-AVR group. No predictors were found in the SAVR cohort. Logistic regression analysis showed a significantly higher risk for PPI with size XL compared to each individual sutureless valve sizes [odds ratio (OR) 0.272 vs size S (95%confidence interval 0.07-0.95), 0.334 vs size M (95% CI 0,16-0; 68), 0.408 vs size L (95% CI 0,21-0.81)] but equivalent risk of PPI rates for all other combination of valve sizes. CONCLUSIONS: Su-AVR is associated with higher PPI rate as compared to SAVR. However, the increased PPI rate appears to be size-dependent with significant higher rate only for size XL. The combination of preoperative conduction disorder and a size XL can lead to a higher probability of early PPI in Su-AVR. CLINICAL TRIAL REGISTRATION NUMBER: NCT02673697.

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.

Apical versus subclavian transcatheter aortic valve implantation: An 8-year United Kingdom analysis.

OBJECTIVES: Subclavian (SC) and transapical (TA) approaches are the main alternatives to the default femoral delivery for transcatheter aortic valve implantation (TAVI). The aim of this study was to compare complications and morbidity/mortality associated with SC and TA in a long-term time frame. METHODS: From January 2007 to July 2015, 1506 patients underwent TAVI surgery in 36 United Kingdom TAVI centers. Primary outcomes were complications according to VARC-2 criteria. The secondary outcome was long-term survival. RESULTS: The enrolled patients were distributed as follows: 1216 in the TA group and 290 in the SC group. There were no differences in the rates of acute myocardial infarction, emergency valve-in-valve, paravalvular leak, balloon post dilatation, cardiac tamponade, stroke, renal replacement therapy, vascular injuries, and 30-day mortality among the groups. Conversely, the rate of permanent pacemaker implantation (p = .02), the procedural time duration (p = .04), and the 12-month mortality (p = .03) was higher in SC than in TA, while in-hospital length of stay was reduced in SC than in TA (p = .01). Up to 8 years, the long-term mortality was not different among groups (p = .77), and no difference in long-term survival between self- versus balloon-expandable devices was found (p = .26). CONCLUSIONS: According to our results, TA provided the best 12-month survival compared to SC, while the long-term survival up to 2900 days is not significantly different between groups, so SC and TA may both represent a safe non-femoral access if femoral is precluded.

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.