Safety and Efficacy of Mini-invasive left atrial appendage closure : a propensity score analysis.

BACKGROUND: Left atrial appendage closure (LAAC) for stroke prevention is validated in patients with non-valvular atrial fibrillation (NVAF) contraindicated to oral anticoagulation. General anesthesia (GA) is often used for procedural guidance by trans-oesophageal echocardiography (TEE); however, its use may be challenging in some patients. The aim of the study was to evaluate the safety and the mid-term efficacy of a mini-invasive LAAC strategy using micro-TEE under procedural sedation. METHODS: Comparison by propensity score of two cohorts of consecutive patients who underwent LAAC: standard TEE-guided LAAC (3D-TEE under GA) and, mini-invasive LAAC strategy (micro-TEE under procedural sedation). The primary endpoint was a composite of embolic or bleeding events, significant per-procedural complication, and cardiovascular deaths within 3 months after LAAC. RESULTS: In total, 432 patients were included (78.7±8 years old, 32.4% of women, CHA2DS2VASC score:4.9±1.1); 127 patients underwent mini-invasive LAAC strategy and were compared to 305 patients standard TEE-guided LAAC. The mini-invasive strategy was acheived in 122/127 (96.1%) planned patients. The primary endpoint occurred in 11.2% of patients from the mini-invasive LAAC strategy group and in 10.3% of patients from the standard TEE group (absolute difference = 0.9%[-6.4; 4.5], hazard-ratio=1.11[0.56; 2.19], p=0.76). Procedural times, fluoroscopy duration and hospital stays were shorter in the mini-invasive LAAC strategy group (p<0.001). CONCLUSIONS: The mini-invasive LAAC strategy is safe and effective compared to the standard TEE-guided LAAC strategy. A mini-invasive LAAC strategy may also be an important tool to help physicians to treat more patients as LAAC indications evolve in the future.

Cardiogenic shock and chronic kidney disease: Dangerous liaisons.

BACKGROUND: Chronic kidney disease (CKD) is one of the leading causes of death worldwide, closely interrelated with cardiovascular diseases, ultimately leading to the failure of both organs - the so-called "cardiorenal syndrome". Despite this burden, data related to cardiogenic shock outcomes in CKD patients are scarce. METHODS: FRENSHOCK (NCT02703038) was a prospective registry involving 772 patients with cardiogenic shock from 49 centres. One-year outcomes (rehospitalization, death, heart transplantation, ventricular assist device) were analysed according to history of CKD at admission and were adjusted on independent predictive factors. RESULTS: CKD was present in 164 of 771 patients (21.3%) with cardiogenic shock; these patients were older (72.7 vs. 63.9years) and had more comorbidities than those without CKD. CKD was associated with a higher rate of all-cause mortality at 1month (36.6% vs. 23.2%; hazard ratio 1.39, 95% confidence interval 1.01-1.9; P=0.04) and 1year (62.8% vs. 40.5%, hazard ratio 1.39, 95% confidence interval 1.09-1.77; P<0.01). Patients with CKD were less likely to be treated with norepinephrine/epinephrine or undergo invasive ventilation or receive mechanical circulatory support, but were more likely to receive renal replacement therapy (RRT). RRT was associated with a higher risk of all-cause death at 1month and 1year regardless of baseline CKD status. CONCLUSIONS: Cardiogenic shock and CKD are frequent "cross-talking" conditions with limited therapeutic options, resulting in higher rates of death at 1month and 1year. RRT is a strong predictor of death, regardless of preexisting CKD. Multidisciplinary teams involving cardiac and kidney physicians are required to provide integrated care for patients with failure of both organs.

Sex disparities in cardiogenic shock: Insights from the FRENSHOCK registry.

BACKGROUND: Cardiogenic shock (CS) is the most severe form of acute heart failure. Discrepancies have been reported between sexes regarding delays, pathways and invasive strategies in CS complicating acute myocardial infarction. However, effect of sex on the prognosis of unselected CS remains controversial. OBJECTIVES: The aim was to analyze the impact of sex on aetiology, management and prognosis of CS. METHODS: The FRENSHOCK registry included all CS admitted in 49 French Intensive Care Units (ICU) and Intensive Cardiac Care Units (ICCU) between April and October 2016. RESULTS: Among the 772 CS patients included, 220 were women (28.5%). Women were older, less smokers, with less history of ischemic cardiac disease (20.5% vs 33.6%) than men. At admission, women presented less cardiac arrest (5.5 vs 12.2%), less mottling (32.5 vs 41.4%) and higher LVEF (30 ± 14 vs 25 ± 13%). Women were more often managed via emergency department while men were directly admitted at ICU/ICCU. Ischemia was the most frequent trigger irrespective of sex (36.4% in women vs 38.2%) but women had less coronary angiogram and PCI (45.9% vs 54% and 24.1 vs 31.3%, respectively). We found no major difference in medication and organ support. Thirty-day mortality (26.4 vs 26.5%), transplant or permanent assist device were similar in both sexes. CONCLUSION: Despite some more favorable parameters in initial presentation and no significant difference in medication and support, women shared similar poor prognosis than men. Further analysis is required to cover the lasting gap in knowledge regarding sex specificities to distinguish between differences and inequalities. NCT02703038.

Optimal Heart Failure Medical Therapy and Mortality in Survivors of Cardiogenic Shock: Insights From the FRENSHOCK Registry.

BACKGROUND: The effects of pharmacological therapy on cardiogenic shock (CS) survivors have not been extensively studied. Thus, this study investigated the association between guideline-directed heart failure (HF) medical therapy (GDMT) and one-year survival rate in patients who are post-CS. METHODS AND RESULTS: FRENSHOCK (French Observatory on the Management of Cardiogenic Shock in 2016) registry was a prospective multicenter observational survey, conducted in metropolitan French intensive care units and intensive cardiac care units. Of 772 patients, 535 patients were enrolled in the present analysis following the exclusion of 217 in-hospital deaths and 20 patients with missing medical records. Patients with triple GDMT (beta-blockers, renin-angiotensin system inhibitors, and mineralocorticoid receptor antagonists) at discharge (n=112) were likely to have lower left ventricular ejection fraction on admission and at discharge compared with those without triple GDMT (n=423) (22% versus 28%, P<0.001 and 29% versus 37%, P<0.001, respectively). In the overall cohort, the one-year mortality rate was 23%. Triple GDMT prescription was significantly associated with a lower one-year all-cause mortality compared with non-triple GDMT (adjusted hazard ratio 0.44 [95% CI, 0.19-0.80]; P=0.007). Similarly, 2:1 propensity score matching and inverse probability treatment weighting based on the propensity score demonstrated a lower incidence of one-year mortality in the triple GDMT group. As the number of HF drugs increased, a stepwise decrease in mortality was observed (log rank; P<0.001). CONCLUSIONS: In survivors of CS, the one-year mortality rate was significantly lower in those with triple GDMT. Therefore, this study suggests that intensive HF therapy should be considered in patients following CS.

P2Y12 Inhibitor Loading Time Before Elective PCI and the Prevention of Myocardial Necrosis.

BACKGROUND: There are dated and conflicting data about the optimal timing of initiation of P2Y12 inhibitors in elective percutaneous coronary intervention (PCI). Peri-PCI myocardial necrosis is associated with poor outcomes. We aimed to assess the impact of the P2Y12 inhibitor loading time on periprocedural myocardial necrosis in the population of the randomized Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting (ALPHEUS) trial, which compared ticagrelor with clopidogrel in high-risk patients who received elective PCI. METHODS: The ALPHEUS trial divided 1809 patients into quartiles of loading time. The ALPHEUS primary outcome was used (type 4 [a or b] myocardial infarction or major myocardial injury) as well as the main secondary outcome (type 4 [a or b] myocardial infarction or any type of myocardial injury). RESULTS: Patients in the first quartile group (Q1) presented higher rates of the primary outcome (P = 0.01). When compared with Q1, incidences of the primary outcome decreased in patients with longer loading times (adjusted odds ratio [adjOR], 0.70 [0.52.-0.95]; P = 0.02 for Q2; adjOR 0.65 [0.48-0.88]; P < 0.01 for Q3; adjOR 0.66 [0.49-0.89]; P < 0.01 for Q4). Concordant results were found for the main secondary outcome. There was no interaction with the study drug allocated by randomization (clopidogrel or ticagrelor). Bleeding complications (any bleeding ranging between 4.9% and 7.3% and only 1 major bleeding at 48 hours) and clinical ischemic events were rare and did not differ among groups. CONCLUSIONS: In elective PCI, administration of the oral P2Y12 inhibitor at the time of PCI could be associated with more frequent periprocedural myocardial necrosis than an earlier administration. The long-term clinical consequences remain unknown.

Characteristics, management, and mid-term prognosis of older adults with cardiogenic shock admitted to intensive care units: Insights from the FRENSHOCK registry.

BACKGROUND: The incidence of heart failure and cardiogenic shock (CS) in older adults is continually increasing due to population aging. To date, prospective data detailing the specific characteristics, management and outcomes of CS in this population are scarce. METHODS: FRENSHOCK is a prospective registry including 772 CS patients from 49 centers. We studied 1-month and 1-year mortality among patients over 75-year-old, adjusted for independent predictors of 1-month and 1-year mortalities. RESULTS: Out of 772 patients included, 236 (30.6%) were 75 years old or more (mean age 81.9 ± 4.7 years, 63.6% male). Compared to patients <75 years old, older adults had a higher prevalence of comorbidities including hypertension, dyslipidemia, chronic kidney disease, and history of heart disease. Older adults were characterized by a lower blood pressure, as well as higher creatinine and lower haemoglobin levels at presentation. Yet, they were less likely to be treated with norepinephrine, epinephrine, invasive ventilation, and renal replacement therapy. They showed a higher 1-month (aHR: 2.5 [1.86-3.35], p < 0.01) and 1-year mortality (aHR: 2.01 [1.58-2.56], p < 0.01). Analysis of both 1-month and 1-year mortality stratified by age quartiles showed a gradual relationship between aging and mortality in CS patients. CONCLUSION: A third of patient with CS in critical care unit are older than 75 years and their risk of death at one month and one year is more than double compared to the younger ones. Further research is essential to identify best therapeutic strategy in this population. NCT02703038.

Transfemoral versus trans-subclavian access in transcatheter aortic valve implantation using self-expandable valve: A propensity-matched comparison.

BACKGROUND: Transcatheter aortic valve implantation is unfeasible for 10-15% of patients using the conventional transfemoral approach. Other alternative approaches, such as the subclavian approach, have emerged, with no clear recommendation indicating the superiority of one technique over another. AIM: To compare the 1-month mortality and postprocedural outcomes of patients undergoing transcatheter aortic valve implantation using a self-expandable valve via transfemoral and subclavian access. METHODS: This was a retrospective single-centre study including 1496 patients who underwent transcatheter aortic valve implantation between January 2016 and December 2020 at Clermont-Ferrand University Hospital, France. Propensity score matching was used to compare transfemoral and subclavian access. RESULTS: After building two propensity score-matched groups of 221 patients each with either access route (total n=442), baseline characteristics were similar. The procedure duration was significantly longer in the subclavian access group (53 [45-64] versus 60 [51-72] minutes; P<0.001), but with a lower amount of contrast agent (138 [118-165] versus 123 [105-150] mL; P<0.001), fluoroscopy time (11.2 [9-14] versus 9.9 [7-12] minutes; P<0.001) and radiation dose (397 [264-620] versus 321 [217-485] mGy; P<0.001). No significant difference was observed concerning 1-month mortality (odds ratio 1.62, 95% confidence interval 0.52-5.03; P=0.39) or periprocedural complications. Follow-up at 1 year confirmed no difference in longer-term mortality (hazard ratio 0.78, 95% confidence interval 0.52-5.03; P=0.43). CONCLUSIONS: The subclavian approach provides similar results to the transfemoral approach in terms of mortality, efficacy and safety; it is a reasonable and effective alternative when the reference transfemoral approach is impossible or seems complex.

One-year outcomes in cardiogenic shock triggered by supraventricular tachycardia: an analysis of the FRENSHOCK multicenter prospective registry.

Background: Cardiogenic shock (CS) is the most severe form of heart failure (HF), resulting in high early and long-term mortality. Characteristics of CS secondary to supraventricular tachycardia (SVT) are poorly reported. Based on a large registry of unselected CS, we aimed to compare 1-year outcomes between SVT-triggered and non-SVT-triggered CS. Methods: FRENSHOCK is a French prospective registry including 772 CS patients from 49 centers. For each patient, the investigator could report 1-3 CS triggers from a pre-established list (ischemic, mechanical complications, ventricular/supraventricular arrhythmia, bradycardia, iatrogenesis, infection, non-compliance, and others). In this study, 1-year outcomes [rehospitalizations, mortality, heart transplantation (HTx), ventricular assist devices (VAD)] were analyzed and adjusted for independent predictive factors. Results: Among 769 CS patients included, 100 were SVT-triggered (13%), of which 65 had SVT as an exclusive trigger (8.5%). SVT-triggered CS patients exhibited a higher proportion of male individuals with a more frequent history of cardiomyopathy or chronic kidney disease and more profound CS (biventricular failure and multiorgan failure). At 1 year, there was no difference in all-cause mortality (43% vs. 45.3%, adjusted HR 0.9 (95% CI 0.59-1.39), p = 0.64), need for HTx or VAD [10% vs. 10%, aOR 0.88 (0.41-1.88), p = 0.74], or rehospitalizations [49.4% vs. 44.4%, aOR 1.24 (0.78-1.98), p = 0.36]. Patients with SVT as an exclusive trigger presented more 1-year rehospitalizations [52.8% vs. 43.3%, aOR 3.74 (1.05-10.5), p = 0.01]. Conclusion: SVT is a frequent trigger of CS alone or in association in more than 10% of miscellaneous CS cases. Although SVT-triggered CS patients were more comorbid with more pre-existing cardiomyopathies and HF incidences, they presented similar rates of mortality, HTx, and VAD at 1 year, arguing for a better overall prognosis. Clinical Trial Registration: https://clinicaltrials.gov, identifier: NCT02703038.

Cardiogenic Shock in Idiopathic Dilated Cardiomyopathy Patients: Red Flag for Myocardial Decline.

Idiopathic dilated cardiomyopathy (IDCM) is one of the most common forms of nonischemic cardiomyopathy worldwide, possibly leading to cardiogenic shock (CS). Despite this heavy burden, the outcomes of CS in IDCM are poorly reported. Based on a large registry of unselected CS, our aim was to shed light on the 1-year outcomes after CS in patients with and without IDCM. FRENSHOCK was a prospective registry including 772 patients with CS from 49 centers. The 1-year outcomes (rehospitalizations, mortality, heart transplantation [HTx], ventricular assist devices [VAD]) were analyzed and adjusted on independent predictive factors. Within 772 CS included, 78 occurred in IDCM (10.1%). Patients with IDCM had more frequent history of chronic kidney failure and implantable cardioverter-defibrillator implantation. No difference was found in 1-month all-cause mortality between groups (28.2 vs 25.8%for IDCM and others, respectively; adjusted hazard ratio 1.14 [0.73 to 1.77], p = 0.57). Patients without IDCM were more frequently treated with noninvasive ventilation and intra-aortic balloon pump. At 1 year, IDCM led to higher rates of death or cardiovascular rehospitalizations (adjusted odds ratio 4.77 [95% confidence interval 1.13 to 20.1], p = 0.03) and higher rates of HTx or VAD for patients aged <65 years (adjusted odds ratio 2.68 [1.21 to 5.91], p = 0.02). In conclusion, CS in IDCM is a very common scenario and is associated with a higher rate of 1-year death or cardiovascular rehospitalizations and a more frequent recourse to HTx or VAD for patients aged <65 years, encouraging the consideration of it as a red flag for myocardial decline and urging for a closer follow-up and earlier evaluation for advanced heart failure therapies.

Mottling as a prognosis marker in cardiogenic shock.

AIMS: Impact of skin mottling has been poorly studied in patients admitted for cardiogenic shock. This study aimed to address this issue and identify determinants of 30-day and 1-year mortality in a large cardiogenic shock cohort of all etiologies. METHODS AND RESULTS: FRENSHOCK is a prospective multicenter observational registry conducted in French critical care units between April and October, 2016. Among the 772 enrolled patients (mean age 65.7 ± 14.9 years; 71.5% male), 660 had skin mottling assessed at admission (85.5%) with almost 39% of patients in cardiogenic shock presenting mottling. The need for invasive respiratory support was significantly higher in patients with mottling (50.2% vs. 30.1%, p < 0.001) and likewise for the need for renal replacement therapy (19.9% vs. 12.4%, p = 0.09). However, the need for mechanical circulatory support was similar in both groups. Patients with mottling at admission presented a higher length of stay (19 vs. 16 days, p = 0.033), a higher 30-day mortality rate (31% vs. 23.3%, p = 0.031), and also showed significantly higher mortality at 1-year (54% vs. 42%, p = 0.003). The subgroup of patients in whom mottling appeared during the first 24 h after admission had the worst prognosis at 30 days. CONCLUSION: Skin mottling at admission in patients with cardiogenic shock was statistically associated with prolonged length of stay and poor outcomes. As a perfusion-targeted resuscitation parameter, mottling is a simple, clinical-based approach and may thus help to improve and guide immediate goal-directed therapy to improve cardiogenic shock patients' outcomes.

Cardiogenic shock in adults with congenital heart disease: Insights from the FRENSHOCK registry.

BACKGROUND: Data on cardiogenic shock in adults with congenital heart disease (ACHD) are scarce. AIM: We sought to describe cardiogenic shock in ACHD patients in a nationwide cardiogenic shock registry. METHODS: From the multicentric FRENSHOCK registry (772 patients with cardiogenic shock from 49 French centres between April and October 2016), ACHD patients were compared with adults without congenital heart disease (non-ACHD). The primary outcome was defined by all-cause mortality, chronic ventricular assist device or heart transplantation at 1year. RESULTS: Out of the 772 patients, seven (0.9%) were ACHD, who were younger (median age: 56 vs. 67years), had fewer cardiovascular risk factors, such as hypertension (14.3% vs. 47.5%) and diabetes (14.3% vs. 28.3%), and no previous ischaemic cardiopathy (0 vs. 61.5%). Right heart catheterization (57.1% vs. 15.4%), pacemakers (28.6% vs. 4.6%) and implantable cardioverter-defibrillators (28.6% vs. 4.8%) were indicated more frequently in the management of ACHD patients compared with non-ACHD patients, whereas temporary mechanical circulatory support (0 vs. 18.7%) and invasive mechanical ventilation (14.3% vs. 38.1%) were less likely to be used in ACHD patients. At 1year, the primary outcome occurred in 85.7% (95% confidence interval: 42.1-99.6) ACHD patients and 52.3% (95% confidence interval: 48.7-55.9) non-ACHD patients. Although 1-year mortality was not significantly different between ACHD patients (42.9%) and non-ACHD patients (45.4%), ventricular assist devices and heart transplantation tended to be more frequent in the ACHD group. CONCLUSIONS: Cardiogenic shock in ACHD patients is rare, accounting for only 0.9% of an unselected cardiogenic shock population. Despite being younger and having fewer co-morbidities, the prognosis of ACHD patients with cardiogenic shock remains severe, and is similar to that of other patients.

Characteristics, management, and outcomes of active cancer patients with cardiogenic shock.

AIMS: Characteristics, management, and outcomes of patients with active cancer admitted for cardiogenic shock remain largely unknown. This study aimed to address this issue and identify the determinants of 30-day and 1-year mortality in a large cardiogenic shock cohort of all aetiologies. METHODS AND RESULTS: FRENSHOCK is a prospective multicenter observational registry conducted in French critical care units between April and October 2016. 'Active cancer' was defined as a malignancy diagnosed within the previous weeks with planned or ongoing anticancer therapy. Among the 772 enrolled patients (mean age 65.7 ± 14.9 years; 71.5% male), 51 (6.6%) had active cancer. Among them, the main cancer types were solid cancers (60.8%), and hematological malignancies (27.5%). Solid cancers were mainly urogenital (21.6%), gastrointestinal (15.7%), and lung cancer (9.8%). Medical history, clinical presentation, and baseline echocardiography were almost the same between groups. In-hospital management significantly differed: patients with cancers received more catecholamines or inotropes (norepinephrine 72% vs. 52%, P = 0.005 and norepinephrine-dobutamine combination 64.7% vs. 44.5%, P = 0.005), but had less mechanical circulatory support (5.9% vs. 19.5%, P = 0.016). They presented a similar 30-day mortality rate (29% vs. 26%) but a significantly higher mortality at 1-year (70.6% vs. 45.2%, P < 0.001). In multivariable analysis, active cancer was not associated with 30-day mortality but was significantly associated with 1-year mortality in 30-day survivors [HR 3.61 (1.29-10.11), P = 0.015]. CONCLUSION: Active cancer patients accounted for almost 7% of all cases of cardiogenic shock. Early mortality was the same regardless of active cancer or not, whereas long-term mortality was significantly increased in patients with active cancer.

Genome-wide association meta-analysis of spontaneous coronary artery dissection identifies risk variants and genes related to artery integrity and tissue-mediated coagulation.

Spontaneous coronary artery dissection (SCAD) is an understudied cause of myocardial infarction primarily affecting women. It is not known to what extent SCAD is genetically distinct from other cardiovascular diseases, including atherosclerotic coronary artery disease (CAD). Here we present a genome-wide association meta-analysis (1,917 cases and 9,292 controls) identifying 16 risk loci for SCAD. Integrative functional annotations prioritized genes that are likely to be regulated in vascular smooth muscle cells and artery fibroblasts and implicated in extracellular matrix biology. One locus containing the tissue factor gene F3, which is involved in blood coagulation cascade initiation, appears to be specific for SCAD risk. Several associated variants have diametrically opposite associations with CAD, suggesting that shared biological processes contribute to both diseases, but through different mechanisms. We also infer a causal role for high blood pressure in SCAD. Our findings provide novel pathophysiological insights involving arterial integrity and tissue-mediated coagulation in SCAD and set the stage for future specific therapeutics and preventions.

One-year outcomes in cardiogenic shock triggered by ventricular arrhythmia: An analysis of the FRENSHOCK multicenter prospective registry.

Background: Cardiogenic shock (CS) is a life-threatening condition carrying poor prognosis, potentially triggered by ventricular arrhythmia (VA). Whether the occurrence of VA as trigger of CS worsens the prognosis compared to non-VA triggers  remains  unclear.  The  aim  of  this  study  was  to  evaluate  1-year  outcomes [mortality, heart transplantation, ventricular assist devices (VAD)] between VA-triggered and non-VA-triggered CS. Methods: FRENSHOCK is a prospective multicenter registry including 772 CS patients from 49 centers. One to three triggers can be identified in the registry (ischemic, mechanical complications, ventricular/supraventricular arrhythmia, bradycardia, iatrogenesis, infection, non-compliance). Baseline characteristics, management and 1-year outcomes were analyzed according to the VA-trigger in the CS population. Results: Within 769 CS patients included, 94 were VA-triggered (12.2%) and were compared to others. At 1 year, although there was no mortality difference [42.6 vs. 45.3%, HR 0.94 (0.67-1.30), p = 0.7], VA-triggered CS resulted in more heart transplantations and VAD (17 vs. 9%, p = 0.02). Into VA-triggered CS group, though there was no 1-year mortality difference between ischemic and non-ischemic cardiomyopathies [42.5 vs. 42.6%, HR 0.97 (0.52-1.81), p = 0.92], non-ischemic cardiomyopathy led to more heart transplantations and VAD (25.9 vs. 5%, p = 0.02). Conclusion: VA-triggered CS did not show higher mortality compared to other triggers but resulted in more heart transplantation and VAD at 1 year, especially in non-ischemic cardiomyopathy, suggesting the need for earlier evaluation by advanced heart failure specialized team for a possible indication of mechanical circulatory support or heart transplantation. Clinical trial registration: https://clinicaltrials.gov, identifier NCT02703038.

Post-Dilatation of New-Generation Self-Expandable Transcatheter Aortic Valves Does Not Increase Atrioventricular Conduction Abnormalities.

The impact that post-dilatation has on the risk of experiencing conduction disorders after post-transcatheter aortic valve replacement with self-expanding valves (SE-TAVR) is unclear. We compared the rate of developing an atrioventricular (AV) high-grade conduction disorder and permanent pacemaker implantation (PPI) in post-TAVR patients undergoing post-dilatation. We enrolled patients with severe symptomatic calcified aortic stenosis (CAS) who were undergoing SE-TAVR between 1 January 2016, and 19 April 2019 at a single French center. Of the 532 patients treated with SE-TAVR, 417 subjects (78.4%) received Corevalve Evolute R and 115 subjects (21.6%) received the latest-generation Corevalve Evolute Pro valve. In total, 104/532 patients (19.5%; 21.6% with Evolute R vs. 12.2% with Evolute Pro, p = 0.024) required post-dilatation. Evolut R was associated with an increased risk of post-dilatation (odds ratio 2.1 (1.01-4.33, p = 0.046)). We did not observe any post-dilatation increases in AV or in intra- and interventricular conduction disorders. In total, 26.1% of participants needed PPI within the first 30 post-procedure days (p = 0.449). Post-dilatation was not associated with a higher PPI risk (subdistribution hazard ratio 1.033 (0.726-1.471); p = 0.857). No significant differences existed between the groups in terms of one-year mortality (10.3%; p = 0.507). Post-dilatation in SE-TAVR did not increase the rate of electrical conduction disorders and PPI in the early implantation phase. The latest generation of SE-TAVR valves was associated with less need for post-dilatation.

Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.

BACKGROUND: New-onset left bundle branch block (LBBB) is one of the most frequent complications after transcatheter aortic valve implantation (TAVI) and is associated with delayed high degree atrioventricular (AV) block. OBJECTIVES: The objectives of this study were to determine the incidence of AV block in such a population and to assess the performance and safety of a risk stratification algorithm on the basis of electrophysiology study (EPS) followed by implantation of a pacemaker or implantable loop recorder (ILR). METHODS: This was a prospective open-label study with 12-month follow-up. From June 8, 2015, to November 8, 2018, 183 TAVI recipients (mean age 82.3 ± 5.9 years) were included at 10 centers. New-onset LBBB after TAVI persisting for >24 hours was assessed by electrophysiology study during initial hospitalization. High-risk patients (His-ventricle interval ≥70 ms) were implanted with a dual-chamber pacemaker recording AV conduction disturbance episodes. Patients at lower risk were implanted with an ILR with automatic remote monitoring. RESULTS: A high-grade AV conduction disorder was identified in 56 patients (30.6%) at 12 months. Four subjects were symptomatic, all in the ILR group. No complications were associated with the stratification procedure. Patients with His-ventricle interval ≥70 ms displayed more high-grade AV conduction disorders (53.2% [25 of 47] vs 22.8% [31 of 136]; P < .001). In a multivariate analysis, His-ventricle interval ≥70 ms was independently associated with the occurrence of a high-grade conduction disorder (subdistribution hazard ratio 2.4; 95% confidence interval 1.2-4.8; P = .010). CONCLUSION: New-onset LBBB after TAVI was associated with high rates of high-grade AV conduction disturbances. The stratification algorithm provided safe and valuable aid to management decisions and reliable guidance on pacemaker implantation.

Impact of Pre-Existing History of Heart Failure on Patient Profile, Therapeutic Management, and Prognosis in Cardiogenic Shock: Insights from the FRENSHOCK Registry.

There is a large heterogeneity among patients presenting with cardiogenic shock (CS). It is crucial to better apprehend this heterogeneity in order to adapt treatments and improve prognoses in these severe patients. Notably, the presence (or absence) of a pre-existing history of chronic heart failure (CHF) at time of CS onset may be a significant part of this heterogeneity, and data focusing on this aspect are lacking. We aimed to compare CS patients with new-onset HF to those with worsening CHF in the multicenter FRENSHOCK registry. Altogether, 772 CS patients were prospectively included: 433 with a previous history of CHF and 339 without. Worsening CHF patients were older (68 +/− 13.4 vs. 62.7 +/− 16.2, p < 0.001) and had a greater burden of extra-cardiac comorbidities. At admission, acute myocardial infarction was predominantly observed in the new-onset HF group (49.9% vs. 25.6%, p < 0.001). When focusing on hemodynamic parameters, worsening CHF patients showed more congestion and higher ventricular filling pressures. Worsening CHF patients experienced higher in-hospital all-cause mortality (31.3% vs. 24.2%, p = 0.029). Our results emphasize the great heterogeneity of the patients presenting with CS. Worsening CHF patients had higher risk profiles, and this translated to a 30% increase in in-hospital all-cause mortality. The heterogeneity of this population prompts us to better determine the phenotype of CS patients to adapt their management.

Emergency bailout surgery saves lives in high-risk patients with complications after TAVR.

INTRODUCTION: With the expansion of the indication for transcatheter aortic valve implantation (TAVR), the value of access to on-site emergency heart surgery at performing centers needs to be assessed. AIMS: To evaluate postoperative mortality after surgical rescue post-TAVR, in a population at high surgical risk. METHODS: Retrospective analysis of a cohort of patients included in the France-TAVI registry who had undergone TAVR with the latest generation valves between January 2017 and February 2020. RESULTS: Among the 968 patients undergoing TAVR, 6 patients (0.62%) were identified as candidates for surgery: 3 in the peri-operative context and 3 during hospitalization. Four subjects were managed in a salvage situation, two due to tamponade, one due to aortic dissection, and one due to aortic annulus rupture. One patient died of a delayed aortic annulus rupture and one patient presented a right coronary occlusion which was medically treated. All patients who underwent emergency surgery were discharged alive from the hospital. CONCLUSIONS: In TAVR patients initially contraindicated for surgery, emergency bailout surgery could be performed successfully with all patients discharged alive. Access to on-site heart surgery represents a life-saving resource for TAVR centers.

Leaflet disruption of ViV-TAVI after bioprosthetic valve fracture leading to severe aortic regurgitation: a case report.

Background: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as an alternative for the treatment of degenerated bioprosthetic valves (BPVs) for high surgical risk patients. However, this procedure often results in patient-prosthesis mismatch. BPV fracture is a novel technique to address this problem. From now, complications following BPV fracture are few. Case summary: We present the case of a 84-year-old female with history of first surgical aortic BPV replacement with a Mitroflow Sorin 23 mm due to severe aotic stenosis in 2009. In 2017, a second intervention due to bioprosthetic aortic valve stenosis valve was performed with valve-in-valve TAVI with CoreValve Evolut R 23 mm. In 2021, she was admitted with severe heart failure due to TAVI degeneration with severe stenosis in the bioprothesis. After heart team discussions, the patient was deemed inoperable for new heart surgery and considered as a candidate for BPV fracture as last possible alternative. After BPV fracture was performed, the patient suffered acute hypotension. Urgent transoesophageal echocardiography and angiogram demonstrated severe acute intra-TAVI aortic insufficiency because of probable disruption of the CoreValve leaflets. The patient was successfully treated with a ViV 23 mm SAPIEN three Edwards valve with a resolution of the aortic insufficiency and improvement of her haemodynamics. The patient remains asymptomatic after 6 months, with improvement in clinical status. Discussion: This case demonstrates a disruption of the transcatheter heart valve leaflets causing severe aortic regurgitation as one of the complication of BPV fracture. To our knowledge, this is the first report of a TAVI in a patient who was already operated with ViV-TAVI. Although case series described few complications with improvement in clinical status, the procedure should be established with appropriate planning and careful technique.