Residual volume of extruded disc material and residual spinal cord compression measured on postoperative MRI do not predict neurological outcomes in dogs following decompressive surgery for thoracolumbar intervertebral disc extrusion.

Published studies on the validity of using quantitative MRI measures of pre- and postoperative spinal cord (SC) compression as prognostic indicators for dogs undergoing surgery for intervertebral disc extrusion (IVDE) are currently limited. The aim of this retrospective analytical study was to describe the volume of postoperative residual extradural material (VREM) and the ratio of the cross-sectional area (CSA) of maximum SC compression to the CSA of SC in a compression-free intervertebral space as MRI measures of preoperative and postoperative compression (residual spinal cord compression, RSCC), and to compare these measures between the neurological outcome in a group of dogs. Inclusion criteria were dogs that underwent surgery for thoracolumbar IVDE, were imaged pre- and immediately postoperatively by MRI, and had a neurological follow-up examination 2 to 5 weeks postoperatively. Two blinded observers independently performed measurements in pre- and postoperative MRI studies. Dogs were classified into positive outcome (PO) and negative outcome (NO) groups based on follow-up neurologic examination scores. Seventeen dogs were included (12 PO, 5 NO). Interobserver agreement for MRI measurements was good to excellent (ICCs: 0.76-0.97). The prevalence of residual extradural material in postoperative MRI studies was 100%. No significant differences in mean preoperative SC compression, mean RSCC, mean SC decompression, or VREM were found between outcome groups (P = .25; P = .28; P = .91, P = .98). In conclusion, neither postoperative VREM nor RSCC could predict successful neurological outcomes.

Management and outcomes of ventricular septal defects after acute myocardial infarction: A multicenter retrospective study.

BACKGROUND AND AIM: The mortality rate of patients with post-myocardial infarction (MI) ventricular septal defects (VSDs) is high, and the benefit of surgery is unclear. We aimed to investigate the management and outcomes of post-MI VSD over a 10-year period in a large cohort. METHODS: Data of patients with post-MI VSD admitted in three French university hospitals from 2008 to 2019 were examined. The characteristics of those who underwent surgery were compared with those who received medical treatment. Mortality risk factors, survival curves, and outcomes at 30 days and 1 year after treatment were determined. RESULTS: Of the 92 patients whose data were examined, 50 underwent surgery and 42 received exclusive medical treatment. All patients were critically ill. Overall, 76.1% of patients received inotropic support, and 63% received mechanical ventilation. Circulatory assistance, mainly via intra-aortic balloon pump and extra-corporeal membrane oxygenation, was provided to 46.7% patients, with 14.1% requiring a second assistance. The median time to surgery was 4 days. At 1 year, mortality was 46% in those who underwent surgery and 83.3% in those treated medically (p < .001). Survival curves at 1 and 3 months showed major differences, and the survival rate showed little change 30 days after treatment. Cardiogenic shock and cardiac arrest emerged as risk factors for mortality. CONCLUSIONS: In our retrospective, multicenter study, the mortality resulting from post-MI VSD did not seem to improve over the last decade. Although surgery carried considerable risks, it improved survival.

Transcatheter edge-to-edge repair following surgical valve repair with ring implantation: Results from the multicentre "Clip-in-Ring" registry.

BACKGROUND: Management of mitral regurgitation recurrence after failed surgical valve repair with ring implantation is controversial. AIM: To describe the French experience regarding midterm safety and efficacy of transcatheter edge-to-edge mitral valve repair (TEER) in patients with failed surgical valve repair with ring implantation. METHODS: The "Clip-in-Ring" registry is a multicentre registry conducted in 11 centres in France, approved by local institutional review boards, of consecutive TEER following surgical valve repair with ring implantation. Outcomes were Mitral Valve Academic Research Consortium (MVARC) technical success, modified 30-day device and procedural success (where 10mmHg is considered as a cut-off for significant mitral stenosis) and MVARC complications. RESULTS: Twenty-three patients were studied: mean age, 69±10years; male sex, 74%; EuroSCORE II, 16±17; left ventricular ejection fraction, 53±12%; mitral regurgitation grade 3+/4+, 17%/78%; New York Heart Association class III/IV, 47%/22%; median surgery to TEER delay, 23 (6-94) months. Technical success was 100%. At discharge, residual mitral regurgitation grade was≤2+ in 87% and median transmitral gradient was 4 (3-5) mmHg. Thirty-day modified MVARC device and procedural success was 82%: four patients (17%) had residual mitral regurgitation grade>2+, including two patients who needed complementary surgery. No patient had a 30-day transmitral gradient>7mmHg. No patient died or had a stroke or any life-threatening complications. One patient presented a vascular access complication requiring transfusion. No other MVARC-2 adverse event was reported. CONCLUSIONS: TEER in patients with failed mitral ring is feasible and safe. Further studies should delineate its exact role in the therapeutic armamentarium for this medical issue.

Sex Differences in Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Outcomes after transcatheter aortic valve replacement (TAVR) and infectious diseases may vary according to sex. METHODS: This multicentre study aimed to determine the sex differences in clinical characteristics, management, and outcomes of infective endocarditis (IE) after TAVR. A total of 579 patients (217 women, 37.5%) who had the diagnosis of definite IE following TAVR were included retrospectively from the Infectious Endocarditis After TAVR International Registry. RESULTS: Women were older (80 ± 8 vs 78 ± 8 years; P = 0.001) and exhibited a lower comorbidity burden. Clinical characteristics and microbiological profiles were similar between men and women, but culture-negative IE was more frequent in women (9.9% vs 4.3%; P = 0.009). A high proportion of patients had a clinical indication for surgery (54.4% in both groups; P = 0.99), but a surgical intervention was performed in a minority of patients (women 15.2%, men 20.3%; P = 0.13). The mortality rate at index IE hospitalisation was similar in both groups (women 35.4%, men 31.7%; P = 0.37), but women exhibited a higher mortality rate at 2-year follow-up (63% vs 52.1%; P = 0.021). Female sex remained an independent risk factor for cumulative mortality in the multivariable analysis (adjusted HR 1.28, 95% CI 1.02-1.62; P = 0.035). After adjustment for in-hospital events, surgery was not associated with better outcomes in women. CONCLUSIONS: There were no significant sex-related differences in the clinical characteristics and management of IE after TAVR. However, female sex was associated with increased 2-year mortality risk.

Very early infective endocarditis after transcatheter aortic valve replacement.

BACKGROUND: Scarce data exist about early infective endocarditis (IE) after trans-catheter aortic valve replacement (TAVR). OBJECTIVE: The objective was to evaluate the characteristics, management, and outcomes of very early (VE) IE (≤ 30 days) after TAVR. METHODS: This multicenter study included a total of 579 patients from the Infectious Endocarditis after TAVR International Registry who had the diagnosis of definite IE following TAVR. RESULTS: Ninety-one patients (15.7%) had VE-IE. Factors associated with VE-IE (vs. delayed IE (D-IE)) were female gender (p = 0.047), the use of self-expanding valves (p < 0.001), stroke (p = 0.019), and sepsis (p < 0.001) after TAVR. Staphylococcus aureus was the main pathogen among VE-IE patients (35.2% vs. 22.7% in the D-IE group, p = 0.012), and 31.2% of Staphylococcus aureus infections in the VE-IE group were methicillin-resistant (vs. 14.3% in the D-IE group, p = 0.001). The second-most common germ was enterococci (34.1% vs. 24.4% in D-IE cases, p = 0.05). VE-IE was associated with very high in-hospital (44%) and 1-year (54%) mortality rates. Acute renal failure following TAVR (p = 0.001) and the presence of a non-enterococci pathogen (p < 0.001) were associated with an increased risk of death. CONCLUSION: A significant proportion of IE episodes following TAVR occurs within a few weeks following the procedure and are associated with dismal outcomes. Some baseline and TAVR procedural factors were associated with VE-IE, and Staphylococcus aureus and enterococci were the main causative pathogens. These results may help to select the more appropriate antibiotic prophylaxis in TAVR procedures and guide the initial antibiotic therapy in those cases with a clinical suspicion of IE. Very early infective endocarditis after trans-catheter aortic valve replacement. VE-IE indicates very early infective endocarditis (≤30 days post TAVR). D-IE indicates delayed infective endocarditis.

Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

BACKGROUND: The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain. OBJECTIVES: The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB). METHODS: Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry. RESULTS: Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HRunadj: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock. CONCLUSIONS: In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications.

Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement.

BACKGROUND: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). METHODS: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. RESULTS: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). CONCLUSIONS: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.

Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.

Clinical Benefit of Extubation in Patients on Venoarterial Extracorporeal Membrane Oxygenation.

OBJECTIVES: Although patients on venoarterial extracorporeal membrane oxygenation for refractory cardiogenic shock are usually supported with mechanical ventilation, it is not clear whether sedation cessation and extubation might improve outcomes. DESIGN: Retrospective cohort study with propensity score overlap weighting analysis. SETTING: Three ICUs in a 1,500-bed tertiary university hospital. PATIENTS: From an overall cohort of 641 patients with venoarterial-extracorporeal membrane oxygenation support, the primary analysis was performed in 344 patients who had been successfully decannulated in order to reduce immortal time bias. MEASUREMENTS AND MAIN RESULTS: Seventy-five patients (22%) were extubated during extracorporeal membrane oxygenation support and were subsequently decannulated alive. Forty-nine percent received noninvasive ventilation, and 25% had emergency reintubation for respiratory, neurologic, or hemodynamic reasons. Higher Simplified Acute Physiology Score II at admission (odds ratio, 0.97; 95% CI [0.95-0.99]; p = 0.008) was associated with a lower probability of extubation, whereas cannulation in cardiac surgery ICU (odds ratio, 3.14; 95% CI [1.21-8.14]; p = 0.018) was associated with an increased probability. Baseline characteristics were well balanced after propensity score overlap weighting. The number of ICU-free days within 30 days of extracorporeal membrane oxygenation decannulation was significantly higher among extubated patients compared with nonextubated patients (22 d [11-26 d] vs 18 d [7-25 d], respectively; p = 0.036). There were no differences in other outcomes including ventilator-associated pneumonia (odds ratio, 0.96; 95% CI [0.51-1.82]; p = 0.90) and all-cause mortality within 30 days of extracorporeal membrane oxygenation decannulation (5% vs 17%; hazard ratio, 0.54; 95% CI [0.19-1.59]; p = 0.27).As a secondary analysis, outcomes were compared in the overall cohort of 641 venoarterial extracorporeal membrane oxygenation-supported patients. Results were consistent with the primary analysis as extubated patients had a higher number of ICU-free days (18 d [0-24 d] vs 0 d [0-18 d], respectively; < 0.001) and a lower risk of death within 30 days of extracorporeal membrane oxygenation cannulation (hazard ratio, 0.45; 95% CI [0.29-0.71]; p = 0.001). CONCLUSIONS: Extubation during venoarterial-extracorporeal membrane oxygenation support is safe, feasible, and associated with greater ICU-free days.

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk. OBJECTIVES: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR. METHODS: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries. RESULTS: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk. CONCLUSIONS: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.

Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality.

OBJECTIVES: This study aimed to evaluate incidence, clinical significance, and predictors of early ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients. BACKGROUND: LVAD implantation is increasingly used in patients with end-stage heart failure. Early VAs may occur during the 30-day post-operative period, but many questions remain unanswered regarding their incidence and clinical impact. METHODS: This observational study was conducted in 19 centers between 2006 and 2016. Early VAs were defined as sustained ventricular tachycardia and/or ventricular fibrillation occurring <30 days post-LVAD implantation and requiring appropriate implantable cardioverter-defibrillator therapy, external electrical shock, or medical therapy. RESULTS: A total of 652 patients (median age: 59.8 years; left ventricular ejection fraction: 20.7 ± 7.4%; HeartMate 2: 72.8%; HeartWare: 19.5%; Jarvik 2000: 7.7%) were included in the analysis. Early VAs occurred in 162 patients (24.8%), most frequently during the first week after LVAD implantation. Multivariable analysis identified history of VAs prior to LVAD and any combined surgery with LVAD as 2 predictors of early VAs. The occurrence of early VAs with electrical storm was the strongest predictor of 30-day post-operative mortality, associated with a 7-fold increase of 30-day mortality. However, in patients discharged alive from hospital, occurrence of early VAs did not influence long-term survival. CONCLUSIONS: Early VAs are common after LVAD implantation and increase 30-day post-operative mortality, without affecting long-term survival. Further studies will be needed to analyze whether pre- or pre-operative ablation of VAs may improve post-operative outcomes. (Determination of Risk Factors of Ventricular Arrhythmias After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device [ASSIST-ICD]; NCT02873169).

Risk factors and prognostic impact of left ventricular assist device-associated infections.

BACKGROUND: Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. METHODS: Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up. RESULTS: Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival. CONCLUSIONS: Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.

Comparison of the Transarterial and Transthoracic Approaches in Nontransfemoral Transcatheter Aortic Valve Implantation.

Transfemoral approach stands as the reference access-route for transcatheter aortic valve implantation (TAVI). Nonetheless, alternatives approaches are still needed in a significant proportion of patients. This study aimed at comparing outcomes between transthoracic-approach (transapical or transaortic) and transarterial-approach (transcarotid or subclavian) TAVI. Data from 191 consecutive patients who underwent surgical-approach TAVI from May 2009 to September 2017 were analyzed. Patients were allocated in 2 groups according to the approach. The primary end point was the 30-day composite of death of any cause, need for open surgery, tamponade, stroke, major or life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary obstruction, or major vascular complications. During the study period, 104 patients underwent transthoracic TAVI (transapical: 60.6%, transaortic: 39.4%) whereas 87 patients underwent transarterial TAVI (subclavian: 83.9%, transcarotid: 16.1%). Logistic EuroSCORE I tended to be higher in transthoracic-TAVI recipients. In-hospital and 30-day composite end point rates were 25.0% and 11.5% (p = 0.025), and 26.0% and 14.9% (p = 0.075) for the transthoracic and transarterial cohorts, respectively. Propensity score-adjusted logistic regression demonstrated no significant detrimental association between the 30-day composite end point and transthoracic access (odds ratio 2.12 95% confidence interval 0.70 to 6.42; p = 0.18). Transarterial TAVI was associated with a shorter length of stay (median: 6 vs 7 days, p <0.001). TAVI approach was not an independent predictor of midterm mortality. In conclusion, nontransfemoral transarterial-approach TAVI is safe, feasible, and associated with comparable rates of major perioperative complications, and midterm mortality compared with transthoracic-approach TAVI.

Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement.

BACKGROUND: Data on long-term outcomes after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) are scarce. The objective of this study was to determine the long-term clinical outcomes and structural valve degeneration (SVD) over time in patients undergoing ViV-TAVR. METHODS AND RESULTS: Consecutive patients undergoing ViV-TAVR in 9 centers between 2009 and 2015 were included. Patients were followed yearly, and clinical and echocardiography data were collected prospectively. SVD was defined as subclinical (increase >10 mm Hg in mean transvalvular gradient+decrease >0.3 cm2 in valve area or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase >20 mm Hg in mean transvalvular gradient+decrease >0.6 cm2 in valve area or new-onset moderate-to-severe aortic regurgitation). A total of 116 patients (mean age, 76±11 years; 64.7% male; mean Society of Thoracic Surgeons score, 8.0±5.1%) were included. Balloon- and self-expandable valves were used in 47.9% and 52.1% of patients, respectively, and 30-day mortality was 6.9%. At a median follow-up of 3 years (range, 2-7 years), 30 patients (25.9%) had died, 20 of them (17.2%) from cardiovascular causes. Average mean transvalvular gradients remained stable up to 5-year follow-up ( P=0.92), but clinically relevant SVD occurred in 3/99 patients (3.0%), and 15/99 patients (15.1%) had subclinical SVD. One patient with SVD had redo ViV-TAVR. CONCLUSIONS: About one-fourth of ViV-TAVR recipients had died after a median follow-up of 3 years. Overall valve hemodynamics remained stable over time and clinically relevant SVD was infrequent, but 1 out of 10 patients exhibited some degree of SVD.

Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry.

OBJECTIVES: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR). BACKGROUND: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described. METHODS: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure. RESULTS: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04). CONCLUSIONS: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.

The second generation cryoballoon has improved durable isolation of left but not right pulmonary veins: new insights from a multicentre study.

Aims: Pulmonary vein isolation (PVI) using second-generation cryoballoon (CB2) is associated with improved outcomes compared with first generation (CB1). We aimed at investigating the characteristics of left and right PV reconnections after CB1 and CB2 ablations in patients with clinical recurrences requiring redo ablation. Methods and results: From 2010 to 2016, 776 patients underwent 28-mm cryoballoon PVI for symptomatic paroxysmal atrial fibrillation (AF) in 3 centres, 279 with CB1 and 497 with CB2. Among them, 94 patients (12.1%) had symptomatic AF recurrences requiring a redo ablation [43 (15.4%) CB1 and 51 (10.3%) CB2]. The benefit of CB2 over CB1 was compared for each PV. Durable PVI was confirmed in 7 CB1 (16.3%) and 14 CB2 (27.4%) patients, and 2.7 ± 2.1 and 1.4 ± 1.4 gaps per patient were found, respectively (P = 0.002). Significantly more left superior and left inferior PVs were found to be isolated in CB2 compared with CB1 group (78.4% vs. 48.8%, P = 0.005 and 78.4% vs. 46.5%, P = 0.003, respectively) while the rate of durable right superior and right inferior PVs isolation were similar (68.6% vs. 60.5%, P = 0.542 and 66.7% vs. 55.8%, P = 0.387, respectively). Significantly fewer gaps were found in left PVs in CB2 patients, while there was no significant difference for right PVs. Gaps localization was similar in both groups. Conclusion: Fewer reconnection gaps are observed during redo ablations of paroxysmal AF in patients primarily ablated with CB2. This difference is driven by less reconnection gaps observed in both left PVs, while no difference was observed for right PVs.

Localization of gaps during redo ablations of paroxysmal atrial fibrillation: Preferential patterns depending on the choice of cryoballoon ablation or radiofrequency ablation for the initial procedure.

BACKGROUND: Pulmonary vein (PV) isolation, using cryoballoon or radiofrequency ablation, is the cornerstone therapy for symptomatic paroxysmal atrial fibrillation (AF) refractory to antiarrhythmic drugs. One-third of the patients have recurrences, mainly due to PV reconnections. AIMS: To describe the different locations of reconnection sites in patients who had previously undergone radiofrequency or cryoballoon ablation, and to compare the characteristics of the redo procedures in both instances. METHODS: Demographic data and characteristics of the initial ablation (cryoballoon or radiofrequency) were collected. Number and localization of reconduction gaps, and redo characteristics were reviewed. RESULTS: Seventy-four patients scheduled for a redo ablation of paroxysmal AF were included; 38 had been treated by radiofrequency ablation and 36 by cryoballoon ablation during the first procedure. For the initial ablation, procedural and fluoroscopy times were significantly shorter for cryoballoon ablation (147.8±52.6min vs. 226.6±64.3min [P<0.001] and 37.0±17.7min vs. 50.8±22.7min [P=0.005], respectively). Overall, an identical number of gaps was found during redo procedures of cryoballoon and radiofrequency ablations. However, a significantly higher number of gaps were located in the right superior PV for patients first ablated with radiofrequency (0.9±1.0 vs. 0.5±0.9; P=0.009). Gap localization displayed different patterns. Although not significant, redo procedures of cryoballoon ablation were slightly shorter and needed shorter durations of radiofrequency to achieve PV isolation. CONCLUSIONS: During redo procedures, gap localization pattern is different for patients first ablated with cryoballoon or radiofrequency ablation, and right superior PV reconnections occur more frequently after radiofrequency ablation. Redo ablation of a previous cryoballoon ablation appears to be easier.

Computer-Assisted Transcatheter Heart Valve Implantation in Valve-in-Valve Procedures.

OBJECTIVE: Valve-in-valve (ViV) procedures are increasingly being considered as an alternative to redo surgery for the treatment of degenerated bioprosthetic heart valves in patients with excessive reoperative risk. The objective of our study was to evaluate the feasibility of computer guidance in transcatheter heart valve (THV) implantation during ViV procedures. METHODS: Preprocedural electrocardiogram-gated computed tomography-scan images were processed using semiautomatic segmentation of the degenerated bioprosthesis' radiopaque landmarks and of the ascending aorta. Virtual three-dimensional (3D) reconstructions were created. A virtual plane was subsequently added to the 3D reconstructions, indicating the optimal landing plane of the THV inside the tissue valve. Within a hybrid operating theater, a 3D/2D registration was used to superimpose the 3D reconstructions, while dynamic tracking was allowed to maintain the superimposition onto the fluoroscopic images. The THV was afterward implanted according to the optimal landing plane. Projection of the ascending aorta and the coronary arteries was used to assess the risk of coronary ostia obstruction. RESULTS: Between January 2014 and October 2014, nine patients underwent aortic ViV procedures in our institution. Among those nine patients, five procedures were retrospectively evaluated as a validation step using the proposed method. The mean (SD) superimposition error was 1.1 (0.75) mm. Subsequently, two live cases were prospectively carried out using our approach, successfully implanting the THV inside the degenerated tissue valve. CONCLUSIONS: Our study demonstrates the feasibility of a computer-guided implantation of THV in ViV procedures. Moreover, it suggests that augmented reality may increase the reliability of THV implantation inside degenerated bioprostheses through better reproducibility.