Early Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest.

BACKGROUND: Extracorporeal cardiopulmonary resuscitation (CPR) restores perfusion and oxygenation in a patient who does not have spontaneous circulation. The evidence with regard to the effect of extracorporeal CPR on survival with a favorable neurologic outcome in refractory out-of-hospital cardiac arrest is inconclusive. METHODS: In this multicenter, randomized, controlled trial conducted in the Netherlands, we assigned patients with an out-of-hospital cardiac arrest to receive extracorporeal CPR or conventional CPR (standard advanced cardiac life support). Eligible patients were between 18 and 70 years of age, had received bystander CPR, had an initial ventricular arrhythmia, and did not have a return of spontaneous circulation within 15 minutes after CPR had been initiated. The primary outcome was survival with a favorable neurologic outcome, defined as a Cerebral Performance Category score of 1 or 2 (range, 1 to 5, with higher scores indicating more severe disability) at 30 days. Analyses were performed on an intention-to-treat basis. RESULTS: Of the 160 patients who underwent randomization, 70 were assigned to receive extracorporeal CPR and 64 to receive conventional CPR; 26 patients who did not meet the inclusion criteria at hospital admission were excluded. At 30 days, 14 patients (20%) in the extracorporeal-CPR group were alive with a favorable neurologic outcome, as compared with 10 patients (16%) in the conventional-CPR group (odds ratio, 1.4; 95% confidence interval, 0.5 to 3.5; P = 0.52). The number of serious adverse events per patient was similar in the two groups. CONCLUSIONS: In patients with refractory out-of-hospital cardiac arrest, extracorporeal CPR and conventional CPR had similar effects on survival with a favorable neurologic outcome. (Funded by the Netherlands Organization for Health Research and Development and Maquet Cardiopulmonary [Getinge]; INCEPTION ClinicalTrials.gov number, NCT03101787.).

Prosthetic Valve Endocarditis After Aortic Valve Replacement: Differences Between Biological and Mechanical Prostheses.

AIMS: Prosthetic valve endocarditis (PVE) is the most severe form of infective endocarditis associated with a high mortality rate. Whether PVE affects biological and mechanical aortic valves to the same extent remains controversial. This study aimed to compare the incidence of re-intervention because of PVE between bioprosthetic and mechanical valves. METHODS: Patients undergoing isolated surgical aortic valve replacement (AVR) or combined AVR in a single cardiac surgery centre between January 1998 and December 2019 were analysed. All patients who underwent re-intervention because of PVE were identified. The primary endpoint was the rate of explants. Freedom from re-intervention and variables associated with re-intervention were analysed using Cox regression analysis including correction for competing risk. RESULTS: During the study period, 5,983 aortic valve prostheses were implanted, including 3,620 biological (60.5%) and 2,363 mechanical (39.5%) prostheses. The overall mean follow-up period was 7.3±5.3 years (median, 6.5; IQR 2.9-11.2 years). The rate of re-intervention for PVE in the biological group was 1.5% (n=54) compared with 1.7% (n=40) in the mechanical group (p=0.541). Cox regression analysis revealed that younger age (HR 0.960, 95% CI 0.942-0.979; p<0.001), male sex (HR 2.362, 95% CI 1.384-4.033; p=0.002), higher creatinine (HR 1.002, 95% CI 0.999-1.004; p=0.057), and biological valve prosthesis (HR 2.073, 95% CI 1.258-3.414; p=0.004) were associated with re-intervention for PVE. After correction for competing risk of death, biological valve prosthesis was significantly associated with a higher rate of re-intervention for PVE (HR 2.011, 95% CI 1.177-3.437; p=0.011). CONCLUSIONS: According to this single-centre, observational, retrospective cohort study, AVR using biological prosthesis is associated with re-intervention for PVE compared to mechanical prosthesis. Further investigations are needed to verify these findings.

Outcomes of emergent cardiac surgery after transcatheter aortic valve implantation.

OBJECTIVE: The aim of this study was to evaluate the reasons for emergent cardiac surgery (ECS) after transcatheter aortic valve implantation (TAVI) and assess outcomes of these patients. METHODS: All patients undergoing ECS following a complicated TAVI procedure at a high-volume TAVI centre in the Netherlands from 1 January 2008 to 1 April 2022 were included. Baseline and procedural characteristics and outcome data (procedural, 30-day and 1­year mortality, in-hospital stroke, 30-day pacemaker implantation, 30-day vascular complications, 30-day deep sternal wound infections and 30-day re-exploration) were collected from patient files and analysed using descriptive statistics. RESULTS: During the study period, 16 of 1594 patients (1.0%) undergoing TAVI required ECS. The main reason for ECS was valve embolisation (n = 9; 56.3%), followed by perforation of the left/right ventricle with guide wire/pacemaker lead (n = 3; 18.8%) and annular rupture (n = 3; 18.8%). Procedural, 30-day and 1­year mortality was 0%, 18.8% (n = 3) and 31.3% (n = 5), respectively. In-hospital stroke occurred in 1 patient (6.3%), a pacemaker was implanted at 30 days in 2 patients (12.5%), and major vascular complications did not occur. CONCLUSION: ECS following complicated TAVI was performed in only a small number of cases. It had a high but acceptable perioperative and 30-day mortality, taking into account the otherwise lethal consequences. In case of valve embolisation, no periprocedural or 30-day mortality was observed for surgical aortic valve replacement (even in a redo setting), which supported the necessity to perform TAVI in centres with cardiac surgical backup on site.

Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest: Design and rationale of the INCEPTION trial.

Return of spontaneous circulation occurs in less than 10% of patients with cardiac arrest undergoing cardiopulmonary resuscitation (CPR) for more than 15 minutes. Studies suggest that extracorporeal life support during cardiopulmonary resuscitation (ECPR) improves survival rate in these patients. These studies, however, are hampered by their non-randomized, observational design and are mostly single-center. A multicenter, randomized controlled trial is urgently warranted to evaluate the effectiveness of ECPR. HYPOTHESIS: We hypothesize that early initiation of ECPR in refractory out-of-hospital cardiac arrest (OHCA) improves the survival rate with favorable neurological status. STUDY DESIGN: The INCEPTION trial is an investigator-initiated, prospective, multicenter trial that will randomly allocate 110 patients to either continued CPR or ECPR in a 1:1 ratio. Patients eligible for inclusion are adults (≤ 70 years) with witnessed OHCA presenting with an initial rhythm of ventricular fibrillation (VF) or ventricular tachycardia (VT), who received bystander basic life support and who fail to achieve sustained return of spontaneous circulation within 15 minutes of cardiopulmonary resuscitation by emergency medical services. The primary endpoint of the study is 30-day survival rate with favorable neurological status, defined as 1 or 2 on the Cerebral Performance Category score. The secondary endpoints include 3, 6 and 12-month survival rate with favorable neurological status and the cost-effectiveness of ECPR compared to CCPR. SUMMARY: The INCEPTION trial aims to determine the clinical benefit for the use of ECPR in patients with refractory OHCA presenting with VF/VT. Additionally, the feasibility and cost-effectiveness of ECPR will be evaluated.

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk.

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm2 for TAVR and 1.6 ± 0.5 cm2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group.

Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study.

BACKGROUND: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve. METHODS: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. RESULTS: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported. CONCLUSIONS: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS. TRIAL REGISTRATION: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).

3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

BACKGROUND: Randomized data comparing outcomes of transcatheter aortic valve replacement (TAVR) with surgery in low-surgical risk patients at time points beyond 2 years is limited. This presents an unknown for physicians striving to educate patients as part of a shared decision-making process. OBJECTIVES: The authors evaluated 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial. METHODS: Low-risk patients were randomized to TAVR with a self-expanding, supra-annular valve or surgery. The primary endpoint of all-cause mortality or disabling stroke and several secondary endpoints were assessed at 3 years. RESULTS: There were 1,414 attempted implantations (730 TAVR; 684 surgery). Patients had a mean age of 74 years and 35% were women. At 3 years, the primary endpoint occurred in 7.4% of TAVR patients and 10.4% of surgery patients (HR: 0.70; 95% CI: 0.49-1.00; P = 0.051). The difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: -1.8% at year 1; -2.0% at year 2; and -2.9% at year 3. The incidence of mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P < 0.001) were lower in the surgery group. Rates of moderate or greater paravalvular regurgitation for both groups were <1% and not significantly different. Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs 12.1 mm Hg surgery; P < 0.001) at 3 years. CONCLUSIONS: Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Surgical Sutureless and Sutured Aortic Valve Replacement in Low-risk Patients.

BACKGROUND: Randomized clinical trials have shown that transcatheter aortic valve replacement is noninferior to surgery in low surgical risk patients. We compared outcomes in patients treated with a sutured (stented or stentless) or sutureless surgical valve from the Evolut Low Risk Trial. METHODS: The Evolut Low Risk Trial enrolled patients with severe aortic stenosis and low surgical risk. Patients were randomized to self-expanding transcatheter aortic valve replacement or surgery. Use of sutureless or sutured valves was at the surgeons' discretion. RESULTS: Six hundred eighty patients underwent surgical aortic valve implantation (205 sutureless, 475 sutured). The Valve Academic Research Consortium-2 30-day safety composite endpoint was similar in the sutureless and sutured group (10.8% vs 11.0%, P = .93). All-cause mortality between groups was similar at 30 days (0.5% vs 1.5%, P = .28) and 1 year (3.3% vs 2.6%, P = .74). Disabling stroke was also similar at 30 days (2.0% vs 1.5%, P = .65) and 1 year (2.6% vs 2.2%, P = .76). Permanent pacemaker implantation at 30 days was significantly higher in the sutureless compared with the sutured group (14.4% vs 2.9%, P < .001). Aortic valve-related hospitalizations occurred more often at 1 year with sutureless valves (9.1% vs 5.1%, P = .04). Mean gradients 1 year after sutureless and sutured aortic valve replacement were 9.9 ± 4.2 versus 11.7 ± 4.7 mm Hg (P < .001). CONCLUSIONS: Among low-risk patients, sutureless versus sutured valve use did not demonstrate a benefit in terms of 30-day complications and produced marginally better hemodynamics but with an increased rate of pacemaker implantation and valve-related hospitalizations.

Recovery of conduction disorders after sutureless aortic valve replacement.

OBJECTIVES: Conduction disorders and the need for permanent pacemaker (PPM) implantation after surgical aortic valve replacement are well-recognized complications. However, in the case of sutureless valve prostheses, it remains unknown whether pacemaker (PM) dependency and conduction disturbances resolve over time. Our aim was to evaluate whether conduction disorders after Perceval sutureless valve implantation recover during follow-up. METHODS: Patients undergoing isolated surgical aortic valve replacement or concomitant aortic valve replacement with coronary artery bypass surgery using the Perceval sutureless valve, between January 2010 and July 2018, were included. Postoperative electrocardiogram findings were analysed to determine the incidence of new-onset left bundle branch blocks (LBBBs) and the requirement for PPM implantation. During a postoperative period of 6-18 months, electrocardiogram findings during PM checks were analysed to determine PM dependency and LBBB persistence. RESULTS: Out of 184 patients who received a Perceval prosthesis during the study period, 39 (21.2%) patients developed new-onset LBBB and 10 patients (5.4%) received a PPM postoperatively. The occurrence of conduction disorders was not associated with valve size. Follow-up was completed in 176 (95.7%) patients. In patients with a new-onset LBBB, 35.9% recovered during follow-up (P = 0.001). Seven out of 10 (70%) patients remained PM dependent. CONCLUSIONS: After Perceval aortic valve implantation, new-onset LBBB recovers in more than one-third of patients during follow-up. In patients who needed a postoperative PPM, the majority remained PM dependent.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

Reintervention After Aortic Valve Replacement: Comparison of 3 Aortic Bioprostheses.

BACKGROUND: The decision to implant a biological valve prosthesis is influenced by the issue of durability. We investigated the rate and the cause of reintervention in 3 different aortic valve bioprostheses. METHODS: The study included all patients who underwent aortic valve replacement with a biological valve prosthesis between October 2009 and December 2018. Three different bioprostheses were compared: Carpentier-Edwards (CE) Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta (St. Jude Medical, St Paul, MN), and Mitroflow (LivaNova, London, United Kingdom). The primary end point was the rate of explantation. The degree of event-free survival and possible predictors for reintervention were also analyzed using Cox regression analysis. RESULTS: In total, 2004 biological aortic valves were implanted, including 923 CE, 719 Trifecta, and 362 Mitroflow bioprostheses. The CE group had a significantly higher degree of event-free survival (917 [99.3%]) compared with the Trifecta (685 [95.3%]) and Mitroflow (340 [93.9%]) groups (P < .0001). The only cause of reintervention in the CE group was prosthetic valve endocarditis (6 [100%]), whereas structural valve deterioration was the most common cause of reintervention in the Trifecta (14 [41.2%]) and Mitroflow (14 [63.6%]) groups. Cox regression analysis revealed that age (hazard ratio [HR] 0.9; 95% confidence interval [CI], 0.9-0.9; P < .0001) and type of prosthesis (Trifecta: HR, 6.3; 95% CI, 2.6-15.2; P < .0001; Mitroflow: HR, 6.0, 95% CI, 2.4-15.1; P < .0001) were associated with lower event-free survival. CONCLUSIONS: The freedom from reintervention after implantation of the CE bioprosthesis is significantly greater than that of the Trifecta and Mitroflow bioprostheses. Further investigations with larger patient populations and long-term follow-up are required to establish their durability and long-term efficacy.

Predictive value of great saphenous vein mapping prior to endoscopic harvesting in coronary artery bypass surgery.

OBJECTIVES: The use of endoscopic vein harvesting in patients undergoing coronary artery bypass grafting is increasing, often using bedside mapping. However, data on the predictive value of great saphenous vein (GSV) mapping are scarce. This study assessed whether preoperative mapping could predict final conduit diameter. METHODS: A prospective registry was created that included 251 patients. Saphenous vein mapping was performed prior to endoscopic vein harvesting at 3 predetermined sites. After harvesting and preparing the GSV, the outer diameters were measured. Appropriate graft size was defined as an outer diameter between 3 and 6 mm. RESULTS: A total of 753 GSV segments were analysed. The average mapping diameter was 3.2 ± 0.7 mm. The harvested GSV had a mean diameter of 4.7 ± 0.8 mm. Mapping diameters were significantly positively correlated with actual GSV diameters (correlation coefficient, 0.47; P < 0.001). If the preoperative mapping diameters were between 1.5 and 5 mm, 96.6% of the GSVs had suitable dimensions after endoscopic vein harvesting. CONCLUSIONS: Preoperative bedside mapping moderately predicts final GSV size after endoscopic harvesting but could not detect unsuitable vein segments. However, the majority of endoscopically harvested GSVs had diameters suitable to be used as coronary bypass grafts.

Benefits of Endoscopic Vein Harvesting in Coronary Artery Bypass Grafting.

BACKGROUND: Earlier reports concerning endoscopic vein harvesting have been controversial regarding the patency of the vein graft after coronary artery bypass grafting (CABG). In addition, data on the quality of life are lacking. In this study, we investigated our experience with endoscopic vein harvesting with regard to these end points. METHODS: The analysis included patients undergoing isolated CABG between 2012 and 2016. Patients were divided in 2 groups stratified by the technique of saphenous vein harvesting: open vs endoscopic. Primary end points were the rate of repeat revascularization and leg wound complications. Secondary end points were the physical and mental quality of life scores of the 36-Item Short Form Health Survey questionnaire. Cox proportional hazard analysis was performed to adjust the end point of repeat revascularization for relevant covariates. RESULTS: The open group included 2123 patients, and the endoscopic group included 883 patients. Overall mortality was not significantly different between the groups (P = .060). Revascularization-free survival was similar between the groups (adjusted hazard ratio, 0.65; 95% confidence interval, 0.42 to 1.02; P = .059). Endoscopic vein harvesting was significantly associated with a decreased hazard for the combined end point of death or repeat revascularization (adjusted hazard ratio, 0.64; 95% confidence interval, 0.46 to 0.90; P = .009). Significantly more leg wound complications were seen in the open group (24 vs 0; P = .002). Postoperative quality of life showed no significant differences between the 2 groups. CONCLUSIONS: Apart from the benefits on leg wound complications, endoscopic vein harvesting was comparable to open vein harvesting in the rate of repeat revascularization and quality of life.

Conduction disorders and impact on survival after sutureless aortic valve replacement compared to conventional stented bioprostheses.

OBJECTIVES: Sutureless and rapid-deployment aortic valve prostheses are frequently used for the treatment of aortic stenosis. However, postoperative left bundle branch block (LBBB) and permanent pacemaker (PPM) implantation have emerged as frequent complications. The aim of this study was to compare the incidence of new-onset LBBB and PPM implantation after sutureless aortic valve replacement (sAVR) with stented bioprostheses, and the impact on postoperative survival. METHODS: Patients undergoing isolated surgical aortic valve replacement (AVR) or concomitant AVR with coronary artery bypass surgery between January 2010 and July 2017 were included in the study. Two groups were defined: sAVR and conventional AVR (cAVR). The findings of preoperative electrocardiograms were compared with postoperative electrocardiogram findings for both groups. The incidence of new-onset LBBB and the requirement for PPM implantation were recorded. The effect of these conduction disorders on late survival was analysed. RESULTS: A total of 987 patients were analysed, consisting of 132 sAVR and 855 cAVR patients. The sAVR group had an increased incidence of new-onset LBBB compared to the cAVR group (16.7% vs 2.3%, P < 0.001). A significantly higher rate of postoperative PPM implantation was found for sAVR patients compared to cAVR (6.8% vs 1.6%, P = 0.001). The multivariate Cox analysis revealed that neither postoperative new-onset LBBB nor PPM implantation was associated with increased mortality (hazard ratio 1.73, 95% confidence interval 0.74-4.03, P = 0.204). CONCLUSIONS: sAVR is associated with an increased risk of new-onset LBBB and PPM requirement compared to cAVR. In this population, postoperative conduction disorders did not affect the mid-term survival.