Composite Of Major Adverse Events Research Articles

Aortic arch registry of type a aortic dissection (AoArch) - rationale, design and definition criteria

BackgroundType A acute aortic dissection (TAAAD) is a deadly condition that demands immediate surgery, because it involves a critically. The mortality and morbidity associated with it are significant, and it is vital that the patient’s conditions and treatment strategies are fully understood to ensure the appropriate management of TAAAD. This study aims to ascertain whether hemiarch repair (HAR) versus extended arch repair (EAR) with or without descending aortic intervention results in better perioperative and late outcomes for patients with TAAAD.MethodsFour leading centers of cardiac surgery from two European countries have joined forces to create a groundbreaking multicenter observational registry (AoArch). This study was approved by the institutional review board (IRB 202201173). We conducted a retrospective review (NCT 0591263) of our prospectively maintained database for patients who underwent operative repair of DeBakey type I or type II dissection from January 1, 2005 to March 2024 (NCT 05927090). We will analyze how patient co-morbidities, referral conditions, and surgical strategies involving hemi-arch repair (HAR) and extended arch repair (EAR) impact early and late adverse events. We have developed a procedure urgency algorithm based on the severity of preoperative hemodynamic conditions and malperfusion due to TAAAD, and we will use it to assess the primary clinical outcomes: in-hospital mortality, late mortality, and reoperations on the aorta. We will define secondary outcomes as permanent neurologic deficit, the need for new dialysis, respiratory failure, a composite of major adverse events (myocardial infarction, cerebrovascular accidents, the need for dialysis, or the need for tracheostomy), and a composite of major adverse pulmonary events (intubation over 48 h, pneumonia, reintubation, tracheostomy), and reoperation due to bleeding.DiscussionThis multicenter registry will definitively determine the prognostic significance of critical preoperative conditions and the efficacy of extended arch interventions and hemiarch repair in reducing the risk of early adverse events after surgery for TAAAD. This registry will provide insights into the long-term durability of different strategies of surgical repair for TAAAD.

The relationship of sex and aortic diameter at the time of acute type A aortic dissection

ObjectiveEvaluate sex differences in patients undergoing repair of acute type A aortic dissection (ATAAD). MethodsSex-stratified, single-center cohort study of patients undergoing ATAAD repair from 1997 to 2022. The primary outcome was aortic diameter at time of presentation with ATAAD. Secondary outcomes were mortality, myocardial infraction, stroke, hemodialysis, tracheostomy, re-exploration for bleeding, a composite of major adverse events, and long-term survival. ResultsIn 390 consecutive patients (150 women), men were younger than women (61.0 years; interquartile range [IQR], 50-70 years vs 70.5 years; IQR, 59-78 years; P < .001), had higher body mass index (28.6; IQR, 25.1-32.3 vs 25.4; IQR, 21.9-29.2; P < .001), more frequent peripheral vascular disease (11.7% vs 4.7%; P = .03), renal insufficiency (36.7% vs 22%; P = .003), malperfusion (34.2% vs 18.7%; P = .007), and smoking history (65% vs 44%; P < .001). There was no sex difference in median aortic diameter at the time of ATAAD (men: 5.3 cm; IQR, 4.9-6.1 cm and women: 5.2 cm; IQR, 4.6-5.9 cm; P = .12) even when adjusted for body mass index (men: 5.7 cm; IQR, 5.4-6.1 cm and women: 5.4 cm; IQR, 5.4-6.1 cm; P = .19). There was no sex difference in mortality (4.6% vs 6.0%; P = .70), major adverse events, or 10-year survival (50.3% vs 58.5%; P = .13). On multivariable analysis, there was no interaction between aneurysm size and sex (interaction P = .62). Sex was not associated with major adverse events (odds ratio, 0.75; 95% CI, 0.07-7.39; P = .81). ConclusionsThere was no sex difference in aneurysm size at the time of presentation of ATAAD, even after adjustment for body mass index, and no interaction between aneurysm size and sex, suggesting that aortic diameter remains a reasonable criterion for intervention irrespective of sex.

Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation.

Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population. In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure. A total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001). Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.).

Long-term outcomes of minimally invasive concomitant mitral and tricuspid valve surgery with surgical ablation.

We compared the outcomes of a right mini-thoracotomy (RMT) versus those of a sternotomy for concomitant mitral and tricuspid valve surgery and surgical ablation. We analysed patients who underwent concomitant mitral and tricuspid valve surgery and surgical ablation at a single institution (mean follow-up: 7 years) after propensity score matching. The primary and secondary outcomes were all-cause death, composite major adverse events (including stroke, reoperation, readmission, permanent pacemaker insertion) and recurrence of atrial fibrillation (A-fib). A subgroup analysis was performed. A total of 797 procedures (mean age: 61.6 years; RMT: 45.2%; female: 66.5%; mitral valve repair: 33.6%) were done; 267 pairs were matched. The 5- and 10-year overall survival in the matched cohort was 92.7% and 86.9% for the RMT group and 92.1% and 83.1% for the sternotomy group (P = 0.879). Significant differences were not observed in major adverse events (P = 0.273; hazard ratio: 0.76) and A-fib recurrence (P = 0.080; hazard ratio: 0.72). The RMT group had lower rates of postoperative low cardiac output syndrome (P = 0.019) and acute renal failure (P = 0.003). Atrial fibrillation high-risk factors (including long-standing A-fib, enlarged left atrium, old age) exhibited significant interactions (P for interaction = 0.002) with the approach regarding A-fib recurrence. In this study, an RMT exhibited no significant differences in long-term outcomes compared to a sternotomy, but it could remain a clinically reasonable option. Patients with a high risk of A-fib may have favourable ablation outcomes with a sternotomy.

Early outcome in patients with STEMI undergoing primary PCI and high Zwolle risk score discharged within 72 hours

Abstract Funding Acknowledgements None. Introduction Zwolle risk score has been used to guide decision for early discharge in patients with ST- elevation acute myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). There is limited evidence on the outcome of patients with high score discharged within 72 hours from primary PCI. Our study aim is to evaluate the outcomes via 1 - month follow up in patients with STEMI undergoing primary PCI, with different Zwolle risk who were discharged within 72 hours from the hospital. Purpose To evaluate 1-month outcome of STEMI patients treated with primary PCI discharged within 72 hours according to Zwolle risk score. Methods We studied 187 consecutive STEMI patients from April 2022 to December 2022, presented in hospital within 12 hours of initial of chest pain, treated with primary PCI and discharged within 72 hours from hospital admission based on physician’s clinical judgement and patient’s preference. Patients were divided in two groups according to Zwolle risk score – low risk (≤3) and high risk (&amp;gt;3). The composite of major adverse events (MACE) consisting of: death, non-fatal re-infarction, stroke and repeat intervention at 1-month follow up was the primary endpoint. Follow up rate was 100%. Results There were 131 patients in the low risk and 56 in high risk groups. Males were 90% versus 80.3% in the low vs high risk group; in addition, mean age was 58.64 ± 10.6 vs 67.8± 6.24 years, respectively; mean ischemic time was 4.78± 3.03 vs 6.9 ± 3.6 hours, respectively; anterior localization was present in 32.8% vs 46.4% of the patients, respectively; 3-vessel coronary artery disease was present in 29.0% vs 46.4% of the patients, respectively; final TIMI 3 flow was present in all vs 96.4% of the patients, respectively. MACE occurred in 7 patients (3.8%) in the low risk group versus 3 patients (5.3%) in the high risk group (P = 0.63). Conclusions In our study population at higher Zwolle risk score was not associated with a worse early outcome among STEMI patients discharged within 72 hours.

Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study

PurposeTo report the first interim analysis of the STRIKE-PE study, evaluating the safety and effectiveness of computer assisted vaccum thrombectomy (CAVT) for the treatment of acute pulmonary embolism (PE). Materials and MethodsThis prospective, international, multicenter study will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle (RV)–to–left ventricle (LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT using the Indigo Aspiration System (Penumbra, Alameda, California). Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and quality-of-life (QoL) assessments. ResultsThe first 150 consecutive patients were treated with 12F catheter CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70.0 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four (2.7%) patients experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale score and QoL measures, and the New York Heart Association class distribution returned to that reported before the index PE. ConclusionsInterim results from the STRIKE-PE study demonstrate a significant reduction in pulmonary artery pressure and RV/LV ratio, a median thrombectomy time of 33.5 minutes, a composite MAE rate of 2.7%, and significant improvements in 90-day functional and QoL outcomes.

Clinical Features and Patient Outcomes in Infective Endocarditis with Surgical Indication: A Single-Centre Experience.

Infective endocarditis (IE) is marked by a heightened risk of embolic events (EEs), uncontrolled infection, or heart failure (HF). Patients with IE and surgical indication were enrolled from October 2015 to December 2018. The primary endpoint consisted of a composite of major adverse events (MAEs) including all-cause death, hospitalizations, and IE relapses. The secondary endpoint was all-cause death. A total of 102 patients (66 ± 14 years) were enrolled: 50% with IE on prosthesis, 33% with IE-associated heart failure (IE-aHF), and 38.2% with EEs. IE-aHF and EEs were independently associated with MAEs (HR 1.9, 95% CI 1.1-3.4, p = 0.03 and HR 2.1, 95% CI 1.2-3.6, p = 0.01, respectively) and Kaplan-Meier survival curves confirmed a strong difference in MAE-free survival of patients with EEs and IE-aHF (p < 0.01 for both). IE-aHF (HR 4.3, 95% CI 1.4-13, p < 0.01), CRP at admission (HR 5.6, 95% CI 1.4-22.2, p = 0.01), LVEF (HR 0.9, 95% CI 0.9-1, p < 0.05), abscess (HR 3.5, 95% CI 1.2-10.6, p < 0.05), and prosthetic detachment (HR 4.6, 95% CI 1.5-14.1, p < 0.01) were independently associated with the all-cause death endpoint. IE-aHF and EEs were independently associated with MAEs. IE-aHF was also independently associated with the secondary endpoint.

Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience

BackgroundPulsed field ablation has recently emerged as an interesting non-thermal energy for atrial fibrillation ablation. At a time of rapid spread of this technology, there is still a lack of prospective real-life data. AimTo describe multicentre prospective safety and 1-year efficacy data in three of the first French centres to use pulsed field ablation. MethodsAll consecutive patients undergoing a first pulsed field ablation were included prospectively. The primary outcome was freedom from documented atrial arrhythmia. The safety endpoint was a composite of major adverse events. Univariate and multivariable analyses, including patient and procedural characteristics, were performed to identify factors predictive of recurrence. ResultsBetween May 2021 and June 2022, 311 patients were included (paroxysmal atrial fibrillation in 53%, persistent atrial fibrillation in 35% and long-standing persistent atrial fibrillation in 11%). Additional non-pulmonary vein pulsed field ablation applications were performed in 104/311 patients. One-year freedom from arrhythmia recurrence was 77.6% in the overall population and was significantly higher in patients with paroxysmal atrial fibrillation (88.4%) compared with patients with persistent atrial fibrillation (69.7%; P<0.001) and those with long-standing persistent atrial fibrillation (49.0%; P<0.001). The major complication rate was 2.6% (tamponade in four patients, stroke in two patients and coronary spasm in one patient). Besides the usual predictors of recurrences (left atrium size, CHA2DS2-VASc score, type of atrial fibrillation), the presence of atrial fibrillation at procedure start was independently associated with arrhythmia recurrence (hazard ratio: 2.04, 95% confidence interval: 1.10–3.77). ConclusionIn this prospective multicentre real-world study, pulsed field ablation for atrial fibrillation ablation seems to be associated with a good safety profile and rather favourable acute and 1-year success rates.

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease

ObjectivePercutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. MethodsThe DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. ResultsWe enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. ConclusionsThe DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Large-bore mechanical thrombectomy for intermediate- and high-risk pulmonary embolism: interim outcomes from the European cohort of the FLASH registry

Abstract Background/Introduction Mechanical thrombectomy is utilized for the treatment of acute pulmonary embolism (PE), but reported outcomes are limited in the European patient population. Purpose To report interim results from the European cohort of a large, prospective all-comer registry of mechanical thrombectomy for PE treatment. Methods The FLASH registry is a multinational, prospective, observational study of safety and effectiveness outcomes for PE treatment using a large-bore mechanical thrombectomy system. FLASH is currently enrolling up to 200 patients in Europe. The primary endpoint is a composite of Major Adverse Events (MAEs) within 48 hours, including device-related deaths, major bleeding, and intraprocedural AEs. Additional assessments include invasive hemodynamics, hospital resource usage, and dyspnea improvement. Results Interim results through 48 hours post-thrombectomy are presented for the first 29 patients enrolled in the European cohort across 4 institutions. Mean patient age was 64.9±14.5 years, 51.7% of patients were male, 10.3% were contraindicated for thrombolysis, 51.7% had concomitant deep vein thrombosis, and 79.3% had centrally located thrombus involving one or both main pulmonary arteries. Per ESC guidelines, 58.6% of patients were classified as high-risk. The remaining 41.4% of patients were classified as intermediate-risk, with 31.0% being intermediate-high-risk. Pre-thrombectomy, the median RV/LV ratio from a composite of computed tomography and echocardiography was 1.31 [IQR: 1.08-1.44], and 38.9% of patients who had cardiac index (CI) measured were in cardiogenic shock (CI ≤2 L/min/m²). Procedural characteristics included a median thrombectomy time of 39 minutes [IQR: 26-49]. Extracorporeal membrane oxygenation was used in 6.9% of patients. Post-thrombectomy, the median length of stay in the intensive care unit (ICU) was 1 overnight [IQR: 0-2], and 48.1% of patients required no overnight ICU stay. In addition, hemodynamic variables, vitals, dyspnea symptoms, and reliance on supplemental oxygen all improved significantly post-thrombectomy (Table 1). Acute safety and mortality outcomes were highly favorable following the procedure (Table 2). All patients survived through 48 hours post-thrombectomy. There were no MAEs (0%), no major access site complications (0%), and no device-related Serious AEs (0%) through 48-hour follow-up. Conclusions Interim results from the first 29 patients in the European cohort of the FLASH registry suggest that large-bore mechanical thrombectomy can be safely performed in both intermediate- and high-risk PE patients, with no MAEs or mortalities observed through 48 hours. Significant improvements observed in multiple hemodynamic and dyspnea-related variables further suggest that thrombectomy can offer effective reperfusion treatment for acute PE.

1-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation

BackgroundThe CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). ObjectivesThis study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. MethodsProhibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). The 1-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAEs]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. ResultsA total of 300 patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (for PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of −0.8% and 95% upper confidence bound of 4.6%. The 6-month MR ≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of −2.5%, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR ≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of −4.1%. The MR ≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of −5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P < 0.05 for all vs baseline). ConclusionsThe CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

1-Year Outcomes of Transcatheter Edge-to-Edge Repair in Anatomically Complex Degenerative Mitral Regurgitation Patients

BackgroundFavorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. ObjectivesThe authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. MethodsPatients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. ResultsNinety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). ConclusionsAt 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy.

Twelve-Month Outcomes of Intravascular Lithotripsy for Treatment of Calcified Popliteal and Infrapopliteal Lesions in Patients With Chronic Limb-Threatening Ischemia.

Vessel calcification is estimated to be present in 30% to 50% of patients with peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is unique compared with other arteries due to its exposure to significant deformation and biomechanical stress during knee motion. Intravascular lithotripsy (IVL) is a novel technique that uses acoustic pressure waves to cause microfractures within the intimal and medial wall calcification. Intravascular lithotripsy is safe in femoropopliteal and infrapopliteal lesions, but follow-up studies are lacking. Therefore, the purpose of this study was to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. This prospective, multicenter cohort study included all patients treated with IVL in the popliteal and infrapopliteal arteries at 4 sites. Standardized follow-up with duplex ultrasonography was scheduled at 6 to 8 weeks and 12 months. The primary safety endpoint was a composite of major adverse events (MAEs) at 30 days. Primary efficacy endpoints were primary patency, limb salvage, and amputation-free survival (AFS) at 12 months. Secondary endpoints were primary-assisted patency and freedom from target lesion revascularization (TLR). Endpoints were distributed for patients with chronic limb-threatening ischemia (CLTI) and intermittent claudication (IC) and estimated using the Kaplan-Meier method. Between April 2021 and March 2023, 29 patients with 30 limbs were treated. Diabetes mellitus (DM) and CLTI were present in 62.1% and 80.0% of patients, respectively. Within the 32 treated lesions, severe calcification was present in 84.4% and bailout stenting was necessary in 12.5% of the lesions. Four MAEs occurred within 30 days: 1 closure device failure, 1 major amputation, and 2 deaths, neither of which was related to the study device. The primary patency, primary-assisted patency, freedom from TLR, limb salvage, and AFS at 12 months were 68.8%, 90.0%, 93.3%, 83.9%, and 57.1% for CLTI patients, respectively. No events occurred in restenosis, re-occlusion, TLR, major amputation, or mortality in patients with IC. This first-ever analysis on follow-up outcomes of IVL in the popliteal and infrapopliteal arteries demonstrated promising safety and efficacy outcomes with a low rate of bailout stenting. Vessel calcification is a common feature in peripheral arterial disease (PAD) and is one of the main challenges in endovascular treatment. The popliteal artery is subjected to biomechanical stress during knee motion, which makes stenting unappealing and often leads to worse clinical outcomes. This study aimed to describe the first follow-up outcomes of IVL in popliteal and infrapopliteal arterial disease. As in line with previous studies, no relevant procedural complications were found and the rate of bail-out stenting was only 12.5%. Moreover, in a complex patient population, this study demonstrated promising safety and efficacy outcomes. The comparison of IVL with angioplasty alone or other vessel preparation devices for popliteal and infrapopliteal arterial disease is warranted.

Performance of Prognostic Scoring Systems in MINOCA: A Comparison among GRACE, TIMI, HEART, and ACEF Scores.

Background: the prognosis of patients with myocardial infarction with non-obstructive coronary arteries (MINOCA) is not benign; thus, prompting the need to validate prognostic scoring systems for this population. Aim: to evaluate and compare the prognostic performance of GRACE, TIMI, HEART, and ACEF scores in MINOCA patients. Methods: A total of 250 MINOCA patients from January 2017 to September 2021 were included. For each patient, the four scores at admission were retrospectively calculated. The primary outcome was a composite of all-cause death and acute myocardial infarction (AMI) at 1-year follow-up. The ability to predict 1-year all-cause death was also tested. Results: Overall, the tested scores presented a sub-optimal performance in predicting the composite major adverse event in MINOCA patients, showing an AUC ranging between 0.7 and 0.8. Among them, the GRACE score appeared to be the best in predicting all-cause death, reaching high specificity with low sensitivity. The best cut-off identified for the GRACE score was 171, higher compared to the cut-off of 140 generally applied to identify high-risk patients with obstructive AMI. When the scores were tested for prediction of 1-year all-cause death, the GRACE and the ACEF score showed very good accuracy (AUC = 0.932 and 0.828, respectively). Conclusion: the prognostic scoring tools, validated in AMI cohorts, could be useful even in MINOCA patients, although their performance appeared sub-optimal, prompting the need for risk assessment tools specific to MINOCA patients.

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4

BackgroundThe fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence. ObjectivesThe primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting. MethodsEXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality. ResultsIn EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 ± 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR ≤ 2+, and 91% achieved MR ≤ 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days. ConclusionsThis study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

BackgroundMitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. ObjectivesThe PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. MethodsPatients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. ResultsThe study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001). ConclusionsThe outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833)

Elephant trunk simplifies thoracoabdominal aortic aneurysm repair without impacting operative risk.

An open two-stage elephant trunk (ET) technique may aid in the technical ease of subsequent thoracoabdominal aortic aneurysm (TAAA) repair. We analyze whether the presence of an ET improves outcomes for patients undergoing extent I and II TAAA repair. From September 1997 to October 2020, 469 patients underwent extent I or II TAAA repair. We compared those with prior ET to those without. Primary outcome was composite major adverse events (MAE) including operative mortality, myocardial infarction, permanent spinal cord injury, cerebrovascular accident, need for tracheostomy, and new need for dialysis. Thirty-eight (8.1%) patients had prior ET and 431 (91.9%) did not. There were no differences in baseline characteristics. The no ET group was more likely to undergo urgent or emergent procedures. Composite MAE occurred in 82 (19%) of the no ET group and 5 (15.8%) of the ET group (p = .785). Operative mortality was 5.5% and not significantly different between the groups (p = 1.00). No patients in the ET group experienced stroke or recurrent laryngeal nerve injury. Median partial bypass and cross-clamp times were significantly greater in the no ET group (28 [24-32] versus19 [16-22] min; p ≤ .001and 42 [32-53] versus 30 [25-39] min; p ≤ .001). Extent I and II TAAA repair after ET can be safely performed in a tertiary referral center with shorter bypass and cross-clamp times. ET eliminates the need for circulatory arrest or clamping a hostile arch.

The impact of concomitant mitral valve intervention on outcomes of aortic root replacement.

To investigate the impact of concomitant mitral valve repair (MVr) or replacement (MVR) at the time of aortic root replacement (ARR). We queried our aortic database for consecutive patients undergoing ARR in combination with MVr or MVR from 1997 to 2021. Patients undergoing valve sparing root replacement (VSRR) were excluded. We compared operative mortality (OM) and a composite of major adverse events (MAE) in those undergoing CVG both with (Group 2) and without a concomitant MV procedure (Group 1). We also analyzed outcomes between patients undergoing MV repair versus MV replacement. Sixty-one patients underwent ARR with concomitant MVr (29/47.5%) or MVR (32/52.5%). Compared to patients in Group 2 (n = 955), those in Group 1 presented with worse NYHA class, lower ejection fraction, higher rate of connective tissue disease, and underwent more frequently urgent/emergent procedures. Group 1 had higher incidence of postoperative MAE (8/61(13%) vs 51/955(5%), p = .03). There was no difference in operative mortality between the two groups (0/61(0%)vs. 3/955(0.3%), p = 1). Compared to the ARR + MVR subgroup, the ARR + MVr subgroup had higher incidence of postoperative MAE (5/29(17.2%) vs. 3/32(9.4%), p = 0.02). Multivariate analysis identified MVr (OR 2.78, 95% confidence interval [CI] [1.03;7.48], p = 0.04) as an independent predictor of MAE. Operative mortality remained low in both groups. The addition of MVR/MVr to composite valve-graft replacement of the aortic root does not increase OM in experienced hands. The incidence of MAEs was higher in those undergoing MVr but may be a reflection of greater preoperative comorbidity rather than issues related to a more complex operation.

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients

BackgroundSevere symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging. ObjectivesThe CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial. MethodsPatients with 3+ or 4+ DMR at prohibitive surgical risk were assessed by a central screening committee and randomized 2:1 (PASCAL:MitraClip). Study oversight also included an echocardiography core laboratory and a clinical events committee. The primary safety endpoint was the composite major adverse event rate at 30 days. The primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) ≤2+ at 6 months. ResultsA prespecified interim analysis in 180 patients demonstrated noninferiority of the PASCAL system vs the MitraClip system for the primary safety and effectiveness endpoints of major adverse event rate (3.4% vs 4.8%) and MR ≤2+ (96.5% vs 96.8%), respectively. Functional and quality-of-life outcomes significantly improved in both groups (P < 0.05). The proportion of patients with MR ≤1+ was durable in the PASCAL group from discharge to 6 months (PASCAL, 87.2% and 83.7% [P = 0.317 vs discharge]; MitraClip, 88.5% and 71.2% [P = 0.003 vs discharge]). ConclusionsThe CLASP IID trial demonstrated safety and effectiveness of the PASCAL system and met noninferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic DMR.

One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair

BackgroundContinued development of transcatheter mitral repair technologies is needed to address the large and diverse population of high-risk patients with symptomatic mitral regurgitation (MR). The new PASCAL Ace implant system, with its narrower profile, complements the original PASCAL transcatheter valve repair system. The aim of this study is to report 1-year outcomes from the early, compassionate-use observational experience with the novel PASCAL Ace implant system. MethodsAfter heart team assessment, adults with symptomatic moderate-to-severe (3+) or severe (4+) MR despite optimal medical therapy were treated under compassionate use at 3 hospitals internationally. Data were prospectively collected, and outcomes were assessed over a 12-month follow-up period. ResultsSeventeen patients (mean age 76 years, 65% male, mean Society of Thoracic Surgeons Predicted Risk of Operative Mortality score 9.6) were treated. MR etiology was degenerative in 29%, functional in 65%, and mixed in 6%; 59% were in New York Heart Association (NYHA) class III-IV. Technical success was achieved in 100%, and procedural success in 94%. At 1 year, MR grade ≤2+ was achieved in 93% (p < 0.001) with 88% survival rate and 94% free from heart failure hospitalization. The composite major adverse event rate was 6% and 100% of patients had ≤NYHA class II symptoms (p < 0.001). ConclusionsAt 1 year, the PASCAL Ace implant system demonstrated feasibility in this early, compassionate use experience in a small group of symptomatic patients with anatomically complex MR. The unique features of the PASCAL Ace implant may expand the treatable MR population.