Predictors of premature termination of cardiac surgery trials: insights from the clinicaltrial.gov database.

OBJECTIVES: Clinical trials that are terminated prematurely may generate incomplete and potentially biased data and the reasons for premature trials termination are poorly understood. Our objective was to describe the incidence of premature trial termination and identify factors associated with it. METHODS: We performed a systematic search on ClinicalTrials.gov to identify all cardiac surgery trials from 1991 to 2023. Trials that were terminated prematurely were identified. Factors independently associated with premature termination were identified using multivariable logistic regression analysis. RESULTS: A total of 746 clinical trials were included; of them 577 were completed and 169 (22.6%) were terminated prematurely. Most of the trials originated from North America (294 [39.4%]), Europe (264 [35.4%]) or Asia (141 [18.9%]). Fourteen of the trials terminated prematurely (8.3%) were phase 1, 75 (44.4%) phase 2, 49 (29.0%) phase 3, and 31 (18.3%) phase 4. Fifty (29.6%) trials were terminated because of slow recruitment, 20 (11.8%) because of sponsor decision and 12 (7.1%) because lack of funding. Left ventricular assist device (LVAD) trials (odds ratio [OR] 3.65, 95% CI: [1.65-8.00] P = 0.001), valve surgery trials (OR 4.30, 95% CI: [2.33-8.00] P < 0.001), aortic surgery trials (OR 2.86 95% CI [1.22-6.43] P = 0.012), Phase 2 (OR 3.02, 95% CI [1.31-7.93] P = 0.015) and phase 4 trials (OR 3.62, 95% CI: [1.43-10.23] P = 0.010) were at higher risk of premature termination while trials performed in Asia (OR 0.18, 95% CI [0.07-0.39] P ≤ 0.001) and Europe (OR 0.49, 95% CI: [0.30-0.80] P = 0.004) were less likely to be terminated prematurely. CONCLUSIONS: Slow recruitment is the most common reason for premature termination of cardiac surgery trials. Trials on LVAD, valve surgery, aortic surgery, phase 2 trials and phase 4 trials are more likely to be terminated, while trials conducted in Asia and Europe are less likely to be terminated prematurely.

Fulminant respiratory failure due to severe pneumothorax after re-do coronary artery bypass grafting treated with veno-venous extracorporeal membrane oxygenation.

This case report details the management of a 79-year-old man who developed massive postoperative pneumothorax following redo coronary artery bypass grafting due to severe lung adhesions. We successfully treated the patient using veno-venous extracorporeal membrane oxygenation without femoral cannulation, allowing for early rehabilitation initiation. Veno-venous extracorporeal membrane oxygenation is a reasonable option for cases of severe respiratory failure due to pneumothorax with lung destruction caused by re-sternotomy during re-do cardiac surgery.

Multi-vessel coronary artery grafting: analyzing the minimally invasive approach and its safety.

Introduction: At our institution, we perform off-pump coronary artery bypass (OPCAB) as a standard procedure. Moreover, patients with favorable coronary anatomy and condition are selected for minimally invasive cardiac surgery (MICS)-OPCAB. We retrospectively compared early outcomes, focusing on safety, between MICS-OPCAB and conventional off-pump techniques for multivessel coronary artery bypass grafting (CABG). Methods: From August 2017 to September 2022, 1,220 patients underwent multivessel coronary artery grafting at our institution. They were divided into the MICS-OPCAB group (MICS group = 163 patients) and the conventional OPCAB group (MS group = 1057 patients). Propensity score matching (1 : 1 ratio) was applied to the MICS-OPCAB and MS groups (149 patients per group) based on 23 preoperative clinical characteristics. Results: After matching, there were no significant differences in preoperative characteristics between the groups. The MICS group had a lower total graft number (2.3 ± 0.6 vs. 2.9 ± 0.8, p < 0.001) and fewer distal anastomoses (2.7 ± 0.8 vs. 3.2 ± 0.9, p < 0.001). There were no significant differences in hospital stay, intensive care unit stay, postoperative complications, and 30-day mortality. The MICS group had less drain output (MICS 350 ml [250-500], MS 450 ml [300-550]; p = 0.013). Kaplan-Meier analysis revealed no significant differences in postoperative MACCE (major adverse cardiac or cerebrovascular events)-free and survival rates between the groups (MACCE-free rate p = 0.945, survival rate p = 0.374). Conclusion: With proper patient selection, MICS-OPCAB can provide good short to mid-term results, similar to those of conventional OPCAB.

Assessing the benefits of anaortic off-pump coronary artery bypass grafting.

Introduction: The procedure called the "aorta no-touch" (NT) or anaortic technique in off-pump coronary artery bypass grafting (OPCAB) is designed to reduce the perioperative risk of stroke. We have observed an increased frequency of anaortic OPCAB procedures at our institution. The main purpose of the present study is to investigate the effectiveness of anaortic OPCAB in reducing the perioperative risk of stroke. Methods: From April 2011 to July 2023, a total of 2,236 patients underwent isolated OPCAB at our single center. The patients were divided into the anaortic group (NT, n = 762) and the aortic group (A, n = 1,474). The NT group was propensity score-matched (PSM) with the A group at a 1:1 ratio (NT n = 640; A n = 640), and matching was performed based on 26 covariates with preoperative clinical characteristics. Results: In both the unmatched and matched cohorts of the NT and A groups, there were no significant differences observed in new stroke rates (NT vs. A; unmatched, 1.0% vs. 1.2%, p = 0.624; matched, 0.9% vs. 1.3%, p = 0.789). The univariable logistic analysis did not identify the anaortic technique as an independent factor negatively associated with new stroke events (OR = 0.81, 95% CI = 0.35-1.86, p = 0.624). Conclusion: The present study did not find the anaortic technique to reduce the perioperative risk of stroke in OPCAB. Hence, further large studies are needed to identify patient cohorts in which anaortic OPCAB is significantly beneficial.

Hypothermic circulatory arrest at 20 ℃ does not deteriorate coagulopathy compared to 28 ℃ in a pig model.

It is believed that a lower temperature setting of hypothermic circulatory arrest (HCA) in thoracic aortic surgery causes coagulopathy, resulting in excessive bleeding. However, experimental studies that eliminate clinical factors are lacking. The objective of this study is to investigate the influence of the temperature setting of HCA on coagulation in a pig model. Ten pigs were divided into the following two groups: moderate temperature at 28 °C (group M, n = 5) or lower temperature at 20 °C (group L, n = 5). Two hours of HCA during a total of 4 h of cardiopulmonary bypass (CPB) were performed. Blood samples were obtained at the beginning (T1) and the end (T2) of the surgery, and coagulation capability was analyzed through standard laboratory tests (SLTs) and rotational thromboelastometry (ROTEM). In SLTs, hemoglobin, fibrinogen, platelet count, prothrombin time, and activated partial thromboplastin time were analyzed. In ROTEM analyses, clotting time and clot formation time of EXTEM, maximum clot firmness (MCF), and maximum clot elasticity (MCE) of EXTEM and FIBTEM were analyzed. Fibrinogen decreased significantly in both groups (group M, p = 0.008; group L, p = 0.0175) at T2, and FIBTEM MCF and MCE also decreased at T2. There were no differences regarding changes in parameters of SLTs and ROTEM between groups. CPB decreases coagulation capacity, contributed by fibrinogen. However, a lower temperature setting of HCA at 20 °C for 2 h did not significantly affect coagulopathy compared to that of HCA at 28 °C after re-warming to 37 °C.

A case of non-bacterial thrombotic endocarditis on the aortic valve following coronary angiography.

Nonbacterial thrombotic endocarditis (NBTE) on the aortic valve involves fibrin and platelet aggregate formation, potentially leading to embolic events. We present a case of NBTE on the aortic valve following coronary angiography (CAG) in a 54-year-old man with multiple comorbidities. Surgical thrombectomy was performed owing to acute cerebral infarcts. This case highlights the significance of considering that mechanical trauma from catheterization during CAG can trigger thrombus formation.

[Early Outcomes and Indications for Surgical Intervention of Preoperative Atrial Fibrillation].

BACKGROUND: This study investigates short-term outcomes following surgical interventions for atrial fibrillation (Af), including the Cox-maze Ⅳ procedure (maze procedure) and pulmonary vein isolation (PVI), performed concurrently with other cardiac surgeries. Additionally, we aim to determine the indications for surgical intervention for Af. METHOD: We retrospectively studied a total of 1,580 patients, out of which 274 had preoperative Af, that underwent cardiac surgery between January 2015 and April 2023. Patients who underwent emergency surgery, died in the hospital postoperatively, or received pacemaker implantation were excluded. Patients were first divided into two groups:the intervention group (n=135, 53.6%) and the non-intervention group( n=117, 46.4%), further categorized by whether they were in sinus rhythm at discharge. The intervention group was then subdivided into the maze procedure group( n=54), and the PVI group (n=76). RESULTS: Within the maze procedure group, significant differences were observed between the sinus rhythm and non-sinus rhythm groups in terms of age, preoperative Af duration, and aortic valve intervention status. In the PVI group, patients with persistent Af, longer preoperative Af duration, and larger left atrium diameter( LAD) were less likely to return to sinus rhythm. Smaller LAD was also a significant factor for returning to sinus rhythm in the non-intervention group. Multivariate analysis for all patients revealed that an LAD smaller than 50 mm was the strongest predictor for returning to sinus rhythm post operation( p<0.01). CONCLUSION: For patients with persistent Af, the maze procedure is favored over PVI as a surgical intervention. When LAD exceeds 50 mm, the likelihood of returning to sinus rhythm is diminished.

Off-pump minimally invasive coronary artery bypass grafting in patients with left ventricular dysfunction: the lampang experience.

Introduction: The minimally invasive cardiac surgery off-pump coronary artery bypass (MICSOPCAB) is technically difficult; therefore, previous studies have indicated that MICSOPCAB should be contraindicated in patients with impaired left ventricular (LV) function. In this study, we investigated the feasibility of MICSOPCAB in patients with impaired LV function. Methods: The 226 patients underwent MICSOPCAB between August 2017 and September 2022. Our study defined impaired LV function as ejection fraction (EF) in echocardiography 40% or less. The patients were divided into Low EF group (n = 39) and Normal EF group (n = 187). Results: The Low EF group was in a more critical preoperative condition than Normal EF group (41.0% in the Low EF group vs. 14.4% in the Normal EF group; p < 0.001). For preoperative transthoracic echocardiography, LV end-diastolic diameter (5.5 ± 0.9 cm in the Low EF group vs. 5.0 ± 0.8 cm in the Normal EF group; p < 0.001) and LV end-systolic diameter (4.4 ± 1.0 cm in the Low EF group vs. 3.4 ± 1.0 cm in the Normal EF group; p < 0.001) were significantly larger in the Low EF group. No differences were found in the operative time (180 [160-240] min in the Low EF group vs. 205 [165-253] min in the Normal EF group; p = 0.231) and the median number of distal anastomoses (2 [1-2] in the Low EF group vs. 2 [1-3] in the Normal EF group; p = 0.073). Intensive care unit stay was longer in the Low EF group than in the Normal EF group (2 [1-2] in the Low EF group vs. 1 [1-2] in the Normal EF group; p = 0.010). Perioperative transfusion was more common in the Low EF group than in the Normal EF group (69.7% vs. 49.2%; p = 0.023). There were no differences in major complications, hospital stay, and 30-day mortality. The Kaplan-Meier curve showed no significant difference in postoperative major adverse cardiac or cerebrovascular events rates between the two groups (p = 0.185). Conclusion: In this study, MICSOPCAB can be performed in patients with low EF having short- and mid-term outcomes similar to patients with normal EF. Therefore, low EF should not be contraindicated in MICSOPCAB.

Two-stage repair for DeBakey type II acute aortic dissection and distal aortic arch aneurysm in a nonagenarian patient.

Although total arch replacement would be performed in a patient with acute type A aortic dissection and concomitant aortic aneurysm in the distal aortic arch, total arch replacement may be too invasive in elderly patients with significant morbidities. A 92-year-old female with acute type II DeBakey aortic dissection and concomitant distal aortic arch aneurysm was successfully treated with hemi-arch replacement followed by thoracic endovascular aortic repair. Hybrid two-stage repair of DeBakey type II aortic dissection complicated by distal arch aneurysm using thoracic endovascular aortic repair after hemi-arch replacement may be effective.

Evaluating Short-Term Postoperative Outcomes in Minimally Invasive Mitral Valve Surgery for Patients with Rheumatic Disease.

Minimally invasive mitral valve surgery (MIMVS) is widespread and has become a standard procedure in cardiac surgery [Chitwood 1997; Carpentier 1996]. Therefore, MIMVS is a common procedure for patients with degenerative disease [Raanani 2010; Iribarne 2010] as well. However, the safety of MIMVS in patients with rheumatic heart disease (RHD) has not thoroughly been investigated, due to the low prevalence of RHD in developed countries, where MIMVS is standardized [Miceli 2015]. Here, we investigated the safety of MIMVS for patients with RHD at Lampang Hospital in Thailand.

Giant Coronary Aneurysm with Coronary-Pulmonary Artery Fistula in a Jehovah's Witness.

With an incidence of 3 in 100 million, giant coronary artery aneurysm (CAA) with coronary artery fistula (CAF) is a very rare condition. To prevent rupture, giant CAA with CAF should be swiftly treated. We present a Jehovah's Witness patient with giant CAA and coronary-pulmonary artery fistula. We resected the giant CAA in one piece, while ligating the CAF, without allogeneic blood transfusion. Due to rarity of these conditions, many thoracic surgeons lack direct experience in its surgical procedures. Herein, we share footage of this surgery as an example of how to safely resect CAA with minimal bleeding.

Interventional Bridging Therapy for Radical Cardiac Surgery in a Patient Seemed to be Inoperable Due to Very Poor Left Ventricular Function: A Case Report.

Cases that are inoperable owing to poor preoperative conditions are sometimes encountered. However, there are some cases that are led to radical treatment by performing bridge therapy. Here, we presented a case of a patient with complex cardiac disease in an inoperable state who underwent bridging therapy that led to successful surgical treatment. A 73-year-old male who received hemodialysis treatment and had severe aortic valve stenosis and coronary artery disease planned surgical treatment. However, he was deemed inoperable owing to his low cardiac function and hemodynamic instability. Therefore, to escape from a fatal condition, we first performed balloon aortic valvuloplasty and percutaneous coronary intervention as palliative procedures. Subsequently, his cardiac function and hemodynamic stability remarkably improved; therefore, after 1 month, we performed a successful radical surgical treatment. Even in inoperable patients, bridging therapy leading to radical treatment is possible.

Mitral valve replacement with papillary muscle tugging approximation in a patient with severely impaired left ventricular function 14 years after initial mitral valve repair.

The best treatment for ventricular functional mitral regurgitation still remains unclear. Papillary muscle tugging approximation (PMTA) is a technique known to preserve function of the sub-valvular apparatus, keeping it functionally in synch with the left ventricle systolic and diastolic dynamics. Herein, we present a case of mitral valve replacement with PMTA in a patient with severely impaired left ventricular function 14 years post initial mitral valve repair, which significantly improved during a course of 4 years after the reoperation without any complications.

Awake Surgical Mitral Valve Repair after Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement has become a popular choice for cases with severe aortic stenosis. However, when severe mitral regurgitation is comorbid in high-risk patients with severe aortic stenosis, therapeutic options must be weighed for each case. Here we present a very frail 88-year-old patient with severe aortic stenosis and severe mitral valve regurgitation who underwent a successful awake minimally invasive mitral valve repair after transcatheter aortic valve replacement.

Rupture of aneurysmal coronary-to-pulmonary artery fistula in a 96-year-old female; report of a case.

Coronary artery fistula (CAF) is a relatively rare congenital abnormality of the coronary arteries; typically, patients who undergo surgery for CAFs are relatively young because it is a congenital disease. Here we present a case of an aneurysmal coronary-to-pulmonary artery fistula rupture in a 96-year-old female. Considering her extreme high age and missing preoperative diagnostics, only local hemostasis without anatomical repair was performed but the patient is still doing well 1 year after the operation.

Proximalized Total Arch Replacement Can Be Safely Performed by Trainee.

BACKGROUND: The aim of the present study was to validate safety of total arch replacement (TAR) using a novel frozen elephant trunk device, operated by trainees as surgical education. METHODS: Sixty-four patients including 19 patients (29.6%) with acute aortic dissection type A (AADA) underwent TAR in our institute between April 2014 and March 2019 were retrospectively analyzed. Twenty-nine patients were operated by trainees (group T) and 35 patients were operated by attending surgeons (group A). RESULTS: Patient characteristics did not differ between groups. Operative time (409.4 ± 87.8 vs. 468.6 ± 129.6 minutes, p = 0.034), cardiopulmonary bypass time (177.7 ± 50.4 vs. 222.9 ± 596.7 minutes, p = 0.019), and hypothermic circulatory arrest time (39.5 ± 13.4 vs. 54.5 ± 18.5 minutes, p = 0.001) were significantly shorter in group A than in group T, but aortic clamping time did not differ between groups (115.3 ± 55.7 vs. 114.2 ± 35.0 minutes, p = 0.924) because the rate of concomitant surgery was higher in group A (37.1 vs. 10.3%, p = 0.014). Thirty-day mortality was 3.1% in the entire cohort. Although operation time was longer in group T, there were no significant difference in postoperative results between the groups, and the experience levels of the main operator were not independent predictors for in-hospital mortality + major postoperative complications. There was no difference in late death and aortic events between groups. CONCLUSIONS: The present study demonstrated that TAR can be safely performed by trainees, and suggests TAR as a possible and safe educational operation.

Aorto-Right Atrial Fistula after Minimally Invasive Tricuspid Valve Repair: A Report of Two Cases.

We experienced two cases of postoperative iatrogenic aorto-right atrial fistula (ARAF) after tricuspid valve repair (TVR) using minimally invasive cardiac surgery (MICS) technique. In both the cases, the flow of ARAF passed through the sinus of Valsalva near the noncoronary cusp (NCC)/right coronary cusp (RCC) commissure or NCC to right atrium. The quality of the fine needle used in the MICS technique may be inferior to that used in conventional surgery; ARAF after TVR could be a unique pitfall with the MICS technique.

Impella CP for treatment of left ventricular free-wall rupture after myocardial infarction: Report of a case.

Unloading of the left ventricle (LV) is essential for the treatment of LV free-wall rupture (LVFWR), and it is well-known that the LV can be optimally unloaded with the Impella system. However, there has been no report on applying the Impella system for the treatment of LVFWR. Here, we report a patient with FWR after massive myocardial infarction who was successfully treated with non-suture repair via median sternotomy and implantation of Impella CP (Abiomed, Danvers, MA).

The Cause of Massive Hemoptysis After Thoracic Endovascular Aortic Repair May Not Always Be an Aortobronchial Fistula: Report of a Case.

Hemoptysis after thoracic endovascular/open aortic repair is relatively rare but a well-known complication, and normally diagnosed with aortobronchial fistula (ABF). Here, we present a patient who suffered from recurrent massive hemoptyses even after multiple thoracic endovascular aortic repairs (TEVARs), where hemoptysis was ultimately controlled by pneumonectomy. In this case, the bleeding source was not the aorta but the lung parenchyma itself, indicating the importance of raising awareness that the cause of massive hemoptysis after TEVAR may not always be an ABF.