Late Outcomes of Surgery Versus Medical Therapy in Patients With Type A Aortic Intramural Hematoma: Meta-Analysis of Reconstructed Time-to-Event Data.

The effect of an initial surgical approach (in comparison with initial medical therapy) in acute type A intramural hematoma remains insufficiently explored. We designed a pooled analysis of Kaplan-Meier-derived individual patient data from studies with follow-up for overall survival (all-cause death). Restricted mean survival time was calculated to evaluate lifetime gain or loss. The Risk of Bias in Non-Randomized Studies of Interventions tool (ROBINS-I) was used to assess risk of bias. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to assess certainty of evidence. Eight studies met our eligibility criteria, including a total of 654 patients (311 patients treated with surgery and 343 patients treated with medical therapy alone). All the studies were non-randomized and observational. The median follow-up was 4.6 years (interquartile range 1.0 to 7.7). Patients who underwent surgery had a significantly lower risk of mortality compared with patients receiving medical therapy alone (hazard ratio 0.51, 95% confidence interval 0.35 to 0.74, p <0.001). The restricted mean survival time was overall 1.1 years greater with surgery compared with medical therapy, and this difference was statistically significant (p <0.001), which means that surgery is associated with lifetime gain. The overall risk of bias (ROBINS-I) was considered moderate-to-serious and the certainty of evidence (GRADE) was deemed to be low. In conclusion, in the overall follow-up, surgery as the initial approach was associated with better late survival and lifetime gain in comparison with medical therapy alone in the setting of acute type A aortic intramural hematoma; however, high-quality randomized trials are warranted to establish the efficacy of the surgical strategy.

FlatWire Sternal Closure System technique for median sternotomy closure.

Sternal closure after median sternotomy traditionally uses a stainless steel wire cerclage. Sternal wires are placed through or around the sternum, and the wire ends are twisted together to bring the sternum back together. Complications of this technique include sternal instability, dehiscence, non-union, and increased pain. Compared to traditional wire cerclage, the Figure 8 FlatWire Sternal Closure System has been demonstrated to be stronger and significantly reduce sternal cut-through and postoperative pain. There was no significant difference in hospital length of stay or mean hospitalization cost. Operative time was slightly longer in the FlatWire group, but this difference has been attributed to the learning curve of mastering the FlatWire technique. This article and supplemental video will demonstrate the technique of FlatWire Sternal Closure System. Briefly, the FlatWire is placed around the sternum, and the FlatWire end is fed through the security box. Once all of the wires are placed, the Figure 8 tensioning device is used to tighten each wire through the security box to the appropriate tensile force. Next, the FlatWires are rotated 90 degrees to hold the sternal position temporarily. Once sternal approximation is achieved, each FlatWire is twisted 120 degrees, and any excess length of the FlatWire is clipped.

Long-Term Outcomes of Patients Undergoing Aortic Root Replacement With Mechanical Versus Bioprosthetic Valves: Meta-Analysis of Reconstructed Time-to-Event Data.

Background An aspect not so clear in the scenario of aortic surgery is how patients fare after composite aortic valve graft replacement (CAVGR) depending on the type of valve (bioprosthetic versus mechanical). We performed a study to evaluate the long-term outcomes of both strategies comparatively. Methods and Results Pooled meta-analysis of Kaplan-Meier-derived time-to-event data from studies with follow-up for overall survival (all-cause death), event-free survival (composite end point of cardiac death, valve-related complications, stroke, bleeding, embolic events, and/or endocarditis), and freedom from reintervention. Twenty-three studies met our eligibility criteria, including 11 428 patients (3786 patients with mechanical valves and 7642 patients with bioprosthetic valve). The overall population was mostly composed of men (mean age, 45.5-75.6 years). In comparison with patients who underwent CAVGR with bioprosthetic valves, patients undergoing CAVGR with mechanical valves presented no statistically significant difference in the risk of all-cause death in the first 30 days after the procedure (hazard ratio [HR], 1.24 [95% CI, 0.95-1.60]; P=0.109), but they had a significantly lower risk of all-cause mortality after the 30-day time point (HR, 0.89 [95% CI, 0.81-0.99]; P=0.039) and lower risk of reintervention (HR, 0.33 [95% CI, 0.24-0.45]; P<0.001). Despite its increased risk for the composite end point in the first 6 years of follow-up (HR, 1.41 [95% CI, 1.09-1.82]; P=0.009), CAVGR with mechanical valves is associated with a lower risk for the composite end point after the 6-year time point (HR, 0.46 [95% CI, 0.31-0.67]; P<0.001). Conclusions CAVGR with mechanical valves is associated with better long-term outcomes in comparison with CAVGR with bioprosthetic valves.

Long-term outcomes of valve-sparing root versus composite valve graft replacement for acute type A aortic dissection: Meta-analysis of reconstructed time-to-event data.

OBJECTIVES: To evaluate the long-term outcomes of valve-sparing aortic root replacement (VSARR) versus composite aortic valve graft replacement (CAVGR) in the treatment of acute type A aortic dissections (ATAAD). METHODS: We performed a pooled meta-analysis of Kaplan-Meier-derived time-to-event data from studies with longer follow-up beyond the immediate postoperative period. RESULTS: Seven studies met our eligibility criteria, comprising a total of 858 patients (367 patients in the VSARR groups and 491 patients in the CAVGR group). We found no statistically significant differences in the overall survival between the groups over time (HR 0.83, 95%CI 0.63-1.10, P = 0.192), but we observed a higher risk of reoperation in the VSARR group when compared with the CAVGR group (HR 9.99, 95% CI 2.23-44.73, P = 0.003). The meta-regression revealed statistically significant positive coefficients for age (P < 0.001) in the analysis of survival, which means that this covariate has a modulating effect on this outcome. The higher the mean age, the higher the HR for overall mortality was found to be with VSARR as compared with CAVGR. Other covariates such as female sex, hypertension, diabetes, connective tissue disorders, bicuspid aortic valve, hemiarch and/or total arch replacement, concomitant coronary bypass surgery did not seem to have any effect on the outcomes. CONCLUSION: VSARR did not confer a better (or worse) survival over time in patients with ATAAD, but it was associated with higher risk of reoperations in the long run.

Robotic applications for intracardiac and endovascular procedures.

The large incisions and long recovery periods that accompany traditional cardiac surgery procedures along with the constant patient demand for minimally invasive procedures have motivated cardiac surgeons to implement the robotic technologies in their armamentarium. The robotic systems have been utilized successfully in various cardiac procedures including atrial septal defect repair, left atrial myxoma resection, MAZE procedure and left ventricular lead placement, yet coronary artery bypass and mitral valve repair still comprise the vast majority of them. This review analyzes the development of the robot-assisted cardiac surgery in recent years, its outcomes, advantages, disadvantages, its patient selection criteria as well as its economic feasibility. Robotic endovascular surgery, albeit its limited applications, is presently considered an attractive alternative to conventional endovascular approaches. The increased flexibility and precision along with the wider range of accessible anatomy provided by the endovascular robotic systems, have increased the pool of patients that can be offered minimally invasive treatment options and have helped to overcome many limitations of the traditional endovascular procedures. With this review we aimed to summarize the applications of the commercially available endovascular robotic devices, as well as the limitations and the future perspectives in the field of endovascular robotic surgery.

Trends in Percutaneous Balloon Mitral Valvuloplasty Complications for Mitral Stenosis in the United States (the National Inpatient Sample [2008 to 2018]).

The epidemiology of mitral stenosis (MS) continues to evolve in the United States. Although the incidence of rheumatic MS has decreased in high-income countries, there is a paucity of data surrounding trends in percutaneous balloon mitral valvuloplasty (PBMV), the current first-line management strategy. This study aimed to identify contemporary trends in PBMV in the United States. Hospitalizations for adults (≥18 years) with MS who underwent PBMV were identified from the National Inpatient Sample from 2008 to 2018. Baseline co-morbidities and outcomes over the study period were determined using Poisson regression. There were 3,980 weighted PBMV cases, 70% of which were women. PBMV hospitalizations decreased from 603 in 2008 to 210 in 2018 (p <0.001). From 2008 to 2018, the age at hospitalization was unchanged in both female and male patients. In contrast, the Charlson Co-morbidity Index increased in both. Baseline heart failure (39% to 64%), hypertension (38% to 43%), and diabetes mellitus (17% to 26%) all substantially increased over the study period. In-hospital mortality occurred in 2% of female and 5% of male patients and was unchanged from 2008 to 2018. Vascular complications (12%) and acute kidney injury (10%) were the most frequent postprocedural complications during the 11-year study period. A composite of mortality or any postprocedural complication did not vary by gender (odds ratio 1.23, 95% confidence interval 0.88 to 1.72). In conclusion, the use of PBMV significantly decreased from 2008 to 2018, and patients with MS who underwent PBMV over this period had an increased burden of co-morbidities, elevated postprocedural complication rate, and no change in in-hospital mortality.

Minimally invasive delivery of a hydrogel-based exosome patch to prevent heart failure.

Coronary heart disease (CHD) has been the number one killer in the United States for decades and causes millions of deaths each year. Clinical treatment of heart ischemic injury relieves symptoms in the acute stage of CHD; however, patients with an infarcted heart muscle can develop heart failure (HF) due to chronic maladaptive remodeling. Regenerative therapy has been studied as a potential treatment option for myocardial infarction (MI) and HF. Cardiac patches have been designed and tested to increase therapeutic retention and integration. However, the delivery usually requires invasive surgical techniques, including open-chest surgeries and heart manipulation. Those procedures may cause chronic adhesions between the heart anterior wall and the chest wall. This study created and tested an injectable ExoGel by embedding mesenchymal stem cell (MSC) -derived exosomes into a hyaluronic acid (HA) hydrogel. ExoGel was injected into the pericardial cavity of rats with transverse aortic constriction (TAC) induced heart failure. ExoGel therapy reduced LV chamber size and preserved wall thickness. The feasibility and safety of ExoGel injection were further confirmed in a pig model.

Mechanical versus bioprosthetic valve for aortic valve replacement: systematic review and meta-analysis of reconstructed individual participant data.

OBJECTIVES: The aim of this study was to compare biological versus mechanical aortic valve replacement. METHODS: We searched MEDLINE, Scopus and Cochrane Library databases for randomized clinical trials and propensity score-matched studies published by 14 October 2021 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Individual patient data on overall survival were extracted. One- and two-stage survival analyses and random-effects meta-analyses were conducted. RESULTS: A total of 25 studies were identified, incorporating 8721 bioprosthetic and 8962 mechanical valves. In the one-stage meta-analysis, mechanical valves cumulatively demonstrated decreased hazard for mortality [hazard ratio (HR): 0.79, 95% confidence interval (CI): 0.74-0.84, P < 0.0001]. Overall survival was similar between the compared arms for patients <50 years old (HR: 0.88, 95% CI: 0.71-1.1, P = 0.216), increased in the mechanical valve arm for patients 50-70 years old (HR: 0.76, 95% CI: 0.70-0.83, P < 0.0001) and increased in the bioprosthetic arm for patients >70 years old (HR: 1.35, 95% CI: 1.17-1.57, P < 0.0001). Meta-regression analysis revealed that the survival in the 50-70 year-old group was not influenced by the publication year of the individual studies. No statistically significant difference was observed regarding in-hospital mortality, postoperative strokes and postoperative reoperation. All-cause mortality was found decreased in the mechanical group, cardiac mortality was comparable between the 2 groups, major bleeding rates were increased in the mechanical valve group and reoperation rates were increased in the bioprosthetic valve group. CONCLUSIONS: Survival rates seem to not be influenced by the type of prosthesis in patients <50 years old. The survival advantage in favour of mechanical valves is observed in patients 50-70 years old, while in patients >70 years old bioprosthetic valves offer better survival outcomes.

Bilateral Thoracoscopic Sympathectomy After Sternotomy for Left Ventricular Assist Device Insertion.

Our case is a 73-year-old male patient with persistent ventricular tachycardia leading to recent syncopal episodes despite ventricular tachycardia ablation and multiple stellate ganglion blocks, frequent hospital admissions, and acute on chronic congestive heart failure requiring an intraaortic balloon pump. The decision was made to proceed with left ventricular assist device placement and bilateral sympathectomies simultaneously. After performing the sternotomy and widely opening bilateral pleural spaces, the lower third of the stellate ganglia to the level of T4 was removed using a combination of the thoracoscope with the sternotomy incision. The use of thoracoscopy greatly assisted with visualization during the sympathectomy.

Initial in-human experience with the conveyor cardiovascular system for the delivery of large profile transcatheter valve devices.

OBJECTIVES: To determine the safety and efficacy of the conveyor cardiovascular system (CCS) to facilitate the delivery of large profile transcatheter valve devices. BACKGROUND: Transcatheter valve devices rely on force provided by the operator to be delivered to their intended position. This delivery may be challenging in a variety of anatomic scenarios. The ability to provide steering from the tip of the device by forming an arterial venous loop may help overcome these challenges. METHODS: Between May, 2019 and October, 2020, five patients were recruited for delivery of transcatheter valve devices with the CCS. These patients were deemed by the operators to have challenging anatomy which could make conventional valve delivery difficult or impossible. These patients were recruited as part of an FDA approved early feasibility study or through an institutional review board approved compassionate use protocol. RESULTS: Three patients underwent transcatheter mitral valve replacement with a SAPIEN-3 valve. One patient each underwent transcatheter aortic valve (TAVR) implantation with a SAPIEN 3 and 1 patient underwent TAVR implantation with a Lotus valve. All patients underwent successful implantation of the valve and removal of the CCS and valve delivery systems. There was no more than trivial mitral regurgitation post procedure in any patient and there was no more than trivial paravavular leak. There were no major in-hospital complications. CONCLUSIONS: The CCS facilitates the delivery of large profile transcatheter valve devices in challenging anatomic scenarios. Further studies are needed with additional valve technologies.

Comparative differences of mitral valve-in-valve implantation: A new mitral bioprosthesis versus current mosaic and epic valves.

OBJECTIVE: Evaluate transcatheter mitral valve replacement (TMVR) valve-in-valve (VIV) outcomes in three different mitral bioprostheses (of comparable measured internal diameters) under stable hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography (CT), and autopsy comparisons pre- and post-valve implantation in a porcine model under matched controlled conditions. BACKGROUND: Impact of surgical bioprosthesis design on TMVR VIV procedures is unknown. METHODS: Fifteen similar-sized Yorkshire pigs underwent pre-procedural CT screening. Twelve had consistent anatomic features and underwent implantation of mitral bioprostheses. Four valves from each of three manufacturers were implanted in randomized fashion: 27-mm Epic, 27-mm Mosaic, and 25-mm Mitris, followed by TMVR VIV with 26 Edwards Sapien3. Post-VIV, suprasternal TEE studies were performed to assess hemodynamic function, followed by a gated contrast CT. After euthanasia, animals underwent necropsy for anatomic evaluation. RESULTS: All 12 animals had successful VIV implantation with no study deaths. The post vivMitris (3.77 ± 0.36)/(2.2 ± 0.25 mmHg) had the lowest peak/mean trans-mitral gradient and the vivEpic the highest (15.5 ± 2.55)/(7.09 ± 1.13 mmHg). All THVs (transcatheter heart valves) had greatest deformation within the center of the THV frame; with the smallest waist opening area in the vivEpic (329 ± 35.8 mm2 ) and greatest in the vivMitris (414 ± 33.12 mm2 ). Bioprosthetic frames without obvious radiopaque markers resulted in the most ventricular implantation of the THV's anteroseptal frame (Epic: -4.52 ± 0.76 mm), versus the most radiopaque bioprosthesis (Mitris: -1.18 ± 2.95 mm), and higher peak LVOT gradients (Epic: 4.82 ± 1.61 mmHg; Mitris: 2.91 ± 1.47 mmHg). CONCLUSIONS: The current study demonstrates marked variations in hemodynamics, THV opening area, and anatomic dimensions among measured similarly sized mitral bioprostheses. These data suggest a critical need for understanding the potential impact of variations in bioprosthesis design on TMVR VIV clinical outcomes.

Comparison of a new bioprosthetic mitral valve to other commercially available devices under controlled conditions in a porcine model.

BACKGROUND/AIM: To evaluate three mitral bioprostheses (of comparable measured internal diameters) under controlled, stable, hemodynamic and surgical conditions by bench, echocardiographic, computerized tomography and autopsy comparisons pre- and postvalve implantation. METHODS: Fifteen similar-sized Yorkshire pigs underwent preprocedural computerized tomography anatomic screening. Of these, 12 had consistent anatomic features and underwent implantation of a mitral bioprosthesis via thoracotomy on cardiopulmonary bypass (CPB). Four valves from each of three manufacturers were implanted in randomized fashion: 27-mm Epic, 27-mm Mosaic, and 25-mm Mitris bioprostheses. After CPB, epicardial echocardiographic studies were performed to assess hemodynamic function and define any paravalvular leaks, followed by postoperative gated contrast computerized tomography. After euthanasia, animals underwent necropsy for anatomic evaluation. RESULTS: All 12 animals had successful valve implantation with no study deaths. Postoperative echocardiographic trans-valve gradients varied among bioprosthesis manufacturers. The 25-mm Mitris (5.1 ± 2.7)/(2.6 ± 1.3 torr) had the lowest peak/mean gradient and the 27-mm Epic bioprosthesis had the highest (9.2 ± 3.7)/(4.6 ± 1.9 torr). Surgical valve opening area (SOA) varied with the 25-mm Mitris having the largest SOA (2.4 ± 0.15 cm2 ) followed by the 27-mm Mosaic (2.04 ± 0.23 cm2 ) and the 27-mm Epic (1.8 ± 0.27 cm2 ) valve. Bench device orthogonal internal diameter measurements did not match manufacturer device size labeling: 25-mm Mitris (23 × 23 mm), 27-mm Mosaic (23 × 22 mm), 27-mm Epic (21 × 21 mm). CONCLUSIONS: Current advertisement/packaging of commercial surgical mitral valves is not uniform. This study demonstrates marked variations in hemodynamics, valve opening area and anatomic dimensions between similar sized mitral bioprostheses. These data suggest a critical need for standardization and close scientific evaluation of surgical mitral bioprostheses to ensure optimal clinical outcomes.

Minimally invasive delivery of therapeutic agents by hydrogel injection into the pericardial cavity for cardiac repair.

Cardiac patches are an effective way to deliver therapeutics to the heart. However, such procedures are normally invasive and difficult to perform. Here, we develop and test a method to utilize the pericardial cavity as a natural "mold" for in situ cardiac patch formation after intrapericardial injection of therapeutics in biocompatible hydrogels. In rodent models of myocardial infarction, we demonstrate that intrapericardial injection is an effective and safe method to deliver hydrogels containing induced pluripotent stem cells-derived cardiac progenitor cells or mesenchymal stem cells-derived exosomes. After injection, the hydrogels form a cardiac patch-like structure in the pericardial cavity, mitigating immune response and increasing the cardiac retention of the therapeutics. With robust cardiovascular repair and stimulation of epicardium-derived cells, the delivered therapeutics mitigate cardiac remodeling and improve cardiac functions post myocardial infarction. Furthermore, we demonstrate the feasibility of minimally-invasive intrapericardial injection in a clinically-relevant porcine model. Collectively, our study establishes intrapericardial injection as a safe and effective method to deliver therapeutic-bearing hydrogels to the heart for cardiac repair.

Transxiphoid Revascularization of the Anterior Descending Coronary Artery with the Left Mammary Artery.

Revascularization of the coronary arteries, via open sternotomy and on cardiopulmonary bypass, remains the most common cardiac surgical procedure in the United States. Patients, and cardiologists, seek an alternative to dividing the sternum while reaping the advantages of left internal mammary artery (LIMA) revascularization of the diseased left anterior descending (LAD) coronary artery. We describe a strictly transxiphoid mammary artery liberation with anastomosis to the anterior descending (TRAX CABG) without sternal division. Of the 26 patients who underwent attempted TRAX CABG, 18 had nonsternotomy LIMA-to-LAD revascularization with completion angiogram to document bypass patency. TRAX CABG offers surgeons a minimally invasive alternative to trans-sternal LIMA-to-LAD in select patients. Conversion to traditional sternotomy has limited unanticipated morbidity and completion angiogram confirms procedural success.

Bioprosthetic aortic valve diameter and thickness are directly related to leaflet fluttering: Results from a combined experimental and computational modeling study.

OBJECTIVE: Bioprosthetic heart valves (BHVs) are commonly used in surgical and percutaneous valve replacement. The durability of percutaneous valve replacement is unknown, but surgical valves have been shown to require reintervention after 10 to 15 years. Further, smaller-diameter surgical BHVs generally experience higher rates of prosthesis-patient mismatch, which leads to higher rates of failure. Bioprosthetic aortic valves can flutter in systole, and fluttering is associated with fatigue and failure in flexible structures. The determinants of flutter in BHVs have not been well characterized, despite their potential to influence durability. METHODS: We use an experimental pulse duplicator and a computational fluid-structure interaction model of this system to study the role of device geometry on BHV dynamics. The experimental system mimics physiological conditions, and the computational model enables precise control of leaflet biomechanics and flow conditions to isolate the effects of variations in BHV geometry on leaflet dynamics. RESULTS: Both experimental and computational models demonstrate that smaller-diameter BHVs yield markedly higher leaflet fluttering frequencies across a range of conditions. The computational model also predicts that fluttering frequency is directly related to leaflet thickness. A scaling model is introduced that rationalizes these findings. CONCLUSIONS: We systematically characterize the influence of BHV diameter and leaflet thickness on fluttering dynamics. Although this study does not determine how flutter influences device durability, increased flutter in smaller-diameter BHVs may explain how prosthesis-patient mismatch could induce BHV leaflet fatigue and failure. Ultimately, understanding the effects of device geometry on leaflet kinematics may lead to more durable valve replacements.

Novel Modification of HeartMate 3 Implantation.

We have modified the HeartMate 3 (Abbott, Abbott Park, IL) implantation technique to better suit our patient population. This modification optimizes the placement of the HeartMate 3 sewing cuff and allows passage of the suture transmurally from endocardium to epicardium in a "cut then sew" technique. We believe this affords a superior seal and protection from tearing friable myocardium.