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.

Mechanical pump complication after HeartMate 3 implantation.

BACKGROUND: With the improvement in postoperative complications and long-term survival post LVAD, continuing to improve clinical outcomes will require efforts to decrease long-term complications. The purpose of this study is to describe the incidence of mechanical pump failure requiring surgery, which we define as pump failure secondary to either outflow graft compression, outflow graft obstruction, or pump thrombosis requiring surgical intervention. METHODS: 141 consecutive adult patients who underwent HeartMate3 Implantation using the "cut-then-sew" implantation technique between September 2015 and September 2021 were included in our study. The primary outcome measure was mechanical pump complication (outflow graft obstruction and or pump thrombosis) requiring surgical intervention. Secondary outcome measures included incidence of bleeding, stroke, renal failure, length of stay, and overall survival. Median follow up was 27.3 months. RESULTS: Eleven (7.8%) of patients developed mechanical pump complications. Six patients developed outflow graft obstruction. Five patients developed acute pump thrombosis. Median time to a mechanical complication was 828 days. Of the 11 patients who underwent surgery, 10 patients (90%) survived to discharge. Overall survival at 1, 3, and 5 years was 82.9%, 69.1% and 55.2% respectively for the entire cohort. CONCLUSION: The mechanical pump complication rate of 7.8% which is quite high may be related to duration of follow up, as the median time to mechanical complication was 828 days. This study highlights an important late complication that occurs post LVAD implantation.

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.

Successful aortic valve replacement by overexpanding a SAPIEN transcatheter heart valve for a large aortic annulus (>900†mm2): a case report.

Background: There are limited commercial valve sizes available for transcatheter aortic valve implantation (TAVI). This makes it challenging or even prohibitive to perform TAVI on large aortic annuli. Case summary: A 78-year-old male with known low-flow, low-gradient severe aortic stenosis presented with progressive dyspnoea, chest pressure, and decompensated heart failure. Successful off-label TAVI was performed for tricuspid aortic valve stenosis with an aortic annulus of >900 mm2. An Edwards S3 29 mm valve was overexpanded with an extra 7 mL of volume at valve deployment. No complications occurred, and only trivial paravalvular leak was seen following implantation. The patient died from a non-cardiovascular cause 8 months following the procedure. Discussion: Patients that require aortic valve replacement with prohibitive surgical risk and have very large aortic valve annuli pose significant technical challenges. This case shows the feasibility of TAVI by overexpanding an Edwards S3 valve.

Suprasternal transcatheter aortic valve replacement: Modified trocar-free technique.

BACKGROUND AND AIM OF STUDY: Transcatheter aortic valve replacement is established as the standard treatment for severe aortic stenosis. Many approaches have been described, including the suprasternal technique, an alternative for patients with unsuitable femoral arteries. We now describe a trocar-free technique for the Suprasternal approach. METHODS AND RESULTS: Under endotracheal anesthesia, an incision is made above the manubrium and dissection is carried down to the innominate artery with adequate exposure for cannulation. Access site is closed with purse-string suture. The Suprasternal approach has relatively few contraindications. CONCLUSION: Our trocar-free technique is a safe and easily reproducible technique for TAVRs in patients with poor femoral access.

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.

Temporal Trends in Internal vs. External Referrals for TAVR in a Large Academic Center: Patients Characteristics and Outcomes.

Background: Since transcatheter aortic valve replacement (TAVR) first became approved for inoperable patients followed by high, intermediate-, and low-risk patients, referrals to TAVR centers have rapidly increased. The purpose of this study was to investigate referral patterns to a large academic TAVR center in the state of North Carolina and evaluate differences between externally and internally referred patients. Methods: Data for all patients who underwent TAVR at our institution between November 2014 and March 2020 were pulled from the Transcatheter Valve Therapy Registry. The electronic medical record was used to determine the referral source. The descriptive statistical analysis was performed using Excel (Microsoft, Redmond, Washington). Results: 491 patients underwent TAVR at our institution between November 2014 and March 2020. Half of the patients were referred by a cardiologist within the same health system (N = 250, 50.9%). Other referral sources included a cardiologist external to the health system (N = 210, N = 42.8%) and a surgeon or proceduralist (such as urologist, surgeon, or gastroenterologist) during the workup for another procedure (N = 26, 5.3%). Over time, there was a trend toward an increasing proportion of patients referred by a cardiologist external to our system, but this trend did not reach statistical significance (20.0% in 2014, 29.2% in 2015, 30.7% in 2016, 53.0% in 2017, 36% in 2018, 48.4% in 2019, and 56.8% in 2020, p=0.06 using the Mann-Kendall trend test). Externally referred patients were less likely to have private insurance and were more likely to have a reduced ejection fraction and had a higher mean gradient across the valve. Postprocedure, externally referred patients were more likely to have the procedure under moderate sedation and less likely to be discharged home. Conclusions: This study presents the referral pattern to a large TAVR center in North Carolina. Over time, there was an increase in external referrals suggesting that TAVR is increasingly adopted as an important component of the management of aortic valve stenosis. Internally and externally referred patients have differences in baseline demographic and clinical characteristics which may have an impact on clinical outcomes.

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.

Early outcomes of the suprasternal transcatheter aortic valve replacement technique.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now an established treatment option for patients with severe aortic stenosis. The most utilized approach remains transfemoral. In patients with difficult femoral access a variety of alternate approaches have been used. Recently, suprasternal access has emerged as a viable alternate approach in patients with very complex vascular access. We describe our 30-day outcomes of patients who underwent suprasternal transcatheter aortic valve replacement (suprasternal [SS]-TAVR), which constitutes the largest single-center cohort to date. METHODS: From May 2016 to September 2021, 658 patients underwent TAVR at our institution. Of which 29 underwent SS-TAVR. We performed a retrospective analysis to evaluate early (30 days) outcomes of this procedure. Main outcomes evaluated included 30-day mortality, stroke and pacemaker rates, length of stay, readmission, and valvular function. RESULTS: All patients were alive 30 days after the procedure. The median hospital length-of-stay was 2 days. Two patients (6.9%) had a stroke on the contra-lateral side of access. Two patients (6.90%) had significant cardiac arrhythmias requiring pacemaker placement. In 30 days, one patient was readmitted (3.45%). CONCLUSIONS: Our data confirm the SS-TAVR as a feasible and safe alternative with comparable results to established approaches in patients who are unsuitable for femoral artery access and offers clinicians another access site in patients with very complex anatomy.

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.

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.

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.

Modified Manouguian technique for aortic root enlargement: A case series.

BACKGROUND: Manouguian aortic root enlargement (ARE) has been a standard root enlargement procedure to assist in patients with a small annular size. We describe a modification to the Manouguian ARE similar to Yang et al. This approach could serve as an alternate technique for performing ARE; to date only case reports have defined this approach and no studies have evaluated its efficacy or safety. METHODS: A retrospective case series was performed on patients who underwent ARE for surgical aortic valve replacement via the modified Manouguian procedure at a single institution. Thirteen patients were identified between 2015 and 2021, and all surgeries were performed by a single operator. Data were collected via the Society of Thoracic Surgeons database and chart review. The primary outcome was difference in valve size after the procedure. RESULTS: The most common indication for surgery was aortic stenosis (12, 92%), with the most common etiology being degenerative calcification (7, 54%). Congenital bicuspid or unicuspid valves were identified in five (38%) patients. The majority (10, 77%) of patients received a mechanical valve. This procedure was successfully performed in all 13 of the patients. Additionally, 13 of the 13 patients (100%) were upsized to a satisfactory valve size based on preoperative echocardiography sizing. CONCLUSIONS: The modified Manouguian aortic enlargement technique can be safely and effectively used as an aortic enlargement procedure in a broad sample of patients.