Temporary Microaxial Support in a Patient With Multiple Post-Myocardial Infarction Mechanical Complications: Bridge to Transplantation.

A 66-year-old man with post-myocardial infarction ventricular septal rupture, apical aneurysm, and pseudoaneurysm presenting in cardiogenic shock received a surgically placed temporary microaxial transvalvular left ventricular assist device. This stabilized hemodynamics and end-organ function, and he subsequently underwent successful heart transplantation. A temporary microaxial transvalvular left ventricular assist device can effectively bridge patients with select mechanical complications of myocardial infarction beyond ventricular septal rupture.

Efficacy of Balloon Expandable Extreme-Low Temperature Ventricular Epicardial Cryoablation: A Preclinical Proof of Concept Evaluation.

BACKGROUND: Current epicardial ablation technologies are limited by the inability to create adequate depth lesions and risk of collateral injury to extracardiac structures. OBJECTIVE: To evaluate the feasibility and efficacy of ventricular epicardial ablation with a novel balloon-expandable extreme-low temperature (XLT) cryoablation catheter with an embedded insulation pontoon for protection of extracardiac structures which has been specifically designed for epicardial ablation. METHODS: 10 healthy swine underwent surgical (6) and subxiphoid percutaneous (4) epicardial access respectively. A total of 3-6 sites were targeted in the right and left ventricular wall for different exposure durations. Ablation was performed with a large footprint (surgical) and smaller footprint (percutaneous) version of the HeartPad® (Corfigo Inc., Montclair, NJ) XLT system. The system consists of the balloon-expandable cryoablation catheter and a console. The console vaporizes liquid helium (-269˚C) and controls continuous delivery of extremely cold helium gas at high flow rates through a high-efficiency ablation element mounted on an expandable insulation pontoon to protect extracardiac structures. Ablation lesions were assessed by gross pathology and histological examination. RESULTS: A total of 42 epicardial lesions were created. The mean lesion depth increased progressively with the ablation time (surgical catheter: 11±2 mm at ≤30 seconds, 13±4 mm at 60 seconds, 15±3 mm at ≥120 seconds, P =0.001; percutaneous catheter: 10±2 mm at 30 seconds, 14±2 mm at 60 seconds, 16±2 mm at 120 seconds], P =0.001). Lesion geometry appeared unaffected by presence and thickness of epicardial fat. One episode of ventricular fibrillation occurred following ablation over the atrioventricular groove and 2 adjacent obtuse marginal arteries. CONCLUSION: Surgical or percutaneous epicardial ablation using the HeartPad® XLT cryoablation system is feasible and can efficiently produce deep ventricular lesions in different epicardial locations.

Contemporary experience with the Commando procedure for anterior mitral anular calcification.

Objective: Anterior mitral anular calcification, particularly in radiation heart disease, and previous valve replacement with destroyed intervalvular fibrosa are challenging for prosthesis sizing and placement. The Commando procedure with intervalvular fibrosa reconstruction permits double-valve replacement in these challenging conditions. We referenced outcomes after Commando procedures to standard double-valve replacements. Methods: From January 2011 to January 2022, 129 Commando procedures and 1191 aortic and mitral double-valve replacements were performed at the Cleveland Clinic, excluding endocarditis. Reasons for the Commando were severe calcification after radiation (n = 67), without radiation (n = 43), and others (n = 19). Commando procedures were referenced to a subset of double-valve replacements using balancing-score methods (109 pairs). Results: Between balanced groups, Commando versus double-valve replacement had higher total calcium scores (median 6140 vs 2680 HU, P = .03). Hospital outcomes were similar, including operative mortality (12/11% vs 8/7.3%, P = .35) and reoperation for bleeding (9/8.3% vs 5/4.6%, P = .28). Survival and freedom from reoperation at 5 years were 54% versus 67% (P = .33) and 87% versus 100% (P = .04), respectively. Higher calcium score was associated with lower survival after double-valve replacement but not after the Commando. The Commando procedure had lower aortic valve mean gradients at 4 years (9.4 vs 11 mm Hg, P = .04). After Commando procedures for calcification, 5-year survival was 60% and 59% with and without radiation, respectively (P = .47). Conclusions: The Commando procedure with reconstruction of the intervalvular fibrosa destroyed by mitral anular calcification, radiation, or previous surgery demonstrates acceptable outcomes similar to standard double-valve replacement. More experience and long-term outcomes are required to refine patient selection for and application of the Commando approach.

Outcomes After Left Atrial Appendage Clip Placement During Cardiac Surgery: A Nationwide Analysis.

This study evaluated the nationwide associations between concomitant left atrial appendage clip (LAAC) placement during cardiac surgery and postoperative outcomes. We identified 1,260,999 patients who underwent coronary artery bypass grafting, valve, and aortic surgeries in the 2016 to 2020 Nationwide Readmissions Database and stratified by concomitant LAAC versus no LAAC placement. Patients who underwent surgical ablation were excluded. Mortality and complications were compared during index admissions and for patients readmitted within 30 and 90 days of the index discharge date for unmatched and propensity score-matched groups. Overall, 6.7% (84,293) of patients underwent cardiac surgery and concomitant LAAC placement without surgical ablation. After propensity score matching, the index admission mortality and overall complications were not different in patients with LAAC versus patients without LAAC. LAAC placement was associated with increased any-cause 30-day readmissions (15% vs 13%, p <0.01). In patients with LAAC, within 30 days, there were no differences in mortality (3.9% vs 3.8%, p = 0.60) or overall complications (64% vs 63%, p = 0.20), whereas stroke was lower (5.3% vs 6.5%, p <0.01) and heart failure was higher (35% vs 30%, p <0.01). For patients readmitted within 90 days, similar findings were observed for any-cause readmissions, mortality, overall complications, stroke, and heart failure. In conclusion, concomitant LAAC placement during cardiac surgery was associated with lower early postdischarge incidence of stroke and a favorable overall risk-benefit profile. Given these short-term findings in a real-world population of all patients who underwent cardiac surgery, longer-term studies with more granular data are needed to evaluate the potential benefit of this practice.

Identifying and mitigating risk of postcardiotomy cardiogenic shock in patients with ischemic and nonischemic cardiomyopathy.

OBJECTIVES: To identify preoperative predictors of postcardiotomy cardiogenic shock in patients with ischemic and nonischemic cardiomyopathy and evaluate trajectory of postoperative ventricular function. METHODS: From January 2017 to January 2020, 238 patients with ejection fraction <30% (206/238) or 30% to 34% with at least moderately severe mitral regurgitation (32/238) underwent conventional cardiac surgery at Cleveland Clinic, 125 with ischemic and 113 with nonischemic cardiomyopathy. Preoperative ejection fraction was 25 ± 4.5%. The primary outcome was postcardiotomy cardiogenic shock, defined as need for microaxial temporary left ventricular assist device, extracorporeal membrane oxygenation, or vasoactive-inotropic score >25. RandomForestSRC was used to identify its predictors. RESULTS: Postcardiotomy cardiogenic shock occurred in 27% (65/238). Pulmonary artery pulsatility index <3.5 and pulmonary capillary wedge pressure >19 mm Hg were the most important factors predictive of postcardiotomy cardiogenic shock in ischemic cardiomyopathy. Cardiac index <2.2 L·min-1 m-2 and pulmonary capillary wedge pressure >21 mm Hg were the most important predictive factors in nonischemic cardiomyopathy. Operative mortality was 1.7%. Ejection fraction at 12 months after surgery increased to 39% (confidence interval, 35-40%) in the ischemic group and 37% (confidence interval, 35-38%) in the nonischemic cardiomyopathy group. CONCLUSIONS: Predictors of postcardiotomy cardiogenic shock were different in ischemic and nonischemic cardiomyopathy. Right heart dysfunction, indicated by low pulmonary artery pulsatility index, was the most important predictor in ischemic cardiomyopathy, whereas greater degree of cardiac decompensation was the most important in nonischemic cardiomyopathy. Therefore, preoperative right heart catheterization will help identify patients with low ejection fraction who are at greater risk of postcardiotomy cardiogenic shock.

Programmatic approach to patients with advanced ischemic cardiomyopathy: Integrating microaxial support into strategies for the modern era.

Patients with advanced ischemic cardiomyopathy manifesting as left ventricular dysfunction exist along a spectrum of severity and risk, and thus decision-making surrounding optimal management is challenging. Treatment pathways can include medical therapy as well as revascularization through percutaneous coronary intervention or coronary artery bypass grafting. Additionally, temporary and durable mechanical circulatory support, as well as heart transplantation, may be optimal for select patients. Given this spectrum of risk and the complexity of treatment pathways, patients may not receive appropriate therapy given their perceived risk, which can lead to sub-satisfactory outcomes. In this review, we discuss the identification of high-risk ischemic cardiomyopathy patients, along with our programmatic approach to patient evaluation and perioperative optimization. We also discuss our strategies for therapeutic decision-making designed to optimize both short- and long-term patient outcomes.

What determines outcomes in multivalve reoperations? Effect of patient and surgical complexity.

OBJECTIVE: Patient characteristics, risks, and outcomes associated with reoperative multivalve cardiac surgery are poorly characterized. Effect of patient variables and surgical components of each reoperation were evaluated with regard to operative mortality. METHODS: From January 2008 to January 2022, 2324 patients with previous cardiac surgery underwent 2352 reoperations involving repair or replacement of multiple cardiac valves at Cleveland Clinic. Mean age was 66 ± 14 years. Number of surgical components representing surgical complexity (valve procedures, aortic surgery, coronary artery bypass grafting, and atrial fibrillation procedures) ranged from 2 to 6. Random forest for imbalanced data was used to identify risk factors for operative mortality. RESULTS: Surgery was elective in 1327 (56%), urgent in 1006 (43%), and emergency in 19 (0.8%). First-time reoperations were performed in 1796 (76%) and 556 (24%) had 2 or more previous operations. Isolated multivalve operations comprised 54% (1265) of cases; 1087 incorporated additional surgical components. Two valves were operated on in 80% (1889) of cases, 3 in 20% (461), and 4 in 0.09% (2). Operative mortality was 4.2% (98 out of 2352), with 1.7% (12 out of 704) for elective, isolated multivalve reoperations. For each added surgical component, operative mortality incrementally increased, from 2.4% for 2 components (24 out of 1009) to 17% for ≥5 (5 out of 30). Predictors of operative mortality included coronary artery bypass grafting, surgical urgency, cardiac, renal dysfunction, peripheral artery disease, New York Heart Association functional class, and anemia. CONCLUSIONS: Elective, isolated reoperative multivalve surgery can be performed with low mortality. Surgical complexity coupled with key physiologic factors can be used to inform surgical risk and decision making.

Left Ventricular Assist Device With External Iliac Artery Outflow Graft Anastomosis.

Durable left ventricular assist devices (LVADs) are a cornerstone therapy for patients with end-stage heart failure, and thus efforts to develop techniques that facilitate their use in an expanded population of patients are critical. Although the preferred outflow graft anastomosis site is the ascending aorta, alternative sites have been described including the descending thoracic and supraceliac abdominal aorta, as well as the innominate and axillary arteries. However, these vessels can be unfavorable targets in the setting of atherosclerosis, aneurysm, insufficient caliber, dissection, or complicated anatomy due to prior interventions. We present the case of a patient undergoing destination therapy LVAD implantation who had a complex surgical history leaving these targets unviable and thus necessitating selection of an alternative site. In this case, the right external iliac artery was successfully used for LVAD outflow graft anastomosis.

Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial.

IMPORTANCE: Left ventricular assist devices (LVADs) enhance quality and duration of life in advanced heart failure. The burden of nonsurgical bleeding events is a leading morbidity. Aspirin as an antiplatelet agent is mandated along with vitamin K antagonists (VKAs) with continuous-flow LVADs without conclusive evidence of efficacy and safety. OBJECTIVE: To determine whether excluding aspirin as part of the antithrombotic regimen with a fully magnetically levitated LVAD is safe and decreases bleeding. DESIGN, SETTING, and PARTICIPANTS: This international, randomized, double-blind, placebo-controlled study of aspirin (100 mg/d) vs placebo with VKA therapy in patients with advanced heart failure with an LVAD was conducted across 51 centers with expertise in treating patients with advanced heart failure across 9 countries. The randomized population included 628 patients with advanced heart failure implanted with a fully magnetically levitated LVAD (314 in the placebo group and 314 in the aspirin group), of whom 296 patients in the placebo group and 293 in the aspirin group were in the primary analysis population, which informed the primary end point analysis. The study enrolled patients from July 2020 to September 2022; median follow-up was 14 months. Intervention: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg/d) or placebo in addition to an antithrombotic regimen. MAIN OUTCOMES AND MEASURES: The composite primary end point, assessed for noninferiority (-10% margin) of placebo, was survival free of a major nonsurgical (>14 days after implant) hemocompatibility-related adverse events (including stroke, pump thrombosis, major bleeding, or arterial peripheral thromboembolism) at 12 months. The principal secondary end point was nonsurgical bleeding events. RESULTS: Of the 589 analyzed patients, 77% were men; one-third were Black and 61% were White. More patients were alive and free of hemocompatibility events at 12 months in the placebo group (74%) vs those taking aspirin (68%). Noninferiority of placebo was demonstrated (absolute between-group difference, 6.0% improvement in event-free survival with placebo [lower 1-sided 97.5% CI, -1.6%]; P < .001). Aspirin avoidance was associated with reduced nonsurgical bleeding events (relative risk, 0.66 [95% confidence limit, 0.51-0.85]; P = .002) with no increase in stroke or other thromboembolic events, a finding consistent among diverse subgroups of patient characteristics. CONCLUSIONS AND RELEVANCE: In patients with advanced heart failure treated with a fully magnetically levitated LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes VKA, is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.

Increasing surgeon experience and cumulative institutional experience drive decreasing hospital mortality after reoperative cardiac surgery.

OBJECTIVE: The study objective was to identify the effects of surgeon experience and age, in the context of cumulative institutional experience, on risk-adjusted hospital mortality after cardiac reoperations. METHODS: From 1951 to 2020, 36 surgeons performed 160,338 cardiac operations, including 32,871 reoperations. Hospital death was modeled using a novel tree-bagged, generalized varying-coefficient method with 6 variables reflecting cumulative surgeon and institutional experience up to each cardiac operation: (1) number of total and (2) reoperative cardiac operations performed by a surgeon, (3) cumulative institutional number of total and (4) reoperative cardiac operations, (5) year of surgery, and (6) surgeon age at each operation. These were adjusted for 46 patient characteristics and surgical components. RESULTS: There were 1470 hospital deaths after cardiac reoperations (4.5%). At the institutional level, hospital death decreased exponentially and became less variable, leveling at 1.2% after approximately 14,000 cardiac reoperations. For all surgeons as a group, hospital death decreased rapidly over the first 750 reoperations and then gradually decreased with increasing experience to less than 1% after approximately 4000 reoperations. Surgeon age up to 75 years was associated with ever-decreasing hospital death. CONCLUSIONS: Surgeon age and experience have been implicated in adverse surgical outcomes, particularly after complex cardiac operations, with young surgeons being novices and older surgeons having declining ability. However, at Cleveland Clinic, outcomes of cardiac reoperations improved with increasing primary surgeon experience, without any suggestion to mid-70s of an age cutoff. Patients were protected by the cumulative background of institutional experience that created a culture of safety and teamwork that mitigated adverse events after cardiac surgery.

Radiation Exposure in Extracorporeal Life Support.

Extracorporeal membrane oxygenation (ECMO) exposes patients to multiple radiologic studies. We hypothesized ECMO patients endure radiation exposure in excess of the International Commission of Radiological Protection (ICRP) recommendations of cumulative effective dose (CED, >20 mSv and 5-year cumulative limit of CED >100 mSv). We conducted a retrospective observational study in an academic medical center between January 2016 and December 2018 involving adult admissions (N = 306) on ECMO. Ionizing radiation was calculated from reference values to determine CED. Approximately 9.4% (N = 29) patients accrued CED >50 mSv and 4.5% (N = 14) accrued CED >100 mSv during ECMO. Over the entire hospitalization, 28% (N = 85) accrued >50 mSv and 14.7% (N = 45) accrued CED >100 mSv. Median CED during ECMO was 2.3 mSv (IQR, -0.82 to 8.1 mSv), and the entire hospitalization was 17.4 mSv (IQR, -4.5 to 56.6 mSv). Thirteen percent of the median CED accrued during hospitalization could be attributed to ECMO. Longer hospitalization was associated with a higher CED (50 days [IQR, -25 to 76 days] in CED >50 vs. 19 days [IQR, -10 to 32 days] in CED <50). Computer tomography (CT) scans and interventional radiology (IR) procedures contributed to 43.8% and 44.86%, respectively, of CED accrued on ECMO and 52.2% and 37.1% of CED accumulated during the whole hospitalization. Guidelines aimed at mitigating radiation exposure are urgently needed.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Outcomes of heart transplant recipients with prior left ventricular assist device associated stroke.

BACKGROUND: Left ventricular assist devices (LVADs) improve survival in patients with end-stage heart failure but are associated with ischemic stroke and intracranial hemorrhage (ICH). The impact of LVAD-associated stroke on transplant candidacy and outcomes has not been characterized. METHODS: Adult patients undergoing LVAD implantation at Cleveland Clinic between 2004 to 2021 were reviewed and patients who developed ischemic stroke or ICH were identified. Post-transplant survival analysis was performed between patients with LVAD-associated stroke vs. without. RESULTS: 917 patients had an LVAD implantation of whom 244 (median age 57, 79% male) underwent subsequent transplant including 25 with prior LVAD-associated stroke. The 1- and 2-year survival after transplant in patients with LVAD-associated stroke were 100% and 95% respectively, compared with 92% and 90% in patients without stroke (p=0.156; p=0.323) Similarly, there was no difference in stroke incidence at 1- and 2 years after transplant between patients with LVAD-associated stroke (4% and 5%) and those without prior stroke (5% and 6%, p = 0.884; p=0.744). CONCLUSIONS: In this single-center retrospective study, patients with LVAD-associated stroke were significantly less likely to undergo heart transplant, but those who underwent heart transplant had similar post-transplant outcomes as patients without history of LVAD-associated stroke. Given the similar outcomes seen in this population, history of LVAD-associated stroke should not be viewed as an absolute contraindication to subsequent heart transplant.

Transcatheter left ventriculoplasty.

Despite significant advances in pharmacological, electrophysiological and valve therapies for heart failure with reduced ejection fraction (HFrEF), the associated morbidity, mortality and healthcare costs remain high. With a constantly growing heart failure population, the existing treatment gap between current and advanced heart failure therapies (e.g., left ventricular [LV] assist devices, heart transplantation) reflects a large unmet need, calling for novel therapeutic approaches. Left ventricular remodelling and dilatation, with or without scar formation, is the hallmark of cardiomyopathy and is associated with poor prognosis. In the era of exciting advances in structural heart interventions, the advent of minimally invasive, device-based therapies directly targeting the LV geometry and promoting physical reverse remodelling has created a new frontier in the battle against heart failure. Interventional heart failure therapy is a rapidly emerging field, encompassing structural heart and minimally invasive hybrid procedures, with two left ventriculoplasty devices currently under investigation in pivotal clinical trials in the US. This review addresses the rationale for left ventriculoplasty, presents the prior surgical and percutaneous attempts in the field, provides an overview of the novel transcatheter left ventriculoplasty devices and their respective trials, and highlights potential challenges associated with establishing such device-based therapies in our armamentarium against heart failure.

Desperate Times Call for Desperate Measures: Bridging to Transplant in the Face of Central Device Infection.

Patients with durable left ventricular assist devices (LVAD) that develop central device infections can prove prohibitively challenging to treat and may require device explant for source control. In bridge to transplant (BTT) LVAD patients, the management of mediastinal infection is further complicated by changes in the 2018 United Network of Organ Sharing (UNOS) allocation system, which resulted in a comparatively lower listing status than in its previous iteration. We present the case of a 36-year-old male with nonischemic cardiomyopathy status post Heartmate 3 (HM3) implantation as BTT who after a year of stable HM3 support, developed a severe bacterial infection along the outflow graft. Despite attempts at finding a suitable donor at his current listing, his clinical status continued to deteriorate. To obtain infection source control, he underwent LVAD explant and insertion of a left axillary artery Impella 5.5 ventricular assist device for necessary hemodynamic support. The patient's listing was upgraded to Status 2, and following the identification of a suitable donor, underwent successful heart transplantation. This case highlights the limitation of the updated UNOS heart allocation system for patients with central device infections and describes the successful use of salvage temporary mechanical circulatory support to bridge to transplantation.