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The aim of this study was to assess the safety and efficacy of a new subxiphoid hybrid epicardial-endocardial atrial fibrillation (AF) ablation and left atrial appendage (LAA) ligation approach for the treatment of persistent AF.

Supplemental Digital Content is available in the text.This study reports the first analysis regarding cost-effectiveness of left ventricular assist device (LVAD) implantation viathoracotomy. Cost-effectiveness of LVADs implanted viathe traditional surgical approach of sternotomy has been improved through the years because of technological advances, along with understanding the importance of patient selection and postimplant management have on positively affecting outcomes. Given the positive clinical outcomes of the thoracotomy approach, we seek to study the cost-effectiveness of a centrifugal LVAD viathis less invasive approach. We developed a Markov model. Survival and quality of life inputs (QALY) for the LVAD arm were based on data from the LATERAL clinical trial. For the Medical Management arm, survival was derived from the Seattle Heart Failure Model. The heart transplant probability was derived from INTERMACS. Survival after heart transplantation used International Society for Heart and Lung Transplantation data. Cost inputs were calculated based on Medicare data and past literature. The incremental cost-effectiveness ratio was found to be $64,632 per quality adjusted life year and $57,891 per life year in the bridge to transplant indication. These results demonstrate further improvement in the overall cost-effectiveness of LVAD therapy and confirm implantation of LVADs viaa less invasive approach as being cost-effective.

Supplemental Digital Content is available in the text.Donor-derived hepatitis C (dd-HCV) infection may increase the risk of renal impairment (RI) among heart transplantation (HT) recipients. Sofosbuvir, an integral component of HCV direct-acting antivirals (DAAs) has also been linked to RI. To date, no study has examined the trends in renal function for HT recipients of dd-HCV infection and assessed safety and efficacy of Sofosbuvir-based DAAs. Between September 2016 and June 2018, 46 HCV-naive patients and one patient with a history of HCV treated pretransplant, underwent HT from HCV-positive donors (follow-up available through October 10, 2018). Patients were treated with Ledipasvir-Sofosbuvir (genotype 1) or Sofosbuvir-Velpatasvir (genotype 3) for 12 or 24 weeks; no dose adjustments were made for renal function. Data on renal function were available for 23 patients who achieved a sustained virologic response at 12 weeks after the treatment (SVR12; cohort A) and 18 patients who completed 1 year of follow-up (cohort B). Treatment of dd-HCV infection was initiated at a median of 6 weeks post-HT. In both cohorts, a nonsignificant reduction in median estimated glomerular filtration rate (eGFR; ml/min/1.73 m2) was noted (cohort A: pretransplant eGFR: 62 [interquartile range {IQR}: 1–84] to SVR12 eGFR: 49 [IQR: 37–82]; p= 0.43; cohort B: pretransplant eGFR: 65 [IQR: 54–84] to 1 year post-HT eGFR: 56 [IQR: 39–75]; p= 0.29). Pretreatment renal function had no significant impact on changes in renal function during treatment. All patients tolerated DAAs well with 100% completion rate to the assigned therapy and duration and 100% success at achieving SVR12. In this first and largest reported case series to date of HT recipients with dd-HCV infection, we observed that neither the dd-HCV infection nor its treatment with Sofosbuvir-based DAAs increased the risk of RI. Sofosbuvir-based DAAs appear safe, tolerable, and effective for HCV treatment even in presence of severe RI.

IMPORTANCE: For patients awaiting heart transplant, hepatitis C–positive donors offer an opportunity to expand the donor pool, shorten wait times, and decrease wait-list mortality. While early reported outcomes among few heart transplant recipients have been promising, knowledge of 1-year outcomes in larger cohorts of patients is critical to shared decision-making with patients about this option. OBJECTIVE: To better define the association of hepatitis C–positive donors with heart transplant volumes, wait-list duration, the transmission and cure of donor-derived hepatitis C, and morbidity and mortality at 1 year. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, single-center observational study of 80 adult (age 18 years or older) patients who underwent heart transplant using hearts from hepatitis C–positive donors between September 2016 and April 2019 at a large academic medical center. Among donors, who were considered hepatitis C–positive if results from hepatitis C antibody and/or nucleic acid testing were positive, 70 had viremia and 10 were seropositive but did not have viremia. Follow-up was available through May 15, 2019. Comparisons were drawn with patients who underwent transplant with hearts from hepatitis C–negative donors during the same period. EXPOSURES: In addition to standard posttransplant management, transplant recipients who developed donor-derived hepatitis C infection were treated with direct-acting antivirals. MAIN OUTCOMES AND MEASURES: The main outcomes included wait-list duration and 1-year survival in all patients, and for those who developed donor-derived hepatitis C, the response to direct-acting antiviral treatment. RESULTS: Of 80 patients, 57 (71.3%) were men, 55 (68.7%) were white, and 17 (26.3%) were black; the median age at transplant was 54.5 years (interquartile range, 46-62 years). Following consent to accept hearts from hepatitis C-exposed donors, the median days to heart transplant was 4 (interquartile range, 1-18). No recipients of donors with negative nucleic acid testing results (10 [12.5%]) developed donor-derived hepatitis C. Of 70 patients who were recipients of donors with positive nucleic acid testing results, 67 (95.7%) developed donor-derived hepatitis C over a median follow-up of 301 days (interquartile range, 142-617). Treatment with direct-acting antivirals was well tolerated and yielded sustained virologic responses in all treated patients. Within the cohort with infection, 1-year patient survival was 90.4%, which was not significantly different compared with the cohort without infection or with patients who received transplants from hepatitis C–negative donors during the same period. CONCLUSIONS AND RELEVANCE: In the era of direct-acting antivirals, hepatitis C–positive donors are a viable option to expand the donor pool, potentially reducing wait-list duration and mortality. In heart transplant recipients with donor-derived hepatitis C, infection is well-tolerated and curable, and 1-year survival is equivalent to that in recipients of hepatitis C–negative donors.

Supplemental Digital Content is available in the text.Anticoagulation reversal agents (ARAs) can minimize bleeding complications associated with mechanical circulatory support devices (MCSDs) explantation at the time of heart transplantation (HT); data on thromboembolic (TE) risk associated with ARAs are limited in this patient population. In this single-center study, we retrospectively analyzed 118 consecutive adults who were supported with durable MCSDs and underwent HT between May 2013 and October 2016. Patients were categorized based on intraoperative use of ARAs (recombinant factor VIIa [n=23], 4-factor prothrombin complex concentrate [n=48], or factor IX complex [n=2]) at the time of HT; these agents were used at discretion of implanting surgeons for bleeding control. The primary outcome of interest was presence of venous or systemic TE events within 3 months of HT. Multivariable logistic regression analyses were used to assess association between TE events and use of ARAs. A total of 71 (60%) patients received ARAs, and a total of 32 patients (27.1%) had TE events (25 venous [median time to diagnosis: 11.5 days; interquartile range {IQR}: 9–31 days], and 10 systemic [median time to diagnosis: 5.5 days; IQR: 4–8 days]); 26 (81.2%) of those with TE events had ARAs used at the time of HT. Multivariable analysis identified use of ARAs as an independent predictor of TE events (multivariable odds ratio: 3.06; 95% CI: 1.09–8.58; p= 0.034). Unplanned intraoperative use of ARAs to control bleeding was associated with a significantly higher risk of TE events among HT recipients bridged with durable MCSD. Future studies are required to further assess safety of these agents and their impact on patient outcomes.

Venoarterial extracorporeal membrane oxygenation has emerged as a viable treatment for patients in cardiogenic shock with biventricular failure and pulmonary dysfunction. Advances in pump and oxygenator technology, cannulation strategies, patient selection and management, and durable mechanical circulatory support have contributed to expanded utilization of this technology. However, challenges remain that require investigation to improve outcomes.

Objective Morbidity due to sternotomy continues to be a significant clinical problem. Poor approximation of the sternum may lead to complications such as sternal dehiscence, infection, and pain. A device to assist in tensioning and twisting standard steel wires during sternal closure has been developed (TORQTMsternal closure device). Manually tightened interrupted wire closures were compared with those tightened and secured with the aid of the device. Performance of the device was assessed clinically.Methods Four cardiovascular surgeons performed manual and device-assisted closures on a biofidelic model. Closure force was measured to determine the residual force and its intraoperator variation. A retrospective review of patients treated before and after the introduction of the device was conducted. Predicted and actual outcomes were compared for the two groups (manual closure and deviceassisted closure).Results Biomechanical testing measured a 75% increase in residual closure force (P< 0.001) and a significant reduction in the variability of the closure force (P= 0.045) for device-assisted closures compared with manual closures. In the retrospective study, 3 of 173 manually closed patients had sterile sternal dehiscence and 1 of 173 had a deep sternal wound infection. In the device closure group, 2 of 127 had a sterile sternal dehiscence and no deep sternal wound infections were reported. No other device-related serious adverse events were reported.Conclusions Biomechanical data showed stronger, more consistent closure forces with the device. The retrospective data attest to the performance of the device.

Objective Morbidity due to sternotomy continues to be a significant clinical problem. Poor approximation of the sternum may lead to complications such as sternal dehiscence, infection, and pain. A device to assist in tensioning and twisting standard steel wires during sternal closure has been developed (TORQTMsternal closure device). Manually tightened interrupted wire closures were compared with those tightened and secured with the aid of the device. Performance of the device was assessed clinically.Methods Four cardiovascular surgeons performed manual and device-assisted closures on a biofidelic model. Closure force was measured to determine the residual force and its intraoperator variation. A retrospective review of patients treated before and after the introduction of the device was conducted. Predicted and actual outcomes were compared for the two groups (manual closure and deviceassisted closure).Results Biomechanical testing measured a 75% increase in residual closure force (P< 0.001) and a significant reduction in the variability of the closure force (P= 0.045) for device-assisted closures compared with manual closures. In the retrospective study, 3 of 173 manually closed patients had sterile sternal dehiscence and 1 of 173 had a deep sternal wound infection. In the device closure group, 2 of 127 had a sterile sternal dehiscence and no deep sternal wound infections were reported. No other device-related serious adverse events were reported.Conclusions Biomechanical data showed stronger, more consistent closure forces with the device. The retrospective data attest to the performance of the device.

The HeartWare ventricular assist device (HVAD) is an implantable continuous-flow centrifugal pump that has allowed the development of sternal-sparing techniques, with the use of alternative outflow strategies. We compared early outcomes for patients bridged with the conventional versusalternative outflow graft strategy. From January 2013 to October 2014, 89 patients with HVAD implantation were identified. Survival was analyzed with Kaplan–Meier methods, and a log-rank test was used to compare outcomes between groups. Thirty patients (34%) had ≥1 previous sternotomy before HVAD implantation. Eight patients (27%) were approached using an alternative outflow graft technique with outflow graft connection to the descending aorta (n = 4, 50%) or left subclavian artery (n = 4, 50%), whereas 22 (73%) were implanted viaa conventional sternotomy approach with the outflow graft to the ascending aorta. Preoperative characteristics (age, Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and Lietz-Miller score) were comparable between groups (all p> 0.05). Median follow-up was 4.7 (2.8–9.3) months of support. Outcomes were comparable between conventional and alternative outflow groups; survival at 6 months was 74% for the conventional group and 83% in the alternative outflow group. An alternative outflow graft strategy can be utilized to support bridged patients with a history of prior sternotomy.

Driveline infections (DLI) are a cause of morbidity after continuous-flow left ventricular assist device (CF-LVAD) implantation. Because driveline trauma contributes to DLI, we assessed whether intraoperative placement of a temporary external anchoring suture (EAS) influenced DLI rate. We analyzed 161 consecutive patients with CF-LVAD (HMII 82; HW 79) implantation. Two groups were defined: placement of EAS (n = 85) or No EAS (n = 76). For NO EAS patients, the driveline was permanently anchored internally to the rectus fascia. Cox proportional analysis was performed to assess the effect of EAS on time to first confirmed DLI. Baseline characteristics were comparable between groups (all p= 0.3). Mean follow-up time was 0.93 years. A total of 18 (11.1%) patients developed confirmed culture positive DLI, with “first infection” rate of 0.13 events/year. Mean time to confirmed DLI was 0.69 years. Driveline infection was less likely (hazard ratio [HR] = 0.28, 0.95 confidence interval [CI] = 0.06–1.25, p= 0.056) to occur in NO EAS (2/18) then in EAS (16/18). Confirmed DLI was comparable between device types (p= 0.3). Multivariable regression adjusted for age, BMI, blood product use, device type, and diabetes showed equivocal effect of EAS (HR = 0.33, 0.95 CI = 0.07–1.54, p= 0.12). Patients with a temporary EAS may have an increased risk of confirmed DLI after device implantation.

The concept of biventricular support with durable centrifugal pumps is evolving, and the surgical strategy and best practice guidelines for implantation of right-sided devices are still unknown. We present optimal strategy for bilateral HeartWare continuous-flow ventricular assist device (HVAD) implantation in a series of four patients. Patients were implanted with the HVAD pumps simultaneously or sequentially. This report offers a perspective on surgical considerations such as right ventricular positioning, implications related to potential risks of obstruction from the tricuspid apparatus, the role if any of downsizing the outflow anastomosis, and considerations for speed adjustments. In this series, one patient died on support and three patients experienced pump thrombosis requiring device revision. All other patients survived until orthotopic heart transplantation, although one of these patients died from perioperative complications, 2 days posttransplantation. Surgical management of patients with medically refractory biventricular heart failure remains challenging and associated with a high incidence of pump thrombosis. Best practice guidelines from experts’ consensus are still needed to address this challenging population.

Background:Much is known about the short-term risks of stroke following cardiac surgery. We examined the rate and predictors of long-term stroke in a cohort of patients who underwent cardiac surgery.Methods:We obtained linked data for patients who underwent cardiac surgery in the province of Ontario between 1996 and 2006. We analyzed the incidence of stroke and death up to 2 years postoperatively.Results:Of 108 711 patients, 1.8% (95% confidence interval [CI] 1.7%–1.9%) had a stroke perioperatively, and 3.6% (95% CI 3.5%–3.7%) had a stroke within the ensuing 2 years. The strongest predictors of both early and late stroke were advanced age (≥ 65 year; adjusted hazard ratio [HR] for all stroke 1.9, 95% CI 1.8–2.0), a history of stroke or transient ischemic attack (adjusted HR 2.1, 95% CI 1.9–2.3), peripheral vascular disease (adjusted HR 1.6, 95% CI 1.5–1.7), combined coronary bypass grafting and valve surgery (adjusted HR 1.7, 95% CI 1.5–1.8) and valve surgery alone (adjusted HR 1.4, 95% CI 1.2–1.5). Preoperative need for dialysis (adjusted odds ratio [OR] 2.1, 95% CI 1.6–2.8) and new-onset postoperative atrial fibrillation (adjusted OR 1.5, 95% CI 1.3–1.6) were predictors of only early stroke. A CHADS2score of 2 or higher was associated with an increased risk of stroke or death compared with a score of 0 or 1 (19.9% v. 9.3% among patients with a history of atrial fibrillation, 16.8% v. 7.8% among those with new-onset postoperative atrial fibrillation and 14.8% v. 5.8% among those without this condition).Interpretation:Patients who had cardiac surgery were at highest risk of stroke in the early postoperative period and had continued risk over the ensuing 2 years, with similar risk factors over these periods. New-onset postoperative atrial fibrillation was a predictor of only early stroke. The CHADS2score predicted stroke risk among patients with and without atrial fibrillation.

The greatest priority in treating atrial fibrillation (AF) is stroke prevention. There are now 3 main approaches to prevention: (1) oral anticoagulation (OAC), (2) eradication of AF, and (3) exclusion of the left atrial appendage (LAA) from the systemic circulation. The goal of this article is to review these approaches, with particular emphasis on nonpharmacologic methods and their role in light of current evidence. OAC is effective but is limited by major bleeding, physician and patient reluctance to use anticoagulants, and patient noncompliance. Eradication of AF with antiarrhythmic drugs has not been effective, and suppression with ablation has not yet been properly tested for stroke prevention. Finally, occlusion of the LAA is promising, but definitive evidence of efficacy for stroke prevention is lacking. Trials such as WATCHMAN LAA System for Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation vs Long-Term Warfarin Therapy (PREVAIL) provide the best quality evidence for LAA device closure, with results suggesting noninferiority to OAC. Surgical trials have yet to show the efficacy of LAA occlusion for stroke prevention. This review highlights the evidence behind each of these approaches and concludes that to date OAC remains the standard for stroke prevention in AF. Future trials will need to address novel OAC therapy when comparing them with LAA exclusion, and large randomized trials will be required to ascertain indications for nonpharmacologic therapy in current practice.

Supplemental Digital Content is available in the text.

A 49-year-old female with congenitally corrected (or levo-) transposition of the great arteries complicated by nonischemic cardiomyopathy presented for worsening heart failure despite guideline-directed medical therapy and was found to be in cardiogenic shock. She successfully underwent ventricular assist device placement with a HeartMate III to her systemic right ventricle as a bridge to transplantation.

Supplemental Digital Content is available in the text.