Partial Heart Transplantation - How to Change the System.

Partial heart transplantation is the first clinically successful approach to deliver growing heart valve implants. To date, 13 clinical partial heart transplants have been performed. However, turning partial heart transplantation into a routine procedure that is available to all children who would benefit from growing heart valve implants poses formidable logistical challenges. Firstly, a supply for partial heart transplant donor grafts needs to be developed. This challenge is complicated by the scarcity of donor organs. Importantly, the donor pools for orthotopic heart transplants, partial heart transplants and cadaver homografts overlap. Secondly, partial heart transplants need to be allocated. Factors relevant for equitable allocation include the indication, anatomical fit, recipient clinical status and time on the wait list. Finally, partial heart transplantation will require regulation and oversight, which only recently has been undertaken by the Food and Drug Administration, which regulates human cellular and tissue-based products. Overcoming these challenges will require a change in the system. Once this is achieved, partial heart transplantation could open new horizons for children who require growing tissue implants.

Days alive and out of hospital for children born with single-ventricle heart disease.

BACKGROUND: This study describes the illness burden in the first year of life for children with single-ventricle heart disease, using the metric of days alive and out of hospital to characterize morbidity and mortality. METHODS: This is a retrospective single-centre study of single-ventricle patients born between 2005 and 2021 who had their initial operation performed at our institution. Patient demographics, anatomical details, and hospitalizations were extracted from our institutional single-ventricle database. Days alive and out of hospital were calculated by subtracting the number of days hospitalized from number of days alive during the first year of life. A multivariable linear regression with stepwise variable selection was used to determine independent risk factors associated with fewer days alive and out of hospital. RESULTS: In total, 437 patients were included. Overall median number of days alive and out of hospital in the first year of life for single-ventricle patients was 278 days (interquartile range 157-319 days). In a multivariable analysis, low birth weight (<2.5kg) (b = -37.55, p = 0.01), presence of a dominant right ventricle (b = -31.05, p = 0.01), moderate-severe dominant atrioventricular valve regurgitation at birth (b = -37.65, p < 0.05), index hybrid Norwood operation (b = -138.73, p < 0.01), or index heart transplant (b = -158.41, p < 0.01) were all independently associated with fewer days alive and out of hospital. CONCLUSIONS: Children with single-ventricle heart defects have significant illness burden in the first year of life. Identifying risk factors associated with fewer days alive and out of hospital may aid in counselling families regarding expectations and patient prognosis.

Partial Heart Transplant in a Neonate With Irreparable Truncal Valve Dysfunction.

Importance: The treatment of neonates with irreparable heart valve dysfunction remains an unsolved problem because there are no heart valve implants that grow. Therefore, neonates with heart valve implants are committed to recurrent implant exchanges until an adult-sized valve can fit. Objective: To deliver the first heart valve implant that grows. Design, Setting, and Participants: Case report from a pediatric referral center, with follow-up for more than 1 year. Participants were a recipient neonate with persistent truncus arteriosus and irreparable truncal valve dysfunction and a donor neonate with hypoxic-ischemic brain injury. Intervention: First-in-human transplant of the part of the heart containing the aortic and pulmonary valves. Main Outcomes and Measures: Transplanted valve growth and hemodynamic function. Results: Echocardiography demonstrated adaptive growth and excellent hemodynamic function of the partial heart transplant valves. Conclusions and Relevance: In this child, partial heart transplant delivered growing heart valve implants with a good outcome at age 1 year. Partial heart transplants may improve the treatment of neonates with irreparable heart valve dysfunction.

Center-level factors associated with shorter length of stay following stage 1 palliation: An analysis of the national pediatric cardiology quality improvement collaborative registry.

BACKGROUND: Stage 1 single ventricle palliation (S1P) has the longest length of stay (LOS) of all benchmark congenital heart operations. Center-level factors contributing to prolonged hospitalization are poorly defined. METHODS: We analyzed data from infants status post S1P included in the National Pediatric Cardiology Quality Improvement Collaborative Phase II registry. Our primary outcome was patient-level LOS with days alive and out of hospital before stage 2 palliation (S2P) used as a balancing measure. We compared patient and center-level characteristics across quartiles for median center LOS, and used multivariable regression to calculate center-level factors associated with LOS after adjusting for case mix. RESULTS: Of 2,510 infants (65 sites), 2037 (47 sites) met study criteria (61% male, 61% white, 72% hypoplastic left heart syndrome). There was wide intercenter variation in LOS (first quartile centers: median 28 days [IQR 19, 46]; fourth quartile: 62 days [35, 95], P < .001). Mortality prior to S2P did not differ across quartiles. Shorter LOS correlated with more pre-S2P days alive and out of hospital, after accounting for readmissions (correlation coefficient -0.48, P < .001). In multivariable analysis, increased use of Norwood with a right ventricle to pulmonary artery conduit (aOR 2.65 [1.1, 6.37]), shorter bypass time (aOR 0.99 per minute [0.98,1.0]), fewer additional cardiac operations (aOR 0.46 [0.22, 0.93]), and increased use of NG tubes rather than G tubes (aOR 7.03 [1.95, 25.42]) were all associated with shorter LOS centers. CONCLUSIONS: Modifiable center-level practices may be targets to standardize practice and reduce overall LOS across centers.

Early identification of patients at risk for delayed recovery of ambulation after elective abdominal surgery.

BACKGROUND: Recovery of preoperative ambulation levels 1 month after surgery represents an important patient-centered outcome. The objective of this study is to identify clinical factors associated with the inability to regain baseline preoperative ambulation levels 28 days postoperatively. METHODS: This is a prospective cohort study enrolling patients scheduled for elective inpatient abdominal operations. Daily ambulation (steps/day) was measured with a wristband accelerometer. Preoperative steps were recorded for at least 3 full calendar days before surgery. Postoperatively, daily steps were recorded for at least 28 days. The primary outcome was delayed recovery of ambulation, defined as inability to achieve 50% of preoperative baseline steps at 28 days postoperatively. RESULTS: A total of 108 patients were included. Delayed recovery (< 50% of baseline preoperative steps/day) occurred in 32 (30%) patients. Clinical factors associated with delayed recovery after multivariable logistic regression included longer operative time (OR 1.37, 95% CI 1.05-1.79), open operative approach (OR 4.87, 95% CI 1.64-14.48) and percent recovery on POD3 (OR 0.73, 95% CI 0.56-0.96). In addition, patients with delayed ambulation recovery had increased rates of postoperative complications (16% vs 1%, p < 0.01) and readmission (28% vs 5%, p < 0.01). CONCLUSION: After elective inpatient abdominal operations, nearly one in three patients do not recover 50% of their baseline preoperative steps 28 days postoperatively. Factors that can be used to identify these patients include longer operations, open operations and low ambulation levels on postoperative day #3. These data can be used to target rehabilitation efforts aimed at patients at greatest risk for poor ambulatory recovery.

Electromagnetic interference on cardiac pacemakers and implantable cardioverter defibrillators during endoscopy as reported to the US Federal Drug Administration.

INTRODUCTION: More than 3 million patients have a cardiac implanted electronic device (CIED) such as a pacemaker or implanted cardioverter-defibrillator in the USA. These devices are susceptible to electromagnetic interference (EMI) leading to malfunction and injury. Radiofrequency energy, the most common modality for obtaining hemostasis during endoscopy, is the most common source of EMI. Few studies have evaluated the effect of endoscopic radiofrequency energy on CIEDs. We aim to characterize CIED dysfunction related to endoscopic procedures. We hypothesize that EMI from endoscopic energy can result in patient injury. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database for CIED dysfunction related to electrosurgical devices over a 10-year period (2009-2019). CIED dysfunction events were identified using seven problem codes (malfunction, electromagnetic interference, ambient noise, pacing problem, over-sensing, inappropriate shock, defibrillation). These were cross-referenced for the terms "cautery, electrocautery, endoscopy, esophagus, colonoscopy, colon, esophagoscopy, and esophagogastroduodenoscopy." Reports were individually reviewed to confirm and characterize CIED malfunction due to an endoscopic procedure. RESULTS: A search for CIED dysfunction resulted in 43,759 reports. Three hundred and eleven reports (0.7%) were associated with electrocautery, and of these, 45 reports (14.5%) included endoscopy. Ten reports involving endoscopy (22%) specified upper (3, 7%) or lower (7, 16%) endoscopy while the remainder were non-specific. Twenty-six of reports involving endoscopy (58%) suffered injury because of CIED dysfunction: Of these, 17 (65%) received inappropriate shocks, 5 (19%) had pacing inhibition with bradycardia or asystole, 3 (12%) had CIED damage requiring explant and replacement, and 1 (4%) patient suffered ventricular tachycardia requiring hospital admission. CONCLUSION: The use of energy during endoscopy can cause dysfunction of CIEDs. This most commonly results in inappropriate defibrillation, symptomatic bradycardia, and asystole. Patients with CIEDs undergoing endoscopy should undergo pre- and post-procedure device interrogation and re-programming to avoid patient injury.

Stray energy transfer in single-incision robotic surgery.

INTRODUCTION: Stray energy transfer from surgical monopolar radiofrequency energy instruments can cause unintended thermal injuries during laparoscopic surgery. Single-incision laparoscopic surgery transfers more stray energy than traditional laparoscopic surgery. There is paucity of published data concerning stray energy during single-incision robotic surgery. The purpose of this study was to quantify stray energy transfer during traditional, multiport robotic surgery (TRS) compared to single-incision robotic surgery (SIRS). METHODS: An in vivo porcine model was used to simulate a multiport or single-incision robotic cholecystectomy (DaVinci Si, Intuitive Surgical, Sunnyvale, CA). A 5 s, open air activation of the monopolar scissors was done on 30 W and 60 W coag mode (ForceTriad, Covidien-Medtronic, Boulder, CO) and Swift Coag effect 3, max power 180 W (VIO 300D, ERBE USA, Marietta, GA). Temperature of the tissue (°C) adjacent to the tip of the assistant grasper or the camera was measured with a thermal camera (E95, FLIR Systems, Wilsonville, OR) to quantify stray energy transfer. RESULTS: Stray energy transfer was greater in the SIRS setup compared to TRS setup at the assistant grasper (11.6 ± 3.3 °C vs. 8.4 ± 1.6 °C, p = 0.013). Reducing power from 60 to 30 W significantly reduced stray energy transfer in SIRS (15.3 ± 3.4 °C vs. 11.6 ± 3.3 °C, p = 0.023), but not significantly for TRS (9.4 ± 2.5 °C vs. 8.4 ± 1.6 °C, p = 0.278). The use of a constant voltage regulating generator also minimized stray energy transfer for both SIRS (0.7 ± 0.4 °C, p < 0.001) and TRS (0.7 ± 0.4 °C, p < 0.001). CONCLUSIONS: More stray energy transfer occurs during single-incision robotic surgery than multiport robotic surgery. Utilizing a constant voltage regulating generator minimized stray energy transfer for both setups. These data can be used to guide robotic surgeons in their use of safe, surgical energy.

Monopolar stray energy in robotic surgery.

INTRODUCTION: Stray energy transfer from monopolar radiofrequency energy during laparoscopy can be potentially catastrophic. Robotic surgery is increasing in popularity; however, the risk of stray energy transfer during robotic surgery is unknown. The purpose of this study was to (1) quantify stray energy transfer using robotic instrumentation, (2) determine strategies to minimize the transfer of energy, and (3) compare robotic stray energy transfer to laparoscopy. METHODS: In a laparoscopic trainer, a monopolar instrument (L-hook) was activated with DaVinci Si (Intuitive, Sunnyvale, CA) robotic instruments. A camera and assistant grasper were inserted to mimic a minimally invasive cholecystectomy. During activation of the L-hook, the non-electric tips of the camera and grasper were placed adjacent to simulated tissue (saline-soaked sponge). The primary outcome was change in temperature from baseline (°C) measured nearest the tip of the non-electric instrument. RESULTS: Simulated tissue nearest the robotic grasper increased an average of 18.3 ± 5.8 °C; p < 0.001 from baseline. Tissue nearest the robotic camera tip increased (9.0 ± 2.1 °C; p < 0.001). Decreasing the power from 30 to 15 W (18.3 ± 5.8 vs. 2.6 ± 2.7 °C, p < 0.001) or using low-voltage cut mode (18.3 ± 5.8 vs. 3.1 ± 2.1 °C, p < 0.001) reduced stray energy transfer to the robotic grasper. Desiccating tissue, in contrast to open air activation, also significantly reduced stray energy transfer for the grasper (18.3 ± 5.8 vs. 0.15 ± 0.21 °C, p < 0.001) and camera (9.0 ± 2.1 vs. 0.24 ± 0.34 °C, p < 0.001). CONCLUSIONS: Stray energy transfer occurs during robotic surgery. The assistant grasper carries the highest risk for thermal injury. Similar to laparoscopy, stray energy transfer can be reduced by lowering the power setting, utilizing a low-voltage cut mode instead of coagulation mode and avoiding open air activation. These practical findings can aid surgeons performing robotic surgery to reduce injuries from stray energy.

Wearable Technology-A Pilot Study to Define "Normal" Postoperative Recovery Trajectories.

BACKGROUND: Emerging wearable technology has the potential to quantify both preoperative and postoperative patient activity. The purpose of this study was to characterize postoperative recovery trajectories for 1 mo after common surgical procedures. MATERIALS AND METHODS: Patients included were scheduled for common elective operations. A wearable activity device was worn for at least 3 d preoperatively and 28 d postoperatively. Postoperative steps per day were compared with preoperative baseline steps, with recovery trajectories reported as a percentage of patients' baseline values. Recovery trajectories were compared between groups based on admission type and operation type. RESULTS: Two hundred ten patients were enrolled, and 143 patients (68%) completed follow-up. Patients took a median 5342 steps per day preoperatively and had significantly decreased steps on the first postoperative day, including those undergoing inguinal hernia repair (22% of baseline steps, P < 0.001). Four weeks postoperatively, steps per day had not returned to baseline in patients undergoing minimally invasive abdominal (88% of baseline, P = 0.035), open abdominal (64% of baseline, P = 0.002), and thoracic (32% of baseline, P = 0.002) operations. All groups of patients showed a rapid recovery of steps during the first postoperative week, followed by a slower return to baseline. Recovery trajectories differed based on both admission type and operation type. CONCLUSIONS: Wearable activity monitors provide useful technology for quantification of postoperative activity recovery trajectories of steps per day in comparison to preoperative activity levels, with internal validity differentiating recovery trajectories grouping by broad categorization of operation type and by admission type. Activity recovery is a patient-centered outcome that can be used for counseling as well as for intervening to improve activity levels after surgery.

Comparison of laparoscopic to open pancreaticoduodenectomy in elderly patients with pancreatic adenocarcinoma.

INTRODUCTION: The purpose of the study is to compare perioperative and survival outcomes in elderly patients undergoing laparoscopic pancreaticoduodenectomy (LPD) to those undergoing open pancreaticoduodenectomy (OPD). METHODS: Patients aged ≥ 75 years with pancreatic adenocarcinoma undergoing LPD or OPD were identified from the NCDB (2010-2013). Baseline characteristics and perioperative outcomes were compared using a χ 2 and Student's t test. The Kaplan-Meier method was used to generate survival curves, and differences were tested using a log-rank test. A multivariate cox proportional hazard model was applied to estimate the hazard ratio (HR) of LPD on overall survival (OS). RESULTS: We identified 1768 patients aged ≥ 75 years who underwent LPD (n = 248, 14.0%) or OPD (n = 1520, 86.0%). The majority of patients in the LPD group had their surgery at facilities performing less than 5 LPDs per year (n = 165, 66.5%). 90-day mortality was significantly lower in the LPD compared to the OPD (7.2 vs. 12.2%, p = 0.049). The laparoscopic conversion rate was 30% (n = 74) and was associated with higher readmission rates (13.5 vs. 8.1%), 30-day mortality (8.0 vs. 3.8%), and 90-day mortality (10.4 vs. 6.0%), but these did not reach statistical significance. Median OS was significantly longer in the LPD group (19.8 vs. 15.6 months, p = 0.022). After adjusting for patient and tumor-related characteristics, there was a trend towards improved survival in the LPD group (HR 0.85, 95% CI 0.69-1.03). CONCLUSION: The vast majority of the NCDB participating facilities perform less than 5 LPD cases per year, which was associated with an increased risk of perioperative mortality. Overall 90-day mortality was significantly lower in the LPD group and there was a trend towards improved OS in the LPD group compared to the OPD group after adjusting for patient and tumor-related characteristics. Studies with increased sample size and longer follow-up are needed before definitive conclusions can be made.