Use of Radiation Therapy for the Treatment of Breast Cancer in 2019 Versus 2020.

Purpose: The COVID-19 pandemic disrupted medical care. Little is known about how radiation therapy (RT) ordering behavior changed during the pandemic. This study examined (1) whether there was a change in the rate at which orders for lumpectomy were followed by orders for RT and (2) whether there was a change in the percentage of RT orders for hypofractionated (HF) RT rather than conventionally fractionated (CF) RT. Methods and Materials: Prior authorization order data from 2019 and 2020, pertaining to patients with commercial and Medicare Advantage health plans, were reviewed to determine whether patients had an order for RT in the 90 days after lumpectomy and if it was for CF or HF RT. Univariate analyses were conducted using χ2 tests, and adjusted analyses were conducted using multivariate logistic regression, controlling for patient age, urbanicity, local median income, region, if the lumpectomy facility was academic, and if the lumpectomy facility was a hospital. Results: In 2019, 47.7% of included lumpectomy orders (2200/4610) were followed by an RT order within 90 days, in contrast to 45.6% (1944/4263) in 2020 (P = .048). Of the RT orders meeting this study's definition of CF or HF, 75.3% of orders placed in 2019 (1387/1843) and 79.0% of orders placed in 2020 (1261/1597) were for HF (P = .011). Adjusted analysis found patients receiving a lumpectomy order in the first quarter of 2020 had significantly reduced odds (odds ratio, 0.84; 95% CI, 0.71-0.99) of receiving an order for RT after lumpectomy, relative to those with orders placed in the first quarter of 2019. Adjusted analysis likewise found significant evidence of increased use of HF RT during the pandemic. Conclusions: In the population examined, physicians were less likely to order RT after lumpectomy in 2020 than in 2019, and if they did, were more likely to order HF RT.

An assessment of the association between patient characteristics and timely lung cancer treatment.

PURPOSE: Prior data have demonstrated relationships between patient characteristics, the use of surgery to treat lung cancer, and the timeliness of treatment. Our study examines whether these relationships were observable in 2019 in patients with Medicare Advantage health plans being treated for lung cancer. METHODS: Claims data pertaining to patients with Medicare Advantage health plans who had received radiation therapy (RT) or surgery to treat lung cancer within 90 days of diagnostic imaging were extracted. Other databases were used to determine patients' demographics, comorbidities, the urbanicity of their ZIP code, the median income of their ZIP code, and whether their treatment was ordered by a physician at a hospital. Multivariable logistic and Cox Proportional Hazards models were used to assess the association between patient characteristics, receipt of surgery, and time to non-systemic treatment (surgery or RT), respectively. RESULTS: A total of 2,682 patients were included in the analysis. In an adjusted analysis, patients were significantly less likely to receive surgery if their first ordering physician was based in a hospital, if they were older, if they had a history of congestive heart failure (CHF), if they had a history of chronic obstructive pulmonary disease, or if they had stage III lung cancer. Likewise, having stage III cancer was associated with significantly shorter time to treatment. CONCLUSIONS: Within a Medicare Advantage population, patient demographics were found to be significantly associated with the decision to pursue surgery, but factors other than stage were not significantly associated with time to non-systemic treatment.

Lung Cancer Treatment Trends During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Claims and Order Data Analysis (2019-2021).

Introduction: Lung cancer is treated using systemic therapy, radiation therapy (RT), and surgery. This study evaluates how utilization of these modalities and cancer stage at initial treatment shifted from 2019 to 2021. Methods: Claims for lung cancer treatment were extracted from the database of a national health care organization offering Medicare Advantage health plans and paired with enrollment data to determine utilization rates. Seasonally adjusted rates were trended, with monotonicity evaluated using Mann-Kendall tests. Using contemporaneous prior authorization order data, the association between year and the patient's cancer stage at the time of the initial RT or surgery order was evaluated through univariable and multivariable analyses. Results: The study considered 140.9 million beneficiary-months of data. There were negative and significantly monotonic trends in utilization of RT (p = 0.033) and systematic therapy (p = 0.003) for initial treatment between January 2020 and December 2021. Analysis of RT and surgery order data revealed that the patients were significantly (p < 0.001) more likely to have advanced (stage III or IV) cancer at the time of their surgery order in 2020 and 2021 than in 2019. After adjusting for urbanicity, age, and local income, a significant relationship between year of the initial order and presence of advanced cancer at the time of ordering was found for surgery orders placed in 2020 (p < 0.001) and 2021 (p < 0.01), but not for RT orders. Conclusions: There was a per-capita reduction in lung cancer treatment in 2020 and 2021, and patients receiving initial orders for surgery after the onset of the pandemic had more advanced cancer.

An assessment of the association between patient race and prior authorization program determinations in the context of radiation therapy.

BACKGROUND: When a physician determines that a patient needs radiation therapy (RT), they submit an RT order to a prior authorization program which assesses guideline-concordance. A rule-based clinical decision support system (CDSS) evaluates whether the order is appropriate or potentially non-indicated. If potentially non-indicated, a board-certified oncologist discusses the order with the ordering physician. After discussion, the order is authorized, modified, withdrawn, or recommended for denial. Although patient race is not captured during ordering, bias prior to and during ordering, or during the discussion, may influence outcomes. This study evaluated if associations existed between race and order determinations by the CDSS and by the overall prior authorization program. METHODS: RT orders placed in 2019, pertaining to patients with Medicare Advantage health plans from one national organization, were analyzed. The association between race and prior authorization outcomes was examined for RT orders for all cancers, and then separately for breast, lung, and prostate cancers. Analyses controlled for the patient's age, urbanicity, and the median income in the patient's ZIP code. Adjusted analyses were conducted on unmatched and racially-matched samples. RESULTS: Of the 10,145 patients included in the sample, 8,061 (79.5%) were White and 2,084 (20.5%) were Black. Race was not found to have a significant association with CDSS or prior authorization outcomes in any of the analyses. CONCLUSIONS: CDSS and prior authorization outcomes suggested similar rates of clinical appropriateness of orders for patients, regardless of race. IMPLICATIONS: Prior authorization utilizing rule-based CDSS was capable of enforcing guidelines without introducing racial bias.

A Description of Outcomes Experienced by Patients Whose Orders for Peripheral Artery Revascularization Were Reviewed by a Nondenial Prior Authorization Program.

OBJECTIVE: After a nondenial prior authorization program evaluates orders for peripheral artery revascularization (PAR), ordering physicians sometimes withdraw their orders based upon program recommendations. Some patients with withdrawn orders receive PAR if claudication does not resolve. To characterize patient outcomes under this program, we evaluated whether associations existed between the withdrawal of patients' initial PAR orders and the presence of claims for PAR and claims mentioning intermittent claudication (IC) in the following 16 weeks. METHODS: Orders for PAR placed from 1/1/19 to 9/30/19 for patients with Medicare Advantage health plans were extracted from a national healthcare organization's database. Claims data from 0 to 16 weeks following the order were reviewed to determine if patients had downstream PAR claims, or if they had emergency department or hospital claims mentioning IC. Chi-square tests were used to assess the association between order withdrawal and downstream PAR, as well as claims mentioning IC. Multivariate logistic regressions were run to assess the same, controlling for patient age, sex, urbanicity, local median income, state obesity rate, type of PAR, ordering physician specialty, and whether PAR was ordered in a hospital setting. RESULTS: Of 1588 orders meeting inclusion criteria, 71.9% (1038/1444) of authorized orders and 61.1% (88/144) of withdrawn orders were followed by PAR within 16 weeks, a significant difference (P < .01). Relatedly, 69.8% (1008/1444) of authorized orders and 70.8% (102/144) of withdrawn orders were followed by IC claims, an insignificant difference. Multivariate logistic regressions showed patients with withdrawn PAR orders had significantly lower adjusted odds of PAR (OR: 0.63; 95% CI: 0.44-0.91), but an insignificant difference in their adjusted odds of IC (OR: 1.10; CI: 0.76-1.64). CONCLUSIONS: Although patients with withdrawn PAR orders were significantly less likely to receive PAR in the subsequent 16 weeks, no association was found between withdrawn PAR orders and subsequent claims mentioning IC.

Rate of Whole-Breast Hypofractionated Radiation Therapy Before Versus After Virtual Tumor Board Implementation.

PURPOSE: The virtual tumor board (VTB) is a multidisciplinary group of specialist physicians who remotely educate the treating physician on the development of an evidence-based cancer treatment plan that will enhance patient outcomes according to the available literature. The use of hypofractionated (HF) radiation therapy (RT) is a preferred approach according to National Comprehensive Cancer Network guidelines and is encouraged by the VTB, when appropriate. MATERIALS AND METHODS: An observational, cohort study using prior authorization and claims data were conducted to show how the relative use of HF and conventional fractionated (CF) RT changed after the implementation of the VTB. Orders and claims for qualifying patients from 1 year before launch (August 2016) to 1 year after launch (August 2018) of the VTB were extracted. Claims were examined to observe which patients received CF (28-35 fractions) versus HF (15-21 fractions) RT. χ2 tests were used to assess the association between time period and the ordering and use of HF RT. Logistic regressions were used to test the association, after adjusting for the patient's age, urbanicity, local average income, and the RT modality used. RESULTS: After implementation, we observed a significantly higher percentage of orders for HF RT (60.3% [n = 1,254 of 2,079] v 53.2% [n = 1,010 of 1,899]; P < .001) and claims for HF RT (71.5% [n = 1,143 of 1,598] v 59.0% [n = 941 of 1,595]; P < .001). Relative to before implementation, the adjusted odds of an order for HF RT was 1.35 (CI, 1.19 to 1.54), and the adjusted odds of a claim for HF RT was 1.76 (CI, 1.52 to 2.04). CONCLUSION: After the VTB was implemented, there was a significant increase in HF RT orders and claims.

Successful venoplasty of superior vena cava stenosis in a patient with a total artificial heart after orthotopic heart transplantation due to primary graft failure.

BACKGROUND: With the limited number of available suitable donor hearts resulting in plateaued numbers of heart transplantations, short- and long-term mechanical circulatory support devices, including the implantation of total artificial hearts (TAHs) are modalities that are increasingly being used as treatment options for patients with end-stage heart failure. The superior vena cava syndrome has been described in this context in various disease processes. We report successful venoplasty for superior vena cava syndrome in a patient with a TAH. CASE PRESENTATION: A 65-year-old man with a history of nonischemic cardiomyopathy had received a left ventricular assist device, and then 2 years later, underwent orthotopic heart transplantation using the bicaval anastomosis technique. The postprocedural course was complicated by primary graft failure, resulting in the need for implantation of a TAH. About 5 months after TAH implantation, he started to develop complications such as volume retention, swelling of the upper extremities, and was diagnosed to have a superior vena cava syndrome. The patient underwent a successful venoplasty of his superior vena cava by interventional radiology with resolution of upper body edema, normalization of renal, and liver function. CONCLUSION: Potential fatal complications caused by catheter or wire entrapment in the right-sided mechanical valve of a TAH have been reported. We describe a safe method for the treatment of superior vena cava syndrome in patients with TAH.

The Association Between Use of Hypofractionation and Treatment Completion Among Recipients of Radiation Therapy Post-Mastectomy.

PURPOSE: Although there is some evidence to support the use of hypofractionated (HF) radiation therapy (RT) postmastectomy, it is not currently the standard of care. RT noncompletion and delayed completion have been shown to lead to inferior outcomes. This study assesses the association between the choice of an HF versus conventionally fractionated regimen and completion. METHODS AND MATERIALS: RT orders placed in 2016 and 2017 for patients with a national health plan, along with the associated claims, were extracted. Each order was assigned a target date for timely completion, as well as a date 30 days after the target, which was used to assess delayed completion. Univariate analyses and logistic regressions were conducted to test for an association between regimen and completion. A Poisson regression was used to examine the association between regimen and length of treatment delay among patients completing RT. RESULTS: Of the 743 orders meeting inclusion criteria, 56 (7.5%) were for HF. Unadjusted analyses found that the timely and delayed completion rates were significantly (P < .001) higher for patients receiving HF. The adjusted odds ratios (HF order versus CF order) were 3.96 (95% confidence interval, 2.23-7.01) for timely completion and 2.64 (95% confidence interval, 1.43-5.15) for completion within 30 days of the target. Among completers, an order for HF was significantly (P < .001) associated with less delay. CONCLUSIONS: When an HF regimen was ordered, patients were more likely to complete therapy without a delay, to complete therapy overall, and, if experiencing a delay, to experience a shorter delay.

Health Care Utilization and Pain Outcomes Following Early Imaging for Low Back Pain in Older Adults.

BACKGROUND: Professional societies have provided inconsistent guidance regarding whether older patients should receive early imaging for low back pain, in the absence of clinical indications. The study assesses the implications of early imaging by evaluating its association with downstream utilization in an elderly population. METHODS: Patients were included if they had a Medicare Advantage plan, had claims-based evidence of low back pain in 2014, and lacked conditions justifying early imaging. The outcomes examined were short-term, nonchronic, and chronic opioid use, steroid injections, and spinal surgery in the following 730 days, and persistent low back pain at 180 to 365 days. Morphine dose equivalents of opioid use was used as a measure of intensity. Logistic and γ regressions were used to assess the association between imaging in the first 6 weeks and the outcomes. RESULTS: Among the 57,293 patients meeting inclusion criteria, the mean age was 71.2, and 26,606 (46.4%) received early imaging. Early imaging was associated with increased adjusted odds of short-term (odds ratio [OR], 1.21; 95% CI, 1.15 to 1.28), nonchronic (OR, 1.78; 95% CI, 1.69 to 1.88), and chronic (OR, 1.13; 95% CI, 1.07 to 1.18) opioid use, as well as steroid injections (OR, 2.55; 95% CI, 2.28 to 2.85) and spinal surgery (OR, 3.40; 95% CI, 2.97 to 3.90). Patients that received early imaging were more likely to experience persistent pain (OR, 1.09; 95% CI, 1.05 to 1.14) and used significantly more morphine dose equivalents if they had nonchronic opioid use. CONCLUSIONS: Early imaging for low back pain in older individuals was common, and was associated with greater utilization of downstream services and persistent pain.

Adult cardiac veno-arterial extracorporeal life support (VA-ECMO): prevention and management of acute complications.

BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been shown to be a viable and effective treatment for patients suffering from refractory cardiogenic shock (rCS), which is associated with high mortality rates. Although ECMO therapy used as short-term mechanical circulatory support (MCS) has shown tremendous growth in its application over the past decade, the complication and mortality rates remain high. This retrospective study analyzes complications associated with VA-ECMO support, evaluates the use of defined protocols at a single center, and examines factors that may contribute to patient complication and mortality. METHODS: This retrospective analysis included 184 patients who were supported with ECMO from September 2014 through March 2018 at Integris Baptist Medical Center (IBMC). Descriptive statistics were generated to analyze baseline characteristics, demographics, complications, and outcomes. RESULTS: Acute myocardial infarct (AMI) was the primary etiology of this cohort (N=40; 22%). The mean age was 55±15 (median 56, range 15-84) years. All patients were inotrope and/or vasopressor dependent prior to ECMO initiation. Mean time on ECMO support was 7.8±7.9 days with median time of 6 days. Total patient days on support were 1,430. Most ECMO cannulations, 97 (52%) were performed within Integris Baptist Medical Center, with 48% done outside the hospital; 38% were performed outside of the hospital by the IBMC ECMO team, and 10.5% were performed by an outside team. Bleeding was noted to be the most common VA ECMO complication [N=41; 22.3%; 0.028 events per patient day (EPPD)]. CONCLUSIONS: A dedicated 24/7 ECMO service using a multidisciplinary team (MDT) and defined protocols in a single center is able to effectively reduce complications due to VA-ECMO support in the sickest of the sick VA-ECMO patients.

Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure.

BACKGROUND: In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure. METHODS: In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points. RESULTS: Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02). CONCLUSIONS: In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).

Presentation at computed tomography (CT) scan of the thorax and first year diagnostic and treatment utilization among patients diagnosed with lung cancer.

BACKGROUND: As Medicare expands the use of computed tomography (CT) for diagnosing lung cancer, there is increased opportunity to diagnose lung cancer in asymptomatic patients. This descriptive study characterizes the disease-specific diagnostic and treatment services that patients with a positive diagnosis following CT received, stratified by presentation at CT. METHODS: Patients who were diagnosed with lung cancer following CT in 2013, had no history of lung cancer, survived at least 1 year, were aged 55-80 years, and had Medicare Advantage insurance were included. Patients were grouped based upon presentation at CT: morbidities unrelated to lung cancer, classic lung cancer symptoms, and cancer syndromes. Patients with none of these factors were categorized into a no diagnoses/symptoms group. The type and intensity of services used in the year following the CT was reported for each group. RESULTS: 1,261 patients were included. Early treatment services were most common in the group with morbidities unrelated to lung cancer (13.7%) and least common in the cancer syndromes group (6.6%). Advanced treatment services were used by 47.3% of the cancer syndromes group versus 23.5% of the no diagnoses/symptoms group. CONCLUSIONS: The intensity of disease-specific diagnostic and treatment services varied by presentation at CT. Patients with no symptoms or morbidities at the time of CT less frequently received advanced interventions. Learning about the utilization patterns of others with a similar presentation at CT may help patients with positive lung cancer diagnoses engage in shared decision making and in norming their experiences against those of other similarly-situated patients.

Do Case Rates Affect Physicians' Clinical Practice in Radiation Oncology?: An Observational Study.

Case rate payments combined with utilization monitoring may have the potential to improve the quality of care by reducing over and under-treatment. Thus, a national managed care organization introduced case rate payments at one multi-site radiation oncology provider while maintaining only fee-for-service payments at others. This study examined whether the introduction of the payment method had an effect on radiation fractions administered when compared to clinical guidelines. The number of fractions of radiation therapy delivered to patients with bone metastases, breast, lung, prostate, and skin cancer was assessed for concordance with clinical guidelines. The proportion of guideline-based care ascertained from the payer's claims database was compared before (2011) and after (2013) the payment method introduction using relative risks (RR). After the introduction of case rates, there were no significant changes in guideline-based care in breast, lung, and skin cancer; however, patients with bone metastases and prostate cancer were significantly more likely to have received guideline-based care (RR = 2.0 and 1.1, respectively, p<0.05). For the aggregate of all cancers, the under-treatment rate significantly declined (p = 0.008) from 4% to 0% after the introduction of case rate payments, while the over-treatment rate remained steady at 9%, with no significant change (p = 0.20). These findings suggest that the introduction of case rate payments did not adversely affect the rate of guideline-based care at the provider examined. Additional research is needed to isolate the effect of the payment model and assess implications in other populations.

Factors Related to Pump Thrombosis With the Heartmate II Left Ventricular Assist Device.

BACKGROUND: Recent reports suggested that HeartMate II (HMII) thrombosis rates may be higher in implants after 2011. We characterize events at HMII centers (>100 HMII implants) whose device thrombosis rates are equivalent or lower than reported by INTERMACS. METHODS: Seven centers pooled implants from 2011 through June 2013 to examine pump thrombus and identify characteristics and clinical strategies that potentially mitigate the risk. A total of 666 patients (age 59 ± 13 years; 81% male) were studied (support duration: 13.7 ± 8.3 months, cumulative: 759 patient years). Median target INR was 2.25 (range 2.0 to 2.5), and median pump speed was 9200 rpm (range 8600 to 9600). Pump thrombus was suspected with clinical evidence (e.g., hemolysis, positive ramp test) requiring intervention (e.g., anticoagulation therapy, pump exchange) or patient death. RESULTS: Suspected pump thrombus occurred in 24/666 (3.6%) patients within three months of implant. At six months, 38/666 (5.7%) had suspected pump thrombus including 24 (3.6%) resulting in pump exchange or death. Stroke (hemorrhagic: 0.049, and ischemic: 0.048 events/patient year) and survival (six months: 88 ± 1%; 1 year: 81 ± 2%) were consistent with national averages. Suspected pump thrombus patients were younger (55 ± 13 vs. 59 ± 13, p = 0.046) and had more females (31.6% vs. 18.3%, p = 0.054). There was no difference in indication, etiology of heart failure, or body size. CONCLUSIONS: This analysis demonstrates low HMII thrombus events. Minimization of risk factors by uniform implant techniques and consistent post-op management may reduce device thrombosis. A larger scale multicenter evaluation may better elucidate the difference in thrombus events between centers.

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support).

OBJECTIVES: A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. BACKGROUND: New device technology developed in the clinical research setting requires validation in a real-world setting. METHODS: The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. RESULTS: Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. CONCLUSIONS: Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).

Effects of gamma radiation on a ventricular assist device and its percutaneous lead components.

A patient supported by a left ventricular assist device (LVAD) presented with an abdominal tumor requiring consolidative radiation therapy. To assess the effects of radiation therapy on the operation of the ventricular assist device (VAD) system and assure that the treatment would be safe for the patient with regard to the operation of the VAD system, sample equipment was irradiated and then tested for functionality. Changes in the mechanical properties of components of the percutaneous lead were measured. After testing, it was concluded that radiation therapy would not impede the operation of the pump or produce deleterious alterations of mechanical properties of the various system components. The patient underwent radiation therapy with a total dose of 2,000 cGy without evident complications. There were no observed effects on the LVAD operation nor any indication of alarms or malfunctions. Subsequently, the patient recovered adequate cardiac function for explant of the LVAD and the recovered components were also analyzed confirming the absence of alterations in material properties that would endanger patient safety.

Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support.

OBJECTIVE: The Levitronix CentriMag (Levitronix LLC, Waltham, Mass) ventricular assist system is designed for temporary left, right, or biventricular support. Advantages include ease of use, excellent reliability, and low thrombosis risk,. which may allow wider application of short-term support and improved outcomes in patients with cardiogenic shock. This multi-institutional study evaluated safety, effectiveness, and outcomes of the CentriMag in patients with cardiogenic shock. METHODS: Thirty-eight patients were supported at 7 centers. Patients included 12 after cardiotomy, 14 after myocardial infarction, and 12 with right ventricular failure after implantable left ventricular assist device placement. Devices were implanted in left (n = 8), right (n = 12), or biventricular (n = 18) configuration. Support was continued until recovery, transplantation, or implantation of long-term ventricular assist device. RESULTS: Mean support duration for the entire cohort (n = 38) was 13 days (1-60 days), with 47% of patients (18/38) surviving 30 days after device removal. Mean CentriMag biventricular support (n = 18) duration was 15 days (1-60 days), with 44% (8/18) surviving at 30 days. Mean CentriMag right ventricular support with a commercially available left ventricular assist device (n = 12) duration was 14 days (1-29 days), with 58% (7/12) surviving at 30 days. Complications included bleeding (21%), infection (5%), respiratory failure (3%), hemolysis (5%), and neurologic dysfunction (11%). There were no CentriMag or pump failures. CONCLUSIONS: In this preliminary study, the CentriMag provided short-term support for patients with cardiogenic shock with a low incidence of device-related complications and no device failures.

Impact of center volume on outcomes of left ventricular assist device implantation as destination therapy: analysis of the Thoratec HeartMate Registry, 1998 to 2005.

BACKGROUND: More than 400 patients with end-stage heart failure underwent left ventricular assist device (LVAD) implantation of LVAD as destination therapy (DT) after the US Food and Drug Administration approval of DT in 2002. Because most of these patients had surgeries at hospitals that were newly accredited, we sought to examine the impact of LVAD center volume on the outcomes of DT. METHODS AND RESULTS: From July 1998 through December 2005, a total of 377 patients underwent implantation of HeartMate I LVAD as DT at 68 centers in the United States. Using data from the Thoratec DT Registry, we examined the association between LVAD center volume at the time of surgery and 1-year survival with DT. Of the studied 377 DT recipients, 53% underwent device implantation at centers that performed 9th DT implant; P=0.009). However, the DT center volume was not an independent predictor of 1-year survival with DT when adjusted for the preoperative DT Risk Score, suggesting that other factors, such as improved candidate selection, may have accounted for the institutional learning curve. CONCLUSIONS: The institutional experience with DT may have a significant impact on outcomes of this therapy. Better selection of candidates, systemic approach to surgical and postoperative care, as well as the long-term medical management most likely all contribute to these improvements.

Outcome of noncardiac surgery in patients with ventricular assist devices.

An increasing number of patients are living with ventricular assist devices (VADs). Many of these patients will require noncardiac surgery for conditions not directly related to their VADs. The aim of this study was to assess the risks and outcomes of noncardiac surgery in these patients. Perioperative and follow-up data from patients with VADs who underwent noncardiac surgery from 1993 to 2006 were analyzed. In that period, 184 VADs were implanted in 155 patients. Thirty-seven patients (24%) subsequently underwent 59 noncardiac surgeries. The mean duration of VAD support before surgery was 229 days. Bleeding was the most common postsurgical complication (10%), necessitating reexploration in 20% of abdominal surgeries. Thirty-day mortality was 12%. No deaths were caused by direct complications of surgery. Successful transplantation occurred in 72% of bridge to transplantation patients who required noncardiac surgery, compared with 71% of these patients who did not require noncardiac surgery (relative risk 1.0, p = 0.9). The average duration of VAD support after noncardiac surgery for destination therapy patients was 324 days, most of which time was spent at home. In conclusion, outcomes after noncardiac surgery in patients with VADs are favorable, and most patients continue to benefit from the intended purpose of mechanical circulatory support after recovering from noncardiac surgery.