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Biomedical subjects

Eric A Rose

Publications and source records attributed to Eric A Rose.

17 recordsLinked to original sources
PubMed2006

Progress versus precision: challenges in clinical trial design for left ventricular assist devices.

New left ventricular assist devices promise fewer adverse events but, currently, only minor improvements in survival. Small (survival) treatment effects, limited patient populations, and the increasing number of left ventricular assist devices in development challenge the efficient conduct of premarketing trials (especially in destination therapy) and, maybe more importantly, hamper innovation. Novel trial designs would facilitate this process. Among a range of trial designs, we opt for small randomized trials, which would preserve the advantages of randomization and also allow for a shorter enrollment period. We also advocate an evidence shift toward postmarketing studies, with the Interagency Registry of Mechanically Assisted Circulatory Support providing a robust infrastructure.

Biomarkers↗
PubMed2005

Recommendations of the National Heart, Lung, and Blood Institute Working Group on Future Direction in Cardiac Surgery.

New surgical procedures, imaging modalities, and medical devices have improved therapy for many patients and made treatment possible for others who have had few options in the past. In February 2004, the National Heart, Lung, and Blood Institute's (NHLBI) Advisory Council proposed that the institute evaluate the status and future directions in cardiac surgery. In response to this recommendation, the NHLBI convened a working group of cardiac surgeons on May 7 and 8, 2004, to assess the state of cardiac surgery research, identify critical gaps in current knowledge, determine areas of opportunity, and obtain specific recommendations for future research activities. The working group discussed surgical revascularization, novel surgical approaches, valvular research directions, biotechnology and cell-based therapy, heart failure, imaging modalities, and barriers to clinical research and presents its recommendations here.

Cardiac Surgical Procedures↗
PubMed2005

Long-term outcomes of coronary-artery bypass grafting versus stent implantation.

BACKGROUND: Several studies have compared outcomes for coronary-artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), but most were done before the availability of stenting, which has revolutionized the latter approach. METHODS: We used New York's cardiac registries to identify 37,212 patients with multivessel disease who underwent CABG and 22,102 patients with multivessel disease who underwent PCI from January 1, 1997, to December 31, 2000. We determined the rates of death and subsequent revascularization within three years after the procedure in various groups of patients according to the number of diseased vessels and the presence or absence of involvement of the left anterior descending coronary artery. The rates of adverse outcomes were adjusted by means of proportional-hazards methods to account for differences in patients' severity of illness before revascularization. RESULTS: Risk-adjusted survival rates were significantly higher among patients who underwent CABG than among those who received a stent in all of the anatomical subgroups studied. For example, the adjusted hazard ratio for the long-term risk of death after CABG relative to stent implantation was 0.64 (95 percent confidence interval, 0.56 to 0.74) for patients with three-vessel disease with involvement of the proximal left anterior descending coronary artery and 0.76 (95 percent confidence interval, 0.60 to 0.96) for patients with two-vessel disease with involvement of the nonproximal left anterior descending coronary artery. Also, the three-year rates of revascularization were considerably higher in the stenting group than in the CABG group (7.8 percent vs. 0.3 percent for subsequent CABG and 27.3 percent vs. 4.6 percent for subsequent PCI). CONCLUSIONS: For patients with two or more diseased coronary arteries, CABG is associated with higher adjusted rates of long-term survival than stenting.

Aged↗
PubMed2004

Is the impact of hospital and surgeon volumes on the in-hospital mortality rate for coronary artery bypass graft surgery limited to patients at high risk?

BACKGROUND: Restriction of volume-based referral for CABG surgery to high-risk patients has been suggested, and earlier studies have reached different conclusions regarding volume-based referral for low-risk patients. METHODS AND RESULTS: Patients who underwent isolated CABG surgery in New York from 1997 through 1999 (n=57 150) were separated into low-risk and moderate-to-high-risk groups with a predicted probability of in-hospital death of 2% as the cutoff point. The provider volume-mortality relationship was examined for both groups. For annual hospital volume thresholds between 200 and 600 cases, the adjusted ORs of in-hospital mortality for high-volume to low-volume hospitals ranged from 0.45 to 0.77 and were all significant for the low-risk group; for the moderate-to-high-risk group, ORs ranged from 0.62 to 0.91, and most were significant. The number needed to treat at higher-volume hospitals to avoid 1 death was greater for the low-risk group (a range of 114 to 446 versus 37 to 184). As the annual surgeon volume threshold increased from 50 to 150 cases, the ORs for high- to low-volume surgeons increased from 0.43 to 0.74 for the low-risk group; for the moderate-to-high-risk group, ORs ranged from 0.79 to 0.86. Compared with patients treated by surgeons with volumes of <125 in hospitals with volumes of <600, patients treated by higher-volume surgeons in higher-volume hospitals had a significantly lower risk of death; in particular, the OR was 0.52 for the low-risk group. CONCLUSIONS: For both low-risk and moderate-to-high-risk patients, higher provider volume is associated with lower risk of death.

Coronary Artery Bypass↗
PubMed2004

A comparison of short- and long-term outcomes after off-pump and on-pump coronary artery bypass graft surgery with sternotomy.

OBJECTIVES: This study was designed to compare in-hospital mortality and complications and three-year mortality and revascularization for off-pump and on-pump coronary artery bypass graft (CABG) surgery after adjusting for patient risk. BACKGROUND: The use of off-pump CABG surgery has increased tremendously in recent years, but little is known about its long-term outcomes relative to on-pump CABG surgery, and most studies have been very small. METHODS: Short- and long-term outcomes (inpatient mortality and complications, three-year risk-adjusted mortality, and mortality/revascularization) were explored for patients who underwent off-pump CABG surgery (9135 patients) and on-pump CABG surgery (59044 patients) with median sternotomy from 1997 to 2000 in the state of New York. RESULTS: Risk-adjusted inpatient mortality was 2.02% for off-pump versus 2.16% for on-pump (p = 0.390). Off-pump patients had lower rates of perioperative stroke (1.6% vs. 2.0%, p = 0.003) and bleeding requiring reoperation (1.6% vs. 2.2%, p < 0.001) and higher rates of gastrointestinal bleeding, perforation, or infarction (1.2% vs. 0.9%, p = 0.003). Off-pump patients had lower postoperative lengths of stay (median 5 days vs. 6 days, p < 0.001). On-pump patients had higher three-year survival (adjusted risk ratio [RR] =1.086, p = 0.045) and higher freedom from death or revascularization (adjusted RR = 1.232, p < 0.001). When analyses were limited to 1999 to 2000, the two-year adjusted hazard ratio for survival was not significant (adjusted RR = 0.99, p = 0.81). CONCLUSIONS: On-pump patients experience better long-term survival and freedom from revascularization than off-pump patients. However, the survival benefit from on-pump procedures was no longer present in the last two years of the study.

Aged↗
PubMed2003

Do hospitals and surgeons with higher coronary artery bypass graft surgery volumes still have lower risk-adjusted mortality rates?

BACKGROUND: Studies that are the basis of recommended volume thresholds for CABG surgery are outdated and not reflective of recent advances in the field. This study examines both hospital and surgeon volume-mortality relations for CABG surgery through the use of a population-based clinical data set. METHODS AND RESULTS: Data from New York's clinical CABG surgery registry from 1997 to 1999 (total number of procedures, 57 150) were used to examine the individual and combined impact of annual hospital volume and annual surgeon volume on in-hospital mortality rates after adjusting for differences in severity of illness. Significantly lower risk-adjusted mortality rates occurred above all annual hospital volume thresholds between 200 and 800 and above all surgeon volume thresholds between 50 and 200. The number needed to treat (NNT) at higher-volume providers to avoid a death was minimized for a hospital threshold volume of 100 (NNT=50) and a surgeon threshold volume of 50 (NNT=118). The risk-adjusted mortality rate (RAMR) for patients undergoing surgery performed by surgeons with volumes of > or =125 in hospitals with volumes of > or =600 was 1.89%. The RAMR was significantly higher (2.67%) for patients undergoing surgery performed by surgeons with volumes of <125 in hospitals with volumes of <600. CONCLUSIONS: Higher-volume surgeons and hospitals continue to have lower risk-adjusted mortality rates, and patients undergoing surgery performed by higher-volume surgeons in higher-volume hospitals have the lowest mortality rates.

Coronary Artery Bypass↗
PubMed2003

Devices as destination therapy.

The use of circulatory support as destination therapy has been a goal for the treatment of endstage heart failure for several decades. Current investigations are evaluating several circulatory pumps with that particular objective. With continued modification of design, the current and future pumps will become more reliable and provide improved quality of life to patients in need of mechanical circulatory assistance. The new pumps on the horizon specifically address reliability, size, and cost, and are based on the centrifugal system. These devices use the Maglev (Magnetic Levitation) concept that allows for frictionless pumping, low thrombogenicity, minimal noise, and increased durability. Further research with this goal in mind and support from the federal government will be the key to the future use of circulatory assistance as destination therapy for heart failure patients. In addition, the cost-effectiveness of these devices will need to be maintained as the technology improves, as in any new technology that confronts a more intuitive option like the native heart.

Clinical Trials as Topic↗
PubMed2003

Immunologic sensitization in recipients of left ventricular assist devices.

OBJECTIVE: Left ventricular assist device implantation is associated with an increased risk of development of circulating anti-HLA class I and II antibodies (sensitization). We investigated the impact of sensitization on posttransplantation outcomes in 105 consecutive left ventricular assist device recipients. METHODS: Five hundred twenty-one consecutive adult cardiac allograft recipients between 1992 and 1999 were retrospectively studied. Of these, 105 were supported with a left ventricular assist device. Pretransplantation and posttransplantation antibody production, time to transplantation after listing, rejection, freedom from transplant coronary artery disease, and survival were evaluated by Kaplan-Meier analysis. Among sensitized left ventricular assist device recipients, 26 were treated with a pretransplantation immunomodulatory regimen consisting of intravenous immunoglobulin and cyclophosphamide. RESULTS: There were no significant differences between left ventricular assist device recipients and nonbridged recipients with respect to pretransplantation demographic characteristics and ABO and HLA matching. Among left ventricular assist device recipients, 66% (69/105) were sensitized before transplantation; in contrast, only 6% (24/399) of nonbridged recipients were sensitized (P <.001). Sensitized untreated left ventricular assist device recipients had both a prolongation of waiting time to transplantation and an increased risk of acute rejection. Pretransplantation immunomodulatory therapy reduced both the increased waiting time and the increased risk of acute rejection. However, sensitization or the use of immunomodulatory therapy in left ventricular assist device-bridged recipients did not influence posttransplantation survival relative to nonbridged recipients. CONCLUSIONS: Left ventricular assist device recipients have survival outcomes similar to those of nonbridged recipients after cardiac transplantation, despite their significantly higher immunologic risk. The reduced rate of transplantation and the increased incidence of rejection observed in sensitized left ventricular assist device recipients are prevented by immunomodulatory therapy. Sensitization will remain an important issue with increased use of left ventricular assist devices, and improved understanding of this is essential to achieve better outcomes in the management of patients with end-stage heart failure.

Actuarial Analysis↗
PubMed2003

Left ventricular assist devices as permanent heart failure therapy: the price of progress.

BACKGROUND DATA: The REMATCH trial evaluated the efficacy and safety of long-term left ventricular assist device (LVAD) support in stage D chronic end-stage heart failure patients. Compared with optimal medical management, LVAD implantation significantly improved the survival and quality of life of these terminally ill patients. To date, however, there have been no analyses of the cost related to the LVAD survival benefit. This paper addresses the cost of hospital resource use, and its predictors, for long-term LVAD patients. METHODS: Detailed cost data were available for 52 of 68 REMATCH patients randomized to LVAD therapy. We combined the clinical dataset with Medicare data, standard billing forms (UB-92), and line item bills provided directly by clinical centers. Charges were converted to costs by using the Ratio-of-Cost-to-Charges for each major resource category. RESULTS: The mean cost for the initial implant-related hospitalization was $210,187 +/- 193,295. When implantation hospitalization costs are compared between hospital survivors and nonsurvivors, the mean costs increase from $159,271 +/- 106,423 to $315,015 +/- 278,713. Sepsis, pump housing infection, and perioperative bleeding are the major drivers of implantation cost, established by regression modeling. In the patients who survived the procedure (n = 35), bypass time, perioperative bleeding, and late bleeding were the drivers of cost. The average annual readmission cost per patient for the overall cohort was $105,326. CONCLUSIONS: The cost of long-term LVAD implantation is commensurate with other life-saving organ transplantation procedures like liver transplantation. As an evolving technology, there are a number of opportunities for improvement that will likely reduce costs in the future.

Aged↗
PubMed2002

Totally endoscopic atrial septal defect repair with robotic assistance.

BACKGROUND: The development of minimally invasive cardiac surgery has been characterized by the performance of increasingly complex operations through progressively smaller incisions. Computer (robotic) enhancement has emerged as a potential facilitator of these procedures, initially by providing enhanced endoscopic camera control and, more recently, by allowing the manipulation of surgical instruments through limited thoracic incisions. This report describes the next step in this progression, namely the performance of an atrial septal defect (ASD) repair entirely through thoracoscopic port incisions. This represents the first U.S. application of robotic technology for totally endoscopic open-heart surgery. MATERIALS AND METHODS: A 33-year-old woman with a secundum atrial septal defect underwent totally endoscopic repair through four port incisions by means of the Da Vinci (Intuitive Surgical, Mountain View, CA) robotic surgical system. Cardiopulmonary bypass was achieved peripherally (femoral Estech endoaortic balloon cannula; femoral and right internal jugular venous Bio-medicus cannulae). The myocardium was protected with antegrade cold blood cardioplegia delivered through the distal port of the arterial cannula. After port insertion, the entire operation, including pericardiotomy, bicaval occlusion, atriotomy, atrial septopexy, and atrial closure, was performed by computer-aided control of a camera and two instrument arms manipulated by a surgeon seated 15 feet away. The fourth port was used for suction and suture passage by the patient-side assistant. The aortic cross-clamp time was 43 minutes, and the postoperative transesophageal echocardiogram demonstrated normal ventricular function and the absence of interatrial shunting. The patient was extubated on the night of surgery, was ambulatory within 15 hours, and was discharged on the morning of postoperative day 3, 63 hours after the procedure. At 30-day follow-up, the patient was well and without complaints, and transthoracic echocardiogram confirmed the continued absence of interatrial shunting. CONCLUSIONS: Computer-aided robotic surgical technology can be used to perform open-heart procedures with a totally endoscopic approach. The benefits of this approach may include decreased perioperative pain, decreased recovery times, and improved cosmesis and patient acceptance. Clinical trials currently in progress will demonstrate whether this technology will be of reproducible value in the management of patients with intracardiac disease on a larger scale.

Adult↗