Biomedical subjects

John P Boehmer

Publications and source records attributed to John P Boehmer.

9 recordsLinked to original sources

PubMed2006

Initial United States experience with the Paracor HeartNet myocardial constraint device for heart failure.

OBJECTIVE: This study was undertaken to review the initial results and surgical safety data for the US Food and Drug Administration safety and feasibility trial of the Paracor HeartNet (Paracor Medical, Inc, Sunnyvale, Calif.) myocardial constraint device. METHODS: Patients with New York Heart Association functional class II or III heart failure underwent device implantation (n = 21) through a left minithoracotomy. RESULTS: The average age was 53 years (31-72 years). There were 18 men and 3 women, and 17 patients had nonischemic etiology of heart failure. Mean heart failure duration was 8.3 years (1.4-18.8 years). Average ejection fraction was 22% (11%-33%), with an average left ventricular end-diastolic dimension of 74 mm (55-94 mm). Previous medical therapy included angiotensin-converting enzyme inhibitors, beta-blockers, diuretics, digoxin, and aldosterone receptor blockers. At implantation, 17 patients had implantable electronic devices: 1 biventricular pacemaker, 11 biventricular pacemakers with cardioverter-defibrillators, and 5 implantable cardioverter-defibrillators. Patient comorbidities included hypertension in 10 cases, diabetes mellitus in 8, myocardial infarction in 1, and ventricular tachycardia in 8. Mean operative time was 68 minutes (42-102 minutes), and implantation time averaged 15 minutes (5-51 minutes). The average time to ambulation was 1.6 days (1-4 days). The intensive care unit stay averaged 3.3 days (1-16 days), and hospital stay averaged 6.3 days (4-16 days). Atrial fibrillation occurred in 2 patients, and there were 2 in-hospital deaths. CONCLUSIONS: The Paracor device can be implanted in patients with heart failure and reduced left ventricular function with a high degree of success. Significant surgical complications were infrequent. The initial US experience supports the conduct of a randomized, controlled, pivotal trial.

Adult↗

PubMed2006

Cardiac failure: mechanical support strategies.

OBJECTIVE: Mechanical support of the circulation is necessary when heart failure becomes refractory to medical support and is typically applied when organ dysfunction occurs as a result of hypoperfusion. However, in timing the intervention, it is important to apply mechanical support before multiple organ failure occurs. The objective of this work is to review the current strategies for mechanical circulatory support in patients with refractory cardiac failure. DESIGN: A review of the use of mechanical circulatory support is presented for patients with refractory cardiac failure. PATIENTS: Data are taken from human studies that were selected to best exemplify the results that may be obtained from various forms of mechanical circulatory support. INTERVENTIONS: Commonly applied forms of mechanical support include mechanical ventilatory support, intraaortic balloon counterpulsation, and hemodialysis or ultrafiltration. If these measures fail, mechanical support of the circulation with ventricular assist devices is possible in specialized centers with expertise in the implantation and management of these devices. The decision to pursue mechanical circulatory support in the critically ill patient is based on the cause of acute decompensation, the potential reversibility of the condition, and the possibility for other treatments to improve the underlying condition or, in highly selected cases, heart transplantation. Newer forms of ventricular assistance that require less surgery are becoming available and may allow use in a broader range of critically ill patients. MAIN RESULTS: There is a range of means to mechanically support the circulation in patients with advanced heart failure. CONCLUSIONS: A variety of means to support the circulation have found application in the treatment of patients with refractory heart failure. More work is required to best identify populations who will benefit from the therapy and to refine the therapy to reduce associated risks.

Acute Kidney Injury↗

PubMed2004

Prediction of heart transplant rejection with a breath test for markers of oxidative stress.

The Heart Allograft Rejection: Detection with Breath Alkanes in Low Levels study evaluated a breath test for oxidative stress in heart transplant recipients, and we report here a mathematical model predicting the probability of grade 3 rejection. The breath test divided the heart transplant recipients into 3 groups: positive for grade 3 rejection, negative for grade 3 rejection, and intermediate. The test was 100% sensitive for grade 3 heart transplant rejection when the p value was >/=0.98, and 100% specific when the p value was </=0.058; in the intermediate group, the breath test determined the probability of grade 3 rejection and the predictive value of the result.

Alkanes↗

PubMed2004

Heart allograft rejection: detection with breath alkanes in low levels (the HARDBALL study).

BACKGROUND: We evaluated a new marker of heart transplant rejection, the breath methylated alkane contour (BMAC). Rejection is accompanied by oxidative stress that degrades membrane polyunsaturated fatty acids, evolving alkanes and methylalkanes, which are excreted in the breath as volatile organic compounds (VOCs). METHODS: Breath VOC samples (n = 1,061) were collected from 539 heart transplant recipients before scheduled endomyocardial biopsy. Breath VOCs were analyzed by gas chromatography and mass spectroscopy, and BMAC was derived from the abundance of C4-C20 alkanes and monomethylalkanes. The "gold standard" of rejection was the concordant set of International Society for Heart and Lung Transplantation (ISHLT) grades in biopsies read by 2 reviewers. RESULTS: Concordant biopsies were: Grade 0, 645 of 1,061 (60.8%); 1A, 197 (18.6%); 1B, 84 (7.9%); 2, 93 (8.8%); and 3A, 42 (4.0%). A combination of 9 VOCs in the BMAC identified Grade 3 rejection (sensitivity 78.6%, specificity 62.4%, cross-validated sensitivity 59.5%, cross-validated specificity 58.8%, positive predictive value 5.6%, negative predictive value 97.2%). Site pathologists identified the same cases with sensitivity of 42.4%, specificity 97.0%, positive predictive value 45.2% and negative predictive value 96.7%. CONCLUSIONS: A breath test for markers of oxidative stress was more sensitive and less specific for Grade 3 heart transplant rejection than a biopsy reading by a site pathologist, but the negative predictive values of the 2 tests were similar. A screening breath test could potentially identify transplant recipients at low risk of Grade 3 rejection and reduce the number of endomyocardial biopsies.

Adult↗

PubMed2003

Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias.

OBJECTIVES: This study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy (CRT) when combined with an implantable cardioverter defibrillator (ICD). BACKGROUND: Long-term outcome of CRT was measured in patients with symptomatic heart failure (HF), intraventricular conduction delay, and malignant ventricular tachyarrhythmias (ventricular tachycardia/ventricular fibrillation [VT/VF]) requiring therapy from an ICD. METHODS: Patients (n = 490) were implanted with a device capable of providing both CRT and ICD therapy and randomized to CRT (n = 245) or control (no CRT, n = 245) for up to six months. The primary end point was progression of HF, defined as all-cause mortality, hospitalization for HF, and VT/VF requiring device intervention. Secondary end points included peak oxygen consumption (VO(2)), 6-min walk (6 MW), New York Heart Association (NYHA) class, quality of life (QOL), and echocardiographic analysis. RESULTS: A 15% reduction in HF progression was observed, but this was statistically insignificant (p = 0.35). The CRT, however, significantly improved peak VO(2) (0.8 ml/kg/min vs. 0.0 ml/kg/min, p = 0.030) and 6 MW (35 m vs. 15 m, p = 0.043). Changes in NYHA class (p = 0.10) and QOL (p = 0.40) were not statistically significant. The CRT demonstrated significant reductions in ventricular dimensions (left ventricular internal diameter in diastole = -3.4 mm vs. -0.3 mm, p < 0.001 and left ventricular internal diameter in systole = -4.0 mm vs. -0.7 mm, p < 0.001) and improvement in left ventricular ejection fraction (5.1% vs. 2.8%, p = 0.020). A subgroup of patients with advanced HF (NYHA class III/IV) consistently demonstrated improvement across all functional status end points. CONCLUSIONS: The CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay.

Aged↗

PubMed2003

Device therapy for heart failure.

Although pharmacologic therapy has made impressive advances in the past decade and is the mainstay of therapy for heart failure (HF), there is still a large unmet need, because morbidity and mortality remain unacceptably high. Implanted medical devices are gaining increasing utility in this group of patients and have the potential to revolutionize the treatment of HF. The majority of devices in clinical use or under active investigation in HF can be grouped into 1 of 4 categories: devices to monitor the HF condition, devices to treat rhythm disturbances, devices to improve the mechanical efficiency of the heart, and devices to replace part or all of the heart's function. There are several devices either approved or under development to monitor the HF condition, ranging from interactive weight scales to implantable continuous pressure monitors. The challenge is to demonstrate that this technology can improve patient outcomes. Pacemakers and implantable cardioverter defibrillators (ICDs) are used to treat heart rhythms in a broad range of patients with heart disease, but they now have a special place in HF management with the prophylactic use of ICDs in patients who have advanced systolic dysfunction. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II study demonstrated a 29% reduction in all-cause mortality with ICDs in patients with a history of a myocardial infarction and a left ventricular (LV) ejection fraction <0.30. LV and multisite pacing are means of improving the mechanical efficiency of the heart. The concept is to create a more coordinated contraction of the ventricles to overcome the inefficiency associated with conduction system delays, which are common in HF. The acute hemodynamic effect can be impressive and is immediate. Several studies of intermediate duration (3 to 6 months) have consistently demonstrated that biventricular pacing improves symptoms and exercise capacity. Mechanical methods of remodeling the heart into a more efficient shape have been under scrutiny for several years. New methods of restraining the heart with prosthetic material are under investigation in humans, with encouraging pilot results. Heart replacement has been evaluated clinically with LV assist devices for several decades. The Randomized Evaluation of Mechanical Assistance Therapy as an Alternative in Congestive Heart Failure (REMATCH) study has demonstrated a proof of concept for the use of mechanical blood pumps to improve survival, functional capacity, and symptoms. Several assist devices with such features as total implantability, improved durability, and smaller size are now under study; these may further improve the outcomes of patients. One year ago, the world witnessed the first clinical use of a totally implantable total artificial heart. Although the long-term outcomes were limited, the device demonstrated an impressive ability to improve organ function and extend survival in the population facing imminent death. Further development in this field is expected. The use of devices in HF now has a strong foothold, and the potential exists for substantially greater use of a broad range of devices in the near future.

Clinical Trials as Topic↗

PubMed2002

Biventricular pacing in congestive heart failure: a boost toward finer living.

With 550,000 new cases each year, congestive heart failure is a major medical problem. Several medical therapies, including digoxin, angiotensin-converting enzyme inhibitors, and beta-blockers, have reduced the number of re-hospitalizations and slowed the progression of congestive heart failure. Angiotensin-converting enzyme inhibitors, some beta-blockers, and the combination of hydralazine with nitrates have improved survival. Despite these benefits, medical therapy frequently fails to improve quality of life. Biventricular pacing has been introduced to resynchronize mechanical and electrical asynchrony frequently observed in patients with heart failure. The most recent pacing trials show an improvement in quality of life and functional class. Long-term data are needed to determine the effect of biventricular pacing on survival. The acute hemodynamic studies suggest that resynchronization pacing therapy may predict a positive long-term benefit for many patients with congestive heart failure.

Autonomic Nervous System↗

PubMedDate not supplied

Report of the first U.S. patient successfully supported long term with the LionHeart completely implantable left ventricular assist device system.

We report our first successful long-term survivor in the United States with the LionHeart (Arrow International, Inc., Reading, PA) completely implantable left ventricular assist device system. The patient was initially deemed a poor candidate for cardiac transplantation and had inotrope-dependent, end-stage cardiac failure. The patient was supported for 13 months with this system. During this period of support, the patient returned to independent living and derived obvious benefits toward his daily activities with the completely implanted system. The device proved to be reliable during this period of support. Through lifestyle modification, the patient was ultimately deemed an appropriate candidate for heart transplantation and ultimately received successful transplantation.

Activities of Daily Living↗

PubMedDate not supplied

A retrospective study of left ventricular assist device-related infections.

Left ventricular assist devices (LVADs) represent considerable technological advancements, which are increasing survival and maintaining the highest quality of life for patients with chronic heart failure. A retrospective analysis of outcomes was conducted on 90 patients during LVAD support with either a Thoratec (n = 41) or HeartMate (n = 49) device, with a median of 56 days (range 3-350 days). Device-related infections occurred in 18 of the 90 subjects (20%). A significant increase in device-related infections was noted with the HeartMate LVAD (chi 2 analysis, P < .05). The drive line was the most common site of device-related infections, accounting for 52.1%, with 31.1% occurring in the pocket and 15.1% in the LVAD itself. There was little if any correlation that existed between time spent in the hospital prior to implantation of an LVAD and the development of device-related infections.

Adolescent↗