Joshua N. Baker

Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device

BACKGROUND Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. METHODS Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. RESULTS The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m(2) (p < 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg (p < 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5-7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. CONCLUSIONS In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.

Outcomes of Transcatheter and Surgical Aortic Valve Replacement in High-Risk Patients With Aortic Stenosis and Left Ventricular Dysfunction Results From the Placement of Aortic Transcatheter Valves (PARTNER) Trial (Cohort A)

Background—The Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated similar survival after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) in high-risk patients with symptomatic, severe aortic stenosis. The aim of this study was to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after TAVR and SAVR and the impact of aortic valve replacement technique on LV function. Methods and Results—The PARTNER trial randomized high-risk patients with severe aortic stenosis to TAVR or SAVR. Patients were stratified by the presence of LV ejection fraction (LVEF) <50%. All-cause mortality was similar for TAVR and SAVR at 30-days and 1 year regardless of baseline LV function and valve replacement technique. In patients with LV dysfunction, mean LVEF increased from 35.7±8.5% to 48.6±11.3% (P<0.0001) 1 year after TAVR and from 38.0±8.0% to 50.1±10.8% after SAVR (P<0.0001). Higher baseline LVEF (odds ratio, 0.90 [95% confidence interval, 0.86, 0.95]; P<0.0001) and previous permanent pacemaker (odds ratio, 0.34 [95% confidence interval, 0.15, 0.81]) were independently associated with reduced likelihood of ≥10% absolute LVEF improvement by 30 days; higher mean aortic valve gradient was associated with increased odds of LVEF improvement (odds ratio, 1.04 per 1 mm Hg [95% confidence interval, 1.01, 1.08]). Failure to improve LVEF by 30 days was associated with adverse 1-year outcomes after TAVR but not SAVR. Conclusions—In high-risk patients with severe aortic stenosis and LV dysfunction, mortality rates and LV functional recovery were comparable between valve replacement techniques. TAVR is a feasible alternative for patients with symptomatic severe aortic stenosis and LV dysfunction who are at high risk for SAVR. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

The Massachusetts General Hospital Pulmonary Embolism Response Team (MGH PERT): Creation of a Multidisciplinary Program to Improve Care of Patients With Massive and Submassive Pulmonary Embolism

Abstract New and innovative tools have emerged for the treatment of massive and submassive pulmonary embolism (PE). These novel treatments, when considered alongside existing therapy, such as anticoagulation, systemic intravenous thrombolysis, and open surgical pulmonary embolectomy, have the potential to improve patient outcomes. However, data comparing different treatment modalities are sparse, and guidelines provide only general advice for their use. Treatment decisions rest on clinician expertise and institutional resources. Because various medical and surgical specialties offer different perspectives and expertise, a multidisciplinary approach to patients with massive and submassive PE is required. To address this need, we created a novel multidisciplinary program – the Massachusetts General Hospital (MGH) Pulmonary Embolism Response Team (PERT) – which brings together multiple specialists to rapidly evaluate intermediate- and high-risk patients with PE, formulate a treatment plan, and mobilize the necessary resources to provide the highest level of care. Development of a clinical, educational, and research infrastructure, as well as the creation of a national PERT consortium, will make our experience available to other institutions and serve as a platform for future studies to improve the care of complex patients with massive and submassive PE.

Thrombectomy using suction filtration and veno-venous bypass: single center experience with a novel device.

To describe the first single center experience with a novel aspiration thrombectomy device.

A Multidisciplinary Pulmonary Embolism Response Team

Correspondence appropriately, but this business model increases the potential for intended or unintended overuse of subsequent interventions. We stand by the statement Dr Lamb and colleagues take issue with: “establishing a discounted rate as a strategy to capture patients...creates a structure that can increase harms from excessive investigation of benign nodules.” 2 The statement is not cited as evidence; it occurs in the discussion of issues regarding screening. We support mak ing screening accessible to those who need it but stand by the opinion that we need the health-care system to appropriately cover the costs of screening (not just the scan itself) with appropriate quality metrics. It would be a poor health policy decision to provide no other structure for lung cancer screening than an inherently confl icted business model with the assumption that it will always turn out to be managed well. We note that our view is consistent with federal policies enacted as part of the Health Insurance Portability and Accountability Act legislation (§ 1128A(a)(5) of the Social Security Act), which forbids gifting services to patients to garner their business. In the absence of a health-care system structure, we support the efforts of institutions, including the laudable example of the Lahey Clinic, to fi nd a way to appropriately implement screening. We believe that clarity about actual costs and potential confl icts is useful in fi nding good ways to manage these issues. We have to be careful because it can be diffi cult to navigate the thin line between superfi cial statements and attractive sound bites that are motivated primarily by a personal agenda and arguments about how it is best for us to proceed with bringing a potential signifi cant health benefi t to those who need it.

Impact of Atrial Fibrillation on Outcomes in Patients Who Underwent Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative treatment for surgical high-risk patients with severe aortic stenosis. The aim of this study was to determine the impact of atrial fibrillation (AF) on procedural outcomes. Data from 137 patients who underwent TAVR using Edwards SAPIEN valve were reviewed. The predictors of new-onset atrial fibrillation (NOAF) after the procedure were analyzed. In addition, the post-TAVR clinical outcomes and adverse events were compared according to the presence and absence of preprocedural and postprocedural AF. Previous AF was present in 49% of the patients who underwent TAVR. After the procedure, NOAF was detected in 21% of patients, and the cumulative incidence of post-TAVR AF was 60%. After TAVR, 50% of all the episodes of NOAF occurred in the initial 24 hours after the procedure. Transapical approach was observed to an important predictor of NOAF (adjusted odds ratio [OR] 5.05, 95% confidence interval [CI] 1.40 to 18.20, p = 0.013). The composite outcome of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after TAVR was significantly higher in patients with previous AF (33 of 67 vs 19 of 70, adjusted OR 2.60, 95% CI 1.22 to 5.54, p = 0.013) compared with patients who did not have previous AF. The presence of post-TAVR AF led to a prolongation in the duration of intensive care unit stay by an average of 70 hours (95% CI 25 to 114.7 hours, p = 0.002). Similarly, post-TAVR AF also led to the prolongation in the hospital stay by an average of 6.7 days (95% CI 4.69 to 8.73 days, p <0.0005). In conclusion, our study demonstrates that the presence of AF before TAVR is an important predictor of the composite end point of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after the procedure. AF after TAVR is more likely to be encountered with the transapical approach and is associated with a prolongation of intensive care unit and hospital stay.

Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF

Objectives The aims of this study were to evaluate the effect of left ventricular (LV) dysfunction on clinical outcomes after transcatheter aortic valve replacement (TAVR) and standard therapy for severe aortic stenosis (AS) and to assess LV ejection fraction (LVEF) recovery and its impact on subsequent clinical outcomes. Methods Cohort B of the Placement of AoRtic TraNscathetER Valves trial randomised 342 inoperable patients with severe AS to TAVR or standard therapy. We defined LV dysfunction as an LVEF <50% and LVEF improvement as an absolute increase in LVEF ≥10% at 30 days. Results Baseline LV dysfunction did not affect survival after TAVR but was associated with increased cardiac mortality at 1 year with standard therapy (59.3% vs 45.8% with normal LVEF; HR=1.71 (95% CI 1.08 to 2.71); p=0.02). In those with LV dysfunction, LVEF improvement occurred in 48.7% and 30.4% of TAVR and standard therapy patients, respectively (p=0.08), and was independently predicted by relative wall thickness and receipt of TAVR. LVEF improvement with standard therapy portended reduced all-cause mortality at 1 year (28.6% vs 65.6% without LVEF improvement; HR=0.32 (95% CI 0.11 to 0.93); p=0.03) but not at 2 years. Conclusions In inoperable patients with severe AS, mild-to-moderate LV dysfunction is associated with higher cardiac mortality with standard therapy but not TAVR. A subset of patients undergoing standard therapy with LV dysfunction demonstrates LVEF improvement and favourable 1-year but not 2-year survival. TAVR improves survival and should be considered the standard of care for inoperable patients with AS and LVEF >20%. Trial registration number ClinicalTrials.gov Unique Identifier #NCT00530894.

First experience with transcatheter valve-in-valve implantation for a stenotic mitral prosthesis within the United States.

A 72-year-old woman with coronary artery bypass graft surgery (CABG) with mitral valve replacement (MVR) using a 27-mm Carpentier-Edwards bioprosthesis (Edwards Lifesciences, Irvine, California) 6 years earlier was referred to our institution with severe, symptomatic prosthetic valve mitral stenosis

Successful Right Ventricular Mechanical Support After Combined Heart-Liver Transplantation

A 45-year-old male with a history of right-sided congestive heart failure associated with cirrhosis presented for combined heart-liver transplantation. At age 28 he was diagnosed with a right-sided cardiac mass. At that time he underwent a massive debulking of the mass associated with excision of the tricuspid valve. Pathology showed thrombus and a benign fibroproliferative process. After his operation he lived with severe tricuspid regurgitation, eventually leading to cardiac cirrhosis associated with recurrent ascites, pleural effusions, a chronic cough, and decreased exercise tolerance. He presented for consideration for combined heart and liver transplantation. Echocardiography performed during his transplant evaluation revealed normal left ventricular size and function, an ejection fraction of 64%, trace mitral regurgitation, and a small and hypokinetic right ventricle with only a small remnant of the tricuspid valve. There was dilation of the right ventricle and inferior vena cava with associated hepatic vein dilation. The interatrial septum was shifted toward the left, consistent with right atrial volume overload. There was evidence of a patent foramen ovale. Right and left cardiac catheterization at the time of initial evaluation demonstrated no evidence of coronary artery disease. Superior vena cava pressure was 24 mmHg, mean right atrial pressure was 26 mmHg, mean pulmonary artery pressure (PA) was 26 mmHg, and pulmonary capillary wedge pressure was 15 mmHg with spontaneous ventilation. Cardiac output was 2.45 L/min and cardiac index 1.3 L/min/m 2 by thermodilution. Pulmonary vascular resistance (PVR) was reported as 359.2 dynes·sec·cm -5 (4.49 Woods units). Liver biopsy was consistent with cirrhosis. Several attempts at radiofrequency ablation for atrial fibrillation were unsuccessful. His condition progressed such that he required intensive care management with sildenafil, intravenous milrinone (0.1 µg/kg/min), dobutamine (70 µg/min), and phenylephrine (10 µg/min) before surgery and was thus admitted to the intensive care unit and listed as status 1A for combined heart-liver transplantation. Sixty-three days after his admission, a suitable 25-year-old brain

Topical Polymyxin-Trimethoprim Prophylaxis May Decrease the Incidence of Driveline Infections in Patients With Continuous-Flow Left Ventricular Assist Devices.

This retrospective cohort study evaluated the effect of topical polymyxin-trimethoprim (poly) prophylaxis on the incidence of driveline infections (DLIs) in patients with continuous-flow left ventricular assist devices. All 84 cases implanted 2005-2014 with device support ≥30 days were reviewed; support ranged 1 m-5.2 yrs. Beginning 2008, poly was applied to the exit site with dressing changes. Sixty-five patients received poly (poly group) for duration of follow-up, 19 did not (no-poly); group baseline characteristics were similar. No patient developed side effects from poly. Nineteen DLIs (10 in no-poly) occurred; not using poly was a risk factor. 89% of poly group DLIs were superficial, 4 were culture-negative. DLI-related bacteremia occurred in 11% of no-poly group and 0% of poly group. Compared with no-poly, poly group demonstrated improved freedom from DLI by Kaplan-Meier analysis (P < 0.0001) and a 75% lower overall and 95% lower deep DLI incidence (P ≤ 0.001). Deep DLIs occurred in 31.6% of no-poly vs. 1.5% of poly patients (P = 0.0004), although mean support duration (1 yr) and % support >1 yr (38%) were similar. These findings, which should be confirmed with larger comparative studies, suggest that topical polymyxin-trimethoprim prophylaxis may be effective in preventing DLIs.