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1.  Clinical Research Priorities in Adult Congenital Heart Disease 
International journal of cardiology  2013;171(3):351-360.
Adult congenital heart disease (ACHD) clinicians are hampered by the paucity of data to inform clinical decision-making. The objective of this study was to identify priorities for clinical research in ACHD.
A list of 45 research questions was developed by the Alliance for Adult Research in Congenital Cardiology (AARCC), compiled into a survey, and administered to ACHD providers. Patient input was sought via the Adult Congenital Heart Association at community meetings and online forums. The 25 top questions were sent to ACHD providers worldwide via an online survey. Each question was ranked based on perceived priority and weighted based on time spent in ACHD care. The top 10 topics identified are presented and discussed.
The final online survey yielded 139 responses. Top priority questions related to tetralogy of Fallot (timing of pulmonary valve replacement and criteria for primary prevention ICDs), patients with systemic right ventricles (determining the optimal echocardiographic techniques for measuring right ventricular function, and indications for tricuspid valve replacement and primary prevention ICDs), and single ventricle/Fontan patients (role of pulmonary vasodilators, optimal anticoagulation, medical therapy for preservation of ventricular function, treatment for protein losing enteropathy). In addition, establishing criteria to refer ACHD patients for cardiac transplantation was deemed a priority.
The ACHD field is in need of prospective research to address fundamental clinical questions. It is hoped that this methodical consultation process will inform researchers and funding organizations about clinical research topics deemed to be of high priority.
PMCID: PMC3940155  PMID: 24411207
Congenital Heart Disease; Tetralogy of Fallot; Transposition of the Great Arteries; Fontan Procedure; Survey
2.  Prevalence and Predictors of Gaps in Care Among Adult Congenital Heart Disease Patients (The Health, Education and Access Research Trial: HEART-ACHD) 
The goal of this project was to quantify the prevalence of gaps in cardiology care, identify predictors of gaps, and assess barriers to care among adult congenital heart disease (ACHD) patients.
ACHD patients risk interruptions in care that are associated with undesired outcomes.
Patients (≥18years) with first presentation to an ACHD clinic completed a survey regarding gaps in, and barriers to, care.
Among 12 ACHD centers, 922 subjects (54% female) were recruited. A >3 year gap in cardiology care was identified in 42%, with 8% having gaps longer than a decade. Mean age at first gap was 19.9 years. The majority of respondents had more than high school education, and knew their heart condition. Most common reasons for gaps included feeling well, unaware follow-up required, and complete absence from medical care. Disease complexity was predictive of gap in care with 59% of mild, 42% of moderate and 26% of severe disease subjects reporting gaps (p<0.0001). Clinic location significantly predicted gaps (p<0.0001) while gender, race, and education level did not. Common reasons for returning to care were new symptoms, referral from provider, and desire to prevent problems.
ACHD patients have gaps in cardiology care; the first lapse commonly occurred around 19 years, a time when transition to adult services is contemplated. Gaps were more common among subjects with mild and moderate diagnoses and at particular locations. These results provide a framework for developing strategies to decrease gaps and address barriers to care in the ACHD population.
PMCID: PMC3664125  PMID: 23542112
Congenital; access to care; barriers
5.  Sildenafil Increases Systemic Saturation and Reduces Pulmonary Artery Pressure in Patients with Failing Fontan Physiology 
Congenital heart disease  2009;4(2):107-111.
The purpose of this study was to investigate the effect of sildenafil in patients with failing Fontan physiology.
A retrospective chart review was performed to compare history and available data in patients with Fontan circulations before and after starting sildenafil. The paired and unpaired Student’s t-tests were used for statistical analyses.
Six patients at our institution with Fontan physiology, persistent symptoms of cyanosis or effusion, and poor hemodynamics as measured in the catheterization laboratory were placed on sildenafil. One patient was not included in the analysis because of insufficient length of treatment. All patients had symptoms of failing Fontan hemodynamics with either persistent cyanosis or effusions. In this group, the mean pulmonary artery pressure was greater than 15 mm Hg (17.4 ± 1.5 mm Hg) with mean estimated pulmonary vascular resistance of 3.5 ± 1.0 Wood units × m2 prior to starting sildenafil.
Sildenafil significantly increased the systemic arterial oxyhemoglobin saturation in this group (82.8 ± 7.3% pre-treatment vs. 91.0 ± 5.5% post-treatment, P = .017). In the four out of five patients who have had follow-up catheterizations, there was a significant decrease in pulmonary artery pressure (17.4 ± 1.5 mm Hg pre-treatment vs. 13.8 ± 2.1 mm Hg post-treatment, P = .018) and in estimated pulmonary vascular resistance pre- and post-sildenafil treatment (3.5 ± 1.0 Wood units × m2 pre-treatment vs. 2.0 ± 0.4 Wood units × m2 post-treatment, P = .031).
Sildenafil may be a useful adjunct to therapy in patients with failing Fontan physiology likely through its function as a pulmonary vasodilator.
PMCID: PMC3159127  PMID: 21866231
Single Ventricle; Fontan; Sildenafil; Pulmonary Vascular Resistance
6.  Performance of Cavopulmonary Palliation at Elevated Altitude 
Circulation  2008;118(14 Suppl):S177-S181.
Outcomes of patients undergoing cavopulmonary palliation for single ventricle physiology may be impacted by living at altitude, as the passive pulmonary circulation is dependent on the resistance of the pulmonary vascular bed. The objective of this study is to identify risk factors for failure of cavopulmonary palliation at elevated altitude.
Methods and Results
Between January 1995 and March 2007, 122 consecutive patients living at a mean altitude of 1600 m (range 305 to 2570) underwent a bidirectional Glenn (BDG). There was one in-hospital mortality and 7 late deaths. 52 have proceeded to the Fontan procedure. Survival after BDG was 92.4% at 5 years. Freedom from palliation failure, defined as death, transplant, BDG/Fontan takedown, or revision was 81% at 5 years. At a mean follow-up of 39.8 months, 90 patients (75%) were in New York Heart Association class I. Patients with failing cavopulmonary circulation had higher pre-BDG pulmonary artery pressure (PAP) (18.3±6.1 mm Hg versus 14.8±5.1 mm Hg, P=0.016) and higher pre-BDG transpulmonary gradient (TPG) (11.2±6.2 mm Hg versus 7.7±4.3 mm Hg, P=0.014). Post-BDG, patients with palliation failure had increased PAP (15.0±5.7 mm Hg versus 10.8±2.8 mm Hg, P=0.008) and indexed pulmonary vascular resistance (PVRI) (2.43±1.0 Wood U · m2 versus 1.52±0.9 Wood U · m2, P=0.007).
The majority of patients at moderate altitude have favorable outcomes after BDG or Fontan palliation. Risk factors for palliation failure at elevated altitude include PAP >15 mm Hg, TPG >8 mm Hg, and PVRI >2.5 Wood U · m2.
PMCID: PMC3129266  PMID: 18824752
Fontan procedure; single ventricle; altitude
7.  Gabapentin decreases morphine consumption and improves functional recovery following total knee arthroplasty 
Moderate to severe pain after total knee arthroplasty often interferes with postoperative rehabilitation and delays discharge from hospital. The present study examined the effects of a four-day postoperative gabapentin (GBP) regimen versus placebo on opioid consumption, pain scores and knee flexion, as well as adverse effects, after total knee arthroplasty.
After obtaining research ethics board approval and informed consent, 40 patients were enrolled in a randomized, single-blind, placebo-controlled, open-label study. Patients were assigned to one of five groups – preoperative placebo/postoperative placebo (G1), preoperative GBP 600 mg/postoperative placebo (G2), preoperative GBP 600 mg/postoperative GBP 100 mg three times per day (G3), preoperative GBP 600 mg/postoperative GBP 200 mg three times per day (G4) and preoperative GBP 600 mg/postoperative GBP 300 mg three times per day (G5). Postoperative GBP or placebo was continued for four days after surgery. Two hours before surgery, all patients received celecoxib 400 mg. Based on the above groupings, patients in G1 received placebo medication, whereas patients in G2, G3, G4 and G5 received gabapentin 600 mg 2 h preoperatively. All patients received femoral and sciatic nerve blocks, followed by spinal anesthesia. Beginning in the postanesthetic care unit, all patients received a regimen of celecoxib 200 mg every 12 h for four days and a patient-controlled morphine analgesia pump for 48 h.
Thirty-six patients (G1, n=7; G2, n=7; G3, n=8; G4, n=7; G5, n=7) completed the study. Data were analyzed by one-way ANOVA followed by a contrast comparing patients who received postoperative GBP (G3, G4 and G5) (n=22) with patients who received placebo postoperatively (G1 and G2) (n=14). Patients who received GBP postoperatively used significantly less patient-controlled morphine analgesia at 24 h, 36 h and 48 h (P<0.05). The postoperative GBP patients had significantly better active assisted knee flexion on postoperative days 2 and 3, with a trend toward better flexion on postoperative day 4. Patients who received GBP postoperatively reported less pruritus than patients who received placebo. There were no differences in pain scores.
These results support the use of GBP in the acute postoperative period. Further trials are needed to delineate the optimal dose, timing and duration of GBP use following surgery.
PMCID: PMC2706552  PMID: 19547761
Functional recovery; Gabapentin; Postsurgical pain; Rehabilitation
8.  Development of Protocols for Randomized Sham-Controlled Trials of Complex Treatment Interventions: Japanese Acupuncture for Endometriosis-Related Pelvic Pain 
Very little research has been conducted in the West to evaluate the clinical efficacy of Japanese acupuncture (JA). The characteristics that define and differentiate JA from Chinese acupuncture styles add specific challenges to the operationalization of treatment protocols for use in clinical trials.
To develop an ecologically valid and viable multimodal treatment intervention, including active and sham protocols, for use in a pilot randomized sham-controlled trial of a style of JA in treating endometriosis related chronic pelvic pain in adolescents and young women.
A focus group format was used to systematize the diagnostic framework, operationalize the intake, design the treatment protocols, and develop a viable and effective sham acupuncture intervention using the Streitberger device and sham moxibustion. Implementation of the treatment protocol employed the manualization process to provide flexibility of treatment while assuring replicability and standardization.
The Japanese Acupuncture Department at the New England School of Acupuncture in Newton, MA.
Completed study visit forms indicated good compliance of study practitioners with active and sham treatment protocols. The specific JA protocols used in our pilot study were well tolerated by the adolescent girls who participated in the trial. No serious adverse events were reported by any participants. Our protocols were successful in maintaining patient blinding and minimizing differences in outcome expectations between treatment groups.
Manualization provided a viable method for conforming to the interactive nature of JA treatments, yet facilitated compliance with a replicable treatment protocol. Sham controls of complex, multicomponent JA interventions pose unique challenges. The modified Streitberger needle in conjunction with sham moxibustion showed promise as a viable control in clinical trails of JA; both components of this sham protocol require further validation.
PMCID: PMC3152801  PMID: 18537469

Results 1-8 (8)