Michael H. Salinger

Increased Risk of Fracture in Patients Receiving Solid Organ Transplants

The success of organ transplantation is related to advances in immunosuppressive therapy. These medications are associated with medical complications including bone damage. The objective of this study was to estimate and compare age, gender‐specific fracture incidence between transplant recipients, and a large sample representative of the civilian noninstitutionalized United States population using the 1994 National Health Interview Survey (NHIS). This was a cohort study set in tertiary care centers. Five hundred and thirty‐nine individuals who received abdominal organ and 61 heart transplants surviving at least 30 days at our institution from 1986 to 1996 were included in the study. Incident fractures were ascertained by mail, in‐person interview, telephone survey, or medical record review. All fractures were verified. Organ‐, age‐, and gender‐specific fracture numbers and rates and person‐years of observation, were calculated for the transplant patients. Weighted age‐ and gender‐specific fracture rates from the 1994 NHIS were applied to the number of person‐years of observation for each organ‐specific age and gender category of transplant patients to generate an expected number of fractures. The ratio of observed to expected number of fractures was used to compare fracture experience of transplant patients to that of the national sample from the 1994 NHIS. Fifty‐six of 600 (9.3%) patients had at least one fracture following 1221 person‐years of observation. The sites of initial symptomatic fracture were as follows: foot (n = 22), arm (n = 8), leg (n = 7), ribs (n = 6), hip (n = 4), spine (n = 3), fingers (n = 3), pelvis (n = 2), and wrist (n = 1). Fracture incidence was 13 times higher than expected in male heart recipients age 45–64 years; nearly 5 times higher in male kidney recipients age 25–44 and age 45–64 years; and 18 times and 34 times higher in female kidney recipients age 25–44 years and 45–64 years compared with NHIS data. We have shown an increased incidence of fractures and estimated the magnitude of this problem in patients undergoing solid organ transplantation. Our work defines the need for a long‐term prospective study of fracture risk in these patients.

Role of heparin after intravenous thrombolytic therapy for acute myocardial infarction.

The optimal approach to management of patients after thrombolytic therapy for acute myocardial infarction (AMI) is unclear. The role of anticoagulation with heparin was evaluated in 75 consecutive patients who received intravenous streptokinase for AMI. Heparin therapy was titrated to keep the partial thromboplastin time (PTT) between 90 and 120 seconds. Seventeen episodes of definite myocardial ischemia (associated with reversible electrocardiographic changes) were observed in 13 patients. When episodes of probable myocardial ischemia are included (typical chest pain relieved by nitroglycerin or associated with more than a 15-mm Hg change in blood pressure but without electrocardiographic changes), 52 episodes occurred in 28 patients. Four episodes of definite and 4 of probable myocardial ischemia occurred within 24 hours of discontinuation of heparin. Analysis of the level of anticoagulation as assessed by PTT at the time of the ischemic events shows that ischemia occurred more often at lower PTTs. Nine hemorrhagic complications occurred, all within 24 hours of streptokinase infusion. In 4 patients bleeding was believed to be major and heparin administration was discontinued; 2 patients with gastrointestinal bleeding required blood transfusions. Our data suggest that after thrombolytic therapy for AMI, the level of anticoagulation is inversely related to the frequency of recurrent ischemic events; that discontinuation of heparin is frequently associated with ischemia; and that administration of heparin is associated with a low incidence of hemorrhagic complications.

Percutaneous balloon aortic valvuloplasty: Antegrade transseptal vs. conventional retrograde transarterial approach

Percutaneous balloon aortic valvuloplasty (BAV) has been limited predominantly to a palliative treatment for poor surgical candidates with critical aortic stenosis and multiple high‐risk or comorbid conditions. The most commonly used technique for BAV is the retrograde approach, in which the balloon is passed via the femoral artery using 12–14 Fr sheaths. We compared an antegrade transseptal approach using the Inoue balloon vs. the retrograde transarterial approach using conventional balloons. The antegrade group had an improved acute hemodynamic outcome, including 20% additional increase of aortic valve area and 20% greater reduction of transaortic valve gradient compared to the retrograde approach. Preclosure with the Perclose device was used for the 14 Fr venous access sites, resulting in immediate hemostasis, minimizing the need for transfusion, and diminishing the period of bed rest. The improved acute efficacy and relative ease of venous access for the antegrade approach facilitate BAV by eliminating the need for large‐caliber arterial access sheaths. The antegrade approach also incorporates technical elements necessary for percutaneous aortic valve replacement and may have expanded applications as an adjunct to this developing therapy. The impact of improved acute results on the long‐term clinical outcome for this patient group will require further study. Catheter Cardiovasc Interv 2005;64:314–321.

Technique of temporary subcutaneous “Figure-of-eight” sutures to achieve hemostasis after removal of large-caliber femoral venous sheaths†

Over the last decade, significant advances have been made in percutaneous treatment of structural heart diseases. Many of these interventions require insertion of large caliber sheaths in the femoral veins. Manual compression, compression devices, and various closure devices have been used for removal of large‐sized venous sheaths. Here, we describe the use of a temporary subcutaneous “Figure‐of‐Eight” suture technique for venous access site closure after removal of large‐caliber sheaths.

Successful closure of a giant true saphenous vein graft aneurysm using the Amplatzer vascular plug

An 85‐year‐old man was found to have a 9 cm diameter true aneurysm of an obtuse marginal saphenous vein graft. The graft was fed by a relatively narrow neck from the proximal remnant of the obtuse marginal graft 10 years after prior coronary artery bypass graft surgery. An Amplatzer vascular plug was used successfully to occlude the neck of the aneurysm. Follow‐up CT scan 1 month afterward demonstrated retained contrast in the aneurysm, demonstrating complete occlusion between the aorta and aneurysm sac. Pressure recordings from within the aneurysm sac suggest bidirectional flow in the neck as the mechanism for the maintained patency of the aneurysm. The use of a vascular plug is an effective method for aneurysm occlusion when the anatomy is suitable.

Cardiac MRI documented left ventricular thrombus complicating acute takotsubo syndrome: an uncommon dilemma

Transient left ventricular apical hypokinesis results in a typical ampullary shape and has been described as Takotsubo cardiomyopathy (TCM). We report a case of TCM with the rare complication of left ventricular thrombus formation. Cardiac magnetic resonance imaging aided the diagnosis by characterizing the non-enhancing mass and evaluating the surrounding myocardium for scarring.

Short-term results of alcohol septal ablation as a bail-out strategy to treat severe left ventricular outflow tract obstruction after transcatheter mitral valve replacement in patients with severe mitral annular calcification

To evaluate the outcomes of the early experience of percutaneous alcohol septal ablation in patients with severe left ventricular outflow tract (LVOT) obstruction post transcatheter mitral valve replacement (TMVR).

Low profile vascular plugs for paravalvular leaks after TAVR.

Paravalvular leak (PVL) after transcatheter aortic valve replacement (TAVR) is associated with less good outcomes. The use of percutaneous plugs is among the strategies to treat PVL after TAVR. Plugs have been limited by the need to pass 4–6 F delivery sheaths between the TAVR stent frame and the native valve leaflets.

Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis: The REPRISE III randomized clinical trial

Importance Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, −∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, −10.1%; Farrington-Manning 97.5% CI, −∞ to −4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, −6.1%; 95% CI, −9.6% to −2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, −10.2%; 95% CI, −16.3% to −4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients. Trial Registration ClinicalTrials.gov Identifier: NCT02202434

Percutaneous closure of an aorta to left atrium fistula with an Amplatzer duct occluder

We describe percutaneous closure of an unusual paravalvular leak, with a communication from the noncoronary cusp of the aortic valve to the left atrium adjacent to a St. Jude mitral valve prosthesis, in the absence of an infection. The patient presented with worsening dyspnea and edema. The anatomic location of the valve annulus adjacent to the noncoronary cusp underlies the etiology of this communication. Outcomes from surgical repair are associated with high mortality. We performed percutaneous closure of the defect, using general anesthesia and transesophageal echo guidance. An Amplatzer duct occluder was placed in the fistula, with immediate and complete closure of the shunt. While no devices specific for closure of paravalvular leaks have been designed, growing experience with a variety of devices and the use of echo guidance have allowed successful therapy in many complex cases.