Pericardiocentesis Under Continuous Ultrasonographic Guidance Using a 7 cm Micropuncture Needle.

OBJECTIVES: To compare procedural success and safety of pericardiocentesis using continuous ultrasonographic visualization of a long (7 cm) micropuncture needle to standard access with an 18 gauge needle without continuous ultrasound guidance. BACKGROUND: Current approaches to pericardiocentesis commonly utilize a large-bore 18 gauge needle for access without allowing for continuous visualization of needle entry into the pericardial space. METHODS: We included all consecutive patients at our institution who underwent pericardiocentesis between November 1, 2011 and March 3, 2016. A total of 21 patients (group 1) underwent pericardiocentesis using a 7 cm micropuncture needle inserted under continuous ultrasonographic guidance, while 51 patients (group 2) underwent pericardiocentesis, mostly with an 18 gauge needle (92%), following preprocedural echocardiography only. The primary endpoint was successful placement of a drain into the pericardial space. RESULTS: The primary endpoint was similar between group 1 and group 2 (100% vs 94%, respectively; P=.26). Successful drainage of pericardial fluid was achieved in 95% of patients in group 1 and in 98% in group 2 (P=.88). The amount of pericardial fluid drained in each group was similar (640 mL vs 557 mL, respectively; P=.26). No procedure-related complications occurred in group 1, compared with 2 cases of right ventricular perforation that occurred in group 2. In-hospital mortality and length of stay were similar. CONCLUSION: This study suggests that an ultrasound-mounted micropuncture needle allows for safe and effective pericardiocentesis. This technique may provide a safer alternative to the standard use of an 18 gauge needle.

Study design and rationale of the heterotopic implantation of the Edwards-Sapien XT transcatheter valve in the inferior VEna cava for the treatment of severe tricuspid regurgitation (HOVER) trial.

BACKGROUND: Tricuspid regurgitation (TR) is an under treated disease. Although surgery for TR remains an effective therapy, many patients are considered to be at a high risk or otherwise inoperable. Caval valve implant (CAVI) offers an alternative to surgery in these patients. Trials assessing the safety and efficacy of caval valve implant are lacking. METHODS: The Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna cava for the treatment of severe Tricuspid Regurgitation (HOVER) trial is an FDA approved, physician initiated, prospective, non-blinded (open label), non-randomized safety and feasibility study to determine the safety and efficacy of the heterotopic implantation of the Edwards-Sapien XT valve in the inferior vena cava for the treatment of severe TR in patients who are at high risk or inoperable. Patients with severe TR in the absence of severe pulmonary hypertension will be recruited. They will be evaluated by a multi-disciplinary team who will agree by consensus that the patients' symptoms are from TR. They will undergo imaging to assess the size of the inferior vena cava (IVC) to determine feasibility of the procedure. If patients meet the inclusion criteria and are free from exclusion criteria, after informed consent they will be eligible for enrollment in the study. A total of 30 patients will be enrolled. The primary objective of the study will be to demonstrate procedural success at 30-days and patient success at 1-year. CONCLUSION: Caval valve implant may present an alternative for patients who are at high risk or inoperable for tricuspid valve surgery (TVS) for TR. © 2016 Wiley Periodicals, Inc.

Radial artery avulsion--a rare complication of transradial catheterization.

Transradial access is becoming the default mode of catheterization in a growing number of centers in the United States. The increasing utilization of transradial access has led to significant reduction in access site complications especially bleeding complications. We report a rare complication of transradial catheterization of radial artery avulsion, which was successfully treated in an endovascular fashion during the index procedure. © 2014 Wiley Periodicals, Inc.

Trends in major entry site complications from percutaneous coronary intervention (from the Dynamic Registry).

Several factors contribute to the risk of percutaneous coronary intervention-related major entry site (MES) complications. We sought to examine the trends in MES among unselected patients during the stent era. Data from the Dynamic Registry including 5 distinct recruitment waves from 1997 to 2006 (n = 10,932) were used to assess baseline characteristics and MES among consecutive patients undergoing percutaneous coronary intervention. MES was defined as bleeding requiring transfusion, pseudoaneurysm, arterial thrombosis or dissection, vascular complication requiring surgery, or retroperitoneal bleed. Uncomplicated hematomas were not included. Several trends were observed in baseline characteristics including an increase from wave 1 to wave 5 in body mass index >30 kg/m(2) (30.2% to 40.4%), renal disease (3.5% to 9.1%), diabetes (28.0% to 34.1%), and hypertension (59.4% to 78%; ptrend <0.001 for all). The use of a thienopyridine increased significantly from wave 1 (49.7%) to wave 5 (84%), whereas glycoprotein IIb/IIIa inhibitor use peaked in wave 3 (53.1%) and then decreased (p <0.001). Access site was predominately femoral, but radial access increased over time (0.3% wave 1, 6.6% wave 5, p ≤0.0001). The rates of MES (2.8% to 2.2%, ptrend = 0.01) and MES requiring transfusion (2.0% to 0.74%, ptrend <0.001) were low and decreased with time. The trend in less risk for MES in later time periods remained after adjustment. In conclusion, MES has decreased over time; however, opportunity for bleeding avoidance strategies still exists.

Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks.

OBJECTIVES: The purpose of this study was to evaluate the feasibility and efficacy of the percutaneous device closure of a consecutive series of patients with periprosthetic paravalvular leaks referred to our structural heart disease center with congestive heart failure and hemolytic anemia. BACKGROUND: Clinically significant periprosthetic paravalvular leak is an uncommon but serious complication after surgical valve replacement. Percutaneous closure has been utilized as an alternative to surgical repair of this defect in high-risk surgical patients. METHODS: This is a retrospective review of 57 percutaneous paravalvular leak closures that were performed in 43 patients (67% male, mean age 69.4 ± 11.7 years) between April 2006 and September 2010. Integrated imaging modalities were used for the evaluation, planning, and guidance of the interventions. RESULTS: Closure was successful in 86% of leaks and in 86% of patients. Twenty-eight of 35 patients improved by at least 1 New York Heart Association functional class. The percentage of patients requiring blood transfusions and/or erythropoietin injections post-procedure decreased from 56% to 5%. Clinical success was achieved in 89% of the patients in whom procedure was successful. The survival rates for patients at 6, 12, and 18 months after paravalvular leak closures were 91.9%, 89.2%, and 86.5%, respectively. Freedom from cardiac-related death at 42 months post-procedure was 91.9%. CONCLUSIONS: Percutaneous closure of symptomatic paravalvular leaks, facilitated by integrated imaging modalities has a high rate of acute and long-term success and appears to be effective in managing symptoms of heart failure and hemolytic anemia.

Percutaneous closure of left ventricular pseudoaneurysm.

BACKGROUND: Left ventricular pseudoaneurysm is a rare but serious complication from myocardial infarction and cardiac surgery. Although standard treatment is surgical intervention, percutaneous closure of left ventricular pseudoaneurysm has become an option for high-risk surgical candidates. Experience with percutaneous treatment is limited to a few single case reports. This is the first series of percutaneous treatment of the left ventricular pseudoaneurysms. METHODS AND RESULTS: This is a retrospective analysis of 9 procedures of percutaneous repair of left ventricular pseudoaneurysm in 7 consecutive patients (ages 51 to 83 years, 6 men) completed in our Structural Heart Disease center from June 2008 to December 2010. All patients were considered as a high risk for surgery because of multiple comorbidities. Multiple imaging modalities were used before, during, and after the procedures to improve success and efficacy. The left ventricular pseudoaneurysms of all 7 patients were successfully repaired. Fluoroscopy time on average was 36.5±24.0 minutes (range, 12.4 to 75.7 minutes). All patients were followed up for a period ranging from 3 to 32 months after the procedure. Each patient improved by at least 1 New York Heart Association functional class, and 4 patients improved by 2 classes. CONCLUSIONS: Transcatheter closure of the left ventricular pseudoaneurysm is a feasible alternative for high-risk surgical candidates. The use of multiple imaging modalities is required for a detail planning and execution of the procedure.

Temporal trends in patient-reported angina at 1 year after percutaneous coronary revascularization in the stent era: a report from the National Heart, Lung, and Blood Institute-sponsored 1997-2006 dynamic registry.

BACKGROUND: Percutaneous coronary intervention (PCI) has witnessed rapid technological advancements, resulting in improved safety and effectiveness over time. Little, however, is known about the temporal impact on patient-reported symptoms and quality of life after PCI. METHODS AND RESULTS: Temporal trends in post-PCI symptoms were analyzed using 8879 consecutive patients enrolled in the National Heart, Lung, and Blood Institute-sponsored Dynamic Registry (wave 1: 1997 [bare metal stents], wave 2: 1999 [uniform use of stents], wave 3: 2001 [brachytherapy], wave 4, 5: 2004, 2006 [drug eluting stents]). Patients undergoing PCI in the recent waves were older and more often reported comorbidities. However, fewer patients across the waves reported post-PCI angina at one year (wave 1 to 5: 24%, 23%, 18%, 20%, 20%; P(trend)<0.001). The lower risk of angina in recent waves was explained by patient characteristics including use of antianginal medications at discharge (relative risk [95% CI] for waves 2, 3, 4 versus 1: 1.0 [0.9 to 1.2], 0.9 [0.7 to 1.1], 1.0 [0.8 to 1.3], 0.9 [0.7 to 1.1]). Similar trend was seen in the average quality of life scores over time (adjusted mean score for waves 1 to 5: 6.2, 6.5, 6.6 and 6.6; P(trend)=0.01). Other factors associated with angina at 1 year included younger age, female gender, prior revascularization, need for repeat PCI, and hospitalization for myocardial infarction over 1 year. CONCLUSIONS: Favorable temporal trends are seen in patient-reported symptoms after PCI in routine clinical practice. Specific subgroups, however, remain at risk for symptoms at 1 year and thus warrant closer attention.

Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry.

OBJECTIVES: We investigated the effectiveness and safety of drug-eluting stents (DES) as used in routine clinical practice. BACKGROUND: Randomized trials have shown that DES prevent target vessel revascularization in selected patients, but whether this translates into superior outcomes, compared with bare-metal stents (BMS), for the full spectrum of patients treated with DES in North America is unknown. METHODS: Patients in the National Heart, Lung, and Blood Institute Dynamic Registry enrolled in 2004 who received at least 1 DES (n = 1,460) were compared with 1,763 patients enrolled in the recruitment period immediately preceding the approval of DES (2001 to 2002) who received at least 1 BMS. RESULTS: Patients receiving DES more often had diabetes mellitus and less often presented with an acute myocardial infarction (MI). At 1 year, cumulative death and MI was 7.6% in DES- and 8.7% in BMS-treated patients (adjusted hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.68 to 1.15; p = 0.34). The 1-year rate of target vessel revascularization was 5.0% in DES and 9.2% in BMS patients (p < 0.001), and the risk of any repeat revascularization by percutaneous coronary intervention or coronary bypass was lower in DES patients (adjusted HR 0.38, 95% CI 0.25 to 0.60; p < 0.001). Patients with both simple and complex lesion characteristics benefited from DES with lower risk of repeat target vessel revascularization by percutaneous coronary intervention compared with BMS (any complex lesion: adjusted HR 0.57, 95% CI 0.39 to 0.83; absence of any complex lesion: adjusted HR 0.44, 95% CI 0.28 to 0.71). The 1-year incidence of stent thrombosis was 1.0% in DES patients. CONCLUSIONS: The generalized use of DES resulted in better outcomes than BMS, with fewer clinically driven revascularization procedures and similar rates of death and MI at 1 year.

Completeness of revascularization for multivessel coronary artery disease and its effect on one-year outcome: a report from the NHLBI Dynamic Registry.

When percutaneous coronary intervention (PCI) is performed in patients with multivessel coronary disease, a targeted revascularization (TR) of diseased vessels is performed more often than complete revascularization (CR). We compared baseline characteristics and 1-year outcomes of patients undergoing TR by operator choice (n = 1,091), TR because CR was unachievable (n = 375), and CR (n = 315) in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry. Patients receiving TR because CR was unachievable were older, had more comorbidities, worse ejection fraction, less often received 2b/3a inhibitors and stents, and less frequently achieved complete angiographic success than either patients receiving TR by choice or CR. Despite these considerable differences, cumulative rates of 1-year mortality, the need for repeat PCI, or coronary bypass surgery were similar in patients who received CR, TR by choice, or TR because CR was unachievable. In multivariable models, after adjustment for clinical characteristics and propensity to receive CR, the hazard ratio for CR versus TR was 1.10 (95% CI: 0.58-2.10) for 1-year mortality; 0.89 (0.60-1.32) for repeat PCI, and 0.92 (0.66-1.29) for repeat PCI or coronary bypass surgery. In conclusion, despite the presence of more unfavorable characteristics, patients undergoing TR demonstrate 1-year outcomes equivalent to those having CR, supporting its continued use in selected patients.

Importance of the postdischarge interval in assessing major adverse clinical event rates following percutaneous coronary intervention.

In-hospital major adverse clinical event (MACE) rates after percutaneous coronary intervention serve as benchmarks of performance. However, accelerated clinical pathways, decreased lengths of stay, and potential delayed effects of percutaneous coronary intervention may result in an underestimation of this traditional measurement of outcome. Records from patients in the first 3 waves of the National Heart, Lung, and Blood Institute's Dynamic Registry (n = 6,676) were reviewed for rates of composite in-hospital MACEs (death, myocardial infarction, and any repeat target vessel revascularization) and postdischarge MACEs (death, myocardial infarction, repeat hospitalization, and repeat target vessel revascularization) through 30 days. Rates for each composite MACE were compared across waves to assess changes over time. Predictors of each MACE category were identified using multivariate analysis. In-hospital MACE decreased significantly (5.4% of wave 1, 4.9% of wave 2, 3.1% of wave 3, p <0.001), whereas stent implantation increased significantly (67.5% of wave 1, 79.1% of wave 2, 86.2% of wave 3, p <0.001). Postdischarge MACE through 30 days remained unchanged (5.1% of wave 1, 5.1% of wave 2, 4.8% of wave 3, p = 0.6). Mean length of stay decreased (2.7 days for wave 1, 2.2 days for wave 3, p <0.001). Disparate clinical, procedural, and angiographic factors were associated with each MACE. Postdischarge MACE rates through 30 days comprise a significant and unchanging fraction of overall procedurally related MACE rates despite improving in-hospital outcomes. Most postdischarge events derive from pathology related to the controlled vessel. A 30-day MACE rate may serve as a more comprehensive measurement of procedural outcome.

Angina 1 year after percutaneous coronary intervention: a report from the NHLBI Dynamic Registry.

BACKGROUND: As percutaneous coronary intervention (PCI) is most commonly performed for relief of angina, it is important to identify factors associated with recurrence of anginal symptoms. METHODS: We examined symptoms at 1-year follow-up in 1755 consecutive NHLBI Dynamic Registry patients who underwent PCI in the setting of symptoms or acute infarction. RESULTS: At 1-year follow-up, 26% of patients reported angina in the previous 6 weeks. Younger patients and females reported more symptoms. History of coronary artery bypass graft (CABG) or PCI, prior myocardial infarction (MI), diabetes, graft disease, and extensive coronary artery disease (CAD) (>4 significant lesions) were also associated with follow-up angina. Patients receiving stents reported less angina (24% vs 29%, P <.05). Completely revascularized patients and those with residual single-vessel disease had comparable 1-year angina rates (23% both subgroups), while 32% of patients with residual multivessel CAD reported symptoms. Patients undergoing repeat PCI during follow-up reported more 1-year angina than others (34% vs 24%, P <.001), whereas those undergoing CABG after post-PCI hospitalization had less symptoms (15% vs 26%, P <.05). After adjustment for baseline symptom status and outcome of index PCI, residual CAD, and reintervention during follow-up, patient characteristics significantly predictive of angina included female sex, age <62 years, and prior MI. CONCLUSIONS: While approximately three quarters of patients receiving PCI are angina-free at 1 year, females continue to have more symptoms, as do other subgroups including patients with history of MI or previous intervention. As these symptoms are associated with self-reported activity and quality of life limitation, evaluations of PCI should include angina as a key follow-up outcome.