Sex Differences in Fractional Flow Reserve-Guided Revascularization: A Nationwide Analysis.

BACKGROUND: Women with coronary artery disease are less likely to be revascularized than men based on angiography alone. Recent studies have shown that female patients have higher fractional flow reserve (FFR) values for a given severity of coronary stenosis. However, gender differences in coronary revascularization rates following FFR assessment are unknown. METHODS: The nationwide inpatient sample database was used to identify all patients who underwent FFR in the United States between January 2009 and December 2010. We used propensity score matching to compare revascularization rates and in-hospital outcomes among men and women undergoing FFR measurements. RESULTS: Among 3712 patients who underwent FFR during the study period, 1235 matched pairs of men and women were identified. The overall revascularization rates were lower in women than men (40.1% vs. 52.8%, p < 0.01). Women were less likely to undergo either percutaneous (35.2% vs. 45.6%, p < 0.01) or surgical revascularization following FFR than men (5.2% vs. 7.4%, p = 0.03). Women had a nonsignificant trend toward higher in-hospital mortality (0.8% vs. 0.5%, p = 0.32) and significantly higher rates of access site hematoma formation (2.7% vs. 0.8%, p < 0.01) compared to men. CONCLUSION: In conclusion, this large nationwide study reveals that coronary revascularization rates are significantly lower in women than in men even after functional assessment with FFR.

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.

Current status of percutaneous right ventricular assist devices: First-in-man use of a novel dual lumen cannula.

Ventricular assist devices have become an accepted therapeutic solution for patients with severe left ventricular dysfunction when pharmacology fails to maintain sufficient cardiac output. Despite various technologies that have allowed left ventricular assist devices to become more reliable and versatile in the past decade, comparatively little attention has been applied to right heart assistance which is still in the early stage of its development. The extracorporeal devices developed thus far have been associated with mobility issues and complications common to ventricular assist devices in general, such as infection, bleeding, and thromboembolism. Designed to obviate the problems previously experienced by other right ventricle (RV)-focused devices, the Protek Duo (CardiacAssist, Pittsburgh, PA) is a novel, fully percutaneous, dual lumen cannula for RV support used in conjunction with the paracorporeal TandemHeart(®) (CardiacAssist, Pittsburgh, PA) pump. We describe our initial experience with the Protek Duo cannula in two different clinical scenarios. In addition, we summarize the current percutaneous mechanical support technology for RV assistance and propose modification of current technology to facilitate its application. © 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.

Comparison of three age groups regarding safety and efficacy of drug-eluting stents (from the National Heart, Lung, and Blood Institute Dynamic Registry).

Limited data exist regarding drug-eluting stent (DES) versus bare metal stent (BMS) use in older patients. From the National Heart, Lung, and Blood Institute Dynamic Registry, 5,089 percutaneous coronary intervention (PCI)-treated patients were studied (October 2001 to August 2006). The differences in 1-year safety (death, myocardial infarction, and their composite) and efficacy (target vessel revascularization [TVR] with PCI and repeat revascularization) outcomes were compared between the patients who received DESs versus BMSs within each age group: <65 years (n = 2,680); 65 to 79 years (n = 1,942); ≥80 years (n = 443). No differences were found in the safety outcomes by stent type in any age group at 1 year. Regarding the effectiveness, lower rates of TVR with PCI and repeat revascularization were observed in the DES patients across all age groups. After propensity-adjusted analysis, the risk of TVR with PCI and repeat revascularization favored DES versus BMS with patients <65 years old (7.4% vs 14.6%, hazard ratio [HR] 0.44, 95% confidence interval [CI] 0.32 to 0.60; 12.3% vs and 17.4%, HR 0.65, 95% CI 0.51 to 0.84, respectively), 65 to 79 years old (4.8% vs 9.5%, HR 0.50, 95% CI 0.31 to 0.80; and 7.6% vs 12.3%, HR 0.62, 95% CI 0.44 to 0.88, respectively), and ≥80 years old (4.5% vs 10.4%, HR 0.15, 95% CI 0.05 to 0.44; and 6.0% vs 14.5%, HR 0.18, 95% CI 0.08 to 0.40, respectively). In conclusion, significant reductions in TVR with PCI and repeat revascularization were noted in all 3 age groups without increases in death or myocardial infarction in this large multicenter PCI registry. Our data support the use of DES, regardless of age.

Vacuum thrombectomy of large right atrial thrombus.

We report a novel technique for percutaneous removal of the right heart thrombi using a suction cannula. This method allowed complete en bloc removal of the right atrial thrombus avoiding surgical procedure in a high risk patient.

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.

Comparison of bare-metal and drug-eluting stents in patients with chronic kidney disease (from the NHLBI Dynamic Registry).

Patients with chronic kidney disease (CKD) have a disproportionate burden of coronary artery disease and commonly undergo revascularization. The role and safety of percutaneous coronary intervention (PCI) using drug-eluting stents (DESs) verses bare-metal stents in patients with CKD not on renal replacement therapy has not been fully evaluated. This study investigated the efficacy and safety of DES in patients with CKD not on renal replacement therapy. Patients were drawn from the National Heart, Lung, and Blood Institute Dynamic Registry and were stratified by renal function based on estimated glomerular filtration rate (GFR). Of the 4,157 participants, 1,108 had CKD ("low GFR" <60 ml/min/1.73 m(2)), whereas 3,049 patients had normal renal function ("normal GFR" ≥60 ml/min/1.73 m(2)). For each stratum of renal function we compared risk of death, myocardial infarction, or repeat revascularization between subjects who received DESs and bare-metal stents at the index procedure. Patients with low GFR had higher 1-year rates of death and myocardial infarction and a decreased rate of repeat revascularization compared to patients with normal GFR. Use of DESs was associated with a decreased need for repeat revascularization in the normal-GFR group (adjusted hazard ratio 0.63, 95% confidence interval 0.50 to 0.79, p <0.001) but not in the low-GFR group (hazard ratio 0.69, 95% confidence interval 0.45 to 1.06, p = 0.09). Risks of death and myocardial infarction were not different between the 2 stents in either patient population. In conclusion, presence of CKD predicted poor outcomes after PCI with high rates of mortality regardless of stent type. The effect of DES in decreasing repeat revascularization appeared to be attenuated in these patients.

Clinical experience with percutaneous left ventricular transapical access for interventions in structural heart defects a safe access and secure exit.

OBJECTIVES: This study sought to evaluate the safety of percutaneous direct left ventricular access for interventional procedures. BACKGROUND: Experience with percutaneous access of the left ventricle (LV) for interventional procedures has been limited and associated with a high percentage of major complications. We report our clinical experience with percutaneous direct LV access for interventional procedures. METHODS: Between March 2008 and December 2010, there were 32 percutaneous transapical punctures in 28 consecutive patients (16 males, mean age 68.2 ± 10.8 years). The delivery sheath sizes ranged from 5- to 12-F. RESULTS: All transapical punctures were successfully performed, and safe closure of the access sites was achieved. Total procedural time was 153.6 ± 49.4 min for procedures converted from conventional approaches to a transapical approach, 129.5 ± 29.6 min for the transapical approach with trans-septal rail support, and 109.3 ± 41.4 min for the planned transapical approach. Fluoroscopy time was 61.3 ± 26.1 min, 29.7 ± 20.8 min, and 27.4 ± 21.4 min, respectively. Fluoroscopy time for closure of mitral paravalvular leaks was reduced by 35%, from 42.6 ± 29.9 min to 27.4 ± 15.6 min. Complications were observed in 2 patients (7.1%). CONCLUSIONS: With meticulous planning, transapical puncture is safe. The transapical access provides a more direct approach to the LV targets for intervention and leads to a significant decrease in the procedural and fluoroscopy times. Device closure of the direct LV access site is a reliable and safe method of hemostasis. Placement of a closure device should be considered if sheaths larger than 5-F are used. Although we used this technique only for paravalvular leak and LV pseudoaneurysm closure, it may have application for other percutaneous structural heart interventions.

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.

Patent foramen ovale, systemic embolization, and closure.

Patent foramen ovale has become the subject of increasing interest in modern cardiovascular disease. This has been the result of several factors including, among others, description of paradoxical embolism, documentation of patent foramen ovale with right to left shunt, the rather ubiquitous use of echocardiography, the issue of stroke prevention, and more recently, the relationship between patent foramen ovale and migraine.

Placement of a large transseptal cannula through an inferior vena cava filter for TandemHeart percutaneous left ventricular assist.

We report a case of successful TandemHeart implantation for cardiogenic shock due to critical aortic stenosis using a 21 Fr transseptal cannula which was safely advanced through an existing inferior vena cava (IVC) filter under fluoroscopic guidance. This supported the patient through balloon valvuloplasty and subsequent definitive surgical valve replacement. This report demonstrates that the IVC filter can be safely crossed with a sheath as large as 21 Fr in size. In addition, patients with an existing IVC filter requiring a TandemHeart percutaneous ventricular assist device should not be denied this device for fear of dislodging the filter.

The parallel wire technique for septal defect closure.

Percutaneous closure of sedundum atrial septal defects (ASD) has been shown to be safe and effective. Usually crossing the defect is relatively straightforward. Occasionally, with fenestrated ASDs, trying to cross the defect(s) may be challenging. We report the use of a "paralle wire" (0.018 or 0.014 inch wire) technique to maintain access and be able to recross the same defect easily in case of misplacement until just before the device was secured and released. This technique could be used also as a "body wire" for large ASDs with deficient rims to reduce the incidence of device prolapse, and for patent foramen ovale and ventricular septal defect closures. This is a simple and easily reproducible method with the equipment readily available in virtually all catheterization laboratories.