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.

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.

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.

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.

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.

Clinical progression of incidental, asymptomatic lesions discovered during culprit vessel coronary intervention.

BACKGROUND: With the reduction in restenosis rates by drug-eluting stents, there is new controversy concerning the optimal management of incidental, nontarget lesions identified during percutaneous coronary intervention (PCI). Such lesions have been treated conservatively because of risk of restenosis but now are being considered for PCI to prevent plaque instability. However, the impact of incidental stenoses on future cardiac events remains unknown. METHODS AND RESULTS: We performed a retrospective cohort study to determine the rate and features of clinical plaque progression using the National Heart, Lung, and Blood Institute Dynamic Registry of consecutive patients undergoing PCI at multiple centers in 1997 to 1998 and 1999. Of 3747 PCI patients, 216 (5.8%) required additional nontarget lesion PCI for clinical plaque progression at 1 year. Fifty-nine percent presented with new unstable angina, and 9.3% presented with nonfatal myocardial infarction. Patients with multivessel coronary artery disease during original PCI were more likely to require nontarget lesion PCI during follow-up (adjusted odds ratio, 1.72 [95% CI, 1.18 to 2.52] for 2 vessels; adjusted odds ratio, 3.37 [95% CI, 2.32 to 4.89] for 3 vessels). Angiographic review showed that the majority (86.9%) of lesions requiring subsequent PCI were < or =60% in severity during original PCI, with the mean lesion stenosis 41.8+/-20.8% at the time of the initial PCI and 83.9+/-13.9% during the recurrent event. CONCLUSIONS: Approximately 6% of PCI patients will have clinical plaque progression requiring nontarget lesion PCI by 1 year. Greater coronary artery disease burden confers a significantly higher risk for clinical plaque progression.

Effect of gender on prognosis following percutaneous coronary intervention for stable angina pectoris and acute coronary syndromes.

Women with non-ST-elevation acute coronary syndromes (NSTACSs) may have better outcomes than men, but the effect of NSTACSs in women undergoing percutaneous coronary intervention (PCI) has not been examined. We performed a prospective, multicenter, cohort study of consecutive patients who underwent PCI for NSTACS and stable angina during 3 National Heart, Lung, and Blood Institute Dynamic Registry recruitment waves (1997 to 2002) to examine the effect of female gender on adverse clinical events after PCI or stable angina for NSTACS. The primary end point was the combined rate of death, myocardial infarction, or rehospitalization for cardiac causes at 1 year. Compared with men with NSTACS (n = 2,124), women (n = 1,338) were older and more often had hypertension, diabetes mellitus, and history of heart failure (p <0.001 for all), whereas multivessel disease was less frequent (p <0.01). Procedural success and in-hospital adverse event rates were similar. Women with NSTACS had the highest 1-year rate of death/myocardial infarction/cardiac rehospitalization compared with women with stable angina pectoris (n = 462) or men (n = 995; women with NSTACS 37.6%, men with NSTACS 29.8%, women with stable angina 29.4%, men with stable angina 27.7%, p <0.001). The higher rate remained after adjustment for differences in baseline characteristics (adjusted hazard ratio 1.37, 95% confidence interval 1.20 to 1.56). Among women, NSTACS conferred a significantly higher risk for adverse events compared with stable angina (adjusted hazard ratio 1.41, p = 0.001), whereas the risk of adverse events was not different in men (adjusted hazard ratio 1.05, p = 0.5). In conclusion, women undergoing PCI for NSTACS have a higher risk of major adverse cardiac events than men or women undergoing PCI for stable angina.

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.

Modeling and risk prediction in the current era of interventional cardiology: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

BACKGROUND: Validation of in-hospital mortality models after percutaneous coronary interventions using multicenter data remains limited. METHODS AND RESULTS: This study evaluated whether multivariable mortality models developed during the pre-stent era by New York State, American College of Cardiology (ACC)-National Cardiovascular Data Registry, Northern New England Cooperative Group, Cleveland Clinic Foundation, and the University of Michigan are relevant in patients undergoing percutaneous coronary intervention in the 1997 to 1999 National Heart, Lung, and Blood Institute Dynamic Registry. Of 4448 Dynamic Registry patients, 73% received > or =1 stent and 28% received a IIB/IIIA receptor inhibitor. In-hospital mortality occurred in 64 patients (1.4%). The New York state model predicted mortality in 69 patients (1.5%; 95% confidence bounds [CI], 0.89% to 1.70%); Northern New England predicted mortality in 60 patients (1.3%; 95% CI, 1.0% to 1.7%); and Cleveland Clinic predicted mortality in 76 patients (1.7%; 95% CI, 1.3% to 2.1%). Among high-risk subgroups, with these 3 models, observed and predicted in-hospital mortality rates in general were not different. The other 2 models yielded different results. The University of Michigan predicted fewer deaths (n=47; 1.1%; 95% CI, 0.7% to 1.3%), and the ACC Registry model predicted 603 deaths (13.5%; 95% CI, 12.6% to 14.4%). Using the ACC Registry model, predicted mortality was higher than observed in each subgroup. CONCLUSIONS: Application of 5 mortality risk models developed from different data sets to patients undergoing percutaneous coronary intervention in the Dynamic Registry predicted, in 3 models, mortality rates that were not significantly different than those observed. In both high and low risk subgroups, the University of Michigan slightly underpredicted mortality, and the ACC Registry predicted significantly higher mortality than that observed.

Temporal variation in inhospital mortality with percutaneous coronary intervention: a report from the National Heart, Lung and Blood Institute Dynamic Registry.

BACKGROUND: Cardiovascular morbidity and mortality display a distinct time dependence also known as circadian variation. Whether such time dependence extends to the risk of procedural-related mortality after percutaneous coronary intervention (PCI) is presently unknown. METHODS: Inhospital mortality was analyzed in 6,347 patients with PCI start times from 8:00 am to 6:59 pm ("usual" workday). The sample was divided into 3 evenly populated groups (morning start 8:00-10:59 AM, midday start 11:00 AM-1:59 PM, afternoon start 2:00-6:59 PM). The association between procedural start time and mortality was assessed using multivariable analysis including a propensity score accounting for factors associated with procedural start time. RESULTS: There was a significant, nonlinear relationship between procedural-related mortality and start time (P = .03). Afternoon start patients were at higher adjusted risk of mortality compared with midday start patients (OR 2.03, 95% CI 1.07-3.83, P = .03 ). Morning start patients were also at higher risk compared with midday start patients although the association was not statistically significant (OR 1.73, 95% CI 0.89-3.39, P = .11). CONCLUSIONS: There is a significant time-dependent variation in the risk of inhospital PCI-related mortality during usual working hours. The highest risk period, taking into account numerous factors that confound this association, is the latter part of the workday. A second period of apparent greater risk occurs during the early part of the workday and is consistent with our present understanding of circadian variation in cardiovascular disease processes.

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.

Impact of age on procedural and 1-year outcome in percutaneous transluminal coronary angioplasty: a report from the NHLBI Dynamic Registry.

BACKGROUND: Older age has been associated with adverse outcomes in patients undergoing percutaneous coronary intervention (PCI). As PCI technology evolves and the US population becomes proportionally older, assessment of PCI in older age groups is essential. METHODS: From the National Heart, Lung, and Blood Institute Dynamic Registry, 4620 PCI-treated patients (1997 to 1999) were studied. Differences in clinical presentation, treatment strategy, and inhospital and 1-year outcomes were compared between patient age groups: younger (<65 years, n = 2537); older (65 to 79 years, n = 1776); and elderly (> or =80 years, n = 307). RESULTS: Older and elderly patients had more cardiac and comorbid noncardiac conditions and more extensive and complex arteriosclerosis, including stenoses in bypass grafts. Stent use was similar as age increased (72% vs 73% vs 73%), as was the use of IIb/IIIa receptor antagonists (29% vs 26% vs 28%). Rates of successful treatment of all attempted lesions were 93%, 92%, and 89%, respectively. Adjusted relative risks of inhospital death (1.0 vs 2.91 vs 3.64) and myocardial infarction (1.0 vs 1.35 vs 2.57) increased by age group, as did 1-year mortality rates (1.0 vs 1.87 vs 3.02). However, the relative magnitude of excess mortality rates at 1 year was comparable to that observed by age in the US general population. Age was not associated with 1-year risk of myocardial infarction or coronary artery bypass grafting. CONCLUSIONS: Although new technologies may allow for treatment of complex disease in older and elderly patients with comorbid disease, the increased procedural risk remains substantial in these patients. After PCI, the long-term relative risk of death is similar to that expected among persons of similar ages in the general population.

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.

Effect of statin therapy prior to elective percutaneous coronary intervention on frequency of periprocedural myocardial injury.

This study evaluated whether pretreatment with statins was associated with a decreased incidence of periprocedural myocardial injury. Periprocedural myocardial injury occurs after percutaneous coronary intervention (PCI) and is associated with adverse outcomes. The pleiotropic properties of statins stabilize plaque and decrease the inflammatory milieu of atherosclerotic lesions. Accordingly, we hypothesized that preprocedural statin therapy would decrease periprocedural myocardial injury. We enrolled 425 patients who underwent successful PCI. The control arm (n = 150) included patients not on statin therapy at the time of PCI, and the statin arm (n = 275) included patients who were taking statin medication before PCI. All patients had serial enzymes measured, including creatine kinase (CK), CK-MB, and troponin I. The incidence of increased levels of CK and CK-MB >3 times normal and the absolute increase in CK and troponin I were compared between groups. The control arm had significantly higher periprocedural levels of CK. In the control group, 6% of patients had CK increases >3 times the upper limit of normal compared with 1.8% in the statin group (p = 0.02). The control arm had a higher frequency of CK-MB increases >3 times the upper limit of normal (7.3% vs 2.2%, p = 0.01). There was a trend toward higher levels of troponin I in the control group (3.21 vs 1.85 ng/ml, p = 0.06). Thus, statin therapy before elective PCI was associated with lower levels of periprocedural CK.

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.

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.