A case report of ventricular septal defect complicating transcatheter aortic valve implant for aortic regurgitation: novel complication and technical considerations.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has proven efficacy in the treatment of aortic stenosis (AS). Understandably, there is increasing enthusiasm for its use to treat aortic regurgitation (AR). However, there are significant anatomical differences between AS and AR which make TAVI for AR more complex. CASE SUMMARY: We present the case of technically challenging TAVI for severe AR, which was complicated by a traumatic ventricular septal defect (VSD) that required percutaneous closure. To our knowledge, this is the first published case of VSD post-TAVI for AR. DISCUSSION: This unanticipated complication highlights anatomical differences between TAVI use in AS and AR. Lack of aortic valve calcification and excessive annular compliance made stable deployment of a self-expanding valve extremely challenging. Despite device oversizing, repeated embolization of the prosthesis into the left ventricular outflow tract traumatized the interventricular septum.

Real-World Experience With Antiplatelet Agents After Percutaneous Coronary Intervention in Patients With an Indication for an Oral Anticoagulant.

ABSTRACT: Patients undergoing percutaneous coronary intervention (PCI) with a clinical indication for oral anticoagulation (OAC) in addition to antiplatelet therapy (APT) necessitate rigorous evaluation of bleeding and ischemic risk to guide therapy. The optimal OAC/APT drug combination and duration of treatment is not known. This study aimed to evaluate the incidence of patients undergoing PCI with an OAC indication and the rationale for post-PCI combined OAC/APT selection in clinical practice. Consecutive patients undergoing PCI with an indication for combined OAC/APT were included in a 12-month retrospective case series. Patient demographics, clinical characteristics, prescribed OAC/APT regimens, and rationale for drug selection were reviewed. PCI was performed in 1650 patients during the study period, with an indication for OAC/APT in 133 (8.1%). A combination of aspirin, P2Y12 inhibitor, and OAC was the most frequently prescribed regime on discharge (n = 103, 81%). Dual antiplatelet therapy (DAPT) in combination with OAC was continued for a mean duration of 6.4 ± 4.4 weeks (range 3-52 weeks) before one antiplatelet was discontinued. There was no significant difference between the mean CHA2DS2-VASc or HAS-BLED score of patients with atrial fibrillation discharged on OAC/DAPT compared with alternate combinations (DAPT alone or OAC/single APT), 3.6 ± 1.3 versus 3.8 ± 1, P = 0.37 and 2.04 ± 0.7 versus 2.05 ± 1.0, P = 0.98, respectively. This case series identifies high variability in OAC/APT treatment duration and limited application of risk scoring systems and high-risk PCI characteristics in the selection of OAC/APT regimens. A more systematic patient assessment is needed to help standardize OAC/APT prescribing for this important patient cohort.

Renal insufficiency, bleeding and prescription of discharge medication in patients undergoing percutaneous coronary intervention in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry.

AIMS: To establish the relationship between renal insufficiency, bleeding and prescription of cardiovascular medication. METHODS AND RESULTS: This was a prospective, multi-center, cohort study of consecutive patients undergoing PCI during three NHLBI Dynamic Registry recruitment waves. Major and minor bleeding, access site bleeding and rates of prescription of cardiovascular medication at discharge were determined based on estimated glomerular filtration rate (eGFR). Renal insufficiency was an independent predictor of major adverse cardiovascular events (MACE). Bleeding events and access site bleeding requiring transfusion were significantly associated with degrees of renal insufficiency (p<0.001). There was an incremental decline in prescription of cardiovascular medication at discharge proportionate to the degree of renal impairment (aspirin, thienopyridine, statin, coumadin (overall p<0.001), beta blocker (overall p=0.003), ACE inhibitor (overall p=0.02). Bleeders were less likely to be discharged on a thienopyridine (95.4% versus 89.9% for bleeding, p<0.001 and 95.3% versus 87.9% for access site bleeding, p=0.005), but not aspirin (96.3% versus 96.2%, p=0.97 and 96.3% versus 93.6%, p=0.29 respectively). Failure to prescribe anti-platelet therapy at discharge was strongly associated with increased MACE at one year. CONCLUSIONS: Renal insufficiency is associated with bleeding in patients undergoing PCI. Patients with renal insufficiency are less likely to receive recommended discharge pharmacotherapy.

Point-of-care platelet function testing predicts bleeding in patients exposed to clopidogrel undergoing coronary artery bypass grafting: Verify pre-op TIMI 45--a pilot study.

BACKGROUND: Guidelines recommend delaying coronary artery bypass grafting (CABG) for 5 days after discontinuing clopidogrel. However, platelet function may recover quicker in certain individuals. HYPOTHESIS: We hypothesized that perioperative measurement of platelet function with a point-of-care P2Y12 inhibitor assay could predict bleeding during CABG in patients exposed to clopidogrel. METHODS: Verify Pre-Op TIMI 45 was a prospective pilot study of 39 patients on clopidogrel who subsequently underwent CABG. Preoperative on-treatment platelet reactivity was assessed with VerifyNow P2Y12 Reaction Units (PRU), with higher PRU indicating more reactive platelets. Outcomes were stratified by PRU quartiles, as well as prespecified cutpoints for the lowest quartile (PRU 173), a cutpoint for major bleeding determined by the Youden index using receiver operator curve analysis (PRU 207), and clopidogrel resistance (PRU 230). RESULTS: Patients in higher PRU quartiles experienced smaller decreases in hemoglobin and hematocrit (P < 0.05 for all comparisons), less major bleeding (P = 0.021), and less major or minor bleeding (P = 0.003). Patients above the PRU 207 and 230 cutpoints had less chest-tube output (P = 0.041 and P = 0.012, respectively), less major bleeding (P = 0.005 and P = 0.036, respectively), and less major or minor bleeding (P = 0.013 and P < 0.001, respectively). By receiver operator curve analysis, preoperative PRU ≤ 207 discriminated between patients with and without major bleeding during surgery (area under the curve: 0.76, 95% confidence interval: 0.59-0.94, P = 0.018). CONCLUSIONS: In this pilot study, we found that point-of-care platelet function assessment could predict bleeding in patients recently exposed to clopidogrel undergoing CABG.

Significance of the learning curve in left atrial appendage occlusion with two different devices.

OBJECTIVE: To evaluate the impact of learning on outcome with use of two different left atrial appendage (LAA) occlusion devices. BACKGROUND: Two self-expanding devices, the Watchman and the Amplatzer Cardiac Plug (ACP), have been used for LAA occlusion in the last few years. It has been demonstrated that complications associated with implantation decrease in frequency with operator experience. However, the role of operator experience has not been compared across the two device types. METHODS: The study comprises 31 consecutive patients who underwent LAA occlusion. We compare the first 10 patients in whom an ACP was implanted with the subsequent eleven patients who underwent ACP implantation and with 10 cases where a Watcthman device was implanted. The composite safety end point comprised procedure-related events and excessive bleeding events. We also performed 3 months echocardiographic and clinical follow-up. RESULTS: There were not significant differences in the basal clinical and echocardiographical characteristics across the three groups. Cardiac complications only occurred in the ACP initial experience group (9% vs. 0% vs. 0% P = 0.04). Echocardiographic and clinical follow-up at 3 months was completed in all patients. No significant residual leak was detected. One patient in the ACP initial experience group developed a thrombus on the device. One patient in ACP late experience presented an ischemic stroke. CONCLUSIONS: Complications associated with LAA occlusion cluster early in the peri-procedural period and significantly decrease in frequency with operator experience. Initial experience gained with one of device may improve outcome with use of alternative LAA occlusion devices.

Effect of elevated pulmonary vascular resistance on outcomes after percutaneous mitral valvuloplasty.

Patients with mitral stenosis with severe pulmonary hypertension constitute a high-risk subset for surgical commissurotomy or valve replacement. The aim of the present study was to examine the effect of elevated pulmonary vascular resistance (PVR) on percutaneous mitral valvuloplasty (PMV) procedural success, short- and long-term clinical outcomes (i.e., mortality, mitral valve surgery, and redo PMV) in 926 patients. Of the 926 patients, 263 (28.4%) had PVR ≥4 Woods units (WU) and 663 (71.6%) had PVR <4 WU. Patients with PVR ≥4 WU were older and more symptomatic and had worse valve morphology for PMV. The patients with PVR ≥4 WU also had lower PMV procedural success than those with PVR <4 WU (78.2% vs 85.6%, p = 0.006). However, after multivariate adjustment, PVR was no longer an independent predictor of PMV success nor an independent predictor of the combined end point at a median follow-up of 3.2 years. In conclusion, elevated PVR at PMV is not an independent predictor of procedural success or long-term outcomes. Therefore, appropriately selected patients with rheumatic mitral stenosis might benefit from PMV, even in the presence of elevated preprocedural PVR.

Difference in outcome among women and men after percutaneous mitral valvuloplasty.

OBJECTIVE: To analyze the differences in anatomical, clinical and echocardiographic characteristics of women and men undergoing PMV and to evaluate the relationship between sex, PMV success, and immediate and long-term clinical outcome. BACKGROUND: Rheumatic mitral stenosis (MS) is predominantly a disease of middle-aged women. Percutaneous mitral valvuloplasty (PMV) has become the standard of care for suitable patients. However little is known about the relationship between sex, PMV success, and procedural outcome. METHODS AND RESULTS: We evaluated measures of procedural success and clinical outcome in consecutive patients (839 women and 176 men) who underwent PMV. Despite a lower baseline echocardiographic score (7.47 ± 2.15 vs. 8.02 ± 2.18, P = 0.002), women were less likely to achieve PMV success (69% vs. 83%, adjusted OR 0.44, 95% CI 0.27-0.74, P = 0.002), and had a smaller post-procedural MV area (1.86 ± 0.7 vs. 2.07 ± 0.7 cm(2), P < 0.001). Overall procedural and in-hospital complication rates did not differ significantly between women and men. However, women were significantly more likely to develop severe MR immediately post PMV (adjusted OR 2.41, 95% CI 1.0-5.83, P = 0.05) and to undergo MV surgery (adjusted HR 1.54, 95% CI 1.03-2.3, P = 0.037) after a median follow-up of 3.1 years. CONCLUSIONS: Compared to men, women with rheumatic MS who undergo PMV are less likely to have a successful outcome and more likely to require MV surgery on long-term follow-up despite more favorable baseline MV anatomy.

Impact of pre- and postprocedural mitral regurgitation on outcomes after percutaneous mitral valvuloplasty for mitral stenosis.

Percutaneous mitral valvuloplasty (PMV) is an effective therapy in patients with significant mitral stenosis. Few studies have examined the effect of mitral regurgitation (MR), a frequent periprocedural finding, on PMV outcomes. We examined the effects of pre- and postprocedural MR after PMV. Contrast left ventriculography was performed before and after PMV, and the MR severity was assessed using Sellers' classification. Clinical, hemodynamic, and morphologic variables were collected for all patients. Consecutive patients (n = 876) undergoing a first PMV procedure at a single tertiary center were evaluated. An increasing preprocedural MR severity was associated with reduced PMV success (no MR, 75%; 1+ MR, 65%; 2+ MR, 44%; p <0.0001), increased in-hospital mortality (0.6% vs 2.8% vs 4.9%, respectively; p = 0.007), and other complications. Increasing grades of pre- and postprocedural MR predicted, independently and in a grade-dependent manner, the composite outcome of mortality, mitral valve surgery, or redo PMV (preprocedural MR >or=1+, relative risk [RR] 1.4, 95% confidence interval [CI] 1.2 to 1.8; preprocedural MR >or=2+, RR 1.6, 95% CI 1.1 to 2.4; postprocedural MR >or=1+, RR 1.6, 95% CI 1.2 to 2.0; postprocedural MR >or=2+, RR 2.2, 95% CI 1.7 to 2.7; and postprocedural MR >or=3+, RR 4.6, 95% CI 3.4 to 6.2, respectively). In conclusion, increasing pre- and postprocedural MR grades independently predicted the long-term clinical outcomes after PMV. Patients with moderate preprocedural MR, in particular, appeared to have suboptimal short- and long-term outcomes, necessitating careful monitoring and early referral for mitral valve surgery, when appropriate.

Percutaneous revascularization of occluded renal arteries in the setting of acute renal failure.

We report the case of a 60-year-old patient with acute renal failure and occluded bilateral renal arteries presenting with acute pulmonary edema and non-ST segment elevation myocardial infarction. The patient required renal replacement therapy with hemodialysis and was subsequently successfully treated with bilateral renal artery stent placement. Marked improvement in renal function was noted within 1 week with freedom from the need for renal replacement therapy at 4 months of follow-up.

Moyamoya disease with peripheral pulmonary artery stenoses and coronary artery fistulae.

Moyamoya is a progressive disorder of the cerebral vasculature. Our report describes a rare case of Moyamoya disease with distal peripheral pulmonary artery stenoses and coronary fistulae in a 12-year-old Caucasian female patient.

Percutaneous revascularization of persistent renal artery in-stent restenosis.

Percutaneous renal artery stenting is a common means of treating atherosclerotic renal artery stenosis. However, renal artery restenosis remains a frequent problem. The optimal treatment of restenosis has not been established and may involve percutaneous renal artery angioplasty or deployment of a second stent. Other modalities include cutting balloon angioplasty, repeat stenting with drug-eluting stents or endovascular brachytherapy. Most recently, use of polytetrafluoroethylene (PTFE)-covered stents may offer a new and innovative way to treat recurrent renal artery stenosis. We describe a case in a patient who initially presented with renal insufficiency and multi-drug hypertension in the setting of severe bilateral renal artery stenosis. Her renal artery stenosis was initially successfully treated by percutaneous deployment of bilateral bare metal renal artery stents. After initial improvement of her hypertension and renal insufficiency, both parameters declined and follow-up duplex evaluation confirmed renal artery in-stent restenosis. Owing to other medical co-morbidities she was felt to be a poor surgical candidate and was subsequently treated first with bilateral cutting balloon angioplasty and second with drug-eluting stent deployment. Each procedure was associated with initial improvement of renal function and blood pressure control, which then later deteriorated with the development of further significant in-stent restenosis. It was then decided to treat the restenosis using PTFE-covered stents. At 12 months of follow-up, the blood pressure had remained stable and renal function had normalized. The covered stents remained free of any significant neointimal tissue or obstruction.

Predicting success and long-term outcomes of percutaneous mitral valvuloplasty: a multifactorial score.

BACKGROUND: Percutaneous mitral valvuloplasty (PMV) success depends on appropriate patient selection. A multifactorial score derived from clinical, anatomic/echocardiographic, and hemodynamic variables would predict procedural success and clinical outcome. METHODS: Demographic data, echocardiographic parameters (including echocardiographic score), and procedure-related variables were recorded in 1085 consecutive PMVs. Long-term clinical follow-up (death, mitral valve replacement, redo PMV) was performed. Multivariate regression analysis of the first 800 procedures was performed to identify independent predictors of procedural success. Significant variables were formulated into a risk score and validated prospectively. RESULTS: Six independent predictors of PMV success were identified: age less than 55 years, New York Heart Association classes I and II, pre-PMV mitral area of 1 cm(2) or greater, pre-PMV mitral regurgitation grade less than 2, echocardiographic score of 8 or greater, and male sex. A score was constructed from the arithmetic sum of variables present per patient. Procedural success rates increased incrementally with increasing score (0% for 0/6, 39.7% for 1/6, 54.4% for 2/6, 77.3% for 3/6, 85.7% for 4/6, 95% for 5/6, and 100% for 6/6; P < .001). In a validation cohort (n = 285 procedures), the multifactorial score remained a significant predictor of PMV success (P < .001). Comparison between the new score and the echocardiographic score confirmed that the new index was more sensitive and specific (P < .001). This new score also predicts long-term outcomes (P < .001). CONCLUSION: Clinical, anatomic, and hemodynamic variables predict PMV success and clinical outcome and may be formulated in a scoring system that would help to identify the best candidates for PMV.

Retrograde versus antegrade percutaneous aortic balloon valvuloplasty: immediate, short- and long-term outcome at 2 years.

BACKGROUND: The short- and long-term vascular risks and hemodynamic benefits of antegrade versus retrograde percutaneous aortic balloon valvuloplasty (PAV) have not been clearly established. With the advent of percutaneous aortic valve replacement strategies, more valvuloplasties are being performed. The antegrade approach may reduce vascular complications, particularly in patients with peripheral vascular disease (PVD). Comparing the clinical efficacy and complications of each technique is warranted. METHODS: A cohort of 157 consecutive patients undergoing PAV between 2000 and 2006 were included in the study. Of these, 46 (29%) patients underwent antegrade PAV and 111 (71%) retrograde PAV. Choice of vascular approach (antegrade or retrograde) were determined by operator preference. The rate of death, nonfatal vascular complications, and 2-year survival was explored. RESULTS: The mean age of the study population was 79 years. Patients undergoing antegrade PAV were more likely hypertensive (56% vs. 39%, P = 0.001) with PVD (41% vs. 18%, P = 0.004). Nevertheless, logistic Euroscores were no different between the groups (antegrade 18% vs. retrograde 14%; P = 0.30). Baseline and postprocedural valve areas were also similar. However, patients undergoing antegrade PAV had significantly fewer vascular complications (2% vs. 19%; P = 0.005). Two-year follow-up revealed no significant difference in death (antegrade 81% vs. retrograde 69%; P = 0.16), stroke, congestive heart failure, and surgical aortic valve replacement. CONCLUSIONS: The hemodynamic benefit of PAV occurs regardless of the selected vascular approach. The antegrade technique results in significantly fewer vascular complications and similar long-term outcomes. Antegrade PAV is feasible and safe, particularly in patients with PVD.

Left atrial appendage exclusion using an Amplatzer device.

Patients with atrial fibrillation are at an increased risk of having a cardioembolic stroke. Most of the thrombi responsible for these ischemic events originate in the left atrial appendage (LAA). Several surgical and percutaneous endovascular techniques have been explored to occlude the LAA. As an alternative of the surgical closure, percutaneous exclusion of the LAA is a new approach used to prevent strokes in high-risk patients with AF and contraindication to long-term oral anticoagulant therapy. Currently, two devices have been developed specifically for percutaneous occlusion of the LAA the PLAATO system and the WATCHMAN filter system. Although the Amplatzer septal occluder device was not originally intended to occlude the LAA it has been used with success in our centre for this purpose. We present an illustrative case of a patient with AF no longer suitable for chronic OCA referred for percutaneous exclusion of the LAA. She was treated successfully with an Amplatzer septal occluder. Although our experience with this device holds promise, future trials will be necessary to explore this strategy.

Diabetic patients treated for unprotected left main coronary artery disease with drug eluting stents: a 3-year clinical outcome study. The diabetes and drug eluting stent for LeFT main registry (D-DELFT).

AIMS: Diabetes mellitus (DM) plays an important role in the development of coronary artery disease. Although previous studies have associated drug-eluting stent (DES) implantation in diabetic patients with favourable clinical and angiographic outcomes, the very long-term efficacy of these devices in diabetic patients undergoing PCI for significant unprotected left main coronary artery (ULMCA) disease has not been established yet. METHODS AND RESULTS: Consecutive diabetic patients (n=100), who underwent elective PCI with DES for de novo lesions in an ULMCA between April 2002 and April 2004 in seven tertiary health care centres, were identified retrospectively and analysed. Consecutive non-diabetic patients (n=193), who underwent elective DES implantation for unprotected ULMCA disease, were selected as a control group. All patients were followed for at least 36 months. At 3-years follow-up, freedom from cardiac death & myocardial infarction (CDMI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) did not differ significantly between groups. The adjusted freedom from major adverse cardiac events (MACE, defined as the occurrence of CD, MI or TVR) was 63.4% in the DM group and 77.6% in the controls (p<0.001). When divided into IDDM and NIDDM sub-groups, insulin-dependent DM (IDDM) but not non IDDM (NIDDM) patients had significantly lower freedom from CDMI, TLR, TVR and MACE compared to controls. CONCLUSIONS: These results suggest that major improvements in DES technology and pharmacotherapy are still required to improve clinical outcome and that the decision to perform percutaneous revascularisation in this subset of patients should be taken cautiously and on a case by case basis.

Sex differences in medical care and early death after acute myocardial infarction.

BACKGROUND: Women receive less evidence-based medical care than men and have higher rates of death after acute myocardial infarction (AMI). It is unclear whether efforts undertaken to improve AMI care have mitigated these sex disparities in the current era. METHODS AND RESULTS: Using the Get With the Guidelines-Coronary Artery Disease database, we examined sex differences in care processes and in-hospital death among 78 254 patients with AMI in 420 US hospitals from 2001 to 2006. Women were older, had more comorbidities, less often presented with ST-elevation myocardial infarction (STEMI), and had higher unadjusted in-hospital death (8.2% versus 5.7%; P<0.0001) than men. After multivariable adjustment, sex differences in in-hospital mortality rates were no longer observed in the overall AMI cohort (adjusted odds ratio [OR]=1.04; 95% CI, 0.99 to 1.10) but persisted among STEMI patients (10.2% versus 5.5%; P<0.0001; adjusted OR=1.12; 95% CI, 1.02 to 1.23). Compared with men, women were less likely to receive early aspirin treatment (adjusted OR=0.86; 95% CI, 0.81 to 0.90), early beta-blocker treatment (adjusted OR=0.90; 95% CI, 0.86 to 0.93), reperfusion therapy (adjusted OR=0.75; 95% CI, 0.70 to 0.80), or timely reperfusion (door-to-needle time