Temporal trends in the use of intraaortic balloon pump associated with percutaneous coronary intervention in the United States, 1998-2008.

BACKGROUND: With conflicting evidence regarding the usefulness of intraaortic balloon pump (IABP), reports of IABP use in the United States have been inconsistent. Our objective was to examine trends in IABP usage in percutaneous coronary intervention (PCI) in the United States and to evaluate the association of IABP use with mortality. METHODS: This is a retrospective, observational study using patient data obtained from the Nationwide Inpatient Sample database from 1998 to 2008. Patients undergoing any PCI (1,552,602 procedures) for a primary diagnosis of symptomatic coronary artery disease and acute coronary syndrome, including non-ST-elevation myocardial infarction and ST-elevation myocardial infarction, were evaluated. RESULTS: The overall use of IABP significantly decreased during the study period from 0.99% in 1998 to 0.36% in 2008 (univariate and multivariate P for trend < .0001). Patients who received IABP had substantially higher rates of shock compared with those who did not receive IABP (38.09% vs 0.70%; P < .0001), which was associated with markedly higher inhospital mortality rates (20.31% vs 0.72%; P < .0001). However, IABP use significantly decreased in patients with shock (36.5%-13.4%) and acute myocardial infarction (2.23%-0.84%) (univariate and multivariate P for trend for both < .0001). A temporal reduction in all-cause PCI-associated mortality from 1.1% in 1998 to 0.86% in 2008 (univariate and multivariate P for trend < .0001) was also observed. CONCLUSIONS: The utilization of IABP associated with PCI significantly decreased between 1998 and 2008 in the United States, even among patients with acute myocardial infarction and shock.

Temporal trends in gastrointestinal bleeding associated with percutaneous coronary intervention: analysis of the 1998-2006 Nationwide Inpatient Sample (NIS) database.

BACKGROUND: Gastrointestinal bleeding (GIB) after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and coronary artery disease (CAD) is associated with high morbidity and mortality. METHODS: The NIS database from 1998 to 2006 was used to identify 1,216,759 PCIs performed for ACS and CAD. We sought to analyze temporal trends in the incidence and in-hospital outcomes of GIB associated with PCI along with its predictors. RESULTS: The overall incidence of GIB was 1.04% (95% confidence interval (CI), 1.02%-1.06%). The incidence of GIB decreased over the study period (P for trend <.0001). The overall mortality in the GIB group was 6.0% (95% CI, 5.6%-6.4%). The adjusted OR for in-hospital mortality and GIB was 4.70 (95% CI, 4.23-5.23; P < .0001); this remained high and essentially unchanged over the study period. Independent predictors of GIB included rectum/anal cancer (OR, 4.64; 95% CI, 3.20-6.73; P < .0001), stomach cancer (OR, 2.74; 95% CI, 1.62-4.66; P = .0002), esophageal cancer (OR, 1.99; 95% CI, 1.08-3.69; P = .0288), colon cancer (OR, 1.69; 95% CI, 1.43-2.02; P < .0001), congestive heart failure (OR, 1.43; 95% CI, 1.35-1.52; P < .0001), and acute myocardial infarction (OR, 1.23; 95% CI, 1.13-1.35; P < .0001). CONCLUSIONS: Although the incidence of GIB associated with PCI decreased from 1998 to 2006 in the face of aggressive therapies for ACS and CAD, the risk of GIB-associated death remained high. Underlying GI malignancy is a significant independent predictor of GIB associated with PCI; identifying these patients may reduce the rate of GIB.

Aortic Valve Predilatation with a Small Balloon, without Rapid Pacing, prior to Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study is to assess the feasibility and clinical outcome of transcatheter aortic valve replacement (TAVR) using aortic valve predilatation (AVPD) with a small, nonocclusive balloon. BACKGROUND: Balloon aortic valvuloplasty (BAV) under rapid pacing is generally performed in TAVR to ensure the passage and sufficient deployment of the prosthesis in the stenotic AV. BAV may cause serious complications, such as left ventricular stunning or cerebrovascular embolism. METHODS: A cohort of 50 consecutive patients with severe aortic stenosis underwent transfemoral TAVR with the Edwards Sapien 3-heart valve. All patients underwent AVPD with a small, nonocclusive balloon (12 × 60 or 14 × 60 mm) without rapid pacing. Procedural data and clinical outcomes were analyzed. RESULTS: The mean age of the cohort was 81 ± 6 years and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13 ± 9. Crossing the AV and prosthesis implantation was successful in all cases. The postprocedural mean AV gradient was 12 ± 5 mmHg. There were no cases of aortic regurgitation ≥ grade 2. No periprocedural stroke occurred. One patient (2%) with chronic atrial fibrillation displayed a transient Wernicke aphasia occurring more than 24 hours after TAVR. Mortality was 0% at 30 days after procedure. CONCLUSION: In TAVR, AVPD with a small, nonocclusive balloon can be safely performed. By avoiding rapid pacing, this technique may be a valid alternative to traditional BAV. Whether or not the use of APVD without rapid pacing translates into less periprocedural complications needs to be assessed in future studies.

Parallel suture technique with ProGlide: a novel method for management of vascular access during transcatheter aortic valve implantation (TAVI).

AIMS: The aim of this study was to evaluate vascular complications using the "parallel suture technique" in patients receiving an Edwards SAPIEN XT (SXT) or SAPIEN S3 (S3) transcatheter heart valve (THV). METHODS AND RESULTS: Two hundred consecutive patients with symptomatic severe aortic stenosis treated with TF-TAVI were included in this study where the "parallel suture technique" was applied for vascular access-site closure. This was achieved by placing the sutures medial and lateral to the puncture site. Vascular access-site complications were defined as vascular dissection, perforation, obstruction, arteriovenous fistula or pseudoaneurysms, and classified according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Duplex sonography was performed routinely in every patient. In patients receiving the S3, the sheath to femoral and iliac artery ratio was significantly lower than in the SXT group, reflecting reduction in sheath sizes for S3. More endovascular interventions were required after SXT implantation as compared to S3 (4% versus 1%, p=0.02). This was due to vascular obstruction or device failure. Moreover, increased life-threatening, major bleedings, and pseudoaneurysms were found in the SXT group (6% versus 1%, p=0.06, 13% versus 3%, p=0.009, 7% versus 1%, p=0.03, respectively). CONCLUSIONS: The "parallel suture technique" using the ProGlide is associated with a low number of vascular complications, even when using larger sheath sizes.

Temporal trends in percutaneous coronary intervention--associated acute cerebrovascular accident (from the 1998 to 2008 Nationwide Inpatient Sample Database).

Acute cerebrovascular accident (CVA) after percutaneous coronary intervention (PCI) for acute coronary syndrome and coronary artery disease is associated with high rates of morbidity and mortality. Nationwide Inpatient Sample from 1998 to 2008 was used to identify 1,552,602 PCIs performed for acute coronary syndrome and coronary artery disease. We assessed temporal trends in the incidence, predictors, and prognostic impact of CVA in a broad range of patients undergoing PCI. The overall incidence of CVA was 0.56% (95% confidence interval [CI] 0.55 to 0.57). The incidence of CVA remained unchanged over the study period (adjusted p for trend=0.2271). The overall mortality rate in the CVA group was 10.76% (95% CI 10.1 to 11.4). The adjusted odds ratio (OR) of CVA for in-hospital mortality was 7.74 (95% CI 7.00 to 8.57, p<0.0001); this remained high but decreased over the study period (adjusted p for trend<0.0001). Independent predictors of CVA included older age (OR 1.03, 95% CI 1.02 to 1.03, p<0.0001), disorder of lipid metabolism (OR 1.31, 95% CI 1.24 to 1.38, p<0.001), history of tobacco use (OR 1.21, 95% CI 1.10 to 1.34, p=0.0002), coronary atherosclerosis (OR 1.56, 95% CI 1.43 to 1.71, p<0.0001), and intra-aortic balloon pump use (OR 1.39, 95% CI 1.09 to 1.77, p=0.0073). A nomogram for predicting the probability of CVA achieved a concordance index of 0.73 and was well calibrated. In conclusion, the incidence of CVA associated with PCI has remained unchanged from 1998 to 2008 in face of improved equipment, techniques, and adjunctive pharmacology. The risk of CVA-associated in-hospital mortality is high; however, this risk has decreased over the study period.

Standardized methodology for transfemoral transcatheter aortic valve replacement with the Edwards Sapien XT valve under fluoroscopy guidance.

OBJECTIVES: To provide a simplified, standardized methodology for a successful transfemoral transcatheter aortic valve replacement (TAVR) procedure with the Sapien XT valve in patients with severe aortic stenosis (AS). BACKGROUND: TAVR is currently reserved for patients with severe, symptomatic AS who are inoperable or at high operative risk. In many institutions, TAVR is performed under general anesthesia with intubation or with conscious sedation. In addition, many institutions still use transesophageal echo (TEE) during the procedure for aortic root angulations and positioning of the valve prior to implantation. Methods. We enrolled 100 consecutive patients (mean age, 80 ± 7 years; range, 50-94 years; female n=59) with severe symptomatic AS. Annulus measurements were based on computed tomography angiograms. All patients underwent fluoroscopy-guided transfemoral TAVR with little to no sedation and without simultaneous TEE. RESULTS: TAVR was predominantly performed with the use of local and central analgesics; only 36% of our cohort received conscious sedation. Procedural success of TAVR was 99%. Transthoracic echocardiography before discharge excluded aortic regurgitation (AR) >2 in all patients (AR >1; n=6). In-hospital stroke rate was 6%. The vessel closure system was successfully employed in 96%. Major vascular complication rate was 1%. The 30-day mortality was 2%. CONCLUSIONS: Fluoroscopy-guided TAVR with the use of just analgesics with or without conscious sedation is safe and effective, and this potentially enables a more time-effective and cost-effective procedure. This paper provides simplified, stepwise guidance on how to perform transfemoral TAVR with the Sapien XT valve.