Conference Highlights: SCAI 2016

Improving PCI Outcomes

PCI is a common procedure, but research indicates that PCI-related bleeding can result in substantial morbidity and mortality. Researchers conducted a study to determine if use of the National Cardiovascular Data Registry bleeding risk calculator applied to evidence-based bleeding avoidance strategies could help reduce bleeding events. For the study, the bleeding risk calculator was used during the intra-procedural “time out.” Based on the score provided by the calculator, patients were divided into high-, intermediate-, or low-bleeding risk groups. Other interventions were used at the discretion of the operator based on risk assessment, access site, and anticoagulant use. During the first 2 years of using this approach, bleeding rates decreased by 40%. In addition, the costs of bleeding complications were reduced by about $1 million across the 21-hospital system assessed in the analysis.

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Moderate Sedation in TAVR

Clinical studies have shown that moderate sedation is increasingly be used in lieu of general anesthesia for transcatheter aortic valve replacement (TAVR). For a new study, investigators compared the effectiveness of moderate sedation with that of general anesthesia among nearly 11,000 patients who underwent TAVR via the percutaneous transfemoral approach between April 2014 and June 2015. Success rates were about 98.5% for both groups. However, those who underwent moderate sedation had a 30-day mortality rate of 2.9%, compared with a rate of 4.1% for those who underwent general anesthesia. Patients in the moderate sedation group, when compared with those in the general anesthesia group, also had lower rates of 30-day mortality of stroke (4.8% vs 6.4%) and shorter hospital stays (6.0 days vs 9.6 days).

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Assessing Robotic PCI

Evidence suggests that robots are increasingly being used to complete various types of surgical procedures. However, data comparing robot- and human-conducted PCI are lacking. Researchers compared outcomes following more than 330 PCI procedures that were either robot- or human-conducted over 18 months. Among treated lesions, approximately 80% were complex. Rates of clinical success were about 99% for both approaches. Radiation exposure and stent deployment were also similar for both approaches. Technical success during robot-conducted PCI was nearly 92% with a single operator, with more than 90% of patients who received robot-assisted PCI doing so with minimal manual assistance. However, robot-assisted PCI took an average of more than 44 minutes to complete, compared with an average of more than 36 minutes for human-conducted PCI.

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Cell Treatment Promising for Refractory Angina

Few treatment options are available for patients with refractory angina. Phase II study results suggest that cell therapy may be a promising approach for this patient population. Researchers conducted an investigation in which patients with class III and IV angina were randomized to open-label standard of care, blinded placebo, or intramyocardial delivery of their own CD34-positive stem cells (CD34+) therapy. Cell-treated patients had lower rates of angina frequency when compared with baseline. Mortality rates at 2 years were 3.7% for the CD34+ group, 10.0% for the placebo group, and 7.1% for the standard of care group. Rates of major adverse events were highest in the standard of care group (68.0%) when compared with the placebo (43.0%) and CD34+ (46.0%) groups. Patients in the CD34+ and placebo groups also experienced 1- to 2-minute improvements in exercise time during the study period. The researchers note that early termination of the study (for financial reasons) precluded a full evaluation of CD34+ therapy’s efficacy.

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Gender Differences in TAVR Outcomes

Few studies have assessed gender differences following transcatheter aortic valve replacement (TAVR). To address this research gap, study investigators analyzed data on more than 23,000 patients who underwent TAVR between 2011 and 2014. They observed the following rates, broken down by gender:

Characteristic	Men	Women
In-hospital vascular complication	4.4%	8.3%
Major bleeding	6.0%	8.0%
Adverse event	13.8%	19.0%
Mortality	24.5%	21.3%
Mortality plus stroke	26.6%	24.4%
Transfemoral TAVR use	65.1%	55.0%

The authors noted that women in the study were slightly older and less likely to have atrial fibrillation or diabetes. However, women had higher rates of moderate-to-severe mitral regurgitation, porcelain aorta, and poor glomerular filtration.

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NEWS FROM SCAI 2016

Sedation Linked to Better TAVR Outcomes

No Early Sex Differences For TAVR

Women Less Likely to Die After TAVR

Cell Tx May Be of Benefit for Refractory Angina

Hint of Benefit From Fat-Derived Regenerative Cells

Calculator May Cut Post Stent Bleeds

AVERT Device Cuts Contrast-Agent Use at PCI, Renal Benefit Unsure

PCI Quality Initiative Cuts Bivalirudin Use, Cost, and Bleeding

Robot-Assisted PCI Works for Complex Lesions in Cohort Study

VIDEOS FROM SCAI 2016