Research Article: Trans-catheter aortic valve replacement program in a community hospital – Comparison with US national data

Date Published: September 27, 2018

Publisher: Public Library of Science

Author(s): Dan Loberman, Shahzad Shaefi, Rephael Mohr, Phillip Dombrowski, Richard B. Zelman, Yifan Zheng, Paul A. Pirundini, Tomer Ziv-Baran, Wisit Cheungpasitporn.

http://doi.org/10.1371/journal.pone.0204766

Abstract

Symptomatic aortic stenosis remains a surgical disease, with aortic valve replacement resulting in symptom reduction and improvement in survival. For patients who are deemed a higher surgical risk, Transcatheter aortic-valve replacement (TAVR) is a viable, less invasive and increasingly common alternative. The study compares early outcomes in patients treated within one year of the commencement of TAVR program in a community hospital against outcomes of TAVR patients from nationwide reported data (Society of Thoracic Surgeons/ American College of Cardiology TVT registry). Preoperative characteristics and standardized procedural outcomes of all patients who underwent TAVR in Cape Cod Hospital between June 2015 and May 2016 (n = 62, CCH group) were compared using standardized data format to those of TAVR patients operated during the same time period in other centers within the United States participating in the STS/ACC TVT Registry (n = 24,497, USA group). Most preoperative patient characteristics were similar between groups. However, CCH patients were older (age≥80 years: 77.4% versus 64.3%, p = 0.032) and more likely to be non-elective cases (37.1% versus 9.7%, p<0.001). All 62 TAVR procedures in CCH were performed in the catheterization laboratory unlike most (89.7%) of the procedures in the USA group that were performed in hybrid rooms. A larger proportion of patients in the USA registry underwent TAVR under general anesthesia (78.2% vs.37.1%, P<0.001). Early aortic valve re- intervention rate was 0/62 (0%) in the CCH group VS. 74/ 24,497 (0.3%) in the USA group. In hospital mortality, which was defined as death of any cause during thirty days from date of operation, (CCH: 0% vs. USA: 2.5%, p = 0.410) and occurrence of early adverse events (including postoperative para-valvular leaks, conduction defects requiring pacemakers, neurologic and renal complications) were similar in the two groups. The study concludes that with specific team training and co-ordination, and with active support of experienced personnel, high risk patients with severe aortic valve stenosis can be managed safely with a TAVR procedure in a community hospital.

Partial Text

Surgical replacement of the aortic valve has been shown to reduce symptoms and improve survival in patients with aortic stenosis [1, 2]. However, in clinical practice, at least 30% of patients with severe aortic stenosis do not undergo open heart surgery for replacement of the aortic valve, owing to relative contraindications such as advanced age, left ventricular dysfunction, and/ or the presence of multiple coexisting conditions [1, 3, 4]. Increasingly for these patients, who are deemed as high surgical risk [5, 6], Trans catheter aortic-valve replacement (TAVR) is rapidly becoming a more viable, less invasive and less morbid alternative [7–9]. Still an immature technology, TAVR was approved by the US Food and Drug Administration (FDA) as recently as late 2011 for the treatment of patients with severe symptomatic aortic stenosis who are judged too ill or frail for the traditional surgical aortic valve replacement (SAVR) [10]. Lately, FDA approval has additionally been granted for a wider population of lower risk patients, further expanding the scope of this new technology. The procedure has rapidly gained patient’s and doctor’s acceptance, particularly for the octogenarian and nonagenarian patient populations. Aortic valve procedures have risen more than 60% since 2012, concomitantly with the number of centers performing TAVR procedures, allowing approximately 24000 TAVRs to be performed during 2016 according to the national TAVR registry published by the STS and ACC associations [11].

The selection of our TAVR patients described reflects typical contemporary referral patterns for this minimal invasive procedure. These are mostly elderly patients with severe aortic stenosis who are judged by a Heart Team, including two cardiac surgeons, to be at high risk for SAVR (i.e., predicted risk of surgical mortality >8% at 30 days), based on the Society of Thoracic Surgeons (STS) risk score [20]. A portion of our patient cohort had lower STS scores. However, after being reviewed by our valve clinic physicians, other parameters that are not included in the STS score were given weight. For instance, a 52 year old female, robust and active, who was status post sternotomy for Goiter removal, and then had heavy radiation to the chest d/t a different malignancy—has a very low calculated STS risk score, but a very high operative risk. All patients deemed adequate for TAVR had one or more of these “other parameters” that made the team favor TAVR over SAVR.

In conclusion, this report describes the initial experience with TAVR in community hospital.

 

Source:

http://doi.org/10.1371/journal.pone.0204766

 

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