Incomplete Revascularization Does Not Hinder TAVR for Severe Aortic Stenosis

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With the input of a multidisciplinary heart team, complete revascularization is not mandatory before transcatheter aortic valve replacement (TAVR) for elderly patients with severe aortic stenosis. The findings, from a single-center study, were published online July 17, 2013, ahead of print in JACC: Cardiovascular Interventions.

Nicolas M. Van Mieghem, MD, and colleagues at Erasmus Medical Center (Rotterdam, The Netherlands), looked at 263 consecutive patients with severe symptomatic aortic stenosis who underwent TAVR between November 2005 and June 2012.

One-Year Survival Similar

Obstructive atherosclerotic disease (> 50% diameter stenosis on visual assessment) was present in 124 patients (47%) of whom 44 (35%) had previously undergone CABG. Of the CABG group, 44 patients (63%) showed progressive native CAD or saphenous vein graft disease at the time of presentation. Among the non-CABG-treated patients, the median Syntax Score was 9. A total of 9 patients presented with ACS (6 NSTE-ACS and 3 STEMI).

All of the ACS patients were treated with ad hoc PCI, with TAVR delayed by at least 1 week. Six of the prior CABG patients underwent attempted PCI (5 staged and 1 concomitant) and obtained complete revascularization. Eighty of the non-CABG patients were slated for PCI (14 staged and 19 concomitant) with treatment resulting in a median residual Syntax Score of 5.

Overall, 99 patients (38% of the entire cohort) were incompletely revascularized after TAVR.

Procedure time and contrast volume were similar regardless of the completeness of revascularization. The majority of Valve Academic Research Consortium  (VARC) endpoints were similar apart from minor vascular complications and major bleeding, both of which were higher in the complete revascularization group (table 1).

Table 1. VARC Endpoints by Revascularization Status

 

Complete

Incomplete

P Value

30-Day/In-Hospital Death
All-Cause
Cardiovascular

 
6.5%
5.8%

 
6.5%
3.2%

 
0.99
0.33

MI
Periprocedural (< 72 hr)
Spontaneous (> 72 hr)

 
0.7%
0

 
0.8%
0

 
0.94
1.00

Cerebrovascular Complications
Major Stroke
Minor Stroke
TIA

 
5.8%
0
2.9%

 
4.8%
1.6%
0.8%

 
0.74
0.13
0.22

Vascular Complications
Major
Minor

 
7.2%
14.4%

 
5.6%
4.0%

 
0.61
0.004

Bleeding Complications
Life Threatening
Major
Minor

 
10.1%
18.7%
12.9%

 
5.6%
6.5%
6.5%

 
0.19
0.003
0.08


One-year Kaplan-Meier survival curves showed similar outcomes in patients with and without complete revascularization at 79.9% vs. 77.4% (P = 0.85).

Eight patients underwent post-TAVR PCI at a median of 140 days (interquartile range [IQR], 0-337 days). Among them, only 2 cases—both STEMI—appeared to directly arise from disease progression.

Heart Team Crucial

Dr. Van Mieghem told TCTMD in an e-mail communication that the study “underscores the importance of a true multidisciplinary heart team approach in order to come up with the best patient-tailored strategy.”

Given that the importance of complete revascularization is “not firmly established” in elderly patients, he said, numerous factors go into decision making with regard to treatment.

“The heart team assessed the myocardium at risk taking into consideration previously infarcted areas and the location of the coronary lesions. For instance, a proximal LAD stenosis in the presence of a normokinetic anterior wall would always be revascularized,” he explained. “Complex lesions providing [blood flow to] infarcted areas would be left untouched.”

Dr. Van Mieghem strongly encouraged clinicians to develop an upfront strategy rather than perform ad hoc PCI. “Also, it seems wise to perform the PCI before the actual valve implantation to overcome the (brief period of) hemodynamic instability while deploying the valve,” he advised, noting the difficulty of doing so after TAVR with CoreValve (Medtronic, Minneapolis, MN), because of the need “to maneuver through the nitinol framework (although all our attempts were successful). More complex lesions requiring more time, contrast, and additional tools should be [treated with] a staged procedure.”

‘Moderation’ the Best Approach

In a telephone interview with TCTMD, Jeffrey W. Moses, MD, of Columbia University Medical Center/Weill Cornell Medical Center (New York, NY), said the study confirms what several other papers have published recently and offers “important lessons for us to be learning now in terms of how to strategize” when treating patients who not only need TAVR but also have CAD.

“Moderation is probably the best strategy here,” Dr. Moses suggested.

There are, he said, valid reasons to not pursue complete revascularization. “Since so much of this is done for quality of life, [the question is] how much the coronary obstructions are contributing to a patient’s symptoms. The last thing you want is to put a valve in and not have the symptoms remit,” Dr. Moses commented. “Secondly, does [the CAD] impact the safety of the valve implant? And does it have an impact on the patient’s survival?”

Though approaches vary, concomitant PCI is “fairly straightforward” for less complex lesions that are not heavily calcified and tend to be focal, he added. “It’s not uncommon these days.”

Stephen G. Ellis, MD, of the Cleveland Clinic (Cleveland, OH), pointed out that it is well known that 40% to 70% of patients with severe aortic stenosis have significant CAD. “Optimal management of such patients has been understudied—certainly there are no randomized trials to help us here,” he said in an e-mail communication with TCTMD, noting that his group has published data on the safety of PCI in this population.

“We, and others, prefer to divide coronary lesions in this setting into those likely to adversely affect the safety of the TAVR procedure itself and other ‘significant’ lesions,” Dr. Ellis noted. Lesions with diameter stenosis of 80% or greater located in the proximal or mid-major epicardial vessels and subtending substantial amounts of myocardium should be treated beforehand, while lesser lesions involve “considerably more discretion,” he explained. “The residual Syntax Score does not make a distinction between these 2 types of stenoses. Often these patients have poor renal function and contrast load becomes a restraining issue.”

Study Details

Approximately half of patients were male, and the average age was 80 ± 7 years. Median follow-up duration was 16 months (IQR, 4.2-28.1 months).

Two-thirds of patients (n = 175) had prior or current CAD, with histories of PCI, CABG, and MI of 28%, 27%, and 25%, respectively.

 


Source:
Van Mieghem NM, van der Boon RM, Faqiri E, et al. Complete revascularization is not a prerequisite for success in current transcatheter aortic valve implantation practice. J Am Coll Cardiol Intv. 2013;Epub ahead of print.

 

 

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Disclosures
  • Drs. Van Mieghem and Ellis report no relevant conflicts of interest.
  • Dr. Moses reports serving as a consultant to Boston Scientific and Cordis.

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